z Nightingale Monitoring System PPM3 User`s Guide

z Nightingale Monitoring System PPM3 User`s Guide
z
Nightingale Monitoring System
PPM3 User's Guide
z
Zoe Medical, Inc.
460 Boston Street
Topsfield, MA 01983
Nightingale Monitoring System PPM3 User's Guide
Part Number 122-0062, Revision B
 Zoe Medical 2005 - 2015 All rights reserved
Printed in the United States of America
C
EC Representative:
Estan AB
Prastgarden
Ostra Stenby
S-61032 Vikbolandet
Sweden
"Nightingale Monitoring System," "Nightingale MPC," "Nightingale PPM3,"
and "Personal Patient Monitor" are trademarks of Zoe Medical, Inc.
The information in this document is subject to change without notice.
This document contains proprietary information that is protected by
copyright. No part of this document may be reproduced in any manner, in
whole or in part (except for brief excerpts in reviews and scientific papers)
without the prior written consent of Zoe Medical.
Zoe Medical makes no warranty of any kind on this material, including but
not limited to, the implied warranties of merchantability and fitness for a
particular purpose. Zoe Medical shall not be liable for errors contained
herein or for incidental or consequential damages concerning the
furnishing, performance, or use of this material.
All Zoe Medical monitoring devices are intended for use only by qualified
medical personnel.
Before using any Zoe Medical monitoring device, be sure to read carefully
and understand all manuals provided with the device.
Caution: United States Federal law restricts this device to sale by or on
the order of a physician.
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User Assistance
If you have a question or need help operating the Nightingale PPM3, please
contact Zoe Medical Technical Support:
Email: [email protected]
Phone: (978) 887-4013
For the latest information about answers to frequently asked questions, please
consult our web site:
www.zoemedical.com
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Table of Contents
User Assistance......................................................................................... iii
General Information...................................................................................xi
1.
Overview........................................................................................ 1-1
1.1.
System Diagram ...................................................................... 1-1
1.2.
Scope of this User's Guide ...................................................... 1-2
1.3.
PPM3 Diagrams ...................................................................... 1-3
1.4.
PPM3 User Interface ............................................................... 1-8
1.5.
Main Features of the PPM3 ................................................... 1-11
2.
Getting Started .............................................................................. 2-1
2.1.
Parts you should have ............................................................. 2-1
2.2.
Mounting solutions................................................................... 2-2
2.3.
How to Connect the PPM3 to Power and Communications..... 2-3
2.3.1.
Checklist before Connecting to Patient.............................. 2-7
2.4.
How to Connect the PPM3 to the Patient ................................ 2-8
2.5.
How to Check the PPM3 Setup ............................................... 2-8
3.
ECG and Heart Rate Monitoring.................................................... 3-1
3.1.
Overview of ECG and Heart Rate Monitoring .......................... 3-1
3.2.
Getting Started with ECG on the PPM3................................... 3-1
3.3.
Checking the ECG Signal ........................................................ 3-2
3.4.
Standard Electrode Placement (AHA) ..................................... 3-5
3.5.
Standard Electrode Placement (IEC)....................................... 3-6
3.6.
Electrode Placement for Paced Patients (AHA)....................... 3-7
3.7.
Electrode Placement for Paced Patients (IEC) ........................ 3-8
3.8.
Verifying Proper Pacemaker Handling..................................... 3-9
3.9.
ECG and Heart Rate Monitoring Messages........................... 3-10
4.
Respiration Monitoring................................................................... 4-1
4.1.
Overview of Respiration Monitoring......................................... 4-1
4.2.
Getting Started with Respiration on the PPM3 ........................ 4-1
4.3.
Checking the Respiration Signal.............................................. 4-1
4.4.
Pediatric Considerations.......................................................... 4-3
4.5.
Respiration Monitoring Messages ........................................... 4-4
5.
Pulse Oximetry Monitoring............................................................. 5-1
5.1.
Overview of Pulse Oximetry Monitoring................................... 5-1
5.2.
Getting Started with Pulse Oximetry on the PPM3 .................. 5-1
5.3.
Checking the Pulse Oximetry Signal........................................ 5-2
5.4.
Pediatric Considerations.......................................................... 5-4
5.5.
Pulse Oximetry Monitoring Messages ..................................... 5-5
6.
Non-Invasive Blood Pressure Monitoring....................................... 6-1
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6.1.
Overview of NBP Monitoring.................................................... 6-1
6.2.
Getting Started with NBP on the PPM3 ................................... 6-1
6.3.
Checking the NBP Measurement ............................................ 6-2
6.4.
Pediatric Considerations.......................................................... 6-6
6.5.
Hypertensive Considerations................................................... 6-6
6.6.
NBP Monitoring Messages ...................................................... 6-7
7.
Oridion CO2 Monitoring.................................................................. 7-1
7.1.
Overview of CO2 Monitoring .................................................... 7-1
7.2.
Getting Started with Oridion CO2 on the PPM3 ....................... 7-1
7.3.
Checking the CO2 Signal ......................................................... 7-2
7.4.
Integrated Pulmonary Index..................................................... 7-3
7.5.
Oridion CO2 Monitoring Messages .......................................... 7-7
8.
Masimo CO2 Monitoring................................................................. 8-1
8.1.
Overview of CO2 Monitoring .................................................... 8-1
8.2.
Getting Started with Masimo CO2 on the PPM3 ...................... 8-2
8.3.
Checking the CO2 Signal ......................................................... 8-4
8.4.
Masimo LED Indicator ............................................................. 8-5
8.5.
Zeroing Masimo CO2 Modules ................................................. 8-5
8.6.
Masimo CO2 Monitoring Messages ....................................... 8-11
9.
Invasive Blood Pressure Monitoring .............................................. 9-1
9.1.
Overview of IBP Monitoring ..................................................... 9-1
9.2.
Checking the IBP Signal(s)...................................................... 9-2
9.3.
IBP Monitoring Messages........................................................ 9-4
10. Temperature Monitoring .............................................................. 10-1
10.1. Checking the Temperature .................................................... 10-1
10.2. Temperature Monitoring Messages ....................................... 10-3
11. Working With Menus ................................................................... 11-1
11.1. Parameter Menus .................................................................. 11-2
11.1.1. ECG and Heart Rate........................................................ 11-2
11.1.2. Respiration ...................................................................... 11-4
11.1.3. Pulse Oximetry ................................................................ 11-5
11.1.4. Non-Invasive Blood Pressure .......................................... 11-7
11.1.5. Oridion CO2 / Capnography ............................................. 11-9
11.1.6. Masimo CO2 / Capnography .......................................... 11-10
11.1.7. Invasive Blood Pressure ................................................ 11-12
11.1.8. Temperature .................................................................. 11-13
11.2. Front Panel Keypad Menus ................................................. 11-14
11.2.1. SETUP Key and Submenus .......................................... 11-14
11.2.2. Password Protected Menus........................................... 11-29
11.2.3. NBP INTERVAL Key...................................................... 11-35
11.2.4. STANDBY Key............................................................... 11-37
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11.2.5. TRENDS Key................................................................. 11-37
11.2.6. MAIN SCREEN Key....................................................... 11-37
12. Managing Alarms......................................................................... 12-1
12.1. Alarm Presentation Basics..................................................... 12-2
12.1.1. Audible Alarm Tones ....................................................... 12-2
12.1.2. Visual Alarm Colors ......................................................... 12-2
12.1.3. How to Silence Alarms..................................................... 12-3
12.1.4. Alarm Messages .............................................................. 12-4
12.1.5. How to Enable or Disable Alarms .................................... 12-5
12.1.6. Alarm Validation............................................................... 12-6
12.1.7. Alarm Handling at Start-up .............................................. 12-6
12.1.8. Alarm Reports.................................................................. 12-6
12.1.9. Audible Alarm Tones While Connected to the MPC ........ 12-7
12.1.10. Second Speaker Alarm Tones ....................................... 12-8
12.2. Alarm Conditions ................................................................... 12-9
12.3. What To Do When You Hear An Alarm Tone ...................... 12-15
12.4. Manual Self-test of the Alarm System.................................. 12-16
13. Centralized Monitoring................................................................. 13-1
13.1. Connecting to the MPC.......................................................... 13-1
13.2. Remote Control Settings........................................................ 13-2
13.3. Disconnecting from the MPC ................................................. 13-2
14. Viewing Trends............................................................................ 14-1
15. Entering Standby Mode ............................................................... 15-1
16. Battery Operation ........................................................................ 16-1
17. Strip Chart Recorder Option ........................................................ 17-1
17.1. Basic Operation ..................................................................... 17-1
17.2. Recorder Settings .................................................................. 17-2
17.3. Strip Chart Recordings .......................................................... 17-3
17.4. Trend Recordings .................................................................. 17-4
17.5. Recorder Messages............................................................... 17-4
18. Troubleshooting........................................................................... 18-1
19. PPM3 Monitor Settings ................................................................ 19-1
20. Accessories ................................................................................. 20-1
21. Cleaning ...................................................................................... 21-1
22. Maintenance and Storage............................................................ 22-1
22.1. PPM3 Functional Tests.......................................................... 22-1
22.2. PPM3 Calibration Procedures ............................................... 22-5
22.3. Battery Replacement ............................................................. 22-7
22.4. Storage .................................................................................. 22-7
22.5. Warranty ................................................................................ 22-8
23. Disposal....................................................................................... 23-1
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24.
viii
Technical Data............................................................................. 24-1
Electromagnetic Compatibility (EMC) Information ........................ 24-11
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Table of Figures
Figure 1.
Figure 2.
Figure 3.
Figure 4.
Figure 5.
Figure 6.
Figure 7.
Figure 8.
Figure 9.
Figure 10.
Figure 12.
Figure 13.
Figure 14.
Figure 15.
Figure 16.
Figure 17.
Figure 18.
Figure 19.
Figure 20.
Figure 22.
Figure 28.
Figure 29.
Figure 31.
Figure 32.
Figure 33.
Figure 34.
Figure 35.
Figure 36.
Figure 37.
Figure 38.
Figure 39.
Figure 40.
Figure 41.
Figure 42.
Figure 43.
Figure 44.
Figure 45.
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PPM3 Front View.................................................................. 1-3
PPM3 Rear View .................................................................. 1-4
PPM3 Left View .................................................................... 1-5
PPM3 Right View.................................................................. 1-6
Partially Engaged Power Connector ..................................... 1-7
Full Engaged Power Connector............................................ 1-7
PPM3 Front Panel ................................................................ 1-8
Sample of PPM3 Main Screen............................................ 1-10
PPM3 Startup Screen ........................................................ 2-4
New Patient Screen With Previous Patient........................ 2-5
Main Screen With No Patient Admitted.............................. 2-6
ECG Waveform and HR Value .......................................... 3-2
Standard AHA Electrode Placement.................................. 3-5
Standard IEC Electrode Placement ................................... 3-6
Paced AHA Electrode Placement ...................................... 3-7
Paced IEC Electrode Placement........................................ 3-8
RR Waveform and Value ................................................... 4-2
SpO2 Waveform and Value................................................ 5-2
Oridion CO2 Waveform and Values ................................... 7-3
Masimo CO2 Waveform and Values .................................. 8-4
IBP Waveforms and Values............................................... 9-2
Setup HR Menu ............................................................... 11-2
HR/PR Values Sourced From SpO2 or ART ................... 11-3
Setup RR Menu ............................................................... 11-4
Setup SpO2 Menu............................................................ 11-5
Setup NBP Menu ............................................................. 11-7
Setup CO2 Menu With Oridion Capnography................... 11-9
Setup CO2 Menu With Masimo Capnography................ 11-10
Setup IBP Menu............................................................. 11-12
Setup TEMP Menu ........................................................ 11-13
SETUP Key Menu.......................................................... 11-14
Main Screen With Alarms Paused Message & Timer .... 11-15
Setup Parameters Menu................................................ 11-16
Numbers Only Main Screen........................................... 11-17
Setup Waveforms Menu ................................................ 11-18
Setup Waveform Menu with IBPs .................................. 11-19
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Figure 46.
Figure 47.
Figure 48.
Figure 49.
Figure 50.
Figure 52.
Figure 53.
Figure 54.
Figure 55.
Figure 56.
Figure 57.
Figure 58.
Figure 59.
Figure 60.
Figure 61.
Figure 62.
Figure 63.
Figure 64.
Figure 65.
Figure 67.
Figure 70.
x
Setup Audio Menu ......................................................... 11-20
Setup Alarms Menu – Screen 1 ..................................... 11-21
Setup Alarms Menu – Screen 2 ..................................... 11-23
Setup Alarms Menu – Screen 3 ..................................... 11-24
Patient Information Menu............................................... 11-25
Restore Department Defaults Menu .............................. 11-26
Setup Administration Menu............................................ 11-27
Setup Configuration Menu ............................................. 11-28
Enter Password Menu ................................................... 11-29
Setup Alarms Menu ....................................................... 11-30
Setup System Menu ...................................................... 11-32
Set Date and Time Menu............................................... 11-33
Save Department Defaults Menu................................... 11-34
Setup NBP Interval Menu .............................................. 11-35
Silenced & Active HR Limit Alarm.................................... 12-3
Trends Menu.................................................................... 14-2
Clear Trends Menu .......................................................... 14-3
Standby Menu.................................................................. 15-1
Standby Mode.................................................................. 15-2
Main Screen With Battery Icon ........................................ 16-1
Setup Recorder Menu...................................................... 17-2
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General Information
This User's Guide provides healthcare professionals the information required for
the safe and effective use of the Nightingale PPM3 (Personal Patient Monitor, 3rd
Generation). The Nightingale PPM3 is a small, lightweight patient monitor
designed to acquire physiological waveforms and parameters, and to transmit this
data to a Nightingale MPC (Multi-patient Console).
For the sake of brevity, the term PPM3 is sometimes used in this document to
refer to the Nightingale PPM3.
The Nightingale MPC is the central monitoring station for the Nightingale
Monitoring System. The Nightingale MPC connects to a network of Nightingale
PPM3 bedside patient monitors, allowing you to view information from up to 64
patients at once.
For the sake of brevity, the term MPC is sometimes used in this document to refer
to the Nightingale MPC.
Before using the PPM3, be sure to read carefully and understand all the chapters
of this User's Guide. Failure to read and understand the instructions may lead to
misuse of the PPM3, which could result in harm to the patients.
Typographical Conventions in this User's Guide
This guide contains warnings, cautions, and notes to help call your attention to the
most important safety and operational aspects of the system. To help identify
these items when they occur in the text, they are shown using the following
typographical conventions:
WARNING – Statements that call attention to the possibility of injury,
death, or other serious adverse reactions associated with the use or
misuse of the device.
CAUTION – Statements that call attention to the possibility of a problem
with the device associated with its use or misuse. Such problems include
device malfunction, device failure, damage to the device or damage to
other property.
Note - Statements that provide supplemental information.
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Indications for Use
The Zoe Medical Nightingale Monitoring System is indicated for use in adult &
pediatric patient populations.
The Zoe Medical Nightingale Monitoring System facilitates the monitoring of:
-
ECG
Impedance respiration
Non-Invasive blood pressure
Invasive blood pressure
Body temperature
Functional arterial oxygen saturation (SpO2)
End-tidal & inspired CO2
The Zoe Medical Nightingale Monitoring System is a prescription device
intended to be used by healthcare professionals in all areas of a healthcare facility.
WARNING – The Nightingale PPM3 is not intended for use in the
following cases:
• Neonatal patients
• Apnea monitoring
• In an MRI environment
• Applications requiring automated arrhythmia detection
• Applications requiring diagnostic-quality ECG
WARNING – DEFIBRILLATION. To avoid the possibility of serious
injury or death during patient defibrillation, do not come into contact
with patient monitor or patient cables. Additionally, proper
placement of defibrillator paddles in relation to the ECG electrodes is
required to minimize harm to the patient. Only use accessories
approved by Zoe Medical for use with the Nightingale PPM3.
WARNING – PACEMAKER PATIENTS. Rate meters may continue to
count the pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon heart rate meter alarms.
Keep pacemaker patients under close surveillance. See the
Technical Data chapter for disclosure of the pacemaker pulse
rejection capability of this instrument.
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WARNING – ELECTROSURGERY. The Nightingale PPM3 is suitable
for use in the presence of electrosurgical (ESU) equipment. The
following precautions should be taken:
•
•
•
•
•
•
•
To minimize the risk of patient burns, only use ESU equipment
that monitors the impedance of the ESU return wires.
Users should be properly trained in the operation of the ESU
equipment.
Keep patient-applied cables (e.g., ECG lead wires) off of earth
ground and away from the ESU knife and return wires to
prevent burns to measurement sites.
To prevent burns to the patient in the event of a defective
neutral ECG electrode of the device, it is necessary to place
ECG electrodes far from the neutral electrode, and as
equidistant as possible from the blade-neutral axis of the
surgical patient monitor.
When activating the ESU device, the ECG signals may be
distorted or may disappear, and Lead Fail or Noise alarms
might be present. The signal should return once the ESU
activation stops.
When activating the device, using the SpO2 parameter as the
heart rate source rather than the ECG parameter to determine
heart rate may be clinically preferred.
Only use accessories approved by Zoe Medical for use with
the Nightingale PPM3.
WARNING – FLAMMABLE ANESTHETICS. An explosion hazard
exists if the monitor is used in the presence of flammable
anesthetics.
WARNING – ANESTHESIA PATIENTS. Constant attention by a
qualified individual is needed whenever a patient is under anesthesia
or connected to a ventilator.
WARNING – ALARM MONITORING. Alarm configuration settings can
be individualized according to patient condition and demographics.
The operator should check the appropriateness of the alarm settings
with each patient admission. Inappropriate alarm configuration
settings may render the alarm system useless. Always respond
promptly to alarms.
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WARNING – ARRHYTHMIA PATIENTS. The Nightingale PPM3 is
designed to operate in the presence of cardiac arrhythmias.
However, the heart rate meter may be adversely affected in some
cases.
WARNING – DEVICE INTERCONNECTIONS. Through its OMD (Other
Medical Device) port, the Nightingale PPM3 can be connected to
external devices. The following precautions should be taken:
•
•
•
•
•
The OMD cable should not be applied to the patient.
Connected devices should be located outside of the patient
vicinity (greater than 1.5 meters) if they do not comply with IEC
60601-1.
The PPM3 should not be connected to devices that are not
described in this manual.
The over-all system leakage current should be tested and
should comply with IEC 60601-1-1.
Nightingale MPC to PPM3 Network installation must be
performed by service personnel that are authorized by Zoe
Medical. Connection of the PPM3 to a network that includes
other equipment could result in previously unidentified risks.
WARNING – BATTERY HANDLING. The Nightingale PPM3 contains a
lithium ion coin cell battery and transport battery pack. The following
precautions should be taken regarding these batteries:
•
•
•
•
•
•
Do not immerse in water.
Do not heat or throw in fire.
Do not leave in conditions over 60 ºC or in a heated car.
Do not attempt to crush or drop.
Only use the battery pack with the Nightingale PPM3.
Follow the instructions in the Disposal chapter of this manual
when the PPM3 is taken out of service.
WARNING – AUDIBLE TONES. The Nightingale PPM3 should sound
audible startup tones whenever it is powered on (two tones followed
by two higher beeps). If a unit does not sound the startup tones
when it is powered on, remove the unit from service and contact Zoe
Medical Technical Support.
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WARNING - To avoid potential for spread of disease or infection,
single-use disposable components (e.g., electrodes, IBP catheters,
disposable SpO2 sensors, disposable temperature probe covers,
single-use blood pressure cuffs, etc.) must not be reused.
CAUTION – For continued operation, always connect the monitor to a wall
outlet when a Low Battery alarm indication occurs. Failure to do this can
lead to an interruption of monitoring.
CAUTION – Do not operate the Nightingale PPM3 near high frequency
emissions (e.g. microwaves).
Note – The battery may need to be recharged if the Nightingale PPM3 has been powered
off for an extended period of time. See the Battery Operation chapter of this manual for
details regarding the battery.
Note – The Nightingale PPM3 NBP parameter is indicated for use pregnant patients,
including those with pre-eclamptic or eclamptic conditions.
Note – Single Use devices should not be reused.
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Overview
1. Overview
This chapter provides an overview of the PPM3, including a diagram showing
how the PPM3 fits into the Nightingale Monitoring System, and a description of
how this User's Guide relates to other Nightingale Monitoring System documents.
This chapter also provides a basic overview of the PPM3 user interface and a list
of the PPM3's main features.
1.1. System Diagram
The main components of the Nightingale Monitoring System are shown in the
following diagram:
Central Monitoring
Station
Facility Telecommunications
Closet
Patient
Bedside
PPM3
MPC
Commercial Multiport
Serial Hub or Ethernet
Router
Ethernet
Up to 64
PPM3's
Serial or
Ethernet
Connections
Figure 1. Nightingale Monitoring System
The PPM3 component serves as the bedside patient monitor. All the Nightingale
PPM3 monitors are connected to the Nightingale MPC at the central station. The
hub or router provides a connection between the Nightingale PPM3's and the
MPC.
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Overview
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Note - The PPM3 is also designed to function in a stand-alone mode, independent of the
MPC.
1.2. Scope of this User's Guide
This User's Guide provides healthcare professionals the information required for
the safe and effective use of the Nightingale PPM3.
For information about how to use the MPC, please consult the Nightingale MPC
User's Guide.
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Overview
1.3. PPM3 Diagrams
Keypad
Control knob
Figure 2. PPM3 Front View
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Power
Indicator
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Overview
Battery Charging Indicator
On/Off Button
Slot for Mounting Tab
Figure 3. PPM3 Rear View
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Overview
SpO2 Connector
NBP Connector
IBP Connector
ECG Connector
TEMP Connector
Other Medical Device
(OMD) Connector
CO2 Input
Connector
Note: Labeled “EtCO2”
in later production units
CO2 Exhaust
Dual Channel Recorder
Connector
Figure 4. PPM3 Left View
(with Oridion Microstream® CO2 and IBP)
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Overview
Power
Connector (to Power Supply)
MPC Central
Station Connector
Network Connector
Figure 5. PPM3 Right View
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Overview
To engage power connector, align with hole as shown holding connector body at
45° angle to the case and press into monitor.
Figure 6. Partially Engaged Power Connector
When fully engaged rotate the connector body so that that it is parallel to the case.
Figure 7. Fully Engaged Power Connector
Power connector is shown fully engaged in the locked position. To remove the
power connector, reverse the above steps.
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Overview
1.4. PPM3 User Interface
The PPM3 user interface makes use of a control knob and a set of keys on the
front panel keypad (for input) and a display screen and speaker (for output). The
front panel looks like the following diagram:
PRINT
ALARM
SILENCE
NBP
INTERVAL
NBP
START /
STOP
STANDBY
SETUP
TRENDS
MAIN
SCREEN
POWER
Figure 8. PPM3 Front Panel
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Overview
You can use the PRINT key to generate a Vital Signs Report at the printer that is
connected to the Nightingale MPC central monitoring station, or store a Vital
Signs Report while the PPM3 is disconnected from the Nightingale MPC. When
the Strip Chart Recorder Option is installed, pressing this key initiates a strip chart
recording.
You can use the ALARM SILENCE key to silence alarm tones when they are
annunciating, and also to remove messages that are being displayed after you
have read them.
You can use the NBP INTERVAL key to change the interval between NBP
measurements in Interval Mode (as well as to enable/disable NBP Interval Mode
– see the NBP Monitoring chapter for more details).
You can use the NBP START / STOP key to start a NBP measurement, if one is
not currently running, or to stop a NBP measurement, if one is currently running.
You can use the STANDBY key to place the monitor into Standby Mode, or
when you are preparing to transport or discharge a patient.
You can use the SETUP key to bring up the menus used to change settings for the
monitor.
You can use the TRENDS key to bring up the trend display.
You can use the MAIN SCREEN key to return to the normal Main Screen
display.
You can use the control knob to navigate the PPM3 menus. Turn the knob to the
left to navigate to the left or up. Turn the knob to the right to navigate right or
down. Press the knob to select a highlighted menu item.
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Overview
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Waveform
Area
Parameter
Areas
Patient
Information
Area
Message
Area
Figure 9. Sample of PPM3 Main Screen
The Main Screen of the PPM3 has four areas one each for displaying
waveforms, parameters, the patient information, and messages.
The Waveform Area has five channels. Menu selections allow you to choose
which waveform to display in which channel.
The Parameter Area is actually in two parts, one to the right of the waveform area
and one below it. The Parameter Area shows the current values of the monitored
parameters.
The Patient Information Area is at the bottom right corner of the display.
The Message Area is at the bottom of the display. Alarm and technical condition
messages are displayed here. One message is displayed at a time. If multiple
messages are active, each message is displayed for approximately 3 seconds at a
time.
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Overview
1.5. Main Features of the PPM3
The Nightingale PPM3 connects to a patient and monitors the patient's vital signs.
The PPM3 contains the hardware and software needed to perform complex data
gathering and signal processing tasks that allow it to produce accurate and reliable
measurements of physiological parameters. The patient’s physiological signals
and parameters are shown as waveforms and numbers on the PPM3 display. The
PPM3 can be set up to generate an alarm when a physiological parameter goes
beyond a preset limit.
The PPM3 can also connect to a Nightingale MPC central monitoring station and
send the waveform and parameter information to the MPC. An operator at the
MPC can then see the waveforms and parameters, and can respond in case there is
an alarm (such as HR getting too high).
The chapters in this User's Guide explain the details of all the main features of the
PPM3. These cover the basic monitoring tasks you may need to do when using
the PPM3. The main features covered in this User's Guide are as follows:
•
•
•
•
•
•
•
•
•
•
•
•
•
ECG and Heart Rate Monitoring (HR)
Respiration Monitoring (RR)
Pulse Oximetry Monitoring (SpO2 and PR)
Non-Invasive Blood Pressure Monitoring (NBP)
CO2/Capnography Monitoring (ETCO2, FICO2, RRc)
Invasive Blood Pressure Monitoring (P1 and P2)
Temperature Monitoring (TEMP)
Connecting to the Nightingale MPC
Managing Alarms
Working With Menus
Viewing Trends
Standby Mode
Battery Functions
In addition, a chapter at the end of this User's Guide includes information about
troubleshooting (what to do if you have a problem with the PPM3). Other
chapters at the end of this User's Guide discuss topics such as accessories for the
PPM3, how to clean the PPM3, and maintenance, storage, and technical
information for the PPM3.
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Getting Started
2. Getting Started
This chapter explains how to get started using the Nightingale PPM3. It explains
the parts you will need, how to make all the necessary connections, and how to
check that everything has been set up and is working correctly.
2.1. Parts you should have
Note – Before proceeding, you should have a look at the PPM3 diagrams in the Overview
Chapter, to make sure that you know what all the part names mean.
The first step in using the PPM3 is to make sure that you have all the parts you are
going to need. Use the following list as a checklist:
1.
2.
3.
4.
5.
Nightingale PPM3
PPM3 Power Supply with integral Power Cable
PPM3 Network Cable (if you will be connecting to the Nightingale MPC)
ECG Cables (if you will be monitoring ECG or Impedance Respiration)
ECG Electrodes (if you will be monitoring ECG or Impedance
Respiration)
6. SpO2 Sensor / Extender Cable (if you will be monitoring SpO2)
7. CO2 sampling lines or airway adapter (if your monitor is configured with a
CO2/Capnography monitoring module)
8. Invasive pressure Y-adapter (if your monitor is configured for IBP
monitoring)
9. Temperature Cable (if you will be monitoring Temperature)
10. Temperature Probe (if you will be monitoring Temperature)
11. NBP Hose (if you will be monitoring NBP)
12. NBP Cuff (if you will be monitoring NBP)
If the PPM3 will be connected to a Nightingale MPC central monitoring station,
you should also be close to a wall plate with a connector labeled "Nightingale
Monitoring System." This wall plate is installed when the Nightingale
Monitoring System network is installed.
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2.2. Mounting solutions
The PPM3 can be mounted to a roll stand or wall bracket using a custom adapter
bracket that is described in the accessories chapter. The maximum height of a roll
stand mount is 100 cm.
A table stand is also available for the PPM3, as described in the accessories
chapter.
WARNING – Please follow installation instructions provided with
mounting hardware to avoid possible hazard of device falling.
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Getting Started
2.3. How to Connect the PPM3 to Power and
Communications
CAUTION – Before making any connections, you need to figure out a
good place to put the PPM3 in relation to the patient. This is important in
order to avoid creating a situation where cables are hanging in places
where they could get tangled up or trip someone.
To connect the PPM3 to power and to communications with the Nightingale
MPC, use the following procedure:
1. Plug the PPM3 Power Supply into a live outlet.
2. Plug the Power Cable Plug into the Power Connector on the back of the
PPM3 (right hand side). The green Battery Charging LED on the back of
the PPM3 should now be illuminated.
3. Press the On/Off Button on the back of the PPM3. After pressing the
On/Off Button you should hear a chirp accompanied by a flash of the
screen. The Power Indicator LED on the front of the PPM3 should be
illuminated.
4. The screen should then go black for a few seconds until the startup screen
shown in the following figure appears. Then as the main screen appears,
you will hear two startup tones followed by two higher-pitched beeps
5. If the PPM3 will be connected to a Nightingale MPC central monitoring
station, connect the Network Cable to the connector labeled as
on the right side of the PPM3. Then plug the other end of the
Network Cable into the wall plate connector marked "Nightingale
Monitoring System."
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Getting Started
Figure 10. PPM3 Startup Screen
To power-down the PPM3, press the On/Off Button until the following screen
appears. The rest of the power-down process will be completed automatically.
The power supply should remain connected for the battery to be recharged.
Figure 11.
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Getting Started
The New Patient Screen follows the Startup Screen. If a patient has previously
been admitted, their information will still be shown in the Patient Information
Area as shown below. To continue with this patient, select "No," and the PPM3
will display the Main Screen with the same Patient Information displayed as
before.
Figure 12. New Patient Screen With Previous Patient
Alternatively, if you will be monitoring a different patient as compared to when
the PPM3 was last powered-down, select "Yes” to discharge the old patient from
the PPM3. This will clear the Patient Information Area and bring up the Main
Screen as shown in Figure 12.
Note – See the Working With Menus chapter for details on how to use the control knob to
select the Yes/No menu items.
Note – If you are using the Nightingale MPC for centralized monitoring, the PPM3 will not
establish a connection until the New Patient question is answered.
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Figure 13. Main Screen With No Patient Admitted
The patient information area will not be filled in until the new patient is admitted
via the Patient Information Menu (see the Working With Menus chapter) or the
MPC.
The waveforms and parameter values will not be displayed until you connect the
PPM3 to the patient.
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2.3.1.
Getting Started
Checklist before Connecting to Patient
Before connecting the PPM3 to a patient:
1. If connecting the PPM3 to a new patient, clean the unit according to the
instructions in the Cleaning chapter.
2. Power up the unit, confirm that the startup tones sound (two tones
followed by two higher-pitched beeps).
3.
4.
5.
6.
7.
Confirm that the power-on LED is lit on the front panel.
Confirm that the display comes up, showing the home screen.
If monitoring SpO2, connect sensor, confirm that LED is lit on sensor.
Press NBP Start Stop key, confirm that pump starts.
Press NBP Start Stop key again, confirm that pump stops.
If you notice any problem in going through the checklist, take the monitor out of
service and contact Zoe Medical Technical Support.
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2.4. How to Connect the PPM3 to the Patient
To connect the PPM3 to the patient requires special instructions depending on
which signals and parameters you are monitoring. Please refer to the chapter for
each signal for instructions about how to make the connection to monitor that
signal.
WARNING – Check the PPM3 and its accessories for cracks, abrasive
edges and other signs of damage before applying sensors to the
patient.
2.5. How to Check the PPM3 Setup
For any patient connections you made, you should have already verified that the
waveform displayed on the PPM3 shows that the connection was good. When
connected to the MPC, you should verify that the patient name is displayed in the
name area of the PPM3 Main Screen. If the patient's name is too long to fit in this
area, you should verify that the patient's initials are displayed.
Before leaving the patient, make sure that the PPM3, the PPM3 Power Supply,
and all the cables are secure and not hanging in a way that would be hazardous to
the patient or to someone caring for the patient.
WARNING – Always make sure that the correct patient name is
displayed in the PPM3 name area when connected to the MPC. This
is to avoid any chance of mistaking the signals and parameters from
one patient with the signals and parameters from another patient at
the central monitoring station.
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ECG and Heart Rate Monitoring
3. ECG and Heart Rate Monitoring
3.1. Overview of ECG and Heart Rate Monitoring
ECG Monitoring works through the sensing the electrical signals generated by the
electrical activity of the heart as it beats. These signals are acquired from chest
electrodes, and the PPM3 amplifies the signals so they can be displayed on the
screen. The patient’s heart rate (HR) is calculated and continuously updated
based on running average of the R to R intervals between each QRS complex.
The ECG and HR monitoring capabilities of the Nightingale PPM3 include:
•
Displaying up to three leads of ECG continuously
•
3-wire cable with lead II monitoring
•
5-wire cable with leads I, II, III, V, AVL, AVR, and AVF.
•
Calculating the average heart rate (HR) in beats per minute (based the top
displayed ECG lead, or Lead II if no ECG lead is displayed)
•
Detecting asystole and ventricular fibrillation (based on heart rate lead)
•
Pacer pulse detection (performed on Lead II)
•
Generating an audible pulse tone for each detected beat
The Nightingale PPM3 is suitable for use in the presence of electrosurgical (ESU)
equipment.
WARNING – ELECTROSURGERY. Consult the safety instructions at
the front of this manual before using electrosurgical equipment.
3.2. Getting Started with ECG on the PPM3
To begin monitoring ECG, use the following procedure:
1. Select and prepare the electrodes.
We recommend using pregelled, Ag/AgCl disposable electrodes. Depending
on the situation, you may want to use either the short-term (foam-backed) or
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long-term (cloth-backed) electrodes. Do not use electrodes after their
expiration date, or if the gel has dried out.
2. Prepare the patient's skin for applying the electrodes.
Getting a good quality ECG signal depends largely on how good the contact is
between the electrodes and the patient's skin. To help assure this, you should
first clip or shave any excess hair and remove any skin residue or oils using an
alcohol pad. To reduce skin impedance, mildly abrade only the electrode
contact site using ultrafine sandpaper (220-400 grit). For diaphoretic patients,
use a benzoin prep to assure tighter adherence of the electrode.
3. Apply the electrodes to the patient.
Apply the pad by using a circular motion on the adhesive area first, then
pressing on the gel area gently, to avoid squeezing out the gel. Please refer to
the diagrams on the following pages for guidance on proper electrode
placement. You should change the electrodes every 24-48 hours to maintain a
good quality ECG signal.
4. Connect the ECG cable lead set to the electrodes and to the PPM3.
3.3. Checking the ECG Signal
When you have connected the patient following the steps listed above, you should
be able to see a clean ECG signal similar to the figure below on the PPM3
display. If the ECG contains artifact or noise, review the steps for proper
electrode site preparation and placement. The PPM3 should also display a
number for the patient's heart rate (HR) and the alarm limit settings.
Figure 14. ECG Waveform and HR Value
To manually test ECG and HR alarm functionality on a daily basis, you may
choose from two approaches. First, if a patient is currently being monitored with
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ECG and Heart Rate Monitoring
ECG, make certain that the alarms are enabled, and then lower the HR upper
alarm limit setting below its current value. Verify that "HR < [upper limit]"
annunciates as a medium grade alarm. Press the ALARM SILENCE key, and
then return the HR upper alarm limit to its previous value. Verify that the alarm
is no longer active, and that ECG monitoring continues normally. Alternatively,
disconnect the RA or LL electrode. Verify that "HR lead off" annunciates as a
low grade alarm. Press ALARM SILENCE and reconnect the electrode. Verify
that the alarm ceases and that the ECG waveform and HR parameter return.
The ECG and Heart Rate Monitoring settings and specifications for the
Nightingale PPM3 may be found in the PPM3 Monitor Settings and Technical
Data chapters. Procedures for changing configuration settings, such as sourcing
pulse rate (PR) from SpO2 while still displaying an ECG waveform, enabling a
HR/PR tone, displaying multiple ECG waveforms, or adjusting alarm limits, may
be found in the Working With Menus chapter.
WARNING – Conductive parts of the ECG patient cables, electrodes,
and associated connections of type CF applied parts, including the
neutral conductor of the patient cable and electrode should not come
into contact with other conductive parts including earth ground.
WARNING – Read safety instructions provided with a defibrillator.
The PPM3 is designed to withstand defibrillation and will recover
within 5 seconds, per IEC 60601-1. Only use accessories approved
by Zoe Medical for use with the Nightingale PPM3.
WARNING – Operating the Nightingale PPM3 with HR/PR limit alarms
disabled means that no low or high HR/PR alarm conditions will
produce alarm notifications. Use this feature with extreme caution.
Patients must be closely observed if HR/PR limit alarms are disabled.
WARNING – Care should be taken to ensure that the total patientapplied current across all patient-connected equipment is less than
10 microamperes (uA). The PPM3 applies approximately 2½ uA.
CAUTION – Line isolation monitor transients may resemble actual cardiac
waveforms and thus inhibit heart rate alarms. To avoid the risk of this
happening, follow the directions for proper electrode placement, and keep
the ECG lead wires away from sources of line noise.
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CAUTION – To avoid large offset potentials due to polarization of
electrodes, be sure to use pregelled, Ag/AgCl disposable electrodes, and
be sure that all electrodes used on a patient are of the same type.
Note – The HR/PR numeric is displayed in green when sourced from ECG (default). The
color changes to cyan or green respectively when sourced from SpO2 or an ART-labeled
IBP.
Note – If an ECG waveform is not displaying on the PPM3, follow the instructions in the
chapter Working With Menus to select one or more ECG waveforms for display.
Note – Visually inspect the ECG cables on a daily basis and follow the instructions in the
Cleaning and Maintenance chapters as needed. Also, check for an inoperable ECG
circuit which would manifest itself as a blank ECG waveform and a "HR lead off"
message.
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3.4. Standard Electrode Placement (AHA)
For ECG cable lead sets with AHA (USA) lead designations, position the
electrodes as shown in the following diagram:
Note – If using a three-wire ECG cable lead set, you only need to apply the RA, LA, and
LL electrodes, and only Lead II will be available.
RA (White)
LA (Black)
V (Brown)
RL (Green)
LL (Red)
Figure 15. Standard AHA Electrode Placement
1. Position the right arm (RA) electrode on the right mid-clavicular line,
directly below the clavicle.
2. Position the left arm (LA) electrode on the left mid-clavicular line, directly
below the clavicle.
3. Position the right leg (RL) electrode on the right mid-clavicular line, 6th
and 7th intercostal space (5-lead cable only).
4. Position the left leg (LL) electrode on the left mid-clavicular line, 6th and
7th intercostal space.
5. Position the chest (V) electrode on the 4th intercostal space, left sternal
border (5-lead cable only).
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3.5. Standard Electrode Placement (IEC)
For ECG cable lead sets with IEC (Europe) lead designations, position the
electrodes as shown in the following diagram:
Note – If using a three-wire ECG cable lead set, you only need to apply the R, L and F
electrodes, and only Lead II will be available.
R (Red)
L (Yellow)
C (White)
F (Green)
N (Black)
Figure 16. Standard IEC Electrode Placement
1. Position the right arm (R) electrode on the right mid-clavicular line,
directly below the clavicle.
2. Position the left arm (L) electrode on the left mid-clavicular line, directly
below the clavicle.
3. Position the neutral (N) electrode on the right mid-clavicular line, 6th and
7th intercostal space (5-lead cable only).
4. Position the left leg (F) electrode on the left mid-clavicular line, 6th and 7th
intercostal space.
5. Position the chest (C) electrode on the 4th intercostal space, left sternal
border (5-lead cable only).
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3.6. Electrode Placement for Paced Patients (AHA)
For ECG cable lead sets with AHA (USA) lead designations, the optimal
electrode placement for patients with pacemakers may be as illustrated in the
following diagram:
Note – If using a three-wire ECG cable lead set, you only need to apply the RA, LA, and
LL electrodes, and only Lead II will be available.
LA (Black)
RA (White)
LL (Red)
V (Brown)
RL (Green)
Figure 17. Paced AHA Electrode Placement
1. Position the right arm (RA) electrode on the right mid-clavicular line, 5th
intercostal space.
2. Position the left arm (LA) electrode on the left mid-clavicular line, directly
below the clavicle.
3. Position the right leg (RL) electrode on the right mid-clavicular line, 6th
and 7th intercostal space (5-lead cable only).
4. Position the left leg (LL) electrode on the left mid-clavicular line, 6th and
5th intercostal space.
5. Position the chest (V) electrode on the 4th intercostal space, right sternal
border (5-lead cable only).
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ECG and Heart Rate Monitoring
3.7. Electrode Placement for Paced Patients (IEC)
For ECG cable lead sets with IEC (Europe) lead designations, the optimal
electrode placement for patients with pacemakers may be as illustrated in the
following diagram:
Note – If using a three-wire ECG cable lead set, you only need to apply the R, L, and F
electrodes, and only Lead II will be available.
L (Yellow)
R (Red)
F (Green)
C (White)
N (Black)
Figure 18. Paced IEC Electrode Placement
1. Position the right arm (R) electrode on the right mid-clavicular line, 5th
intercostal space.
2. Position the left arm (L) electrode on the left mid-clavicular line, directly
below the clavicle.
3. Position the neutral (N) electrode on the right mid-clavicular line, 6th and
7th intercostal space (5-lead cable only).
4. Position the left leg (F) electrode on the left mid-clavicular line, 6th and 5th
intercostal space.
5. Position the chest (C) electrode on the 4th intercostal space, right sternal
border (5-lead cable only).
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ECG and Heart Rate Monitoring
3.8. Verifying Proper Pacemaker Handling
For paced patients, proper electrode placement results in pacer tick marks along
the top of each ECG waveform channel on the Nightingale PPM3 and the MPC.
These tick marks occur at the point where the PPM3 detects a pacer pulse.
The PPM3 rejects pacer pulses rather than calling them QRS’s (per IEC 60601-227). However, it is important to keep paced patients under close surveillance and
not to entirely rely on rate meters for these patients (as indicated in the warning at
the start of this manual).
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3.9. ECG and Heart Rate Monitoring Messages
Note – Factory default HR alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Message
Parameter
Value
Possible Cause
HR < [lower limit]
[number]
The patient's heart rate
has fallen below the
current lower alarm limit.
HR > [upper limit]
[number]
The patient's heart rate
has risen above the
current upper alarm limit.
Suggested Action
Check the patient and provide any
necessary clinical care.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
HR asystole
ASY
No QRS detected for last
4 seconds
Check the ECG lead being used to
calculate the heart rate (the top
displayed lead) – make sure that the
QRS amplitude on this lead is at least
0.5 mV.
Change to another ECG lead to get
adequate QRS amplitude.
Reposition or change electrodes if no
lead gives adequate QRS amplitudes.
Remember the importance of good
skin preparation techniques.
Check the patient and provide any
necessary clinical care.
HR ventricular fibrillation
VF
No organized ventricular
rhythm detected
Check the ECG lead being used to
calculate the heart rate (the top
displayed lead) – make sure that the
QRS amplitude on this lead is at least
0.5 mV.
Change to another ECG lead to get
adequate QRS amplitude.
Reposition or change electrodes if no
lead gives adequate QRS amplitudes.
Remember the importance of good
skin preparation techniques.
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Message
ECG and Heart Rate Monitoring
Parameter
Value
Possible Cause
Unplugged cable
Broken cable
Loose lead wire
HR lead off
[blank]
Faulty lead wire
Dried out electrode
Inoperable ECG circuit
Intentional removal by
clinician
Suggested Action
Check to make sure electrodes are still
securely attached to the patient, and
reattach if necessary. Remember the
importance of good skin preparation
techniques.
Check to make sure all the lead wires
are still connected to the electrodes.
Check to make sure the lead wires are
securely connected to the PPM3.
Check to make sure there are no
broken lead wires.
Turn monitor off, then back on
If message persists, contact Zoe
technical support.
Press ALARM SILENCE in the event of
intentional removal by clinician.
Calm the patient.
Patient movement
HR artifact
---
Electrical noise from
auxiliary equipment
Bad electrode contact
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Isolate the patient from auxiliary
equipment, if possible.
Check to make sure electrodes are still
securely attached to the patient, and
reattach if necessary. Remember the
importance of good skin preparation
techniques.
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Respiration Monitoring
4. Respiration Monitoring
4.1. Overview of Respiration Monitoring
Respiration monitoring works by measuring the impedance between the LL and
RA electrodes (or the R and F electrodes for IEC lead designations). The
impedance changes as the patient's chest expands and contracts during the breath
cycle. To measure the changes in impedance, the PPM3 passes a very small,
high-frequency current between the electrodes. This current is too small to cause
any harm to the patient or any interference with ECG monitoring.
The Respiration monitoring capabilities of the Nightingale PPM3 include:
•
Calculating the average respiration rate (RR) in respirations per minute
•
Displaying the respiration waveform continuously
The same electrodes are used for both ECG and Respiration monitoring.
Note – PPM3 models configured with capnography modules are also able to calculate
RR from the CO2 waveform. See the CO2 monitoring chapter in this user’s guide for more
information.
4.2. Getting Started with Respiration on the PPM3
To begin monitoring Respiration, follow the patient preparation and electrode
placement procedures that are described at the start of the ECG monitoring
chapter of this manual.
4.3. Checking the Respiration Signal
When you have connected the patient to the monitor, you should be able to see a
clean, slowly oscillating Respiration signal on the PPM3 display. This may take
up to 30 seconds after the patient has been connected. The PPM3 should also
display the patient's respiration rate (RR) and alarm limit settings.
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Figure 19. RR Waveform and Value
To manually test RR alarm functionality on a daily basis, you may choose from
two approaches. First, if a patient’s respiration is currently being monitored,
make certain that the alarms are enabled, and then lower the RR upper alarm limit
setting below its current value. Verify that "RR < [upper limit]" annunciates as a
medium grade alarm. Press the ALARM SILENCE key, and then return the RR
upper alarm limit to its previous value. Verify that the alarm is no longer active,
and that RR monitoring continues normally. Alternatively, disconnect the RA or
LL electrode. Verify that "RR lead off" (interleaved with "HR lead off")
annunciates as a low grade alarm. Press ALARM SILENCE and reconnect the
electrode. Verify that the alarm ceases and that the RR waveform and parameter
return.
The Respiration Monitoring settings and specifications for the Nightingale PPM3
may be found in the PPM3 Monitor Settings and Technical Data chapters.
Procedures for changing configuration settings, such as enabling alarms, or
adjusting alarm limits, may be found in the Working With Menus chapter.
WARNING – Operating the Nightingale PPM3 with RR limit alarms
disabled means that no low or high RR alarm conditions will produce
alarm notifications. Use this feature with extreme caution. Patients
must be closely observed if RR limit alarms are disabled.
WARNING – When using an ECG electrode to calculate respiration
rate via the thorax impedance method, movement artifacts
may create inaccurate results. Respiration rates derived from CO2
parameter is not subject to such movement artifacts.
Note – If the Respiration waveform is not currently selected for display on the PPM3,
follow the instructions in the chapter on Working With Menus to select this waveform for
display.
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4.4. Pediatric Considerations
Cardiogenic artifact (heart rate pulsations that appear as "breaths" in the
respiration signal) can be quite pronounced in pediatric patients. This can cause
the respiration rate to be artificially high (approaching the heart rate). To reduce
cardiogenic artifact, move the White RA electrode (AHA lead designation) or the
Red R electrode (IEC lead designation) from the right clavicle down to the right
mid-clavical line, 4th intercostal space.
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Respiration Monitoring
4.5. Respiration Monitoring Messages
Note – Factory default RR alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Message
Parameter
Value
Possible Cause
Suggested Action
RR < [lower limit]
[number]
The patient's respiration
rate has fallen below the
current lower alarm limit.
RR > [upper limit]
[number]
The patient's respiration
rate has risen above the
current upper alarm limit.
Check the patient and provide any
necessary clinical care.
Check the patient and provide any
necessary clinical care.
---
The patient's respiration
rate has risen above the
maximum value the
monitor can accurately
detect.
RR out of range (too high)
Electrical noise from
auxiliary equipment
Monitor confused by
signal artifact
Unplugged cable
Broken cable
Loose lead wire
Faulty lead wire
RR lead off
[blank]
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Isolate the patient from auxiliary
equipment, if possible.
Check to make sure electrodes are still
securely attached to the patient, and
reattach if necessary. Remember the
importance of good skin preparation
techniques.
Check to make sure electrodes are still
securely attached to the patient, and
reattach if necessary. Remember the
importance of good skin preparation
techniques.
Check to make sure all the lead wires
are still connected to the electrodes.
Dried out electrode
Check to make sure the lead wires are
securely connected to the PPM3.
Inoperable respiration
detection circuit
Check to make sure there are no
broken lead wires.
Intentional removal by
clinician
Press ALARM SILENCE in the event of
intentional removal by clinician.
Turn monitor off, then back on
If message persists, contact Zoe
technical support.
Calm the patient.
Patient movement
RR artifact
---
Electrical noise from
auxiliary equipment
Bad electrode contact
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Isolate the patient from auxiliary
equipment, if possible.
Check to make sure electrodes are still
securely attached to the patient, and
reattach if necessary. Remember the
importance of good skin preparation
techniques.
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Pulse Oximetry Monitoring
5. Pulse Oximetry Monitoring
5.1. Overview of Pulse Oximetry Monitoring
Pulse oximetry monitoring works by shining light of two different wavelengths
through the patient's tissues (such as a fingertip) and measuring the absorption of
the light by the hemoglobin in the patient's arterial blood. The way the blood
absorbs the different wavelengths indicates the amount of oxygen in the blood.
Since this amount is constantly changing during each beat of pulse as new blood
comes in and old blood returns to the heart, it is also possible to detect a pulse rate
from this signal. The Nightingale PPM3 SpO2 algorithm uses the qualified
pulsatile data averaged over a 60 second period to report the SpO2 value.
The pulse oximetry monitoring capabilities of the Nightingale PPM3 include:
•
Measuring the functional oxygen saturation of the patient's arterial
hemoglobin (SpO2)
•
Calculating the patient's pulse rate (PR)
•
Displaying the pulse oximetry waveform (plethysmograph) continuously
•
Generating an audible pulse tone for each detected pulse, with the pulse
tone pitch being tied to the SpO2 value (higher pitch used for higher SpO2)
5.2. Getting Started with Pulse Oximetry on the
PPM3
To begin pulse oximetry monitoring, use the following procedure:
1. Select a sensor that is appropriate for the patient’s weight.
2. Attach the sensor to the patient per the instructions that come with the
sensor. Please refer to the Accessories chapter for a list of approved SpO2
sensors. Clean reusable sensors before and after each use.
3. Connect the sensor cable to the SpO2 cable on the PPM3.
Note – See the Section 12.1.1 "ECG and Heart Rate" in the Working With Menus chapter
for information on how to display pulse rate (PR) from the SpO2 source.
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5.3. Checking the Pulse Oximetry Signal
When you have connected the patient following the steps listed above, you should
be able to see a clean pulse oximetry waveform on the PPM3 display as shown
below. The PPM3 label for this waveform is SpO2. The PPM3 should also
display values for the patient's oxygen saturation (SpO2) and alarm limit settings.
Figure 20. SpO2 Waveform and Value
To manually test SpO2 alarm functionality on a daily basis, apply a probe to a
finger and wait for a SpO2 value to appear. Then lower the upper alarm limit
setting below the current value. Verify that "SpO2 < [upper limit]" annunciates as
a medium grade alarm. Press the ALARM SILENCE key, and return the upper
alarm limit to its previous value. Verify that the alarm is no longer active and that
SpO2 monitoring continues normally.
The Pulse Oximetry Monitoring settings and specifications for the Nightingale
PPM3 may be found in the PPM3 Monitor Settings and Technical Data chapters.
Procedures for changing configuration settings, such as sourcing the pulse rate
(PR) from SpO2, enabling a pulse tone, or adjusting alarm limits, may be found in
the Working With Menus chapter.
WARNING – Only use pulse oximetry sensors and extender cables
approved by Zoe Medical for use with the Nightingale PPM3.
Unapproved components can result in degraded performance and/or
device malfunction.
WARNING – Change the sensor at least every four hours (every 2
hours for poorly perfused patients). Move the sensor if you see any
signs of skin irritation or impaired circulation. Reposition at least
once every 24 hours to allow the patient’s skin to breathe.
WARNING – Tissue damage or inaccurate measurements may be
caused by incorrect SpO2 sensor application or use, such as
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Pulse Oximetry Monitoring
wrapping too tightly, applying supplemental tape, failing to inspect
periodically, or failing to position appropriately. Read the
instructions provided with the SpO2 sensor carefully prior to use.
WARNING – Elevated levels of carboxyhemoglobin or
methemoglobin in monitored patients can result in inaccurate pulse
oximetry readings.
WARNING – A pulse oximeter should be considered as an early
warning device. As a trend towards patient deoxygenation is
indicated, blood samples should be analyzed by a laboratory cooximeter.
WARNING – Operating the PPM3 with SpO2 limit alarms disabled
means that no low or high SpO2 alarm conditions will produce alarm
notifications. Use this feature with extreme caution. Patients must
be closely observed if SpO2 limit alarms are disabled.
CAUTION – The Nightingale PPM3 does not produce a SpO2 alarm until a
valid SpO2 signal is obtained. This is intended to reduce nuisance alarms
during initial patient connection.
CAUTION – Read instructions provided with the sensor to understand the
best application technique and all relevant safety information.
CAUTION – Do not apply the sensor on the same limb as the NBP cuff.
During blood pressure measurements, the perfusion is temporarily
reduced, which can result in inaccurate pulse oximetry readings.
CAUTION – Pulse oximetry sensors are susceptible to high ambient light
interference including surgical lights, especially xenon light sources,
ambient photodynamic therapy (e.g., Bilirubin lamps), fluorescent lights,
infrared heating lamps, direct sunlight. Shield the sensor as necessary.
CAUTION – Pulse oximetry readings may be inaccurate in the presence of
excessive motion artifact or tremors. If questionable readings are
obtained, re-check the patient’s vital signs by alternate means before
administering medication.
Note – If the SpO2 waveform is not currently selected for display on the PPM3, follow the
instructions in the chapter on Working With Menus to select this waveform for display.
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Note – The SpO2 waveform is not proportional to pulse volume.
Note – The accuracy of a pulse oximeter probe or a pulse oximeter monitor cannot be
assessed with a functional tester. The accuracy of the SpO2 parameter in the Nightingale
PPM3 has been validated with a co-oximeter per ISO 80601-2-61.
5.4. Pediatric Considerations
It is important to select a SpO2 sensor that is appropriate for the weight of the
patient. For example, a clean pulse oximetry waveform may not be obtainable
when an adult sensor is used on a small child. Weight-range information can be
found in the packaging that comes with the SpO2 sensor.
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5.5. Pulse Oximetry Monitoring Messages
Note – Factory default SpO2 alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Message
SpO2 < [lower limit]
SpO2 > [upper limit]
Parameter
Value
[number]
[number]
Possible Cause
The patient's oxygen
saturation has fallen
below the current lower
alarm limit.
The patient's oxygen
saturation has risen
above the current upper
alarm limit.
Suggested Action
Check the patient and provide any
necessary clinical care
Change the alarm limit if it is no longer
clinically appropriate
Check the patient and provide any
necessary clinical care
Change the alarm limit if it is no longer
clinically appropriate
HR < [lower limit]
Note – When PR is
sourced from SpO2 the
Pulse Rate is labeled in
cyan as "HR (SpO2)" in
the HR parameter box.
PR alarm conditions
annunciate as HR
alarms.
[number]
The patient's pulse rate
has fallen below the
current lower alarm limit.
[number]
The patient's pulse rate
has risen above the
current upper alarm limit.
Check the patient and provide any
necessary clinical care
Change the alarm limit if it is no longer
clinically appropriate
HR > [upper limit]
Note – When PR is
sourced from SpO2 the
Pulse Rate is labeled in
cyan as "HR (SpO2)" in
the HR parameter box.
PR alarms use the HR
alarm limit settings. PR
alarm conditions
annunciate as HR
alarms.
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Check the patient and provide any
necessary clinical care
Change the alarm limit if it is no longer
clinically appropriate
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Pulse Oximetry Monitoring
Message
SpO2 check sensor
placement
Parameter
Value
---
Possible Cause
Suggested Action
Check to make sure the sensor is
attached fully and securely to the
patient
Sensor has become
detached from patient or
is not fully inserted on
patient’s finger
Select "SpO2 Alarm Pause" in the
Setup SpO2 menu
Sensor has been
intentionally removed by
the clinician
Cover the sensor with opaque material,
such as a towel, to reduce ambient
light
Excessive ambient light
Reattach the sensor, possibly on a
smaller or larger finger
Bad sensor (no red light
coming from sensor)
Replace sensor if there is no red light
coming from it.
Check the patient and provide any
necessary clinical care
Poor perfusion
SpO2 weak signal
---
Large tissue mass
Nail polish
Bad SpO2 sensor
Warm the patient’s extremities if
needed
Reattach the sensor on a smaller
finger
Remove any nail polish that may be
interfering with the red light
Replace the SpO2 sensor
HR weak signal
Note When PR is
sourced from SpO2 the
Pulse Rate will be
labeled in cyan as "HR
(SpO2)" in the HR
parameter box. A weak
pulse rate signal will
annunciate as "HR weak
signal."
SpO2 replace sensor
SpO2 unplugged
SpO2 artifact
Check the patient and provide any
necessary clinical care
Poor perfusion
---
Large tissue mass
Nail polish
Bad SpO2 sensor
Reattach the sensor on a smaller
finger
Remove any nail polish that may be
interfering with the red light
Replace the SpO2 sensor
---
[blank]
---
Bad SpO2 sensor
Replace the SpO2 sensor.
Incorrect set-up within
the PPM3.
Contact Zoe technical support.
SpO2 sensor not
connected to SpO2 cable
Check to make sure the SpO2 sensor
is securely connected to the SpO2
cable on the monitor
Patient movement or
coughing
Calm the patient
Hemodynamic
interference
Small tissue mass
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Warm the patient’s extremities if
needed
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Reattach the sensor on another finger
with less movement
Reattach the sensor on a larger finger
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NBP Monitoring
6. Non-Invasive Blood Pressure
Monitoring
6.1. Overview of NBP Monitoring
The PPM3 uses an oscillometric method to measure the patient’s blood pressure.
In this method, a blood pressure cuff is quickly inflated above the patient’s
systolic pressure, and then the cuff pressure is slowly released in a series of steps.
At each cuff pressure step, oscillations in the cuff pressure are measured. These
oscillations are made by the underlying blood vessels which are pushing on the
cuff during the cardiac cycle. From these oscillations, the patient’s blood pressure
can be derived.
The Non-Invasive Blood Pressure (NBP) monitoring capabilities of the
Nightingale PPM3 include:
•
Calculating the patient's systolic, mean, and diastolic blood pressures
•
Spot check and automatic measurement intervals
6.2. Getting Started with NBP on the PPM3
To begin NBP monitoring, use the following procedure:
1. Attach the NBP cuff to the patient.
Please refer to the Accessories chapter for a list of Zoe Medical approved
NBP cuffs for use with the Nightingale PPM3. In order to get good
quality NBP measurements, you need to use a cuff that is the appropriate
size for the patient. Measure the circumference of the patient's limb and
compare this to the size marked on the NBP cuff.
The patient should be sitting or lying down, and the patient's arm or leg
should be relaxed, extended, and resting on a stationary support.
Wrap the deflated cuff snugly around the patient's arm or leg according to
current AHA guidelines, taking care not to restrict blood circulation.
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If wrapping around the arm, wrap the cuff at 2 to 5 cm above the elbow
crease, and place the artery mark (↓) over the patient's brachial artery,
pointing to the patient's hand.
If wrapping around the leg, wrap the cuff around the middle of the thigh,
and place the artery mark (↓) over the patient's femoral artery, pointing to
the patient's foot.
Instruct the patient to remain quiet and still during the measurement.
2. Connect the NBP cuff to the NBP hose, and connect the hose to the PPM3.
Try to allow 5 min elapse before taking the first measurement in Step 3.
3. Start the NBP measurement by pressing the NBP START/STOP key on
the PPM3 front panel.
4. After starting a measurement, if for any reason you want to stop it, simply
press the NBP START/STOP key again.
5. To configure the PPM3 to take measurements automatically at a preset
interval, press the NBP INTERVAL key on the front panel or select NBP
Interval in the Setup NBP menu. Once changed from something other than
Off, the PPM3 will display the message "NBP Interval – N minutes" in the
message area, where N is the interval. See Section 10.2.3 NBP
INTERVAL KEY for more information on NBP Interval Mode.
6.3. Checking the NBP Measurement
When you have connected the patient following the steps listed above, you should
be able to take a blood pressure measurement. When the measurement completes,
the PPM3 should display the blood pressure in the NBP parameter area as shown
below along with alarm limit settings (shown as disabled below) and a time
stamp. The patient's systolic and diastolic pressures are displayed in as SYS/DIA
while the mean pressure is displayed in parentheses.
Figure 21.
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To manually test NBP alarm functionality on a daily basis, first apply the cuff to
yourself or a patient according the instructions given above. Then enable NBP
alarms and lower the systolic upper alarm limit setting to a value that is certain to
generate an alarm when measured against you or the patient’s pressure. Start the
NBP measurement by pressing the NBP Start/Stop key. After the measurement
completes, verify that "NBPs < [upper limit]" annunciates as a medium grade
alarm. Press the ALARM SILENCE key, and return the systolic upper alarm
limit to its previous value. Verify that the alarm is no longer active.
The NBP Monitoring settings and specifications for the Nightingale PPM3 may
be found in the PPM3 Monitor Settings and Technical Data chapters. Procedures
for changing configuration settings, such as enabling alarms, adjusting alarm
limits, or setting up an automatic measurement interval, may be found in the
Working With Menus chapter.
WARNING – Only use blood pressure (NBP) cuffs approved by Zoe
Medical for use with the Nightingale PPM3. See the Accessories
chapter.
WARNING – The cuff should fit snugly according to current AHA
guidelines. Use the correct size cuff for the intended limb (see
indication of cuff size in cm printed on the cuff) of the patient. The
terminology printed on some BP cuffs like "child," "adult," "thigh,"
etc., is only an indication of the size of the cuff and should not be
used to determine if the cuff is suitable for the limb. Make sure the
index on the cuff is aligned with the brachial artery and that it falls
within the range markers to determine whether the particular cuff fits
the patient’s limb or not.
WARNING – In some cases, frequent and prolonged measurements
can result in petechia, ischemia, purpura or neuropathy. You should
check the cuff site regularly when taking frequent measurements
over an extended time period. You should also check the patient for
any signs of restricted circulation in the extremities of the limb
where the NBP cuff is wrapped. Switch the blood pressure cuff site
as per hospital protocol or at least every four hours.
WARNING – Operating the PPM3 with NBP limit alarms disabled
means that no low or high NBP alarm conditions will produce alarm
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notifications. Use this feature with extreme caution. Patients must
be closely observed if NBP limit alarms are disabled.
WARNING – Be sure that the NBP hose is not kinked during a
measurement. Kinks in the hose could lead to sustained pressure in
the blood pressure cuff, which could cause limb damage to the
patient.
WARNING – Avoid applying the cuff to a wounded limb as this can
cause further injury. Use with caution in patients with
dermatological disease, subcutaneous laceration, or other
integumentary compromise as there may exist a skin damage hazard
during electronic NBP measurements. Follow prudent evidencebased clinical practice to determine if an electronic blood pressure is
safe for these patients.
WARNING – There may be an increased risk of hematomas in
patients with serious coagulation problems.
WARNING – Avoid applying the cuff to a limb with a catheter, arteriovenous shunt or infusion pump applied. The cuff pressure could
produce damage to the tissues surrounding the catheter, shunt or
the infusion needle, or compromise the infusion flow.
WARNING – Avoid placing the blood pressure cuff on the arm next to
where a patient has had a mastectomy.
WARNING – To avoid the potential for spread of disease or infection,
reusable blood pressure cuffs should be cleaned after each patient
use. Disposable blood pressure cuffs should not be used with
multiple patients.
CAUTION – Do not apply the NBP cuff on the same limb as the SpO2
sensor. During blood pressure measurements, perfusion is temporarily
reduced, which can result in inaccurate pulse oximetry readings.
CAUTION – Do not allow the NBP cuff or hose to come into contact with
fluids. If this occurs, consult the Cleaning chapter of this manual for drying
instructions. Check the hose and cuff frequently for signs of damage or
debris. An obstruction in the hose may interfere with inflation and
deflation, resulting in inaccurate NBP readings.
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NBP Monitoring
CAUTION – To obtain accurate blood pressure readings, keep the limb
and the cuff motionless.
CAUTION – The NBP cuff should be at the same level as the patient's
heart. If you cannot place the NBP cuff at this level, add to the measured
pressure values 1.4 mmHg for each 2 cm above the heart level, or
subtract 1.4 mmHg for each 2 cm below heart level.
CAUTION – NBP measurements may not be accurate if the patient is
convulsive, experiencing tremors, or is defibrillated during the
measurement.
CAUTION – NBP measurements may be affected by extremes of
temperature, humidity, and altitude. Always ensure that the Nightingale
PPM3 is operated and stored within its specified environmental conditions.
Note – Blood pressure measurements determined with this device are equivalent to those
obtained by a trained observer using the cuff/stethoscope auscultation method, within the
limits prescribed by the American National Standard, Electronic or automated
sphygmomanometers.
Note – The Auto Mode setting is remembered between power cycles. However, the
PPM3 does not start Auto Mode NBP measurements after power up until the NBP
Start/Stop key is pressed. This tells the PPM3 that the cuff has been applied to the
patient and that NBP monitoring should commence.
Note – NBP readings are not continuous, but are updated each time a NBP
measurement is taken. Use a shorter Auto Mode setting for more frequent updating of the
patient’s blood pressure.
Note – During a measurement, a variety of safety checks are performed. These checks
can cause the measurement to be cancelled and pressure to be released from the cuff.
The safety checks include an overpressure check (to make sure the cuff pressure is not
greater than 270 mmHg), a check to make sure the measurement does not take longer
than 2¼ minutes, and other checks for technical problems such as a blocked line.
Note – This device functions according to specifications in the presence of common
arrhythmias such as atrial or ventricular premature beats or atrial fibrillation.
Note – This device can be used to determine blood pressure over a heart rate range of
30 bpm to 240 bpm.
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6.4. Pediatric Considerations
The initial inflation pressure can be adjusted in the Set-up Parameter NBP menu.
The default value is 160 mmHg. This can be lowered to 100 mmHg for pediatrics,
thereby reducing measurement time and increasing patient comfort. If necessary
after the initial measurement, the PPM will use the previous systolic pressure
value to select the inflation cuff pressure.
The PPM3 automatically senses when an infant cuff is attached and limits the
maximum cuff pressure to 180 mmHg, as opposed to 270 mmHg for larger cuffs.
6.5. Hypertensive Considerations
For hypertensive patients (e.g., systolic pressure greater than 220 mmHg), it may
be necessary to repeat a NBP measurement if the first attempt is unsuccessful.
The PPM3 will "learn" the patient’s blood pressure profile from the first attempt,
even if it is unsuccessful, and use a higher inflation pressure on a subsequent
measurement attempt.
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6.6. NBP Monitoring Messages
Note – Factory default NBP alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Message
NBPs < [lower limit]
NBPs > [upper limit]
NBPd < [lower limit]
NBPd > [upper limit]
NBPm < [lower limit]
NBPm > [upper limit]
NBP Interval – N Minutes
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Parameter
Value
[number]
[number]
[number]
[number]
[number]
[number]
NA
Possible Cause
The patient's systolic
pressure has fallen
below the current lower
alarm limit.
The patient's systolic
pressure has risen above
the current upper alarm
limit.
The patient's diastolic
pressure has fallen
below the current lower
alarm limit.
The patient's diastolic
pressure has risen above
the current upper alarm
limit.
The patient's mean
pressure has fallen
below the current lower
alarm limit.
The patient's mean
pressure has risen above
the current upper alarm
limit.
The PPM3 is in NBP
Interval Mode with N
being the time interval
between automatic
measurements.
Suggested Action
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
None required.
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NBP Monitoring
Message
Parameter
Value
Possible Cause
Suggested Action
Check the patient and provide any
necessary clinical care
Poor limb perfusion
NBP weak signal
---
Improper cuff placement
Cuff size too large for the
patient
Persistent patient
movement or coughing
NBP artifact
---
Hemodynamic
interference (varying
pulse amplitudes due to
breathing or valvular
problem)
Hose is clogged or
leaking
NBP cuff leak
---
Check to make sure the cuff is
wrapped properly, with the "artery"
mark lined up over the brachial artery
Check the limb circumference against
the recommended range as printed on
the cuff, to insure the cuff is not too big
Check the patient and provide any
necessary clinical care
Calm the patient
Move the cuff to another limb with less
movement
If no obvious patient motion, switching
to the other limb may still help in the
case of hemodynamic interference
Check the cuff and hose for signs of
damage
Leaky cuff or hose
Check for leaks in the cuff or hose and
replace if necessary
Cuff not applied to
patient
Check that cuff and hose are
connected to the monitor
Check that cuff is applied to patient
NBP blocked hose –
check patient
Check the patient and insure that the
cuff is deflated
---
Pinched Hose
Check for kinks or obstructions in the
hose
Replace hose if necessary
NBP measurement time
exceeded
NBP problem detected
NBP cannot measure
---
---
---
The measurement time
limit (2¼ minutes) was
exceeded, usually due to
motion artifact
Monitor has detected a
hardware problem
Initial inflation pressure
may not have been high
enough (if patient’s
systolic pressure is
above 200 mmHg)
See suggestions for "NBP artifact"
Repeat the measurement
Check the patient and insure that the
cuff is deflated
Turn the monitor off, then on.
If message persists, contact Zoe
technical support.
Repeat the measurement (monitor will
automatically adjust to using a higher
initial inflation pressure if needed)
Patient movement
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Oridion CO2 Monitoring
7. Oridion CO2 Monitoring
7.1. Overview of CO2 Monitoring
CO2 monitoring – also known as capnography – is a non-invasive method for
monitoring the level of carbon dioxide in a patient’s breath in order to help assess
their ventilation status. The Oridion Microstream® modules used in the
Nightingale PPM3 utilize a process known as sidestream capnography, whereby a
portion of a patient’s inhaled and exhaled gases are diverted and continuously
passed through an infrared spectrometer. From the amount of infrared light
absorbed, the amount of CO2 present can be determined. In order to sample the
patient’s breath, a sampling line is typically placed in the nose and/or in the
mouth for non-intubated patients and in-line with the airway tubing for intubated
patients.
The CO2 monitoring capabilities of the Nightingale PPM3 configured with
Oridion Microstream® capnography include:
•
Measuring the patient’s end-tidal carbon dioxide (ETCO2)
•
Measuring the patient’s fractional inspired carbon dioxide (FICO2)
•
Calculating the patient’s respiration rate (RRc) from CO2
•
Calculating the patient’s Integrated Pulmonary Index (IPI)
•
Displaying CO2 waveform (capnograph) continuously
•
Detecting Apnea conditions with a configurable time setting
7.2. Getting Started with Oridion CO2 on the PPM3
To begin CO2 monitoring with Oridion Microstream® sidestream capnography,
use the following procedure:
1. If CO2 monitoring has not been enabled (indicated by the presence of
impedance respiration box with blue labels underneath the green HR
parameter box), press the SETUP key on the PPM3, scroll the control
knob to Parameters, press the knob, press on the highlighted "ETCO2
Enabled," scroll to "Yes," and press the knob. Press the Main Screen key
to apply the changes. Now the CO2 waveform area and parameter box
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should appear in yellow beneath the top channel ECG lead – replacing the
impedance respiration parameter box and waveform area.
2. Select the proper Oridion CapnoLine® or FilterLine® single-use sampling
line based on clinical guidelines and hospital standard of care.
3. Open the cover labeled Microstream® ETCO2 on the PPM3 left side.
4. Place the orange or yellow threaded connector of the sampling line into
the CO2 input port beneath the opened cover.
a. Gently turn the connector clockwise into the CO2 input port until a
secure connection is achieved. DO NOT OVER TIGHTEN. Over
tightening may warp the connector such that ventilation or the CO2
measurement may be compromised. This assures that there is no
leakage of gases during measurement at the connection point and that
measurement accuracy is not compromised.
b. When the connector is secure, the CO2 pump should start and the
"CO2 Warming Up" message will briefly appear.
5. Securely connect all components and check connections for leaks
according to standard clinical procedures.
6. Connect the patient applied end of the sampling line to the patient as per
instructions included with the CapnoLine ® or FilterLine® packaging.
7. The CO2 waveform and numeric parameter values should appear within
approximately 10 seconds.
7.3. Checking the CO2 Signal
When you have connected the patient following the steps listed above, you should
be able to see a CO2 waveform on the PPM3 display as shown below. The PPM3
should also display values for the patient's end-tidal carbon dioxide (ETCO2),
fractional inspired carbon dioxide (FICO2), respiration rate from CO2 (RRc),
Integrated Pulmonary Index (IPI), and alarm limit settings. The infrared light
source used in the Microstream® module generates only the specific wavelengths
characteristic of the CO2 absorption spectrum. Therefore, no compensations are
required when different concentrations of N2O, O2, anesthetic agents, and water
vapor are present in the patient’s gases.
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Figure 22. Oridion CO2 Waveform and Values
To manually test CO2 monitoring alarm functionality on a daily basis, you may
use the following approach. First, either connect the patient to the Nightingale
PPM3 using the above procedure or continue as follows with a patient who is
already being monitored. Then, enable the alarms ETCO2, RRc, FICO2, and IPI.
Next, lower the ETCO2 upper alarm limit setting below its current value. Verify
that "ETCO2 < [upper limit]" annunciates as a medium grade alarm. Press the
ALARM SILENCE key, and return the ETCO2 upper alarm limit to its previous
value. Verify that the alarm is no longer active, and that CO2 monitoring
continues normally. Repeat this process in turn for the RRc, FICO2, and IPI
parameters (lower limit).
The CO2 Monitoring settings and specifications for the Nightingale PPM3 may be
found in the PPM3 Monitor Settings and Technical Data chapters. Procedures for
changing configuration settings, such as adjusting alarm limits, changing the
waveform size (amplitude), setting the apnea time, or enabling or disabling IPI,
etc. may be found in the Working With Menus chapter.
7.4. Integrated Pulmonary Index
The Integrated Pulmonary Index (IPI) is a parameter that uses capnography,
respiration rate, pulse rate (from SpO2), and pulse oximetry to articulate a single
numeric value to describe a patient’s overall ventilatory status. All four values
are necessary to calculate the IPI parameter. The IPI may provide an early
indication of ventilatory changes that may not be evident in any of the four
parameters individually. Also, since IPI is based on physiological parameters that
can change with age, the Nightingale PPM3 will prompt you to pick from one of
three pediatric age changes (1-3 years, 3-6 years, and 6-12 years) when using IPI
with a pediatric patient type selected.
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The IPI is a numeric value ranging from 1 to 10, where 10 indicates optimal
pulmonary status. According to Oridion Medical, the following table presents a
guide for clinical intervention based on IPI numeric values. Contact Oridion
Medical for further details on IPI clinical intervention. The Nightingale PPM3
supports an IPI low alarm limit such that an alarm is annunciated when the IPI
value drops below a configured low alarm limit setting.
Figure 23. Integrated Pulmonary Index
Oridion Medical (2009). Integrated Pulmonary IndexTM. Retrieved from
http://www.oridion.com/Assets/Products/Technology/IPIChart.jpg.
WARNING – Operating the Nightingale PPM3 with CO2x limit alarms
disabled (where x = ETCO2, RRc, FICO2, and IPI) means that no low or
high CO2x alarm conditions will produce alarm notifications. Use
this feature with extreme caution. Patients must be closely observed
if CO2x limit alarms are disabled.
WARNING – When monitoring an anesthetized patient in an operating
room environment, it is recommended to connect the CO2 exhaust
port of the Nightingale PPM3 to the hospital’s waste gas scavenging
system so as to prevent exposure for other patients and hospital
personnel to the patient’s respiratory sample. Ensure that sampled
gases are not returned from the exhaust port to a breathing system
such as a ventilator. Use standard clinical guidelines and/or hospital
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procedures. Scavenge vacuum greater than 1mmHg may result in
damage to the Nightingale PPM3.
WARNING – Always inspect the airway for a tight connection before
attaching it to the patient.
WARNING – Remove the airway sampling line from the patient’s
airway while nebulizing medications are being delivered.
WARNING – Route all tubing away from the patient’s throat to avoid
strangulation.
WARNING – Do not apply pressurized air to any outlet or tubing
connected to the monitor. Pressure may destroy sensitive elements.
WARNING – When using a sampling line for intubated patients with a
closed suction system, do not place the airway adapter between the
suction catheter and endotracheal tube. This is to ensure that the
airway adapter does not interfere with the functioning of the suction
catheter.
WARNING – Do not cut or remove any part of the sampling line.
Cutting the sampling line could lead to erroneous readings.
WARNING – If too much moisture enters the sampling line (i.e., from
ambient humidity or breathing of unusually humid air), the message
"Purging Line" will appear in the message area. If the sampling line
cannot be cleared, the message "Occluded Line" will appear in the
message area. Replace the sampling line once the "Occluded Line"
message appears.
CAUTION – The Nightingale PPM3 does not produce a CO2 alarms until a
valid CO2 signal is obtained. This is intended to reduce nuisance alarms
during initial patient connection.
CAUTION – Microstream® ETCO2 sampling lines are designed for single
patient use, and are not to be reprocessed. Do not attempt to clean,
disinfect, sterilize or flush any part of the sampling line as this can cause
damage to the monitor.
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CAUTION – Before use, carefully read the Microstream® ETCO2 sampling
lines Directions for Use.
CAUTION – Only use Microstream® ETCO2 sampling lines to ensure the
monitor functions properly.
Note – When the caution message "Occluded Line" appears on the screen, indicating
that the sampling line which is attached to the monitor is blocked, the monitor’s CO2
pump will stop pumping the patient’s breath into the monitor for testing. Follow the
instructions that appear in the Troubleshooting chapter of this manual: First disconnect
and reconnect the sampling line. If the message still appears, disconnect and replace
the line. Once a working sampling lie is attached to the monitor, the pump will
automatically resume operation.
Note – The IPI is not intended to replace accurate clinician assessment of the patient’s
ventilatory status. The IPI can be used as another data point in the overall assessment
of the patient.
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7.5. Oridion CO2 Monitoring Messages
Note – Factory default CO2 alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Parameter
Value
Possible Cause
ETCO2 < [lower limit]
[number]
The patient’s ETCO2
parameter value has
fallen below the current
lower alarm limit.
Check the patient and provide any
necessary clinical care.
ETCO2 > [upper limit]
[number]
The patient’s ETCO2
parameter value has
risen above the current
upper alarm limit.
Check the patient and provide any
necessary clinical care.
[number]
The patient’s FICO2
parameter value has
risen above the current
upper alarm limit.
Check the patient and provide any
necessary clinical care.
Message
FICO2 > [upper limit]
[number]
RR < [lower limit]
-or[0]
RR > [upper limit]
RR out of range (too high)
[number]: The patient’s
respiration rate (RRc)
has fallen below the
current lower alarm limit.
[0]: No breath has been
detected for the userconfigurable apnea time.
[number]
The patient’s respiration
rate (RRc) has risen
above the current upper
alarm limit.
The patient’s respiration
rate (RRc) has risen
above the maximum
value the monitor can
accurately detect.
---
Suggested Action
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Monitor confused by
signal artifact.
IPI < [lower limit]
CO2 Warming Up
March 2015
[number]
---
The patient’s IPI
parameter value has
fallen below the current
lower alarm limit.
CO2 module is preparing
to acquire data.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Allow more time.
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Message
IPI age range not set
CO2 Unplugged
CO2 Occluded Line
Parameter
Value
---
Possible Cause
For pediatric patients,
the age range must be
set to correctly determine
IPI.
z
Suggested Action
Set the age range in the CO2 setup
screen.
Connect the CO2 sampling line to the
PPM3.
---
CO2 sampling line is not
connected.
---
CO2 sampling line cannot
be cleared due to
moisture or other
obstruction.
Replace the sampling line. If connected
to scavenging system, disconnect to see
if message disappears.
Disable CO2 monitoring in the PPM3
Parameters menu if these parameters
are no longer clinically required.
CO2 Purging Line
---
Microstream module is
trying to clear excess
humidity
If the message disappears, resume
usage. If the purging operation is
unsuccessful or the Occluded Line
message appears, disconnect the line
and reattach. If the problem continues,
replace the sampling line.
CO2 problem detected
---
CO2 interface has
encountered a problem.
Check the CO2 subsystem including
sampling line and exhaust port. Verify
that the exhaust port is not blocked.
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Masimo CO2 Monitoring
8. Masimo CO2 Monitoring
8.1. Overview of CO2 Monitoring
CO2 monitoring – also known as capnography – is a method for assessing a
patient’s ventilation status through the monitoring of carbon dioxide levels in
their breath. Two different Masimo capnography modules – the ISATM and the
IRMATM – are available for use with the Nightingale PPM3. The Masimo ISATM
utilizes a non-invasive approach known as sidestream capnography, whereby a
portion of a patient’s inhaled and exhaled gases are diverted into a disposable
nasal cannula. The gases collected through the cannula are continuously passed
through a moisture-eliminating wick/bacterial filter and then through an infrared
spectrometer, which is housed within the small ISA module. Based on the
amount of infrared light absorbed, the amount of CO2 present and the respiration
rate can be determined.
Figure 24. Masimo ISA Module
With Nomoline
Figure 25. Masimo IRMA Module
With Airway Adapter
The Masimo IRMATM utilizes an approach known as mainstream capnography in
which a disposable airway adapter is inserted directly in-line with the patient’s
breathing circuit, such that all of their inhaled and exhaled gases are analyzed.
The IRMA module, which contains the infrared spectrometer, clips around the
outside of the adapter. From the perspective of the clinician, the ISA and IRMA
module uses the same user interface and connect through the same OMD port on
the Nightingale PPM3.
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The CO2 monitoring capabilities of the Nightingale PPM3 configured with
Masimo capnography include:
•
Measuring the patient’s end-tidal carbon dioxide (ETCO2)
•
Measuring the patient’s fractional inspired carbon dioxide (FICO2)
•
Calculating the patient’s respiration rate (RRc) from CO2
•
Displaying CO2 waveform (capnograph) continuously
•
Detecting Apnea conditions with a configurable time setting
8.2. Getting Started with Masimo CO2 on the PPM3
To begin CO2 monitoring with Masimo ISA or IRMA capnography, use the
following procedure:
1. Connect the electrical/data cable which is part of the ISA module or
IRMA adapter into the Other Medical Device (OMD) port labeled as
“1010 B”or “EtCO2” on the left side of the PPM3.
2. If CO2 monitoring has not been enabled (indicated by the presence of
impedance respiration box with blue labels underneath the green HR
parameter box), press the SETUP key on the PPM3, scroll the control
knob to Parameters, press the knob, press on the highlighted "ETCO2
Enabled," scroll to "Yes," and press the knob. Press the Main Screen key
to apply the changes. Now the CO2 waveform area and parameter box
should appear in yellow beneath the top channel ECG lead – replacing the
impedance respiration parameter box and waveform area.
3. Connect Masimo accessories:
a. ISA (sidestream):
Connect a Masimo Nomoline accessory to the
Light Emitting Gas Inlet (LEGI) connector on
the front of the ISA module (See Figure 24).
The most commonly used accessory will be the
Nomoline adapter with a female Luer Lock
connector. Once the adapter is plugged
Figure 26. Nomoline Adpater
in, the LEGI will begin flashing in green
Female Luer Lock
as the ISA self-zeroes, and the message
area on the PPM3 will display "CO2 Warming Up."
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This will only last a few seconds, and the LEGI will change to a steady
green when the module is ready.
b. IRMA (mainstream):
Using the appropriate adult or pediatric IRMA airway
adapter, snap the IRMA module in place onto the
adapter. The LED on top of the module will begin
flashing in green as the IRMA self-zeroes, and the
message area on the PPM3 will display "CO2 Warming
Up." This will only last a few seconds, and the LED
will change to a steady green when the module
Figure 27. Snapping IRMA
is ready.
Onto Adapter
4. Apply to patient or breathing circuit:
a. ISA (sidestream):
Connect an appropriate nasal cannula or other sampling line with a
male Luer Lock fitting to the Nomoline adapter. Apply the other end
to the patient according to the instructions supplied.
Note – Using sampling lines or cannulas with an inner diameter larger than 1 mm
will increase the ISA’s total response time.
b. IRMA (mainstream):
Connect the IRMA airway adapter between the breathing circuit Ypiece and the patient’s endotracheal tube – or into any other suitable
ventilation system. Perform a tightness check of the breathing circuit.
5. With either the ISA or IRMA module the CO2 waveform and numeric
parameter values should appear on the PPM3 main screen within a few
seconds. Verify parameter values and waveforms for correctness.
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8.3. Checking the CO2 Signal
When you have connected the patient following the steps listed above, you should
be able to see a CO2 waveform on the PPM3 display as shown below. The PPM3
should also display values for the patient's end-tidal carbon dioxide (ETCO2),
fractional inspired carbon dioxide (FICO2), respiration rate from CO2 (RRc), and
alarm limit settings. With either the ISA or IRMA modules there is negligible
impact on CO2 measurement accuracy in the presence of O2 or N2O as long as the
correct O2 and/or N2O Compensation value has been selected. See Figure 37 as
well as the PPM3 Monitor Settings chapter.
Figure 28. Masimo CO2 Waveform and Values
To manually test CO2 monitoring alarm functionality on a daily basis, you may
use the following approach. First, either connect the patient to the Nightingale
PPM3 using the above procedure or continue as follows with a patient who is
already being monitored. Then, enable the alarms ETCO2, RRc, and FICO2.
Next, lower the ETCO2 upper alarm limit setting below its current value. Verify
that "ETCO2 < [upper limit]" annunciates as a medium grade alarm. Press the
ALARM SILENCE key, and return the ETCO2 upper alarm limit to its previous
value. Verify that the alarm is no longer active, and that CO2 monitoring
continues normally. Repeat this process in turn for the RRc and FICO2
parameters.
The CO2 Monitoring settings and specifications for the Nightingale PPM3 may be
found in the PPM3 Monitor Settings and Technical Data chapters. Procedures for
changing configuration settings, such as adjusting alarm limits, changing the
waveform size (amplitude), setting the apnea time, or selection O2 and/or N2O
compensation values may be found in the Working With Menus chapter.
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8.4. Masimo LED Indicator
The LEGI Status Indicator on the ISA module and the Status LED on the IRMA
module may be interpreted according to the table presented below. Also consult
any result messages the PPM3 may present as found in Section 8.6 – Masimo CO2
Monitoring Messages.
Color and Pattern
Indication
Steady green light
Blinking green light
System OK
Zeroing in progress
Steady blue light
Steady red light
Blinking red light
Anesthetic agent present
Sensor error
Check adapter
8.5. Zeroing Masimo CO2 Modules
For the IRMA (mainstream) CO2 module, zeroing is performed by snapping a
new IRMA airway adapter onto the IRMA module, without connecting the airway
adapter to the patient circuit, and then pressing the Zero Set menu button in the
Setup CO2 menu. An alert tone will sound when the zeroing procedure has
started, along with a “CO2 zeroing” message. The alert tone will resound when
the zeroing procedure has completed.
Special care should be taken to avoid breathing near the airway adapter before or
during the Zeroing procedure. The presence of ambient air (21% O2 and 0% CO2)
in the IRMA airway adapter is of crucial importance for a successful zeroing.
Zeroing needs to be performed only when an offset in gas values is observed, or
when the “CO2 needs zeroing” message is displayed. When initially connecting
the IRMA CO2 probe to the PPM3 or when changing IRMA airway adapters,
allow a 10-second warm-up period before initiating the zeroing procedure.
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Once zeroing has completed, reconnect the airway adapter into the breathing
circuit, using the Getting Started instructions that are described earlier in this
section.
For the ISA (sidestream) CO2 module, zeroing is performed automatically by the
module by switching the gas sampling from the breathing circuit to ambient air.
This auto-zeroing is performed 1 to 3 times per 24 hours, and takes less than 3
seconds to complete. The zeroing procedure can also be initiated via the Zero Set
menu button in the Setup CO2 menu, though this is not usually needed.
.
WARNING (ISA) – The ISA sidestream gas analyzer is intended for
use by authorized healthcare professional only.
WARNING (ISA) – Carefully route the sampling line to reduce the risk
of patient entanglement or strangulation.
WARNING (ISA) – Do not lift the ISA or the PPM3 monitor by the
sampling line as it could disconnect from the ISA or PPM3, causing
the ISA or PPM3 to fall on the patient.
WARNING (ISA) – Dispose Nomoline Family sampling lines in
accordance with local regulations for biohazardous waste.
WARNING (ISA) – Use only airway T-adapters with the sampling point
in the center of the adapter.
WARNING (ISA) – Do only use sample lines intended for anesthetic
agents if N2O or anesthetic agents are being used.
WARNING (ISA) – Do not use T-adapter with infants, as this adds 7
ml dead space to the patient circuit.
WARNING (ISA) – Do not use the ISA analyzer with metered-dose
inhalers or nebulized medications as this may clog the bacteria filter.
WARNING (ISA) – Since a successful zeroing requires the presence
of ambient air (21% O2 and 0% CO2), ensure that the ISA is placed in a
well ventilated place. Avoid breathing near the ISA sidestream gas
analyzer before or during the zeroing procedure.
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WARNING (ISA) – Never sterilize or immerse the ISA sidestream gas
analyzer in liquid.
WARNING (ISA) – ISA sidestream gas analyzer is intended only as an
adjunct in patient assessment. It must be used in conjunction with
other assessments of clinical signs and symptoms.
WARNING (ISA) – Measurements can be affected by mobile and
portable RF communications equipment. Make sure that the ISA
sidestream analyzer is used in the electromagnetic environment
specified in this manual.
WARNING (ISA) – Replace the sampling line if the sampling line input
connector starts flashing red, or a "CO2 Occluded Line” message
appears on the PPM3.
WARNING (ISA) – No modification of this equipment is allowed
without authorization of the manufacturer. If this equipment is
modified, appropriate inspection and testing must be conducted to
ensure continued safe operation.
WARNING (ISA) – ISA sidestream gas analyzers are not appropriate
for MRI environments.
WARNING (ISA) – During MRI scanning, the ISA must be placed
outside the MRI suite.
WARNING (ISA) – Use of high frequency electrosurgical equipment in
the vicinity of the ISA analyzer may product interference and cause
incorrect measurements.
WARNING (ISA) – Do not apply negative pressure to remove
condensed water from the Nomoline family sampling line.
WARNING (ISA) – Too strong positive or negative pressure in the
patient circuit might affect the sample flow.
WARNING (ISA) – Strong scavenging suction pressure might affect
the sample flow.
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WARNING (ISA) – Exhaust gases should be returned to the patient
circuit or to a scavenging system.
WARNING (ISA) – Due to the risk of patient cross-infection, always
use a bacteria filter on the exhaust port side if sampled gas is
intended to be re-breathed.
WARNING (ISA) – Do not place the ISA gas analyzer in any position
that might cause it to fall on the patient.
WARNING (ISA) – Do not re-use disposable single-patient use
Nomoline Family sampling lines due to the risk of cross
contamination.
WARNING (ISA) – Do not sterilize or immerse Nomoline Family
sampling lines in liquid.
WARNING (ISA) – Do not operate the ISA sidestream gas analyzer if
the enclosure is damaged.
WARNINGS (IRMA) – The IRMA probe is intended for use by
authorized and trained medical personnel only.
WARNINGS (IRMA) – The IRMA probe is intended only as an adjunct
in patient assessment. It must be used in conjunction with other
assessments of clinical signs and symptoms.
WARNINGS (IRMA) – The IRMA probe must not be used with
flammable anesthetic agents.
WARNINGS (IRMA) – Disposable IRMA airway adapters shall not be
reused. Reuse of the single use adapter can cause cross infection.
WARNINGS (IRMA) – Used airway adapters shall be disposed of in
accordance with local regulations for medical waste.
WARNINGS (IRMA) – Do not use the IRMA Adult/Pediatric airway
adapter with infants as the adapter adds 6 ml dead space to the
patient circuit.
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WARNINGS (IRMA) – Do not use the IRMA infant airway adapter with
adults as this may cause excessive flow resistance.
WARNINGS (IRMA) – Measurements can be affected by mobile and
RF communications equipment. It should be assumed that the IRMA
probe is used in the electromagnetic environment specified in this
manual.
WARNINGS (IRMA) – Do not place the IRMA airway adapter between
the endotracheal tube and an elbow as this may allow patient
secretions to block the adapter windows and result in incorrect
operation.
WARNINGS (IRMA) – To keep secretions and moisture from pooling
on the windows or oxygen sensor port, always position the IRMA
probe in a vertical position with the LED pointing upwards.
WARNINGS (IRMA) – Do not use the IRMA airway adapter with
metered dose inhalers or nebulized medications as this may affect
the light transmission of the airway adapter windows.
WARNINGS (IRMA) – Incorrect probe zeroing will result in false gas
readings.
WARNINGS (IRMA) – Incorrect agent selection by the user for IRMA
OR (no automatic agent identification) will result in false agent
readings.
WARNINGS (IRMA) – Replace the airway adapter if rainout or
condensation occurs inside the airway adapter.
WARNINGS (IRMA) – Use only PHASEIN manufactured IRMA airway
adapters.
WARNINGS (IRMA) – The IRMA probe is not intended to be in patient
contact.
CAUTION (ISA) – The ISA analyzer should be securely mounted in order
to avoid the risk of damage to the ISA.
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CAUTION (ISA) – Do not operate the ISA sidestream gas analyzer outside
the specified operating environment.
CAUTION (ISA) – (U.S. only) Federal law restricts this device to sale by or
on the order of a licensed healthcare practitioner.
CAUTION (IRMA) – Never sterilize or immerse the IRMA probe in liquid.
CAUTION (IRMA) – IRMA airway adapters are non-sterile devices. Do not
autoclave the devices as this will damage them.
CAUTION (IRMA) – Do not apply tension to the probe cable.
CAUTION (IRMA) – Do not operate the IRMA probe outside the specified
operating environment.
CAUTION (IRMA) – (U.S. only) Federal law restricts this device to sale by
or on the order of a physician.
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8.6. Masimo CO2 Monitoring Messages
Note – Factory default CO2 alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Message
ETCO2 < [lower limit]
ETCO2 > [upper limit]
FICO2 > [upper limit]
Parameter
Value
Possible Cause
[number]
The patient’s ETCO2
parameter value has
fallen below the current
lower alarm limit.
Check the patient and provide any
necessary clinical care.
[number]
The patient’s ETCO2
parameter value has
risen above the current
upper alarm limit.
Check the patient and provide any
necessary clinical care.
[number]
The patient’s FICO2
parameter value has
risen above the current
upper alarm limit.
Check the patient and provide any
necessary clinical care.
[number]
RR < [lower limit]
-or[0]
RR > [upper limit]
RR out of range (too high)
[0]: No breath has been
detected for the userconfigurable apnea time.
[number]
---
[number]: The patient’s
respiration rate (RRc)
has fallen below the
current lower alarm limit.
The patient’s respiration
rate (RRc) has risen
above the current upper
alarm limit.
The patient’s respiration
rate (RRc) has risen
above the maximum
value the monitor can
accurately detect.
Suggested Action
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
Monitor confused by
signal artifact.
CO2 Warming Up
---
CO2 module is preparing
to acquire data.
Allow more time.
CO2 Unplugged
---
ISA module or IRMA
sensor have become
unplugged from PPM3.
Reconnect the electrical/data cable to
OMD port labeled “1010 B” or "EtCO2".
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Message
CO2 Occluded Line
CO2 No Sampling Line
CO2 Check Adapter
Parameter
Value
Possible Cause
z
Suggested Action
---
ISA CO2 sampling line
cannot be cleared due to
moisture or other
obstruction.
Replace the sampling line. If connected
to scavenging system, disconnect to see
if message disappears.
---
ISA CO2 sampling line
has become unplugged
from the LEGI connector
on the front of the
module.
Reconnect the sampling line.
---
1) The lens within IRMA
airway adapter has
become fogged or
blocked.
Replace or reconnect the airway adapter.
2) IRMA airway adapter
has become unplugged
from the sensor.
CO2 Needs Zeroing
CO2 Check Sensor
CO2 problem detected
8-12
---
CO2 zero offset needs to
be removed.
Follow the zeroing procedure provided in
this chapter.
---
ISA module or IRMA
sensor have reported an
internal error.
Disconnect the module or adapter from
the PPM3 and then reconnect. Contact
technical support if the problem
continues.
CO2 interface has
encountered a problem.
Check the CO2 subsystem including
sampling line and exhaust port. Verify
that the exhaust port is not blocked.
Power-cycle the PPM3. Contact
technical support if the problem
continues.
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IBP Monitoring
9. Invasive Blood Pressure Monitoring
9.1. Overview of IBP Monitoring
Invasive blood pressure monitoring (P1 and P2) is a direct measurement of the
patient’s arterial or venous pressure. The invasive pressure setup, consisting of
connecting tubing, a pressure transducer, and a fluid source to maintain pressure
(all connected together by stopcocks) is attached to the catheter. The transducer is
placed at the same level with the heart, and is electrically zeroed. The transducer
is a piezo-resistive device that converts the pressure signal to a voltage. The
monitor interprets the voltage signal so that pressure data and pressure waveforms
can be displayed.
The IBP monitoring capabilities of the Nightingale PPM3 include:
•
Measuring the patient’s pressures across two IBP channels (P1 and P2)
•
Calculating the P1 and P2 values in mmHg using either Sys/Dia (Mean) or
(Mean) Sys/Dia formats
•
Calculating pulse rate from an IBP labeled as ART
•
Displaying P1and P2 values with a choice of P1 and P2 (default) or ART,
PA, and CVP labels
•
Displaying P1 and P2 waveforms continuously
To begin IBP monitoring, use the following procedure:
1. If IBP monitoring has not been enabled (indicated by the absence of P1 or
P2 parameter boxes and waveform areas below SpO2), press the Setup key
on the PPM3, scroll the control knob to Parameters and press, scroll to
"IBP Channels," press the knob, and scroll from "None" to "1" or "2"
pressing the knob to select your choice. Press the Main Screen key to
apply the changes. Now the P1 and P2 waveform areas and parameter
boxes (or just P1 if "1" was selected) should appear beneath the SpO2 area.
"P1 needs zeroing" and "P2 needs zeroing" messages should also appear in
the message area.
2. Connect the PPM3 IBP Y-cable accessory to the P1/P2 labeled invasive
pressure port on the left side of the Nightingale PPM3. Then connect the
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invasive pressure cable(s) to the Y-cable, while keeping track of the P1
and P2 labels on Y-cable connectors to make sure you have the correct
IBP cable connected to the correct port on the Y-cable.
Note – From this point, complete steps 3 through 9 first for P1. Repeat, substituting P2
for P1 as required.
3. Connect each transducer manifold to the correct invasive pressure cable.
4. Scroll the control knob to the P1 parameter box and press the knob.
5. Select the invasive pressure label for this channel if the P1 default is not
appropriate.
6. Verify format (Sys/Dia or Mean) and waveform size are appropriate.
7. Zero the pressure by opening the transducer vent, and then scrolling the
PPM3 control knob to "Zero Set" and pressing. This should cause the "P1
needs zeroing message" to transition to "P1 zeroing" and then "P1 zero
okay." The numeric values for P1 should also display as zeroes.
8. Close the transducer vent.
9. Connect the transducer to the patient per clinical guidelines. Follow
standard hospital procedures for zeroing and flushing the pressure line.
9.2. Checking the IBP Signal(s)
When you have connected the patient following the steps listed above, you should
be able to see IBP waveform(s) on the PPM3 display as shown below. The PPM3
should also display values for the patient's P1 and P2 pressures (with correct
formats and labels) as well as the alarm limit settings (shown as disabled for
systolic, mean, and diastolic below).
Figure 29. IBP Waveforms and Values
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To manually test IBP alarm functionality on a daily basis, you may choose from
two approaches. First, if a patient is currently being monitored with IBP, make
certain the alarms are enabled, and then lower the P1 (or P2) systolic upper alarm
limit setting below its current value. Verify that "P1s < [upper limit]" (or P2s)
annunciates as a medium grade alarm. Press the ALARM SILENCE key, and
return the upper alarm limit to its previous value. Verify that the alarm is no
longer active. Alternatively, when first connecting an IBP, unplug the IBP cable
from the Y-cable after completing step 7 above. Verify that "P1 unplugged" (or
P2) alarm annunciates as a low grade alarm. Plug the cable back in. Verify that
the alarm ceases. Then re-zero the pressure and continue with steps 8 and 9.
The IBP Monitoring settings and specifications for the Nightingale PPM3 may be
found in the PPM3 Monitor Settings and Technical Data chapters. Procedures for
changing configuration settings, such as adjusting waveform sizes, alarm limits,
etc. may be found in the Working With Menus chapter.
WARNING – All invasive procedures involve risks to the patient. Use
aseptic technique. Follow catheter manufacturer's instructions and
established hospital guidelines.
WARNING – Always follow the hospital standard of care and prudent
clinical discretion for connecting, zeroing, and monitoring IBP lines.
WARNING – Operating the Nightingale PPM3 with P1 and/or P2 alarm
limits disabled means that no low or high P1 and/or P2 alarm
conditions will product alarm notifications. Use this feature with
extreme caution. Patients must be closely observed if P1 and/or P2
limit alarms are disabled.
WARNING – Ensure that no part of the patient connections touches
any electrically conductive material including earth.
WARNING – Only use invasive pressures transducers that can
withstand defibrillation as required by ANSI/AAMI BP22 standard.
WARNING – Mechanical shock to the invasive blood pressure
transducer may cause severe shifts in zero balance and calibration,
and cause erroneous readings.
Note – To reduce nuisance alarms, the invasive pressure alarms are inactivated for a few
seconds during the zeroing process. Invasive pressure alarms are reactivated shortly
after the zeroing process has been completed.
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IBP Monitoring
9.3. IBP Monitoring Messages
Note – Factory default IBP alarm and limit settings may be found in the PPM3 Monitor
Settings chapter.
Note – Substitute P2 for P1 as required in the following table.
Message
Parameter
Value
Possible Cause
Suggested Action
Check the patient and provide any
necessary clinical care.
P1s < [lower limit]
P1m < [lower limit]
[number]
P1d < [lower limit]
The patient's invasive
systolic/diastolic/mean
pressure has fallen
below the current lower
alarm limit.
Verify that the values are not due to
artifact by checking the position of the
patient, cables and transducer. Zero set
the pressure if necessary.
Change the alarm limit if it is no longer
clinically appropriate.
Check the patient and provide any
necessary clinical care.
P1s > [upper limit]
P1m > [upper limit]
The patient's invasive
systolic/diastolic/mean
pressure has risen above
the current upper alarm
limit.
Verify that the values are not due to
artifact by checking the position of the
patient, cables and transducer. Zero set
the pressure if necessary.
--
The invasive signal is out
of range.
--
IBP cable or transducer
not plugged
Change the alarm limit if it is no longer
clinically appropriate.
Verify the position of the patient, cables
and transducer. Zero set the pressure if
necessary
Verify that the cable and transducer are
properly connected.
[number]
P1d > [upper limit]
P1 signal out of range [low]
P1 signal out of range [high]
P1 unplugged
Press ALARM SILENCE if intentionally
unplugged by clinician.
Unable to zero
--
Stopcock is not open
Open the stopcock and check tubing and
cables
Zero required
--
IBP channel not zeroed
Zero the IBP channel
Zero required and 60 seconds
has expired
--
IBP channel not zeroed
Zero the IBP channel
Calibration required
--
IBP channel requires
calibration
Arrange for calibration service of the IBP
channel
Calibration in progress
--
IBP channel calibration
is in progress
Wait until the calibration process is
completed
Cannot calibrate
--
Calibration failed
Contact Zoe Medical technical support
ART: Check Transducer
--
ART IBP pressure below
10mmHg
Check ART catheter to ensure that it is
properly positioned and connected
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Temperature Monitoring
10. Temperature Monitoring
The temperature monitoring capabilities of the Nightingale PPM3 include:
•
Measuring the patient's temperature using a core temperature probe
•
Displaying the TEMP parameter in degrees Celsius or degrees Fahrenheit
To begin temperature monitoring, use the following procedure:
1. Fully insert the probe into a probe cover.
2. Apply the probe to the patient
Please refer to the Accessories chapter for a list of Zoe Medical
approved temperature probes for use with the Nightingale PPM3.
For oral application: Insert the probe as indicated in the Zoe
Medical "Oral Temperature Probe Instructions," P/N 122-0030.
For surface application: Apply the probe to a location on the
patient that stays fairly dry (the abdomen is recommended). To
ensure good adhesion, clean the skin with alcohol before-hand.
Tape the probe and cable to the patient’s skin.
3. Connect the temperature probe cable to the PPM3.
Note
Probe performance is unaffected when used without a probe cover.
Note
Follow the instructions for use provided with the probe packaging.
Note
Place the probe according to the clinical techniques of your hospital.
Note
Skin surface temperature is typically 2 to 3 °F below core temperature.
10.1. Checking the Temperature
When you have connected the patient following the steps listed
above, you should be able to see a temperature value on the
PPM3 display as well as the alarm limit settings (shown as
disabled below).
Figure 30. TEMP Value
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To manually test TEMP alarm functionality on a daily basis, you may choose
from two approaches. First, if a patient’s temperature is currently being
monitored, make certain the alarms are enabled, and then lower the TEMP upper
alarm limit setting below its current value. Verify that "TEMP < [upper limit]"
annunciates as a medium grade alarm. Press the ALARM SILENCE key, and
return the upper alarm limit to its previous value. Verify that the alarm is no
longer active, and that temperature monitoring continues normally. Alternatively,
before initiating temperature monitoring with a patient, you can verify TEMP
alarm functionality by rubbing a probe (with cover applied) between your hands
until an upper limit alarm is generated.
The Temperature Monitoring settings and specifications for the Nightingale
PPM3 may be found in the PPM3 Monitor Settings and Technical Data chapters.
Procedures for changing the units or adjusting alarm limits may be found in the
Working With Menus chapter.
WARNING – Disabling the Temperature alarm limits means that no
low or high TEMP alarm conditions will produce alarm notifications.
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10.2. Temperature Monitoring Messages
Note – Factory default Temperature alarm and limit settings may be found in the Menu
Settings table in the PPM3 Monitor Settings chapter.
Message
TEMP < [lower limit]
TEMP > [upper limit]
TEMP unplugged
TEMP out of range
Parameter
Value
Possible Cause
[number]
The patient's
temperature has fallen
below the current lower
alarm limit.
Check the patient and provide any
necessary clinical care.
[number]
The patient's
temperature has risen
above the current upper
alarm limit.
Check the patient and provide any
necessary clinical care.
[blank]
---
Temperature probe
disconnected
The patient's
temperature has risen
above the maximum
value the monitor can
accurately detect.
There is a problem with
the connections or with
the hardware.
TEMP problem detected
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Suggested Action
---
Monitor has detected a
hardware problem.
Change the alarm limit if it is no longer
clinically appropriate.
Change the alarm limit if it is no longer
clinically appropriate.
Check to make sure the temperature
probe is connected to the temperature
cable.
Check to make sure the temperature
cable is connected to the PPM3.
Check the patient and provide any
necessary clinical care.
Check the temperature cable
connections.
Turn the monitor off, then on.
If message persists, contact Zoe
technical support.
Turn the monitor off, then on.
If message persists, contact Zoe
technical support.
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11. Working With Menus
The PPM3 menus allow you to view the configuration settings for each of the
vital sign parameters and make changes to the settings as necessary. This is
accomplished by navigating the different menus via the control knob. Turning the
knob clockwise or counterclockwise allows you to scroll through menu items.
Pressing the knob selects the currently highlighted menu item.
When the PPM3 is displaying the Main Screen, turning the knob highlights the
various parameter boxes in turn. Selecting a given parameter box brings up a
menu that allows you to change settings related to that parameter. When you
have entered the change you wanted to make, select OK. If you select Cancel, the
menu will disappear, and the setting will keep the value it had when you first
brought up the menu.
This chapter instructs you in how to use these parameter setup menus as well as
the menus behind keys on the PPM3 front panel.
Note – The complete list of factory default settings for the Nightingale PPM3 may be
found in the PPM3 Monitor Settings chapter.
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11.1. Parameter Menus
11.1.1.
ECG and Heart Rate
Figure 31. Setup HR Menu
Setting
Description
Lower Limit
HR/PR alarm lower limit
Upper Limit
HR/PR alarm upper limit
Auto
Auto-adjust lower limit to 80% of current value and upper limit to
125% of current value.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm condition
ECG Lead
Select lead used for HR processing
Size
Changes display amplitude of ECG waveform
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HR Source
Calculate HR/PR from ECG (default green), SpO2 (cyan), or ARTlabeled IBP (red). See Figure 28 for HR/PR parameter box
appearance when HR Source is SpO2 or ART.
Pulse Tone Source
Enables audible tones for each detected beat. When source is
SpO2, the tone pitch varies (higher SpO2 % = higher pitch).
ECG Filter
Set to either Monitor (0.67 – 40 Hz) or Diagnostic (0.05 – 40 Hz)
Cal
Injects a simulated 1 mv calibration pulse into the ECG waveform
Figure 32. HR/PR Values Sourced From SpO2 or ART
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Respiration
Figure 33. Setup RR Menu
Setting
Description
Lower Limit
RR alarm lower limit
Upper Limit
RR alarm upper limit
Auto
Auto-adjust lower limit to 80% of current value and upper limit to
125% of current value.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm condition
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11.1.3.
Working With Menus
Pulse Oximetry
Figure 34. Setup SpO2 Menu
Setting
Description
Lower Limit
SpO2 alarm lower limit
Upper Limit
SpO2 alarm lower limit
Auto
Auto-adjust SpO2 lower limit to 95% of current value and set
upper limit to 100%.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm condition
HR Source
Calculate HR/PR from ECG (default), SpO2, or ART-labeled
IBP. See Figure 28 for HR/PR parameter box appearance
when HR Source is SpO2 or ART.
Pulse Tone Source
Enables audible tones for each detected beat. When source is
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SpO2, the tone pitch varies (higher SpO2 % = higher pitch)
SpO2 Alarm
Acknowledge
11-6
Clears SpO2 alarms until a patient is once again detected at the
SpO2 sensor
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11.1.4.
Working With Menus
Non-Invasive Blood Pressure
Figure 35. Setup NBP Menu
Setting
Description
Lower Limit
NBP systolic/mean/ diastolic alarm lower limits
Upper Limit
NBP systolic/mean/ diastolic alarm upper limits
Auto
Auto-adjust NBP lower limits to 80% of current values and upper
limits to 125% of current values.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm conditions
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NBP Interval
Take NBP measurements automatically at periodic intervals. The
NBP Interval setting is remembered between power cycles.
However, the PPM3 does not start Interval Mode NBP
measurements after power up until the NBP Start/Stop key is
pressed. This tells the PPM3 that the cuff has been applied to the
patient and that NBP monitoring should commence.
Initial Inflation
Pressure
The NBP cuff is inflated to this pressure if a systolic pressure from
previous measurement is not displayed. Otherwise, 40 mmHg is
added to the previous systolic pressure for the next inflation
pressure.
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11.1.5.
Working With Menus
Oridion CO2 / Capnography
Figure 36. Setup CO2 Menu With Oridion Capnography
Setting
Description
Lower Limit
ETCO2, RRc, & IPI alarm lower limits
Upper Limit
ETCO2, RRc, & FICO2 alarm upper limits
Auto
Auto-adjust lower limits to 80% of current values and upper limits to
125% of current values.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm conditions
Size
Changes display amplitude of CO2 waveform
Apnea Time
Time since last breath before RRc alarm annunciates
IPI Enabled
Enables (Yes) or disables (No) Integrated Pulmonary Index
Age Range
Required age range for IPI use with pediatric patient
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Masimo CO2 / Capnography
Figure 37. Setup CO2 Menu With Masimo Capnography
Setting
Description
Lower Limit
ETCO2 & RRc alarm lower limits
Upper Limit
ETCO2, RRc, & FICO2 alarm upper limits
Auto
Auto-adjust lower limits to 80% of current values and upper
limits to 125% of current values.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm conditions
Size
Changes display amplitude of CO2 waveform
Apnea Time
Time since last breath before RRc alarm annunciates
O2 Compensation
Adjust CO2 value based on this range O2% in fresh gas
N2O Compensation
Adjust CO2 value based on this range N2O% in fresh gas
Zero Set
Initiate manual zeroing of CO2 sensor (see Masimo CO2
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Monitoring chapter)
CO2 Alarm
Acknowledge
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Clears CO2 alarms and parameter values until a patient is once
again detected at the CO2 sensor
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Invasive Blood Pressure
Figure 38. Setup IBP Menu
Setting
Description
Lower Limit
P1 systolic/mean/diastolic alarm lower limits
Upper Limit
P1 systolic/mean/diastolic alarm upper limits
Auto
Auto-adjust lower limits to 80% of current values and upper limits to
125% of current values.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm conditions
Label
Changes label from default to ART, PAP, or CVP.
Size
Changes display amplitude of P1 waveform
Format
Displays either Sys/Dia or Mean numeric value in larger font
Zero Set
Zeroes P1 when transducer vent has been opened
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11.1.8.
Working With Menus
Temperature
Figure 39. Setup TEMP Menu
Setting
Description
Lower Limit
TEMP alarm lower limit
Upper Limit
TEMP alarm upper limit
Auto
Auto-adjust lower limit to 95% of current value and upper limit to
105% of current value.
Alarms On
Enables (Yes) or disables (No) alarms
Print on Alarm
Print a strip chart summary upon alarm conditions
Note – When you change the TEMP Units setting (°F or °C) from the Setup System
menu, recheck the TEMP alarm limit settings, as some round-off error may occur when
the limit settings are switched to the new units of measure.
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11.2. Front Panel Keypad Menus
11.2.1.
SETUP Key and Submenus
When you press the SETUP key on the PPM3 front panel, the top-level Setup
Menu appears.
Figure 40. SETUP Key Menu
This menu gives you access to a variety of functions and sub-menus.
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If you select the "Alarm Pause" item, the PPM3 will temporarily disable all alarm
monitoring. Selecting "Alarm Resume" from the same spot on the Setup Menu
will resume alarm monitoring. An "Alarms Paused" condition is indicated in the
message area with a timer indicating when alarm monitoring will resume. There
is also an alarms paused symbol displayed to the left of the message area.
Figure 41. Main Screen With Alarms Paused Message & Timer
WARNING – Pausing all alarms pauses all alarm conditions including
lethal arrhythmias (Asystole and VFib). Use this feature with extreme
caution as alarm checking is suspended for all alarm conditions.
Patients must be closely observed if all alarms are suspended.
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If you select the "Parameters" item, the Setup Parameters Menu appears.
Figure 42. Setup Parameters Menu
The Setup Parameters menu allows you to enable ETCO2 (CO2 / Capnography)
and IBP (Invasive Blood Pressure) Monitoring, if these components are present in
your Nightingale PPM3 monitor, but have not been turned on from a software
standpoint.
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If you change "Numbers Only" to "Yes," the Main Screen will display all the
monitored physiological parameters with large numbers instead of sharing some
of the space with waveforms.
Figure 43. Numbers Only Main Screen
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If you select the "Waveforms" item, the Setup Waveforms Menu is displayed.
Figure 37 below shows the Setup Waveforms Menu as it is appears when IBP
Monitoring is not enabled. Figure 38 shows the menu as it appears when two IBP
channels have been enabled.
Figure 44. Setup Waveforms Menu
The Setup Waveforms Menu allows you to choose which physiological
waveforms to display in each of the three possible waveform display channels
(five with two IBP channels enabled). The range of possible choices for the
waveform display channels may be found in the Waveform Settings table in the
PPM3 Monitor Settings chapter. For ECG and CO2 waveforms, you can also
choose what size (amplitude) setting to use. For the CO2 waveform, you can also
choose whether the CO2 waveform is filled in to make it more visible from a
distance.
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This menu is also used to set the sweep speed for the eraser bar, turn on or turn
off the display of ECG labels on the main display, and to turn on or turn off the
display of spikes that are drawn in the waveforms to show where the monitor
detects beats.
Figure 45. Setup Waveform Menu with IBPs
You may also choose the size (amplitude) of the invasive pressure waveforms.
Note – When a communications link with the MPC is established, these settings will be
overridden by those that are received from the MPC. In the case where the sweep speed
is set to 50 mm/sec at the MPC, the PPM3 will use a 25 mm/sec sweep speed instead.
This is the highest sweep speed that is supported by the PPM3.
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If you select the "Audio" item, the Setup Audio Menu appears.
Figure 46. Setup Audio Menu
The Speaker Volume allows you to change the volume for alarm tones.
The HR/PR Tone Volume allows you to change the volume for pulse tones. You
can also enable the HR/PR Tone and select the source from this menu, just as you
can from the Setup HR and Setup SpO2 menus.
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If you select the "Alarms" item, the Setup Alarms Menu appears. The three
screens associated with this menu are presented below and on the following two
pages.
Figure 47. Setup Alarms Menu – Screen 1
This menu provides access to the alarm settings for all parameters at once for your
convenience. Any changes made here are also reflected in the individual
parameter box menus, and vice versa.
The factory default values and ranges of possible values for all alarm limits may
be found in the Parameter Settings table of the PPM3 Monitor Settings chapter.
When you select the "Auto" feature for a parameter’s alarms, the PPM3
automatically adjusts the upper and lower limits based on the current value of the
parameter. The rules used for each of the parameters are provided in the table on
the next page.
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Parameter
Lower limit adjustment
Upper limit adjustment
Changed to 80% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
Changed to 125% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
FICO2
N/R
Changed to 125% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
IPI
Changed to 75% of the
current parameter value (or
the nearest allowable value
given the alarm limit settings
rules)
HR/PR, RR,
ETCO2, RRc
NBPs/m/d,
P1s/m/d,
P2s/m/d
N/R
SpO2
Changed to 95% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
Set to 100%
Temp
Changed to 95% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
Changed to 105% of the
current parameter value (or
the nearest allowable value
given alarm limit rules)
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Figure 48. Setup Alarms Menu – Screen 2
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Figure 49. Setup Alarms Menu – Screen 3
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If you select the "Patient Information" item, the Patient Information Menu
appears.
Figure 50. Patient Information Menu
This menu provides a way of entering and examining patient information. Entries
such as name, ID, or room will appear on the Main Screen and printed reports. If
you are using the Nightingale MPC, entries made here when admitting a patient
will be transmitted to the MPC. Also, if a patient is admitted at the MPC and
assigned to a particular PPM3, the information will be transmitted to this menu.
The Patient Information Menu is also the place to
change the patient type from Adult to Pediatric.
As shown in the figure, a symbol indicating the
current patient type is displayed in the lower right
area of the Main Screen. Refer to the PPM3
Monitor Settings chapter to compare factory
default adult and pediatric settings.
Figure 51. Adult Patient Type
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If you select the "Restore Department Defaults" item, the Restore Department
Defaults Menu appears.
Figure 52. Restore Department Defaults Menu
When you choose to Restore Department Defaults, any changes made to the
patient settings (parameter & waveform settings) for the current patient will be
restored to the previously saved Department Default values. Or, if no Department
Defaults have previously been created, the settings will be restored to the Factory
Default values found in the PPM3 Monitor Settings chapter.
Department Defaults can only be saved from within the password protected Setup
System Menu.
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If you select the "Administration" item, the Setup Administration Menu appears.
Figure 53. Setup Administration Menu
Each of the selections on this menu leads to further submenus.
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If you select the "Configuration" item, the Setup Configuration Menu appears.
Figure 54. Setup Configuration Menu
The Setup Configuration menu provides a way of seeing what hardware and
software versions are currently installed on the Nightingale PPM3.
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11.2.2.
Working With Menus
Password Protected Menus
If you select "Alarms," "System," "Service," or "Factory" on the Setup
Administration Menu, the PPM3 brings up the Enter Password Menu.
Figure 55. Enter Password Menu
This menu allows you to enter a password to proceed to the Setup Alarms or
Setup System menu.
The password for these menus is located at the end of the Maintenance and
Storage chapter of this document.
Note – The Service and Factory setup menus are intended to be used by trained service
and production personnel.
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The Setup Alarms Menu allows changes to certain aspects of alarm handling.
Figure 56. Setup Alarms Menu
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The settings that can be changed via the Setup Alarms menu include:
Setting
Description
Alarm Silence Time
Time that alarm will be silenced after you press the
ALARM SILENCE key (unless a new alarm comes in)
Alarm Suspend Time
Time that alarms will be suspended after you select the
Alarm Suspend item in the top level Setup menu
Can Suspend All Alarms
This setting controls if the clinician is able to suspend all
alarms including lethal arrhythmias (Asystole and VFib).
Alarm Validation
Enables/disables alarm validation (if enabled, limit alarms
are not annunciated until values have been out of limits for
a set period of time – see Managing Alarms chapter)
Second Speaker Time
Time that elapses while an alarm tone in sounding before
the second speaker starts sounding
Note -- When a communications link with the MPC is established, these settings will be
overridden by those that are received from the MPC.
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The Setup System Menu allows changes to a few items that are rarely changed.
Figure 57. Setup System Menu
The settings that can be changed via the Setup System menu include:
Setting
Description
Temp Units
Allows you to choose °F or °C
Height Units
Allows you to choose inches (in) or centimeters (cm)
Weight Units
Allows you to choose pounds (lb) or kilograms (kg)
Print Location
When connecting to the MPC, allows you to specify where
hard copy reports are printed (Bedside Only, Central Only,
Bedside And Central)
NOTE – When a communications link with the MPC is established, these Units settings
will be overridden by those received from the MPC.
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If you select the "Select Date and Time" item, the Set Date and Time Menu
appears.
Figure 58. Set Date and Time Menu
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If you select the "Save Department Defaults" item, the Save Department Defaults
Menu appears.
Figure 59. Save Department Defaults Menu
The Save Department Defaults menu allows you to configure the PPM3 for your
particular application. Once the patient monitoring settings have been configured
as desired, selecting this choice will allow you to save the current settings as the
baseline for all new patients. The settings that are saved include all of those listed
in the Parameter Settings and Waveform Settings tables found in the PPM3
Monitor Settings chapter.
WARNING – A potential hazard can exist if the department default
alarm settings are not consistent among all the Nightingale PPM3
monitors deployed within the same clinical area.
The Show Event Log item brings up the system event log, which contains useful
troubleshooting information.
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11.2.3.
Working With Menus
NBP INTERVAL Key
If you press the NBP INTERVAL key, the PPM3 brings up the menu that allows
you to change the automatic NBP Interval Mode settings.
Figure 60. Setup NBP Interval Menu
To select an automatic NIBP interval:
1. Press the NBP INTERVAL key to display the Setup NBP Interval menu.
2. Select the NBP Interval item by pressing the control knob.
3. Scroll the control knob to the desired NIBP Interval (Off, 2m, 3m, 5m, 10m,
15m, 30m, and 60 minutes) and press to select it.
4. Press OK button or the MAIN SCREEN key to enter/apply that change or
press Cancel to cancel the changes.
- Selecting OK with an interval chosen prompts the monitor to begin that
interval. You can manually initiate by pressing the NBP START/STOP
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key, but the system will automatically take the first and subsequent
measurements based on the o’clock as per the system time.
The chosen interval is displayed as “NBP Interval – N Minutes” in the
system message area, where N is the value selected.
To stop a particular measurement within NBP Interval Mode, simply press the
NBP START/STOP key. However, “NBP Interval – N Minutes” will continue to
be displayed in the message area, and another measurement will automatically be
initiated at the next interval. To fully disable NBP Interval Mode, you must reenter the Setup NBP Interval menu and change the Interval to Off.
The NBP Interval setting is remembered after a Standby or a power cycle with the
same patient. However, the PPM3 does not automatically initiate NBP Interval
Mode measurements after a Standby or a power cycle until the NBP
START/STOP key is pressed. This tells the PPM3 that the cuff has been applied
to the patient and that NBP monitoring should commence. Once the key has been
pressed, the interval will display in the message area and the measurements will
proceed thereafter based on the o’clock as per the system time.
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11.2.4.
Working With Menus
STANDBY Key
If you press the STANDBY key, the Standby Menu appears, presenting you with
the various Standby options. See the Entering Standby Mode chapter for details
regarding Standby Mode.
11.2.5.
TRENDS Key
If you press the TRENDS key, the Nightingale PPM3 brings up the Trends
display. See the Viewing Trends chapter for details regarding trends.
11.2.6.
MAIN SCREEN Key
If you press the MAIN SCREEN key, the Nightingale PPM3 goes back to the
Main Screen.
Note – If a menu is on display when you press the MAIN SCREEN key, the PPM3
interprets this as if you had first selected the OK button on the menu. Any settings
changes that would have been effected with the OK button are applied.
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12. Managing Alarms
You can configure the PPM3 to audibly and visually report an alarm condition
when a patient’s physiological parameter goes beyond a predetermined limit.
Some parameter alarms are enabled as a factory defaults. One example is the
heart rate alarm, which sounds and flashes when the patient’s heart rate rises
above 120 bpm or drops below 50 bpm. Alarm monitoring can be individually
configured for each physiological parameter.
Both the Nightingale PPM3 and the Nightingale MPC support alarm monitoring.
When the PPM3 and MPC are connected, they use the same alarm monitoring
settings. If a setting is changed at either the PPM3 or the MPC, then the setting is
updated at both the PPM3 and the MPC. This is also true for alarm silencing. For
example, if you silence an alarm at the PPM3 by pressing the ALARM SILENCE
key on the front panel keypad, it is also silenced at the MPC.
When the PPM3 and MPC are initially connected, there is special handling to
merge the alarm settings of the two devices. Please see the Centralized
Monitoring chapter (Remote Control Settings) for more details.
In addition to the physiological parameter alarm monitoring, the PPM3 will report
technical alarm conditions that prevent monitoring such as lead off, a low battery
condition, or when the connection is lost between the PPM3 and the MPC for
some reason.
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12.1. Alarm Presentation Basics
There are three "grades" of alarms on the PPM3 – high, medium, and low – and
they all present in different ways as described in the following two tables.
12.1.1.
Audible Alarm Tones
If you hear a…
It represents…
Five higher-pitch tones (three
quick, pause, two more)
repeated every 8 seconds
A "high grade" alarm indicating an
immediately life-threatening condition
(e.g. asystole or ventricular fibrillation)
Three medium-pitch tones
repeated every 15 seconds
A "medium grade" alarm indicating a
physiological condition that may be
serious (e.g. parameter limit violations)
A single lower-pitch tone
repeated every 20 seconds
A "low grade" alarm indicating a
technical condition (e.g. lead off)
12.1.2.
Visual Alarm Colors
If you see a…
Red background
parameter box
and message area
Yellow
background
parameter box
and message area
Cyan background
parameter box
and message area
12-2
And …
It represents…
Flashing color – twice
per second
A "high grade" alarm is
currently active and has not
been acknowledged
Solid color with alarm
silence symbol to the left
of the message area
A "high grade" alarm is
currently active but has
already been silenced
Flashing color once
every 2 seconds
A "medium grade" alarm is
currently active and has not
been acknowledged
Solid color with alarm
silence symbol to the
left of the message area
A "medium grade" alarm is
currently active but has
already been silenced
Solid color
A "low grade" alarm is
currently active and has not
been acknowledged
Solid color with alarm
silence symbol to the
left of the message area
A "low grade" alarm is
currently active but has
already been silenced
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Since several parameters could be alarming at the same time, the alarm tone and
color will reflect the highest grade alarm condition that is currently active on the
PPM3. Refer to the tables in Section 11.2 Alarm Conditions to see how different
alarm conditions are categorized by grade.
12.1.3.
How to Silence Alarms
Action may be taken to “silence" alarms in one of the following two ways.
•
Pressing the ALARM SILENCE key on the front panel
•
Changing the parameter alarm limits such that the current value is no
longer out of limits (if the alarm was a limit violation alarm)
If after pressing ALARM SILENCE, the alarm condition is still true, the tone will
cease, the flashing backgrounds will change to a solid color, and the alarm silence
symbol will appear to the left of the message area.
Figure 61. Silenced & Active HR Limit Alarm
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If the alarm condition is still true when the "alarm silence time" expires (as
configured in the Setup Alarms menu), then the backgrounds of the parameter box
and message area will automatically resume flashing and the alarm tone resume as
well. However, if the alarm condition goes away while the alarm is silenced, then
the backgrounds will automatically switch to black and the tone will not resume.
Each alarm condition has an associated "annunciation type." The annunciation
type is one of the following:
•
"One-time" – the annunciation will be done only once (annunciation
ends once you silence the condition, even if the condition is still true).
•
"Persistent" – the annunciation will repeat after the "alarm silence
time" expires, as long as the alarm condition is true.
Alarm conditions that are "one-time" include an unplugged probe, a lead-off and
all NBP alarm conditions. The remaining alarm conditions are "persistent."
The lethal Asystole and Ventricular Fibrillation alarms are both "persistent" and
"latching." What is meant by "latching" is that they require acknowledgment. So
if a patient goes into an asystole or ventricular fibrillation condition and then
returns to a normal sinus rhythm within the HR alarm limits, the "HR Asystole"
or "HR Ventricular Fibrillation" alarms will continue to annunciate until they are
acknowledged with the ALARM SILENCE key. If the patient is in a normal
sinus rhythm at the time the key is pressed, they will not resume. On the other
hand, if the ALARM SILENCE key is pressed when either of these two lethal
alarms first annunciate, they will behave like other persistent alarms.
12.1.4.
Alarm Messages
When an alarm condition is active, a text message is displayed in the message
area at the bottom of the display (e.g. "HR lead off"). If there are multiple alarm
conditions, then the messages are displayed in a "round-robin" manner. That is,
one message is displayed at a time. If multiple messages are active, each message
is displayed for approximately 3 seconds at a time. See the Alarm Conditions
section of this chapter for a list of alarm messages.
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12.1.5.
Managing Alarms
How to Enable or Disable Alarms
Alarm conditions are not annunciated unless alarms are enabled for a given
parameter. The enabling or disabling of alarms is done via the "Alarms On"
selection item in the Setup Alarms menu or in the individual parameter setup
menus. See Figures 47, 48, and 49 in the "Working With Menus" chapter, which
present the Setup Alarms Menu.
Alarms may be temporarily disabled for all parameters by choosing the Alarm
Pause item in the Setup menu. See Figure 34 in the "Working With Menus"
chapter, which shows the main screen with the "Alarms Paused" message, timer,
and symbol. When this menu item is selected, all alarms are disabled for the
"Alarm Pause Time" (as configured in the Setup Alarms menu under the Setup
Administration menu).
When the alarm pause time expires, alarm monitoring is restored for each
parameter based on the "Alarms On" menu setting for the parameter. You can
restore alarm monitoring before the alarm pause timer expires by selecting the
Alarm Resume item – which takes the place of Alarm Pause on the Setup menu
(the two items toggle).
Alarms can be indefinitely disabled for all parameters by entering Standby Mode.
See the Entering Standby Mode chapter for details.
WARNING – Pausing all alarms pauses all alarm conditions including
lethal arrhythmias (Asystole and VFib). Use this feature with extreme
caution as alarm checking is suspended for all alarm conditions.
Patients must be closely observed if all alarms are suspended.
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12.1.6.
Alarm Validation
Under the password-protected Setup Alarms menu (under the Setup
Administration menu), there is a feature called Alarm Validation. When this
feature is enabled, certain parameter limit violations are not considered to be in
alarm until they have existed for a certain time period, as listed below:
Limit Violation
Alarm Validation
Time
HR Upper Limit
5 seconds
HR Lower Limit
5 seconds
RR Upper Limit
5 seconds
SpO2 Upper Limit
5 seconds
SpO2 Lower Limit
5 seconds
IBP Upper Limit
5 seconds
IBP Lower Limit
5 seconds
The purpose of this feature is to reduce nuisance alarms in which parameter
values may go out of limits for a very short time.
Note – Alarm Validation is enabled as a factory default.
12.1.7.
Alarm Handling at Start-up
When the PPM3 is initially powered-up or brought out of standby, alarms will not
be annunciated for a given parameter until the lead set or probe has been applied
to the patient. This prevents nuisance alarms for parameters that are not being
monitored on a given patient.
12.1.8.
Alarm Reports
When the Nightingale PPM3 is connected to the MPC Central Station, an alarm
report is stored at the MPC for each medium- and high-grade alarm that is
annunciated for the HR parameter. This includes upper and lower limit
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violations, Asystole, and Ventricular Fibrillation. These reports include a
snapshot of the physiological parameters and an ECG waveform "strip" from the
PPM3.
When the PPM3 is disconnected from the MPC (in Transport Mode), the 10 most
recent alarm reports are stored within the PPM3. The reports will remain in the
PPM3 memory even if power is turned off. When the PPM3 is reconnected to the
MPC, the reports are transferred to the MPC. Manually-generated reports (via the
PPM3’s print key) are also stored while in Transport Mode, and are counted as
part of the 10 reports.
See the MPC User’s Guide discussion on the Alarm Log for more details on alarm
reports.
12.1.9.
Audible Alarm Tones While Connected to the MPC
When the PPM3 is connected to the MPC central station, it can be configured to
sound an alarm tone for high-grade alarms only (e.g., Asystole). This may be
especially helpful at night when the patient is sleeping. If the communications
link between the PPM3 and MPC is broken, the monitor will once again generate
an alarm tone for all alarms.
This feature is configured at the MPC. See the MPC User’s Guide for more
details.
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12.1.10.
z
Second Speaker Alarm Tones
The second speaker feature of the Nightingale PPM3 enhances the alarm tone
functionality by providing a completely independent backup to the monitor's main
speaker.
The way the second speaker works is very simple. Whenever the monitor starts
sounding an audible tone for an alarm condition, it starts a timer. If the alarm
tone is still sounding after a certain length of time (normally two minutes), the
second speaker will also start sounding. When you silence the alarm, both the
main speaker and the second speaker (if it was sounding) are silenced.
The amount of time delay between when the main speaker starts sounding and
when the second speaker starts sounding can be set anywhere between 0 to 180
seconds via the Setup Alarms menu (under the Setup Administration menu).
Since the second speaker has a slightly different sound than the main speaker, it
also serves to provide you with an indication of when a given alarm has been
sounding for longer than the pre-set delay time.
Other than starting the second speaker after the pre-set delay time, there is no
change to the way the monitor handles alarms, or to the way you need to respond
in order to silence or suspend the alarm tones.
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12.2. Alarm Conditions
The tables in this section contain lists of all the conditions the PPM3 can detect
for each parameter, along with alarm characteristics of the condition. The first
row in each table contains the "normal condition" for the parameter, and the other
rows contain the "alarm conditions" for the parameter.
Columns in these tables have the following meaning:
•
Condition – the name of the condition
•
Display value – the value displayed for the parameter when the condition
is true (applies only to physiological parameters)
•
Alarm grade – as defined earlier in this chapter
•
Message – the text of a message displayed in the message area when the
condition is true
•
Annunciation type – as defined earlier in this chapter
Note – The delay between alarm annunciation on the PPM3 and remote annunciation on
the MPC central station should be no more than 1 sec.
General Monitor Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
Monitor okay
N/A
None
None
Persistent
Monitor problem detected
N/A
Low
Monitor need service
One-time
MPC Communication Link Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
MPC link okay
N/A
None
None
Persistent
MPC link lost
N/A
Low
MPC connection lost
Persistent
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PPM3 Battery Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
Battery okay
N/A
None
None
Persistent
Battery low
N/A
Low
Battery low
One time
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
HR within limits
<Number>
None
None
Persistent
HR < LL
<Number>
Medium
HR < LL
Persistent
HR > UL
<Number>
Medium
HR > UL
Persistent
HR Asystole
ASY
High
HR asystole
Persistent
HR Ventricular Fibrillation
VF
High
HR ventricular fibrillation
Persistent
HR Lead-off (after
startup/standby)
<Blank>
None
None
Persistent
HR Lead-off (after leads applied)
<Blank>
Low
HR lead off
One Time
---
Low
HR artifact
Persistent
HR Conditions:
HR Artifact
RR Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
RR within limits
<NUM>
None
None
None
RR < LL
<NUM>
Medium
RR < LL
Persistent
RR > UL
<NUM>
Medium
RR > UL
Persistent
---
Low
RR out of range (too high)
Persistent
Lead-off (after start-up / standby)
<Blank>
None
None
Persistent
Lead-off (after leads applied)
<Blank>
Low
RR lead off
One Time
---
Low
RR artifact
Persistent
RR > 120 breaths/min
Resp Artifact
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SpO2 Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
SpO2 within limits
<NUM>
None
None
None
SpO2 < LL
<NUM>
Medium
SpO2 < LL
Persistent
SpO2 > UL
<NUM>
Medium
SpO2 > UL
Persistent
---
Low
SpO2 replace sensor
One Time
<Blank>
None
None
Persistent
SpO2 Cannot regulate LED
intensity (after finger in probe)
---
Low
SpO2 check sensor
placement
Persistent
SpO2 Pulsations Too Weak
---
Low
SpO2 weak signal
Persistent
SpO2 Probe is disconnected
(after start-up/standby)
<Blank>
None
None
Persistent
SpO2 Probe is disconnected
(after finger in probe)
---
Low
SpO2 unplugged
One Time
SpO2 motion artifact
---
Low
SpO2 artifact
Persistent
SpO2 Bad Probe
SpO2 Cannot regulate LED
intensity (after start-up/standby)
PR Conditions:
Note When PR is sourced from SpO2, the Pulse Rate is labeled in cyan as "HR
(SpO2)" in the HR parameter box. When PR is sourced from an ART-labeled IBP, the
PR is labeled in red as "HR (ART)." PR alarm conditions annunciate as HR alarms.
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
PR within limits
<NUM>
None
None
None
PR < LL
<NUM>
Medium
HR < LL
Persistent
PR > UL
<NUM>
Medium
HR > UL
Persistent
---
Low
SpO2 replace sensor
One Time
<Blank>
None
None
Persistent
PR Cannot regulate LED
intensity (after finger in probe)
---
Low
SpO2 / HR check sensor
placement
Persistent
PR Pulsations Too Weak
---
Low
SpO2 / HR weak signal
Persistent
PR Probe is disconnected
(after start-up/standby)
<Blank>
None
None
Persistent
PR Probe is disconnected
(after finger in probe)
---
Low
SpO2 / HR unplugged
One Time
PR motion artifact
---
Low
SpO2 artifact
Persistent
PR Bad Probe
PR Cannot regulate LED
intensity (after start-up/standby)
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NBP Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
NBPs within limits
<NUM>
None
None
None
NBPs < LL
<NUM>
Medium
NBPs < LL
One Time
NBPs > UL
<NUM>
Medium
NBPs > UL
One Time
NBPm within limits
<NUM>
None
None
None
NBPm < LL
<NUM>
Medium
NBPm < LL
One Time
NBPm > UL
<NUM>
Medium
NBPm > UL
One Time
NBPd within limits
<NUM>
None
None
None
NBPd < LL
<NUM>
Medium
NBPd < LL
One Time
NBPd > UL
<NUM>
Medium
NBPd > UL
One Time
NBP Pulsations Too Small
---
Low
NBP weak signal
One Time
NBP Too Much Motion
---
Low
NBP artifact
One Time
NBP Leaky Cuff or Hose
---
Low
NBP cuff leak
One Time
NBP Pinched Hose
---
Medium
NBP blocked hose -- check
patient
One Time
NBP Measurement Time-out
(2¼ minutes)
---
Low
NBP measurement time
exceeded
One Time
NBP Pump or Valve Failure or
NBP Safety Timer Expired or
Other H/W-related problem
---
Medium
NBP problem detected
One Time
NBP Bad Profile Shape
---
Low
NBP cannot measure
One Time
CO2 Conditions:
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
ETCO2 within limits
<Number>
None
None
Persistent
ETCO2 < [lower limit]
<Number >
Medium
ETCO2 < LL
Persistent
ETCO2 > [upper limit]
<Number >
Medium
ETCO2 > UL
Persistent
FICO2 within limits
<Number>
None
None
Persistent
FICO2 > [upper limit]
<Number >
Medium
FICO2 > UL
Persistent
RRc within limits
<Number>
None
None
Persistent
RRc < [lower limit]
<Number >
Medium
RR < LL
Persistent
RRc > [upper limit]
<Number >
Medium
RR > UL
Persistent
ETCO2 out of range (high)
<Number >
Medium
CO2 out of range (high)
Persistent
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FICO2 out of range (high)
<Number >
Medium
CO2 out of range (high)
Persistent
CO2 Unplugged (after startup/standby)
<Blank>
None
None
Persistent
CO2 Unplugged (after line
connected)
<Blank>
Low
CO2 unplugged
One Time
Power up (10 to 30 seconds)
<Blank>
None
CO2 warming up
Persistent
In Self-Maintenance Mode (autozero)
<Blank>
None
CO2 zeroing
Persistent
Module is purging the line
<Blank>
None
CO2 purging line
Persistent
Line is occluded
---
Low
CO2 occluded line
Persistent
H/W failure – module malfunction
---
Low
CO2 problem detected
One Time
Calibration in progress
<Blank>
None
CO2 calibrating
Persistent
Calibration completed – ok
N/A
Alert
CO2 calibration ok
Alert
Calibration failed – supplied gas
is not close to expected value
N/A
Alert
CO2 cal failed – wrong gas
Alert
Calibration failed – occlusion
during known gas sampling
N/A
Alert
CO2 cal failed
Alert
Calibration failed – FilterLine
unplugged during calibration
N/A
Alert
CO2 cal failed
Alert
IBP (P1 and P2) Conditions:
Note – P2 has the same conditions as P1. Substitute P1 with P2 as required in the
following table.
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
Systolic pressure within limits
<Number>
None
None
Persistent
Systolic pressure < LL
<Number >
Medium
P1s < LL
Persistent
Systolic pressure > UL
<Number >
Medium
P1s > UL
Persistent
Mean pressure within limits
<Number>
None
None
Persistent
Mean pressure < LL
<Number >
Medium
P1m < LL
Persistent
Mean pressure > UL
<Number >
Medium
P1m > UL
Persistent
Diastolic pressure within limits
<Number>
None
None
Persistent
Diastolic pressure < LL
<Number >
Medium
P1d < LL
Persistent
Diastolic pressure > UL
<Number >
Medium
P1d > UL
Persistent
HR (ART) within limits
<Number>
None
None
Persistent
HR (ART) < LL
<Number >
Medium
HR < LL
Persistent
HR (ART) > UL
<Number >
Medium
HR > UL
Persistent
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Pressure signal out of range
(low)
<Number >
Medium
P1 out of range (low)
Persistent
No pulse rate due to static
pressure
---
Low
HR weak signal
Persistent
Unplugged (after startup/standby)
<Blank>
None
None
Persistent
Unplugged (after line connected)
<Blank>
Low
P1 unplugged
One Time
Zero required (when transducer
is initially connected)
<Blank>
None
P1 needs zeroing
Persistent
Zero required and 60 seconds
has expired.
---
Low
P1 needs zeroing
Persistent
Zero in progress
<Blank>
None
P1 zeroing
Persistent
Zero failed – pulsatile waveform
N/A
Alert
P1 unable to zero - unstable
Alert
Zero failed – out of range
N/A
Alert
P1 unable to zero - out of
range
Alert
Calibration required
<Blank>
None
P1 needs calibration
Persistent
Calibration required and 60
seconds has expired.
---
Low
P1 needs calibration
Persistent
Calibration in progress
<Blank>
None
P1 calibrating
Persistent
Calibration failed – pulsatile
waveform
N/A
Alert
P1 unable to calibrate unstable
Alert
Calibration failed – bad cal
resistor
---
Low
P1 problem detected
Persistent
Condition
Display
Value
Alarm
Grade
Message
Annunciation
Type
TEMP within limits
<NUM>
None
None
None
TEMP < LL
<NUM>
Medium
TEMP < LL
Persistent
TEMP > UL
<NUM>
Medium
TEMP > UL
Persistent
Temperature Conditions:
Temp > 50 degrees C
---
Low
TEMP out of range
Persistent
TEMP probe disconnected
---
Low
TEMP unplugged
One Time
TEMP bad calibration resistor
---
Low
TEMP problem detected
Persistent
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12.3.
Managing Alarms
What To Do When You Hear An Alarm Tone
When you hear an alarm tone, you should look at the message area of the PPM3
display screen to see why the tone is sounding. The action you should take
depends on the message you see, as the following table shows:
Message displayed
What to do
Check the patient.
Any physiological alarms
Consult the messages table in the appropriate physiological
monitoring chapter (e.g., ECG Monitoring) for possible
causes and suggested actions.
Check to make sure that the Network Cable is still securely
connected to the PPM3 and to the wall plate marked
"Nightingale Monitoring System."
MPC connection lost
Talk to the MPC operator and check to make sure that the
MPC is still operating normally.
If none of these steps is successful, contact Zoe Medical
Technical Support.
Power-cycle the PPM3.
Monitor problem detected
Battery low
March 2015
If this message continues, contact Zoe Medical Technical
Support.
Plug the PPM3 Monitor into a wall outlet to recharge the
internal battery.
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12.4. Manual Self-test of the Alarm System
You can manually self-test test the alarm system by the following steps:
•
Make certain that the SpO2 alarms on (via the Setup SpO2 parameter
menu). Attach the SpO2 sensor to your index finger and wait for the
monitor to display a SpO2 parameter value. Unplug the sensor from the
PPM3. After 10 seconds, the PPM3 should sound a low grade alarm tone,
flash the SpO2 parameter box, and display the message "SpO2 unplugged."
•
If the PPM3 is being monitored at the MPC, then disconnect the PPM3
from the communications wall outlet. After 30 seconds, the PPM3 should
sound a low grade alarm tone and display the message "MPC connection
lost."
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Centralized Monitoring
13. Centralized Monitoring
This chapter describes how to connect the Nightingale PPM3 to the Nightingale
MPC central monitoring station. In such installations, communication lines will
have been installed from the MPC to the various patient locations where
monitoring will be performed. Near the patient location, these communication
lines will be connected to a wall plate marked "Nightingale Monitoring System."
The PPM3 is connected to this wall plate.
In the Nightingale Monitoring System, the MPC can automatically track the
patient’s movement when the PPM3 is moved from one patient location to
another. It is not necessary to reassign the patient at the MPC.
For details on patient monitoring at the MPC, please see the Nightingale MPC
User’s Guide.
13.1. Connecting to the MPC
In order to connect the PPM3 to the MPC, connect the Network Cable to the
Network Connector labeled as
on the right side of the PPM3. Then plug the
other end of the Network Cable into the wall plate connector marked "Nightingale
Monitoring System.”
When this connection is made (and the PPM3 is powered-on), the MPC and
PPM3 will start to communicate with each other. If a patient is already admitted
at the PPM3, the MPC will start monitoring that patient (even if a different patient
had been admitted at the MPC). However, if no patient had been admitted at the
PPM3, then patient information is loaded into the PPM3 from the MPC.
In either case, you should see the patient name in the patient name area of the
PPM3 main display screen. For new patients, it is a good idea to admit the patient
at the MPC first, since you can then verify that the connection has been made
correctly while you are at the patient's bedside.
WARNING – Always make sure that the correct patient name is
displayed in the PPM3 name area when connected to the MPC. This
is to avoid any chance of mistaking the signals and parameters from
one patient with the signals and parameters from another patient at
the central monitoring station.
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13.2. Remote Control Settings
Most settings used to control the PPM3 can also be set by the MPC operator.
These settings are described in the Working With Menus chapter and include:
•
Patient information (name and initials)
•
Alarm settings (limit settings, alarm on/off settings)
•
Waveforms to display
•
NBP initial inflation pressure and auto-mode setting
•
Pulse tone source
If a setting is changed at either the PPM3 or the MPC, the new setting is used at
both the PPM3 and MPC.
If a patient is already admitted at the PPM3 when a connection is initially made
between the PPM3 and MPC, the PPM3 and MPC alarm settings are merged such
that the more conservative settings are used. That is, the narrower alarm limit
range is used and a parameter alarm remains enabled if it was enabled at either the
PPM3 or MPC.
If no patient is admitted at the PPM3 when the connection is made, then the
PPM3 will use the MPC’s settings without modification.
Some settings are not controllable at the PPM3 when the PPM3 is connected to
the MPC. These include settings that have a system-wide impact at the MPC (e.g.,
the temperature units of measure, alarm suspend time-out values). These settings
are identified in the Working With Menus chapter.
13.3. Disconnecting from the MPC
The PPM3 can be disconnected from the MPC either by detaching the Network
Cable from the wall box or from the connector on the right side of the monitor.
If this is done in order to transport the patient somewhere, then the "Transport
Patient" menu item should be selected in the Standby menu before detaching the
from the network. This will place the MPC in Transport Mode for this patient and
will prevent a "connection lost" alarm from sounding at either the PPM3 or the
MPC. See the Entering Standby Mode chapter for more details.
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Viewing Trends
14. Viewing Trends
Each time the PPM3 takes a NBP blood pressure measurement or at userselectable intervals, it stores the following physiological parameters (provided
they are in use or are enabled) in the trends table along with the current time:
•
Heart Rate or Pulse Rate
•
Non-Invasive Blood Pressure (s/d/m)
•
Respiration Rate
•
Oxygen Saturation (SpO2)
•
End-tidal CO2 (ETCO2)
•
Fractional inspired CO2 (FICO2)
•
Integrated Pulmonary Index (IPI)
•
Temperature (T1)
•
Invasive Blood Pressure (P1 s/d/m and P2 s/d/m)
If a HR value is being sourced from ECG, the trends table will show a HR column
labeled in green.
If PR is being sourced from SpO2, there will be a PR column labeled in cyan.
If PR is being sourced from an ART-labeled IBP, there will be a PR column
labeled in red.
Up to 72 hours of trends data may be stored on the PPM3. All trend samples can
be manually deleted via the trends menu. They are also deleted when a patient is
discharged at the MPC.
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You can view the trends for a patient by pressing the TRENDS key.
Figure 62. Trends Menu
By selecting the "Print" item, you can get a hard copy of the trends data if the
optional Strip Chart Recorder is configured with your PPM3 (see the Strip Chart
Recorder Option chapter).
If your PPM3 is connected to the MPC, this report will print out immediately on
the printer configured with the MPC. Otherwise, the data will be stored
internally, and will upload and print automatically the next time the PPM3 is
connected to the MPC.
Using the up and down arrows on the Trends menu, you can scroll backward and
forward in time through the trends data.
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Viewing Trends
The "Clear" menu item will cause all the trends data to be deleted. Before this
happens, you will be prompted with the following confirmation.
Figure 63. Clear Trends Menu
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Entering Standby Mode
15. Entering Standby Mode
If you press the "Standby" key while a patient is admitted to the PPM3, the PPM3
will present you with the various Standby Mode options.
Figure 64. Standby Menu
Select the "Enter Standby Mode" menu item if you wish to temporarily suspend
all monitoring for this patient (say, when the patient is being bathed). This will
place both the PPM3 and the MPC in Standby Mode for this patient. In addition,
the PPM3 will display the Standby Mode Display.
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Figure 65. Standby Mode
When a key is pressed the previous patient must be confirmed. If you select
"No," that patient will be discharged and a new patient will be admitted. Navigate
to the Setup Patient Information Menu to enter information for the new patient.
Figure 66. Wakeup From Standby Mode
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Entering Standby Mode
WARNING – Patient monitoring will be suspended at both the PPM3
and MPC for this patient when the Enter Standby Mode menu item is
selected.
Select the "Transport Patient" menu item if you are about to disconnect the PPM3
from the MPC in order to move the patient. This will place the MPC in Transport
Mode for this patient and will prevent Connection Lost alarms from being
sounded at both the PPM3 and MPC.
WARNING – Patient monitoring will be suspended at the MPC for this
patient when the Transport Patient menu item is selected.
When the PPM3 is reconnected to the MPC, the MPC will automatically exit
Transport Mode and resume monitoring.
Select the "Discharge Patient" menu item if you are finished monitoring this
patient. This will de-assign the patient from both the PPM3 and MPC (although
the patient’s trend data will still be archived at the MPC). In addition, the PPM3
will restore the monitor’s parameter and waveform settings to the Department
Defaults (last saved setup), and suspend monitoring (as described above).
WARNING – Patient monitoring will be suspended at the MPC for this
patient when the Discharge Patient menu item is selected.
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Battery Operation
16. Battery Operation
The PPM3 contains a lithium-ion rechargeable battery that allows you to
disconnect the PPM3 from the wall power and use it for applications where
mobility is required.
When the PPM3 battery is fully charged, it provides for at least 4 hours of normal
operation. When the PPM3 is operating on battery power, a battery icon appears
on the PPM3 screen to the right of the time. The battery icon is designed to give
an approximate sense of how much battery life is remaining.
Figure 67. Main Screen With Battery Icon
When the battery is running out of charge, the battery icon starts to blink, a Low
Battery alarm message is displayed, and an alarm tone is annunciated. When this
happens, as little as 5 minutes of battery charge is remaining, and the PPM3
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should be connected to a wall outlet in order to prevent a loss of patient
monitoring.
When the battery power is too low to continue normal operation, the PPM3
display will go blank and a constant low-grade tone will be generated.
When the PPM3 is reconnected to the wall power it will begin recharging.
Battery charging occurs regardless of whether the PPM3 is powered on. For
every hour of battery use, it takes about one hour to recharge the battery. A fully
depleted battery takes about 5 hours to fully recharge.
The green LED on the back of the PPM3 indicates that the battery is being
charged. To determine when the battery is full charged, disconnect the battery
from the wall power and check the battery icon on the PPM3 Main Screen (shown
above).
The toggle switch on the back of the PPM3 allows you to turn the PPM3 on and
off.
See the Maintenance chapter for details on how to have the battery replaced.
WARNING – Consult the safety instructions at the front of this
manual regarding the proper use and disposal of the battery.
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Strip Chart Recorder Option
17. Strip Chart Recorder Option
17.1. Basic Operation
PPM3 monitors may be configured with an optional 50mm strip chart recorder
available from Zoe Medical. To start a recording, press the Print key. When a
recording is in progress, you can press the Print key to stop it.
Figure 68. PPM3 Recorder Connection
Plug the recorder cable into the
connector labeled as
on the left
side of the PPM3.
Figure 69.
Replacing Recorder Paper
Press down on the recorder door latch to
release the door. Remove the old spool,
and replace with a new roll. The paper
should come out from under the roll, as
shown in the photo.
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17.2. Recorder Settings
If after pressing the SETUP key, you select the "Recorder" item, the Setup
Recorder menu will appear.
Figure 70. Setup Recorder Menu
The Waveform 1 setting controls which waveform is shown in the top channel of
the strip chart recordings. The Waveform 2 setting controls which waveform is
shown in the bottom channel of the strip chart recordings. If this setting value is
Off, or if it is set to ECG2 but only one ECG waveform is selected for display, the
strip chart recording will have only one waveform.
The Recording Time setting controls the amount of time represented on strip chart
recordings. The Recording Delay setting controls how much of the printed strip
represents time prior to the event that initiated the recording, whether a key press
or an alarm.
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Strip Chart Recorder Option
17.3. Strip Chart Recordings
Strip chart recordings contain a waveform area that includes a 40 mm-wide grid
with descriptive text above and below the grid. The waveform grid has major
divisions at 5 mm intervals and minor divisions at 1 mm intervals, in both the x
and y direction.
The waveform area contains one or two user-selected waveforms. If one
waveform is selected, the waveform uses the entire grid. If two waveforms are
selected, each waveform uses half of the grid, with no overlap. If the same
waveform is selected for both waveform channels, it is treated as a single
waveform selection (i.e., one waveform using the entire grid).
Any displayed waveform may be selected for printing. The printed waveform
scaling and lead-off handling matches that of the displayed waveform. The
descriptive text above the waveform area describes the top waveform. The text
below the waveform area describes the bottom waveform (or is left blank if only 1
waveform is printed). The descriptive text includes the waveform label, the
waveform scale and the associated parameter value. For ECG waveforms, the
frequency response (fixed at monitor) is printed. Additionally, the descriptive
text above the waveform area includes the current date/time, the waveform delay,
and the sweep speed (fixed at 25 mm/sec).
Strip chart recordings contain a trailer with the current date/time and a list of all
parameters (label, value, and units of measure) that are currently on display.
Alarm-generated strip chart recordings contain a header with an "Alarm
Snapshot" banner and a list of the parameters (label, value, and units of measure)
that are currently in alarm.
When a strip chart recording is in progress, you can cancel it by pressing the Print
key.
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Strip Chart Recorder Option
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17.4. Trend Recordings
When the recorder option is installed, the recorder can print out a Trend Report.
This report contains the same information that is presented in the trends display,
with the following additions:
•
A header that includes a Trend Report title and the date/time of the trend
report.
•
The date is displayed along with the time of trend data entries.
•
All trend data entries are printed (including those more than 24 hours old).
•
Temperature is printed in the currently active units of measure along with
the units of measure.
•
A "Patient Demographic" trailer is printed. This provides a space for the
user to write the patient’s name and id, as well as comments. If patient
has been admitted, the patient’s name is printed.
17.5. Recorder Messages
If the recorder door is open, a technical alarm tone sounds and the message
"Recorder door open" is displayed in the bottom display message area.
If the recorder is out of paper, a technical alarm tone sounds and the message
"Recorder out of paper" is displayed in the bottom display message area.
When the recorder option is installed but the recorder is not physically connected,
a technical alarm tone sounds and the message "Recorder problem detected" is
displayed in the bottom display message area.
If the monitor senses a recorder error condition, a technical alarm tone sounds and
the message "Recorder problem detected" is displayed in the bottom display
message area.
When the "Recorder problem detected" message is displayed, the cause of the
failure is logged in the event log for viewing by service personnel.
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Troubleshooting
18. Troubleshooting
The following table is meant to help you solve problems that you may encounter
while operating the PPM3. If you are still experiencing a problem and none of
these steps seem to help, please contact Zoe Technical Support:
WARNING – With the exception of battery replacement, modifications
or repairs of the PPM3 must be done by service personnel that are
authorized by Zoe Medical. Unauthorized modification or repairs may
void the warranty.
Email: [email protected]
Phone: (978) 887-1410
Trouble Symptom
Possible Causes
The PPM3 is plugged in but it
does not start up
Verify that the power outlet is
working.
No power to outlet
The PPM3 Power Supply is not
working
The PPM3 won’t run on battery
power.
March 2015
Things to Try
Verify that the green power LED
on the PPM3 front panel is
illuminated.
Verify that the green charging
LED on the PPM3 rear panel is
illuminated.
If possible, try using a different
PPM3 Power Supply to see if that
is the problem.
The PPM3 is powered off.
Set the power switch to the On
position.
Internal system error
Power cycle the PPM3 – if
condition persists, stop using the
PPM3, contact Zoe Medical
Technical Support to request a
repair or replacement
Battery needs recharging.
Connect the PPM3 to wall power.
Verify that the green charging
LED on the PPM3 rear panel is
illuminated.
Battery will not hold a charge
Replace battery according to the
instructions in the Maintenance
and Storage chapter.
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Troubleshooting
Trouble Symptom
Possible Causes
Things to Try
Patient Information has not been
entered into a standalone PPM3.
Supply the information in the
Setup Patient Information menu.
No connection to MPC
Verify the PPM3 is powered on,
the Network Cable is securely
connected to the PPM3 and the
wall plate labeled "Nightingale
Monitoring System"
Patient has not been admitted at the
MPC
Verify that the patient is admitted
at the MPC
The patient was admitted to the
wrong small view area on the MPC
Verify that the patient is admitted
into the correct small view area
for the PPM3
The connection cabling to the PPM3
has been changed in the
telecommunications closet
Stop using the PPM3, contact Zoe
Medical Technical Support to recheck the system installation
The PPM3 front panel keypad is
not working right
Keypad failure
Stop using the PPM3, contact Zoe
Medical Technical Support to
request a repair or replacement
The PPM3 knob is not working
right
Knob failure
Stop using the PPM3, contact Zoe
Medical Technical Support to
request a repair or replacement
The PPM3 display is not working
right
Display failure
Stop using the PPM3, contact Zoe
Medical Technical Support to
request a repair or replacement
No patient name appears on the
PPM3
The patient name on the PPM3
does not match the name on the
MPC
The PPM3 is not working right
and displays an error message
Operating system failure
The PPM3 displays a message
stating that the disk is too full.
The PPM3’s disk is too full and needs
to be cleaned up.
Stop using the PPM3, contact Zoe
Medical Technical Support to
request a repair or replacement
The PPM3 displays a message
stating that the CPU is too busy.
Internal system failure
Stop using the PPM3, contact Zoe
Medical Technical Support to
request a repair or replacement
Recorder problem detected
Recorder is disconnected, or monitor
has sensed an error condition in the
recorder.
(Recorder option only)
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Power cycle the PPM3 – if
condition persists, stop using the
PPM3, contact Zoe Medical
Technical Support to request a
repair or replacement
Check to be sure the recorder is
still connected.
If this does not help, stop using
the recorder, and contact Zoe
Medical Technical Support to
request a repair or replacement
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PPM3 Monitor Settings
19. PPM3 Monitor Settings
The following tables show the factory default settings (Patient Data, Parameter,
Waveform, and Device) for the Nightingale PPM3 monitor. Note the differences
in certain parameter settings for Adult and Pediatric patient types. You may
adjust the parameter and waveform settings for your particular application, and
then save this configuration as a department default for all new patients. These
department default settings can be adjusted as needed for specific patients, as
shown in the Working With Menus chapter. System Settings are specific to a
particular PPM3 device.
Patient Data Settings
Setting name
Default
value
Possible values
Patient Last Name
<BLANK>
any text string (39 characters maximum)
Patient Middle Initial
<BLANK>
any text string (1 characters maximum)
Patient First Name
<BLANK>
any text string (39 characters maximum)
Patient ID
<BLANK>
any text string (39 characters maximum) but
may not include the following characters (since
they are not legal Windows file names, and the
Patient ID is used to create folder and file
names):
\ / : * ? " < > |
Patient Type
Adult
Patient Sex
<BLANK>
Unknown (BLANK), Male, Female
Patient Date Of Birth Year
<BLANK>
(Current Year – 150) up to Current Year
Patient Date Of Birth Month
<BLANK>
1 - 12
Patient Date Of Birth Day
<BLANK>
1 – maximum number of days in specified
month and year
Patient Height
<BLANK>
Patient Weight
<BLANK>
March 2015
Adult, Pediatric
0 – 157 inches
0 – 400 cm
0 – 1100 lbs
0 – 500 kg
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PPM3 Monitor Settings
Parameter Settings
Setting name
Default value
Adult / Pediatric
Possible values
ETCO2 Enabled
No
---
Yes, No
IBP Channels
None
---
None, 1, 2
Numbers Only
No
---
Yes, No
HR Lower Alarm Limit
50 bpm
---
15 to 299 bpm, Off
HR Upper Alarm Limit
120 bpm
150 bpm
16 to 300 bpm, Off
HR Alarms On
Yes
---
Yes, No
HR Print on Alarm
No
---
Yes, No
II
---
I, II, III, V, aVL, aVR, aVF
10 mm/mV
---
2.5 mm/mV, 5 mm/mV, 10 mm/mV, 15 mm/mV
ECG
---
ECG, SpO2, ART
Off
---
ECG, SpO2, Off
Monitor
(0.67 – 40
Hz)
---
RR Lower Alarm Limit
5 bpm
10 bpm
5 to 149 bpm, Off
RR Upper Alarm Limit
20 bpm
45 bpm
6 to 150 bpm, Off
RR Alarms On
Yes
---
Yes, No
RR Print on Alarm
No
---
Yes, No
ETCO2 Lower Alarm Limit
35 mmHg
---
0 to 145 mmHg, Off
ETCO2 Upper Alarm Limit
45 mmHg
---
5 to 150 mmHg, Off
ETCO2 Alarms On
Yes
---
Yes, No
ETCO2 Print on Alarm
No
---
Yes, No
2 mmHg
---
0 to 98 mmHg, Off
FICO2 Alarms On
Yes
---
Yes, No
FICO2 Print on Alarm
No
---
Yes, No
RRc Lower Alarm Limit
5 bpm
10 bpm
5 to 149 bpm, Off
RRc Upper Alarm Limit
20 bpm
45 bpm
6 to 150 bpm, Off
RRc Alarms On
Yes
---
Yes, No
RRc Print on Alarm
No
---
Yes, No
0 to 40
mmHg
---
0 to 20 mmHg, 0 to 40 mmHg, 0 to 60 mmHg, 0 to 80
mmHg
20 seconds
---
10, 15, 20, 25, 30 seconds
0 to 30
---
0 to 30, 31 to 70, 71 to 100
ECG Lead
(ECG Lead) Size
HR Source
Pulse Tone Source
ECG Filter
FICO2 Upper Alarm Limit
(CO2 waveform) Size
Apnea Time
O2 Compensation (Masimo)
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Diagnostic (0.05 – 40 Hz)
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PPM3 Monitor Settings
Parameter Settings
Setting name
N2O Compensation (Masimo)
Default value
Adult / Pediatric
Possible values
0 to 30
---
0 to 30, 31 to 70
Yes
---
Yes, No
IPI Lower Limit
4
---
1 to 9, Off
IPI Alarms On
No
---
Yes, No
IPI Print on Alarm
No
---
Yes, No
IPI Pediatric Age Range
N/A
<BLANK>
SpO2 Lower Alarm Limit
90%
---
50 to 99%, Off
SpO2 Upper Alarm Limit
IPI Enabled (Oridion)
1 to 3 years, 3 to 6 years, 6 to 12 years
100%
---
51 to 100%, Off
SpO2 Alarms On
Yes
---
Yes, No
SpO2 Print on Alarm
No
---
Yes, No
P1s Lower Alarm Limit
90 mmHg
---
-10 to 249 mmHg, Off
P1s Upper Alarm Limit
180 mmHg
145 mmHg
-9 to 250 mmHg, Off
P1s Alarms On
No
---
Yes, No
P1s Print on Alarm
No
---
Yes, No
P1m Lower Alarm Limit
75 mmHg
---
-10 to 229 mmHg, Off
P1m Upper Alarm Limit
110 mmHg
---
-9 to 230 mmHg, Off
P1m Alarms On
No
---
Yes, No
P1m Print on Alarm
No
---
Yes, No
P1d Lower Alarm Limit
55 mmHg
---
-10 to 209 mmHg, Off
P1d Upper Alarm Limit
100 mmHg
---
-9 to 210 mmHg, Off
P1d Alarms On
No
---
Yes, No
P1d Print on Alarm
No
---
Yes, No
P1 Label
P1
---
P1, ART, PA, CVP
0 to 200
mmHg
---
P1 Format
SYS/DIA
---
SYS/DIA, MEAN
P2s Lower Alarm Limit
90 mmHg
---
-10 to 249 mmHg, Off
P2s Upper Alarm Limit
180 mmHg
145 mmHg
-9 to 250 mmHg, Off
P2s Alarms On
No
---
Yes, No
P2s Print on Alarm
No
---
Yes, No
P2m Lower Alarm Limit
75 mmHg
---
-10 to 229 mmHg, Off
P2m Upper Alarm Limit
110 mmHg
---
-9 to 230 mmHg, Off
(P1 waveform) Size
March 2015
-10 to 20 mmHg, -10 to 60 mmHg, 0 to 150 mmHg,
0 to 200 mmHg, 0 to 250 mmHg, 0 to 300 mmHg
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PPM3 Monitor Settings
Parameter Settings
Setting name
Default value
Adult / Pediatric
P2m Alarms On
No
Possible values
---
Yes, No
No
---
Yes, No
P2d Lower Alarm Limit
55 mmHg
---
-10 to 209 mmHg, Off
P2d Upper Alarm Limit
100 mmHg
---
-9 to 210 mmHg, Off
---
Yes, No
P2m Print on Alarm
P2d Alarms On
No
P2d Print on Alarm
No
---
Yes, No
P2 Label
P2
---
P2, ART, PA, CVP
0 to 200
mmHg
---
SYS/DIA
---
(P2 waveform) Size
P2 Format
TEMP Lower Alarm Limit (Note:
Depends On User Setting For
TEMP Units)
36.0 C
TEMP Upper Alarm Limit (Note:
Depends On User Setting For
TEMP Units)
39.0 C
TEMP Alarms On
97.0 F
102.0 F
No
-10 to 20 mmHg, -10 to 60 mmHg, 0 to 150 mmHg,
0 to 200 mmHg, 0 to 250 mmHg, 0 to 300 mmHg
SYS/DIA, MEAN
32.0 to 41.9 degrees C, Off
---
89.6 to 107.5 degrees F, Off
32.1 to 42.0 degrees C, Off
---
89.7 to 107.6 degrees F, Off
---
Yes, No
No
---
Yes, No
NBPs Lower Alarm Limit
90 mmHg
---
30 to 249 mmHg, Off
NBPs Upper Alarm Limit
180 mmHg
145 mmHg
31 to 250 mmHg, Off
TEMP Print on Alarm
NBPs Alarms On
No
---
Yes, No
No
---
Yes, No
NBPm Lower Alarm Limit
75 mmHg
---
20 to 229 mmHg, Off
NBPm Upper Alarm Limit
110 mmHg
---
21 to 230 mmHg, Off
---
Yes, No
No
---
Yes, No
NBPd Lower Alarm Limit
55 mmHg
---
10 to 209 mmHg, Off
NBPd Upper Alarm Limit
100 mmHg
---
11 to 210 mmHg, Off
---
Yes, No
---
Yes, No
Off
---
Off, 1, 2, 3, 5, 10, 15, 30, 60, 120 minutes
NBP Initial Inflation Pressure
160
mmHg
120 mmHg
Trend Interval
15 min
---
NBPs Print on Alarm
NBPm Alarms On
No
NBPm Print on Alarm
NBPd Alarms On
No
NBPd Print on Alarm
No
NBP Interval
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Nightingale PPM3 User's Guide
100 to 270 mmHg in steps of 10 mmHg
1 min, 5 min, 15 min, 1 h, 4 h
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PPM3 Monitor Settings
Waveform Settings
Setting name
Default
value
Possible values
Channel 1 Waveform
II
I, II, III, V, aVL, aVR, aVF
Channel 2 Waveform
RESP
I, II, III, V, aVL, aVR, aVF, RESP, CO2
Channel 3 Waveform
SpO2
I, II, III, V, aVL, aVR, aVF, SpO2
Channel 4 Waveform
P1
I, II, III, V, aVL, aVR, aVF, P1
Channel 5 Waveform
P2
I, II, III, V, aVL, aVR, aVF, P2
ECG I Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG II Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG III Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG V Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG AVL Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG AVR Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
ECG AVF Waveform Size
10 mm/mV
2.5, 5, 10, 15 mm/mv
CO2 Waveform Size
0 to 40
mmHg
0 to 20, 0 to 40, 0 to 60, 0 to 80 mmHg
P1 Waveform Size
0 to 200
mmHg
-10 to 20, -10 to 60, 0 to 150, 0 to 200, 0 to 250,
0 to 300 mmHg
P2 Waveform Size
0 to 200
mmHg
-10 to 20, -10 to 60, 0 to 150, 0 to 200, 0 to 250,
0 to 300 mmHg
Sweep Speed
25 mm/sec
Show Beat Detect Spikes
No
6.25, 12.5, 25 mm/sec
No, Yes
Recorder Settings
Setting name
Default value
Possible values
Waveform 1
ECG1
ECG1, ECG2, RESP, CO2, SpO2, P1, P2,
NIBP
Waveform 2
RESP
ECG1, ECG2, RESP, CO2, SpO2, P1, P2,
NIBP
Recording Time
12 seconds
8, 12, 20 seconds
Recording Delay
6 seconds
0, 6, 10 seconds
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PPM3 Monitor Settings
Device Settings
Speaker Volume
6
1 to10
Pulse Tone Volume
4
1 to 10
Alarm Silence Time
1 minute
1, 2, or 3 minutes
Alarm Pause Time
1 minute
1, 2, or 3 minutes
Can Pause All Alarms
Yes
Yes, No
Alarm Validation
On
On, Off
Second Speaker Time
2 minutes
0, 1, 2, 3 minutes
Temp Units
Degrees F
Degrees F, Degrees C
CO2 Units
mmHg
mmHg, kPa
Height Units
in
in, cm
Weight Units
lbs
lbs, kg
Print Location
Bedside Only
Bedside Only, Central Only, Bedside and
Central
Set Date / Time Year
--
1980 - 3000
Set Date / Time Month
--
1 - 12
Set Date / Time Day
--
1 – 31 (depending on month and leap year
status)
Set Date / Time Hour
--
0 - 23
Set Date / Time Minute
--
0 -59
Simulated Data Mode
Off
On, Off
Language
English
English
Notch Filter
60 Hz
60 Hz, 50 Hz, Off
NIBP Cal. Mode
Off
On, Off
Monitor ID
<BLANK>
Any text string (23 characters maximum)
<BLANK>
Any text string (11 characters maximum, must
obey serial number convention for product)
Show Diagnostic Messages
No
Yes, No
SpO2 Tracing
Off
On, Off
NIBP Tracing
Off
On, Off
IBP Installed
None
None, 2
ETCO2 Installed
None
None, Oridion (Internal), PhaseIn (External)
Serial Number
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Accessories
20. Accessories
The following table shows the accessories approved by Zoe Medical for use with
the Nightingale PPM3.
WARNING Use only approved accessories with the PPM3. Using
non-approved accessories may result in damage to the monitoring
equipment, measurement error, or harm to the patient, and may void
warranty coverage.
Part Number
Description
ECG Monitoring Accessories
421-0014
ECG 3 Lead Set, US, 1.5 meter, Snap-On
421-0038
ECG 3 Lead Set, US, 3.0 meter, Snap-On
421-0110
ECG 5 Lead Set, US, 1.5 meter, Snap-On
421-0032
ECG 5 Lead Set, US, 3.0 meter, Snap-On
SpO2 Monitoring Accessories
180-3014
SpO2 Sensor, Reusable
180-3008
SpO2 Extender Cable (4 foot)
180-3007
SpO2 Extender Cable (8 foot)
NBP Monitoring Accessories
180-1004
NBP Hose
180-1022
NBP Cuff, Adult (26-35 cm)
180-1023
NBP Cuff, Large Adult (32-42 cm)
180-1029
NBP Cuff, Infant (8-14 cm)
180-1030
NBP Cuff, Child (13-20 cm)
180-1031
NBP Cuff, Adult Long (29-38 cm)
180-1033
NBP Cuff, Thigh (42-50 cm)
CO2 Monitoring Accessories
010-427
Oridion Smart CapnoLine Plus and FilterLine Sample Pack
IBP Monitoring Accessories
421-6101
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Cable, Adapter 2 Channel Invasive Blood Pressure
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Accessories
Part Number
421-0058
Description
Transducer Adapter Cable
Temperature Monitoring Accessories
180-4009
Oral Temperature Probe Kit
180-4005
Probe Covers, 250 count
Mounting Brackets and Accessories
180-8008
Table Stand
180-8016
Pole Mount
180-8017
Roll Stand Kit
180-8014
Wall Mount Channel and Arm Kit. Requires PPM3 Pole Mount
Power Supply
725-0037
PPM3 Power Supply
180-6001
Power Cord US (10 ft)
180-1055
Lithium-Ion Battery
Strip Chart Recorder Option
180-0100
50mm Strip Chart Recorder
180-8024
50mm Strip Chart Recorder Mounting Bracket
180-0102
Thermal Paper Roll, 50 mm wide 10 each
180-0101
Thermal Paper Roll, 50 mm wide 100 each
Communication Cables
421-0052
PPM3 Serial Cable
421-0053
PPM3 Network Cable
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Cleaning
21. Cleaning
This table provides cleaning instructions for the PPM3, which should be cleaned
monthly or as warranted. Accessories should be cleaned before application to a
patient. Before cleaning, refer to the cautions listed after the table.
Part
Recommended cleaning method
Materials
•
•
•
Nightingale PPM3
•
•
Enzymatic detergent such as ENZOL (US) or
CIDEZYME (outside the US)
Distilled water
Disinfectant solution (such as CIDEX OPA, or
a 10% solution of household bleach (5.25%
sodium hypochlorite) in distilled water)
Soft cloths and/or soft-bristled brushes
Protective gloves and eyewear
ECG Cables
TEMP Cable
Procedure
SpO2 Cable
IBP Y-Cable
NBP Cuff
NBP Hose
PPM3 Power Supply
PPM3 Power Cord
OMD Cable
Temperature Probe Covers
March 2015
1. Disconnect the unit from the wall outlet.
2. Put on gloves and protective eyewear.
3. Prepare the enzymatic detergent according to the
manufacturer's instructions, and also the
disinfectant solution, in separate containers.
4. Apply detergent to product using a soft cloth. If
material is dried on, allow to sit for 1 minute.
5. Wipe smooth surfaces with the cloth.
6. Use a soft-bristle brush on visibly soiled areas and
irregular surfaces.
7. Remove detergent from product using cloth
dampened in distilled water.
8. Repeat as necessary.
9. Apply disinfectant solution on affected area using
a soft cloth. Allow product to sit for 5 minutes.
10. Wipe away excess solution and clean product
again with cloth dampened in distilled water.
11. Allow 2 hours for drying.
Temperature probes are one-time use only.
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Cleaning
Part
Recommended cleaning method
Materials
•
Reusable SpO2 Sensor
70% isopropyl alcohol pad
Procedure
Remove sensor from patient and disconnect from
sensor cable. Wipe off with alcohol pad. Allow sensor
to dry before placing it on a patient.
Materials
•
Masimo IRMA (Mainstream)
CO2 Probe
Cloth moistened with 70% (max) ethanol or
isopropyl alcohol
Procedure
Remove probe from patient and disconnect from
airway adapter. Wipe off with cloth. Allow probe to
dry before placing it on a patient.
Materials
•
Masimo ISA (Sidestream) CO2
Analyzer
Cloth moistened with 70% (max) ethanol or
isopropyl alcohol
Procedure
Remove probe from patient. Keep sampling line
connected while cleaning to prevent liquids and dust
from entering the analyzer via the LEGI connector.
Wipe off with cloth. Allow analyzer to dry before
placing it on a patient.
CAUTION – Always disconnect the PPM3 from AC mains before cleaning.
CAUTION – Do not use harsh chemicals for cleaning – in particular, do
not use disinfectants that contain phenol as they can spot plastics. Do not
steam autoclave, gas sterilize, irradiate, subject to intense vacuum, or
immerse in water or cleaning solution. Be careful to avoid getting cleaning
liquids into connectors or the unit. If this occurs, allow the unit to dry in
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Cleaning
warm air for 2 hours, then check to make sure all monitoring functions are
still working properly.
CAUTION – Take particular care when cleaning the NBP cuff, NBP hose,
and NBP connector on the PPM to prevent fluid from entering the
connectors. Fluid in the NBP airway may affect blood pressure
determination accuracy and damage the monitor.
CAUTION – Microstream® ETCO2 sampling lines are designed for single
patient use, and are not to be reprocessed. Do not attempt to clean,
disinfect, sterilize or flush any part of the sampling line as this can cause
damage to the monitor.
CAUTION – Accessories that fall on the floor should be inspected for
contamination and proper functionality. If contamination is observed, then
this cleaning procedure should be followed.
CAUTION – The user has the responsibility to validate any deviations from
the recommended method of cleaning and disinfection.
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Maintenance and Storage
22. Maintenance and Storage
The following table shows the recommended maintenance procedures for the
Nightingale PPM3 monitor and its accessories. The Nightingale PPM3 monitor
does not require periodic recalibration – with the exception of the Oridion
Microstream® CO2 module (see the PPM3 Calibration Procedures after the
Functional Tests). However, it is a good idea to check that the monitor is in good
working order, as described in the following table. These functional tests should
be done every 12 months, and they can be performed by clinicians or qualified
service personnel. The following equipment is needed to perform these
procedures:
•
•
•
•
•
ECG/Respiration Simulator (e.g., Fluke Biomedical MPS-450)
SpO2 Simulator (e.g., Fluke Biomedical Index-2)
Blood Pressure Simulator (e.g., Fluke Biomedical BP-Pump2)
Safety Analyzer (e.g., Fluke Biomedical 505 Series)
Oridion Microstream® calibration kit from Air Liquide (Scott
Medical); Part Number T4653ORFCD – including a canister of 5%
CO2, 21% O2, with the balance N2 along with a T-piece connection
and a calibration Filterline.
22.1. PPM3 Functional Tests
PPM3 Function
Procedure
Mechanical Integrity
Check for cracks, abrasive edges and other signs of damage.
Knob
Verify menu navigation functionality by turning and pressing.
Front Panel Keys
PRINT key: verify that a Vital Signs Report is generated at the MPC’s printer.
ALARM SILENCE key: verify that alarm tone can be silenced.
NBP INTERVAL key: verify NBP Interval menu is displayed.
NBP START / STOP key: verify NBP measurement starts and stops.
STANDBY key: verify that unit enters Standby mode or displays Standby
Menu
SETUP key: verify that the top level Setup menu is displayed.
TRENDS key: verify that the Trends menu is displayed
MAIN SCREEN key: verify that the Main Screen is displayed
Power LED
Verify that the green power LED is illuminated on the front of the PPM3.
Battery Charging LED
Verify that the green charging LED is illuminated on the back of the PPM3
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Maintenance and Storage
PPM3 Function
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Procedure
when plugged into mains power.
Speaker
Power-cycle the PPM3 and verify that the power-up speaker test tones are
generated.
Second Speaker
Power-cycle the PPM3 and verify that the power-up second speaker test
tones are generated.
ECG / Respiration
Connect ECG leads to Patient Simulator.
• Verify proper heart rate at 30 and 300 bpm (+/- 2 bpm or +/- 1%).
• Verify 1 mV test pulse (Lead II).
• Verify proper respiration rate at 15 and 120 bpm (+/- 3 bpm).
SpO2
Connect to Patient Simulator (select appropriate sensor type).
• Verify proper SpO2 value at 84% and 96% (+/- 2%).
• Verify proper PR value at 30 and 240 bpm (+/- 5%).
NBP
NOTE: Do not allow system to remain pressurized and stable below 20
mmHg. The monitor will remove this pressure as a zero offset and this will
affect the validity of the calibration check.
NOTE: The following are required to perform this test: NIBP simulator or
sphygmomanometer along with a Y-adapter and a hand inflation bulb.
Pressure Accuracy Test: Via the Service settings, put the NIBP in to
calibration mode. Set the pressure to 25 mmHg and 225 mmHg respectively
and verify that the pressure values reported by the PPM3 patient monitor
matches (±2 mmHg) of that reported on the simulator or
sphygmomanometer. Release pressure.
Overpressure Test: Inflate cuff to 300 mmHg. Verify that the pressure is
automatically dumped at 300 +/- 30 mmHg.
Leak Test: Inflate a cuff to 150 mmHg. Allow cuff pressure to settle (thermal
effect). Verify that the pressure drops less than 4 mmHg in 1 minute. Verify
that the pressure is automatically dumped after 180 seconds. Set the NIBP
back to normal mode. Power cycle the monitor.
Measurement Accuracy Test: Connect to Patient Simulator and take a
NIBP measurement. Verify proper NIBP value at 120/80 (+/- 5 bpm).
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PPM3 Function
Oridion Microstream® CO2
Maintenance and Storage
Procedure
NOTE: Use only certified calibration gas apparatus that has not reached its
expiration date. This cal gas can be applied to the PPM3 patient monitor in
pulses that simulate patient breaths.
1. Connect the supplied CO2 calibration FilterLine between the PPM3 and the
cal gas canister.
2. Pulse the calibration gas actuator, holding it depressed for 10 seconds and
released for 10 seconds (3 BPM). This will allow enough time for the
ETCO2 to stabilize in both inhaled and exhaled states.
3. Verify that the ETCO2 value reads 38 ± 2 mmHg and the FICO2 value
reads 0 ± 2 mmHg.
NOTE: Factor a ±0.05 correction for every 100mmHg of ambient barometric
pressure above or below sea level respectively.
NOTE: The PPM3 should be returned to Zoe Medical for periodic servicing of
the CO2 system after 30,000 hours of CO2 use.
Masimo IRMA and ISA CO2
NOTE: Use only certified calibration gas apparatus that has not reached its
expiration date. This cal gas can be applied to the PPM3 patient monitor in
pulses that simulate patient breaths.
1. Connect the PPM3 to a calibration gas canister (5% CO2, 21% 02,
Balance N2)
2. Pulse the calibration gas actuator, holding it depressed for 10 seconds and
released for 10 seconds (3 BPM). This will allow enough time for the CO2
values to stabilize.
3. Verify that the FiCO2 value is 0-2 mmHg and that the ETCO2 value is
within the range that is defined in the following table:
Masimo ISA (Sidestream) CO2
1.
2.
3.
4.
5.
March 2015
Current Atmospheric Pressure
Expected etCO2
mmHg
mbar
mmHg
600 - 619
800 - 825
28 - 33
620 - 639
826 - 852
29 - 34
640 - 659
853 - 879
30 - 35
660 - 679
880 - 905
31 - 36
680 - 699
906 - 932
32 - 37
700 - 719
933 - 959
33 - 38
720 - 739
960 - 985
34 - 39
740 - 759
986 - 1012
35 - 40
760 - 779
1013 - 1039
36 - 41
780 - 799
1040 - 1065
37 - 42
Connect a new Nomoline sampling line with male luer lock to the ISA
LEGI and check that the LEGI shows a steady green light.
Connect a short silicon tubing with an inner diameter of 3/32” (2.4 mm)
to the Nomoline male luer.
Exhale a long breath into the silicon tubing until the CO2 concentration
is greater than 34 mmHg.
Quickly connect the silicon tubing tightly to the ISA exhaust port.
Wait 1 minute until the CO2 concentration has stabilized. Note the
value.
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Maintenance and Storage
PPM3 Function
Procedure
6.
IBP (P1 and P2)
z
•
•
Wait 1 minute and check that the CO2 concentration has not decreased
more than 3 mmHg. If it has decreased more there is a major leakage in
the ISA unit or in the Nomoline. Do not operate the ISA if there is a
major leakage in the unit.
Connect static pressure sources at 20 and later at 100 mmHg to IBP
sensors P1 and P2. Verify correct pressure is displayed for each (± 2
mmHg).
Connect a patient simulator with dynamic IBP waveform for radial artery
of 120/80. Verify correct pressure waveform and values are displayed
(± 2 mmHg).
Temperature
None (self-checking).
Leakage Current
Connect to Safety Analyzer.
WARNING – FOLLOW SAFETY INSTRUCTIONS AS INDICATED IN THE
MANUAL FOR THE ANALYZER.
Verify Patient Lead Leakage (to ground): < 10 uA.
Verify Patient Lead Leakage (inter-lead): < 10 uA.
Verify Patient Lead Leakage (mains applied to leads): < 50 uA.
Verify Leakage to ground (normal): < 500 uA.
Verify Leakage to ground (reversed polarity): < 1000 uA.
Verify Leakage to ground (neutral opened): < 1000 uA.
In order to prevent the Nightingale PPM3 monitor’s risk current from increasing
beyond safe limits, the ECG cable should be cleaned according to the instruction
in the Cleaning chapter of this manual.
To place the PPM3 back in service after maintenance has been performed,
connect the PPM3 to a wall outlet, insuring that cables do not present a tripping
hazard.
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22.2.
Maintenance and Storage
PPM3 Calibration Procedures
Trained service technicians with the PPM3 Service password can perform the
following procedures.
PPM3 Function
Procedure
Oridion Microstream® CO2
module
The Oridion Microstream ® CO2 module within the PPM3 does not require
calibration during normal clinical operation. The PPM3 displays a "CO2
Calibration Due" message when the manufacturer’s suggested number of
operating hours has been reached. Calibrate the CO2 module when this
message is displayed. It is recommended to calibrate the CO2 module on an
annual basis or after 4000 hours of use, whichever comes first. In the first
year, the CO2 module should be calibrated after 1200 hours of use. The
number of hours until calibration is due may be found in the PPM3 event log,
which is accessed by pressing the PPM3 SETUP Key, then selecting
"Administration," then "System,” and then "Show Event Log."
NOTE: Calibration should be performed by a trained technician.
NOTE: Ensure that the calibration gas and regulator are functioning properly
before calibration.
NOTE: Calibration of the CO2 module will require a calibrated gas mixture of
5% CO2, 21% O2, with the balance N2. The calibration kit available from Air
Liquide (Scott Medical); Part Number T4653ORFCD contains a canister of
the above gas mixture, a T-piece connector and a Calibration Filterline.
To calibrate the CO2 module:
1. Press the PPM3 SETUP Key, then select "Administration," followed by
"Service," and "Calibration" (password required to access this screen)
2. Prior to calibration initiation, connect the CO2 calibration line to the monitor.
3. Attach the calibrated CO2 gas mixture to the CO2 calibration line.
4. Select "Start CO2 Calibration" on the screen. The PPM3 displays "CO2
Calibrating" for up to 1 minute.
5. Once completed, the PPM3 displays "CO2 Calibration Complete" or "CO2
Calibration Failed."
6. If the calibration fails, determine the cause of failure appropriate to the
displayed error message given then repeat the CO2 calibration procedure.
7. Upon successful completion, remove the calibration gas from the monitor.
Dispose of it according to the instructions supplied with the kit.
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PPM3 Function
Procedure
IBP – Invasive Blood Pressure
The IBP (P1 and P2) interfaces do not require calibration during normal
clinical operation. In order to calibrate the IBP interfaces, perform the
following:
1. Connect a static pressure source, such as ambient air, to pressure
transducer that is connected to the P1 invasive pressure interface.
2. Select "Start P1 Calibration," after first pressing the SETUP key, then
"Administration," then "Service,” then "Calibration” (password required to
access this screen).
3. Await "P1 Calibration OK" message, or similar if the interface is labeled
something other than P1.
4. Repeat for interface P2.
NBP – Non-Invasive Blood
Pressure
The NIBP interface does not require calibration during normal clinical
operation. The accuracy of the NIBP pressure sensor and overall functionality
of the NIBP interface can be verified as detailed in the Nightingale PPM3
Functional Tests. If further calibration is required, contact Zoe Medical
Technical Support.
If there is a failure in one of the above procedures, please contact Zoe Medical
Technical Support. If a PPM3 unit needs to be returned to the factory for repair,
Technical Support will provide a return authorization number.
Email: [email protected]
Phone : (978) 887-1410
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Maintenance and Storage
22.3. Battery Replacement
The internal Lithium-Ion battery does not require any special maintenance. If the
battery is no longer holding a charge, it may need to be replaced. Under normal
conditions of use, the battery lifetime is around three years.
The procedure for replacing the battery is as follows:
1.
2.
3.
4.
Power down the device.
Remove the battery access door on the bottom of the device.
Remove the old battery by pulling on the strap that is attached to the battery.
Insert the new battery, taking care to face the label-side of the battery towards the
front of the device. (The battery will not fully insert, otherwise.)
5. Reattach the battery access door.
WARNING – APPROVED BATTERIES. Only use batteries that are
listed in the Accessories chapter.
22.4. Storage
Storage Temperature
-4 to 140 °F (-20 to 60 °C)
Storage Humidity
15% to 95% non-condensing
Storage Altitude
0 to 40,000’ (0 to 12,192 m)
CAUTION – The monitor may not conform to all of its performance
specifications if stored outside these environmental specifications or used
outside of the environmental specifications in the Technical Data chapter
of this manual.
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Maintenance and Storage
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22.5. Warranty
ZOE MEDICAL INCORPORATED warrants this product, other than its
expendable parts, to be free from defects in materials and workmanship for a
period of twenty-four (24) months from the date of original delivery to the buyer
or to buyer's order, provided that same is properly operated under conditions of
normal use, and that periodic maintenance and service is performed. This same
warranty is made for a period of thirty (30) days on expendable parts. This
warranty shall become null and void if product has been repaired other than by
Zoe Medical, Inc. (Zoe), or if the product has been subject to misuse, accident,
negligence or abuse.
Zoe Medical’s sole obligation under this warranty is limited to repairing a product
which has been reported to Zoe’s Technical Service Center during normal
business hours and shipped transportation prepaid. Zoe Medical shall not be
liable for any damages including but not limited to incidental damages,
consequential damages or special damages.
This warranty is in lieu of any other warranties, guarantees or conditions,
including merchantability or fitness for a particular purpose. The remedies under
this warranty are exclusive and Zoe Medical neither assumes nor authorizes
anyone to assume for it any other obligation in connection with the sale or repair
of its products.
ZOE MEDICAL, INCORPORATED PRODUCTS CONTAIN PROPRIETARY
COPY WRITTEN MATERIAL. ALL RIGHTS ARE RESERVED BY ZOE
MEDICAL, INCORPORATED.
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Maintenance and Storage
Password Control
To access the Setup Alarms or Setup System menu, perform the following steps
when presented with the Password menu:
•
•
•
•
Set Dial 1 to 49
Set Dial 2 to 48
Set Dial 3 to 46
Select OK
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Disposal
23. Disposal
The disposal of accessories such as electrodes, blood pressure cuffs, temperature
probes, SpO2 sensors, and CO2 sampling lines & calibration gases should be
carried out according to the manufacturer’s recommendations.
At the end of its useful life, the Nightingale PPM3 should be properly disposed of
as well. In particular, the PPM3 contains a lithium coin battery, a lithium ion
battery, and electronic circuit boards which should not be incinerated or exposed
to extreme heat. See warnings at the start of this manual for further precautions.
Contact your local waste disposal agency for guidance on the proper recycling or
disposal of these components.
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Technical Data
24. Technical Data
General
Dimensions
11.3”W x 7.2”H x 2.4”D (288 mm x 182 mm x 60 mm)
Weight
4.5 lb (2.0 g), 5.0 lb w/ Oridion Microstream® CO2 (2.3 kg)
Finish
PC/ABS
Power Requirements
100 – 240 VAC, 1.2 A max
Mains Frequency Range
50 – 60 Hz
Power Consumption
12W nominal, 30W (when charging battery)
Standards Conformance
IEC 60601-1:2005 (General Safety)
AAMI ES60601-1:2005 (General Safety)
CSA C22.2#60601-1:2008 (General Safety)
IEC 60601-1-2:2007 (Class B) (EMC)
IEC 60601-1-4:2000 (General Safety)
IEC 60601-1-8:2006 (Alarms)
IEC 60601-2-27:2011 (ECG Monitoring)
AAMI SP10:2002/A1:2003 (Non-Invasive Blood Pressure)
ISO 80601-2-30:2009 (Non-Invasive Blood Pressure)
IEC 60601-2-34:2011 (Invasive Blood Pressure)
ISO 80601-2-55:2011 (CO2 Respiratory Gas Monitoring)
ISO 80601-2-56:2009 (Temperature)
ISO 80601-2-61:2011 (SpO2)
IEC 62366:2007 (Usability)
IEC 62304:2006 (Software)
Patient Risk Current
(IEC 60601-1)
Electromedical Apparatus with Isolated Patient Connection.
Meets the following limits:
Enclosure Risk Current < 100 µA
Patient-applied Risk Current < 10 µA
Patient Isolation Risk Current < 50 µA
Earth Risk Current < 500 µA
Type of Protection (Electrical)
Class I
Degree of Protection (Electrical)
Type CF, Defibrillation-proof
Degree of Protection (Water)
Ordinary Equipment (IPX1)
Disinfecting Method
Per the instructions in the Cleaning chapter
Degree of Safety (Flammable
Anesthetic Mixture)
Not suitable for use in the presence of a Flammable Anesthetic
Mixture
Mode of Operation
Continuous
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Technical Data
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PPM3 Device Markings
European CE Mark according to Council Directives 93/42/EEC
For indoor-use only
Consult accompanying documents before using this device.
06/2013
Manufacture date (month/year)
Type CF Equipment (Defibrillation-proof)
Zoe Medical Part Number
Serial Number
Do not dispose as unsorted municipal waste. European Union
Directive 2002/96 on Waste Electrical and Electronic Equipment
(WEEE) requires separate handling for waste disposal
according to national requirements
IPX1
Indicates device has been tested for safety from vertically
dripping water; specifically, it indicates DRIP PROOF, a higher
than ordinary level of protection from drips, leaks, and spills.
External AC/DC power supply; only use Zoe Medical P/N 7250037-X
Local Area Network interface
Interface for Nightingale MPC central station
Interface for Other Medical Devices – Reserved for future use
Recorder interface
ECG
24-2
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Technical Data
SpO2
Pulse Oximetry connector
NBP
Non-Invasive Blood Pressure connector
P1/P2
Invasive Blood Pressure (dual) connector for P1 and P2
TEMP
Temperature connector
Microstream® ETCO2
Oridion CO2 input connector
Oridion CO2 exhaust connector
ETCO2
Masimo CO2 module connector
Battery
Type
Lithium-Ion Rechargeable
Discharging Time
4 hours (minimum)
Charging Time
5 hours
Charging Method
Battery is charged while monitor is connected to AC main
Environmental
Cooling
Convection (no fan)
Operating Temperature
32 to 104 °F (0 to 40 °C)
Storage Temperature
-4 to 140 °F (-20 to 60 °C)
Operating Humidity
15% to 90% non-condensing
Storage Humidity
15% to 95% non-condensing
Operating Altitude
0 to 15,000’ (0 to 4572 m)
Storage Altitude
0 to 40,000’ (0 to 12,192 m)
Alarm Signal Sound Pressure
45 to 80 dB(A)
Display
Type
Active Matrix LCD
Size
8.4 inches (diagonal)
Matrix
800 x 600 pixels
Number of Waveform Channels
Up to 5
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Technical Data
Sweep Speed
6.25, 12.5, 25 mm/s
Display Mode
Eraser Bar
z
ECG
Accessories
3-lead cable, 5-lead cable
Input Connector
7-pin connector
Displayable Leads
3-lead cable: I, II, III, AVL, AVR, AVF
5-lead cable: I, II, III, AVL, AVR, AVF, V
HR Resolution
1 bpm (beats per minute)
Measurement Range
15 to 300 bpm
Measurement Accuracy
±2 bpm or ±1%, whichever is greater
Response Time
Per IEC 60601-2-27, change from 80 to 120 bpm: < 7 seconds
Per IEC 60601-2-27, change from 80 to 40 bpm: < 11 seconds
Report Interval
1 second
HR Averaging Scheme
Average of the 10 most recent, valid R-R intervals, discarding
the shortest and longest interval
Time To Alarm - Tachycardia
IEC 60601-2-27, ECG Complex B1: < 10 sec (5 sec typical)
IEC 60601-2-27, ECG Complex B2: < 10 sec (9 sec typical)
Notch Filter Frequency
50Hz, 60 Hz, Off
Filter Bandwidth
Monitor Mode: 0.67 Hz to 40 Hz (-3 dB)
Diagnostic Mode: 0.05 to 40 Hz (-3 dB)
Dynamic Range AC
±5 mV, per IEC 60601-2-27
Dynamic Range DC
±300 mV, per IEC 60601-2-27
Electrode Impedance
>2.5 MOhm , per IEC 60601-2-27
Defibrillation Protection
Complies with IEC 60601-2-27
Pacer Pulse Detection
Lead II, I and V
Pacer Pulse Rejection
Rejects all pulses of amplitude ±2mV to ±700mV and duration
0.1 to 2 ms, per IEC 60601-2-27, Clause 201.12.1.101.13
Tall T-Wave Rejection
Rejects T-Waves less than or equal to 120% of a 1mV QRS and
a Q-T interval of 350 ms, per IEC 60601-2-27, Clause
201.12.1.101.17
HR Response to Irregular
Rhythm
IEC 60601-2-27, ECG Complex A1: HR is 80 bpm
IEC 60601-2-27, ECG Complex A2: HR is 65 bpm
IEC 60601-2-27, ECG Complex A3: HR is 120 bpm
IEC 60601-2-27, ECG Complex A4: HR is 91 bpm
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Technical Data
Active Noise Suppression
RL drive (< 5 µA)
Pulse Tone
Yes
Respiration
Method
Impedance Pneumography
Input Connector
Same as ECG
Sensing Lead
II
RR Resolution
1 bpm (breaths per minute)
Measurement Range
0 to 120 bpm
Measurement Accuracy
±3 bpm
Measurement Sensitivity
0.25 ohms (minimum)
Report Interval
1 second
Bandwidth
0.17 to 3.3 Hz (-3dB)
Impedance Measuring Current
40 µA @ 28 kHz square wave across Lead II
Pulse Oximetry
Method
Absorption – Spectrophotometric (dual wavelength)
(Functional oxygen saturation of arterial hemoglobin)
Input Connector
9-pin connector
SpO2 / PR Resolution
SpO2: 1 O2%
PR: 1 bpm (beat per minute)
Measurement Range
SpO2: 20 to 100%
PR: 30 to 240 bpm
Measurement Accuracy
SpO2: from 70 to 100%: ±2% (O2%), < 70%: unspecified
PR: ± 3 bpm
Measurement Test Method
Comparison versus co-oximeter, per ISO 80601-2-61
Report Interval
1 second. Numeric values held < 30 seconds
Pulse Tone
Yes (pulse tone pitch tied to SpO2 parameter value)
Alarm Signal Generation Delay
< 0.5 sec
Non-Invasive Blood Pressure
Method
Oscillometric
Input Connector
Single Lumen Hose (Quick-Disconnect fitting)
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Technical Data
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Cuff
Infant, Child, Small Adult, Adult, Large Adult
Derived Parameters
Systolic, Mean, Diastolic
Resolution
1 mmHg
Measurement Range
Systolic: 30 to 250 mmHg
Mean: 20 to 230 mmHg
Diastolic: 10 to 210 mmHg
Measurement Accuracy
Complies with AAMI SP10
Transducer Accuracy
± 3 mmHg
Pulse Rate Range
30 to 240 bpm
Pulse Rate Accuracy
± 5% or ± 2 bpm, whichever is greater
Update Interval
Upon measurement completion
Measurement Time
30 seconds (typical)
< 135 seconds (maximum)
Initial Cuff Pressure
160 mmHg (user-selectable)
Repeated Cuff Pressure
Previous systolic + 40 mmHg
Static Cuff Pressure Accuracy
± 3 mmHg
Overpressure Cutoff
290 ± 3 mmHg (normal means), 300 ± 10 mmHg (back-up)
Measurement Modes
Single Measurement or Auto (Interval) Measurement
Auto Measurement Settings
Off, 3, 5, 10, 15, 30, 60, 120 minutes
Oridion CO2 / Capnography
OEM Board
Oridion miniMediCO2
Method
Sidestream (Non-dispersive IR)
Units
mmHg
Parameters
ETCO2, FICO2, RRc, IPI
CO2 Measurement Range
ETCO2 & FICO2: 0 to 150 mmHg
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Technical Data
ETCO2 & FICO2: 0 to 38 mmHg: ± 2 mmHg
> 38 to 150 mmHg: ± (5% of reading + 0.08% for every 1 mmHg
above 38 mmHg)
CO2 Measurement Accuracy
Accuracy applies for breath rates of up to 80 bpm. For breath
rates above 80 bpm, accuracy is 4 mmHg or ±12 % of reading
whichever is greater, for ETCO2 values exceeding 18 mmHg.
This is tested according to and is compliant with ISO 21647. To
achieve the specified accuracies for breath rates above 60 bpm,
the Microstream FilterLine H Set for Infant/Neonatal (p/n
006324) must be used. Above 55°C module temperature,
±1mmHg or ± 2.5% (whichever is greater) has to be added to
the tolerance of the accuracy specs.
CO2 Resolution
ETCO2 & FICO2: 1 mmHg
RRc (Resp. Rate) Measurement
Range
0 to 120 bpm
0 to 70 bpm: ± 1 bpm
71 to 120 bpm: ± 2 bpm
RRc Measurement Accuracy
ETCO2, FICO2, and Respiration accuracy tested according to
ISO21647 using a mixture of gases (5% CO2, 21% O2, N2
balance) supplied via function generator and breath simulator
application. Respiration rates from 10-60 bpm for
adults/pediatrics as measured in 10 bpm discrete steps were
tested for 1 minute before moving forward to the next value and
at the end of this one minute period modules readings were
taken.
RRc Resolution
1 bpm
IPI Range
0 to 10
Barometric Pressure Range
430 to 795 mmHg
Barometric Pressure
Compensation
Automatic
Report Interval
1 second
Flow Rate
50 ml / min (-7.5 to +15 ml / min), flow measured by volume
Warm-up Time Required to
Meet Accuracy Specifications
Typical: 30 seconds
Max: 180 seconds (No readings until warm-up completed)
Total System Response Time
3.5 sec (typical) using standard Microstream FilterLine ®
Drift of Measurement Accuracy
Meets accuracy specifications when the calibration schedule is
followed in the General Care & Maintenance section
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Technical Data
Measurement Accuracy for Gas
Mixture
Meets ISO 21647 Clause 51.101.3 (Tables 101 and 103):
± (volume fraction of 0.43% + 8% of gas level)
Measurement Accuracy in the
Presence of Interfering Gases
Meets ISO 21647 Clause 101.1 (Tables 101 and 105):
± (volume fraction of 0.43% + 8% of gas level)
Masimo ISATM CO2 / Capnography
Method
Sidestream (Non-dispersive IR)
Units
mmHg
Parameters
ETCO2, FICO2, RRc
CO2 Measurement Range
ETCO2 & FICO2: 0 to 150 mmHg
As measured with dry single gases:
0 to 15 vol%: ±(0.2 vol% + 2% of reading)
CO2 Measurement Accuracy
15 to 25 vol%: unspecified
CO2 Resolution
1 mmHg
RRc (Resp. Rate) Measurement
Range
0 to 150 ± 1 bpm
RRc Resolution
1 bpm
Barometric Pressure Range
525 to 1200 hPa
Barometric Pressure
Compensation
Automatic
Report Interval
Per breath
Flow Rate
50 ± 10 sml/min
Warm-up Time Required to
Meet Accuracy Specifications
< 10 seconds (concentrations reported and full accuracy)
Total System Response Time
< 3 seconds (with 2m Nomoline sampling line)
Drift of Measurement Accuracy
Complies with EN ISO 21647:2004 standard
Measurement Accuracy for Gas
Mixture
Complies with EN ISO 21647:2004 standard
Measurement Accuracy in the
Presence of Interfering Gases
Complies with EN ISO 21647:2004 standard
Masimo IRMATM CO2 / Capnography
Method
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Nightingale PPM3 User's Guide
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Technical Data
Units
mmHg
Parameters
ETCO2, FICO2, RRc
CO2 Measurement Range
ETCO2 & FICO2: 0 to 150 mmHg
Dry single gases at 22 ± 5°C and 1013 ± 40 hPa
0 to 15 vol%: ±(0.2 vol% + 2% of reading)
CO2 Measurement Accuracy
15 to 25 vol%: unspecified
All conditions
±(0.3 kPa + 4% of reading)
CO2 Resolution
1 mmHg
RRc (Resp. Rate) Measurement
Range
0 to 150 bpm. RRc is displayed after 3 breaths and the average
value is updated every breath.
RRc Resolution
1 bpm
Barometric Pressure Range
525 to 1200 hPa
Barometric Pressure
Compensation
Automatic
Report Interval
Per breath
Warm-up Time Required to
Meet Accuracy Specifications
< 10 seconds (concentrations reported and full accuracy)
Total System Response Time
< 1 second
Drift of Measurement Accuracy
Complies with EN ISO 21647:2004 standard
Measurement Accuracy for Gas
Mixture
Complies with EN ISO 21647:2004 standard
Measurement Accuracy in the
Presence of Interfering Gases
Complies with EN ISO 21647:2004 standard
Invasive Blood Pressure
Transducer Type
Strain gauge
Transducer Excitation Voltage
5.00 VDC ± 1 %
Frequency Response
0-12 Hz
Measurement Units
mmHg
Parameters
Diastolic, Systolic, Mean for all except Mean-only for CVP
Measurement Range
-50 to 300 mmHg
Measurement Accuracy
± 1 mmHg or ± 1 %, whichever greater
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Technical Data
IBP Resolution
1 mmHg
Pulse Rate Measurement Range
30 - 250 bpm
Pulse Rate Accuracy
± 2 bpm or ±2 %, whichever greater
Numeric Update Rate
Every 3 seconds
z
Temperature
Compatibility
YSI 400-series probes
Measurement Mode
Direct (as defined in ISO 80601-2-56)
Input Connector
2-pin connector
Display Units
°F and °C (user-selectable)
Measurement Resolution
0.1 °F (0.1 °C)
Measurement Range
41.0 to 122.0 °F (5.0 to 50.0 °C)
Measurement Accuracy
±0.2 °F (±0.1 °C) plus probe tolerance
Transient Response
Within 30 seconds from 25 to 27 °C
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Technical Data
Electromagnetic Compatibility (EMC) Information
Medical electrical equipment requires special precautions regarding
Electromagnetic Compatibility (EMC). Portable and mobile Radio Frequency
(RF) communications equipment can affect devices like the Nightingale PPM3.
As such, the Nightingale PPM3 should not be used adjacent to other equipment. If
this is not practical, then observe the Nightingale PPM3 to make sure it is
operating properly after installation.
Also, the use of accessories other than those recommended by Zoe Medical may
result in increased EMC emissions or decreased EMC immunity of the
Nightingale PPM3.
Guidance and manufacturer’s declaration: electromagnetic emissions
The Nightingale PPM3 is intended for use in the electromagnetic environment specified below.
The user of the Nightingale PPM3 should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment / guidance
Group 1
The Nightingale PPM3 uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
The Nightingale PPM3 is suitable for use in all
establishments including domestic and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Complies
IEC 61000-3-3
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Technical Data
Guidance and manufacturer’s declaration: electromagnetic immunity
The Nightingale PPM3 is intended for use in the electromagnetic environment specified below.
The user of the Nightingale PPM3 should assure that it is used in such an environment.
Immunity test
Electrostatic
discharge
(ESD)
IEC 60601
test level
Compliance
level
±6 kV contact
±6 kV contact
±8 kV air
±8 kV air
±2 kV for
power
supply lines
±2 kV for
power
supply lines
±1 kV for
input/output
lines
±1 kV for
input/output
lines
±1 kV
differential
Mode
±1 kV
differential
Mode
±2 kV common
mode
±2 kV common
mode
<5 % UT
(>95 % dip in
UT)
for 0.5 cycle
<5 % UT
(>95 % dip in
UT)
for 0.5 cycle
Electromagnetic environment /
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
IEC 61000-4-2
Electrical fast
transient/burst
Mains power quality should be that of a
typical commercial or hospital
environment.
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-411
40 % UT
(60 % dip in
UT)
for 5 cycles
70 % UT
(30 % dip in
UT)
24-12
Mains power quality should be that of a
typical commercial or hospital
environment.
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the
Nightingale PPM3 requires continued
operation during power mains
40 % UT
interruptions, it is recommended that the
(60 % dip in UT) Nightingale PPM3 be powered from an
for 5 cycles
uninterruptible power supply or a fully
charged battery.
70 % UT
(30 % dip in UT)
for 25 cycles
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Technical Data
for 25 cycles
<5 % UT
(>95 % dip in
UT)
for 5 s
Power
frequency
(50/60 Hz)
magnetic field
3 A/m
<5 % UT
(>95 % dip in
UT)
for 5 s
3 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital environment.
IEC 61000-4-8
Note – UT is the AC mains voltage prior to application of the test level.
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Technical Data
Guidance and manufacturer’s declaration: electromagnetic immunity
The Nightingale PPM3 is intended for use in the electromagnetic environment specified below.
The user of the Nightingale PPM3 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance
level
Electromagnetic environment /
guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the Nightingale PPM3,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Recommended separation distance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80
MHz
3 V/m
80 MHz to 2.5
GHz
3 Vrms
d = 1.2
3 V/m
d = 1.2
d = 2.3
80 MHz to 800 MHz
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site surveya, should be
less than the compliance level in each
frequency rangeb.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
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Technical Data
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due
to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Nightingale PPM3 is used exceeds the applicable RF
compliance level above, the Nightingale PPM3 should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting
or relocating the PPM3 monitor.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Technical Data
Recommended separation distances between portable and mobile RF communications equipment
and the Nightingale PPM3
The Nightingale PPM3 is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The user of the Nightingale PPM3 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Nightingale PPM3 as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
(m)
(W)
150 kHz to 80
80 MHz to 800
800 MHz to 2.5
MHz
MHz
GHz
d = 1.2
d = 1.2
d = 2.3
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W)
according to the transmitter manufacturer.
Note 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
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