Spinal Modulation MN0600 Patient Programmer, TNS Trial Neurostimulator, INS Implantable Neurostimulator User Manual
Reklaam
Reklaam
Patient
Programmer
Model
MN0600
User
Manual
Spinal
Modulation,
Inc.
1135
O’Brien
Drive
Menlo
Park,
CA
94025
USA
CAUTION
–
Investigational
Device
Limited
by
Federal
(US)
Law
to
Investigational
Use
Copyright © June 2011 by Spinal Modulation, Inc.
All Rights Reserved.
No portion of this manual may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, or any information storage and retrieval systems, without the express written permission of Spinal Modulation, Inc.
LP0015 Rev E, June 2011
S PINAL M ODULATION , I NC .
P ATIENT P ROGRAMMER U SER M ANUAL
T ABLE OF C ONTENTS
E XPLANATION OF S YMBOLS ON P RODUCT OR P ACKAGE L ABELING ....................................................................... 3
G LOSSARY .............................................................................................................................................. 4
I NTRODUCTION ........................................................................................................................................ 5
I NDICATIONS FOR U SE ............................................................................................................................... 5
D ESCRIPTION ........................................................................................................................................... 5
W ARNING .............................................................................................................................................. 5
P RECAUTIONS – F OR Y OUR P ATIENT P ROGRAMMER AND Y OUR S TIMULATOR D EVICE ............................................. 6
P RECAUTIONS – F OR Y OUR T HERAPY ............................................................................................................ 7
P ATIENT P ROGRAMMER F EATURES ............................................................................................................ 10
C HARGING THE B ATTERY .......................................................................................................................... 10
P ROGRAMMER P OWER U P ....................................................................................................................... 10
M AIN M ENU ......................................................................................................................................... 12
C ONNECTING TO Y OUR S TIMULATOR D EVICE ................................................................................................ 13
P AIN C ONTROL S CREEN ........................................................................................................................... 15
B ACK TO M AIN M ENU ........................................................................................................................ 15
S ELECT G ROUP .................................................................................................................................. 15
P ROGRAMMER S TATUS B AR ................................................................................................................. 16
A DJUSTING Y OUR S TIMULATOR D EVICE S ETTINGS ......................................................................................... 16
T URNING OFF S TIMULATION ................................................................................................................. 16
P AIN C ONTROL T AB ............................................................................................................................ 17
A DJUST S TIMULATION L EVEL FOR A B ODY R EGION ....................................................................................... 17
I NFO T AB ......................................................................................................................................... 18
D EVICE T AB AND P HYSICIAN T AB ............................................................................................................... 18
C LINIC T AB ............................................................................................................................................ 18
U SING Y OUR TNS D EVICE .................................................................................................................... 19
U SING Y OUR INS D EVICE ......................................................................................................................... 19
A UTHORIZED E UROPEAN R EPRESENTATIVE .................................................................................................. 19
C OMPANY C ONTACT I NFORMATION ........................................................................................................... 19
G UIDANCE AND MANUFACTURER ’ S DECLARATION .......................................................................................... 20
ELECTROMAGNETIC EMISSIONS ............................................................................................................... 20
E LECTROMAGNETIC I MMUNITY .............................................................................................................. 21
A PPENDIX I: INS B ATTERY L IFE ................................................................................................................. 23
A PPENDIX II: T ROUBLESHOOTING .............................................................................................................. 32
2
Explanation of Symbols on Product or Package Labeling
Model Number
Serial Number
Read the Manual
Consult the Manual
Contents of Package are Non ‐ Sterile
Manufacturing Date
Manufacturer
Warning.
Pay
attention.
Protected against Electric Shock
Not waterproof.
Applies to the Programmer when it is not in its carrying case.
Limited waterproof.
Applies to the TNS.
Applies to the Programmer in its carrying case.
Turns the Programmer ON and OFF.
Turns stimulation OFF on the TNS.
Keep Dry
Store between ‐ 10°C and 50°C (14°F and 122°F)
Store between 0 and 93% humidity
The device is a radio transmitter
Magnet.
Shows the location of the Programmer magnet.
Australia C ‐ tick
Authorized European Representative
3
Glossary
Lead – Surgical wire: takes electrical signals from the neurostimulator to the stimulation area.
Stimulation – Small electrical pulses: produces a tingling sensation and replaces pain signals.
Stimulator –Device that makes electrical pulses that stimulate the nerves in your spine: defined as Trial
Neurostimulator or Implantable Neurostimulator.
Trial Neurostimulator (TNS) ‐ External stimulator device that clips onto your belt: attaches to the connector cable and which is connected to leads implanted in the area near your spine.
Implantable Neurostimulator (INS) ‐ Stimulator device implanted in your back or abdomen: attaches to leads implanted in the area near your spine.
Connector Cable – Cable that connects the leads to your trial stimulator device.
Patient Programmer – Portable, hand ‐ held device: allows you to adjust the stimulation settings.
Clinical Programmer – Portable, hand ‐ held device: allows the clinician to program the stimulator device.
Computer Tomography (CT) Imaging – Computerized X ‐ ray imaging: produces electronic images of tissues and organs.
Diathermy – High energy heat: used to cut or cauterize during surgery or a type of therapy.
Electromagnetic Interference (EMI) – Electrical signals that interfere with the device function.
Magnetic Resonance Imaging (MRI) – Medical imaging: produces electronic images of tissues and organs.
Paresthesia – Tingling sensation felt during therapy delivery: produced by spinal cord stimulation.
Precaution –Situation that could cause uncomfortable stimulation and possible damage to the stimulator device or Patient Programmer.
Program – Instructions or changes to stimulation settings that are programmed into the Patient Programmer and transmitted to the stimulator device.
Stimulation Level – Measure of stimulation: can be increased or decreased within a range specified by your doctor.
Warning – Potentially serious hazard that could cause injury or death.
4
I NTRODUCTION
Your Patient Programmer is used to program your stimulator device, if required.
This User Manual gives detailed instructions on how to safely use your Patient Programmer and your stimulator device.
It also instructs you on how to recharge your Patient Programmer.
See your doctor if you have any questions.
I NDICATIONS FOR U SE
The Spinal Modulation Neurostimulator System was designed to be used to manage prolonged pain as stated in the following indication statement:
The Spinal Modulation neurostimulation system is indicated as an aid in the management of chronic, intractable, neuropathic pain of the lower limbs ‐ including unilateral or bilateral pain, associated with the following conditions: radicular pain, peripheral neuropathies.
D ESCRIPTION
The Clinical and Patient Programmers are used to connect to the stimulator device.
– The Clinical Programmer controls the stimulator device.
Only your doctor and/or Spinal Modulation clinical personnel may use the Clinical Programmer.
– The Patient Programmer allows you to adjust the settings of the stimulator device.
Your doctor specifies the range of settings.
It also allows you to turn OFF all stimulation, if required.
The Patient Programmer is a portable, handheld device.
It is designed to be easy to use.
It can be plugged into a power outlet or powered by an internal, rechargeable battery.
The Patient
Programmer uses an internal magnet to connect to the stimulator device.
This allows the patient to control stimulation settings.
W ARNING
•
Do not use your Patient Programmer or the stimulator device until your doctor has trained you.
•
Do not use your Patient Programmer until your doctor has set up your stimulator device.
•
Do not undergo any elective magnetic resonance imaging (MRI) procedure.
If MRI is necessary, your physician must remove any lead(s).
Your doctor must also disconnect the TNS or INS device.
Use of
MRI in the area of the lead(s) may dislodge the lead(s) or damage the TNS or INS.
If a voltage is induced through the lead, it may cause uncomfortable (“jolting” or “shocking”) levels of stimulation.
•
Do not undergo any diathermy (high energy heat) procedures.
Diathermy may cause bodily injury or damage to the stimulator device.
•
Do not remove the lead(s) or Connector Cable during the trial period.
An infection may result.
•
Changes in body position can increase pain or cause uncomfortable stimulation.
Use the Patient
Programmer to adjust stimulation levels or to turn OFF stimulation, if required.
5
Warnings (continued)
•
Strong electromagnetic fields may interfere with the stimulator device.
This interference can affect the stimulation level and cause discomfort.
Avoid theft detection devices at store and library exits.
Also avoid airport security screeners.
Do not stand near the screening equipment.
•
Other equipment that may cause interference includes but is not limited to: power generators, arc welders and large magnetized speakers.
Do not stand near these devices.
•
Do not leave your Programmer Charger where pets, children or you may become entangled in the cord, causing a fall or strangulation.
•
Report a rash due to system components to your doctor.
If your throat or tongue starts to swell get emergency aid immediately.
P RECAUTIONS – F OR Y OUR P ATIENT P ROGRAMMER AND Y OUR S TIMULATOR D EVICE
Follow these precautions to avoid damage to and assure proper function of your Patient Programmer and stimulator device.
•
Do not drop or mishandle your Patient Programmer or stimulator device.
Physical damage to the devices may impair their function.
•
Do not wash the Patient Programmer or TNS device with excessive water.
Do not get either device wet.
Excessive moisture may impair their function.
If cleaning is necessary, remove soil with a soft damp cloth.
•
Do not shower or bathe with the TNS device.
(You may take a sponge bath if the TNS device does not get wet.)
•
Avoid contact with body fluids for the TNS and Patient Programmer.
Contamination may cause damage to the devices.
•
Do not use abrasive or caustic cleaning products on your Patient Programmer or TNS device.
•
Do not use any equipment or accessories that are not supplied with your Patient Programmer.
Do not plug anything into the connector at the bottom of the programmer.
It is for Clinic use only.
•
Do not open the cases of the Patient Programmer or TNS device or modify them in any way.
This may expose the devices to elements that alter their function.
•
Do not place your Patient Programmer close to credit cards or other cards with magnetic strips.
The Patient Programmer magnet may demagnetize your cards.
Keep the Patient Programmer away from computer hard drives and magnetic storage devices.
•
Do not operate the Patient Programmer or stimulator device outside the temperature range of ‐
5°C to 45°C (23°F to 113°F).
Rapid temperature changes may affect proper device operation.
•
Do not store the Patient Programmer outside the temperature range of ‐ 10°C to 50°C (14°F to
122°F).
•
Do not leave the Patient Programmer in a car or other places where temperatures can exceed
50°C (122°F).
6
Device Precautions (continued)
•
Failure of your stimulator system, although unlikely, is possible due to random component failure.
If any part of your stimulator system stops working or you see a change in how it works, discontinue use and contact your doctor during normal business hours.
•
Return your Patient Programmer and TNS device to your doctor at the end of the trial period.
Do not discard or burn the Patient Programmer or TNS device.
Fire may cause the internal batteries to explode.
•
Do not try to replace the TNS device battery, even if the TNS device does not function.
Only Spinal
Modulation personnel may replace the TNS device battery.
•
Do not use any other company’s device to program your stimulator device.
Use only the Patient
Programmer provided by Spinal Modulation.
•
Do not allow unauthorized use of your Patient Programmer.
This may cause unwanted programming changes.
•
Do not use the Patient Programmer or stimulator device near explosive or flammable gases.
Serious injury may occur.
•
Do not use the Programmer Charger if the power cord is damaged, excessively worn or frayed.
This may cause injury or damage your stimulation device.
•
To remove power from the Programmer Charger when not in use, unplug from the wall.
•
Frequent programming of your implanted device will cause the battery to deplete faster.
Avoid unnecessary programming.
P RECAUTIONS – F OR Y OUR T HERAPY
Follow these precautions to maintain appropriate therapy:
•
Follow proper wound care techniques, as instructed by your doctor.
•
Do not rub or press on the implant site.
This may cause the leads to dislodge or your skin to erode.
It may also cause inversion of the INS.
•
Avoid excessive bending, twisting and stretching.
Do not lift objects over ten pounds.
These activities may cause the leads to move.
Understimulation or overstimulation may result.
•
Avoid driving a car or operating other potentially dangerous machinery while stimulation is ON.
You could be distracted from vehicle or device operation if sudden changes in stimulation were to occur.
•
Your stimulator device may affect the operation of other implantable devices, such as pacemakers or implantable cardiac defibrillators.
Tell your doctor about any other implantable devices that you have or are scheduled to get.
7
Therapy Precautions (continued)
•
Tell your regular doctor(s) or healthcare providers that you have a stimulator device.
Do not undergo any elective medical procedures without first discussing them with your physician.
Some medical devices or therapies, such as those listed below, may interfere with your stimulator device: o Electrocautery – Electric probe to cauterize blood vessels and stop bleeding during surgery.
o Lithotripsy – Shock waves to break up gallstones and kidney stones.
o Therapeutic Radiation – Used to destroy cancer cells.
o High ‐ output ultrasound – Sound waves to treat bone and muscle injuries, or to stimulate muscle or improve blood flow.
o RF Ablation – Radio frequency energy to cause controlled tissue damage.
o Microwave Ablation – Alternating electric field to cause controlled tissue damage.
o Dental procedures, electrolysis, static field therapeutic magnets and diagnostic X ‐ ray.
•
Appoint a family member or friend to tell emergency medical personnel that you have a stimulator device, in case you need emergency care.
You will be given a Medical Alert Card to carry with you.
This card will inform emergency medical personnel that you have a stimulator device.
If you have any concerns about your stimulator device, contact your doctor during normal business hours.
RF Operating Frequencies
Nearby equipment emitting strong magnetic fields can interfere with RF communication, even if the other equipment complies with CISPR emission requirements.
The operating characteristics are as follows:
MICS band: 402 ‐ 405 MHz
The effective radiated power is below the limits as specified in
Europe: EN ETSI 301 839 ‐ 2
USA FCC 47 CFR Part 95; 95.601
‐ 95.673
Subpart E, 95.1201
‐ 95.1219
FCC ID: Y8L ‐ MN0700
This device may not interfere with stations operating in the 400.150–406.000
MHz band in the
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.
.
8
P ATIENT P ROGRAMMER O VERVIEW
Your Patient Programmer is a portable, handheld device.
It is powered by an internal, rechargeable battery.
It can also be plugged into a power outlet.
Your Patient Programmer works with your stimulator device to control stimulation.
Your doctor will explain how to use the Patient Programmer to adjust stimulation for optimal pain relief.
Keep your Patient Programmer near you at all times.
This allows you to adjust stimulation, if necessary.
Carry your Patient Programmer in the case provided as the case provides protection from water.
Your Patient Programmer system consists of:
•
Patient Programmer with Stylus (and internal magnet) MN0600
•
Auxiliary Magnet MN3300
•
Programmer Charger MN3400
Input: 100 ‐ 240 VAC, 50 ‐ 60 Hz, 0.6A
Output: 5V 3.0A
•
Carrying Case MN3500
•
Patient Programmer User Manual (this document)
•
Patient Information Sheet
•
Patient Medical Alert Card
Patient Programmer
Programmer Power
•
Battery Status Bar
•
AC – Battery Charging
•
100% – Battery Charge Complete
Stylus
Programmer
Charger
9
P ATIENT P ROGRAMMER F EATURES
With your Patient Programmer, you can:
•
Turn OFF all stimulation, if required.
•
Turn stimulation ON or OFF for each body region.
•
Adjust the stimulation level for each body region.
•
Change the Group for stimulation.
See “Select Group” under the “Pain Control Screen” section.
•
View your stimulator device ID information.
•
View your name or your ID number.
•
View your lead implant date.
•
View your physician name, clinic name and contact information.
C HARGING THE B ATTERY
You will need the Programmer Charger provided to charge the Patient Programmer battery.
Charging the battery takes approximately 2–4 hours for a full charge.
The Programmer Status Bar at the bottom of the screen shows the battery charge level.
1.
Connect the Programmer Charger to a power outlet.
2.
Connect the Charger to your Patient Programmer.
When the battery is charging, the battery icon on the screen shows “AC”.
When charging is complete, 100% shows next to the battery icon.
Your Patient Programmer will operate normally and does not use battery power when it is connected to a power outlet.
Connect your Patient Programmer to the Charger and attach to an outlet regularly to keep it charged.
Your Patient Programmer and Programmer Charger have an expected service period of up to three years.
Improper charging may reduce this period.
P ROGRAMMER P OWER U P
Press the “ ” button to turn ON your Patient Programmer screen.
The Main Menu will display.
Press here to turn on
Programmer Screen
10
NOTE: If the Patient Programmer does not turn ON, charge the battery, and try again.
11
M AIN M ENU
The Programmer Main Menu displays two main functions:
•
Connect: Allows you to connect to your stimulator device; also allows you to adjust stimulation settings.
•
Programmer Setup: Allows you to set your Patient
Programmer date and time; also allows you to view information about your stimulator device.
The Main Menu identifies the device as your Spinal Modulation
Patient Programmer.
Your physician, clinic and the clinic phone number are also shown.
The Programmer status bar is located at the bottom of the Main
Menu.
The status bar shows the Programmer–stimulator connection status.
It also shows the battery charge level and the time.
See the “Programmer Status Bar” section in this User
Manual for more detail.
You can change the time and date and access the Programmer
Info screen from the Programmer Setup screen.
You can also view your stimulator device serial number and your name or patient ID.
The Programmer Info screen shows your programmer serial number, software version and manufacturing date.
It also shows the basestation firmware version.
12
Stimulator Device Binding
Your doctor will bind your stimulator device to your Patient Programmer.
You cannot edit this information.
Connect
Press the “Connect” button on the Main Menu to connect to your stimulator device.
Once connected, you can adjust stimulation settings.
See the “Connecting to Your Stimulator Device” section below for more
detail.
Magnet
A magnet is located under the magnet symbol on the back side of the Patient Programmer.
Place the magnet over the stimulator device to check for connection between the Patient Programmer and stimulator device.
See the “Connecting to Your Stimulator Device” section below for more detail.
Magnet
Connecting to Your Stimulator Device
Use your Patient Programmer to connect to your stimulator device.
•
Make sure that your Patient Programmer is turned ON and that the Main Menu displays.
Your Patient
Programmer must be within 6 feet of your stimulator device.
•
Press the “Connect” button.
The Patient Programmer will begin searching for the stimulator device.
An icon shows on the screen to indicate that it is busy.
•
Position the magnet on the Patient Programmer over your stimulator device and move around in a circular motion to initiate communication.
The Patient Programmer chimes when it is connected to your stimulator device.
The Pain Control screen displays.
“Connected” shows in the status bar at the bottom left of the screen.
If your Patient Programmer cannot connect to your stimulator device, an error message displays.
“Disconnected” shows in the status bar.
If your Patient Programmer cannot connect to your stimulator device, go back to the Main Menu.
Press
“Connect” again.
Move the magnet in a circular fashion over your stimulator device.
Repeat until the Patient
Programmer connects to the stimulator device.
NOTE: If after 2 minutes your Patient Programmer cannot connect to the stimulator device, place the
Patient Programmer over the stimulator device again.
An error message may display.
The message asks you
13
to confirm that your Patient Programmer is near enough to the stimulator device.
After confirming that your
Patient Programmer is within 6 feet of the stimulator device, press “OK”.
Press “Connect” again.
14
P AIN C ONTROL S CREEN
At the top of the Pain Control screen.
The ID Heading shows your name or ID number and your stimulator device’s serial
number.
The “Turn All Stimulation OFF” button is below the ID
Heading.
Two tabs are below the “Turn All Stimulation OFF” button: the
“Pain Control” tab and the “Info” (Information) tab.
See the
“Adjusting Your Stimulator Device Settings” section in this
User Manual for more detail.
The “Exit” button at the bottom right side of the screen returns you to the Main Menu.
ID Heading, located at the top of the screen, shows the following information:
•
Your Identification (ID) Number
•
Your Stimulator Device Serial Number
B ACK TO M AIN M ENU
The “Exit” button closes the Pain Control window, ends the session, and returns to the Main Menu.
NOTE: When programming is complete, select the “Exit” button and power off the programmer to conserve power.
S ELECT G ROUP
The “Select Group” button is located in the center of the Pain Control screen.
Press “Select Group” to display a drop down menu.
The drop down menu has up to four groups defined by your doctor.
When you select a group name, the stimulator device switches settings to the new group.
15
P ROGRAMMER S TATUS B AR
The Programmer Status Bar is located at the bottom of the Patient Programmer screen.
The status bar shows the Programmer ‐ stimulator connection status, the battery charge level and the time.
•
Programmer ‐ Stimulator Connection Status : Shows “Connecting” when the Patient Programmer is trying to connect to the stimulator device; shows “Connected” when the Patient Programmer is connected to the stimulator device; and shows “Disconnected” when the Patient Programmer is disconnected from the stimulator device.
•
Programmer Battery Level : Shows the Patient Programmer battery charge level.
•
Programmer Clock : Shows the time.
See the “Main Menu” section in this User Manual for more detail.
A DJUSTING Y OUR S TIMULATOR D EVICE S ETTINGS
You can adjust your stimulator device settings from the Pain Control screen.
Stimulation can be turned ON or OFF for up to four regions of your body.
You can also adjust the stimulation level for any of those regions.
T URNING OFF S TIMULATION
•
Press the “Turn All Stimulation OFF” button to stop all stimulation therapy.
A confirmation window appears, asking do you want to turn OFF all stimulation.
NOTE: After turning OFF all stimulation, you can restore stimulation therapy for each of the body regions individually.
See the “Turn Stimulation ON or OFF for a Body Region” section below.
16
P AIN C ONTROL T AB
Select the “Pain Control” tab located at the top of the Pain
Control screen.
From the “Pain Control” tab, you can turn stimulation ON or OFF for each body region.
You can also adjust the stimulation level for each body region.
T URN S TIMULATION O N OR O FF FOR A B ODY R EGION
Your Patient Programmer shows the names of one to four body regions in which your leads have been placed.
To turn stimulation ON or OFF for a body region:
•
Select the body region by pressing the desired tab.
•
Press the “OFF” button to stop stimulation to that region.
When stimulation is OFF, the “OFF” button is black.
•
Press the “ON” button to start stimulation to that region.
When stimulation is ON, the “ON” button is green.
A DJUST S TIMULATION L EVEL FOR A B ODY R EGION
Verify that you have selected the correct body region tab on the Pain Control screen.
•
Press the “Down” button to decrease the stimulation level.
•
Press the “Up” button to increase the stimulation level.
Stimulation Level Indicator:
The stimulation level indicator is located between the “Up” and “Down” buttons.
The indicator moves up or down as you adjust the stimulation level for the selected body region.
The indicator shows the current stimulation level as compared to the maximum set by your doctor.
NOTE: The indicator bar is green when you have reached the maximum stimulation level.
17
I NFO T AB
The “Info” (Information) tab contains three tabs, the “Device” tab, the “Physician” tab, and the “Clinic” tab.
D EVICE T AB AND P HYSICIAN T AB
The “Device” tab and “Physician” tab show the following information:
Stimulator Voltage Information
NOTE: INS battery information (does not pertain to external TNS device).
Stimulator Identification Information
•
Stimulator Device Firmware Version.
•
Date INS device was implanted (does not pertain to external TNS device).
Physician Information
•
Your doctor’s name.
•
Your doctor’s contact phone number.
•
Your doctor’s email contact.
C LINIC T AB
The “Clinic” tab shows the following information:
Clinic Information
•
Your clinic’s name.
•
Your clinic’s address.
•
After Hours Contact: A phone number to contact someone in case of an emergency.
18
U SING Y OUR INS D EVICE
To connect your Programmer to your INS, push the “Connect” button on the Patient
Programmer.
Move the Patient Programmer magnet over the implant location in a circular motion.
This will allow you to adjust stimulation settings using the Patient Programmer.
U SING Y OUR TNS D EVICE
To connect your Programmer to your TNS, push the
“Connect” button on the Patient Programmer.
Move the
Patient Programmer magnet over the TNS in a circular motion.
This will allow you to adjust stimulation settings using the Patient Programmer.
To quickly turn stimulation off, press the red button on the TNS for more than 2 seconds or push the “Turn all Stimulation OFF” button on the Programmer screen.
To enable stimulation after pressing either button, you must connect with your Patient
Programmer and turn the stimulation back on.
Your Spinal Modulation Neurostimulator System complies with the following International Standards
•
IEC 60601 ‐ 1: 2005
•
ISO 14708 ‐ 1: 2000
•
IEC 60601 ‐ 1 ‐ 11: 2010
•
IEC 60601 ‐ 1 ‐ 2: 2007
•
ISO 14708 ‐ 3: 2008
A UTHORIZED E UROPEAN R EPRESENTATIVE
MediTech Strategic Consultants B.V.
Maastrichterlaan 127 ‐ 129
6291 EN Vaals, Netherlands
C OMPANY C ONTACT I
Spinal Modulation, Inc.
1135 O’Brien Drive
Menlo Park, CA 94025
U.S.A.
NFORMATION
Telephone: (650) 543 ‐ 6800 (24 hour support line)
Fax: (650) 327 ‐ 2336
Email: [email protected]
19
G UIDANCE AND MANUFACTURER ’ S DECLARATION
ELECTROMAGNETIC EMISSIONS
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spinal Modulation Neurostimulator System should assure that it is used in such an environment.
Emissions test Compliance
RF Emissions 1 Group 2
Class B
Electromagnetic environment
–
guidance
The Spinal Modulation Neurostimulator System must emit electromagnetic energy in order to perform its intended function.
Nearby electronic equipment may be affected.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Class B
Complies
CISPR 14-1 Complies
The Spinal Modulation Neurostimulator System is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
The Patient Programmer is not intended to be connected to other equipment except the Model 3400 Programmer Charger
20
The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spinal Modulation Neurostimulator System should assure that it is used in such an environment.
Immunity
Guidance and Manufacturer’s Declaration
E LECTROMAGNETIC I MMUNITY
Electrostatic discharge
(ESD)
Electrical fast transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short interruptions and voltage variations on power supply
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
IEC 60601
Test Level
IEC 61000-4-2
± 2 kV for power supply lines
± 1 kV
<5%
U for input lines input/output
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
IEC 61000-4-11
T (>95% dip in for 0.5 cycle
lines
U T)
40% U T (60% dip in U T)
for 5 cycles
70% U T (30% dip in U T) for 25 cycles
<5% U T (>95% dip in U T) for 5 s
NOTE U T is the a.c. mains voltage prior to application of the test level .
3 A/m
Compliance
Level
± 6 kV contact
± 8 kV air
Pass
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 %.
Mains power quality should be that of a typical commercial or home environment
Mains power quality should be that of a typical commercial or home environment
Mains power quality should be that of a typical commercial or home environment
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial, hospital, or home environment.
21
Guidance and Manufacturer’s Declaration
E LECTROMAGNETIC I MMUNITY
The Spinal Modulation Neurostimulation System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spinal Modulation Neurostimulation System should assure that it is used in such an environment
Immunity test
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 60601 TEST
LEVEL
3 Vrms
150 kHz to 80 MHz
3 V/m
Compliance level
3 V
3 V/m
Electromagnetic environment guidance
Portable and mobile RF communications equipment should be used no closer to any part of Spinal Modulation Neurostimulation
System, than 0.2 meter, based on transmitters of 80 MHz to 2.5 GHz.
Interference may occur in the vicinity of equipment marked with the following symbol:
IEC 61000-4-3 80 MHz to 2,5 GHz
Recommended separation distances between portable and mobile RF communications equipment
and the Spinal Modulation Neurostimulation System
The Spinal Modulation Neurostimulation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Spinal Modulation Neurostimulation
System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System
Rated maximum output power of transmitter
W
0.01
Separation distance according to frequency of transmitter m
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.12m 0.12m 0.23m
0.1
0.37m 0.37m 0.74m
1
1.17m 1.17m 2.33m
10
3.70m 3.70m 7.37m
100
11.70m 11.70m 23.30m
NOTE 1 At 80 MHz and 800 MHz, 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.
22
Appendix I: INS Battery Life
The following four tables estimate INS battery life under the given load impedance conditions.
Tables 1 through 4 list estimated longevity based on 1 ‐ lead stimulation, active 24 hours a day.
To estimate longevity for multiple active leads and to account for daily usage, use the following formula:
Where,
C2 =
3014
Longevity for Lead 2 Settings
- 35 Daily Usage Lead 2
And,
Daily Usage Lead 1, 2, 3 and 4 are fractional values equal to the number of hours stimulation is enabled for each lead daily divided by 24 hours.
Note:
Do
not
enter
values
for
C1,
C2,
C3
or
C4
for
corresponding
leads
that
are
inactive.
Example:
Estimate longevity for 2 lead stimulation with lead 1 settings of 0.8mA, 40Hz, 200µs across 600 ohms continuously stimulating, and lead 2 settings of 1.0mA, 60Hz, 400µs across 1Kohm stimulating for 16 hours per day.
From Table 1 (600 ohms), longevity for lead 1 settings = 58.9
months
From Table 2 (1 Kohm), longevity for lead 2 settings = 34.1
months
Calculated C1 = (3014 / 58.9
– 35) * (24 / 24) = 16.2
Calculated C2 = (3014 / 34.1
– 35) * (16 / 24) = 35.6
Estimated longevity for this example = 3014 / (16.2
+ 35.6
+ 35) = 34.7
months
23
Table 1: Load Impedance = 600 ohms
All longevity values are in months
Pulsewidth
Amplitude Frequency 40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
0.1mA
0.2mA
0.4mA
0.6mA
0.8mA
4Hz 83.9
83.8
83.6
83.4
83.2
83.0
82.8
82.7
82.6
20Hz 81.5
80.9
80.1
79.2
78.3
77.5
76.7
75.9
75.8
40Hz 78.6
77.6
76.0
74.5
73.0
71.6
70.2
68.9
68.6
60Hz 76.0
74.6
72.4
70.3
68.3
66.5
64.7
63.1
62.7
80Hz 73.5
71.8
69.1
66.6
64.2
62.1
60.0
58.1
57.8
100Hz 71.2
69.2
66.1
63.2
60.6
58.2
56.0
53.9
53.5
4Hz 83.8
83.6
83.2
82.8
82.5
82.1
81.7
81.4
81.3
20Hz 81.1
80.1
78.3
76.7
75.1
73.6
72.2
70.8
70.5
40Hz 78.0
76.0
73.0
70.2
67.6
65.2
63.0
60.9
60.5
60Hz 75.1
72.4
68.3
64.7
61.5
58.5
55.9
53.4
53.0
80Hz 72.4
69.1
64.2
60.0
56.4
53.1
50.2
47.6
47.1
100Hz 69.8
66.1
60.6
56.0
52.0
48.6
45.6
42.9
42.4
4Hz 83.7
83.2
82.5
81.7
81.0
80.3
79.6
78.9
78.8
20Hz 80.4
78.3
75.1
72.2
69.4
66.9
64.6
62.4
61.9
40Hz 76.7
73.0
67.6
63.0
58.9
55.4
52.2
49.4
48.9
60Hz 73.3
68.3
61.5
55.9
51.2
47.2
43.8
40.9
40.4
80Hz 70.1
64.2
56.4
50.2
45.2
41.2
37.8
34.9
34.4
100Hz 67.3
60.6
52.0
45.6
40.5
36.5
33.2
30.4
29.9
4Hz 83.5
82.8
81.7
80.7
79.6
78.6
77.6
76.6
76.4
20Hz 79.7
76.7
72.2
68.2
64.6
61.3
58.4
55.7
55.2
40Hz 75.4
70.2
63.0
57.1
52.2
48.1
44.6
41.6
41.0
60Hz 71.5
64.7
55.9
49.1
43.8
39.6
36.1
33.2
32.6
80Hz 68.1
60.0
50.2
43.1
37.8
33.6
30.3
27.6
27.1
100Hz 64.9
56.0
45.6
38.4
33.2
29.2
26.1
23.6
23.1
4Hz 83.4
82.5
81.0
79.6
78.2
76.9
75.7
74.4
74.2
20Hz 79.0
75.1
69.4
64.6
60.3
56.6
53.3
50.4
49.8
40Hz 74.2
67.6
58.9
52.2
46.9
42.5
38.9
35.9
35.3
60Hz 69.9
61.5
51.2
43.8
38.3
34.1
30.7
27.9
27.4
80Hz 66.1
56.4
45.2
37.8
32.4
28.4
25.3
22.8
22.3
100Hz 62.7
52.0
40.5
33.2
28.1
24.4
21.5
19.3
18.9
24
Table 1: Load Impedance = 600 ohms (Continued)
All longevity values are in months
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz 83.2
82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
20Hz 78.3
73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
40Hz 73.0
65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
60Hz 68.3
58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
80Hz 64.2
53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
100Hz 60.6
48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
4Hz 82.8
81.2
78.6
76.1
73.8
71.7
69.6
67.7
67.3
20Hz 76.7
70.1
61.3
54.5
49.0
44.6
40.8
37.7
37.1
40Hz 70.2
59.9
48.1
40.2
34.5
30.3
26.9
24.3
23.8
60Hz 64.7
52.3
39.6
31.9
26.6
22.9
20.1
17.9
17.5
80Hz 60.0
46.4
33.6
26.4
21.7
18.4
16.0
14.2
13.8
100Hz 56.0
41.7
29.2
22.5
18.3
15.4
13.3
11.7
11.4
4Hz 82.5
80.3
76.9
73.8
71.0
68.3
65.9
63.6
63.2
20Hz 75.1
66.9
56.6
49.0
43.3
38.7
35.0
32.0
31.4
40Hz 67.6
55.4
42.5
34.5
29.1
25.1
22.1
19.7
19.3
60Hz 61.5
47.2
34.1
26.6
21.9
18.6
16.1
14.2
13.9
80Hz 56.4
41.2
28.4
21.7
17.5
14.7
12.7
11.1
10.9
100Hz 52.0
36.5
24.4
18.3
14.6
12.2
10.5
9.2
8.9
4Hz 56.6
53.8
49.7
46.2
43.1
40.5
38.1
36.0
35.6
20Hz 46.3
38.2
29.6
24.1
20.4
17.6
15.5
13.9
13.6
40Hz 37.7
28.0
19.6
15.1
12.3
10.3
8.9
7.8
7.7
60Hz 31.8
22.1
14.7
11.0
8.8
7.3
6.3
5.5
5.3
80Hz 27.5
18.3
11.7
8.6
6.8
5.6
4.8
4.2
4.1
100Hz 24.3
15.6
9.8
7.1
5.6
4.6
3.9
3.4
3.3
4Hz 52.6
47.4
40.8
35.8
31.8
28.7
26.1
24.0
23.6
20Hz 35.3
25.9
17.9
13.7
11.1
9.3
8.0
7.0
6.9
40Hz 25.0
16.5
10.5
7.7
6.1
5.0
4.3
3.7
3.6
60Hz 19.4
12.1
7.4
5.4
4.2
3.5
2.9
2.5
2.5
80Hz 15.8
9.6
5.8
4.1
3.2
2.6
2.2
1.9
1.9
100Hz 13.3
7.9
4.7
3.3
2.6
2.1
1.8
1.6
1.5
25
Table 2: Load Impedance = 1 Kohm
All longevity values are in months
Pulsewidth
Amplitude Frequency 40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
0.1mA
0.2mA
0.4mA
0.6mA
0.8mA
4Hz 83.9
83.8
83.6
83.4
83.2
83.0
82.8
82.7
82.6
20Hz 81.5
80.9
80.1
79.2
78.3
77.5
76.7
75.9
75.8
40Hz 78.6
77.6
76.0
74.5
73.0
71.6
70.2
68.9
68.6
60Hz 76.0
74.6
72.4
70.3
68.3
66.5
64.7
63.1
62.7
80Hz 73.5
71.8
69.1
66.6
64.2
62.1
60.0
58.1
57.8
100Hz 71.2
69.2
66.1
63.2
60.6
58.2
56.0
53.9
53.5
4Hz 83.8
83.6
83.2
82.8
82.5
82.1
81.7
81.4
81.3
20Hz 81.1
80.1
78.3
76.7
75.1
73.6
72.2
70.8
70.5
40Hz 78.0
76.0
73.0
70.2
67.6
65.2
63.0
60.9
60.5
60Hz 75.1
72.4
68.3
64.7
61.5
58.5
55.9
53.4
53.0
80Hz 72.4
69.1
64.2
60.0
56.4
53.1
50.2
47.6
47.1
100Hz 69.8
66.1
60.6
56.0
52.0
48.6
45.6
42.9
42.4
4Hz 83.7
83.2
82.5
81.7
81.0
80.3
79.6
78.9
78.8
20Hz 80.4
78.3
75.1
72.2
69.4
66.9
64.6
62.4
61.9
40Hz 76.7
73.0
67.6
63.0
58.9
55.4
52.2
49.4
48.9
60Hz 73.3
68.3
61.5
55.9
51.2
47.2
43.8
40.9
40.4
80Hz 70.1
64.2
56.4
50.2
45.2
41.2
37.8
34.9
34.4
100Hz 67.3
60.6
52.0
45.6
40.5
36.5
33.2
30.4
29.9
4Hz 83.5
82.8
81.7
80.7
79.6
78.6
77.6
76.6
76.4
20Hz 79.7
76.7
72.2
68.2
64.6
61.3
58.4
55.7
55.2
40Hz 75.4
70.2
63.0
57.1
52.2
48.1
44.6
41.6
41.0
60Hz 71.5
64.7
55.9
49.1
43.8
39.6
36.1
33.2
32.6
80Hz 68.1
60.0
50.2
43.1
37.8
33.6
30.3
27.6
27.1
100Hz 64.9
56.0
45.6
38.4
33.2
29.2
26.1
23.6
23.1
4Hz 83.4
82.5
81.0
79.6
78.2
76.9
75.7
74.4
74.2
20Hz 79.0
75.1
69.4
64.6
60.3
56.6
53.3
50.4
49.8
40Hz 74.2
67.6
58.9
52.2
46.9
42.5
38.9
35.9
35.3
60Hz 69.9
61.5
51.2
43.8
38.3
34.1
30.7
27.9
27.4
80Hz 66.1
56.4
45.2
37.8
32.4
28.4
25.3
22.8
22.3
100Hz 62.7
52.0
40.5
33.2
28.1
24.4
21.5
19.3
18.9
26
Table 2: Load Impedance = 1 Kohm (Continued)
All longevity values are in months
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz 83.2
82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
20Hz 78.3
73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
40Hz 73.0
65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
60Hz 68.3
58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
80Hz 64.2
53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
100Hz 60.6
48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
4Hz 82.8
81.2
78.6
76.1
73.8
71.7
69.6
67.7
67.3
20Hz 76.7
70.1
61.3
54.5
49.0
44.6
40.8
37.7
37.1
40Hz 70.2
59.9
48.1
40.2
34.5
30.3
26.9
24.3
23.8
60Hz 64.7
52.3
39.6
31.9
26.6
22.9
20.1
17.9
17.5
80Hz 60.0
46.4
33.6
26.4
21.7
18.4
16.0
14.2
13.8
100Hz 56.0
41.7
29.2
22.5
18.3
15.4
13.3
11.7
11.4
4Hz 58.4
57.2
55.1
53.3
51.5
49.9
48.3
46.9
46.6
20Hz 53.1
48.2
41.8
36.9
33.0
29.8
27.3
25.1
24.7
40Hz 47.7
40.3
32.1
26.6
22.8
19.9
17.6
15.9
15.5
60Hz 43.2
34.6
26.0
20.8
17.4
14.9
13.0
11.6
11.3
80Hz 39.6
30.4
21.9
17.1
14.0
11.9
10.3
9.1
8.9
100Hz 36.5
27.0
18.9
14.5
11.8
9.9
8.6
7.5
7.4
4Hz 53.0
49.1
43.6
39.2
35.7
32.7
30.2
28.0
27.6
20Hz 36.3
28.4
20.9
16.5
13.6
11.6
10.1
9.0
8.8
40Hz 26.1
18.6
12.6
9.6
7.7
6.4
5.5
4.8
4.7
60Hz 20.3
13.9
9.1
6.7
5.3
4.4
3.8
3.3
3.2
80Hz 16.7
11.0
7.1
5.2
4.1
3.4
2.9
2.5
2.5
100Hz 14.1
9.2
5.8
4.2
3.3
2.7
2.3
2.0
2.0
4Hz 51.4
46.5
40.2
35.4
31.6
28.6
26.1
24.0
23.6
20Hz 32.7
24.5
17.4
13.4
10.9
9.2
8.0
7.0
6.9
40Hz 22.4
15.4
10.1
7.6
6.0
5.0
4.3
3.7
3.7
60Hz 17.1
11.3
7.2
5.3
4.2
3.4
2.9
2.5
2.5
80Hz 13.8
8.9
5.5
4.0
3.2
2.6
2.2
1.9
1.9
100Hz 11.6
7.3
4.5
3.3
2.6
2.1
1.8
1.6
1.5
27
Table 3: Load Impedance = 1.5
Kohm
All longevity values are in months
Pulsewidth
Amplitude Frequency 40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
0.1mA
0.2mA
0.4mA
0.6mA
0.8mA
4Hz 83.9
83.8
83.6
83.4
83.2
83.0
82.8
82.7
82.6
20Hz 81.5
80.9
80.1
79.2
78.3
77.5
76.7
75.9
75.8
40Hz 78.6
77.6
76.0
74.5
73.0
71.6
70.2
68.9
68.6
60Hz 76.0
74.6
72.4
70.3
68.3
66.5
64.7
63.1
62.7
80Hz 73.5
71.8
69.1
66.6
64.2
62.1
60.0
58.1
57.8
100Hz 71.2
69.2
66.1
63.2
60.6
58.2
56.0
53.9
53.5
4Hz 83.8
83.6
83.2
82.8
82.5
82.1
81.7
81.4
81.3
20Hz 81.1
80.1
78.3
76.7
75.1
73.6
72.2
70.8
70.5
40Hz 78.0
76.0
73.0
70.2
67.6
65.2
63.0
60.9
60.5
60Hz 75.1
72.4
68.3
64.7
61.5
58.5
55.9
53.4
53.0
80Hz 72.4
69.1
64.2
60.0
56.4
53.1
50.2
47.6
47.1
100Hz 69.8
66.1
60.6
56.0
52.0
48.6
45.6
42.9
42.4
4Hz 83.7
83.2
82.5
81.7
81.0
80.3
79.6
78.9
78.8
20Hz 80.4
78.3
75.1
72.2
69.4
66.9
64.6
62.4
61.9
40Hz 76.7
73.0
67.6
63.0
58.9
55.4
52.2
49.4
48.9
60Hz 73.3
68.3
61.5
55.9
51.2
47.2
43.8
40.9
40.4
80Hz 70.1
64.2
56.4
50.2
45.2
41.2
37.8
34.9
34.4
100Hz 67.3
60.6
52.0
45.6
40.5
36.5
33.2
30.4
29.9
4Hz 83.5
82.8
81.7
80.7
79.6
78.6
77.6
76.6
76.4
20Hz 79.7
76.7
72.2
68.2
64.6
61.3
58.4
55.7
55.2
40Hz 75.4
70.2
63.0
57.1
52.2
48.1
44.6
41.6
41.0
60Hz 71.5
64.7
55.9
49.1
43.8
39.6
36.1
33.2
32.6
80Hz 68.1
60.0
50.2
43.1
37.8
33.6
30.3
27.6
27.1
100Hz 64.9
56.0
45.6
38.4
33.2
29.2
26.1
23.6
23.1
4Hz 83.4
82.5
81.0
79.6
78.2
76.9
75.7
74.4
74.2
20Hz 79.0
75.1
69.4
64.6
60.3
56.6
53.3
50.4
49.8
40Hz 74.2
67.6
58.9
52.2
46.9
42.5
38.9
35.9
35.3
60Hz 69.9
61.5
51.2
43.8
38.3
34.1
30.7
27.9
27.4
80Hz 66.1
56.4
45.2
37.8
32.4
28.4
25.3
22.8
22.3
100Hz 62.7
52.0
40.5
33.2
28.1
24.4
21.5
19.3
18.9
28
Table 3: Load Impedance = 1.5
Kohm (Continued)
All longevity values are in months
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz 83.2
82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
20Hz 78.3
73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
40Hz 73.0
65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
60Hz 68.3
58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
80Hz 64.2
53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
100Hz 60.6
48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
4Hz 58.2
57.1
55.4
53.8
52.3
50.8
49.5
48.2
47.9
20Hz 52.0
47.9
42.5
38.1
34.6
31.6
29.1
27.0
26.6
40Hz 45.9
40.0
32.9
27.9
24.3
21.5
19.3
17.4
17.1
60Hz 41.1
34.2
26.8
22.1
18.7
16.3
14.4
12.9
12.6
80Hz 37.2
30.0
22.7
18.2
15.2
13.1
11.5
10.2
10.0
100Hz 33.9
26.6
19.6
15.5
12.8
10.9
9.5
8.5
8.3
4Hz 56.4
54.6
51.9
49.5
47.2
45.2
43.3
41.6
41.3
20Hz 45.7
40.4
33.8
29.1
25.6
22.8
20.5
18.7
18.4
40Hz 36.9
30.4
23.6
19.2
16.2
14.1
12.4
11.1
10.9
60Hz 30.9
24.4
18.1
14.4
11.9
10.2
8.9
7.9
7.7
80Hz 26.6
20.4
14.7
11.5
9.4
8.0
6.9
6.1
6.0
100Hz 23.4
17.5
12.3
9.5
7.8
6.5
5.7
5.0
4.9
4Hz 52.6
49.1
44.2
40.2
36.9
34.1
31.6
29.5
29.1
20Hz 35.3
28.5
21.6
17.4
14.5
12.5
10.9
9.7
9.5
40Hz 25.0
18.7
13.2
10.1
8.3
7.0
6.0
5.3
5.2
60Hz 19.3
13.9
9.5
7.2
5.8
4.8
4.2
3.6
3.6
80Hz 15.8
11.1
7.4
5.5
4.4
3.7
3.2
2.8
2.7
100Hz 13.3
9.2
6.1
4.5
3.6
3.0
2.6
2.2
2.2
4Hz 52.6
49.1
44.2
40.2
36.9
34.1
31.6
29.5
29.1
20Hz 35.3
28.5
21.6
17.4
14.5
12.5
10.9
9.7
9.5
40Hz 25.0
18.7
13.2
10.1
8.3
7.0
6.0
5.3
5.2
60Hz 19.3
13.9
9.5
7.2
5.8
4.8
4.2
3.6
3.6
80Hz 15.8
11.1
7.4
5.5
4.4
3.7
3.2
2.8
2.7
100Hz 13.3
9.2
6.1
4.5
3.6
3.0
2.6
2.2
2.2
29
Table 4: Load Impedance = 2 Kohm
All longevity values are in months
Pulsewidth
Amplitude Frequency 40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
0.1mA
0.2mA
0.4mA
0.6mA
0.8mA
4Hz 83.9
83.8
83.6
83.4
83.2
83.0
82.8
82.7
82.6
20Hz 81.5
80.9
80.1
79.2
78.3
77.5
76.7
75.9
75.8
40Hz 78.6
77.6
76.0
74.5
73.0
71.6
70.2
68.9
68.6
60Hz 76.0
74.6
72.4
70.3
68.3
66.5
64.7
63.1
62.7
80Hz 73.5
71.8
69.1
66.6
64.2
62.1
60.0
58.1
57.8
100Hz 71.2
69.2
66.1
63.2
60.6
58.2
56.0
53.9
53.5
4Hz 83.8
83.6
83.2
82.8
82.5
82.1
81.7
81.4
81.3
20Hz 81.1
80.1
78.3
76.7
75.1
73.6
72.2
70.8
70.5
40Hz 78.0
76.0
73.0
70.2
67.6
65.2
63.0
60.9
60.5
60Hz 75.1
72.4
68.3
64.7
61.5
58.5
55.9
53.4
53.0
80Hz 72.4
69.1
64.2
60.0
56.4
53.1
50.2
47.6
47.1
100Hz 69.8
66.1
60.6
56.0
52.0
48.6
45.6
42.9
42.4
4Hz 83.7
83.2
82.5
81.7
81.0
80.3
79.6
78.9
78.8
20Hz 80.4
78.3
75.1
72.2
69.4
66.9
64.6
62.4
61.9
40Hz 76.7
73.0
67.6
63.0
58.9
55.4
52.2
49.4
48.9
60Hz 73.3
68.3
61.5
55.9
51.2
47.2
43.8
40.9
40.4
80Hz 70.1
64.2
56.4
50.2
45.2
41.2
37.8
34.9
34.4
100Hz 67.3
60.6
52.0
45.6
40.5
36.5
33.2
30.4
29.9
4Hz 83.5
82.8
81.7
80.7
79.6
78.6
77.6
76.6
76.4
20Hz 79.7
76.7
72.2
68.2
64.6
61.3
58.4
55.7
55.2
40Hz 75.4
70.2
63.0
57.1
52.2
48.1
44.6
41.6
41.0
60Hz 71.5
64.7
55.9
49.1
43.8
39.6
36.1
33.2
32.6
80Hz 68.1
60.0
50.2
43.1
37.8
33.6
30.3
27.6
27.1
100Hz 64.9
56.0
45.6
38.4
33.2
29.2
26.1
23.6
23.1
4Hz 83.4
82.5
81.0
79.6
78.2
76.9
75.7
74.4
74.2
20Hz 79.0
75.1
69.4
64.6
60.3
56.6
53.3
50.4
49.8
40Hz 74.2
67.6
58.9
52.2
46.9
42.5
38.9
35.9
35.3
60Hz 69.9
61.5
51.2
43.8
38.3
34.1
30.7
27.9
27.4
80Hz 66.1
56.4
45.2
37.8
32.4
28.4
25.3
22.8
22.3
100Hz 62.7
52.0
40.5
33.2
28.1
24.4
21.5
19.3
18.9
30
Table 4: Load Impedance = 2 Kohm (Continued)
All longevity values are in months
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz 58.9
58.2
57.2
56.1
55.1
54.2
53.3
52.4
52.2
20Hz 55.0
52.2
48.2
44.8
41.8
39.2
36.9
34.8
34.4
40Hz 50.7
46.3
40.3
35.7
32.1
29.1
26.6
24.5
24.2
60Hz 47.1
41.5
34.6
29.7
26.0
23.1
20.8
18.9
18.6
80Hz 44.0
37.7
30.4
25.4
21.9
19.2
17.1
15.4
15.1
100Hz 41.2
34.5
27.0
22.2
18.9
16.4
14.5
13.0
12.7
4Hz 56.7
55.4
53.2
51.3
49.5
47.8
46.2
44.7
44.4
20Hz 46.7
42.4
36.8
32.5
29.1
26.4
24.1
22.2
21.8
40Hz 38.2
32.8
26.6
22.3
19.2
16.9
15.1
13.6
13.3
60Hz 32.4
26.8
20.8
17.0
14.4
12.4
11.0
9.8
9.6
80Hz 28.1
22.6
17.1
13.7
11.5
9.8
8.6
7.7
7.5
100Hz 24.8
19.6
14.5
11.5
9.5
8.1
7.1
6.3
6.2
4Hz 54.5
52.3
49.1
46.2
43.6
41.3
39.2
39.2
37.0
20Hz 40.1
34.7
28.4
24.1
20.9
18.4
16.5
16.5
14.6
40Hz 30.1
24.5
18.6
15.1
12.6
10.9
9.6
9.6
8.3
60Hz 24.1
18.9
13.9
11.0
9.1
7.7
6.7
6.7
5.8
80Hz 20.1
15.4
11.0
8.6
7.1
6.0
5.2
5.2
4.5
100Hz 17.2
13.0
9.2
7.1
5.8
4.9
4.2
4.2
3.6
4Hz 53.2
50.5
46.5
43.1
40.2
37.7
35.4
33.4
33.0
20Hz 36.7
31.0
24.5
20.3
17.4
15.1
13.4
12.1
11.8
40Hz 26.5
20.9
15.4
12.2
10.1
8.7
7.6
6.7
6.6
60Hz 20.7
15.7
11.3
8.8
7.2
6.1
5.3
4.6
4.5
80Hz 17.0
12.6
8.9
6.8
5.5
4.7
4.0
3.6
3.5
100Hz 14.4
10.6
7.3
5.6
4.5
3.8
3.3
2.9
2.8
4Hz 53.2
50.5
46.5
43.1
40.2
37.7
35.4
33.4
33.0
20Hz 36.7
31.0
24.5
20.3
17.4
15.1
13.4
12.1
11.8
40Hz 26.5
20.9
15.4
12.2
10.1
8.7
7.6
6.7
6.6
60Hz 20.7
15.7
11.3
8.8
7.2
6.1
5.3
4.6
4.5
80Hz 17.0
12.6
8.9
6.8
5.5
4.7
4.0
3.6
3.5
100Hz 14.4
10.6
7.3
5.6
4.5
3.8
3.3
2.9
2.8
31
Appendix II: Troubleshooting
Pop Up Message Possible Solution
Connection with your stimulator was lost. Please reconnect.
Unable to connect to your stimulator.
Please contact your physician during normal business hours.
• Swipe the programmer over the stimulator to establish connection and reconnect to the device.
• If you still cannot connect, move the programmer closer to the stimulator. Continue to swipe the magnet over the stimulator.
• Move to another location; there may be interference in your current location.
• Press “OK” and attempt to reconnect to the stimulator.
• Swipe the programmer over the stimulator to establish connection and reconnect to the device.
• If you still cannot connect, move the programmer closer to the stimulator and continue to swipe the magnet over the stimulator.
• Move to another location; there may be interference in your current location.
• Contact your doctor during normal business hours if the problem continues.
Unable to connect to your stimulator. Please try again. • Swipe the programmer over the stimulator to establish connection and reconnect to the device.
• If you still cannot connect, move the programmer closer to the stimulator and continue to swipe the magnet over the stimulator.
• Move to another location; there may be interference in your current location.
Your stimulator battery is low. It will need to be replaced soon. Please contact your physician during normal business hours (only applies to the INS).
• Contact your doctor during normal business hours to set up an appointment. Your stimulator has reached Elective Replacement
Interval (ERI).
Your stimulator battery needs to be replaced. Stimulation has been turned OFF permanently.
Please contact your physician during normal business hours (only applies to the INS).
Stimulation for one or more leads has been turned OFF.
Please contact your physician during normal business hours.
• Contact your doctor during normal business hours to set up an appointment. Your stimulator has reached End of Service (EOS) and will not stimulate. It must be replaced.
•
•
Swipe the programmer over the stimulator to establish connection and reconnect to the device.
Go the Pain Control screen and turn on the lead that has been turned off.
• If you are unable to turn it back on, contact your doctor during normal business hours.
• Contact your doctor during normal business hours. All stimulation has been turned OFF. Please contact your physician during normal business hours.
Stimulation has been turned OFF due to a magnet. Please use your programmer to restore stimulation.
You have turned all Stimulation OFF.
Please use your programmer to restore stimulation.
Programmer battery is low. Please recharge.
• Swipe the programmer over the stimulator to establish connection and reconnect to the device.
• Go to the Pain Control screen. Turn on each lead one at a time.
• You have turned off the device by pressing the switch on the TNS or by pressing the “Turn All Stimulation OFF” button on the programmer.
• Swipe the programmer over the stimulator to establish connection and reconnect to the device.
• Go the Pain Control screen. Turn on the leads that have been turned off.
• The battery has reached 30% on the programmer and needs to be recharged.
32
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