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Bradycardia and Tachycardia Devices
Merlin™ Patient Care System
Help Manual
For the following devices:
Accent™, Accent MRI™, Accent™ RF, Accent™ ST, Accent ™ ST MRI
Allure™, Allure Quadra™, Allure Quadra™ RF, Allure™ RF
AnalyST™, AnalyST Accel™
Anthem™, Anthem™ RF
Assurity™, Assurity™ +, Assurity MRI™
Auricle™
Current™, Current™ RF, Current™+, Current Accel™
Ellipse™
Endurity™, Endurity™ Core, Endurity MRI™
Fortify™, Fortify™ ST, Fortify Assura™
Promote™, Promote™ RF, Promote™+, Promote™ LAP, Promote Accel™, Promote™ Q,
Promote Quadra™
Quadra Allure MP™, Quadra Allure MP™ RF, Quadra Assura™, Quadra Assura MP™
Unify™, Unify Assura™, Unify Quadra™, Unify Quadra MP™
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries.
ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. © 2014 St. Jude Medical, Inc. All Rights Reserved.
Contents
i
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Promote™, Promote™ RF, Promote Accel™, Promote™+, Promote™ Q, Promote™ LAP, and Promote Quadra ™
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vii
Tools Menu
Contents:
Session Records. Opens the Session Records (page 1) and PDFs (page 5) windows.
MerlinConduct™ Settings (page 3)
Customer Support. Provides contact information for Technical Support representatives. See also Technical Support (page
? Button
> Educational Materials > Help.
Accessed From: Help button
Tools
The Tools menu opens a number of programmer tools, including:
PSA. Opens the PSA application. See the Merlin™ PCS PSA Wand Reference Manual.
Session Records:
-
Session Records. Opens archived data (for tachycardia devices only).
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Connections.
-
MerlinReflect™ Settings. Opens the Connections window to enable the MerlinReflect feature. (See the
Merlin™ Connectivity manual for more information.)
-
-
Administration. Opens a window to add, create or delete new locations for connections to the Merlin PCS. (See the Merlin
Connectivity manual for more information.)
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Location & Networks. Opens the Connections window to select locations, check the connection strength, and list recent transmissions. (See the Merlin Connectivity manual for more information.)
Educational Materials:
-
Help. Opens links for on-line Help for all supported devices.
-
Demos. Opens device demonstrations.
Maintenance. Opens utilities for programmer maintenance (for use by St. Jude Medical personnel only).
Preferences (page 5). Opens the Merlin PCS settings for language, date, format, audio, etc.
Clinical Studies. Opens information for studies (for use by St. Jude Medical personnel only).
Customer Support. Provides contact information for Technical Support. (page 161)
Print Screen (page 6). Prints an image of the screen.
Export Screen (page 6). Exports an image to a USB flash drive or floppy drive.
Accessed From: Tools Button
Session Records
The Session Records window allows you to search, review, and export programming session records that are recorded on the programmer's hard disk. Each session record contains one or more snapshots of the session captured during programming, measurement, and testing. Each snapshot is a representation of the programmer screen performed when the operation took place.
The records can be exported to an external media device or a PC in a format for an external PC database or for Merlin.net™ PCN.
To retrieve a specific session record, you can use the Search function, which filters the data by Patient Name, Patient ID, and device
Serial Number (obtained from the Patient Data information) and the Device Model and Session Date.
A new Session Record is created at the beginning of each programming session. You can review any operation performed during the session up to the time the Session Records button is selected.
You can open the Session Records function from the Start-Up screen or during a programming session.
You can also export a Session Record without viewing the record or starting a Session Records session from the Tools Menu. To do
CAUTION
Session Records and PDF Reports are erased from the Merlin PCS after the number of days specified in the Data
>Preferences > Data Management.
See also:
Find a Session Record (page 2)
Export a Session Record (page 2)
Review a Session Record (page 2)
Import a Session Record (page 2)
1
Accessed From: Tools menu > Session Records button
Find a Session Record
To find a record from the Sessions Record window:
1.
Select Tools > Session Records.
2.
3.
Select the device model you want to access.
The Session Records window opens. You can search by device model type, patient name, patient ID, date range, and device serial number.
Select a search field and enter the data.
4.
When you select the device model type and date range, a drop-down menu appears. When you select any other field, an onscreen keyboard appears to enter the data. If a data field is left blank, the search function reviews all entries. The search text is not case-sensitive.
Select the Search button.
The Session Records meeting the Search criteria appear in the table below. You can sort the data by selecting a column heading.
1.
2.
3.
Instructions to Export a Session Record
4.
5.
6.
After obtaining a record, select the Export button on the left side of the window.
Select a record to export.
Connect a USB flashdrive, USB floppy, or a PC connected by a 9-pin serial to USB cable into one of the USB ports on the
Merlin PCS.
Select the Export Selected button.
Select the type of data you want to save.
The PC database-compatible record is smaller and contains only data for PC-based database programs. The Merlin.net PCNcompatible record is larger and contains more detailed information.
The programmer locates any connected media devices and asks you to which device would you would like to export the record.
Select the desired media option and then the Export button.
Merlin.net PCN-compatible records are saved in a folder entitled "Unity" that contains a compressed file named after the device's model number, serial number, and session date. PC database-compatible records are saved to a file called
"XXXXXX.log," where "XXXXXX" is the device serial number.
Review a Session Record
1.
2.
3.
4.
After obtaining a record, select the Review button on the left side of the window.
Select the record to review.
The Session Files window shows the device model, serial number, and session date and time. The window also shows all the operations performed during the session and the time each was performed. Each operation is a snapshot of all programmer screens at that moment. Select the View Most Recent button to see the last operation performed.
Select the operation you would like to see or the Most Recent Button.
The Session File window opens, which shows the snapshot of the programmer screen, with the device and session information in the Rhythm Data window. You can select the buttons on the right side to see other screens captured during the operation.
However, you cannot perform any functions that would require communication with the device. This includes the ability to change parameter settings, run tests, update or clear diagnostics, read device battery and lead data, acquire a morphology template, etc.
You can perform the following operations from the Session File window:
-
View Alerts from the FastPath™ Summary window
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Export Data from the Wrap-Up™ window
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Print Reports from any window
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End Session from any window where it is displayed
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Close the Session File and view another Session Record.
Navigate through the Session File. When you have finished, select the Select New File Button to continue to view other Session
Records or End Session, to return to the Session Records window.
3.
4.
5.
Import a Session Record
1.
2.
6.
7.
Select the Import button on the left side of the window.
Connect a USB flashdrive, USB floppy, or a PC connected by a 9-pin serial to USB cable into one of the USB ports on the
Merlin™ PCS.
Select the Read Ext. Media button.
Select the media from which to import.
Select the Import button.
The session records are read from the external media and presented in the table. To sort the records, select a column heading.
To review the session record prior to copying it to your Merlin PCS, select the record.
Select the records you want to copy to your Merlin PCS.
Select the Copy to Merlin PCS button.
2
MerlinConduct™ Settings
From the MerlinConduct™ Settings window you can enable the MerlinConduct feature on the programmer and select Advanced
MerlinConduct feature is in use.
CAUTION
Emergency operations are not available from the MerlinConduct™ application on the tablet. Emergency operations must be initiated from the programmer. See the Merlin™ PCS User’s Manual for additional information
NOTE
The tablet is non-sterile.
See also:
Connect to the Tablet (page 3)
Set up a Wireless Connection (page 3)
Launch the MerlinConduct™ Application on the Tablet (page 3)
Advanced MerlinConduct™ Settings (page 4)
Disconnect from the Tablet (page 4)
Accessed From: Tools menu > Connections > MerlinConduct Settings
Connect to the Tablet
To connect the programmer to the tablet with the MerlinConduct™ feature:
1.
2.
Enable the MerlinConduct™ Feature on the Programmer (page 3).
Enable the Wireless Connection (page 3) between the tablet and the programmer.
3.
Launch the MerlinConduct™ Application on the Tablet (page 3).
Enable the MerlinConduct™ Feature on the Programmer
1.
2.
Select Tools > Connections > MerlinConduct™ Settings.
Select the MerlinConduct button to enable the MerlinConduct feature.
The button shows the current state of the feature.
Wireless Connection
A wireless connection is needed to connect the programmer and the tablet. A wireless accessory must be installed in the
Merlin™ PCS before you can set up a wireless connection or launch the MerlinConduct™ feature. For wireless accessory set up see the Merlin™ PCS User’s Manual for additional information.
Wireless connection options:
Confirm the Merlin PCS network is selected. A wireless connection for the programmer has been set up.
NOTE
should only need to Confirm the Merlin PCS network is selected.
1) Select Settings > Select Wi-Fi on the tablet.
> Select the Merlin PCS network name, 2) Launch the MerlinConduct application
Set up a Wireless Connection
On the tablet:
1.
2.
Select Settings > Select Wi-Fi
> Select Other Network.
Enter the Network Name and select the Security type:
3.
4.
button is enabled.
Select the Other Network button.
Enter the password.
5.
The password is shown on the MerlinConduct Settings window.
The password is case sensitive.
Select the Join button.
6.
A check appears next to the network name once the connection is established.
Return to the home screen on the tablet.
Launch the MerlinConduct™ Application on the Tablet
On the tablet:
1
Wi-Fi is a trademark of the Wi-Fi Alliance.
2 Wi-Fi is a trademark of the Wi-Fi Alliance.
3
1.
2.
3.
Select the MerlinConduct™ application.
Enter the session code.
The session code is shown on the programmer screen.
Select the Start button.
The programmer shows the connection status between the programmer and the tablet. If no connection is made, see
Troubleshooting the MerlinConduct™ Application (page 4).
NOTE
If you return to the home screen on the tablet, the programmer screen on the tablet is only hidden from view. This does not end the MerlinConduct™ session between the tablet and the programmer, or end the programmer session.
NOTE
The MerlinConduct™ feature on the programmer is disabled after 4 hours of inactivity.
Advanced MerlinConduct™ Settings
From the Advanced MerlinConduct™ Settings window you can set the password duration and the session code length.
Disconnect from the Tablet
On the programmer:
1.
2.
Select Tools > Connections > MerlinConduct™ Settings.
Select the MerlinConduct button to disable the connection between the programmer and the tablet.
The button shows the current state of the feature.
Loss of Wireless Network Connection
If your wireless network connection is lost, check the message on the tablet and follow the instructions.
Table 1. Behavior after Wireless Network connection is lost
Session Type
Merlin PSA session
Device Session
System Behavior
Programmer delivers emergency VVI (high output) pacing. A connection lost message is shown on the tablet.
If temporary programming is in effect on the programmer (such as during a threshold test) the device reverts to permanent settings and the test is canceled. A connection lost message is shown on the tablet.
Notifications
To reduce tablet pop up distractions while using the MerlinConduct™ application, it is recommended to set the notifications to
Banner or Off.
Troubleshooting the MerlinConduct™ Application
If no wireless connection was made, you may have entered an incorrect session code, wireless password, or selected another wireless network. Check the message on the tablet and follow the instructions.
No Wireless or Network Selected
The programmer was unable to connect to the tablet because the programmer's wireless network was not selected.
You may have selected an incorrect wireless network or a wireless network has not been selected. Check the tablet to verify that you selected the correct wireless network.
NOTE
To ensure a stable wireless connection, keep the tablet away from other electronic equipment. For example, avoid placing the tablet on the Merlin printer, even when the printer is not in use.
Invalid Session Code
An invalid session code or no session code was entered when the MerlinConduct™ feature was launched. See Launch the
code and connected to the correct programmer.
Additional Information
NOTE
Only use the MerlinConduct™ application for its intended use. See the Merlin™ PCS User's Manual for additional information.
4
System Requirements
iPad
tablet, generation 2 or greater
iOS 5.1 or greater
CAUTION
Any modifications to the tablet or its operating system may impair the functionality of the MerlinConduct™ feature.
Do not incinerate, crush, short-circuit, modify, or disassemble the tablet.
Precautions
Always end the MerlinConduct™ feature on the programmer when not in use
Do not use the MerlinConduct application if the tablet is damaged
Do not use the MerlinConduct application if the tablet's operating system has been compromised or tampered with
Never share the programmer's network name or password
Always use the MerlinConduct application in close proximity to the Merlin™ PCS programmer
Do not use the MerlinConduct application when insufficient battery life remains on the tablet
Do not use the MerlinConduct application in an area where the wireless connection is low
PDFs
Every time you select any Print button to create a report, the Merlin PCS programmer saves the report as a PDF (portable document file
). This file can be exported to a flash drive connected to one of the programmer's USB ports. You must install Adobe™
Acrobat™ Reader or Adobe Reader™ on your PC to view the PDF
From the PDFs window, you can:
Check the number of PDFs stored on the programmer's hard disk that have not been exported
Export all the stored PDFs.
Export the Most Recent PDFs (created in the last actual session or demo session, including your current session.
Delete all PDFs.
When you select one of the Export buttons, the Export Data (page 149) screen appears.
The file naming and storing of the PDFs are as follows:
All PDFs are stored in a folder entitled "PDFs."
Subfolder Name: "Date of PDF creation"
Sub-subfolder Name: "Patient Name_Model Number_Device Serial Number" (read from the Patient Data)
File Name: "Device name_Device Model Number_Device Serial Number_Reportname.pdf"
Example: In the PDF folder is a subfolder called "2008-03-22." In this subfolder is a sub-subfolder called "John
Smith_PromoteRF_3207-36_201399." Inside the sub-subfolder is the PDF titled: "PromoteRF_3207-36_201399_TestResults.pdf
"containing the test results for John Smith on 3/22/2008.
The Merlin PCS can store a total of 30 "Date of PDF creation" subfolders containing PDFs. When 30 subfolders are stored on the programmer, the oldest subfolder is erased when a newer subfolder is created.
CAUTION
Session Records and PDF Reports are erased from the Merlin PCS after the number of days specified in the Data
>Preferences > Data Management.
Accessed From: Tools menu > Session Records > PDFs
Preferences
The Preferences window contains the following tabs for setting the Merlin PCS options:
Date & Time. Sets the year, date, and local time
Language & Formats. Sets the:
-
Display and Help Language
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Date Format
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Time Format
-
Number Format
-
ECG Notch Filter. The ECG Notch Filter Frequency reduces ECG interference from the programmer's AC power line frequency. Check with your local authorities for your power line frequency.
Wireless. Sets the wireless communications on or off.
After the time setting selected, the programmer erases all Session Records and PDF Reports older that the Data Management setting.
Accessed From: Tools menu > Preferences button
3 iPad is a trademark of Apple Inc., registered in the US and other countries.
4
The programmer does not create a PDF for Freezes printed from the Start-Up screen, the Print Screen function, real-time printing, or on-screen Help.
5 Adobe, Acrobat, and Adobe Reader are trademarks of Adobe Systems Incorporated.
5
NOTE
It is important to set an accurate date and time because the device's diagnostic tests and other functions use the date and time from the programmer.
Audio Preferences
This screen contains two panels:
General Audio. Select the On button to allow audio cues for programmer activity. You can also select a volume level. The Off button turns all sounds off (except Charging Audio).
Charging Audio (Tachy devices only). Select the On button for an audio cue when the capacitors charge during a programming session.
NOTE
setting.
Accessed From: Tools menu > Preferences button > Audio tab
Printer Preferences
Every time you select any Print button to create a report, the Merlin™ PCS programmer saves the report as a PDF (portable document file)
. This file can be exported to a flash drive connected to one of the programmer's USB ports. You must install
Adobe™ Acrobat™ Reader or Adobe Reader™ on your PC to view the PDF.
The Printer Preferences window contains two panels:
Selected Printer. You have three choices:
PDF Only (Paperless). Sends reports to the programmer's hard disk as a PDF (paperless printing) with no paper documents.
-
Internal & PDF. Sends the report to the programmer's internal printer and simultaneously creates a PDF on the hard disk.
-
External & PDF. Sends the report to an external USB printer and simultaneously creates a PDF on the hard disk. Before reports can be sent to an external printer, you must first connect the external printer to any one of the USB ports on the programmer. For more information on connecting an external printer, see the Merlin PCS User's Manual.
Number of Paper Copies. This selects how many reports are printed by the internal or external printer whenever a Print button is selected.
NOTE
Supported Printers. The Merlin PCS can print to many laser jet printers. For a list of compatible printers, contact your
St. Jude Medical Representative or Technical Support (page 161).
Accessed From: Tools menu > Preferences > Printer tab
Print Screen
The Print Screen button prints an image of the current screen. To send the image to an external printer, go to the Tools Menu >
Preferences > Printer tab and select the External button.
This function does not create a PDF.
For more information on printing, see Print Menu Settings.
Accessed From: Tools menu > Print Screen button
Export Screen
(.png) file and send the file to any storage device (floppy drive, or flash drive) connected to one of the programmer's USB ports. The
Merlin™ PCS detects all connected devices and asks you to select the device to receive the data.
Accessed From: Tools menu > Export Screen button
6 The programmer does not create a PDF for Freezes printed from the Start-Up screen, the Print Screen function, real-time printing, or on-screen Help.
6
Rhythm Display
Contents:
Rhythm Display Setup Instructions (page 14)
Rhythm Display
The Rhythm Display, seen on the Main Programming Window, can show up to five concurrent waveforms (or channels) that can be individually configured and adjusted. You can drag and drop any waveform to a new position when you select the Channel Control buttons on the left edge of the waveform. You can also freeze the display or print it in real time.
Three types of waveforms can be shown in the Rhythm Display:
ECG (electrocardiogram) (page 7)
EGM (intracardiac electrogram) (page 13)
The controls for the Rhythm Display include the:
• Channel Control buttons. Indicates the current waveform for each channel. Select this button to show the Waveform Control buttons or the Marker Control buttons.
• Waveform Control buttons, which are opened from the Channel control buttons on the left side of the display. The first button opens
the ECG (page 7) or EGM (page 13) window.
• Adjust Display (page 14) button
• Freeze Capture button
See also:
Rhythm Display Setup Instructions (page 14)
ECG
The Rhythm Display can show up to five ECG waveforms simultaneously from seven possible ECG vectors. There are two ways to change the ECG display:
Waveform Control (page 14) buttons, which set the gain and the waveform source
For an example of a typical ECG setup, refer to the Merlin™ PCS Model 3650 User’s Manual.
See also:
Markers
Markers are symbols that represent therapies, paced and sensed events, intervals, refractory periods, and algorithm activity.
7
BiSt
ASt
VSt
APP
VPP
You can choose markers as one of the five channels. Markers can be configured either as:
Basic. Basic markers appear along a time line and include:
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Brady Basic Event Markers (page 8)
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Tachy Basic Event Markers (page 9)
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Brady Special Event Markers (page 9)
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Episode Trigger Event Markers (page 10)
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Discrimination Channel (Far Field MD™/SecureSense™) Markers (page 10)
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Tachy Detection, Diagnosis, and Therapy Markers (page 10)
-
Tachy Charge Delivery Markers (page 11)
-
-
User Initiated and Test Markers (page 12)
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Waveform Channel Markers (page 13)
Full. In addition to the basic markers, the following markers also appear:
Interval and Refractory Markers (Full Markers)
There are two ways to change the marker configuration:
Select the Adjust Display (page 14) button and select the desired configuration.
Brady Basic Event Markers
AS
AP
VS
VP
Table 2. Brady basic event markers
Marker Description
Atrial event sensed in refractory period
Atrial sensed event
Atrial paced event
Ventricular sensed event
Ventricular paced event
Example
When the Ventricular Pacing parameter is set to:
• RV Only. The VP marker has a right-pointing tick mark.
• LV Only. The VP marker has a left-pointing tick mark.
• Biventricular. The marker is BP. See below.
BP Biventricular paced event When the Ventricular Pacing parameter is set to
Biventricular and the Interventricular Delay parameter is set to:
• RV First. The BP marker points right.
• LV First. The BP marker points left.
• Simultaneous. The BP tick-mark points down.
BiS
VSP
Biventricular sensed event
Ventricular Safety Standby
Biventricular triggered event
Atrial triggered event
Ventricular triggered event
Atrial paced event followed by ACap Confirm backup pulse
Ventricular paced event followed by RVCap Confirm or
V. AutoCapture backup pulse
8
Tachy Basic Event Markers
Table 3. Tachy basic event markers
F
X
Marker
T
T1
T2
–
Return to Sinus
Description
Binned interval: VT zone
Binned interval: VT-1 zone
Binned interval: VT-2 zone
Binned interval: VF zone
Binned interval reconfirmed
(underlined)
Unbinned interval (dash)
Return to sinus rhythm after Tachy therapy
Example
Interval and Refractory Markers (Full Markers)
Interval and refractory markers are shown in the following diagram. For CRT-Ds and CRT-Ps, only the first ventricular pacing pulse is identified by a marker. The location of the second ventricular pacing pulse must be calculated based on the Interventricular Delay setting.
Figure 1. Interval and refractory markers (full markers)
1.
Refractory Period (Line)
2.
A-A Interval
3.
A-V Interval
4.
V-V Interval
5.
Absolute Refractory Period (Thicker Line)
Brady Special Event Markers
Table 4. Brady special event markers
Marker
AMS
AFx
SIR
HYS
VIP
Neg-HYS
--> A-Noise or --> V-Noise
A-Noise or V-Noise
<-- A-Noise or <-- V-Noise
LOC
Description
AMS ongoing (appears with each ventricular event)
AF Suppression algorithm operation
Activity Sensor-indicated rate
Rate Hysteresis started by search timer or sensed event
VIP search started
Negative AV Hysteresis Search started
Entry into noise reversion mode
Continuation of noise reversion mode
Exit from noise reversion mode
Loss of capture
Example
9
Episode Trigger Event Markers
Table 5. Episode trigger event markers
Marker
-->AMS
<--AMS
AT/AF
PMT
VT/VF
Description
AMS entry
AMS Exit
AT/AF Detection
PMT detection
VT/VF detection or diagnosis
Example
If an event triggers EGM storage, a vertical bar with a "Trigger" flag appears at the trigger point.
Magnet Magnet reversion
Noise
HAR
HVR
PVC
HYS
Noise reversion
High atrial rate
High ventricular rate
PVC detection
Advanced hysteresis
Discrimination Channel (Far Field MD™/SecureSense™) Markers
Table 6. Discrimination Channel (Far Field MD/SecureSense) Markers
Marker
NSO
RV Lead Noise
SecureSense™ Timeout
NSVT or NSVF
VS2
Description
Non-sustained oversensing
RV lead noise episode
SecureSense RV lead noise algorithm has timed out
Non-sustained episodes of VT/VF
Ventricular beats sensed on the
SecureSense EGM channel
Example
Tachy Detection, Diagnosis, and Therapy Markers
Table 7. Tachy detection, diagnosis, and therapy markers
Marker
VT
VF
SVT
(Monitor)
<
=
>
Description
VT, VT-1, or VT-2 diagnosis
VF diagnosis
SVT diagnosis
VT or VT-1 diagnosis in a monitoronly rate zone
AF/AFL rate zone classification appended to the diagnosis
Sinus Tach rate zone classification appended to the diagnosis
VT/VF rate zone classification
Example
The marker display formula for tachy detection, diagnosis, and therapy delivery is [Diagnosis] [Discriminator]
([Therapy]).
If the diagnosis is VF or SVT discrimination is disabled, then the marker display formula is [Diagnosis] ([Therapy]).
7 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
8
Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
9 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
10
Available in devices with Non-sustained VT/VF Episode Capability.
11 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
10
Table 7. Tachy detection, diagnosis, and therapy markers
Marker
(ATP---)
Description appended to the diagnosis
ATP therapy
(ATP---)
(ATP*---)
(No More Therapies)
Example
ATP prior to charging
ATP while charging
No additional therapies available
Dashes (---) appear for the length of time that ATP therapy is ongoing.
Asterisks (***) appear for the length of time that it takes the capacitors to charge to the programmed energy/voltage.
VT Timeout Expired VT Therapy Timeout
SVT Timeout Expired SVT Discrimination
Timeout
Bigeminy SVT diagnosis due to bigeminal rhythm
SVT Timeout-Bigeminy
DBT
Manual
High voltage lead issue
Expired SVT Discrimination
Timeout but therapy inhibited due to bigeminal rhythm
A shock is delivered via Manual or
Timed Device Based Testing
A shock has been delivered via the programmer Shock button
High current due to high voltage lead issue detected. HV therapy not delivered.
High voltage circuit damage Charge aborted due to possible high voltage circuit damage
Tachy Charge Delivery Markers
Table 8. Tachy charge delivery markers
Marker
*
(HV)
Description
Charging for shock delivery
High-voltage therapy
Example
Asterisks (***) appear for the length of time that it takes the capacitors to charge to the programmed energy/voltage.
11
Table 8. Tachy charge delivery markers
Marker
Fibber: DC
Fibber: Shock-
T
DBT
Manual
Shock icon
(nn) J
(nn) V
Description
DC Fibber induction
Shock-on-T delivered
Device-based testing
Emergency shock delivered
Shock delivered
Programmed energy (in Joules)
Programmed voltage (in Volts)
Morphology Markers
Example
Table 9. Morphology markers
Marker
X
Description
Template non-match
Template match nn Morphology Score (% Match)
Example
The morphology score, template match, and template non-match markers are shown only with full markers, or when the Morphology
Template window is open. These markers are not displayed after a VF diagnosis until return to sinus is confirmed. Markers are green when a potential template is scored.
User Initiated and Test Markers
Table 10. User initiated and test markers
Marker
Programmed
Interrogating
Template
Description
Device programming
Device interrogation
A template was acquired or retrieved
Example
12
Table 10. User initiated and test markers
Marker
Temporary
Description
Temporary programming
Example
[Test Value]
[Test Type] Test Started
[Test Type] Test Ended
Test Canceled
Capture Lost/Sensing Lost
NIPS: Extrastimuli ---
Test parameter setting
The type of test started
The type of test ended
Test canceled
Capture/sensing lost during test
NIPS extrastimuli delivered
Test value markers appear each time a test parameter setting is changed during a test.
NIPS: Burst ---
Fibber: Burst ---
Fibber: DC
Fibber: Shock-T
STIM
LOC
Waveform Channel Markers
NIPS S1 Burst stimulation
Fibber Burst stimulation
DC Fibber induction
Shock-on-T delivered
NIPS, Shock-on-T, or ATP
Therapy stimulation
Loss of Capture
Table 11. Waveform channel markers
Marker
[New Configuration]
+ Gain
- Gain
Description
The ECG or EGM channel configuration was changed
An increase in the gain setting
A decrease in the gain setting
Dashes (---) appear for the length of time that stimulation is ongoing.
Example
EGM
EGMs (intracardiac electrograms) show the heart's electrical activity as sensed by the device. The shape and size of the waveform
upon the device type and implanted leads.
The Rhythm Display can show up to three EGM waveforms simultaneously in a variety of configurations. Select the Adjust Display
(page 14) button to select the waveform source, configuration, and gain as well as the ECG Filter.
13
Waveform Control
The Waveform Control buttons on the left side of the Rhythm Display control the waveform's appearance. To open the controls,
four additional buttons:
Figure 2. Waveform control buttons
1.
Configuration button. Opens the ECG Configuration
(page 14), the EGM Configuration (page 15) window,
or the Markers (page 7) selection buttons (Basic or
Full).
2.
AutoGain button. Allows the programmer to continually and automatically set the gain.
3.
Plus (+) and Minus (-) buttons. Allow you to set the gain manually.
4.
Markers button. Allows you to show Basic or Full markers on the Rhythm Display and provides access to Markers help.
Accessed From: Rhythm Display > Waveform Control button
Rhythm Display Setup Instructions
1.
2.
Select the Adjust Display button to the right of the Rhythm Display.
The Adjust Display (page 14) window appears.
Locate position 1.
3.
4.
Select the Source you want to see in position 1 (ECG, EGM, Markers, or Off).
The programmer selects a default Configuration for the Source.
Select the Configuration button.
5.
you selected Markers (page 7), select the Basic or Full button.
Choose the configuration.
6.
7.
Repeat these steps for the remaining waveforms.
To change the default sweep speed, select the Sweep Speed button and choose a speed.
8.
9.
To set the ECG filter (to reduce electromagnetic interference), select the ECG Filter button.
To refresh the AutoGain settings, select the Update AutoGains button.
NOTE
Rhythm Display Settings. The Rhythm Display settings for each device model are stored in the programmer. For example, when you select Rhythm Display settings for a Promote device session, the same Rhythm Display settings are used for the next Promote device session, until you readjust the Rhythm Display settings.
Adjust Display
The Adjust Display window changes the:
Configuration of the waveform
Sweep Speed
ECG Filter to reduce electromagnetic interference
The following buttons are also available:
Update AutoGains. Recalculates the gain of waveforms currently displayed in the Rhythm Display and that are set to Auto.
See also:
Rhythm Display Setup Instructions (page 14)
Accessed From: Rhythm Display > Adjust Display button
ECG Configuration
The ECG Configuration window changes the ECG vector on the Rhythm Display.
See ECG (page 7) for a typical ECG setup.
To achieve the ECG vectors, select the following electrodes:
I. LA(+) – RA(-)
II. LL(+) – LA(-)
III. LL(+) – RA(-)
14
aVR. RA(+) – LA(-) + LL(-)
aVL. LA(+) – RA(-) + LL(-)
aVF. LL(+) – RA(-) + LA(-)
Chest. V
Accessed From: Adjust Display > Configuration button
EGM Configuration
The EGM Configuration window changes the EGM source on the Rhythm Display.
The available settings depend upon the device type and the Lead Type setting.
setting. This option utilizes the device’s secondary sensing channel.
displays the device’s far-field channel (secondary sensing channel) used for Far Field Morphology and SecureSense sensing.
Leadless ECG Settings
without an SVC coil, select a cathode.
lead is programmed to Bipolar. When the ventricular lead is programmed to Unipolar or Uncoded, the LeadLess ECG setting is equal to A-tip to V-tip.
programmed to Bipolar. When the right ventricular lead is programmed to Unipolar or Uncoded, the LeadLess ECG setting is equal to
A-tip to RV-tip. When the atrial port is plugged, the Leadless ECG setting is ineffective; choose custom electrodes instead.
In Single-Chamber Pacemakers, (page 163) the Leadless ECG setting is not available.
capability (page 199), you can also create a customized EGM configuration. In the Custom
type.
column, select the “…” button to open
a window to choose the cathode and anode for the configuration. The tables below show the custom configurations for each device
See also:
Stored EGM Configuration (page 135).
Table 12. Custom EGM cathode and anode settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
CRT-Ds
A-tip
A-ring
RV-tip
RV-ring
LV-tip
LV-ring
RV-coil
Can
SVC
Leadless ECG
LV Distal Tip 1
LV Mid 2
LV Mid 3
LV Proximal 4
Dual-Chamber ICDs
A-tip
A-ring
V-tip
V-ring
RV-coil
Can
SVC
Leadless ECG
Single-Chamber ICDs
V-tip
V-ring
RV-coil
Can
SVC
Leadless ECG
12 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
13
Available in devices without VectSelect Quartet™ LV Pulse Configuration Capability.
14 Available when the LV Lead Type parameter is set to Bipolar.
15
Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
16 Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
17
Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
18 Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
15
Table 13. Custom EGM cathode and anode settings for CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers
CRT-Ps
A-tip
A-ring
RV-tip
RV-ring
LV-tip
Dual-Chamber Pacemakers
A-tip
A-ring
V-tip
V-ring
Can
LV Distal Tip 1
LV Mid 2
LV Mid 3
LV Proximal 4
LV-ring
BV-tip
BV-ring
Can
Leadless ECG
Leadless ECG
Accessed From: Adjust Display > Configuration button
Single-Chamber Pacemakers
V-tip
V-ring
Can
Freeze Capture
The Freeze button captures the most recent 30 s of the waveform and shows the data in the Freeze Captures window. You can drag and drop any waveform to a new position. The controls on the Freeze Captures window include the:
Waveform Control (page 14) buttons, including the Hide button, which hides the selected waveform
Marker Control (page 7) buttons
Restore Channels button, which restores the hidden waveforms
Sweep Speed button
Show Calipers button, which shows calipers that can be moved with button controls to display time measurements for a portion of the freeze
Hide Calipers button, which toggles to the Show Calipers button
Scroll buttons
You can also print the frozen waveform immediately (select the Print button) or at the end of the session (select the Print with Wrap-
Up™ button).
Accessed From: Freeze button
19 Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
20
Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
21 Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
22
Available in devices with VectSelect Quartet™ LV Pulse Configuration Capability.
23 Available when the LV Lead Type parameter is set to Bipolar.
16
FastPath™ Summary Screen
Contents:
Patient Data: Lead Information (page 18)
Indications for Implant (page 18)
Select Additional Reports to be Printed with the FastPath Summary (page 19)
FastPath™ Summary
Select any button on the FastPath™ Summary window for more detail.
Alerts (page 17) button. Opens a list of conditions requiring attention.
Battery button. Shows the last measured battery voltage
or remaining capacity to ERI percentage
, a longevity gauge illustrating the time left to ERI (based on the current rate of usage and other data), and the date and duration of the last max
estimate includes ERI in its range of values, the gauge is red and the message reads "ERI in <3 mos." Select this button to open
the Battery Details (page 45) window.
Brady Parameters button. Opens the Brady Parameters (page 63) window.
Tachy Zone button. Opens the Tachy Parameters (page 89) window.
Episodes button. In CRT-Ds, dual-chamber ICDs, and single-chamber ICDs, the VT/VF Episodes button opens the VT/VF
(page 163), the Episodes button opens the Episode directory (page 21).
Diagnostics button. In CRT-Ds, dual-chamber ICDs, and single-chamber ICDs, the Diagnostics button shows the percentage of
there are two Diagnostics buttons. The Diagnostic Rates button opens the Rates window, which displays the percentage of paced events and the percentage of time the devices was in either and the percentage of time the device was in either Mode
button.
Test Results buttons. Shows the current test or measurement status and the previous results for each available test or measurement (including those out-of-clinic). Each button opens a test window or the latest results of a test or impedance
End Session button
you to select additional reports to be printed with the FastPath Summary Report. For information on the contents of the
FastPath Summary Report, see Reports (page 167).
Paced AV Delay, Sensed AV Delay, and Interventricular Delay settings.
Accessed From: FastPath Summary button
Alerts
The Alerts window lists conditions or patient notifications detected since the last follow-up. The list contains buttons that open related windows. Alerts that have not been viewed are in bold.
Accessed From: FastPath Summary button > Alerts button
Patient Data
The Patient Data window displays patient, lead, and device information and allows you to enter this data in the device’s memory. If
voltage, and low voltage lead impedance trends. For data fields that open an on-screen keyboard, you can alternatively use a USB keyboard connected to one of the USB ports.
When you are finished entering data, select the Program button to permanently store the data.
The data fields include:
Patient Name and ID. Opens an on-screen keyboard for data entry.
the Exercise & Activity (page 30) diagnostic data.
EF button. Set the patient’s Ejection Fraction.
length, and serial number, and lead implant date. If you change the lead implant date, the programmer displays the Clear
24
Battery voltage is not shown for devices with a Greatbatch Medical Models 2753, 2850, and 2950 batteries.
25 Devices with a Greatbatch Medical Model 2850, Model 2950, or Model 2753 battery only.
17
Device Implant Date button. You can automatically Select Today’s Date or separately enter data for the month, day, and year.
Indications for Implant button. Opens the Indications for Implant window.
Implant Notes button. Opens a field for entering implant notes.
Physicians. Opens on-screen keyboards for data entry.
Accessed From: Main Programming window
Patient Data: Lead Information
The Patient Data: Lead Information window allows you set the following characteristics for all implanted leads:
Manufacturer
Lead Model
Lead Length
Lead Serial Number
Lead Implant Date
Additional Cardiac Hardware? (page 18)
Chamber
Impedance trends.
you select a unipolar lead model in this window, the Lead Type parameter is re-set to Unipolar from Bipolar.
For single-chamber devices, select the Lead Chamber button to choose an Atrial or Ventricular implant site.
Accessed From: Main Programming window > Patient Data button > Lead Information button
NOTE
Diagnostics. ST Settings must be re-initialized following the programming of a new implant date. In addition, ST
Thresholds are set to 100% and ST Diagnostics and Episode Alerts are cleared from memory
Additional Cardiac Hardware?
Select the Additional Cardiac Hardware? button to record the presence or absence of any active or abandoned cardiac hardware that may reside in the patient at the time of implant. The presence of any additional cardiac hardware contraindicates the use of an MRI scan even in patients with MR Conditional pacing systems. You may also indicate that the presence of hardware is unknown.
Devices with MR Conditional Programming Capability (page 191)
Clear Trends
The Clear Trends window allows you to clear the following trends:
Lead Impedance (page 46) for all leads
HV Lead Impedance for the RV lead (see Ventricular HV Lead (page 46) Impedance)
Sense (amplitude trend) for leads (see Sense Tests (page 42))
AutoCapture™ pacing and Cap Confirm (see This Session (page 41))
Accessed From: Main Programming window > Patient Data button > Lead Information button > Implant Date button
Indications for Implant
The Indications for Implant window allows you to select one of more standard indications or enter a custom indication.
Accessed From: Main Programming window > Patient Data button> Indications for Implant button
Note
The Note window allows you to enter additional information about the patient.
When you select the Highlight At Every Follow-up check-box, the pencil icon on the main programming window is highlighted and the information appears as an Alert at the next programming session.
Accessed From: Main Programming window > Note button
On-Screen Keyboard
Use the On-Screen Keyboard to enter data.
Special Char key. Select the Special Char key and then select another key to display the special character (labeled in green on the key).
Inactive Keys. Inactive keys mean that the device does not support the character.
Repeating Keys. If you press and hold most keys on the on-screen keyboard, they are not repeatedly typed. The exceptions are the arrow keys, the Space key, the Enter key, and the Backspace key.
26 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
18
External Keyboard. You can use an external keyboard connected to the programmer through any of its USB ports. Both keyboards can operate simultaneously.
Select Additional Reports to be Printed with the FastPath™ Summary
The Select Additional Reports to be Printed with the FastPath™ Summary window allows you to include three additional reports when you queue the FastPath Summary report for printing. For a full explanation of the content of the reports, select the hyperlinks for each report.
Select the check-box for each report you would like to print with the FastPath Summary.
Select Cancel to exit the window without selecting additional reports.
Select Print to print the FastPath Summary Report and each checked report.
Save Settings button. Select this button to store your preferences for future programming sessions.
For information on the contents of the FastPath Summary Report, see Reports (page 167).
The additional reports are:
Episode Summary or Extended Episodes (see Episodes Settings (page 168))
Diagnostics Summary or Extended Diagnostics (see Select Diagnostics Reports for Printing (page 168))
Parameters
-
Patient and device data
-
All programmed parameter and trigger settings
See also:
Accessed From: FastPath Summary window > Print button
19
Episodes
that contains the:
opens a window that contains the:
Episode Directory (page 21). See Episode Directory, VT/VF Episodes and Other Episodes (page 21).
For information on selecting the triggers for recording episodes, see Episode Triggers (page 138).
Accessed From: Episodes button
Episode Directory, VT/VF Episodes and Other Episodes
device.
When you select the Episode Directory, VT/VF Episodes or Other Episodes tab, the window shows only "new" episodes, which are the episodes recorded since the last programming session or when the Update Episodes button was last selected. Any stored EGMs not cleared from the device at a previous follow-up are "old" episodes. Select the Include Old Episodes button to view all episodes.
From the Episode Directory, VT/VF Episodes, and Other Episodes windows, you can:
window.
Sort the Directory. Select a column heading
Retrieve EGMs from the Device. Select the Update Episodes button to manually retrieve stored EGMs.
Print a Single Episode. Select the Print Selected button to print a detailed report for any episode selected for printing.
Print All Episodes. Select the Select All for Printing button, then select the Print Selected button.
Episode Directory
The Episode Directory is available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers. Episodes listed here include:
High Ventricular Rate
AT/AF Detection
High Atrial Rate
AMS Entry
AMS Exit
Consecutive PVCs
Noise Reversion
PMT
Magnet Response
Advanced Hysteresis
VT/VF Episodes
The VT/VF Episodes Directory is available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs. Episodes listed here include:
VT
VT-1
VT-2
VF
Non-sustained (VT/VF)
VT Timeout
SVT Timeout
SVT
Return to Sinus
Fibber
RV Lead Noise
(VT, VT-1, VT-2, or VF zones or during an SVT or SVT Timeout episode)
SecureSense™ Timeout
(VT, VT-1, VT-2, or VF zones) (see SecureSense™ Settings (page 90))
NOTE
episodes are defined as VT/VF episodes that are longer than six intervals but shorter than the programmed No. Intervals required for classification as tachyarrhythmia.
27 Available in devices with Non-sustained VT/VF Episode Capability.
28
Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
29 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
21
Other Episodes
The Other Episodes Directory is available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs. Episodes listed here include:
AT/AF Detection
AMS
Noise Reversion
PMT
Magnet Response
Emergency Shock
Morphology Template Update
Non-sustained RV Lead Noise
(see SecureSense™ Settings)
Episode Display Column Headings
Not all episode directories contain all of these column types.
Alerts. Indicates if a related alert exists.
Date and Time.
Type. Type of episode.
Duration. (CRT-Ds, dual-chamber ICDs, and single-chamber ICDs only)
CL. The episode cycle length. (CRT-Ds, dual-chamber ICDs, and single-chamber ICDs only)
Status. See Status explanations below.
Print icon. The episode is selected for printing.
The Status column lists the status of stored EGMs associated with that episode. The Status icons indicate the following states:
• Blue Circling Arrow. The SEGM is being retrieved.
• New EGM. The episode detail has been retrieved and is ready to view.
• Cleared. The episode has been cleared from the device.
• Old EGM. The episode was viewed in a previous session.
• No EGM. The episode is corrupted or was cleared before it was read.
See also:
Accessed From: Episodes button > Episode Directory, VT/VF Episodes tab or Other Episodes tab
Episode Detail
with information on the date, time, trigger type, and alert status.
You can change the appearance of the waveform just as you would change a frozen waveform (See Freeze Capture).
The Episode Details window also includes the:
Arrow buttons, which scroll to the previous or next episode
Restore Channels button, which shows hidden waveforms.
Date, Time, and Type of the episode
Duration of the episode (VT/VF
, AMS, and AT/AF episodes only)
Diagnosis button (VT/VF Episodes only). A large Diagnosis button appears if an SVT diagnosis is followed by a VT diagnosis during the episode. A small Diagnosis button appears if the diagnosis remained unchanged during the episode. It contains information on the diagnosis, the CL (cycle length), and the Time to Diagnosis. If the diagnosis is VF, the button is only
Therapy and Results (VT/VF Episodes only) button. Lists all therapies (ATP, VF, etc.) delivered during an episode along with
the results of each. Aborted therapies and any special events such as device reversions or ongoing charging are also listed
ATP Therapy Details button (VT/VF Episodes only). This button appears if any ATP therapies were delivered. Select this button
to open the ATP Therapy Details (page 23) window
.
Alerts. Lists any alert conditions associated with an episode. See Alerts (page 17).
30 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
31
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
32 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
33
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
34 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
22
HV Therapy (VT/VF Episodes only). If a high-voltage shock was delivered during the episode, this button lists detailed information on the capacitor charge times, the last lead impedance measurement, and the shock waveform settings for that episode
AMS or AT/AF Diagnostics
. Lists the diagnostic summary information for either AMS or AT/AF episodes. Select this button to
open the Mode Switch and AT/AF (page 28) or AT/AF (page 29) window.
Display SecureSense™ Markers
. Select this check-box to view the VS
Capability (page 198). Opens the ST Diagnostics window.
Print button. Prints the episode information and the stored EGM.
2
markers generated on the secondary sensing
channel on the EGM (see Waveform Channel Markers (page 13)).
View ST Diagnostics button. Available when viewing a recent VT or VF episode in devices with ST Monitoring Phase 2
NOTE
Zone Nearest Detection. The Episode Detail for Non-sustained VT/VF episodes specifies a “Zone Nearest Detection” in the Diagnosis box. This is defined as the rate zone in which the arrhythmia would have been classified had it continued rather than reverting to sinus rhythm.
VT/VF Episodes tab or Other Episodes tab > Specific Episode Detail button
Episodes button > Episodes tab or Other Episodes tab > Specific Episode Detail button
ATP Therapy Details
The ATP Therapy Details window lists the burst cycle lengths (BCL) of the first and last ATP bursts delivered and the successful BCL for all ATP therapies.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > VT/VF Episodes tab or Other Episodes tab > Specific Episode Detail button > ATP Therapy
Details button
Diagnosis Details
The Diagnosis Details window displays the SVT diagnostic details for the current episode at the time of the initial diagnosis. The details include the condition initially diagnosed, CL (cycle length), Time to Diagnosis, and Zone. If the device’s final diagnosis was different from its initial diagnosis, a second panel shows the condition and other details of the final diagnosis.
NOTE
No. of SVT Diagnoses. This is the number of episodes in the current directory that were determined to be SVT throughout the entire episode. "No. of SVT Diagnoses" is distinguished from "SVT Diagnoses in Episodes" reported in the SVT
by the device, even if the final diagnosis of the episode was VT/VF.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > VT/VF Episodes tab or Other Episodes tab > Specific Episode Detail button > Diagnosis Details button
SVT Criteria Statistics
The SVT Criteria Statistics window shows the number of SVT diagnoses and the measured SVT discriminator values for the selected episode.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > VT/VF Episodes tab or Other Episodes tab > Specific Episode Detail button > Diagnosis Details button > SVT Criteria Statistics button
Episode Tree
The Episode Tree window is a graphic summary of new tachy episodes (detected from the time that the diagnostic data were last cleared until the last interrogation).
The window presents a graphic distribution of all VT/VF episodes categorized into each programmed therapy zone or "branch" (for example, VT-1, VT-2, VF, SVT Timeout). At the top of each zone is an Episode button that shows the number of episodes recorded in that zone and if there is an associated stored EGM.
Under each Episode button are Diagnosis buttons ("leaves") showing the diagnosis of each episode (see Leaf types in the table below). If therapy was delivered for VT or VF, then therapy results are listed below.)
35 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
36
Available in CRT-Ps and dual-chamber pacemakers.
37 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
23
showing the number of VT/VF episodes where the tachyarrhythmia exceeded six cycles but did not reach the detection limit (that is, specified by the No. Intervals parameter setting).
buttons on the detail window to view each episode in that category.
Table 14. Leaf definition for the Episode Tree
Type of Leaf
SVT
NSVT
RV Lead Noise
VT
NSVF
VF
VT, VT-1, VT-2
Found in Branch
VT, VT-1, VT-2
VT, VT-1, VT-2, SVT Timeout
VT, VT-1, VT-2, VF
VT, VT-1, VT-2, SVT Timeout
VF
VF
SVT Timeout
Leaf Definition
Supraventricular tachycardia
Non-sustained ventricular tachycardia (no therapy delivered)
RV Lead Noise as defined by the SecureSense™ algorithm has inhibited therapy
Ventricular tachycardia
Non-sustained ventricular fibrillation (no therapy delivered)
Ventricular fibrillation
Occurring in the VT, VT-1, or VT-2 zones
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > Episode Tree tab
Logs
The Logs window (available in CRT-Ps, Dual-Chamber Pacemakers, and Single-Chamber Pacemakers) displays compilations of recorded episodes detected from the time that the diagnostic data were last cleared until the last interrogation. The window contains the:
window.
High Ventricular Rate Log. Lists the number of high ventricular rate episodes and the date of the most recent episode recorded since the episodes were last cleared. Select this button to open the High Ventricular Rate Log window.
Device Reversions button, which lists the type and number of reversions and the date and time of the most recent reversions.
Resets are also listed here.
Accessed From: Episodes button > Logs tab
High Ventricular Rate Log
The High Ventricular Rate Log displays details of each recorded episode of high ventricular rate, that is, rates exceeding the
Ventricular Rate Threshold and the Number of Cycles specified in the High Ventricular Rate: Episode Trigger and Alert Trigger (page
130) window. The details include:
The EGM of the episode. Select the EGM button to open the Episode Detail (page 22).
Date of the episode
Time of the episode
Average high ventricular rate, calculated from the start to the end of the episode
Duration, which includes the intervals recorded above the Ventricular Rate Threshold setting
Logs & Summaries
The Logs & Summaries window (available in CRT-Ds, Dual-Chamber ICDs, and Single-Chamber ICDs) displays compilations of recorded episodes detected from the time that the diagnostic data were last cleared until the last interrogation. The windows contain the:
SVT Diagnosis Summary and Morphology Template button, which lists all SVT episodes categorized by the Rate Branch
-
AF/AFL (V<A) (Atrial fibrillation/atrial flutter). The number of VT-1/VT-2 episodes in the V<A Rate Branch.
-
Sinus (V=A). The number of VT-1/VT-2 episodes in the V=A Rate Branch.
-
VT (V>A). The number of VT-1/VT-2 episodes in the V>A Rate Branch.
-
SVT Episodes. The number of VT-1/VT-2 Episodes with all VT/VF diagnoses inhibited.
38
For episodes in the VT/VF zones, NSVT or NSVF refers to VT/VF rhythms that exceeded the No. Intervals parameter setting but did not result in delivery of therapy. This should be distinguished from the “Non-sustained” Episode Tree column that records VT/VF where the tachyarrhythmia exceeded six cycles but did not reach the number of intervals for detection (specified by No. Intervals).
39 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
24
HV Charging/Non-sustained RV Lead Noise button, which lists the number of HV charges and, in devices with
this window to open the HV Charging & Non-sustained RV Lead Noise Details window.
Therapy Summary button, which lists number of ATP and Shocks delivered for each Zone Configuration, the last HV lead impedance measurement, the number of aborted shocks, and the results of ATP therapy in devices with ATP Therapy Prior to
this window to open the Therapy Summary Details (page 26) window.
Device Reversions button, which lists the type and number of reversions and the date and time of the most recent reversions.
Resets are also listed here.
Available in: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > Logs & Summaries tab
SVT Diagnosis Summary & Morphology Template Details
The SVT Diagnosis Summary & Morphology Template Details consists of three panels:
SVT Diagnosis Summary, a table showing all SVT diagnoses for all programmed rate zones. The list of reported diagnoses differs according to the settings for Zone Configuration, SVT Discrimination Mode, and SVT Upper Limit. The number in parenthesis at the top of each column shows the total number of episodes at initial diagnosis for the VT zone.
Table 15. SVT diagnosis summary definitions
Abbreviation
AF/AFL (V<A)
Sinus Tach (V=A)
VT (V>A)
SVT Episodes
SVT Diagnoses in Episodes
Sinus Tach diagnoses (V=A) due to AV
Interval
Definition
Number of VT-1 or VT-2 diagnoses where the atrial rate was faster than the ventricular rate
Number of VT-1 or VT-2 diagnoses where the atrial rate was equal to the ventricular rate
Number of VT-1 or VT-2 diagnoses where the atrial rate was slower than the ventricular rate
Number of VT-1 or VT-2 episodes with all diagnoses inhibited
Total number VT-1 or VT-2 episodes with a diagnosis inhibited
Total number of episodes where VT-1 diagnosis occurred due to AV Association in the A=V
Rate Branch
NOTE
Diagnoses in Episodes. This is the number of times SVT was diagnosed by the device, even if the final diagnosis of the episode was VT/VF. "Diagnosis in Episodes" is distinguished from the "No. of SVT Episodes" reported in the Diagnosis
throughout the entire episode.
Discrimination Criteria for SVT Diagnoses, a table showing the number of times each discriminator was used to diagnose the
SVT (and to inhibit therapy) or where bigeminal rhythm avoidance was used to inhibit therapy and a button that opens the SVT
Discrimination Details (page 91) window.
Morphology Template, a list showing details of Morphology Template Auto Update attempts, the number of Morphology
Update stored EGMs of a morphology update, an stored EGM icon than be selected to open the Morphology Update Episode
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > Logs & Summaries tab > SVT Diagnosis Summary button
HV Charging and Non-sustained RV/V Oversensing Details
Charging Panel only.
HV Charging Panel
The HV Charging Panel contains:
Total HV charges
Voltage range of all charges recorded over the sampled and lifetime periods
Button linking to the Capacitor Maintenance (page 119) parameters
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
25
Non-sustained RV/V Oversensing Details
The Non-sustained RV/V Oversensing Details panel contains the Non-sustained Oversensing (NSO) Episode Log, which lists the total number of NSO episodes, the date and time of each episode, and an icon indicating an NSO stored EGM. The Log holds up to 32 of the most recent episodes and can be sorted by selecting the column headings.
Available In: Devices with SecureSense™ RV Lead Noise Discrimination Capability (page 198)
Accessed From: Episodes button > Logs & Summaries tab > HV Charging button
Therapy Summary Details
The Therapy Summary Details window lists the:
Number of ATP therapies and shocks delivered in each Zone Configuration (page 89)
Last measured HV lead impedance
Information on aborted shocks
ATP therapy result for each Zone Configuration
Graphs that show the number of ATP bursts delivered for each successful therapy for Therapy 1 and Therapy 2 (available in
devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability (page 179)).
Lifetime ATP in the VF Zone, showing the number of total ATP therapies delivered and their effect on VF termination (available in devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability).
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Episodes button > Logs & Summaries tab > Therapy Summary button
26
Diagnostics
Contents:
Mode Switch and AT/AF (page 28)
CorVue™ Congestion Monitoring (page 37)
See also:
Accessed From: Diagnostics button
Rates
The Rates tab of the Diagnostics window contains four panels:
Atrial Heart Rate Histogram (page 27)
Total time sampled and total time in AMS or AT/AF
Last read data
Accessed From: Diagnostics button > Rates tab
Atrial Heart Rate Histogram
The Atrial Heart Rate Histogram display shows the distribution of all atrial paced and sensed events by rate ( min§) recorded since the diagnostics were last cleared
. Each histogram bar represents the percentage of time the patient’s intrinsic or paced rate fell within a specific rate range. Each bar is divided into color-coded segments, which indicate the portion that was paced or sensed.
The Histogram display also contains the settings of certain rate parameters, a histogram legend, the percentage of total time sampled
Algorithm (page 87)-paced, if the AF Suppression parameter is On.)
If the Sensor parameter is programmed On or Passive, a yellow dot appears in each rate range. The position of the dot on the bar graph represents the percentage of paced events that would result if the rate was determined exclusively by response to the activity sensor.
NOTE
The Sensor parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC Model
1240.
Events
The Events display includes:
A summary of the percentage of the time that all events were paced and triggered, for both the current time sampled and over the lifetime of the device
A bar graph that shows the percentage of the total time sampled for each event type. Thus, an Events display with an AS-VS event type of 94% indicates that during the last sampling period (defined below the graph), 94% of the time, events were of the
AS-VS type. The percentage calculation is based on the time sampled of the events divided by the total time of the histogram.
A summary of all paced events, described in the following table, is listed above the Events graph.
Table 16. Explanation of event summary data
Event Summary Symbol
AP
VP
RVP
Dual-Chamber Modes
AP-VP + AP-VS
AS-VP + AP-VP
AS-RVP + AP-RVP
BP
VSt
AS-BP + AP-BP
AS-VSt +AP-VSt
AV Conduction AP-VS + AS-VS
The Events histogram does not include time in AMS.
Biventricular event types include:
AS-RVP. Atrial sensed, right ventricular paced
AP-RVP. Atrial paced, right ventricular paced
Single-Chamber Modes
AP
VP
N/A
N/A
VSt
N/A
40 If the device has mode-switched, the Heart Rate Histogram does not record any events. Events during PMT Response and PVC Response do not update the Atrial Heart Rate
Histogram.
41 Includes events during Auto Mode Switch.
27
AS-BP. Atrial sensed, biventricular paced
AP-BP. Atrial paced, biventricular paced.
Dual-chamber event types include:
AS-VP. Atrial sensed, ventricular paced
AS-VS. Atrial sensed, ventricular sensed
AS-VSt. Atrial sensed, ventricular triggered (on sensed event)
AP-VP. Atrial paced, ventricular paced
AP-VS. Atrial paced, ventricular sensed
AP-VSt. Atrial paced, ventricular triggered (on sensed event)
PVC. Premature ventricular contraction (a ventricular sensed event after a VS or VP event not preceded by a sensed atrial event)
Single-chamber event types include:
VS. Ventricular sensed
VP. Ventricular paced
VSt. Ventricular triggered (on sensed event).
NOTE
Rounding. Values >0 but <1 are designated as <1. Numbers from 1 to 10 are rounded up to the closest single-digit decimal number. Numbers from 10 to 99 are rounded up to the closest integer. Numbers greater than 99 and less than
100 are shown as ">99."
Conduction
The Conduction tab of the Diagnostics window contains four panels:
Ventricular Heart Rate Histogram (page 28)
AV Intervals (page 28) diagnostics
Total time sampled and total time in AMS or AT/AF
Last read data
Accessed From: Diagnostics button > Conduction tab
Ventricular Heart Rate Histogram
The Ventricular Heart Rate Histogram shows the distribution of all ventricular paced and sensed events by rate ( min§) recorded since the diagnostics were last cleared or that was a PVC.
42 . Each histogram bar represents the percentage of time the patient’s intrinsic or paced rate
fell within a specific rate range. Each bar is divided into color-coded segments, which indicate the portion that was paced or sensed
The Histogram display also contains the settings of certain rate parameters, a histogram legend, the percentage of total time sampled
If the Sensor parameter is programmed On or Passive, a yellow dot appears in each rate range. The position of the dot on the bar graph represents the percentage of paced events that would result if the rate was determined exclusively by response to the activity sensor.
NOTE
The Sensor parameter available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC Model
1240.
AV Intervals
The AV Intervals display is available in dual-chamber modes and includes:
The percentage of all AV intervals that were paced and the number of VS-AS intervals that were less than 80 ms
A bar graph that shows the distribution of all recorded AV intervals by interval duration. Each histogram bar represents the percentage of time the patient’s AV interval fell within a specific interval duration range. Each bar is divided into color-coded segments, which indicate the portion that was paced or sensed.
Mode Switch and AT/AF
window if the Auto Mode Switch Parameter is set to Off.
Mode Switch
window contains the:
AMS Log and AT/AF Log (page 29) button, which opens the AMS Log window
Total time sampled and total time in AMS
42 The histogram does not include events that occurred during Auto Mode Switch.
28
Last read data
Accessed From: Diagnostics button > Mode Switch tab
AT/AF Burden
The AT/AF Burden display shows a graph of the percentage of AT/AF Burden over a 52-week period. Each data point on the graph equals the percentage of time the patient was in AT/AF for a seven-day period.
In addition, the display shows two figures:
AT/AF Burden. The percentage of time that AT/AF was detected since the diagnostics were last cleared (see Clear Diagnostics
Total AT/AF Burden. The percentage of time that AT/AF was detected since the Trends were cleared (that is, since the Clear
Trends (page 149) button was selected).
NOTE
Overview.
The Total AT/AF Burden is calculated based on the all the information in the Trends database. This may exceed the 52week display in the AT/AF Burden graph.
AMS Summary
The AMS Summary contains information on mode-switch activity, including two histograms:
Peak A Rate. Each bar represents the number of mode-switch episodes that occurred at a filtered atrial rate within the rate range.
Duration. Each bar represents the number of episodes that occurred in a single duration range.
Percentage mode switch is the time the device spent in mode switch divided by the total time sampled. The histogram does not show an ongoing AMS episode
V Rates During AMS
The V Rates During AMS panel contains a histogram showing ventricular activity during mode switches. Use this histogram to determine if the mode switch algorithm has successfully suppressed high ventricular pacing.
Each bar represents the percentage of the total time that ventricular events fell inside a specific rate range. Each bar is divided into paced (VP) and sensed (VS) events.
NOTE
Rounding. Values >0 but <1 are designated as <1. Numbers from 1 to 10 are rounded up to the closest single-digit decimal number. Numbers from 10 to 99 are rounded up to the closest integer. Numbers greater than 99 and less than
100 are shown as ">99."
AMS Log and AT/AF Log
window if the Auto Mode Switch Parameter is set to Off.
AMS Log
The AMS Log lists all mode-switch events stored in the device’s memory.
The Log contains five columns. To change the sort order, select the button at the top of the desired column.
Date
Time
Peak Atrial Rate
Duration
Capacity. The AMS Log can hold up to 32 events. The episode with the longest duration, the atrial episode with the fastest rate, and the first 16 events are frozen in the device memory (but can be cleared). The remaining events are recorded "continuously." That is, when the memory is full, events continue to be recorded and newer events overwrite older events.
NOTE
Rounding. Values >0 but <1 are designated as <1. Numbers from 1 to 10 are rounded up to the closest single-digit decimal number. Numbers from 10 to 99 are rounded up to the closest integer. Numbers greater than 99 and less than
100 are shown as ">99."
AT/AF
The AT/AF (atrial tachycardia/atrial fibrillation) tab of the Diagnostics window is available when the Auto Mode Switch parameter is off. The window contains:
43 The duration of an ongoing episode is factored into Percentage Mode Switched and Number of AMS Episodes.
29
V Rates During AT/AF (page 30)
AT/AF Log (page 30) button, which opens the AT/AF Log window
Total time sampled and total time in AT/AF
Last read data
See also:
Accessed From: Diagnostics button > Mode Switch tab
AT/AF Burden
The AT/AF Burden display shows a graph of the percentage of AT/AF Burden over a 52-week period. Each data point on the graph equals the percentage of time the patient was in AT/AF for a seven-day period.
In addition, the display shows two figures:
AT/AF Burden. The percentage of time that AT/AF was detected since the diagnostics were last cleared (see Clear Diagnostics
Total AT/AF Burden. The percentage of time that AT/AF was detected since the Trends were cleared (that is, since the Clear
Trends (page 149) button was selected).
NOTE
Overview.
The Total AT/AF Burden is calculated based on the all the information in the Trends database. This may exceed the 52week display in the AT/AF Burden graph.
AT/AF Summary
The AT/AF Summary display shows the total number of AT/AF episodes sampled and two histograms:
Peak A Rate. Each bar represents the number of AT/AF events that occurred at an atrial rate within the rate range.
Duration. Each bar represents the number of AT/AF events that occurred in a single duration range.
V Rates During AT/AF
The V Rates During AT/AF panel contains a histogram showing ventricular activity during AT/AF episodes.
Each bar represents the percentage of the total time that ventricular events fell inside a specific rate range. Each bar is divided into paced (VP) and sensed (VS) events.
NOTE
Rounding. Values >0 but <1 are designated as <1. Numbers from 1 to 10 are rounded up to the closest single-digit decimal number. Numbers from 10 to 99 are rounded up to the closest integer. Numbers greater than 99 and less than
100 are shown as ">99."
AT/AF Log
The AT/AF Log lists all AT/AF events stored in the device memory.
The log contains five columns. To change the sort order of the log, select the button at the top of the desired column.
Date
Time
Peak Atrial Rate
Duration
Capacity. The AT/AF Log can hold up to 32 events. The episode with the longest duration, the episode with the fastest rate, and the first 14 events are frozen in the device memory (but can be cleared). The next 16 events are recorded "continuously." That is, when the memory is full, events continue to be recorded and newer events overwrite older events.
AT/AF Definition
AT/AF (atrial tachycardia/atrial fibrillation) is defined as an average atrial rate greater than the Atrial Tachycardia Detection Rate
(ATDR) setting. To determine if AT/AF has occurred, the device computes an average atrial rate. If that average and the current rate are higher than the setting for the ATDR parameter, the device records a single episode of AT/AF. The calculation does not distinguish between tachycardia and fibrillation.
Exercise & Activity
The Exercise & Activity tab of the Diagnostics window contains:
Daily Exercise Training (page 31)
Total Daily Activity (page 31)
window
30
Total time sampled
Last read data
NOTE
The Exercise & Activity diagnostic tab and the tools associated with it are not available in Endurity™ Core devices.
Accessed From: Diagnostics button > Exercise & Activity tab
Daily Exercise Training
The Daily Exercise Training trend is a bar graph that indicates how much exercise a patient performed each day for the last 30 days.
Exercise is activity lasting longer than one minute, and it stops after activity has stopped for two minutes. The trend shows the amount of time the patient approached his or her maximum heart rate each day when exercising. The algorithm that computes the heart rate avoids counting high heart rates or high activity sensor values not associated with exercise. The first 48 hours after implant are used to establish a baseline, and no trend data is available until after this time.
Each histogram bar is divided into durations of "light," "moderate," and "vigorous" activity. The assignment to each division is based
Total Daily Activity
The Total Daily Activity trend is a bar graph that indicates how many hours each day the patient was "active" for the last 30 days. In this trend, "Activity" is defined as input to the sensor that exceeds the resting heart rate. That threshold rate is determined by the
The Total Daily Activity trend includes both "activity" (sensor input over a certain threshold) and "exercise," (maximum heart rate
window.
Exercise & Activity Diagnostic Tools
The Exercise & Activity Diagnostic Tools window contains two functions:
Target Heart Rate
(from "light" to "vigorous.") The Target Heart Rate is a percentage of the Patient's maximum heart rate (220 min§ minus the patient's age, as determined by the patient's Birth Date setting which is selected in the Patient Data window.)
The programmer selects a nominal percentage of a maximum heart rate, but you can change this setting. To use the programmer's nominal Target Heart Rate, select the Select Nominal Target Rate button.
and enter the patient's date of birth.
Activity Recalibration
Select the Activity Recalibration button to recalibrate the patient’s resting rate. This calculation is used to determine what level of
ST Monitoring
The ST Monitoring tab of the Diagnostics window allows you to view diagnostic data including:
ST Histogram Data (page 32) window.
ST Episode Log (page 32) button showing a summary of ST episode events and ST Episode event types
open the ST Episode Log (page 32) window.
Go to Setup. Select this button to open the ST Monitoring Setup (page 33) window.
View ST Diagnostics
. Select this button to open ST Diagnostics: (Today) window.
Print Trend button to print the 1-month and 6-month resting zone trends.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab
NOTE
Changes in the ST segment of the electrocardiogram have been known to be indicative of cardiac conditions such as myocardial ischemia and acute coronary syndromes. Carefully evaluate any reported changes in the ST segment reported, along with the patient’s history, physical examination, and other clinical information, to determine if further clinical testing
(e.g., stress testing) is warranted. The ST Monitoring feature should not be used alone to make clinical decisions.
44
Available in devices with ST Monitoring Phase 2 Capability.
45 Available in devices with ST Monitoring Phase 2 Capability.
31
ST Deviation Trend
The ST Deviation Trend shows the range of ST deviation values collected over the last six months, including the minimum, maximum, and most frequently occurring ST deviation values for each ST Heart Rate Zone. Two views are available for each heart rate zone:
1 Month. The one-month view displays daily ST deviation data for the last month.
6 Months. The six-month view shows weekly ST deviation data collected over the last six months.
To view an ST Deviation Trend, select the desired heart rate zone and either the 1-month or 6-months view using the Heart Rate and
View buttons. Use the Adjust mV Scale button and the Zoom In and Zoom Out buttons to increase or decrease the mV range of the trend.
To print ST Deviation Trend data, select the Print Trend button.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab
ST Histogram Data
The ST Histogram displays all ST deviation values for each heart rate zone. Two histogram views can be displayed:
Seven-day histogram. Shows cumulative ST deviation data from the last seven days.
One-day histogram. Displays ST deviation data from the current day, as well as each of the last six days. Select the Day button and choose the desired day to view daily ST deviation data.
beneath each histogram as well as the date and time the data were collected.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > ST Histogram Data button
ST Episode Log
The ST Episode Log lists the 30 most recent ST episodes stored in the device’s memory
The Log contains the following columns. To change the sort order, select the button at the top of the desired sort column.
Date and Time of episode onset
Episode Type
Episode Duration
Heart rate at onset of episode
Maximum ST shift percentage
button to view the ST episode detail, including baseline, ST episode onset and maximum ST shift waveforms, date and time of the ST episode, Episode Type
, ST episode duration, and additional details of the episode.
The ST Episode Log lists up to 30 episodes and five stored EGMs:
ST episodes are stored "continuously." That is, when the memory is full, events continue to be recorded and newer events overwrite older events. The first ST Episode is stored until it is manually cleared.
EGMs. The first EGM is stored until it is manually cleared. The remaining four EGMs are stored continuously; EGMs continue to be recorded and newer EGMS overwrite older EGMs.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > ST Episode Log button
Episode Type
The ST Monitoring feature is capable of detecting and reporting two types of ST Episodes: Type I and Type II
. The alerts that are reported in the FastPath™ Summary, Merlin.net™ PCN, and Patient Notifier can be triggered by Type I ST Episodes, but not Type II
ST Episodes.
Type I ST Episodes occur if:
An ST Episode is detected in the Resting Heart Rate Zone and the heart rate has not decreased > 10 beats per minute over the past 10 minutes, or
An ST Episode is detected in an Elevated Heart Rate Zone and persists 10 minutes or longer
Type II ST Episodes occur if:
An ST Episode is detected in the Resting Heart Rate Zone and the heart rate has decreased > 10 beats per minute over the past 10 minutes, or
An ST Episode is detected in an Elevated Heart Rate Zone and persists less than 10 minutes,
46
The ST Episode Log lists the first ST Episode and the 29 most recent episodes.
47 Available in devices with ST Monitoring Phase 2 Capability.
48
Available in devices with ST Monitoring Phase 2 Capability.
49 Available in devices with ST Monitoring Phase 2 Capability.
32
NOTE
Alert Triggers. When you select Show on FastPath or Notify Patient for the ST Type I Episode Alert Triggers, only Type I
ST Episodes trigger an alert on the FastPath™ Summary screen and a Patient Notification.
Available In: Devices with ST Monitoring Phase 2 Capability (page 198)
Access From: Diagnostics button > ST Monitoring tab > ST Episode Log button
ST Episode EGMs
The ST Episode Detection window displays the details of an ST Episode EGM (up to five ST Episode EGMs are stored in the device memory). Select one of the EGMs to see:
Baseline ST, episode onset, and maximum ST shift EGMs
Date and time of the ST episode
Episode Type
ST episode duration
Heart rate and heart rate zone at onset
Threshold at onset
Graphic displays of the isoelectric and ST intervals at onset for the baseline beat and onset beat
Up to five episode EGMs are available for viewing. ST Episode EGMs are stored "continuously." That is, when the memory is full, events continue to be recorded and newer events overwrite older events. The first EGM is stored until it is manually cleared. The remaining four EGMs are stored continuously; EGMs continue to be recorded and newer EGMS overwrite older EGMs. To advance to the next ST Episode, press the green Arrow button, which scrolls to the next episode.
Maximum ST Shift EGM as a source for selecting the representative beat.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > ST Episode Log button > EGM button
ST Monitoring Setup
The ST Monitoring Setup window shows the device’s current ST Monitoring parameter settings, including the representative beat,
ST heart rate zones, isoelectric intervals, ST intervals, and the positive and negative thresholds. Select the applicable parameter tab or button to change the settings. For more information, select one of the following links:
Isoelectric Interval (page 34)
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button
Instructions for ST Monitoring Setup
1.
2.
3.
From the Diagnostics window, select the ST Monitoring tab.
Select the Go to Setup button. The Go to Setup button displays in one of two colors:
choose to automatically program these suggested values or manually program the individual parameters.
When you press the green Go to Setup button, a window opens asking "Do you want to program the suggested values?"
Program the suggested values by pressing the Program & Exit Setup button. To manually program the parameters, press the Go
to Manual Setup button to open the ST Monitoring Setup: Isoelectric Interval (page 34) tab.
Blue. When the Go to Setup button is blue, the suggested ST Monitoring parameter values are not available and the parameters must be programmed manually. Select the blue Go to Manual Setup button to open the ST Monitoring Setup: Isoelectric Interval
Suggested Values
50 Available in devices with ST Monitoring Phase 2 Capability.
51
Available in devices with ST Monitoring Phase 2 Capability.
52 Available in devices with ST Monitoring Phase 2 Capability.
33
You can scroll through the baseline EGM at the top of the window and select a different complex. To accept the suggested threshold values, select the green Program & Exit Setup button. To bypass the suggested values and manually enter the threshold values (or any ST Monitoring parameter setting), select the blue Go to Manual Setup button.
ST Beat Selection
You can select a representative beat from any ST Monitoring Setup tab by pressing the Select New Beat button:
1.
2.
Touch a typical sensed beat in the rhythm strip to select a representative beat.
Press the Select This Beat button to select the new sensed beat.
3.
an ST Freeze, select the Choose New Source button.
To select a different representative beat, select the Choose New Source button.
This opens a window prompting you to "Select a waveform source." Choose a source and the select the Get Waveform button.
The selections include:
-
Baseline. Opens the ST Baselines (page 34) window.
-
Freeze. Selects an EGM Freeze from the Rhythm Display and returns to the ST Beat Selection window. The beat must be intrinsic and fall within the resting heart rate zone.
-
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Any ST Monitoring Setup tab
ST Baselines
Every six hours, the device looks for a new ST Baseline that represents the patient's "baseline" ST Deviation. The ST Baselines window displays up to four of the most recent baseline EGMs and the date, time, and heart rate associated with the baseline. Select the desired baseline by pressing the corresponding Select This Baseline button.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Any ST Monitoring Setup tab>Select New Beat button
Isoelectric Interval
contains the:
Heart Rate Zones (page 36) window.
manually program all ST Parameters.
Graphic showing the representative beat
Arrow buttons to move the start and end of the isoelectric interval
Select New Beat button, which opens the ST Beat Selection (page 34) window
Preview button
Program button
There are two ways to program the Isoelectric Interval parameters:
Representative Beat. The Start and End arrows allow you to select the desired Isoelectric Interval start and end points for the resting heart rate zone. If you choose the representative beat from a baseline, the Isoelectric Interval parameters for the
Elevated 1, Elevated 2, and Elevated 3 zones are automatically calculated when the Resting heart rate zone is programmed. If you choose the representative beat from an elevated heart rate zone, only the Isoelectric Interval parameters for the heart rate zone reflected on the representative beat is programmed.
to program the Isoelectric Interval Start and the Isoelectric Interval Duration independently for the Resting, Elevated 1, Elevated
2, and Elevated 3 zones. If you program the Isoelectric Start or Isoelectric Duration in the Resting Heart Rate Zone from this panel, the Isoelectric Interval Start and the Isoelectric Interval Duration for the Elevated 1, Elevated 2, and Elevated 3 zones are automatically calculated.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Isoelectric Interval tab
ST Interval
the:
Heart Rate Zones (page 36) window.
34
manually program all ST Parameters.
Graphic showing the representative beat
Arrow buttons to move the start and end of the isoelectric interval
Select New Beat button, which opens the ST Beat Selection (page 34) window
Preview button
Program button
There are two ways to program the ST Interval parameters:
Representative Beat. The Start and End arrows allow you to select the desired ST Interval start and end points for the resting heart rate zone. If you choose the representative beat from a baseline, the ST Interval parameters for the Elevated 1, Elevated 2, and Elevated 3 zones are automatically calculated when the Resting heart rate zone is programmed. If you choose the representative beat from an elevated heart rate zone, only the ST Interval parameters for the heart rate zone reflected on the representative beat is programmed.
program the ST Start and the ST Duration parameters independently for the Resting, Elevated 1, Elevated 2, and Elevated 3 zones. If you program the ST Start and the ST Duration parameters in the Resting Heart Rate Zone from this panel, the ST Start and the ST Duration parameters for the Elevated 1, Elevated 2, and Elevated 3 zones are automatically calculated.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > ST Interval tab
Positive Threshold
Heart Rate Zones (page 36) window.
Positive Threshold Parameters button, which lists the settings for the programmed and suggested Positive Threshold settings for
ST Parameters.
Graphic showing the representative beat
Up and Down Arrow buttons to adjust the Positive Threshold settings on the representative beat
Select New Beat button, which opens the ST Beat Selection (page 34) window
Preview button
Program button
the automatically suggested settings.
There are three ways to program the Positive Threshold parameter:
Representative Beat. The up (+) and down (-) arrows allow you to select the desired Positive Threshold level for the Resting heart rate zone. If you choose the representative beat from a baseline or freeze, the Positive Threshold for the Elevated 1,
Elevated 2, and Elevated 3 zones will be automatically calculated when the Positive Threshold for the Resting heart rate zone is programmed. If you choose the representative beat from an elevated heart rate zone, only the Positive Threshold for the heart rate zone reflected on the representative beat is programmed.
to program the Positive Threshold parameter independently for the Elevated 1, Elevated 2, and Elevated 3 zones. If you program the Positive Threshold for the Resting heart rate zone from this panel, the Positive Threshold for the Elevated 1,
Elevated 2, and Elevated 3 zones are automatically calculated.
View Suggested Values button. Select the View Suggested Values button (if available) to select the recommended Positive
Threshold values. This will automatically batch the suggested threshold values for the Positive Threshold in the Resting,
Elevated 1, Elevated 2, and Elevated 3 zones for programming.
Available In: Devices with St Monitoring Capability (page 198)
Negative Threshold
Heart Rate Zones (page 36) window.
Negative Threshold Parameters button, which lists the settings for the programmed and suggested Negative Threshold settings for all four ST heart rate zones. Select this button to open the ST Parameters window to view and manually program all ST
Parameters.
Graphic showing the representative beat
Up and Down Arrow buttons to adjust the Negative Threshold settings on the representative beat
Select New Beat button, which opens the ST Beat Selection (page 34) window
Preview button
Program button
to the automatically suggested settings.
There are three ways to program the Negative Threshold parameter:
Representative Beat. The up (+) and down (-) arrows allow you to select the desired Negative Threshold level for the Resting heart rate zone. If you choose the representative beat from a baseline or freeze, the Negative Threshold for the Elevated 1,
35
Elevated 2, and Elevated 3 zones will be automatically calculated when the Negative Threshold for the Resting heart rate zone is programmed. If you choose the representative beat from an elevated heart rate zone, only the Negative Threshold for the heart rate zone reflected on the representative beat is programmed.
to program the Negative Threshold parameter independently for the Elevated 1, Elevated 2, and Elevated 3 zones. If you program the Negative Threshold for the Resting heart rate zone from this panel, the Negative Threshold for the Elevated 1,
Elevated 2, and Elevated 3 zones are automatically calculated.
View Suggested Values button. Select the View Suggested Values button (if available) to select the recommended Negative
Threshold values. This will automatically batch the suggested threshold values for the Negative Threshold in the Resting,
Elevated 1, Elevated 2, and Elevated 3 zones for programming.
Available In: Devices with ST Monitoring Capability (page 198)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Negative Threshold tab
ST Heart Rate Zones
The ST Heart Rate Zones window shows the device’s current settings for the Resting, Elevated 1, Elevated 2, and Elevated 3 Heart
Rate Zones and allows you to program the maximum Resting rate by pressing the Resting Max arrows. Elevated 1, Elevated 2 and
Elevated 3 zones will be automatically updated when the Resting zone is changed such that the remaining three zones are equally divided
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Heart Rate Zones button
ST Parameters
Isoelectric Duration (page 36)
ST Interval Duration (page 36)
Isoelectric Start
The Isoelectric Start parameter determines the starting point for the Isoelectric Interval for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Isoelectric Interval tab
Isoelectric Duration
The Isoelectric Duration parameter determines the length of the Isoelectric Interval for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Isoelectric Interval tab
ST Interval Start
The ST Interval Start parameter determines the starting point for the ST Interval for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > ST Interval tab
ST Interval Duration
The ST Interval Duration parameter determines the length of the ST Interval for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > ST Interval tab
Positive Threshold
The Positive Threshold parameter sets the positive threshold for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
53 Available ST Heart Rate Zone settings are based on lower rate limits and tachycardia zone configurations.
36
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Positive Threshold tab
Negative Threshold
The Negative Threshold parameter sets the negative threshold for each heart rate zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > ST Monitoring tab > Go to Setup button > Negative Threshold tab
ST Diagnostics
The ST Diagnostics window shows the ST Enhanced Diagnostics data, which can be triggered by an ST Episode (1st episode and four most recent episodes), a VT/VF Episode (1st episode and most recent episode), or by the start of the programming session
(“Today”). The window shows:
ST Baseline. Frozen Rhythm Display taken at the time of the episode or the baseline measured 24 hours prior to the start of the programming session.
ST Snapshots. The ST Snapshots are four-second recordings of the ST EGM channel taken every 90 seconds, providing a record of events just prior to an episode. The programmer displays up to eight ST Snapshots, spanning the last 12 minutes.
ST Deviation and Heart Rate Trend. This graph shows the ST Deviation (in mV) and Heart Rate (in min§) on the y-axis and time in 15-minute intervals on the x-axis. Up to 24 hours of data can be viewed by using the arrow keys to scroll through the trend. Markers indicate the recording of ST Episodes and VT/VF Episodes. Select the Adjust mV Scale button to zoom in or out of the trend.
Episode Details. Notebox containing the time and duration of the triggering episode (not available on the “Today” window).
Print button.
NOTE
ST Deviation data may be unavailable if the ST algorithm is currently in use. Heart Rate data is always available, unless insufficient data have been collected.
Available In: Devices with ST Monitoring Phase 2 Capability (page 198)
Accessed From: Episodes button > VT/VF Episodes tab > Specific Episode Detail button > View ST Diagnostics button
Accessed From: Diagnostics button > ST Monitoring tab > ST Episodes Log > Specific Episode Detail button > View ST Diagnostics button
Accessed From: Diagnostics button > ST Monitoring tab > View ST Diagnostics button
CorVue™ Congestion Monitoring
The CorVue™ Congestion Monitoring tab of the Diagnostics window contains:
Congestion monitoring graph. The top graph shows the daily impedance and the reference impedance. Congestion episodes are indicated when the daily impedance is below the reference impedance for the number of days programmed in the
Congestion Trigger. Any changes in the Congestion Trigger setting and any AT/AF alerts are also shown.
Congestion episode graph. Congestion episodes are shown in the bottom graph. Blue bars represent the Pre-Trigger State, when the congestion duration is less than the programmable Congestion Trigger. Orange bars represent the Post-Trigger State, when the congestion duration exceeds the Congestion Trigger.
Zoom in button and Zoom out button. Select a button to choose the period of time (1 month, 3 months, or 1 year) shown in the graphs.
See Clinical Comments button. Select the button to see or add comments. Any clinical comments are noted, by date, on the
Congestion Monitoring graph.
See Congestion Details button
Congestion Trigger button
You can turn the Congestion Monitoring Diagnostic Feature On or Off.
NOTE
Congestion Monitoring measurements may be affected in patients undergoing dialysis or parenteral inotrope therapy. The
Congestion Monitoring feature has not been specifically evaluated in patients with capped or unused leads, coronary stents, or metal artificial heart valves.
Available In: Devices with Congestion Monitoring Capability
Accessed From: Diagnostics button > Congestion Monitoring tab
CorVue™ Details
The Date Triggered window shows a list of congestion episodes by the date each congestion episode was triggered. The most recent
20 congestion episodes are shown in the list. To view the details of a congestion episode, select a date and select the Go To button.
The selected congestion episode is highlighted in the congestion monitoring graph and congestion episode graph.
If there are no congestion episodes, the button name is No Congestion Episodes and is inactive.
Accessed From: Diagnostics button > Congestion Monitoring tab> See Congestion Details button
37
CorVue™ Trigger
The Congestion Trigger button shows the currently programmed Congestion Trigger. The Congestion Trigger is the number of days that the daily impedance is below the reference impedance, which indicates a congestion episode. To change the Congestion
Trigger, select the Congestion Trigger button. In the Congestion Trigger window, select the number of days.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Diagnostics button > Congestion Monitoring tab> Congestion Trigger button
Add/Edit Clinical Comment
Use this window to add or delete clinical comments. Select the clinical Comment button to open an on-screen keyboard.
Accessed From: Diagnostics button > Congestion Monitoring tab> See Clinical Comments button.
38
Tests
The Tests window contains the following tabs:
Battery & Leads (page 44). Battery voltage, signal amplitude, and pacing lead impedance measurements
Capacitor (page 46). Capacitor maintenance
Sensor
Optimization and devices without VectSelect Quartet™ LV Configuration capability)
-
Auto VectSelect Quartet™ Test (page 47)
-
VectSelect Quartet MultiVector Tools (page 50) for LV thresholds
-
QuickOpt™ Timing Cycle Optimization (page 52)
signal amplitude, lead impedance, and high-voltage lead impedance
in a single operation.
Accessed From: Tests button
Real-Time Measurements
The Real-Time Measurements window provides a means to obtain frequently used measurements in a single operation without performing each individual measurement. The window shows the last measured data above each check-box for each chamber and for the Sense, Lead Impedance, and High-Voltage Lead Impedance
4.
5.
6.
To acquire the real-time measurements:
1.
2.
3.
If you want to acquire only selected measurements, select the appropriate check-boxes for the desired measurements.
Set the test parameters for the measurements (Mode, Base Rate, Paced AV Delay, and Sensed AV Delay).
Select the Start Temporary button to implement the test settings.
Select the Update All or Update Selected button.
The window updates the measurements above each selected button. You can print the results in the Wrap-Up™ Report.
Accessed From: Tests button > Capture & Sense tab > Acquire RTM button
Capture & Sense
The Capture & Sense Test window shows recent capture and sense test results. To start a test, select any button.
A green button indicates that the test has not been performed in the current session. A blue button indicates that a test has been performed. A red button indicates that the Pulse Amplitude or Sensitivity safety margin is less than 2:1 or the Pulse Width safety margin is less than 3:1.
The Update Sense button automatically performs the available atrial and right ventricular Sense Tests.
This window also contains a button to Real-Time Measurements (page 39).
Accessed From: Tests > Capture & Sense tab
Capture Test
See Capture Test Instructions (page 40).
The Capture Test measures the atrial or ventricular capture thresholds to help determine an appropriate Pulse Amplitude or Pulse
Width setting. Two test methods are available:
results
reports the results.
The Capture Test window contains these tabs:
Perform Test (page 40), used to set up and run the test
This Session (page 41), reports the results from the current session
Last Session (page 41), reports the results from the last session
Follow-up EGM (page 42) reports the most recent automatic, out-of-clinic measurements.
54 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
55
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
56 Not available for the LV2 Capture Test.
39
NOTE
When both MultiPoint™ Pacing and V. Triggering are enabled, both the CapConfirm Setup Test and the CapConfirm Test
Option are not available. To enable CapConfirm testing, disable either MulitPoint Pacing or V. Triggering, perform the testing, and then re-enable the MulitPoint Pacing or V. Triggering parameter.
Accessed From: Tests > Capture & Sense tab > Capture button
NOTE
The Cap Confirm Test results and Follow-up EGMs are not available in Endurity™ Core devices.
Perform Test
The Perform Test window contains a test button and the:
Current permanent settings for the Mode, Base Rate, Paced/Sensed AV Delay (dual-chamber modes, Decrement Test Method only), and Starting Pulse Width or Pulse Amplitude parameters (Decrement Test Method only). Select the "…" button for more settings.
AutoCapture/CapConfirm) and other Decrement test parameters.
Additional Parameters (page 42) button. Opens a window to temporarily set other test parameters.
Start Temporary button.
Setup button for RVCap™ Confirm, LVCap™ Confirm or AutoCapture™ Test Confirm. This button is available when the Test
Method is set to Decrement. Select this button to change the Test Method to CapConfirm/AutoCapture and to allow the Setup
Test to run prior to the Capture Test.
Perform AutoCapture test, LVCap Confirm Setup, or RVCap Confirm Setup button. For ventricular capture tests, check this button to run an AutoCapture or CapConfirm test before the capture test. When you select this button, the Test Method changes
or Cap Confirm (when the Decrement Test Method is selected from the Options from Decrement to AutoCapture pacing window).
MultiVector Testing button. For LV capture tests, this button opens the VectSelect Quartet™ MultiVector Tools window for
devices with VectSelect Quartet LV Pulse Configuration capability (page 199).
Capture Test Instructions
AutoCapture™ Pacing and Cap Confirm Test Methods (page 41)
3.
4.
5.
Decrement Test Method
1.
2.
6.
7.
8.
9.
Open the Tests page.
There are two ways to navigate to the Tests Page:
a) From the FastPath Summary window, select the button in the Capture column for the chamber you want to test.
b) From the Main Menu, select the Tests button and then choose the chamber you want to test.
The Perform Test window opens.
To change the Test Method from the Cap Confirm or AutoCapture method to the Decrement method, select the Options button.
Otherwise, skip to Step 7.
The Options window opens.
Select the Decrement Mode button.
Select the Decrement Mode (Pulse Amplitude or Pulse Width).
Select a setting for the Number of Cycles/Step parameter.
This parameter determines how many paced cycles the programmer counts before it reduces the Pulse Amplitude or Pulse
Width setting to the next step.
Close the Test Options window.
The Perform Test window opens.
parameters need to be reset. If necessary, select the Waveform Control button on the Rhythm Display to reset the waveform.
To program the device to the temporary settings before the test begins, select the Start Temporary button.
To begin the test, select and hold the Hold to Test button.
The device delivers the starting pulse for the programmed Number of Cycles/Step. After the cycles have elapsed, the device’s
Pulse Amplitude or Pulse Width setting is reduced to the next setting, until you release the test button or the device reaches
0.25 V or 0.1 ms.
Watch the EGM for loss of capture. When this occurs, release the test button.
setting.
NOTE
You can stop the test at any time by releasing the Hold to Test button.
57 In CRT-Ps, AutoCapture™ pacing is not available when the Sense Configuration is set to BV Bipolar or BV Unipolar
40
AutoCapture™ Pacing and Cap Confirm Test Methods
The AutoCapture™ pacing and Cap Confirm methods automatically determine the capture threshold when the AutoCapture or Cap
Confirm parameters are programmed On.
1.
Select the Tests button.
2.
3.
4.
Select the appropriate Capture button.
Otherwise, skip to Step 8.
-
Select the Options button and change the Test Method setting to AutoCapture or Cap Confirm setting, or
-
Select the AutoCapture, RVCap Confirm, or the LVCap Confirm Setup button and skip to Step 8. This runs the AutoCapture
Setup function or Cap Confirm Setup Test, which tests if the pulse generator system can operate the V. AutoCapture or Cap
Confirm function.
NOTE
5.
6.
7.
8.
9.
Select the AutoCapture or Cap Confirm Setup button only if you are setting up the feature for the first time or if you have recently changed any of the following parameters: V. AutoCapture, Cap Confirm, Pulse Width, Pulse Configuration, Lead
Type, AutoCapture/Cap Confirm Paced/Sense AV Delay parameters. If you select the button, the Test Method is automatically changed to the AutoCapture or Cap Confirm method.
For Test Method, select the AutoCapture or Cap Confirm setting.
Close the Test Options window.
The Perform Test window appears.
For ventricular testing, check or un-check the AutoCapture or Perform Cap Confirm Setup button.
to determine if these need to be reset.
To program the device to the temporary settings before the test begins, select the Start Temporary button.
Select the Start Test button.
If the Perform AutoCapture, RVCap Confirm, or LVCap Confirm Setup button is checked, the Setup test precedes the capture test. If the device passes the Setup Test, then the capture test proceeds. You can monitor the test from the waveform. Select
NOTE
Selecting the Cancel button aborts the test and does not record a result.
This Session
This window contains the Capture Test waveform recorded during the most recent programming session. You can view, change, or print the waveform like any Freeze Capture. The window shows:
For the Decrement Test, a "Capture Lost" flag on the waveform at the programming step (vertical line) next to where the test was ended. If this flag in not correctly set, touch the strip where the capture was lost to reset the flag.
For the Decrement Test, a button showing the current setting for the parameter tested (Pulse Amplitude or Pulse Width). Select the button to change the setting.
If the AutoCapture™ pacing or Cap Confirm Setup Test was run, the Setup Test recommendation.
The AutoCapture Trend or Cap Confirm Trend, a line graph showing up to 52 weeks of measured capture threshold readings.
Samples are recorded every seven days.
A list of other test parameters and a Program button to program the V. AutoCapture or Cap Confirm parameter is highlighted in green (if the Setup Test was successfully run).
A Print button to print the results.
The Safety Margin is highlighted in orange if the ratio is less than 2:1 for Pulse Amplitude or 3:1 for Pulse Width. The Safety Margin is highlighted in blue if it is greater than or equal to these margins.
Available In: Tests > Capture & Sense tab > Capture button > This Session tab
Last Session
The Last Session window contains the results of the last Capture test recorded before the current programming session.
Accessed From: Tests > Capture & Sense tab > Capture button < Last Session tab
Options
From the Capture Test: Options window, select a setting for the following parameters:
BiVCap™ Confirm Capability (page 183), or V. AutoCapture™ Capability (page 199)).
Decrement Mode. This mode determines which parameter is reduced during the test.
Number Cycles/Step. This parameter determines how many paced cycles the programmer counts before it reduces the Pulse
Amplitude or Pulse Width setting to the next step.
Accessed From: Tests > Capture & Sense tab > Capture button> Test Settings tab > Options button
41
Additional Parameters
The Additional Parameters window temporarily sets other test parameters. Temporarily programmed parameter settings are restored when the test ends or is canceled.
Accessed From: Tests>Capture & Sense tab>Capture button> test Settings tab>Additional Parameters button
Follow-up EGM
window contains:
A Follow-up EGM showing five complexes from the most recent out-of-clinic automatic capture threshold measurement that was used to identify capture (the complexes are shown chronologically from left to right).
The AutoCapture Trend or the Cap Confirm Trend, a line graph showing up to 52 weeks of measured capture threshold readings. Samples are recorded every seven days.
The current programmed settings for the V. AutoCapture, Cap Confirm, Pulse Amplitude, Pulse Configuration, and Pulse Width parameters (the green A symbol indicates automatic operation).
Print button
NOTE
If the tab is labeled "Today" the EGMs were recorded within the last 24 hours. Otherwise, the tab displays the date of the last recording.
Only automatic, out-of-clinic measurements are saved in the AutoCapture or Cap Confirm Trend. Measurements obtained during a programming session are noted in the trend with a green dot, but are not saved in memory.
The Follow-up EGM window for the Atrial Capture Test is not available in Endurity™ Core devices. Endurity Core devices do not display a Follow-up EGM for the out-of-clinic Ventricular AutoCapture Test, but do display the AutoCapture Trend and current programmed settings.
Accessed From: Tests > Capture & Sense > Capture/Ventricle button > Today/[Date] tab
Sense Tests
Sense Threshold tests measure atrial or ventricular signal amplitude and help determine an appropriate Sensitivity setting. Two test methods are available:
Automatic (page 43). Automatically measures the signal amplitude and reports the results
Sensitivity setting.
Test.
Sense Test and Ventricular Sense Test.
NOTE
Off.
The Sense Test window contains the following tabs:
Perform Test (page 40). Used to set up the test
This Session (page 41). Reports the results from the current session
Last Session (page 41). Reports the results from the last session
Follow-up EGM (page 42). Reports the most recent automatic, out-of-clinic measurements.
See also:
Sense Test Instructions (page 42).
Accessed From: Tests > Capture & Sense tab > Sense/Ventricle or Sense/Atrium button
NOTE
The Follow-up EGM is not not available in Endurity™ Core devices.
Perform Test
The Perform Test window contains a test button and the:
Current permanent settings for the starting Sensitivity (Increment only), Mode, Base, Rate, and Paced/Sensed AV Delay (dualchamber modes) parameters. Select the "..." button for more settings.
Options (page 41) button. Chooses the sense test method (Atrial Sense Test only).
Additional Parameters (page 42) button. Opens a window to temporarily set other test parameters.
Start Temporary button.
Sense Test Instructions
42
Automatic
The Automatic method automatically determines the signal amplitude.
1.
Select the Tests button.
2.
3.
Select the appropriate Sense button.
If the Options button indicates Increment (Atrial Sense Test only) as the Test Method or if you want to change the Number of
Measurements parameter, select the Options (page 41) button. Otherwise, skip to Step 7.
4.
5.
6.
For Test Method, select Automatic.
Select a setting for the Number of Measurements parameter.
This parameter determines how many times the system measures the signal amplitude before stopping the test. The Monitor setting allows the test to run for 120 cycles.
Close the Options window.
7.
8.
The Perform Test window appears.
button to determine if these need to be reset. If necessary, select the Waveform Control button on the Rhythm Display to reset the waveform.
To program the device to the temporary settings before the test begins, select the Start Temporary button.
To begin the test, select the Start Test button.
The system measures the signal amplitude (shown in the Rhythm Display) and the test completes automatically. The This
Session (page 41) window appears with the test results.
Increment
The Increment method manually determines the chamber’s signal amplitude.
1.
Select the Tests button.
2.
3.
Select the Sense/Atrium or Sense/Ventricle button.
of Cycles/Step parameter, select the Options button. Otherwise, skip to Step 7.
4.
5.
6.
For Test Method, select Increment.
Select the setting for the Number of Cycles/Step parameter.
This parameter determines how many sensed cycles the programmer counts before it increases the Sensitivity setting to the next step.
Close the Options window.
7.
8.
9.
The Perform Test window appears.
Review the temporary settings for the test parameters and reset any parameters that require it. Review the Additional
Rhythm Display to reset the waveform.
To program the device to the temporary settings before the test begins, select the Start Temporary button.
To begin the test, select the Hold to Test button.
The device senses at the starting Sensitivity setting for the programmed Number of Cycles/Step parameter. After the cycles have elapsed, the Sensitivity value is increased (mV value) to the next setting, until you remove your finger from the Hold to Test button or the device reaches the minimum sensed activity (maximum Sensitivity setting or 5 mV) and automatically ends the test.
Watch the ECG for loss of sensing. When this occurs, release the Hold to Test button.
The This Session (page 41) window appears with the test results.
This Session
The This Session window contains the results of the Sense Test recorded during this programming session. You can view, change, or print the waveform like any Freeze Capture.
If the patient had insufficient rhythm to perform the test, the results are displayed as "None."
The window contains:
A button for programming the A. Sensitivity (page 76) or V. Sensitivity
parameter (Increment A. Sense test or V. Sense Test)
The Safety Margin (ratio of the measured signal amplitude to the Sensitivity setting).
The Sense Configuration setting.
A "Sensing Lost" flag (Increment A. Sense Test or V. Sense Test) on the waveform at the programming step (vertical line) next to where the test was ended. If this flag is not correctly set, touch the strip where sensing was lost to reset the flag.
The Amplitude Trend, a line graph of median weekly sense threshold measurements over time. The Trend displays the Sense
Configuration (page 80) setting programmed at the time the weekly sample was taken.
Accessed From: Tests > Capture & Sense tab > Sense/Ventricle or Sense/Atrium button
58
When the Sensitivity setting (mV) is increased, the actual sensitivity of the device decreases. Thus, as the test progresses, the device becomes less able to sense intrinsic activity.
59
Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
60 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
43
Last Session
The Last Session window contains:
The results of the last recorded Sense Tests.
The Amplitude Trend, a line graph of median weekly sense threshold measurements over time. The Trend displays the Sense
Configuration (page 80) setting programmed at the time the weekly sample was taken.
Accessed From: Tests > Capture & Sense tab > Sense/Ventricle or Sense/Atrium button > Last Session tab
Options
From the Options window, select a method to determine sense threshold. The options are:
Automatic (page 43), automatically measures the signal amplitude and reports the results.
Increment (page 43), manually reduces the A. Sensitivity or V. Sensitivity
61 setting during the test, reports the results, and
suggests an A. Sensitivity or V. Sensitivity setting.
Number of Cycles/Step. If the Increment method is selected, this parameter determines how many sensed cycles the programmer counts before it increases the Sensitivity setting
to the next step.
Number of Measurements. If the Automatic method is selected, this parameter determines how many times the system measures the signal amplitude before stopping the test. The Monitor setting allows the test to run for 120 cycles.
Accessed From: Tests > Capture & Sense tab > Sense/Ventricle or Sense/Atrium button > Perform Test tab > Options button
Additional Parameters
The Additional Parameters window temporarily sets other test parameters. Permanently programmed parameter settings are restored when the test ends or is canceled.
Accessed From: Tests > Capture & Sense tab > Sense/Ventricle or Sense/Atrium button > Perform Test tab >
Additional Parameters button
AV Delays
The AV Delays window allows you to program the following parameters during a test:
Accessed From: Tests > Capture & Sense tab > Sense-Ventricle or Sense-Atrium button > Perform Test tab > Paced/Sensed AV
Delay "…" button
Follow-up EGM
The window contains:
A follow-up EGM showing five complexes from the most recent out-of-clinic automatic P-wave or R-wave measurement (the complexes are shown chronologically from left to right).
The Amplitude Trend, a line graph of median weekly sense threshold measurements over time. The Trend displays the Sense
Configuration (page 80) setting programmed at the time the weekly sample was taken.
indicates automatic monitoring).
Print button.
Program button to change the Sensitivity setting (programmable only if Sensitivity is not autoprogrammed).
NOTE
If the tab is labeled "Today," the EGMs were recorded within the last 24 hours. Otherwise, the tab displays the date of the last recording.
Only automatic, out-of-clinic measurements are saved in the Amplitude Trend. Measurements obtained during a programming session are noted in the trend with a green dot, but are not saved in memory.
Accessed From: Tests > Capture & Sense > Sense/Ventricle button or Sense/Atrium > Today/[Date] tab
NOTE
The Follow-up EGM is not not available in Endurity™ Core devices.
Battery & Leads
The Battery & Leads window contains:
Battery button. Shows the last measured battery voltage current rate of usage and other data), and the date and duration of the last max charge
.
64 , a longevity gauge illustrating the time left to ERI (based on the
65 . Select this button to open the Battery
61 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
62
When the Sensitivity setting (mV) is increased, the actual sensitivity of the device decreases. Thus, as the test progresses, the device becomes less able to sense intrinsic activity.
63
When the Sensitivity setting (mV) is increased, the actual sensitivity of the device decreases. Thus, as the test progresses, the device becomes less able to sense intrinsic activity.
44
LV2 lead) and today’s lead impedance measurements. A red button border indicates an alert, if, for example, the lead impedance measurements are beyond programmed limits. A green button border indicates no recent measurements in the last
30 days. A blue button indicates recent results. Select any of these buttons to open the Lead Impedance window for details on the lead impedance.
Ventricular HV Lead Impedance (page 46) button
, which includes a thumbnail view of the HV Lead Impedance Trend and
Select this button to open the Ventricular HV Lead Impedance window.
Update Leads button. Select this button to measure lead impedance.
today’s lead impedance measurements. A red button border indicates an alert, if, for example, the lead impedance measurements are beyond programmed limits. A green button border indicates no recent measurements in the last 30 days.
Include HV check button impedance
. Select or deselect this button to include or exclude the measurement of the high voltage lead
.
Real-Time Measurements button. Opens the Real-Time Measurements (page 39) window.
Accessed From: Tests > Battery & Leads tab
Battery Details
The Battery Details window contains:
The Longevity Gauge, which illustrates the time left to ERI. The longevity is based on calculations that factor the:
-
amount of time needed to consume the remaining battery capacity
current rate of battery consumption anticipated or projected capacitor charges
device duty cycle.
The calculation is made at the start of every session and whenever a programming change affects the estimate.
Battery Information, including the Last Max Charge time and date
, the last unloaded battery voltage measurement
, the battery current, remaining capacity to ERI percentage
The Voltage Trend
years of data
The Ideal Battery Voltage Trend Thumbnail
. This shows a lifetime voltage trend approximation for the battery for
comparison purposes.
The Update Values and Print buttons
The Clear ERI button that appears when the device reports ERI
that there is a potential for a false detection of ERI
to the programmer and when the programmer determines
. If you select this button, the programmer disables the ERI condition and
allows you to reset the ERI Patient Notifier trigger (see Alert Triggers (page 129)).
Accessed From: Tests > Battery & Leads tab > Battery button
Magnet Rate
Magnet Rate (sometimes known as the Battery Test Rate) corresponds to the device's battery voltage and is an indicator of service life. As battery power is depleted, the Magnet Rate gradually declines from Beginning-of-Life (BOL) at 100 min§ to approximately 85
(EOL). The following table lists representative Magnet Rates and the approximate corresponding battery voltage.
NOTE
(page 163), the device paces at a Magnet Rate of 100
min§ unless the device is either:
•
Interrogated by a programmer when the battery voltage is less than or equal to 2.95 V. The Magnet Rate correlates to the measured battery voltage as shown in the following table.
•
At or below the ERI battery voltage. The Magnet Rate is 85 min§.
Table 17. Magnet rates between BOL and EOL and corresponding battery voltage values
Magnet Rate (
100 (BOL)
min§)
Voltage
3.2
64
Not available for devices with a Greatbatch Medical Model 2850 battery, Model 2753 battery, or Model 2950 battery.
65 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
66
When the device estimates that ERI will occur in less than 90 days, the gauge will display in red and the message will read "ERI in <3 months."
67 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
68 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
69
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
70 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
71
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
72 Not available for devices with a Greatbatch Medical Model 2850 battery, Model 2753 battery, or Model 2950 battery.
73
Devices with a Greatbatch Medical Model 2850, Model 2950, or Model 2753 battery only.
74 Not available for devices with a Greatbatch Medical Model 2850 battery, Model 2753 battery, or Model 2950 battery.
75
Not available for devices with a Greatbatch Medical Model 2850 battery, Model 2753 battery, or Model 2950 battery.
76 Not available for devices with a Greatbatch Medical Model 2850 battery, Model 2753 battery, or Model 2950 battery.
77
Devices with a Greatbatch Medical Model 2850, Model 2950, or Model 2753 battery only.
78 Not all Magnet Rates are shown
45
Table 17. Magnet rates between BOL and EOL and corresponding battery voltage values
Magnet Rate (
100
100
97.9
93.6
89.3
85.0 (ERI)
80.7 (EOL)
min§)
2.8
2.7
2.6
2.5
Voltage
3.1
3.0
2.9
Lead Impedance
For each implanted lead, the Lead Impedance window shows the:
One-year impedance trend
Impedance trend of the last seven days of lead measurements
Current pulse configuration
Date and results of the first lead impedance measurement for each programmed pulse configuration
Lifetime Range of lead impedance measurements for each programmed pulse configuration
Lead Impedance Monitoring button, which lists the current Lead Monitoring setting, the Upper and Lower Limit settings. Select
this button to open the Lead Monitoring Parameters (page 80) window
Update Values button and Print buttons
Accessed From: Tests > Battery & Leads tab > Lead Impedance button
Ventricular HV Lead Impedance
The Ventricular HV Lead Impedance window
shows the:
One-year impedance trend and test configuration legend
Impedance trend of the last seven days of lead measurements
Current configuration
Date and results of the first lead impedance measurement for each test configuration
Lifetime Range of lead impedance measurements for each test configuration
HV Lead Impedance Monitoring button, which lists the current Upper and Lower Limit settings. Select this button to open the
Lead Monitoring Parameters (page 80) window
Buttons to set the Test Configuration parameter
Update Values button and Print buttons
NOTE
A report of "No Measurement" in the First Measurement and Lifetime Range data indicates that no measurement was taken or all measurements were out of range.
CAUTION
Defibrillation Lead Impedance. Do not implant the device if the acute high-voltage lead impedance is less than
20
¬ or if the lead impedance of a chronic lead is less than 15 ¬. The device may be damaged if high-voltage therapy is delivered into an impedance less than 15
¬. A warning message appears after the device has delivered a shock if the measured impedance is less than 15 ¬.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Tests > Battery & Leads tab > Lead Impedance button
Capacitor
The Capacitor window contains the:
Initiate Maintenance button. Select this button to dump all residual voltage and charge the capacitors to maximum voltage
This is followed by a Charge Time optimization phase that lasts approximately 10 seconds.
.
Listing of the Voltage (maximum voltage of therapy) and Charge Time (time needed for the most recent capacitor maintenance). These are blank if the Initiate Maintenance button is not selected during the session. The window displays a "---" if an arrhythmia or charge timeout occurred during the capacitor maintenance.
Date, duration, and reason for the Last Max Charge
Charging Parameters button, which opens the Capacitor Maintenance (page 119) parameters window.
When the unloaded battery voltage reaches a specific level, the Charge Interval setting changes to optimize the battery performance.
See also:
79
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
80 For 40J devices, the capacitors charge to the voltage equivalent to 36J.
46
Capacitor Maintenance Details (page 47).
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Tests button > Capacitor tab
NOTE
If the capacitor maintenance charge interval is decreased, the timer does not reset until after the next capacitor maintenance. Perform a manual capacitor maintenance to reset the charge interval.
Capacitor Maintenance Details
The charge time is normally less than 10 seconds. If an extended period of time elapses between high-voltage charges, the dielectric material within the high-voltage capacitors may become deformed. This can prolong the first charge time following a period of disuse.
The device charges the high-voltage capacitors to their maximum voltage without a charge for maximum-voltage therapy.
if the Charge Interval (page 119) setting has passed
If an arrhythmia is detected while a capacitor maintenance charge is in progress or has been recently completed, the voltage of the therapy delivered is either the programmed voltage or the voltage remaining on the capacitors, whichever is greater. With voltage already on the capacitors, the charge time necessary to reach the therapy voltage is reduced.
Sensor
The Sensor window contains the Reset Auto Threshold (page 47) button.
This is a programmer-guided procedure to clear and recalculate the Measured Average Sensor data, which are used for setting
18-hour period.
NOTE
The Sensor tab and the Reset Auto Threshold procedure are available in all devices except the Endurity™ Core DC Model
2140 and Endurity Core SC Model 1240.
1.
2.
3.
4.
Reset Auto Threshold
5.
6.
Select the Tests button.
Select the Sensor tab.
Select the Reset Auto Threshold button.
Have the patient rest quietly for the duration of the procedure or approximately 30 pacing cycles. The procedure may be delayed for over a minute following capacitor maintenance or therapy delivery.
Select the Start Procedure button.
As the programmer clears the activity data from the device, the screen shows a countdown for approximately 30 s. The Done button appears when the procedure is complete.
Select the Done button.
NOTE
seconds in the collection of sensor date may occur if the capacitors were recharged immediately before the Reset Auto
Threshold procedure. This delay is not used in the on-screen countdown.
Timing Optimization/CRT Toolkit Tab
Timing Optimization tab (For devices with QuickOpt Timing Optimization), see: QuickOpt™ Timing Cycle Optimization (page
CRT Toolkit
The CRT Toolkit window provides access to the following tools to assist in setting the quadripolar lead's Pulse Amplitude, Pulse
Width, Pulse Configuration, Cap Confirm, and Intraventricular Delay settings. The window contents include:
this button to begin a sequence of procedures that will aid in the selection of the LV Pulse Configuration setting. The sequence begins with automatic measurement of RV-LV conduction times and proceeds to automatic tests for LV capture, followed by an option to choose the parameter settings selected by Auto VectSelect algorithm. See Instructions for the Auto VectSelect™ test
a sequence of procedures that will aid in the selection of the LV1 and LV2 Pulse Configuration settings. The sequence begins with automatic measurement of RV-LV conduction times and proceeds to automatic tests for LV capture, followed by an option to choose the parameter settings selected by Auto VectSelect algorithm. See Instructions for the Auto VectSelect™ test (page
you can program Pulse Amplitude, Pulse Width, and Pulse Configuration for the quadripolar lead, test and record PNS (phrenic nerve stimulation), and perform capture tests.
81 For 40J devices, the capacitors charge to the voltage equivalent to 36J.
47
Perform QuickOpt™ button. Opens the QuickOpt™ Optimization Wizard that automatically measures the width of the sense and pace signals with pre-set test parameters and calculates optimal delay settings.
each portion of the delay optimization calculation manually with an ability to adjust the pre-set test parameters.
WARNING
For CRT-Ds, when any procedure in the CRT Toolkit is performed, tachycardia and fibrillation detection are suspended and no arrhythmia therapy is delivered.
NOTE
pacing (Sensor (page 65)) are suspended.
Test Results. The measurements and test results are saved on the programmer only for the duration of the session.
Results are cleared at the end of the session.
A Sense Configuration. During the QuickOpt procedure, the A Sense Configuration is programmed to Unipolar.
MultiPoint™ Pacing. The QuickOpt Timing Cycle Optimization test is not designed for MultiPoint Pacing.
Recommendations for Ventricular Pacing do not include MultiPoint Pacing settings (RV -> LV1 - LV2 and LV1 -> LV2 ->
RV).
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab
Instructions for the Auto VectSelect Test
The Auto VectSelect Quartet Test allows you to automatically measure RV-LV conduction times and automatically conduct capture tests for recommended LV Pulse Configuration settings.
1.
2.
3.
From the Main Menu, select Tools > CRT Toolkit tab and select the Perform MPP Auto VectSelect button (for MultiPoint pacing) or the Perform Auto VectSelect button (for .BiV pacing).
The Measure RV-LV Conduction time (page 49) window opens.
If you want to change the parameters used for the test, select the Additional Parameters button under the heart diagram. This
programmed for the measurements.
Ensure that the temporary parameters are appropriate or select new settings. To test the temporary settings, select the Start
Temporary button. When complete, close the window.
4.
5.
6.
In the Measure RV-LV Conduction time window, select the Perform Measurements button.
The programmer institutes the test settings and begins to measure the delay between sensing an RV signal and a signal from the four electrodes on the LV lead (Proximal4 to Can, Mid3 to Can, Mid2 to Can, Distal Tip1 to Can).
capture threshold testing of any pulse configuration. Each available vector is provided with a check box to include it in the capture testing. When the window opens, up to four test vectors have been automatically checked by the Auto VectSelect algorithm as recommended test vectors.
From the Auto VectSelect Quartet Capture Test window, you can do any of the following:
-
Re-run the RV-LV measurements. Select the RV-LV Conduction time box to re-open the Measure RV-LV Conduction Time window.
-
Review and adjust the capture test temporary parameters. Select the Additional Parameters button to open the Additional
-
Check or uncheck test vectors to add them to batch for capture testing.
-
Begin automatic capture testing of the selected test vectors. Select the Measure LV Thresholds button.
while the automatic capture tests are conducted. To skip a test vector, select the Skip Current Vector button. Once the tests are complete, you can do any of the following:
-
Review the Test Results. Select the button in the Test Results capture column to see the EGM test result of each test. Test failures are labeled "n/a" but are viewable.
-
Re-run the RV-LV measurements. Select the RV-LV Conduction time box to re-open the Measure RV-LV Conduction Time window.
-
Perform a manual capture test on any vector. Select the Perform Manual Capture Testing button to open the Manual
Capture Test (page 50) window.
Repeat the automated capture test. Select the Perform Auto Capture test to re-open the Auto VectSelect Quartet Capture
Test window.
-
Test the selected vectors for PNS. Select the Check PNS button to open the Phrenic Nerve Stimulation (PNS) Test (page
-
Print the test results. Select the Print button.
-
Program the LV pulse parameters suggested by the automated test. See Selection Method and Programmed Parameters below.
48
7.
8.
9.
NOTE
Before finalizing your selection, it is recommended to perform the PNS test on each vector with a capture test result to obviate the occurrence of PNS.
Selection Method and Programmed Parameters.
Following automatic capture testing, use these buttons to program an automatically batched set of parameters (Cap Confirm,
Pulse Configuration, Pulse Amplitude, and Pulse Width). These settings are selected by the Auto VectSelect algorithm, based on the results of the RV-LV measurements and automatic capture tests. Choose a Selection Method button to batch store the
Programmed Parameters to the suggested programmed settings. The Selection Method choices are:
-
Programmed. The currently programmed settings.
-
Latest Activation. Settings that are based on the lowest capture threshold for the cathode with the longest RV-LV conduction time.
-
Widest Spacing. For devices with MultiPoint Pacing. Settings that represent the greatest anatomical separation between anode and cathode.
-
Earliest and Latest Activation. For devices with MultiPoint Pacing. Settings that are based on the earliest RV-LV conduction time for LV1 and the latest conduction time for LV2.
If you want to change any of the settings, select the individual parameter buttons on the left to choose the desired setting.
Once you have selected the parameter settings you want, you can select Preview to see the changes that will occur or select
Program to permanently program the parameters.
Measure RV-LV Conduction Time
The Measure RV-LV Conduction Time window helps you determine the conduction time from the right ventricle to each of the four electrodes on the Quadripolar LV pacing lead. The test measures the delay between sensing an RV signal and a signal from the four electrodes on the LV lead (Proximal4 to Can, Mid3 to Can, Mid2 to Can, Distal Tip1 to Can). You can change the measurement
MultiVector Tools window (page 50).
Perform Measurements button. Select this button to start the automatic conduction measurement. If you have accessed this window through the Perform Auto VectSelect button, when the measurements are complete, the Auto VectSelect Quartet™ Capture
Test window opens, which allows you to test left ventricular capture thresholds. Otherwise, select the Perform Measurements button to open the VectSelect Quartet MultiVector Tools window or select the Close button to return to the previous window.
Available In: Devices with VectSelect Quartet™ LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button, Perform MPP Auto VectSelect button, or
VectSelect Quartet MultiVector Tools window
Accessed From: Phrenic Nerve Stimulation (PNS) Test window or Manual Capture Test window
RV-LV Conduction Time: Additional Parameters
The RV-LV Conduction Time: Additional Parameters window allows you to set the test parameters for the RV-LV Conduction Time measurements.
The two available test methods are:
RV Pace. The programmer delivers a series of pulses from the RV lead and measures the conduction time to the LV electrode, within a window of 0 to 300 ms after the VP marker.
RV Sense. The programmer measures the conduction time sensed between the right ventricle and the LV electrodes, within a window of 50 ms before to 200 ms after the VS marker.
Other parameters that may be temporarily set during the test include:
Mode
Base Rate
Pacing AV Delay
Sensed AV Delay
PVARP
V. Pace Refractory
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button or VectSelect Quartet MultiVector Tools window
Accessed from: Auto VectSelect Quartet Capture Test, Manual Capture Test, Phrenic Nerve Stimulation (PNS) Test
Auto VectSelect Quartet™ Capture Test
The Auto VectSelect Quartet™ Capture Test window allows you select any available LV Pulse Configuration for automatic capture threshold testing.
The window contains:
Dynamic heart diagram. Highlights the LV electrodes currently selected for the LV Pulse Configuration. The arrow indicates the direction of the pulse (cathode to anode).
RV-LV conduction time measurements.
49
Checkboxes. Select a checkbox to test the pulse configuration. Preselected checkboxes are chosen based on the results of the
RV-LV conduction time measurements and other criteria.
Measure LV Thresholds. Once you have selected the pulse configurations you wish to test, select this button to begin capture
See Instructions for the Auto VectSelect Quartet Test (page 48).
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Access MultiVector Tools button > Perform Auto Capture Test button
Accessed From: Tests button > Capture and Sense tab > LV/LV1/LV2 Capture test > MultiVector Testing button > Perform Auto
Capture Test button
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button or Perform MPP Auto VectSelect button >
Measure RV-LV conduction time > Perform Measurements button
VectSelect Quartet™ MultiVector Tools
NOTE
The VectSelect Quartet™ MultiVector Tools window contains:
Dynamic heart diagram. Highlights the LV electrodes currently selected for the LV Pulse Configuration. The arrow indicates the direction of the pulse (cathode to anode).
RV-LV conduction time measurements.
Print button. Creates the CRT Toolkit Report, which includes the results of the RV-LV Conduction Time, VectSelect Quartet™
MultiVector Testing, and QuickOpt™ Timing Cycle Optimization (see Test Results Settings (page 169)).
for each test vector. (see Instructions for Conducting MultiVector Testing).
for each selected vector.
Perform Auto Capture Test. Opens the Auto VectSelect Quartet™ Capture Test window to begin automatic capture testing.
Test Results table. Displays all the results of the Capture and PNS tests. Select a highlighted Capture test result button to open details of the test result.
Selection Method and Programmed Parameters:
Following automatic capture testing, use these buttons to program an automatically batched set of parameters (Cap Confirm,
Pulse Configuration, Pulse Amplitude, and Pulse Width). These settings are selected by the Auto VectSelect algorithm, based on the results of the RV-LV measurements and automatic capture tests. Choose a Selection Method button to batch store the
Programmed Parameters to the suggested programmed settings. The Selection Method choices are:
-
Programmed. The currently programmed settings.
-
Latest Activation. Settings that are based on the lowest capture threshold for the cathode and the longest RV-LV conduction time.
-
Widest Spacing. For devices with MultiPoint Pacing. Settings that represent the greatest anatomical separation between anode and cathode.
-
Earliest and Latest Activation. For devices with MultiPoint Pacing. Settings that are based on the earliest RV-LV conduction time for LV1 and the latest conduction time for LV2.
Programmable Parameters. Select each button to change the batched parameters suggested by the automatic testing. You can program the Pulse Configuration, Cap Confirm, Pulse Amplitude, and Pulse Width for LV, LV1, and LV2.
Program and Preview buttons for new settings for the programmable parameters
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Access MultiVector Tools button
Accessed From: Tests button > Capture and Sense tab > LV/LV1/LV2 Capture test > MultiVector Testing button
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button or Perform MPP Auto VectSelect button > Auto
VectSelect Capture Test window > Measure LV Thresholds button
VectSelect Manual Capture Test
The Manual Capture Test window allows you to perform and record individual capture tests for any LV Pulse Configuration. The window contains:
Dynamic heart diagram. Highlights the LV electrodes currently selected for the LV Pulse Configuration. The arrow indicates the direction of the pulse (cathode to anode).
RV-LV conduction time measurements.
Test Results table. Displays the results of all Capture and PNS tests conducted in the current programming session. Select a highlighted Capture test result button to open details of the test result.
50
Test Vector Settings. To manually test the capture threshold for a particular pulse configuration, use the buttons to select the test vector, Pulse Amplitude, and Pulse Width. Once you have select the correct settings, select the Start Manual Capture Test button to begin the test.
See Instructions for the Manual Capture Test (page 51).
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Access MultiVector Tools button
Accessed From: Tests button > Capture and Sense tab > LV/LV1/LV2 Capture test > MultiVector Testing button
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button or Perform MPP Auto VectSelect button > Auto
VectSelect Capture Test window > Measure LV Thresholds button
Instructions for the VectSelect Manual Capture Test
The Manual Capture Test allows you to manually test the capture threshold of each possible LV Pulse Configuration.
1.
If you wish to re-measure the RV-LV conduction time before testing, select the RV-LV Conduction Time window to open the
Measure RV-LV Conduction Time (page 49) window.
2.
If you wish to change any test parameters other than the Pulse Amplitude and Pulse Width, select the Additional Parameters
button to open the MultiVector Testing: Additional Parameters (page 52) window.
3.
4.
To begin the test, select the test vector (right side of the screen) you would like to test. To choose the vector, you can:
-
Select the right or left arrows to move between vectors, or
-
Select the Test Vector button to see a list of all possible vectors.
Each vector selected is shown in the Dynamic Heart Diagram on the right side of the screen.
Set the Pulse Amplitude and Pulse Width settings so that you can ensure capture. Select either the parameter button to see a range of settings or use the + and - buttons to increase or decrease the setting.
Select the Start Manual Capture Test button.
5.
6.
7.
The programmer initiates the temporarily programmed parameters.
Decrease the Pulse Amplitude setting using the - button until the devices loses capture.
Increase the Pulse Amplitude until capture is restored.
8.
Select the Record Capture Loss button.
9.
The test ends and the results are listed in the Test Results table.
You can choose another vector to test or close the test window.
The Phrenic Nerve Stimulation (PNS) Test window allows you to observe the occurrence of PNS during high voltage pulses at a particular LV Pulse Configuration and to record your results in the Test Results table. The window contains:
Dynamic heart diagram. Highlights the LV electrodes currently selected for the LV Pulse Configuration. The arrow indicates the direction of the pulse (cathode to anode).
RV-LV conduction time measurements.
Test Results table. Displays the results of all Capture and PNS tests conducted in the current programming session. Select a highlighted Capture test result button to open details of the test result.
Test Vector Settings. To manually test the PNS for a particular LV Pulse Configuration, use the buttons to select the test vector,
Pulse Amplitude, and Pulse Width. Once you have select the correct settings, select the Check PNS button to begin the test.
See Instructions for the Phrenic Nerve Stimulation (PNS) Test (page 51).
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Access MultiVector Tools button
Accessed From: Tests button > Capture and Sense tab > LV/LV1/LV2 Capture test > MultiVector Testing button
Instructions for the Phrenic Nerve Stimulation (PNS) Test
The Phrenic Nerve Stimulation (PNS) Test allows you to deliver a high voltage pulse to any LV Pulse Configuration to determine if
PNS results. By recording your findings in the programmer, the Auto VectSelect algorithm can eliminate any vector that causes PNS and help pinpoint the suggested parameter set.
1.
If you wish to re-measure the RV-LV conduction time before testing, select the RV-LV Conduction Time window to open the
Measure RV-LV Conduction Time (page 49) window.
2.
If you wish to change any test parameters other than the Pulse Amplitude and Pulse Width, select the Additional Parameters
button to open the MultiVector Testing: Additional Parameters (page 52) window.
3.
4.
To begin the test, select the test vector (right side of the screen) you would like to test. To choose the vector, you can:
-
Select the right or left arrows to move between vectors, or
-
Select the Test Vector button to see a list of all possible vectors.
Each vector selected is shown in the Dynamic Heart Diagram on the right side of the screen.
Set the Pulse Amplitude and Pulse Width settings to evaluate PNS. Select either the parameter button to see a range of settings or use the + and - buttons to increase or decrease the setting.
51
5.
6.
7.
8.
9.
10.
11.
Select the Check PNS button.
The programmer initiates the temporarily programmed parameters.
Examine the Rhythm Display for signs of PNS. Change the Pulse Amplitude and Pulse Width settings as needed..
Select the Record PNS button if PNS is present or select the Record No PNS button if the patient does not report PNS. The findings are recorded in the Test Results column.
Repeat the process for each Test Vector of interest.
Close the test window to return to the VectSelect Quartet MultiVector Tools window.
Select one of the batched settings in the Selection Method column. Any vector that has PNS present will not be included in the selection.
You may wish to re-run the Automatic LV Capture Thresholds again, replacing any vector with PNS with vectors that have no
PNS.
MultiVector Testing: Additional Parameters
The VectSelect Quartet™ MultiVector Testing: Additional Parameters window allows you to set the test parameters for
VectSelect Quartet™ MultiVector Testing.
Available parameters that may be temporarily set during the test include:
LV Pulse Configuration
LV Pulse Amplitude
LV Pulse Width
Mode
Base Rate
V. Pace Refractory
Paced AV Delay
Sensed AV Delay
Available In: Devices with VectSelect Quartet LV Pulse Configuration capability (page 199)
Accessed From: Tests button > CRT Toolkit tab > Access MultiVector Tools button
Accessed From: Tests button > Capture and Sense tab > LV/LV1/LV2 Capture test > MultiVector Testing button
Accessed From: Tests button > CRT Toolkit tab > Perform Auto VectSelect button or Perform MPP Auto VectSelect button > Auto
VectSelect Capture Test window > Measure LV Thresholds button
VectSelect Quartet™ Capture Results
The VectSelect Quartet Capture Results window shows the Capture Test waveform for a specific test vector recorded during the
VectSelect Quartet™ MultiVector Testing. You can view, change, or print the waveform like any Freeze Capture.
The window also shows the tested LV Pulse Configuration, the Pulse Width and Pulse Amplitude of the LV capture, an results of any
PNS test.
QuickOpt™ Timing Cycle Optimization
temporary parameter settings and calculates optimal settings. The optimization procedure is only available in DDD, DDI, and VVI modes.
The QuickOpt Timing Cycle Optimization window contains two buttons:
Perform Test. Opens the QuickOpt™ Optimization Wizard that automatically measures the width of the sense and pace signals with pre-set test parameters and calculates optimal delay settings.
portion of the delay optimization calculation manually with an ability to adjust the pre-set test parameters.
Available in: Devices with QuickOpt Timing Cycle Optimization capability (page 195)
Accessed From: Tests button > Timing Optimization tab
WARNING
Timing Cycle Optimization is performed, tachycardia and fibrillation detection are suspended and no arrhythmia therapy is delivered.
NOTE
pacing (Sensor (page 65)) are suspended.
52
Test Results. The measurements and test results are saved on the programmer only for the duration of the session.
Results are cleared at the end of the session.
V Sense Configuration. During procedure, the V Sense Configuration is programmed to RV Bipolar.
A Sense Configuration. During procedure, the A Sense Configuration is programmed to Unipolar.
MultiPoint™ Pacing. The QuickOpt Timing Cycle Optimization test is not designed for MultiPoint Pacing.
Recommendations for Ventricular Pacing do not include MultiPoint Pacing settings (RV -> LV1 - LV2 and LV1 -> LV2 ->
RV).
QuickOpt™ Optimization: Perform Manual Test
The QuickOpt™ Timing Cycle Optimization window contains controls to measure the width of the atrial sense signals and to optimize
contains the following buttons and check-boxes:
Perform Test. Select one of these buttons to open the manual measurement controls (QuickOpt™ Optimization: Manual Test
(page 53)). The button also shows any previous QuickOpt measurements.
measurement.
Check-boxes. Select any of these to check (store for programming) or un-check (leave the parameter unchanged) the proposed setting. To permanently program the setting, select the Program Optimal Values button below.
Program Optimal Values. After a successful measurement, select this button to permanently program the recommended settings.
Print Report. After a successful measurement, select this button to print the results.
Accessed From: Tests > Timing Optimization tab > Manual Testing & Results button
QuickOpt™ Optimization: Manual Test
The QuickOpt™ Timing Cycle Optimization window shows:
The Start Test button to begin measuring the width of the pace or sense signal. This toggles to the Stop Test button that appears after nine events have been measured.
Additional buttons to change relevant parameters during the test.
The Cancel Temporary button to cancel the measurement.
See Instructions for the QuickOpt Optimization Manual Measurement (page 53).
Accessed From: Tests > Timing Optimization tab > Manual Testing & Results button > Perform Test buttons
Instructions for the QuickOpt™ Optimization Manual Measurement
1.
2.
3.
4.
5.
6.
7.
8.
9.
From the Tests window, select the Timing Optimization tab.
Select the Manual Testing & Results button.
The QuickOpt™ Timing Cycle Optimization window opens.
Select one of the Perform Test buttons.
The QuickOpt Timing Cycle Optimization window opens for that measurement. Green buttons show temporarily programmed settings.
Select any available parameter button to temporarily change the setting during the test.
To reveal the underlying rhythm, set low Base Rate and long Paced/Sensed AV Delay settings.
Select the Start Test button.
The programmer institutes the temporary settings and begins to measure pace or sense signals. The procedure requires at least nine events to compute the optimal setting. The number of the measured cycles appears in the window. After nine events have been successfully measured, the Stop Test button is available. The measurements continue until you select the Stop Test button.
After nine events, select the Stop Test button.
The QuickOpt Timing Cycle Optimization window appears. You can either reject the proposed settings (Step 7) or accept them
(Step 8).
To reject the suggested setting, uncheck the box next to the parameter and select the X at the top right corner of the screen to
close the screen and return to the QuickOpt™ Timing Cycle Optimization (page 52) window.
To accept any suggested setting, select any of the check-boxes. Then, select the Program Optimal Values button.
changes.
Select the Program button to program the new settings or the Discard Changes button to reject the proposed changes.
QuickOpt™ Optimization Freeze Capture
The QuickOpt Freeze Optimization Capture window contains up to the most recent 30 s of the EGM, Markers data, and Surface ECG
various aspects of the screen display and print the results. The window also contains the average measurement, the eight measurements used, and the optimal values for all Delay parameters.
Accessed From: Tests > Timing Optimization tab > Manual Testing & Results button > EGM button
53
Fibber & NIPS
to conduct the Fibrillation Induction (Fibber) test and the Noninvasive Programmed Stimulation (NIPS) test and the NIPS window
the Noninvasive Programmed Stimulation (NIPS) test. These tests use the device’s circuitry to introduce asynchronous electrical impulses to the myocardium at precise intervals in a predetermined pattern. The programmer disables arrhythmia detection and diagnosis during the test.
(DC) to induce fibrillation. You can terminate arrhythmias induced with the V. Fibber Test with the Device-Based Testing (page
which you can manually apply a pacing burst to a chamber to induce an arrhythmia; or the Extrastimuli Test, in which you can program the length of the initial pacing burst followed by timed additional stimuli to induce an arrhythmia.
Accessed From: Tests button > Fibber & NIPS tab (CRT-Ds, Dual-Chamber ICDs, and Single-Chamber ICDs)
Accessed From: Tests button > NIPS tab (CRT-Ps, Dual-Chamber Pacemakers, and Single-Chamber Pacemakers)
CAUTION
RF Communication. While you are conducting the Fibber and NIPS tests, ensure that at least four telemetry strength indicator LEDs appear on the programmer and the Merlin™ Antenna. If fewer LEDs are lit, the device may lose its communication link when it charges or dumps the capacitors. If this occurs, the test ends and the device returns to its permanently programmed parameters.
NOTE
Telemetry Communication. During Fibber and NIPS tests, telemetry communication with the device must be maintained.
If the telemetry link is broken during the test, the device returns to its permanently programmed parameters.
ERI. Fibber and NIPS testing are not available when the device reaches ERI.
Stopping the Test. When you communicate with the device via the inductive telemetry wand, you can stop the test by removing the wand. However, if you use RF communication, you must select the Cancel Test button to stop the test.
Fibber Test
From Fibber test window, you can:
Choose the type of Fibber test to conduct (Fibber Mode).
-
Burst (page 55). Delivers bursts of stimuli at short cycle lengths with no extra stimuli.
-
-
Shock-on-T. Delivers overdrive pacing followed by a properly timed high-voltage shock (V. Fibber Test only).
Set the Fibber Test Parameters (page 55).
defibrillate the patient after an arrhythmia was induced.
View the Time Since Last Induction. The length of time that has elapsed since the end of the last arrhythmia induction. This timer resets each time an arrhythmia induction is initiated.
Run the test (select the Enable Fibber button).
View the test results when you select the Display New Episodes button. This opens the detail of the fibber test episode.
See also:
Fibber Test Instructions (page 55)
Device-Based Testing (page 57)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
WARNING
Always have a separate standby external defibrillator immediately available.
WARNING
disabled.
CAUTION
RF Communication. While you are conducting the Fibber and NIPS tests, ensure that at least four telemetry strength indicator LEDs appear on the programmer and the Merlin™ Antenna. If fewer LEDs are lit, the device may lose its communication link when it charges or dumps the capacitors. If this occurs, the test ends and the device returns to its permanently programmed parameters.
NOTE
Telemetry Communication. During Fibber test, telemetry communication with the device must be maintained. If the telemetry link is broken during the test, the device returns to its permanently programmed parameters.
Therapy. All antitachyarrhythmia therapies are right-ventricular only.
Atrial Burst Fibber Mode. Backup ventricular pacing is available when burst stimuli are delivered to the atrium (see V.
54
Fibber Test Instructions
Shock-on-T
4.
5.
6.
1.
2.
3.
Burst
7.
8.
9.
10.
11.
Establish telemetry between the device and the programmer.
Select the Tests button.
Select the Fibber & NIPS tab.
Select the Atrial or Ventricular Fibber button.
Set the Fibber Mode to Burst.
parameters.
Waveform) (page 111) and navigate back to the Fibber window.
Select the Enable Fib button.
Press and hold the Hold to Apply Burst button for the desired duration. The arrhythmia induction ends if the telemetry link is broken.
Release the Hold to Apply Burst button to end the test. The device delivers therapy after the arrhythmia induction. See Device
Repeat from step 6 if desired.
DC
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Establish telemetry between the device and the programmer.
Select the Tests button.
Select the Fibber & NIPS tab.
Select the Ventricular Fibber button.
Set the Fibber Mode to DC
Set the Pulse Duration (page 56) setting.
111) and navigate back to the Fibber window.
Select the Enable Fib button.
Select the Induce Fib button.
The arrhythmia induction ends if the telemetry link is broken.
Repeat from step 6, if desired.
The device delivers therapy after the arrhythmia induction. See Device-Based Testing (page 57).
1.
2.
3.
4.
5.
6.
Shock-on-T
7.
8.
9.
10.
Establish telemetry between the device and the programmer.
Select the Tests button.
Select the Fibber & NIPS tab.
Select the Ventricular Fibber button.
Set the Fibber Mode to Shock-on-T.
111) and navigate back to the Fibber window.
Select the Enable Fib button.
Select the Induce Fib button.
The arrhythmia induction ends if the telemetry link is broken.
Repeat from step 6, if desired.
The device delivers therapy after the arrhythmia induction. See Device-Based Testing (page 57).
Fibber Test Parameters
See Fibber Test Instructions (page 55).
Pulse Duration (page 56). This parameter is available for the V. Fibber DC test.
S2 Shock Energy/Voltage (page 56). This parameter is available for the V. Fibber Shock-on-T test.
S1 Count (page 56).This parameter is available for the V. Fibber Shock-on-T test.
55
S1S2 (page 56). This parameter is available for the V. Fibber Shock-on-T test.
V. Support Rate (page 57). This parameter is available for A. Fibber Burst test.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
Pulse Amplitude
The Pulse Amplitude parameter determines the delivered stimuli voltage.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
Pulse Width
The Pulse Width parameter determines the duration of the fibber stimuli.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
Pulse Duration
The Pulse Duration parameter determines the length of time that the direct-current (DC) pulse is delivered through the high-voltage electrodes.
See also:
Parameter Availability and Settings
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
The Pulse Duration parameter determines the length of time that the direct-current (DC) pulse is delivered through the high-voltage electrodes.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
S2 Shock Energy/Voltage
The S2 Shock Energy/Voltage parameter determines the amount of energy delivered during the S2 Shock. It is delivered when a Twave is detected for the V. Fibber Shock-on-T Test. When the Waveform Mode parameter is set to Tilt, the settings are Joules; then
the Waveform Mode (page 112) parameter is set to Pulse Width, the settings are in Volts.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
S1 Count
The S1 Count parameter determines the number of stimuli delivered in the S1 drive cycle preceding a shock-on-T. The first stimulus is delivered synchronously with a sensed or paced event.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
S1S1
This parameter specifies the amount of time between all S1 stimuli in the Burst or Shock-on-T Fibber modes.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
S1S2
The S1S2 parameter specifies the amount of time that the device waits after the last S1 stimulus to deliver the high voltage S2 shock.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
56
V. Support Rate
The V. Support Rate parameter is the pacing rate of the stimulus delivered to the ventricle during A. Fibber (VOO pacing).
CAUTION
information.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular Fibber button
Device-Based Testing
The Device-Based Testing parameters allow you to select how to terminate any arrhythmias induced by the ventricular fibber tests.
available parameters. For more information, see:
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Tests button > Fibber & NIPS tab > Ventricular Fibber button
WARNING
arrhythmia induction is not available if Tachy Therapy is disabled.
NOTE
If the capacitors have not charged to the desired voltage by the time the therapy is scheduled or selected for delivery, the therapy is postponed until the desired voltage is reached.
If the capacitors take longer than 32 s to reach the desired voltage, the device delivers the voltage present on the capacitors.
1st Therapy Method
The 1st Therapy Method parameter determines how the first therapy is delivered after the ventricular Fibber Test induces an arrhythmia. The settings are:
Automatic. The device automatically detects, diagnoses, and treats an arrhythmia induced by the test. The method uses the currently programmed detection and therapy parameters. You can change these settings if you select the Defib Therapy
available when the Zone Configuration parameter is Off.
Hold to Apply Burst button. For the DC and Shock-on-T tests, the timer starts after the programmer delivers the inducing shock.
Manual. In the Manual method, after the arrhythmia induction, you can manually start the therapy when you select the Deliver
Therapy button. The therapy energy or voltage is determined by the 1st Therapy (page 57) parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Ventricular Fibber button
1st Therapy
The 1st Therapy parameter determines the amount of energy or voltage that is delivered during the Timed or Manual therapy methods. Subsequent therapies are delivered according to the programmed Detection Criteria. This parameter is only available when
the 1st Therapy Method (page 57) parameter is set to Timed or Manual.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Ventricular Fibber button
Time to Therapy
The Time to Therapy parameter determines the delay between the end of arrhythmia induction and delivery of the high-voltage
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Ventricular Fibber button
57
NIPS Test
The NIPS (Non-Invasive Programmed Stimulation) Test allows you to induce or terminate an arrhythmia by delivering trains of pacing bursts to the atrium or ventricle. From the NIPS window, you can:
Choose the type of NIPS test to conduct (Extrastimuli (page 58) or Burst (page 55)).
-
The Burst Test allows you to manually apply a burst of low-voltage pulses to a chamber
-
The Extrastimuli Test allows you to apply a burst of low-voltage pulses to a chamber and to program the length of the initial pacing burst followed by timed additional stimuli.
Set the displayed NIPS Parameters (page 59).
Set additional NIPS Test Parameters (page 60).
Print the current NIPS Test Parameters with the Print Settings button.
Run the tests.
Display New Episodes. Select this button to view the episode detail of any arrhythmia induced by extrastimuli. This button is
163), and Single-Chamber Pacemakers (page 163).
See also:
NIPS Test Instructions (page 58).
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
WARNING
CAUTION
RF Communication. While you are conducting the Fibber and NIPS tests, ensure that at least four telemetry strength indicator LEDs appear on the programmer and the Merlin™ Antenna. If fewer LEDs are lit, the device may lose its communication link when it charges or dumps the capacitors. If this occurs, the test ends and the device returns to its permanently programmed parameters.
CAUTION
Ventricular Backup Pacing is delivered in the VOO (page 154) Mode.
NOTE
Telemetry Communication. During NIPS tests, telemetry communication with the device must be maintained. If the telemetry link is broken during the test, the device returns to its permanently programmed parameters.
Therapy. In CRT-Ds (page 161), Dual-Chamber ICDs (page 162), and Single-Chamber ICDs (page 162), all
antitachyarrhythmia therapies are right-ventricular only.
NIPS Test Instructions
4.
5.
6.
7.
1.
2.
3.
Extrastimuli
NOTE
To print out the currently programmed NIPS parameters, select the Print settings button.
Establish telemetry between the device and the programmer.
Select the Tests button.
Select the Fibber & NIPS
Select the Atrial or Ventricular NIPS button.
Select the Extrastimuli radio button.
Set the NIPS Parameters (page 59) and the additional NIPS Test Parameters (page 60).
Select the Start NIPS button.
The pulse train for the programmed S1 Count begins. The pulse train ends if the telemetry link is broken or if you select the
Cancel Test button.
Burst
1.
Establish telemetry between the device and the programmer.
2.
3.
4.
Select the Tests button.
Select the Fibber & NIPS or NIPS tab.
Select the Atrial or Ventricular NIPS button.
5.
Select the Burst radio button.
82
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
83 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
58
6.
7.
8.
Set the S1S1 (page 56) parameter and set additional NIPS Test Parameters (page 60).
Press and hold the Hold to Apply Burst button for the desired duration.
Release the Hold to Apply Burst button to end the test.
NIPS Parameters
The availability of NIPS parameters depends on which method of NIPS you choose: Extrastimuli or Burst.
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
S1 Count
The S1 Count parameter specifies the number of S1 stimuli that the device will deliver during the NIPS test. This is only available with the Extrastimuli method.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
S1S1
This parameter is the amount of time that the device waits after the last paced/sensed event before delivering the first S1 stimulus and the amount of time between all subsequent S1 stimuli.
If you select the Fixed Mode, the S1S1 parameter remains at a fixed setting in ms. If you select the Adaptive Mode, the S1S1 parameter is calculated as a percentage of the last measured interval.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
S1S2
The S1S2 parameter is the amount of time that the device will wait after the last S1 stimulus to deliver the S2 NIPS stimulus. This is only available with the Extrastimuli method.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
S2S3
The S2S3 parameter is the amount of time that the device waits after the S2 stimulus to deliver the S3 NIPS stimulus. This is only available with the Extrastimuli method.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
S3S4
The S3S4 parameter is the amount of time that the device waits after the S3 stimulus to deliver the S4 NIPS stimulus. This is only available with the Extrastimuli method.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
59
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
NIPS Test Parameters
See NIPS and S1 Burst Test Instructions.
The NIPS test parameters include the following:
Sinus Node Recovery Delay (page 60)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
Pulse Amplitude
The NIPS Pulse Amplitude the amount of voltage delivered to the myocardium during NIPS testing. It is independent of the current programmed setting for the Pulse Amplitude parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
Pulse Width
The NIPS Pulse Width parameter is the duration of the pulse during NIPS testing. It is independent of the current programmed setting for the Pulse Width parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
Pulse Configuration
The NIPS Pulse Configuration parameter sets the anode and cathode of the pulse during NIPS testing. The NIPS setting for this parameter is independent of the current programmed setting for the Pulse Configuration parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
Sinus Node Recovery Delay
The Sinus Node Recovery Delay parameter is the time allowed between the final atrial NIPS pulse and the resumption of normal atrial pacing. This delay provides a period with no external stimulation to allow time for the sinus node to recover from the stimuli.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
V. Support Rate
The V. Support Rate parameter is the pacing rate of the stimulus delivered to the ventricle during A. NIPS (VOO pacing). During the delivery of atrial NIPS, the V. Pulse Amplitude and V. Pulse Width parameters of the backup pacing are set at the current programmed settings.
See also:
Parameter Availability and Settings (page 201)
60
Accessed From: Tests button > Fibber & NIPS tab > Atrial or Ventricular NIPS button (CRT-Ds, Dual-Chamber ICDs, and Single-
Chamber ICDs)
Accessed From: Tests button > NIPS tab > Atrial or Ventricular NIPS button (CRT-Ps, Dual-Chamber Pacemakers, and Single-
Chamber Pacemakers)
Temporary Pacing
From the Temporary Pacing window you can initiate temporary pacing. Temporary Pacing is also available through the Preview
Changes window.
The window also contains the following buttons from which you can select settings for use during temporary pacing. These parameters can be adjusted while temporary pacing is ongoing. The new values are immediately in effect.
LV Pulse Configuration (page 80)
Ventricular Pace Refractory (page 82)
Post-Ventricular Atrial Blanking (page 81)
Pulse Amplitude
Pulse Width
The following parameters are not selectable during temporary pacing and remain as selected:
Atrial and Ventricular Sensitivity (page 76)
Ventricular Safety Standby (page 83)
WARNING
pacing, tachycardia and fibrillation detection is suspended and no arrhythmia therapy is delivered.
NOTE
responsive pacing (Sensor (page 65)) are suspended.
Telemetry Communication. During temporary pacing, telemetry communication with the device must be maintained. The temporary pacing settings are in effect only when the Temporary Pacing window is shown and only during telemetry communication with the device. If telemetry communication between the device and the programmer breaks, temporary pacing ends and the permanent parameters are restored within two seconds.
Accessed From: Tests > Temporary Pacing
61
Brady Parameters
The Brady Parameters window shows most of the programmable brady parameters divided into groups. Select the appropriate button to change parameter settings. The buttons are:
Refractories & Blanking (page 80)
AT/AF Detection & Response (page 85)
Rates & Refractories (page 87) (single chamber devices only)
Accessed From: Parameters button > Brady tab
Basic Operation
From the Basic Operation window, you can change the settings for the following parameters:
Ventricular Pacing
Interventricular Delay
V. Noise Reversion Mode (page 64)
Episodal Pacing Mode (page 65)
Restore Last Settings (page 67)
MultiPoint™ Pacing Settings (page 67)
Accessed From: Parameters button > Brady tab > Basic Operation button
Mode
The Mode parameter determines the basic pacing operation of the device.
For timing diagrams and mode description, see Mode Descriptions (page 151).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Ventricular Pacing
The Ventricular Pacing parameter determines which ventricles are paced and the order in which they are paced. When you select the LV—>RV or RV—>LV settings, you can also set the Interventricular Delay parameter.
Pacing parameter.
If you program the Ventricular Pacing parameter to a setting other than RV -> LV1 -> LV2 or the LV1 -> LV2 -> RV, then MultiPoint pacing is disabled.
NOTE
In order to enable MultiPoint Pacing when the RVCap Confirm or LVCap Confirm parameter is On, the pacing Delay must be programmed to 15 ms or greater.
MultiPoint Pacing is not available during Temporary Programming. If you temporarily program any parameters when
MultiPoint Pacing is enabled, the Ventricular Pacing parameter is autoprogammed to either the RV -> LV or LV -> RV settings.
LVCap Confirm can be enabled while MultiPoint Pacing is enabled. However, the LVCap Confirm setting only applies to the
LV1 Pulse Amplitude setting. The RV Cap Confirm and LV Cap Confirm parameters can be enabled when the MultiPoint
Pacing Delay (page 67) setting is 15 ms or greater.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
63
V. Triggering
The V. Triggering parameter enables the device to send a pulse to the myocardium immediately following the detection of an intrinsic pulse. The V. Triggering parameter is only available when the Mode parameter is set to VVI(R) or DDI(R). Enabling this parameter changes the pacing mode to either VVT(R) or DDT(R).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
NOTE
The Hysteresis Rate parameter is unavailable when the V. Triggering parameter is enabled.
must be at least 30 ms longer than the longest tachycardia detection interval when both the V. Triggering parameter and tachycardia therapy are enabled.
You can enable or disable the V. Triggering parameter by re-setting the Mode parameter.
When both MultiPoint™ Pacing and V. Triggering are enabled, the RVCap™ Confirm and the LVCap™ Confirm setting
"On" is not available. To program RVCap Confirm or LVCap Confirm On, disable either MulitPoint Pacing or V. Triggering.
Interventricular Delay
The Interventricular Delay parameter determines the interval between the pulses delivered to the ventricles when the Ventricular
Pacing parameter is set to either LV–>RV or RV–>LV. The Interventricular Delay setting can be evaluated with the QuickOpt™ Timing
Cycle Optimization (page 52) test.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button > Ventricular Pacing parameter button
Magnet Response
The Magnet Response parameter determines if the device recognizes a magnet when it is placed over the device.
Normal, a strong magnetic field suspends tachy detection and prevents delivery of tachyarrhythmia therapy. When the Magnet
Response is Ignore, the device ignores the presence of a magnet and delivers therapy as usual. Bradycardia pacing is not affected by a magnet placed over a CRT-D, dual-chamber ICD, or single-chamber ICD.
Response is programmed to Battery Test and the magnet is placed over the device, the device paces asynchronously at the Magnet
Rate, which is an indication of battery status. If Magnet Response is programmed Off and the magnet is placed over the device, the device will not respond to the placement of the magnet.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
NOTE
Detection and Therapy. In CRT-Ds, dual-chamber ICDs, and single-chamber ICDs, a magnet placed over the device can be useful in the prevention of tachyarrhythmia detection and delivery of therapy if a programmer is not available to turn
the device Off (page 120). See the device user’s manual for more information on the use of magnets.
120 ms during magnet application.
parameter is set to the Battery Test setting, the device stores the episode after a two-second delay and performs a Battery
Test after a five-second delay.
V. Noise Reversion Mode
The V. Noise Reversion Mode algorithm prevents the device from sensing high-frequency noise on the ventricular channel as
Reversion Mode algorithm is enabled the device sets the pacing rate to 50
min§. In CRT-Ps (page 162), Dual-Chamber Pacemakers
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
NOTE
available in DDD(R), DDI(R), and VVI(R) pacing modes. In CRT-Ps, Dual-Chamber Pacemakers, and Single-Chamber
Pacemakers, the V. Noise Reversion Mode parameter is available in DDD(R), DDI(R), DVI(R), VVI(R), and VDD(R) pacing modes.
64
Episodal Pacing Mode
The Episodal Pacing Mode parameter determines the pacing mode used during an episode. The device changes to the Episodal
Pacing Mode setting after the third non-sinus interval and ends when the device redetects sinus.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Sensor
The Sensor parameter turns on rate-responsive pacing, which enables the device to increase or decrease its pacing rate based on activity sensor data.
When Passive is selected, the device does not activate rate-responsive pacing, but it records diagnostic data that can be read in the
NOTE
Elective Replacement Indicator (ERI). When the device reaches ERI, it automatically reprograms Sensor to Off, which disables rate-modulated pacing.
The Sensor parameter is .available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC Model
1240.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Threshold
A lower Threshold setting allows the sensor to respond to lower levels of activity, while a higher setting makes the sensor respond only to higher activity levels.
The "Auto" settings allow the device to automatically adjust the Threshold parameter above or below the Measured Average Sensor
(MAS) value, a calculation of the patient’s activity over the previous 18 hours. Thus, a setting of Auto (+1.0) automatically sets the
Threshold parameter to 3.0 if the MAS value is 2.0. The MAS value is continually updated with new sensor data.
The MAS value appears under the Threshold button.
To clear and recalculate the MAS value, select the Reset Auto Threshold button.
NOTE
The Threshold parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC
Model 1240.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Slope
The Slope parameter assigns a flatter (low setting) or steeper (high setting) slope to the sensor rate-response. Lower settings, or flatter responses, limit the response to activity to small increases in the pacing rate. Higher settings, or steeper responses, allow the rate to increase to higher pacing rates. The figure below illustrates the various settings for the Slope parameter.
The "Auto" settings allow the device to automatically adjust the Slope parameter above or below the Measured Auto Slope, which is a calculation of the patient’s activity over the previous seven days.
Figure 3. Slope
1.
Increase in rate min§
2.
Sensor level
3.
Low activity
4.
High activity
5.
Slope 16
6.
Slope 1
65
NOTE
The Slope parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC Model
1240.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Max Sensor Rate
The Max Sensor Rate parameter is the fastest pacing rate allowed by the rate-responsive pacing. It is also the fastest Sensor (page
65)-indicated rate that can be recorded when the Sensor parameter is set to Passive.
at least 30 ms longer than the longest programmed tachycardia detection interval to prevent arrhythmia detection at the Max Sensor
Rate setting.
NOTE
The Max Sensor Rate parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core
SC Model 1240.
See also:
Parameter Availability and Settings (page 201)
Brady tab > Basic Operation button
Refractories button
Reaction Time
for rapid rate increases, while a Slow setting only allows the rate to increase slowly.
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Basic Operation button
Rates & Refractories button
NOTE
Slope (page 65). Reaction Time increases are limited by the Slope setting.
The Reaction Time parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC
Model 1240.
Recovery Time
rapid rate decreases, while a Very Slow setting only allows the rate to decrease slowly.
Rate (page 68) setting following an advanced hysteresis intervention.
See also:
Parameter Availability and Settings (page 201)
Brady tab > Basic Operation button
Refractories button
NOTE
Slope (page 65). Recovery Time increases are limited by the Slope setting.
parameter is Off.
The Recovery Time parameter is available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC
Model 1240.
66
Restore Last Settings
The Restore Last Settings button automatically restores all of the previous bradycardia and tachycardia parameter settings if the
Mode (page 63) parameter is set to Pacing Off and/or the Zone Configuration (page 89) is set to Off.
In single-chamber pacemakers, dual-chamber pacemakers, and CRT-Ps, the Restore Last Settings button restores all previous bradycardia parameters when the Mode parameter is set to Pacing Off, AOO, VOO, or DOO. Changes to any parameter while in these
Modes are reverted to the previous setting when you select the Restore Last settings button.
MultiPoint™ Pacing
From the MultiPoint™ Pacing window, you can change settings for the following parameters:
Ventricular Pacing
LV1 Pulse Configuration (page 60)
LV2 Pulse Configuration (page 67)
MultiPoint Post-Ventricular Atrial Blanking (page 67)
help determine the capture thresholds.
NOTE
MultiPoint Pacing is only available at pacing rates of 110 min§ or less.
When MultiPoint Pacing is enabled and the V. Triggering or AMS V. Triggering parameters are enabled, then the
MultiPoint Pacing enables triggered pacing.
MultiPoint Pacing is not available during Temporary Programming. If you temporarily program any parameters when
MultiPoint Pacing is enabled, the Ventricular Pacing parameter is autoprogammed to either the RV -> LV or LV -> RV settings.
When both MultiPoint™ Pacing and V. Triggering are enabled, the RVCap™ Confirm and the LVCap™ Confirm setting
"On" is not available. To program RVCap Confirm or LVCap Confirm On, disable either MulitPoint Pacing or V. Triggering.
Available in: Devices with MultiPoint™ Pacing Capability (page 192)
Accessed From: Parameters button > Brady tab > Basic Operation button > MultiPoint Pacing button
Delay
The Delay parameter determines the interval between the pulses delivered to the right and left ventricles when MultiPoint™ Pacing is enabled (see Ventricular Pacing). The interval between each pulse is independently programmable.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button > MultiPoint Pacing button
NOTE
Oversensing. Oversensing may occur when high MultiPoint Pacing Pulse Amplitude settings and long MultiPoint Pacing
Pulse Width settings are programmed along with long MultiPoint Pacing Delay settings and maximum Sensitivity settings.
RVCap Confirm and LV Cap Confirm. In order to enable MultiPoint Pacing when the RVCap Confirm or LVCap Confirm parameter is On, the pacing Delay must be programmed to 15 ms or greater.
MultiPoint™ Pacing LV2 Pulse Configuration
The MultiPoint™ Pacing LV2 Pulse Configuration parameter determines the polarity of the second LV pacing pulse delivered. The first LV pacing pulse polarity is determined by the Pulse Configuration parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button > MultiPoint Pacing button
MultiPoint™ Pacing PVAB
establishes an atrial refractory period after ventricular paced and sensed events to prevent the atrial channel from detecting far-field
R-waves when MultiPoint Pacing is enabled.
Atrial events falling within the MultiPoint Pacing PVAB period do not update the filtered atrial rate interval (FARI), nor are they used
falling in this period are not counted in the AT/AF diagnostics.
NOTE
MultiPoint PVAB pacing is only available at pacing rates of 110 min§ or less.
MultiPoint PVAB pacing is only available when MultiPoint Pacing is enabled.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button > MultiPoint Pacing button
67
Rates
From the Rates window, you can change the settings for the following parameters:
You can also access the following:
parameters.
For single-chamber devices, see Rates & Refractories (page 87).
Accessed From: Parameters button > Brady tab > Rates button
Base Rate
The Base Rate parameter sets the patient’s minimum pacing rate. Typically, rates can fall lower than the Base Rate setting only if
Hysteresis Rate (page 69), Rest Rate (page 68), or Post-Shock Base Rate (page 118) is enabled.
In DDD and atrial modes, the Base Rate interval is measured from an atrial stimulus to the next atrial stimulus without an intervening sensed atrial event. In VDD and ventricular modes (including DVI and DDI modes), the interval is from a ventricular stimulus to the next stimulus without an intervening sensed ventricular event (or an intervening sensed atrial event in VDD mode).
See also:
Parameter Availability and Settings (page 201)
Parameters button > Rates tab > Basic Operation button
Rates & Refractories button
NOTE
Elective Replacement Indicator (ERI). In CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers, when battery voltage decreases to ERI, the actual pacing interval is 100 ms longer than the programmed Base Rate interval. See
Programmed Pacing Rates and Actual Pacing Rates at ERI (page 331).
Rest Rate
patient is asleep or in long periods of rest.
When the Rest Rate parameter is enabled, the device analyzes activity data over a seven-day period. When it detects that the patient has been inactive for more than 15 to 20 minutes, it switches the pacing rate from the Base Rate setting to the Rest Rate setting.
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Rates button
Rates & Refractories button
NOTE
are disabled when the Rest Rate parameter is enabled.
enabled, the Base Rate setting is used as the Rest Rate setting.
Base Rate (page 68). The available Rest Rate settings are limited by the Base Rate setting.
Max Track Rate
The Max Track Rate (MTR) parameter is the maximum ventricular pacing rate allowed by the device. If the device in DDD(R) or
VDD(R)
84 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
68
that the ventricular paced rate does not exceed the MTR setting. Occasional pauses (Wenckebach behavior) may occur in accord with normal upper rate behavior.
As an aid to programming, when the Max Track Rate parameter is programmed, the programmer shows the intrinsic atrial rate at which 2:1 AV block occurs.
MTR cycle length must be at least 30 ms longer than the longest programmed tachycardia cycle length and is limited by the programmed Paced AV Delay, Sensed AV Delay, and PVARP settings.
See also:
Parameter Availability and Settings (page 201)
Brady tab > Rates button
NOTE
higher than the Max Track Rate setting.
Interval/Rate setting
.
programmed Paced AV Delay, Sensed AV Delay, and PVARP settings.
High Tracking Rates. When programming Maximum Tracking Rates of 190, 200, or 210 min§, ensure that these rates are appropriate for the patient.
Interactions with Algorithms. The interaction of a number of algorithms may allow the device to override the Max Track
Rate and Max Sensor Rate settings. These include all ventricular-based algorithms and the AF Suppression™ Algorithm
upper rate behavior, contact Technical Support (page 161).
Max Trigger Rate
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Basic Operation button
Hysteresis Rate
preferred to pacing. When the Hysteresis Rate parameter is enabled, the device decreases the pacing rate from the Base Rate setting to the Hysteresis Rate setting when it senses intrinsic activity. If the device fails to sense intrinsic activity, the device switches back to the Base Rate setting.
Operation at the Hysteresis Rate setting is triggered by a P-wave in atrial-based modes [DDD(R), AAI(R) and VDD(R)
wave in ventricular-based modes [DDI(R), VVI(R) and DVI(R)
].
] and an R-
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Rates button
Rates & Refractories button
NOTE
the device detects sensor activity.
Suppression algorithm is enabled.
Rest Rate (page 68). The Rest Rate parameter takes precedence over the Hysteresis Rate parameter.
Post-Shock Base Rate (page 118). The Post-Shock Base Rate
parameter takes precedence over the Hysteresis Rate parameter.
Ventricular Pacing. The Hysteresis Rate parameter is not available if the Ventricular Pacing parameter is set to a biventricular pacing sequence and the Mode parameter is set to the VVI setting.
85
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
86 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
87
Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
88 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
69
Hysteresis Tracking Rate
When VDD(R) mode is programmed, the Hysteresis Tracking Rate nonprogrammable parameter is the minimum intrinsic atrial rate at which P-waves can be tracked. This rate interval equals the sum of currently programmed Hysteresis Rate interval and the Sensed
When VDD(R) mode is programmed, the Hysteresis Tracking Rate value appears on the programmer screen below the Hysteresis
Rate button.
Advanced Hysteresis Functions
Up to five additional parameters are available in some devices when the Hysteresis Rate parameter is enabled. The parameters include:
Intervention Duration (page 71)
Search Interval
The Search Interval parameter tells the device to periodically extend the pacing interval by the programmed number of minutes to
five minutes to search for intrinsic activity.
If the device senses an intrinsic beat during the search, it reduces the rate to the programmed Hysteresis Rate setting. If no intrinsic beat is sensed during the Hysteresis Rate interval, the device delivers a pulse at the end of the interval and begins pacing at the
See also:
Parameter Availability and Settings (page 201)
Parameters button > Rates tab > Rates button
Rates & Refractories button
Cycle Count
The Cycle Count parameter determines the number of cycles the device searches for intrinsic activity when Hysteresis Rate is enabled.
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Rates button
Rates & Refractories button
NOTE
Intervention Rate
restored to a higher pacing rate.
When the Intervention Rate parameter is enabled, the device begins pacing at the Intervention Rate setting when the pacing rate falls
setting along a time line described by the Recovery Time (page 66) parameter.
If the Intervention Rate parameter is programmed Off, the device paces at the programmed Base Rate setting if the intrinsic rate drops below the Hysteresis Rate setting.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Rates button
NOTE
Episodes. If the Intervention Rate parameter is enabled, it autoprograms the Advanced Hysteresis Trigger On in devices with that function
.
89 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
70
Intervention Duration
The Intervention Duration parameter is not programmable if the Intervention Rate parameter is Off.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Rates button
Delays
From the Delays window, you can change the settings for the following parameters:
Rate Responsive AV Delay (page 72)
Ventricular Intrinsic Preference (VIP™) Parameter (page 72)
Negative AV Hysteresis/Search (page 73)
You can also access the following:
(page 73), and Search Cycles (page 74) parameters.
Accessed From: Parameters button > Brady tab > Delays button
Paced AV Delay
The Paced AV Delay parameter is the interval between a paced atrial event and a paced ventricular event.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
Rate, or Post-Shock Base Rate settings. The maximum Paced AV Delay settings for all programmed Base Rate, AMS Base
Rate, and Post-Shock Base Rate settings are shown in the following table.
Table 18. Maximum Paced AV Delay settings
AMS Base Rate, Post-Shock Base Rate, or Base Rate
(
min§)
30–90
95-100
105
110
115-120
125
130-160
170
Maximum Paced AV Delay (ms)
200
180
170
160
350
300
250
225
Sensed AV Delay
The Sensed AV Delay parameter is the interval between a sensed atrial event and a paced ventricular event.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
setting. The Sensed AV Delay setting must be shorter than or equal to the Paced AV Delay setting.
90 Rates > 100 are only available in CRT-Ps and dual-chamber pacemakers.
71
Rate Responsive AV Delay
intrinsic atrial rate. A Low setting changes the Paced/Sensed AV Delay setting by one ms for each onemin§ change in the Sensorindicated rate, AF Suppression pacing-driven rate, or sensed intrinsic atrial rate. A High setting changes the Paced/Sensed AV Delay setting by three ms for each onemin§ change in the Sensor-indicated rate, AF Suppression pacing-driven rate, or sensed intrinsic atrial rate. Thus as pacing rates rise, the device decreases both the Paced and Sensed AV Delay settings until the Max Sensor Rate
(page 66), Max Track Rate (page 68), or Shortest AV Delay (page 72) setting is reached.
either 60 min§ or a Base Rate set above 60 min§. When the Sensor-indicated rate or sensed intrinsic atrial rate falls below 60 min§, the algorithm terminates.
For all other devices, the algorithm begins to operate when the rate exceeds either 90 min§ or a Base Rate set above 90 min§.
When the Sensor-indicated rate or sensed intrinsic atrial rate falls below 90 min§, the algorithm terminates.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
Post-Shock Duration
91 . The Rate Responsive AV Delay parameter is disabled during the Post-Shock Duration.
Ventricular Noise Reversion. The Rate Responsive AV Delay parameter is disabled during Ventricular Noise Reversion.
See V. Noise Reversion Mode (page 64).
Ventricular Episode
92 . The Rate Responsive AV Delay setting is disabled during a ventricular episode.
Shortest AV Delay
Sensed AV Delay interval will occur.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
Rate Responsive AV Delay parameter is enabled and the Mode setting is DDD(R), DDIR, VDD(R)
.
disabled but the Negative AV Hysteresis/Search parameter is enabled. This defines the lower limit of delay-shortening by the Negative AV Hysteresis/Search parameter.
Ventricular Intrinsic Preference (VIP™) Parameter
The Ventricular Intrinsic Preference (VIP™) parameter enables an algorithm which allows the device to search for intrinsic
Delay and Paced AV Delay settings are extended to allow the intrinsic conduction to continue.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
Pacing Mode. The VIP algorithm is available only when Mode is DDD(R) or VDD(R).
Conditions for Operation. The VIP algorithm cannot be enabled:
•
When the Base Rate (page 68) setting is >110
min§ and the Rate Responsive AV Delay (page 72) parameter is
enabled
•
When the Ventricular Pacing mode is not RV Only
•
When the Negative AV Hysteresis/Search (page 73) parameter is enabled
VIP suspends operation:
91 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
92
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
93 Available in CRT-Ps and dual-chamber pacemakers.
94
Available in CRT-Ps and dual-chamber pacemakers.
95 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
72
•
When the intrinsic atrial rate or Sensor (page 65)-indicated rate is
≥ 110 min§
• During a Capture or Sense test
•
Following the delivery of a high-voltage shock during the Post-Shock Duration interval if the Post-Shock Mode parameter is enabled.
•
When mode-switching occurs. See Auto Mode Switch (page 85).
PVCs have no effect on this feature.
Negative AV Hysteresis/Search
The settings are the amount the Paced/Sensed AV Delay is decreased after an R-wave detection.
When the Negative AV Hysteresis/Search parameter is enabled, a detected R-wave shortens the Paced/Sensed AV Delay setting. This remains in effect for 31 cycles after R-wave detection. If another R-wave is not detected in that time, the permanently programmed
Paced/Sensed AV Delay setting is restored. If another R-wave is detected during the 31-cycle period, the shortened Paced/Sensed
AV Delay setting remains in effect for 255 cycles.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
NOTE
DDD(R).
override or further shorten the Paced/Sensed AV Delay interval beyond the setting for the Negative AV Hysteresis/Search parameter.
setting below the Shortest AV Delay setting.
turned on if the VIP algorithm is enabled.
2:1 Block Rate
The programmer displays the intrinsic atrial rate at which 2:1 AV block will occur in DDD(R) mode.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button
VIP™ Parameter Settings
From the VIP™ Settings window, you can change the settings for the following parameters:
Ventricular Intrinsic Preference (VIP™) Parameter (page 72)
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button > VIP™ Settings button
VIP™ Extension
for intrinsic conduction.
If an R-wave is sensed during the extension, the ventricular pulse is inhibited and the extended Sensed AV Delay interval remains in
Delay setting is restored until the Search Interval times out.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button > VIP™ Settings button
Search Interval
intrinsic conduction.
96 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
73
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button > VIP™ Settings button
Search Cycles
for intrinsic conduction.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Delays button > VIP™ Settings button
Capture & Sense
From the Capture & Sense window, you can change the following settings used for pacing and sensing:
Cap Confirm/V. AutoCapture™ parameter (page 74)
Cap Confirm/V. AutoCapture™ Settings (page 76)
SenseAbility™ Sensing Algorithm Settings (page 77)
Accessed From: Parameters button > Brady tab > Capture & Sense button
Cap Confirm/V. AutoCapture™ parameter
The Cap Confirm/V. AutoCapture™ parameter periodically measures the capture threshold and automatically sets the Pulse
76) parameter (accessed from the Cap Confirm/V. AutoCapture Settings (page 76) window).
The capture threshold is measured with the "threshold search" algorithm, in which the device decreases the Pulse Amplitude 0.25 V below the last measured capture threshold. If this results in a loss of capture, the device emits a 5.0 V backup safety pulse and increases the Pulse Amplitude in steps of 0.125 V to search for a new capture threshold. When the threshold is found, the device sets a new Automatic Pulse Amplitude by adding a safety margin to the capture threshold measurement.
To operate the Cap Confirm/V. AutoCapture function, you must:
For ACap™ Confirm, RVCap™ Confirm, and V. AutoCapture parameters, implant a low polarization, bipolar pacing lead in the appropriate chamber
For LVCap™ Confirm, implant a low polarization lead, either unipolar or bipolar
For RVCap Confirm, LVCap Confirm, and V. AutoCapture parameters, run the Cap Confirm/V. AutoCapture Setup test (see
The Cap Confirm/V. AutoCapture parameter has up to four settings:
Setup. This setting is available when there are no valid Cap Confirm/V. AutoCapture setup test results (not available for ACap
On. The devices measures the threshold, automatically adjusts the Automatic Pulse Amplitude setting, and records the threshold measurement in the Threshold Trend, a graph of all threshold measurements (available on the This Session (page
41) and Follow-up EGM (page 42) windows).
Monitor. The devices measures and records the capture threshold in the Threshold Trend but does not adjust the Pulse
Amplitude setting (not available for V. AutoCapture parameters).
Off. The device does not measure or record the capture threshold and does not automatically adjust the Pulse Amplitude setting.
When the Cap Confirm/V. AutoCapture parameter is programmed to the On or Monitor settings, a number of programming changes occur:
When set to On, the programmer shows the Automatic Pulse Amplitude and additional V. AutoCapture/Cap Confirm parameters; Pulse Amplitude becomes unavailable.
programming.
The device adds a safety margin to the last measured capture threshold.
Safety Margins for each parameter:
For the RVCap Confirm and LVCap Confirm parameters, the Automatic Pulse Amplitude parameter is set to the last measured
amplitude = measured threshold + Pacing Margin setting. If the capture threshold has not been measured, the Automatic Pulse
Amplitude parameter is set to 5.0 V.
For the V. AutoCapture parameter, the Automatic Pulse Amplitude parameter is set to the last capture threshold plus 0.25 V.
For the ACap Confirm parameter, the safety margin setting depends on the size of the measured atrial capture threshold, as described in this table.
74
Table 19. Amount of Pulse Amplitude increase over the measured atrial capture threshold
Atrial Capture Threshold (V)
≤ 1.5
1.625 — 2.25
Additional Amplitude (V)
1.0
2.375 — 3.0
1.5
2.0
3.125 — 3.875 Fixed at 5.0 V
Monitor.
When the Cap Confirm/V. AutoCapture parameter is programmed to Off or Monitor, the Pulse Amplitude parameter is set to twice the measured capture threshold (maximum 5.0 V, minimum 2.0 V).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button
NOTE
The ACap Confirm parameter is not available in Endurity™ Core devices.
High Base Rate Settings. The ACap Confirm function does not operate at intrinsic atrial rates or Base Rate settings at or above 120 min§. If the device detects these high rates, it attempts capture measurement an hour later.
MultiPoint™ Pacing. LVCap Confirm can be enabled while MultiPoint Pacing is enabled. However, the LVCap Confirm setting only applies to the LV1 Pulse Amplitude setting. The RV Cap Confirm and LV Cap Confirm parameters can be
In order to enable MultiPoint Pacing when the RVCap Confirm or LVCap Confirm parameter is On, the pacing Delay must be programmed to 15 ms or greater.
When both MultiPoint™ Pacing and V. Triggering are enabled, the RVCap™ Confirm and the LVCap™ Confirm setting
"On" is not available. To program RVCap Confirm or LVCap Confirm On, disable either MulitPoint Pacing or V. Triggering.
Threshold Search Delays. The device delays a scheduled threshold search if one of the following conditions exist:
•
Auto Mode Switch (page 85) entry (ACap Confirm only)
•
VT or VF episode
•
Automatic P- and R-wave measurement (see Sense Tests (page 42)) (all)
•
Lead Monitoring measurement (see Lead Impedance (page 46))
•
Threshold search in another chamber.
Pulse Amplitude
The Pulse Amplitude parameter determines how much electrical potential is applied to the myocardium during the pacing stimulus.
The Pulse Amplitude setting can be evaluated with the Capture & Sense (page 39) test.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button
NOTE
LV2 Pulse Amplitude. For devices with MultiPoint™ Pacing Capability, the Pulse Amplitude parameter determines the setting of the LV2 pacing pulse.
Oversensing. Oversensing may occur when high LV1/LV2 Pulse Amplitude settings and long LV1/LV2 Pulse Width settings are programmed along with long MultiPoint Pacing Delay settings and maximum Sensitivity settings.
Pulse Width
setting can be evaluated with the Capture & Sense (page 39) test.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button
97 In steps of 0.125V.
98
At the 1.125 and 1.375 settings, the additional increase in the pulse amplitude is 1.125.
99 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
75
NOTE
LV2 Pulse Width. For devices with MultiPoint™ Pacing Capability, the Pulse Width parameter determines the setting of the LV2 pacing pulse.
Oversensing. Oversensing may occur when high LV1/LV2 Pulse Amplitude settings and long LV1/LV2 Pulse Width settings are programmed along with long MultiPoint Pacing Delay settings and maximum Sensitivity settings.
AutoSense
The AutoSense parameter enables an algorithm that adjusts the atrial and ventricular
explanation, see AutoSense Function (page 78).
sensitivity for optimal sensitivity. For a full
When the AutoSense parameter is set to On, the atrial sensitivity automatically adjusts as the amplitude of the atrial complex changes.
When the atrial AutoSense parameter is set to Off, the atrial sensitivity remains fixed at the programmed atrial Sensitivity (page
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button
NOTE
Sensing. Ventricular sensing only occurs in the right ventricle.
The AutoSense parameter is not available in Endurity™ Core devices.
Sensitivity
The Sensitivity parameter determines the threshold above which the device responds to sensed events. The Auto setting turns
autosensing on or off (see AutoSense Function (page 78)).
Algorithm Settings (page 77) window. The device does not sense LV events, except during testing.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button
NOTE
Oversensing. Oversensing may occur when high LV1/LV2 Pulse Amplitude settings and long LV1/LV2 Pulse Width settings are programmed along with long MultiPoint™ Pacing Delay settings and maximum Sensitivity settings.
Cap Confirm/V. AutoCapture™ Settings
From the Cap Confirm/V. AutoCapture™ Settings window, you can change the settings of the following parameters:
Cap Confirm/V. AutoCapture™ parameter (page 74)
Backup Pulse Configuration (page 76)
V. AutoCapture™/Cap Confirm Paced/Sensed AV Delay parameter (page 76)
Backup Pulse Configuration
The Backup Pulse Configuration parameter allows you to program the polarity configuration of the backup safety pulse for the Cap
Confirm/V. AutoCapture™ parameter (page 74) parameter to either the bipolar or unipolar settings.
Accessed From: Parameters button > Brady tab > Capture & Sense button > Cap Confirm Settings button
Search Interval
The Search Interval parameter selects the timing of automatic threshold searches when the Cap Confirm/V. AutoCapture™
parameter (page 74) is set to Monitor or On.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > Cap Confirm Settings button
V. AutoCapture™/Cap Confirm Paced/Sensed AV Delay parameter
When the RVCap™ Confirm, LVCap™ Confirm, or V. AutoCapture™ parameter is selected, the V. AutoCapture/Cap Confirm
Paced/Sensed AV Delay parameter sets the Paced AV Delay and Sensed AV Delay parameters used when the device performs a
Threshold Search.
100 Available only when the right ventricular Sense Configuration is set to Bipolar.
76
NOTE
The recommended setting for this parameter is 50/25. Fusion is more likely with longer delays and may cause inaccurate threshold search results.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > Cap Confirm Settings button
Pacing Margin
When either the RVCap™ Confirm or LVCap™ Confirm parameter is enabled, the Pacing Margin parameter is the extra voltage that is to be added to the measured threshold in determining the Automatic Pulse Amplitude. Thus, the Cap Confirm pulse amplitude = measured threshold + Pacing Margin setting.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > Cap Confirm Settings button
SenseAbility™ Sensing Algorithm Settings
From the SenseAbility™ Sensing Algorithm Settings window, you can change the settings for the following parameters:
Advanced Settings (page 79) (Low Frequency Attenuation (page 79))
See also:
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button
NOTE
Low-amplitude Signals. Changing any of these parameters may affect the ability to sense low-amplitude signals.
Nominal Settings. Nominally, these Sensing Parameters are set close to their most sensitive settings. Change them only if there is a specific need to do so.
The SenseAbility Sensing Algorithm and related parameters are not available in Endurity™ Core devices.
Max Sensitivity
The Max Sensitivity parameter is the highest sensitivity the device can achieve. You can set the Max Sensitivity parameter independently for:
Atrial Max Sensitivity is the maximum atrial sensitivity to which the atrial threshold can decay.
Sensitivity is the maximum sensitivity to which the ventricular pacemaker threshold can decay.
Sensitivity is the maximum sensitivity to which the ventricular pacemaker threshold can decay.
In CRT-Ds, dual-chamber ICDs, and single-chamber ICDs, Ventricular Defibrillator Max Sensitivity is the maximum sensitivity to which the ventricular defibrillator threshold can decay.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button
NOTE
Oversensing. The Ventricular Pacemaker Max Sensitivity setting should only be changed from the nominal setting if
and Atrial Pace Refractory (page 82) parameters.
Decay Delay
The Decay Delay parameter determines the amount of time after the sensed or paced refractory period that the threshold remains at
of P-waves and T-waves.
77
Figure 4. An example of Decay Delay
1.
Threshold Start
2.
Decay Delay of 0 ms
3.
Decay Delay of 60 ms
When the ventricular Post-Paced Decay Delay is set to Auto, the device automatically adjusts the Decay Delay used after a ventricular paced pulse to compensate for QT-interval shortening associated with fast pacing rates.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button
NOTE
Low-amplitude Signals. Changing the Decay Delay setting may affect the ability to sense low-amplitude signals.
programmable in the atrium.
Threshold Start
The Threshold Start parameter determines the maximum peak amplitude that is sensed during the refractory period for a sensed event. Threshold Start can be used to prevent oversensing of P-waves and T-waves.
Post-Sensed Threshold Start. After a sensed event, the device determines the maximum amplitude signal detected during the
period, the sensing threshold automatically adjusts to the higher of either the Threshold Start setting or a percentage of that maximum amplitude with an absolute maximum value of 6 mV in the ventricle or 3 mV in the atrium. This percentage is known as the Post-Sensed Threshold Start.
With Ventricular Post-Paced Threshold Start set to Auto, the device automatically adjusts the Threshold Start used for a ventricular paced pulse to provide increased sensitivity at fast pacing rates.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button
NOTE
Low-amplitude Signals. Changing the Threshold Start setting may affect the ability to sense low-amplitude signals.
programmable.
Select Nominals
(page 77), and Threshold Start (page 78) parameters to their nominal values.
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button
AutoSense Function
The AutoSense feature automatically adjusts the device’s sensitivity to cardiac signal to more accurately sense in both the atrium and the right ventricle over a wide range of signal strengths. Sensing is controlled by a number of parameters working in concert: Max
Sensed), and Paced and Sensed Refractory Period (Post-Paced and Post-Sensed). In the example in the figure below, the device senses the maximum signal from an R-wave at 6 mV. The sense channel begins to measure R-waves at the Post-Sensed Decay
Delay setting (in this example, 50% of maximum measured signal or approximately 3 mV). It maintains this gain level for the duration of the Decay Delay setting (in this example, 0 ms) and then linearly increases the gain (reduces the mV setting) until the next sensed beat or until it reaches the Max Sensitivity setting (1 mV in this example). When an R-wave is sensed, it begins its Refractory Period and restarts the cycle when the Refractory Period ends.
The AutoSense features works in a similar manner for atrial post-sensed and post-paced signals and for ventricular post-paced signals. The function automatically adjusts various parameter settings in the presence of extremely strong or weak signals so that all signal strengths can be adequately detected and classified.
78
Figure 5. Automatic sensitivity control in the right ventricle
1.
Sense refractory
2.
R-wave is sensed
3.
Max R-wave amplitude measured at 6 mV
4.
Threshold Start set to
3 mV
5.
3 mV
6.
Max R-wave amplitude measured at 4 mV
7.
Threshold Start set to
3 mV
8.
2 mV
9.
Max Sensitivity Threshold
Advanced Settings
From the SenseAbility™ Advanced Settings window, you can change the settings for the following parameters:
Low Frequency Attenuation (page 79).
Low Frequency Attenuation
The Advanced Settings button enables you to turn the Low Frequency Attenuation filter On or Off. The Low Frequency Attenuation filter increases the R to T wave amplitude ratio, which may enhance sensing performance and may reduce oversensing T waves.
Turning the Low Frequency Attenuation filter On or Off changes the device’s sensing performance. This may include slight changes in waveform shape, resulting in small differences in R wave measurements or slight changes in VF waveform shape. The Morphology
Template is unaffected. For more information on how turning the Low Frequency Attenuation filter On or Off affects the sensing
ability of the device, contact Technical Support (page 161).
Accessed From: Parameters button > Brady tab > Capture & Sense button > SenseAbility™ Settings button > Advanced Settings button
Leads
From the Leads window, you can change the settings for the following parameters:
change the settings of the SecureSense™ RV Lead Noise Discrimination feature.
Accessed From: Parameters button > Brady tab > Leads button
Lead Type
The Lead Type parameter determines the type of implanted lead.
See also:
Parameter Availability and Settings (page 201)
NOTE
“PLUGGED” PORT SETTING.
•
restricts the availability of certain pacing modes and Tests that require an active lead in the plugged receptacle.
Thus, setting the Atrial Lead parameter to Plugged will eliminate all atrial-based Tests and modes.
• The Plugged setting is only available for the Atrial and LV Lead Types.
•
Lead Type, Pulse Configuration, and Sense Configuration once it detects the presence of a lead and determines its polarity. An alert reporting this automatic detection and programming will be available after the programmer has detected the update.
Lead Chamber
79
See also:
Parameter Availability and Settings (page 201)
Pulse Configuration
The Pulse Configuration parameter determines the polarity of the pacing pulse.
See also:
Parameter Availability and Settings (page 201)
NOTE
Pulse Configuration parameter determines the polarity of the second LV pacing pulse.
Sense Configuration
The Sense Configuration parameter determines how sensing occurs.
See also:
Parameter Availability and Settings (page 201)
Lead Monitoring Parameters
From the Lead Monitoring window, you can change the settings for the following parameters:
HVLI Monitoring Lower Limit (page 80)
HVLI Monitoring Upper Limit (page 80)
Accessed From: Parameters button > Brady tab > Leads button > Lead Monitoring button
Lead Monitoring
The Lead Monitoring parameter enables automatic monitoring of lead impedance values and automatic switching
See also:
Parameter Availability and Settings (page 201)
Lower Limit
The Lower Limit parameter determines the lower limit to the range of acceptable pacing lead impedance measurements.
See also:
Parameter Availability and Settings (page 201)
Upper Limit
The Upper Limit parameter determines the upper limit to the range of acceptable pacing lead impedance measurements.
See also:
Parameter Availability and Settings (page 201)
HVLI Monitoring Lower Limit
The HVLI Monitoring Lower Limit parameter determines the lower limit to the range of acceptable high-voltage lead impedance measurements.
See also:
Parameter Availability and Settings (page 201)
HVLI Monitoring Upper Limit
The HVLI Monitoring Upper Limit parameter determines the upper limit to the range of acceptable high-voltage lead impedance measurements.
See also:
Parameter Availability and Settings (page 201)
Refractories & Blanking
From the Refractories & Blanking window, you can change the settings for the following parameters:
Post-Ventricular Atrial Blanking (page 81)
Rate Responsive PVARP/V Ref (page 81)
101 Not available in high-voltage devices and CRT-Ps with VectSelect Quartet™ LV Pulse Configuration capability.
80
Shortest PVARP/V Ref (page 82)
Atrial Pace Refractory (page 82)
Atrial Sense Refractory (page 82)
Ventricular Pace Refractory (page 82)
Ventricular Sense Refractory (page 83)
SenseAbility™ Sensing Algorithm Settings (page 77)
Additional Settings, PVC & PMT (page 83)
For single-chamber devices, see Rates & Refractories (page 87).
Accessed From: Parameters button > Brady tab > Refractories & Blanking button
PVARP
The Post Ventricular Atrial Refractory Period (PVARP) parameter sets the amount of time that the device is unresponsive to signals from the atrial sensing circuit to avoid inappropriate response to stimuli. The PVARP parameter is intended to prevent nonphysiologic or retrograde P-waves from inhibiting the atrial stimulus.
The PVARP period begins after an intrinsic R-wave, PVC, or a ventricular paced pulse in DDI(R) or DDD(R) modes.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button
Post-Ventricular Atrial Blanking
The Post-Ventricular Atrial Blanking parameter establishes an atrial refractory period after ventricular paced and sensed events to prevent the atrial channel from detecting far-field R-waves.
Atrial events falling within the Post-Ventricular Atrial Blanking period do not update the filtered atrial rate interval (FARI), nor are they
used by the Rate Branch (page 93) algorithm
102 for dual-chamber SVT Discrimination Mode 103 (see SVT Discrimination in Sinus
Tach (page 94)). Events falling in this period are not counted in the AT/AF (page 29) diagnostics.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button
NOTE
with caution as it may have adverse effects on atrial sensing, and indirectly, SVT discriminators and the Auto Mode Switch function.
Blanking parameter is only available when the SVT Discrimination mode is set to the Dual Chamber setting or when the
Mode or Post-Shock Mode parameter is set to the DDIR or DDD(R) setting.
Blanking and MultiPoint Pacing PVAB parameters are independently programmable.
MultiPoint Pacing PVAB (page 67) is only available at pacing rates of 110
min§ or less.
Rate Responsive PVARP/V Ref
the filtered atrial rate in DDD(R) mode.
and PVARP settings:
If the Sensor is On, to preserve a 10% atrial alert period at the Maximum Sensor Rate
If the Sensor is Off, to preserve a 10% atrial alert period at the Maximum Tracking Rate
In single-chamber modes, a one ms change is made for each onemin§ change in the pacing rate
A Medium setting changes the Post-Paced Refractory Period and PVARP settings to preserve a 20% atrial alert period at the maximum rate. A High setting changes the Post-Paced Refractory Period and PVARP settings to preserve a 30% atrial alert period at the maximum rate.
For all other devices, a Low setting changes the ventricular Post-Paced Refractory Period and PVARP settings by one ms for each onemin§ change in the pacing rate. A High setting changes the ventricular Post-Paced Refractory Period and PVARP settings by three ms for each onemin§ change in the pacing rate.
Thus as pacing rates rise, the device decreases both the ventricular Post-Paced Refractory Period and PVARP settings until the Max
pacing rate exceeds 60
the algorithm is suspended.
102
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
103 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
81
For all other devices, the algorithm begins to operate when the intrinsic rate or pacing rate exceeds 90 min§. When the rate falls below 90 min§, the algorithm is suspended. The pacing rate is determined by whichever rate is highest: Base Rate, Sensor-indicated
rate, AMS Base Rate (page 86), or AF Suppression™ Algorithm-driven rate.
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Refractories & Blanking button
Rates & Refractories button
NOTE
the Rate Responsive PVARP/V Ref parameter is renamed Rate Responsive Atrial Refractory Period.
Rate Responsive Ventricular Refractory Period and Mode. When the Mode parameter is set to VVI(R), the Rate
Responsive PVARP/V Ref parameter is renamed Rate Responsive Ventricular Refractory Period.
Ventricular Noise Reversion. The Rate Responsive PVARP/V Ref parameter is disabled during Ventricular Noise
Reversion. See V. Noise Reversion Mode (page 64).
Ventricular Episode. The Rate Responsive PVARP/V Ref parameter is disabled during a ventricular episode.
Mode. The Rate Responsive PVARP/V Ref parameter is available in DDD(R), VDD(R), DDI(R), VVI(R), and AAI(R) modes.
Shortest PVARP/V Ref
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Refractories & Blanking button
Rates & Refractories button
NOTE
Shortest PVARP/V Ref parameter is renamed Shortest Atrial Refractory Period.
PVARP/V Ref parameter is renamed Shortest Ventricular Refractory Period.
Ventricular Pace Refractory period setting.
Atrial Pace Refractory
The Atrial Pace Refractory period parameter is the amount of time that the device is unresponsive to atrial signals from the sensing circuits following an atrial paced event. It allows the device to avoid inappropriate responses to stimuli. Events occurring in the Atrial
Pace Refractory period are not counted in the Filtered Atrial Rate (FARI) or in the Rate Branch average.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button
NOTE
Sensing Anomalies. Increasing the Atrial or Ventricular Pace Refractory period decreases the sensing time available between paced events.
Mode. Atrial Pace Refractory is programmable only when the Mode is set to AAT or AAI.
Atrial Sense Refractory
The Atrial Sense Refractory period parameter is the amount of time that the device is unresponsive to atrial signals from the sensing circuits following an atrial sensed event to avoid inappropriate responses to stimuli. Events occurring in the Atrial Sense Refractory period are not counted in the Filtered Atrial Rate (FARI) or in the Rate Branch average.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button
Ventricular Pace Refractory
The Ventricular Pace Refractory parameter is a refractory period that occurs after a paced event. The refractory period is initiated by a ventricular paced event and either ends when the period times out or is reset when another ventricular paced event occurs.
82
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Refractories & Blanking button
Rates & Refractories button
NOTE
Sensing Anomalies. Increasing the Atrial or Ventricular Pace Refractory period decreases the sensing time available between paced events.
Ventricular Sense Refractory
The Ventricular Sense Refractory parameter is a refractory period that occurs after a sensed event. The refractory period is initiated by a ventricular sensed event and either ends when the period times out or is reset when another ventricular sensed event occurs.
See also:
Parameter Availability and Settings (page 201)
Parameters button > Brady tab > Refractories & Blanking button
Rates & Refractories button
Additional Settings, PVC & PMT
From the Additional Settings, PVC & PMT window, you can change the settings for the following parameters:
Ventricular Blanking (page 83)
Ventricular Safety Standby (page 83)
For single-chamber devices, see Rates & Refractories (page 87).
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
Ventricular Blanking
The Ventricular Blanking parameter determines an absolute refractory period in the ventricular channel immediately following an atrial output pulse in dual-chamber modes. This absolute refractory period minimizes the chances of the ventricular channel sensing the atrial output and inappropriately inhibiting the ventricular output.
In DDD(R) and DDI(R) pacing, an atrial output pulse initiates ventricular blanking, but a P-wave that inhibits the atrial pulse does not.
The "Auto" setting, available in dual chamber pacemakers and CRT-Ps, employs sensing of ventricular signals following the atrial pacing pulse and automatically increases the initial blanking period if ventricular signals are sensed. Continued sensing of ventricular signals increases the blanking periods until a maximum of 52 ms is reached or until the device senses no ventricular signals.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
Ventricular Safety Standby
The Ventricular Safety Standby algorithm prevents the device from inappropriately sensing crosstalk that would inhibit the ventricular pulse output. If crosstalk is sensed, a ventricular pulse is delivered 120 ms after the atrial pulse. Signals sensed outside of the detection window inhibit the ventricular pulse.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
NOTE
programmed shorter than 120 ms, the ventricular pulse is delivered at that interval.
Crosstalk occurs when atrial output signals are sensed by the ventricular channel and results in the inhibition of the ventricular pulse. Clinically, crosstalk can usually be identified by atrial pacing with no ventricular channel output.
Crosstalk typically occurs with:
• high Atrial Pulse Amplitude or Pulse Width settings
83
• low Ventricular Sensitivity settings (greater sensitivity)
• rapid pacing rates
sensed, the Ventricular Safety Standby parameter can prevent the inappropriate inhibition of ventricular output.
Arrhythmia Unhiding
The Arrhythmia Unhiding parameter
enables an adaptive relative refractory period to search for arrhythmias hidden by pacing.
This may happen when fast atrial rates are tracked or when sensor-driven pacing rates shorten alert periods. As shown in the figure below, Arrhythmia Unhiding increases the alert period (through an adaptive relative refractory period or ARRP) to unmask arrhythmias hidden by pacing. An ARRP is enabled when the ventricular pacing cycle length is less than two times the longest
Figure 6. Arrhythmia Unhiding
1.
Pace pulse
2.
Pacing interval/2 - 30 ms
3.
Defib sensitivity
4.
ARRP
5.
Pace refractory period
6.
Current pacing interval
If a sensed event occurs during the ARRP and the next event is paced, then the ARRP is enabled again. If no sensed event occurs during the ARRP or the next event is not paced, then the pace refractory period returns to normal. Once the number of intervals specified by Arrhythmia Unhiding have occurred consecutively with a sensed event during the ARRP, the pacing cycle length is extended for six cycles in an attempt to reveal the arrhythmia.
If no arrhythmia is revealed during the extended pacing interval, the ARRP is not re-enabled for 10 cycles in order to prevent unnecessary extension of the pacing interval.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
NOTE
not Off (page 120) and the Mode is VVIR, DDIR, or DDD(R).
PVC Response
The PVC Response parameter detects and responds to premature ventricular contractions (PVCs) when the device is in DDD(R) mode. The PVC Response algorithm detects a PVC if: (1) an R-wave is not preceded by an atrial event; or (2) a P-wave is detected in
The Atrial Pace setting is a response to a PVC confirmation. The response consists of a continuous extension of the PVARP setting to
475 ms, followed by an atrial alert period of 330 ms until a P-wave is tracked outside the extended PVARP period.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
NOTE
Diagnostics. The Rates (page 27) window reports the total number of PVCs detected by the device.
Atrial Diagnostics. An Atrial Pace response can result in the appearance of fast atrial rates in atrial diagnostics such as
the Atrial Heart Rate Histogram (page 27).
PMT Response
The PMT Response parameter has three settings:
Off. No PMTs are detected.
Passive. PMTs are detected as described below and counted in the diagnostics, but the device does not respond to stop the
PMT.
Atrial Pace. PMTs are detected as described below and the Atrial Pace response is started to end to the PMT.
104 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
84
When you set the PMT Response parameter to either Passive or Atrial Pace, you can select the PMT Response button in the
Detection. If the device detects eight consecutive P–P intervals above the PMT Detection Rate, the device calculates the stability of the eight VP-AS intervals. If the device determines that the VP-AS intervals are stable, then for the ninth interval, the device:
Shortens the Sensed AV Delay (page 71) interval by 50 ms (if the AS-VP interval is
≥100 ms)
Increases the Sensed AV Delay interval by 50 ms (if the AS-VP interval is < 100 ms)
If the tenth VP-AS interval is nearly equal to the ninth VP-AS interval, the device concludes that PMT is present and begins its response. If the ninth and tenth intervals differ by more than 16 ms, then the device concludes that PMT is not present and the detection algorithm is repeated after 256 cycles.
NOTE
If the intrinsic rate is equal to the Max Track Rate during detection, then the Sensed AV Delay is increased by 50 ms, rather than decreased.
Response. The device suspends the ventricular output and delivers an atrial pulse 330 ms after the detected retrograde P-wave, followed by normal operation.
NOTE
Auto Mode Switch (page 85). The PMT algorithm is suspended during an Auto Mode Switch.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
PMT Detection Rate
The PMT Detection Rate parameter determines at what rate the device becomes alert to the presence of pacemaker-mediated
tachycardia (PMT) when the PMT Response (page 84) parameter is enabled. The settings begin at 90
min§ (or higher if the Base
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > Refractories & Blanking button > Additional Settings button
NOTE
Base Rate. The PMT Detection Rate setting cannot be slower than the Base Rate setting, and is auto-selected to a setting
10 min§ faster than the Base Rate setting if you attempt to set the PMT Detection Rate parameter equal to or slower than the Base Rate setting.
Max Track Rate (MTR). The PMT Detection Rate setting cannot be faster than the MTR parameter, and is auto-selected to equal to the MTR setting if you attempt to set the MTR setting faster than the PMT Detection Rate setting.
AT/AF Detection & Response
From the AT/AF Detection & Response window, you can change the settings for the following parameters:
Atrial Tachycardia Detection Rate (page 86)
AMS Max Trigger Rate (page 86)
AF Suppression™ Algorithm Pacing (page 87)
Overdrive Pacing Cycles (page 87)
Maximum AF Suppression™ Rate (page 87)
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
NOTE
VOO(R), or DOO(R).
Auto Mode Switch
The Auto Mode Switch (AMS) parameter prevents atrial-based timing modes from tracking atrial tachycardias and causing pacemaker-mediated tachycardia (PMT). The Auto Mode Switch algorithm switches the mode from DDD(R) to a ventricular-timing mode (DDI, DDIR, DDT, DDTR, VVT, VVTR, VVI, or VVIR)
when the atrial rate surpasses the Atrial Tachycardia Detection Rate
105
The atrial pulse may be inhibited if a P-wave is detected during an alert period.
106 DDT(R) and VVT(R) modes are only available in devices with Ventricular Triggering Capability.
85
Rather than use the actual atrial rate, which cannot always distinguish between sustained tachycardia and intermittent fast cycles,
AMS uses the Filtered Atrial Rate Interval (FARI), which is based on a comparison of the current atrial rate to a continually updated average rate.
DDD(R) or VDD(R) mode.
Diagnostic data on mode switching can be found in the Mode Switch and AT/AF (page 28) diagnostic.
device is mode-switched. Auto Mode Switch is not available when the Mode parameter is set to DDT or VVT. These settings also
enable the AMS V. Triggering (page 86) parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
AMS V. Triggering
VVT(R) settings for Auto Mode Switch.
prevent triggering if the ventricular rate gets too fast during an AMS episode.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
Atrial Tachycardia Detection Rate
The Atrial Tachycardia Detection Rate (ATDR) parameter sets the atrial rate at which the device mode-switches when the Auto Mode
available because it is also used to classify events in atrial tachycardia and trigger EGM storage. Atrial events at rates greater than the
ATDR setting are recorded in the AT/AF (page 29) and Rates (page 27) diagnostics.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
NOTE
PVARP (page 81). During a mode switch, the PVARP parameter is set to 82 ms
programmed PVARP setting.
107 . When the atrial rate falls below the
AF Suppression pacing-driven rate, Max Track Rate setting, or the Sensor-indicated rate, the device reverts to the
AMS Base Rate
The AMS Base Rate parameter sets the ventricular pacing rate when the device has switched from DDD(R) mode to the
parameter is enabled.
Unless the Mode Switch Base Rate parameter is set to a specific setting, it is auto-selected to equal the permanently programmed
Base Rate setting.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
AMS Max Trigger Rate
pacing reaches this rate, the Mode switches to DDI(R) or VVI(R). The parameter becomes available when the AMS V. Triggering parameter is set to On.
The device maintains the AMS Max Trigger Rate setting at least 5 min§ above the Base Rate and AMS Base Rate settings and at
least 30 ms above the Atrial Tachycardia Detection Rate (page 86).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
107 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
86
AF Suppression™ Algorithm
The AF Suppression™ algorithm enables the device to pace the atrium at rates faster than the intrinsic atrial rate in order to overdrive and suppress paroxysmal or persistent atrial fibrillation (AF). The AF Suppression algorithm is available in AAI(R) and
DDD(R) modes.
When the algorithm detects two P-waves in a 16-cycle window, the device increases the pacing rate to overdrive the intrinsic
Rest Rate (page 68) setting, or the Sensor (page 65)-indicated rate.
Diagnostic data on the AF Suppression algorithm can be found in the Rates (page 27) diagnostic.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
NOTE
the Base Rate, AMS Base Rate (page 86), or Sensor-indicated rate.
selected to Off and the pacing rate immediately increases to the Sensor-indicated rate when the Sensor-indicated rate is greater than the current AF Suppression pacing-driven rate.
AF Suppression Rate setting.
Rate-Responsive Stimulation. The paced rate increases to the Sensor-indicated rate when it is greater than the current
AF Suppression pacing-driven rate.
algorithm is enabled, the Rate Responsive AV Delay and Rate Responsive PVARP/V Ref parameters are auto-selected to
Medium, if the parameters are set to Off or Low.
Ventricular Episode. The AF Suppression algorithm is disabled during a ventricular episode.
Overdrive Pacing Cycles
The Overdrive Pacing Cycles parameter is the number of cycles the device overdrives the pacing rate before the AF Suppression™
indicated rate.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
Maximum AF Suppression™ Rate
The Maximum AF Suppression™ Rate parameter determines the fastest rate that the device can pace the atrium in response to the
AF Suppression algorithm.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Brady tab > AT/AF Detection & Response button
NOTE
Base Rate (page 68). The Base Rate setting cannot exceed the Maximum AF Suppression Rate setting.
Rates & Refractories
From the Rates & Refractories window, you can change the settings for the following parameters:
Ventricular Pace Refractory (page 82)
Ventricular Sense Refractory (page 83)
Rate Responsive PVARP/V Ref (page 81)
Shortest PVARP/V Ref (page 82)
SenseAbility™ Sensing Algorithm Settings (page 77)
Accessed From: Parameters button > Brady tab > Rates & Refractories button
87
Tachy Parameters
The Tachy Parameters window contains a summary of information on the device’s current ShockGuard™ Technology settings. Select any of these buttons to open windows to change these settings:
ShockGuard Technology Settings (Zone Configuration Window) (page 89)
DeFT Response™ Technology Settings (Shock Waveform) (page 111)
Redetection & Post Detection Criteria (page 116)
Capacitor Maintenance (page 119)
Tachy Therapy Detailed Descriptions (page 119)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab
ShockGuard™ Technology Settings (Zone Configuration Window)
The ShockGuard™ Settings window (Zone Configuration) shows the device’s current ShockGuard Technology settings for the number of tachy zones selected for therapy, the tachycardia detection criteria, the SVT discrimination option and details, and the therapy to be delivered to each zone. Select the parameter buttons to change the settings. For more information, select one of the following links:
SVT Discrimination Details (page 91)
window
Morphology Scoring. Select this button to open the Morphology Scoring Window (page 103)
SecureSense™ RV Lead Noise Discrimination. Select this button to change the settings of the SecureSense™ Settings feature
See also:
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button
Zone Configuration
The Zone Configuration parameter determines the number of rate zones the device recognizes for detection, diagnosis, and therapy delivery.
See also:
Tachy Therapy Enable/Disable (page 166)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button
Detection Criteria
You can program the following Detection Criteria parameters independently for each rate zone:
Detection Interval/Rate (page 89)
See also:
Tachyarrhythmia Detection Description (page 120)
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button
Detection Interval/Rate
The Detection Interval/Rate parameter is the interval/rate that must be exceeded within each rate zone to be counted toward detection of a tachyarrhythmia. The Detection Interval/Rate is independently programmable in each rate zone.
See also:
Tachyarrhythmia Detection Description (page 120)
Parameter Availability and Settings (page 201)
108 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
89
Accessed From: Parameters button > Tachy tab > Zone Configuration button
NOTE
the Zone Configuration setting changes.
Detection Interval. Each detection interval must be at least 30 ms longer than the next fastest detection interval.
No. Intervals
The No. Intervals parameter sets the number of binned intervals within each rate zone that must be shorter than the Detection
programmable in each rate zone.
See also:
Tachyarrhythmia Detection Description (page 120)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button
NOTE
Time for Detection. Programming a lower No. Intervals setting may shorten the time for the detection of a tachyarrhythmia. Programming a greater No. Intervals setting may increase the time for the detection of a
tachyarrhythmia. See Tachyarrhythmia Detection Description (page 120).
SecureSense™ Settings
The SecureSense Settings window allows you to program the SecureSense™ algorithm to help prevent inappropriate therapy delivered due to the presence of noise generated by a V or RV lead failure.
You can program the following parameters from this window:
SecureSense™
Far Field MD™/SecureSense™ Configuration (page 90)
SecureSense™ Timeout Until Therapy (page 91)
Trigger Alert for Non-sustained RV Oversensing (NSO) (page 91)
Available In: Devices with SecureSense™ RV Lead Noise Discrimination Capability (page 198)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
Accessed From: Parameters button > Alert Notification tab > SecureSense button
Accessed From: Parameters button > Brady tab > Leads button > SecureSense button
SecureSense™ Parameter
When programmed to On, the SecureSense™ parameter enables an algorithm to (1) detect RV or V lead noise, (2) inhibit therapy when lead noise is detected, and (3) detect non-sustained lead noise that has an insufficient number of intervals to meet VT/VF detection thresholds but can still be identified as lead noise. The SecureSense algorithm utilizes a far field sensing or
“Discrimination” channel to detect lead noise, and its configuration is set by the Far Field MD™/SecureSense™ Configuration parameter.
The algorithm operates by comparing the rate of sensed events on the primary sensing channel (V Sense Amp) to the rate of sensed events on the Discrimination channel. If the device detects a fast rate on the primary channel and sinus rates on the Discrimination channel, the device classifies the signals as noise and inhibits VT/VF therapy.
When programmed to Passive, the algorithm detects noise and provide diagnostics and EGMs, but does not inhibit VT/VF therapy.
The algorithm also detects short episodes of noise that are not long enough to cause VT/VF detection.
From the Alert Triggers window, you can program the device to trigger an alert and vibratory patient notifier when lead noise or nonsustained lead noise is detected. You can also program the device (from the Episode Triggers window) to record an episode (store a
EGM) when non-sustained lead noise is detected. Finally, from both the Alert Triggers and Episode Triggers windows, you can program the device to trigger an alert and record an episode if the SecureSense algorithm classifies a rhythm as a non-sustained RV lead noise event.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
Far Field MD™/SecureSense™ Configuration
The Far Field MD™/SecureSense™ Configuration parameter sets the electrode configuration of the far-field (Discrimination) channel used in both the SecureSense™ algorithm and the Far Field MD™ Morphology Discrimination algorithm (see Morphology Type). The signal from this far field vector channel is compared to the near field vector on the primary sensing channel in order to diagnose RV
Lead Noise. This parameter also controls what configuration is displayed when the Discrimination channel is shown in EGMs or
Stored EGMs.
90
Ideally, the Discrimination channel should have an R-wave amplitude greater than 1 mV with no noticeable myopotentials. The nominal setting (RVcoil-Can) is the appropriate choice for most patients. If you have a concern about the integrity of the RV coil or if you are using integrated bipolar leads, the RVtip - Can setting may be preferable.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
SecureSense™ Timeout Until Therapy
The SecureSense™ Timeout Until Therapy sets a limit on the amount of time the device can inhibit the delivery of therapy while detecting RV or V lead noise through the SecureSense algorithm.
When the diagnosis of lead noise is first made, the Timeout algorithm begins counting. If the algorithm reaches the programmed setting but the device continues to detect noise, then the device delivers ATP therapy or charging for therapy begins on the next Rwave diagnosed as VT/VF. If no lead noise is detected at the end of the Timeout period, then the device withholds therapy.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
Trigger Alert for Non-sustained RV/V Oversensing (NSO)
The Trigger Alert for Non-sustained RV/V Oversensing (NSO) parameter defines the number of non-sustained oversensing episodes that the device needs to detect before triggering an NSO clinical alert or patient notification.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
SVT Discrimination
The SVT Discrimination parameters define the upper limit at which the device will not classify a tachyarrhythmia or deliver therapy
setting is a rate overlap zone that spans the VT (or VT-1) zone or both the VT-1 and VT-2 zones.
To enable or disable the VT, VT-1, or VT-2 SVT Discrimination, select the On/Off button for SVT discrimination on the ShockGuard™
disabled in the VT-1 zone, it is also disabled in the VT-2 zone.
SVT Upper Limit parameter is used to define the SVT Discrimination Zone, the programmed setting is displayed within the SVT
Discrimination Zone button in the corresponding rate zone.
See also:
SVT Discrimination Details (page 91)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button
NOTE
Diagnosis. The SVT discriminators only affect the initial diagnosis of an episode. They do not influence redetection after a failed first therapy.
Rate Crossover is a condition where the maximum rate of a supraventricular rhythm can exceed the slowest ventricular
so that they do not affect diagnosis and delivery of therapy.
SVT Discrimination Details
means to help diagnose SVT when manually reviewing EGMs). From this window, you can program the following:
SVT Discrimination Mode (page 92)
SVT Discrimination Timeout (page 92)
Therapy After Timeout (page 92)
SVT Discriminators (page 93), which include:
-
Rate Branch (page 93) (CRT-Ds and Dual-Chamber ICDs only)
-
-
-
Arrhythmia Onset/Sudden Onset Window (page 101)
-
See also:
SVT Discrimination Timeout Description (page 127)
91
SVT Discrimination Description (page 120)
SVT Discrimination Criteria Programming Guidelines (page 122)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
SVT Discrimination Mode
The SVT Discrimination mode defines the sensing method used to discriminate between ventricular tachycardias (VT) and
supraventricular tachycardias (SVT) within the SVT Discrimination (page 91).
Only rhythms with running interval averages that fall within the SVT Discrimination Zone are evaluated by the SVT Discriminators
Use the Ventricular Only setting (CRT-Ds and Dual-Chamber ICDs) when an atrial lead is not present or when atrial sensing is unavailable.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
NOTE
Diagnosis. The dual chamber SVT Discrimination mode uses both atrial and right-ventricular information from the SVT discriminators in making a diagnosis, whereas the Ventricular Only SVT Discrimination mode only uses right-ventricular information.
Rhythm Classification. When the SVT Discrimination mode is set to Dual Chamber and SVT discriminators are enabled, the device is more likely to classify a rhythm as VT. When the SVT Discrimination mode is set to Ventricular Only and SVT discriminators are enabled, the device is less likely to classify a rhythm as VT.
disabled. The diagnostic data are still reported and can be accessed from various diagnostic screens. See Diagnostics
SVT Discrimination Timeout
The SVT Discrimination Timeout parameter is the amount of time to diagnose a rhythm as SVT before therapy is delivered.
As protection against delivering SVT Discrimination Timeout-directed therapy into a bigeminal rhythm, the device must detect more tachyarrhythmia intervals than sinus intervals before it delivers therapy.
See also:
Therapy After Timeout (page 92)
SVT Discrimination Timeout Description (page 127)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
Therapy After Timeout
expires. The Therapy After Timeout parameter is available only if the SVT Discrimination Timeout parameter is available and enabled.
See also:
SVT Discrimination Timeout Description (page 127)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
SVT Upper Limit
The SVT Discrimination Zone extends from the VT or VT-1 detection rate up to (but not including) the SVT Upper Limit. When SVT
therapy for a rhythm falling into this SVT Discrimination Zone unless those discriminators classify the rhythm as VT according to the
programmed Diagnosis (page 94).
If the SVT Upper Limit is programmed Off, arrhythmia diagnosis is not affected by the SVT discriminators.
You can also enable or disable the VT, VT-1, or VT-2 SVT Discrimination Zone with the On/Off buttons for SVT discrimination on the
ShockGuard™ Technology Settings (Zone Configuration Window) (page 89).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
92
NOTE
configurations.
Rate Crossover is a condition where the maximum rate of a supraventricular rhythm can exceed the slowest ventricular
that they do not affect diagnosis and delivery of therapy.
SVT Discriminators
The SVT Discriminators are a set of programmable tools that can analyze the current rhythm to distinguish VT/VF from sinus or atrial
Zone or 3 Zone, the Rate Branch discriminator is unavailable, and the discrimination begins when a rhythm is analyzed by the
Additional Discriminators.
You can also disable a discriminator to skip an analysis.
When the Zone Configuration parameter is set to Off or 1 Zone, then SVT Discriminators are not available, but the Morphology
Scoring (page 103) parameter can be used to help retrospectively diagnose SVT using EGMs.
Select any button to choose the parameter setting or to open a window to program additional discrimination settings.
The SVT discriminators include:
Rate Branch (page 93) (Dual Chamber SVT Discrimination only)
Additional Discriminators
-
-
-
Arrhythmia Onset/Sudden Onset (page 101)
See also:
SVT Discrimination Description (page 120)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
NOTE
discriminators are enabled, the device is more likely to classify a rhythm as VT. When the SVT Discrimination Mode parameter is set to Ventricular Only and SVT discriminators are enabled, the device is less likely to classify a rhythm as VT.
SVT Discriminators. At least one of the SVT Discriminators must be programmed On in each rate branch.
SVT Discriminators that are set to Passive do not influence Tachycardia Diagnosis Criteria.
Rate Branch
The Rate Branch SVT discriminator compares the current ventricular rhythm to the atrial rate. This parameter is only available when
three branches, utilizing any discriminators that are On or Passive:
V<A -- Typically, atrial fibrillation or atrial flutter (AF/AFL). The rhythm’s EGM complex can then be checked against the current
the criteria set by the Diagnosis (page 94) parameter.
compared to the template for similarities in morphology. Then, it can be tested to determine if the onset was sudden or gradual
rhythm is diagnosed according to the criteria set by the Diagnosis parameter.
V>A -- Typically, V Tach or V Fib (VT/VF). If the ventricular rate is greater than the atrial rate, no further discrimination is needed and the device begins to deliver therapy.
The AF/AFL and VT/VF rate branches are always On. The Sinus Tach rate branch is enabled by the SVT Discrimination in Sinus Tach
See also:
Rate Branch Detailed Description (page 121)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
109 If the Rate Branch analysis determines that the rhythm is VT or VF, no additional analysis is made; the device immediately begins therapy.
93
Diagnosis
device diagnoses VT. The settings include:
If Any. Only one discriminator must classify the rhythm as VT before VT is diagnosed.
If All. All the enabled discriminators must classify the rhythm as VT before VT is diagnosed.
the SVT Discriminators are set to On.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button
Sinus Tach Rate Branch Control
You can program the following parameters from the Sinus Tach Rate Branch Control window:
SVT Discrimination in Sinus Tach (page 94)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Details button > Sinus Tach button
SVT Discrimination in Sinus Tach
ventricular rhythm equals the atrial rhythm (V=A), the event is classified as VT/VF and the device initiates therapy.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Details button > Sinus Tach button
AV Interval Delta
The AV Interval Delta parameter sets the maximum difference between the second longest and second shortest AV interval in the complexes found during detection. If the rhythm is V=A, but the difference between the AV intervals is greater than the setting for the
AV Interval Delta parameter, then the rhythm is immediately diagnosed as ventricular tachycardia and Morphology and Sudden
Onset/Chamber Onset are not evaluated. If the difference is less than the AV Interval Delta setting, the rhythm can be analyzed further for diagnosis of SVT.
The larger the difference between the long and short AV intervals, the more likely the rhythm is "dissociated," that is, not associated with a stable AV interval, a characteristic of VT or VF. If the AV intervals vary only a small amount, the rhythm is more likely to have a stable AV association, often characteristic of Sinus Tach or SVT.
See also:
Rate Branch Detailed Description (page 121)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Details button > Sinus Tach button
NOTE
parameter is set to Dual Chamber.
Concurrent VTs and SVTs. The AV Interval Delta parameter may be useful for patients who have VTs concurrent with
SVTs for which therapy is erroneously inhibited by the Rate Branch (page 93) discriminator.
Rhythm Classification. When the AV Interval Delta parameter is set to a shorter interval, it is more likely that a rhythm is classified as VT.
Morphology Window
From the Morphology window, you can acquire a new morphology template, evaluate the existing template, or program one of the following Morphology discriminator parameters:
Morphology in AF/A Flutter (V<A Rate Branch: Morphology) (page 95)
Morphology in Sinus Tach (V=A Rate Branch: Morphology) (page 95)
Template Match Criteria (page 95)
Morphology No. of Matches (page 96)
Morphology Window Size (page 96)
Template Auto Update (page 96)
Morphology Template (page 102)
Morphology Template Pacing Hysteresis (page 96)
Far Field MD™/SecureSense™ Configuration (page 90)
94
See also:
Morphology Detailed Description (page 121)
Details of the Template Auto Update (page 97)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Morphology
The Morphology parameter enables the device to compare the shape of a characteristic sinus rhythm complex (morphology template) to an arrhythmia’s complexes. The Passive setting allows the device to store diagnostic information but does not affect the diagnosis of VT.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Morphology in AF/A Flutter (V<A Rate Branch: Morphology)
The Morphology in Sinus Tach (V=A Rate Branch: Morphology) parameter enables the device to compare the shape of a characteristic sinus rhythm complex (morphology template) to an arrhythmia’s complexes in the V=A Rate Branch when the SVT
not affect the diagnosis of VT.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Morphology in Sinus Tach (V=A Rate Branch: Morphology)
The Morphology in AF/A Flutter (V<A Rate Branch: Morphology) parameter enables the device to compare the shape of a characteristic sinus rhythm complex (morphology template) to an arrhythmia’s complexes in the V<A Rate Branch when the SVT
information but does not affect the diagnosis of VT.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
% Match
The % Match parameter is the degree of similarity that must exist between a complex and the template for it to be considered a match. Complexes with scores equal to or exceeding the percentage match are classified as matching the template. If the
Morphology parameter is programmed On or Passive, a check mark appears on real-time EGMs under each complex that matches the template. An "x" marks complexes that do not match the template.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
NOTE
Rhythm Classification. When the % Match parameter is set to a higher setting, it is more likely that a rhythm is classified as VT.
Rate Branch (page 93). For CRT-Ds and Dual-Chamber ICDs, the % Match parameter is not independently
programmable in the AF/AFL and Sinus Tach rate branches.
Template Match Criteria
95
setting before a diagnosis of VT is made. Thus, with the Morphology No. of Matches parameter, you can set the number of complexes that come within a percentage of a match to the established morphology (template) of a sinus complex. With the
Morphology Window Size parameter, you can set the number of complexes to compare against the template.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Morphology No. of Matches
The Morphology No. of Matches parameter is the number of R-wave complexes within a limit of R-wave complexes (the Morphology
as SVT. If the observed number of matches is less than the programmed number of matches, the Morphology discriminator classifies the rhythm as VT. If the number of observed matches is equal to or greater than the programmed number, the discriminator classifies the rhythm as SVT.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
NOTE
Rate Branch (page 93). For CRT-Ds and Dual-Chamber ICDs, the Morphology No. Matches parameter is not
independently programmable in the AF/AFL and Sinus Tach rate branches.
Rhythm Classification. When the % Match parameter is set to a higher setting, it is more likely that a rhythm is classified as VT.
Morphology Window Size
The Morphology Window Size parameter is the number of complexes prior to detection used to determine the origin of a rhythm (SVT or VT) based on the morphology of the rhythm. The Window Size must be less than the programmed number of intervals for any
tachycardia detection (VT, VT-1, or VT-2) within the SVT Discrimination (page 91).
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Template Auto Update
The Template Auto Update parameter is the amount of time between automatic evaluations of the active morphology template. The device periodically checks to see that the active morphology template is still similar enough to the baseline complex. If the template is not similar enough, the device attempts to update it.
When the Template Auto Update timer expires, the device determines if the baseline rhythm is suitable for sampling. Conditions that disqualify the rhythm include:
the average interval is less than 500 ms or the current VT/VT-1 detection cycle length setting
noise reversion is ongoing
NIPS or Fibber test is operating
a potential VT/VF episode is ongoing.
If any of these conditions are detected, the device postpones the update for a period designated by the parameter setting. If, however, the conditions are not present, the device updates the template.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button >
Morphology button
Morphology Template Pacing Hysteresis
parameter enables the device to temporarily adjust certain pacing parameters to reduce ventricular pacing and to allow intrinsic activity to be sensed. This improves the possibility of successfully acquiring a potential morphology template out-of-clinic. When the device has not been able to update the template for the past seven days, it adds 100 ms to the programmed Paced AV Delay setting
96
and disables the Negative AV Hysteresis/Search algorithm. If the Mode is set to DDI or VVI, the Base Rate is also temporarily reduced to a minimum of 40 min§. When the template is acquired, the programmed settings revert.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Morphology button
Far Field MD™/SecureSense™ Configuration
The Far Field MD™/SecureSense™ Configuration parameter sets the electrode configuration of the far-field (Discrimination) channel used in both the SecureSense™ algorithm and the Far Field MD™ Morphology Discrimination algorithm (see Morphology Type). The signal from this far field vector channel is compared to the near field vector on the primary sensing channel in order to diagnose RV
Lead Noise. This parameter also controls what configuration is displayed when the Discrimination channel is shown in EGMs or
Stored EGMs.
Ideally, the Discrimination channel should have an R-wave amplitude greater than 1 mV with no noticeable myopotentials. The nominal setting (RVcoil-Can) is the appropriate choice for most patients. If you have a concern about the integrity of the RV coil or if you are using integrated bipolar leads, the RVtip - Can setting may be preferable.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SecureSense button
Advanced Settings
The Advanced Settings window allows you to specify the Morphology Type parameter to enable either the Far Field MD Morphology
Discrimination or Original MD settings.
Available In: Devices with Far Field MD™ Morphology Discrimination Capability (page 188)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Morphology button > Advanced Settings button
Morphology Type
The Morphology Type parameter specifies the algorithm used to obtain the characteristic sinus rhythm template used for morphology discrimination. You can choose either Original MD (RVtip-RVring EGM vector) or Far Field (the EGM vector specified by the Far Field
MD/SecureSense™ Configuration parameter).
The Original MD setting obtains R-wave morphologies based on the near-field RVtip-RVring sense amp channel signal and uses that data to compute morphology match scores. The Far Field MD setting uses the near-field RVtip-RVring channel to align R-waves, but compares the R-wave morphologies and computes match scores based on the signal from the far-field channel, which is set by the
Far Field MD/SecureSense Configuration parameter.
When the Morphology Type parameter is set to Far Field, the morphology template cannot be acquired manually. See Instructions for
Acquiring a Morphology Template.
NOTE
When the Morphology Type setting is changed, the Episodes, Stored EGMs, and the active morphology template are all cleared from the device.
See also:
Morphology Detailed Description (page 121)
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Morphology button > Advanced Settings button
Details of the Template Auto Update
The figures below show how the Template Auto Update evaluates the current active template.
97
Figure 7. Template Auto Update in devices without Far Field MD Morphology Discrimination Capability
98
See Morphology Template (page 102).
Interval Stability Window
From the Interval Stability window, you can program the following Interval Stability discriminator parameters:
AV Association (page 100) Delta
Interval Stability Window Size (page 101)
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
Interval Stability
The Interval Stability parameter enables a discriminator that distinguishes between atrial fibrillation (AF) (more rate-variability) and VT
100) or SIH Count (page 100), and Interval Stability Window Size (page 101) parameters are enabled.
110
Only available for Dual Chamber SVT Discrimination.
111 Only available for Ventricular Only SVT Discrimination.
99
is set to On w/AVA (AV association), the AV Association Delta (page 100) parameter is available.
When the SVT Discrimination Mode parameter is set to Ventricular Only and the Interval Stability parameter is set to On w/SIH
(sinus interval history), the SIH Count (page 100) parameter is available.
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
Stability Delta
The Stability Delta parameter defines the acceptable difference between the second longest and the second shortest ventricular
intervals in a recent group of intervals defined by the Interval Stability Window Size (page 101).
When the measured Stability Delta interval is equal to or longer than the programmed Stability Delta setting, the Interval Stability
(page 99) discriminator classifies the rhythm as SVT.
When the measured Stability Delta interval is shorter than the programmed Stability Delta setting, the Interval Stability discriminator classifies the rhythm as VT.
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
NOTE
Rhythm Classification. When the Stability Delta parameter is set to a longer interval, it is more likely that a rhythm is classified as VT.
AV Association Delta
The AV Association Delta (AVA Delta) parameter defines the acceptable difference between the second longest and the second
discriminator classifies the rhythm as SVT. When the Interval Stability parameter is set to On w/AVA and the Interval Stability discriminator classifies the rhythm as SVT, the measured AV Association Delta interval is not checked.
When the measured AVA Delta interval is longer than or equal to the programmed AVA Delta setting, the Interval Stability (page
99) discriminator classifies the rhythm as VT.
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
NOTE
Rhythm Classification. When the AV Association Delta parameter is set to a shorter interval, it is more likely that a rhythm will be classified as VT.
is set to Dual Chamber.
SIH Count
The SIH (Sinus Interval History) Count parameter defines the number of sinus intervals or average intervals of a rhythm that can occur during detection of a rhythm classified as VT.
When the number of sinus intervals or the average intervals of a rhythm is greater than or equal to the SIH Count, the Interval
Stability (page 99) discriminator classifies the rhythm as SVT. The rhythm may be regularized AF.
When the number of sinus intervals or the average intervals of a rhythm is less than the SIH Count, the Interval Stability discriminator classifies the rhythm as VT.
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
NOTE
Rhythm Classification. When the SIH Count parameter is set to a larger number of intervals, it more likely that a rhythm will be classified as VT.
100
Interval Stability Window Size
The Interval Stability Window Size parameter determines the number of intervals prior to the detection of an arrhythmia that are used to evaluate the stability of an arrhythmia. The Interval Stability Window Size setting must be less than or equal to the selected No.
See also:
Interval Stability Detailed Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Interval
Stability button
Sudden Onset Window
selected, this window is titled “Arrhythmia Onset.”
Criteria:
SVT Discrimination setting = Dual Chamber
Sinus Tach V=A = On
For CRT-Ds and dual-chamber devices, this window is titled "Sudden Onset."
Otherwise, this window is titled “Sudden Onset.”
From this window, you can program the following Arrhythmia Onset/Sudden Onset discriminator parameters:
Chamber Onset (page 101) (Arrhythmia Onset window only)
See also:
Sudden Onset Description (page 122)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Sudden
Onset button
Chamber Onset
The Chamber Onset parameter helps discriminate between VT and SVT by determining which chamber is driving an abrupt rate increase. If the Chamber Onset algorithm determines that the atrial rate has increased prior to the ventricular rate, then the arrhythmia is determined to be an SVT. If the ventricular rate is found to increase prior to the atrial rate, the arrhythmia is determined to be VT. The algorithm also factors in how quickly the ventricular rate changed (see Sudden Onset), and will also diagnose an SVT based on that criterion.
The Chamber Onset parameter is available in the V=A Rate Branch during dual chamber discrimination, where either Sudden Onset or Chamber Onset can be enabled.
The On” setting initiates the Chamber Onset algorithm and turns off the Sudden Onset parameter. The “Off” setting shifts the function from the Chamber Onset algorithm to the Sudden Onset algorithm. When set to the “Passive” setting, the device analyzes the rhythms and collects data but does not contribute to the SVT discrimination.
See also:
Arrhythmia Onset/Sudden Onset Detailed Description
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Arrhythmia
Onset button
Sudden Onset
The Sudden Onset parameter enables a discriminator that distinguishes between VT (abrupt onset) and sinus tachycardia (gradual onset) in patients whose maximum sinus rates can exceed their slowest ventricular tachyarrhythmia rates ("rate overlap").
See also:
Sudden Onset Description (page 122)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Sudden
Onset button
Onset Delta
The Onset Delta parameter determines the abruptness of a tachycardia’s onset. If the measured Onset Delta interval is equal to or greater than the programmed Onset Delta setting, the Sudden Onset discriminator classifies the rhythm as VT. If the measured difference is less than the delta, the discriminator classifies the rhythm as SVT. The Onset Delta parameter can be programmed as a specific change in the interval (Fixed) or as a percentage of change in the interval (Adaptive).
See also:
Sudden Onset Description (page 122)
101
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > SVT Discrimination Details button > Sudden
Onset button
NOTE
Rhythm Classification. When the Onset Delta parameter is set to a shorter interval or smaller percentage, it is more likely that a rhythm is classified as VT.
rhythms and ventricular tachycardias. The results of a stress test may be helpful in selecting an appropriate Onset Delta setting.
detection interval and the fastest pacing interval.
Morphology Template
The following buttons are available on the Morphology Template window:
Automatic button. Select this button to automatically acquire an active morphology template.
Manual button. Select this button to manually acquire a potential morphology template
Acquire button. Initiates the morphology template maintenance algorithm.
Template window(s). This window shows a snapshot of the Active Template (currently in use) and the date and time of its acquisition. When you select the Manual template acquisition method, the window also shows both the Active and Potential
Template snapshots, the date and time of the acquisition, buttons to select the template to score, and a button to activate the
Potential Template. At the bottom of the window, the text "scoring..." indicates that the device is comparing the active template to the currently measured complexes.
You can also temporarily program the following parameters from the Morphology Template window to ensure the appearance of intrinsic rhythm:
Mode
Base Rate
Paced AV Delay
Sensed AV Delay
See also:
Template Auto Update (page 96)
Instructions for Acquiring a Morphology Template (page 102)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Acquire/Evaluate Template button
NOTE
(page 95) parameter, the active template is retained in the device.
Instructions for Acquiring a Morphology Template
3.
4.
5.
Automatic
1.
2.
6.
From the Zone Configuration window, select the SVT Details button or the Morphology Scoring button.
From the SVT Details window or the Morphology Scoring window, select the Acquire/Evaluate Template button.
The button text presents the current template status (Active template Present or No Active Template).
On the Morphology Template page, select the Automatic button.
Set any of the pacing parameters to optimize sensing of sinus rhythm. Select the Start Temporary button when complete.
Select the Acquire button.
If the device successfully senses intrinsic rhythm and a usable active template is available, the programmer asks if you want to keep the current active template or clear and update the template. If you select the Keep Template button, the programmer shows the snapshot of the complex in the Active Template window and uses that complex to compare against new complexes.
If you select the Clear and Update Template button, the device restarts its sensing routine, and upon completion, the programmer shows the snapshot of the complex in the Active Template window and uses that complex to compare against new complexes.
If the waveform does not appear representative, repeat the procedure or use the Manual acquisition method.
Manual
1.
From the Zone Configuration window, select the SVT Details button or the Morphology Scoring button
2.
From the SVT Details window or the Morphology Scoring window, select the Acquire/Evaluate Template button.
The button text presents the current template status (Active template Present or No Active Template)
3.
On the Morphology Template page, select the Manual button.
112
Not available when the Morphology Type parameter is set to Far Field.
113 Not available when the Morphology Type parameter is set to Far Field.
102
4.
5.
6.
If an active template is available, windows for both the Potential and Active templates appear.
Set any of the pacing parameters to optimize sensing of sinus rhythm. Select the Start Temporary button when complete.
Select the Acquire button.
If the device is unable to sense intrinsic rhythm, the programmer asks you to adjust the pacing parameters and try again.
If the device successfully senses intrinsic rhythm and a usable active template is available, the programmer shows snapshots of the complexes in the Potential and Active Template windows. You have three options:
- To continue to use the Active Template for scoring (that is, to compare the Active Template to the currently sensed complex), select the Active button.
-
- To use the potential button for scoring, select the Potential button.
-
- To replace the Active Template with the Potential Template, select the Activate Potential button.
If the waveform does not appear representative, repeat the procedure.
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Acquire/Evaluate Template button
Morphology Scores
Morphology scores indicate the percentage of similarity of the current rhythm to the template. Morphology Markers appear on the marker channel on the Rhythm Display when:
An active template exists and is used for scoring.
A potential template exists and is used for scoring. These scores are only generated and appear on the Rhythm Display (page
7) when the Morphology Template window is displayed.
When the Morphology discriminator is set to On or Passive, a check mark appears on Rhythm Display below each complex that matches the active template and an "X" is placed below each complex that does not match the active template, based on the %
scores and "X’s" indicate mismatches.
Morphology Scoring Window
From the Morphology Scoring window, you can enable the following parameters:
Template Auto Update (page 96)
See also:
Morphology Template (page 102)
Morphology Scoring
The Morphology Scoring parameter enables scoring of the sensed R-waves during VF episodes against the active template. An active template must exist to enable Morphology Scoring. Active and potential templates are not cleared when Morphology Scoring is disabled.
See also:
Morphology Template (page 102)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Morphology button
NOTE
Zone Therapy
The Zone Therapy window allows you to program therapies for each active rate zone. A table in the top right indicates which rate zones are programmed and their current limits. The buttons on the window include:
Active/Monitor button. This button, which is available for VT-1 Therapy (3 Zones) or VT Therapy (2 Zones), toggles between two settings:
-
Active. Delivers the programmed therapy at the current settings.
-
Monitor. Withholds therapy in the VT-1 or VT rate zone but records all activity in the Diagnostics.
ATP Prior to Charging (page 105)
See also:
VT Therapy Timeout Description (page 128)
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
103
Accessed From: Parameters button > Tachy tab > Zone Configuration button
VT Therapy Timeout
The VT Therapy Timeout parameter determines the amount of time the device can deliver tachycardia therapy. When the VT Therapy
Timeout setting expires, the device abandons tachycardia therapies and delivers VF therapy.
As protection against delivering VT Therapy Timeout directed therapy into a bigeminal rhythm, the device must detect more tachyarrhythmia intervals than sinus intervals before it delivers therapy.
See also:
VT Therapy Timeout Description (page 128)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button
Timeout Trigger
The available settings depend on the programmed Zone Configuration (page 89) settings.
See also:
VT Therapy Timeout Description (page 128)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button
Therapy
From the Zone Therapy window, you can program successive therapies for each available rate zone. In each rate zone, Therapy 1 is delivered before Therapy 2, and so on, until the device reaches Therapy 4. You can program up to four therapies in the VT zones and three or four
therapies in the VF zone (for a total of up to seven delivered therapies in the VF zone).
The tables below show the therapies available within the rate zones and the energy/voltage settings available for CVRT and Defib therapies.
Table 20. Therapies available
Therapy Number
Therapy 1
Therapy 2
Therapy 3
Therapy 4
Rate Zone
VT/VT-1
Off
; ATP; CVRT
Off
; ATP; CVRT
Off
; CVRT
Off; CVRT; CVRT x 2
VT-2
ATP; CVRT
Off
; ATP; CVRT
Off
; CVRT
Off; CVRT; CVRT x 2
VF
Defib
Defib
Defib x 4
N/A
Capability
Therapy Number
Therapy 1
Rate Zone
VT/VT-1
Off
; ATP; CVRT
VT-2
ATP; CVRT
VF
Defib; ATP Prior to Charging;
ATP While Charging
Therapy 2
Therapy 3
Therapy 4
Off
; ATP; CVRT
Off
; CVRT
Off; CVRT; CVRT x 2
Off
Off
; ATP; CVRT
; CVRT
Off; CVRT; CVRT x 2
Defib
Defib
114 Available with ATP Prior to Charging or ATP While Charging On.
115
Once a CVRT or Defib setting has been selected in a zone, subsequent therapies must be greater than or equal to the setting for the previous therapy.
116 Also turns off subsequent therapies within the rate zone.
117
Also turns off subsequent therapies within the rate zone.
118 Also turns off subsequent therapies within the rate zone.
119 Also turns off subsequent therapies within the rate zone.
120
Also turns off subsequent therapies within the rate zone.
121 Once a CVRT or Defib setting has been selected in a zone, subsequent therapies must be greater than or equal to the setting for the previous therapy.
122
Also turns off subsequent therapies within the rate zone.
123 Also turns off subsequent therapies within the rate zone.
124
Also turns off subsequent therapies within the rate zone.
125 Also turns off subsequent therapies within the rate zone.
126
Also turns off subsequent therapies within the rate zone.
127 Available with ATP Prior to Charging or ATP While Charging On.
128
Available with ATP Prior to Charging or ATP While Charging Off.
129 Available with ATP Prior to Charging or ATP While Charging On.
Defib x 4
; N/A
104
Table 22. CVRT and Defib therapy settings
Device Detection Zone
VT/VT-1/VT-2/VF (Therapy 1) VT/VT-1/ VT-2
(Therapy 2, 3, 4);
VF (Therapy 2
VF (Therapy 3
Tilt
40 J Devices (Battery Model
36 J Devices (Battery Model
36 J Devices (Battery Model
30 J Devices(Battery Model
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0; 36.0
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0; 36.0
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; … 40.0
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0; 36.0
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0; 36.0
17.5; 20.0; … 30.0; 32.0; …
40.0
17.5; 20.0; … 27.5; 30.0;
32.0; 34.0; 36.0
17.5; 20.0; … 27.5; 30.0;
32.0; 34.0; 36.0
15.0; 17.5; … 30.0
Pulse Width (V)
40 J Devices (Battery Model
40 J Devices (Battery Model
36 J Devices (Battery Model
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0
50; 100; … 800; 830
50; 100; … 800; 845
50; 100; … 800
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0
50; 100; … 800; 830; 875
50; 100; … 800; 845; 890
50; 100; … 800; 875
700; 750; 800; 830; 875
700; 750; 800; 845; 890
700; 750; 800; 875
36 J Devices and 30 J Devices
(Battery Model 2555 (page
See also:
50; 100; … 800; 830
Tachyarrhythmia Therapy Description (page 128)
Parameter Availability and Settings (page 201)
50; 100; … 800; 830
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button
700; 750; 800; 830
NOTE
voltage depends on the current settings of the Waveform parameter and the 1st Phase Tilt parameters. At some tilt settings, high energy values may convert to voltage levels that are not achievable. If this occurs, the programmer selects the highest energy value that can be achieved.
ATP Prior to Charging
The ATP Prior to Charging feature enables the device to deliver a single sequence of ATP therapy before the device charges for HV delivery in the VF zone. After you choose the ATP Prior to Charging parameter, program the Upper Rate Cutoff, which is the upper rate that ATP will be delivered in the VF zone.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > VF Therapy 1 > ATP Prior to
Charging/ATP While Charging/Defib
ATP While Charging
The ATP While Charging feature enables the device to deliver a single sequence of ATP therapy while the device charges for HV delivery in the VF zone. After you choose the ATP While Charging parameter, program the Upper Rate Cutoff, which is the upper rate that ATP will be delivered in the VF zone.
NOTE
In Ellipse devices, the ATP While Charging parameter is disabled at ERI.
130 Available with ATP Prior to Charging or ATP While Charging Off.
131
This is the full range of settings displayed by the programmer. Depending on other parameter settings, the programmer may not allow all settings to be programmed.
132 For devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability, also applicable for VF Therapy 3 when ATP Prior to Charging or ATP While
Charging is enabled.
133 For devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability, also applicable for VF Therapy 4 when ATP Prior to Charging or ATP While
Charging is enabled.
134 Available energy settings depend on the configuration of the DeFT Response™ Technology Settings (Shock Waveform).
105
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > VF Therapy 1 > ATP Prior to
Charging/ATP While Charging/Defib
ATP Details
The ATP Details window shows a summary of the antitachycardia pacing (ATP) settings for each rate zone and therapy. Select a
for each Zone.
NOTE
For ATP settings in the VF Zone
135 , settings from Therapy 1 in the adjacent VT zone are used. If ATP is Off in the adjacent
VT zone, the ATP settings are nominal.
For more information, select one of the following links:
ATP Pulse Amplitude (page 106)
See also:
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button > ATP Details button
ATP Pulse Amplitude
The ATP Pulse Amplitude parameter determines how much electrical potential is applied to the myocardium during the ATP pacing stimulus.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button > ATP Details button
ATP Pulse Width
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button > ATP Details button
ATP Upper Rate Cutoff
Use the ATP Upper Rate Cutoff parameter to specify the rate in min§ above which ATP therapy in the VF zone will not be delivered.
If the intrinsic rate is above the parameter setting, the device does not attempt ATP therapy. The setting for the ATP Upper Rate
Cutoff cannot be equal to or slower than the VF Detection Rate\Interval.
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Zone Therapy button > ATP Details button
ATP Parameters
The ATP Details window allows you to program parameters that control the timing and delivery of antitachycardia pacing (ATP). For
include:
Add Stimuli Per Burst (page 107)
Minimum Burst Cycle Length (page 107)
See also:
Parameter Availability and Settings (page 201)
135 For devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability.
106
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
Number of Bursts
The Number of Bursts parameter determines the maximum number of pacing bursts delivered during ATP.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
Number of Stimuli
The Number of Stimuli parameter determines the number of stimuli (pulses) delivered in each burst.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
Surface ECG. In Current, Current RF, Promote, and Promote RF devices, the first stimulus is delivered synchronously with a sensed event. Since the stimulus is synchronized to the downslope of the bipolar EGM, the surface ECG typically shows the stimulus to be the calculated first pulse interval plus 40 to 80 ms after onset of the QRS complex. The remaining
the intrinsic rhythm.
In all other devices, the first stimulus of the ATP pulse train is also delivered synchronously with a sensed event and is equal to the first calculated Burst Cycle Length following the intrinsic event on which the VT/VF diagnosis was made. Thus, if Burst Cycle Length is set to 85% (Adaptive) and the VT cycle length is 400 ms, then the stimulus would equal 340 ms.
The remaining stimuli in the burst are delivered as VOO pacing at the programmed Burst Cycle Length interval, regardless of the intrinsic rhythm.
Add Stimuli Per Burst
The Add Stimuli Per Burst parameter adds one additional stimulus per burst after the first burst. The total number of stimuli per burst is limited to 20 stimuli.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
Burst Cycle Length
The Burst Cycle Length parameter determines the amount of time that each pacing stimuli in a burst is delivered. Readaptive (page
either of the following configurations:
Adaptive. The initial burst cycle length is a percentage of the average tachycardia interval.
Fixed. The device uses the programmed Burst Cycle Length setting, regardless of the cycle length of the tachycardia.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
Burst Cycle Length interval is reached during a burst, the device delivers the remaining stimuli at the programmed
Minimum Burst Cycle Length interval.
Minimum Burst Cycle Length
The Minimum Burst Cycle Length parameter determines the shortest cycle length delivered within a burst.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
107
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
Minimum Burst Cycle Length interval is reached during a burst, the device delivers the remaining stimuli at the Minimum
Burst Cycle Length interval when the Readaptive, Scanning, or Ramp parameters are enabled, or when the Burst Cycle
Length parameter is set to Adaptive.
Readaptive
The Readaptive parameter enables the recalculation of the initial burst cycle length based on the tachycardia interval average measured at each subsequent diagnosis. The burst cycle length is only recalculated when more than one burst is delivered in an episode. The Readaptive parameter may be useful in patients with more than one VT that falls within a single tachycardia zone.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
Length interval is reached during a burst, the device delivers the remaining stimuli at the programmed Minimum Burst
Cycle Length interval.
Scanning
The Scanning parameter determines the initial cycle length between bursts. When the Scanning parameter is enabled, the initial
disabled, the initial burst cycle length of each burst is the same.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button >
ATP Details summary button
NOTE
interval is reached during a burst, the device delivers the remaining stimuli at the programmed Minimum Burst Cycle
Length interval.
Scan Step
The Scan Step parameter determines the amount that the cycle length decreases from one burst to the next when the Scanning
(page 108) parameter is enabled.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button >
ATP Details summary button
Max Step
The Max Step parameter determines the maximum difference between the first cycle length of the current burst and the first cycle length of the previous burst.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
Scanning parameters are both enabled.
Ramp
The Ramp parameter enables the successive decrease in intervals between stimuli within a burst.
108
When the Ramp parameter is enabled, each interval after the first in a burst is decremented by the programmed Ramp Step (page
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
NOTE
interval is reached during a burst, the device delivers the remaining stimuli at the programmed Minimum Burst Cycle
Length interval.
Ramp Step
The Ramp Step parameter determines the amount by which each interval between stimuli within a burst is decremented when the
Ramp (page 108) parameter is enabled.
See also:
ATP Therapy Configurations (page 109)
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Zone Configuration button > Therapy button > ATP Details button > ATP Details summary button
ATP Therapy Configurations
Table 23. ATP Burst configurations and detailed description
Ramp
On
Off
On
Off
On
Off
Off
On
Readaptive
Off
On
On
Off
Off
Off
On
On
Scanning
On
Off
Off
Off
Off
On
On
On
Detailed Description
ATP Therapy Detail A (page 109)
ATP Therapy Detail B (page 109)
ATP Therapy Detail C (page 110)
ATP Therapy Detail D (page 110)
ATP Therapy Detail E (page 110)
ATP Therapy Detail F (page 110)
ATP Therapy Detail G (page 111)
ATP Therapy Detail H (page 111)
NOTE
antitachycardia pacing therapy at an interval shorter than the programmed Minimum Burst Cycle Length interval.
ATP Therapy Detail A
stimuli within all bursts is constant. The Burst Cycle Length parameter is programmed as either a Fixed interval (in milliseconds) or
Adaptive interval (a percentage of the average tachycardia rate).
The figure below diagrams ATP with a fixed Burst Cycle Length interval of 300 ms.
1.
Pulse width
2.
Burst cycle length
ATP Therapy Detail B
burst is decreased.
109
The figure below diagrams ATP with a fixed Burst Cycle Length interval of 250 ms and a Ramp Step interval of 20 ms.
1.
Pulse width
2.
Burst cycle length
ATP Therapy Detail C
interval.
The figure below diagrams ATP with a fixed Burst Cycle Length interval of 380 ms and a Scan Step interval of 10 ms.
1.
Pulse width
2.
Burst cycle length
ATP Therapy Detail D
each subsequent burst is decreased by the Scan Step (page 108) interval.
The figure below diagrams ATP with fixed Burst Cycle Length interval of 350 ms, a Ramp Step interval of 20 ms, and a Scan Step interval of 10 ms.
1.
Pulse width
2.
Burst cycle length
ATP Therapy Detail E
stimuli within all bursts is constant. The initial burst is delivered at the programmed Burst Cycle Length interval. The Burst Cycle
Length interval for each subsequent burst is recalculated based on the most recent tachycardia rate.
The figure below diagrams ATP with an adaptive Burst Cycle Length of 80%.
1.
Pulse width
2.
Burst cycle length
3.
VT cycle length
ATP Therapy Detail F
programmed Burst Cycle Length interval. The Burst Cycle Length interval for each subsequent burst is recalculated based on the most recent tachycardia rate.
110
The figure below diagrams ATP with an adaptive Burst Cycle Length of 80% and a Ramp Step interval of 15 ms.
1.
Pulse width
2.
Burst cycle length
3.
VT cycle length
ATP Therapy Detail G
stimuli within each burst is constant. The initial burst is delivered at the programmed Burst Cycle Length interval. The Burst Cycle
Length interval for each subsequent burst is recalculated based on the most recent tachycardia rate. The Burst Cycle Length interval
The figure below diagrams ATP with an adaptive Burst Cycle Length of 80%, a Scan Step interval of 20 ms, and a Max Step interval of 80 ms. The minimum Burst Cycle Length is 150 ms.
1.
Pulse width
2.
Burst cycle length
3.
VT cycle length
ATP Therapy Detail H
programmed Burst Cycle Length interval. The initial Burst Cycle Length interval for each subsequent burst is also recalculated based
maximum difference between the first cycle length of the current burst and the first cycle length of the previous burst is limited by
the Max Step (page 108) interval.
The figure below diagrams ATP with an adaptive Burst Cycle Length of 80%, a Scan Step interval of 20 ms, a Ramp Step interval of
15 ms, and a Max Step interval of 80 ms. The minimum Burst Cycle Length is 150 ms.
1.
Pulse width
2.
Burst cycle length
3.
VT cycle length
DeFT Response™ Technology Settings (Shock Waveform)
The DeFT Response™ Settings window allows you to program the high-voltage shock waveform parameters. The central panel in the
therapy. The availability of parameters and data in the Waveform Settings panel depends on the setting of the Zone Configuration
(page 89), Waveform Mode (page 112), and Waveform (page 111).
Shock Configuration. The direction that the high-voltage current travels based on the SVC Electrode and RV Polarity settings.
VF Shocks (Defib) and VT Shocks (CVRT) (page 113) buttons. See Waveform Settings (page 113).
Tuned Waveform Help (page 113)
DynamicTx Over-Current Detection (page 112)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Waveform
The Waveform parameter determines if a biphasic or a monophasic waveform is delivered during high-voltage therapy. The
Waveform setting is used for all high-voltage therapies.
111
A Biphasic waveform is generated by the concatenation of both positive-polarity and negative-polarity truncated exponential waveforms. The leading-edge voltage of the second phase of the waveform is 100% of the residual voltage of the first phase of the waveform.
A Monophasic waveform is only the first half of a biphasic waveform.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Waveform Mode
The Waveform Mode parameter determines if the delivered high-voltage therapy waveform is based on Tilt or Pulse Width. This
Tilt. The percentage of the delivered energy either in a monophasic waveform or in the first phase of a biphasic waveform.
Pulse Width. The amount of time it will take for 65% of the initial delivered voltage to dissipate in either a monophasic waveform or in the first phase of a biphasic waveform.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Shock Configuration
The Shock Configuration parameter determines how the high-voltage current travels between the SVC electrode, can, and RV electrode.
See also:
Parameter Availability and Settings (page 201)
NOTE
•
you must confirm that the HV lead contains a working SVC coil.
•
Programming the Shock Configuration parameter to the RV to Can setting automatically programs the
DynamicTx algorithm parameter to Off.
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
RV Polarity
The RV Polarity parameter determines the polarity of the RV electrode and the direction of current flow for the shock waveform.
of current flow across the Shock Configuration setting. When the parameter is set to Anode (+), the current flows from the RV electrode to the destination of the Shock Configuration parameter. The Cathode (-) setting reverses this flow. The second phase of the biphasic high-voltage waveform is reversed.
When the Waveform parameter is set to Monophasic, the RV electrode polarity is the same as the first phase of a Biphasic waveform.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
DynamicTx™ Over-Current Detection Algorithm
algorithm enables the device to automatically change the Shock Configuration and Shock Energy settings if the pulse generator detects an abnormally low lead impedance when high voltage therapy begins.
If an excessive amount of current is detected during high voltage therapy due to low lead impedance, the device stops the shock
high voltage lead issue") is presented on the FastPath™ Summary and a patient notification is delivered. The next attempts at therapy during the same VT/VF episode are delivered using an alternative shock configuration.
If normal impedance is measured at the alternative setting, therapy is delivered. However, therapy is withheld if low impedance continues to be detected, and the DynamicTx algorithm switches the Shock Configuration to the next possible setting.
RV to SVC & Can. If the lead issue occurs when the programmed Shock Configuration setting is RV to SVC & Can, the algorithm changes the setting first to RV to Can. If low impedance is detected at the RV to Can setting, the algorithm changes the setting to RV to SVC. If low impedance is detected at the RV to SVC setting, then the algorithm changes the setting back to RV to SVC & Can and restarts the procedure.
RV to SVC. If the lead issue occurs when the programmed Shock Configuration setting is RV to SVC, the algorithm changes the setting first to RV to Can. If low impedance is detected at the RV to Can setting, then the algorithm switches to the RV to SVC setting and restarts the procedure.
The algorithm continues to search for a viable setting until the episode ends or a shock can be delivered.
112
NOTE
Programming the Shock Configuration parameter to the RV to Can setting automatically programs the DynamicTx algorithm parameter to Off.
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Waveform Settings
shows:
The Estimated Defib and CVRT Tilt are based on a calculation using the last measured shock impedance measurement. This is
available if the Waveform Mode (page 112) parameter is set to Pulse Width.
The Estimated Defib and CVRT Pulse Width are based on a calculation of the capacitor strength and the last HV Lead
The last measured Shock Impedance value
you choose an appropriate VF Shocks and VT Shocks Pulse Width setting. To see all possible values in the table select the
Tuned Waveform Help (page 113) button.
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
VF Shocks (Defib) and VT Shocks (CVRT)
The VF Shocks (Defib) and VT Shocks (CVRT) parameters determine the length of the defibrillation therapy (Defib) or cardioversion therapy (CVRT) shock waveform. Use these parameters to set the waveform’s Tilt or Pulse Width, depending on the type of shock set
phases.
To assist in setting this parameter, the Waveform Settings panel shows the estimated shock waveform Pulse Width or Tilt (depending on the setting for the Waveform Mode parameter), based on the device settings and measurements.
The available settings are shown in the table below.
Table 24. Settings for the high-voltage output Tilt and Pulse Width
Waveform
Monophasic
Biphasic - 1st Phase
Biphasic - 2nd
Phase
Therapy
VF Shocks
VT Shocks
VF Shocks
VT Shocks
VF Shocks
VT Shocks
HV Output Mode
Tilt
42; 50; 60; 65% (Nominal: 65%)
Same as Defib; 42; 50; 60; 65%
(Nominal: 65%)
42; 50; 60; 65% (Nominal: 65%)
Same as Defib; 42; 50; 60; 65%
(Nominal: 65%)
Equal to first phase
Equal to first phase
Pulse Width
3.0; 3.5; … 12.0 ms (Nominal: 5.5 ms)
Same as Defib; 3.0; 3.5; … 12.0 ms
(Nominal: Same as Defib)
3.0; 3.5; … 12.0 ms (Nominal: 5.5 ms)
Same as Defib; 3.0; 3.5; … 12.0 ms
(Nominal: Same as Defib)
1.2; 1.5; 2.0; … 12.0 ms
(Nominal: 5.5 ms)
Same as Defib; 1.2; 1.5; 2.0; … 12 ms
(Nominal: Same as Defib)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Tuned Waveform Help
NOTE
In order to ensure a 10 J safety margin, verify that the maximum delivered energy at the new Pulse Width setting is at least
10 J greater than the defibrillation threshold (DFT).
The values presented in these tables are based on a theory of biphasic defibrillation waveforms ("Burping Theory
Use the tables below and these instructions to guide you in the selection of an appropriate Pulse Width setting for the VF Shocks
(Defib) and VT Shocks (CVRT) (page 113) parameters.
Instructions for Tuned Waveform Help
1.
Note the Shock Impedance measurement on the Waveform Settings (page 113) panel.
136
The second phase must be less than or equal to the first phase.
137 Kroll MW. A minimal model of the single capacitor biphasic defibrillation waveform. PACE 1994; 17:1782 – 1792.
113
2.
3.
4.
Look in the first column in the appropriate table for your device (based on battery model) for the corresponding Shock
Impedance value (R value, in ¬).
J/875 V).
J/875 V), and Battery Model 2850 (page 182) (40 J/890 V)
Scan across the row to the first two columns. The values in the "Typical" column for P1 (Phase 1 of the biphasic shock) and P2
(Phase 2) show a typical response. You can program these settings for the VF Shocks (Defib) and VT Shocks (CVRT) (page
113) parameters and attempt to defibrillate the patient again.
If the shock delivered using the "Typical" settings was not effective, attempt to defibrillate again using the Pulse Width settings first in the "Faster" column. If that is not acceptable, attempt to defibrillate again using settings in the "Slower" column.
NOTE
Tips for using these tables:
•
When removing the SVC coil, make sure to double-check Shock Impedance due to the likely change in measured impedance.
•
If P1 or P2 are not altered by more than half a millisecond, little has changed.
•
Optimization may not help a poor vector.
•
Common sense preempts the tables
84
86
88
90
92
76
78
80
82
94
96
66
68
70
72
74
60
62
64
52
54
56
58
46
48
50
38
40
42
44
30
32
34
36
Table 25. ICD alternative defibrillation biphasic waveform Pulse Width setting recommendations for devices with Battery Model 2356
(page 180) (30 J/830 V) and Battery Model 2950 (page 183) (36 J/875 V)
R (
¬) Block #1
Typical
Block #2
Faster
Block #3
Slower
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.0
5.5
5.5
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
P1 (ms)
3.0
3.0
3.5
3.5
3.5
3.5
3.5
3.5
3.0
3.0
2.5
2.5
2.5
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.5
3.5
3.0
3.0
3.0
3.0
3.0
P2 (ms)
3.0
3.0
3.5
3.5
3.5
3.5
3.5
3.0
4.0
4.0
4.0
4.5
4.5
4.0
4.0
4.0
4.0
4.5
4.5
3.5
3.5
3.5
3.5
4.0
4.0
4.0
4.0
3.0
3.0
3.5
3.5
3.5
3.5
3.5
P1 (ms)
N/A
3.0
3.0
3.0
3.0
3.0
3.0
3.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
P2 (ms)
N/A
2.5
2.5
2.5
2.5
2.0
2.0
2.0
6.0
6.0
6.0
6.0
6.0
5.5
5.5
5.5
5.5
6.0
6.0
5.0
5.0
5.0
5.0
5.0
5.5
5.5
5.5
4.5
4.5
4.5
4.5
4.5
5.0
5.0
P1 (ms)
3.5
3.5
N/A
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
3.5
3.5
4.0
4.0
4.0
3.5
3.5
3.5
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.5
4.5
4.5
4.5
4.0
4.5
4.5
P2 (ms)
3.5
3.5
N/A
4.0
4.0
4.0
4.0
4.0
114
Table 25. ICD alternative defibrillation biphasic waveform Pulse Width setting recommendations for devices with Battery Model 2356
(page 180) (30 J/830 V) and Battery Model 2950 (page 183) (36 J/875 V)
R ( ¬)
Block #1
Typical
Block #2
Faster
Block #3
Slower
98
100
102
104
106
108
5.5
5.5
5.5
5.5
5.5
5.5
3.0
3.0
2.5
2.5
2.5
2.5
4.5
4.5
4.5
4.5
4.5
4.5
2.0
2.0
2.0
2.0
2.0
2.0
6.0
6.0
6.5
6.5
6.5
6.5
3.5
3.5
3.5
3.5
3.5
3.5
84
86
88
90
92
76
78
80
82
70
72
74
60
62
64
66
68
102
104
106
108
94
96
98
100
52
54
56
58
46
48
50
38
40
42
44
30
32
34
36
Table 26. ICD alternative defibrillation biphasic waveform Pulse Width setting recommendations for devices with Battery Model 2555
R (
¬) Block #1
Typical
Block #2
Faster
Block #3
Slower
5.5
5.5
5.5
5.5
5.5
5.0
5.0
5.0
5.5
4.5
4.5
4.5
5.0
5.0
5.0
5.0
5.0
6.0
6.0
6.0
6.0
5.5
5.5
5.5
5.5
4.0
4.0
4.0
4.5
4.5
4.5
4.5
P1 (ms)
3.5
3.5
3.5
3.5
3.5
4.0
4.0
4.0
3.0
3.0
2.5
2.5
2.5
3.0
2.5
2.5
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.0
2.5
2.5
2.5
2.5
2.5
2.5
2.5
2.5
3.0
3.0
3.0
3.0
3.0
3.0
3.0
P2 (ms)
3.5
3.5
3.5
3.5
3.0
3.5
3.5
3.0
4.5
4.5
4.5
4.5
4.5
4.0
4.0
4.5
4.5
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.0
4.5
4.5
5.0
5.0
4.5
4.5
4.5
4.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
P1 (ms)
3.0
3.0
3.0
3.0
3.0
3.0
3.0
3.5
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
2.0
P2 (ms)
2.5
2.5
2.0
2.0
2.0
2.0
2.0
2.0
6.0
6.0
6.5
6.5
6.5
6.0
6.0
6.0
6.0
5.5
5.5
5.5
5.5
5.5
5.5
5.5
6.0
6.5
6.5
7.0
7.0
6.5
6.5
6.5
6.5
4.5
4.5
5.0
5.0
5.0
5.0
5.0
P1 (ms)
N/A
4.0
4.0
4.0
4.0
4.5
4.5
4.5
3.5
3.5
3.5
3.5
3.5
4.0
4.0
3.5
3.5
4.0
4.0
4.0
4.0
4.0
4.0
3.5
4.0
3.5
3.5
3.5
3.5
3.5
3.5
3.5
3.5
4.5
4.0
4.5
4.0
4.0
4.0
4.0
P2 (ms)
N/A
4.0
4.0
4.0
4.0
4.5
4.5
4.5
115
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > DeFT Response Settings (Shock Waveform) button
Redetection & Post Detection Criteria
The programmer allows you to change other detection criteria not used for routine programming but that may be necessary to finetune a device in some patients. These criteria include:
Post Detection Interval/Rate (page 116)
See also:
Post Detection Description (page 117)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Redetection & Post-Detection button
VT Redetection
The VT Redetection parameter determines the number of binned tachycardia intervals necessary for the redetection of tachycardia after VT, VT-1, or VT-2 therapy.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Redetection & Post-Detection button
NOTE
of VT, VT-1, or VT-2 detection intervals.
required for tachycardia redetection in the VT-1 and VT-2 zones.
the device requires six intervals for tachycardia redetection, regardless of the programmed VT Redetection setting.
Sinus Redetection
The Sinus Redetection parameter determines the number of binned sinus intervals required after the detection of a tachyarrhythmia to consider the arrhythmia terminated. A Fast (3 intervals) setting decreases the number of intervals necessary for the redetection of a sinus rhythm. A Slow (7 intervals) setting increases the number of intervals for redetection of sinus rhythm.
Changing the Zone Configuration (page 89) does not nominalize this parameter.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Redetection & Post-Detection button
Post Detection Interval/Rate
The Post Detection Interval/Rate parameter determines the interval/rate used for the redetection of an arrhythmia slowed by device therapy. Once device therapy is delivered and the arrhythmia cycle length remains shorter than the post detection interval/rate for
the programmed number of VT Redetection (page 116) intervals, the device delivers the next therapy.
parameter settings for each Post Detection Interval/Rate are listed in the following table.
Table 27. Post Detection Interval/Rate settings
Post Detection Interval/Rate
1 Zone
Zone Configuration
2 Zones 3 Zones
138 This is the full range of settings displayed by the programmer. Depending on other parameter settings, the programmer may not allow all settings to be programmed.
116
Table 27. Post Detection Interval/Rate settings
Post Detection Interval/Rate Zone Configuration
1 Zone 2 Zones
Post VT or Post VT-1
Post VF or Post VF/VT-2
N/A
Same as VF or VF +50 ms in
10 ms increments
(Nominal: Same as VF)
Absolute Range: 200, 210, …
590 ms
Same as VT to VT +30 ms in
5 ms increments
(Nominal: Same as VT)
Absolute Range: 300, 310, …
590 ms
Same as VT to Same as VF in
10 ms increments
(Nominal: Same as VT)
Absolute Range: 200, 210, …
590 ms
Accessed From: Parameters button > Redetection & Post-Detection button
3 Zones
Same as VT-1 to VT-1 +30 ms in 5 ms increments
(Nominal: Same as VT-1)
Absolute Range: 300, 305, …
590 ms
Same as VT-1 to Same as VT-2 in 10 ms increments
(Nominal: Same as VT-1)
Absolute Range: 200, 210, …
590 ms
Post Detection Description
1 Zone Configuration (page 117)
2 Zones Configuration (page 117)
3 Zones Configuration (page 117)
1 Zone Configuration
whose initial tachyarrhythmia is routinely slowed by therapy but remains hemodynamically compromised. In this case, the Post VF
Detection Interval/Rate Interval parameter can be reprogrammed to allow detection of this slower rhythm.
If the Post VF Detection Interval/Rate parameter is left at the nominal setting, intervals from 0 to 50 ms longer than the VF Detection
Interval/Rate parameter are not counted toward either redetection of sinus or redetection of fibrillation.
Appropriately setting the Post VF Detection Interval/Rate parameter assures that the next VF therapy is delivered if the arrhythmia cycle length is temporarily lengthened by therapy. This prevents the device from identifying a new episode and delivering the same, previously ineffective therapy.
If the Post VF Detection Interval/Rate parameter is changed from the nominal setting, redetection of sinus requires the average interval to be longer than the programmed Post VF Detection Interval/Rate setting.
See also:
ShockGuard™ Technology Settings (Zone Configuration Window) (page 89)
Redetection & Post Detection Criteria (page 116)
2 Zones Configuration
arrhythmia is routinely converted by VF therapy to a fast sinus tachycardia within the VT Detection Interval/Range. It may not be appropriate to attempt to treat that rhythm. The Post VF Detection Interval/Rate setting could, therefore, be made shorter than the interval of the sinus tachycardia. Intervals longer than the Tach Detection Interval/Rate setting are counted toward sinus redetection.
After VT therapy has been delivered, the Post VT Detection Interval/Rate setting defines the criteria for tachycardia redetection.
If VT therapy slows the arrhythmia but the interval is still short enough to satisfy the Post VT Detection Interval/Rate criteria, the device delivers additional VT therapy. Intervals that are longer than the Post VT Detection Interval/Rate setting are counted toward sinus redetection.
After VF therapy has been delivered, the Post VF Detection Interval/Rate setting is used as the criteria for VF redetection.
arrhythmia cycle length meets either the VT Therapy Timeout or the Post VF Detection Interval/Rate criteria for a minimum of six intervals. The programmed VT Therapy Timeout detection time does not have to expire again before delivery of the next therapy.
See also:
ShockGuard™ Technology Settings (Zone Configuration Window) (page 89)
Redetection & Post Detection Criteria (page 116)
3 Zones Configuration
the criteria for VT-1 redetection. If VT-1 therapy slows the arrhythmia but the interval is still short enough to satisfy the Post VT-1
Detection Interval/Rate criteria, the device delivers additional VT-1 therapy. Intervals longer than the Post VT-1 Detection
Interval/Rate setting are counted toward sinus redetection.
After delivering the VT-1 therapy in the 3 Zone configuration, the average of the intrinsic intervals must be longer than the programmed Post VT-1 Detection Interval/Rate setting for the device to redetect sinus rhythm.
117
After delivering the VT-2 or VF therapy, the average of the intrinsic intervals must be longer than the programmed VT-1 Detection
Interval/Rate setting for the device to redetect sinus rhythm.
After VF therapy has been delivered, the Post VF/VT-2 Detection Interval/Rate setting is used as the criteria for VF Redetection. Thus, if the VF therapy slows the arrhythmia, but the interval is still short enough to satisfy the Post VF/VT-2 Detection Interval/Rate criteria, the device delivers additional VF therapy.
When the Post VF/VT-2 Detection Interval/Rate setting is changed from the nominal setting, if a VF therapy slows the rate to less than the Post VF/VT-2 Interval/Rate setting but faster than VT-1, the device monitors the arrhythmia but does not give additional therapy
until the rhythm accelerates or the VT Therapy Timeout (page 104) period expires.
See also:
ShockGuard™ Technology Settings (Zone Configuration Window) (page 89)
Redetection & Post Detection Criteria (page 116)
Post-Shock Pacing
From the Post-Shock Pacing window, you can change the settings for the following parameters:
Post-Shock Base Rate (page 118)
Post-Shock Duration (page 118)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Post-Shock Mode
The Post-Shock Mode parameter determines the pacing mode used after a high-voltage shock is delivered. The Post-Shock Mode
shown in the table below.
Table 28. Post-Shock Mode settings
Pacing Mode
AAI(R)
VVI(R)
DDI(R)
Available Post-Shock Mode for CRT-Ds and
Dual-Chamber ICDs
Off, AAI, VVI, DDI
Off, VVI, DDI
Off, AAI, VVI, DDI
DDD(R) Off, AAI, VVI, DDI, DDD
Pacer Off, AOO(R),VOO(R) or DOO(R) N/A
See also:
Redetection & Post Detection Criteria (page 116)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Available Post-Shock Mode for Single-
Chamber ICDs
N/A
Off, VVI
N/A
N/A
N/A
Post-Shock Base Rate
The Post-Shock Base Rate parameter sets the minimum pacing rate after a high-voltage shock is delivered. The Post-Shock Base
Rate is effective immediately after the Post-Shock Pause (page 118) interval.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Post-Shock Pause
The Post-Shock Pause parameter is the length of time that must pass after a high-voltage shock is delivered and post-shock pacing can begin. In some patients, pacing immediately after a high-voltage shock is delivered may be arrhythmogenic.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Post-Shock Duration
The Post-Shock Duration parameter is the length of time that pacing, using the post-shock pacing parameters, continues after a high-voltage shock is delivered. The Post-Shock Duration interval begins immediately after the high-voltage shock is delivered.
118
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
NOTE
Interactions. During the Post-Shock Duration interval, the Sensor (rate-responsive pacing) and Rate Responsive AV Delay
(page 72) parameters are disabled.
Pulse Amplitude
The post-shock Pulse Amplitude parameter determines how much electrical potential is applied to the myocardium during pacing that follows the delivery of a high-voltage shock. The post-shock Pulse Amplitude setting must be equal to or greater than the
Post-Shock Pause (page 118) interval.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Pulse Width
The post-shock Pulse Width parameter determines how long the pulse amplitude is applied to the myocardium during pacing that follows the delivery of a high-voltage shock. The post-shock Pulse Width setting must be equal to or greater than the permanent
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Post-Shock Pacing button
Capacitor Maintenance
The Capacitor Maintenance window shows the voltage that the high-voltage capacitors will charge to for capacitor maintenance
charging. You can change the setting of the Charge Interval (page 119).
See also:
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Parameters button > Tachy tab > Capacitor Maintenance button
Charge Interval
The Charge Interval parameter determines the time between automatic capacitor maintenance charges.
NOTE
between 2.56 and 2.86 V, the Charge Interval parameter only allows the 1 month setting
. See Factors That Affect
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Tachy tab > Capacitor Maintenance button
Tachy Therapy Detailed Descriptions
Tachyarrhythmia Detection Description (page 120)
SVT Discrimination Description (page 120)
Tachyarrhythmia Therapy Description (page 128)
Zone Descriptions
The following tachyarrhythmia therapy zone configurations are available:
139 For devices with Battery Model 2753, Battery Model 2850, and Battery Model 2950, the 4, 5, and 6 month settings are available.
119
NOTE
therapy zones.
Off
The Off configuration does not allow tachyarrhythmia diagnosis or therapy. The device does not store diagnostic information or episodes associated with ventricular tachyarrhythmias. Episodes induced by device-based testing are stored. Morphology Scoring
Window (page 103) is available.
This configuration is useful during:
An immediate postoperative period when there may be an increased incidence of supraventricular arrhythmias
A period when the patient is under continuous surveillance in the hospital
Surgery using electrosurgical equipment that might trigger high-voltage outputs from the device
Device implant or explant
Use the Tachy Therapy Enable/Disable (page 166) button to temporarily disable tachy therapies.
1 Zone
The 1 Zone configuration allows detection of a single tachyarrhythmia rate (referred to as "fibrillation").
SVT discriminators are not available in this device configuration.
2 Zones
The 2 Zones configuration recognizes two tachyarrhythmia detection rates:
Tachycardia (VT), the slower rate
Fibrillation (VF), the faster rate
SVT discriminators are available in the VT rate zone. See SVT Discrimination Details (page 91).
3 Zones
The 3 Zone configuration recognizes three tachyarrhythmia detection rates:
Tachycardia (VT-1), the slowest rate
Tachycardia (VT-2), a faster rate
Fibrillation (VF), the fastest rate
Rate Zone Legend
Discrimination Zone cutoff.
Tachyarrhythmia Detection Description
The device classifies detected events based on both the current interval and a running interval average (an average of the current interval and the previous three intervals). To satisfy the detection criteria and be counted toward detection, both the current interval and the running interval average must be shorter than or equal to the longest tachyarrhythmia Detection Interval/Rate. The interval is classified as the shorter of either (1) the interval or (2) the interval average. Detection occurs when a detection zone classifies its required No. Intervals.
After therapy is delivered or a rhythm is classified as SVT, the device must classify a minimum number of intervals before it redetects
Detection Interval/Rate (page 116), and Tachyarrhythmia Therapy Description (page 128).
After several intervals are classified during an episode, the device forces a mode switch to a non-tracking pacing mode and disables rate-responsive pacing (Sensor) to prevent high-rate pacing during an episode from potentially masking an arrhythmia.
A bigeminal rhythm may have intervals as well as running interval averages faster than the programmed Detection Interval/Rate. To protect against delivering therapy into a bigeminal rhythm, the device must detect more tachyarrhythmia intervals than sinus intervals before it delivers therapy.
If discriminators are enabled, they must classify a rhythm as VT before the device will deliver tachycardia therapy. See SVT
Discrimination Details (page 91).
SVT Discrimination Description
Rate Branch Detailed Description (page 121)
Morphology Detailed Description (page 121)
Interval Stability Detailed Description (page 122)
Arrhythmia Onset Description (page 122)
Sudden Onset Description (page 122)
SVT Discrimination Criteria Programming Guidelines (page 122)
SVT Discrimination Timeout Description (page 127)
120
Rate Branch Detailed Description
The following figure diagrams how the Rate Branch discriminator works with the other SVT discriminators to classify a rhythm as VT or SVT in the Dual Chamber discrimination setting.
Figure 9. Rate Branch flow diagram
flutter.
help distinguish 1:1 retrograde VT from sinus tachycardia or atrial tachycardia with 1:1 conduction.
determines that there is dissociation between the atrial and ventricular rhythms, Morphology and Sudden Onset or Chamber
Onset (page 101) are not evaluated and diagnosis occurs immediately.
VT/VF Rate Branch. When the ventricular rate is greater than the atrial rate (V>A), no discrimination criteria are used to qualify the diagnosis. Diagnosis occurs and the device initiates therapy.
Morphology Detailed Description
The Morphology discriminator compares the shape (morphology) of sinus complexes to an arrhythmia’s complexes to help
configuration to use to select the complexes: Far Field or Original MD. These settings are explained here: see Morphology Type.
a stored template complex. A morphology score is assigned, indicating the percentage similarity of the complex to the stored
template. See Morphology Template (page 102).
is requested by the programmer (for example, during real-time EGM display). During an episode, scoring stops once the initial diagnosis of VT has been made. Therefore, no scores appear on the EGM after charging begins or during redetection. Scoring starts
When Morphology is set to Passive, the device stores diagnostic information, but the Morphology discriminator does not affect diagnosis. For CRT-Ds and Dual-Chamber ICDs, Morphology is programmed independently for the AF/AFL and Sinus Tach rate branches. In devices with Far Field MD Morphology Discrimination Capability, the Far Field MD/SecureSense™ Configuration parameter can also be independently programmed.
121
Interval Stability Detailed Description
to Off and to the following settings:
On. When the Interval Stability discriminator is set to On, the device stores diagnostic information on AV association (AVA) or sinus interval history (SIH) as well as the stability of the arrhythmia; however, only the Interval Stability discriminator affects the diagnosis of a rhythm.
Passive. When the Interval Stability discriminator is set to Passive, the device stores diagnostic information on AVA or SIH as well as the stability of the arrhythmia, but the Interval Stability discriminator does not affect the diagnosis of a rhythm.
On w/AVA. When the Interval Stability discriminator is set to On w/AVA and the rhythm is classified as VT, the measured AV
Association Delta (the difference between the second longest and the second shortest AV interval in a recent group of intervals
intervals, the rhythm is classified as SVT. If the AV intervals are unstable, the rhythm is classified as VT. This setting may be
useful in recognizing atrial flutter. See Interval Stability Window Size (page 101).
On w/SIH. When the Interval Stability discriminator is set to On w/SIH (Sinus Interval History) and the rhythm is classified as
VT, the number of sinus intervals or average intervals during detection of the arrhythmia (the measured SIH Count) is
measured SIH Count is equal to or greater than the programmed Interval Stability: SIH Count, the rhythm is classified as SVT.
When Interval Stability is On w/SIH and the rhythm is classified as SVT, the SIH Count is not checked. This setting may be useful in recognizing AF that has regularized.
Arrhythmia Onset/Sudden Onset Detailed Description
using the onset of the tachyarrhythmia as a discriminator for diagnosing SVT: Chamber Onset and Sudden Onset. All other devices provide only the Sudden Onset discriminator.
Chamber Onset Description
The Chamber Onset discriminator compares the timing of the rate increase in the atrium to that of the ventricle. If the onset of the rate increase occurs in the atrium before the ventricle, than the arrhythmia is considered an SVT. Alternatively, a rate increase occurring in the ventricle before the atrium is considered to be a VT. The algorithm also factors in how quickly the ventricular rate
Sudden Onset Description
The Sudden Onset discriminator compares the average interval to previous interval averages to determine whether the difference
(either absolute or percentage change) is large enough to satisfy the Sudden Onset criterion. Since average intervals are used for the comparison, a single long interval during a gradual increase in rate may (appropriately) result in failure to satisfy the Sudden Onset
amid several short intervals will probably still allow the Sudden Onset criterion to be satisfied.
Sudden Onset discriminator does not affect diagnosis. If Sudden Onset is programmed On, the device stores diagnostic information and considers the Onset Delta before diagnosing VT.
SVT Discrimination Criteria Programming Guidelines
Programming Considerations (page 123)
Ventricular Only SVT Discrimination (page 125)
Dual Chamber SVT Discrimination (page 125)
The utility of the SVT Discriminators (page 93) is summarized in the following table.
Table 29. Summary of SVT discrimination criteria and their uses
SVT Discriminator
Possible Application
Distinguish SVT with rapid atrial rates from VT
Distinguish normally conducted rhythms, such as sinus tachycardia or atrial fibrillation, from VT
Considerations in Selecting
Use only if an atrial lead is in place and reliable atrial sensing is present.
Use only if the baseline rhythm % Match (page 95) scores are
near 100% during baseline rhythm.
May be inappropriate for use in patients with rate-related bundle-branch blocks or in patients with VT morphology similar to their baseline rhythm.
Morphology collects its automatic template during sinus rhythm and is unlikely to recognize the rate-related bundle branch block as matching sinus. In these cases, a manual template can be collected during rapid atrial pacing in-clinic.
In some cases, AF can conduct to the ventricle with some degree of aberrancy. For these patients, it is valuable to have
Morphology turned On with Interval Stability in an "If Any"
Diagnosis Criteria configuration.
122
Table 29. Summary of SVT discrimination criteria and their uses
SVT Discriminator
Interval Stability with SIH
Interval Stability with AVA
Possible Application
Distinguish sinus tachycardia from VT
Distinguish atrial tachycardia and 1:1 SVTs from VT
Considerations in Selecting
May be inappropriate for use in patients with exercise induced
VT or very slow VT. If the exercise-induced VT rate is not faster than the sinus tachycardia rate, consider setting the Sudden
Onset parameter to passive or use it with Morphology and an "If
Any" Diagnosis criteria.
If the patient’s sinus rate is unlikely to be in the VT detection zone, the Sudden Onset discriminator may not be useful.
May be inappropriate for patients with atrial tachycardias that conduct to the ventricles on a 1:1 basis.
Use in patients with Atrial Flutter and other SVTs likely to fall into the V=A rate branch. Use in combination with Morphology in “If All” Diagnosis criteria.
May be inappropriate for use in patients with exercise induced
VT or very slow VT. If the exercise-induced VT rate is not faster than the sinus tachycardia rate, consider setting the Chamber
Onset parameter to passive or use it with Morphology and an “If
Any” Diagnosis criteria.
Distinguish atrial fibrillation from
VT
Distinguish atrial fibrillation with rate regularization from VT
Use with caution if the patient’s VT has exhibited rate variability
Use with caution if the patient’s VT has exhibited rate variability
Distinguish atrial flutter from VT Use with caution if the patient’s VT has exhibited rate variability
Programming Considerations
When making changes to the SVT Discrimination parameter settings, consider that each individual parameter setting influences whether the device defines a rhythm as VT or SVT. The figures below represent the range of settings for each discriminator; the
and with Far Field MD Morphology Discrimination Capability (page 188).
123
Figure 10. SVT discrimination parameters for devices with DecisionTx Programming Capability (for the Number of Intervals parameter, the nominal setting varies according to the Zone Configuration setting and the device). See tables below for nominal settings
Figure 11. SVT discrimination parameters for devices with Far Field MD Morphology Discrimination Capability (for the Number of
Intervals parameter, the nominal setting varies according to the Zone Configuration setting and the device). See the tables below for nominal settings.
124
Ventricular Only SVT Discrimination
Once a potential episode is detected, the VR discrimination mode looks at four factors prior to designating the rhythm as an SVT or a
VT. These are:
1.
2.
3.
How suddenly did the rhythm start? (Sudden Onset (page 101))
What is the shape of the QRS complex compared to normal sinus rhythm? (Morphology (page 95))
Is the ventricular rhythm stable? (Interval Stability (page 99))
4.
How often does the ventricular rhythm alternate with sinus beats? (SIH Count (page 100))
Until you have determined more appropriate settings by considering the patient’s history or diagnostic data, use the recommended
(nominal) settings found in the tables below.
When the discriminators are set to On or Passive, the device stores diagnostic data for events that fall within the SVT Discrimination.
This includes the measured deltas for the Sudden Onset and Interval Stability parameters, information about the morphology template performance, and the classification of the rhythm by each discriminator. Refer to this data when choosing the appropriate discriminators and settings to use in the future.
Figure 12. Ventricular Only SVT discriminators
Dual Chamber SVT Discrimination
Once a potential episode is detected, Dual Chamber Discrimination mode looks at five factors prior to making a determination of whether the rhythm is SVT or VT. These are:
1.
Which chamber is going faster? (Rate Branch (page 93))
2.
3.
4.
5.
What is the shape of the QRS complex compared to the normal sinus rhythm? (Morphology (page 95))
Is the ventricular rhythm stable? (Interval Stability (page 99))
Figure 13. Dual-Chamber SVT discriminators
125
Until you have determined more appropriate settings by considering the patient’s history or diagnostic data, use the recommended
(nominal) settings found in the tables below.
Nominal Settings
The following tables summarize the nominal values for the SVT Discrimination parameters. These values are automatically selected when VT/VF detection is enabled via the Zone Configuration parameter. The final table displays the nominal settings for the Detection
Rate/Interval and Number of Intervals parameters for each Zone Configuration.
Older generation devices with the previous nominal settings can also take advantage of the new recommended nominal settings via manual programming of these settings.
Table 30. Nominal SVT discriminator settings for the Dual Chamber SVT Discrimination setting
Parameter
Interval Stability (page
Stability Delta (page
Interval Stability
Window Size (page
AV Association Delta
AnalyST, AnalyST Accel, Auricle,
Current, Current Accel,
Current+, Promote,
Promote Accel, Promote+,
Promote Q, Promote LAP devices
AF/AFl (V<A)
Rate Branch
On
Sinus Tach
(V=A)
Rate Branch
Devices with DecisionTx™
Programming Capability (page
AF/AFl (V<A)
Rate Branch
On w/AVA
Sinus Tach
(V=A)
Rate Branch
80 ms
12
60 ms (Passive)
40 ms
12
On, 60 ms
On On On On
Template Match Criteria
No. of Matches (page
Morphology Type (page
AV Interval Delta
Arrhythmia Onset
(Sudden Onset (page
If Any
60%
5 of 8 n/a (Original MD)
Off
Sudden Onset: On
(Fixed)
100 ms
If Any If All
60%
7 of 12 n/a (Original MD)
On,60 ms
Sudden Onset: On
(Fixed)
100 ms
If All
Devices with Far Field MD™
Morphology Discrimination
AF/AFl (V<A)
Rate Branch
On w/AVA
40 ms
12
On, 60 ms
On
If All
Sinus Tach
(V=A)
Rate Branch
90%
3 of 10
Far Field
On
Off
Chamber Onset:
On n/a
If All
Table 31. Nominal SVT discriminator settings for the Ventricular Only SVT Discrimination setting
Parameter
Interval Stability (page
Stability Delta (page
AnalyST, AnalyST Accel, Auricle,
Current, Current Accel,
Current+, Promote,
Promote Accel, Promote+,
Promote Q, Promote LAP devices
Passive
Devices with DecisionTx™
Programming Capability (page
On w/SIH
80 ms 40 ms
Devices with Far Field MD™
Morphology Discrimination
Passive
40 ms
126
Table 31. Nominal SVT discriminator settings for the Ventricular Only SVT Discrimination setting
Parameter
Interval Stability
Window Size (page
Template Match
(Morphology No. of
Morphology Window
Morphology Type (page
Sudden Onset (page
AnalyST, AnalyST Accel, Auricle,
Current, Current Accel,
Current+, Promote,
Promote Accel, Promote+,
Promote Q, Promote LAP devices
12
Devices with DecisionTx™
Programming Capability (page
12
2 (Passive)
On
60%
5 of 8 n/a
Passive (Fixed)
100 ms
If Any
2
On
60%
7 of 12 n/a
On (Fixed)
100 ms
If 2 of 3
Devices with Far Field MD™
Morphology Discrimination
12
2 (Passive)
On
90%
3 of 10
Far Field
Passive (Fixed)
100 ms n/a
Table 32. Nominal settings for Detection/Interval Rate, Number of Intervals, and SVT Upper Limit parameters for each Zone
Configuration
Parameter AnalyST, AnalyST Accel, Auricle, Current,
Current Accel, Current+, Promote,
Promote Accel, Promote+, Promote Q,
Promote LAP devices
Devices with DecisionTx™ Programming
Capability (page 424) and Far Field MD™
Morphology Discrimination Capability (page
1 Zone
VF Detection Rate
VF Number of Intervals
2 Zones
VF Detection Rate
VF Number of Intervals
VT Detection Rate
VT Number of Intervals
3 Zones
VF Detection Rate
VF Number of Intervals
VT2 Detection Rate
VT2 Number of Intervals
VT1 Detection Rate
VT1 Number of Intervals
SVT Upper Limit
167 min§ / 360 ms
12 intervals
181 min§ / 330 ms
12 intervals
139 min§ / 430 ms
12 intervals
181 min§ / 330 ms
12 intervals
160 min§ / 375 ms
12 intervals
139 min§ / 430 ms
12 intervals
Same as VT-2 (160 min§ / 375 ms)
187 min§ / 320 ms
12 intervals
214 min§ / 280 ms
12 intervals
171 min§ / 350 ms
16 intervals
214 min§ / 280 ms
12 intervals
181 min§ / 330 ms
16 intervals
150 min§ / 400 ms
18 intervals
Same as VF (214 min§ / 280ms)
SVT Discrimination Timeout Description
The programming flexibility of the device allows it to inhibit therapy when supraventricular tachycardias (SVT) are detected. To prevent the potentially inappropriate inhibition of therapy for a long period of time, however, the device has an SVT discrimination timeout feature. This feature is a "timer" that allows the device to inhibit therapy delivery for SVTs for a programmable length of time.
93)) and initiates the programmed Therapy After Timeout (page 92).
127
When SVT discriminators are set to On or the SVT Discrimination mode is set to Dual Chamber, the SVT Discrimination Timeout timer starts when a Diagnosis is inhibited by the SVT Diagnosis algorithm.
The SVT Discrimination Timeout timer stops and resets when it expires and therapy is initiated, when a tachyarrhythmia diagnosis occurs, or when sinus rhythm is detected.
See also:
SVT Discrimination Timeout in a Monitor Only Zone (page 128)
SVT Discrimination Timeout in a Monitor Only Zone
disabled to create a monitor only zone. In this case, all VT therapies are disabled and SVT discriminators do not operate in the only zone that does have therapies enabled (fibrillation).
create a Monitor Only Zone and the SVT discriminators apply to rhythms within the VT-2 rate zone. In that case, the SVT
Discrimination Timeout timer starts when the device detects an average interval shorter than or equal to the VT-2 detection interval.
rhythms within the VT-2 rate zone, the SVT Discrimination Timeout timer is not available and therapy is delivered as programmed.
Tachyarrhythmia Therapy Description
While charging its capacitors for a high-voltage shock, the device checks continuously for the presence of a tachyarrhythmia and confirms that one is still present before it delivers therapy. Therapy is delivered even if the arrhythmia rate slows but is still within any programmed tachyarrhythmia detection rate range (or faster than the sinus redetection interval). This is the process of reconfirmation.
If the device detects sinus rhythm before delivering therapy, it terminates charging and aborts the shock. The voltage on the capacitors is not "dumped" when charging terminates, but decreases gradually with time. Within 1 hour, very little voltage is left on
ATP synchronously into the sensed event that caused diagnosis.
If cardioversion is the first tachycardia therapy, a maximum of five cardioversion shocks can be delivered for that rhythm in a single
A maximum of 6 fibrillation shocks can be delivered in a single episode. The first and second shocks are delivered once each; the third fibrillation therapy consists of up to 4 shocks, as necessary. All high-voltage shocks are delivered synchronously with sensed events.
associated initial voltage. When the HV Output Mode is configured to Pulse Width, therapies are programmed in voltage and displayed with the associated estimated delivered energy.
If all therapies in a zone are delivered without terminating the tachyarrhythmia, the device will continue to count intervals
(consecutive or isolated) that fall into other zones until either the patient's rate falls below the programmed detection rate (i.e., sinus detection) or another zone's detection criteria are met
VT Therapy Timeout Description
switching to defibrillation therapy. When the VT Therapy Timeout parameter is enabled, the timer begins counting once VT or VT-1
parameter.) If the therapy is not effective in stopping the tachyarrhythmias within the time specified by the Timeout setting, then the device abandons tachycardia therapies and delivers fibrillation therapies.
If the tachycardia accelerates to fibrillation, the device delivers fibrillation therapy in the normal manner without requiring the VT
Therapy Timeout timer to expire. If all tachycardia therapies have been delivered and the arrhythmia is still present and has not been accelerated, no further therapy is delivered until the VT Therapy Timeout timer expires.
The VT Therapy Timeout timer also terminates when sinus rhythm is detected.
Once the VT Therapy Timeout timer is triggered, expires, or terminates, it cannot restart within that episode.
See also:
VT Therapy Timeout in a Monitor Only Zone (page 128)
VT Therapy Timeout in a Monitor Only Zone
create a monitor only zone.
monitor only zone. The VT Therapy Timeout timer starts after VT-2 therapy is delivered.
128
Alert Notification Parameters
Contains:
AT/AF Alert Triggers (page 131)
Patient Notifier Delivery (page 132)
Patient Notifier Description (page 132)
Percent Pacing Alert Triggers (page 133)
Congestion Monitoring (page 134)
Alert Notification
The Alert Notification window contains two buttons that you can use to program the Alert Triggers. The Alert Triggers can be used for
certain critical conditions; (2) the Patient Notifier function emits a vibratory
sensation so that the patient is aware of
initiate a test of the stimulation experienced during a Patient Notification.
and duration of the patient notification signal.
See also:
Patient Notifier Sequence (page 133)
Patient Notifier Daily Measurements (page 133)
Available In: Devices with Patient Notifier Capability (page 192)
Accessed From: Parameters button > Alert Notification tab
Alert Triggers
function.
You can select to view alerts on the FastPath Summary Alerts box for a condition by selecting the Show on FastPath check-box next to the Trigger conditions listed in the window. You can also notify the patient of any triggering condition by selecting the Patient
Notifier check-box.
For some Alert Triggers listed below, you cannot de-select the Show on FastPath option for these conditions. That is, these conditions will always generate a programmer Alert:
Device at ERI
Device Parameter Reset
Backup VVI
Charge Time Limit Reached
Possible HV Circuit Damage
Available triggers are listed below:
Device at ERI
Affect Device Longevity (page 335)).
Charge Time Limit Reached
Possible HV Circuit Damage
143 . The high-voltage capacitors have not reached the programmed voltage within 32 s.
144 . The device circuitry or a high voltage lead may be damaged.
Device Parameter Reset. A reset has occurred that altered some or all of the permanently programmed parameters. For
parameter settings during device reset, see Reset Function (page 172).
Lead Impedance Out of Range. The lead impedance was measured above or below the limits specified by the Lead
Monitoring Parameters for a specific chamber (A, V, RV, LV). To adjust the upper and lower limits of optimal impedance range
HVLI Out of Range
. The high-voltage lead impedance was measured above or below the limits specified by the Lead
Monitoring Parameters. To adjust the upper and lower limits of the optimal impedance range, select this button to open the
Backup VVI. The device is operating in the Backup VVI and/or Backup Defibrillation Only mode. For parameter settings during
Backup VVI/DFO, see Backup VVI and Defibrillation Only settings (page 174).
AT/AF Episode
. A single AT/AF episode has exceeded the programmed Episode Duration setting Continuous Time in AT/AF
140 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
141
Available in devices with Auditory Patient Notifier capability.
142 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
143
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
144 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
145
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
146 Available in devices with AT/AF Alert Triggers Capability.
129
AT/AF Burden
program these parameters.
V Rate During AT/AF
to open the AT/AF Alert Triggers (page 131) window to program these parameters.
Therapy is Inhibited Due to Lead Noise.
(Available when the SecureSense™ paramter is On.) The SecureSense™
window.
Two Episodes of Non-sustained RV/V Oversensing (NSO) detected. (Available when the SecureSense™ parameter is set to
On or Passive).
Select this button to open the SecureSense™ Settings (page 90) window.
Percent BiV/RV/V Pacing Alert (Less/Greater Than __%)
151 . The percentage of paced events to total events has exceeded
Congestion Monitoring Alert. The congestion episode has exceeded the programmed Congestion Trigger in the Congestion
ST Suggested Thresholds Available Alert
. The ST Monitoring feature has updated suggested thresholds available for programming.
device automatically monitors changes in the ST segment and creates an Alert if the ST segment changes meet the criteria for
Notification if the device detects any ST Episode.
the device automatically monitors changes in the ST segment and creates an Alert if the ST segment changes meet the criteria
device detects any Type I ST Episodes.
changes in the ventricular rate and creates an Alert if the rate exceeds the Ventricular Rate Threshold setting for a duration specified by the Number of Cycles parameter. To program these parameters, select this button to open the High Ventricular
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button
NOTE
ST Episode Alert.
•
Carefully evaluate any reported changes in the ST segment reported, along with the patient’s history, physical examination, and other clinical information, to determine if further clinical testing (e.g., stress testing) is warranted.
•
Devices without ST Monitoring Phase 2 Capability. Programming the ST Episode patient notifier disables all currently selected Patient Notification alert triggers except the Device Parameter Reset and the Back-Up VVI triggers. Disabled alerts can be reprogrammed on by manually reselecting the desired alert buttons.
•
Devices with ST Monitoring Phase 2 Capability. Programming the ST Type I Episode patient notifier disables all currently selected Patient Notification alert triggers except the Device Parameter Reset and the Back-Up VVI triggers. Disabled alerts can be reprogrammed on by manually reselecting the desired alert buttons.
NOTE
Battery Voltage Below ERI. The Patient Notifiers may not work if the battery voltage falls below ERI.
NOTE
the patient notifier within the pulse generator is permanently disabled when in or near an MRI scanner. In MR Conditional
ICDs, the patient notifier is not affected by the MRI scanner.
High Ventricular Rate: Episode Trigger & Alert Trigger
The High Ventricular Rate: Episode Trigger and Alert Trigger window allows you to set two parameters that generate either a High V
Ventricular Rate Threshold. The sensed ventricular rate above which the device will record a High V Rate trigger if the rate occurs for longer than the Number of Cycles parameter.
Number of Cycles. The number of cycles above the Ventricular Rate Threshold that the device counts before it generates an episode or alert.
147
Available in devices with AT/AF Alert Triggers Capability.
148 Available in devices with AT/AF Alert Triggers Capability.
149
Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
150 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
151
Available in devices with Percent Pacing Alert Capability.
152 Available in devices with ST Monitoring Capability.
130
Available in: Devices with High Ventricular Rate Diagnostic capability (page 190)
Accessed From: Parameters button > Episode Settings tab > Episode EGMs button > High Ventricular Rate button
AT/AF Alert Triggers
The AT/AF Alert Triggers window allows you to set the conditions for monitoring and notifying the patient of AT/AF conditions. The three alerts include:
Evaluation Period (page 131) parameters.
V Rates During AT/AF. The ventricular rate above which monitoring and notification occurs and the duration of the high
Evaluation Period (page 131) parameters.
Available In: Devices with AT/AF Alert Triggers Capability (page 178)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
Continuous Time in AT/AF
The Continuous Time in AT/AF parameter sets the length of time a patient must be in AT/AF before triggering the AT/AF Episode alert trigger.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
Total Time in AT/AF
The Total Time in AT/AF parameter sets the minimum duration that the patient must be in AT/AF for the programmed Evaluation
Period (page 131) by the before generating an AT/AF Burden Alert Trigger.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
Evaluation Period (AT/AF Burden)
The Evaluation Period parameter sets the period (daily or weekly) in which AT/AF Burden alerts are generated. The daily setting limits the number of AT/AF Burden alerts to a single day. The Weekly setting limits the number of alerts to a single week.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
High V. Rate Threshold
The High V. Rate Threshold is the sensed or sensor-driven ventricular rate during AT/AF above which the device defines as a High V.
Rate. The device records a High V. Rate During AT/AF Alert Trigger if the rate continues for a time longer that the Total Time in High
(page 68) setting or the AMS Base Rate (page 86) setting.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
Total Time in High V. Rate
The Total Time in High V. Rate parameter is the amount of time the device must record high ventricular rates during AT/AF (defined
During AT/AF Alert Trigger.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
131
Evaluation Period (V. Rate During AT/AF)
The Evaluation Period parameter sets the time period during which the V. Rate During AT/AF is measured. When the Evaluation
Period ends, the device restarts the measurement.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > AT/AF Episode button, AT/AF Burden button, or
V Rates During AT/AF button
Patient Notifier Delivery
From the Patient Notifier Delivery window you can change the settings for the following parameters:
Number of Notifications (page 132)
Time Between Notifications (page 132)
See also:
Patient Notifier Description (page 132)
Patient Notifier Sequence (page 133)
Patient Notifier Daily Measurements (page 133)
Available In: Devices with Patient Notifier Capability (page 192)
Accessed From: Parameters button > Patient Notifiers tab > Patient Notifier Delivery button
Vibration Duration
The Vibration Duration parameter determines the length of time that the individual vibratory stimulus lasts.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Patient Notifiers tab > Patient Notifier Delivery button
Auditory Duration
The Auditory Duration parameter determines the length of time that the individual auditory stimulus lasts.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Patient Notifiers tab > Patient Notifier Delivery button
Number of Notifications
The Number of Notifications parameter determines the number of times a notification (2 vibrations/auditory stimuli, 16 seconds apart) is delivered.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Patient Notifiers tab > Patient Notifier Delivery button
Time Between Notifications
The Time Between Notifications parameter is the amount of elapsed time between notifications.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Patient Notifiers tab > Patient Notifier Delivery button
Patient Notifier Description
Patient Notifier Sequence (page 133)
Patient Notifier Daily Measurements (page 133)
The Patient Notifier is a vibratory
153 stimulus that comes from a small motor in the device or an auditory 154 stimulus that comes from
a small beeper inside the device. The device can be programmed to vibrate (or beep) when specific triggers occur.
during the delivery of a Patient Notifier and for 10 seconds afterwards.
Sequence, the current notification sequence continues and there is no second sequence. However, all Patient Notifier triggers that
have been met are listed in the Alerts portion of the FastPath™ Summary Screen (page 17).
153
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
154 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
132
Once a Patient Notifier is delivered, that specific Patient Notifier trigger is auto-selected Off until you have (1) re-enabled the trigger
Notifier Triggers window when the Patient Notifier condition has been met and all the notifications have been delivered.
Patient Notifier Sequence
(page 132) delivered 16 seconds apart.
Figure 14. The Patient Notifier sequence
1.
Stimulus On
2.
Stimulus Off
3.
16 seconds
4.
Time Between
Notifications
5.
Notification
6.
Stimulus Duration
7.
Stimulus
The Patient Notifier sequence for the following triggers is not programmable:
The Device Parameter Reset sequence is 2 stimuli, 6 seconds long, 16 seconds apart every 10 hours for a total of 4 sequences.
The Back Up VVI sequence is 2 stimuli, 6 seconds long, 16 seconds apart every 10 hours until telemetry connection with the programmer is established.
Patient Notifier Daily Measurements
The unloaded battery voltage and pacing lead impedance measurements are made once every 23 hours to ensure that the
trends and Battery Voltage trend (see Battery Details (page 45)).
Percent Pacing Alert Triggers
The Percent Pacing Alert Triggers window enables you to program an alert if the percent pacing falls below or above a certain percentage for a specified duration. Two parameters can be programmed.
Available In: Devices with Percent Pacing Alert Capability (page 194)
Percentage BiV Pacing Limit
The Percentage BiV Pacing Limit (Percent Pacing Less Than) parameter sets the minimum percentage of total paced pulses that will
CRT-Ds, Allure, Allure Quada, and Quadra Allure MP devices.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > Percent V Pacing Alert
Percentage RV/V Pacing Limit
The Percentage RV/V Pacing Limit (Percent Pacing Greater Than) parameter sets the maximum percentage of total paced pulses
only for dual-chamber and single-chamber ICDs, CRT-Ds. This parameter is also available in Allure, Allure Quadra, Assurity,
Endurity, and Quadra Allure MP devices
.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > Percent V Pacing Alert
Percent Pacing Alert Duration
Percentage RV/V Pacing Limit (page 133) parameter must be exceeded before an alert is triggered.
See also:
Parameter Availability and Settings (page 201)
155 CRT-Ps with this feature must have the Ventricular Pacing parameter programmed to RV Only.
133
Accessed From: Parameters button > Alert Notification tab > Alert Triggers button > Percent V Pacing Alert
CorVue™ Monitoring
From this window, you can program the Congestion Trigger (page 38) parameter.
134
Episode Settings
Contains:
Stored EGM Configuration (page 135)
Episode Trigger: High Ventricular Rate (page 139)
Episode Settings
The Episode Settings window contains two buttons that you can use to program the following:
See also:
NOTE
To ensure that all important episodes are collected, it is recommended that you clear the episodes from the device
memory at the end of each session. See Clear Diagnostics (page 149).
Stored EGM Configuration
From the Stored EGM Configuration window you can change the settings for the following parameters:
VT/VF EGM Max Duration (page 135)
High V Rate EGM Max Duration (page 135)
VT/VF Pre-Trigger Max Duration (page 135)
High V Rate Pre-Trigger Max Duration (page 136)
VT/VF EGM Max Duration
The VT/VF EGM Max Duration parameter determines the maximum length of a VT/VF stored EGM. The VT/VF EGM Max Duration parameter is timed from the beginning of the pre-trigger and stops either four seconds after the redetection of sinus rhythm or when the VT/VF EGM Max Duration setting is reached, whichever occurs first.
A longer duration of stored EGMs allows fewer episodes to be stored. For information on the number of EGMs that can be stored in
the device, see "Priority" in Episode Triggers (page 138).
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
High V Rate EGM Max Duration
The High V Rate EGM Max Duration parameter determines the maximum length of a high ventricular rate stored EGM. The High
V Rate EGM Max Duration parameter is timed from the beginning of the pre-trigger and stops when the High V Rate EGM Max
Duration setting is reached.
A longer duration of stored EGMs allows fewer episodes to be stored. For information on the number of EGMs that can be stored in
the device, see "Priority" in Episode Triggers (page 138).
NOTE
The High V Rate EGM Max Duration parameter is not available in Endurity™ Core devices.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
VT/VF Pre-Trigger Max Duration
The VT/VF Pre-Trigger Max Duration parameter determines the amount of time recorded before the EGM storage trigger.
The VT/VF Pre-Trigger Max Duration setting should be based on the programmed Event Trigger and the type of information you wish to store. For example, to store events leading up to detection, program the Event Trigger to VT/VF with a relatively long pre-trigger
stored.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
135
High V Rate Pre-Trigger Max Duration
The High V Rate Pre-Trigger Max Duration parameter determines the amount of time recorded before the EGM storage trigger.
The High V Rate Pre-Trigger Max Duration setting should be based on the programmed Event Trigger and the type of information you wish to store. For example, to store events leading up to detection, program the Event Trigger to high ventricular rate with a relatively long pre-trigger duration. The available settings for the High V Rate Pre-Trigger Max Duration depend upon the number of EGM
NOTE
The High V Rate Pre-Trigger Max Duration parameter is not available in Endurity™ Core devices.
See also:
Parameter Availability and Settings
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
Channels
The Channels parameter determines the number of EGM channels stored with each stored EGM. More stored channels allow fewer episodes to be stored.
Channel 3 as the Discrimination Channel to store SEGMs for VT/VF episodes.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
NOTE
Stored EGM Capacity.
•
CRT-Ds (page 161), Dual-Chamber ICDs (page 162), and Single-Chamber ICDs (page 162) can store
approximately 45 minutes of stored EGM records at a setting of 1 Channel. A setting of 2 Channels stores approximately 22 minutes. A setting of 3 Channels stores approximately 15 minutes.
•
CRT-Ps (page 162), Dual-Chamber Pacemakers (page 163), and Single-Chamber Pacemakers (page 163) can
store approximately 14 minutes of stored EGM records at a setting of 1 Channel. A setting of 2 Channels stores approximately 8 minutes. A setting of 3 Channels stores approximately 5 minutes.
•
However, Endurity™ Core devices can only store approximately two minutes at a setting of 1 Channel.
•
Stored EGM capacity.
Configuration
The Configuration parameters determine the electrode source for each of the EGM channels. The Leadless ECG setting is a representation of what a surface ECG may have recorded during the episode.
without an SVC coil, select a cathode.
configuration.
In Single-Chamber Pacemakers (page 163), the Leadless ECG setting is not available.
NOTE
the third EGM channel, ST Monitoring must be programmed Off.
Table 33. Stored EGM Configuration settings for CRT-Ds without quadripolar lead support
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
RV Bipolar
RV Unipolar Tip
RV Unipolar Ring
V Sense Amp
LV Bipolar
LV Unipolar Tip
LV Unipolar Ring
Leadless ECG
A tip-RV tip
Custom
136
Table 34. Stored EGM Configuration settings for CRT-Ds with quadripolar lead support
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
RV Bipolar
RV Unipolar Tip
RV Unipolar Ring
V Sense Amp
Distal tip 1 - Mid 2
Distal tip 1 - Can
Mid 2 - Can
Table 35. Stored EGM Configuration settings for dual-chamber ICDs
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
V Bipolar
V Unipolar Tip
V Unipolar Ring
V Sense Amp
Table 36. Stored EGM Configuration settings for single-chamber ICDs
Configuration
V Bipolar
V Unipolar Tip
V Unipolar Ring
V Sense Amp
Leadless ECG
Custom
Table 37. Stored EGM Configuration settings for CRT-Ps without quadripolar lead support
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
RV Bipolar
RV Unipolar Tip
RV Unipolar Ring
V Sense Amp
LV Bipolar
LV Unipolar Tip
LV Unipolar Ring
BV Bipolar
BV Unipolar Tip
BV Unipolar Ring
Leadless ECG
A tip-RV tip
Custom
Leadless ECG
A tip-V tip
Custom
A ring-RV ring
A tip-BV tip
Custom
Leadless ECG
Table 38. Stored EGM Configuration settings for CRT-Ps with quadripolar lead support
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
RV Bipolar
RV Unipolar Tip
RV Unipolar Ring
V Sense Amp
Distal tip 1 - Mid 2
Distal tip 1 - Can
Mid 2 - Can
Table 39. Stored EGM Configuration settings for dual-chamber pacemakers
Configuration
A Bipolar
A Unipolar Tip
A Unipolar Ring
A Sense Amp
V Bipolar
V Unipolar Tip
V Unipolar Ring
V Sense Amp
A tip-V tip
A ring-V ring
A ring-V tip
Leadless ECG
Custom
Leadless ECG
137
Table 40. Stored EGM Configuration settings for single-chamber pacemakers
Configuration
V Bipolar
V Unipolar Tip
V Unipolar Ring
V Sense Amp
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button
NOTE
EGM Storage. If an episode that triggers electrogram storage occurs while the programmer is communicating with the device, the real-time ECG/EGM configuration rather than the EGM source Configuration settings are used to store the
EGM.
Custom
store far-field EGMs.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Stored EGM Configuration button > Configuration button
Episode Triggers
From the Episode Triggers window, you can prioritize episode triggers for EGM storage.
Triggers. The device stores EGMs for various types of episodes.
-
Atrial Episode
. An EGM is stored when the Atrial Tachycardia Detection Rate (page 86) is exceeded (AT/AF Detection
record. The device stores the first, last and fastest rate episodes.
-
VF setting). The VF Trigger can only be set to high Priority.
-
VT
setting). The VT Trigger can be set to low or high Priority.
-
PMT cleared.
-
PVC
PVCs parameter.
Consecutive PVCs stores an episode.
. Sets the number of consecutive PVCs that must be counted before the PVC Trigger parameter
Advanced Hysteresis
. An EGM is stored when the device detects a drop in the intrinsic rate that triggers the
Intervention Rate (page 70) algorithm (see Advanced Hysteresis Functions (page 70)).
-
High Ventricular Rate
. An EGM is stored when the ventricular rate exceeds the Ventricular Rate Threshold setting for a duration specified by the Number of Cycles parameter. To program these parameter, select this button to open the High
Ventricular Rate: Episode Trigger and Alert Trigger window where you can select the settings for the Ventricular Rate
Threshold (page 139) and Number of Cycles (page 139) parameters.
-
Noise Reversion. An EGM is stored when atrial and/or ventricular noise reversion is exited.
-
Magnet Response. An EGM is stored when the magnet is applied.
-
Morphology Template Update
Template Auto Update (page 96).
. An EGM is stored when the morphology template is updated automatically. See
. An EGM is stored when a non-sustained VT/VF episode is recorded (See Note (page 21) for
-
Non-sustained VT/VF definition).
-
Non-sustained RV Lead Noise
. An EGM is stored when a SecureSense™ non-sustained RV lead noise episode is
recorded. See SecureSense™ Settings (page 90).
Priority. The Priority determines the number of EGMs stored for each episode trigger.
-
Off. No EGMs are stored for an episode trigger.
156 Not available in single-chamber devices.
157
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
158 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
159
Not available in single-chamber devices.
160 Not available in single-chamber devices.
161
Not available in single-chamber devices.
162 Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
163
Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
164 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
165
Available in devices with Non-sustained VT/VF Episode Capability.
166 Available in devices with SecureSense™ RV Lead Noise Discrimination Capability.
138
-
Low. At least one EGM is stored and protected in the memory. Subsequent triggers of the same type are stored on a firstin, first-out basis. When the memory is full, high-priority episodes overwrite any unprotected low-priority or high-priority episodes.
High. At least one EGM is stored and protected in the memory. Subsequent triggers of the same type are stored on a firstin, first-out basis. When the memory is full, high-priority episodes overwrite any unprotected low-priority or high-priority episodes.
Accessed From: Parameters button > Episode Settings tab > Episode EGMs button
NOTE
Mode Switch parameter is enabled and the Mode parameter is set to DDD(R).
PMT Termination is only available if PMT Response (page 84) is enabled.
episodes are defined as VT/VF episodes that are longer than six intervals but shorter than the programmed No. Intervals required for classification as tachyarrhythmia.
Episode Trigger: High Ventricular Rate
A High Ventricular Rate EGM is recorded if the sensed ventricular rate exceeds the setting for the Ventricular Rate Threshold parameter for a duration set by the Number of Cycles parameter.
Available in: Accent, Accent RF, Accent ST, Accent MRI, Accent ST MRI, Anthem, Anthem RF devices
Accessed From: Parameters button > Episode Settings tab > Episode EGMs button > High Ventricular Rate button
Ventricular Rate Threshold
The Ventricular Rate Threshold (High Ventricular Rate) parameter specifies the minimal rate that the device must sense before it begins to count cycles to record a High Ventricular Rate EGM. If the device counts a series of consecutive cycles greater than the
Number of Cycles (page 139) parameter, then it triggers the collection of an EGM.
See also:
Parameter Availability and Settings (page 201)
Number of Cycles (High Ventricular Rate)
The Number of Cycles (Consecutive High Ventricular Rate Cycles) parameter specifies the number of consecutive cycles that the
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Episode Settings tab > Episode Triggers button > High Ventricular Rate button
High Ventricular Rate: Episode Trigger & Alert Trigger
The High Ventricular Rate: Episode Trigger and Alert Trigger window allows you to set two parameters that generate either a High V
Ventricular Rate Threshold. The sensed ventricular rate above which the device will record a High V Rate trigger if the rate occurs for longer than the Number of Cycles parameter.
Number of Cycles. The number of cycles above the Ventricular Rate Threshold that the device counts before it generates an episode or alert.
Available in: Devices with High Ventricular Rate Diagnostic capability (page 190)
Accessed From: Parameters button > Episode Settings tab > Episode EGMs button > High Ventricular Rate button
Episode Trigger: Atrial Episode
Use the window to select the type of episode you want to record as well as the criteria for each episode type to be recorded.
Accessed From: Parameters button > Episode Settings tab > Episode EGMs button > Atrial Episode button
Atrial Episode Type
The Atrial Episode Type selects the type of atrial episode you want to record. When you select a type, one of the three panels below becomes active to set the trigger criteria.
See also:
Parameter Availability and Settings (page 201)
AMS Trigger Type
The AMS Trigger Type determines if an atrial episode is recorded on AMS Entry, AMS Exit, or both exit and Entry.
139
See also:
Parameter Availability and Settings (page 201)
Atrial Tachycardia Detection Rate
The Atrial Tachycardia Detection Rate sets the threshold above which all rates are defined as tachycardias and are recorded as High
Atrial Rate EGMs.
See also:
Atrial Tachycardia Detection Rate parameter (page 86)
Parameter Availability and Settings (page 201)
High Atrial Rate
The High Atrial Rate parameter specifies the minimal atrial rate that the device must sense before it begins to count cycles for a High
triggers the collection of an EGM.
See also:
Parameter Availability and Settings (page 201)
Number of Cycles (High Atrial Rate)
The Number of Cycles parameter specifies the number of consecutive cycles that the device must count for rates above the High
Atrial Rate (page 140) setting to trigger a High Atrial Rate EGM.
See also:
Parameter Availability and Settings (page 201)
140
Diagnostic Settings
The Diagnostic Settings tab of the Parameters window allows you to enable or disable:
ST Monitoring Feature (page 141)
CorVue™ Monitoring Diagnostic Feature
ST Monitoring Feature
The ST Monitoring feature detects and analyzes acute voltage shifts in the ST segment of ventricular sensed events by continuously
automatically enabled at implant when the device is interrogated. You can program additional ST Monitoring parameters from the ST
Monitoring Setup (page 33) window:
Isoelectric Start (page 36) and Isoelectric Duration (page 36)
ST Interval Start (page 36) and ST Interval Duration (page 36)
Positive Threshold (page 35) and Negative Threshold (page 35)
Select the Print button to print the ST Monitoring parameter settings along with other critical parameter settings.
window.
NOTE
Changes in the ST segment of the electrocardiogram have been known to be indicative of cardiac conditions such as myocardial ischemia and acute coronary syndromes. Carefully evaluate any reported changes in the ST segment reported, along with the patient’s history, physical examination, and other clinical information, to determine if further clinical testing
(e.g., stress testing) is warranted. The ST Monitoring feature should not be used alone to make clinical decisions.
See also:
ST Monitoring Diagnostic (page 141)
Available In: Devices with ST Monitoring Capability (page 198)
ST Monitoring Diagnostic
The ST Monitoring Diagnostic parameter enables the ST Monitoring feature. The ST Monitoring Diagnostic parameter is automatically enabled at implant when the device is interrogated or it can be turned On or Off
167 from the Diagnostic Settings tab available from the
Parameters button.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Parameters button > Diagnostic Settings tab
NOTE
ST Monitoring is suspended:
•
Following ventricular tachyarrhythmia detection
• Following high voltage tachyarrhythmia therapy
•
When high atrial rates are detected
• In the presence of ventricular noise reversion
•
During High voltage capacitor maintenance
•
During a Merlin™ Patient Care System programming session
•
When ST Monitoring is programmed On, Negative AV Hysteresis/Search (page 73) is autoprogrammed Off.
CorVue™ Congestion Monitoring Feature
The CorVue™ Congestion Monitoring feature can be turned On or Off from the Diagnostic Settings tab available from the Parameters
window.
See also:
Parameter Availability and Settings (page 201)
Available In: Devices with CorVue™ Congestion Monitoring Capability (page 184)
Accessed From: Parameters button > Diagnostic Settings tab
167 Setting the ST Monitoring parameter to Off clears all ST Monitoring diagnostic data.
141
Custom Sets
Custom Sets are predefined "snapshots" of parameter settings that can be saved in the programmer memory and loaded into the device from the Custom Sets window. From this window, you can also review all saved custom sets, rename a set, and delete a set.
A maximum of 20 custom parameter sets can be stored for each device model. You can load customized parameters at any time during a programming session.
Create and Save a Custom Set (page 143)
Delete a Custom Set (page 143)
Rename a Custom Set (page 143)
Export a Custom Set (page 144)
Import a Custom Set (page 144)
Available In: All Devices
Accessed From: Parameters button > Custom Sets tab
Create and Save a Custom Set
To create and save the currently programmed settings as a custom set:
1.
2.
3.
Select the Custom Sets tab.
Select the Save Parameter Set button.
If the selected setting for a parameter is different from the programmed setting (for example, a temporarily programmed setting), the selected setting is saved.
The on-screen keyboard appears.
Type a name for the custom settings and select the Done button.
The Custom Sets window appears with the newly saved custom set listed by its name and Lead Type settings.
NOTE
You cannot change settings of a saved custom set. If you wish to change a parameter in a saved custom set, you must load the custom set you want to change, select the Rename Set button and give the older custom set a new name or delete it, and then save the changed set with the desired name.
Load a Custom Set
4.
5.
6.
To load a saved custom set:
1.
Select the Parameters button.
2.
3.
Select the Custom Sets tab.
Select one of the existing parameter sets from the list in the Custom Sets window.
Select the Load Set button.
To review the newly loaded parameter settings, select the Preview button.
To program the settings, select the Program button.
7.
To revert to the previously programmed parameters, select the Undo button.
NOTE
Review the parameter settings after you load a custom parameter set to ensure that the loaded custom parameter set is appropriate for the patient.
You cannot load a set if the current Lead Type parameter is set to Unipolar and the custom set is set to Bipolar
Delete a Custom Set
To delete a saved custom set:
1.
2.
Select the Parameters button.
Select the Custom Sets tab.
3.
4.
Select one of the existing parameter sets from the list in the Custom Sets window.
Select the Delete Set button.
Rename a Custom Set
To rename a saved custom set:
1.
Select the Parameters button.
2.
3.
Select the Custom Sets tab.
Select one of the existing parameter sets from the list in the Custom Sets window.
4.
5.
Select the Rename Set button.
Type in the new name for the custom set and select the Done button.
143
6.
7.
8.
To review the newly loaded parameter settings, select the Preview button.
To program the settings, select the Program button.
To revert to the previously programmed parameters, select the Undo button.
Export a Custom Set
To export a saved custom set:
1.
2.
Select the Parameters button.
Select the Custom Sets tab.
3.
4.
Select one of the existing parameter sets from the list in the Custom Sets window.
Select the Export Set button.
5.
6.
Select where you want to export the custom set.
Select the Export button.
7.
Select the Done button.
To export a batch of saved custom sets, grouped by device family:
1.
Select the Parameters button.
2.
3.
Select the Custom Sets tab.
Select the Export by Family button.
4.
5.
Select the device family.
Select where you want to export the custom set.
6.
7.
Select the Export button.
Select the Done button.
Import a Custom Set
5.
6.
2.
3.
4.
This procedure will import all customs sets saved to a media device. To import one or several custom sets:
1.
Select the Parameters button.
Select the Custom Sets tab.
Select the Import All button.
Select where you want to import the custom set from.
Select the Import button.
Select the Done button.
144
MRI Settings
Contains:
MRI Settings: Active (page 147)
MRI Settings
The MRI Settings window allows you to program basic operating parameters for an MR Conditional pulse generator that are in effect during an MRI scan.
See also:
From the MRI Settings window, you can:
Enable the MRI Settings in an MR Conditional pulse generator (for a complete list of these devices, see MR Conditional
Programming capability (page 191))
Change and save the MRI Settings in the pulse generator
Temporarily program the pulse generator to test the effect of the MRI Settings on the patient
Access the MRI Checklist (page 146) to prepare the patient for an MRI scan
Determine if communication between the pulse generator and the handheld activator device is enabled (only in devices with
SJM MRI Activator™ handheld device capability (page 191))
Enable the pulse generator to communicate with the handheld activator device (only in devices with SJM MRI Activator™
handheld device capability (page 191)).
WARNING
Before you attempt to scan a patient with an implanted MR Conditional pacing system, read all the instructions in
before proceeding with the MRI scan.
In addition to the parameter settings, the MRI Settings window contains the following buttons:
Undo All. Restores all nominal or previously programmed MRI Settings.
Test MRI Settings. Temporarily programs the MRI Settings to help you determine their effect on the patient. When the test is complete, select the Cancel Test button.
Save MRI Settings. Saves the currently selected MRI Settings.
generator (only in devices with SJM MRI Activator™ handheld device capability (page 191)).
NOTE
the patient notifier within the pulse generator is permanently disabled when in or near an MRI scanner. In MR Conditional
ICDs, the patient notifier is not affected by the MRI scanner.
Available In: Devices with MR Conditional Programming Capability (page 191)
Accessed From: Parameters button > MRI Settings tab
MRI Parameters
The MRI parameter settings are stored and tested from the MRI settings screen. These settings are only in effect when you select the
activator (only in devices with SJM MRI Activator™ handheld device capability (page 191)).
programmed. In all other MR Conditional devices, diagnostic data collection is suspended while MRI Settings are enabled.
The MRI Settings provide only basic pacing functions and limit the pulse generator’s interactions with the electromagnetic radiation during the MRI scan.
induced voltages. Choices are either Pacing Off or an available asynchronous mode (AOO, VOO, or DOO).
MRI Pulse Configuration (page 60)
CAUTION
In MR Conditional ICDs, Tachy Therapy is disabled when MRI Settings are programmed.
See also:
Parameter Availability and Settings (page 201)
145
MRI Checklist
Use the MRI Checklist window to verify the current MRI Settings and to ensure that all the conditions for an MRI scan are in place before programming the MRI Settings. From this window, you can also enable the SJM MRI Activator™ handheld device (only in
after each condition is verified. If a box is left unchecked, you will not be able to program the MRI settings or enable the handheld activator.
After you have checked all the boxes, you will see one of the following green buttons:
Program MRI Settings. Select this button to program the MRI settings in the pulse generator in preparation for an imminent MRI
enable the pulse generator to communicate with the handheld activator and save the MRI Settings. This button does not enable the
communication with the handheld activator is enabled.
Conditions Required for MRI - Pacemakers
Specific conditions must be met before a patient with an MR Conditional pulse generator can have an MRI scan. Refer to the MRI
Procedure Information document for a complete list of all conditions.
In addition, the following conditions must all be met before the patient can have an MRI scan:
Bipolar Capture Thresholds are stable. Select the test button for the corresponding chamber to perform a Capture Test (page
39) to verify that capture thresholds are stable.
data for each lead and verify the lead impedances are within range.
NOTE
The Bipolar Pacing Lead Impedance check-mark is not available (and the patient cannot be scanned) if any of the following conditions are present:
•
The most recent bipolar atrial or ventricular lead impedance measurement is not available
• A clinical alert exists for a bipolar atrial or ventricular lead impedance measurement
•
The lead impedance is outside of the programmed range.
ensure the implanted leads are St. Jude Medical MR Conditional leads. Some St. Jude Medical MR Conditional leads are equipped with a unique radiopaque marker that can aid in identification. Refer to the MRI Procedure Information Document for more information on MR Conditional leads.
No Additional Cardiac Hardware (adapters, extenders, abandoned leads). The Additional Cardiac Hardware...[Present/Not
hardware is stored. If you do not know whether additional hardware is present, you can confirm its absence with an x-ray or other diagnostic image.
Accessed From: Parameters button > MRI Settings tab > Setup MRI Activator or Setup for MRI Now button
Conditions Required for MRI - ICDs
Specific conditions must be met before a patient with an MR Conditional ICD can have an MRI scan. Refer to the MRI Procedure
Information document for a complete list of all conditions.
In addition, the following conditions must all be met before the patient can have an MRI scan:
Bipolar Capture Thresholds are stable. If applicable, select the test button for the corresponding chamber to perform a
Capture Test (page 39) to verify that capture thresholds are stable.
data for each lead and verify the lead impedances are within range.
NOTE
The Bipolar Pacing Lead Impedance check-mark is not available (and the patient cannot be scanned) if any of the following conditions are present:
•
The most recent bipolar atrial or ventricular lead impedance measurement is not available
• A clinical alert exists for a bipolar atrial or ventricular lead impedance measurement
•
The lead impedance is outside of the programmed range.
HV Tests are performed and within range.
Select the Prepare Capacitor button to discharge the capacitor.
-
defibrillation lead(s) impedance.
CAUTION
It is important to measure the impedance of all defibrillation coils prior to the MR scan. For devices with single coil leads, measure the RV Coil impedance. For devices with dual coil leads, measure both the RV Coil and SVC Coil lead impedance.
146
Do not proceed with the MRI scan if any impedance measurement is out of range. A defect in HV lead may compromise patient safety during an MRI scan.
SJM leads are labeled for MRI and No Additional Cardiac Hardware (adapters, extenders, abandoned leads). You must verify that the leads are St. Jude Medical MR Conditional leads and that no additional hardware is present. You can check with
whether additional hardware is present, you can confirm its absence with an x-ray or other diagnostic image.Some St. Jude
Medical MR Conditional leads are equipped with a unique radiopaque marker that can aid in identification. Refer to the MRI
Procedure Information Document for more information on MR Conditional leads.
Accessed From: Parameters button > MRI Settings tab > Setup for MRI Now button
MRI Settings: Active
The MRI Settings: Active window displays the currently programmed MRI Settings, the pulse generator’s permanent programmed settings, and the following buttons:
Disable MRI Settings. Select this button to return to the permanent programmed settings.
Print MRI Report. Select this button to print a report containing the patient data, parameter settings, lead information, and a log of the times and durations the MRI Settings were enabled and disabled, and the MRI checklist results. Also accessible from the Print button > Reports tab.
End Session. After enabling the MRI Settings, end the programming session before proceeding to the MRI scan. Once the scan is complete, interrogate the pulse generator to disable MRI Settings and restore the permanently programmed settings.
Accessed From: Parameters button > MRI Settings tab > Setup for MRI Now button > MRI Checklist window
147
Wrap-Up™ Overview
Contents:
Wrap-Up™ Overview
Restore Initial Values (page 150)
Wrap-up™ Overview
The Wrap-Up™ Overview window provides a place for your final review of session activities and includes the following:
Battery Information. Shows the last measured battery voltage, a gauge illustrating the time left to ERI (based on battery voltage
), and the date and duration of the last max charge
. The text is displayed in red (alert status) if the device is at ERI.
Test Status panel. Reports completed and uncompleted tests.
Session Notes panel. Reports the status of routine follow-up tasks.
Programming Changes. Lists all changes in programmed parameter settings.
Burden (page 29) Trend and Exercise & Activity (page 30) Trend.
for the AT/AF Burden and Exercise & Activity Trend data), Episodes (page 21), ST Diagnostics
stored EGMs from the device memory
Clear after Printing button. Select this check-box to automatically clear diagnostics from the device memory after printing the reports from the Wrap-Up window.
Print Reports button. Prints all reports listed in the Selected Report button.
Accessed From: Wrap-Up Overview button
Export Data
To export data:
1.
Insert the USB connector from a media device into one of the three USB ports on the programmer.
2.
3.
4.
The media device can be a USB floppy drive, a USB flash drive, or a PC connected to the Merlin™ PCS through a 9-pin serial to USB connector cable. The floppy drive must be powered through the USB drive, not by an external power source.
Select the format for the exported data.
The PC database-compatible record is smaller and contains only data for PC-based database programs. Select the Export Data button. The Merlin.net™ PCN-compatible record is larger and contains more detailed information.
The programmer lists all connected media devices.
Select the desired media device. If a media device has not been detected, select the Redetect Media button.
Select the Export button.
Accessed From: Wrap-Up Overview button > Export Data button
Clear Trends
collected by the programmer during the session remains available until you select the End Session button.
Accessed From: Wrap-Up Overview button > Clear Trends button
Clear Diagnostics
programmer during the session remains available until you select the End Session button.
NOTE
Clearing Diagnostics will clear all AT/AF Alerts.
Accessed From: Wrap-Up Overview button > Clear Diagnostics button
168 Battery voltage is not shown for devices with a Greatbatch Medical Models 2753, 2850, and 2950 batteries.
169
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
170 Includes ST Histograms, ST Deviation 1-month and 6-month Trends, ST Episodes (including ST EGMs), ST Baselines, and ST Diagnostics (if available).
149
Restore Initial Values
The Restore Initial Values button reprograms the settings that were read at the initial interrogation. When you press the Program button, all parameter changes made during the session are lost.
Accessed From: Wrap-Up Overview button > Restore Initial Values button
150
Mode Descriptions
St. Jude Medical™ devices may be programmed to the following pacing and therapy modes. All permanent pacing modes can also
be programmed to operate with rate-modulation (R). See Rate-Responsive Modes (page 158).
Table 41. Available Modes
Dual-Chamber
Atrial
Ventricular
Off Modes
DDD
(Dual-Chamber Pacing, Sensing, and Inhibition; Atrial Tracking)
See DDD Mode timing diagram (page 151).
The DDD Mode is a dual-chamber, atrial-based timing mode in which increases or decreases in the sensed atrial rate are duplicated by similar changes in the ventricular rate. Sensed P-waves or R-waves inhibit output pulses, while no intrinsic activity during the alert periods result in delivered pulses. There are four pacing states:
1.
2.
AP. During the atrial alert period, no atrial sensed event is detected, and the device delivers an atrial pulse (AP) at the end of
V. channel becomes alert to R-waves.
3.
VS. During the Paced/Sensed AV Delay, the V. channel senses a ventricular sensed event (VS) and inhibits the pulse but does
out. Then, both channels become alert to sensed events.
4.
VP. The V. channel does not sense any signals during the Paced/Sensed AV Delay and delivers a ventricular pulse (VP) at the
Then, both channels become alert to sensed events.
Indications. DDD operation is indicated in the presence of AV conduction disorders with normal or abnormal sinus node function and if the patient may benefit from a high degree of ventricular pacing.
tachyarrhythmias or silent atria. However, the device’s Auto Mode Switch feature can automatically switch the device to DDI operation in the presence of atrial tachyarrhythmias. Retrograde conduction, though not a contraindication, requires the careful setting of the PVARP parameter.
Figure 15. DDD Mode timing diagram
1.
Programmed Rate
Blanking Period
Refractory Period
Alert Period
PVARP
Output Pulse
Paced/Sensed AV Delay
Sensed Event
171 In CRT-Ds, Dual-Chamber ICDs, and Single-Chamber ICDs, DOO, AOO, and VOO modes are available as permanent pacing modes only when the Zone configuration is set to
Off or Tachy Therapy is set to Disabled. Otherwise, DOO, AOO, and VOO modes are available only for Temporary Pacing.
172 In CRT-Ds, Dual-Chamber ICDs, and Single-Chamber ICDs, AAT mode is available only for Temporary Pacing.
151
DDI
(Dual-Chamber Pacing, Sensing, and Inhibition; No Atrial Tracking)
See DDI Mode timing diagram (page 152).
The DDI mode is a non-tracking, dual-chamber mode in which sensed atrial activity does not cause a change in timing. Atrial tachycardias do not result in increased pacing rates. There are four pacing states:
1.
AS. A sensed atrial event (AS) inhibits the A. pulse and begins an atrial refractory period which ends at the V. pulse. The
2.
3.
4.
AP. During the atrial alert period, no atrial sensed event is detected, and the device delivers an atrial pulse (AP) at the end of
VS. During the V. alert period of the Paced AV Delay, the channel detects a ventricular sensed event (VS), inhibits the pulse,
Then, both channels become alert to sensed events.
VP. The V. channel does not detect a sensed event during the alert period or the Paced AV Delay and delivers a pulse (VP) at the end of the delay. The Ventricular Pace Refractory and PVARP begin and remain in effect until the periods time out. Then, both channels become alert to sensed events.
Indications. DDI operation is indicated in situations where dual-chamber pacing is required and there is a specific reason that atrial tracking is not desired.
Contraindications. DDI operation is contraindicated in AV block with normal sinus node function and silent atria and in AV block with chronic atrial fibrillation or flutter.
Figure 16. DDI Mode timing diagram
1.
Programmed Rate
Blanking Period
Refractory Period
Alert Period
PVARP
Output Pulse
Paced/Sensed AV Delay
Sensed Event
DDT
(Dual-Chamber Pacing, Sensing, and Triggering)
See DDT Mode timing diagram (page 153).
The DDT mode is a non-tracking, dual-chamber mode in which sensed atrial activity does not cause a change in timing. Atrial tachycardias do not result in increased pacing rates.
In this atrial inhibited, ventricular triggered pacing mode, the device senses (in the atrium and right ventricle) and paces (in the atrium and both ventricles) at the programmed Base Rate, AV Delay, and Interventricular Delay. The device paces either in the absence of intrinsic activity or synchronously with the sensing of an R-wave. The device allows biventricular and RV-only pacing.
During the AV Delay, if the device senses a ventricular event, it delivers an output pulse synchronous with the sensed event and restarts the timing cycle. If it does not sense a ventricular event by the end of the AV Delay, it delivers an output pulse and restarts the timing cycle.
The figure below depicts the operation of DDT mode.
Indications. DDT operation is intended for patients who may benefit from simultaneous pacing of left and right ventricles when the ventricular intrinsic activity exceeds the Base Rate setting.
Contraindications. DDT mode is contraindicated in high-grade AV block with normal sinus nodal function and silent atria.
Available In: CRT-Ds and CRT-Ps with Ventricular Triggering Capability (page 200)
152
Figure 17. DDT Mode timing diagram
1.
Programmed Rate
Blanking Period
Refractory Period
Alert Period
PVARP
Output Pulse
Paced/Sensed AV Delay
Sensed Event
DOO
(Dual-Chamber Asynchronous Pacing)
See DOO Mode timing diagram (page 153).
In DOO mode, the device paces in the atrium and ventricle(s)
regardless of intrinsic activity.
at the programmed Base Rate and Paced AV Delay (page 71)
CAUTION
DOO(R) mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias.
Indications. DOO operation is indicated when there is a need for pacing in the atrium and ventricle with the likelihood that significant electromagnetic or electromyogenic noise could inappropriately inhibit or trigger the device.
Contraindications. DOO operation is contraindicated in the presence of competitive intrinsic cardiac rhythm.
Figure 18. DOO Mode timing diagram
1.
Programmed Rate
Refractory Period
Output Pulse
Paced/Sensed AV Delay
DVI
(Dual-Chamber Pacing; Ventricular Sensing, Inhibition)
See DVI Mode timing diagram (page 154).
The DVI mode is a dual-chamber mode in which sensed atrial activity is ignored, although the device can pace the atrium. The DVI mode has three states:
1.
which the V. channel remains alert to sensed events.
173 All CRT-Ds and CRT-Ps allow biventricular and RV-only pacing.
153
2.
3.
VS. During the Paced AV Delay, the V. channel detects a ventricular sensed event (VS), inhibits the pulse, and resets the timing. The V. Refractory Period begins and remains in effect until the periods time out. Then, the V. channel becomes alert to
R-waves.
VP. The V. channel does not detect a sensed event during the Paced AV Delay and delivers a pulse (VP) at the end of the delay. The V. Refractory Period begins and continues until the period times out. Then, the V. channel becomes alert to Rwaves.
Indications. DVI operation is indicated in situations where atrial and ventricular pacing are required and there is a specific reason that atrial sensing is not desired.
Contraindications. DVI operation is contraindicated in the presence of competitive intrinsic atrial rhythms or silent atria.
Available In: CRT-Ps (page 162) and Dual-Chamber Pacemakers (page 163)
Figure 19. DVI Mode timing diagram
1.
Programmed Rate
Blanking Period
Refractory Period
Alert Period
Output Pulse
Paced/Sensed AV Delay
Sensed Event
VVI
(Ventricular Pacing, Sensing, and Inhibition)
See VVI Mode timing diagram (page 154).
In VVI mode, the device paces the ventricle(s)
174 at the programmed rate if it does not detect a sensed event. If the device detects a
sensed event during the alert period, it withholds the pulse and it resets the timing period to the start of the Ventricular Sense
Indications. VVI operation is indicated for symptomatic bradycardia of any etiology. This includes, but is not limited to, AV block or sinus node dysfunction and the various manifestations of sinus node dysfunction, including sinus node arrest, sinus bradycardia, and brady-tachy syndrome.
Contraindications. VVI operation is contraindicated in the presence of pacemaker syndrome.
Figure 20. VVI Mode timing diagram
1.
Programmed Rate
Refractory Period
Alert Period
Output Pulse
Sensed Event
VOO
(Ventricular Asynchronous Pacing)
174 All CRT-Ds and CRT-Ps allow biventricular and RV-only pacing. Devices with LV-Only Pacing Capability also provide LV-only pacing.
154
See VOO Mode timing diagram (page 155).
In VOO mode, the device paces the ventricle(s)
at the programmed rate regardless of the intrinsic rhythm.
CAUTION
VOO(R) mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous ventricular tachyarrhythmias.
Indications. VOO operation may be indicated for patients who are subject to electromagnetic interference or electromyogenic noise and who need continual ventricular pacing.
Contraindications. VOO operation is contraindicated in patients who have a competitive intrinsic cardiac rhythm and who have or are likely to experience pacemaker syndrome during single-chamber ventricular pacing.
Figure 21. VOO Mode timing diagram
1.
Programmed Rate
Refractory Period
Output Pulse
VDD
(Ventricular Pacing; Dual-Chamber Sensing and Inhibition; Atrial Tracking)
See VDD Mode timing diagram (page 156).
The VDD mode is a dual-chamber, atrial-tracking mode with no atrial output in which ventricular pacing is synchronized to intrinsic atrial activity. The device senses in both chambers but only paces in the ventricle. The mode maintains a minimum atrial alert
timing cycles infringe upon the atrial alert window. There are three pacing states:
1.
2.
AS. A sensed atrial event during the V-V interval initiates the Sensed AV Delay and may extend the V-V interval while AV synchrony is maintained. It is possible to track a sinus rhythm resulting in a rate lower than the programmed Base Rate.
VS. If the atrial channel detects a sensed event and the V. channel detects a sensed event during the Sensed AV Delay, the device resets the V-V timing.
3.
VP. If no atrial and no ventricular events are sensed, the device paces the ventricle (VVI pacing).
Indications. VDD operation is indicated for AV block with normal sinus function.
Contraindications. VDD operation is contraindicated for sinus node dysfunction, chronic atrial flutter or fibrillation, inadequate atrial sensing, or silent atria.
Available In: CRT-Ps (page 162) and Dual-Chamber Pacemakers (page 163)
175 All CRT-Ds and CRT-Ps allow biventricular and RV-only pacing. Devices with LV-Only Pacing Capability also provide LV-only pacing.
155
Figure 22. VDD Mode timing diagram
1.
Programmed Rate
Refractory Period
Alert Period
PVARP
Output Pulse
Paced/Sensed AV Delay
Sensed Event
VVT
(Ventricular Pacing, Sensing, and Triggering)
See VVT Mode timing diagram (page 156).
In VVT mode, the device stimulates the ventricles at the programmed rate in the absence of intrinsic ventricular activity. Intrinsic ventricular activity during the alert period causes the device to deliver an output pulse synchronously with the detected ventricular event.
Indications. VVT operation may be useful in avoiding inappropriate inhibition of the pulse generator due to electromagnetic or electromyogenic interference. A triggered mode paces on detection of such signals, instead of being inhibited by them.
VVT operation may also be used to identify the sensing site within a complex and for temporary diagnostic use in the evaluation and management of arrhythmias performed by triggering the device output through chest wall pacing.
Contraindications. VVT operation is contraindicated in the presence of pacemaker syndrome.
Available In: Devices with Ventricular Triggering Capability (page 200)
Figure 23. VVT Mode timing diagram
1.
Programmed Rate
Refractory Period
Alert Period
Output Pulse
Sensed Event
AAI
(Atrial Pacing, Sensing, and Inhibition)
See AAI Mode timing diagram (page 157).
In AAI mode, the device paces the atrium at the programmed rate if the atrial events are not sensed. If the device detects a sensed
Indications. AAI operation is indicated for symptomatic bradycardia caused by sinus node dysfunction.
Contraindications. AAI operation is contraindicated in the presence of AV conduction disorders, chronic atrial fibrillation, or atrial flutter.
156
Figure 24. AAI Mode timing diagram
1.
Programmed Rate
Refractory Period
Alert Period
Output Pulse
Sensed Event
AAT
(Atrial Pacing, Sensing, and Triggering)
See AAT Mode timing diagram (page 157).
detects a sensed event during the alert period, it delivers a pulse synchronously with the sensed event.
Indications. AAT may be useful to avoid inappropriate pulse inhibition resulting from electromagnetic or electromyogenic interference. AAT operation can also be used to identify the sensing site within a complex and to evaluate and manage arrhythmias elicited by chest wall stimulation.
Contraindications. AAT operation is contraindicated in the presence of AV conduction disorder, atrial fibrillation, or atrial flutter.
Figure 25. AAT Mode timing diagram
1.
Programmed Rate
Refractory Period
Alert Period
Output Pulse
Sensed Event
AOO
(Atrial Asynchronous Pacing)
See AOO Mode timing diagram (page 158).
In AOO mode, the device paces the atrium at the programmed rate regardless of intrinsic rhythm.
CAUTION
AOO(R) mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous atrial tachyarrhythmias.
Indications. AOO operation may be indicated for patients who are subject to electromagnetic interference or electromyogenic noise and who need continual atrial pacing.
Contraindications. AOO operation is contraindicated in the presence of competitive intrinsic cardiac rhythm or AV conduction disorders.
157
Figure 26. AOO Mode timing diagram
1.
Programmed Rate
Refractory Period
Output Pulse
Pacing Off
CAUTION
Pacing Off mode is not recommended for pacemaker-dependent patients or patients who might be affected by even a short cessation of pacemaker function.
In Pacing Off mode, atrial and ventricular pacing is disabled. This mode is useful primarily for temporary diagnostic evaluation and recording of intrinsic activity. When this mode is programmed, the programmer does not show the measured rate.
When Mode is set to Pacing Off, the Restore Parameters button is available. Since the previously programmed parameters are stored in the device, it is not necessary to use the same programmer to turn the device off and to restore parameters.
Rate-Responsive Modes
programmed parameters. Rate-responsiveness can be enabled with any permanent pacing mode.
Indications. Indications for rate-modulated modes are the same as those without rate-modulation, except that rate-modulated modes are further indicated when an increase in pacing rate with activity is desired.
Contraindications. Contraindications for rate-modulated modes are the same as those without rate modulation, except that ratemodulated modes are also contraindicated when pacing rates above the programmed Base Rate may not be well tolerated.
NOTE
Rate Responsive modes are available in all devices except the Endurity™ Core DC Model 2140 and Endurity Core SC
Model 1240.
Operating Modes for Single-Chamber Accent™ Devices
Additional atrial operating modes are available for Accent single-chamber devices
with the lead implanted in the atrium. To select one of these modes, you must first program the Lead Chamber parameter to the Atrium setting (accessible from the Brady
Parameters > Leads window). Then select one of the available Mode settings from the Brady Parameters > Basic Operation window.
When you select the Atrium Lead Chamber setting, the programmer institutes the following values to ensure optimal operation in the atrium:
Sensitivity is set to 0.5 mV
Pace Refractory period is set to 250 ms
V. AutoCapture is set to Off.
Each mode can also be programmed with Sensor On (R).
NOTE
Although the atrial chamber is selected, some diagnostics, markers, and parameters will display a “V” label. For example, the atrial paced parameter is labeled “VP” in the Rhythm Display and the EGM is labeled Ventricular EGM.
VVI(R)-AAI(R)
The VVI-AAI(R) mode uses VVI (page 154) timing and markers but operates in the atrium.
In VVI-AAI(R) mode, the device paces the atrium at the programmed rate if it does not detect a sensed event. If the device detects a sensed event during the alert period, it withholds the pulse and it resets the timing period to the start of the Atrial Sense Refractory period.
VOO(R)-AOO(R)
The VOO(R)-AOO(R) mode uses VOO(R) (page 154) timing and markers but operates in the atrium.
In VOO(R)-AOO(R) mode, the device paces the atrium at the programmed rate regardless of the intrinsic rhythm.
NOTE
VOO(R)-AOO(R) mode is primarily intended for temporary use. Long-term use may result in competitive pacing, which may induce potentially dangerous tachyarrhythmias.
176
Applicable for the Merlin PCS equipped with Model 3330 software v. 10.2.2 or higher.
177 If you program the Sensitivity setting to AutoSense, the Pace Refractory period is autoprogrammed to 190 ms.
158
VVT(R)-AAT(R)
The VVT(R)-AAT(R) mode uses VVT(R) (page 156) timing and markers but operates in the atrium.
In VVT(R)-AAT(R) mode, the device stimulates the atrium at the programmed rate in the absence of intrinsic atrial activity. Intrinsic atrial activity during the alert period causes the device to deliver an output pulse synchronously with the detected atrial event.
159
Table 42. CRT-Ds
Name
Promote
Auricle
Promote RF
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Additional Programming Information
Contents:
Main Programming Window (page 163)
Telemetry Communication (page 164)
Tachy Therapy Enable/Disable (page 166)
Device Parameters and Settings Selection (page 166)
Emergency Operation (page 170)
MRI Settings Reset Values (page 173)
Backup VVI and Backup Defibrillation Only Settings (page 174)
Fortify™ ST Device Software Upgrade (page 175)
Technical Support
St. Jude Medical maintains 24-hour phone lines for technical questions and support:
1 818 362 6822
1 800 722 3774 (toll-free within North America)
+ 46 8 474 4147 (Sweden)
For additional assistance, call your local St. Jude Medical representative.
Supported Devices
Refer to the Merlin™ PCS Start-Up Help Manual for a list of all devices that can be interrogated by the Merlin PCS equipped with
Model 3330 software.
The devices listed in the following tables are discussed in this help system
.
Single-Chamber ICDs (page 162)
Dual-Chamber Pacemakers (page 163)
Single-Chamber Pacemakers (page 163)
CRT-Ds
Model Number
3107-30, 3107-36, 3107-36Q, 3109-30, 3109-36, CD3207-36Q
3107-36P
3207-30, 3207-36, 3213-30, 3213-36
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40C, CD3361-40Q,
CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
178 Not all device models are available in all countries.
161
Dual-Chamber ICDs
Table 43. Dual-chamber ICDs
Name
Current DR
Current DR RF
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Single-Chamber ICDs
Table 44. Single-Chamber ICDs
Name
Current VR
Current VR RF
Current+ VR
Current Accel VR
AnalyST VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
CRT-Ps
Table 45. CRT-Ps
Name
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
2107-30, 2107-36, CD2207-36Q
2207-30, 2207-36
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD2217-36
CD2219-30, CD2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
Model Number
1107-30, 1107-36, CD1207-36Q
1207-30, 1207-36
CD1211-36, CD1211-36Q
CD1215-30, CD1215-36, CD1215-36Q
CD1217-30, CD1217-36
CD1219-30, CD1219-36, CD1219-36Q
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
Model Number
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
162
Dual-Chamber Pacemakers
Table 46. Dual-chamber pacemakers
Name
Accent DR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core (DC)
Endurity Core (DR)
Endurity
Endurity MRI
Accent DR RF
Assurity
Assurity+
Assurity MRI
Single-Chamber Pacemakers
Model Number
PM2112
PM2122, PM2222
PM2124, PM2224
PM2126, PM2226
PM2140
PM2152
PM2160, PM2162
PM2172
PM2212
PM2240
PM2260
PM2272
Table 47. Single-chamber pacemakers
Name
Accent SR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core (SC)
Endurity Core (SR)
Endurity
Endurity MRI
Accent SR RF
Assurity
Assurity+
Assurity MRI
Model Number
PM1110
PM1122, PM1222
PM1124, PM1224
PM1126, PM1226
PM1140
PM1152
PM1160, PM1162
PM1172
PM1210
PM1240
PM1260
PM1272
Main Programming Window
The Main Programming window is the upper portion of the screen that contains the following buttons:
? button. Opens the context-sensitive on-screen help menu.
Tools menu. Opens a menu for the PSA application, preferences, and other functions.
Telemetry Communication (page 164) icons. Displays the current condition of the RF Telemetry link.
Tachy Therapy Enable (page 166)/Disable
. Opens a window to temporarily disable tachyarrhythmia therapies.
Patient Data (page 17). Opens a window to write and edit patient information into the device memory.
Note (page 18). Opens a window for additional patient data.
Measured Heart Rate
Rhythm Display (page 7). Shows the real-time waveforms.
Adjust Display (page 14) button. Opens a window to adjust the Rhythm Display.
Freeze Capture button. Freezes the Rhythm Display and opens a window to adjust and print the frozen waveform.
the internal printer. An icon with a cord indicates the programmer is connected to an external printer (see the figure below).
Preferences > Printer (Printer Preferences (page 6)).
179 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
163
Figure 27. Printer icons
1.
Internal printer in use
2.
External printer connected
3.
Paperless or PDF printing selected
Telemetry Communication
Contents:
RF Telemetry Communication (page 164)
Telemetry Interruption (page 165)
Wand-Only Telemetry (page 166)
RF Telemetry Communication
Devices equipped with RF communication are programmed and operated identically to devices with inductive telemetry. To establish
RF communication between the device and the programmer and to troubleshoot communications problems, you must first attach the RF Antenna to the programmer. Please refer to the Merlin™ Patient Care System User’s Manual that accompanies the programmer and the Merlin Antenna. Use the telemetry strength indicators to evaluate the communication.
If the device is RF-compatible, an icon in the upper left-hand corner of the screen during the programming session indicates the status of the RF communication link. If an RF icon does not appear on the screen during the session, the device is not RFcompatible. See the table below.
CAUTION
Fibber & NIPS (page 54) Tests. While you are conducting the Fibber
180 and NIPS tests, ensure that at least four
telemetry strength indicator LEDs appear on the programmer and the Merlin Antenna. If fewer LEDs are lit, the device may break its communication link when it charges or dumps the capacitors and the device returns to its permanently programmed parameters.
181 . If this occurs, the test ends
Loss of RF Communication. If RF communication is lost, a single LED on the antenna and the programmer flashes while the system attempts to recover telemetry contact. The system searches for the device for 60 seconds before prompting you to Continue Session (try to re-connect the RF communication) or Continue with Wand Only (try to establish inductive telemetry communication).
NOTE
Keep the inductive telemetry wand connected to the programmer during an RF communication session in case you lose
RF communication.
When you interrogate an RF-capable device, the programmer uses RF communication as the primary telemetry method. If the system fails to establish RF communication, the programmer uses inductive telemetry.
To end RF communication, select the End Session button to close the device session. If you do not use the End Session button and simply move the device out of RF communication range, the system attempts to re-establish RF
. Use the End Session button to decrease battery drain
communication for up to three hours after the start of the session
and improve longevity.
Just as with the use of inductive telemetry, loss of RF communication during clinical testing ends the test and restores permanently programmed parameters. Ensure proper RF communication before any testing.
RF communication is suspended when you start the PSA application during a programming session and is restored when you close the PSA application
180 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
181
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
182 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
164
Table 48. RF telemetry icons
Location
Start-Up Screen Icons
RF Telemetry Status
Disconnected RF Base Station/Not
Working
Icon
Ready to connect to device
Application Icons
Active RF telemetry connection
Inactive RF telemetry connection
Only wand telemetry is available
Telemetry Interruption
Interruption in telemetry can occasionally occur, and when it does, you can resume communications with the programmer or you can end the device session:
Continue. To attempt to resume the session using the current telemetry mode (RF or Inductive), select the Continue button.
Continue with Wand Only
by selecting the Continue with Wand Only button. Once you have selected this button, position the wand over the device to continue the session.
End Session. To close the device session, select the End Session button. To print summary reports for the session, select the
Print Selected Reports check-box.
Loss of RF telemetry ends clinical testing and restores permanently programmed parameters. Restart the desired operation once inductive communication has been established.
can also be managed using the telemetry button on the main programming window. Select this button to enable or disable RF telemetry.
Resuming Telemetry
temporarily disabled after 3 minutes of programmer inactivity in order to preserve battery longevity. RF telemetry can also be disabled by pressing the telemetry button on the application screen. When this occurs, you can resume the current session using RF telemetry, inductive telemetry, or you can end the device session.
Continue. To attempt to resume the session using RF Telemetry, select the Continue button.
Continue with Wand Only.
To continue the session using inductive telemetry, select the Continue with Wand Only button.
Once you have selected this button, position the wand over the device to continue the session.
End Session. To close the device session, select the End Session button. To print summary reports for the session, select the
Print Selected Reports check-box.
Loss of RF telemetry ends clinical testing and restores permanently programmed parameters. Restart the desired operation once inductive communication has been established.
In CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers, RF Telemetry can also be managed using the telemetry button on the main programming window. Select this button to enable or disable RF telemetry.
183
For devices with RF telemetry capability.
184 Available in devices with RF Telemetry capability only.
165
Wand-Only Telemetry
telemetry may be temporarily disabled in order to preserve battery longevity. This is a normal maintenance function and is only in effect for the current session. When this temporary loss of RF telemetry occurs, you can continue the session using inductive telemetry.
When RF telemetry is temporarily disabled, you can choose to end the session or continue the session using wand-only inductive communication from the Wand-Only Telemetry window.
Continue with Wand Only.
185 To continue the session using inductive telemetry, select the Continue with Wand Only button.
Once you have selected this button, position the wand over the device to continue the session.
End Session. To close the device session, select the End Session button. To print summary reports for the session, select the
Print Selected Reports check-box.
Loss of RF telemetry ends clinical testing and restores permanently programmed parameters. Restart the desired operation once inductive communication has been established.
Tachy Therapy Enable/Disable
The Tachy Therapy Enable/Disable button on the main programming window is available when any tachyarrhythmia therapy has been programmed. Select this button to disable VT/VF detection and therapy delivery without affecting other programmed
parameters
noise from the equipment, interpret it as an arrhythmic episode, and deliver therapy. When therapy is disabled, diagnostic data are not updated or cleared.
NOTE
When tachy therapy is disabled through this button, the device stores all previous tachy parameter settings and restores them when the therapy is enabled. When you use the Off Zone Configuration setting, the tachy parameters are not stored
The button reports two states:
Tachy Therapy is Disabled. The programmed parameters are stored in the device. Changes to the device parameters
(including tachy parameters) may be programmed.
Tachy Therapy is Enabled. All previously programmed parameters are restored, including any parameters programmed while therapies are disabled.
Since the previously programmed parameters are stored in the device, it is not necessary to use the same programmer to disable and enable therapies.
See also:
Parameter Availability and Settings (page 201)
Available In: CRT-Ds (page 161), Dual-Chamber ICDs (page 162), Single-Chamber ICDs (page 162)
Accessed From: Main Programming window
Device Parameters and Settings Selection
To change the setting for any parameter, select the desired parameter button. A setting selection window appears. The range of settings is usually indicated at the top and bottom of the scroll bar. The current permanently programmed setting is marked with a small device icon. The nominal value for the setting is indicated by an "N" to the right of the setting.
Autoprogramming Designators
When you select a new setting, it may result in the automatic re-programming of related parameters. Settings that result in autoprogramming of other parameters are marked in the settings window with a right-angle arrow. The settings window also displays an explanatory note to clarify the setting's relationship with other parameters.
To see the entire set of pending programming changes before you program new settings, select the Preview button (Preview Changes
Preview Changes
The Preview Changes window lists all parameters and settings selected for programming. It also contains the:
Discard Changes button to reject all proposed parameter changes
Undo button to return the last parameter you changed to its prior setting (and any associated auto-selection changes). This does not affect settings made before the last parameter change.
Program button to permanently program the listed parameters
Start Temporary (page 167) button to temporarily program the listed parameters
NOTE
The "down arrow" icon next to the programmed parameter indicates an autoprogramming change. The "triangle" icon indicates the parameter is actively selected by the user for change.
185
Available in devices with RF Telemetry capability only.
186 When tachy therapy is disabled, AT/AF Detection is also disabled.
166
Start Temporary
When the Start Temporary button is selected from the Preview Changes window, the Discard Changes button disappears, the green highlights turn orange, and the device operates with those settings in effect until the:
Cancel Temporary button is selected, which restores all permanently programmed settings or
The Program button is selected, which permanently programs the temporary settings.
If telemetry is lost while temporary settings are programmed, the device reverts to its permanently programmed settings. The programmer prompts you to either continue or end the session. Select the Continue button to attempt to re-establish communication between the device and programmer.
Print Menu
The Print Menu window contains two tabs:
To send the image to an external printer, go to the Tools Menu > Preferences > Printer tab and select the External button.
Reports
Select Diagnostics Reports for Printing (page 168)
Test Results Settings (page 169)
Select Episodes for Printing (page 169)
Select Freezes for Printing (page 169)
Select Referral Reports for Printing (page 169)
Wrap-Up™ Overview Settings
The Reports tab of the Print Menu window allows you to select or deselect any report in the print queue, to select the data included in the report, and to print all selected reports.
The Reports tab contains all available reports, with the type of report currently selected and a check-box next to each selection. To change the type of data printed in any report, select the labeled button.
To place a report in the queue to print, select the check-box next to the report button.
To change the preferences for printing a report, select the button with the report name to open a pop-up dialogue. After you have selected your preferences, you have three choices:
Cancel button. Select this button to cancel any changes to the preferences.
Done button. Select this button to implement the changes for this programming session only.
Save Settings button. Select this button to store your preferences for future programming sessions.
To export your saved PDFs, select the PDFs button. The PDFs button displays the number of pending files.
The types of reports that are available include:
Patient data
-
Battery data
-
Capture and sense test results
-
Lead impedance measurements
-
Key parameter settings
-
Diagnostics and episodes summary
-
Notes
-
A listing of all alerts.
Episodes. For CRT-Ds, Dual-chamber ICDs, and single-chamber ICDs, select the Episodes button to open the Episodes
extended summary ("Extended Episodes" report.)
For CRT-Ps, Dual-chamber pacemakers, and single-chamber pacemakers, the Episodes Summary report contains the following data:
-
Time last read and last cleared
-
Selected Episodes Triggers, with the number of recorded episodes and EGMs
-
The number and type of device reversions
-
A listing of the Episodes Log.
you to choose to print the shorter summary ("Diagnostics Summary" report) or the extended summary ("Extended Diagnostics" report) and the DirectTrend™
report and the AT/AF
Alert reports.
freezes and the addition of leads and battery data.
Parameters. Select the Parameters check-box to queue the following data for printing:
-
Patient and device data
-
All programmed parameter and trigger settings
VT/VF Stored EGMs
, Other Stored EGMs
. Select the Stored EGMs button to open the Select
Episodes for Printing (page 169) window to choose which Stored EGMs to print.
187
The DirectTrend™ report is only available for devices with the Enhanced Diagnostic Trend Capability.
188 The AT/AF Report is only available for devices with the AT/AF Alert Triggers Capability.
189
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
190 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
167
select which Referral Reports to print.
Wrap-Up Overview. Select the Wrap-Up Overview button to open the Wrap-Up Overview Settings window to print out a second
Wrap-Up Overview report for the patient.
Accessed From: Print button > Reports tab
Episodes Settings
For CRT-Ds, Dual-chamber ICDs, and single-chamber ICDs, the Episodes Summary Settings window allows you to select which data will be included in the Episodes Settings report. You can select either:
Summary, which queues the following data for printing:
-
Time last read and last cleared
A summary of all antitachycardia therapy delivered
Last HV lead impedance measurement
-
ATP therapy results
-
Text of Alerts
-
The Episode Tree graphically displaying zone configurations and therapies
-
All recorded episodes (VT/VF and Other) with time, rate, type, duration, therapeutic response, and associated alert
(Episodes Log)
Extended, which queues all of the data in the Summary report for printing as well as:
Causes of aborted shock and number of emergency shocks
-
Selected Episode Triggers, with the number of recorded episodes
-
Graphs of the number of Episodes converted by ATP bursts for all therapies
-
Episodes converted by ATP
-
LIfetime ATP use in the VF Zone
-
Morphology Template information
-
SVT diagnosis summary and Discrimination Criteria for SVT Diagnosis
-
A listing of Device Reversions
-
High-voltage charging data.
Accessed From: Print button > Reports tab > Episodes button
Select Diagnostics Reports for Printing
The Select Diagnostics Report for Printing window allows you to select the data that will be included in the Diagnostics report. You can select:
Summary, which queues the following data for printing:
All Events recorded since the last reading
-
Atrial and Ventricular Heart Rate histograms
-
AT/AF Burden Trend
-
V Rates During AMS
-
AMS Summary.
-
AT/AF Episodes Mode Switch Duration
Extended, which queues all of the data in the Summary report for printing as well as:
Key parameter settings
Events graphs
-
AV Intervals diagnostics
-
Tabular data for the V. Rates During AMS, Atrial and Ventricular Heart Rate histograms
-
Weekly readings of the AT/AF Burden
-
AMS Log
-
All Daily Exercise Training diagnostics.
-
CorVue™ Congestion Monitoring Graph and Congestion Details (page 37).
-
ST Episodes Summary
-
ST Deviation Trend.
DirectTrend™ Report. The Direct Trend report, available for devices with the Enhanced Diagnostic Trend Capability (page
187), is a collection of three-month daily, one-year weekly
or one-year daily
, diagnostic trends. Weekly reports compile the data once a week, while the daily reports compile trends every day. The DirectTrend report includes:
-
AT/AF Total Duration Trend. The total time in AT/AF (page 29).
-
-
AT/AF Frequency Trend. The number of AT/AF episodes per day.
-
AT/AF Episode Average/Max Duration Trend. The average and maximum AT/AF episode durations for each day.
-
Daily Percent Pacing Trend. The daily percentage of atrial and ventricular pacing.
-
Daily Heart Rate Trend. The night and day ventricular heart rates for each day.
-
Daily Activity Trend. The total daily activity duration.
-
CorVue Congestion Monitoring Trend and Episode graph.
191
Available in CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers.
192 Available in devices with ATP Therapy Prior to Charging and ATP Therapy While Charging Capability.
193
One-year weekly trends are not available in devices with Enhanced Diagnostic Trend (1-Year Daily Reports) Capability.
194 One-year daily trends are only available in devices with Enhanced Diagnostic Trend (1-Year Daily Reports) Capability.
168
the diagnostics were last cleared, the AT/AF Alert report is not available. However, you can still select the AT/AF Alert check-box to queue the report to be printed in future sessions should an AT/AF Alert be triggered.
The report contains:
-
Recent AT/AF alerts
-
AT/AF Alert Trigger settings
-
Key parameter settings
-
AT/AF Detection and Response parameter settings
-
Key AT/AF Log Episodes
-
AT/AF Burden Trend
V. Rates During AMS
-
AMS Summary
AT/AF Episodes Mode Switch Duration
Accessed From: Print button > Reports tab > Diagnostics button
Test Results Settings
The Test Results Settings window sets the size of the Capture and Sense test results printout and allows you to include or exclude information on Battery & Leads and the CRT Toolkit Report (in devices with VectSelect Quartet™ LV Pulse Configuration capability
(page 199)). There are two radio buttons:
Small Freezes radio button prints freezes and long-term trends in reduced size, with each chamber’s results fitted to a single page.
Large Freezes radio button prints larger sized freezes and long-term trends, resulting in longer reports.
(page 46) window in the report.
Measurements (page 49), and QuickOpt™ Timing Cycle Optimization Measurements (page 52).
The Save Settings button records your preferences for future programming sessions.
Accessed From: Print button > Reports tab > Test Results button
Select Episodes for Printing
The Select Episodes for Printing window allows you to choose which episodes to include in the printed report. Select the check-box
Diagnostics check-box if desired to include ST Snapshots, Deviation and Heart Rate Trend with the printed report of the first and most recent VT or VF Episode.
Accessed From: Print button > Reports tab > VT/VF Stored EGMs, Other Stored EGMs, Stored EGMs buttons
Select Freezes for Printing
The Select Freezes for Printing window allows you to choose which freezes to include in the printed report. Select the check-box next to each freeze to add to the print queue, or select the Select All button.
Accessed From: Print button > Reports tab > Freezes button
Select Referral Reports for Printing
The Select Referral Reports for Printing window allows you to choose which reports you would like to print. The availability of the reports depends on the capabilities of the devices. The choices can include:
Heart In Focus™ report. The Heart in Focus report prints a one-page, abbreviated summary of selected diagnostics and episodes since date last cleared. These can include the current key parameter settings, patient information, Daily Exercise
29) trend, V Rates During AMS (page 29) histogram, and key AMS Log (page 29) Episodes.
ST Monitoring
. The ST Monitoring report includes physician, patient, and device information, new VT/VF episodes within 15 minutes of an ST Episode, High Ventricular Rate episodes (in pacemakers only), and ST interval shift diagnostics including the
CorVue™ Congestion Monitoring. The Congestion Monitoring report shows the information in the CorVue Congestion
Monitoring tab, including the graphs, any episodes recorded, and any clinical comments.
MRI Summary Report. Select the MRI Summary Report button to print out a report containing the patient data, MRI Settings
Accessed From: Print button > Reports tab > Referral Reports button
195 Available in devices with ST Monitoring Capability.
169
Wrap-Up™ Overview Settings
Select the check-box on the Wrap-Up™ Overview Settings window to print a second copy of the Wrap-Up Overview for the patient.
Accessed From: Print button > Reports tab > Wrap-Up Overview button
Settings
The Settings tab of the Print Menu window allows you to set print preferences for printing at the start of the programming session and let you change the settings for PDFs, Page Headers and Printer Preferences in the current session.
Reports Printed at Interrogation. Select the check-box to enable the programmer to print reports when a device is initially interrogated. Un-check the box if you do not want reports printed at initial interrogation. Select the Reports Printed at
Reports Selected for Printing. Select the check-box to select the reports for printing when you select the Print button on the
FastPath™ Summary screen, the Print Menu, and the End Session screen. Select the Reports Printed at Interrogation button to
open the Reports Selected for Printing (page 170) window to select which reports to print.
Printer Preferences. Opens the Printer Preferences (page 6) window, which allows you to:
select the number of copies printed for each report
choose to print reports with paperless printing (to PDF) or paper printing from the internal printer or an external printer.
appears on the page headers and footers of the reports.
PDFs. Opens the PDFs (page 5) window to export or delete PDFs.
Accessed From: Print button > Settings tab
Reports Printed at Interrogation
The Reports Printed at Interrogation window allows you to choose which reports to include in the report printed at interrogation.
When you have made your choices, select the Save Settings button to store your preferences for future programming sessions. The choices include:
FastPath™ Summary
Episodes
Diagnostics
Parameters
Presenting Rhythm Freeze.
The type of report printed for the Episodes and Diagnostics reports is determined by the saved settings accessed on the Reports
Accessed From: Print button > Settings tab > Reports Printed at Interrogation button
Reports Selected for Printing
The Reports Selected for Printing window allows you to choose which reports to queue at the next programming session. When you have made your choices, select the Save Settings button to store your preferences for future programming sessions. The choices include:
FastPath™ Summary
Episodes
Diagnostics
Test Results
Parameters
Referral Reports
Presenting Rhythm Freeze
Wrap-Up™ Overview.
The type of report printed is determined by the settings accessed on the Reports (page 167) window.
Accessed From: Print button > Settings tab > Reports Selected for Printing button
Page Header & Footer Settings
The Page header & footer settings window allows you to include the patient name and patient ID in the report header and the clinic name in the report footer. Select the appropriate check-box or the on-screen keyboard to input the clinic name. When you have made your choices, select the Save Settings button to store your preferences for future programming sessions.
Accessed From: Print button > Settings tab > Page Header Settings button
Emergency Operation
The console has two emergency option buttons:
Emergency Shock. (page 171) Opens the Emergency Shock window.
cleared from the device. Selected but not yet programmed values are lost. The Emergency VVI settings are listed in the table below.
196 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
170
Another emergency operation built into the device is Reset Function (page 172)
Emergency Shock
See Emergency Shock Instructions (page 171).
The programmer can be used to manually deliver a shock synchronized to the R-wave
The programmer transmits the Emergency Shock command to the device via the current device session’s current telemetry channel.
Thus, if the session uses RF communication, the programmer transmits the Emergency Shock command via the RF communication channel. If the session uses inductive telemetry, the programmer transmits the Emergency Shock command via the inductive telemetry channel. All Emergency Shocks delivered outside the current session use the inductive telemetry channel.
CAUTION
RF Communication. While you are performing an Emergency Shock procedure, ensure that at least four telemetry strength indicator LEDs appear on the programmer and the Merlin Antenna. If fewer LEDs are lit, the device may break its communication link when it charges or dumps the capacitors. If this occurs, the attempt to shock ends and the device returns to its permanently programmed parameters.
WARNING
A synchronous high-voltage shock delivered into a sinus rhythm may induce atrial or ventricular tachyarrhythmias.
See also:
Parameter Availability and Settings (page 201)
Accessed From: Shock console button
Emergency Shock Instructions
To deliver an emergency shock
1.
Select the Shock button on the console.
2.
3.
Select the Emergency Shock Energy/Voltage setting.
Select the Deliver Shock button.
The shock is delivered synchronously with the next sensed event. If sensed event does not occur, the shock is delivered after the next bradycardia pacing time-out. If bradycardia pacing is disabled, the shock is delivered as if the device were pacing at
30 min§. The delivery of an emergency shock triggers the storage of an EGM.
If the capacitors have started charging and the telemetry link is lost, the capacitors continue to charge and the emergency shock is delivered. After the shock is delivered, the detection counters are reinitialized and the device is ready to detect a new tachyarrhythmia episode.
Emergency VVI Settings
Table 49. Emergency VVI settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
Parameter
Pacing Mode
Pulse Amplitude
Pulse Width
Sense Configuration
Pulse Configuration
Ventricular Pacing Chamber
Ventricular Pacing Rate
Ventricular Sensitivity
Rate Hysteresis
Sensor
Ventricular Post- Pace Refractory
Setting
VVI
7.5 (V)
0.6 (ms)
Bipolar
Bipolar
RV Only
70 min§
310 (ms)
Not affected
Off
Off
197 Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
198
Available in CRT-Ds, dual-chamber ICDs, and single-chamber ICDs.
199 CRT-Ds only.
171
Table 50. Emergency VVI settings for CRT-Ps, dual-chamber pacemakers, and single-chamber pacemakers
Parameter
Mode
Ventricular Noise Reversion Mode
Sensor
V. Triggering
Base Rate
Rest Rate
Hysteresis Rate
V. Pulse Amplitude
V. Pulse Width
V. Sensitivity
Ventricular Pacing Chamber
V. Pulse Configuration
V. Sense Configuration
V. Sense Refractory
V. Pace Refractory
Emergency VVI Settings
VVI
VOO
Off
Off
70 min§
Off
Off
7.5 V
0.6 ms
2.0 mV
No change
Unipolar
Unipolar Tip
325 ms
325 ms
Reset Function
If the device encounters any transitory errors in the software or hardware, it operates a "reset" routine that attempts to overcome the error and restore normal operation. Whenever the reset function is invoked, the programmer displays a Device Parameter Reset alert
case, the user typically downloads device history from the Session Records (page 1) window.
In the majority of cases, the reset function can successfully recover from an error. In some cases, the Stored EGMs are lost, even if the reset is successful.
If the reset function is unsuccessful, the device restores as many permanently programmed settings as possible, but it may resort to
reset state. In this mode, fibrillation is diagnosed after 12 fibrillation interval detections, if no prior backup defibrillation has occurred.
If the device has counted a previous backup defibrillation therapy, then fibrillation is diagnosed after 6 detections. The system reconfirms the diagnosis when it bins 6 more fibrillation intervals.
Because the device stores permanently programmed parameters in RAM and ROM programmability is a likely outcome for an error condition.
, full restoration of permanent settings and
Table 51. Device Reset settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
Parameter
Backup Pacing
Mode
Pulse Amplitude
Pulse Width
Reset Setting
VVI
5.0 V
0.6 ms
2.0 mV (fixed) Sensitivity
RV Pulse Configuration
LV Pulse Configuration
V. Sense Configuration
Noise Refractory Extension
RV Bipolar (Tip to Ring)
LV Distal Tip to RV Coil
RV-Tip to RV-Ring
125 ms
Refractory Period
Base Rate
V. Pacing
337.5 ms (62.5 ms absolute; 275 ms relative)
67 min§
LV—>RV
Interventricular Pace Delay
16 ms
200 CRT-Ps only.
201
CRT-Ds, dual-chamber ICDs, and single-chamber ICDs store permanently programmed parameters in RAM and ROM. CRT-Ps, dual-chamber pacemakers, and singlechamber pacemakers store permanently programmed parameters in RAM only.
202
CRT-Ds only.
203 CRT-Ds only.
172
Table 51. Device Reset settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
Parameter
Backup Defibrillation
Sensitivity range
Sensitivity
Post Pace Refractory
Post Paced Sensitivity
Post Sensed Decay Delay
Post Paced Decay Delay
HV Refractory Period
Post Sense Refractory
Number of Tachy Therapy Levels
Shock waveform
Maximum Shocks per Episode
Shock Configuration
Reset Setting
6.3 mV
AutoSense mode
425 ms
25% of full scale
0 ms
0 ms
1 s
125 ms
1 (VF)
Biphasic, 65% tilt, maximum energy
6
RV to SVC & Can
Table 52. Device Reset settings for CRT-Ps, dual-chamber pacemakers, and single chamber pacemakers
Parameter
Backup Pacing
Mode
Pulse Amplitude
Pulse Width
Sensitivity
RV Pulse Configuration
LV Pulse Configuration
V. Sense Configuration
Noise Refractory Extension
Refractory Period
Base Rate
V. Pacing
Interventricular Pace Delay
Reset Setting
VVI
5.0 V
0.6 ms
2.0 mV (fixed)
RV Tip to Can
LV Tip to Can
RV-Tip to Can
125 ms
337 ms (62.5 ms absolute; 275 ms relative)
67 min§
LV—>RV
16 ms
MRI Settings Reset Values
If a problem is encountered in the device microprocessor while MRI settings are in effect, the device will institute these settings.
Table 53. MRI Settings reset values
Parameter
Basic Operation
MRI Mode
Magnet Response
Rates
MRI Base Rate
Reset Setting
VOO
Ignore
85 min§
204 CRT-Ds only.
205
CRT-Ps only.
206 The MRI Base Rate remains at the programmed setting at ERI.
207
CRT-Ps only.
208 CRT-Ps only.
173
Table 53. MRI Settings reset values
Parameter
Delays
MRI Paced AV Delay
Capture & Sense
MRI A. Pulse Amplitude
MRI V. Pulse Amplitude
MRI A. Pulse Width
MRI V. Pulse Width
Leads
MRI A. Pulse Configuration
MRI V. Pulse Configuration
Reset Setting
120 ms
5.0 V
5.0 V
1.0 ms
1.0 ms
Bipolar
Bipolar
Backup VVI and Backup Defibrillation Only Settings
In rare instances or during a firmware upgrade, the pulse generator may revert to Backup VVI (BVVI) and, if Tachy Therapy is
Enabled, Backup Defibrillation Only (BDFO) operation at the programmed settings listed in the tables below. These values are not programmable.
When the device has reverted to Backup VVI operation, the programmer will display a pop-up message indicating that the device is operating at the Backup VVI values. Press [Continue] and the system will attempt to store device data, print a Backup VVI report, and export data to send to St. Jude Medical,
Under some conditions, the previously programmed settings can be restored. The programmer will execute a short routine
(approximately five minutes) to restore the device to normal operation. Normal follow-up testing should be performed and the parameter settings should be reviewed.
In CRT-Ds and ICDs, if fibrillation detection and defibrillation are enabled when the device is in BDFO state, fibrillation is diagnosed after 12 fibrillation interval detections if no prior backup defibrillation has occurred. If the device has counted a previous backup defibrillation therapy, then fibrillation is diagnosed after six detections. The system reconfirms the diagnosis when it bins six more fibrillation intervals.
WARNING
In CRT-Ds and ICDs, Backup VVI (BVVI) operation changes the SenseAbility™ sensing algorithm, the SVT
Discrimination settings, and other parameters. If oversensing occurs (such as T-wave oversensing) and Tachy
Therapy is enabled, the device may deliver high voltage therapy(s) (based on the maximum sensitivity setting of
0.3 mV and the fixed VF Detection Rate of 146
min§). When the device enters the BVVI mode, there may be a pause in pacing support of up to three seconds.
Table 54. Backup VVI/DFO operational settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
Parameter
Backup Pacing
Mode
Pulse Amplitude
Pulse Width
Pacemaker Max Sensitivity
RV Pulse Configuration
LV Pulse Configuration
Sense Configuration
V Pace Refractory Period
Base Rate
Ventricular Pacing
Setting
VVI
5.0 V
0.6 ms
2.0 mV (fixed)
RV Bipolar (tip to ring)
LV Distal Tip to RV Ring
RV Bipolar (tip to ring)
321.5 ms
67 min§
LV -> RV
209 Dual-chamber devices only.
210
Dual-chamber devices only.
211 Dual-chamber devices only.
212
Dual-chamber devices only.
213 CRT-Ds only.
214
For dual-chamber and single-chamber devices only. For CRT-Ds , the V. Pace Refractory Period is 337.5 ms.
215 CRT-Ds only.
174
Table 54. Backup VVI/DFO operational settings for CRT-Ds, dual-chamber ICDs, and single-chamber ICDs
Parameter
Interventricular Delay
Backup Defibrillation
Low Frequency Attenuation Filter
SVT Discrimination
Sensitivity Range
Sensitivity
Defib Max Sensitivity
Post Paced Refractory
Post Paced Sensitivity
Post Paced Decay Delay
Post Paced Threshold Start
Post Sensed Decay Delay
Post Sensed Threshold Start
HV Refractory Period
Post Sensed Refractory
Number of Tachy Therapy Levels
Shock Waveform
Maximum Shocks per Episode
Shock Configuration
VF Detection Rate
Setting
16 ms
Off
Off
6.3 mV
AutoSense
0.3 mV
425 ms
25% of full scale
0 ms
1.0 mV
0 ms
50%
1 s
125 ms
1 (VF)
Biphasic, 65% tilt, maximum energy
6
RV to SVC & Can
146 min§
Table 55. Backup VVI operational settings for CRT-Ps, dual-chamber pacemakers, and single chamber pacemakers
Parameter
Mode
Base Rate
RV Pulse Configuration
LV Pulse Configuration
Sense Configuration
Pulse Amplitude
Pulse Width
V Pace Refractory Period
Sensitivity
Ventricular Pacing
Interventricular Delay
Setting
VVI
67 min§
Unipolar Tip
Unipolar Tip
Unipolar Tip
5.0 V
0.6 ms
321.5 ms
2.0 mV (fixed)
LV -> RV
16 ms
Fortify™ ST Device Software Upgrade
Fortify™ ST Device Software Upgrade:
INSTRUCTIONS
1.
It is recommended that you attach a surface ECG to the patient and monitor it during the upgrade procedure.
2.
3.
External defibrillation equipment should be available and ready.
Interrogate the device and perform a routine device follow-up. A FastPath™ Alert is shown on the Merlin™ PCS when a device software upgrade is available.
216 CRT-Ds only.
217
CRT-Ps only.
218 For dual-chamber and single-chamber devices only. For CRT-Ps , the V. Pace Refractory Period is 337.5 ms.
219
CRT-Ps only.
220 CRT-Ps only.
175
4.
5.
6.
7.
8.
9.
programmed to Enabled, you will be prompted to Disable Tachy Therapy. Select the Disable Therapy button.
Ensure that the telemetry wand is placed securely over the device for the duration of the upgrade. The RF antenna CANNOT be used for telemetry during the upgrade.
Select the Upgrade Device button.
The progress bar shows the status of the upgrade: The upgrade should take less than two minutes.
When the upgrade is complete, the "Upgrade Successful" message appears.
10.
11.
Select the Enable Therapy button to enable Tachy Therapy and end the session. If it is instead desired to leave Tachy Therapy programmed to Disabled, select the End Session button. Be advised that Tachy Therapy will not be available.
Re-interrogate the device and confirm that the Tachy Therapy Enable/Disable function is programmed to Enabled.
Verify that all brady and tachy parameters are set appropriately for the patient.
TECHNICAL & SAFETY NOTES
Emergency operations (VVI and SHOCK buttons) are not available during the upgrade. Real-time EGMs are temporarily unavailable during the upgrade. It is recommended that you attach a surface ECG to the patient and monitor it during the upgrade procedure. External defibrillation equipment should be available and ready.
During the upgrade, the device temporarily operates in Backup VVI. Upon entry into BVVI, there may be a pacing pause of up to three seconds. For additional information on Backup VVI and Backup DFO, refer to the Backup VVI and Backup Defibrillation
After the upgrade, only ST Diagnostics are cleared. All other diagnostic data and all parameter settings are preserved.
After the upgrade, ACap™ Confirm or Ventricular AutoCapture™ may be in high output mode. AutoCapture thresholds will be reassessed automatically when the session ends.
If the device software upgrade is interrupted, the Merlin™ PCS displays the message "Upgrade Failed; Tachy Therapy is
DISABLED."
-
Place the telemetry wand securely over the device. The RF antenna CANNOT be used for telemetry during the upgrade.
-
Select the Retry Upgrade button.
Do not power off the Merlin PCS or allow the patient to leave the clinic until the Merlin PCS displays the "Upgrade
Successful" message.
-
Re-interrogate the device to ensure that all parameters including Tachy Therapy Enabled have been reviewed and set.
WARNING
Tachy Therapy is DISABLED during the upgrade. It is recommended you monitor the patient with a surface ECG during the upgrade. External defibrillation equipment should be available and ready.
176
Feature Capabilities Lists
ACap™ Confirm Capability (page 177)
AT/AF Alert Triggers Capability (page 178)
ATP Therapy Prior to Charging and ATP Therapy While Charging Capability (page 179)
Auditory Patient Notifier Capability (page 180)
Auto Lead Polarity Detection Capability (page 180)
BiVCap™ Confirm Capability (page 183)
Chamber Onset Discrimination Capability (page 183)
CorVue™ Congestion Monitoring Capability (page 184)
DecisionTx™ Programming Capability (page 184)
DF4-LLHH Lead Capability (page 185)
DynamicTx™ Algorithm Capability (page 185)
Enhanced AT/AF Diagnostics Capability (page 186)
Enhanced Diagnostic Trend Capability (page 187)
Enhanced Diagnostic Trend (1-Year Daily Reports) Capability (page 187)
Enhanced Rate Responsive Pacing Capability (page 188)
Far Field MD™ Morphology Discrimination Capability (page 188)
Follow-up EGMs Capability (page 189)
High Ventricular Rate Alert Capability
Left Atrial Pressure Sensor Capability (page 190)
Low Frequency Attenuation Capability (page 191)
LV-Only Pacing Capability (page 191)
MR Conditional Programming Capability (page 191)
SJM MRI Activator™ Handheld Device Capability (page 191)
MultiPoint™ Pacing Capability (page 192)
Non-sustained VT/VF Episode Capability (page 192)
Patient Notifier Capability (page 192)
Percent Pacing Alert Capability (page 194)
Plugged Port Lead Type Capability (page 194)
QuickOpt™ Timing Cycle Optimization Capability (page 195)
RF Telemetry Capability (page 196)
SecureSense™ RV Lead Noise Discrimination Capability (page 198)
ST Monitoring Capability (page 198)
ST Monitoring Phase 2 Capability (page 198)
VectSelect Quartet™ LV Pulse Configuration and IS4-LLLL Lead Capability (page 199)
V AutoCapture™ Capability (page 199)
Ventricular Triggering Capability (page 200)
ACap™ Confirm Capability
Table 56. Devices with ACap Confirm capability
Name
Current Accel DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Model Number
CD2215-30, CD2215-36, CD2215-36Q
CD2219-30, CD221936, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
177
Quadra Assura MP
Endurity
Endurity MRI
Assurity
Assurity+
Assurity MRI
Accent DR
Accent ST
Accent MRI
Accent ST MRI
Accent DR RF
Anthem
Allure
Allure Quadra
Quadra Allure MP
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP RF
Table 56. Devices with ACap Confirm capability
Name
Unify Assura
Quadra Assura
Model Number
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1160, PM1162
PM1172
, PM2172
PM1240
, PM2240
PM1260
, PM2260
PM1272
, PM2272
PM2112
PM2122, PM2222
PM2124, PM2224
PM2126, PM2226
PM2212
PM3112
PM3120
PM3140
PM3160
PM3212
PM3222
PM3242
PM3262
AT/AF Alert Triggers Capability
Table 57. Devices with AT/AF Alert Triggers capability
Name
Current+ DR
Current Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Model Number
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2275-36, CD2275-36Q, CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q,
CD2311-36, CD2311-36Q, CD2377-36, CD2377-36C, CD2377-36-Q, CD2377-36QC
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
221 Available only when chamber is set to Atrium.
222
Available only when chamber is set to Atrium.
223 Available only when chamber is set to Atrium.
224
Available only when chamber is set to Atrium.
225 Available only when chamber is set to Atrium.
178
Quadra Assura MP
Accent DR
Accent ST DR
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent DR RF
Accent ST DR RF
Assurity
Assurity+
Assurity MRI
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Table 57. Devices with AT/AF Alert Triggers capability
Name
Unify Assura
Quadra Assura
Model Number
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C, CD3361-
40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C, CD3367-
40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM2112
PM2122, PM2224,
PM2124, PM2226
PM2126
PM2140, PM2152
PM1160
PM1172
PM2212
PM2222
PM1240
PM1260
PM1272
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
ATP Therapy Prior to Charging and ATP Therapy While Charging Capability
Table 58. Devices with ATP Therapy Prior to Charging and ATP Therapy While Charging capability
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Unify
Promote Quadra
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
226
Available only when chamber is set to Atrium.
227 Available only when chamber is set to Atrium.
228
Available only when chamber is set to Atrium.
229 Available only when chamber is set to Atrium.
230
Available only when chamber is set to Atrium.
231 Available only when chamber is set to Atrium.
179
Table 58. Devices with ATP Therapy Prior to Charging and ATP Therapy While Charging capability
Name
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Model Number
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
Auditory Patient Notifier Capability
Table 59. Devices with Auditory Patient Notifier Capability
Name
Accent SR
Accent ST
Accent MRI
Accent ST MRI
Accent SR RF
Assurity+
Accent DR
Accent DR RF
Accent ST
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Auto Lead Polarity Detection Capability
Model Number
PM1110
PM1122, PM1222, PM2122
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1210
PM1260, PM2260
PM2112
PM2212
PM2222
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
Table 60. Devices with Auto Lead Polarity Detection capability
Name
Endurity Core
Endurity
Endurity MRI
Assurity MRI
Battery Model 2356
Model Number
PM1140, PM1152, PM2140, PM2152
PM1162, PM2162
PM1172, PM2172
PM1272, PM2272
Table 61. Devices with a Greatbatch Medical Model 2356 battery
Name
Current VR
Current VR RF
Current Accel VR
Model Number
1107-30
1207-30
CD1215-30
180
Table 61. Devices with a Greatbatch Medical Model 2356 battery
Name
AnalyST VR
AnalyST Accel VR
Current DR
Current DR RF
Current Accel DR
AnalyST DR
AnalyST Accel DR
Promote
Promote RF
Promote Accel
Model Number
CD1217-30
CD1219-30
2107-30
2207-30
CD2215-30
CD2217-30
CD2219-30
3107-30, 3109-30
3207-30, 3213-30
3215-30
Battery Model 2555
Name
Current VR
Current VR RF
Current+ VR
Current Accel VR
AnalyST VR
AnalyST Accel VR
Current DR
Current DR RF
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Promote
Auricle
Promote RF
Promote+
Promote Accel
Promote Q
Promote LAP
Table 62. Devices with a Greatbatch Medical Model 2555 battery
Model Number
1107-36, CD1207-36Q
1207-36
CD1211-36, CD1211-36Q
CD1215-36, CD1215-36Q
CD1217-36
CD1219-36, CD1219-36Q
2107-36, CD2207-36Q
2207-36
CD2211-36, CD2211-36Q
CD2215-36, CD2215-36Q
CD2217-36
CD2219-36, CD2219-36Q
3107-36, 3107-36Q, 3109-36, 3213-36, CD3207-36Q
3107-36P
3207-36
CD3211-36, CD3211-36Q
CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
Battery Model 2662
Table 63. Devices with a Greatbatch Medical Model 2662 battery
Name
Accent SR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Model Number
PM1110
PM1122, PM1222, PM2122
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
181
Table 63. Devices with a Greatbatch Medical Model 2662 battery
Name
Accent SR RF
Assurity
Assurity+
Assurity MRI
Accent DR
Accent DR RF
Accent ST
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Battery Model 2753
Model Number
PM1210
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM2112
PM2212
PM2222
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
Table 64. Devices with a Greatbatch Medical Model 2753 battery
Name
Promote Quadra
Battery Model 2850
Model Number
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
Table 65. Devices with a Greatbatch Medical Model 2850 battery
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Unify
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
182
Battery Model 2950
Table 66. Devices with a Greatbatch Medical Model 2950 battery
Name
Ellipse VR
Ellipse DR
Model Number
CD1275-36, CD1275-36Q, CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q,
CD1311-36, CD1311-36Q, CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
BiVCap™ Confirm Capability
Table 67. Devices with BiVCap Confirm capability
Name
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
Chamber Onset Discrimination Capability
Table 68. Devices with Chamber Onset Discrimination capability
Name
Fortify Assura DR
Ellipse DR
Unify Assura
Quadra Assura
Quadra Assura MP
Model Number
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
183
CorVue™ Congestion Monitoring Capability
Table 69. Devices with CorVue Congestion Monitoring capability
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Assurity
Assurity+
Assurity MRI
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
DecisionTx™ Programming Capability
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q, CD1359-40, CD1359-40C,
CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q, CD2359-40, CD2359-40C,
CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2377-36, CD2377-36C,
CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C, CD3361-40C, CD3361-40QC
CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
Table 70. Devices with DecisionTx Programming capability
Name
Fortify VR
Fortify ST VR
Fortify DR
Fortify ST DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
184
DF4-LLHH Lead Capability
Table 71. Devices with DF4-LLHH Lead capability
Name
Current VR
Current+ VR
Current Accel VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Current DR
Current+ DR
Current Accel DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote
Promote+
Promote Accel
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Model Number
CD1207-36Q
CD1211-36Q
CD1215-36Q
CD1219-36Q
CD1233-40Q, CD1234-40Q
CD1235-40Q
CD1257-40Q, CD1259-40Q, CD1261-40Q, CD1359-40Q, CD1359-40QC
CD1275-36Q, CD1277-36Q, CD1279-36Q, CD1311-36Q, CD1377-36Q,
CD1377-36QC
CD2207-36Q
CD2211-36Q
CD2215-36Q
CD2219-36Q
CD2233-40Q, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40Q, CD2259-40Q, CD2261-40Q, CD2359-40Q, CD2359-40QC
CD2275-36Q, CD2277-36Q, CD2279-36Q, CD2311-36Q, CD2377-36Q,
CD2377-36QC
3107-36Q, CD3207-36Q
CD3211-36Q
CD3215-36Q
CD3234-40, CD3234-40Q, CD3235-40Q
CD3237-40Q, CD3239-40Q
CD3249-40Q, CD3251-40Q
CD3255-40Q
CD3257-40Q, CD3261-40Q, CD3361-40Q, CD3361-40QC
CD3265-40Q, CD3267-40Q, CD3367-40Q, CD3367-40QC
CD3271-40Q, CD3371-40Q, CD3371-40QC
DynamicTx™ Over-Current Detection Algorithm Capability
Table 72. Devices with DynamicTx™ Over-Current Detection algorithm capability
Name
Fortify Assura VR
Ellipse VR
Fortify Assura DR
Ellipse DR
Unify Assura
Quadra Assura
Quadra Assura MP
Model Number
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1311-36, CD1311-36Q, CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3361-40, CD3361-40C, CD3361-40C, CD3361-40QC
CD3367-40, CD3367-40C, CD3367-40Q, CD3367-40QC
CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
232 SJ4-LLHH is equivalent to DF4-LLHH. St. Jude Medical's SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
185
Enhanced AT/AF Diagnostics Capability
Quadra Assura MP
Accent DR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent DR RF
Assurity
Assurity+
Assurity MRI
Anthem
Anthem RF
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Table 73. Devices with Enhanced AT/AF Diagnostics capability
Name
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Model Number
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD2217-36
CD2219-30, CD221936, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM2112
PM2122, PM2222
PM2272
PM3112
PM3212
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
PM2124, PM2224
PM2126, PM2226
PM2140, PM2152
PM2160, PM2162
PM2172
PM2212
PM2240
PM2260
186
Enhanced Diagnostic Trend Capability
Table 74. Devices with Enhanced Diagnostic Trend capability
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Endurity Core
Endurity
Endurity MRI
Assurity
Assurity+
Assurity MRI
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
Enhanced Diagnostic Trend (1-Year Daily Reports) Capability
Table 75. Devices with Enhanced Diagnostic Trend (1-Year Daily Reports) capability
Name
Fortify Assura VR
Ellipse VR
Fortify Assura DR
Ellipse DR
Unify Assura
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
187
Table 75. Devices with Enhanced Diagnostic Trend (1-Year Daily Reports) capability
Name
Quadra Assura
Quadra Assura MP
Endurity Core
Endurity
Endurity MRI
Assurity
Assurity+
Assurity MRI
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
Enhanced Rate Responsive Pacing Capability
Table 76. Devices with Enhanced Rate Responsive Pacing Capability
Name
Accent DR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent DR RF
Assurity
Assurity+
Assurity MRI
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
PM2112
PM2122, PM2222
PM2124, PM2224
PM2126, PM2226
PM2140, PM2152
PM2160, PM2162
PM2172
PM2212
PM2240
PM2260
PM2272
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
Far Field MD™ Morphology Discrimination Capability
Table 77. Devices with Far Field MD Morphology Discrimination capability
Name
Fortify Assura VR
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
188
Table 77. Devices with Far Field MD Morphology Discrimination capability
Name
Ellipse VR
Fortify Assura DR
Ellipse DR
Unify Assura
Quadra Assura
Model Number
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Quadra Assura MP
Follow-up EGMs Capability
Table 78. Devices with Follow-up EGMs capability
Name
Current+ VR
Current Accel VR
AnalyST VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Accent SR
Model Number
CD1211-36, CD1211-36Q
CD1215-30, CD1215-36, CD1215-36Q
CD1217-30, CD1217-36
CD1219-30, CD1219-36, CD1219-36Q
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD2217-36
CD2219-30, CD2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1110
189
Table 78. Devices with Follow-up EGMs capability
Name
Accent ST
Accent MRI
Accent ST MRI
Endurity
Endurity MRI
Accent SR RF
Assurity
Assurity+
Assurity MRI
Accent DR
Accent DR RF
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
High Ventricular Rate Diagnostic Capability
Model Number
PM1122, PM1222, PM2122, PM2222
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1210
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM2112
PM2212
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
Table 79. Devices with High Ventricular Rate Diagnostic capability
Name
Endurity Core
Endurity
Endurity MRI
Assurity
Assurity+
Assurity MRI
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Left Atrial Pressure Sensor Capability
Model Number
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
Table 80. Devices with Left Atrial Pressure Sensor capability
Name
Auricle
Promote LAP
Model Number
3107-36P
CD3223-36P
190
Low Frequency Attenuation Capability
Table 81. Devices with Low Frequency Attenuation capability
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2275-36, CD2275-36Q, CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q,
CD2311-36, CD2311-36Q, CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Quadra Assura MP
LV-Only Pacing Capability
Table 82. Devices with LV-only Pacing capability
Name
Promote
Model Number
3109-30, 3109-36, 3213-30, 3213-36
MR Conditional Programming Capability
Table 83. Devices with MR Conditional Programming capability
Name
Ellipse VR
Ellipse DR
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Assurity MRI
Model Number
CD1377-36Q, CD1377-36QC
CD2377-36Q, CD2377-36QC
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1162, PM2162
PM1172, PM2172
PM1272, PM2272
SJM MRI Activator™ Handheld Device Capability
Table 84. Devices with MRI Activator™ Handheld Device capability
Name
Accent MRI
Model Number
PM1124, PM1224, PM2124, PM2224
191
Table 84. Devices with MRI Activator™ Handheld Device capability
Name
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Assurity MRI
MultiPoint™ Pacing Capability
Model Number
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1162, PM2162
PM1172, PM2172
PM1272, PM2272
Table 85. Devices with MultiPoint Pacing capability
Name
Promote Q
Promote Quadra
Unify Quadra MP
Quadra Assura MP
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD3227-36
CD3237-40, CD3237-40Q
CD3255-40, CD3255-40Q
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM3160
PM3262
Non-sustained VT/VF Episode Capability
Table 86. Devices with Non-sustained VT/VF Episode capability
Name
Fortify Assura VR
Ellipse VR
Fortify Assura DR
Ellipse DR
Unify Assura
Quadra Assura
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Quadra Assura MP
Patient Notifier Capability
Table 87. Devices with Patient Notifier capability
Name
Current VR
Current VR RF
Current+ VR
Current Accel VR
AnalyST VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Model Number
1107-30, 1107-36, CD1207-36Q
1207-30, 1207-36
CD1211-36, CD1211-36Q
CD1215-30, CD1215-36, CD1215-36Q
CD1217-30, CD1217-36
CD1219-30, CD1219-36, CD1219-36Q
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
192
Table 87. Devices with Patient Notifier capability
Name
Fortify Assura VR
Ellipse VR
Current DR
Current DR RF
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote
Auricle
Promote RF
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Accent SR
Accent ST
Accent MRI
Accent ST MRI
Accent SR RF
Assurity+
Accent DR
Accent DR RF
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
2107-30, 2107-36, CD2207-36Q
2207-30, 2207-36
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD2217-36
CD2219-30, CD2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
3107-30, 3107-36, 3107-36Q, 3109-30, 3109-36, CD3207-36Q
3107-36P
3207-30, 3207-36, 3213-30, 3213-36
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3253-40, CD3253-40Q, CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40C, CD3361-40Q,
CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1110
PM1122, PM1222, PM2122, PM2222
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1210
PM1260, PM2260
PM2112
PM2212
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
193
Percent Pacing Alert Capability
Table 88. Devices with Percent Pacing Alert capability
Name
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent SR RF
Assurity
Assurity+
Assurity MRI
Allure
Allure Quadra
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Plugged Port Lead Type Capability
Model Number
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1122, PM1222, PM2122, PM2222
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1210
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM3120
PM3140
PM3222
PM3242
PM3160
PM3262
Table 89. Devices with Plugged Port Lead Type capability
Name
Fortify DR
Fortify ST DR
Fortify Assura DR
Model Number
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
194
Table 89. Devices with Plugged Port Lead Type capability
Name
Ellipse DR
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Accent DR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent DR RF
Assurity
Assurity+
Assurity MRI
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Model Number
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM2112
PM2260
PM2272
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM2122, PM2222
PM2124, PM2224
PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM2160, PM2162
PM2172
PM2212
PM2240
PM3160
PM3262
QuickOpt™ Timing Cycle Optimization Capability
Table 90. Devices with QuickOpt Timing Cycle Optimization capability
Name
Current DR
Current DR RF
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote
Model Number
2107-30, 2107-36, CD2207-36Q
2207-30, 2207-36
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD2217-36
CD2219-30, CD2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
3107-30, 3107-36, 3107-36Q, 3109-30, 3109-36, CD3207-36Q
195
Quadra Assura MP
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Assurity
Assurity+
Assurity MRI
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Table 90. Devices with QuickOpt Timing Cycle Optimization capability
Name
Auricle
Promote RF
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Model Number
3107-36P
3207-30, 3207-36, 3213-30, 3213-36
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM2122, PM2222
PM2124, PM2224
PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM2160, PM2162
PM2172
PM2240
PM2260
PM2272
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
RF Telemetry Capability
Table 91. Devices with RF Telemetry capability
Name
Current VR
Current VR RF
Current+ VR
Current Accel VR
AnalyST DR
AnalyST VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Model Number
CD1207-36Q
1207-30, 1207-36
CD1211-36, CD1211-36Q
CD1215-30, CD1215-36, CD1215-36Q
CD2217-30
CD1217-30, CD1217-36
CD1219-30, CD1219-36, CD1219-36Q
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
196
Table 91. Devices with RF Telemetry capability
Name
Fortify Assura VR
Ellipse VR
Current DR
Current DR RF
Current+ DR
Current Accel DR
AnalyST DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Promote
Promote RF
Promote+
Promote Accel
Promote Q
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Quadra Assura MP
Accent SR RF
Accent ST
Accent MRI
Accent ST MRI
Assurity
Assurity+
Assurity MRI
Accent DR RF
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP RF
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2207-36Q
2207-30, 2207-36
CD2211-36, CD2211-36Q
CD2215-30, CD2215-36, CD2215-36Q
CD2217-30, CD 2217-36
CD2219-30, CD 2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3207-36Q
3207-30, 3207-36, 3213-30, 3213-36
CD3211-36, CD3211-36Q
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QCv
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1210
PM1222, PM2222
PM1224, PM2224
PM1226, PM2226
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM2212
PM3212
PM3222
PM3242
PM3262
197
SecureSense™ RV Lead Noise Discrimination Capability
Table 92. Devices with SecureSense™ RV Lead Noise Discrimination capability
Name
Fortify Assura VR
Ellipse VR
Fortify Assura DR
Ellipse DR
Unify Assura
Quadra Assura
Model Number
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC Quadra Assura MP
ST Monitoring Capability
Table 93. Devices with ST Monitoring capability
Name
AnalyST VR
AnalyST Accel VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
AnalyST DR
AnalyST Accel DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Accent ST
Accent ST MRI
Accent ST
Accent ST MRI
Accent ST
Accent ST MRI
Accent ST
Accent ST MRI
ST Monitoring Phase 2 Capability
Model Number
CD1217-30, CD1217-36
CD1219-30, CD1219-36, CD1219-36Q
PM1122
PM1126
PM1222
PM1226
PM2122
PM2126
PM2222
PM2226
CD1235-40, CD1235-40Q
CD1259-40, CD1259-40Q, CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2217-30, CD2217-36
CD2219-30, CD2219-36, CD2219-36Q
CD2235-40, CD2235-40Q
CD2259-40, CD2259-40Q, CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
Table 94. Devices with ST Monitoring Phase 2 capability
Name
Fortify ST VR
Fortify Assura VR
Ellipse VR
Model Number
CD1235-40, CD1235-40Q
CD1259-40, CD1259-40Q, CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
Fortify ST DR CD2235-40, CD2235-40Q
233
Fortify ST devices have the ST Monitoring Phase 2 capability only if they have undergone a firmware upgrade. Please contact Technical Support for questions concerning the upgrade.
198
Table 94. Devices with ST Monitoring Phase 2 capability
Name
Fortify Assura DR
Ellipse DR
Model Number
CD2259-40, CD2259-40Q, CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
VectSelect Quartet™ LV Pulse Configuration and IS4-LLLL Lead Capability
Table 95. Devices with the VectSelect Quartet™ LV pulse configuration feature and IS4-LLLL Lead capability
Name
Promote Q
Promote Quadra
Unify Quadra
Unify Quadra MP
Quadra Assura
Quadra Assura MP
Allure Quadra
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
V AutoCapture™ Capability
Model Number
CD3221-36, CD3227-36
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM3140
PM3242
PM3160
PM3262
Table 96. Devices with V AutoCapture capability
Name
Current Accel VR
AnalyST Accel VR
Fortify VR
Fortify ST VR
Fortify Assura VR
Ellipse VR
Current Accel DR
AnalyST Accel DR
Fortify DR
Fortify ST DR
Fortify Assura DR
Ellipse DR
Accent SR
Accent SR RF
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Model Number
CD1215-30, CD1215-36, CD1215-36Q
CD1219-30, CD1219-36, CD1219-36Q
CD1233-40, CD1233-40Q, CD1234-40, CD1234-40Q
CD1235-40, CD1235-40Q
CD1257-40, CD1257-40Q, CD1259-40, CD1259-40Q, CD1261-40, CD1261-40Q,
CD1359-40, CD1359-40C, CD1359-40Q, CD1359-40QC
CD1277-36, CD1277-36Q, CD1279-36, CD1279-36Q, CD1311-36, CD1311-36Q,
CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC
CD2215-30, CD2215-36, CD2215-36Q
CD2219-30, CD2219-36, CD2219-36Q
CD2233-40, CD2233-40Q, CD2234-40, CD2234-40Q
CD2235-40, CD2235-40Q
CD2257-40, CD2257-40Q, CD2259-40, CD2259-40Q, CD2261-40, CD2261-40Q,
CD2359-40, CD2359-40C, CD2359-40Q, CD2359-40QC
CD2277-36, CD2277-36Q, CD2279-36, CD2279-36Q, CD2311-36, CD2311-36Q,
CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC
PM1110
PM1210
PM1122, PM1222, PM2122, PM2222
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
234 SJ4-LLLL is equivalent to IS4-LLLL. St. Jude Medical's SJ4 and IS4 connector cavities comply with ISO27186:2010(E).
199
Table 96. Devices with V AutoCapture capability
Name
Endurity MRI
Assurity
Assurity+
Assurity MRI
Accent DR
Accent DR RF
Ventricular Triggering Capability
Model Number
PM1172, PM2172
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM2112
PM2212
Quadra Assura MP
Accent SR
Accent ST
Accent MRI
Accent ST MRI
Endurity Core
Endurity
Endurity MRI
Accent SR RF
Assurity
Assurity+
Assurity MRI
Accent DR
Accent DR RF
Anthem
Allure
Allure Quadra
Anthem RF
Allure RF
Allure Quadra RF
Quadra Allure MP
Quadra Allure MP RF
Table 97. Devices with Ventricular Triggering capability
Name
Promote+
Promote Accel
Promote Q
Promote LAP
Unify
Promote Quadra
Unify Quadra
Unify Quadra MP
Unify Assura
Quadra Assura
Model Number
CD3211-36, CD3211-36Q
PM2212
PM3112
PM3120
PM3140
PM3212
PM3222
PM3242
PM3160
PM3262
CD3215-30, CD3215-36, CD3215-36Q
CD3221-36, CD3227-36
CD3223-36P
CD3234-40, CD3234-40Q, CD3235-40, CD3235-40Q
CD3237-40, CD3237-40Q, CD3239-40, CD3239-40Q
CD3249-40, CD3249-40Q, CD3251-40, CD3251-40Q
CD3255-40, CD3255-40Q
CD3257-40, CD3257-40Q, CD3261-40, CD3261-40Q, CD3361-40, CD3361-40C,
CD3361-40Q, CD3361-40QC
CD3265-40, CD3265-40Q, CD3267-40, CD3267-40Q, CD3367-40, CD3367-40C,
CD3367-40Q, CD3367-40QC
CD3271-40, CD3271-40Q, CD3371-40, CD3371-40C, CD3371-40Q, CD3371-40QC
PM1110
PM1122, PM1222, PM2122, PM2222
PM1124, PM1224, PM2124, PM2224
PM1126, PM1226, PM2126, PM2226
PM1140, PM1152, PM2140, PM2152
PM1160, PM1162, PM2160, PM2162
PM1172, PM2172
PM1210
PM1240, PM2240
PM1260, PM2260
PM1272, PM2272
PM2112
200
Parameter Availability and Settings
Parameter availability and settings described below are for all devices described in this help manual.
Parameter
Availability
Single-Chamber ICDs (page
Parameter Availability
1st Therapy Method (page 57) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Parameter
1st Therapy, Ventricular Fibber
Settings
30; 35; … 95%
Settings
Automatic; Timed; Manual
Availability
30 J devices with Battery
36 J devices with Battery
J devices with Battery Model
40 J devices with Battery
36 J Devices with Battery
Settings
Timed or Manual 1st Therapy
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0 J
Timed or Manual 1st Therapy
Method, Pulse Width Waveform
Mode: 50; 100; … 800; 830 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0;
36.0 J
Timed or Manual 1st Therapy
Method, Pulse Width Waveform
Mode: 50; 100; … 800; 830 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0; 32.0; 34.0;
36.0 J
Timed or Manual 1st Therapy
Method, Pulse Width Waveform
Mode: 50; 100; … 800; 830;
845 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
0.1; 0.2; … 1.0; 2.0; … 10.0;
12.5; … 30.0 J
Timed or Manual 1st Therapy
Method, Pulse Width Waveform
Mode: 50; 100; … 800 V
Parameter
Availability
Chamber Pacemakers (page
Settings
Displayed value
Parameter
Add Stimuli Per Burst (page
Availability
Single-Chamber ICDs (page
Settings
On; Off
Nominal
Devices with Far Field MD™
Morphology Discrimination
Other devices: 60%
Nominal
Automatic
Nominal
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
15 J
Timed or Manual 1st Therapy
Method, Pulse Width
Waveform Mode: 600 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
15 J
Timed or Manual 1st Therapy
Method, Pulse Width
Waveform Mode: 600 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
15 J
Timed or Manual 1st Therapy
Method, Pulse Width
Waveform Mode: 600 V
Timed or Manual 1st Therapy
Method, Tilt Waveform Mode:
15 J
Timed or Manual 1st Therapy
Method, Pulse Width
Waveform Mode: 600 V
Nominal n/a
Nominal
Off
201
Parameter
AF Suppression (AF
Suppression Algorithm) (page
Availability
Chamber Pacemakers (page
Family Single-Chamber
Pacemakers when Chamber is set to Atrium
Parameter
Availability
Chamber Pacemakers (page
Parameter
AMS Max Trigger Rate (page
Availability
CRT-Ds with Ventricular
Triggering Capability (page
CRT-Ps with Ventricular
Triggering Capability
Parameter Availability
Chamber Pacemakers (page
Parameter
Availability
Devices with Ventricular
Triggering Capability (page
Parameter Availability
Arrhythmia Unhiding (page 84) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Parameter Availability
AT/AF Episode, see Continuous Time in AT/AF (page 131)
Parameter
ATP Pulse Amplitude (page
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
ATP Upper Rate Cutoff (page
Availability
Devices with ATP Therapy Prior to Charging and ATP Therapy
While Charging Capability
Parameter Availability
Atrial Episode Type (page 139) CRT-Ps (page 162), Dual-
Chamber Pacemakers (page
Single-Chamber Pacemakers when Chamber is set to Atrium
Settings
On; Off
Settings
40; 45; … 135 min§
40; 45; … 170 min§
Settings
90; 100; … 150
90; 100; … 180
Settings
Settings
1.0; 1.5 ms
Settings min§
AMS; AT/AF Detection; High
Atrial Rate min§
Entry; Exit; Entry & Exit
Settings
On; Off
Settings
Off; 2; 3; … 15 intervals
Settings
Settings
7.5 V
Settings
200; 210; … 400 ms
Nominal
Off
Nominal
80 min§
80 min§
Nominal
130
130
On min§ min§
Nominal
Entry
Nominal
Nominal
3 intervals
Nominal
Nominal
Non-programmable
Nominal
1.0 ms
Nominal
240 ms
Nominal
High Atrial Rate
202
Parameter Availability
Atrial Pace Refractory (page 82) CRT-Ds (page 161), Dual-
Chamber Pacemakers (page
Parameter
Atrial Refractory (Pace)
Availability
Assurity and Endurity Single-
Chamber Pacemakers when
Chamber is set to Atrium
Parameter
Atrial Sense Refractory (page
Availability
Settings Nominal
190; 220; … 400; 440; 470 ms 190 ms
Settings
190; 220; … 400; 440;
470 ms
Nominal
190 ms
Chamber Pacemakers (page
Settings
Dual-chamber pacing Mode:
93; 125; 157 ms
AAI pacing mode: 93; 125;
157 ms
Dual-chamber pacing Mode:
93; 125; 157; 190 ms
AAI pacing mode: 93; 125; 157;
190; 220;... 400; 440; 470 ms
Nominal
Dual-chamber pacing mode:
93 ms
AAI pacing mode: 93 ms
Dual-chamber pacing mode:
93 ms
AAI pacing mode: 93 ms
Parameter
Atrial Refractory (Sense)
Availability
Assurity and Endurity Single-
Chamber Pacemakers when
Chamber is set to Atrium
Settings
93; 125; 157; 190; 220;...
400; 440; 470 ms
Parameter
Atrial Tachycardia Detection
Availability
Chamber Pacemakers (page
and Endurity Family
Pacemakers
Settings
110; 120; … 200; 225; … 300 min§
Parameter Availability
Chamber Pacemakers (page
Patient Notifier Capability (page
Settings
2; 4; … 16 s
Parameter
Availability
Chamber Pacemakers (page
Settings
Off; DDI; DDIR; VVI; VVIR; DDT;
DDTR; VVT; VVTR
Parameter
Availability
Chamber Pacemakers
Settings
Atrial: Off; On
Ventricular: On
Atrial: Off; On
Ventricular: Off; On
Parameter
AV Association Delta (page
Parameter
Availability
Availability
Settings
30; 40; … 150 ms
Settings
Off; 30; 40; … 150 ms
Nominal
93 ms
Nominal
180
6 s min§
Nominal
Nominal
DDIR
Nominal
Atrial: On
Ventricular: Nonprogrammable
Atrial: Off
Ventricular: Off
Nominal
60 ms
Nominal
Devices with DecisionTx
Programming Capability (page
Other devices: Off
235
Available only when chamber is set to Atrium.
236 Not available in Endurity™ Core devices.
203
Parameter
Backup Pulse Configuration
Parameter
Channels, Stored EGMs (page
Availability
with ACap Confirm Capability
AutoCapture Capability (page
Single-Chamber ICDs (page
Chamber Pacemakers (page
Confirm Capability (page 183),
V AutoCapture Capability (page
Single-Chamber Pacemakers
Parameter
Parameter Availability
Burst Cycle Length (page 107) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Parameter
Availability
Devices with ACap Confirm
Devices with BiVCap Confirm
Parameter
Cap Confirm Paced/Sensed AV
Parameter
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Availability
Devices with BiVCap Confirm
Availability
Chamber Onset Discrimination
Availability
Chamber Pacemakers (page
Single-Chamber ICDs (page
Settings
Bipolar (non programmable)
Bipolar (non programmable)
Atrial: Bipolar (non programmable)
RV and V: Unipolar; Bipolar
Unipolar; Bipolar
Settings
30; 35; … 100 min§
30; 35; … 130; 140;
...170 min§
Settings
Adaptive: 50; 51; … 100%
Fixed 200; 205; … 550 ms
Settings
Atrium: On; Monitor; Off
RV: Setup; On; Monitor; Off
LV: Setup; On; Monitor; Off
Settings
50/25; 100/70; 120/100 ms
Settings
Passive; On; Off
Settings
1; 2; 3 channels
1; 2; 3 channels
Nominal
Bipolar
Bipolar
Atrial: Bipolar
RV and V: Bipolar
Bipolar
Nominal
60 min§
60 min§
Nominal
Adaptive: 85%
Nominal
Atrium: Monitor
RV: Off
LV: Off
Nominal
50/25 ms
Nominal
On
Nominal
2 channels
1 channel
237
If RV Lead Type is set to Unipolar, then the Backup Pulse Configuration is set to Unipolar.
238 If RV Lead Type is set to Unipolar, then the Backup Pulse Configuration is set to Unipolar.
204
Parameter
Availability
Single-Chamber ICDs (page
Settings
Devices with Battery Model
… 6 months
Devices with Battery Model
2753 (page 182), Battery Model
6 months
Nominal
Devices with Battery
Model 2356 and Battery
Model 2555: 3 months
Devices with Battery Model
2753 and Battery Model 2850:
4 months
Devices with Battery Model
2950: 6 months
Parameter
Configuration, Stored EGM
Parameter
Availability
All devices
Availability
Devices with CorVue
Congestion Monitoring
Settings Nominal
See parameter description for details.
Settings
8; 9; … 18 days
Nominal
Dual-Chamber ICDs (page
Chamber Pacemakers (page
CorVue Congestion Monitoring
Capability (page 184): 16 days
Parameter Availability Settings
Consecutive High Atrial Rate Cycles, see Number of Cycles (Consecutive High Atrial Rate Cycles)
Nominal
Parameter Availability Settings Nominal
Parameter
Continuous Time in AT/AF
Parameter
CorVue Congestion Monitoring
Availability
Devices with AT/AF Alert
Triggers Capability (page 178)
Availability
Devices with CorVue
Congestion Monitoring
Settings Nominal
30 min; 1; 3; 6; 9; 12; 24 hours 3 hours
Settings
On; Off
Nominal
Off
Parameter
Custom, Stored EGM
Availability
those with VectSelect Quartet™
LV Pulse Configuration capability
CRT-Ds with VectSelect
Quartet™ LV Pulse
Configuration capability (page
Dual-Chamber ICDs (page
Single-Chamber ICDs (page
Settings
A tip; A ring; RV tip; RV ring
LV tip; LV ring
SVC
A tip; A ring; RV tip; RV ring;
RV-coil; LV Distal tip 1; LV Mid
2; LV Mid 3; Can; LV Proximal
4; SVC
A tip; A ring; V tip; V ring coil; Can; SVC
V tip; V ring
SVC
; RV-coil; Can;
Nominal n/a n/a n/a n/a
Parameter
Cycle Count, Hysteresis Rate
Availability
All devices
Settings
1; 2; … 16 cycles
Nominal n/a
239
RVring is only available when the RV lead type is Bipolar.
240 LVring is only available when the LV Lead Type is Bipolar.
241
V-ring is only available when the Ventricular Lead Type is Bipolar.
242 V-ring is only available when the Ventricular Lead Type is Bipolar.
205
Parameter
Availability
Dual-Chamber ICDs (page
Settings
Auto
; 7 0; 30; 60; 95; 125;
160; 190; 220 ms
Auto
;7 0; 30; 60; 95; 125;
160; 190; 220 ms
Nominal
Devices with Low Frequency
Attenuation Capability (page
Atrium Post-Sensed: 0 ms
Atrium Post-Paced: 0 ms
RV Post-Sensed: 60 ms
RV Post-Paced: 0 ms
Other devices:
Atrium Post-Sensed: 0 ms
Atrium Post-Paced: 0 ms
RV Post-Sensed: 60 ms
RV Post-Paced: Auto
Devices with Low Frequency
Attenuation Capability (page
Atrium Post-Sensed: 0 ms
Atrium Post-Paced: 0 ms
Ventricular Post-Sensed:
60 ms
Ventricular Post-Paced: 0 ms
Other devices:
Atrium Post-Sensed: 0 ms
Atrium Post-Paced: 0 ms
Ventricular Post-Sensed:
60 ms
Ventricular Post-Paced: Auto
Ventricular Post-Sensed:
60 ms
Ventricular Post-Paced: Auto
Dual-Chamber Pacemakers
Single-Chamber
Pacemakers
, Auto
;7 0; 30; 60; 95; 125;
160; 190; 220 ms
Parameter
Pacing
Parameter
Detection Interval/Rate (page
Parameter
Availability
CRT-Ds with MultiPoint Pacing
Availability
Single-Chamber ICDs (page
Availability
Single-Chamber ICDs (page
243
The Auto setting is only available for ventricular channels.
244 The Auto setting is only available for ventricular channels.
245
Not available in Endurity™ Core devices.
246 Not available in Endurity™ Core devices.
247
The Auto setting is only available for ventricular channels.
248 Only available when SVT Discrimination is set to Ventricular Only.
Settings
Delay 1: 5; 10; … 80 ms
Delay 2: 5; 10; … 50 ms
Nominal
Delay 1 (Pacing): 10 ms
Delay 2 (Pacing): 10 ms
Delay 1 (Triggered modes): 5 ms
Delay 2 (Triggered modes): 5 ms
Settings
This is the full range of settings displayed by the programmer.
Depending on other parameter settings, the programmer may not allow all settings to be programmed.
VT or VT-1 rate zone: 230; 235;
240; … 590 ms
VT-2 rate zone: 230; 235; …
550 ms
VF rate zone in 1 Zone (page
210; … 430 ms
VF rate zone in 2 Zones (page
Zone Configuration: 200; 210;
… 430 ms
Nominal
Devices with DecisionTx
Programming Capability (page
Morphology Discrimination
VT rate zone in 2 Zone
Configuration: 350 ms
VT-1 rate zone in 3 Zone
Configuration: 400 ms
VT-2 rate zone: 330 ms
VF rate zone in 1 Zone
Configuration: 320 ms
VF rate zone in 2 Zones or
3 Zones Zone Configuration:
280 ms
Other devices:
VT or VT-1 rate zone: 430 ms
VT-2 rate zone: 375 ms
VF rate zone in 1 Zone
Configuration: 360 ms
VF rate zone in 2 Zones or
3 Zones Zone Configuration:
330 ms
Settings
If Any; If All; If 2 of 3
Nominal
Devices with Far Field MD
Morphology Discrimination
206
Chamber setting: If All
Ventricular Only setting: n/a
Devices with DecisionTx
Programming Capability (page
Dual-Chamber setting: If All
Ventricular Only Setting:
If 2 of 3
Other devices: If Any
Parameter
DynamicTx Over-Current
Parameter
Availability
Devices with DynamicTx Over-
Current Detection Algorithm
Availability
Devices with Battery Model
Devices with Battery Model
Devices with Battery Model
Devices with Battery Model
Settings
On; Off
Settings
Pulse Width Waveform Mode
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5; …
30.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 830 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5; …
30.0; 32.0; 34.0; 36.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 845; 890 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5; …
30.0; 32.0; 34.0; 36.0; 40.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 830; 875 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5; …
30.0; 32.0; 34.0; 36.0; 40.0 J
Nominal
On
Nominal n/a n/a n/a n/a
Parameter
Episodal Pacing Mode (page
Availability
Settings
DDI; VVI; AAI
Nominal
DDI
Parameter
Evaluation Period, AT/AF
Parameter
Evaluation Period, V. Rate
Availability
Devices with AT/AF Alert
Triggers Capability (page 178)
Availability
Devices with AT/AF Alert
Triggers Capability (page 178)
Settings
Daily; Weekly
Settings
Daily
Nominal
Daily
Nominal
Non-programmable
Parameter
Far Field MD/SecureSense
Availability
Devices with Far Field MD
Morphology Discrimination
SecureSense™ RV Lead Noise
Discrimination Capability (page
Parameter Availability
Chamber Pacemakers (page
Single-Chamber Pacemakers
set to Atrium
Settings
V Tip-Can
Coil-Can
; RV Tip-Can
; RV
Settings
125; 150 … 300 min§
Nominal
RV Coil-Can
Nominal
150 min§
Parameter
High V Rate EGM Max Duration
Availability
Chamber Pacemakers
,
Single-Chamber Pacemakers
249 This setting is only available in Dual-chamber ICDs and Single-Chamber ICDs.
250
This setting is only available in CRT-Ds.
251 Not available in Endurity™ Core devices.
Settings
20; 30 s; 1; 2; 3; 4; 5 min
Nominal
20 s
207
Parameter
High V Rate Pre-Trigger Max
Parameter
HVLI Monitoring Upper Limit
Availability
CRT-Ps, Dual-Chamber
Pacemakers
Chamber Pacemakers
Parameter Availability
High Ventricular Rate, see Ventricular Rate Threshold (page 225)
Parameter
High V. Rate Threshold (page
Parameter
HVLI Monitoring Lower Limit
Availability
Devices with AT/AF Alert
Triggers Capability (page 178)
Availability
Single-Chamber ICDs (page
Availability
devices), Dual-Chamber ICDs
CRT-Ds (40 J devices)
Parameter
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Settings Nominal
2; 10; 14; 20; 30; 40; 50; 60 s 14 s
Settings
Settings Nominal
60; 70; … 150; 175; 200 min§ 100 min§
Settings
20; 25; … 80
¬
Settings
40; 50; … 200
¬
40; 50; … 125
¬
Settings
Off; 30; 35; … 95 min§
Off; 30; 35; … 150 min§
Settings
Dual Chamber SVT
Discrimination Mode (page 92):
Off; Passive; On; On w/AVA
Ventricular Only SVT
Discrimination Mode: Off;
Passive; On; On w/SIH
Nominal
Nominal
20
¬
Nominal
200
125
Off
Off
¬
¬
Nominal
Nominal
Devices with Far Field MD
Morphology Discrimination
Dual Chamber SVT
Discrimination Mode: On w/AVA
Ventricular Only SVT
Discrimination Mode: Passive
Devices with DecisionTx
Programming Capability (page
Dual Chamber SVT
Discrimination Mode: On w/AVA
Ventricular Only SVT
Discrimination Mode: On w/SIH
Other devices:
Dual Chamber SVT
Discrimination Mode: On
Ventricular Only SVT
Discrimination Mode: Passive
Parameter
Interval Stability Window Size
Availability
Single-Chamber ICDs (page
Parameter Availability
Intervention Duration (page 71) CRT-Ps (page 162), Dual-
Chamber Pacemakers (page
Settings
8; 9; … 20 intervals
Settings
1; 2; … 10 min
Nominal
12 intervals
Nominal
3 min
252 Not available in Endurity™ Core devices.
208
Parameter
Availability
Chamber Pacemakers (page
Parameter
Interventricular Delay
Availability
Parameter Availability
Isoelectric Duration (page 36)
Devices with ST Monitoring
Settings
Off; Base Rate; Intrinsic+0;
Intrinsic+10; Intrinsic+20;
Intrinsic+30; 80; 90 …
120 min§
Settings
10
Nominal
Off
Nominal n/a
Settings
24; 30;…156 ms
Nominal
Resting: 54 ms
Elevated 1: 48 ms
Elevated 2: 42 ms
Elevated 3: 42 ms
Parameter
Availability
Devices with ST Monitoring
Settings
64; 70;…196 ms
Nominal
Resting: 148 ms
Elevated 1: 130 ms
Elevated 2: 124 ms
Elevated 3: 118 ms
Parameter
Availability
Single-Chamber Pacemakers
Settings
Atrium, Ventricle
Nominal
Ventricle
Parameter
Availability
Single Chamber ICDs (page
Chamber Pacemakers (page
Settings
Monitor
Monitor; Polarity Switch
Parameter
Availability
Plugged Port Lead Type
Plugged Port Lead Type
without Plugged Port Lead Type
Capability
Settings
Atrial: Bipolar
RV: Bipolar
LV: (without VectSelect
Quartet™ LV Pulse
Configuration capability (page
Uncoded
LV (with VectSelect Quartet™
LV Pulse Configuration capability): Quadripolar;
Uncoded
Atrial: Bipolar; Plugged
RV: Bipolar
LV (without VectSelect
Quartet™ LV Pulse
Configuration capability):
Unipolar; Bipolar; Uncoded;
Plugged
LV (with VectSelect Quartet™
LV Pulse Configuration capability): Quadripolar;
Uncoded; Plugged
Atrial: Bipolar
Ventricular: Bipolar
253
10 ms is not available when the Ventricular Pacing chamber is set to LV ->- RV.
254 The Polarity Switch setting is not available for the left ventricular lead in CRT-Ps.
Nominal
Non-programmable
Monitor
Nominal
Atrial: Non-programmable
RV: Non-programmable
LV: (without VectSelect
Quartet™ LV Pulse
Configuration capability):
Uncoded
LV (with VectSelect Quartet™
LV Pulse Configuration capability): Quadripolar
Atrial:Bipolar
RV: Non-programmable
LV (without VectSelect
Quartet™ LV Pulse
Configuration capability):
Uncoded
LV (with VectSelect Quartet™
LV Pulse Configuration capability): Quadripolar
Atrial: Non-programmable
Ventricular:
Non-programmable
209
Parameter
Low Frequency Attenuation
Parameter
Parameter
Parameter
Max Sensitivity (page 77) with
Low Frequency Attenuation
Parameter
Max Sensitivity (page 77), ICDs
and CRT-Ds with Low
Frequency Attenuation (page
Parameter
Max Sensitivity (page 77), for
Pacemakers and CRT-PS
Dual-Chamber ICDs with
Plugged Port Lead Type
Capability
Single-Chamber ICDs (page
VectSelect Quartet™ LV Pulse
Configuration capability (page
VectSelect Quartet™ LV Pulse
Configuration capability
Dual-Chamber Pacemakers
Single Chamber Pacemakers
Atrial: Bipolar; Plugged
Ventricular: Bipolar
Ventricular: Bipolar
Atrial: Unipolar, Bipolar,
Uncoded, Plugged
RV: Unipolar, Bipolar, Uncoded
LV: Quadripolar; Uncoded,
Plugged
Atrial: Unipolar, Bipolar,
Uncoded, Plugged
RV: Unipolar, Bipolar, Uncoded
LV: Unipolar, Bipolar,
Uncoded, Plugged
Atrial: Unipolar, Bipolar,
Uncoded, Plugged
Ventricular: Unipolar, Bipolar,
Uncoded
Unipolar, Bipolar, Uncoded
Atrial: Bipolar
Ventricular: Nonprogrammable
Ventricular:
Non-programmable
Atrial: Uncoded
RV: Uncoded
LV: Quadripolar
Atrial: Uncoded
RV: Uncoded
LV: Uncoded
Atrial: Uncoded
Ventricular: Uncoded
Uncoded
Settings
On; Off
Nominal
On
Availability
Devices with Low Frequency
Attenuation Capability (page
Availability
All devices
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Availability
Settings
100; 150; … 500
Settings
Normal; Ignore
Off; Battery Test
¬
Nominal
200
¬
Nominal
Normal
Battery Test
Single-Chamber ICDs (page
Availability
Single-Chamber ICDs (page
Availability
Chamber Pacemakers
Single-Chamber
Pacemakers
Settings
Atrium: 0.2; 0.3; … 1.0 mV
RV Pacemaker: Same as Defib;
0.3; … 2.0 mV
RV Defib: 0.3; … 1.0 mV
Ventricular Pacemaker: Same as Defib; 0.3; … 2.0 mV
Ventricular Defib: 0.3; …
1.0 mV
Nominal
Atrium: 0.2 mV
RV Pacemaker: Same as Defib
RV Defib: 0.5 mV
Ventricular Pacemaker: Same as Defib
Ventricular Defib: 0.5 mV
Settings
Atrium: 0.2; 0.3; … 1.0 mV
RV Pacemaker: Same as Defib;
0.2; 0.3; … 2.0 mV
RV Defib: 0.2; 0.3; … 1.0 mV
Ventricular Pacemaker: Same as Defib; 0.2; 0.3; … 2.0 mV
Ventricular Defib: 0.2; 0.3; …
1.0 mV
Nominal
Atrium: 0.2 mV
RV Pacemaker: Same as Defib
RV Defib: 0.3 mV
Ventricular Pacemaker: Same as Defib
Ventricular Defib: 0.3 mV
Settings
Atrial: 0.2; 0.3; … 1.0 mV
Ventricular Pacemaker: 0.2;
0.3; … 2.0 mV
Ventricular Pacemaker: 0.2;
0.3; … 2.0 mV
Nominal
Atrial: 0.2 mV
Ventricular Pacemaker: 0.5 mV
Ventricular Pacemaker: 0.5 mV
255
Not available in Endurity™ Core devices.
256 Not available in Endurity™ Core devices.
210
Parameter
Availability
Single-Chamber ICDs (page
Chamber (page
Chamber (page
, Single-
Settings
80; 85; … 150
180 min§ min§
80; 85; … 150; 160; 170;
Nominal
110
130 min§ min§
Parameter
Availability
Single-Chamber ICDs (page
Settings
10; 15; … 100 ms
Nominal
50 ms
Parameter
Availability
Assurity, Endurity Dual-
Chamber Pacemakers (page
163) (except for Endurity Core
devices)
Chamber Pacemakers (page
devices)
Settings
90; 95; … 130; 140; 150 min§ 110 min§
90; 95; … 130; 140;
…210 min§
90; 95; … 130; 140;
…180 min§
Nominal
130
130 min§ min§
Parameter
Availability
Devices with Ventricular
Triggering Capability (page
Settings
90; 100; … 150 min§
Nominal
130 min§
Parameter
Maximum AF Suppression
Availability
Chamber Pacemakers (page
Single-Chamber Pacemakers when Chamber is set to
Atrium
Settings
80; 85; … 150 min§
80; 85; … 150; 160;
…180 min§
Parameter
Minimum Burst Cycle Length
Availability
Single-Chamber ICDs (page
Parameter
Availability
All devices
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Morphology in AF/A Flutter
(V<A Rate Branch: Morphology)
Availability
Parameter
Morphology in Sinus Tach (V=A
Rate Branch: Morphology)
Availability
257
Not available in Endurity™ Core DC devices.
258 Not available in Endurity™ Core SC devices.
Settings
150; 155; … 400 ms
Settings
Nominal
110
120 min§ min§
Nominal
200 ms
Nominal
See parameter description or Mode Descriptions (page 151) for
details.
Settings
On; Passive; Off
Settings
On; Passive; Off
Settings
On; Passive; Off
Nominal
On
Nominal
On
Nominal
On
211
Parameter
Morphology No. of Matches
Availability
Single-Chamber ICDs (page
Settings
3; 4; … 20 complexes
Parameter
Morphology Template Pacing
Availability
Devices with Far Field MD
Morphology Discrimination
Parameter Availability
Morphology Scoring (page 103) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Parameter
Availability
Devices with Far Field MD
Morphology Discrimination
Parameter
Morphology Window Size (page
Availability
Single-Chamber ICDs (page
Settings
On; Off
Settings
On; Off
Settings
Far Field; Original MD
Settings
6; 8; … 20 complexes
Parameter
Availability
Devices with MR Conditional
Programming Capability (page
Parameter
Availability
Single-chamber Accent MRI,
Accent ST MRI devices
All other single-chamber pacemakers with MR
Conditional Programming
Capability
Dual-chamber pacemakers with MR Conditional
Programming Capability
Single-chamber ICDs with MR
Conditional Programming
Capability
Dual-chamber ICDs with MR
Conditional Programming
Capability
Parameter Availability
MRI Paced AV Delay (page 71) Dual-chamber devices with MR
Conditional Programming
Parameter Availability
MRI Pulse Amplitude (page 75) Devices with MR Conditional
Programming Capability (page
Settings
30; 35; … 120 min§
Settings
VOO; Pacing Off
AOO, VOO, Pacing Off
VOO, DOO, Pacing Off
VOO, Pacing Off
VOO, DOO, Pacing Off
Settings
25; 30; 40; … 120 ms
Settings
5.0; 7.5 V
Nominal
Devices with Far Field MD
Morphology Discrimination
complexes
Devices with DecisionTx
Programming Capability (page
Other devices: 5 complexes
Nominal
CRT-Ds: On
Dual-Chamber ICDs, Single-
Chamber ICDs: Off
Nominal
Off
Nominal
Far Field
DOO
VOO
DOO
Nominal
Devices with Far Field MD
Morphology Discrimination
complexes;
Devices with DecisionTx
Programming Capability (page
Other devices: 8 complexes
Nominal
85 min§
Nominal
VOO
VOO
Nominal
120 ms
Nominal
5.0 V
212
Parameter
MRI Pulse Configuration (page
Availability
Devices with MR Conditional
Programming Capability (page
Settings
Bipolar
Nominal
Non-programmable
Parameter
Availability
Devices with MR Conditional
Programming Capability (page
Settings
1.0 ms
Nominal
Non-programmable
Parameter
MultiPoint Pacing LV1 Pulse
Availability
Devices with MultiPoint Pacing
Parameter Availability
Single-Chamber ICDs (page
Settings
Distal tip 1-Mid 2; Distal tip 1-
Proximal 4; Distal tip 1-RV
Coil; Mid 2-Proximal 4; Mid 2-
RV Coil; Mid 3-Mid 2; Mid 3-
Proximal 4; Mid 3-RV Coil;
Proximal 4-Mid 2; Proximal 4-
RV Coil
Parameter
MultiPoint Pacing LV2 Pulse
Availability
Devices with MultiPoint Pacing
Settings
Distal tip 1-Mid 2; Distal tip 1-
Proximal 4; Distal tip 1-RV
Coil; Mid 2-Proximal 4; Mid 2-
RV Coil; Mid 3-Mid 2; Mid 3-
Proximal 4; Mid 3-RV Coil;
Proximal 4-Mid 2; Proximal 4-
RV Coil
Parameter
MultiPoint Pacing Post-
Ventricular Atrial Blanking
Availability
Devices with MultiPoint Pacing
Parameter
Negative AV Hysteresis/Search
Availability
Chamber Pacemakers (page
Parameter Availability
Devices with ST Monitoring
Settings
125; 130; … 260 ms
Settings
Off; -10; -20; … -120 ms
Settings
Resting: 6; 8; … 100%
Elevated 1: 2; 4; … 100%
Elevated 2: 2; 4; … 100%
Elevated 3: 2; 4; … 100%
Parameter
Availability
Single-Chamber ICDs (page
Settings
Nominal
Mid 3-RV Coil
Nominal
150 ms
Nominal
Off
Nominal
100%
Nominal
8; 9; … 25; 30; … 100 intervals Devices with DecisionTx
Programming Capability (page
Field MD Morphology
Discrimination Capability (page
VT rate zone in 2 Zone
Configuration: 16 intervals
VT-1 rate zone in 3 Zone
Configuration: 18 intervals
VT-2 rate zone: 16 intervals
VF rate zone: 12 intervals
Other devices: 12 intervals
Settings
1; 2; … 15 bursts
Nominal
Distal tip 1-Mid 2
Nominal
3 bursts
213
Parameter
(Consecutive High Atrial Rate
Cycles)
Availability
Chamber Pacemakers (page
Single-Chamber Pacemakers
set to Atrium
Parameter
(Consecutive High Ventricular
Rate Cycles)
Availability
Chamber Pacemakers (page
Parameter
Number of Notifications (page
Availability
Devices with Patient Notifier
Parameter Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Overdrive Pacing Cycles (page
Availability
Chamber Pacemakers (page
Single-Chamber Pacemakers when Chamber is set to Atrium
Parameter
Availability
Chamber Pacemakers (page
Parameter
Availability
Devices with BiVCap Confirm
Parameter
Percent Pacing Alert Duration
Availability
Devices with Percent Pacing
Settings
2; 3; … 5; 10; … 20 cycles
Settings
2; 3; … 5; 10; … 20 cycles
Settings
1; 2; … 16 notifications
Settings
2; 3; … 20 stimuli
Settings
Adaptive: 4; 6; … 86%
Fixed: 30; 35; … 500 ms
Settings
15; 20; … 40 cycles
Settings
25; 30; 40; … 200; 225; …
300; 350 ms
Settings
0.25; 0.50; … 2.5 V
Settings
1; 7; 30; 90 days
Parameter
Percentage BiV Pacing Limit
(Percent Pacing Less Than)
Parameter
Percentage RV/V Pacing Limit
(Percent Pacing Greater Than)
Availability
Allure Quadra, Quadra Allure
MP devices
Availability
Single-Chamber ICDs (page
Assurity, Endurity, Quadra
Allure MP devices
Settings
60; 65; … 80; 81; … 100%
Settings
0; 5; … 95%
Parameter Availability
PMT Detection Rate (page 85) CRT-Ds (page 161), Dual-
Settings
90; 95; … 150
259 CRT-Ps with this feature must have the Ventricular Pacing parameter programmed to RV Only. min§
Nominal
5 cycles
Nominal
5 cycles
Nominal
4 notifications
Nominal
8 stimuli
Nominal
Adaptive: 18%
Fixed: 100 ms
Nominal
15 cycles
Nominal
200 ms
Nominal n/a
Nominal
7 days
Nominal
90%
Nominal
40%
Nominal
110 min§
214
Parameter
Chamber Pacemakers (page
Availability
Chamber Pacemakers (page
Availability
Devices with ST Monitoring
90; 95; … 180
Settings min§
Off; Passive; Atrial Pace
Off; Passive; Atrial Pace; Extend
PVARP
130 min§
Nominal
Atrial Pace
Atrial Pace
Parameter
Parameter
Post Detection Interval/Rate
Availability
Single-Chamber ICDs (page
Parameter
Post-Shock Base Rate (page
Availability
Single-Chamber ICDs (page
Parameter
Post-Shock Duration (page
Availability
Single-Chamber ICDs (page
Parameter Availability
Single-Chamber ICDs (page
Parameter Availability
Single-Chamber ICDs (page
Parameter
Post-Ventricular Atrial Blanking
Availability
Dual-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Availability
Dual-Chamber ICDs (page
Single-Chamber ICDs (page
Parameter
Pulse Amplitude, Fibber Test
Availability
Single-Chamber ICDs (page
Settings
Resting: 6; 8; … 100%
Elevated 1: 2; 4; … 100%
Elevated 2: 2; 4; … 100%
Elevated 3: 2; 4; … 100%
Settings
Nominal
100%
Nominal
See parameter description for details.
Settings
30; 35; … 100 min§
Settings
0.5; 1; 2.5; 5; 7.5; 10 min
Settings
0.25; 0.50; … 4.0; 4.5; …
7.5 V
0.25; 0.50; … 4.0; 4.5; …
7.5 V
0.25; 0.50; … 4.0; 4.5; …
7.5 V
Nominal
60 min§
Nominal
0.5 min
Settings Nominal
See parameter description for details.
Settings
1; 2; … 7 s
Settings
60; 70; … 250 ms
60; 70; … 250 ms
60; 70; … 250 ms
Settings
Burst or Shock-on-T Fibber
Mode: 5.0; 7.5 V
Nominal
2 s
Nominal
70 ms
60 ms
150 ms
Nominal
A: 2.5 V
RV: 2.5 V
LV: 2.5 V
A: 2.5 V
Ventricular: 2.5 V
Ventricular: 2.5 V
Nominal
Burst or Shock-on-T Fibber
Mode: 7.5 V
215
Parameter
Pulse Amplitude, NIPS Test
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Pulse Amplitude, Post-Shock
Availability
Single-Chamber ICDs (page
Parameter Availability
VectSelect Quartet™ LV Pulse
Configuration capability (page
Settings
0.25; 0.50; … 3.75; 4.0; 4.5;
… 7.5 V
0.25; 0.50; … 3.75; 4.0; 4.5;
… 7.5 V
Settings
0.25; 0.50; … 7.5 V
Nominal
7.5 V
Programmed Pulse Amplitude
Nominal
7.5 V
CRT-Ds without VectSelect
Quartet™ LV Pulse
Configuration capability
Settings
Atrium: Bipolar
RV: Bipolar
LV/LV1/LV2: Distal tip 1-Mid 2;
Distal tip 1-Proximal 4; Distal tip 1-RV Coil; Mid 2-Proximal
4; Mid 2-RV Coil; Mid 3-Mid 2;
Mid 3-Proximal 4; Mid 3-RV
Coil; Proximal 4-Mid 2;
Proximal 4-RV Coil
Atrium: Bipolar
RV: Bipolar
LV: Bipolar; LV tip-RV coil;
LV ring-RV coil
Atrium: Bipolar
Ventricular: Bipolar
Ventricular: Bipolar
Nominal
Atrium: Non-programmable
RV: Non-programmable
LV/LV1: Distal tip 1-Mid 2
LV2: Mid 3-RV Coil
Atrium: Non-programmable
RV: Non-programmable
LV: LV tip-RV coil (with Unipolar or Uncoded Lead Type) or
Bipolar (with Bipolar Lead Type)
Atrium: Non-programmable
Ventricular: Non-programmable
Ventricular: Non-programmable
Dual-Chamber ICDs (page
Single-Chamber ICDs (page
VectSelect Quartet™ LV Pulse
Configuration capability
VectSelect Quartet™ LV Pulse
Configuration capability
Dual-Chamber Pacemakers
Single-Chamber Pacemakers
Atrium: Bipolar; Unipolar
RV: Bipolar; Unipolar
LV/LV1/LV2: Distal tip 1-Mid 2;
Distal tip 1-Proximal 4;
Distal tip 1-RV Ring;
Distal tip 1-Can; Mid 2–
Proximal 4; Mid 2-RV Ring;
Mid 2-Can; Mid 3-Mid 2;
Mid 3-Proximal 4; Mid 3-
RV Ring; Mid 3-Can;
Proximal 4-Mid 2; Proximal 4-
RV Ring; Proximal 4-Can
Atrium: Bipolar; Unipolar
RV: Bipolar; Unipolar
LV: Bipolar; Unipolar; LV tip-
RV ring; LV ring-RV ring
Atrium: Unipolar
RV: Unipolar
LV/LV1: Distal tip 1-Mid 2;
LV2: Mid 3-RV Ring
Atrium: Unipolar
RV: Unipolar
LV: Unipolar
Atrium: Bipolar; Unipolar
Ventricular: Bipolar; Unipolar
Atrium: Unipolar
Ventricular: Unipolar
Ventricular: Bipolar; Unipolar Ventricular: Unipolar
Parameter
Pulse Configuration, NIPS Test
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Settings
Bipolar
Unipolar (tip–case); Bipolar
(tip–ring)
Nominal
Non-programmable
Same as Pulse Configuration settings
216
Parameter
Pulse Duration, Fibber Test
Availability
Single-Chamber ICDs (page
Parameter
Parameter
Pulse Width, Fibber Test (page
Availability
All devices
Availability
Single-Chamber ICDs (page
Parameter
Pulse Width, NIPS Test (page
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Pulse Width, Post-Shock (page
Availability
Single-Chamber ICDs (page
Parameter
Availability
Chamber Pacemakers (page
Parameter
Availability
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Availability
Parameter
Rate Responsive AV Delay
Availability
Anthem, Anthem RF, Dual-
Chamber Pacemakers (page
Allure, Allure Quadra, Quadra
Allure MP devices
260 Available only in VDD(R) mode.
Settings
0.5; 1.0; … 5.0 s
Settings
0.05; 0.1; 0.2; … 1.5 ms
Settings
1.0; 1.5 ms
Settings
0.05; 0.1; 0.2; … 1.5 ms
0.05; 0.1; 0.2; … 1.5 ms
Settings
0.05; 0.1; 0.2; … 1.5 ms
Settings
125; 150; … 500 ms
Settings
Off; Atrial Pace
Off; Atrial Pace; Extended
PVARP
Settings
On; Off
Settings
5; 10; … 30 ms
Nominal
Off
Off
Settings Nominal
See parameter description for details
Settings
Off; Low; Medium; High
Off; Low; Medium; High
Off; Low; Medium; High
Nominal
2.0 s
Nominal
0.5 ms
Nominal
1.5 ms
Nominal
1.0 ms
Programmed Pulse Width
Nominal
1.5 ms
Nominal
275 ms
Nominal
Off
Nominal
10 ms
Nominal
Medium
Off
Medium
217
Parameter
Rate Responsive AV Delay
Availability
Anthem Family CTR-Ps,
Accent Family, Dual-Chamber
Pacemakers
Allure Family CRT-Ps, Assurity,
Endurity Family Dual-Chamber
Pacemakers
Parameter
Rate Responsive PVARP/V Ref
Availability
Allure, Allure Quadra, Assurity,
Endurity, Quadra Allure MP devices
All other devices
Parameter
Parameter
Availability
All devices
Availability
Single-Chamber ICDs (page
Parameter
Parameter
Availability
All devices
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
S1 Count, Fibber Test (page
Availability
Single-Chamber ICDs (page
Parameter Availability
S1 Count, NIPS Test (page 59) All devices
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Parameter
S2 Shock Energy/Voltage,
Availability
All devices
Availability
Devices with Battery Model
Settings
Off; Low; Medium; High
Off; Low; Medium; High
Off; Low; Medium; High
Settings
Off; Low; Medium; High
Nominal
Medium
Off
Medium
Nominal
High
Low
Settings Nominal
Very Fast; Fast; Medium; Slow Fast
Settings
On; Off
Nominal
Off
Settings Nominal
Fast; Medium; Slow; Very Slow Medium
Settings
Off; 30; 35; … 95 min§
Off; 30; 35; … 150 min§
Settings
Anode(+); Cathode(-)
Settings
2; 3; … 25 stimuli
Settings
2; 3; … 25 stimuli
Settings
Shock-on-T Fibber Mode: 100;
110; … 800 ms
Burst Fibber Mode: 20; 30; …
100 ms
Settings
Off; 100; 110; … 800 ms
Settings
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5;
15.0; … 27.5; 30.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 830 V
Nominal
Off
Off
Nominal
Anode(+)
Nominal
8 stimuli
Nominal
8 stimuli
Nominal
Shock-on-T Fibber Mode:
600 ms
Burst Fibber Mode: 30 ms
Nominal
Off
Nominal
Tilt Waveform Mode: 2.0 J
Pulse Width Waveform Mode:
200 V
261
Not available in Endurity™ Core SC (model 1140) or Endurity Core DC (model 2140) devices.
262 Not available in Endurity™ Core SC (model 1140) or Endurity Core DC (model 2140) devices.
218
Devices with Battery Model
Devices with Battery Model
Devices with Battery Model
Devices with Battery Model
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5;
15.0; … 27.5; 30.0; 32.0; …
36.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 830 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5;
15.0; … 27.5; 30.0; 32.0; …
36.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 830 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5;
15.0; … 27.5; 30.0; 32.0; …
36.0 J
Pulse Width Waveform Mode:
50; 100; … 800; 845 V
Tilt Waveform Mode: 0.1; 0.2;
… 1.0; 2.0; … 10.0; 12.5;
15.0; … 27.5; 30.0 J
Pulse Width Waveform Mode:
50; 100; … 800 V
Parameter
Availability
All devices
Parameter
Parameter
Availability
All devices
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Search Cycles, VIP Extension
Availability
Chamber Pacemakers (page
Parameter
Search Interval, Cap Confirm/V.
Availability
Devices with ACap Confirm
Confirm Capability (page 183),
V AutoCapture Capability (page
Parameter
Search Interval, Hysteresis Rate
Availability
All devices
Parameter
Search Interval, VIP Extension
Availability
Chamber Pacemakers (page
Parameter Availability
Settings
Off; 100; 110; … 800 ms
Settings
Off; 100; 110; … 800 ms
Settings
5; 10; … 30 ms
Settings
On (Dec); Off
Settings
1; 2; 3 cycles
Settings
8; 24 hrs
Settings
Off; 1; 5; 10; 15; 30 min
Settings
30 s; 1; 3; 5; 10; 30 min
Settings
Atrial: Bipolar
Ventricular: RV Bipolar
Tilt Waveform Mode: 2.0 J
Pulse Width Waveform Mode:
200 V
Tilt Waveform Mode: 2.0 J
Pulse Width Waveform Mode:
200 V
Tilt Waveform Mode: 2.0 J
Pulse Width Waveform Mode:
200 V
Tilt Waveform Mode: 2.0 J
Pulse Width Waveform Mode:
200 V
Nominal
Off
Nominal
Off
Nominal
10 ms
Nominal
On (Dec)
Nominal
1 cycle
Nominal
8 hrs
Nominal
Off
Nominal
1 min
Nominal
Non-programmable
219
Dual-Chamber ICDs (page
Bipolar Non-programmable
VectSelect Quartet™ LV Pulse
Configuration capability (page
Dual-Chamber Pacemakers
Single-Chamber Pacemakers
Atrium: Bipolar; Unipolar Tip;
Unipolar Ring
Ventricular: RV Bipolar;
RV Unipolar Tip; RV Unipolar
Ring; LV Bipolar; LV Unipolar
Tip; LV Tip to RV Tip;
BV Bipolar; BV Unipolar Tip
LV: RV Bipolar; RV Unipolar Tip;
RV Unipolar Ring; LV Distal tip
1-Mid2; LV Distal tip 1-Can; LV
Distal tip1-RV Tip; BV Bipolar;
BV Unipolar Tip
Atrium: Bipolar; Unipolar Tip;
Unipolar Ring
Ventricular: Bipolar;
Unipolar Tip; Unipolar Ring
Ventricular: Bipolar;
Unipolar Tip; Unipolar Ring
Atrium: RV Unipolar Tip
Ventricular: RV Unipolar Tip
Atrium: Bipolar
Ventricular: Bipolar
Atrium: Unipolar Tip
Ventricular: Unipolar Tip
Ventricular: Unipolar Tip
Parameter
SecureSense™
Availability
Devices with SecureSense™
RV Lead Noise Discrimination
Parameter
SecureSense™ Timeout Until
Availability
Devices with SecureSense™
RV Lead Noise Discrimination
Parameter
Availability
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Availability
All devices
Parameter Availability
Shock Configuration (page 112) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Settings
Passive; On; Off
Settings
Off; 15; 30; ... 60; 90 s
Settings
25; 30; 40; … 200; 225; …
325 ms
Settings
Atrial: Auto
1.0 mV
Ventricular: Auto
Atrial: Auto
5.0 mV
Settings
On; Passive; Off
Settings
RV to SVC
Ventricular: Auto
; 0.2; …
0.5; 0.75; 1.0; ...2.0; 2.5; ...4.0;
; 1.0;
1.5; … 5.0; 6.0; … 10; 12.5 mV
RV to SVC & Can; RV to Can;
Nominal
On
Nominal
Off
Nominal
150 ms
Nominal
Atrial: Auto
Ventricular:
Non-programmable
Atrial: 0.5 mV
Ventricular: 2.0 mV
Nominal
Passive
Nominal
RV to SVC & Can
263 If the RV Lead Type is set to Unipolar, the nominal is RV Unipolar Tip.
264
If the A Lead Type is set to Unipolar, the nominal is Unipolar Tip.
265 If the RV Lead Type is set to Unipolar, the nominal is RV Unipolar Tip.
266
"Auto" is not a selectable setting but is displayed in the Sensitivity button when the AutoSense parameter is set to On.
267 "Auto" is not a selectable setting but is displayed in the Sensitivity button when the AutoSense parameter is set to On.
268
Atrial Sensitivity settings of 0.1 mV can be susceptible to crosstalk.
269 "Auto" is not a selectable setting but is displayed in the Sensitivity button when the AutoSense parameter is set to On.
270
Ventricular Sensitivity settings of 0.5 mV can be susceptible to crosstalk.
271 If the ventricular Lead Type is set to Unipolar, the nominal is 1.0 mV.
272
Not available in Endurity™ Core SC (model 1140) or Endurity Core DC (model 2140) devices.
273 The RV to SVC setting is only available in devices with DynamicTx Over-Current Detection algorithm capability.
220
Parameter
Availability
Chamber Pacemakers (page
Parameter
Shortest PVARP/V Ref (page
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Sinus Node Recovery Delay
Availability
Chamber Pacemakers (page
Parameter Availability
Single-Chamber ICDs (page
Parameter
Availability
All devices
Settings Nominal
25; 30; … 50; 60; … 120 ms 100 ms
Settings
125; 150; … 475 ms
125; 150; … 475 ms
Settings
1; 2; … 8 intervals
Settings
1; 2; … 5 s
Settings
Fast (3 intervals); Nominal
(5 intervals); Slow (7 intervals)
Nominal
225 ms
175 ms
Nominal
2 intervals
Nominal
1 s
Nominal
Nominal (5 intervals)
Parameter
Parameter
ST Heart Rate Zones (Resting
Availability
Single-Chamber ICDs (page
Availability
Devices with ST Monitoring
Settings
1; 2; … 16; Auto (-1); Auto
(+0); Auto (+1); Auto (+2); Auto
(+3)
Nominal
8
Settings
30; 35; … 500 ms
Nominal
Devices with DecisionTx
Programming Capability (page
Field MD Morphology
Discrimination Capability (page
Other devices: 80 ms
Settings
Resting: 40
; 42; …128 min§
Elevated 1: 64; 66; …132 min§
Elevated 2: 68; 70; …136 min§
Elevated 3: 72; 74; …140 min§
(or lowest VT Detection Rate)
Nominal
Resting: 86 min§
Elevated 1: 104 min§
Elevated 2: 122 min§
Elevated 3: 140 min§
Parameter Availability
ST Interval Duration (page 36)
Devices with ST Monitoring
Settings
24; 30; …246 ms
Parameter
Availability
Devices with ST Monitoring
Settings
24; 30; … 246 ms
Nominal
Resting: 54 ms
Elevated 1: 48 ms
Elevated 2: 42 ms
Elevated 3: 42 ms
Nominal
Resting: 72 ms
Elevated 1: 66 ms
Elevated 2: 60 ms
Elevated 3: 54 ms
274
Not available in Endurity™ Core SC (model 1140) or Endurity Core DC (model 2140) devices.
275 Or the lowest programmed pacing rate.
221
Parameter
ST Monitoring Diagnostic (page
Parameter
Parameter
VT/VT-1/VT-2 Rate Zones
Availability
Single-Chamber ICDs (page
Parameter
SVT Discrimination in Sinus
Parameter
SVT Discrimination Mode (page
Availability
Availability
Single-Chamber ICDs (page
Parameter
SVT Discrimination Timeout
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Tachy Therapy Enable/Disable
Availability
Devices with ST Monitoring
Availability
Single-Chamber ICDs (page
Availability
Single-Chamber ICDs (page
Settings
On; Off
Settings
Off; Passive; On
Settings
On; Off
Settings
On; Off
Settings
Nominal
On
Nominal
Dual Chamber; Ventricular Only Dual Chamber
Ventricular Only
Settings
Off; 20; 30; 40; 50 s; 1; 2; …
10; 15; … 60 min
Settings
Off; 250; 255; … 585 ms; Same as VT-2; Same as VF
Settings
Disabled; Enabled
Nominal
Devices with Far Field MD
Morphology Discrimination
Dual Chamber SVT
Discrimination Mode: Off
Ventricular Only SVT
Discrimination Mode: Passive
Devices with DecisionTx
Programming Capability (page
Dual Chamber SVT
Discrimination Mode: On
Ventricular Only SVT
Discrimination Mode: On
Other devices:
Dual Chamber SVT
Discrimination Mode: On
Ventricular Only SVT
Discrimination Mode: Passive
Nominal
Devices with DecisionTx
Programming Capability (page
Field MD Morphology
Discrimination Capability (page
VT-2 rate zone: On
Other Devices:
VT or VT-1 rate zone: On
VT-2 rate zone: Off
Nominal
On
Non-programmable
Nominal
Off
Nominal
Devices with DecisionTx
Programming Capability (page
Discrimination Capability (page
Other devices:
2 Zones Zone Configuration
3 Zones Zone Configuration
Nominal n/a
222
Parameter
Template Auto Update (page
Availability
Single-Chamber ICDs (page
Settings
Devices with Far Field MD
Morphology Discrimination
Capability (page 188): Off; 3; 9;
12 hours; 1; 3; 7; 14; 30 days
Other devices: Off; 8 hours; 1;
3; 7; 14; 30 days
Nominal
Devices with Far Field MD
Morphology Discrimination
Capability: 3 hours
Other CRT-Ds: Off
Other Dual-Chamber ICDs,
Single-Chamber ICDs: 1 day
Parameter
Template Match Criteria (page
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter
Therapy After Timeout (page
Availability
Single-Chamber ICDs (page
Parameter
Availability
All devices
Parameter
for CRT-Ds and ICDs with Low
Frequency Attenuation
Parameter
for CRT-Ds and ICDs without
Low Frequency Attenuation capability
Availability
Dual-Chamber ICDs (page
Single-Chamber ICDs (page
Settings Nominal
See Morphology No. of Matches (page 96) and Morphology
Settings
See parameter description for details
Settings
VT Therapy; VF Therapy
Nominal
Nominal
VT Therapy
Settings
1.0; 1.5; … 7.0; Auto (-0.5);
Auto (+0.0); Auto (+0.5); Auto
(+1.0); Auto (+1.5); Auto (+2.0)
Nominal
Auto (+0.0)
Settings
Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
RV Post-Sensed: 50; 62.5; 75;
100%
RV Post-Paced: Auto; 0.2; 0.3;
… 3.0 mV
Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Nominal
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
RV Post-Sensed: 50%
RV Post-Paced: 1.0 mV
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
Ventricular Post-Sensed: 50%
Ventricular Post-Paced: 1.0 mV
Ventricular Post-Sensed: 50%
Ventricular Post-Paced: 1.0 mV
Availability
Settings
Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
RV Post-Sensed: 50; 62.5; 75;
100%
RV Post-Paced: Auto; 0.2; 0.3;
… 3.0 mV
Dual-Chamber ICDs (page 162) Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Nominal
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
RV Post-Sensed: 62.5%
RV Post-Paced: Auto
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
Ventricular Post-Sensed:
62.5%
Ventricular Post-Paced: Auto
276 Not available in Endurity™ Core SC (model 1140) or Endurity Core DC (model 2140) devices.
223
Single-Chamber ICDs (page
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Ventricular Post-Sensed:
62.5%
Ventricular Post-Paced: Auto
Parameter
for CRT-Ps and Pacemakers
Availability
Dual-Chamber Pacemakers
Single-Chamber Pacemakers
Settings
Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
RV Post-Sensed: 50; 62.5; 75;
100%
RV Post-Paced: Auto; 0.2; 0.3;
… 3.0 mV
Atrium Post-Sensed: 50; 62.5;
75; 100%
Atrium Post-Paced: 0.2; 0.3; …
3.0 mV
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Ventricular Post-Sensed: 50;
62.5; 75; 100%
Ventricular Post-Paced: Auto;
0.2; 0.3; … 3.0 mV
Nominal
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
RV Post-Sensed: 75%
RV Post-Paced: Auto
Atrium Post-Sensed: 50%
Atrium Post-Paced: 0.8 mV
Ventricular Post-Sensed: 75%
Ventricular Post-Paced: Auto
Ventricular Post-Sensed: 75%
Ventricular Post-Paced: Auto
Parameter
Time Between Notifications
Parameter
Availability
Devices with Patient Notifier
Settings
10; 22 hrs
Nominal
10 hrs
Availability
Single-Chamber ICDs (page
Settings
3; 4; … 20 s
Nominal
10 s
Parameter
Availability
Single-Chamber ICDs (page
Settings
2 Zones Zone Configuration: VT
Therapy
3 Zones Zone Configuration:
VT-2 Therapy; VT-1 & VT-2
Therapy
Nominal
2 Zones Zone Configuration:
Non-programmable
3 Zones Zone Configuration:
VT-1 & VT-2 Therapy
Parameter Availability
Total Time in AT/AF (page 131) Devices with AT/AF Alert
Triggers Capability (page 178)
Parameter
Total Time in High V. Rate
Availability
Devices with AT/AF Alert
Triggers Capability (page 178)
Parameter Availability
Trigger Alert for NSO (page 91) Devices with SecureSense™
RV Lead Noise Discrimination
Parameter
Availability
All devices
Settings
0.5; 1; 3; 6; 9; 12; 24; 36;
48 hrs
Settings
1; 3; 6; 9; 12 hrs
Settings
1 - 5 episodes
Settings
400; 500; 600; 750; 1000; …
2500; 3000
¬
Parameter
Availability
Devices with V AutoCapture
Settings
Setup; On; Off
Parameter
V. AutoCapture Paced/Sensed
Availability
Devices with V AutoCapture
Settings
50/25; 100/70; 120/100 ms
Nominal
6 hrs
Nominal
6 hrs
Nominal
5 episodes
Nominal
2000
¬
Nominal
Off
Nominal
50/25 ms
277 Not available in Endurity™ Core devices.
224
Parameter
V. Noise Reversion Mode (page
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Single-Chamber Pacemakers
Parameter
V. Support Rate, Atrial Fibber
Availability
Parameter
V. Support Rate, Atrial NIPS
Availability
Chamber Pacemakers (page
Parameter
Parameter
Ventricular Pace Refractory
Availability
Devices with Ventricular
Triggering Capability (page
Parameter Availability
Ventricular Blanking (page 83) CRT-Ds (page 161), Dual-
Chamber Pacemakers (page
Parameter
Ventricular Intrinsic Preference
Availability
Chamber Pacemakers (page
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Settings
Pacing Off; VOO; DOO
Pacing Off; VOO
Pacing Off; VOO, DOO
Pacing Off; VOO
Settings
Off; 30; 35 … 95
Settings
Off; 30; 35 … 95
Settings
On; Off
Settings
44; 52 ms min§ min§
Auto; 12; 16; ... 52 ms
Settings
Off; On
Settings
125; 160; 190; … 400; 440;
470 ms
125; 160; 190; … 400; 440;
470; 500 ms
Parameter
Ventricular Pacing
Availability
MultiPoint Pacing Capability),
MultiPoint Pacing Capability
Settings
LV+RV (Simultaneous); LV —>
RV; RV —> LV; RV Only; LV
Only
LV+RV (Simultaneous); LV —>
RV; RV —> LV; RV Only; RV—
>LV1—>LV2; LV1—>LV2—
>RV
Parameter
Ventricular Rate Threshold
Availability
Chamber Pacemakers (page
Settings
125; 150 … 300
Parameter
Ventricular Safety Standby
Availability
278 If the Atrial Lead Type is set to Plugged, then the nominal value is VOO.
279
If the LV Lead Type parameter is set to "Plugged", then the nominal setting is "RV Only".
280 If the LV Lead Type parameter is set to "Plugged", then the nominal setting is "RV Only".
Settings
On; Off min§
Nominal
Pacing Off
Pacing Off
DOO
VOO
Off
Off
52 ms
Nominal
Nominal
CRT-Ds, Dual-Chamber ICDs:
Off
CRT-Ps, Dual-Chamber
Pacemakers: 50
Nominal
Nominal min§
Accent, Accent RF, Anthem,
Anthem RF devices: Auto
All other devices: 44 ms
Nominal
Off
Nominal
250 ms
250 ms
Nominal
LV+RV (Simultaneous)
LV+RV (Simultaneous)
Nominal
150
Nominal
On min§
225
Chamber Pacemakers (page
Parameter
Ventricular Sense Refractory
Availability
Single-Chamber ICDs (page
Chamber Pacemakers (page
Parameter Availability
Single-Chamber ICDs (page
Parameter Availability
Single-Chamber ICDs (page
Parameter
Availability
Chamber Pacemakers (page
Parameter
Availability
Single-Chamber ICDs (page
Parameter Availability
Single-Chamber ICDs (page
Parameter Availability
VT Therapy Timeout (page 104) CRT-Ds (page 161), Dual-
Single-Chamber ICDs (page
Parameter
VT/VF EGM Max Duration (page
Availability
Single-Chamber ICDs (page
Parameter
VT/VF Pre-Trigger Max Duration
Availability
Single-Chamber ICDs (page
Parameter
Availability
Single-Chamber ICDs (page
Settings
125; 157 ms
125; 157; 160; 190; 220; ...
400; 440; 470; 500 ms
Settings
Settings
Biphasic; Monophasic
Nominal
125 ms
250 ms
Nominal
See parameter description for details.
Settings
2; 4; … 16 s
Settings
6; 7; … 20 intervals
Settings
Off; 10 s; 20 s; … 120 s;
2.5 min; 3.0 min; … 5.0 min
Settings
30 s; 1; 2; 3; 4; 5 min
Nominal
6 s
Settings Nominal
50; 75; … 150; 160; … 200 ms 100 ms
Nominal
6 intervals
Settings Nominal
See parameter description for details.
Nominal
Off
Nominal
1 min
Settings Nominal
2; 10; 14; 20; 30; 40; 50; 60 s 14 s
Nominal
Biphasic
226
Parameter
Availability
Single-Chamber ICDs (page
Parameter Availability
Single-Chamber ICDs (page
Settings
Tilt; Pulse Width
Settings
Nominal
Tilt
Nominal
Off
227
Accent™, Accent MRI™, Accent™ RF, Accent™ ST, and
Accent™ ST MRI Devices Technical Data
The tables below are applicable to the following Accent™, Accent MRI™, Accent™ RF, Accent™ ST, and Accent™ ST MRI device models:
Accent SR PM1110
Accent ST PM1122
Accent MRI PM1124
Accent ST MRI PM1126
Accent SR RF PM1210
Accent ST PM1222
Accent MRI PM1224
Accent ST MRI PM1226
Accent DR PM2112
Accent ST PM2122
Accent MRI PM2124
Accent ST MRI PM2126
Accent DR RF PM2210
Accent DR RF PM2212
Accent ST PM2222
Accent MRI PM2224
Accent ST MRI PM2226
The technical data below include:
Shipped and Standard Settings (page 229)
Operating Parameters Tolerances (page 233)
Physical Specifications (page 235)
X-ray Identification (page 235)
Spare Parts And Accessories (page 236)
Shipped and Standard Settings
Table 98. Shipped and Standard settings for Accent family single-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Shipped Settings
VVI
Battery Test
VOO
Passive
130
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60
Off
Off
Off min§
1 cycle
Off min§
3 min
Medium
Nominal (Standard) Settings
60 min§
Off
Off
Off
1 cycle
Off
3 min
Medium
VVI
Battery Test
VOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
281 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
229
Table 98. Shipped and Standard settings for Accent family single-chamber pacemakers
Parameter
Capture & Sense
V. AutoCapture Pacing
Pulse Amplitude
Pulse Width
Sensitivity
AutoSense
Max Sensitivity
Post-Paced Decay Delay
Post-Sensed Decay Delay
Post-Paced Threshold Start
Post-Sensed Threshold Start
Backup Pulse Configuration
Search Interval
Leads
Lead Type
Pulse Configuration
Sense Configuration
Lead Monitoring
Upper Limit
Lower Limit
Refractories & Blanking
Sense Refractory
Pace Refractory
Rate Responsive VREF
Shortest VREF
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
Off
2.5 V
0.4 ms
2.0 mV
Off
0.5 mV
Auto
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
See Package label
Bipolar
Monitor
2000
200
¬
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
Off
2.5 V
0.4 ms
2.0 mV
Off
0.5 mV
Auto
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
Unipolar
Unipolar Tip
Monitor
2000
¬
200
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Table 99. Shipped and Standard settings for Accent family dual-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Shipped Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Nominal (Standard) Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
282 If the right ventricular Lead Type is set to Unipolar, the nominal is Unipolar.
283
If the Lead Type is set to Bipolar, the nominal is Bipolar.
284 If the Lead Type is set to Bipolar, the nominal is Bipolar.
285
Available only in devices with MR Conditional Programming Capability.
286 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
230
Table 99. Shipped and Standard settings for Accent family dual-chamber pacemakers
Parameter
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
VIP Extension
VIP Search Interval
VIP Search Cycles
Negative AV/PV Hysteresis w/Search
Capture & Sense
ACap Confirm
V. AutoCapture Pacing
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
A. Max Sensitivity
A. Post-Paced Decay Delay
A. Post-Sensed Decay Delay
A. Post-Paced Threshold Start
A. Post-Sensed Threshold Start Percentage
A. Post-Sensed Minimum Start Threshold
A. AutoSense
V. Sensitivity
V. Max Sensitivity
V. Post-Sense Decay Delay
V. Post-Paced Decay Delay
V. Post-Sense Threshold Start Percentage
V. Post-Paced Threshold Start
V. AutoSense
Shipped Settings
Fast
Medium
Off
60
Off
Off
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off min§
130 min§
Off
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
287 If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
Nominal (Standard) Settings
Fast
Medium
Off
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
Off
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
60 min§
Off
130 min§
Off
Off
1 cycle
Off
3 min
Medium
231
Table 99. Shipped and Standard settings for Accent family dual-chamber pacemakers
Parameter
AutoCapture Pacing
A. Backup Pulse Configuration
V. Backup Pulse Configuration
A. Search Interval
V. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
V. Lead Type
A. Pulse Configuration
V. Pulse Configuration
A. Sense Configuration
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression Pacing
Overdrive Pacing Cycles
Maximum AF Suppression Rate
MRI Settings
MRI Mode
MRI Base Rate
288 If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
289
If the Lead Type is set to Bipolar, the nominal is Bipolar.
290 If the Lead Type is set to Bipolar, the nominal is Bipolar.
291
If the Mode is set to AAI or AAT, the nominal is 200ms.
292 Available only in devices with MR Conditional Programming Capability.
Shipped Settings
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
See Package label
See Package label
See Package label
See Package label
Monitor
Monitor
2000
2000
200
200
¬
¬
¬
¬
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
DDIR
180
DOO
85 min§
80 min§
Off
15 cycles
120 min§ min§
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
DDIR
180 min§
80 min§
Off
15 cycles
120 min§
DOO
85 min§
Nominal (Standard) Settings
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Unipolar
Unipolar
Unipolar Tip
Unipolar Tip
Monitor
Monitor
2000
¬
2000
¬
200
¬
200
¬
232
Table 99. Shipped and Standard settings for Accent family dual-chamber pacemakers
Parameter
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
5.0 V
Bipolar
1.0 ms
Operating Parameters Tolerances
Nominal (Standard) Settings
5.0 V
Bipolar
1.0 ms
Table 100. Operating parameter/measurement tolerances for single-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Capture & Sense
Pulse Amplitude
Pulse Width
Sensitivity
Leads
Lead Monitoring
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 30% or 0.3 mV, whichever is greater
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
Table 101. Operating parameter/measurement tolerances for dual-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Delays
Paced AV Delay
Sensed AV Delay
Shortest AV Delay
VIP Search Interval
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 10 ms
± 10 ms
± 5 ms
± 2 sec
293 Sensitivity is with respect to a 20ms haversine test signal.
233
Capture & Sense
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
V. Sensitivity
AutoCapture Pacing/Cap Confirm
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Monitoring
V. Lead Monitoring
Refractories & Blanking
A. Refractory (PVARP)
A. Absolute Refractory Period
V. Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
PMT Detection Rate
AT/AF Detection & Response
Atrial Tachycardia Detection Rate
AMS Base Rate
Maximum AF Suppression Rate
NIPS Tolerances
Table 102. NIPS options
Parameter
Coupling Interval
S1 , S2, S3, and S4 Cycle
V. Backup Rate (VOO Pacing)
Sinus Node Recovery Delay
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 0.04 ms
± 30%
± 30% or 0.3 mV, whichever is greater
± 5 ms
± 20% (200 - 2000
¬)
± 30% (100 - 200 ¬, 2000 - 3000 ¬)
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
-4/+10 ms
± 20 ms
± 15 ms
± 15 ms
± 15 ms
Tolerance
± 10 ms
± 5 ms
± 15 ms
± 1 sec
294
Sensitivity is with respect to a 20ms haversine test signal.
295 Sensitivity is with respect to a 20ms haversine test signal.
234
Physical Specifications
Table 103. Physical Specifications for Accent and Accent ST devices
Specification
PM1110
PM1122
Titanium
Case Material
Case Coating
None
RF Antenna Material
None
Connector Material
Epoxy
Dimensions (mm) (h x l x t)
42 x 52
Weight (g)
18
Displacement volume (cm³)
9.5 ± 0.5
Lead Connector
IS-1
Dimensions and weight values are nominal.
PM1210
PM1222
Titanium
52 x 52 x 6
23
12.8 ± 0.5
PM2112
PM2122
None
46 x 52
19
10.5 ± 0.5
PM2212
PM2222
Titanium
52 x 52 x 6
23
12.9 ± 0.5
Table 104. Physical Specifications for Accent MRI and Accent ST MRI devices
Specification
PM1124
PM1126
Titanium
Case Material
Case Coating
None
RF Antenna Material
None
Connector Material
Epoxy
Dimensions (mm) (h x l x t)
46 x 52 x 6
Weight (g)
22
Displacement volume (cm³)
12.0 ± 0.5
Lead Connector
IS-1
Dimensions and weight values are nominal.
Battery Voltage
PM1224
PM1226
Titanium
53 x 52 x 6
24
13.1 ± 0.5
PM2124
PM2126
None
53 x 52 x 6
23
13.1 ± 0.5
PM2224
PM2226
Titanium
53 x 52 x 6
24
13.1 ± 0.5
Table 105. Battery voltage for devices with Battery Model 2662 (page 181)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.2 V (beginning of life)
2.6 V
2.5 V
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 106. X-ray ID codes
Device Model
PM1110, PM1122, PM1210, PM1222, PM2112, PM2122, PM2212, PM2222
PM1124, PM1126, PM1224, PM1226, PM2124, PM2126, PM2224, PM2226
X-ray ID Model Code
HI
HM MRI
296
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
297 (h x l x t) = height by length by thickness.
298
Maximum allowable value.
299 Maximum allowable value.
300
Accepts IS-1 short terminal pin leads.
301 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
302
(h x l x t) = height by length by thickness.
303 Accepts IS-1 short terminal pin leads.
235
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 107. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-IP-2
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
IS-1 receptacle plug
236
Allure™, Allure Quadra™, and Quadra Allure MP™ Devices
Technical Data
The tables below are applicable to the following Allure™ device models:
Allure PM3120
Allure Quadra PM3140
Allure RF PM3222
Allure Quadra RF PM3242
Quadra Allure MP PM3160
Quadra Allure MP RF PM3262
The technical data below include:
Shipped and Standard Settings (page 237)
Operating Parameters Tolerances (page 239)
Physical Specifications (page 241)
X-ray Identification (page 241)
Spare Parts And Accessories (page 241)
Shipped and Standard Settings
Table 108. Shipped and Standard settings for Allure, Allure Quadra, and Quadra Allure MP devices
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Ventricular Pacing
Interventricular Delay
Shipped Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Simultaneous
11.7 ms
Nominal (Standard) Settings
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
60 min§
Off
130 min§
Off
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
60
Off min§
130 min§
Off
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Medium
100 ms
Off
304 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Simultaneous
11.7 ms
237
Table 108. Shipped and Standard settings for Allure, Allure Quadra, and Quadra Allure MP devices
Parameter
VIP Extension
VIP Search Interval
VIP Search Cycles
Negative AV/PV Hysteresis w/Search
Capture & Sense
ACap Confirm
RVCap Confirm
LVCap Confirm
A. Pulse Amplitude
RV. Pulse Amplitude
LV. Pulse Amplitude
A. Pulse Width
RV. Pulse Width
LV. Pulse Width
A. Sensitivity
A. Max Sensitivity
A. Post-Paced Decay Delay
A. Post-Sensed Decay Delay
A. Post-Paced Threshold Start
A. Post-Sensed Threshold Start Percentage
A. Post-Sensed Minimum Start Threshold
A. AutoSense
RV. Sensitivity
RV Max Sensitivity
RV Post-Sense Decay Delay
RV Post-Paced Decay Delay
RV Post-Sense Threshold Start Percentage
RV Post-Paced Threshold Start
R AutoSense
AutoCapture Pacing
A. Backup Pulse Configuration
RV. Backup Pulse Configuration
A. Search Interval
RV. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
RV. Lead Type
LV. Lead Type
A. Pulse Configuration
RV. Pulse Configuration
LV. Pulse Configuration
A. Sense Configuration
Shipped Settings
100 ms
1 min
1 cycle
Off
Off
Off
Off
2.5 V
2.5 V
2.5 V
0.4 ms
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Uncoded
See Package label
See Package label
See Package label
See Package label
Nominal (Standard) Settings
100 ms
1 min
1 cycle
Off
Off
Off
Off
2.5 V
2.5 V
2.5 V
0.4 ms
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Uncoded
Unipolar
Unipolar
Allure: Bipolar;
Allure Quadra; Quadra Allure MP:
Distal Tip 1-Mid 2
Bipolar
305 If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
306
If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
307 If the A Lead Type is set to Unipolar, the nominal is Unipolar Tip.
238
Table 108. Shipped and Standard settings for Allure, Allure Quadra, and Quadra Allure MP devices
Parameter
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression
Overdrive Pacing Cycles
Maximum AF Suppression Rate
Shipped Settings
See Package label
Monitor
Monitor
2000
2000
200
200
High
On
Off
130
DDIR
180
Off
¬
¬
¬
¬
275 ms
93 ms
190 ms
250 ms
250 ms
175 ms
150 ms
44 ms
A Pace on PMT min§ min§
80 min§
15 cycles
120 min§
Nominal (Standard) Settings
Monitor
Monitor
2000
¬
2000
¬
200
¬
200
¬
275 ms
93 ms
190 ms
250 ms
250 ms
High
175 ms
150 ms
44 ms
On
Off
130 min§
DDIR
180
min§
80 min§
Off
15 cycles
120 min§
A Pace on PMT
Allure: Bipolar;
Allure Quadra; Quadra Allure MP:
Distal Tip 1-Mid 2
Operating Parameters Tolerances
Table 109. Operating parameter/measurement tolerances for CRT-Ps
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
308 If the Mode is set to AAI or AAT, the nominal is 200ms.
239
Table 109. Operating parameter/measurement tolerances for CRT-Ps
Parameter/Measurement
Delays
Paced AV Delay
Sensed AV Delay
Shortest AV Delay
VIP Search Interval
Capture & Sense
A. Pulse Amplitude
RV. Pulse Amplitude
LV. Pulse Amplitude
A. Pulse Width
RV. Pulse Width
LV. Pulse Width
A. Sensitivity
V. Sensitivity
AutoCapture Pacing/Cap Confirm
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Monitoring
Tolerance
± 10 ms
± 10 ms
± 5 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 0.04 ms
± 0.04 ms
± 30%
± 30% or 0.3 mV, whichever is greater
± 5 ms
V. Lead Monitoring
± 20% (200 - 2000
¬)
± 30% (100 - 200 ¬, 2000 - 3000 ¬)
± 20% (200 - 2000
¬)
± 30% (100 - 200 ¬, 2000 - 3000 ¬)
Refractories & Blanking
A. Refractory (PVARP)
A. Absolute Refractory Period
V. Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
PMT Detection Rate
AT/AF Detection & Response
Atrial Tachycardia Detection Rate
AMS Base Rate
Maximum AF Suppression Rate
NIPS Tolerances
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
-4/+10 ms
± 20 ms
± 15 ms
± 15 ms
± 15 ms
Table 110. NIPS options
Parameter
Coupling Interval
S1 , S2, S3, and S4 Cycle
V. Backup Rate (VOO Pacing)
309
Sensitivity is with respect to a 20ms haversine test signal.
310 Sensitivity is with respect to a 20ms haversine test signal.
Tolerance
± 10 ms
± 5 ms
± 15 ms
240
Table 110. NIPS options
Parameter
Sinus Node Recovery Delay
Physical Specifications
Tolerance
± 1 sec
Table 111. Physical Specifications for Allure, Allure Quadra, and Quadra Allure MP devices
Specification
Case Material
Case Coating
RF Antenna Material
Connector Material
Dimensions (mm) (h x l x t)
Weight (g)
Displacement volume
Lead Connector
(cm³)
PM3120
Titanium
None
None
Epoxy
55x 59 x 6
24
14 ± 0.5
IS-1
Dimensions and weight values are nominal.
PM3140
PM3160
Titanium
None
None
Epoxy
56 x 59 x 6
26
15 ± 0.5
IS-1/IS4-LLLL
PM3222
Titanium
None
Titanium
Epoxy
55 x 59 x 6
24
14 ± 0.5
IS-1
Battery Voltage
PM3242
PM3262
Titanium
None
Titanium
Epoxy
56 x 59 x 6
27
15 ± 0.5
IS-1/IS4-LLLL
Table 112. Battery voltage for Allure, Allure Quadra, and Quadra Allure MP devices
Parameter
Battery voltage
Elective replacement voltage (unloaded)
Data
3.20 V (beginning of life)
2.62 V
End-of-life voltage (unloaded) 2.47 V
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 113. X-ray ID codes
Device Model
PM3120, PM3140, PM3222, PM3242, PM3160, PM3262
X-ray ID Model Code
HI
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 114. Spare parts and accessories
Model Number
442-2
AC-0130
424
Device Description
Torque driver
Silicone oil
Medical adhesive
311
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
312 (h x l x t) = height by length by thickness.
313
±0.5 cm³
314 Accepts IS-1 short terminal pin leads.
315
Accepts IS-1 short terminal pin leads or IS4-LLLL quadripolar leads.
316 Accepts IS-1 short terminal pin leads or IS4-LLLL quadripolar leads.
241
Table 114. Spare parts and accessories
Model Number
AC-0160
AC-IP-2
AC-IS4PP
Device Description
Magnet
IS-1 receptacle plug
IS4/DF4 port plug
317 For use with IS4-LLLL bores.
242
AnalyST™ and AnalyST Accel™ Devices Technical Data
The tables below are applicable to the following AnalyST™ and AnalyST Accel™ device models:
AnalyST VR CD1217-30
AnalyST VR CD1217-36
AnalyST Accel VR CD1219-30
AnalyST Accel VR CD1219-36
AnalyST Accel VR CD1219-36Q
AnalyST DR CD2217-30
AnalyST DR CD2217-36
AnalyST Accel DR CD2219-30
AnalyST Accel DR CD2219-36
AnalyST Accel DR CD2219-36Q
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
The technical data below include:
Physical Specifications (page 243)
Device Configurations (page 244)
Operating Parameters Tolerances (page 245)
X-ray Identification (page 246)
Spare Parts And Accessories (page 246)
Physical Specifications
Table 115. Physical specifications for AnalyST and AnalyST Accel 36 J devices
Specification
CD1217-36
CD1219-36
Dimensions (cm) (h x l x t)
7.6 x 5.0 x 1.4
Weight (g)
79
Displacement volume (cm³)
41
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
42
Noise detection rate
CD2217-36
CD2219-36
7.7 x 5.0 x 1.4
80
42
42
100 or more sensed events per second
Lead compatibility
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1
3.2 mm bipolar lead connector.
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Battery
CD1219-36Q
7.4 x 5.0 x 1.4
79
41
42
High voltage and RV low voltage: one DF4-
LLHH lead connector
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2555, One cell
CD2219-36Q
7.4 x 5.0 x 1.4
80
41
42
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one
IS-1 3.2 mm bipolar lead connector.
318
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
319 (h x l x t) = height by length by thickness.
243
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
CD1217-30
CD1219-30
7.5 x 5.0 x 1.3
73
37
Titanium
Epoxy
CD2217-30
CD2219-30
7.6 x 5.0 x 1.3
74
38
Silicone
34
100 or more sensed events per second
34
High voltage: one or two DF-1
3.2 mm lead connectors.
Low voltage: one IS-1 3.2 mm bipolar lead connector.
High voltage: one or two DF-1
3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2356, One cell
Battery
Device Configurations
Table 116. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
AnalyST DR,
AnalyST Accel DR
AnalyST VR,
AnalyST Accel VR
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
VVI(R), Pacer Off; Additional modes available in the tachyarrhythmia therapies Off configuration: VOO(R); Additional modes available as temporary modes: VOO
SVT Discrimination Mode
AnalyST DR,
AnalyST Accel DR
AnalyST VR,
AnalyST Accel VR
Ventricular Only, Dual Chamber
Ventricular Only
A Pulse Configuration and Sense Configuration
AnalyST DR,
AnalyST Accel DR
V Pulse Configuration and Sense Configuration
All Models
Bipolar (A-tip to A-ring)
Bipolar (V-tip to V-ring)
Battery Voltage
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.45 V
2.35 V
320 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
321
(h x l x t) = height by length by thickness.
322 Sensing only in the right atrium and right ventricle.
244
Operating Parameters Tolerances
Table 118. Operating parameter/measurement tolerances
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50
¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15%
± 10 ms
± 10 ms
± 15% (200 to <=1000 ¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV
(whichever is greater)
323 Dual-chamber devices only.
324
Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
325 Load > 200ohms.
245
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 119. X-ray ID codes
Device Model
CD1217-30/36, CD1219-30/36/36Q, CD2217-30/36, CD2219-30/36/36Q
X-ray ID Model Code
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 120. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
326 Dual-chamber ICDs and CRTDs only.
246
Anthem™ Devices Technical Data
The tables below are applicable to the following Anthem™ device models:
Anthem PM3112
Anthem RF PM3212
The technical data below include:
Shipped and Standard Settings (page 247)
Operating Parameters Tolerances (page 249)
Physical Specifications (page 251)
X-ray Identification (page 251)
Spare Parts And Accessories (page 251)
Shipped and Standard Settings
Table 121. Shipped and Standard settings for Anthem devices
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Ventricular Pacing
Interventricular Delay
Shipped Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Simultaneous
11.7 ms
Nominal (Standard) Settings
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
VIP Extension
VIP Search Interval
VIP Search Cycles
Negative AV/PV Hysteresis w/Search
60 min§
Off
130 min§
Off
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
60
Off min§
130 min§
Off
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
327 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Simultaneous
11.7 ms
247
Table 121. Shipped and Standard settings for Anthem devices
Parameter
Capture & Sense
ACap Confirm
RVCap Confirm
LVCap Confirm
A. Pulse Amplitude
RV. Pulse Amplitude
LV. Pulse Amplitude
A. Pulse Width
RV. Pulse Width
LV. Pulse Width
A. Sensitivity
A. Max Sensitivity
A. Post-Paced Decay Delay
A. Post-Sensed Decay Delay
A. Post-Paced Threshold Start
A. Post-Sensed Threshold Start Percentage
A. Post-Sensed Minimum Start Threshold
A. AutoSense
RV Sensitivity
RV Max Sensitivity
RV Post-Sense Decay Delay
RV Post-Paced Decay Delay
RV Post-Sense Threshold Start Percentage
RV Post-Paced Threshold Start
RV AutoSense
AutoCapture
A. Backup Pulse Configuration
RV. Backup Pulse Configuration
A. Search Interval
RV. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
RV. Lead Type
LV. Lead Type
A. Pulse Configuration
RV. Pulse Configuration
LV. Pulse Configuration
A. Sense Configuration
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
Shipped Settings
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Uncoded
Bipolar
See Package label
See Package label
See Package label
See Package label
Monitor
Monitor
2000
¬
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Off
Off
Off
2.5 V
2.5 V
2.5 V
0.4 ms
0.4 ms
0.4 ms
0.5 mV
0.3 mV
328 If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
329
If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
330 If the LV Lead Type is set to Unipolar or Uncoded, the nominal is Unipolar Tip.
331
If the RV Lead Type is set to Unipolar or Uncoded, the nominal is Unipolar Tip.
332 If the RV Lead Type is set to Unipolar or Uncoded, the nominal is Unipolar Tip.
248
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Uncoded
Unipolar
Unipolar
Bipolar
Unipolar Tip
Bipolar
Monitor
Monitor
2000
¬
Nominal (Standard) Settings
Off
Off
Off
2.5 V
2.5 V
2.5 V
0.4 ms
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Table 121. Shipped and Standard settings for Anthem devices
Parameter
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
A. Sense Refractory
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression
Overdrive Pacing Cycles
Maximum AF Suppression Rate
Shipped Settings
2000
¬
200
¬
200
¬
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
DDIR
93 ms
180 min§
80 min§
Off
15 cycles
120 min§
Operating Parameters Tolerances
Table 122. Operating parameter/measurement tolerances for CRT-Ps
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Delays
Paced AV Delay
Sensed AV Delay
Shortest AV Delay
VIP Search Interval
333 If the Mode is set to AAI or AAT, the nominal is 200ms.
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 10 ms
± 10 ms
± 5 ms
± 2 sec
249
Nominal (Standard) Settings
2000
¬
200
¬
200
¬
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
DDIR
93 ms
180 min§
80 min§
Off
15 cycles
120 min§
Table 122. Operating parameter/measurement tolerances for CRT-Ps
Parameter/Measurement
Capture & Sense
A. Pulse Amplitude
RV. Pulse Amplitude
LV. Pulse Amplitude
A. Pulse Width
RV. Pulse Width
LV. Pulse Width
A. Sensitivity
V. Sensitivity
AutoCapture Pacing/Cap Confirm
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Monitoring
Tolerance
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 0.04 ms
± 0.04 ms
± 30%
± 30% or 0.3 mV, whichever is greater
± 5 ms
V. Lead Monitoring
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
Refractories & Blanking
A. Refractory (PVARP)
A. Absolute Refractory Period
V. Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
PMT Detection Rate
AT/AF Detection & Response
Atrial Tachycardia Detection Rate
AMS Base Rate
Maximum AF Suppression Rate
NIPS Tolerances
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
-4/+10 ms
± 20 ms
± 15 ms
± 15 ms
± 15 ms
Table 123. NIPS options
Parameter
Coupling Interval
S1 , S2, S3, and S4 Cycle
V. Backup Rate (VOO Pacing)
Sinus Node Recovery Delay
Tolerance
± 10 ms
± 5 ms
± 15 ms
± 1 sec
334
Sensitivity is with respect to a 20ms haversine test signal.
335 Sensitivity is with respect to a 20ms haversine test signal.
250
Physical Specifications
Table 124. Physical Specifications for Anthem devices
Specification
Case Material
Case Coating
RF Antenna Material
Connector Material
Dimensions (mm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Lead Connector
Dimensions and weight values are nominal.
Battery Voltage
PM3112
Titanium
None
None
Epoxy
52 x 52 x 6
21
11.5 ± 0.5
IS-1
PM3212
Titanium
Epoxy
57 x 52 x 6
25
13.7 ± 0.5
IS-1
Table 125. Battery voltage for devices with Battery Model 2662 (page 181)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.2 V (beginning of life)
2.6 V
2.5 V
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 126. X-ray ID codes
Device Model
PM3112, PM3212
X-ray ID Model Code
HI
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 127. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-IP-2
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
IS-1 receptacle plug
336 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
337
(h x l x t) = height by length by thickness.
338 Accepts IS-1 short terminal pin leads.
251
Assurity™, Assurity™+, and Assurity MRI ™ Devices
Technical Data
The tables below are applicable to the following Assurity™, Assurity™ +, and Assurity MRI™ device models:
Assurity PM1240
Assurity+ PM1260
Assurity MRI PM1272
Assurity PM2240
Assurity+ PM2260
Assurity MRI PM2272
The technical data below include:
Shipped and Standard Settings (page 253)
Operating Parameters Tolerances (page 257)
Physical Specifications (page 258)
X-ray Identification (page 259)
Spare Parts And Accessories
Shipped and Standard Settings
Table 128. Shipped and Standard settings for Assurity, Assurity+, and Assurity MRI single-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Capture & Sense
V. AutoCapture Pacing
Pulse Amplitude
Pulse Width
Sensitivity
AutoSense
Max Sensitivity
Post-Paced Decay Delay
Shipped Settings
VVI
Battery Test
VOO
Passive
130
Fast
Off
60
Off
Off
Off
Off min§
Auto (+ 0.0)
Auto (+ 2)
Medium min§
1 cycle
Off
3 min
Medium
2.5 V
0.4 ms
2.0 mV
Off
0.5 mV
Auto
Nominal (Standard) Settings
VVI
Battery Test
VOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60
Off
Off
Off
1 cycle
Off
3 min
Medium
Off min§
2.5 V
0.4 ms
2.0 mV
Off
0.5 mV
Auto
339 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
253
Table 128. Shipped and Standard settings for Assurity, Assurity+, and Assurity MRI single-chamber pacemakers
Parameter
Post-Sensed Decay Delay
Post-Paced Threshold Start
Post-Sensed Threshold Start
Backup Pulse Configuration
Search Interval
Leads
Lead Type
Pulse Configuration
Sense Configuration
Lead Monitoring
Upper Limit
Lower Limit
Refractories & Blanking
Sense Refractory
Pace Refractory
Rate Responsive VREF
Shortest VREF
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
See Package label
Bipolar
Monitor
2000
200
¬
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
Unipolar
Monitor
2000
200
Low
VOO
85
5.0 V
¬
¬
250 ms
250 ms
175 ms min§
Bipolar
1.0 ms
Unipolar Tip
Table 129. Shipped and Standard settings for Assurity, Assurity+, and Assurity MRI dual-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Shipped Settings
DDD
Battery Test
DOO
Passive
130
Fast
Off
60
Off min§
130
Off min§
Auto (+ 0.0)
Auto (+ 2)
Medium min§
Nominal (Standard) Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60
Off
Off min§
130 min§
340 If the right ventricular Lead Type is set to Unipolar, the nominal is Unipolar.
341
If the Lead Type is set to Bipolar, the nominal is Bipolar.
342 If the Lead Type is set to Bipolar, the nominal is Bipolar.
343
Available only in devices with MR Conditional Programming Capability.
344 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
254
Table 129. Shipped and Standard settings for Assurity, Assurity+, and Assurity MRI dual-chamber pacemakers
Parameter
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
VIP Extension
VIP Search Interval
VIP Search Cycles
Negative AV/PV Hysteresis w/Search
Capture & Sense
ACap Confirm
V. AutoCapture Pacing
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
A. Max Sensitivity
A. Post-Paced Decay Delay
A. Post-Sensed Decay Delay
A. Post-Paced Threshold Start
A. Post-Sensed Threshold Start Percentage
A. Post-Sensed Minimum Start Threshold
A. AutoSense
V. Sensitivity
V. Max Sensitivity
V. Post-Sense Decay Delay
V. Post-Paced Decay Delay
V. Post-Sense Threshold Start Percentage
V. Post-Paced Threshold Start
V. AutoSense
AutoCapture Pacing
A. Backup Pulse Configuration
V. Backup Pulse Configuration
A. Search Interval
V. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
Shipped Settings
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
Off
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Nominal (Standard) Settings
Off
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
Off
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
345
If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
346 If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
255
Table 129. Shipped and Standard settings for Assurity, Assurity+, and Assurity MRI dual-chamber pacemakers
Parameter
V. Lead Type
A. Pulse Configuration
V. Pulse Configuration
A. Sense Configuration
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression Pacing
Overdrive Pacing Cycles
Maximum AF Suppression Rate
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
Shipped Settings
Uncoded
See Package label
See Package label
See Package label
See Package label
Monitor
Monitor
2000
¬
2000 ¬
200 ¬
200 ¬
On
On
A Pace on PMT
130
180
80 min§
Off
15 cycles
120
DOO
85 min§
DDIR min§ min§ min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
Uncoded
Unipolar
Unipolar
Unipolar Tip
Unipolar Tip
Monitor
Monitor
2000
2000
200
200
275 ms
93 ms
190 ms
250 ms
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
DDIR
180
DOO
85
¬
¬
¬
¬ min§
80 min§
Off
15 cycles
120 min§ min§
5.0 V
Bipolar
1.0 ms
347
If the Lead Type is set to Bipolar, the nominal is Bipolar.
348 If the Lead Type is set to Bipolar, the nominal is Bipolar.
349
If the Mode is set to AAI or AAT, the nominal is 200ms.
350 Available only in devices with MR Conditional Programming Capability.
256
Operating Parameters Tolerances
Table 130. Operating parameter/measurement tolerances single-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Capture & Sense
Pulse Amplitude
Pulse Width
Sensitivity
Leads
Lead Monitoring
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 30% or 0.3 mV, whichever is greater
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
Table 131. Operating parameter/measurement tolerances for dual-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Delays
Paced AV Delay
Sensed AV Delay
Shortest AV Delay
VIP Search Interval
Capture & Sense
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
V. Sensitivity
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 10 ms
± 10 ms
± 5 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 0.04 ms
± 30%
± 30% or 0.3 mV, whichever is greater
351 Sensitivity is with respect to a 20ms haversine test signal.
352
Sensitivity is with respect to a 20ms haversine test signal.
353 Sensitivity is with respect to a 20ms haversine test signal.
257
AutoCapture Pacing/Cap Confirm
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Monitoring
± 5 ms
V. Lead Monitoring
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
Refractories & Blanking
A. Refractory (PVARP)
A. Absolute Refractory Period
V. Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
PMT Detection Rate
AT/AF Detection & Response
Atrial Tachycardia Detection Rate
AMS Base Rate
Maximum AF Suppression Rate
NIPS Tolerances
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
-4/+10 ms
± 20 ms
± 15 ms
± 15 ms
± 15 ms
Table 132. NIPS options
Parameter
Coupling Interval
S1 , S2, S3, and S4 Cycle
V. Backup Rate (VOO Pacing)
Sinus Node Recovery Delay
Physical Specifications
Table 133. Physical Specifications for Assurity, Assurity+, Assurity MRI devices
Specification
Case Material
Case Coating
RF Antenna Material
PM1240
PM1260
PM1272
PM2240
PM2260
PM2272
Titanium
None
Titanium
Connector Material
Dimensions (mm) (h x l x t)
Weight (g)
Displacement volume
Lead Connector
Dimensions and weight values are nominal.
Epoxy
47 x 50 x 6
20
10.4 ± 0.5
IS-1
354 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
355
(h x l x t) = height by length by thickness.
356 ±0.5 cm³
357
Accepts IS-1 short terminal pin leads.
358 Accepts IS-1 short terminal pin leads.
Tolerance
± 10 ms
± 5 ms
± 15 ms
± 1 sec
258
Battery Voltage
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.60 V
2.47 V
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 135. X-ray ID codes
Device Model
PM1240, PM1260, PM2240, PM2260,
PM1272, PM2272
X-ray ID Model Code
HI
HM MRI
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 136. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-IP-2
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
IS-1 receptacle plug
259
Auricle™ Devices Technical Data
The tables below are applicable to the following Auricle device models:
Auricle 3107-36P
The technical data below include:
Physical Specifications (page 261)
Device Configurations (page 261)
Operating Parameters Tolerances (page 262)
X-ray Identification (page 263)
Spare Parts And Accessories (page 263)
Physical Specifications
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
Battery
3107-36P
8.5 x 5.1 x 1.6
90
46
Titanium
Epoxy, tecothane, titanium
Silicone
42
100 or more sensed events per second
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one, two or three IS-1 3.2 mm bipolar (RA, RV, and
LV) lead connectors OR one or two IS-1 3.2 mm bipolar (RA and
RV) lead connectors and one IS-1 3.2 mm unipolar (LV) lead connector.
LAP sensor
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2555,
One cell
Device Configurations
Table 137. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
SVT Discrimination Mode
Ventricular Only, Dual Chamber
A Pulse Configuration and Sense Configuration
Bipolar (A-tip to A-ring)
RV Pulse Configuration and Sense Configuration
Bipolar (RV-tip to RV-ring)
LV Pacing Configuration
Bipolar (LV-tip to LV-ring), LV-tip to RV-coil, LV-ring to RV-coil
359 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
360
(h x l x t) = height by length by thickness.
361 Sensing only in the right atrium and right ventricle.
261
Battery Voltage
Table 138. Battery voltage for devices with Battery Model 2555 (page 181)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.45 V
2.35 V
Operating Parameters Tolerances
Table 139. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50
¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15% Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
362 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
± 10 ms
262
Table 139. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
Tolerance
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV (whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
X-ray ID codes
Device Model
3107-36P
X-ray ID Model Code
UL
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 140. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
LAP 1121
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
TwinLock™ Header Screws
363
Load > 200ohms.
364 Dual-chamber ICDs and CRTDs only.
263
Current™, Current™+, Current™ RF, and Current Accel™
Devices Technical Data
The tables below are applicable to the following Current™ device models:
Current VR 1107-30
Current VR 1107-36
Current VR RF 1207-30
Current VR RF 1207-36
Current VR CD1207-36Q
Current+ VR CD1211-36
Current+ VR CD1211-36Q
Current Accel VR CD1215-30
Current Accel VR CD1215-36
Current Accel VR CD1215-36Q
Current DR 2107-30
Current DR 2107-36
Current DR RF 2207-30
Current DR RF 2207-36
Current DR CD2207-36Q
Current+ DR CD2211-36
Current+ DR CD2211-36Q
Current Accel DR CD2215-30
Current Accel DR CD2215-36
Current Accel DR CD2215-36Q
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
The technical data below include:
Physical Specifications (page 265)
Device Configurations (page 266)
Operating Parameters Tolerances (page 267)
X-ray Identification (page 268)
Spare Parts And Accessories (page 268)
Physical Specifications
Table 141. Physical specifications for Current 30 J devices
Specification
1107-30 1207-30
CD1215-30
7.5 x 5.0 x 1.3
Dimensions (cm) (h x l x t)
6.9 x 5.0 x 1.3
Weight (g)
71
Displacement volume (cm³)
34
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
34
Noise detection rate
73
37
100 or more sensed events per second
Lead compatibility
Battery
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1 3.2 mm bipolar lead connector.
2107-30
7.0 x 5.0 x 1.3
72
35
2207-30
CD2215-30
7.6 x 5.0 x 1.3
74
38
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2356, One cell
365
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
366 (h x l x t) = height by length by thickness.
265
Table 142. Physical specifications for Current 36 J devices
Specification
1107-36 1207-36
CD1211-36
CD1215-36
7.6 x 5.0 x 1.4
Dimensions (cm) (h x l x t)
7.0 x 5.0 x 1.4
Weight (g)
76
Displacement volume (cm³)
38
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
42
Noise detection rate
79
41
100 or more sensed events per second
Lead compatibility
Battery
2107-36
7.1 x 5.0 x 1.4
78
39
2207-36
CD2211-36
CD2215-36
7.7 x 5.0 x 1.4
80
42
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1 3.2 mm bipolar lead connector.
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2555, One cell
Table 143. Physical specifications for Current 36 J devices with "Q" header
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
CD1207-36Q
CD1211-36Q
CD1215-36Q
7.4 x 5.0 x 1.4
79
41
Titanium
Epoxy
Silicone
42
CD2207-36Q
CD2211-36Q
CD2215-36Q
7.4 x 5.0 x 1.4
80
41
100 or more sensed events per second
High voltage and RV low voltage: one
DF4-LLHH lead connector
High voltage and RV low voltage: one
DF4-LLHH lead connector.
RA low voltage: one IS-1 3.2 mm bipolar lead connector.
Lithium/silver vanadium oxide; Greatbatch Medical, Model 2555, One cell
Battery
Device Configurations
Table 144. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
Current DR,
Current DR RF,
Current+ DR,
Current Accel DR
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
367
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
368 (h x l x t) = height by length by thickness.
369
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
370 (h x l x t) = height by length by thickness.
266
Current VR,
Current VR RF,
Current+ VR,
Current Accel VR
SVT Discrimination Mode
Current DR,
Current DR RF,
Current+ DR,
Current Accel DR
Current VR,
Current VR RF,
Current+ VR,
Current Accel VR
A Pulse Configuration and Sense Configuration
Current DR,
Current DR RF,
Current+ DR,
Current Accel DR
V Pulse Configuration and Sense Configuration
All Models
Battery Voltage
VVI(R), Pacer Off; Additional modes available in the tachyarrhythmia therapies Off configuration: VOO(R); Additional modes available as temporary modes: VOO
Ventricular Only, Dual Chamber
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.45 V
2.35 V
Operating Parameters Tolerances
Table 146. Operating parameter/measurement tolerances
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Ventricular Only
Bipolar (A-tip to A-ring)
Bipolar (V-tip to V-ring)
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
371 Sensing only in the right atrium and right ventricle.
372
Dual-chamber devices only.
373 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
± 5 ms
± 50 ms
± 40 µs
< 3 ¬
± 15% at 50 ¬
± 0.15 s
± 5%
± 10%
267
Table 146. Operating parameter/measurement tolerances
Parameter/Measurement
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Tolerance
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15% Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000 ¬)
± 15% or ± 100 mV
(whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 147. X-ray ID codes
Device Model
1107-36/30, 2107-36/30
1207-36/30, CD1207-36Q, CD1211-36/36Q, CD1215-36/36Q/30, 2207-36/30,
CD2207-36Q, CD2211-36/36Q, CD2215-36/30/36Q
X-ray ID Model Code
KA
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 148. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
374
Load > 200ohms.
375 Dual-chamber ICDs and CRTDs only.
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
268
Table 148. Spare parts and accessories
Model Number
AC-IS4PP
Device Description
IS4/DF4 port plug
269
Ellipse™ Devices Technical Data
The tables below are applicable to the following Ellipse™ and Ellipse™ ST device models:
Ellipse VR CD1277-36
Ellipse VR CD1277-36Q
Ellipse VR CD1279-36
Ellipse VR CD1279-36Q
Ellipse VR CD1311-36
Ellipse VR CD1311-36Q
Ellipse VR CD1377-36
Ellipse VR CD1377-36C
Ellipse VR CD1377-36Q
Ellipse VR CD1377-36QC
Ellipse DR CD2277-36
Ellipse DR CD2277-36Q
Ellipse DR CD2279-36
Ellipse DR CD2279-36Q
Ellipse DR CD2311-36
Ellipse DR CD2311-36Q
Ellipse DR CD2377-36
Ellipse DR CD2377-36C
Ellipse DR CD2377-36Q
Ellipse DR CD2377-36QC
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
Models with the "C" suffix are coated with Parylene.
The technical data below include:
Physical Specifications (page 272)
Device Configurations (page 272)
Operating Parameters Tolerances (page 273)
X-ray Identification (page 274)
Spare Parts And Accessories (page 274)
271
Physical Specifications
Table 149. Physical specifications for Ellipse devices
Specification
CD1277-36
CD1279-36
CD1311-36
CD1377-36
CD1377-36C
CD2277-36
CD2279-36
CD2311-36
CD2377-36
CD2377-36C
Dimensions (cm) (h x l x t)
6.8 x 5.1 x 1.2
Weight (g)
66
Displacement volume (cm³)
30.6
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
39
Noise detection rate
6.9 x 5.1 x 1.2
66
30.8
39
100 or more sensed events per second
Lead compatibility
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1
3.2 mm bipolar lead connector.
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Battery
CD1277-36Q
CD1279-36Q
CD1311-36Q
CD1377-36Q
CD1377-36QC
6.6 x 5.1 x 1.2
67
30.2
39
High voltage and RV low voltage: one DF4-
LLHH lead connector
CD2277-36Q
CD2279-36Q
CD2311-36Q
CD2377-36Q
CD2377-36QC
7.0 x 5.1 x 1.2
68
31.3
39
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one
IS-1 3.2 mm bipolar lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model 2950, One cell
Device Configurations
Table 150. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
Ellipse DR devices
Ellipse VR devices
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
VVI(R), Pacer Off; Additional modes available in the tachyarrhythmia therapies Off configuration: VOO(R); Additional modes available as temporary modes: VOO
SVT Discrimination Mode
Ellipse DR devices
Ellipse VR devices
Ventricular Only, Dual Chamber
Ventricular Only
A Pulse Configuration and Sense Configuration
Ellipse DR devices
V Pulse Configuration and Sense Configuration
All Models
Bipolar (A-tip to A-ring)
Bipolar (V-tip to V-ring)
376 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
377
(h x l x t) = height by length by thickness.
378 Sensing only in the right atrium and right ventricle.
272
Battery Voltage
Table 151. Battery voltage for devices with Battery Model 2950 (page 183)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 152. Operating parameter/measurement tolerances
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Burst Fibber Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50 ¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15%
379
Dual-chamber devices only.
380 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
273
Table 152. Operating parameter/measurement tolerances
Parameter/Measurement
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
Tolerance
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV
(whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 153. X-ray ID codes
Device Model
CD1277-36/36Q, CD1279-36/36Q, CD1311-36/36Q, CD1377-
36/36C/36Q/36QC, CD2277-36/36Q, CD2279-36/36Q CD2311-36/36Q,
CD2377-36/36C/36Q/36QC
X-ray ID Model Code
KF
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 154. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
381
Load > 200ohms.
382 Dual-chamber ICDs and CRTDs only.
274
Endurity™, Endurity™ Core, and Endurity MRI™ Devices
Technical Data
The tables below are applicable to the following Endurity™, Endurity™ Core, and Endurity MRI™ device models:
Endurity Core (SC) PM1140
Endurity Core (SR) PM1152
Endurity PM1160
Endurity PM1162
Endurity MRI PM1172
Endurity Core (DC) PM2140
Endurity Core (DR) PM2152
Endurity PM2160
Endurity PM2162
Endurity MRI PM2172
The technical data below include:
Shipped and Standard Settings (page 275)
Operating Parameters Tolerances (page 282)
Physical Specifications (page 284)
X-ray Identification (page 284)
Spare Parts And Accessories (page 284)
Shipped and Standard Settings
Table 155. Shipped and Standard settings for Endurity and Endurity MRI single-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Capture & Sense
V. AutoCapture Pacing
Pulse Amplitude
Pulse Width
Sensitivity
Shipped Settings
VVI
Battery Test
VOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60 min§
Off
Off
Off
1 cycle
Off
3 min
Medium
Off
2.5 V
0.4 ms
2.0 mV
Nominal (Standard) Settings
VVI
Battery Test
VOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60 min§
Off
Off
Off
1 cycle
Off
3 min
Medium
Off
2.5 V
0.4 ms
2.0 mV
383 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
275
Table 155. Shipped and Standard settings for Endurity and Endurity MRI single-chamber pacemakers
Parameter
AutoSense
Max Sensitivity
Post-Paced Decay Delay
Post-Sensed Decay Delay
Post-Paced Threshold Start
Post-Sensed Threshold Start
Backup Pulse Configuration
Search Interval
Leads
Lead Type
Pulse Configuration
Sense Configuration
Lead Monitoring
Upper Limit
Lower Limit
Refractories & Blanking
Sense Refractory
Pace Refractory
Rate Responsive VREF
Shortest VREF
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
Off
0.5 mV
Auto
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
See Package label
Bipolar
Monitor
2000
¬
200
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
Off
0.5 mV
Auto
60 ms
Auto
75%
Bipolar
8 hr
Uncoded
Unipolar
Monitor
2000
200
¬
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Unipolar Tip
Table 156. Shipped and Standard settings for Endurity Core single-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
Shipped Settings
VVI
Battery Test
VOO
Passive
130
Fast min§
Auto (+ 0.0)
Auto (+ 2)
Medium
Nominal (Standard) Settings
VVI
Battery Test
VOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
384 If the right ventricular Lead Type is set to Unipolar, the nominal is Unipolar.
385
If the Lead Type is set to Bipolar, the nominal is Bipolar.
386 If the Lead Type is set to Bipolar, the nominal is Bipolar.
387
Available only in devices with MR Conditional Programming Capability.
388 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
389
Not available in Endurity™ Core SC devices.
390 Not available in Endurity™ Core SC devices.
391
Not available in Endurity™ Core SC devices.
392 Not available in Endurity™ Core SC devices.
393
Not available in Endurity™ Core SC devices.
394 Not available in Endurity™ Core SC devices.
276
Table 156. Shipped and Standard settings for Endurity Core single-chamber pacemakers
Parameter
V. Triggering
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Capture & Sense
V. AutoCapture Pacing
Pulse Amplitude
Pulse Width
Sensitivity
AutoSense
Backup Pulse Configuration
Search Interval
Leads
Lead Type
Pulse Configuration
Sense Configuration
Lead Monitoring
Upper Limit
Lower Limit
Refractories & Blanking
Sense Refractory
Pace Refractory
Rate Responsive VREF
Shortest VREF
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
Off
60
Off
Off
Off
Off
Off min§
1 cycle
3 min
Medium
2.5 V
0.4 ms
2.0 mV
N/A
Bipolar
8 hr
Uncoded
See Package label
Bipolar
Monitor
2000
200
¬
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
Off
Uncoded
Unipolar
Unipolar Tip
Monitor
2000
¬
200
¬
250 ms
250 ms
Low
175 ms
VOO
85 min§
5.0 V
Bipolar
1.0 ms
60 min§
Off
Off
Off
1 cycle
Off
3 min
Medium
Off
2.5 V
0.4 ms
2.0 mV
N/A
Bipolar
8 hr
Table 157. Shipped and Standard settings for Endurity and Endurity MRI dual-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Shipped Settings
DDD
Battery Test
Nominal (Standard) Settings
DDD
Battery Test
395 If the right ventricular Lead Type is set to Unipolar, the nominal is Unipolar.
396
If the Lead Type is set to Bipolar, the nominal is Bipolar.
397 If the Lead Type is set to Bipolar, the nominal is Bipolar.
398
Available only in devices with MR Conditional Programming Capability.
399 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
277
Table 157. Shipped and Standard settings for Endurity and Endurity MRI dual-chamber pacemakers
Parameter
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
VIP Extension
VIP Search Interval
VIP Search Cycles
Negative AV/PV Hysteresis w/Search
Capture & Sense
ACap Confirm
V. AutoCapture Pacing
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
A. Max Sensitivity
A. Post-Paced Decay Delay
A. Post-Sensed Decay Delay
A. Post-Paced Threshold Start
A. Post-Sensed Threshold Start Percentage
A. Post-Sensed Minimum Start Threshold
A. AutoSense
V. Sensitivity
V. Max Sensitivity
Shipped Settings
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60
Off
130
Off
Off
Off
Off
Off
Off
Off
Off min§ min§
1 cycle
3 min
Medium
200 ms
150 ms
100 ms
100 ms
1 min
1 cycle
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
Nominal (Standard) Settings
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
60
Off
Off
Off min§
130 min§
1 cycle
Off
3 min
Medium
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
1 cycle
Off
Off
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
0.3 mV
0 ms
0 ms
0.8 mV
50%
0.3 mV
Off
2.0 mV
0.5 mV
400 If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
278
Table 157. Shipped and Standard settings for Endurity and Endurity MRI dual-chamber pacemakers
Parameter
V. Post-Sense Decay Delay
V. Post-Paced Decay Delay
V. Post-Sense Threshold Start Percentage
V. Post-Paced Threshold Start
V. AutoSense
AutoCapture Pacing
A. Backup Pulse Configuration
V. Backup Pulse Configuration
A. Search Interval
V. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
V. Lead Type
A. Pulse Configuration
V. Pulse Configuration
A. Sense Configuration
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression Pacing
Shipped Settings
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
See Package label
See Package label
See Package label
See Package label
Monitor
Monitor
2000
2000
200
200
Low
Auto
On
On
130
DDIR
180
80
Off
¬
¬
¬
¬
275 ms
93 ms
190 ms
250 ms
250 ms
175 ms
150 ms
A Pace on PMT min§ min§ min§
Nominal (Standard) Settings
60 ms
Auto
75%
Auto
Off
Bipolar
Bipolar
8 hr
8 hr
50/25 ms
Uncoded
Uncoded
Unipolar
Unipolar
Unipolar Tip
Unipolar Tip
Monitor
Monitor
2000
2000
200
200
¬
¬
¬
¬
275 ms
93 ms
190 ms
250 ms
DDIR
180
80
Off min§ min§
250 ms
Low
175 ms
150 ms
Auto
On
On
A Pace on PMT
130 min§
401
If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
402 If the Lead Type is set to Bipolar, the nominal is Bipolar.
403
If the Lead Type is set to Bipolar, the nominal is Bipolar.
404 If the Mode is set to AAI or AAT, the nominal is 200ms.
279
Table 157. Shipped and Standard settings for Endurity and Endurity MRI dual-chamber pacemakers
Parameter
Overdrive Pacing Cycles
Maximum AF Suppression Rate
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Shipped Settings
15 cycles
120 min§
DOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
15 cycles
120
DOO min§
85 min§
5.0 V
Bipolar
1.0 ms
Table 158. Shipped and Standard settings for Endurity Core dual-chamber pacemakers
Parameter
Basic Operation
Mode
Magnet Response
Ventricular Noise Reversion Mode
Sensor
Max Sensor Rate
Threshold
Slope
Reaction Time
Recovery Time
V. Triggering
Shipped Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Nominal (Standard) Settings
DDD
Battery Test
DOO
Passive
130 min§
Auto (+ 0.0)
Auto (+ 2)
Fast
Medium
Off
Rates
Base Rate
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Cycle Count
Intervention Rate
Intervention Duration
Recovery Time
60 min§
Off
130 min§
Off
Off
1 cycle
Off
3 min
Medium
60 min§
Off
130 min§
Off
Off
1 cycle
Off
3 min
Medium
Delays
Paced AV Delay
Sensed AV Delay
Rate Responsive AV Delay
Shortest AV Delay
Ventricular Intrinsic Preference (VIP)
VIP Extension
VIP Search Interval
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
200 ms
150 ms
Off
100 ms
Off
100 ms
1 min
VIP Search Cycles 1 cycle 1 cycle
405
Available only in devices with MR Conditional Programming Capability.
406 If parameters have not been previously programmed and are not autoprogrammed, the device will institute these standard or nominal settings.
407
Not available in Endurity™ Core DC devices.
408 Not available in Endurity™ Core DC devices.
409
Not available in Endurity™ Core DC devices.
410 Not available in Endurity™ Core DC devices.
411
Not available in Endurity™ Core DC devices.
412 Not available in Endurity™ Core DC devices.
280
Table 158. Shipped and Standard settings for Endurity Core dual-chamber pacemakers
Parameter
Negative AV/PV Hysteresis w/Search
Capture & Sense
ACap Confirm
V. AutoCapture Pacing
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
A. AutoSense
V. Sensitivity
V. AutoSense
AutoCapture Pacing
A. Backup Pulse Configuration
V. Backup Pulse Configuration
A. Search Interval
V. Search Interval
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Type
V. Lead Type
A. Pulse Configuration
V. Pulse Configuration
A. Sense Configuration
V. Sense Configuration
A. Lead Monitoring
V. Lead Monitoring
A. Upper Limit
V. Upper Limit
A. Lower Limit
V. Lower Limit
Refractories & Blanking
A. Refractory (PVARP)
A. Sense Refractory
A. Pace Refractory
V. Sense Refractory
V. Pace Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
V. Safety Standby
PVC Options
Shipped Settings
Off
N/A
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
N/A
2.0 mV
N/A
N/A
Bipolar
N/A
8 hr
50/25 ms
Uncoded
Uncoded
See Package label
See Package label
See Package label
See Package label
Monitor
Monitor
2000
2000
200
200
¬
¬
¬
¬
275 ms
93 ms
190 ms
250 ms
250 ms
High
175 ms
150 ms
44 ms
On
Off
413 If the A. Lead Type is set to Unipolar, the nominal is 1.0mV.
414
If the RV Lead Type is set to Unipolar, the nominal is Unipolar.
415 If the Lead Type is set to Bipolar, the nominal is Bipolar.
416
If the Lead Type is set to Bipolar, the nominal is Bipolar.
417 If the Mode is set to AAI or AAT, the nominal is 200ms.
275 ms
93 ms
190 ms
250 ms
250 ms
High
175 ms
150 ms
44 ms
On
Off
Uncoded
Uncoded
Unipolar
Unipolar
Unipolar Tip
Unipolar Tip
Monitor
Monitor
2000
¬
2000
¬
200
¬
200
¬
Nominal (Standard) Settings
Off
N/A
Off
2.5 V
2.5 V
0.4 ms
0.4 ms
0.5 mV
N/A
2.0 mV
N/A
N/A
Bipolar
N/A
8 hr
50/25 ms
281
Table 158. Shipped and Standard settings for Endurity Core dual-chamber pacemakers
Parameter
PMT Options
PMT Detection Rate
AT/AF Detection and Response
Auto Mode Switch
Atrial Tachycardia Detection Rate
AMS Base Rate
AF Suppression Pacing
Overdrive Pacing Cycles
Maximum AF Suppression Rate
MRI Settings
MRI Mode
MRI Base Rate
MRI Pulse Amplitude
MRI Pulse Configuration
MRI Pulse Width
Operating Parameters Tolerances
Shipped Settings
A Pace on PMT
130 min§
DDIR
180 min§
80 min§
Off
15 cycles
120 min§
DOO
85 min§
5.0 V
Bipolar
1.0 ms
Nominal (Standard) Settings
A Pace on PMT
130 min§
DDIR
180 min§
80 min§
Off
15 cycles
120 min§
DOO
85 min§
5.0 V
Bipolar
1.0 ms
Table 159. Operating parameter/measurement tolerances single-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Rest Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Capture & Sense
Pulse Amplitude
Pulse Width
Sensitivity
Leads
Lead Monitoring
Tolerance
± 15 ms
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 30% or 0.3 mV, whichever is greater
± 20% (200 - 2000 ¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
Table 160. Operating parameter/measurement tolerances for dual-chamber pacemakers
Parameter/Measurement
Basic Operation
Max Sensor Rate
Rates
Base Rate
Tolerance
± 15 ms
± 15 ms
418
Available only in devices with MR Conditional Programming Capability.
419 Sensitivity is with respect to a 20ms haversine test signal.
282
Rest Rate
Max Tracking Rate
Hysteresis Rate
Search Interval
Intervention Rate
Intervention Duration
Delays
Paced AV Delay
Sensed AV Delay
Shortest AV Delay
VIP Search Interval
Capture & Sense
A. Pulse Amplitude
V. Pulse Amplitude
A. Pulse Width
V. Pulse Width
A. Sensitivity
V. Sensitivity
AutoCapture Pacing/Cap Confirm
V. AutoCapture Paced/Sensed AV Delay
Leads
A. Lead Monitoring
V. Lead Monitoring
Refractories & Blanking
A. Refractory (PVARP)
A. Absolute Refractory Period
V. Refractory
Rate Responsive PVARP/VREF
Shortest PVARP/VREF
Post Ventricular Atrial Blanking (PVAB)
V. Blanking
PMT Detection Rate
AT/AF Detection & Response
Atrial Tachycardia Detection Rate
AMS Base Rate
Maximum AF Suppression Rate
NIPS Tolerances
Table 161. NIPS options
Parameter
Coupling Interval
S1 , S2, S3, and S4 Cycle
V. Backup Rate (VOO Pacing)
Sinus Node Recovery Delay
420
Sensitivity is with respect to a 20ms haversine test signal.
421 Sensitivity is with respect to a 20ms haversine test signal.
± 15 ms
± 15 ms
± 15 ms
± 2 sec
± 15 ms
± 2 sec
± 10 ms
± 10 ms
± 5 ms
± 2 sec
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 20% (BOL to ERI)
± 30% (ERI to EOL)
± 0.04 ms
± 0.04 ms
± 30%
± 30% or 0.3 mV, whichever is greater
± 5 ms
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
± 20% (200 - 2000
¬)
± 30% (100 - 200
¬, 2000 - 3000 ¬)
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
± 10 ms
-4/+10 ms
± 20 ms
± 15 ms
± 15 ms
± 15 ms
Tolerance
± 10 ms
± 5 ms
± 15 ms
± 1 sec
283
Physical Specifications
Table 162. Physical Specifications for Endurity and Endurity<MRI> devices
Specification
PM1140
PM1152
PM1160
PM1162
PM1172
Titanium Case Material
Case Coating
RF Antenna Material
Connector Material
Dimensions (mm) (h x l x t)
Weight (g)
Displacement volume
None
None
Epoxy
41 x 50 x 6
19
9.7 ± 0.5
Lead Connector
Dimensions and weight values are nominal.
IS-1
Battery Voltage
PM2140
PM2152
PM2160
PM2162
PM2172
Titanium
None
None
Epoxy
46 x 50 x 6
19
10.4 ± 0.5
IS-1
Table 163. Battery voltage for Endurity, Endurity MRI devices
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.60 V
2.47 V
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 164. X-ray ID codes
Device Model
PM1160, PM2160
X-ray ID Model Code
HI
PM1140, PM1152, PM1162, PM1172, PM2140, PM2152, PM 2162, PM2172 HM MRI
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 165. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-IP-2
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
IS-1 receptacle plug
422
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
423 (h x l x t) = height by length by thickness.
424
±0.5 cm³
425 Accepts IS-1 short terminal pin leads.
284
285
Fortify™ and Fortify™ ST Devices Technical Data
The tables below are applicable to the following Fortify™ and Fortify™ ST device models:
Fortify VR CD1233-40
Fortify VR CD1233-40Q
Fortify VR CD1234-40
Fortify VR CD1234-40Q
Fortify ST VR CD1235-40
Fortify ST VR CD1235-40Q
Fortify DR CD2233-40
Fortify DR CD2233-40Q
Fortify DR CD2234-40
Fortify DR CD2234-40Q
Fortify ST DR CD2235-40
Fortify ST DR CD2235-40Q
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
The technical data below include:
Physical Specifications (page 287)
Device Configurations (page 288)
Operating Parameters Tolerances (page 288)
X-ray Identification (page 289)
Spare Parts And Accessories (page 289)
Physical Specifications
Table 166. Physical specifications for Fortify ST devices
Specification
CD1233-40
CD1234-40
CD1235-40
CD2233-40
CD2234-40
CD2235-40
Dimensions (cm) (h x l x t)
7.3 x 4.0 x 1.4
Weight (g)
76
Displacement volume (cm³)
35
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
45
Noise detection rate
7.4 x 4.0 x 1.4
76
35
45
100 or more sensed events per second
Lead compatibility
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1
3.2 mm bipolar lead connector.
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Battery
CD1233-40Q
CD1234-40Q
CD1235-40Q
7.1 x 4.0 x 1.4
75
35
45
High voltage and RV low voltage: one DF4-
LLHH lead connector
CD2233-40Q
CD2234-40Q
CD2235-40Q
7.1 x 4.0 x 1.4
75
35
45
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one
IS-1 3.2 mm bipolar lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model 2850, One cell
426
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
427 (h x l x t) = height by length by thickness.
287
Device Configurations
Table 167. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
Fortify DR
Fortify ST DR
Fortify VR
Fortify ST VR
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
VVI(R), Pacer Off; Additional modes available in the tachyarrhythmia therapies Off configuration: VOO(R); Additional modes available as temporary modes: VOO
SVT Discrimination Mode
Fortify DR
Fortify ST DR
Fortify VR
Fortify ST VR
A Pulse Configuration and Sense Configuration
Fortify DR
Fortify ST DR
Ventricular Only, Dual Chamber
Ventricular Only
Bipolar (A-tip to A-ring)
V Pulse Configuration and Sense Configuration
All Models Bipolar (V-tip to V-ring)
Battery Voltage
Table 168. Battery voltage for devices with Battery Model 2850 (page 182)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 169. Operating parameter/measurement tolerances
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
428 Sensing only in the right atrium and right ventricle.
429
Dual-chamber devices only.
430 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
± 5 ms
± 50 ms
± 40 µs
288
Table 169. Operating parameter/measurement tolerances
Parameter/Measurement
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Tolerance
< 3
¬
± 15% at 50
¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15% Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV
(whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 170. X-ray ID codes
Device Model
CD1233-40/40Q, CD1234-40/40Q, CD1235-40/40Q, CD2233-40/40Q,
CD2234-40/40Q, CD2235-40/40Q
X-ray ID Model Code
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 171. Spare parts and accessories
Model Number
442-2
431 Load > 200ohms.
Device Description
Torque driver
289
Table 171. Spare parts and accessories
Model Number
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
432 Dual-chamber ICDs and CRTDs only.
290
Fortify Assura ™ Devices Technical Data
The tables below are applicable to the following Fortify Assura™ device models
Fortify Assura VR CD1257-40
Fortify Assura VR CD1257-40Q
Fortify Assura VR CD1259-40
Fortify Assura VR CD1259-40Q
Fortify Assura VR CD1261-40
Fortify Assura VR CD1261-40Q
Fortify Assura VR CD1359-40
Fortify Assura VR CD1359-40C
Fortify Assura VR CD1359-40Q
Fortify Assura VR CD1359-40QC
Fortify Assura DR CD2257-40
Fortify Assura DR CD2257-40Q
Fortify Assura DR CD2259-40
Fortify Assura DR CD2259-40Q
Fortify Assura DR CD2261-40
Fortify Assura DR CD2261-40Q
Fortify Assura DR CD2359-40
Fortify Assura DR CD2359-40C
Fortify Assura DR CD2359-40Q
Fortify Assura DR CD2359-40QC
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
Models with the "C" suffix are coated with Parylene.
The technical data below include:
Physical Specifications (page 292)
Device Configurations (page 292)
Operating Parameters Tolerances (page 293)
X-ray Identification (page 294)
Spare Parts And Accessories (page 294)
433 Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-
LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
291
Physical Specifications
Table 172. Physical specifications for Fortify Assura devices
Specification
CD1257-40
CD1259-40
CD1261-40
CD1359-40
CD1359-40C
CD2257-40
CD2259-40
CD2261-40
CD2359-40
CD2359-40C
Dimensions (cm) (h x l x t)
7.3 x 4.0 x 1.4
Weight (g)
76
Displacement volume (cm³)
35
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
45
Noise detection rate
7.4 x 4.0 x 1.4
76
35
45
100 or more sensed events per second
Lead compatibility
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one IS-1
3.2 mm bipolar lead connector.
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one or two IS-1 3.2 mm bipolar lead connectors.
Battery
CD1257-40Q
CD1259-40Q
CD1261-40Q
CD1359-40Q
CD1359-40QC
7.1 x 4.0 x 1.4
75
35
45
High voltage and RV low voltage: one DF4-
LLHH lead connector
CD2257-40Q
CD2259-40Q
CD2261-40Q
CD2359-40Q
CD2359-40QC
7.1 x 4.0 x 1.4
75
35
45
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one
IS-1 3.2 mm bipolar lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model 2850, One cell
Device Configurations
Table 173. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
Fortify Assura DR
Fortify Assura VR
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
VVI(R), Pacer Off; Additional modes available in the tachyarrhythmia therapies Off configuration: VOO(R); Additional modes available as temporary modes: VOO
SVT Discrimination Mode
Fortify Assura DR
Fortify Assura VR
Ventricular Only, Dual Chamber
Ventricular Only
A Pulse Configuration and Sense Configuration
Fortify Assura DR
Fortify ST DR
V Pulse Configuration and Sense Configuration
All Models
Bipolar (A-tip to A-ring)
Bipolar (V-tip to V-ring)
434 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
435
(h x l x t) = height by length by thickness.
436 Sensing only in the right atrium and right ventricle.
292
Battery Voltage
Table 174. Battery voltage for devices with Battery Model 2850 (page 182)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 175. Operating parameter/measurement tolerances
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Burst Fibber Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50 ¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15%
437
Dual-chamber devices only.
438 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
293
Table 175. Operating parameter/measurement tolerances
Parameter/Measurement
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
Tolerance
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV
(whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 176. X-ray ID codes
Device Model
CD1257-40/40Q, CD1259-40/40Q, CD1261-40/40Q, CD1359-
40/40C/40Q/40QC, CD2257-40/40Q, CD2259-40/40Q, CD2261-40/40Q,
CD2359-40/40C/40Q/40QC
X-ray ID Model Code
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 177. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
439
Load > 200ohms.
440 Dual-chamber ICDs and CRTDs only.
294
Promote™, Promote™ RF, Promote Accel™, Promote™+,
Promote™ Q, Promote™ LAP, and Promote Quadra ™
Devices Technical Data
The tables below are applicable to the following Promote™ device models:
Promote 3107-30
Promote 3107-36
Promote 3107-36Q
Promote 3109-30
Promote 3109-36
Promote RF 3207-30
Promote RF 3207-36
Promote CD3207-36Q
Promote+ CD3211-36
Promote+ CD3211-36Q
Promote RF 3213-30
Promote RF 3213-36
Promote Accel CD3215-30
Promote Accel CD3215-36
Promote Accel CD3215-36Q
Promote Q CD3221-36
Promote LAP CD3223-36P
Promote Q CD3227-36
Promote Quadra CD3237-40
Promote Quadra CD3237-40Q
Promote Quadra CD3239-40
Promote Quadra CD3239-40Q
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
Models CD3221-36 and CD3239-40/40Q use an IS4-LLLL LV pacing lead and support a programmable LV pacing vector.
Models CD3227-36 and CD3237-40/40Q use an IS4-LLLL LV pacing lead, support ten programmable LV pacing vectors, and support multiple LV pacing pulses (MultiPoint™ Pacing). SJ4-LLLL is equivalent to IS4-LLLL. St. Jude Medical's SJ4 and IS4 connector cavities comply with ISO27186:2010(E).
The technical data below include:
Physical Specifications (page 296)
Device Configurations (page 297)
Operating Parameters Tolerances (page 298)
X-ray Identification (page 299)
Spare Parts And Accessories (page 299)
295
Physical Specifications
Table 178. Physical specifications for Promote devices
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
Battery
3107-30
3109-30
7.4 x 5.0 x 1.3
74
37
Titanium
Epoxy
3107-36
3109-36
7.5 x 5.0 x 1.4
80
41
Silicone
34 42
100 or more sensed events per second
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one, two or three IS-1 3.2 mm bipolar (RA,
RV, and LV) lead connectors OR one or two IS-1 3.2 mm bipolar (RA and RV) lead connectors and one IS-1
3.2 mm unipolar (LV) lead connector.
Lithium/silver vanadium oxide; Greatbatch Medical,
Model 2555, One cell
3107-36Q
7.3 x 5.1 x 1.4
82
40
42
High voltage and RV low voltage: one DF4-LLHH lead connector.
RA and LV low voltage: one or two IS-1 3.2 mm bipolar lead connectors OR one IS-
1 3.2 mm bipolar (RA) lead connector and one IS-1 3.2 mm unipolar (LV) lead connector.
Lithium/silver vanadium oxide; Greatbatch Medical,
Model 2356, One cell
Table 179. Physical specifications for Promote, Promote RF, Promote+, Promote Accel devices
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
3207-36
CD3211-36
3213-36
CD3215-36
8.1 x 5.0 x 1.4
82
3207-30
3213-30
CD3215-30
8.0 x 5.0 x 1.3
76
CD3207-36Q
CD3211-36Q
CD3215-36Q
7.5 x 5.0 x 1.4
82
Can material
Header material
Septum material
Stored energy (J)
43
Titanium
Epoxy
Silicone
39 42
Noise detection rate
Lead compatibility
Battery
42 34
100 or more sensed events per second
42
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one, two or three IS-1 3.2 mm bipolar (RA,
RV, and LV) lead connectors OR one or two IS-1 3.2 mm bipolar (RA and RV) lead connectors and one IS-1
3.2 mm unipolar (LV) lead connector.
Lithium/silver vanadium oxide; Greatbatch Medical,
Model 2555, One cell
Lithium/silver vanadium oxide; Greatbatch
Medical, Model 2356,
One cell
High voltage and RV low voltage: one DF4-LLHH lead connector.
RA and LV low voltage: one or two IS-1 3.2 mm bipolar lead connectors OR one IS-
1 3.2 mm bipolar (RA) lead connector and one IS-1 3.2 mm unipolar (LV) lead connector.
Lithium/silver vanadium oxide; Greatbatch Medical,
Model 2555, One cell
441
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
442 (h x l x t) = height by length by thickness.
443
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
444 (h x l x t) = height by length by thickness.
296
Table 180. Physical specifications for .Promote Q, Promote LAP, and Promote Quadra. devices
Specification
CD3221-36
CD3227-36
Dimensions (cm) (h x l x t)
8.5 x 5.0 x 1.4
Weight (g)
88
Displacement volume (cm³)
49
Can material
Titanium
Header material
Epoxy
Septum material
Silicone
Stored energy (J)
42
Noise detection rate
CD3237-40
CD3239-40
8.1 x 5.1 x 1.5
88
46
45
100 or more sensed events per second
Lead compatibility
Battery
High voltage: one or two DF-1 3.2 mm lead connectors.
RA and RV Low voltage: one or two IS-1
3.2 mm bipolar lead connectors.
LV low voltage: one IS-4-LLLL quadripolar lead connector.
Lithium/silver vanadium oxide;
Greatbatch Medical,
Model 2555, One cell
CD3237-40Q
CD3239-40Q
7.4 x 5.1 x 1.5
87
44
45
CD3223-36P
8.5 x 5.1 x 1.6
90
46
42
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one
IS-1 3.2 mm bipolar lead connector.
LV low voltage: one
IS4-LLLL quadripolar lead connector.
Lithium/silver vanadium oxide; Greatbatch
Medical, Model 2753, One cell
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one, two or three IS-1 3.2 mm bipolar (RA, RV, and
LV) lead connectors
OR one or two IS-1
3.2 mm bipolar (RA and RV) lead connectors and one
IS-1 3.2 mm unipolar
(LV) lead connector.
LAP Sensor.
Lithium/silver vanadium oxide;
Greatbatch Medical,
Model 2555, One cell
Device Configurations
Table 181. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
All Promote devices except those with Ventricular
Triggering Capability
Promote devices with Ventricular Triggering Capability
AAI(R), VVI(R), DDI(R), DDD(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
AAI(R), VVI(R), VVT(R) DDI(R), DDD(R), DDT(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
SVT Discrimination Mode
Ventricular Only, Dual Chamber
A Pulse Configuration and Sense Configuration
Bipolar (A-tip to A-ring)
RV Pulse Configuration and Sense Configuration
Bipolar (RV-tip to RV-ring)
Distal tip 1-Mid 2; Distal tip 1-Proximal 4; Distal tip 1-RV Coil; Mid 2-Proximal 4; Mid 2-RV Coil; Mid 3-Mid 2; Mid 3-Proximal 4; Mid
3-RV Coil; Proximal 4-Mid 2; Proximal 4-RV Coil
445 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
446
(h x l x t) = height by length by thickness.
447 Sensing only in the right atrium and right ventricle.
297
LV Pulse Configuration (CRT-Ds without VectSelect Quartet™ LV Pulse Configuration Capability)
Bipolar (LV-tip to LV-ring), LV-tip to RV-coil, LV-ring to RV-coil
Battery Voltage
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Data
3.20 V (beginning of life)
2.45 V
2.35 V
Table 183. Battery voltage for devices with Battery Model 2753
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 184. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50
¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
448 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
298
Table 184. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Tolerance
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15% Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV (whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
X-ray ID codes
Device Model
3107-36/36Q/30, 3109-36/30
3207-36/30, CD3207-36Q, CD3211-36/36Q, 3213-36/30, CD3215-36/36Q/30,
CD3221-36, CD3227-36, CD3237-40/40Q, CD3239-40/40Q
CD3223-36P
X-ray ID Model Code
KA
KC
UL
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 185. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
449
Load > 200ohms.
450 Dual-chamber ICDs and CRTDs only.
299
Quadra Assura™ and Quadra Assura MP™ Devices Technical
Data
The tables below are applicable to the following Quadra Assura™ and Quadra Assura MP™ device models:
Quadra Assura CD3265-40
Quadra Assura CD3265-40Q
Quadra Assura CD3267-40
Quadra Assura CD3267-40Q
Quadra Assura MP CD3271-40
Quadra Assura MP CD3271-40Q
Quadra Assura CD3267-40
Quadra Assura CD3367-40C
Quadra Assura CD3367-40Q
Quadra Assura CD3367-40QC
Quadra Assura MP CD3371-40
Quadra Assura MP CD3371-40C
Quadra Assura MP CD3371-40Q
Quadra Assura MP CD3371-40QC
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
Models CD3265-40/40Q and CD3267-40/40Q use an IS4-LLLL LV pacing lead and supports a programmable LV pacing vector. Models CD3271-40 and CD3271-40Q use an IS4-LLLL LV pacing lead, support ten programmable LV pacing vectors, and support multiple LV pacing pulses (MultiPoint™ Pacing) SJ4-LLLL is equivalent to IS4-LLLL. St. Jude
Medical's SJ4 and IS4 connector cavities comply with ISO27186:2010(E).
Models with the "C" suffix are coated with Parylene.
The technical data below include:
Physical Specifications (page 302)
Device Configurations (page 302)
Operating Parameters Tolerances (page 303)
X-ray Identification (page 304)
Spare Parts And Accessories (page 304)
301
Physical Specifications
Table 186. Physical specifications for Quadra Assura and Quadra Assura MP devices
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
Battery
CD3265-40
CD3267-40
CD3271-40
CD3367-40
CD3367-40C
CD3371-40
CD3371-40C
8.3 x 4.1 x 1.4
83
4038
Titanium
Epoxy
Silicone
CD3265-40Q
CD3267-40Q
CD3271-40Q
CD3367-40Q
CD3367-40QC
CD3271-40Q
CD3271-40QC
7.6 x 4.1 x 1.4
81
45
100 or more sensed events per second
45
High voltage: one or two DF-1
3.2 mm lead connectors.
RA and RV Low voltage: one or two
IS-1 3.2 mm bipolar lead connectors.
LV low voltage: one IS-4-LLLL quadripolar lead connector.
High voltage and RV low voltage: one
DF4-LLHH lead connector.
RA low voltage: one IS-1 3.2 mm bipolar lead connector.
LV low voltage: one IS4-LLLL quadripolar lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model
2850, One cell
Device Configurations
Table 187. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
AAI(R), VVI(R), VVT(R) DDI(R), DDD(R), DDT(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
SVT Discrimination Mode
Ventricular Only, Dual Chamber
A Pulse Configuration and Sense Configuration
Bipolar (A-tip to A-ring)
RV Pulse Configuration and Sense Configuration
Bipolar (RV-tip to RV-ring)
Distal tip 1-Mid 2; Distal tip 1-Proximal 4; Distal tip 1-RV Coil; Mid 2-Proximal 4; Mid 2-RV Coil; Mid 3-Mid 2; Mid 3-Proximal 4; Mid
3-RV Coil; Proximal 4-Mid 2; Proximal 4-RV Coil
LV Pulse Configuration (CRT-Ds without VectSelect Quartet™ LV Pulse Configuration Capability)
Bipolar (LV-tip to LV-ring), LV-tip to RV-coil, LV-ring to RV-coil
451 The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
452
(h x l x t) = height by length by thickness.
453 Sensing only in the right atrium and right ventricle.
302
Battery Voltage
Table 188. Battery voltage for devices with Battery Model 2850 (page 182)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 189. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Burst Fibber Pulse Amplitude
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50 ¬
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15%
454 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
303
Table 189. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
Tolerance
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV (whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 190. X-ray ID codes
Device Model
CD3265-40/40Q, CD3267-40/40Q, CD3271-40/40Q, CD3367-40/40C/40Q/40QC,
CD3371-40/40C/40Q/40QC
X-ray ID Model Code
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 191. Spare parts and accessories
Model Number
442-2
AC-0130
424
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Torque driver
Silicone oil
Medical adhesive
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
455
Load > 200ohms.
456 Dual-chamber ICDs and CRTDs only.
304
Unify™, Unify Assura™, Unify Quadra™, and Unify Quadra
MP™ Devices Technical Data
The tables below are applicable to the following Unify™, Unify Assura™, Unify Quadra™, and Unify Quadra MP™ device models:
Unify CD3234-40
Unify CD3234-40Q
Unify CD3235-40
Unify CD3235-40Q
Unify Quadra CD3249-40
Unify Quadra CD3249-40Q
Unify Quadra CD3251-40
Unify Quadra CD3251-40Q
Unify Quadra MP CD3255-40
Unify Quadra MP CD3255-40Q
Unify Assura CD3257-40
Unify Assura CD3257-40Q
Unify Assura CD3261-40
Unify Assura CD3261-40Q
Unify Assura CD3361-40
Unify Assura CD3361-40C
Unify Assura CD3361-40Q
Unify Assura CD3361-40QC
NOTE
Models with the "Q" suffix are functionally equivalent in all respects to the same model without the "Q" suffix, except for the header. Models without the "Q" suffix use DF-1 lead connectors for the high-voltage leads, and models with the "Q" suffix use a single DF4-LLHH lead connector for the high-voltage leads and for the low voltage RV lead. SJ4-LLHH is equivalent to DF4-LLHH. SJ4 and DF4 connector cavities comply with ISO 27186:2010(E).
Models CD3249-40/40Q and CD3251-40/40Q use an IS4-LLLL LV pacing lead and support a programmable LV pacing vector. Model CD3255-40/40Q uses an IS4-LLLL LV pacing lead, support ten programmable LV pacing vectors, and support multiple LV pacing pulses (MultiPoint™ Pacing) SJ4-LLLL is equivalent to IS4-LLLL. St. Jude Medical's SJ4 and
IS4 connector cavities comply with ISO27186:2010(E).
Models with the "C" suffix are coated with Parylene.
The technical data below include:
Physical Specifications (page 306)
Device Configurations (page 307)
Operating Parameters Tolerances (page 307)
X-ray Identification (page 308)
Spare Parts And Accessories (page 308)
305
Physical Specifications
Table 192. Physical specifications for Unify, Unify Assura devices
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
Battery
CD3234-40
CD3235-40
CD3257-40
CD3261-40
CD3361-40
CD3361-40C
7.9 x 4.0 x 1.4
78
36
Titanium
CD3234-40Q
CD3235-40Q
CD3257-40Q
CD3261-40Q
CD3361-40Q
CD3361-40QC
7.3 x 4.0 x 1.4
77
36
Epoxy
Silicone
45
100 or more sensed events per second
45
High voltage: one or two DF-1 3.2 mm lead connectors.
Low voltage: one, two or three IS-1 3.2 mm bipolar (RA, RV, and LV) lead connectors OR one or two IS-1 3.2 mm bipolar (RA and RV) lead connectors and one IS-1 3.2 mm unipolar (LV) lead connector.
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA and LV low voltage: one or two IS-1 3.2 mm bipolar lead connectors OR one IS-1 3.2 mm bipolar (RA) lead connector and one IS-1
3.2 mm unipolar (LV) lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model 2850, One cell
Table 193. Physical specifications for Unify Quadra, Unify Quadra MP devices
Specification
Dimensions (cm) (h x l x t)
Weight (g)
Displacement volume (cm³)
Can material
Header material
Septum material
Stored energy (J)
Noise detection rate
Lead compatibility
Battery
CD3249-40
CD3251-40
CD3253-40
CD3255-40
8.3 x 4.1 x 1.4
83
40
Titanium
CD3249-40Q
CD3251-40Q
CD3255-40Q
7.6 x 4.1 x 1.4
81
38
Epoxy
Silicone
45
100 or more sensed events per second
45
High voltage: one or two DF-1 3.2 mm lead connectors.
RA and RV Low voltage: one or two IS-1
3.2 mm bipolar lead connectors.
LV low voltage: one IS-4-LLLL quadripolar lead connector.
High voltage and RV low voltage: one DF4-
LLHH lead connector.
RA low voltage: one IS-1 3.2 mm bipolar lead connector.
LV low voltage: one IS4-LLLL quadripolar lead connector.
Silver vanadium oxide/carbon monofluoride; Greatbatch Medical, Model 2850, One cell
457
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
458 (h x l x t) = height by length by thickness.
459
The dimensions, weight, and displacement volume are nominal values based on engineering model measurements.
460 (h x l x t) = height by length by thickness.
306
Device Configurations
Table 194. Device configurations
Tachyarrhythmia Configuration
Defibrillator with No Tachycardia Response (1 Zone: VF);
Defibrillator with Tachycardia Response - Single Tachycardia Discrimination (2 Zones: VT, VF);
Defibrillator with Tachycardia Response - Two Tachycardia Rate Discrimination (3 Zones: VT-1, VT-2, VF); Off
Bradyarrhythmia Mode
AAI(R), VVI(R), VVT(R) DDI(R), DDD(R), DDT(R), Pacer Off;
Additional modes available in the tachyarrhythmia therapies Off configuration: AOO(R), VOO(R), DOO(R);
Additional modes available as temporary modes: AOO, VOO, DOO, AAT
SVT Discrimination Mode
Ventricular Only, Dual Chamber
A Pulse Configuration and Sense Configuration
Bipolar (A-tip to A-ring)
RV Pulse Configuration and Sense Configuration
Bipolar (RV-tip to RV-ring)
Distal tip 1-Mid 2; Distal tip 1-Proximal 4; Distal tip 1-RV Coil; Mid 2-Proximal 4; Mid 2-RV Coil; Mid 3-Mid 2; Mid 3-Proximal 4; Mid
3-RV Coil; Proximal 4-Mid 2; Proximal 4-RV Coil
LV Pulse Configuration (CRT-Ds without VectSelect Quartet™ LV Pulse Configuration Capability)
Bipolar (LV-tip to LV-ring), LV-tip to RV-coil, LV-ring to RV-coil
Battery Voltage
Table 195. Battery voltage for devices with Battery Model 2850 (page 182)
Parameter
Battery voltage
Elective replacement voltage (unloaded)
End-of-life voltage (unloaded)
Operating Parameters Tolerances
Data
3.20 V (beginning of life)
2.59 V
2.54 V
Table 196. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Pacing Parameters
Paced AV Delay
Pace Refractory Period
Pacing Interval
Pacing Pulse Width
Pace Pulse Amplitude
Tolerance
± 10 ms
± 10 ms
± 15 ms
± 40 µs
± 25% (BOL to ERI)
± 30% (ERI to EOL)
Sense Parameters
Sensing Refractory Periods
Cardioversion/Defibrillation Parameters
Post-Shock Refractory Period
Shock Pulse Width
Output Impedance
HV Lead Impedance
± 5 ms
± 50 ms
± 40 µs
< 3
¬
± 15% at 50
¬
461
Sensing only in the right atrium and right ventricle.
462 Pulse width of 0.5 ms into 500 ohms at 37°C with telemetry inactive.
307
Table 196. Operating parameter/measurement tolerances for CRT-Ds
Parameter/Measurement
Cap Charge Time
Stored Voltage
Delivered Energy: at Max Energy
20 J < to < Max Energy
5 J < to < 20 J
1 J < to < 5 J
Arrhythmia Detection Parameters
Detection Intervals
SVT/VT Therapy Timers
Interval Stability Delta
AV Delta
Sudden Onset Delta
Arrhythmia Induction Parameters
Post Therapy Pacing Pause
Burst Fibber Interval
Shock-on-T
NIPS Interval
ATP Pacing Interval
Tolerance
± 0.15 s
± 5%
± 10%
± 15%
± 20%
± 30%
± 10 ms
± 3 s
± 10 ms
± 10 ms
± 10 ms
± 0.25 s
± 15 ms
± 5 ms
± 15 ms
± 5 ms (fixed)
± 3% (adaptive)
± 15% Burst Fibber Pulse Amplitude
Diagnostics / Real-Time Status Data
Sensed Interval
Minimum/Maximum Cycle Length
Pacing Lead Impedance (2 & 4 V)
Pacing Voltage Measurement
± 10 ms
± 10 ms
± 15% (200 to <=1000
¬)
± 20% (1000 <=2000
¬)
± 15% or ± 100 mV (whichever is greater)
X-ray Identification
Each pulse generator has an X-ray absorptive marker for non-invasive identification. The marker consists of the St. Jude Medical logo
(SJM) and a two-letter model code shown in the following table.
Table 197. X-ray ID codes
Device Model
CD3234-40/40Q, CD3235-40/40Q, CD3249-40/40Q, CD3251-40/40Q, CD3255-
40/40Q, CD3257-40/40Q, CD3261-40/40Q, CD3357-40/40C/40Q/40QC,
CD3361-40/40C/40Q/40QC
X-ray ID Model Code
KC
Spare Parts and Accessories
Only the accessories shown in the following table are approved for use with these devices.
Table 198. Spare parts and accessories
Model Number
442-2
AC-0130
424
463 Load > 200ohms.
Device Description
Torque driver
Silicone oil
Medical adhesive
308
Table 198. Spare parts and accessories
Model Number
AC-0160
AC-DP-3
AC-IP-2
AC-IS4PP
Device Description
Magnet
DF-1 receptacle plug
IS-1 receptacle plug
IS4/DF4 port plug
464 Dual-chamber ICDs and CRTDs only.
309
Clinician Use Information for Bradycardia Devices
Clinician Use Information for Tachycardia Devices (page 333).
Contents:
Elective Replacement Indicator (ERI) (page 330)
Device Longevity
Many individual factors affect pulse generator service life, such as programmed parameters, percentage of time paced, internal impedance, etc. The projected longevity data in the following tables are based on accelerated battery test data under certain conditions and do not account for such factors as sensor-driven pacing rate changes, effects of rate-limiting algorithms, the patient’s medical condition, or effects of a specific pacing prescription. Furthermore, these data are based on battery life projections, which are approximations.
ERI precedes EOL by a wide margin of safety, not less than three months under normal circumstances.
Accent™ SR Model PM1110 Projected Time From Implant to EOL
Table 199. Accent™ SR Model PM1110 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 13.2 13.6
ERI to EOL in Months
(Mean)
1.0 V 6.4 6.6
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
12.9
9.1
13.8
10.6
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
6.3
4.6
6.7
5.2
Pacing at 60 min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
16.1
15.3
16.2
15.7
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
7.8
7.4
7.8
7.6
RV 1000
¬
13.8
6.7
14.3
11.5
7.0
5.7
16.3
15.9
7.9
7.7
Accent Models ST SR PM1122, MRI PM1124, and ST MRI PM1126 Projected Time From Implant to EOL
Table 200. Accent Models ST SR PM1122, MRI PM1124, and ST MRI PM1126 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 14.7 15.2
ERI to EOL in Months
(Mean)
1.0 V 7.1 7.3
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
14.2
9.8
15.4
11.5
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
7.0
4.9
7.5
5.7
RV 1000
¬
15.4
7.5
16.1
12.6
7.8
6.2
311
Table 200. Accent Models ST SR PM1122, MRI PM1124, and ST MRI PM1126 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60 min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
17.6
16.7
17.8
17.1
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
8.6
8.1
8.6
8.3
RV 1000
¬
17.9
17.4
8.7
8.4
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On, ST Monitor On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
14.2
9.8
15.4
11.5
16.1
12.6
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
7.0
4.9
7.5
5.7
7.8
6.2
Endurity™ Core Models PM1140 and PM 1152 Projected Time From Implant to EOL
Table 201. Endurity Core Models PM1140 and PM 1152 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60 min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 15.4 16.0
ERI to EOL in Months
(Mean)
1.0 V 10.0 10.3
Pacing at 60 min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
14.8
10.1
16.0
11.9
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
9.7
6.8
10.5
7.9
Pacing at 60
min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
14.3
9.5
15.6
11.2
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
9.5
6.4
10.3
7.5
RV 1000
¬
16.3
10.5
16.8
13.1
11.0
8.7
16.4
12.5
10.7
8.3
Endurity™ Models PM1160, PM 1162, and Endurity MRI PM1172 Projected Time From Implant to
EOL
Table 202. Endurity Models PM1160, PM 1162, and Endurity MRI Model PM1172 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 15.0 15.5
ERI to EOL in Months
(Mean)
1.0 V 9.8 10.1
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
14.4
9.9
15.6
11.6
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
9.5
6.7
10.2
7.8
RV 1000
¬
15.9
10.3
16.3
12.8
10.7
8.5
465 Only applicable in devices with ST Monitoring capability.
312
Table 202. Endurity Models PM1160, PM 1162, and Endurity MRI Model PM1172 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60 min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
18.5
17.5
18.7
17.9
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
12.0
11.4
12.1
11.4
RV 1000
¬
18.8
18.2
12.2
11.8
Accent SR RF Model PM1210 Projected Time From Implant to EOL
Table 203. Accent SR RF Model PM1210 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 12.9 13.3
ERI to EOL in Months
(Mean)
1.0 V 6.3 6.4
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
12.5
8.9
13.4
10.3
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
6.1
4.5
6.5
5.1
Pacing at 60 min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
15.5
14.8
15.7
15.1
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
7.5
7.2
7.6
7.3
RV 1000
¬
13.5
6.5
13.9
11.2
6.8
5.6
15.7
15.3
7.6
7.4
Accent Models ST SR RF PM1222, MRI PM1224, and ST MRI PM1226 Projected Time From
Implant to EOL
Table 204. Accent Models ST SR RF PM1222, MRI PM1224, and ST MRI PM1226 Projected Time From Implant to EOL
Pulse Amplitude
RV 500 ¬ RV 750 ¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 14.2 14.7
ERI to EOL in Months
(Mean)
1.0 V 6.9 7.2
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
13.7
9.6
14.8
11.1
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
6.8
4.8
7.3
5.6
RV 1000 ¬
15.0
7.3
15.4
12.2
7.6
6.1
Pacing at 60
min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
16.9
16
17.1
16.4
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
8.3
7.9
8.3
8.0
17.1
16.7
8.4
8.2
313
Table 204. Accent Models ST SR RF PM1222, MRI PM1224, and ST MRI PM1226 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60 min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On, ST Monitor On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
13.7
9.6
14.8
11.1
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
6.8
4.8
7.3
5.6
RV 1000
¬
15.4
12.2
7.6
6.1
Assurity Models PM1240, PM 1260 and Assurity MRI Model PM1272 Projected Time From Implant to EOL
Table 205. Assurity Models PM1240, PM1260 and Assurity MRI Model PM1272 Projected Time From Implant to EOL
Pulse Amplitude
RV 500
¬
RV 750
¬
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
1.0 V 14.5 15.0
ERI to EOL in Months
(Mean)
1.0 V 9.5 9.8
Pacing at 60
min§, 100% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
13.9
9.7
15.0
11.3
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
9.2
6.5
10.0
7.6
RV 1000
¬
15.3
10.0
15.7
12.4
10.3
8.3
Pacing at 60
min§, 10% VVI Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
17.7
16.8
17.9
17.2
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
11.6
11.0
11.7
11.3
18.0
17.5
11.7
11.4
Accent DR Model PM2112 Projected Time From Implant to EOL
Table 206. Accent DR Model PM2112 Projected Time From Implant to EOL
Pulse Amplitude
A 500 ¬
RV 500
¬
A 750 ¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.3 10.1
ERI to EOL in Months
(Mean)
A 2.5 V
RV 1.0 V
4.6 5.0
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.2 10.2
A 3.5 V
RV 3.5 V
5.8 7.0
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
4.6
3.1
5.0
3.6
A 1000 ¬
RV 1000
¬
10.5
5.1
10.8
7.9
5.3
4.0
466 Only applicable in devices with ST Monitoring capability.
314
Table 206. Accent DR Model PM2112 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
10.7 11.4
A 3.5 V
RV 3.5 V
7.8 8.9
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
5.3
4.0
5.6
4.5
A 1000
¬
RV 1000
¬
11.9
9.7
5.8
4.8
Accent Models ST DR PM2122, MRI PM2124, and ST MRI PM2126 Projected Time From Implant to EOL
Table 207. Accent Models ST DR PM2122, MRI PM2124, and ST MRI PM2126 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.5 10.3
ERI to EOL in Months
(Mean)
A 2.5 V
RV 1.0 V
4.7 5.1
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.4 10.4
A 3.5 V
RV 3.5 V
5.9 7.1
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
4.7
3.1
5.2
3.7
A 1000
¬
RV 1000
¬
10.7
5.3
11.0
8.0
5.5
4.1
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
11.0 11.7
A 3.5 V
RV 3.5 V
7.9 9.1
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
5.5
4.1
5.8
4.6
12.2
9.9
6.0
4.9
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On, ST Monitor On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
9.4
5.9
10.4
7.1
11.0
8.0
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
4.7
3.1
5.2
3.7
5.5
4.1
467 Only applicable in devices with ST Monitoring capability.
468
Only applicable in devices with ST Monitoring capability.
469 Only applicable in devices with ST Monitoring capability.
315
Endurity Core Models PM2140 and PM2152 Projected Time From Implant to EOL
Table 208. Endurity Core Models PM2140 and PM2152 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
10.2 11.1
ERI to EOL in Months
(Mean)
A 2.5 V
RV 1.0 V
6.8 7.3
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.9 11.1
A 3.5 V
RV 3.5 V
6.1 7.4
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
6.7
4.2
7.4
5.1
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
11.8 12.6
A 3.5 V
RV 3.5 V
8.4 9.7
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
7.8
5.7
8.4
6.5
A 1000
¬
RV 1000
¬
11.6
7.6
11.8
8.4
7.9
5.7
13.2
10.61
8.7
7.1
Endurity Models PM2160, PM2162 and Endurity MRI Model 2172 Projected Time From Implant to
EOL
Table 209. Endurity Models PM2160, PM2162 and Endurity MRI Model PM2172 Projected Time From Implant to EOL
ERI to EOL in Months
(Mean)
Pulse Amplitude
A 2.5 V
RV 1.0 V
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.9 10.7
6.6 7.1
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.7 10.8
A 3.5 V
RV 3.5 V
6.0 7.3
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
6.5
4.2
7.2
5.0
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
11.4 12.3
A 3.5 V
RV 3.5 V
8.2 9.5
A 1000
¬
RV 1000
¬
11.2
7.4
11.5
8.3
7.6
5.6
12.7
10.3
316
Table 209. Endurity Models PM2160, PM2162 and Endurity MRI Model PM2172 Projected Time From Implant to EOL
ERI to EOL in Months
(Mean)
Pulse Amplitude
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
A 500
¬
RV 500
¬
7.6
5.6
A 750
¬
RV 750
¬
8.1
6.3
A 1000
¬
RV 1000
¬
8.4
6.9
Accent DR RF Model PM2212 Projected Time From Implant to EOL
Table 210. Accent DR Model PM2112 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.1 9.8
ERI to EOL in Months
(Mean)
A 2.5 V
RV 1.0 V
4.6 4.9
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
8.9 9.9
A 3.5 V
RV 3.5 V
5.7 6.8
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
4.5
3.0
4.9
3.6
A 1000
¬
RV 1000
¬
10.2
5.1
10.5
7.7
5.2
3.9
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
10.4 11.1
A 3.5 V
RV 3.5 V
7.6 8.7
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
5.2
3.9
5.5
4.4
11.5
9.5
5.7
4.7
Accent Models ST PM2222, MRI PM2224, and ST MRI PM2226 Projected Time From Implant to
EOL
Table 211. Accent Models ST PM2222, MRI PM2224, and ST MRI PM2226 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
A 750
¬
RV 750
¬
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.3 10.0
ERI to EOL in Months
(Mean)
A 2.5 V
RV 1.0 V
4.7 5.0
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.1 10.1
A 3.5 V
RV 3.5 V
5.7 6.9
A 1000
¬
RV 1000
¬
10.5
5.2
10.7
7.8
470 Only applicable in devices with ST Monitoring capability.
317
Table 211. Accent Models ST PM2222, MRI PM2224, and ST MRI PM2226 Projected Time From Implant to EOL
ERI to EOL in Months
(Mean)
Pulse Amplitude
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
A 500
¬
RV 500
¬
4.6
3.1
A 750
¬
RV 750
¬
5.1
3.6
A 1000
¬
RV 1000
¬
5.3
4.0
Pacing at 60
min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
10.7 11.4
A 3.5 V
RV 3.5 V
7.8 8.9
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
5.3
4.0
5.7
4.5
11.8
9.7
5.8
4.9
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On, ST Monitor On
Implant to ERI in Years
(Mean)
RV 2.5 V
RV 3.5 V
9.1
5.7
10.1
6.9
10.7
7.8
ERI to EOL in Months
(Mean)
RV 2.5 V
RV 3.5 V
4.6
3.1
5.1
3.6
5.3
4.0
Assurity Models PM2240, PM2260 and Assurity MRI Model PM2272 Projected Time From Implant to EOL
Table 212. Assurity Models PM2240, PM2260 and Assurity MRI Model PM2272 Projected Time From Implant to EOL
ERI to EOL in Months
(Mean)
Pulse Amplitude
A 500
¬
RV 500 ¬
A 750
¬
RV 750 ¬
Pacing at 60 min§, 100% DDD Pacing, AutoCapture parameter On, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 1.0 V
9.6 10.4
A 2.5 V
RV 1.0 V
6.9 6.4
A 1000
¬
RV 1000 ¬
10.9
7.2
Pacing at 60
min§, 100% DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
9.4 10.5
A 3.5 V
RV 3.5 V
5.9 7.1
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
6.3
4.1
7.0
5.0
11.2
8.1
7.4
5.5
Pacing at 60 min§, 100% RA, 10% RV DDD Pacing, AutoCapture parameter Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
11.1 11.9
A 3.5 V
RV 3.5 V
8.0 9.2
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
A 3.5 V
RV 3.5 V
7.4
5.5
7.9
6.2
12.3
10.0
8.2
6.7
471
Only applicable in devices with ST Monitoring capability.
472 Only applicable in devices with ST Monitoring capability.
318
Anthem Model PM3112 Projected Time From Implant to EOL
Table 213. Anthem Model PM3112 Projected Time From Implant to EOL
Pulse Amplitude
A 500
¬
RV 500
¬
LV 500 ¬
Pacing at 60
min§, 100% DDD BiV Pacing, Cap Confirm Off
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
7.9
4.5
ERI to EOL in Months
(Mean)
A 3.5 V
RV 3.5 V
LV 3.5 V
A 2.5 V
RV 2.5 V
LV 2.5 V
4.0
A 3.5 V
RV 3.5 V
LV 3.5 V
2.5
A 750
¬
RV 750
¬
RV 750
¬
9.0
5.6
4.5
3.0
Allure Models PM3120 and PM3140 Projected Time From Implant to EOL
Table 214. Allure Models PM3120 and PM3140 Projected Time From Implant to EOL
Pulse Amplitude
A 500 ¬
RV 500
¬
LV 500 ¬
Pacing at 60
min§, 100% DDD BiV Pacing, Cap Confirm Off
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
8.2
A 3.5 V
RV 3.5 V
LV 3.5 V
4.5
A 750 ¬
RV 750
¬
RV 750
¬
9.4
5.7
ERI to EOL in Months
(Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
A 3.5 V
RV 3.5 V
LV 3.5 V
6.6
4.0
7.5
4.9
Table 215. Allure Models PM3120 and PM3140 Projected Time From Implant to EOL (70 min§)
Pulse Amplitude
A 500
¬
RV 500
¬
LV 500
¬
Pacing at 70
min§,100% DDD-BiV Pacing, Cap Confirm Off
Implant to ERI in Years (Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
A 3.5 V
RV 3.5 V
LV 3.5 V
A 5.0 V
RV 5.0 V
LV 5.0 V
7.0
3.7
2.7
A 1000
¬
RV 1000
¬
RV 1000
¬
9.8
6.5
4.9
3.4
A 1000 ¬
RV 1000
¬
RV 1000
¬
10.2
6.7
8.1
5.5
A 300
¬
RV 300
¬
LV 300
¬
5.6
2.6
1.9
319
Table 215. Allure Models PM3120 and PM3140 Projected Time From Implant to EOL (70 min§)
ERI to EOL in Months (Mean)
Pulse Amplitude
A 500
¬
RV 500
¬
LV 500
¬
5.8 A 2.5 V
RV 2.5 V
LV 2.5 V
A 3.5 V
RV 3.5 V
LV 3.5 V
3.5
A 5.0 V
RV 5.0 V
LV 5.0 V
2.7
Anthem RF Model PM3212 Projected Time From Implant to EOL
Table 216. Anthem RF Model PM3212 Projected Time From Implant to EOL
Pulse Amplitude
A 500 ¬
RV 500
¬
LV 500 ¬
Pacing at 60 min§, 100% DDD BiV Pacing, Cap Confirm Off
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
7.7
4.4
ERI to EOL in Months
(Mean)
A 3.5 V
RV 3.5 V
LV 3.5 V
A 2.5 V
RV 2.5 V
LV 2.5 V
4.0
A 3.5 V
RV 3.5 V
LV 3.5 V
2.5
A 750 ¬
RV 750
¬
RV 750
¬
8.8
5.5
4.4
3.0
Allure RF Models PM3222 and PM3242 Projected Time From Implant to EOL
A 300
¬
RV 300
¬
LV 300
¬
4.8
2.7
2.1
A 1000 ¬
RV 1000
¬
RV 1000
¬
9.5
6.4
4.8
3.4
Table 217. Allure RF Models PM3222 and PM3242 Projected Time From Implant to EOL (60 min§)
Pulse Amplitude
A 500
¬
RV 500
¬
LV 500 ¬
Pacing at 60
min§, 100% DDD BiV Pacing, Cap Confirm Off
Implant to ERI in Years
(Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
8.0
4.5
A 750
¬
RV 750
¬
RV 750
¬
9.2
5.6
ERI to EOL in Months
(Mean)
A 3.5 V
RV 3.5 V
LV 3.5 V
A 2.5 V
RV 2.5 V
LV 2.5 V
6.5 7.3
A 3.5 V
RV 3.5 V
LV 3.5 V
4.0 4.8
A 1000
¬
RV 1000
¬
RV 1000
¬
10
6.5
7.9
5.5
473 Calculated with a Pulse Width of 0.4 ms.
320
Table 218. Allure RF Models PM3222 and PM3242 Projected Time From Implant to EOL (70 min§)
Pulse Amplitude
A 500
¬
RV 500
¬
LV 500
¬
Pacing at 70
min§,100% DDD-BiV Pacing, Cap Confirm Off
Implant to ERI in Years (Mean)
A 2.5 V
RV 2.5 V
LV 2.5 V
ERI to EOL in Months (Mean)
A 3.5 V
RV 3.5 V
LV 3.5 V
A 5.0 V
RV 5.0 V
LV 5.0 V
A 2.5 V
RV 2.5 V
LV 2.5 V
6.8
3.6
2.7
5.7
3.4
A 300
¬
RV 300
¬
LV 300
¬
5.5
2.6
1.9
4.7
2.7
A 3.5 V
RV 3.5 V
LV 3.5 V
A 5.0 V
RV 5.0 V
LV 5.0 V
2.7 2.1
Quadra Allure MP RF Model PM3262 Projected Time From Implant to EOL
Table 219. Quadra Allure MP RF Model PM3262 Projected Time From Implant to EOL (60 min§)
Pulse Amplitude
500
¬
750
¬
Pacing at 60 min§, 100% VVI Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV - 2.5 V
RV - 3.5 V
13.9
9.6
15.0
11.2
ERI to EOL in Months
(Mean)
RV - 5.0 V
RV - 2.5 V
RV - 3.5 V
8.0
10.8
7.7
9.6
11.6
8.9
900
¬
15.4
11.9
10.4
12.0
9.4
RV - 5.0 V 6.5 7.7 8.2
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 100% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
6.7 7.9 8.4
3.6 4.6 5.1
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
2.2 3.0 3.4
474 Calculated with a Pulse Width of 0.5 ms.
321
ERI to EOL in Months
(Mean)
Pulse Amplitude
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
500 ¬
6.5
750 ¬
7.4
900 ¬
7.7
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
4.0 4.8 5.2
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
3.2 3.8 4.1
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 100% A Pacing, 0.5 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
6.3 7.5 8.0
3.3 4.2 4.7
ERI to EOL in Months
(Mean)
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
2.0
6.2
3.7
2.7
7.1
4.5
3.1
7.5
4.9
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
3.0 3.6 3.9
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 0% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.5 6.7 7.2
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.2 5.3 5.8
4.1 5.2 5.7
ERI to EOL in Months
(Mean)
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
6.2
5.2
7.1
6.1
7.5
6.5
322
Pulse Amplitude
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
500 ¬
4.8
750 ¬
5.7
900 ¬
6.1
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 15% A Pacing, 0.4 ms Pulse Width Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.4 6.6 7.2
4.1 5.2 5.7
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.0
6.1
5.1
5.0
7.0
6.0
5.6
7.4
6.5
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
4.6 5.5 5.9
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 50% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.3 6.4 7.0
4.0 5.1 5.6
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
3.7
5.8
5.0
4.2
4.7
6.7
5.8
5.1
5.3
7.2
6.3
5.5
Pulse Amplitude
500
¬
750
¬
900
¬
323
Pulse Amplitude
500 ¬ 750 ¬ 900 ¬
Pacing at 60
min§, 100% DDD BiV Pacing, 100% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.0 6.2 6.7
3.9 4.9 5.4 A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
3.4 4.4 4.9
ERI to EOL in Months
(Mean)
5.5 6.4 6.8 A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
4.7
3.9
5.7
4.7
6.1
5.1
Table 220. Quadra Allure MP RF Model PM3262 Projected Time From Implant to EOL (70 min§)
Pulse Amplitude
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
500
¬
750
¬
Pacing at 70 min§,100% DDD-BiV Pacing, 100% A Pacing, 0.5 ms Pulse Width, Cap Confirm Off,
Stored EGMS On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
5.7 6.8
2.8 3.7
1.8 2.4
ERI to EOL in Months
(Mean)
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
5.7 6.6
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
3.4
2.8
4.2
3.3
Pulse Amplitude
500
¬
750
¬
900
¬
7.3
4.2
2.7
6.9
4.5
3.6
900
¬
324
Pulse Amplitude
500 ¬ 750 ¬ 900 ¬
Pacing at 70
min§, 100% DDD-BiV Pacing, 15% A Pacing, 0.4ms Pulse Width, Cap Confirm Off, Stored EGM On, 3 hours
Telemetry Session at Implant, 20 minutes in clinic telemetry usage
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
4.8 5.9 6.4
4.4 5.5 6.0
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
3.7
3.1
5.7
5.4
4.4
4.7
4.0
6.5
6.2
5.2
5.2
4.5
6.9
6.6
5.7
A - 3.5 V
RV - 3.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.0 4.8 5.2
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 70
min§, 100% DDD-BiV Pacing, 15% A Pacing, 0.4ms Pulse Width, Cap Confirm On, Stored EGM On, 3 hours
Telemetry Session at Implant, 20 minutes in clinic telemetry usage
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.0 V
LV1 - 3.0 V
LV2 - 3.0 V
4.9 6.0 6.5
4.5 5.6 6.1
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.0 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
4.4
3.6
5.7
5.5
5.5
4.6
6.6
6.4
6.0
5.1
7.0
6.8
325
Pulse Amplitude
A - 3.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 5.0 V
LV2 - 5.0 V
500 ¬
5.3
4.7
750 ¬
6.2
5.6
Quadra Allure MP Model PM3160 Projected Time From Implant to EOL
900 ¬
6.6
6.0
Table 221. Quadra Allure MP Model PM3160 Projected Time From Implant to EOL (60 min§)
Pulse Amplitude
500 ¬ 750 ¬
Pacing at 60
min§, 100% VVI Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
RV - 2.5 V
RV - 3.5 V
14.3
9.8
15.5
11.5
900 ¬
15.9
12.3
ERI to EOL in Months
(Mean)
RV - 5.0 V
RV - 2.5 V
RV - 3.5 V
RV - 5.0 V
8.1
11.1
7.8
6.6
9.8
12.0
9.1
7.8
10.6
12.4
9.6
8.4
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60 min§, 100% DDD BiV Pacing, 100% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
6.8 8.0 8.6
3.6 4.6 5.2 A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
2.3 3.0 3.5
ERI to EOL in Months
(Mean)
6.6 7.5 7.9
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
4.0 4.8 5.3
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
3.2 3.8 4.2
Pulse Amplitude
500
¬
750
¬
900
¬
326
Pulse Amplitude
500 ¬ 750 ¬ 900 ¬
Pacing at 60
min§, 100% DDD BiV Pacing, 100% A Pacing, 0.5 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
6.4 7.6 8.2
3.3 4.3 4.8 A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
2.0 2.7 3.1
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
6.3 7.2 7.6
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
3.7 4.6 5.0
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
3.0 3.6 3.9
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 0% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.6 6.8 7.4
4.2 5.3 5.9
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.2 5.3 5.8
ERI to EOL in Months
(Mean)
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
6.3
5.3
7.2
6.2
7.6
6.7
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
4.8 5.7 6.2
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 15% A Pacing, 0.4 ms Pulse Width Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.5 6.7 7.3
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.2 5.3 5.8
327
ERI to EOL in Months
(Mean)
Pulse Amplitude
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
500 ¬
4.0
6.2
5.2
750 ¬
5.1
7.1
6.1
900 ¬
5.7
7.5
6.6
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
4.7 5.6 6.0
Pulse Amplitude
500 ¬ 750 ¬ 900 ¬
Pacing at 60 min§, 100% DDD BiV Pacing, 50% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.3 6.5 7.1
4.1 5.2 5.7
ERI to EOL in Months
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
3.8
5.9
5.0
4.8
6.8
5.9
5.3
7.3
6.4
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
4.3 5.2 5.6
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 60
min§, 100% DDD BiV Pacing, 100% A Pacing, 0.4 ms Pulse Width, Cap Confirm Off, Stored EGMs On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
5.1 6.3 6.8
3.9 5.0 5.5
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
3.4 4.4 4.9
328
ERI to EOL in Months
(Mean)
Pulse Amplitude
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 3.5 V
RV - 3.5 V
LV1 - 4.0 V
LV2 - 4.0 V
500 ¬
5.6
4.8
3.9
750 ¬
6.5
5.7
4.7
900 ¬
7.0
6.1
5.2
Table 222. Quadra Allure MP Model PM3160 Projected Time From Implant to EOL (70 min§)
Pulse Amplitude
500
¬
750
¬
Pacing at 70
min§,100% DDD-BiV Pacing, 100% A Pacing, 0.5 ms Pulse Width, Cap Confirm Off,
Stored EGMS On
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
5.8 7.3
2.9 4.1
ERI to EOL in Months
(Mean)
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 2.5 V
LV2 - 2.5 V
1.8
5.8
2.7
7.0
900
¬
7.8
4.6
3.0
7.4
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
3.4 4.5 4.8
A - 5.0 V
RV - 5.0 V
LV1 - 5.0 V
LV2 - 5.0 V
2.7 3.6 3.9
Pulse Amplitude
A - 2.5 V
RV - 2.5 V
LV1 - 3.5 V
LV2 - 3.5 V
500
¬
750
¬
900
¬
Pacing at 70 min§, 100% DDD-BiV Pacing, 15% A Pacing, 0.4ms Pulse Width, Cap Confirm Off, Stored EGM On, 3 hours
Telemetry Session at Implant, 20 minutes in clinic telemetry usage
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
4.9 6.0 6.6
4.5 5.6 6.2
3.8 4.8 5.3
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
3.2 4.1 4.6
A - 3.5 V
RV - 3.5 V
LV1 - 5.0 V
LV2 - 5.0 V
329
ERI to EOL in Months
(Mean)
Pulse Amplitude
A - 2.5 V
RV - 2.5 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.5 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 3.5 V
LV1 - 3.5 V
LV2 - 3.5 V
500 ¬
5.7
5.5
4.4
750 ¬
6.6
6.3
5.3
900 ¬
7.0
6.7
5.7
A - 3.5 V
RV - 3.5 V
LV1 - 5.0 V
LV2 - 5.0 V
4.0 4.8 5.2
Pulse Amplitude
500
¬
750
¬
900
¬
Pacing at 70 min§, 100% DDD-BiV Pacing, 15% A Pacing, 0.4ms Pulse Width, Cap Confirm On, Stored EGM On, 3 hours
Telemetry Session at Implant, 20 minutes in clinic telemetry usage
Implant to ERI in Years
(Mean)
A - 2.5 V
RV - 2.0 V
LV1 - 3.0 V
LV2 - 3.0 V
5.0 6.1 6.6
4.6 5.7 6.2 A - 2.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
4.5 5.6 6.1
3.6 4.6 5.1
ERI to EOL in Months
(Mean)
A - 3.5 V
RV - 2.0 V
LV1 - 5.0 V
LV2 - 5.0 V
A - 2.5 V
RV - 2.0 V
LV1 - 3.0 V
LV2 - 3.0 V
A - 2.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 3.5 V
LV2 - 3.5 V
A - 3.5 V
RV - 2.0 V
LV1 - 5.0 V
LV2 - 5.0 V
5.8
5.5
5.4
4.7
6.7
6.4
6.2
5.6
7.1
6.8
6.7
6.0
Elective Replacement Indicator (ERI)
ERI (used synonymously with RRT) is the point at which the battery voltage can only maintain adequate operation for a nominal period of six months before End-of-Life (EOL) for models PM1160, PM1240, PM1260, PM2160, PM2240, PM2260, PM3120,
PM3140, PM3160, PM3222, PM3242, and PM3262 and for three months before End-of-Life (EOL) for all other St. Jude Medical™ pacemakers and CRT-Ps.
When the device exhibits signs of ERI, described below, replace it expeditiously. There are a number of indicators to this condition:
The pacing interval increases by 100 ms over the Base Rate to reduce current drain. The difference between the programmed
330
The programmer displays an alert that the device has detected ERI
The Battery & Leads (page 44) window displays a Clear ERI (page 331) button.
The Sensor is programmed Off.
The battery voltage has decreased to 2.6 V.
The Magnet Rate (page 45) measures approximately 85.0
min§ or less.
The following features no longer operate at ERI:
-
-
AF Suppression™ Algorithm (page 87)
Clear ERI
reported under such conditions as extreme cold temperatures or exposure to EMI sources such as electrocautery and defibrillation.
WARNING
At ERI, the nominal life of Allure, Assurity, and Endurity devices is approximately six months. The nominal life of other devices is approximately three months. The device should be replaced expeditiously.
CAUTION
High output settings or high rates may shorten the time to ERI.
If the programmer shows an ERI warning message, fully evaluate the device.
NOTE
Autoprogrammed Parameters. The programmed parameters that were autoprogrammed at ERI are not restored to their initial settings when Clear ERI is selected. Interrogate and reprogram the device.
Programmed Pacing Rates and Actual Pacing Rates at ERI
Table 223. Programmed pacing rates and actual pacing rates (in min§) at ERI
Programmed Rate
80
85
90
95
100
105
65
70
75
45
50
55
60
Actual Rate at ERI
(100 ms interval increase)
70.6
74.4
78.3
82.0
85.7
89.4
41.9
46.2
50.4
54.5
58.6
62.7
66.7
Programmed Rate
145
150
155
160
165
170
110
115
120
125
130
135
140
Actual Rate at ERI
(100 ms interval increase)
116.8
120.0
123.2
126.3
129.4
132.5
93.0
96.5
100.0
103.4
106.8
110.2
113.5
End-of-Life
In most pacers and CRT-Ps, EOL occurs when the battery voltage has fallen to below 2.5 V. In Allure, Allure Quadra, Assurity,
Assurity MRI, Assurity+, Endurity, Endurity MRI, and Quadra Allure MP devices, EOL is 2.47 V.
331
Clinician Use Information for Tachycardia Devices
Clinician Use Information for Bradycardia Devices (page 311).
Contents:
Performing Device-Based Testing (page 333)
Factors That Affect Device Longevity (page 335)
Device Longevity Tables (page 335)
Patient Selection
Assess the patient's current and anticipated clinical needs and select a device that fulfills those needs.
Prior to implant:
Evaluate and classify the patient’s ventricular tachyarrhythmias to establish the patient's candidacy for the device
Determine the rates of inducible and spontaneous ventricular arrhythmias, as well as the patient's maximum sinus rate and the rates of any supraventricular tachyarrhythmias to assist in programming rate detection and discriminator parameters
If the patient’s drug regimen changes, re-evaluate the patient’s arrhythmias and sinus rhythm rates as required and reprogram the rate detection and morphology scoring parameters accordingly.
If the patient’s disease progresses or changes over time, re-evaluate the patient's arrhythmias and reprogram the device detection,
SVT/VT discrimination, and therapy parameters accordingly.
In patients with frequent nonsustained episodes, program the arrhythmia detection and SVT discrimination parameters carefully and consider drug therapy to minimize excessive battery depletion from frequent high-voltage charging.
Extremely frequent ventricular or supraventricular tachyarrhythmias may be contraindications if adequate battery longevity cannot be achieved through careful programming of the pulse generator.
Testing at Implant
Due to the nature of the implantation procedure, the physician and support staff should be familiar with all of the components of the system and the material in this manual before beginning the procedure.
After implanting the leads, test the lead systems. Because of the difference in capacitance between the pulse generator and an external stimulation device, we strongly recommend device-based testing. However, you may want to use a single, initial test using an external stimulation device to screen for patients with a high defibrillation threshold before you open the pulse generator package.
strongly recommend that supplemental testing be done with the pulse generator.
WARNING
Due to the nature of the procedure, a separate standby external defibrillator should always be immediately available.
Performing Device-Based Testing
Table 224. Recommended thresholds and amplitudes
Parameter Acute Chronic
LV pacing capture threshold
RV pacing capture threshold
Atrial pacing capture threshold
R-wave amplitude
< 3 V
< 2 V
< 2 V
5 mV or greater
< 5 V
< 5 V
< 5 V
2 mV or greater
P-wave amplitude
1.
Implant the leads and pulse generator.
2.
3.
2 mV or greater 1 mV or greater
Use the programmer to interrogate the pulse generator.
Measure pacing capture thresholds, pacing lead impedances and R-wave and P-wave amplitudes and store the data for trending analysis (see table above).
4.
NOTE
Very small-amplitude signals during tachycardia or fibrillation may result in prolonged arrhythmia detection times or inability to detect an arrhythmia.
Check the sensing lead(s) real-time EGM for discontinuity or any artifact that might indicate lead damage.
333
5.
6.
7.
Note that tapping the device header with an instrument or finger may produce artifacts on the real-time EGM.
Set the high-voltage waveform tilt or pulse width to the desired value.
If the waveform is Fixed PW, you should deliver an emergency shock of at least 200 V to evaluate the lead impedance before programming the pulse width. If the waveform is Fixed Tilt, no impedance calculation is required.
CAUTION
Do not implant the pulse generator if the acute defibrillation lead impedance is less than 20
¬ or the lead impedance of chronic leads is less than 15
¬ . Damage to the device may result if high-voltage therapy is delivered into an impedance of less than 15
¬ .
Set up the device configuration parameters as desired and program the device On.
Induce ventricular fibrillation and monitor detection and therapy delivery. Adjust voltage and repeat until defibrillation threshold is determined.
8.
9.
10.
WARNING
For effective defibrillation, place the device in the pocket before arrhythmia induction or defibrillation testing.
If you are using the programmer’s device-based testing function, note that if the desired therapy voltage is not reached before the time delay has elapsed (in Timed mode) or therapy has been requested (in Manual mode), therapy delivery is postponed until the therapy voltage has been reached.
If energy requirements are excessive, the defibrillation leads may need to be repositioned, or the device reprogrammed to a different waveform, tilt, pulse width or polarity, or a different lead system chosen. If an SVC electrode is implanted, it can also be reprogrammed Off or On.
The energy requirement for reliable arrhythmia termination should be at least 10 J less than the pulse generator’s maximum output. This equates to a voltage requirement for termination of no more than approximately 640 to 685 V, depending on programmed waveform, pulse width, and defibrillation lead impedance.
The choice of defibrillation lead system should be based on clinical factors and energy requirements. If energy requirements cannot be met with a given lead system, or if acute defibrillation lead impedance is low, a different lead system may alleviate the problem.
If the patient’s condition permits, it is recommended that redetection be assessed after a failed shock at implant or predischarge testing.
If the R-wave amplitude is very small, detection times may be prolonged or the device may be unable to detect an arrhythmia.
If an arrhythmia is induced but the real-time EGM does not indicate that tachyarrhythmia intervals are being counted, the Rwave amplitude may be too low or the programmed tachyarrhythmia detection rate may be higher than the induced rate.
When testing is finished, go to the Capture Testing screen to evaluate the pacing capture thresholds. The capture threshold trends update automatically.
The unloaded battery voltage, signal amplitude, and pacing lead impedance trends are automatically updated by the device once a month.
Set up the device configuration and parameters as described in the appropriate reference manual.
Refer to the patient's electrophysiology (EP) study and documented spontaneous arrhythmia episodes for programming detection criteria.
Confirm bradycardia sensing and pacing as described in the next section.
Testing Before Hospital Discharge
If appropriate, use noninvasive stimulation to induce the clinical arrhythmias and confirm the appropriateness of the device's programmed settings. Review the performance of the morphology template, if applicable.
Test the Patient Notifier. This will help familiarize the patient with the vibration they will feel when a Patient Notifier is delivered.
Take a chest X-ray to provide a basis for comparison should later changes in shock efficacy or lead impedance make the lead system suspect.
Clinical and animal studies have shown that the high-voltage lead impedance drops significantly in the first seven days post-implant.
Over the next few weeks, it gradually returns to near-implant level. In view of the recovery of the lead impedance level, no concomitant adjustment to the high-voltage pulse width is recommended during this period.
Confirming Bradycardia Sensing and Pacing
St. Jude Medical recommends that operating room testing include confirmation of bradycardia sensing and pacing at the programmed parameters.
1.
Program tachyarrhythmia therapies Off and confirm appropriate sensing during intrinsic conduction.
2.
3.
Program the device to DDD or VVI pacing and set the pacing rate and (in DDD mode) AV Delay so the pulse generator paces
100% of the time.
If the real-time EGM shows T-waves that appear to be over half the size of the QRS complex and if the device is not pacing at the programmed rate (indicating T-wave sensing), increase the Decay Delay or Threshold Start.
Confirming Parameter Settings
At the end of the programming session, interrogate the device and confirm that the final parameter settings are correct.
334
Factors That Affect Device Longevity
The longevity of the pulse generator depends strongly on the frequency of high-voltage charging. An increase in pacing output parameters or a decrease in pacing lead impedance also decreases battery longevity. In some cases, this may cause the period from
ERI (Elective Replacement Indicator) to EOL to decrease to less than three months.
The longevity calculations in the following tables represent a device programmed with the Patient Notifier at nominal settings and with one notification sequence delivered at ERI. When a device is programmed with the Patient Notifier at nominal settings, each
Patient Notifier sequence delivered depletes the battery by 0.1%. For example, with the Patient Notifier at nominal settings, the impact to device longevity for each notification sequence delivered is 4 days with no pacing, 3 days with 100% pacing in VVI pacing mode, 2 days with 100% pacing in DDD pacing mode, and <1 day with 100% pacing in DDD pacing mode with biventricular pacing and no atrial pacing.
When a device is programmed with the Patient Notifier at maximum settings, each Patient Notifier sequence delivered depletes the battery by 1%. For example, when the Patient Notifier is at maximum settings, the impact to device longevity for each notification sequence delivered is 1.2 months with no pacing, 1.0 months with 100% pacing in VVI pacing mode, 0.8 months with 100% pacing in DDD pacing mode, and 0.5 months with 100% pacing in DDD pacing mode with biventricular pacing and no atrial pacing. For
information on programming the Patient Notifier parameters, see Alert Notification (page 129).
Device Longevity Tables
The following tables list the projected device longevity.
Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (page 335)
Battery longevity for Promote Quadra 40 J devices (page 340)
Battery longevity for Unify Quadra, Unify Quadra MP 40 J devices (page 343)
Battery longevity for Unify 40 J devices (page 346)
Battery longevity for Fortify Assura DR 40 J devices (page 348)
Battery longevity for Fortify DR, Fortify ST DR 40 J devices (page 350)
Battery longevity for Fortify Assura VR 40 J devices (page 351)
Battery longevity for Fortify VR, Fortify ST VR 40 J devices (page 353)
Battery longevity for Promote Q 36 J devices (page 354)
Battery longevity for Ellipse DR 36 J devices (page 356)
Battery longevity for Ellipse VR 36 J devices (page 358)
Battery longevity for AnalyST DR 36 J and AnalyST Accel DR 36 J devices (page 360)
Battery longevity for AnalyST VR 36 J and AnalyST Accel VR 36 J devices (page 361)
Battery longevity for Promote, Promote RF, Promote Accel 30 J devices (page 363)
Battery longevity for Current DR, Current DR RF, Current Accel DR 30 J devices (page 361)
Battery longevity for Current VR, Current VR RF, Current Accel VR 30 J devices (page 364)
Battery longevity for AnalyST DR 30 J and AnalyST Accel DR 30 J devices (page 365)
Battery longevity for AnalyST VR 30 J and AnalyST Accel VR 30 J devices (page 366)
Battery Longevity for Quadra Assura™, Quadra Assura MP™, and Unify Assura™ 40 J Devices
Table 225. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL past EOL
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
10.1 yr
17.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
11.1 yr
18.9 mo
10.2 yr
17.5 mo
9.5 yr
16.4 mo
8.3 yr
14.5 mo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
11.1 yr
18.9 mo
9.9 yr
17.0 mo
8.9 yr
15.4 mo
7.4 yr
13.0 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
475
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
335
Table 225. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action past EOL
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
11.1 yr
18.9 mo
9.2 yr
15.9 mo
7.9 yr
13.7 mo
6.1 yr
10.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
11.7 yr
19.9 mo
N/A
11.5 yr
19.5 mo
N/A
11.2 yr
19.1 mo
N/A
10.7 yr
18.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 900 ¬
11.1 yr
18.9 mo
10.5 yr
18.0 mo
10.1 yr
17.3 mo
9.2 yr
15.9 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
N/A
10.3 yr
17.6 mo
N/A
9.6 yr
16.6 mo
N/A
8.5 yr
14.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.1 yr
18.9 mo
9.9 yr
17.0 mo
8.9 yr
15.4 mo
7.4 yr
13.0 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 10.8 yr 9.0 yr 7.6 yr 5.9 yr None
ERI to EOL 18.5 mo 15.5 mo 13.4 mo 10.5mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 500 ¬
Normal 10.8 yr 9.5 yr 8.4 yr 6.9 yr None
ERI to EOL 18.5 mo 16.3 mo 14.7 mo 12.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 10.8 yr 6.9 yr 5.0 yr 3.3 yr None
ERI to EOL 18.5 mo 12.1 mo 9.0 mo 5.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 500 ¬
Normal 10.8 yr 7.8 yr 6.1 yr 4.2 yr None
ERI to EOL 18.5 mo 13.6 mo 10.8 mo 7.6 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 300 ¬
336
Table 225. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing
Normal 10.1 yr 5.7 yr 4.0 yr 2.5 yr None
ERI to EOL 17.3 mo 10.1 mo 7.2 mo 4.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 500 ¬
3.20-2.59 Normal 10.1 yr 6.6 yr 5.0 yr 3.3 yr None
2.59-2.54 ERI to EOL 17.3 mo 11.7 mo 8.8 mo 5.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
3.20-2.59 Normal 11.1 yr 9.3 yr 8.0 yr 6.2 yr None
2.59-2.54 ERI to EOL 5.5 mo 5.2 mo 5.0 mo 4.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
2.54-2.40
Normal 11.1 yr 9.9 yr 8.9 yr 7.5 yr None
ERI to EOL 5.5 mo 5.3 mo 5.2 mo 4.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal 10.5 yr 9.1 yr 8.0 yr 6.4 yr None
ERI to EOL 18.9 mo 17.0 mo 15.4 mo 13.0 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
10.5 yr
18.9 mo
9.6 yr
17.6 mo
8.8 yr
16.6 mo
7.5 yr
14.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
10.5 yr
18.9 mo
7.8 yr
15.9 mo
6.2 yr
13.7 mo
4.4 yr
10.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Normal 10.5 yr 8.6 yr 7.3 yr 5.6 yr None
ERI to EOL 18.9 mo 17.0 mo 15.4 mo 13.0 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL
11.1 yr
18.9 mo
9.9 yr
17.0 mo
9.1 yr
15.7 mo
7.8 yr
13.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
476 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
477
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
478 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
479
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
480 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
337
Table 225. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
No pacing
N/A
25% pacing
N/A
50% pacing
N/A
100% pacing
N/A past EOL Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
N/A
10.3 yr
17.7 mo
N/A
9.8 yr
16.9 mo
N/A
8.8 yr
15.3 mo
N/A
Recommended
Action
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Table 226. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL past EOL
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.3 mo
10.9 yr
18.7 mo
10.3 yr
17.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60 min§, 500 ¬
11.1 yr
18.9 mo
10.3 yr
17.7 mo
9.7 yr
16.6 mo
8.6 yr
14.9 mo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.4 ms, 60
min§, 500 ¬
Normal
ERI to EOL
11.1 yr
18.9 mo
10.0 yr
17.2 mo
9.1 yr
15.7 mo
7.7 yr
13.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.4 ms, 60
min§, 500 ¬
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
9.4 yr
16.2 mo
8.1 yr
14.2 mo
6.4 yr
11.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
11.7 yr
19.9 mo
11.5 yr
19.5 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL past EOL
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 900 ¬
11.1 yr
18.9 mo
10.6 yr
18.1 mo
10.2 yr
17.5 mo
9.4 yr
16.3 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.4 ms, 60 min§, 900 ¬
Normal 11.1 yr 10.4 yr 9.8 yr 8.8 yr None 3.20-2.59
481 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
482
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
338
Table 226. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
18.9 mo
25% pacing
17.8 mo
50% pacing
16.9 mo
100% pacing
15.2 mo ERI to EOL past EOL N/A N/A N/A N/A
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.4 ms, 60 min§, 900 ¬
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
N/A
10.0 yr
17.1 mo
N/A
9.1 yr
15.7 mo
N/A
7.7 yr
13.5 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.4 ms, 70
min§, 300 ¬
Normal 10.8 yr 9.1 yr 7.9 yr 6.2 yr None
ERI to EOL 18.5 mo 15.8 mo 13.8 mo 11.0 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.4 ms, 70
min§, 500 ¬
Normal 10.8 yr 9.6 yr 8.7 yr 7.2 yr None
ERI to EOL 18.5 mo 16.6 mo 15.0 mo 12.7 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.4 ms, 70
min§, 300 ¬
Normal 10.8 yr 7.2 yr 5.3 yr 3.6 yr None
ERI to EOL 18.5 mo 12.6 mo 9.5 mo 6.4 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.4 ms, 70
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Normal 10.8 yr 8.0 yr 6.4 yr 4.6 yr None
ERI to EOL 18.5 mo 14.0 mo 11.3 mo 8.1 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.4 ms, 70
min§, 300 ¬
Normal 10.1 yr 6.0 yr 4.3 yr 2.7 yr None
ERI to EOL 17.3 mo 10.6 mo 7.7 mo 4.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.4 ms, 70
min§, 500 ¬
3.20-2.59 Normal 10.1 yr 6.9 yr 5.3 yr 3.6 yr None
2.59-2.54 ERI to EOL 17.3 mo 12.2 mo 9.4 mo 6.4 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.4 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
3.20-2.59 Normal 11.1 yr 9.4 yr 8.2 yr 6.5 yr None
2.59-2.54 ERI to EOL 5.5 mo 5.3 mo 5.0 mo 4.6 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.4 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
Normal
ERI to EOL
11.1 yr
5.5 mo
10.0 yr
5.3 mo
9.2 yr
5.2 mo
7.8 yr
4.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
339
Table 226. Battery longevity for Quadra Assura, Quadra Assura MP, Unify Assura 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.4 ms, 60
min§, 500 ¬
Normal 10.5 yr 9.2 yr 8.2 yr 6.7 yr None
ERI to EOL 18.9 mo 17.2 mo 15.7 mo 13.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.4 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.5 yr
18.9 mo
9.6 yr
17.8 mo
8.9 yr
16.8 mo
7.7 yr
15.2 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.4 ms, 60
min§, 500 ¬
Normal
ERI to EOL
10.5 yr
18.9 mo
8.0 yr
16.2 mo
6.5 yr
14.2 mo
4.7 yr
11.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.4 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Normal 10.5 yr 8.8 yr 7.6 yr 6.0 yr None
ERI to EOL 18.9 mo 17.2 mo 15.7 mo 13.4 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.4 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
N/A
10.0 yr
17.2 mo
N/A
9.3 yr
16.0 mo
N/A
8.1 yr
14.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.4 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
11.1 yr
18.9 mo
N/A
10.4 yr
17.8 mo
N/A
9.9 yr
17.1 mo
N/A
9.1 yr
15.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Promote Quadra™ 40 J Devices
Table 227. Battery longevity for Promote Quadra 40 J devices
Battery
Voltage
Range
3.20-2.59
Battery
Condition
Normal
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
12.6 yr 12.2 yr 11.8 yr 11.0 yr
Recommended
Action
None
483 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
484
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
485 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
486
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
487 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
488
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
489 Longevity is calculated based on three charges per year and eighteen months from the date of manufacture.
340
Table 227. Battery longevity for Promote Quadra 40 J devices
Battery
Voltage
Range
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
ERI to EOL past EOL
Normal
ERI to EOL
Approximate Duration
Recommended
Action
No pacing
24.0 mo
25% pacing
23.3 mo
50% pacing
22.5 mo
100% pacing
21.1 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
11.5 yr
22.0 mo
10.7 yr
20.7 mo
10.1 yr
19.5 mo
9.0 yr
17.5 mo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
11.5 yr
22.0 mo
10.4 yr
20.0 mo
9.4 yr
18.3 mo
8.0 yr
15.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL past EOL
11.5 yr
22.0 mo
9.7 yr
18.8 mo
8.4 yr
16.4 mo
6.6 yr
13.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
12.6 yr
24.0 mo
12.4 yr
23.6 mo
12.1 yr
23.2 mo
11.7 yr
22.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL past EOL
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
11.5 yr
22.0 mo
11.1 yr
21.2 mo
10.6 yr
20.5 mo
9.9 yr
19.2 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60 min§, 900 ¬
Normal
ERI to EOL past EOL
11.5 yr
22.0 mo
N/A
10.8 yr
20.8 mo
N/A
10.2 yr
19.7 mo
N/A
9.2 yr
17.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.5 yr
22.0 mo
10.4 yr
20.0 mo
9.4 yr
18.3 mo
8.0 yr
15.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 11.1 yr 9.3 yr 8.1 yr 6.4 yr None
ERI to EOL 21.3 mo 18.1 mo 15.8 mo 12.6 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 500 ¬
Normal
ERI to EOL
11.1 yr
21.3 mo
9.9 yr
19.1 mo
8.9 yr
17.3 mo
7.4 yr
14.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
341
Table 227. Battery longevity for Promote Quadra 40 J devices
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 11.1 yr 7.2 yr 5.4 yr 3.6 yr None
ERI to EOL 21.3 mo 14.3 mo 10.7 mo 7.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 500 ¬
Normal 11.1 yr 8.2 yr 6.5 yr 4.6 yr None
ERI to EOL 21.3 mo 16.0 mo 12.8 mo 9.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 300 ¬
Normal 10.3 yr 6.1 yr 4.3 yr 2.7 yr None
ERI to EOL 20.0 mo 12.0 mo 8.6 mo 5.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 500 ¬
3.20-2.59 Normal 10.3 yr 7.0 yr 5.3 yr 3.6 yr None
2.59-2.54 ERI to EOL 20.0 mo 13.8 mo 10.6 mo 7.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
3.20-2.59 Normal 11.5 yr 9.8 yr 8.5 yr 6.7 yr None
2.59-2.54 ERI to EOL 6.6 mo 6.3 mo 6.0 mo 5.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
2.54-2.40
Normal 11.5 yr 10.4 yr 9.5 yr 8.1 yr None
ERI to EOL 6.6 mo 6.4 mo 6.2 mo 5.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
Normal 10.9 yr 9.5 yr 8.4 yr 6.9 yr None
ERI to EOL 22.0 mo 20.0 mo 18.3 mo 15.7 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.9 yr
22.0 mo
10.0 yr
20.8 mo
9.2 yr
19.7 mo
8.0 yr
17.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal 10.9 yr 8.0 yr 6.3 yr 4.4 yr None
490 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
491
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
492 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
342
Table 227. Battery longevity for Promote Quadra 40 J devices
Battery
Voltage
Range
Battery
Condition
No pacing
22.0 mo
Approximate Duration
25% pacing
18.2 mo
50% pacing
15.6 mo
100% pacing
12.1 mo
Recommended
Action
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
ERI to EOL past EOL N/A N/A N/A N/A
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60 min§, 900 ¬
Normal 10.9 yr 8.9 yr 7.6 yr 5.8 yr None
ERI to EOL 22.0 mo 18.6 mo 17.7mo 14.8mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60 min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
11.5 yr
22.0 mo
N/A
10.4 yr
20.1 mo
N/A
9.7 yr
18.7 mo
N/A
8.5 yr
16.5 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
11.5 yr
22.0 mo
N/A
10.8 yr
20.9 mo
N/A
10.4 yr
20.0 mo
N/A
9.5 yr
18.5 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Unify Quadra™, Unify Quadra MP™ 40 J Devices
Table 228. Battery longevity for Unify Quadra, Unify Quadra MP 40 J devices
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.9 yr
21.2 mo
10.4 yr
20.3 mo
9.9 yr
19.5 mo
9.1 yr
18.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Normal
ERI to EOL past EOL
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.2 yr
20.0 mo
N/A
9.4 yr
18.5 mo
N/A
8.7 yr
17.2 mo
N/A
7.6 yr
15.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60 min§, 500 ¬
Normal
ERI to EOL past EOL
10.2 yr
20.0 mo
N/A
9.0 yr
17.9 mo
N/A
8.1 yr
16.2 mo
N/A
6.7 yr
13.6 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal 10.2 yr 8.4 yr 7.2 yr 5.5 yr None
493
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
494 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
495
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
496 Longevity is calculated based on three charges per year and eighteen months from the date of manufacture.
343
Table 228. Battery longevity for Unify Quadra, Unify Quadra MP 40 J devices
Battery
Voltage
Range
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
No pacing
20.0 mo
Approximate Duration
25% pacing
16.8 mo
50% pacing
14.4 mo
100% pacing
11.3 mo
Recommended
Action
ERI to EOL Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Normal
ERI to EOL past EOL
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 900 ¬
10.9 yr
21.2 mo
10.5 yr
20.6 mo
10.2 yr
20.1 mo
9.7 yr
19.1 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.2 yr
20.0 mo
9.7 yr
19.1 mo
9.2 yr
18.2 mo
8.4 yr
16.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.2 yr
20.0 mo
9.4 yr
18.6 mo
8.8 yr
17.4 mo
7.7 yr
15.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.2 yr
20.0 mo
9.0 yr
17.9 mo
8.1 yr
16.1 mo
6.7 yr
13.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 10.0 yr 8.2 yr 7.0 yr 5.4 yr None
ERI to EOL 19.5 mo 16.3 mo 14.0 mo 10.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 500 ¬
Normal 10.0 yr 8.7 yr 7.7 yr 6.3 yr None
ERI to EOL 19.5 mo 17.2 mo 15.4 mo 12.7 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 300 ¬
Normal 10.0 yr 6.3 yr 4.6 yr 3.0 yr None
ERI to EOL 19.5 mo 12.7 mo 9.4 mo 6.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 500 ¬
Normal 10.0 yr 7.1 yr 5.5 yr 3.8 yr None
ERI to EOL 19.5 mo 14.3 mo 11.3 mo 7.9 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 300 ¬
Normal
ERI to EOL
9.3 yr
18.3mo
5.2 yr
10.6 mo
3.6 yr
7.5 mo
2.3 yr
4.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
344
Table 228. Battery longevity for Unify Quadra, Unify Quadra MP 40 J devices
Battery
Voltage
Range
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 500 ¬
3.20-2.59 Normal 9.3 yr 6.1 yr 4.5 yr 3.0 yr None
2.59-2.54 ERI to EOL 18.3mo 12.3 mo 9.2 mo 6.2 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
3.20-2.59 Normal 10.2 yr 8.5 yr 7.3 yr 5.6 yr None
2.59-2.54 ERI to EOL 5.7 mo 5.5 mo 5.2 mo 4.7 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
2.54-2.40 past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
2.54-2.40
Normal 10.2 yr 9.1 yr 8.2 yr 6.8 yr None
ERI to EOL 5.7 mo 5.6 mo 5.4 mo 5.1 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal 9.7 yr 8.3 yr 7.3 yr 5.8 yr None
ERI to EOL 20.0 mo 17.9 mo 16.2 mo 13.6 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
9.7 yr
20.0 mo
8.8 yr
18.6 mo
8.0 yr
17.4 mo
6.8 yr
15.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
9.7 yr
20.0 mo
7.1 yr
16.8 mo
5.6 yr
14.4 mo
4 yr
11.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Normal 9.7 yr 7.9 yr 6.7 yr 5.1 yr None
ERI to EOL 20.0 mo 17.9 mo 16.2 mo 13.5 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
10.2 yr
20.0 mo
N/A
9.1 yr
17.9 mo
N/A
8.3 yr
16.6 mo
N/A
7.1 yr
14.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
497 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
498
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
499 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
500
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
501 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
345
Table 228. Battery longevity for Unify Quadra, Unify Quadra MP 40 J devices
Battery
Voltage
Range
Battery
Condition
3.20-2.59
2.59-2.54
Normal
ERI to EOL
No pacing
10.2 yr
20.0 mo
Approximate Duration
25% pacing
9.5 yr
18.7 mo
50% pacing
8.9 yr
17.7 mo
Recommended
Action
100% pacing
8.0 yr
16.0 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40 past EOL N/A N/A
Battery Longevity for Unify™ 40 J Devices
N/A N/A
Table 229. Battery longevity for Unify 40 J devices
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.8 yr
21.2 mo
10.3 yr
20.3 mo
9.9 yr
19.5 mo
9.1 yr
18.1 mo
Recommended
Action
Normal
ERI to EOL past EOL N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.1 yr
20.0 mo
9.3 yr
18.5 mo
8.6 yr
17.2 mo
7.5 yr
15.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
10.1 yr
20.0 mo
9.0 yr
17.9 mo
8.1 yr
16.2 mo
6.7 yr
13.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL past EOL
10.1 yr
20.0 mo
8.4 yr
16.8 mo
7.1 yr
14.4 mo
5.5 yr
11.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
10.8 yr
21.2 mo
N/A
10.5 yr
20.6 mo
N/A
10.2 yr
20.1 mo
N/A
9.6 yr
19.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 900 ¬
10.1 yr
20.0 mo
9.6 yr
19.0 mo
9.1 yr
18.2 mo
8.3 yr
16.7 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.1 yr
20.0 mo
9.4 yr
18.7 mo
8.7 yr
17.4 mo
7.7 yr
15.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
502
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
503 Longevity is calculated based on three charges per year and eighteen months from the date of manufacture.
346
Table 229. Battery longevity for Unify 40 J devices
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.1 yr
20.0 mo
9.0 yr
17.9 mo
8.0 yr
16.1 mo
6.7 yr
13.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70
min§, 300 ¬
Normal
ERI to EOL past EOL
9.9 yr
19.5 mo
N/A
8.1 yr
16.3 mo
N/A
6.9 yr
14.0 mo
N/A
5.3 yr
10.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 70 min§, 500 ¬
Normal
ERI to EOL past EOL
9.9 yr
19.5 mo
N/A
8.6 yr
17.2 mo
N/A
7.7 yr
15.4 mo
N/A
6.3 yr
12.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 300 ¬
Normal
ERI to EOL past EOL
9.9 yr
19.5 mo
N/A
6.2 yr
12.7 mo
N/A
4.6 yr
9.4 mo
N/A
3.0 yr
6.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Pacing parameters: DDD-BiV, RV 3.5 V, LV 3.5 V, A 3.5 V, 0.5 ms, 70
min§, 500 ¬
Normal
ERI to EOL
9.9 yr
19.5 mo
7.1 yr
14.3 mo
5.5 yr
11.3 mo
3.8 yr
7.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 300 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
9.2 yr
18.3mo
5.2 yr
10.6 mo
3.6 yr
7.5 mo
2.2 yr
4.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 5.0 V, LV 5.0 V, A 5.0 V, 0.5 ms, 70
min§, 500 ¬
3.20-2.59
2.59-2.54
Normal
ERI to EOL
9.2 yr
18.3mo
6.0 yr
12.3 mo
4.5 yr
9.2 mo
3.0 yr
6.2 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40 past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
5.7 mo
N/A
8.4 yr
5.5 mo
N/A
7.2 yr
5.2 mo
N/A
5.6 yr
4.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 3.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
5.7 mo
N/A
9.0 yr
5.6 mo
N/A
8.1 yr
5.4 mo
N/A
6.8 yr
5.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
347
Table 229. Battery longevity for Unify 40 J devices
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60 min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
10.1 yr
20.0 mo
N/A
9.0 yr
17.9 mo
N/A
8.3 yr
16.6 mo
N/A
7.1 yr
14.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
10.1 yr
20.0 mo
N/A
9.4 yr
18.7 mo
N/A
8.9 yr
17.7 mo
N/A
8.0 yr
16.0 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Fortify Assura™ DR 40 J Devices
Table 230. Battery longevity for Fortify Assura DR 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
10.1 yr
17.3 mo
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
11.7 yr
19.9 mo
11.5 yr
19.5 mo
11.2 yr
19.1 mo
10.7 yr
18.3 mo
N/A N/A N/A N/A
Recommended
Action
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
11.1 yr
18.9 mo
10.2 yr
17.5 mo
9.5 yr
16.4 mo
8.3 yr
14.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
11.1 yr
18.9 mo
10.5 yr
18.0 mo
10.1 yr
17.3 mo
9.2 yr
15.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.1 yr
5.5 mo
N/A
10.2 yr
5.4 mo
N/A
9.5 yr
5.3 mo
N/A
8.3 yr
5.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
504
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
505 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
506
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
348
Table 230. Battery longevity for Fortify Assura DR 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
3.20-2.59
2.59-2.54
2.54-2.40
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.1 yr
5.5 mo
N/A
10.5 yr
5.4 mo
N/A
10.1 yr
5.4 mo
N/A
9.2 yr
5.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.8 yr
18.4 mo
N/A
10.1 yr
17.3 mo
N/A
9.6 yr
16.5 mo
N/A
8.7 yr
15.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.8 yr
18.4 mo
N/A
10.3 yr
17.7 mo
N/A
10.0 yr
17.1 mo
N/A
9.3 yr
16.1 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Table 231. Battery longevity for Fortify Assura DR 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
Battery
Condition
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.3 mo
10.9 yr
18.7 mo
10.3 yr
17.6 mo
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬
11.7 yr
19.9 mo
11.5 yr
19.5 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
N/A N/A N/A N/A
Recommended
Action
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 500 ¬
11.1 yr
18.9 mo
10.3 yr
17.7 mo
9.7 yr
16.6 mo
8.6 yr
14.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.1 yr
18.9 mo
10.6 yr
18.1 mo
10.2 yr
17.5 mo
9.4 yr
16.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal 11.1 yr 10.3 yr 9.7 yr 8.6 yr None
507
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
508 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
509
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
349
Table 231. Battery longevity for Fortify Assura DR 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
5.5 mo
25% pacing
5.4 mo
50% pacing
5.3 mo
100% pacing
5.1 mo ERI to EOL past EOL N/A N/A N/A N/A
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60 min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.1 yr
5.5 mo
N/A
10.6 yr
5.4 mo
N/A
10.2 yr
5.4 mo
N/A
9.4 yr
5.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.4 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
Normal
ERI to EOL
10.8 yr
18.4 mo
10.1 yr
17.4 mo
9.7 yr
16.7 mo
8.9 yr
15.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.4 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.8 yr
18.4 mo
N/A
10.3 yr
17.7 mo
N/A
10.0 yr
17.2 mo
N/A
9.4 yr
16.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Fortify™, Fortify™ ST DR 40 J Devices
Table 232. Battery longevity for Fortify, Fortify ST DR 40 J devices
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 500 ¬
10.8 yr
21.2 mo
10.3 yr
20.3 mo
9.9 yr
19.5 mo
9.1 yr
18.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.1 yr
20.0 mo
9.3 yr
18.5 mo
8.6 yr
17.2 mo
7.5 yr
15.1 mo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
10.8 yr
21.2 mo
10.5 yr
20.6 mo
10.2 yr
20.1 mo
9.6 yr
19.1 mo
N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
10.1 yr
20.0 mo
9.6 yr
19.0 mo
9.1 yr
18.2 mo
8.3 yr
16.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
510 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
511
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
512 Longevity is calculated based on three charges per year and eighteen months from the date of manufacture.
350
Table 232. Battery longevity for Fortify, Fortify ST DR 40 J devices
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A N/A Replace immediately
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
10.1 yr
5.7 mo
9.3 yr
5.6 mo
8.6 yr
5.5 mo
7.5 yr
5.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
10.1 yr
5.7 mo
N/A
9.6 yr
5.7 mo
N/A
9.1 yr
5.6 mo
N/A
8.3 yr
5.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL past EOL
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60 min§, 500 ¬,
ACap Confirm/V AutoCapture On
9.8 yr
19.5 mo
N/A
9.2 yr
18.3 mo
N/A
8.7 yr
17.4 mo
N/A
7.9 yr
15.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL past EOL
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60 min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
9.8 yr
19.5 mo
N/A
9.4 yr
18.7 mo
N/A
9.0 yr
18.0 mo
N/A
8.4 yr
16.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Fortify Assura™ VR 40 J Devices
Table 233. Battery longevity for Fortify Assura VR 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
10.1 yr
17.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.7 yr
19.9 mo
11.5 yr
19.5 mo
11.2 yr
19.1 mo
10.7 yr
18.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
11.7 yr
5.6 mo
11.3 yr
5.5 mo
10.8 yr
5.5 mo
10.1 yr
5.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
513
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
514 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
515
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
351
Table 233. Battery longevity for Fortify Assura VR 40 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A N/A Replace immediately
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
11.7 yr
5.6 mo
11.5 yr
5.6 mo
11.2 yr
5.5 mo
10.7 yr
5.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60
min§, 500 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
11.4 yr
19.4 mo
N/A
11.1 yr
18.9 mo
N/A
10.8 yr
18.5 mo
N/A
10.4 yr
17.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60 min§, 900 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
11.4 yr
19.4 mo
N/A
11.2 yr
19.1 mo
N/A
11.0 yr
18.8 mo
N/A
10.7 yr
18.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Table 234. Battery longevity for Fortify Assura VR 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 500 ¬
11.7 yr
19.9 mo
11.3 yr
19.3 mo
10.9 yr
18.7 mo
10.3 yr
17.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.7 yr
19.9 mo
11.5 yr
19.5 mo
11.3 yr
19.2 mo
10.8 yr
18.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
11.7 yr
5.6 mo
11.3 yr
5.5 mo
10.9 yr
5.5 mo
10.3 yr
5.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.7 yr
5.6 mo
N/A
11.5 yr
5.6 mo
N/A
11.3 yr
5.5 mo
N/A
10.8 yr
5.5 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 1.0 V, 0.4 ms, 60 min§, 500 ¬, V. AutoCapture parameter On
516 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
517
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
518 Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 16 days for each additional month of shelf time.
519 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
352
Table 234. Battery longevity for Fortify Assura VR 40 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
Normal
ERI to EOL
11.4 yr
19.4 mo
11.1 yr
19.0 mo
10.9 yr
18.6 mo
10.5 yr
18.0 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.4 ms, 60
min§, 900 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
No pacing
11.4 yr
19.4 mo
N/A
25% pacing
11.2 yr
19.1 mo
N/A
50% pacing
11.0 yr
18.8 mo
N/A
100% pacing
10.7 yr
18.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Fortify™, Fortify ™ ST VR 40 J Devices
Table 235. Battery longevity for Fortify, Fortify ST VR 40 J devices
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
10.8 yr
21.2 mo
10.3 yr
20.3 mo
9.9 yr
19.5 mo
9.1 yr
18.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.8 yr
21.2 mo
10.5 yr
20.6 mo
10.2 yr
20.1 mo
9.6 yr
19.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
10.8 yr
5.8 mo
10.3 yr
5.7 mo
9.9 yr
5.7 mo
9.1 yr
5.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
10.8 yr
5.8 mo
N/A
10.5 yr
5.8 mo
N/A
10.2 yr
5.7 mo
N/A
9.6 yr
5.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.59
2.59-2.54
Pacing parameters: VVI, RV 1.0 V, 0.5 ms, 60 min§, 500 ¬, ACap Confirm/V AutoCapture On
Normal
ERI to EOL past EOL
10.5 yr
20.6
N/A
10.1 yr
20.0 mo
N/A
9.9 yr
19.5 mo
N/A
9.4 yr
18.6 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
Pacing parameters: VVI, RV 1.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/RVCap Confirm/LVCap Confirm On
3.20-2.59 Normal 10.5 yr 10.2 yr 10.0 yr 9.6 yr None
520
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
521 Longevity is calculated based on three charges per year and eighteen months from the date of manufacture.
522
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
523 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
353
Table 235. Battery longevity for Fortify, Fortify ST VR 40 J devices
Battery
Voltage
Range
2.59-2.54
Battery
Condition
ERI to EOL
No pacing
20.6 mo
Approximate Duration
25% pacing
20.1 mo
50% pacing
19.8 mo
100% pacing
19.1 mo
Recommended
Action
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40 past EOL N/A N/A
Battery Longevity for Promote™ Q 36 J Devices
N/A N/A
Table 236. Battery longevity for Promote Q 36 J devices
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
7.8 yr
9.8 mo
N/A
7.3 yr
9.1 mo
N/A
6.8 yr
8.5 mo
N/A
6.1 yr
7.6 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60 min§, 500 ¬
Normal
ERI to EOL past EOL
7.8 yr
9.8 mo
N/A
7.0 yr
8.8 mo
N/A
6.4 yr
8.0 mo
N/A
5.5 yr
6.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL past EOL
7.8yr
9.8 mo
N/A
7.0 yr
8.3 mo
N/A
5.8 yr
7.2 mo
N/A
4.6 yr
5.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
7.8 yr
9.8 mo
7.5 yr
9.4 mo
7.2 yr
9.0 mo
6.6 yr
8.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
7.8 yr
9.8 mo
7.3 yr
9.2 mo
6.9 yr
8.6 mo
6.2 yr
7.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
7.6 yr
9.7 mo
6.9 yr
8.6 mo
6.3 yr
7.9 mo
5.3 yr
6.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
7.3 yr
9.2 mo
6.5 yr
8.0 mo
5.8 yr
7.2 mo
4.8 yr
5.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
524
Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
525 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
354
Table 236. Battery longevity for Promote Q 36 J devices
Battery
Voltage
Range
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
25% pacing
50% pacing
100% pacing past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RA/RV/LV1/LV2 2.5 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
7.3 yr
9.2 mo
6.8 yr
8.4 mo
6.3 yr
7.9 mo
5.5 yr
6.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 500 ¬
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL
7.3 yr
9.2 mo
5.7 yr
7.0 mo
4.6 yr
5.7 mo
3.4 yr
4.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV1/LV2 5.0 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Normal 7.3 yr 6.2 yr 5.4 yr 4.3 yr None
ERI to EOL 9.2 mo 7.8 mo 6.7 mo 5.3 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V past EOL N/A N/A N/A Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
7.8 yr
9.8 mo
N/A
7.1 yr
8.9 mo
N/A
6.6 yr
8.2 mo
N/A
5.8 yr
7.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
7.8 yr
9.8 mo
N/A
7.4 yr
9.3 mo
N/A
7.0 yr
8.8 mo
N/A
6.4 yr
8.0 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Auricle™, Promote™, Promote™+, Promote™ RF, Promote Accel™,
Promote™ LAP 36 J Devices
Table 237. Battery longevity for Auricle, Promote, Promote+, Promote RF, Promote Accel, Promote LAP 36 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
8.2 yr
10.2 mo
N/A
7.5 yr
9.3 mo
N/A
7.0 yr
8.6 mo
N/A
6.1 yr
7.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60 min§, 500 ¬
Normal 8.2 yr 7.2 yr 6.5 yr 5.4 yr None
526
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
527 MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
528
MultiPoint™ Pacing enabled, devices with MultiPoint™ Pacing Capability only.
529 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
530
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
531 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
355
Table 237. Battery longevity for Auricle, Promote, Promote+, Promote RF, Promote Accel, Promote LAP 36 J devices
Battery
Voltage
Range
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
Approximate Duration
Recommended
Action
No pacing
10.2 mo
25% pacing
8.9 mo
50% pacing
8.0 mo
100% pacing
6.5 mo ERI to EOL past EOL N/A N/A N/A N/A
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60 min§, 500 ¬
Normal
ERI to EOL past EOL
8.2 yr
10.2 mo
N/A
6.7 yr
8.3 mo
N/A
5.7 yr
7.0 mo
N/A
4.4 yr
5.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
8.2 yr
10.2 mo
7.7 yr
9.6 mo
7.3 yr
9.0 mo
6.6 yr
8.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
8.2 yr
10.2 mo
7.5 yr
9.3 mo
7.0 yr
8.6 mo
6.1 yr
7.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
8.2 yr
10.2 mo
N/A
7.2 yr
8.9 mo
N/A
6.4 yr
7.9 mo
N/A
5.3 yr
6.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
8.1 yr
10.0 mo
N/A
7.4 yr
9.2 mo
N/A
6.9 yr
8.5 mo
N/A
5.9 yr
7.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
8.1 yr
10.0 mo
N/A
7.7 yr
9.5 mo
N/A
7.3 yr
9.0 mo
N/A
6.6 yr
8.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Ellipse™ DR 36 J Devices
Table 238. Battery longevity for Ellipse DR 36 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
Battery
Condition
Normal
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
11.1 yr 10.6 yr 10.1 yr 9.4 yr
Recommended
Action
None
532
RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
533 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
534
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 18 days for each additional month of shelf time.
356
Table 238. Battery longevity for Ellipse DR 36 J devices (calculated at 0.5 ms Pulse Width)
Battery
Voltage
Range
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Approximate Duration
Recommended
Action
No pacing
7.0 mo
25% pacing
6.9 mo
50% pacing
6.8 mo
100% pacing
6.6 mo Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
10.4 yr
6.8 mo
9.6 yr
6.6 mo
8.9 yr
6.4 mo
7.7 yr
6.1 mo
N/A
N/A
N/A
N/A
N/A
N/A
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
11.1 yr
7.0 mo
10.8 yr
6.9 mo
10.5 yr
6.9 mo
9.9 yr
6.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.4 yr
6.8 mo
9.9 yr
6.7 mo
9.4 yr
6.6 mo
8.6 yr
6.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
10.4 yr
3.9 mo
9.6 yr
3.9 mo
8.9 yr
3.8 mo
7.7 yr
3.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
10.4 yr
3.9 mo
N/A
9.9 yr
3.9 mo
N/A
9.4 yr
3.9 mo
N/A
8.6 yr
3.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60 min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
6.8 mo
N/A
9.4 yr
6.6 mo
N/A
8.9 yr
6.5 mo
N/A
8.1 yr
6.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
6.8 mo
N/A
9.6 yr
6.7 mo
N/A
9.3 yr
6.6 mo
N/A
8.7 yr
6.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Table 239. Battery longevity for Ellipse DR 36 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
535
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
536 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
537
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 18 days for each additional month of shelf time.
357
Table 239. Battery longevity for Ellipse DR 36 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60 min§, 500 ¬
11.1 yr
7.0 mo
N/A
10.6 yr
6.9 mo
N/A
10.2 yr
6.8 mo
N/A
9.5 yr
6.6 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 500 ¬
10.4 yr
6.8 mo
9.6 yr
6.7 mo
9.0 yr
6.5 mo
8.0 yr
6.2 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Normal
ERI to EOL
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬
11.1 yr
7.0 mo
10.8 yr
6.9 mo
10.5 yr
6.9 mo
10.1 yr
6.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 900 ¬
Normal
ERI to EOL
10.4 yr
6.8 mo
9.9 yr
6.7 mo
9.5 yr
6.6 mo
8.8 yr
6.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
10.4 yr
3.9 mo
9.6 yr
3.9 mo
9.0 yr
3.8 mo
8.0 yr
3.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD, 2.5 V, 0.4 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
10.4 yr
3.9 mo
N/A
9.9 yr
3.9 mo
N/A
9.5 yr
3.9 mo
N/A
8.8 yr
3.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.4 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
6.8 mo
N/A
9.5 yr
6.6 mo
N/A
9.0 yr
6.5 mo
N/A
8.3 yr
6.3 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.4 ms, 60 min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.59
2.59-2.54
2.54-2.40
Normal
ERI to EOL past EOL
10.1 yr
6.8 mo
N/A
9.7 yr
6.7 mo
N/A
9.4 yr
6.6 mo
N/A
8.8 yr
6.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Ellipse™ VR 36 J Devices
Table 240. Battery longevity for Ellipse VR 36 J devices (calculated at 0.5 ms Pulse Width)
Battery Battery Approximate Duration
538
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
539 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
Recommended
358
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
Condition
No pacing
25% pacing
50% pacing
100% pacing
Action
Normal
ERI to EOL past EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 500 ¬
11.1 yr
7.0 mo
N/A
10.6 yr
6.9 mo
N/A
10.1 yr
6.8 mo
N/A
9.4 yr
6.6 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
11.1 yr
7.0 mo
10.8 yr
6.9 mo
10.5 yr
6.9 mo
9.9 yr
6.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
11.1 yr
4.0 mo
10.6 yr
4.0 mo
10.1 yr
3.9 mo
9.4 yr
3.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL
11.1 yr
4.0 mo
10.8 yr
4.0 mo
10.5 yr
4.0 mo
9.9 yr
3.9 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60
min§, 500 ¬, V. AutoCapture parameter On
Normal
ERI to EOL
10.7 yr
6.9 mo
10.4 yr
6.8 mo
10.1 yr
6.8 mo
9.7 yr
6.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60
min§, 900 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
10.7 yr
6.9 mo
N/A
10.5 yr
6.9 mo
N/A
10.3 yr
6.8 mo
N/A
9.9 yr
6.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.54-2.40
Table 241. Battery longevity for Ellipse VR 36 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
Battery
Condition
Normal
ERI to EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 500 ¬
11.1 yr
7.0 mo
10.6 yr
6.9 mo
10.2 yr
6.8 mo
9.5 yr
6.6 mo
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40 past EOL
Normal
ERI to EOL past EOL
Recommended
Action
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬
11.1 yr
7.0 mo
10.8 yr
6.9 mo
10.5 yr
6.9 mo
10.1 yr
6.8 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
540
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 18 days for each additional month of shelf time.
541
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
542 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
543
Longevity is calculated based on six months from the date of manufacture, two hours of RF communication time at implant, standard device testing (four charges at implant), and recommended capacitor maintenance. Device longevity decreases by 18 days for each additional month of shelf time.
359
Table 241. Battery longevity for Ellipse VR 36 J devices (calculated at 0.4 ms Pulse Width)
Battery
Voltage
Range
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
3.20-2.59
2.59-2.54
2.54-2.40
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60 min§, 500 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.1 yr
4.0 mo
N/A
10.6 yr
4.0 mo
N/A
10.2 yr
3.9 mo
N/A
9.5 yr
3.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 2.5 V, 0.4 ms, 60
min§, 900 ¬, Two HV charges monthly after ERI
Normal
ERI to EOL past EOL
11.1 yr
4.0 mo
N/A
10.8 yr
4.0 mo
N/A
10.5 yr
4.0 mo
N/A
10.1 yr
3.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 1.0 V, 0.4 ms, 60
min§, 500 ¬, V. AutoCapture parameter On
Normal
ERI to EOL
10.7 yr
6.9 mo
10.4 yr
6.9 mo
10.2 yr
6.8 mo
9.7 yr
6.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.4 ms, 60
min§, 900 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
10.7 yr
6.9 mo
N/A
10.5 yr
6.9 mo
N/A
10.3 yr
6.8 mo
N/A
10.0 yr
6.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for AnalyST™ DR, AnalyST Accel™ DR 36 J Devices
Table 242. Battery longevity for AnalyST DR, AnalyST Accel DR 36 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
Normal
ERI to EOL past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
8.2 yr
10.2 mo
7.5 yr
9.3 mo
7.0 yr
8.6 mo
6.1 yr
7.4 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
8.2 yr
10.2 mo
7.7 yr
9.6 mo
7.3 yr
9.0 mo
6.6 yr
8.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/V AutoCapture On
8.1 yr
10.0 mo
N/A
7.7 yr
9.6 mo
N/A
7.4 yr
9.1 mo
N/A
6.8 yr
8.4 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
544
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
545 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
546
Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
547 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
360
Table 242. Battery longevity for AnalyST DR, AnalyST Accel DR 36 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Normal
ERI to EOL past EOL
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60 min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
8.1 yr
10.0 mo
N/A
7.8 yr
9.7 mo
N/A
7.6 yr
9.4 mo
N/A
7.2 yr
8.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for AnalyST™ VR, AnalyST Accel™ VR 36 J Devices
Table 243. Battery longevity for AnalyST VR, AnalyST Accel VR 36 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
8.4 yr
11.1 mo
8.0 yr
10.5 mo
7.6 yr
10.0 mo
7.0 yr
9.1 mo
Recommended
Action
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 900 ¬
8.4 yr
11.1 mo
8.1 yr
10.7 mo
7.8 yr
10.3 mo
7.4 yr
9.7 mo
N/A N/A N/A N/A
Pacing parameters: VVI, RV 1.0 V, 0.5 ms, 60
min§, 500 ¬,
V AutoCapture On
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
8.3 yr
10.9 mo
8.1 yr
10.7 mo
7.9 yr
10.4 mo
7.6 yr
9.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: VVI, RV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
V AutoCapture On
8.3 yr
10.9 mo
N/A
8.2 yr
10.7 mo
N/A
8.0 yr
10.5 mo
N/A
7.7 yr
10.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Current™ DR, Current™+ DR, Current™ DR RF, Current Accel™ DR 36 J
Devices
Table 244. Battery longevity for Current DR, Current+ DR, Current DR RF, Current Accel DR 36 J devices
Battery Battery Approximate Duration
Recommended
548 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
549
Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
550 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
551
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
552 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
361
Voltage
Range
Condition
No pacing
25% pacing
50% pacing
100% pacing
Action
3.20-2.45
2.45-2.35
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
8.2 yr
10.2 mo
7.5 yr
9.3 mo
7.0 yr
8.6 mo
6.1 yr
7.4 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.45
2.45-2.35
Normal
ERI to EOL
8.2 yr
10.2 mo
7.7 yr
9.6 mo
7.3 yr
9.0 mo
6.6 yr
8.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
Normal
ERI to EOL
8.1 yr
10.0 mo
7.7 yr
9.6 mo
7.4 yr
9.1 mo
6.8 yr
8.4 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
2.35-2.25
Normal
ERI to EOL past EOL
8.1 yr
10.0 mo
N/A
7.8 yr
9.7 mo
N/A
7.6 yr
9.4 mo
N/A
7.2 yr
8.9 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Current™ VR, Current™+ VR, Current™ VR RF, Current Accel VR 36 J
Devices
Table 245. Battery longevity for Current VR, Current+ VR, Current VR RF, Current Accel VR 36 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
Normal
ERI to EOL
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
8.4 yr
11.1 mo
8.0 yr
10.5 mo
7.6 yr
10.0 mo
7.0 yr
9.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Normal
ERI to EOL
8.4 yr
11.1 mo
8.1 yr
10.7 mo
7.8 yr
10.3 mo
7.4 yr
9.7 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60
min§, 500 ¬, V. AutoCapture parameter On
Normal
ERI to EOL past EOL
N/A N/A N/A N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 900 ¬
8.3 yr
10.9 mo
N/A
8.1 yr
10.7 mo
N/A
7.9 yr
10.4 mo
N/A
7.5 yr
9.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, 1.0 V, 0.5 ms, 60 min§, 900 ¬, V. AutoCapture parameter On
Normal 8.3 yr 8.2 yr 8.0 yr 7.7 yr None
553 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
554
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
555 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
556
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
557 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
362
Table 245. Battery longevity for Current VR, Current+ VR, Current VR RF, Current Accel VR 36 J devices
Battery
Voltage
Range
2.45-2.35
2.35-2.25
Battery
Condition
ERI to EOL past EOL
No pacing
10.9 mo
N/A
Approximate Duration
25% pacing
10.7 mo
N/A
50% pacing
10.5 mo
N/A
100% pacing
10.2 mo
N/A
Recommended
Action
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Promote™, Promote™ RF, Promote Accel™ 30 J Devices
Table 246. Battery longevity for Promote, Promote RF, Promote Accel 30 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
6.5 yr
8.2 mo
5.9 yr
7.3 mo
5.4 yr
6.6 mo
4.6 yr
5.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL
6.5 yr
8.2 mo
5.7 yr
7.1 mo
5.1 yr
6.3 mo
4.2 yr
5.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 500 ¬
Normal
ERI to EOL past EOL
6.5 yr
8.2 mo
N/A
5.4 yr
6.6 mo
N/A
4.6 yr
5.5 mo
N/A
3.5 yr
4.2 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 900 ¬
6.5 yr
8.2 mo
6.1 yr
7.5 mo
5.7 yr
7.0 mo
5.0 yr
6.1 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL
Pacing parameters: DDD-BiV, RV 2.5 V, LV 2.5 V, A 2.5 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL past EOL
6.5 yr
8.2 mo
N/A
6.0 yr
7.4 mo
N/A
5.5 yr
6.7 mo
N/A
4.7 yr
5.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD-BiV (no atrial pacing), RV 2.5 V, LV 5.0 V, 0.5 ms, 60
min§, 900 ¬
Normal
ERI to EOL
6.5 yr
8.2 mo
5.7 yr
7.1 mo
5.1 yr
6.2 mo
4.2 yr
5.0 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately past EOL N/A N/A N/A N/A
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL
5.9 yr
7.9 mo
5.4 yr
7.3 mo
5.0 yr
6.7 mo
4.4 yr
5.8 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
558
Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
559 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
363
Table 246. Battery longevity for Promote, Promote RF, Promote Accel 30 J devices
Battery
Voltage
Range
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
Approximate Duration
No pacing
N/A
25% pacing
N/A
50% pacing
N/A
100% pacing
N/A past EOL Replace immediately
Pacing parameters: DDD-BiV, RV 2.0 V, LV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
Normal
ERI to EOL past EOL
5.9 yr
7.9 mo
N/A
5.6 yr
7.5 mo
N/A
5.3 yr
7.1 mo
N/A
4.8 yr
6.5 mo
N/A
Recommended
Action
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Current™ DR, Current™ DR RF, and Current Accel™ DR 30 J Devices
Table 247. Battery longevity for Current DR, Current DR RF, Current Accel DR 30 J devices
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
3.20-2.45
2.45-2.35
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
6.5 yr
8.2 mo
5.9 yr
7.3 mo
5.4 yr
6.6 mo
4.6 yr
5.6 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
3.20-2.45
2.45-2.35
Normal
ERI to EOL
6.5 yr
8.2 mo
6.1 yr
7.5 mo
5.7 yr
7.0 mo
5.0 yr
6.1 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
Normal
ERI to EOL
5.9 yr
7.9 mo
5.7 yr
7.5 mo
5.4 yr
7.2 mo
5.0 yr
6.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
2.35-2.25
Normal
ERI to EOL past EOL
5.9 yr
7.9 mo
N/A
5.8 yr
7.7 mo
N/A
5.6 yr
7.4 mo
N/A
5.3 yr
7.0 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for Current™ VR, Current™ VR RF, Current Accel™ VR 30 J Devices
Table 248. Battery longevity for Current VR, Current VR RF, Current Accel VR 30 J devices
Battery
Voltage
Range
Battery
Condition
Approximate Duration
25% pacing
50% pacing
Recommended
Action
No pacing
100% pacing
3.20-2.45 Normal
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
6.7 yr 6.4 yr 6.1 yr 5.6 yr None
560 RVCap™ Confirm, LVCap™ Confirm, and ACap™ Confirm are available in models with ACap Confirm Capability and BiVCap™ Confirm Capability only.
561
Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
562 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
563
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
564 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
364
Table 248. Battery longevity for Current VR, Current VR RF, Current Accel VR 30 J devices
Battery
Voltage
Range
Battery
Condition
No pacing
9.0 mo
Approximate Duration
25% pacing
8.5 mo
50% pacing
8.1 mo
100% pacing
7.3 mo
Recommended
Action
2.45-2.35 ERI to EOL Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25 past EOL
Normal
ERI to EOL past EOL
N/A
6.7 yr
9.0 mo
N/A
N/A
6.5 yr
8.6 mo
N/A
N/A
6.3 yr
8.4 mo
N/A
N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 900 ¬
5.9 yr
7.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
Normal
ERI to EOL
6.5 yr
9.3 mo
6.4 yr
9.1 mo
6.2 yr
8.9 mo
6.0 yr
8.5 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Pacing parameters: DDD, RV 1.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬, ACap Confirm/V. AutoCapture parameter On
3.20-2.45
2.45-2.35
2.35-2.25
Normal
ERI to EOL past EOL
6.5 yr
9.3 mo
N/A
6.4 yr
9.2 mo
N/A
6.3 yr
9.0 mo
N/A
6.1 yr
8.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Battery Longevity for AnalyST™ DR, AnalyST Accel™ DR 30 J Devices
Table 249. Battery longevity for AnalyST DR, AnalyST Accel DR 30 J devices
Battery
Voltage
Range
Battery
Condition
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
3.20-2.45
2.45-2.35
2.35-2.25
Normal
ERI to EOL past EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60 min§, 500 ¬
6.5 yr
8.2 mo
5.9 yr
7.3 mo
5.4 yr
6.6 mo
4.6 yr
5.6 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
3.20-2.45
2.45-2.35
Normal
ERI to EOL
Pacing parameters: DDD, 2.5 V, 0.5 ms, 60
min§, 900 ¬
6.5 yr
8.2 mo
6.1 yr
7.5 mo
5.7 yr
7.0 mo
5.0 yr
6.1 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL
3.20-2.45
2.45-2.35
2.35-2.25
Normal
ERI to EOL past EOL
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 500 ¬,
ACap Confirm/V AutoCapture On
5.9 yr
7.9 mo
5.7 yr
7.5 mo
5.4 yr
7.2 mo
5.0 yr
6.6 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A N/A N/A N/A
Pacing parameters: DDD, RV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
ACap Confirm/RVCap Confirm/LVCap Confirm On
3.20-2.45 Normal 5.9yr 5.8 yr 5.6 yr 5.3 yr
565 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
566
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
567 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
568
ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
569 ACap™ Confirm and V. AutoCapture™ parameters are available in devices with ACap Confirm Capability and V AutoCapture Capability only.
None
365
Table 249. Battery longevity for AnalyST DR, AnalyST Accel DR 30 J devices
Battery
Voltage
Range
2.45-2.35
Battery
Condition
ERI to EOL
No pacing
7.9 mo
Approximate Duration
25% pacing
7.7 mo
50% pacing
7.4 mo
100% pacing
7.0 mo
Recommended
Action
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately 2.35-2.25 past EOL N/A N/A N/A N/A
Battery Longevity for AnalyST™ VR, AnalyST Accel™ VR 30 J Devices
Table 250. Battery longevity for AnalyST VR, AnalyST Accel VR 30 J devices
Battery
Voltage
Range
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
3.20-2.45
2.45-2.35
2.35-2.25
Battery
Condition
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
Normal
ERI to EOL past EOL
No pacing
Approximate Duration
25% pacing
50% pacing
100% pacing
Recommended
Action
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60
min§, 500 ¬
6.7 yr
9.0 mo
6.4 yr
8.5 mo
6.1 yr
8.1 mo
5.6 yr
7.3 mo
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately N/A
6.7 yr
9.0 mo
N/A
N/A
6.5 yr
8.6 mo
N/A
N/A
6.3 yr
8.4 mo
N/A
N/A
Pacing parameters: VVI, 2.5 V, 0.5 ms, 60 min§, 900 ¬
5.9 yr
7.8 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, RV 1.0 V, 0.5 ms, 60
min§, 500 ¬,
V AutoCapture On
6.5 yr
9.3 mo
6.4 yr
9.1 mo
6.2 yr
8.9 mo
6.0 yr
8.5 mo
N/A N/A N/A N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
Pacing parameters: VVI, RV 2.0 V, A 2.0 V, 0.5 ms, 60
min§, 900 ¬,
V AutoCapture On
6.5 yr
9.3 mo
N/A
6.4 yr
9.2 mo
N/A
6.3 yr
9.0 mo
N/A
6.1 yr
8.7 mo
N/A
None
Replace within 3 mo, or immediately if frequently charging or pacing amplitude(s)
> 2.5 V
Replace immediately
570 Longevity is calculated based on four charges per year and eighteen months from the date of manufacture.
571
V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
572 V. AutoCapture™ parameter is available in devices with V AutoCapture Capability only.
366
Clinical Studies
Contents:
Accent MRI™ Pacemaker and Tendril MRI™ Lead Investigational Device Exemption Study (MRI Study)
Performance of Chamber Onset and Far Field Morphology SVT Discriminators (page 367)
Detect Fluid Early from IntrA-thoracic Impedance MoniToring (DEFEAT-PE STUDY) (page 370)
Promote™ Q CRT-D and Quartet™ Left Ventricular Heart Lead Study (page 373)
DecisionTx™ Programming (page 386)
AF Suppression™/CRT-D Study (page 392)
Automaticity Clinical Investigation (page 397)
Frontier II: Summary of Clinical Investigations (page 404)
RHYTHM ICD Study: V-V Optimization Phase (page 418)
Zephyr IDE Clinical Trial (page 420)
Performance of Chamber Onset and Far Field Morphology SVT Discriminators
Testing and analysis was conducted to evaluate the performance impact from the Chamber Onset and Far Field Morphology SVT
Discriminators.
Methodology
EGM Clip testing was performed to assess the diagnosis accuracy of the Chamber Onset and Far Field Morphology discriminators at nominal values, compared to their predecessor algorithms, Sudden Onset and Original Morphology Discrimination (MD). EGM clips adjudicated as SVT or VT by board certified EPs were played through Ellipse/Assura device firmware with the new algorithm enabled and again with the old algorithm enabled instead.
Four scenarios were assessed:
Sensitivity and specificity of Sudden Onset vs Chamber Onset
Sensitivity and specificity of Original Morphology Discriminator (MD) vs Far Field MD™ discriminator
Sensitivity and specificity utilizing all discrimination features including rate branch at nominal settings for Unify/Fortify (devices without Chamber Onset or Far Field MD™ discriminator) vs Ellipse/Assura (devices with Chamber Onset and Far Field MD discriminator)
Positive predictive value (PPV), negative predictive value (NPV), false positive rate (FPR), and false negative rate (FNR) for a population of 10,000 episodes using conditional probability analysis at nominal settings for Unify/Fortify (devices without
Chamber Onset or Far Field MD discriminator) vs Ellipse/Assura (devices with Chamber Onset and Far Field MD discriminator)
Data
EGM clips were randomly sampled from multiple St. Jude Medical-sponsored clinical studies and registries. Clips used for Chamber
Onset testing included an atrial and ventricular bipolar channel and were from tachycardias where the ventricular and atrial rates were approximately the same. Clips used for Far Field Morphology testing included a near field bipolar ventricular channel, a far field ventricular channel (RVtip-Can or RVcoil-Can), and morphology scores in order to assess performance of Original MD on the same clip. A second EGM that included a normal ventricular rate served as the source of the template used in morphology evaluation.
Results
Sudden Onset vs Chamber Onset
The table below shows the performance of the Chamber Onset algorithm vs. the Sudden Onset algorithm (with 95% confidence intervals calculated using the bootstrap method), for a total of 374 adjudicated patient clips and 778 simulated clips (Number of VT patient clips = 77, Number of SVT patient clips = 297, Number of VT simulated clips = 778 )
Table 251. Chamber Onset vs. Sudden Onset
Arrhythmia Type (V=A) Prevalence of arrhythmia type, in patients with device detected episodes, based on ACT (%)
SVT
Sudden Onset Chamber Onset
All SVT
AT with 1:1 conduction
8.0
5.8
Specificity (%)
[95% confidence interval]
23.9
[18.7, 29.1]
18.9
[13.6, 24.2]
77.4
[72.8, 82.1]
76.5
[71.2, 81.8]
573
Where specificity or sensitivity is equal to 100%, the confidence intervals could not be calculated.
574 Note that the total includes one additional episode with far-R oversensing not associated with a clinical arrhythmia.
Number of clips evaluated
297
238
367
Table 251. Chamber Onset vs. Sudden Onset
Arrhythmia Type (V=A) Prevalence of arrhythmia type, in patients with device detected episodes, based on ACT (%)
Sinus Tach 1.7
Sudden Onset Chamber Onset Number of clips evaluated
AVNRT
VT
0.5
82.8
[69.1, 96.4]
3.4
[0, 10.2]
100.0
62.1
[44.9, 79.2]
Sensitivity (%)
[95% confidence interval]
29
29
All VT/VF 0.7 97.9
[96.9, 98.9]
84.4
[82.0, 86.9]
855
Fast (> 170 bpm) VT with
1:1 Retrograde
Slow (< 170 bpm)VT with
1:1 retrograde conduction
0.5
0.3
97.6
[96.1, 99.3]
97.1
[95.3, 98.8]
91.4
[88.4, 94.3]
83.0
[79.1, 87.0]
347
342
Fast (> 170 bpm)VT with
1:1 retrograde and frequent PACs near initiation of arrhythmia
0.1 100.0 72.9
[66.1, 79.7]
166
As can be observed based on the results, it may be preferable to program Chamber Onset to Passive in those patients that are known to have slow VTs (< 170 bpm) or a history of 1:1 retrograde conduction along with frequent PACs. It is important to note that
1:1 arrhythmias are specifically challenging for physicians. A recent publication based on results from the OMNI study demonstrated that individual physician arrhythmia accuracy varies from 22% to 100% with a median of 87.7%
. The study also indicated that non-VT/VF arrhythmias with 1:1 AV conduction had significantly lower accuracy than other episodes (57.6% vs 93.2%). In contrast, the Chamber Onset algorithm had accuracy for non-VT/VF arrhythmias of 77.4%.
Original MD vs Far Field MD™ Discrimination
The table below shows the performance of the Far-Field Morphology vs. Original Morphology Discrimination setting (with 95% confidence intervals calculated using the bootstrap method), for a total of 206 adjudicated patient clips (Number of VT patient clips
= 52, Number of SVT patient clips = 154).
Table 252. Far-Field Morphology vs. Original Morphology
Arrhythmia Type
All SVT
AT/AF/AFl
AVNRT
Sinus Tachycardia
Other
All VT/VF
Prevalence of arrhythmia type, in patients with device detected episodes, based on
ACT (%)
SVT
Original MD Far-Field MD
Specificity (%)
[95% confidence interval]
30.3
24.6
0.9
2.8
84.4
[72.8, 96.0]
79.3
[65.0, 93.7]
100.0
100.0
94.8
[91.1, 98.5]
94.0
[89.2, 98.7]
91.7
[71.4, 100]
100.0
2.1 100.0 100.0
VT
16.9
1.1
Sensitivity (%)
[95% confidence interval]
65.4
[50.3, 80.5]
25.0
[0.0, 55.7]
84.6
[73.0, 96.3]
50.0
[0.7, 89.3]
Number of clips evaluated
154
116
12
20
6
52
VT + Simultaneous
AT/AF/AF
4
Overall Discrimination Performance
Total adjudicated clips = 206
575 Fischer A, Patel A, et al., Wide variability in manual classification of arrhythmias in dual and triple chamber defibrillators during follow-up. Heart Rhythm, 2012; 9 (5S), S380.
576
Where specificity or sensitivity is equal to 100%, the confidence intervals could not be calculated.
577 Note that the total includes VT/VF episodes without AT/AF/AFl.
368
Number of VT = 52
Number of SVT = 154
Table 253. Devices with Sudden Onset and Original MD vs Devices with Chamber Onset and Far Field MD Discrimination (at
Nominal Settings)
Sensitivity
Specificity
Devices Sudden Onset and Original MD Devices with CO and FFMD
78.8% 86.5%
[65.0%, 92.7%] [75.7%, 97.4%]
82.5%
[75.4%, 89.5%]
95.5%
[91.8%, 99.1%]
Table 254. Performance by Rate Branch (%)
V>A
V=A
V<A
Single Chamber
Sensitivity
Specificity
Sensitivity
Specificity
Sensitivity
Specificity
Sensitivity
Specificity
Devices Sudden Onset and
Original MD
100.0 na
100.0
88.5
0.0
95.0
75.7
71.7
Devices with CO and FFMD
100.0 na
100.0
100.0
0.0
97.5
86.5
90.0
Table 255. Estimated Overall Device Performance for 10,000 episodes at nominal 2 zone detection rates and discriminator settings
(%)
Positive predictive value
Negative predictive value
False positive rate
False negative rate
Devices Sudden Onset and Original MD Devices with CO and FFMD
63.2 78.2
98.8
36.8
1.2
98.0
21.8
2.0
Table 256. Sensitivity of Sudden Onset and Chamber Onset, patient clip testing
Sudden Onset
Chamber Onset
Chamber Onset - Sudden Onset
Sensitivity (%)
96.1
83.1
-13.0
95% bootstrap confidence interval
91.8%, 100.0%
75.1%, 91.1%
-20.2%, -5.8%
Table 257. Sensitivity of Sudden Onset and Chamber Onset, virtual patient clip testing
Sudden Onset
Chamber Onset
Chamber Onset - Sudden Onset
Sensitivity (%)
98.1
84.6
-13.5
95% bootstrap confidence interval
916.8%, 98.9%
81.8%, 87.0%
-16.0%, -11.0%
Table 258. Specificity Sudden Onset and Chamber Onset
Sudden Onset
Specificity (%)
23.9
95% bootstrap confidence interval
18.7%, 29.1%
369
Table 258. Specificity Sudden Onset and Chamber Onset
Chamber Onset
Specificity (%)
Chamber Onset - Sudden Onset
77.4
53.5
95% bootstrap confidence interval
72.8%, 82.1%
47.6%, 59.5%
Table 259. Sensitivity of Original Morphology and Far Field Morphology
Original Morphology
Far Field Morphology
Sensitivity (%)
65.4
84.6
19.2
Far Field Morphology - Original
Morphology
95% bootstrap confidence interval
50.3%, 80.5%
73.0%, 96.3%
2.2%, 36.3%
Table 260. Specificity of Original Morphology and Far Field Morphology
Original Morphology
Far Field Morphology
Far Field Morphology - Original
Morphology
Specificity (%)
84.4
94.8
10.4
95% bootstrap confidence interval
72.8%, 96.0%
91.1%, 98.5%
-2.5%, 23.3%
Conclusions
The new Chamber Onset and Far Field Morphology discriminators reduce inappropriate therapy caused by false positive diagnoses.
While each individual discriminator may not be appropriate for all patients, when used in combination, these features demonstrate an improved specificity while maintaining a low false negative rate.
Detect Fluid Early from IntrA-thoracic Impedance MoniToring (DEFEAT-PE STUDY)
The purpose of this pivotal IDE study was to demonstrate the safety and effectiveness of the CorVue™ Thoracic Impedance
Monitoring algorithm in the St. Jude Medical CRT-D devices and VR/DR devices.
Study Endpoints
The objective of this study was to demonstrate the safety and effectiveness of the CorVue™ Thoracic Impedance Monitoring algorithm.
The primary efficacy endpoint was the false positive rate (FPR) per patient-year of follow up. The FPR is the number of times the fluid index exceeded the CorVue Threshold (and was unrelated to an event) divided by the number of patient-years of
impedance event if the rising occurs within 30 days prior to the event, or if the rising occurs when the event is ongoing.
Otherwise, it is considered to be unrelated to an event.
The secondary efficacy endpoint was sensitivity of the impedance monitoring feature to detect events. This was calculated as the proportion of heart failure (HF) events with a detected impedance event.
Figure 28. Impedance monitoring feature
370
Study Design
The study was a non-randomized, multi-center pivotal study that collected information on intrathoracic impedance measurements from St. Jude Medical CRT-D and ICD devices. The study was conducted at 34 investigational centers located in the U.S., and 162 patients (80 ICD and 82 CRT-D) were enrolled.
At enrollment, the CorVue™ Thoracic Impedance Monitoring algorithm was turned On. Following enrollment, patient follow-up visits were completed at Baseline, three months after baseline, and every three months thereafter until study completion.
Inclusion and Exclusion Criteria
Eligible patients met all of the following:
1.
Implanted for at least 31 days with a St. Jude Medical CRT-D or ICD capable of enabling impedance data collection.
2.
3.
4.
Implanted with a right atrial bipolar pacing lead (if applicable), a right ventricular true bipolar defibrillation lead, and a
St. Jude Medical endocardial left ventricular bipolar pacing lead (if applicable).
Had at least one hospitalization or emergency room visit within the past six months for decompensated heart failure requiring medical treatment with at least one of the following pharmacological agents: intravenous diuretics, intravenous inotropes, intravenous nitrates, Natrecor therapy or £100% increase in oral diuretic therapy.
Had the ability to provide informed consent for study participation and was willing and able to comply with the prescribed follow-up tests and schedule of evaluation.
Patients were excluded if they met any of the following:
1.
2.
Were less than 18 years of age.
Implanted with an RV integrated pacing/defibrillator lead.
3.
4.
Implanted with a capped or inactive RA or RV pacing/defibrillator lead.
Implanted with a non-St. Jude Medical LV pacing lead.
5.
6.
Implanted with an epicardial lead.
Had end-stage renal disease requiring hemodialysis.
7.
8.
Received intermittent infusions of positive inotropic agents (at home, in an outpatient clinic, or in a short-stay unit) for refractory end-stage HF.
Were pregnant or planning a pregnancy in the next six months.
9.
10.
Were currently participating in a clinical investigation that included an active treatment arm.
Had a life expectancy of less than six months due to any condition.
Clinical Study Results
Patient enrollment in the DEFEAT-PE study began on June 9, 2009 and ended on June 30, 2010. A total of 162 patients were enrolled in the study. Eighteen patients were withdrawn prior to the baseline visit resulting in a total of 144 patients included in the analyses. The average duration of follow-up for the CRT-D cohort was 9.2 ± 5.4 (range 0 to 20.3) patient-months, and the ICD cohort had an average time of follow-up as 11.3 ± 3.9 (range 1.8 to 19.1) patient-months.
False Positive Rate
The primary efficacy endpoints for both cohorts (CRT-D and ICD) were demonstrated by the FPR per patient-year of follow-up.
The hypothesis is formally expressed as follows:
H0: Expected FPR
£1.5 per patient-year of follow-up
•Ha: Expected FPR <1.5 per patient-year of follow-up
The desired outcome is to reject the null hypothesis. The null hypothesis is rejected at the 5% significance level if the 95% upper confidence limit (UCL) for expected FPR is less than 1.5 per patient-year of follow-up.
Analysis
Algorithm with Nominal Setting of 14 days
Based on the nominal threshold setting of 14 days, there were 112 departures above the CorVue Threshold that occurred in 144 patients between the Baseline visit and the data cutoff date.
Among these 112 departures, 18 were related to an event and 94 were unrelated. The total follow-up patient-years with available impedance measurements were 97.97 years. The FPR was 0.96 with a 95% UCL of 1.14. The 95% UCB was less than the objective performance criterion of 1.5 (see the table below. Therefore the null hypothesis was rejected at the 5% level of significance.
Table 261. FPR for algorithm with nominal setting in combined CRT-D and ICD cohorts
Algorithm
Programming
14 day nominal value
Patient
Cohort
CRT-D
+ICD
N (Total Years of Follow Up)
144 (97.97)
Number of
False
Positives
144 (97.97)
FPR Per Patient
Year of Follow
Up
0.96
95% Upper
Confidence
Limit (UCL)
1.14
Objective
Performance
Criteria (OPC)
1.50
371
Algorithm with Nominal CorVue Threshold and Programmable CorVue Threshold
An additional analysis was carried out by using a programmable CorVue Threshold. In the additional analysis, the CorVue Threshold was set at 14 days and was then reprogrammed after the first false positive or false negative event. The method used for reprogramming the CorVue Threshold is described below:
All events since the last visit were reviewed. If a false positive event was noted and the patient did not have any true positive events, the CorVue Threshold was adjusted to a higher threshold value (i.e., from 14 days to 15 days). If the patient had any true positive events prior to the device interrogation, the CorVue Threshold was unchanged.
If the clinical event was a false negative, the CorVue Threshold was adjusted to a lower value (i.e., from 14 days to 13 days).
Figure 29. Diagram of CorVue Threshold reprogramming process
There were 79 patients who were reprogrammed after a first false positive or false negative event. The results of nominal settings with programmable CorVue Threshold were presented by combining both cohorts.
Based on the nominal CorVue Threshold of 14 days and using a programmable CorVue Threshold, there were 110 departures above the fluid index that occurred in 144 patients between the Baseline visit and the data cutoff date.
Among these 110 departures, 20 were related to an event and 90 were unrelated. The total follow-up with available impedance measurement was 97.97 patient-years. The FPR was 0.92 with a 95% UCL of 1.09. The 95% UCB was less than the objective performance criterion of 1.5 (see the table below). Therefore the null hypothesis was rejected at the 5% level of significance.
Table 262. FPR for algorithm with programmable CorVue Threshold in combined CRT-D and ICD cohorts
Algorithm
Programming
Patient
Cohort
N (Total Years of Follow Up)
Number of
False
Positives
90
FPR Per
Patient Year of
Follow Up
95% Upper
Confidence
Limit (UCL)
0.92 1.09
Objective
Performance
Criteria (OPC)
1.50 Nominal of 14 days
+ programmable threshold
CRT-D
+ICD
144 (97.97)
Sensitivity
The secondary efficacy endpoints for both cohorts (CRT-D and ICD) were demonstrated by the sensitivity of the fluid index to detect events. This is calculated as the proportion of events with a related departure to the total number of events. A departure is considered to be related to an event if the event begins within 30 days of the index rising above the CorVue Threshold or if the rise occurs when the event is ongoing.
372
The hypothesis is formally expressed as follows:
H0: Sensitivity
¢ 50%
•Ha: Sensitivity > 50%
The desired outcome was to reject the null hypothesis at the 5% significance level. The null hypothesis will be rejected at the 5% significance level if the 95% lower confidence limit (LCL) for sensitivity is greater than 50%.
Algorithm with Nominal Setting of 14 days
There were a total of 79 events in ICD and CRT-D cohort combined: 21 were related to a fluid index greater than the CorVue
Threshold and 58 were not. The sensitivity was 26.6% with a 95% LCL of 18.6%.
Table 263. Sensitivity of algorithm with nominal CorVue Threshold
Algorithm
Programming
Patient
Cohort
N Number of True
Positives
21
Number of
False
Positives
58
Sensitivity 95% Lower
Confidence Limit
(LCL)
18.6% ICD (new nominal of 14 days)
CRT-D
+ICD
144 26.6%
Algorithm with Nominal CorVue Threshold and Programmable CorVue Threshold
As described above for the false positive rate, an additional analysis was carried out with the nominal CorVue Threshold of 14 days and a programmable CorVue Threshold. The CorVue Threshold was initially set at 14 days and then reprogrammed after the first
There were 79 patients who were reprogrammed after a first false positive or false negative event. There were a total of 79 events in the ICD and CRT-D cohorts combined: 23 were related to a fluid index greater than the CorVue Threshold and 56 were not. The sensitivity was 29.1% with a 95% LCL of 20.8%.
Table 264. Sensitivity of algorithm with nominal CorVue Threshold and programmable CorVue Threshold
Algorithm
Programming
Patient
Cohort
N
144
Number of True
Positives
23
Number of
False
Positives
56
Sensitivity
29.1% Nominal of 14 days
+ programmable threshold
CRT-D
+ICD
95% Lower
Confidence Limit
(LCL)
20.8%
Summary
In the DEFEAT PE study, the use of an impedance monitoring algorithm was tested rigorously in an IDE trial for the first time. As noted in the primary endpoint analysis above, the performance of the algorithm demonstrated a false positive rate of 0.96 (1.14 UCL) and a mean sensitivity of 26.6%. This FPR met the objective performance criteria of
¢1.5 and compares well to the published data.
Promote™ Q CRT-D and Quartet™ Left Ventricular Heart Lead Study
The objective of this study was to assess the safety and efficacy of the Promote™ Q CRT-D and Quartet™ left ventricular heart lead
(Promote™ Q device system) in a patient population indicated for cardiac resynchronization
Primary Objectives
Safety of the Promote Q device system was evaluated in terms of freedom from LV lead-related complications through three months.
Safety of the Promote Q device system was evaluated in terms of freedom from system-related complications through three months.
Efficacy of the system was evaluated in terms of the percentage of patients with an LV- pacing threshold of <2.5V at 0.5 ms in
Vector 1 (D1-M2) and at least one other nonstandard programmable biventricular lead vector at three months. Standard vectors
(i.e., vectors already available with a standard bipolar left ventricular lead) include Vector 1 (D1-M2), Vector 3 (D1-RV coil) and
Vector 5 (M2-RV coil). Nonstandard vectors include Vector 2 (D1-P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4),
Vector 8 (M3-RV coil), Vector 9 (P4-M2), and Vector 10 (P4-RV coil).
578
St. Jude Medical Promote Q CRT-D and Quartet Left Ventricular Heart Lead IDE Study included the Promote Q CRT-D Model CD3221-36 and Quartet Model 1458Q left ventricular heart lead. The data apply by similarity to the Promote Quadra™ and Unify Quadra™ devices.
373
Figure 30. Image of Ten Quartet LV lead vectors on the heart and cathode to anode reference for each vector
Inclusion and Exclusion Criteria
Patients were included if they met all of the following:
1.
Had an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D system for treatment of heart failure or life-threatening ventricular tachyarrhythmia(s).
2.
Were receiving a new implant or undergoing an upgrade from an existing ICD or pacemaker implant with no prior LV lead placement
7.
8.
9.
10.
11.
4.
5.
6.
1.
2.
3.
3.
Were able to provide informed consent for study participation and willing and to comply with the prescribed follow-up tests and schedule of evaluations.
Patients were excluded if they had any of the following:
A recent CVA or TIA within three months of enrollment
A contraindication for emergency thoracotomy
A hypersensitivity to a single 1.0 mg dose of dexamethosone sodium phosphate or short-term contact with heparin
A classification of Status 1 for cardiac transplantation or consideration for transplantation over the next three months
A cardiac transplantation within 40 days of enrollment
A recent myocardial infarction, unstable angina, or cardiac revascularization (PTCA, Stent, or CABG) within 40 days of enrollment
Participation in a clinical investigation that includes an active treatment arm
Pregnancy or plans to become pregnant during the duration of the study
A life expectancy of less than six months due to any condition
Age under 18 years
Inability to comply with the follow-up schedule.
374
Clinical Study Results
A total of 178 patients were enrolled at 24 clinical sites in the Promote Q CRT-D and Quartet left ventricular heart lead study. The first patient was enrolled on October 2, 2009. The total time of follow-up was 849.64 patient months. The average time of follow-up was 4.77 ± 1.94 (range 0.99 to 9.82) patient-months.
The table below contains a summary of the demographic information on all patients included in the Promote Q CRT-D and Quartet left ventricular heart lead study (178 patients).
Age (years)
Mean ± SD
Range
Gender, n (%)
Female
Male
Ethnicity, n (%)
Hispanic or Latino
Not Hispanic or Latino
Failed to Report
Race, n (%)
Asian
Black or African American
White
Other
Failed to Report
NYHA Class, n (%)
Class III
Class IV
LV Ejection Fraction (%
Mean ± SD
Range
Cardiomyopathy Etiology, n (%)
Ischemic
Non-Ischemic
Alcoholic
Hypertensive
Idiopathic
Valvular Disease
Other
Cardiovascular History, n (%)
Coronary Artery Disease
Myocardial Infarction
Unstable Angina
Prior Cardiac Interventions
CABG
PTCA/ Stents/Atherectomy
Arrhythmia History, n (%)
Atrial Arrhythmia
Ventricular Arrhythmia
Table 265. Promote Q CRT-D and Quartet left ventricular heart lead study demographics
Demographic Variable
75 (42.1%)
3 (1.7%)
24 (13.5%)
27 (15.2%)
7 (3.9%)
14 (7.9%)
122 (68.5%)
77 (43.3%)
23 (12.9%)
98 (55.1%)
72 (40.4%)
43 (24.2%)
71 (39.9%)
53 (29.8%)
All Enrolled Patients
(N=178)
68 ± 11
(31, 87)
56 (31.5%)
122 (68.5%)
11 (6.2%)
161 (90.4%)
6 (3.4%)
5 (2.8%)
29 (16.3%)
140 (78.7%)
2 (1.1%)
2 (1.1%)
175 (98.3%)
3 (1.7%)
25 ± 7
(9, 50)
103 (57.9%)
375
Table 265. Promote Q CRT-D and Quartet left ventricular heart lead study demographics
Demographic Variable
Other Medical Conditions, n (%)
No Other Medical Condition
Diabetes
COPD
Renal Disease
Hypertension
Pacer Dependent
Other (e.g., valve disease/replacement, hyperlipidemia, peripheral vascular disease)
All Enrolled Patients
(N=178)
19 (10.7%)
70 (39.3%)
36 (20.2%)
33 (18.5%)
134 (75.3%)
13 (7.3%)
78 (43.8%)
Primary CRT-D Indication for Implant, n (%)
Upgrade from pacemaker
HF with wide QRS, NYHA Class III or ambulatory Class IV, and EF <35%
(ACC/AHA/HRS Class I Recommendation)
HF with NYHA Class III or ambulatory Class IV, EF <35% and frequent dependence on ventricular pacing (ACC/AHA/HRS Class IIa
Recommendation)
HF with NYHA Class III or ambulatory Class IV, EF <35%, QRS > 120 ms, and AF (ACC/AHA/HRS Class IIa Recommendation)
Upgrade from ICD
PAVE (Patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class III or IV symptoms)
9 (5.1%)
115 (64.6%)
8 (4.5%)
14 (7.9%)
28 (15.7%)
4 (2.2%)
Current Drug Therapy, n (%)
ACE Inhibitors
ARBs
Beta Blockers
Calcium Channel Blockers
Cardiac Glycosides (Digitalis)
Diuretics
Inotropes
114 (64.0%)
37 (20.8%)
155 (87.1%)
18 (10.1%)
57 (32.0%)
143 (80.3%)
1 (0.6%)
Nitrates
Antiarrhythmics (Class I)
24 (13.5%)
2 (1.1%)
Antiarrhythmics (Class III) 31 (17.4%)
Vasodilators 2 (1.1%)
Of the 178 patients enrolled in the Promote Q CRT-D and Quartet left ventricular heart lead study, 170 lead implants were successful
(95.5% implant success rate). The reasons for an unsuccessful implant were: Inability to obtain stable lead position (n=4); poor venous anatomy or the inability to advance the lead into a small caliber coronary sinus vein (n=2); diaphragmatic/phrenic nerve stimulation (n=1); and cardiopulmonary arrest (n=1). All eight patients with unsuccessful implants were followed for a period of 30 days for adverse events and then were withdrawn from the study.
Primary Objective Results
1. Safety Objective 1: Freedom from left ventricular lead-related complications through three months >
85%
Freedom from LV lead-related complications through three months was estimated as 96% with a 97.5% lower confidence boundary
(LCB) of 93%. The 97.5% LCB was greater than the objective performance criterion of 85%. Hence, the objective was met.
2. Safety Objective 2: Freedom from system-related complications through three months > 75%
The survival from system-related complications through three months was estimated as 92% with a 97.5% LCB of 88%. The 97.5%
LCB was greater than the objective performance criterion of 75%. Hence, the objective was met.
376
3. Efficacy Objective: Responder rate of biventricular pacing at three months > 75%
The primary effectiveness endpoint for the Promote Q system was the responder rate to biventricular pacing at three months. A responder per protocol was defined as a patient with an LV-pacing threshold of <2.5V at 0.5 ms in the D1-M2 pacing configuration
(Vector 1) AND at least one other nonstandard programmable biventricular lead vector. Nonstandard vectors included Vector 2 (D1-
P4), Vector 4 (M2-P4), Vector 6 (M3-M2), Vector 7 (M3-P4), Vector 8 (M3-RV coil), Vector 9 (P4-M2), and Vector 10 (P4-RV coil).
Prespecified Analysis
Analysis per statistical plan: Per the statistical analysis plan, patients with unsuccessful implants (who therefore did not have threemonth data) were treated as nonresponders. The responder rate at three months in this analysis was estimated as 79.7% with a
97.5% LCB of 73%. Since the responder rate was < 75% at the three-month visit, the objective was not met.
Alternate Analysis
Complete case analysis: In the complete case analysis, patients with successful implants who had evaluable pacing capture threshold measurements at the three-month visit were included. The responder rate at three months was estimated as 83.9% with a
97.5% LCB of 77.2%, which is greater than the objective performance criterion of 75%. Hence, the objective was met.
Additional Data
Below are histograms summarizing the study population's capture threshold measurements for each vector at the three-month visit.
Figure 31. Number of patients in each subset of capture threshold measurements using Vector 1 (D1-M2) at three months postimplant
377
Figure 32. Number of patients in each subset of capture threshold measurements using Vector 2 (D1-P4) at three months postimplant
Figure 33. Number of patients in each subset of capture threshold measurements using Vector 3 (D1-RV Coil) at three months postimplant
378
Figure 34. Number of patients in each subset of capture threshold measurements using Vector 4 (M2-P4) at three months postimplant
Figure 35. Number of patients in each subset of capture threshold measurements using Vector 5 (M2-RV Coil) at three months post-implant
379
Figure 36. Number of patients in each subset of capture threshold measurements using Vector 6 (M3-M2) at three months postimplant
Figure 37. Number of patients in each subset of capture threshold measurements using Vector 7 (M3-P4) at three months postimplant
380
Figure 38. Number of patients in each subset of capture threshold measurements using Vector 8 (M3-RV Coil) at three months post-implant
Figure 39. Number of patients in each subset of capture threshold measurements using Vector 9 (P4-M2) at three months postimplant
381
Figure 40. Number of patients in each subset of capture threshold measurements using Vector 10 (P4-RV Coil) at three months post-implant
NOTE
The histograms include measurements when LV-lead electrodes were positioned more proximally outside the coronary vein (e.g., in the coronary sinus).
The table below summarizes the number and percentage of patients who had capture thresholds < 2.5V in each vector during the three-month office visit. Outcomes at the pre-discharge and one-month visit were similar to the three-month visit. As observed in the table below, the Quartet lead enabled multiple vectors with capture thresholds of less than 2.5V.
Table 266. Patients with capture thresholds < 2.5V in each vector at three months
Vector
3
4
1
2
5
D1 - M2
D1 - P4
D1 - RVCOIL
M2 - P4
M2 - RVCOIL
Capture Threshold < 2.5V
@ Three Month Follow-Up
# of pts (N=161)
136
137
145
90
119
% of pts
84
85
90
56
74
8
9
6
7
M3 - M2
M3 - P4
M3 - RVCOIL
P4 - M2
68
61
93
32
42
38
58
20
10 P4 - RVCOIL 40 25
The table below summarizes the utilization of individual electrodes (D1, M2, M3 and P4) as anode or cathode to form multiple vectors. It is important to understand how often each electrode is part of the vector configuration with a capture threshold of < 2.5V during the three-month visit. Each electrode is frequently associated (i.e., is part of the vector as a cathode or anode) with a vector configuration with capture threshold < 2.5V. Outcomes at the pre-discharge and one-month visit were similar to the three-month visit.
382
Table 267. Patients with capture thresholds < 2.5V using D1, M2, M3, and P4 electrodes at three months
Electrodes
D1
M2
M3
Capture threshold <2.5V @ 3 Months
# of pts
(N = 161)
145
119
93
% of pts
90
74
85
P4 137 85
The table below displays the lead impedance performance at the three month visit. Outcomes at the pre-discharge and one-month visit were similar to the three-month visit. Impedance values are within normal limits for all ten vectors. The nonstandard vectors
(vectors 8 and 10) provide two additional lower impedance options for the clinician to utilize.
Table 268. LV lead impedance (
¬) for the ten vectors at follow-up visits
Vector Type
Vector 1=D1-M2
Vector 2=D1-P4
Vector 3=D1-RVcoil
Vector 4=M2-P4
Vector 5=M2-RVcoil
Vector 6=M3-M2
Vector 7=M3-P4
Vector 8=M3-RVcoil
Vector 9=P4-M2
Vector 10=P4-RVcoil
Three Month
Follow-Up
(N=161)
Mean ± SD (n)
1071.4 ± 277.1 (161)
1051.7 ± 256.4 (161)
591.8 ± 159.1 (161)
1022.4 ± 290.3 (161)
557.4 ± 154.0 (160)
1022.9 ± 305.5 (160)
1000.3 ± 298.7 (160)
543.8 ± 156.0 (160)
1046.1 ± 303.1 (160)
509.1 ± 144.5 (160)
Final Vector Programming
In the IDE study, the final vector selection was left to the physician's discretion. Physicians could program any of the available ten vectors. As shown in the data above, physicians had multiple vector options available to choose from. The data in the table below show that physicians initially chose to program the vectors they were most familiar with (i.e., standard vectors). As the follow-ups progressed from pre-discharge to one-month to three-month, it appeared that the physicians started to program nonstandard vectors
(in the mid and basal region) more frequently.
6
7
2
5
8
9
1
3
5
Total
Table 269. Final Programmed Vectors at Follow Up Visits
Vector
D1 - M2
D1 - RVCOIL
M2 - RVCOIL
D1 - P4
M2 - P4
M3 - M2
M3 - P4
M3 - RVCOIL
P4 - M2
1
6
0
2
0
152
1
Programmed at Predischarge
# of pts (n =
170)
90
% of pts
52.9
34
28
20.0
16.5
89.4
0.6
1.2
0.0
0.6
3.5
0.0
Programmed at 1 month
3
0
147
0
# of pts (n =
168)
89
38
20
56
10
0
% of pts
0.0
1.8
0.0
34
53.0
22.6
87.5
87.5
6.0
0.0
Programmed at 3 months
1
1
142
1
# of pts (n =
164)
79
36
142
61
12
0
% of pts
0.6
0.6
0.6
38
22.0
22.0
86.6
86.6
7.3
0.0
383
Table 269. Final Programmed Vectors at Follow Up Visits
Vector
10
Total
P4 - RVCOIL
Programmed at Predischarge
# of pts (n =
170)
8
18
% of pts
4.7
10.6
Programmed at 1 month
# of pts (n =
168)
6
21
% of pts
3.6
12.5
Programmed at 3 months
# of pts (n =
164)
4
22
% of pts
2.4
13.4
Successful Reduction (%) of Capture Thresholds and Elimination (%) of Phrenic Nerve Stimulation by VectSelect Quartet™ LV pacing options
The ability to switch among the ten LV-lead vectors of the Quartet lead (VectSelect Quartet™ LV pacing options) was evaluated for successful reduction of capture threshold and elimination of phrenic nerve stimulation (PNS). High pacing thresholds and PNS are often observed in cardiac resynchronization therapy systems. Approaches to avoiding and managing these problems include device programming, reoperation, or abandonment of the left ventricular lead. Additional vectors reduce the need for invasive interventions by offering additional programming options. The VectSelect™ capability of the Quartet lead prevents the need for invasive interventions for LV lead-related issues. The successful reduction of capture thresholds and elimination of PNS by the
VectSelect Quartet LV pacing options are presented below. The table below displays the incidence and resolution of PNS and elevated capture threshold in the Quartet and QuickFlex™ µ LV leads.
Table 270. Resolution of PNS and Elevated Capture Thresholds
Phrenic Nerve Stimulation (PNS) Comparison
Patients in Promote Q/ Quartet IDE
(N=178)
Patients in QuickFlex µ IDE(N=86)
Patients (%) in whom PNS was clinically observed
23 (12.9%) 10 (11.6%)
Patients (%) in whom PNS was clinically observed and could not be resolved
0 (0%) 2 (20%)
Patients (%) in whom PNS was clinically observed and resolved by switching to a different pacing configuration
17 (74%) 4 (40%)
Patients (%) in whom PNS was clinically observed and resolved by changing pacing output
Elevated Capture Threshold Comparison
6 (26%) 4 (40%)
Patients (%) in whom elevated capture thresholds were observed
1(0.6%) 1(1.2%)
Patients (%) in whom elevated capture threshold was clinically observed and resolved by switching to a different pacing configuration
1(0.6%) 1(1.2%)
In the Quartet LV lead, diaphragmatic/phrenic nerve stimulation was eliminated by changing the pacing vector in 17 out of 23 (74%) patients.
As shown in the table below, standard pacing vectors were associated more often with PNS adverse events than nonstandard pacing vectors.
Table 271. Vectors used to resolved PNS Adverse Events
Quartet Configuration
Standard pacing vectors (N=10)
Vector 1=D1-M2
Vector 3=D1-RVcoil
Vector 5=M2-RVcoil
Nonstandard pacing vectors (N=7)
Vector 2=D1-P4
Resolution of PNS with VectSelect Quartet LV pacing options
N=17(%)
5 (29.4%)
3 (17.6%)
2 (11.8%)
0 (0%)
384
Table 271. Vectors used to resolved PNS Adverse Events
Quartet Configuration
Vector 4=M2-P4
Vector 6=M3-M2
Vector 7=M3-P4
Vector 8=M3-RVcoil
Vector 9=P4-M2
Vector 10=P4-RVcoil
Resolution of PNS with VectSelect Quartet LV pacing options
N=17(%)
0 (0%)
0 (0%)
1 (5.9%)
5 (29.4%)
0 (0%)
1 (5.9%)
Summary of Conclusions from Promote Q/Quartet IDE study:
The freedom from left ventricular lead-related complications through three months was estimated at 96% with a 97.5% LCB of
93%. This primary safety endpoint was met at the 2.5% significance level.
The freedom from system-related complications through three months was estimated as 92% with a 97.5% LCB of 88%. This co-primary safety endpoint was met at the 2.5% significance level.
Utilizing the complete case analysis, the primary effectiveness endpoint was estimated as 83.9% with a 97.5% LCB of 77.2%.
This primary effectiveness endpoint was met at the 2.5% significance level.
Out-of-clinic diaphragmatic/phrenic nerve stimulation was reported in 23 (14.3%) of patients with a successful implant and all of these events were resolved without invasive intervention. Diaphragmatic/phrenic nerve stimulation was eliminated by changing the pacing vector in 17 out of those 23 (73.9%) patients.
-
Standard pacing vectors were associated more often with PNS adverse events than nonstandard pacing vectors.
-
Both standard and nonstandard pacing vectors were used to resolve PNS. Out of the nonstandard vectors, vector 8 was a common vector that was used to resolve PNS.
Multiple vector options with capture threshold < 2.5V were available for programming for patients at each visit and each programmable electrode was frequently utilized in a vector configuration with capture threshold < 2.5V across different followup visits.
Impedance values are within normal limits for all ten vectors. The nonstandard vectors provide two additional lower impedance options for the clinician to utilize.
Summary of Published Literature
The Quartet™ LV lead can enable LV pacing at the preferred site without compromising lead stability for better management of heart failure patients. Multiple published studies have been conducted that demonstrate the clinical benefits of this system.
Intra-operative clinical benefits
Unpredictable patient anatomy and pacing complications such as PNS or high thresholds may decrease implant efficiency by requiring LV lead repositioning. However, the four electrodes of the Quartet lead provide more options to better manage implant challenges in CRT patients and to reduce the need for lead repositioning.
Dänschel et al. reported that in 31% of patients (21/68), novel pacing vectors on the quadripolar electrode lead were utilized to avoid lead repositioning due to pacing complications such as PNS or high thresholds
In a separate 45 patient study by Forleo et al., lead repositioning was avoided in 6/7 patients in the quadripolar electrode lead group presenting with significant PNS while all 5 patients exhibiting PNS in the bipolar electrode lead group required lead repositioning to a different vein
In a study of 33 patients, Thibault et al. demonstrated that the Quartet lead allowed for resolution of PNS without the need to reposition the lead in 100% (9/9) of patients experiencing PNS during implant
23 minutes longer than the average procedure
.
. Repositioning can lead to implant times about
Post-implant clinical benefits
After implant, the inability to resolve PNS or high thresholds may necessitate surgical LV lead revisions, which are often associated with pocket re-entry risks, such as infection.
As observed in the Promote Q/Quartet IDE, PNS was resolved through programming in 100% (23/23) of cases postoperatively
shown to be significantly less in patients with the Quartet lead than those with a conventional bipolar lead
Sperzel et al. noted a 1.4% (1/70) surgical revision rate for the Quartet lead at one month post-implant
LV lead surgical revision rates reported in the literature (4%)
.
.
Additionally, Sperzel et al. demonstrated that at one month post implant, the additional proximal electrodes available on the
Quartet lead were used in 24% (16/67) of cases to optimize pacing parameters and prevent cases of PNS
.
579 Dänschel, W. et al. Initial clinical experience with a novel left ventricular quadripolar lead. Oral Session 183/5. Europace, 2010; 12 (suppl 1): i127. Abstract 183/5.
580
Forleo, GB. et al. Left ventricular pacing with a new quadripolar transvenous lead for CRT: early results of a prospective comparison with conventional implant outcomes.
Heart Rhythm. 2011 Jan;8(1):31-7.
581
Thibault, B. et al. Electrode Selection to Avoid Phrenic Stimulation with a Quadripolar Left Heart Lead. Heart Rhythm 8: AB30-3 (2011).
582 1042 patients. Data on file at St. Jude Medical.
583
Tomassoni G, et al. Post Operative Performance Of A Novel Left Ventricular Quadripolar Electrode Lead, Heart Rhythm 8: P01-43 (2011).
584 Forleo, GB. et al. Left ventricular pacing with a new quadripolar transvenous lead for CRT: early results of a prospective comparison with conventional implant outcomes.
Heart Rhythm. 2011 Jan;8(1):31-7.
585 Sperzel JK, et al. Initial clinical experience with a novel left ventricular quadripolar lead [abstract]. HRS 2010 Poster Session 5 Friday, May 14, 2010, 2:00 PM-5:00 PM,
[PO5-151].
586 Moss AJ, et al. Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events. N Engl J Med 2009;361:1329-1338.
385
As is shown in these study results, the Quartet LV lead offers noninvasive lead repositioning options that may reduce the need for surgical revisions and improve post-operative efficiency.
The additional electrode choices available with the Quartet LV lead make it possible to advance the distal tip close to the apex of the heart where the lead is often more stable while retaining the ability to pace in a more basal region by using the proximal electrodes
the propensity for heart failure hospitalization or death when compared to pacing in a more basal location
found that patients with apical LV pacing showed less improvement in NYHA class and less LV reverse remodeling compared to those with mid-ventricle or basal pacing
589 . The Quartet lead uniquely enables LV pacing in a more basal region without
compromising a stable lead position.
DecisionTx™ Programming
Performance Analysis of DecisionTx™ Programming in Combination with Low Frequency
Attenuation and ATP
Analysis was performed to evaluate the effect of the following St. Jude Medical™ (SJM) features in decreasing the number of inappropriate and unnecessary shocks.
DecisionTx™ Programming, a group of parameter settings designed to optimize SVT Discrimination (see SVT Discrimination
Criteria Programming Guidelines)
Antitachycardia pacing (ATP)
Low Frequency Attenuation, a filtering algorithm designed to improve sensing
The analysis was performed using data from the Advancements in ICD Therapy (ACT) registry, an SJM sponsored data collection effort that followed over 5,000 ICD and CRT-D patients for a two-year period. No specific programming guidelines were provided at implant or during follow-up in the ACT registry.
Patients selected for this performance analysis were required to have:
One or more VT/VF Detections (appropriate or inappropriate) at some time during the two-year follow-up period
A stored EGM associated with at least one of the VT/VF Detections
Morphology scores available in the stored EGMs (Morphology Discrimination did not have to be enabled)
A total of 824 patients met these qualifications, comprising 3,805 VT/VF Detections. One episode/EGM documenting VT/VF Detection was randomly selected from each of the 824 patients and used for the analysis. Eleven EGMs were found not analyzable, leaving a total of 813 episodes for the analysis.
Impact of DecisionTx™ Programming
The analysis compared the diagnosis of each episode to the predicted outcome had the DecisionTx™ Programming settings been programmed at the time of the episode. Fifty-eight SVT episodes occurring during the two-year follow-up period were diagnosed as
VT and treated with unnecessary HV therapy. Analysis of these episodes found that 47 episodes (80.3%) would have been correctly diagnosed as SVT with DecisionTx Programming and would have not been treated with HV therapy. Thus, using the DecisionTx
Programming settings would have resulted in an 80.3% decrease in the number of SVTs inappropriately treated with HV Therapy.
Impact of ATP Usage
An analysis by Sweeney et al.
occurring at rates < 188 bpm and 82.5% of VTs occurring at rates between 188 bpm and 250 bpm. DecisionTx™ Programming includes ATP as the initial therapy in all rate zones. The analysis found that using programming guided by DecisionTx Programming parameters would result in a 40.7% reduction in the delivery of HV Therapy. There were a small number of episodes (1.7%) that were unsuccessfully treated with ATP and required HV therapy to terminate the VT/VF Episode. As ATP was initially attempted for these episodes, DecisionTx Programming did not impact their outcome.
Low Frequency Attenuation Enabled
Bench-testing has demonstrated that the enhanced Low Frequency Attenuation filter eliminates oversensing of the T-wave in 95% of tested QRS-complexes the filter been applied.
oversensing would have been eliminated. Thus, none of these episodes that received HV therapy would have resulted in shock had
Summary
The analysis found that 18.2% of episodes detected as VT/VF in the ACT registry were treated with HV therapy. However, had the patients been able to benefit from the use of DecisionTx™ Programming, in combination with improved sensing with the Low
Frequency Attenuation Filter and use of ATP as the initial therapy, only 7.8% of episodes detected as VT/VF would have been treated with a shock (see the table below)). For VT/VF episodes <250 bpm, the percentage receiving HV therapy would decrease from 5.1% to 0.84%. Furthermore, 98.5% of VT/VF Detections would have been managed without inappropriate delivery of HV therapy.
587
Sperzel JK, et al. Initial clinical experience with a novel left ventricular quadripolar lead [abstract]. HRS 2010 Poster Session 5 Friday, May 14, 2010, 2:00 PM-5:00 PM,
[PO5-151].
588
Singh, JP. et al. Left ventricular lead position and clinical outcome in the Multicenter Automatic Defibrillator Implantation Trial Cardiac Resynchronization Therapy (MADIT-
CRT) trial. Circulation. 2011 Mar 22;123(11):1159-66.
589
Merchant, FM. et al. Impact of segmental left ventricle lead position on cardiac resynchronization therapy outcomes. Heart Rhythm 2010;7:639 - 644.
590 Sweeney et al. Differences in effects of electrical therapy type for ventricular arrhythmia on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010;
7(3); 353-360.
591 Report on file, St. Jude Medical, Sylmar, California.
386
Table 272. Summary of results of the impact of DecisionTx™ Programming on VT/VF episodes from the ACT Registry
Cause of Shock
VT/VF
VT (<188 bpm)
VT (188-250 bpm)
VT (>250 bpm) & VF
Unsuccessful ATP
Non-VT/VF
SVT
Oversensing
Other (bigeminy, noise, etc)
Total
% of VT/VF detections not treated with HV therapy
% of VT/VF detections without inappropriate HV therapy
Baseline
% of VT/VF Detections treated with HV Therapy
10.6%
0.5%
4.6%
3.8%
1.7%
7.6%
7.1%
0.4%
0.1%
18.2%
Baseline
81.8%
92.4%
DecisionTx™ Programming
Projected % of VT/VF
Detections treated with
HV Therapy
6.3%
0.04%
0.8%
3.8%
1.7%
1.5%
1.4%
0.0%
0.1%
7.8%
DecisionTx™
Programming
92.2%
98.5%
Projected % Reduction
40.7%
80.3%
57.1%
Acute IEGM Studies
Description of the Acute IEGM Studies
The Acute Evaluation of Programmer Guided PV and AV Delays Using IEGM Method and Echocardiogram for Optimization Study,
(Acute IEGM PV and AV Study) and the Acute Evaluation of Programmer Guided VV Delay Using IEGM Method and Echocardiogram for Optimization in Cardiac Resynchronization Therapy (Acute IEGM-CRT VV Study) were acute, multi-center clinical trials designed to determine if the IEGM method of optimizing PV and AV delays and VV delay, respectively, was comparable to standard echo determinations.
This was assessed using the Concordance Correlation Coefficient (CCC) for the paired aortic velocity time integral (AVTI) values on each patient.
Inclusion/Exclusion Criteria
Table 273. Inclusion and exclusion criteria
Inclusion
Criteria
Acute IEGM PV and AV Study
Patient has been implanted with a
St. Jude Medical™ Dual-Chamber ICD
D
or CRT-
Acute IEGM-CRT VV Study
Patient has been implanted with a
St. Jude Medical
CRT-D
Patient can provide informed consent for study participation and be willing and able to comply with the prescribed tests.
Exclusion
Criteria
No intrinsic atrial activity (atrial rate
¢ 40 bpm). AV block or no intrinsic atrial activity (atrial rate
¢ 40 bpm).
Have RV ring anodal stimulation during LV pacing at two times the voltage of the LV capture threshold.
Have Atrial Fibrillation at the time of the study testing and evaluation.
Unable to provide analyzable echocardiographic images. (For example, due to an inadequate acoustic window).
Have undergone an echocardiographic assessment within the previous two hours.
Under the age of 18 years.
Pregnant at the time of testing.
592 PhotonDR, PhotonµDR, EpicDR, Epic+DR, AtlasDR, or Atlas+DR device.
593
EpicHF or Atlas+HF device.
594 EpicHF or Atlas+HF device.
387
Patient Population
A summary of the enrollment assessment information on all patients included in the Acute IEGM PV and AV Study and the Acute
IEGM-CRT VV Study is shown in the following table.
Table 274. Enrollment assessment information
Demographic Variable
Age (years):
Mean ± SD
Range
Gender, n (%):
Male
Female
NYHA Class, n (%):
I
II
III
IV
No Heart Failure
LV Ejection
Fraction (%):
Mean ± SD
Range
QRS Duration (ms):
Mean ± SD
Range
Cardiomyopathy Classification:
Ischemic, n (%):
Non-Ischemic, n (%):
None
26 ± 10
10-60
134 ± 32
80-200
43 (74%)
14 (24%)
1 (2%)
Acute IEGM PV and AV Study Overall
Group (N = 58)
68 ± 11
41-89
47 (81%)
11 (19%)
3 (5%)
20 (34%)
30 (52%)
4 (7%)
1 (2%)
24 ± 9
10-49
148 ± 24
100-206
35 (61%)
22 (39%)
0
Acute IEGM-CRT VV Study Overall
Group (N = 57)
71 ± 10
42-89
42 (74%)
15 (26%)
0
10 (18%)
43 (75%)
4 (7%)
0
Patient Cohort for the Acute IEGM PV and AV Study
Fifty-eight patients were enrolled in the Acute IEGM PV and AV Study. For the PV delay determination, two patients could not have
AVTI measurements performed at the PV delays determined by the IEGM method due to the presence of intrinsic conduction.
Therefore, a total of 56 patients with paired AVTI measurements for the PV delay determinations were used for this analysis. For the
AV delay determination, two patients could not have AVTI measurements performed at the AV delays determined by the IEGM method due to the presence of intrinsic conduction. Therefore, a total of 56 patients with paired AVTI measurements for the AV delay determinations were used for this analysis.
Patient Cohort for the Acute IEGM-CRT VV Study
Fifty-seven patients were enrolled in the Acute IEGM-CRT VV Study. The IEGM method test was unable to be conducted on one patient due to their programmed sensitivity settings. The IEGM AVTI image was inadvertently not saved on the site's original echo tape for a second patient. And a third patient's data was not able to be analyzed due to a protocol deviation whereby the AVTI measurement using the IEGM-derived VV delay value was not performed (the site mistakenly repeated the AVTI measurement using the Echo-optimal VV delay and, as a result, no paired data was available). Therefore, analyzable data was available for a total of
54 patients and was used to evaluate the primary endpoint for the VV delay determination.
Of the 54 analyzable patients, the AVTI values for the IEGM VV delays were not measured at the Echo-derived optimal PV delays as specified in the protocol for two patients. For one patient, the PV delay was programmed to 120 ms instead of the optimal PV delay of
100 ms and for the other patient the PV delay was programmed to 120 ms instead of the optimal PV delay of 160 ms. Although the
AVTI measurements at these suboptimal VV delays do not correlate as well with the maximum AVTI measured with the optimal
PV delay and therefore, reduce the likelihood of proving the effectiveness of the IEGM algorithm, both of these patients are included in the primary analysis in order to avoid bias.
595 Two patients did not have LVEF available.
388
Primary Objectives
The Acute IEGM PV and AV Study
The study endpoints were the CCC between the maximum echo aortic VTI (Max Echo AVTI) and AVTI at the PV and AV delays determined by the IEGM AVTI. Per the protocol, the Max Echo AVTI values for PV delay and AV delay were determined as the maximum AVTI value of a total of seven selected PV and AV delays including the IEGM-predicted PV and AV delays. The primary hypothesis was assessed based on the first 52 analyzable patients for each with a two-sided p-value together with a two-sided 95% confidence interval (CI) of the CCC. Analyses based on all analyzable patients are also presented.
The specific objectives were:
The CCC between the Max Echo AVTI and AVTI at the PV delay determined by the IEGM method will not be less than 0.90.
The CCC between the Max Echo AVTI and AVTI at the AV delay determined by the IEGM method will not be less than 0.90.
The Acute IEGM-CRT VV Study
The study endpoint was the CCC between the Max Echo AVTI and AVTI at the VV delay determined by the IEGM method. Per the protocol, the Max Echo AVTI value was determined as the maximum AVTI value of a total of ten (10) selected VV delays including the
IEGM-predicted VV delay. The primary hypothesis was assessed based on the minimum required sample size of 52 analyzable patients with a two-sided p-value together with a two-sided 95% confidence interval of the CCC. Analyses based on all analyzable patients are also presented.
The specific objective was:
The CCC between the Max Echo AVTI and AVTI at the VV delay determined by the IEGM method will not be less than 0.90.
Study Results
Minimum Sample Size Cohort Analysis
Table 275. Minimum sample size cohort analysis
PV Delay (n = 52)
AV Delay (n = 52)
Evaluation Method Median AVTI (cm) Mean AVTI ± SD
(cm)
Max Echo
26.1 27.9 ± 10.1
Median Optimized
Delay (ms)
130
Mean Optimized
Delay ± SD (ms)
124 ± 32
IEGM
24.5 26.3 ± 9.3 130 128 ± 16
The CCC between Max Echo AVTI and IEGM AVTI values was 96.7% with the 95% CI of (94.6% 98.0%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01. Therefore, the objective was met and the IEGM method was in agreement with the Echo optimization for determining the PV delay.
Max Echo
25.8 25.7 ± 9.0 170 167 ± 28
IEGM
24.1 24.5 ± 8.5 180 178 ± 16
The CCC between Max Echo and IEGM AVTI values was 97.7% with a 95% CI of (96.2%, 98.6%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01.
Therefore the objective was met and the IEGM method was in agreement with the Echo optimization for determining the AV delay.
VV Delay
(n = 52)
Max Echo
26.8 27.9 ± 8.9 15 (LV First) 14 ± 45 (LV First)
IEGM
25.8 26.3 ± 8.6 10 (LV First) 13 ± 21 (LV First)
The CCC between Max Echo and IEGM AVTI values was 96.6% with a 95% CI of (94.4%, 98.0%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01.
Therefore the objective was met and the IEGM method was in agreement with the Echo optimization for determining the VV delay.
All-Patient Analysis
Table 276. All-patient analysis
PV Delay
(n = 56)
Evaluation Method Median AVTI (cm) Mean AVTI ± SD
(cm)
Max Echo
26.1 27.7 ± 9.9
Median Optimized
Delay (ms)
125
Mean Optimized
Delay ± SD (ms)
123 ± 32
IEGM
24.6 26.1 ± 9.1 130 128 ± 16
The CCC between Max Echo AVTI and IEGM AVTI values was 96.1% with the 95% CI of (93.7% 97.6%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01. Therefore, the objective was met and the IEGM method was in agreement with the Echo optimization for determining the PV delay.
AV Delay
(n = 56)
Max Echo
IEGM
24.7
23.6
25.5 ± 8.8
24.2 ± 8.4
170
180
165 ± 28
178 ± 16
389
Table 276. All-patient analysis
Evaluation Method Median AVTI (cm) Mean AVTI ± SD
(cm)
Median Optimized
Delay (ms)
Mean Optimized
Delay ± SD (ms)
The CCC between Max Echo and IEGM AVTI values was 97.5% with a 95% CI of (96.0%, 98.5%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01.
Therefore the objective was met and the IEGM method was in agreement with the Echo optimization for determining the AV delay.
VV Delay
(n = 54)
Max Echo
26.5 27.7 ± 8.8 15 (LV First) 15 ± 44 (LV First)
IEGM
25.1 26.2 ± 8.5 10 (LV First) 13 ± 20 (LV First)
The CCC between Max Echo and IEGM AVTI values was 96.6% with a 95% CI of (94.4%, 97.9%), exceeding the objective performance criteria of 90%. The two-sided p-value assessing the primary hypothesis was <0.01.
Therefore the objective was met and the IEGM method was in agreement with the Echo optimization for determining the VV delay.
Summary
In summary, the primary study objectives were met for the PV delay, AV delay, and VV delay determinations. Thus, the IEGM method is effective in deriving the optimized PV, AV, and VV delays in comparison to the standard Echo optimization method.
ADOPT-A Study
Summary of the ADOPT-A Clinical Study
The purpose of the ADOPT-A clinical study was to evaluate the safety and efficacy of the AF Suppression™ pacing feature (formerly called Dynamic Atrial Overdrive or DAO). Since the AF Suppression pacing feature included in the Current™ and Promote™ devices is functionally identically to the feature in the pacemakers implanted in the ADOPT-A study, no additional clinical evaluation was performed. Patients enrolled in the ADOPT-A study were implanted with either a Trilogy™ DR+ /DAO 2360L /2364L or an
Integrity™ AFx DR 5346 device. The DAO (Dynamic Atrial Overdrive) algorithm was incorporated in all three models. The DAO algorithm is designed to provide atrial pacing (atrial overdrive pacing) a majority of the time and bases the pacing rate on the detection of intrinsic atrial activity (or on sensor indicated rate). A total of 39 clinical centers worldwide have participated in the
ADOPT-A study. Of these clinical centers, there are 28 U.S. centers, eight Canadian Centers, and three U.K. centers. A total of
399 patients have been implanted since August 14, 1998.
Patient Population
The primary objective of this randomized, controlled, single-blinded study is to investigate whether DDDR pacing at 60 ppm with the
Dynamic Atrial Overdrive (DAO) pacing algorithm can prevent episodes of symptomatic atrial fibrillation more effectively than DDDR pacing at 60 ppm in patients with symptomatic paroxysmal or persistent atrial fibrillation and sinus node dysfunction with one or more 1991 ACC/AHA Class 1 bradycardia pacing indications. The secondary objectives include number of symptomatic AF episodes, patient health-related quality of life, cardioversions, and hospitalizations.
The overall study population consisted of 399 patients. The patient characteristics are shown in the following table. Of the
399 patients, 196 patients were randomized to the DAO OFF control group and 203 patients were randomized to the DAO ON control group. There were no statistically significant differences in gender, age, ejection fraction, NYHA class, antiarrhythmic drug use, or pre-implant symptomatic AF episode frequency between the DAO ON and DAO OFF groups.
In addition to the required sinus node dysfunction indication, other indications were also reported. The additional reported indications for implant are shown in the following table.
Table 277. Patient characteristics
Mean Age
Male
Female
Mean Left Ventricular Ejection Fraction
Mean Symptomatic Atrial Fibrillation Episodes Prior to
Implant (six months)
Table 278. Additional indications for pacemaker implant
Second Degree AV Block
Third Degree AV Block (Complete)
DAO OFF (n=196)
71.22 ± 9.81
50%
50%
57% ± 12
7.89 ± 4.24
DAO ON (n=203)
71.31 ± 9.97
51%
49%
56% ±13
8.14 ± 4.19
No. of Patients: DAO OFF (%) No. of Patients: DAO ON (%)
7 (3.6%) 10 (4.9%)
3 (1.5%) 8 (3.9%)
390
Table 278. Additional indications for pacemaker implant
Bifascicular or Trifascicular
Hypersensitive Carotid Sinus Syndrome or Neurovascular
Syndrome
No. of Patients: DAO OFF (%) No. of Patients: DAO ON (%)
2 (1.0%) 2 (0.9%)
3 (1.5%) 0 (0.0%)
Methods/Results
Prior to discharge, all patients were provided with a cardiac event recorder and instructed to its use whenever they felt symptomatic.
Patients were asked to carry this recorder with them until the six-month follow-up evaluation at which time it should be returned to the investigational center. Patients were instructed to transmit all ECG episodes recorded by the device by telephone to a central receiving center. All transmitted ECGs were analyzed by two electrophysiologists to classify the rhythm and assess the existence of
Atrial Fibrillation (AF) according to a specific ECG classification system.
An AF-day was defined as a day on which a patient transmitted a recording documenting AF, as classified by the reviewing electrophysiologists. If multiple recordings documenting AF were transmitted on a given day by an individual patient, that day was still considered as one AF-day.
For the study population, AF burden is defined as the total number of AF-days divided by the cumulative follow-up days of the population over the study period.
AF Burden Reduction. The percentage of atrial pacing in the DAO ON group was 92.9% compared to 67.9% in the DAO OFF group
(p<0.0001). Antiarrhythmic drug use during the follow-up period for the large majority of patients did not change. For the minority of patients with antiarrhythmic drug changes (i.e., new drug added, change in dosage and/or drug discontinued), there was no statistically significant difference between the DAO OFF and DAO ON groups. Of all the symptomatic atrial tachyarrhythmias observed during the study, 90.4% were classified as Atrial Fibrillation episodes.
Of the 399 patients, a total of 288 (158 in the DAO OFF group and 130 in the DAO ON group) were included in the efficacy analysis.
Patients were prospectively excluded for lack of follow-up duration (n=55), DAO parameter misprogramming at implant (n=22), missing baseline ECG/data (n=8) or unsuccessful atrial lead implant (n=1). In addition, the first 25 enrolled patients were excluded as investigator requested changes were made to the protocol precluding pooling of the data.
The distribution of AF Burden over time is shown in the following figure. The AF Burden Reduction is shown in the following table.
The DAO ON group had 22,526 days of total cumulative follow-up time with a total of 421 AF-days, while the DAO OFF group has
27,359 days of cumulative follow-up time with a total of 682 AF-days. The AF burden for DAO ON and DAO OFF groups are 1.869% and 2.493% respectively.
A statistically significant and consistently decreasing AF burden observed over time between DAO ON vs. DAO OFF group (p<0.05) is shown in the following figure and table.
Figure 41. Distribution of AF burden
391
Table 279. AF burden reduction
Total Patients
Patients with AF Days
Total of AF Days
DAO OFF
158
81
682
DAO ON
73
73
421
Total Follow-Up Duration (days) 27,359 22,526
AF Burden 2.493% 1.869%
Secondary objective results are further described below:
Symptomatic AF Episodes. There is a statistically significant reduction in the number of symptomatic AF episodes six months post implant compared to six months prior to implant in both the DAO ON (3.2 ± 8.6 vs. 8.4 ± 4.2) and DAO OFF (4.3 ± 11.5 vs. 8.1 ± 4.2) groups (p<0.0001).
Patient Health Related Quality of Life. Using the SF-36 Quality of Life instrument as a qualitative measure of the patients' well being, there is a statistically significant improvement in the standardized physical component (PCS) scores within the DAO ON group (p=0.013). In the standardized mental component (MCS) scores, there is a statistically significant improvement within both the DAO OFF and the DAO ON groups (p<0.001). Additionally, in the Social Functioning (SF) sub-scale, there is a statistically higher improvement in the DAO ON group when comparing between groups (p=0.003).
Hospitalizations. The DAO ON group has a 6.3% reduction of hospitalization days when compared to the DAO OFF group, although the difference was not statistically significant.
Cardioversions. The DAO ON group has a 62.7% reduction of cardioversions when compared to the DAO OFF group.
Adverse Events
None of the deaths or complications that occurred during the clinical study was related to the DAO algorithm. The only DAO-related observation was intolerance to high rate pacing reported in five patients, two of which were resolved by either medication or programmed parameter adjustment.
Summary
The results of analyses demonstrate that the AF burden was significantly reduced when the Dynamic Atrial Overdrive (DAO) algorithm was programmed ON when compared to the DAO OFF group. The positive results suggest that the Dynamic Atrial
Overdrive (DAO) pacing algorithm has proved to be safe and effective during the course of the study.
AF Suppression™/CRT-D Study
Summary of the AF Suppression™/CRT-D Study
The Atrial Fibrillation Suppression Pacing in Cardiac Resynchronization Therapy Devices (AF Suppression™/CRT-D) study was a prospective, randomized study designed to demonstrate that AF Suppression pacing does not negatively affect CRT effectiveness in patients receiving CRT-D therapy.
The clinical study was conducted using the Epic+™ HF V-352 and Atlas™+ HF V-344 devices. However, the data collected also applies to the Promote™ devices. Since the Promote devices are functionally equivalent to the Epic+/Atlas+ devices with respect to the AF Suppression Pacing feature, no additional clinical evaluation was required to support the safety and effectiveness of the
Promote CRT-Ds.
The objective of this clinical study was to demonstrate that AF Suppression pacing does not negatively affect CRT effectiveness in patients currently receiving CRT therapy. Since the AF Suppression feature would not typically be turned on immediately after device implantation, and since the primary objective was to demonstrate that the addition of AF Suppression pacing does not negatively impact the known efficacy of CRT in patients currently receiving CRT, the study enrolled patients who were already receiving CRT therapy with stable heart failure symptoms.
The study was a multi-center, randomized, blinded, controlled clinical study. Patients enrolled in this study were randomized in a 1:1 ratio to one of two groups: CRT with AF Suppression ON and CRT with AF Suppression OFF. The primary endpoint of the study was comparison of the mean change in Six-Minute Hall Walk distance at three months.
Study Inclusion and Exclusion criteria are listed below:
Inclusion Criteria
Previously implanted SJM CRT-D pulse generator capable of AF Suppression pacing for a minimum of three months.
Stable HF symptoms (i.e., no heart failure hospitalizations or need for intravenous inotropes or diuretics within 30 days of enrollment) while receiving cardiac resynchronization therapy.
Ability to complete the Six-Minute Hall Walk Test with the only limiting factor(s) being related to their cardiac fitness.
Ability to independently comprehend and complete a quality of life questionnaire.
Ability to provide informed consent for study participation. Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
Continuous atrial fibrillation (continuous is defined as AF lasting > One Month) within one-year prior to enrollment
Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next three months.
Recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, stent or CABG) within 40 days of enrollment.
Recent CVA or TIA within three months of enrollment.
392
Participating in a clinical investigation that includes an active treatment arm.
Pregnant or a planning for pregnancy in the next six months.
Life expectancy of less than six months.
Less than 18 years of age.
The study design for the trial is shown in the following figure. The total time of follow-up from the time of randomization as of June
28, 2006 was 948.6 patient-months. The average time of follow-up was 5.0 ± 2.4 (range < 1 to 9.3) patient months.
Figure 42. Study overview
Patient Population
Patient Population
A total of 188 patients were enrolled in the AF Suppression/CRT-D study. All patients were randomized at the end of the baseline visit. Randomization was blocked by investigational site. Of the 188 patients, 97 were randomized to the AF Suppression ON group and 91 were randomized to the AF Suppression OFF group.
The analyzable patient group for the study is shown in the following.
393
Figure 43. Analyzable patient group
A summary of baseline information for the 156 patients who completed a six-minute walk test at three months is shown in the following table. This patient group will be included in the primary analysis of the primary endpoint. The baseline information is also broken down by randomization group. The table shows that the two groups are comparable in all variables presented.
Table 280. Comparison of baseline variables between the treatment and control groups for the primary patient cohort (N = 156)
Variable
Age
Mean ± SD
Range
Gender
Male
Female
NYHA Class, n (%)
I
II
III
IV
Not reported
LV Ejection Fraction (%)
Mean ± SD
Range
Cardiomyopathy Classification, n (%)
Ischemic
CAD
Myocardial Infarction
CABG
PTCA
Unstable Angina
Overall Group
(N=156)
68.6 ± 10.2
(38,88)
118 (76%)
38 (24%)
12 (8%)
83 (53%)
57 (37%)
2 (1%)
2 (1%)
28.2 ± 11.3
(8,70)
129 (83%)
125 (97%)
101 (78%)
78 (60%)
51 (40%)
21 (16%)
AF Suppression ON
(N = 80)
69.4 ± 10.8
(38,88)
63 (79%)
17 (21%)
5 (6%)
45 (56%)
28 (35%)
1 (1%)
1 (1%)
27.6 ± 9.8
(9,61)
66 (83%)
64 (97%)
55 (83%)
39 (59%)
27 (41%)
11 (17%)
AF Suppression OFF
(N = 76)
67.8 ± 9.5
(47,87)
55 (72%)
21 (28%)
7 (9%)
38 (50%)
29 (38%)
1 (1%)
1 (1%)
28.7 ± 12.7
(8,70)
63 (83%)
61 (97%)
46 (73%)
39 (62%)
24 (38%)
10 (16%) p-value
ON vs. OFF
0.35
0.35
0.66
0.55
0.95
596
This p-value was calculated by combining Class III and IV as one category.
597 Individual patients may be included in more than one subcategory.
394
Table 280. Comparison of baseline variables between the treatment and control groups for the primary patient cohort (N = 156)
Variable
Non-Ischemic
Hypertensive
Idiopathic
Valvular
Other
Atrial Arrhythmia History, n (%)
Other Medical History
Hypertension
Diabetes
COPD
Other
None
Baseline Medications, n (%)
ACE
ARB
Beta Blockers
Diuretics
Positive Inotropes
Nitrates
Anti-Coagulants/Anti-
Platelets
Calcium Channel Blockers
Antiarrhythmics
Anti-Hypertensives
Quality of Life (total):
Mean ± SD
Range
6-Minute Hall Walk Distance (m):
Mean ± SD
Range
Overall Group
(N=156)
27 (17%)
7 (26%)
9 (33%)
4 (15%)
7 (26%)
66 (42%)
120 (77%)
65 (42%)
31 (20%)
83 (53%)
8 (5%)
100 (64%)
33 (21%)
148 (95%)
125 (80%)
57 (37%)
41 (26%)
117 (75%)
13 (8%)
42 (27%)
62 (40%)
34.4 ± 26.2
(0,98)
315 ± 115
(37,641)
AF Suppression ON
(N = 80)
14 (18%)
3 (21%)
4 (29%)
3 (21%)
4 (29%)
37 (46%)
62 (78%)
32 (40%)
13 (16%)
43 (54%)
4 (5%)
49 (61%)
18 (23%)
78 (98%)
59 (74%)
25 (31%)
19 (24%)
54 (68%)
7 (9%)
23 (29%)
30 (38%)
32.7± 25.7
(0,93)
313 ± 127
(37,641)
AF Suppression OFF
(N = 76)
13 (17%)
4 (31%)
5 (38%)
1 (8%)
3 (23%)
29 (38%)
58 (76%)
33 (43%)
18 (24%)
40 (53%)
4 (5%)
51 (67%)
15 (20%)
70 (92%)
66 (87%)
32 (42%)
22 (29%)
63 (83%)
6 (8%)
19 (25%)
32 (42%) p-value
ON vs. OFF
0.31
0.86
0.66
0.24
0.89
0.94
0.45
0.67
0.13
0.04
0.16
0.46
0.03
0.85
0.60
0.56
36.2 ± 26.9
(0,98)
318 ± 100
(37,579)
0.41
0.82
Primary Objective and Results
The data was cut off when a total of 156 patients completed a six-minute walk test at three months.
The primary endpoint is based on the mean change in six-minute walk distance from baseline to three months in the ON and OFF groups. Patients were analyzed in their randomized group according to intention-to-treat.
The walk distance at Baseline and three months, as well as the difference between Baseline and three months in each of the ON and
OFF groups is shown in the following table. The 95% lower confidence bound on the difference between the mean change in the ON group and OFF group, based on a two-sample t-distribution is -9.3 m, which is greater than the pre-specified objective criterion of -
20 m. Hence, the null hypothesis is rejected, and therefore the mean change in the AF Suppression ON group is not inferior to the mean change in the AF Suppression OFF group.
Table 281. Baseline and three-month six-minute walk distance
Baseline
3-months
Change
AF Suppression ON
Mean ± SD (m)
(N = 80)
313 ± 127
315 ± 128
2 ± 55
AF Suppression OFF
Mean ± SD (m)
(N = 76)
317 ± 100
314 ± 107
-3 ± 52
598 Individual patients may be included in more than one subcategory.
395
Secondary Objectives and Results
Six-Minute Hall Walk Distance: Comparison of Standard Deviation of Change at Three Months
The standard deviations for the change in six-minute walk distance between three months and baseline is compared between the
ON and OFF groups. The p-value for the F test is 0.70, demonstrating that there is no evidence for a difference in standard deviations between the ON and OFF groups.
Additionally, the distribution-free Ranklike test for dispersion was used to test the equality of the standard deviations in the two groups. This is a non-parametric test and does not depend on the normality of the change in walk distance distributions. A subgroup size of six was used to perform this test. The p-value for this test is 0.81, once again demonstrating that there is no evidence for a difference in standard deviations between the ON and OFF groups.
Six-Minute Walk Distance: Comparison of Proportion Increased, No Change, and Decreased
In addition to the primary analysis of the six-minute walk distance, as stated in the protocol, an analysis was carried out on the number of patients who had an increase in walk distance (by more than 10 m), had no change (i.e. change from Baseline was between -10 and 10 m), and decreased (by more than 10 m). This analysis was carried out for the same patient cohort as in the primary analysis of the primary endpoint.
Table 282. Change in walk distance
Change in Walk Distance AF Suppression ON
(N = 80)
34 (43%)
AF Suppression OFF
(N = 76)
30 (39%)
Increased by
£10 m, n (%)
No Change, between -10 m and 10 m, n
(%)
14 (18%) 16 (21%)
Decreased by ¢–10 m, n (%)
32 (40%) 30 (39%) p-value
0.84
A chi-square test was carried out to compare the proportions between the two groups. As expected, the two groups showed no statistically significant difference (p = 0.84) at the 5% significance level. Hence, once again it is concluded that the change in walk distance is comparable between the ON and OFF groups.
Patient Discontinuation/Withdrawals
A total of seven patients participating in the AF Suppression/CRT-D Study were withdrawn from the study. One patient died and was withdrawn from the study. Of the remaining six patients, four were withdrawn prior to completion of the three-month visit.
A summary of patients who were withdrawn from the study is shown in the following table.
Table 283. Patient discontinuations/withdrawals (excludes withdrawals for deaths)
Reason for Withdrawal
Participation terminated by investigator
Participation terminated by investigator
Participation terminated by investigator
Patient request
Patient request
Patient request
Treatment Group
ON
ON
ON
OFF
ON
OFF
Days after Enrollment
3
188
9
3
86
1
Conclusions Drawn from the Clinical Study
The clinical study results show that there was no statistically significant difference in the mean change in Six-Minute Hall Walk distance at three months between the AF Suppression ON and AF Suppression OFF groups. The secondary endpoints (comparison of the standard deviation of change in Six-Minute Hall Walk distance at three months and the comparison of the proportion increased/unchanged/decreased in the Six-Minute Hall Walk distance at three months) also showed no statistically significant difference between the two groups.
The clinical data demonstrates that AF Suppression pacing does not negatively affect CRT effectiveness in patients receiving CRT-D therapy.
396
Automaticity Clinical Investigation
Summary of Clinical Investigation
The Automaticity Clinical Investigation was conducted to show that the St. Jude Medical™ Current Accel™ ICD Models CD2215-36 and CD1215-36 and Promote Accel™ CRT-D Model CD3215-36 are safe and effective.
This study was a prospective, non-randomized, multi-center clinical trial. Patients were enrolled at 15 investigational centers located in the US. A total of 128 patients were enrolled in the study. Data are presented on the first 19, 38, and 45 patients available to complete the primary endpoint analysis for the ACap™ Confirm, Ventricular AutoCapture™ (VAC), and LVCap™/RVCap™ Confirm features, respectively, as defined in the protocol. The total time of follow-up was 747.6 patient months. The average time of follow-up was 5.84 ± 1.96 (range 1.38 to 9.00) patient months.
The number of patients implanted with each device model is shown in the following table.
Table 284. Number of Patients with Each Device Model
Device Model
CD1215-36
CD2215-36
CD3215-36
Total
Number of Patients
14
33
81
128
Inclusion Criteria:
Eligible patients met all of the following:
Have an approved indication, as outlined by AHA/HRS guidelines, for implantation of an ICD or a CRT-D for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of an existing ICD or CRT-D system to replace the pulse generator.
Have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed followup tests and schedule of evaluations.
Exclusion Criteria:
Patients were excluded if they met any of the following:
Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.
•Have had a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA, Stent or CABG) within 40 days of enrollment.
•Have had a recent CVA or TIA within 3 months of enrollment.
•Are allergic to dexamethasone sodium phosphate (DSP).
•Currently participating in a clinical investigation that includes an active treatment arm.
•Pregnant or are planning for pregnancy within 6 months following enrollment.
•Have a life expectancy of less than 6 months.
•Less than 18 years of age.
A summary of the demographic information for all enrolled patients is shown in the following table.
Table 285. Demographic Information for All Enrolled Patients
Demographic
Age (years)
Mean ± SD
Range
Gender, N (%)
Male
Female
Ventricular Arrhythmia History, N (%)
Atrial Arrhythmia History, N (%)
Cardiomyopathy Etiology, N (%)
Ischemic
Non-Ischemic
None
Cardiovascular History, N (%)
All Patients (N=128)
67 ± 12
39-88
96 (75%)
32 (25%)
58 (45%)
46 (36%)
87 (68%)
37 (29%)
4 (3%)
397
Table 285. Demographic Information for All Enrolled Patients
Demographic
Prior Myocardial Infarction
Prior Unstable Angina
Prior CABG
Prior PTCA
Primary Indication for CRT-D Implant, N (%)
HF with wide QRS
HF – no sinus rhythm (ACC/HRS/HFSA Class IIa indication: NYHA Class III or ambulatory Class IV heart failure symptoms, LVEF
¢ 35%, QRS £ 120 ms, atrial fibrillation, optimal recommended medical therapy)
HF – no sinus rhythm and no QRS (ACC/HRS/HFSA Class IIa indication: NYHA Class III or ambulatory Class IV heart failure symptoms, LVEF
¢ 35%, optimal recommended medical therapy, frequent dependence on ventricular pacing.)
CRT-D Replacement (CRT-D or CRT-D system change-out)
PAVE + ICD Indication
ICD Replacement (ICD or ICD system change-out)
Familial Condition
MADIT II
SCD-HeFT
Syncope
VT
VF
Baseline Medications
, N (%)
ACE
ARB
Beta Blockers
Calcium Channel Blockers
Cardiac Glycosides
Diuretics
Nitrates
Antiarrhythmics (Class I)
Antiarrhythmics (Class III)
All Patients (N=128)
70 (55%)
20 (16%)
50 (39%)
46 (36%)
61 (48%)
3 (2%)
4 (3%)
9 (7%)
4 (3%)
18 (14%)
1 (1%)
8 (6%)
15 (12%)
1 (1%)
3 (2%)
1 (1%)
78 (61%)
26 (20%)
105 (82%)
17 (13%)
34 (27%)
96 (75%)
33 (26%)
2 (2%)
17 (13%)
Primary Objective and Results
The data was cut off when data on the first 19, 38, and 45 patients available to complete the primary endpoint analysis for the
ACap™ Confirm, VAC, and LVCap™/RVCap™ Confirm features, respectively, was available.
Primary Safety Endpoint
The primary safety endpoint for this study is freedom from system related complications through 3 months.
H
0
: Freedom from system related complications through 3 months
≤ 85%
H
1
: Freedom from system related complications through 3 months > 85%
All 128 enrolled patients were included in this analysis. The survival time for patients who experienced a system related complication was calculated as the number of days from the date of successful implant to the date the complication was first identified. For patients who did not experience a system related complication and withdrew from the study before the time of analysis, the survival time was censored on the date of their withdrawal. For patients who did not experience a system related complication by the time of analysis, the survival time was censored on the date of data cut-off. The Kaplan-Meier estimate of freedom from system related complications at 3 months was 93.6% and its standard error using Greenwood’s formula was 0.022. The 95% lower confidence bound was 89.9%, which was greater than the objective performance criteria of 85%. The null hypothesis was rejected at the 5% significance level.
Primary Effectiveness Endpoints
599 Individual patients may be included in more than one subcategory.
398
ACap™ Confirm Effectiveness Endpoint
The effectiveness endpoint for the ACap™ Confirm feature is the difference in bipolar atrial capture thresholds determined by ACap
Confirm and by a manual test at 3 months. where represents the absolute mean difference in bipolar atrial capture thresholds at 3 months.
A total of 76 patients had paired bipolar atrial capture threshold measurements from ACap Confirm and a manual test at 3 months.
As specified in the statistical analysis plan, the primary analysis was performed on the first 19 patients who had paired bipolar atrial capture threshold measurements at 3 months. The data are summarized in the following table.
Table 286. ACap Confirm Effectiveness Endpoint – Primary Analysis (N = 19)
Range
Mean ± SD
ACap Confirm (V)
(0.375, 2.000)
0.743 ± 0.357
Manual Test (V)
(0.500, 1.000)
0.737 ± 0.195
Difference
ACap Confirm and Manual Test
(-0.125, 1.250)
0.0066 ± 0.3103
Median 0.750 0.750 -0.1250
The p-values from the two one-sided tests were both < 0.001. Therefore, the p-value for testing the null hypothesis, which was calculated as the larger p-value from the two one-sided tests, was < 0.001. The null hypothesis was rejected at the 1.67% significance level.
VAC Effectiveness Endpoint
The effectiveness endpoint for VAC is the difference in bipolar ventricular capture thresholds determined by VAC and by a manual test at 3 months. where represents the absolute mean difference in bipolar ventricular capture thresholds at 3 months.
A total of 43 patients had paired bipolar ventricular capture threshold measurements from VAC and a manual test at 3 months. As specified in the statistical analysis plan, the primary analysis was performed on the first 38 patients who had paired bipolar ventricular capture threshold measurements at 3 months. The data are summarized in the following table.
Table 287. VAC Effectiveness Endpoint – Primary Analysis (N = 38)
Range
Mean ± SD
VAC (V)
(0.375, 2.750)
0.809 ± 0.405
Manual Test (V)
(0.500, 3.000)
0.862 ± 0.442
Difference
VAC – Manual Test
(-0.250, 0.250)
-0.0526 ± 0.0948
Median 0.750 0.750 -0.0625
The p-values from the two one-sided tests were both < 0.0001. Therefore, the p-value for testing the null hypothesis, which was calculated as the larger p-value from the two one-sided tests, was < 0.0001. The null hypothesis was rejected at the 1.67% significance level.
LVCap™ Confirm/RVCap™ Confirm Effectiveness Endpoints
The effectiveness endpoints for the LVCap™ Confirm/RVCap™ Confirm features are the difference in bipolar LV capture thresholds determined by LVCap Confirm and by a manual test at 3 months and the difference in bipolar RV capture thresholds determined by
RVCap Confirm and by a manual test at 3 months. LVCap Confirm/RVCap Confirm will be met at a significance level of α if and only if both LVCap Confirm and RVCap Confirm are met at a significance level of
α.
399
where represents the absolute mean difference in bipolar LV (for LVCap Confirm) or RV (for RVCap Confirm) capture thresholds at 3 months.
A total of 45 patients had both paired bipolar LV capture threshold measurements from LVCap Confirm and a manual test and paired bipolar RV capture threshold measurements from RVCap Confirm and a manual test at 3 months. As specified in the statistical analysis plan, the primary analysis was performed on the first 45 patients who had both paired bipolar LV capture threshold measurements from LVCap Confirm and a manual test and paired bipolar RV capture threshold measurements from RVCap Confirm and a manual test at 3 months. The data are summarized in the following tables.
Table 288. LVCap Confirm Effectiveness Endpoint – Primary Analysis (N = 45)
LVCap Confirm (V) Manual Test (V)
Range
Mean ± SD
Median
(0.625, 2.875)
1.458 ± 0.631
1.250
(0.750, 3.000)
1.456 ± 0.618
1.250
Difference
LVCap Confirm – Manual Test
(-0.375, 1.625)
0.0028 ± 0.2852
0.000
Table 289. RVCap Confirm Effectiveness Endpoint – Primary Analysis (N = 45)
Range
Mean ± SD
RVCap Confirm (V)
(0.375, 2.250)
0.739 ± 0.279
Manual Test (V)
(0.500, 2.250)
0.794 ± 0.278
Difference
RVCap Confirm – Manual Test
(-0.250, 0.125)
-0.0556 ± 0.0824
Median 0.750 0.750 0.000
The p-values from the two one-sided tests for LVCap Confirm were both < 0.0001. Therefore, the p-value for testing the null hypothesis for LVCap Confirm was < 0.0001. The p-values from the two one-sided tests for RVCap Confirm were both < 0.0001.
Therefore, the p-value for testing the null hypothesis for RVCap Confirm was < 0.0001. Both null hypotheses were rejected at the
1.67% significance level.
Discussion of Primary Endpoints
The primary safety endpoint of system related complications was met at the 5% significance level. The ACap™ Confirm effectiveness endpoint, VAC effectiveness endpoint, and the LVCap™ Confirm/RVCap™ Confirm effectiveness endpoint were all met at the 1.67% significance level. The pre-specified criteria for study success, as specified in the statistical analysis plan, were met.
DEFINITE Trial
Summary of the DEFINITE Trial
The purpose of the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Trial was to evaluate the hypothesis that an implantable cardioverter defibrillator (ICD) will reduce the risk of death in patients with non-ischemic cardiomyopathy and moderate-to-severe left ventricular dysfunction. Patients enrolled in the DEFINITE trial were randomly assigned to receive either standard oral medical therapy for heart failure (HF) or standard oral medical therapy for HF and a single-chamber
ICD. A total of 229 patients were randomized to each study group. The DEFINITE trial was a prospective, randomized, investigatorinitiated study based on previously reported observational data
. Standard oral medical therapy included angiotensin converting enzyme inhibitors (ACE) or ACE substitute (hydralazine and nitrates or angiotensin receptor II blockers [ARBs]) as well as beta blocker therapy unless the beta blocker therapy was contraindicated (beta blocker therapy used in the trial "carvedilol or metoprolol"). Digoxin and diuretic therapy were utilized to manage clinical symptoms. Antiarrhythmics such as amiodarone were discouraged, but were used if necessary to manage supraventricular tachyarrhythmias and/or atrial fibrillation.
Patient Population
The patient cohort for the DEFINITE trial included a non-ischemic cardiomyopathy population with a history of symptomatic heart failure, moderate to severe LV dysfunction (LVEF
¢ 35%) and the presence of ambient arrhythmias. Ambient arrhythmias were
600
Levine JH, Waller T, Hoch D, Greenberg S, Goldberger J, Kadish A. Implantable cardioverter defibrillator: use in patients with no symptoms and at high risk. Am Heart J
1996;131:59-65.
400
defined by an episode of non-sustained ventricular tachycardia on Holter or telemetric monitoring (three to 15 beats at a rate of more than 120 bpm or an average of at least 10 premature ventricular complexes per hour on 24-hour Holter monitoring. It was required that the absence of clinically significant coronary artery disease (CAD) as the cause of the cardiomyopathy be confirmed by coronary angiography or by a negative stress imaging study. The definitions for the presence of CAD are as follows: a) coronary angiography demonstrating
£ 50% proximal or 75% distal luminal stenosis in one or more of the main coronary arteries; b) stress testing with nuclear perfusion imaging or dobutamine echocardiography demonstrating any evidence of ischemia; or c) history of documented
Q-wave myocardial infarction. Patients eligible for participation were also required to be 18-80 years of age.
Patients were excluded if they had coronary artery disease, unexplained syncope within the past six months, prior cardiac arrest, VT of more than 15 beats at a rate of 120 bpm, NYHA Class IV heart failure at the time of enrollment, familial cardiomyopathy with history of sudden cardiac death, existing permanent pacemaker, EP study within the past three months or amiodarone therapy for ventricular arrhythmias
Methods/Results
Patients were randomly assigned to one of the two treatment groups: standard oral medical therapy for HF and oral medical therapy for HF along with a single-chamber ICD. Randomization was stratified by center and also by the use or non-use of amiodarone to treat supraventricular tachyarrhythmias or atrial fibrillation. For the patients receiving an ICD implantation, the ICDs were programmed with a VVI pacing rate of 40 beats per minute and ventricular fibrillation (VF) detection rate of 180 beats per minute.
Patients were followed as per their randomization assignment at three-month intervals. All patients assigned to the control group underwent ICD implantation if they experienced an arrhythmic event. If patients experienced a cardiac arrest or an unexplained syncope, these were said to be consistent with an arrhythmic event. All patient deaths were reviewed by an independent events committee using the Epstein
The baseline characteristics of the two groups were compared with the use of two-sample t-tests for continuous variables and chisquare tests for categorical variables. Baseline characteristics were similar for both treatment groups with the exception of duration of heart failure: 3.27 years in the standard-therapy group and 2.39 years in the ICD group, (p = 0.04) (see the following table).
Table 290. Baseline characteristics
Characteristic
Age (yrs) average (range)
Gender: Male (%)
Race (%)
White
African-American
Hispanic
Other
Hx of Diabetes (%)
Hx of A-Fib (%)
CDM Years
average (range)
NYHA Class (%)
I
II
III
QRS (ms) average (range)
LBBB (%)
RBBB (%)
Qualifying Arrhythmia (%)
NSVT Only
PVC Only
NVST and PVC
LVEF % average (range)
Walk Distance (m)
All Patients
(n = 458)
58.4 (20-84)
326 (71)
308 (67)
118 (26)
26 (6)
5 (1)
105 (23)
112 (24)
2.83 (0-39)
99 (22)
263 (57)
96 (21)
115 (78-196)
90 (20)
15 (3)
103 (22)
43 (9)
312 (68)
21 (7-35)
319 (18-1316)
Standard Therapy
Group
(n = 229)
58.1 (22-79)
160 (70)
154 (67)
59 (26)
13 (6)
3 (1)
53 (23)
60 (26)
3.27 (0-39)
41 (18)
139 (61)
49 (21)
116 (79-192)
45 (20)
7 (3)
52 (23)
22 (10)
155 (68)
22 (10-35)
328 (18-1316)
ICD Group
(n = 229)
58.4 (20-84)
166 (72)
155 (68)
59 (26)
13 (6)
2 (1)
52 (23)
52 (23)
2.39 (0-21)
58 (25)
124 (54)
47 (21)
115 (78-196)
45(20)
8 (4)
51 (22)
21 (9)
157 (69)
21 (7-35)
311 (29-1143)
601
Epstein AE, Carlson MD, Fogoros RN, Higgins SL, Venditti FJ Jr. Classification of death in antiarrhythmia trials. J Am Coll Cardiol 1996;27:433-42.
602 P < 0.05 vs. standard therapy.
401
Table 290. Baseline characteristics
Characteristic All Patients
(n = 458)
Standard Therapy
Group
(n = 229)
ICD Group
(n = 229) average (range)
The log-rank test was used to compare Kaplan–Meier survival curves in the two groups, and the Cox proportional-hazards model was used to adjust for covariates and to estimate the hazard ratio for death and corresponding 95% confidence interval in the ICD group as compared with the standard-therapy group a mean (±SD) 29.0 ± 14.4 months.
.All analyses were conducted according to the intention to treat. Follow-up lasted for
Overall Mortality
The DEFINITE study was designed to have a statistical power of 85% based on a one-sided test, assuming two-year mortality rates of
15% in the standard-therapy group and 7.5% in the ICD group and the enrollment of 458 patients, with the pre-defined stopping point for analysis at the time of the 56th death. A two-sided test was performed to improve robustness of the analysis and in order to retain 85% statistical power, the results were analyzed at the 68th death. The results of the two-sided analyses are presented below.
Results – 68 Deaths
Using the revised analysis stopping point of 68 deaths
604 for the two-sided survival analysis, 40 deaths occurred in the Standard
therapy group and 28 deaths occurred in the ICD group. Total mortality rates (all cause) for each group at one year was 6.2% for the
Standard therapy group and 2.6% for the ICD group and at two years was 14.1% and 7.9% for the two groups, respectively (see the following table). While there were fewer deaths in the ICD group than in the standard therapy group (28 vs. 40), the difference in overall survival was not statistically significant (p = 0.08; hazard ratio 0.65, 95% confidence interval 0.40 to 1.06; see the following figure).
Table 291. Mortality
Patient Group
Standard Therapy Group
ICD Group
Number of Patient Deaths One-Year Mortality (%)
40
28
Figure 44. Kaplan-Meier survival curve, total mortality
6.2
2.6
Two-Year Mortality (%)
14.1
7.9
A pre-specified secondary endpoint of the study was Arrhythmic Sudden Death. A total of 17 sudden deaths were reported as part of the 68-death analyses. There were fewer sudden cardiac deaths in the ICD group (3) than the Standard therapy group (14) (see the following figure).
603
Kalbfleish JD, Prentice RL. The statistical analysis of failure time data. New York: John Wiley, 1980:321.
604 Kadish A, Dyer A, Daubert JP, et.al., Prophylactic Defibrillator Implantation in Patients with Nonischemic Dilated Cardiomyopathy. N Engl J Med 2004;350:2151-8.
402
Figure 45. Kaplan-Meier survival curve, arrhythmic sudden deaths
Device related complications and observations were reported and an overview of the observations and complications that occurred during the trial are detailed in the following table. There were no unanticipated adverse effects reported during the DEFINITE trial. A total of 48 complications were reported during the study. There were three complications that occurred during implantation of the
ICDs. All complications associated with implantation were resolved and there were no procedure-related deaths. During follow-up
45 complications were reported.
Table 292. Observed adverse events (n = 227)
Complications (total)
Hemothorax
Pneumothorax
Bleeding
High Defibrillation/Cardioversion
Requirements > 650 V
Detection Difficulties
Lead Dislodgment or Migration
Lead System Fracture
Lead System Insulation Damage
Infection Requiring Explant
Erosion
Venous Thrombosis
Suspected Device Malfunction
Battery Depletion
Device Recall
Observations (total)
Prolonged Procedure (> 180 min)
Bleeding
2
1
1
1
# Pts AEs
(n = 227)
44
1
5
1
1
2
2
1
4
25
1
58
2
1
605 Some patients experience more than one adverse event.
< 1%
1.8%
< 1%
< 1%
< 1%
< 1%
< 1%
2.2%
11.0%
< 1%
25.6%
< 1%
< 1%
% of Pts with AEs
19.4%
< 1%
< 1%
< 1%
< 1%
1
5
1
1
2
2
1
4
25
1
105
2
1
# of AEs
1
2
48
1
1
0.001
0.006
0.003
0.003
0.001
0.001
0.001
0.007
0.037
0.001
0.156
0.003
0.001
AE/pt-years
(n = 672.3 yrs)
0.071
0.001
0.001
0.003
0.001
403
Table 292. Observed adverse events (n = 227)
Cardiac Perforation
High Defibrillation/Cardioversion
Requirements > 650 V
High Defibrillation/Cardioversion
Requirements > 750 V
Detection Difficulties
High Pacing Thresholds (> 2 V @
0.5 ms)
Low R-wave Amplitude (< 3 mV)
Infection Not Requiring Explant
Venous Thrombosis
2
1
3
1
1
# Pts AEs
(n = 227)
1
4
1
Inappropriate Shock Therapies 46
% of Pts with AEs
< 1%
1.8%
< 1%
< 1%
< 1%
< 1%
< 1%
1.3%
20.3%
# of AEs
1
4
1
1
1
2
1
3
88
AE/pt-years
(n = 672.3 yrs)
0.001
0.006
0.001
0.001
0.001
0.003
0.001
0.004
0.131
Summary
There were fewer deaths in the ICD group than in the standard therapy group (hazard ratio 0.65). Total mortality rates (all cause) for each group at one year was 6.2% for the Standard therapy group and 2.6% for the ICD group and at two years was 14.1% and 7.9% for the two groups, respectively. The difference in all cause mortality using a two-sided test was not statistically significant (p = 0.08).
A pre-specified secondary endpoint of the study was Arrhythmic Sudden Death. There were fewer sudden cardiac deaths in the ICD group (3) than in the Standard therapy group (14).
Frontier II: Summary of Clinical Investigations
See also the PAVE Study (page 409) below.
VecToR Study
The VecToR CRT-P study was designed to pursue approval for cardiac resynchronization therapy for a Heart Failure (HF) patient population, which, in the investigators' opinion, does not need the additional benefit of back up defibrillation. An identical system
(i.e., Frontier biventricular pacing system) as used in the PAVE population was used in the VecToR CRT-P population. The safety data presented shows that the system is safe for its intended use and demonstrates the safety of the Frontier CRT-P system.
The VecToR (CRT-P) study did not enroll sufficient numbers of randomized patients to meet its effectiveness objectives. Although the
VecToR (CRT-P) study and the RHYTHM (CRT-D) study used different pulse generators (Frontier and Epic HF, respectively), both used the same biventricular pacing function which is delivered through the legally marketed SJM Aescula lead to provide cardiac resynchronization therapy. Data from the RHYTHM Study is used to demonstrate CRT effectiveness, as the patient populations in
RHYTHM and VecToR are comparable.
The VecToR study was a prospective, double-blind, randomized, controlled, multi-center clinical trial of patients with New York Heart
Association Class III/IV congestive heart failure, and was conducted at 41 participating sites (39 in the US, 2 in Canada). The study compared the safety and effectiveness of cardiac resynchronization pacing therapy (CRT-P), using the Frontier Model 5508 pulse generator and the Aescula 1055K Left Heart Lead to no CRT-P therapy.
Study Inclusion and Exclusion criteria are listed below:
1.
2.
3.
4.
5.
Inclusion Criteria
6.
7.
8.
Symptomatic ischemic or nonischemic dilated cardiomyopathy, which is not due to reversible causes.
Left ventricular end-diastolic diameter >54mm as measured by echocardiography.
Left ventricular ejection fraction
≤ 35% as measured by echocardiography.
QRS duration of ≥140 ms.
Stable but advanced heart failure due to left ventricular dysfunction (diagnosed for at least 6 months) despite stable conventional medical therapy.
Completed the 6-minute walk test as outlined in the protocol with the only limiting factor(s) being fatigue and/or shortness of breath.
Adequate cardiographic acoustic windows.
Provided informed consent for study participation and, are willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
1.
2.
Can walk >450 meters during the 6-minute walk test.
Have standard bradycardia indications or likely to need pacing within the next 6-months.
404
3.
4.
Are classified as NYHA Class I or II.
Have a history of persistent or chronic atrial fibrillation or a history of atrial fibrillation which required intervention to revert to normal sinus rhythm.
5.
6.
7.
Have an implanted cardioverter defibrillator (ICD) or, are being considered for implantation of an ICD.
Are contraindicated for an emergency thoracotomy.
8.
Are considered status 1 for cardiac transplantation and are likely to receive transplantation within 1 year
Are being treated with parenteral inotropic agents (e.g., dobutamine) or have been treated with such agents within the past 30 days.
Have prosthetic valve replacement(s).
9.
10.
11.
Have severe musculoskeletal disorder(s).
Are under the age of 18 years.
12.
13.
14.
Are pregnant or plan a pregnancy in the next 6 months.
Are currently participating or participated within the past 30 days in any clinical investigation.
Have a life expectancy of less than 6 months.
15.
16.
Cannot independently comprehend and complete the Minnesota Living With Heart Failure questionnaire.
Are allergic to dexamethasone sodium phosphate (DSP).
To gain initial experience, investigators were given the option of prospectively determining that the first two patients implanted would not be randomized and would not count toward the implant success rate. However, these "Roll-In" patients met all inclusion criteria, were blinded to their treatment arm, and were followed per protocol. As such and as defined in the protocol, this "Roll-In" group is included in the safety analysis. All patients received the pacing system comprised of the investigational Frontier pulse generator and
Aescula left heart lead, and a legally marketed right atrial and right ventricular lead. Patients were followed every 3 months for the first twelve months, and every six months thereafter. Patients in the CRT OFF group were allowed to cross over after completing the requirements of the 6-month visit.
As of September 7, 2004, the total time of follow-up from the time of successful implant in 120 patients was 2383 patient months.
The average time of follow-up was 19.9 ± 8.9 (range 0.8 to 35.4) patient months.
Patient Population
The overall VecToR study population included 144 patients. Fifty-nine (59) patients were randomized to ON, and 47 patients were randomized to OFF. Revision C of the VecToR protocol excluded NYHA Class II patients. Thirty-eight (38) were "roll-in" patients (nonrandomized) and received the cardiac resynchronization pacing therapy system (Frontier pulse generator and Aescula lead system).
Safety analyses include all patients with the Frontier pulse generator and the Aescula left heart lead, including ON, OFF, and roll-in.
The mean age was 67.1
± 9.7 years and there were 62.5% male and 37.5% female. Twenty-nine percent (29%) of the patients were
NYHA Class II, 65% were NYHA Class III, and 6% were NYHA Class IV prior to implant.
Primary Safety Objectives and Results
The primary safety objectives for the VecToR study are presented below.
Freedom from System-Related Complications Through Six Months
Objective: The lower bound of the one-sided 95% confidence interval of the freedom from system-related complications will not be less than 70%. A system-related complication was defined as a complication that is caused by a failed pacing system. A pacing system refers to all implanted components, including the pulse generator, leads, and the interaction of these components.
Results: There were 12 system-related complications in 11 patients within six-months follow-up. The freedom from system-related complications is 90.7% with a lower bound of 86.4%. Objective met.
Freedom from Pulse Generator-Related Complications Through Six Months
Objective: The lower bound of the one-sided 95% confidence interval of the freedom from pulse generator-related complications for the combined group through six months will not be less than 90%.
Results: There were no pulse generator-related complications through six months. The survival rate is 100% with a lower bound of
97.1%. Objective met.
Freedom from Aescula™ Lead-Related Complications Through Six Months
Objective: The lower bound of the one-sided 95% confidence interval of the freedom from Aescula™ lead-related complication through six months will not be less than 75%.
Results: There were 8 Aescula lead-related complications in 8 patients through six-months follow-up. All patients from the VecToR study who were successfully implanted are included in this analysis. The freedom from Aescula lead-related complications is 93.3% with a lower bound of 89.5%. Objective met.
Rate of Successful Implantation of the Aescula™ Lead
Objective: The lower bound of the one-sided 95% confidence interval of the successful implantation rate of the Aescula lead will not be less than 80%. The success rate was defined as the proportion of patients who received the complete pacing system.
Results: A total of 144 patients who were randomized to CRT ON or OFF in the VecToR study and underwent attempted BV implants. One hundred and twenty (120) were successfully implanted. The rate of successful implant of the Aescula lead is 84% with a lower bound of 78% which does not meet the protocol defined objective for this endpoint (lower 95% confidence bound of
80%).
405
Aescula™ Lead Pacing Threshold at Six Months
Objective: The upper bound of the one-sided 95% confidence interval of mean capture threshold will not be greater than 3.0 V for the combined group at six months.
Results: The electrical performance data of the LV lead were available on a total of 110 patients at six months. The pacing threshold at six months for the LV lead is 2.10 V with an upper bound 95% confidence interval of 2.34 V. Objective met.
RHYTHM Study
The RHYTHM ICD Study demonstrated that the SJM CRT-D system (Epic HF and Aescula lead) was safe and effective in NYHA
Class III and IV heart failure patients with prolonged QRS duration and served as the basis for the recent PMA approved (PMA #
P030054). The RHYTHM ICD study enrolled patients who also had a current ICD indication, which at the time the study was initiated included patients who were indicated for an ICD solely for primary prevention or prophylaxis (i.e., the patients were at risk of ventricular tachyarrhythmias and sudden death due to other clinical characteristics, but had not experienced a spontaneous or induced tachycardia).
The RHYTHM ICD study was a prospective, multicenter, randomized, double-blind, controlled clinical investigation designed to assess the safety and effectiveness of the Epic HF ICD system in patients who were indicated for implantable cardioverter defibrillation therapy with New York Heart Association Classification of III or IV and a prolonged QRS duration. The objective of this clinical study was to verify the safety and effectiveness of the Epic HF ICD (Model V-338) system in an ICD indicated patient population with advanced heart failure (NYHA Classification III or IV) and prolonged QRS duration.
Study Inclusion and Exclusion criteria are listed below:
1.
2.
3.
5.
6.
7.
Inclusion Criteria
4.
8.
9.
Approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s).
Symptomatic, advanced heart failure (ischemic or non-ischemic) not due to reversible causes, diagnosed for at least 6-months.
New York Heart Association (NYHA) Classification of III or IV, despite receiving a minimum of 90 days of appropriate pharmacological therapy.
Receive optimal pharmacological therapy for CHF (including angiotensin converting enzyme inhibitor and beta blocker, as tolerated) which has been stable during the 30 days prior to enrollment.
Left ventricular ejection fraction (LVEF)
≤ 35%.
Ventricular conduction delay manifested as a QRS duration ≥150 msec.
Ability to complete cardiopulmonary exercise stress testing and 6-Minute hall walk test, with the only limiting factor(s) being fatigue and/or shortness of breath.
Ability to independently comprehend and complete a quality of life questionnaire (Minnesota Living with Heart Failure).
Ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
1.
2.
Standard bradycardic indication for pacing.
History of chronic atrial fibrillation (continuous AF lasting > 1 Month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month.
7.
8.
9.
10.
11.
3.
4.
5.
6.
Ability to walk > 450 meters during the 6-Minute walk test.
NYHA Classification of I or II.
Contraindication for an emergency thoracotomy.
Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 6-months.
Recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within 1 month of enrollment.
Recent CVA or TIA - within 3 months of enrollment.
Severe musculoskeletal disorder(s).
Pregnant or a planning for pregnancy in next 6-months.
Currently participating in, or has participated in any clinical investigation within the last 30 days. (the only exception being that of a registry trial)
12.
13.
Life expectancy of less than 6-months.
Less than 18 years of age.
All patients who met enrollment criteria underwent implantation of the Epic HF ICD system and a St. Jude Medical left ventricular pacing lead. ICD therapy was activated at the time of implant for all patients. Patients underwent Baseline evaluation between two weeks and 30 days following successful device implantation. Baseline was considered time zero for the purposes of evaluation of resynchronization study endpoints.
Patients were randomized following completion of Baseline testing and were assigned to either the treatment group (CRT ON) or the control group (CRT OFF) at a 2:1 ration. Patients who underwent unsuccessful implantation of the Epic HF ICD system were followed for a period of 30 days prior to withdrawal from the study. All patients who were successfully implanted were followed at 1, 3, 6 and every 3 months thereafter until the study was completed. Cross-over from the control group was allowed after completing the 6month visit.
As of March 17, 2004, the total time of follow-up from the time of successful implant was 2205 patient months. The average time of follow-up was 12.1 ± 3.4 (range 0.3 to 20.3) patient months.
406
Patient Population
Of the 205 patients enrolled in the RHYTHM ICD study, one hundred and eighty-three (183) lead implant attempts were successful
(180 successful on the first attempt and 3 successful on the second attempt). One additional patient had a successful left ventricular lead implant, but had high defibrillation thresholds. This patient was withdrawn from the study and received a heart transplant, leaving a total of 182 successful system implants.
Patients who were successfully implanted with the Epic HF ICD system had a Baseline visit approximately two weeks after implant, during which the following tests/assessments were performed: Electrical measurements on RA, RV and LV leads, cardiopulmonary exercise (CPET) test, echocardiogram, NYHA class assessment, 6 minute walk test, and Minnesota Living with Heart Failure questionnaire. Of the 182 patients with successful implants, two patients expired and one patient withdrew from the study before the
Baseline visit and therefore, 179 patients had a Baseline visit. One additional patient who had a Baseline follow-up visit refused randomization and all the Baseline evaluations except device interrogation and electrical measurements, but remained in the study.
Therefore, a total of 178 patients completed the requirements of the Baseline visit.
Primary Effectiveness Objective and Results
Cardiac Resynchronization Therapy Effectiveness (Peak VO2)
Objective: To determine if the treatment group (CRT ON) shows a statistically significant improvement over the control group (CRT
OFF) at six months.
Results: In the intention-to-treat analysis, patients who crossed over from the CRT OFF group to the CRT ON group during the study were analyzed according to the original treatment group they belonged to. A summary of the improvement in peak VO2 values in the two treatment groups for this analysis is shown in the following table. The average improvement in the CRT ON group over the CRT
OFF group was approximately 1.9 ml/kg/min. The p-value was 0.001. Objective met.
Table 293. Improvement in Peak VO2 Values (ml/kg/min) Intention-to-Treat Analysis (N=126)
Baseline
6-months
CRT OFF
Mean ± SD
(N = 43)
12.8 ± 3.7
11.4 ± 5.6
Change -1.41 ± 4.6
Overall improvement in CRT ON vs. CRT OFF = 1.9 ml/Kg/min
CRT ON
Mean ± SD
(N = 83)
11.2 ± 3.0
11.7 ± 3.2
0.52 ± 2.5
Secondary Objective and Results
Improvement in NYHA Class at Six Months Over Baseline
Objective: To determine if the treatment group (CRT ON) shows an improvement over the control group (CRT OFF) at six months.
Results: The average change in NYHA Class from Baseline to 6-months for each group is shown in the following table. Objective met.
Table 294. Baseline and Six Month NYHA Class (N=126)
Baseline
6-months
CRT OFF
Mean ± SD
(N = 43)
2.86 ± 0.52
2.58 ± 0.73
CRT ON
Mean ± SD
(N = 83)
3.01 ± 0.33
2.53 ± 0.69
Change -0.28 ± 0.63
Improvement in Quality of Life at Six Months Over Baseline
-0.48 ± 0.65
Objective: To determine if the treatment group (CRT ON) shows an improvement over the control group (CRT OFF) at six months.
Results: Patient quality of life (QOL) was assessed with the Minnesota Living with Heart Failure questionnaire. A lower score indicates an improvement in quality of life. A summary of the improvement in Quality of Life in the two groups from baseline to 6 months is shown in the following table.
Table 295. Improvement in Quality of Life Score (N=126)
CRT OFF
Mean ± SD
(N = 43)
CRT ON
Mean ± SD
(N = 83)
407
Table 295. Improvement in Quality of Life Score (N=126)
Baseline
6-months
CRT OFF
Mean ± SD
(N = 43)
42.0 ± 23
45.4 ± 31
CRT ON
Mean ± SD
(N = 83)
48.3 ± 24
40.4 ± 22
Change 3.4 ± 31 -7.8 ± 22
The average improvement in the CRT ON group over the CRT OFF group was approximately 11 points. Objective met.
Improvement in Six-Minute Hall Walk at Six Months Over Baseline
Objective: To determine if the treatment group (CRT ON) shows an improvement over the control group (CRT OFF) at six months.
Results: A summary of the improvement in 6-minute walk distance between baseline and 6 months is shown in the following table.
Table 296. Improvement in Six Minute Walk Distance (meters) (N=126)
Baseline
6-months
CRT OFF
Mean ± SD
(N = 43)
298 ± 94
283 ± 150
CRT ON
Mean ± SD
(N = 83)
284 ± 105
297 ± 122
Change -15 ± 142 13 ± 74
The average improvement in the CRT ON group over the CRT OFF group was approximately 28 meters.
Additional Data
Biventricular Pacing at Six Months
The average percentage of biventricular pacing at the 6-month visit in the 83 patients who were in the CRT ON group among the 126 patients in the primary resynchronization cohort was 95% ± 6%, with a range of 70% to 100%.
ECHO Data
Echocardiographic analysis was performed at the baseline and 6-month follow-up visits. The following parameters were evaluated from the echocardiographic analysis: LVEDD, LVESD, LVEF, MR, E/A Wave Point Ratio, and Sphericity Index. Cardiac dyssynchrony
(including Pre-Ejection Delay Time and Intraventricular Mechanical Delay) was also evaluated at baseline and 6-Months. A summary of the improvement in these parameters between baseline and 6-months is shown in the following table.
Table 297. Improvement in Echocardiography Parameters
Parameter
LVEDD (mm)
LVESD (mm)
LVEDV (ml)
LVESV (ml)
LVEF (%)
MR (grade)
E/A Wave Point Ratio
Sphericity Index
Pre-Ejection time (ms)
IVMD (ms)
Tei Index
CRT OFF
(N = 40)
Mean ± SD
-2.4 ± 6.5
-3.0 ± 6.4
-37 ± 53
-36 ± 47
2.9 ± 6.2
0.10 ± 0.50
-0.02 ± 1.2
0.02 ± 0.1
7.3 ± 33
-6.4 ± 48
-0.05 ± 0.5
CRT ON
(N = 82)
Mean ± SD
-4.3 ± 5.4
-4.6 ± 7.0
-43 ± 69
-43 ± 58
4.3 ± 9.9
-0.06 ± 0.74
-0.08 ± 0.8
-0.02 ± 0.1
-1.5 ± 52
-14.5 ± 52
-0.4 ± 0.8
408
Table 297. Improvement in Echocardiography Parameters
Parameter CRT OFF
(N = 40)
Mean ± SD
-55 ± 103 Contraction Interval (ms)
PAVE Study
CRT ON
(N = 82)
Mean ± SD
-94 ± 124
Summary of the PAVE Study
The Post-AV Node Ablation Evaluation (PAVE) study was a prospective, randomized, controlled, multi-center clinical trial conducted at 49 participating sites (44 in the US, five in Canada) comparing the safety and effectiveness results for patients receiving the
Frontier™ Model 5508 CRT-P and the Aescula™ 1055K left heart lead to those receiving legally marketed right ventricular pulse generators and standard leads following an AV nodal ablation for chronic atrial fibrillation. Chronic AF is defined as persisting without interruption for at least one month.
Patients with chronic (permanent) atrial fibrillation may also be indicated for and receive an ICD under FDA approved standard ICD indication language. The standard ICD indication includes patients who have experienced an episode of ventricular tachycardia or ventricular fibrillation (secondary prevention) or meet the criteria for prophylactic ICD therapy (primary prevention). Likewise, patients who have atrial fibrillation may receive a biventricular pacemaker if they have undergone AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. The prospective, randomized, controlled PAVE study was completed and successfully demonstrated that biventricular pacing is safe and effective in post-AV nodal ablation patients with NYHA Class II or III heart failure. The addition of ICD back-up therapy will not affect the biventricular pacing performance of the device and ICD therapy is the standard of care in patients with an ICD indication and chronic (permanent) atrial fibrillation. In addition, St. Jude Medical
CRT-D devices have previously been proven to be safe and effective (RHYTHM ICD Study) in patients with an ICD indication and
NYHA Class III or IV heart failure with prolonged QRS durations and LVEF
¢ 35%. Since the Promote™ CRT-D provides biventricular pacing similar to the Frontier II CRT-P
606 , no additional clinical evaluation was performed.
The study's cumulative implant duration for all enrolled patients was 8,979 months with a mean of 24.33 ± 15.22 months (range of
0.13 to 55.95 months). Two hundred and ten patients underwent successful LV lead placement. The cumulative duration for all investigational patients (BV, LV and Roll-in groups only) was 5,928 months.
For this randomized study, the key inclusion criteria were:
Patients who will undergo complete AV nodal ablation for chronic atrial fibrillation (defined as persisting without interruption for at least one month) resulting in complete AV block
Patients who are on a stable medical therapy regimen, and
Patients who are able to complete the six-minute walk with the only limiting factor(s) being fatigue and/or shortness of breath.
Key study exclusion criteria were:
Patients who are classified as NYHA Class IV
•Patients who can walk > 450 m in six-minute walk test
•Patients who have an implanted ICD or being considered for implant of an ICD
•Patients with prosthetic valve replacements
•Patients with severe musculoskeletal disorder(s). and
•Patients who cannot independently comprehend and complete the quality of life questionnaire.
The overall study population included 369 patients. One hundred and fifty-one were randomized to BV, and 109 were randomized to
RV. In addition, 53 were randomized to LV pacing under a previous revision of the investigational plan. Fifty-six were "Roll-in" patients (nonrandomized) and received the biventricular pacing system (Frontier CRT-P and Aescula lead system). All patients had permanent pacemaker implant indication following an elective AV nodal ablation for chronic atrial fibrillation. The mean age was 69.3
± 9.93 years; 34.4% were female and 65.6% were male. Fourteen percent of the patients had no diagnosis of heart failure or were
NYHA Class I, 49% were NYHA Class II, and 37% were NYHA Class III prior to implant.
Primary Effectiveness Objective and Result
Exercise Capacity as Measured by Distanced Walked in Six-Minute Walk Test
Objective: To determine if the treatment group (BV) shows a statistically significant improvement over the control group (RV) at the six months follow-up time.
Results: The treatment group (BV) showed statistically significant improvement over the control group (RV) in distance walked from pre-implant to six months (p = 0.03). The BV group also had a greater percentage of patients showing improvements than the RV group (p = 0.035). The improvement in the six-minute walk between BV and RV groups is shown in the following figure. The improvement distribution in the six-minute walk between BV and RV groups is shown in the following table.
606 The Frontier II CRT-P has the same functionality as the Frontier CRT-P with the addition of independently programmable ventricular outputs.
409
Figure 46. Improvements in six-minute walk distance in BV and RV groups (p = 0.03)
Table 298. Distribution of improvement in BV and RV Group in six-minute walk (p = 0.035)
Improved (> 5 m)
No Change (–5 to 5 m)
Worsened (< –5 m)
RV (N = 66)
46 (69.70%)
4 (6.06%)
16 (24.24%)
BV (N = 84)
69 (82.14%)
4 (4.76%)
11 (13.10%)
Secondary Effectiveness Objectives and Results
Quality of Life as Measured by SF-36 Score
Objective: To determine if the BV group shows improvement over the RV group at the six-month follow-up in the health-related quality of life as measured by the SF-36 score.
Results: Using the SF-36 Quality-of-Life questionnaire, a standardized measurement of quality of life, the study found that for the six-week to six-month visit time period, the improvement in SF-36 scales was not different between groups.
Functional Capacity as Measured by Peak VO2
Objective: To determine if the BV group shows improvement in functional capacity, as measured by peak VO2, from the six-week follow-up to the six-month follow-up.
Results: The BV group showed an improvement of 0.86 ml/kg/min in peak VO2 from six weeks to six months measured during CPX testing. The BV group also had a greater percentage of patients showing improvement in peak VO2. The improvement in peak VO2 in
BV and RV groups is shown in the following figure. The distribution of improvement in peak VO2 between BV and RV groups is shown in the following table.
Figure 47. Figure 1-2. Improvements in peak VO2 in BV and RV groups
410
Table 299. Distribution of improvements in VO2 in BV and RV groups
Change in Peak VO2
(ml/kg/min)
Improved (> 0.5)
No Change (–0.5 to 0.5)
Worsened (< –0.5)
RV (N = 10)
4 (40%)
0 (0%)
6 (60%)
BV (N = 35)
21 (60.0%)
4 (11.4%)
10 (28.6%)
RHYTHM ICD Study
Summary of the RHYTHM ICD Study
The St. Jude Medical, Inc. Resynchronization for HemodYnamic Treatment for Heart Failure Management (RHYTHM) ICD study was conducted under an IDE (investigational device exemption).
The purpose of the clinical study was to assess the safety and effectiveness of the Epic HF CRT-D system in patients who were indicated for standard implantable cardioverter defibrillation therapy with New York Heart Association Classification of III or IV and a prolonged QRS duration. Since the Promote device is functionally equivalent to the Epic HF device with respect to the biventricular pacing therapies, no additional clinical evaluation was performed.
The RHYTHM ICD study was a prospective, multicenter, randomized, double-blind, controlled clinical investigation designed to assess the safety and effectiveness of the Epic HF CRT-D system in patients who were indicated for standard implantable cardioverter defibrillation therapy with New York Heart Association Classification of III or IV and a prolonged QRS duration. The products being evaluated were the Epic HF V-338
CRT-D and the Aescula™ and QuickSite™ LV leads.
The RHYTHM ICD study design is shown in the following figure.
Figure 48. Figure 1-1. RHYTHM ICD study design
Study Objectives
The objective of this clinical study was to verify the safety and effectiveness of the Epic HF CRT-D (Model V-338) system in a standard ICD indicated patient population with advanced heart failure (NYHA Classification III or IV) and prolonged QRS duration.
607
The EpicHF ModelV338 devices included in the RHYTHM ICD study did not include the AutoIntrinsic Conduction Search or the Rate-Responsive PVARP programmable parameters, or devicebased battery management. For information on these features, refer to the reference manual.
411
Primary Objectives
The following are the primary safety and effectiveness objectives defined for this study.
Safety of the Epic HF CRT-D system evaluated in terms of survival from LV lead and system-related complications.
Defibrillation system effectiveness determined in terms of detection/redetection times and compared to those observed in the
St. Jude Medical Photon™ DR device clinical investigation.
Resynchronization effectiveness evaluated in terms of exercise capacity, as measured by cardiopulmonary exercise testing.
Secondary Objectives
The secondary objectives are listed below.
NYHA Classification
Quality of Life Questionnaire
Six-Minute Hall Walk Test
Implant success rate for the Aescula Model 1055K LV pacing lead
Aescula Model 1055K LV lead electrical performance
Patient Selection Criteria
Inclusion Criteria
Patients eligible for enrollment had:
An approved indication for implantation of a standard ICD for treatment of a life-threatening ventricular tachy\-arrhythmia(s).
Symptomatic, advanced heart failure (ischemic or non-ischemic) not due to reversible causes, diagnosed for at least six months.
A New York Heart Association (NYHA) Classification of III or IV, despite receiving a minimum of 90 days of appropriate pharmacological therapy.
Received optimal pharmacological therapy for CHF (including angiotensin converting enzyme inhibitor and beta blocker, as tolerated) which has been stable during the 30 days prior to enrollment.
A left ventricular ejection fraction (LVEF) ¢ 35%.
A ventricular conduction delay manifested as a QRS duration
£ 150 ms.
The ability to complete cardiopulmonary exercise stress testing and six-minute hall walk test, with the only limiting factor(s) being fatigue and/or shortness of breath.
•The ability to independently comprehend and complete a quality of life questionnaire.
•The ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Exclusion Criteria
Eligible patients did not/were not:
Have a standard bradycardic indication for pacing.
Have a history of chronic atrial fibrillation (continuous AF lasting > one month) within one year prior to enrollment or have undergone cardioversion for AF in the past month.
Have the ability to walk > 450 m during the six-minute walk test.
Have a NYHA Classification of I or II.
Have a contraindication for an emergency thoracotomy.
Have a classification of Status 1 for cardiac transplantation or consideration for transplantation over the next six months.
Have a recent myocardial infarction, unstable angina or cardiac revascularization (PTCA or CABG) within one month of enrollment.
Have a recent CVA or TIA - within three months of enrollment.
Have severe musculoskeletal disorder(s).
Pregnant or a planning for pregnancy in the next six months.
Currently participating in, or had participated in any clinical investigation within the last 30 days. (The only exception being that of a registry trial.)
Have a life expectancy of less than six months.
Less than 18 years of age.
Clinical Study Results
Patient Population
Two hundred and five patients were enrolled at 50 clinical sites in the RHYTHM ICD clinical investigation. The first Epic HF V-338 and Aescula 1055K left ventricular lead system was implanted on July 8, 2002. The first QuickSite 1056K lead was implanted on
March 26, 2003.
Of the 205 patients enrolled in the RHYTHM ICD study, 183 lead implant attempts were successful (180 successful on the first attempt and three successful on the second attempt). One additional patient had a successful left ventricular lead implant, but had high defibrillation thresholds. This patient was withdrawn from the study and received a heart transplant, leaving a total of
182 successful system implants. A breakdown of the reasons for the 23 unsuccessful implants is shown in the following figure.
412
Table 300. Unsuccessful implants (N = 23)
Reason
LV Lead-Related:
Unable to Cannulate the CS
Unable to Obtain Distal Placement
Unable to Obtain Stable Lead Position
High Pacing Thresholds
CS Dissection
Other:
# Patients
7
6
3
3
3
High Defibrillation Threshold 1
TOTAL 23
The leads used and the number of successful system implants for each category of leads are shown in the following figure.
Figure 49. Figure 1-2. Number of patients attempted and implanted with Model 1055K and 1056K leads
The total time of follow-up from the time of successful implant was 2,755 patient-months. The average time of follow-up was
15.1 ± 4.1 (range 0.3 to 23.8) patient-months.
Baseline Demographic Data
Patients who were successfully implanted with the Epic HF CRT-D system had a Baseline visit approximately two weeks after implant, during which the following tests/assessments were performed: Electrical measurements on RA, RV and LV leads, cardiopulmonary exercise (CPET) test, echocardiogram, NYHA class assessment, six-minute walk test, and Minnesota Living with
Heart Failure (MLWHF) questionnaire. Of the182 patients with successful implants, two patients expired and one patient withdrew from the study before the Baseline visit and therefore, 179 patients had a Baseline visit. One additional patient who had a Baseline follow-up visit refused randomization and all the Baseline evaluations except device interrogation and electrical measurements, but remained in the study. Therefore, a total of 178 patients completed the requirements of the Baseline visit.
The summarized reported data on the 178 patients available for analysis at the Baseline visit, as well as broken down by randomization group is shown in the following table.
Table 301. Summary of baseline variables and comparisons between CRT OFF and CRT ON groups
Demographic variable Overall Group
(n = 178)
CRT OFF
(N = 59)
CRT ON
(N = 119) p-value
(CRT ON vs.
CRT OFF)
608
Of the 182patients that had successful system implants, two patients expired and one patient withdrew from the study before their Baseline visit; one additional patient refused randomization and all Baseline evaluations, except device interrogation and electrical measurements, and therefore, is not included.
413
Table 301. Summary of baseline variables and comparisons between CRT OFF and CRT ON groups
Demographic variable Overall Group
(n = 178)
CRT OFF
(N = 59)
CRT ON
(N = 119)
NYHA Class, n (%):
I
II
III
IV
LV Ejection Fraction (%) - ECHO:
Mean ± SD
Range
QRS Duration (ms):
Mean ± SD
Range
LVEDD (mm):
Mean ± SD
Range
LVESD (mm):
Mean ± SD
Range
Quality of Life Score:
Mean ± SD
Range
Six-Minute Walk (m):
Mean ± SD
Range
CPET Test:
Peak VO
2
(ml/kg/min):
Mean ± SD
Range
Exercise Time (minutes):
Mean ± SD
Range
Baseline Medications, n (%):
ACE Inhibitors/Substitutes
Beta Blockers
Angiotensin Receptor Blockers
Diuretics
Positive Inotropics/Glycoside
Nitrates
Anti-Coagulants & Anti-Platelets
Calcium Channel Blockers
Anti-Arrhythmics
3 (1.7%)
10 (5.6%)
154 (86.5%)
11 (6.2%)
24.8 ± 7.7
(9, 48)
168 ± 15
(120, 210)
66.2 ± 8.8
(47.7, 85.9)
57.0 ± 9.87
(37.1, 78.2)
48 ± 24
(0, 103)
280 ± 99
(31, 561)
11.3 ± 3.3
(4.3, 26.9)
8.3 ± 3.3
(0.7, 19.8)
129 (72.5%)
147 (82.6%)
34 (19.1%)
157 (88.2%)
112 (62.9%)
62 (34.8%)
150 (84.3%)
20 (11.2%)
42 (23.6%)
2 (3.4%)
4 (6.8%)
50 (84.7%)
3 (5.1%)
23.3 ± 6.4
(11, 43)
167 ± 15
(130, 200)
66.0 ± 9.4
(50.1, 84.2)
56.9 ± 10.5
(37.9, 78.2)
46 ± 24
(4, 100)
291 ± 89
(31, 480)
12.3 ± 3.5
(6.0, 23.1)
8.9 ± 3.6
(2.3, 19.8)
44 (74.6%)
52 (88.1%)
10 (16.9%)
54 (91.5%)
39 (66.1%)
23 (39.0%)
48 (81.4%)
9 (15.3%)
13 (22.0%)
1 (0.8%)
6 (5.0%)
104 (87.4%)
8 (6.7%)
25.6 ± 8.3
(9, 48)
169 ± 16
(120, 210)
66.2 ± 8.5
(47.7, 85.9)
57.1 ± 9.4
(37.1, 76.2)
48 ± 24
(0, 103)
275 ± 103
(37, 561)
10.8 ± 3.0
(4.3, 26.9)
8.0 ± 3.2
(0.7, 16.5)
85 (71.4%)
95 (79.8%)
24 (20.2%)
103 (86.6%)
73 (61.3%)
39 (32.8%)
102 (85.7%)
11 (9.2%)
29 (24.4%)
0.79
0.24
0.76
0.47
0.65
0.51
0.59
0.35
0.87
Primary Safety Endpoint Results
LV Lead-Related Complications (at Six Months)
The following table summarizes the LV lead-related complications at six months. One hundred and fifty-five patients who had a successful 1055K LV lead implant were analyzed for this endpoint. A total of 11 patients experienced 13 1055K LV lead-related complications.
The survival from 1055K lead-related complications at six-months was calculated as 92.8% with a 95% lower confidence bound of
89.4%, which is greater than the objective performance criteria of 75%. p-value
(CRT ON vs.
CRT OFF)
0.40
0.88
0.93
0.53
0.30
0.006
0.08
0.61
0.07
414
Table 302. Aescula 1055K LV lead-related complications
Description of
Complication
Diaphragmatic Stimulation
Lead Dislodgment/Migration
Elevated Pacing Threshold
Number of Events
3
9
1
Number of Patients
3
8
1
TOTAL 13 11
Epic HF System-Related Complications (at Six Months)
The System Related Complications at six months are shown in the following table. One hundred and eighty-two patients who had a successful Epic HF system implant with either the Aescula or QuickSite LV lead were analyzed for this endpoint. A total of 14 patients experienced 18 Epic HF system-related complications.
The survival from system-related complications at six months was calculated as 92.8% with a 95% lower confidence bound of
89.7%, which is greater than the objective performance criteria of 70%.
Table 303. Epic HF system-related complications
Description of
Complication
Diaphragmatic Stimulation
High Defibrillation/Cardioversion Requirements
Infection
Lead Dislodgment/Migration
Elevated Pacing Threshold
TOTAL
Number of Events
3
2
2
9
2
18
Number of Patients
3
2
2
8
2
14
Survival from All Complications (at Six Months)
In addition to the protocol-specified LV lead-related and system-related complication endpoints, survival from all complications at six months, including procedural complications and patients with unsuccessful implants, was analyzed following a review of the clinical results.
Two hundred and five patients who were attempted with the Epic HF system were included in this analysis. All complications experienced by each patient are shown in the following table. A total of 22 patients experienced 31 complications.
The survival from all complications at six months was calculated as 89.6% with a 95% lower confidence bound of 85.9%.
Table 304. All complications
Description of
Complication
Bleeding/Hematoma
Blood Clot/Thrombosis
CS Dissection
Diaphragmatic/Phrenic Nerve Stimulation
High Defibrillation/Cardioversion Requirements
Infection
Noise on EGM Post-Shock (non-SJM RV lead)
Lead Dislodgment/Migration
Retained Foreign Body
Pneumothorax
Elevated Pacing Threshold
TOTAL
Number of Events
9
1
2
1
2
2
31
2
3
6
1
2
Number of Patients
6
1
2
3
2
8
1
2
1
2
2
22
609
One patient experienced both a lead dislodgment/migration and diaphragmatic stimulation, and one patient experienced two lead dislodgments/migrations.
610 One patient experienced both a lead dislodgment/migration and diaphragmatic stimulation, one patient experienced two lead dislodgments/migrations, one patient had high defibrillation threshold and lead dislodgment/migration, and one patient had an elevated pacing threshold and an infection.
611 Five patients each experienced two complications and one patient experienced four complications.
415
Primary Effectiveness Endpoint Results
Defibrillation System Effectiveness: VF Detection/Redetection Times
The defibrillation system effectiveness of the Epic HF CRT-D system was evaluated by comparing the time to detect or redetect an episode of ventricular fibrillation to performance criteria established in the protocol based on historical data from the Photon DR device study (P910023/S47). A total of 440 episodes in 172 patients were analyzed for detection times, and 90 episodes in
55 patients were analyzed for redetection times.
A summary of the detection and redetection times for VF episodes is shown in the following table. The mean detection and redetection times were within the objective performance criteria of 3.4 seconds and 1.9 seconds, respectively. The p-values for the detection and redetection time hypotheses were less than 0.0004. The 95% upper confidence bound was 3.11 seconds for the mean detection time and 1.61 seconds for the redetection time.
Table 305. Summary of VF detection and redetection times
Summary n (episodes)
N (patients)
Mean ± SD
Detection Time
440
172
3.1 ± 0.66
Redetection Time
90
55
1.6 ± 0.35
Range (1.5, 6.8) (0.8, 2.8)
Primary Cardiac Resynchronization Therapy Effectiveness Endpoint
The resynchronization effectiveness of the Epic HF CRT-D system was evaluated by comparing the CRT ON group to the CRT OFF group for peak VO
2
, an indicator of a patient’s maximal exercise capacity. Patients completed a CPET at the baseline visit approximately two weeks after their CRT-D implant, and again at the six-month visit. The sample size required to satisfy this endpoint was 126 patients.
In the intention-to-treat analysis, patients who crossed over from the CRT OFF group to the CRT ON group during the study were analyzed according to the original treatment group they belonged to.
A summary of the improvement in peak VO2 values in the two treatment groups for this analysis is shown in the following table. The average improvement in the CRT ON group over the CRT OFF group was approximately 1.9 ml/kg/min. The p-value was 0.001.
Table 306. Improvement in peak VO2 values (ml/kg/min) intention-to-treat analysis (N = 126)
Baseline
Six-months
CRT OFF
Mean ± SD
(N = 43)
12.8 ± 3.7
11.4 ± 5.6
CRT ON
Mean ± SD
(N = 83)
11.2 ± 3.0
11.7 ± 3.2
Change -1.41 ± 4.6
Overall improvement in CRT ON vs. CRT OFF = 1.9 ml/kg/min
0.52 ± 2.5
Analysis of Exercise Time
The improvement in exercise time between the Baseline and six-month visits was analyzed. Patients who were not able to perform the CPET at six-months due to documented heart failure were assigned exercise times of 0. The following table shows that the CRT
ON group had an improvement in exercise time over the CRT OFF group of approximately 109 seconds. The p-value was 0.002.
Table 307. Change in exercise time (seconds) (N = 126)
Baseline
Six-months
CRT OFF
Mean ± SD
(N = 43)
558 ± 216
510 ± 270
Change
Overall improvement in CRT ON vs. CRT OFF = 109 seconds
-50.4 ± 252
Secondary Endpoint Results
Resynchronization Effectiveness
CRT ON
Mean ± SD
(N = 83)
498 ± 192
558 ± 210
58.2 ± 132
416
Secondary endpoints for resynchronization effectiveness were NYHA class, Quality of Life, and the Six-Minute Hall Walk Test. These endpoints were evaluated on the same patient group that was analyzed for the Peak VO2 endpoint.
New York Heart Association Classification
The average change in NYHA Class from Baseline to six months for each group is shown in the following table. Overall the improvement in the CRT ON group was greater than the improvement in the CRT OFF group by approximately 0.2 functional classes.
Table 308. Average improvement in NYHA class (N = 126)
Baseline
Six-months
CRT OFF
Mean ± SD
(N = 43)
2.86 ± 0.52
2.58 ± 0.73
CRT ON
Mean ± SD
(N = 83)
3.01 ± 0.33
2.53 ± 0.69
Change -0.28 ± 0.63
Overall change in CRT ON vs. CRT OFF = 0.2 functional classes
-0.48 ± 0.65
Quality of Life
Patient quality of life was assessed with the MLWHF questionnaire. A lower score indicates an improvement in quality of life.
A summary of the improvement in quality of life in the two treatment groups is shown in the following table. The average improvement in the CRT ON group over the CRT OFF group was approximately 11 points.
Table 309. Improvement in quality of life score (N = 126)
Baseline
Six-months
CRT OFF
Mean ± SD
(N = 43)
42.0 ± 23
45.4 ± 31
CRT ON
Mean ± SD
(N = 83)
48.3 ± 24
40.4 ± 22
Change 3.4 ± 31
Overall improvement in CRT ON vs. CRT OFF = 11 points
-7.8 ± 22
6-Minute Hall Walk Test
A summary of the improvement in six-minute walk distance in the two treatment groups for this analysis is shown in the following table. The average improvement in the CRT ON group over the CRT OFF group was approximately 28 m.
Table 310. Improvement in six-minute walk distance (m) (N = 126)
Baseline
Six-months
CRT OFF
Mean ± SD
(N = 43)
298 ± 94
283 ± 150
Change -15 ± 142
Overall improvement in CRT ON vs. CRT OFF = 28 m
CRT ON
Mean ± SD
(N = 83)
284 ± 105
297 ± 122
13 ± 74
Additional Data
Echocardiographic Data
Echocardiographic analysis was performed at the Baseline and six-month follow-up visits. The following parameters were evaluated from the echocardiographic analysis: LVEDD, LVESD, LVEF, MR, E/A Wave Point Ratio, and Sphericity Index. Cardiac dyssynchrony
(including Pre-Ejection Delay Time and Intraventricular Mechanical Delay) was also evaluated at Baseline and six months. A summary of the improvement in these parameters between Baseline and six months is shown in the following table.
417
Table 311. Improvement in echocardiography parameters
Parameter
LVEDD (mm)
LVESD (mm)
LVEDV (ml)
LVESV (ml)
LVEF (%)
MR (grade)
CRT OFF
Mean ± SD
(N = 40)
-2.4 ± 6.5
-3.0 ± 6.4
-37 ± 53
-36 ± 47
2.9 ± 6.2
0.10 ± 0.50
CRT ON
Mean ± SD
(N = 82)
-4.3 ± 5.4
-4.6 ± 7.0
-43 ± 69
-43 ± 58
4.3 ± 9.9
-0.06 ± 0.74
E/A Wave Point Ratio
Sphericity Index
Pre-Ejection time (ms)
IVMD (ms)
-0.02 ± 1.2
0.02 ± 0.1
7.3 ± 33
-6.4 ± 48
-0.08 ± 0.8
-0.02 ± 0.1
-1.5 ± 52
-14.5 ± 52
Tei Index
Contraction Interval (ms)
-0.05 ± 0.5
-55 ± 103
-0.4 ± 0.8
-94 ± 124
Biventricular Pacing at Six Months
The average percentage of biventricular pacing at the six-month visit in the 83 patients who were in the CRT ON group among the
126 patients in the primary resynchronization cohort was 95% ± 6%, with a range of 70 to 100%.
Patient Discontinuation/Withdrawals
A total of 47 patients participating in the RHYTHM ICD study were withdrawn from the study. Twenty patients (including the
19 patients with unsuccessful LV lead implants and the one patient with an unsuccessful system implant due to high defibrillation thresholds) were withdrawn approximately one month after unsuccessful system implants in accordance with the protocol.
Twenty-two patients died and were also withdrawn from the study. Three of the 22 deaths occurred in patients who had previously unsuccessful implants. In addition to these 20 unsuccessful implants and 22 deaths, five additional patients were withdrawn from the study. A summary of the reason for these five patient withdrawals is shown in the following table.
Table 312. Patient discontinuations/withdrawals (excludes withdrawals for deaths and after unsuccessful implants)
Reason for
Withdrawal
System Explant
Heart Transplant
Patient Request
Patient Request
Patient’s Family Request
CRT Group
N/A
ON
ON
ON
ON
Days after Implant
1
75
28
397
293
Conclusions Drawn From The RHYTHM ICD Study
In NYHA Class III and IV heart failure patients with LV dyssynchrony and a standard ICD indication, this study demonstrated that cardiac resynchronization is safe and improves functional status.
RHYTHM ICD Study: V-V Optimization Phase
Summary of the V-V Optimization Phase of the RHYTHM ICD Study
The objective of the V-V Optimization Phase of the RHYTHM ICD study was to demonstrate that optimizing the interventricular timing of biventricular pacing therapy yields an improvement in exercise capacity (Peak VO
2
) or in left ventricular performance as measured by echocardiography using the left ventricular end systolic diameter (LVESD), that is similar to simultaneous biventricular pacing in a standard ICD indicated patient population with advanced heart failure (NYHA Classification III or IV) and prolonged QRS duration.
Included in the study were the Epic HF Models V-337 and V-338
devices and the Atlas+ HF Model V-343 device.
612
Patient was withdrawn before the Baseline visit and randomization.
613 The EpicHF ModelV338 device had the Interventricular Pace Delay enabled by the programmer.
418
The primary endpoint was stated as follows (where p is defined as the percentage of patients improved):
Patients completed a cardiopulmonary exercise test (CPET) and an echocardiography test at the Baseline and six-month visits. The sample size required to satisfy the endpoint was 120 patients (72 in the Simultaneous group and 48 in the Optimized group).
The total time of follow-up from the time of successful implant was 3328.7 patient months. The average time of follow-up was 15.2 ±
4.3 (range 0.7 to 26.7) patient months.
Summary of V-V Optimization
At the time of the Baseline visit, all patients underwent echo guided optimization of their AV delay. Patients who were randomized to the Optimized group also underwent echo guided optimization of the interventricular pace delay (V-V delay). Optimization of the V-V delay was determined using the procedure defined in the protocol, which evaluated multiple V-V delays ranging from 20-80 ms with either the LV or RV chamber selected as the first chamber paced. This testing sequence was randomized to minimize any bias in performing this evaluation. The final programmed value for the V-V delay was determined based on the maximum left ventricular velocity time integral (VTI), which was assessed by pulse wave Doppler interrogation of the left ventricular outflow tract.
The distribution of the optimized V-V delay settings among the 48 patients in the Optimized group is shown in the following table. The optimized V-V settings were approximately evenly distributed among the patients. Only five patients (10.4%) were optimized to the simultaneous setting.
Table 313. Distribution of optimized V-V delay among optimized group
First Chamber Paced:
V-V Delay
LV First: 80 ms
LV First: 40 ms
LV First: 20 ms
Simultaneous
RV First: 20 ms
RV First: 40 ms
RV First: 80 ms
Number of Patients
(N = 48)
6 (12.5%)
8 (16.7%)
9 (18.8%)
5 (10.4%)
7 (14.6%)
6 (12.5%)
7 (14.6%)
Clinical Study Results
Three patients in the V-V Optimization Phase of the RHYTHM ICD study were not able to complete all the testing requirements at six months due to worsening heart failure. One patient was withdrawn prior to the six-month visit when he received a heart transplant. This patient did not complete a six-month CPET or echocardiographic evaluation. The other two patients completed a sixmonth echocardiographic evaluation, but were not able to complete a six-month CPET due to worsening heart failure.
A summary of the Peak VO2 and LVESD values at Baseline and six months, as well as the improvement from Baseline in the two treatment groups are shown in the following tables.
Table 314. Baseline and six-month peak VO2 (ml/kg/min)
Baseline
Six-months
Change
Simultaneous
Mean ± SD
(N = 72)
11.3 ± 3.1
11.9 ± 3.3
0.57 ± 2.6
Table 315. Baseline and six-month and LVESD (mm)
Baseline
Six-months
Change
Simultaneous
Mean ± SD
(N = 72)
57.0 ± 9.8
52.2 ± 9.8
-4.7 ± 7.2
Optimized
Mean ± SD
(N = 45)
11.5 ± 3.5
12.4 ± 3.4
0.93 ± 3.2
Optimized
Mean ± SD
(N = 45)
54.1 ± 12.1
50.7 ± 11.9
-3.4 ± 5.8
419
An analysis of the observed difference between the Optimized and Simultaneous groups was performed. A significant p-value (p <
0.05) meant that optimized pacing was not inferior to simultaneous pacing. The analysis compared patients that showed improvement in both Peak VO2 and LVESD. A summary of this analysis is shown in the following table. The observed difference in proportion improved between the Simultaneous and Optimized groups (i.e., p sim
– p opt
) is 0.6% and the 95% Blackwelder confidence interval for the difference is (-100%, 14.5%). The p-value was 0.0004. The null hypothesis was rejected, and therefore optimized V-V pacing is not inferior to simultaneous pacing. Overall, improvement in Peak VO2 and improvement in LVESD did not trend in the same direction. Simultaneous patients showed a greater improvement in LVESD and Optimized patients showed a greater improvement in Peak VO2.
Table 316. Percent of improvement in peak VO2 (ml/kg/min) and LVESD (mm)
Simultaneous
(N = 72)
Peak VO2 LVESD
Optimized
(N = 45)
Peak VO2
% Improved
% No Change
% Worsened
% Improved
in Peak
VO2 and LVESD
37.5%
38.9%
23.6%
19.4%
47.2%
44.4%
8.3%
45.8%
27.1%
27.1%
18.8%
43.8%
45.8%
10.4%
LVESD
Conclusions Drawn From the VV Optimization Phase of the RHYTHM ICD Study
Cardiac resynchronization therapy (CRT) with optimization of V-V delay was shown to be similar to CRT with simultaneous pacing in terms of the percentage of patients that were found to be responders.
Zephyr IDE Clinical Trial
The Zephyr IDE Clinical Trial was conducted using the Zephyr DR 5820 and Zephyr XL DR 5826 pulse generators. The Zephyr pulse generator was evaluated in a multicenter (15 US centers) clinical trial involving 161 patients.
There were four primary endpoints for the Zephyr IDE clinical study.
Safety of the device system: Freedom from system related complications
Safety of the VAC feature: Success rate of VAC (as determined by the presence of back up pulses on 24 hour Holter)
Effectiveness of VAC: Difference in ventricular capture threshold determined by VAC and by a manual test (semi-automatic capture threshold test)
Effectiveness of ACC: Difference in atrial capture threshold determined by ACC and by a manual test (semi-automatic capture threshold test)
Patient Population
The overall study population consisted of 161 enrolled patients. All patients were evaluated for safety of the device system, 142 patients were evaluated for VAC effectiveness, 82 patients were evaluated for ACC effectiveness, and 64 patients were evaluated for
VAC safety. Of these patients, 91 (56.5%) were females and 70 (43.5%) were males. The mean age at implant was 71.8 ± 11.6 years. The primary indications for pulse generator implantation in the study population are summarized in the following table.
Table 317. Primary Indications for Implantation
Indication
Sinus Node Dysfunction
Sinus Bradycardia
Heart Block
Syncope
No. of Patients (%)
62 (38.5%)
53 (32.9%)
36 (22.4%)
8 (5.0%)
Neurocardiogenic Syncope 2 (1.2%)
The mean duration of implant for all patients in the study was 5.1 ± 1.5 months (minimum duration: 0; maximum duration: 9.1 months).
614
Improvement in Peak VO2 was defined as an increase of at least 1.1ml/kg/min and improvement in LVESD was defined as a decrease of at least 5mm.
615 Improvement in Peak VO2 was defined as an increase of at least 1.1ml/kg/min and improvement in LVESD was defined as a decrease of at least 5mm.
420
Primary Safety Endpoint for the Zephyr Device System
System related complications of the Zephyr device through the 3 month visit
The system related complications at three months are shown in the following table. All 161 patients were included in this endpoint analysis. None of the complications were related to the investigational pulse generator. A total of 3 patients experienced 3 system related complications in this study.
The survival from system related complications at 3 months was estimated as 98.1% with a 95% lower confidence bound of 95.2%, using Greenwood's formula, which is greater than the objective performance criteria of 85%. Hence, the null hypothesis is rejected at the 5% significance level.
Table 318. System Related Complications
Event Description
Lead Dislodgement or Migration - RV lead
Lead Body Prolapse - RA Lead
Phrenic Nerve/Diaphragmatic Stimulation - RA lead
Total
Primary Safety Endpoint for VAC
# of Patients
1
1
1
3
# of Events
1
1
1
3
Safety of VAC at the 3 month follow up visit
The primary analysis was performed on all patients who had analyzable 24-hour Holter monitor testing results. Sixty-four patients were available in the "analyzable" patient cohort for the primary safety endpoint, which is greater than the required sample size of 62 patients. This analysis was carried out on all available 64 patients.
None of the patients included in the analysis had consecutive losses of capture not followed by a back up pulse. Therefore, the success rate of VAC at 3 months by Holter Monitor was estimated as 100%, with 95% confidence limits (94.3%, 100%). The p-value for the VAC safety endpoint is 0.01. Hence, the null hypothesis is rejected.
Primary Effectiveness Endpoint
Effectiveness of VAC at the 3 month follow up visit
The primary analysis was performed on the first 65 patients who had paired bipolar ventricular capture threshold measurements at 3 months. The data are summarized in the following table.
The 95% two-sided confidence limits on the difference in the median ventricular capture thresholds were calculated based on the distribution-free confidence intervals method for percentiles described in Hahn and Meeker and are shown in Table 5. The confidence interval is within the equivalence limit of (-0.25, 0.25) V, hence the null hypothesis is rejected at the 2.5% significance level. Since this safety endpoint is met at the stricter criterion of the 2.5% significance level, it is also met at the 5% significance level.
Table 319. Primary Analysis - Bipolar Ventricular Capture Thresholds at 3 months VAC Effectiveness Patient Cohort (N=65)
Median
Mean ± SD
VAC Test (V)
0.88
1.0 + 0.51
Semi-Automatic
Threshold Test (V)
1.00
1.1 + 0.52
Difference
VAC - Semi-Automatic (V)
-0.13
-0.06 ± 0.21
Range
95% confidence limits on median difference (V)
(0.38, 3.13)
(-0.13, 0.0)
(0.25, 2.75) (-0.75, 0.88)
Effectiveness of ACC at the 3 month follow up visit
The primary analysis was performed on the first 41 patients who had paired atrial bipolar capture threshold measurements at 3 months. The data are summarized in the following table.
The 95% two-sided confidence limits on the difference in the median atrial capture thresholds are calculated based on the distribution-free confidence intervals method for percentiles described earlier, and are shown in Table 6. Since this endpoint is met at the stricter criterion of the 2.5% significance level, it is also met at the 5% significance level.
421
Table 320. Primary Analysis - Atrial Capture Thresholds at 3 months ACC Effectiveness Patient Cohort (N=41)
Median
Mean ± SD
Range
95% confidence limits on median difference (V)
ACC Test (V)
0.63
0.73 + 0.30
(0.38, 1.88)
(-0.13, 0.0)
Semi-Automatic
Threshold Test (V)
0.75
0.79 + 0.32
(0.25, 2.0)
Difference
ACC - Semi-Automatic (V)
-0.13
-0.06 ± 0.10
(-0.25, 0.25)
422
References
Contents:
AF Suppression™ Algorithm (page 423)
QuickOpt™ Optimization (page 423)
DecisionTx™ Programming (page 424)
For additional information on these references, call your local St. Jude Medical representative.
AF Suppression™ Algorithm
Freedman RA, Graumann R, Alonso J, Chhabra A, Volosin K, Zhang X and Investigators from the RARE study. Predictors of atrial fibrillation progression in a pacemaker population: role of Atrial Fibrillation Suppression algorithm. Heart Rhythm. 2005; 2:
2S16, AB9–1.
Schuchert A; Carlson MD and the ADOPT-A Investigators. Effect of atrial overdrive pacing on the onset of heart failure in pacemaker patients. Heart Rhythm. 2005; 2: S18, AB9–5.
CRT Therapy
Baker II JH, McKenzie III J, Beau S, Greer GS, Porterfield J, Fedor M, Greenberg S, Daoud EG, Corbisiero R, Bailey JR,
Porterfield L. Acute Evaluation of Programmer-Guided AV/PV and VV Delay Optimization Comparing an IEGM Method and
Echocardiogram for Cardiac Resynchronization Therapy in Heart Failure Patients and Dual-Chamber ICD Implants.
J Cardiovasc Electrophysiol. 2007; 18: 185–191 DOI:10.1111/j.1540-8167.2006.00671.x.
Wasserman K, Sun X and Hansen JE. Effect of Biventricular Pacing on the Exercise Pathophysiology of Heart Failure. Chest.
2007; 132: 250–261; DOI: 10.1378/chest.06–2872.
Doshi RN, Daoud EG, Fellows C, Turk K, Duran A, Hamdan MH, and Pires LA for the PAVE Study Group. Left Ventricular-
Based Cardiac Stimulation Post AV Nodal Ablation Evaluation (The PAVE Study). J Cardiovasc Electrophysiol. 2005; 16: 1160–
1165.
QuickOpt™ Optimization
Min X, Meine M, Baker II JH, Pires LA, Turk KT, Horn ME, Kowal RC, Paris M, Park E, Fain ES. Estimation of the Optimal VV
Delay by an IEGM-Based Method in Cardiac Resynchronization Therapy. Pace. 2007; 30: S19–S22.
Boriani G, Muller CP, Seidl KH, Grove R, Vogt J, Dansche W, Schuchert A, Djiane P, Biffi M, Becker T, Bailleul C, Trappe HJ.
Randomized comparison of simultaneous biventricular stimulation versus optimized interventricular delay in cardiac resynchronization therapy. The Resynchronization for the HemodYnamic Treatment for Heart Failure Management II implantable cardioverter defibrillator (RHYTHM II ICD) study; Resynchronization for the HemodYnamic Treatment for Heart
Failure Management II Investigators. Am Heart J. 2006; 151: 1050–1057.
Primary Prevention
Kadish A, Schaechter A, Subacius H, Thattassery E, Sanders W, Anderson KP, Dyer A, Goldberger J and Levine J. Patients With
Recently Diagnosed Nonischemic Cardiomyopathy Benefit From Implantable Cardioverter-Defibrillators. JACC. 2005; 47: 2477-
2482.
Kadish, A, et al. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med.
2004; 350: 2151-2158.
Schaechter A, Kadish AH. DEFibrillators In Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE). Card
Electrophysiol Rev. 2003; 7: 457-462.
ST Monitoring
Asbach S, Weiss I, Wenzel B et al., Pacing Clin Electrophysiol. 2006; 29: 1334.
Fischell TA, Fischell DR, Fischell RE et al., J Am Col of Cardiol. 2006; 48: 2306.
Baron TW, Faber TS, Grom A et al., Europace 2006; 8: 994.
Clinical Performance of the ST Monitoring Algorithm
Results from a clinical study conducted at the Dante Pazzanese Institute of Cardiology in Sao Paulo, Brazil demonstrated the potential clinical benefit of the early detection of rapidly progressive ST segment shifts using an investigational monitoring device.
This investigational device and AnalyST device use the same algorithm for ST segment monitoring of the intracardiac electrogram.
One primary endpoint of this study was to show the ability of the implanted system to accurately record ST segment shifts that occur without an associated heart rate elevation, from acute occlusion of a coronary artery during PCI (percutaneous coronary intervention). This is predictive of what the device would record from the acute closure of a coronary artery from a heart attack.
Subjects enrolled in the study were implanted with an investigational device prior to undergoing a coronary artery stent implantation.
Electrogram data were collected via the implanted system during a balloon inflation either during stent delivery or pre-dilatation.
Results from the study indicate that the implanted system was able to detect ST segment changes across multiple types of lesions within the 3 major epicardial arteries during PCI. These intracardiac ST changes were consistent with the ST segment changes typically seen on surface leads. A total of 20 subjects were enrolled and followed at 1, 3, and every 6 months since implantation.
Over 22 patient years of implantation data are available, with the average follow-up time of 12 months, ranging from 3 to 18 months.
423
During the follow-up period, two subjects experienced ST shift events on their intracardiac electrograms. These were detected by the device and confirmed via angiography to be related to coronary occlusions requiring revascularization. Both subjects presented with mild or no clinical symptoms and no EKG changes on the diagnostic 12 lead electrocardiogram when they presented at the hospital.
The patients were admitted for observation and administered anti-platelet medications, such as heparin and clopidogrel. Nine to twelve (9-12) hours after their index event, both subjects experienced a second significant ST shift event. Following these second events, both subjects underwent angiography. Both coronary angiograms demonstrated new complex thrombotic lesions of over 70% stenosis that angiographically appeared to be related to a ruptured plaque. In the second patient, the ruptured plaque site was directly confirmed by intravascular ultrasound (IVUS). Both subjects were successfully revascularized.
With more than 100,000 electrogram segments monitored the study also demonstrates that patients at high risk for AMI will have relatively stable ST shift levels over time. After implementing an algorithm update after the fifth patient was enrolled in the study, no false positive or false negative ST shift detections were observed through the completion of the study.
The study concludes that the implanted system can detect progressive ST shifts on the intracardiac electrogram due to coronary occlusions including early detection of those resulting from ruptured plaque events. There were no clinically significant device-related adverse events in the study.
Potential of an intracardiac electrogram for the rapid detection of coronary artery occlusion
In 2005, Fischell et al
reported the results of occlusion testing by measuring ST segment shifts during percutaneous coronary intervention (PCI). A temporary 4 Fr catheter was placed in the RV apex and IEGMS were recorded from the RV apex to a skin electrode place on the left chest. Simultaneous V6 ECG recordings were obtained in this 14 patient study to evaluate the relationship of ST changes during occlusion between the surface and intracardiac signals.
In this study, ST segment shifts were detected in the intracardiac electrogram in 14 of 14 patients and 17 of 17 vessels during occlusion. The IEGM demonstrated a mean ST segment of -11.2 mV. After 2 minutes of occlusion the mean ST segment shift was -
6.9 mV. Thus, there was an absolute ST shift upward of 4.3 mV.
Comparison of surface ECG to IEGM
Among the cohort, there was a greater percentage ST shift in the intracardiac electrogram compared with the surface lead at both 1 min of inflation (P=.00037) and after 2 min (P=.00011), indicating superior sensitivity of the intracardiac as compared with the simultaneous recordings from a surface lead. The ST segment amplitude was measured relative to the PR segment height. Both surface and intracardiac signals were normalized by describing ST changes as a percentage of the QRS complex amplitude. Within
2 min. of balloon occlusion, a mean ST segment shift of 36.4% was observed in the intracardiac electrogram. The magnitude of ST shift recorded from the intracardiac electrogram during occlusion was similar for all 3 epicardial coronary distributions (LAD, LCX, and RCA). Furthermore, the magnitude of ST shift was greater on the intracardiac recording than the precordial (V6) ECG lead. In nearly all cases, ST shift returned to baseline levels within 120–240 seconds following balloon deflation.
This study demonstrates the ability of an intracardiac lead to rapidly detect myocardial ischemia/injury during acute coronary occlusion in the setting of balloon angioplasty.
DecisionTx™ Programming
Performance Analysis of DecisionTx™ Programming in Combination with Low Frequency
Attenuation and ATP
Analysis was performed to evaluate the effect of the following St. Jude Medical™ (SJM) features in decreasing the number of inappropriate and unnecessary shocks.
DecisionTx™ Programming, a group of parameter settings designed to optimize SVT Discrimination (see SVT Discrimination
Criteria Programming Guidelines (page 122))
Antitachycardia pacing (ATP)
Low Frequency Attenuation, a filtering algorithm designed to improve sensing
The analysis was performed using data from the Advancements in ICD Therapy (ACT) registry, an SJM sponsored data collection effort that followed over 5,000 ICD and CRT-D patients for a two-year period. No specific programming guidelines were provided at implant or during follow-up in the ACT registry.
Patients selected for this performance analysis were required to have:
One or more VT/VF Detections (appropriate or inappropriate) at some time during the two-year follow-up period
A stored EGM associated with at least one of the VT/VF Detections
Morphology scores available in the stored EGMs (Morphology Discrimination did not have to be enabled)
A total of 824 patients met these qualifications, comprising 3,805 VT/VF Detections. One episode/EGM documenting VT/VF
Detection was randomly selected from each of the 824 patients and used for the analysis. Eleven EGMs were found not analyzable, leaving a total of 813 episodes for the analysis.
Impact of DecisionTx™ Programming
The analysis compared the diagnosis of each episode to the predicted outcome had the DecisionTx™ Programming settings been programmed at the time of the episode. Fifty-eight SVT episodes occurring during the two-year follow-up period were diagnosed as
VT and treated with unnecessary HV therapy. Analysis of these episodes found that 47 episodes (80.3%) would have been correctly diagnosed as SVT with DecisionTx Programming and would have not been treated with HV therapy. Thus, using the DecisionTx
Programming settings would have resulted in an 80.3% decrease in the number of SVTs inappropriately treated with HV Therapy.
616 Fischell TA, Fischell DR, Fischell RE et al., Cardiovasc Revasc Med. 2005; 6: 14.
424
Impact of ATP Usage
An analysis by Sweeney et al.
of four prospective trials found that ATP as the first therapy converted an average of 92.4% of VTs occurring at rates < 188 min§ and 82.5% of VTs occurring at rates between 188 min§ and 250 min§. DecisionTx™ Programming includes ATP as the initial therapy in all rate zones. The analysis found that using programming guided by DecisionTx Programming parameters would result in a 40.7% reduction in the delivery of HV Therapy. There were a small number of episodes (1.7%) that were unsuccessfully treated with ATP and required HV therapy to terminate the VT/VF Episode. As ATP was initially attempted for these episodes, DecisionTx Programming did not impact their outcome.
Low Frequency Attenuation Enabled
Bench-testing has demonstrated that the enhanced Low Frequency Attenuation filter eliminates oversensing of the T-wave in 95% of tested QRS-complexes
. Analysis of these episodes found that 100% of episodes incorrectly diagnosed as VT/VF due to T-wave oversensing would have been eliminated. Thus, none of these episodes that received HV therapy would have resulted in shock had the filter been applied.
Summary
The analysis found that 18.2% of episodes detected as VT/VF in the ACT registry were treated with HV therapy. However, had the patients been able to benefit from the use of DecisionTx™ Programming, in combination with improved sensing with the Low
Frequency Attenuation Filter and use of ATP as the initial therapy, only 7.8% of episodes detected as VT/VF would have been treated with a shock (in the table below). For VT/VF episodes <250 min§, the percentage receiving HV therapy would decrease from 5.1% to
0.84%. Furthermore, 98.5% of VT/VF Detections would have been managed without inappropriate delivery of HV therapy.
Table 321. Summary of results of the impact of DecisionTx Programming on VT/VF episodes from the ACT Registry
Cause of Shock Baseline
% of VT/VF Detections treated with HV Therapy
10.6%
0.5%
DecisionTx Programming
Projected % of VT/VF
Detections treated with
HV Therapy
6.3%
0.04%
Projected % Reduction
40.7% VT/VF
VT (<188 min§)
VT (188-250 min§)
VT (>250 min§) & VF
Unsuccessful ATP
Non-VT/VF
SVT
Oversensing
Other (bigeminy, noise, etc)
4.6%
3.8%
1.7%
7.6%
7.1%
0.4%
0.1%
0.8%
3.8%
1.7%
1.5%
1.4%
0.0%
0.1%
80.3%
Total
% of VT/VF detections not treated with HV therapy
% of VT/VF detections without inappropriate HV therapy
18.2%
Baseline
81.8%
92.4%
7.8%
DecisionTx Programming
92.2%
98.5%
57.1%
ASSERT Study
Summary of the ASSERT Clinical Study
The primary objective of the ASSERT clinical study (“ASymptomatic atrial fibrillation and Stroke Evaluation in pacemaker patients and the atrial fibrillation Reduction atrial pacing Trial”) was to evaluate whether subclinical atrial tachycardia (AT) and atrial fibrillation (AF) episodes, detected by a pacemaker or implantable cardioverter defibrillator (ICD) early after implantation, are associated with an increased risk of ischemic stroke or systemic embolism in elderly hypertensive patients. Patients enrolled in the
Assert study were implanted with an Identity™ ADx DR pacemaker (Models 5386 or 5380), Victory (Models 5816 or 5810), or an
Atlas™ II/Epic™ II ICD device. The study defined subclinical AT or AF as device-detected atrial arrhythmias lasting > 6 minutes and with a rate > 190 beats per minute ( min§). The AT/AF detection algorithms were available in all the pacemaker and ICD models. A total of 2,580 patients were enrolled across 136 clinical centers worldwide. Detection of subclinical AT or AF via the device in the first three months following implant was associated with a increased hazard ratio of 2.5 for ischemic stroke.
Patient Population
Patients were eligible if they had a history of hypertension requiring medical therapy, were 65 years of age or greater, and had received their first implant of a St. Jude Medical dual-chamber pacemaker or ICD in the preceding eight weeks. Patients were
617 Sweeney et al. Differences in effects of electrical therapy type for ventricular arrhythmia on mortality in implantable cardioverter-defibrillator patients. Heart Rhythm. 2010;
7(3); 353-360.
618 Report on file, St. Jude Medical, Sylmar, California.
425
excluded if they had any history of AF or atrial flutter lasting more than five minutes or if they required a Vitamin K antagonist (VKA) for any reason.
Methods/Results
After giving written informed consent, patients had their pacemaker or ICD programmed according to protocol-specific parameters specified in Tables M-1 and M-2, respectively. An atrial tachycardia detection rate of 190 min§ was programmed, the AF suppression algorithm was programmed “Off”, and electrogram storage was activated. The Post Ventricular Atrial Blanking period was programmed to eliminate any farfield R-wave oversensing allowing for high atrial sensitivities to be used. Testing for any myopotentials oversensing was also done in all patients. Three months after study enrollment, patients returned to the clinic and had their pacemaker or ICD interrogated. Device-detected atrial arrhythmias lasting > 6 minutes and with a rate > 190 min§ was the study pre-specified definition of subclinical AT or AF. For the cohort study of subclinical AF, patients were classified as having, or not having, at least one adjudicated episode of subclinical AT or AF during the period from enrollment to the three-month visit. In addition, at this visit pacemaker patients (but not ICD patients) were randomized to have AF Suppression™ pacing programmed on or off.
Table 322. Pacemaker programming guidelines
Parameter
Pacing Parameters
Mode
Base Rate
Max Tracking Rate
Max Sensor Rate
PVAB (Post Ventricular Atrial Blanking)
A. Sensitivity
Auto Mode Switch
Atrial Tachycardia Detection Rate
AutoIntrinsic Conduction Search
AF Suppression™ algorithm
AV Delay
Stored EGM Options
Sampling Option
No. of Stored EGMs
Channel
A EGM Configuration
A. Dynamic Range
AT/AF Detection
Table 323. ICD programming guidelines
Parameter
Pacing Parameters
Mode
Base Rate
Max Tracking Rate (recommended)
Max Sensor Rate (recommended)
A. Sensitivity
Auto Mode Switch
Atrial Tachycardia Detection Rate
AutoIntrinsic Conduction Search (recommended)
AF Suppression™ algorithm
AV Delay
Tachycardia Parameters
Setting
DDD or DDDR
< 60 min§
110-150 min§
£ Max Tracking Rate
25 ms greater than the measured far-field R interval (V-paced; 100 ms minimum)
0.1 - 0.5 mV
Enabled
190 min§
20 or 30 ms
Off, then randomized at month 3
Various (set to allow intrinsic conduction)
Continuous
12
Single
Atip-Aring
±3.0 mV
On
Setting
DDD or DDDR
< 50 min§ unless indicated for brady pacing
110-150 min§
£ Max Tracking Rate
Automatic, Max 0.2 mV
Enabled
190 min§
20 or 30 ms
Off, then randomized at month 3
Various (set to allow intrinsic conduction)
426
Table 323. ICD programming guidelines
Parameter
SVT Discrimination Timeout
VT-1 Detection Rate (recommended)
Special Parameters
SVT Upper Limit
Far R Suppression
Shock Energy Setting
Defibrillation Energy (for all shocks) - (recommended)
Setting
> 6 min
£ 180 min§
Same as VF
25 ms
Max
Patient Disposition and Baseline Characteristics
Between December 2004 and September 2009, 2,580 patients were enrolled after receiving a first pacemaker or ICD implant at 134 sites in 23 countries in North America, Europe, and Asia. There were 2,451 patients who received a pacemaker and 129 who received an ICD. There were 14 patients (0.5%) who were lost to follow-up. A total of 261 patients (10.1%) had at least one confirmed, device-detected, subclinical AT or AF, between enrollment and the three-month visit. After this pre-defined arrhythmia detection period, patients were followed for a mean of 2.5 years, during which time subclinical AT or AF occurred in a further 633
(25%) of patients. Clinical AT or AF, defined as AT/AF observed on a surface ECG at a follow-up visit, occurred in a total of 112 patients after the three-month visit; and in seven patients only before the three-month visit. Patients with subclinical AT or AF had a similar age and prevalence of prior heart failure to those without, but did have a higher prevalence of sinus nodal disease and a lower resting heart rate (Table M-3). Randomized treatment groups were well balanced. There were 990 (42.3%) patients with septal placement of the atrial lead.
Table 324. Characteristics at time of enrollment of patients according to whether or not subclinical atrial tachycardia or fibrillation was detected between enrollment and three months
Device Detected Subclinical Atrial Tachycardia or Fibrillation detected between enrollment and three-month visit
Yes (N=261) No (N=2319) P-value
Age (years ± SD)
Male
Systolic Blood Pressure sitting (mmHg) (mean
± SD)
Heart Rate ( min§) (mean ± SD)
BMI (mean ± SD)
Prior Stroke
Prior Transient Ischemic Attack
History of Heart Failure
Diabetes Mellitus
Prior Myocardial Infarction
CHADS
2
Score (mean ± SD)
Sinus Node Disease (± AV Node Disease)
AV Node Disease (without Sinus Node
Disease)
Atrial Lead in Septal Position
Diagnosis of Hypertension >10 years
LVH on ECG
Days from Implant to Enrollment (mean ± SD)
Aspirin
Beta Blocker
Statin
77 ± 7
147 (55%)
137 ± 20
68 ±12
28 ± 5
18 (7%)
13 (5%)
39 (15%)
59 (23%)
32 (12%)
2.2 ± 1.1
130 (50%)
132 (51%)
101 (39%)
115 (44%)
6 (2%)
25 ± 22
160 (61%)
94 (36%)
113 (43%)
76 ± 7
1359 (59%)
137 ± 20
70± 12
27 ± 5
168 (7%)
113 (5%)
335 (14%)
674 (29%)
427 (18%)
2.3 ± 1.0
964 (42%)
1279 (55%)
972 (42%)
965 (41%)
105 (5%)
29 ± 40
1430 (62%)
849 (37%)
1112 (49%)
0.13
0.27
0.60
0.001
0.43
0.84
0.94
0.83
0.03
0.01
0.47
0.01
0.16
0.32
0.45
0.09
0.04
0.91
0.85
0.15
427
Stroke and Systemic Embolism
Detection of subclinical AT or AF between enrollment and the 3-month visit significantly increased the risk of ischemic stroke or systemic embolism from 0.69 to 1.69%/year during subsequent follow up (HR= 2.49, 95% CI: 1.28-4.85, p=0.007) (Table M-4). In an analysis, adjusted for baseline imbalances in stroke risk factors, the effect of subclinical AT or AF on the risk of stroke or systemic embolism was virtually unchanged; HR = 2.50 (95% CI: 1.28-4.89), p=0.008. Of the 51 patients who had an ischemic stroke or systemic embolism during the follow up period, 11 had subclinical AT or AF detected between enrollment and the three-month visit and none had clinical AF detected. The population-attributable risk of subclinical AT or AF for ischemic stroke of systemic embolism was 13%. Using time-dependent analysis including all device-detected AT or AF during follow up, episodes > 6 minutes increased risk of ischemic stroke or systemic embolism compared to none (HR = 1.76, 95% CI: 0.99 - 3.11, p = 0.05); with a similar increase in risk for episodes > 6 hours (HR = 2.00; 95% CI: 1.13 - 3.55, p =0.02) and > 24 hours (HR = 1.98; 95% CI: 1.11 - 3.51, p
=0.02).
Table 325. Clinical outcomes occurring after the three-month visit, according to whether subclinical atrial tachycardia or fibrillation
(AT or AF) was detected between enrollment and the three-month visit or not
Clinical Outcome
Ischemic stroke or Systemic
Embolism
Ischemic Stroke
Systemic Embolism
Myocardial Infarction
Vascular Death
Stroke, Myocardial
Infarction or Vascular Death
Hospitalization for Heart
Failure
Clinical Atrial Fibrillation or
Flutter on Surface ECG
Subclinical atrial tachycardia or fibrillation between enrollment and 3 months
Present
N= 261
Absent
N= 2319 events
11
%/year
1.69 events
40
%/year
0.69
10
1
7
19
29
20
41
1.54
0.15
1.07
2.92
4.45
3.07
6.29
36
4
39
153
206
131
71
0.62
0.07
0.67
2.62
3.53
2.24
1.22
Subclinical atrial tachycardia or fibrillation present vs. absent
HR
2.49
2.52
2.24
1.52
1.11
1.25
1.36
5.56
95% CI
1.28 - 4.85
1.25 - 5.08
0.25 - 20.1
0.68 - 3.42
0.69 - 1.79
0.85 - 1.84
0.85 - 2.19
3.78 - 8.17 p
0.007
0.01
0.47
0.31
0.67
0.27
0.20
<0.001
CHADS2
There were 600 patients with a CHADS
2
score of 1 (23%), 1129 with a CHADS
2
score of 2 (44%) and 848 with a CHADS
2
score of
> 2 (33%). The relative risk of ischemic stroke or systemic embolism associated with device-detected AT was consistent across different levels of baseline stroke risk (p value for trend = 0.35) (Table M-5). The absolute rate of stroke increased with increasing score, reaching 3.78% per year in patients with subclinical AT or AF and a CHADS
2
score of > 2.
Table 326. Risk of ischemic stroke or systemic embolism after the three-month visit, according to both baseline CHADS visit
2
Score, and to whether or not subclinical atrial tachycardia or fibrillation (AT or AF) was detected between enrollment and the three-month
CHADS2
Score
1
2
> 2
Total
Patients
600
1129
848
Subclinical Atrial Tachyarrhythmia between enrollment and 3 months Subclinical Atrial
Present
68
119
72
1
4
6
0.56
1.29
3.78
Absent patients events %/year patients events %/year
532
1010
776
4
22
18
0.28
0.77
0.97
Tachyarrhythmia
Present vs. absent
HR
2.11
1.83
3.93
95% CI
0.23 - 18.9
0.62 - 5.40
1.55 - 9.95 p
0.35
Aspirin and Oral Anticoagulant Therapy
At baseline 61% of patients with subclinical AT or AF, and 62% of those without, were receiving aspirin, and no patients were receiving a Vitamin K antagonist. Over the course of the study, 194 patients received a vitamin K antagonist, including 47 (18.0%) the patients who had a subclinical AT or AF by three months.
Effect of Atrial Overdrive Pacing
In the randomized comparison of atrial overdrive pacing ON versus OFF in the pacemaker patients, rates of development of clinical
AT or AF were low and the intervention had no statistically significant effect on this or any other outcomes.
428
Summary
Subclinical AT or AF is very common in pacemaker patients with a history of hypertension, but without prior diagnosis of clinical AF.
It often precedes development of clinically overt AF, but mostly remains subclinical. The population-attributable risk of stroke or systemic embolism associated with subclinical atrial tachyarrhythmias was 13%.
429
Index
A
A Cap Confirm Capability ...............................................177
AAI Mode ......................................................................157
AAT Mode .....................................................................157
Active Button, Zone Therapy ..........................................103
Activity Recalibration ...................................................... 31
Adaptive Burst Cycle Length ..........................................107
Add Stimuli Per Burst, ATP Therapy ...............................107
Add/Edit Clinical Comment, CorVue Monitoring ................ 38
Additional Cardiac Hardware ........................................... 18
Additional Parameters
Capture Test ............................................................ 42
Sense Tests ............................................................. 42
Additional Settings, PVC & PMT ...................................... 83
Adjust Display ................................................................ 14
Advanced Hysteresis, Episode Triggers ...........................138
Advanced Settings, Far Field Morphology Discrimination .. 97
AF Suppression Algorithm ............................................... 87
Alert Notification ............................................................129
Test Notifier Button .................................................129
Alert Triggers.................................................................129
Alerts ............................................................................. 17
Additional Cardiac Hardware .................................... 18
Allure, Allure Quadra, Quadra Allure MP Devices Technical
Data .........................................................................235
Amplitude Trend ....................................................... 41, 42
AMS
AMS Log .................................................................. 29
AMS Summary ......................................................... 29
AMS Base Rate .............................................................. 86
AMS Max Trigger Rate .................................................... 86
AMS V. Triggering........................................................... 86
AMS, see Auto Mode Switch ........................................... 29
AnalyST Technical Data .................................................241
Anthem Technical Data .................................................245
AOO Mode ....................................................................157
Arrhythmia Onset/Sudden Onset Detailed Description .....122
Arrhythmia Onset/Sudden Onset Window ........................101
Arrhythmia Unhiding ...................................................... 84
AT/AF
AT/AF Summary ....................................................... 30
Burden .................................................................... 29
Definition ................................................................. 30
Detection & Response Parameters ............................ 85
Diagnostics .............................................................. 30
Log 30
V Rates During AT/AF ............................................... 30
AT/AF Alert Notification..................................................131
AT/AF Alert Triggers Capability .......................................178
AT/AF Burden ................................................................ 29
ATP
ATP Details Window ................................................106
ATP Therapy Details Episodes................................... 23
Parameters .............................................................106
Pulse Amplitude ......................................................106
Pulse Width ............................................................106
Therapy Configurations ............................................109
ATP Prior to Charging ....................................................105
ATP Therapy Prior to Charging .......................................179
ATP Therapy While Charging..........................................179
ATP While Charging .......................................................106
Atrial Episode, EGM Storage ...........................................138
Atrial Heart Rate Histogram ............................................ 27
Atrial Max Sensitivity ....................................................... 76
Atrial Pace Refractory ..................................................... 82
Atrial Sense Refractory ................................................... 82
Atrial Tachycardia Detection Rate .................................... 86
Audio Preferences ............................................................ 6
Auricle Technical Data ...................................................259
Auto Mode Switch ........................................................... 85
Auto Mode Switch Diagnostics, see Mode Switch Diagnostics
................................................................................. 28
Automatic Pulse Amplitude ............................................. 74
Automatic Test Option, Sense Tests ................................. 43
AutoSense Function ........................................................ 78
AutoSense Parameter...................................................... 76
AV Association Delta ..................................................... 100
AV Delays Window .......................................................... 44
AV Interval Delta ............................................................. 94
AV Intervals Diagnostics .................................................. 28
B
Backup Defibrillation, Reset Settings .............................. 172
Backup Pulse Configuration ............................................ 76
Backup Safety Pulse ....................................................... 74
Base Rate ...................................................................... 68
Intervals at ERI ....................................................... 330
Baselines ....................................................................... 34
Basic Operation Parameters ............................................ 63
Battery & Leads, Tests .................................................... 45
Battery Details, Tests ...................................................... 45
Battery Model 2356 ...................................................... 181
Battery Model 2555 ...................................................... 181
Battery Model 2753 ...................................................... 182
Battery Model 2850 ...................................................... 182
Battery Model 2950 ...................................................... 183
Battery Test Rate, see Magnet Rate ................................. 45
Battery Voltage at ERI.................................................... 330
Beat Selection ................................................................ 34
Beginning-of-Life (BOL) ................................................... 45
Bigeminal Rhythm
SVT Discrimination Timeout and ................................ 92
Tachycardia Detection and ...................................... 121
VT Therapy Timeout and ......................................... 104
BiVCap Confirm Capability ............................................. 183
Block Rate...................................................................... 73
Brady Pacing, Emergency VVI ....................................... 170
Brady Parameters ........................................................... 63
AT/AF Detection & Response .................................... 85
Basic Operation ........................................................ 63
Capture & Sense....................................................... 74
Delays ...................................................................... 71
Leads ....................................................................... 79
Rates ....................................................................... 68
Rates & Refractories ................................................. 87
Refractories & Blanking ............................................ 80
Bradycardia Device Longevity ........................................ 309
Bradycardia Devices
Clinician Use Information ........................................ 309
Bradycardia Pacing, Testing at Implant .......................... 332
Burst Cycle Length
Adaptive ................................................................. 107
ATP Therapy .......................................................... 107
Fixed ..................................................................... 107
Burst Test
Fibber ...................................................................... 54
Instructions (Fibber) ................................................. 55
Instructions (NIPS) ................................................... 58
NIPS ........................................................................ 58
C
Cap Confirm Parameter ................................................... 74
Cap Confirm Settings ...................................................... 76
Cap Confirm Trend ................................................... 41, 42
Capabilities ................................................................... 177
Capacitor Maintenance
Arrhythmia Detection during ...................................... 47
Details of .................................................................. 47
Capacitor Maintenance Window ..................................... 119
Capacitor Test ................................................................ 46
Capacity, Stored EGM ................................................... 136
431
Capture & Sense Parameters ........................................... 74
Capture Test ................................................................... 39
Additional Parameters ............................................... 42
Instructions .............................................................. 40
Last Session ............................................................. 41
Options .................................................................... 41
This Session ............................................................. 41
Chamber Onset ............................................................. 101
Chamber Onset Discrimination Capability ....................... 184
Channel Control Buttons .................................................... 7
Charge Interval.............................................................. 120
Clear Diagnostics Button ............................................... 149
Clear ERI ................................................................ 45, 330
Clear Trends
Patient Data .............................................................. 18
Wrap-up Overview ................................................... 149
Clinician Use Information for Bradycardia Devices .......... 309
Clinician Use Information for Tachycardia Devices .......... 331
Commanded Shock, see Emergency Shock .................... 171
Configuration ................................................................ 135
Congestion Details ........................................................... 38
Congestion Monitoring ................................................... 134
Congestion Trigger .......................................................... 38
Consecutive High Ventricular Rate Cycles ....................... 139
Consecutive PVCs, Episode Triggers ............................... 138
Continuous Time in AT/AF ............................................. 131
CorVue Congestion Monitoring ......................................... 37
CorVue Congestion Monitoring Capability ........................ 184
CorVue Congestion Monitoring Feature ........................... 141
Crosstalk......................................................................... 83
CRT Toolkit ..................................................................... 47
CRT Toolkit Report ........................................................ 169
Current Technical Data .................................................. 263
Custom EGM .................................................................. 15
Custom Sets ................................................................. 143
Create and Save a Custom Set ................................. 143
Delete a Custom Set ................................................ 143
Export a Custom Set ................................................ 144
Import a Custom Set ............................................... 144
Load a Custom Set .................................................. 143
Rename a Custom Set ............................................. 143
Cycle Count, Hysteresis Rate ........................................... 70
D
Daily Exercise Training .................................................... 31
Date ................................................................................. 5
DC Fibber Test ................................................................ 54
Instructions .............................................................. 55
DDD Mode .................................................................... 151
DDI Mode ..................................................................... 152
DDT Mode .................................................................... 152
Decay Delay .................................................................... 77
Defib Therapy Button ...................................................... 57
Defibrillation Testing ...................................................... 331
DeFT Response Technology Settings .............................. 111
Delay, Multisite Pacing .................................................... 67
Delays Parameters .......................................................... 71
Deliver Therapy Button .................................................... 57
Detection Criteria Parameters .......................................... 89
Detection Interval/Rate .................................................... 89
Device
Bradycardia Device Longevity .................................. 309
Tachycardia Device Longevity ................................. 333
Device-Based Testing ...................................................... 57
Devices Supported by Merlin ......................................... 161
Diagnosis Details, Episodes .............................................. 23
Diagnosis, SVT Discrimination .......................................... 94
Diagnostic Settings ........................................................ 141
ST Monitoring ......................................................... 141
Diagnostics ..................................................................... 27
AT/AF ....................................................................... 30
Mode Switch ............................................................. 28
Diagnostics, Select Diagnostics for Printing ..................... 168
DirectTrend Reports ..................................................... 168
DOO Mode ................................................................... 153
Duration, AT/AF Summary Diagnostics ............................ 30
Duration, Mode Switch Diagnostics .................................. 29
DVI Mode ..................................................................... 154
DynamicTx Over-Current Detection Algorithm ................. 113
Waveform Settings .................................................. 113
E
ECG ................................................................................. 7
ECG Configuration .......................................................... 14
EF Button ....................................................................... 17
EGM
ST Monitoring........................................................... 31
EGM Configuration.......................................................... 15
EGM Source Configuration, Episode Settings .................. 136
Elective Replacement Indicator ..................................... 330
Ellipse Technical Data ................................................... 269
Emergency Operation ................................................... 170
Emergency Shock ......................................................... 171
RF Communication................................................. 171
Emergency VVI Pacing .................................................. 170
End-of-Life ................................................................... 309
Enhanced AT/AF Diagnostics Capability ............ 29, 186, 187
Enhanced Diagnostic Trend (1-Year Daily Reports) Capability
............................................................................... 188
Enhanced Diagnostic Trend Capability ........................... 187
Episodal Pacing Mode .................................................... 65
Episode Directory ........................................................... 21
Episode Settings ........................................................... 135
Episode Tree .................................................................. 23
Episode Triggers ........................................................... 138
Episode Type, ST Monitoring ........................................... 32
Episodes ........................................................................ 21
ATP Therapy Details ................................................. 23
Detail ....................................................................... 22
Diagnosis Details ...................................................... 23
HV Charging Panel, Episodes .................................... 25
Logs & Summaries ................................................... 24
Non-sustained RV/V Oversensing Details ................... 26
Other ....................................................................... 21
SVT Criteria Statistics ................................................ 23
SVT Diagnosis Summary and Morphology Template
Details ............................................................... 25
Therapy Summary .................................................... 26
Update Episodes Button ........................................... 21
VT/VF Episodes ........................................................ 21
Episodes, Select Episodes for Printing ............................ 169
ERI, Clear Button ............................................................ 45
ERI, see Elective Replacement Indicator ........................ 330
Events, Rates Diagnostics ............................................... 27
Exercise & Activity Diagnostic Tools ................................. 31
Exercise & Activity Diagnostics ........................................ 31
Export
Data ...................................................................... 149
Export Screen ................................................................... 6
Extrastimuli Test, NIPS.................................................... 58
Instructions .............................................................. 58
F
Far Field MD/SecureSense Configuration ......................... 90
FARI .............................................................................. 85
FastPath Summary Screen .............................................. 17
Feature capabilities ....................................................... 177
Fibber & NIPS Window ................................................... 54
Fibber Device-Based Testing ........................................... 57
First Therapy Method ............................................... 57
Parameters .............................................................. 57
Time to Therapy ....................................................... 58
Fibber Mode................................................................... 54
Fibber Test ..................................................................... 54
Instructions .............................................................. 55
432
Pulse Duration ......................................................... 56
RF Communication .................................................. 54
S1 Count ................................................................. 56
S2 Shock Energy ...................................................... 56
Time Since Last Induction ........................................ 54
Fibrillation Induction ....................................................... 54
Filtered Atrial Rate Interval .............................................. 85
Fixed Burst Cycle Length ...............................................107
Follow-up EGM
Capture Test ............................................................ 42
Sense Test ............................................................... 42
Follow-up EGMs Capability .............................................190
Fortify Assura Technical Data .........................................289
H
Hardware Reset, see Reset Function ..............................172
Heart In Focus Report ...................................................169
Heart Rate Histogram
Atrial ....................................................................... 27
Ventricular ............................................................... 28
Help Button ..................................................................... 1
High Ventricular Rate ....................................................139
High Ventricular Rate, Episode Triggers ..........................138
HV Lead Impedance ....................................................... 46
HVLI Monitoring
Lower Limit .............................................................. 80
Upper Limit ............................................................. 80
Hysteresis Rate ......................................................... 69, 76
Intervention Duration ................................................ 71
Intervention Rate ...................................................... 70
I
Impedance, Lead ........................................................... 46
Implant Notes ................................................................ 17
Implantation Testing ......................................................331
Brady Pacing ..........................................................332
Brady Sensing .........................................................332
Pacing Thresholds...................................................331
Include Battery & Leads Button, Test Results Settings .....169
Include Old Episodes Button ........................................... 21
Increment Test Option, Sense Tests ................................ 43
Initial Values, Restore ....................................................150
Instructions .................................................................... 14
Acquiring a Morphology Template ............................102
Capture Test ............................................................ 40
Emergency Shock ...................................................171
Fibber Test .............................................................. 55
NIPS Test ................................................................ 58
QuickOpt Optimization .............................................. 53
Rhythm Display Setup .............................................. 14
Sense Tests ............................................................. 43
Interval Stability
Description .............................................................122
Parameter ................................................................ 99
Window ................................................................... 99
Window Size ...........................................................101
Intervention Duration ...................................................... 71
Intervention Rate ............................................................ 70
Interventricular Delay ...................................................... 64
Isoelectric Interval .......................................................... 34
L
Large Freezes, Test Result Settings ................................169
Last Session
Capture Test ............................................................ 41
Sense Tests ............................................................. 41
Lead Impedance ............................................................ 46
Changes Over Time .................................................332
Lead Information, Patient Data ................................... 17, 18
Lead Monitoring ............................................................. 80
Lead Type ...................................................................... 79
Leadless ECG ......................................................... 15, 136
Leads Parameters ........................................................... 79
Left Atrial Pressure Sensor Capability ............................. 192
Legend, Rate Zone ........................................................ 120
Logs
AMS Log & AT/AF Log............................................... 29
AT/AF ...................................................................... 30
Logs & Summaries, Episodes ........................................... 24
Logs (Episodes) .............................................................. 24
Low Frequency Attenuation Capability ............................ 192
Low Frequency Attenuation Filter ..................................... 79
Lower Limit
HVLI Monitoring ....................................................... 80
Impedance Monitoring .............................................. 80
LV-Only Pacing Capability .............................................. 192
M
Magnet Rate ................................................................... 45
Magnet Response ........................................................... 64
Main Programming Window........................................... 163
Marker Control Buttons ..................................................... 7
Markers ............................................................................ 7
Brady Basic Event Markers ......................................... 8
Brady Special Event Markers ....................................... 9
Episode Trigger Event Markers .................................. 10
Interval and Refractory Markers (Full Markers) ............. 9
Morphology Markers ................................................. 12
Tachy Basic Event Markers ......................................... 9
Tachy Charge Delivery Markers ................................. 12
Tachy Detection, Diagnosis, and Therapy Markers ...... 10
User Initiated and Test Markers ................................. 12
Waveform Channel Markers ...................................... 13
Match, see % Match ....................................................... 95
Max Sensitivity ................................................................ 77
Max Sensor Rate............................................................. 66
Max Step, ATP Therapy ................................................. 108
Max Track Rate .............................................................. 69
Maximum AF Suppression Rate ....................................... 87
Measured Auto Slope ...................................................... 65
Measured Average Sensor ............................................... 65
MerlinConduct Settings ..................................................... 3
Minimum Burst Cycle Length ........................................ 108
Mode ............................................................................. 63
Descriptions ........................................................... 151
Mode Switch Diagnostics ................................................. 28
Monitor Button, Zone Therapy ....................................... 103
Monitor Only Zone ........................................................ 103
SVT Discrimination Timeout and .............................. 128
VT Therapy Timeout and ......................................... 128
Morphology
Description ............................................................. 122
Parameter ................................................................ 95
Scores.................................................................... 103
Window Size ............................................................. 96
Morphology in AF/A Flutter .............................................. 95
Morphology in Sinus Tach ............................................... 95
Morphology No. of Matches ............................................. 96
Morphology Scoring Parameter ...................................... 103
Morphology Scoring Window .......................................... 103
Morphology Template.................................................... 102
Instructions ............................................................ 102
Morphology Template Pacing Hysteresis .......................... 97
Morphology Template Update, EGM Storage .................. 138
Morphology Type ............................................................ 97
Morphology Window ........................................................ 94
MR Conditional Programming Capability ........................ 193
MRI Checklist ............................................................... 146
MRI Parameters............................................................ 145
MRI Settings ................................................................. 145
Active..................................................................... 147
MRI Settings Reset Values ............................................. 173
MultiPoint Pacing Settings ............................................... 67
Delay, Multisite Pacing .............................................. 67
433
MultiPoint Pacing LV2 Pulse Configuration ................. 67
MultiPoint Pacing Post-Ventricular Atrial Blanking ...... 67
N
Negative AV Hysteresis/Search......................................... 73
Negative Threshold ......................................................... 37
NIPS
Instructions .............................................................. 58
Parameters ............................................................... 59
Pulse Configuration ................................................... 60
RF Communication ................................................... 58
Test ......................................................................... 58
Test Parameters ........................................................ 60
No. Intervals, Detection Criteria ........................................ 90
Noise Reversion, EGM Storage ....................................... 138
Nominal Value Icon ....................................................... 166
Noninvasive Programmed Stimulation, see NIPS ............... 58
Non-sustained RV/V Oversensing Details .......................... 26
Non-sustained VT/VF Episode Capability ........................ 193
Note ............................................................................... 18
Number of Bursts, ATP Therapy .................................... 107
Number of Cycles (Consecutive High Ventricular Rate
Cycles) ..................................................................... 139
Number of Cycles/Step
Capture Test ............................................................. 41
Sense Tests .............................................................. 41
Number of Notifications ................................................. 132
Number of Stimuli, ATP Therapy .................................... 107
O
Off Setting, Zone Configuration....................................... 120
One Zone...................................................................... 120
On-Screen Keyboard ....................................................... 18
Onset Delta ................................................................... 101
Options
Capture Test ............................................................. 41
Sense Tests .............................................................. 41
Other Episodes................................................................ 21
Overdrive Pacing Cycles .................................................. 87
P
Paced AV Delay .............................................................. 71
Parameters
ATP ....................................................................... 106
Brady ....................................................................... 63
DeFT Response Technology .................................... 111
Interval Stability ........................................................ 99
Modes .................................................................... 151
Redetection & Post-Detection Criteria ....................... 116
Selection ................................................................ 166
SenseAbility Sensing Algorithm Settings ..................... 77
Sinus Tach Rate Branch Control ................................ 94
Zone Therapy ......................................................... 103
Patient
Pre-Discharge EP Testing ........................................ 332
Selection ................................................................ 331
Patient Data .................................................................... 17
Lead Information ....................................................... 18
Patient Information .......................................................... 18
Patient Notifier
Configuration .......................................................... 132
Daily Measurements................................................ 133
Description ............................................................. 132
Sequence ............................................................... 133
PC Shock, see Emergency Shock ................................... 171
Select Episodes for Printing ..................................... 169
PDFs ................................................................................ 5
Peak A Rate
AT/AF Summary ....................................................... 30
Mode Switch Diagnostics ........................................... 29
Percent Match ................................................................ 95
Percent Pacing Alert Capability ...................................... 195
Percent Pacing Alert Duration (Duration) ....................... 134
Percentage BiV Pacing Limit (Percent Pacing Less Than) 133
Percentage RV/V Pacing Limit (Percent Pacing Greater Than)133
Perform Test
Capture Test ............................................................ 40
Sense Tests ............................................................. 40
Plugged Port Lead Type Capability................................. 196
PMT Detection Rate ........................................................ 85
PMT Response ............................................................... 84
Additional Settings .................................................... 83
PMT Settings .................................................................. 83
PMT Termination, Episode Triggers ............................... 138
Positive Threshold .......................................................... 37
Post Detection
Description ............................................................ 117
Interval/Rate .......................................................... 117
Post-Shock
Base Rate .............................................................. 119
Duration................................................................. 119
Mode ..................................................................... 118
Pause .................................................................... 119
Pulse Amplitude ..................................................... 119
Pulse Width ........................................................... 119
Post-Shock Pacing Window ........................................... 118
Post-Ventricular Atrial Blanking (PVAB) ........................... 81
MultiPoint Pacing Post-Ventricular Atrial Blanking ...... 67
Preferences ...................................................................... 6
Preview Changes .......................................................... 166
Print Reports ................................................................ 167
Print Screen ..................................................................... 6
Print Settings ................................................................ 170
Printer Icon .................................................................. 163
Priority, Episode Triggers ............................................... 138
Problem Solving
Low Acute Lead Impedance .................................... 331
Prolonged Arrhythmia Detection Times .................... 331
Programmed Setting Icon .............................................. 166
Programmer Commanded Shock, see Emergency Shock 171
Pulse Amplitude ............................................................. 75
Post-Shock ............................................................ 119
Pulse Amplitude, ATP ................................................... 106
Pulse Configuration ......................................................... 80
MultiPoint Pacing LV2 Pulse Configuration ................. 67
NIPS ........................................................................ 60
Pulse Width .................................................................... 76
Post-Shock ............................................................ 119
Pulse Width, ATP ......................................................... 106
PVAB, see Post-Ventricular Atrial Blanking ....................... 81
PVARP ........................................................................... 81
PVC & PMT Settings ....................................................... 83
PVC Count, Episode Triggers ......................................... 138
PVC Response ................................................................ 84
PVC Response, Additional Settings .................................. 83
Q
QuickOpt Optimization .................................................... 52
Instructions .............................................................. 53
Manual Test ............................................................. 53
R
Ramp Step, ATP Therapy .............................................. 109
Ramp, ATP Therapy ..................................................... 109
Rate Branch ................................................................... 93
Description ............................................................ 121
Rate Overlap ................................................................ 101
Rate Responsive Atrial Refractory Period, see Rate
Responsive PVARP/V Ref ........................................... 81
Rate Responsive AV Delay .............................................. 72
Rate Responsive PVARP/V Ref ........................................ 81
Rate Responsive Ventricular Refractory Period, see Rate
Responsive PVARP/V Ref ........................................... 81
434
Rate Zone Legend .........................................................120
Rate-Responsive Modes ................................................158
Rates & Refractories ....................................................... 87
Rates Parameters ........................................................... 68
Reaction Time ................................................................ 66
Readaptive, ATP Therapy ..............................................108
Real-Time Measurements ............................................... 39
Recommended Replacement Time, see Elective
Replacement Indicator ..............................................330
Reconfirmation ..............................................................128
Recovery Time ............................................................... 66
Redetection & Post-Detection Criteria Window ................116
References, Clinical .......................................................427
Referral Reports (Heart In Focus) ...................................167
Refractories & Blanking Parameters ................................ 80
Refractory Period
A. Pace ................................................................... 82
A. Sense .................................................................. 82
V. Pace .................................................................... 82
V. Sense .................................................................. 83
Report Settings ...................................................... 169, 170
Reports, Print ................................................................167
CRT Toolkit Report ..................................................169
Referral Reports (Heart In Focus) ............................167
Select Diagnostics Reports for Printing .....................168
Select Episodes for Printing .....................................169
Select Referral Reports for Printing...........................169
Test Results, Print Menu .........................................167
Representative Beat ....................................................... 34
Baselines ................................................................. 34
Reset Function ..............................................................172
Rest Rate ....................................................................... 68
Restore Initial Values Button ..........................................150
RF Communication........................................................164
Emergency Shock ...................................................171
Fibber and NIPS ...................................................... 54
Fibber Test .............................................................. 54
NIPS ....................................................................... 58
RF Telemetry ................................................................164
RF Telemetry Capability .................................................198
Rhythm Display ................................................................ 7
Setup Instructions .................................................... 14
Update Auto Gains Button ........................................ 14
RRT, see Elective Replacement Indicator ........................330
RV Polarity Parameter, DeFT Response Settings .............112
S
Safety Margin, Cap Confirm and V. AutoCapture .............. 74
Scan Step, ATP Therapy ................................................108
Scanning, ATP Therapy .................................................108
Search Frequency .......................................................... 76
Search Interval ............................................................... 76
SecureSense
Trigger Alert for NSO ................................................ 91
SecureSense RV Lead Noise Discrimination Capability ....200
SecureSense Timeout Until Therapy ................................ 91
Select Diagnostics Reports for Printing ...........................168
Select Episodes for Printing ............................................169
Select Nominals Button .................................................. 78
Select Referral Reports for Printing .................................169
Sense Configuration ........................................................ 80
Sense Tests ................................................................... 42
Additional Parameters .............................................. 42
Automatic Option ..................................................... 43
Increment Option ..................................................... 43
Instructions .............................................................. 43
Last Session ............................................................. 41
Options .................................................................... 41
This Session ............................................................ 41
SenseAbility Sensing Algorithm Settings ........................... 77
Sensed AV Delay ............................................................ 71
Sensing Parameters, see SenseAbility Sensing Algorithm
Settings ..................................................................... 77
Sensitivity ....................................................................... 76
AutoSense Function .................................................. 78
Sensor............................................................................ 65
Sensor Threshold, see Threshold ..................................... 65
Session Record ................................................................. 1
Audio Preferences ...................................................... 2
Find a Session Record ................................................ 2
Import a Session Record ............................................. 2
Review a Session Record ............................................ 2
Select New Files Button .............................................. 2
Session Records ......................................................... 2
Settings, Print Menu ..................................................... 170
Shock Configuration .............................................. 111, 112
Shock Impedance ......................................................... 113
Shock Waveform Parameters see DeFT Response
Technology Settings .................................................. 111
ShockGuard Technology Settings ..................................... 89
Shock-on-T Fibber .......................................................... 54
Instructions .............................................................. 55
Shortest Atrial Refractory Period, see Shortest PVARP/V Ref
................................................................................. 82
Shortest AV Delay ........................................................... 72
Shortest PVARP/V Ref ..................................................... 82
Shortest Ventricular Refractory Period, see Shortest PVARP/V
Ref ............................................................................ 82
SIH Count .................................................................... 100
Sinus Interval History see SIH Count ............................. 100
Sinus Node Recovery Delay ............................................. 60
Sinus Redetection ......................................................... 117
Sinus Tach Rate Branch Control ...................................... 94
Slope ............................................................................. 65
Small Freezes, Test Result Settings ................................ 169
Software Reset, see Reset Function ............................... 172
Source ......................................................................... 138
ST Diagnostics ................................................................ 37
ST Episode EGMs ........................................................... 33
ST Interval ...................................................................... 35
ST Monitoring
Baselines ................................................................. 34
Beat Selection .......................................................... 34
Diagnostic Settings ................................................. 141
Diagnostics............................................................... 31
Episode Type, ST Monitoring ..................................... 32
Isoelectric Interval ..................................................... 34
Negative Threshold ................................................... 37
Parameters............................................................... 36
Positive Threshold .................................................... 37
ST Diagnostics .......................................................... 37
ST Interval ................................................................ 35
ST Monitoring Setup Window ..................................... 33
Suggested Values ..................................................... 34
ST Monitoring Capability ................................................ 200
ST Monitoring Diagnostics ............................................... 31
Episode Type, ST Monitoring ..................................... 32
ST Deviation Trend ................................................... 32
ST Episode EGMs ..................................................... 33
ST Episode Log ......................................................... 32
ST Histogram Data .................................................... 32
ST Monitoring Parameter ............................................... 141
ST Monitoring Parameters ............................................... 36
Isoelectric Duration ................................................... 36
Isoelectric Start ......................................................... 36
Negative Threshold ................................................... 37
Positive Threshold .................................................... 37
ST Heart Rate Zones ................................................. 36
ST Interval Duration .................................................. 36
ST Interval Start ........................................................ 36
ST Monitoring Phase 2 Capability................................... 201
ST Monitoring Setup Window ........................................... 33
Stability Delta ................................................................ 100
Start Temporary Button ........................................... 40, 167
Stat Shock, see Emergency Shock ................................. 171
Stored EGM Capacity .................................................... 136
Stored EGM Configuration ............................................. 135
Stored EGM Configuration Parameters ........................... 135
435
Sudden Onset
Description ............................................................. 122
Rate Overlap ........................................................... 101
Sudden Onset Parameter............................................... 101
Suggested Values ............................................................ 34
Summary Report
Settings .......................................................... 167, 170
Summary Screen ............................................................ 17
Supported Devices ........................................................ 161
SVT Criteria Statistics ....................................................... 23
SVT Diagnosis Summary and Morphology Template Details
.................................................................................. 25
SVT Discrimination .......................................................... 91
AV Association Delta ............................................... 100
AV Interval Delta ....................................................... 94
Chamber Onset....................................................... 101
Description ............................................................. 121
Diagnosis.................................................................. 94
Interval Stability ........................................................ 99
Interval Stability Window Size ................................... 101
Morphology .............................................................. 95
Morphology No. of Matches ....................................... 96
Morphology Scoring ................................................ 103
Morphology Template .............................................. 102
Morphology Template Pacing Hysteresis .................... 97
Morphology Window Size ........................................... 96
Onset Delta ............................................................. 101
Percent Match .......................................................... 95
Programming Guidelines ......................................... 123
SIH Count............................................................... 100
Stability Delta .......................................................... 100
Sudden Onset ......................................................... 101
SVT Upper Limit ....................................................... 92
Template Auto Update .............................................. 96
Template Match Criteria ............................................ 96
Therapy After Timeout ............................................... 92
SVT Discrimination Details Window .................................. 91
SVT Discrimination in Sinus Tach ..................................... 94
SVT Discrimination Mode................................................. 92
SVT Discrimination Timeout ............................................. 92
Description ............................................................. 127
SVT Discriminators .......................................................... 93
Interval Stability ........................................................ 99
Morphology Window .................................................. 94
Rate Branch ............................................................. 93
SVT Upper Limit .............................................................. 92
T
Tachy
Parameters ............................................................... 89
Therapy .................................................................. 104
Tachyarrhythmia Detection
Description ............................................................. 121
Therapy Delivery Conditions .................................... 121
Tachyarrhythmia Therapy
Description ............................................................. 128
Tachycardia Device Longevity ....................................... 333
Tachycardia Devices, Clinician Use Information .............. 331
Target Heart Rate ............................................................ 31
Technical Data
Allure, Allure Quadra, Quadra Allure MP Devices
Technical Data ................................................. 235
AnalyST .................................................................. 241
Anthem .................................................................. 245
Auricle ................................................................... 259
Ellipse .................................................................... 269
Fortify Assura ......................................................... 289
Technical Support ......................................................... 161
Telemetry, RF ............................................................... 164
Template Auto Update .................................................... 96
Template Match Criteria .................................................. 96
Template, see Morphology Template .............................. 102
Temporary Pacing ........................................................... 61
Temporary Program ...................................................... 167
Test Result Settings ...................................................... 169
Test Results, Print Menu ............................................... 167
CRT Toolkit Report ................................................. 169
Testing at Implant
Brady Pacing ......................................................... 332
Brady Sensing ........................................................ 332
Defibrillation ........................................................... 331
Equipment ............................................................... 54
Pacing Thresholds .................................................. 331
Tests
Battery & Leads ........................................................ 45
Capacitor ................................................................. 46
Capture.................................................................... 39
CRT Toolkit .............................................................. 47
Fibber ...................................................................... 54
NIPS ........................................................................ 58
QuickOpt Optimization .............................................. 52
Sense ...................................................................... 42
Therapy After Timeout .................................................... 92
Therapy Summary Details ............................................... 26
Therapy Zone
Off 120
One Zone ............................................................... 120
Three Zones ........................................................... 120
Two Zones ............................................................. 120
Therapy, Tachy ............................................................ 104
This Session
Capture Test ............................................................ 41
Sense Tests ............................................................. 41
Three Zones ................................................................. 120
Threshold ....................................................................... 65
Threshold Search Frequency, see Search Interval ............ 76
Threshold Start ............................................................... 78
Threshold Trend ............................................................. 74
Time ............................................................................ 135
Time Between Notifications ........................................... 132
Time Since Last Induction, Fibber ................................... 54
Timeout Trigger ............................................................ 104
Tools ................................................................................ 1
Total Daily Activity........................................................... 31
Trend
Amplitude ................................................................ 41
Clear Data ................................................................ 18
HV Lead Impedance ................................................. 46
Ideal Battery Voltage ................................................. 45
Lead Impedance ...................................................... 46
Voltage .................................................................... 45
Trigger Alert for NSO ....................................................... 91
Tuned Waveform Help .................................................. 114
Two Zones ................................................................... 120
U
Undo ........................................................................... 166
Update Auto Gains Button .............................................. 14
Update Episodes Button ................................................. 21
Update Sense ................................................................. 39
Upper Limit
HLVI Monitoring ....................................................... 80
Impedance Monitoring .............................................. 80
V
V AutoCapture Capability ............................................... 202
V Rates During AMS ....................................................... 29
V Rates During AT/AF ..................................................... 30
V. AutoCapture Parameter ............................................... 74
V. AutoCapture Settings .................................................. 76
V. Noise Reversion Mode ................................................ 64
V. Support Rate .............................................................. 57
V. Triggering ................................................................... 64
V<A Rate Branch
Morphology, see Morphology in AF/A Flutter ............. 95
436
V=A Rate Branch
Morphology, see Morphology in Sinus Tach .............. 95
Ventricular Blanking ....................................................... 83
Ventricular Defibrillator Max Sensitivity ............................ 76
Ventricular Heart Rate Histogram .................................... 28
Ventricular HV Lead Impedance ...................................... 46
Ventricular Intrinsic Preference ....................................... 72
Ventricular Pace Refractory ............................................. 82
Ventricular Pacemaker Max Sensitivity ............................. 76
Ventricular Pacing .......................................................... 63
Ventricular Rate Threshold (High Ventricular Rate)..........139
Ventricular Safety Standby .............................................. 83
Ventricular Sense Refractory ........................................... 83
Ventricular Triggering Capability .....................................202
VF Episode Trigger ........................................................138
VF Shocks (Defib) .........................................................113
Vibration Duration .........................................................132
VIP see Ventricular Intrinsic Preference ........................... 72
Voltage Trend ................................................................. 45
VOO Mode ....................................................................155
VOO(R)-AOO(R) Mode ...................................................158
VT Episode Trigger ........................................................138
VT Redetection ..............................................................116
VT Shocks (CVRT) .........................................................113
VT Therapy Timeout ......................................................104
Description .............................................................128
VT/VF EGM Max Duration ..............................................135
VT/VF Episodes .............................................................. 21
VT/VF Pre-Trigger Max Duration ............................. 135, 136
VVI Mode ......................................................................155
VVI(R)-AAI(R) Mode ......................................................158
VVT Mode .....................................................................156
VVT(R)-AAT(R) Mode ....................................................159
W
Waveform Control Buttons .............................................. 14
Waveform Help .............................................................114
Waveform Mode ............................................................112
Waveform Parameter .....................................................112
Waveform Settings .........................................................113
Window Size
Interval Stability .......................................................101
Morphology .............................................................. 96
Wireless Connection ......................................................... 3
Z
Zone Configuration
Parameter ................................................................ 89
Window (ShockGuard Settings) ................................. 89
Zone Therapy Window ...................................................103
437
Cardiac Rhythm Management Division
Manufacturer:
St. Jude Medical
European Authorized Representative:
St. Jude Medical
Cardiac Rhythm
Management Division
15900 Valley View Court
Sylmar, CA 91342 USA
+1 818 362 6822
Manufacturing Site:
St. Jude Medical Puerto Rico LLC
Lot A Interior - #2 Rd Km. 67.5
Santana Industrial Park
Arecibo, PR 00612
USA sjm.com
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
Manufacturing Site:
St. Jude Medical Operations (M) Sdn. Bhd.
Plot 102, Lebuhraya Kampung Jawa,
Bayan Lepas Industrial Zone
11900 Penang
Malaysia
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
Lane Cove NSW 2066
Australia
April 2015
Art 60064012/A
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