Spinal Modulation orporated MN0700 Clinical Programmer User Manual LP0014 Rev Draft FCC CProg

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Clinical Programmer
Model MN0700
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.
LP0014 Rev E, June 2011
TABLE OF CONTENTS
EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING ....................................................................... 4
INTRODUCTION ........................................................................................................................................ 5
INDICATIONS FOR USE ............................................................................................................................... 5
DESCRIPTION........................................................................................................................................... 5
WARNINGS ............................................................................................................................................. 6
PRECAUTIONS ......................................................................................................................................... 7
CLINICAL PROGRAMMER SYSTEM OVERVIEW ................................................................................................. 8
CLINICAL PROGRAMMER FEATURES .............................................................................................................. 8
MAGNET ................................................................................................................................................ 9
CHARGING THE CLINICAL PROGRAMMER BATTERY ........................................................................................... 9
PROGRAMMER POWER UP ....................................................................................................................... 10
MAIN MENU......................................................................................................................................... 10
DEMO ................................................................................................................................................. 10
PROGRAMMER SETUP ............................................................................................................................. 10
CHANGE THE DATE ................................................................................................................................. 11
CHANGE THE TIME ................................................................................................................................. 11
SWITCH TO FCE PROGRAMMER ............................................................................................................... 11
ESTABLISHING COMMUNICATION WITH THE NS DEVICE .................................................................................. 11
BACK TO MAIN MENU ............................................................................................................................ 12
NAVIGATION AND SCREEN ELEMENTS .......................................................................................................... 12
NEUROSTIMULATOR DASHBOARD .............................................................................................................. 12
PROGRAMMER STATUS BAR ..................................................................................................................... 13
WORKSPACE NAVIGATION ....................................................................................................................... 13
TEMPORARY AND PERMANENT PROGRAMMING ........................................................................................... 14
MORE ON EDITING TEXT FIELDS ................................................................................................................. 14
USING THE WORKSPACES ......................................................................................................................... 15
PROFILE WORKSPACE .............................................................................................................................. 15
PATIENT INFORMATION TAB [PROFILE >PATIENT] ....................................................................................... 15
CLINIC INFORMATION TAB [PROFILE >CLINIC]............................................................................................. 16
STIMULATOR INFORMATION TAB [PROFILE >NS] ........................................................................................ 16
LEADS INFORMATION TAB [PROFILE >LEADS] ............................................................................................. 17
SYSTEM INFORMATION TAB [PROFILE >SYSTEM]......................................................................................... 17
STIM WORKSPACE .................................................................................................................................. 18
STIM TABS [STIM >TARGET NAME] .......................................................................................................... 18
IMPEDANCE TABS [STIM >IMPEDANCE] ..................................................................................................... 21
MAP WORKSPACE .................................................................................................................................. 21
GROUP WORKSPACE ............................................................................................................................... 21
LEAD TABS [GROUP >GROUP NAME]........................................................................................................ 22
AUTHORIZED EUROPEAN REPRESENTATIVE .................................................................................................. 22
COMPANY CONTACT INFORMATION ........................................................................................................... 22
GUIDANCE AND MANUFACTURER’S DECLARATION.......................................................................................... 23
ELECTROMAGNETIC EMISSIONS ................................................................................................................ 23
ELECTROMAGNETIC IMMUNITY ................................................................................................................ 24
APPENDIX I: PROGRAMMABLE PARAMETERS AND VALUES ............................................................................... 27
APPENDIX II: INS BATTERY LIFE ................................................................................................................ 28
APPENDIX III: TROUBLESHOOTING ............................................................................................................. 37
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
Introduction
The Clinical Programmer (MN0700) is part of the Spinal Modulation Neurostimulator System. It is
intended to be used by the clinical investigator or a Spinal Modulation representative to query and
program the Neurostimulator (NS), to retrieve data from the NS and to allow for adjustment of the
patient’s therapy. This User Manual gives detailed instructions on how to use the Clinical Programmer
safely, how to recharge it and how to use it to set up the patient’s pain management therapy.
Indications for Use
The Spinal Modulation Neurostimulator 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.
Description
Patients who are indicated for Spinal Modulation’s Implantable Neurostimulator System (INS) system
will first undergo a trial period using an external Trial Neurostimulator System (TNS) connected to leads
placed within the epidural space near the dorsal root ganglion (DRG). Up to four leads may be placed
and connected to the Neurostimulator.
Although the leads and stimulator hardware used differ, the programmer hardware and instructions for
programming the TNS and INS devices are the same.
NOTE: In this manual the general abbreviation “NS” is used for information which applies to both
TNS and INS. In all other cases the specific abbreviations “TNS” or “INS” are used.
For specific description of the TNS and INS system components and implant procedures, refer to the
relevant labeling.
Two programmers are available to interact with the NS device.
1. The Clinical Programmer described in this user manual is used to program the stimulation
parameters for the NS, as determined by the investigator. The NS delivers the programmed
stimulation parameters (energy) to the implanted Leads.
2. The Patient Programmer allows the patient to adjust the stimulation settings of the NS devices
within limits preset by the investigator. The Patient Programmer also allows the patient to turn
stimulation off, if necessary. For further information and instructions related to the patient
programmer, refer to the respective user manual.
Warnings
The Warnings listed below pertain to the Clinical Programmer only:
•
The investigator must be trained by Spinal Modulation personnel before using the Clinical
Programmer.
•
Do not use the Clinical Programmer with a NS device that appears to be faulty or fails to
properly communicate.
•
Improper use of the Clinical Programmer may cause irreversible injury to the patient. All
subjects are to be awake and conversant during the procedure to minimize the likelihood of any
nerve damage.
•
Always set the NS device amplitude to 0 µA when repositioning a lead or attaching the
Connector Cable to the external TNS. When restarting stimulation, increase the NS amplitude
slowly until the desired paresthesia is achieved.
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.
Precautions
The following precautions should be taken to avoid damage to the Clinical Programmer and to assure
proper function:
•
Do not drop or mishandle the Clinical Programmer. Physical damage to the Clinical Programmer
may impair its function.
•
Do not spill fluids on or wash the Clinical Programmer. Excessive moisture may impair its
function. If cleaning is necessary, remove soil with a soft damp cloth.
•
Do not use abrasive or caustic cleaning products on the Clinical Programmer.
•
Do not attempt to open the case of the Clinical Programmer. Attempts to open the case may
expose the Clinical Programmer to elements that alter its function.
•
The Clinical Programmer has an internal magnet. Keep the Clinical Programmer away from any
credit cards, hard drives or magnetic storage devices as it may demagnetize them.
•
Do not operate the Clinical Programmer outside the temperature range of ‐5°C to 45°C. Rapid
temperature changes may affect proper device operation.
•
Do not store the Clinical Programmer outside the temperature range of ‐10°C to 50°C.
•
Do not leave the Clinical Programmer in a car or other places where temperatures can exceed
50°C.
•
Do not burn or otherwise dispose of the Clinical Programmer. Fire may cause the internal
battery to explode.
•
Do not allow unauthorized use of the Clinical Programmer to avoid injury to patients.
•
The NS device can only be programmed using Spinal Modulation’s Clinical or Patient
Programmer. Do not try to use any other manufacturer’s device to program it.
•
Do not use the Clinical Programmer or NS in the presence of explosive or flammable gases as
this may cause serious injury.
•
If there is any concern regarding the proper function of the Spinal Modulation NS System, please
contact your Spinal Modulation representative.
•
Do not use the Programmer Charger if the power cord is damaged, excessively worn or frayed.
This may cause injury or damage the Programmer.
•
Frequent programming of the implanted device will cause the battery to deplete faster. Avoid
unnecessary programming.
The TNS should always be worn either outside of clothing or outside the dressing holding the
leads in place.
•
Clinical Programmer System Overview
The Clinical Programmer allows you to establish two‐way communication with the patient’s NS device
for querying and programming.
It is a portable, hand‐held device that can be plugged into a power outlet or be powered by an internal
battery. The battery is rechargeable using the Programmer Charger provided and a power outlet.
The Clinical Programmer System includes:
•
Clinical Programmer (with Stylus) MN0700
•
Programmer Charger MN3400
•
External Auxiliary Magnet MN3300
•
Carrying Case MN3500
•
Clinical Programmer User Manual (this document)
Stylus
Programmer Charger
Clinical Programmer
The Carrying Case will keep the Programmer dry. Store and transport the Programmer in the Carrying
Case when you are not using it.
Clinical Programmer Features
With the Clinical Programmer, you can:
•
Turn OFF all stimulation.
•
Turn stimulation ON for up to four leads and measure lead impedance.
•
Change stimulation settings for each lead.
•
Configure Patient Controlled Therapy settings for each lead.
•
Enter patient and lead identification information, clinician and clinic name and contact
information, and clinician’s notes.
•
Create and name groups of stimulation sets with each group containing up to four leads with
different settings on each lead.
•
Perform a real time trial (test) to assess the patient stimulation response for each lead.
•
Acquire identification, diagnostic, and historic information about the NS device.
Magnet
A magnet is built into the Clinical Programmer. It is located on the back side of the Programmer
underneath the indent with the magnet symbol (shown below).
The NS system has the capability of detecting the presence of a magnet. The magnet puts the NS device
in communication mode, allowing it to connect to the Programmer.
An alternate function of the magnet is that by holding the magnet over the device long enough, all
stimulation therapy will be switched off. (Refer to “Workspace ‐ Profile>System” section for more
information).
PRECAUTION: Keep the programmer magnet away from credit cards. It may erase the
magnetic strip and render the card useless.
Charging the Clinical Programmer Battery
You will need the Programmer Charger provided, to charge the battery in your Clinical Programmer. It
takes approximately 2–4 hours to fully charge the battery. The battery charge level is indicated in the
“Programmer Status Bar” at the bottom of the screen.
1. Connect the Charger to a power outlet.
Input: 100‐240 VAC, 50‐60 Hz, 0.6A
Output: 5V
3.0A
2. Connect the Charger to your Programmer.
3. When the battery is charging, the battery icon on the screen contains “AC”. When the charging
is complete, the indicator next to the battery icon will be at approximately 100%.
When the Clinical Programmer is connected to a power outlet as described above, it is powered by the
outlet and will not use battery power. When the Clinical Programmer is charging, the Programmer
battery icon reflects the current status of the battery. Connect the Clinical Programmer to the Charger
and attach to an outlet regularly to keep it charged.
Programmer Power Up
Turn the Clinical Programmer ON by pressing the “ “button. The Main Menu will be displayed.
NOTE: If the Clinical Programmer screen does not turn on, follow the instructions for charging the
battery, and try again.
Main Menu
The Main Menu displays three primary functions:
•
Demo: Puts the system into a stand‐alone demo mode
allowing you to use all programmer functions without
it being connected to a NS.
•
Programmer Setup: Allows you to set the Clinical
Programmer date and time, activate the FCE
Workspace on the Programmer, and set and modify
the Programmer password.
•
Connect to Stimulator: Opens a screen that allows you
to communicate with the NS device.
The Main Menu identifies the device as the Spinal Modulation
Clinical Programmer.
Furthermore, Programmer’s Serial
Number, Software Version, Basestation Firmware Version and Manufacturing date are displayed.
At the bottom of the Main Menu, the status bar displays the Programmer – NS connection status, the
battery charge level and the time. Refer to the section on the Programmer Status Bar in this User
Manual.
Demo
Select “Demo” on the Main Menu to initiate Demo mode.
Buttons will be purple to indicate that the Programmer is
operating in Demo mode. No NS device is needed for this
mode —just the Programmer. The Programmer will have
simulated NS data on it and will simulate the RF communication with the NS. This means that at the
start of every Demo session, the data will always be the same.
Programmer Setup
Select “Programmer Setup” on the Main Menu to get the
setup screen.
10
Change the Date
Select the drop down arrow on the right side of the “Set
Date” box. A calendar will appear and you can set the
month, day and year using your stylus.
Change the Time
To change the time (24 hour format), first select the hour or
minute field that you would like to change.
To change the selected field, use the “Up” or “Down”
arrows to increase, decrease or toggle the setting.
NOTE: Establishing a connection updates the NS
device’s clock to the newly set time.
Switch to FCE Programmer
By checking this box the Clinical Programmer will get
additional functionality, which should only be used by Spinal Modulation’s Field Clinical Engineers and
Staff.
Establishing Communication with the NS Device
To change the patient’s stimulation settings, you must first establish communication between the
Clinical Programmer and the patient’s NS device.
1. Make sure that the Clinical Programmer is turned
on and the Main Menu screen is displayed
2. Press “Connect to Stimulator” on the Main Menu.
3. Select the text box next to “Stimulator SN:”
4. Enter the serial number using the pop‐up
keyboard. The Programmer is case sensitive so use
uppercase letters only.
If the serial number format is valid for a NS device, the
“Connect” button will be enabled.
5. Press the “Connect” button.
After pressing the “Connect” button, the “Cancel” button
becomes enabled. If the Cancel button is pressed, the
telemetry connection is cancelled.
11
6. Move the Clinical Programmer magnet over the NS device in a circular motion to connect.
The indicator status bar on the bottom left of the screen will display “Connected” if the connection
attempt is successful. If the Programmer could not communicate with the NS device, an error message
will appear and “Disconnected” will be displayed in the status bar.
NOTE: If after 2 minutes the Clinical Programmer has failed to communicate with the NS device, the
programmer will automatically cancel the connection attempt. Try to communicate with the NS
device by pressing the “Connect” button again moving the magnet symbol on the Clinical
Programmer over the NS device in a circular fashion.
When a successful connection is established, the Programmer chimes and the NS device will be queried.
7. For the duration of the programming session keep the Clinical Programmer within 6 feet of the
NS device. Moving the programmer too far away may cause telemetry connection to be lost.
Back to Main Menu
Located at the bottom right side of the Programmer Connect window, the “Exit” button is used to return
to the Main Menu.
Navigation and screen elements
Neurostimulator Dashboard
Once the selected NS device is connected to the Clinical
Programmer, the NS Dashboard is displayed in the screen’s
header providing:
•
Patient ID: the patient’s ID Number.
•
Stimulator Serial Number: the NS device’s serial
number.
•
Alerts button: The button turns orange when any
of the NS System Alerts become active. When the
“Alerts” button is orange, press the button to
display a window showing details of all the System
Alerts. An example of the screenshot is shown to
the right.
12
Programmer Status Bar
Located at the bottom of the Clinical Programmer screen, the Programmer Status Bar displays:
•
Programmer ‐ NS Connection Status: Displays the status of the communication between the
Clinical Programmer and the NS device: “Connecting” is displayed when establishing a
connection. “Connected” is displayed when there is communication between the Clinical
Programmer and the NS device. “Disconnected” is displayed when there is no communication
between the Clinical Programmer and the NS device.
•
Programmer Battery Level: Displays the Clinical Programmer battery charge level. It is
recommended that your Programmer be connected to the power supply provided and attached
to an outlet when not in use.
•
Programmer Clock: Displays the time. See User Manual section on Change the Time.
Workspace Navigation
Once the NS is connected, tabs are displayed for the
systems’ four main workspaces (“Profile”, “Stim”, “Map”
and “Group”). The Workspaces are used to view and
program the NS therapy settings and to obtain diagnostic
information. A record of the programmed settings and diagnostic information is generated after every
session. A fifth Workspace labeled “FCE” will only appear when FCE mode is ON.
Workspace screens and sub‐screens are navigated by selecting the labeled tabs. Once selected, a tab
will be highlighted in yellow.
Located at the bottom of each of the Workspaces are the
“ALL”, “Program” and “Exit” buttons.
•
Exit button: is used to close the current window, end the patient therapy session, and return to
the Main Menu.
NOTE: Returning to the Main Menu or turning off your Programmer will not change any of the
programmed NS settings.
NOTE: When programming is complete, select the “Exit” button to conserve power.
•
Program button: programs all changes made within the current Workspace.
•
ALL button: is used to turn all stimulation off.
13
Temporary and Permanent Programming
Whenever a change is made to a parameter value or other data field while the NS is within telemetry
range, this value immediately becomes temporarily active. The corresponding value or data selection
appear in a red bold underlined font.
Temporary programmed values or text data can be permanently programmed by pressing the program
button. The font color changes from red to black.
NOTE: When leaving a Workspace while values are temporarily active you will be prompted to either
program these values permanently or cancel the pending changes.
NOTE: Parameters can be temporarily active on multiple tabs of the same Workspace.
More on editing text fields
NOTE: Selecting a text field will pop up a keyboard at the bottom of the screen, allowing the
information to be revised. To close the keyboard after modifying the entry, press the keyboard key
centered in the blue bar at the bottom of the screen.
While text fields are being edited they appear in a black bold
font (no underline). At the same time to the right of the text
field a red dot is shown indicating that editing is in progress.
Editing can be in progress for multiple fields at the same
time.
Once editing for a field is complete, tap the red‐dot to make
the change temporarily active. The red dot disappears and
the font changes from black bold to red bold underlined.
Only upon pressing the programming button does the change
become permanently programmed and the font color
changes from red to black.
14
Using the Workspaces
Profile Workspace
Press the “Profile” tab to access the Profile Workspace. The Profile Workspace is divided into five tabs
(“Patient”, “Clinic”, “NS”, “Leads” and “System”) which are used to:
•
Enter patient information;
•
Enter clinician contact information;
•
Enter NS device information;
•
Enter lead identification information;
•
Change basic system parameters;
Patient Information Tab [Profile >Patient]
Enter or modify the patient information in the fields provided:
•
Patient Name: Enter the patient’s name using the on‐screen keyboard.
•
ID: Enter the patient’s unique identification using the on‐screen keyboard.
•
Date of Birth: Enter the patient's date of birth using the drop‐down calendar.
•
Primary and secondary Diagnosis: Select the patient's diagnosis from a drop‐down list (Refer to
Appendix I for selection set)
•
Notes: Enter notes if needed.
15
Clinic Information Tab [Profile >Clinic]
Enter or modify the physician and clinic information in the text
fields provided:
•
Physician Name
•
Clinic Name
•
Clinic after hours contact phone number
•
Clinic Phone number
•
Clinic Email
•
Clinic Address
Stimulator Information Tab [Profile >NS]
The NS tab provides a summary of information related to the
NS.
•
Date of Implant: Enter the Stimulator date of use
using the drop‐down calendar.
•
Implant battery voltage: the current battery voltage is
automatically displayed here.
•
History: shows recent programming history.
NOTE: The battery information pertains to an INS and does not
pertain to the TNS.
16
Leads Information Tab [Profile >Leads]
Lead 1 through Lead 4 are the default labels used to
identify the implanted leads in the “Stim” Workspace. It is
recommended that these names be changed into
something more meaningful, for example the body region
it covers.
•
Target Name: for each of the implanted leads,
enter the body region covered (text field).
For each of the leads enter the Lot and Model number:
•
Lot #: enter the last four digits of the Lot number
found on the lead packaging.
•
Model #: enter the lead Model number.
System Information Tab [Profile >System]
From the system tab the following system parameters can be
managed:
•
Periodic Impedance interval: set the periodicity with
which you want the system to measure lead
impedance.
•
Follow‐up Period: A calculated field which displays
the recommended follow‐up time based on the
programmed settings. It is an indicator of when the
programmer will run out of memory and will begin to
overwrite old data.
•
Ramp Duration: Ramp duration is how long it takes
for the NS to reach the requested amplitude. If set
to 8 seconds, the NS will take 8 seconds to get from 0
to the requested amplitude when a lead is switched
from not enabled to enabled. Ramping also occurs
when the step between the current amplitude and
the next amplitude is greater than 100 mV.
•
Magnet Turnoff Time: allows you to control how long it takes before a magnet held over the
device switches off delivered therapy.
17
Stim Workspace
Press the “Stim” tab to access the Stimulation Settings Workspace. The Stimulation Settings Workspace
is divided into five tabs which are used to:
•
Activate (turn on) up to four leads
•
Adjust electrode configurations
•
Measure impedance
•
Set nominal values to begin stimulation
•
Perform trial mapping
•
Confirm the response and sensation of specific body regions to be stimulated
Stim Tabs [Stim >Target Name]
The Stim tabs are the main tabs from which therapy is
controlled and programmed. This can be done either
temporarily (testing) or permanently.
•
Select group: select the group for which you want
to change the stimulation settings.
NOTE: in the Group Workspace, up to four different
groups can be defined each with their own stimulation
parameters. A group can be linked for example to a
specific activity or posture. Refer to the Group
Workspace section in this manual for more
information.
•
Select the tab: labeled with the target for which
you want to adapt stimulation parameters. (In the
sample screen eg. “L Foot”)
NOTE: There are up to four tabs that can be labeled with the body region in which stimulation with
the corresponding lead is targeting (defined in Profile>Leads). For each body region (lead)
stimulation can be adjusted independently.
•
Electrode Configuration: Each lead has four electrodes each of which can be programmed with
a positive or negative polarity, or be programmed as neutral (off). There must be at least one
positive and one negative electrode before the Clinical Programmer allows the amplitude to be
adjusted and for the lead to be enabled.
1. Select one of the four electrodes by clicking on it using the stylus. Clicking once will turn the
electrode positive (“+”), clicking it twice will turn it negative (“‐“) and clicking it three times
will turn it Neutral (“N”) again. To exit from the electrode editing mode, click on the
neighboring Impedance box.
2. Continue, by setting each of implanted leads with at least one positive and one negative
electrode for each body region to be treated.
•
Impedance: Press the “Instant Impedance” button (“Ω“) to measure the lead’s impedance.
Once pressed, the impedance value will be displayed underneath the button. If you want the NS
18
to use this Instant Impedance value for therapy delivery, press the “Transfer Instant Impedance”
button (“Æ“).
NOTE: The patient may feel the effect of the impedance measurement. Alert the patient to the
possible stimulation.
NOTE: A transferred impedance value is required before other stimulation parameters can be
selected.
•
Enable: Select “ON” to enable the lead so that it provides stimulation therapy to the patient.
Select “OFF” if the lead is not being used.
When Enable is ON, the “ON” button will turn the color green.
When Enable is OFF, the “OFF” button will turn the color black.
The button border is red if the activation state is different from the programmed value.
WARNING: Once Enable is ON for this target, any parameter change will be
immediately active.
NOTE: If a lead is enabled on a non active tab of the “Stim” Workspace, the tab will turn the color
green. The active tab stays the color yellow.
NOTE: The lead is disabled and the amplitude is automatically changed to zero when the lead
electrode configuration changes. The lead electrode configuration must be valid prior to activating
the lead. A valid lead configuration must include at least one positive and one negative electrode.
19
•
Location: Enter the spinal level where stimulation therapy is delivered by this trial lead
•
Pulse Parameters: To select and change pulse parameters, first press the desired increment
level: Fine (>), Medium (>>), Coarse (>>>).
ƒ
Amplitudes below 2.0 mA (>: 25 µA, >>: 50 µA, >>>: 200 µA)
ƒ
Amplitudes above 2.0 mA (>: 50 µA, >>: 100 µA, >>>: 400 µA)
ƒ
Pulse Width (>: 10 µs, >>: 40 µs, >>>: 100 µs)
ƒ
Frequency (>: 2 Hz, >>: 4 Hz, >>>: 10 Hz)
ƒ
The UP(^) and Down(∨) buttons next to the specific pulse parameter will allow the user
to change the setting at the desired increments.
The following table lists the pulse parameters, their range, increments and default value:
Specifications
Range
Step Size
Default Value
Pulse Amplitude ‐ PA (µA)
0 – 6000 µA
25 µA: 0‐2000 µA
50 µA: 2000‐6000 µA
0 µA
Maximum Pulse Amplitude ‐ Max (µA)
Programmable by Patient
Same as PA
Same as PA
0 µA
Pulse Width – PW (µs)
40 – 720 µs
10 µs
40 µs
Pulse Frequency ‐ PF (Hz)
4 – 100 Hz
2 Hz
60 Hz
(Depending on measured impedance)
•
Maximum Amplitude: Enter the maximum stimulation amplitude, from the clinically set
amplitude up to 6.0 mA that the patient is allowed to set for each lead.
WARNING: Unless the stimulation settings are known for a specific patient, start with a
Pulse Amplitude of 0 µA.
•
Stimulus Response: Allows you to assign a descriptor to a set of programmed pulse parameters.
The descriptor is composed of a body region where the sensation is felt and a description of the
sensation. (Eg. Upper Back & Massaging Æ Upper Back Massaging). A Stimulus Response must
be selected in order to Program the set of pulse parameters. The Load Other button pulls down
a drop down menu and allows the user to load another Stimulus Response that has been
previously saved for that lead.
NOTE: When restarting stimulation, increase the amplitude slowly until the desired effect is
achieved.
20
Impedance Tabs [Stim >Impedance]
The impedance button (Ω) initiates impedance
measurements between adjacent electrode couples in all of
the configured leads and displays on the Imp screen.
Map Workspace
Press the “Map” tab to access the Map Workspace.
The Map Workspace allows you to define which lead
connects to each of the NS ports. It therefore provides the
ability to automatically move saved settings from one Port
to another.
Each lead is identified by its location (spinal level) entered in
the Stim Workspace.
Group Workspace
Press the “Group” tab to access Group Workspace.
The Group Workspace is divided into four tabs (Groups) by default named “Awake”, “Sleeping”,
Exercising” and “Sleeping”). Each tab summarizes Group specific settings for each of the implanted
leads. These Groups can be easily programmed as needed by the patient using the Patient Programmer.
21
Lead Tabs [Group >Group Name]
Each Group can be configured by selecting the desired tab.
•
Name: The Group can be renamed here (free‐form
text entry)
•
For Patient Use: The Group will be displayed on
the Patient Programmer only if this box is checked.
Note that the currently active Group must be
checked/enabled.
•
On Programmer / On Stimulator: These buttons
toggle to allow the user to view either the
Programmer values (possibly not programmed yet
to the Stimulator) or the values programmed on
the Stimulator
•
Lead 1 through Lead 4: The Stimulus Response for
each Lead within a Group can be changed here.
Stimulus Responses that have been previously
saved for that Lead will be shown in the drop down
menu.
•
Response / Discard: Unwanted Stimulus Response definitions can be discarded here. This may
be needed once the user has used up the maximum number of Stimulus Responses (12).
The Spinal Modulation Neurostimulator System complies with the following International Standards
•
IEC 60601‐1: 2005
•
ISO 14708‐1: 2000
•
IEC 60601‐1‐11: 2010
•
ISO 14708‐3: 2008
•
IEC 60601‐1‐2: 2007
AUTHORIZED EUROPEAN REPRESENTATIVE
MediTech Strategic Consultants B.V.
Maastrichterlaan 127-129
6291 EN Vaals, Netherlands
COMPANY CONTACT INFORMATION
Spinal Modulation, Inc.
1135 O’Brien Drive
Menlo Park, CA 94025
U.S.A.
Telephone: (650) 543-6800 (24 hour support line)
Fax: (650) 327-2336
Email: clinicalsupport@spinalmodulation.com
22
GUIDANCE 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
RF emissions
CISPR 11
Harmonic emissions
IEC 61000‐3‐2
Voltage fluctuations/
flicker emissions
IEC 61000‐3‐3
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.
Class B
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.
CISPR 14‐1
Complies
The Clinical Programmer is not intended to be connected to
other equipment except the Model 3400 Programmer Charger
23
Guidance and manufacturer’s declaration
Electromagnetic Immunity
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
IEC 60601
Test Level
Electrostatic discharge IEC 61000‐4‐2
(ESD)
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
Electrical fast
transient/burst
IEC 61000‐4‐4
± 2 kV for power supply lines
± 1 kV for input/output lines
Surge
IEC 61000‐4‐5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Mains power quality should be that
of a typical commercial or home
environment
Voltage dips, short
interruptions and
voltage variations on
power supply
input lines
IEC 61000-4-11
<5 % UT (>95 % dip in UT)
for 0,5 cycle
40 % UT (60 % dip in UT)
for 5 cycles
70 % UT (30 % dip in UT)
for 25 cycles
<5 % UT (>95 % dip in UT)
for 5 s
Mains power quality should be that
of a typical commercial or home
environment
NOTE UT is the a.c. mains voltage
prior to application of the test level.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000‐4‐8
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial, hospital, or home
environment.
24
Guidance and manufacturer’s declaration
Electromagnetic Immunity
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
IEC 60601 TEST
LEVEL
3 Vrms
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000‐4‐3
80 MHz to 2,5 GHz
Compliance
level
3V
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 the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
The recommended separation distance is a
minimum of 0.2 meter for transmitters of
80 MHz to 2.5 GHz
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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.
25
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
0.01
Separation distance according to frequency of transmitter
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
1.17m
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.
26
Appendix I: Programmable parameters and values
Parameter
Programmable Values
Default
Pulse Amplitude
0 – 6000 µA
0 µA
0‐2000 µA (25 µA increments)
2000‐6000 µA (50 µA increments)
Maximum Pulse Amplitude
Same as Pulse Amplitude
0 µA
Pulse Width
40 – 720 µs (10 µs increments)
40 µs
Pulse Frequency
4 – 100 Hz (2 Hz increments)
60 Hz
Data Field
Selectable Values
Diagnosis
Abdominal Pain; Axial Low Back Pain; Axial Neck Pain; CRPS Type 1;
CRPS Type 2; Diabetic Peripheral Neuropathy; FBSS; FNSS; Lower
Extremity Neuropathic Pain; Neuropathic Pain; Other; Peripheral
Neuropathy; Phantom Pain; Post‐Herpetic Neuralgia; Post Surgical
Pain; Radicular Arm Pain; Radicular Leg Pain; Thoracic Pain; Upper
Extremity Neuropathic Pain; Visceral Pain;
(Primary and Secondary)
Periodic Impedance Interval
Off; 30 s; 1 min; 5 min; 20 min; 30 min; 1 h; 12 h; 1 days; 10 days; 30
days
Lead Model Number
MN0300; MN0400
Stimulus Response Anatomy
Off; Neck; Shoulder; Scapula; Upper Back; Middle Back; Lower Back;
Back & Leg; Thigh; Knee; Lower Leg; Ankle; Foot(top); Foot(bottom);
Toes; Chest; Axila; Ribs; Abdomen; Hip; Groin; Upper Arm; Elbow;
Forearm; Hands; Fingers
Stimulus Response Sensation
Off; Burning; Buzzing; Cold; Comforting; Cramping; Heavy; Massaging;
Numb; Other; Pain; Paresthesia; Pressure; Relief; Soothing; Spasm;
Tapping; Tingling; Vibrating; Warm
Spine Location
L L1; R L1; L L2; R L2; L L3; R L3; L L4; R L4; L L5; R L5; L T1; R T1; L T2; R
T2; L T3; R T3; L T4; R T4; L T5; R T5; L T6; R T6; L T7; R T7; L T8; R T8; L
T9; R T9; L T10; R T10; L T11; R T11; L T12; R T12; L S1; R S1; L S2; R S2;
L S3; R S3; L S4; R S4; L S5; R S5; L C1; R C1; L C2; R C2; L C3; R C3; L C4;
R C4; L C5; R C5; L C6; R C6; L C7; R C7; L C8; R C8
Magnet Turnoff Time
Off; 1 s; 2 s; 3 s; 4 s; 5 s; 6 s; 7 s; 8 s; 9 s; 10 s; 15 s; 20 s; 25 s; 30 s; 40
s; 50 s; 1 min; 70 s; 80 s; 90 s; 100 s; 110 s; 2 min
Ramp Duration
0 s; 1 s; 2 s; 3 s; 4 s; 5 s; 6 s; 7 s; 8 s
27
Appendix II: 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
28
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
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
0.2mA
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
0.4mA
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
0.6mA
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
0.8mA
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
29
Table 1: Load Impedance = 600 ohms (Continued)
All longevity values are in months
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
83.2 82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
78.3 73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
73.0 65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
68.3 58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
64.2 53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
60.6 48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
82.8 81.2
78.6
76.1
73.8
71.7
69.6
67.7
67.3
76.7 70.1
61.3
54.5
49.0
44.6
40.8
37.7
37.1
70.2 59.9
48.1
40.2
34.5
30.3
26.9
24.3
23.8
64.7 52.3
39.6
31.9
26.6
22.9
20.1
17.9
17.5
60.0 46.4
33.6
26.4
21.7
18.4
16.0
14.2
13.8
56.0 41.7
29.2
22.5
18.3
15.4
13.3
11.7
11.4
82.5 80.3
76.9
73.8
71.0
68.3
65.9
63.6
63.2
75.1 66.9
56.6
49.0
43.3
38.7
35.0
32.0
31.4
67.6 55.4
42.5
34.5
29.1
25.1
22.1
19.7
19.3
61.5 47.2
34.1
26.6
21.9
18.6
16.1
14.2
13.9
56.4 41.2
28.4
21.7
17.5
14.7
12.7
11.1
10.9
52.0 36.5
24.4
18.3
14.6
12.2
10.5
9.2
8.9
56.6 53.8
49.7
46.2
43.1
40.5
38.1
36.0
35.6
46.3 38.2
29.6
24.1
20.4
17.6
15.5
13.9
13.6
37.7 28.0
19.6
15.1
12.3
10.3
8.9
7.8
7.7
31.8 22.1
14.7
11.0
8.8
7.3
6.3
5.5
5.3
27.5 18.3
11.7
8.6
6.8
5.6
4.8
4.2
4.1
24.3 15.6
9.8
7.1
5.6
4.6
3.9
3.4
3.3
52.6 47.4
40.8
35.8
31.8
28.7
26.1
24.0
23.6
35.3 25.9
17.9
13.7
11.1
9.3
8.0
7.0
6.9
25.0 16.5
10.5
7.7
6.1
5.0
4.3
3.7
3.6
19.4 12.1
7.4
5.4
4.2
3.5
2.9
2.5
2.5
15.8
9.6
5.8
4.1
3.2
2.6
2.2
1.9
1.9
13.3
7.9
4.7
3.3
2.6
2.1
1.8
1.6
1.5
30
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
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
0.2mA
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
0.4mA
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
0.6mA
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
0.8mA
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
31
Table 2: Load Impedance = 1 Kohm (Continued)
All longevity values are in months
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
83.2 82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
78.3 73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
73.0 65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
68.3 58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
64.2 53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
60.6 48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
82.8 81.2
78.6
76.1
73.8
71.7
69.6
67.7
67.3
76.7 70.1
61.3
54.5
49.0
44.6
40.8
37.7
37.1
70.2 59.9
48.1
40.2
34.5
30.3
26.9
24.3
23.8
64.7 52.3
39.6
31.9
26.6
22.9
20.1
17.9
17.5
60.0 46.4
33.6
26.4
21.7
18.4
16.0
14.2
13.8
56.0 41.7
29.2
22.5
18.3
15.4
13.3
11.7
11.4
58.4 57.2
55.1
53.3
51.5
49.9
48.3
46.9
46.6
53.1 48.2
41.8
36.9
33.0
29.8
27.3
25.1
24.7
47.7 40.3
32.1
26.6
22.8
19.9
17.6
15.9
15.5
43.2 34.6
26.0
20.8
17.4
14.9
13.0
11.6
11.3
39.6 30.4
21.9
17.1
14.0
11.9
10.3
9.1
8.9
36.5 27.0
18.9
14.5
11.8
9.9
8.6
7.5
7.4
53.0 49.1
43.6
39.2
35.7
32.7
30.2
28.0
27.6
36.3 28.4
20.9
16.5
13.6
11.6
10.1
9.0
8.8
26.1 18.6
12.6
9.6
7.7
6.4
5.5
4.8
4.7
20.3 13.9
9.1
6.7
5.3
4.4
3.8
3.3
3.2
16.7 11.0
7.1
5.2
4.1
3.4
2.9
2.5
2.5
14.1
9.2
5.8
4.2
3.3
2.7
2.3
2.0
2.0
51.4 46.5
40.2
35.4
31.6
28.6
26.1
24.0
23.6
32.7 24.5
17.4
13.4
10.9
9.2
8.0
7.0
6.9
22.4 15.4
10.1
7.6
6.0
5.0
4.3
3.7
3.7
17.1 11.3
7.2
5.3
4.2
3.4
2.9
2.5
2.5
13.8
8.9
5.5
4.0
3.2
2.6
2.2
1.9
1.9
11.6
7.3
4.5
3.3
2.6
2.1
1.8
1.6
1.5
32
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
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
0.2mA
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
0.4mA
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
0.6mA
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
0.8mA
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
33
Table 3: Load Impedance = 1.5 Kohm (Continued)
All longevity values are in months
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
83.2 82.1
80.3
78.6
76.9
75.4
73.8
72.4
72.1
78.3 73.6
66.9
61.3
56.6
52.5
49.0
46.0
45.4
73.0 65.2
55.4
48.1
42.5
38.1
34.5
31.6
31.0
68.3 58.5
47.2
39.6
34.1
29.9
26.6
24.0
23.6
64.2 53.1
41.2
33.6
28.4
24.6
21.7
19.4
19.0
60.6 48.6
36.5
29.2
24.4
20.9
18.3
16.3
15.9
58.2 57.1
55.4
53.8
52.3
50.8
49.5
48.2
47.9
52.0 47.9
42.5
38.1
34.6
31.6
29.1
27.0
26.6
45.9 40.0
32.9
27.9
24.3
21.5
19.3
17.4
17.1
41.1 34.2
26.8
22.1
18.7
16.3
14.4
12.9
12.6
37.2 30.0
22.7
18.2
15.2
13.1
11.5
10.2
10.0
33.9 26.6
19.6
15.5
12.8
10.9
9.5
8.5
8.3
56.4 54.6
51.9
49.5
47.2
45.2
43.3
41.6
41.3
45.7 40.4
33.8
29.1
25.6
22.8
20.5
18.7
18.4
36.9 30.4
23.6
19.2
16.2
14.1
12.4
11.1
10.9
30.9 24.4
18.1
14.4
11.9
10.2
8.9
7.9
7.7
26.6 20.4
14.7
11.5
9.4
8.0
6.9
6.1
6.0
23.4 17.5
12.3
9.5
7.8
6.5
5.7
5.0
4.9
52.6 49.1
44.2
40.2
36.9
34.1
31.6
29.5
29.1
35.3 28.5
21.6
17.4
14.5
12.5
10.9
9.7
9.5
25.0 18.7
13.2
10.1
8.3
7.0
6.0
5.3
5.2
19.3 13.9
9.5
7.2
5.8
4.8
4.2
3.6
3.6
15.8 11.1
7.4
5.5
4.4
3.7
3.2
2.8
2.7
13.3
9.2
6.1
4.5
3.6
3.0
2.6
2.2
2.2
52.6 49.1
44.2
40.2
36.9
34.1
31.6
29.5
29.1
35.3 28.5
21.6
17.4
14.5
12.5
10.9
9.7
9.5
25.0 18.7
13.2
10.1
8.3
7.0
6.0
5.3
5.2
19.3 13.9
9.5
7.2
5.8
4.8
4.2
3.6
3.6
15.8 11.1
7.4
5.5
4.4
3.7
3.2
2.8
2.7
13.3
9.2
6.1
4.5
3.6
3.0
2.6
2.2
2.2
34
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
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
0.2mA
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
0.4mA
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
0.6mA
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
0.8mA
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
35
Table 4: Load Impedance = 2 Kohm (Continued)
All longevity values are in months
1.0mA
1.5mA
2.0mA
4.0mA
6.0mA
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
4Hz
20Hz
40Hz
60Hz
80Hz
100Hz
Pulsewidth
40uS 100uS 200uS 300uS 400uS 500uS 600uS 700uS 720uS
58.9 58.2
57.2
56.1
55.1
54.2
53.3
52.4
52.2
55.0 52.2
48.2
44.8
41.8
39.2
36.9
34.8
34.4
50.7 46.3
40.3
35.7
32.1
29.1
26.6
24.5
24.2
47.1 41.5
34.6
29.7
26.0
23.1
20.8
18.9
18.6
44.0 37.7
30.4
25.4
21.9
19.2
17.1
15.4
15.1
41.2 34.5
27.0
22.2
18.9
16.4
14.5
13.0
12.7
56.7 55.4
53.2
51.3
49.5
47.8
46.2
44.7
44.4
46.7 42.4
36.8
32.5
29.1
26.4
24.1
22.2
21.8
38.2 32.8
26.6
22.3
19.2
16.9
15.1
13.6
13.3
32.4 26.8
20.8
17.0
14.4
12.4
11.0
9.8
9.6
28.1 22.6
17.1
13.7
11.5
9.8
8.6
7.7
7.5
24.8 19.6
14.5
11.5
9.5
8.1
7.1
6.3
6.2
54.5 52.3
49.1
46.2
43.6
41.3
39.2
39.2
37.0
40.1 34.7
28.4
24.1
20.9
18.4
16.5
16.5
14.6
30.1 24.5
18.6
15.1
12.6
10.9
9.6
9.6
8.3
24.1 18.9
13.9
11.0
9.1
7.7
6.7
6.7
5.8
20.1 15.4
11.0
8.6
7.1
6.0
5.2
5.2
4.5
17.2 13.0
9.2
7.1
5.8
4.9
4.2
4.2
3.6
53.2 50.5
46.5
43.1
40.2
37.7
35.4
33.4
33.0
36.7 31.0
24.5
20.3
17.4
15.1
13.4
12.1
11.8
26.5 20.9
15.4
12.2
10.1
8.7
7.6
6.7
6.6
20.7 15.7
11.3
8.8
7.2
6.1
5.3
4.6
4.5
17.0 12.6
8.9
6.8
5.5
4.7
4.0
3.6
3.5
14.4 10.6
7.3
5.6
4.5
3.8
3.3
2.9
2.8
53.2 50.5
46.5
43.1
40.2
37.7
35.4
33.4
33.0
36.7 31.0
24.5
20.3
17.4
15.1
13.4
12.1
11.8
26.5 20.9
15.4
12.2
10.1
8.7
7.6
6.7
6.6
20.7 15.7
11.3
8.8
7.2
6.1
5.3
4.6
4.5
17.0 12.6
8.9
6.8
5.5
4.7
4.0
3.6
3.5
14.4 10.6
7.3
5.6
4.5
3.8
3.3
2.9
2.8
36
Appendix III: Troubleshooting
Pop‐up Messages
All stimulation has been turned OFF.
Cancelled Connect Request
Changes since last programming were
lost due to loss of connection with the
stimulator. Please reconnect to
stimulator.
Connected to stimulator.
Communication is poor.
Connecting to stimulator...
Connection Established.
Condition
Buttons Resolution
All stimulation turned off due to data “OK”
Contact your Spinal
corruption or Device being in
Modulation
Hibernate mode.
Representative.
Cancel was pressed with connecting
attempt in progress.
Communication was lost prior to
“OK”
Reconnect to
programming attempt.
stimulator and re‐enter
program changes.
All RF channels have noise levels
above the noise threshold.
“Connect” button on the main menu
was pressed.
Connection attempt was successful.
Try moving to an area
with fewer sources of
noise.
“OK”
Connection with stimulator was lost.
Please reconnect.
Dropped RF connection.
Do you want to program changes?
Invalid FCE password. Please try again.
A new Workspace or Exit button was
selected without saving
(programming) changes.
Invalid FCE password was entered.
Lead N detected a Current Too High
condition.
During an impedance measurement,
the measured current was too high.
“OK”
Lead N impedance of NNN Ω is out of
range.
Maximum stimulation output has been
reached.
Please specify a Stimulus Response
before programming
Lead impedance is out of range
“OK”
Maximum stimulation output has
been reached (5.2V).
Attempt to program a set of pulse
parameters without a Stimulus
Response Name.
PDA battery reaches 30%.
“OK”
Programmer battery is low. Please
recharge.
Programmer is booting after a reset.
When you click OK the Programmer will
switch off. Press the Power button to
restart.
Programmer storage space is full. File
logging has stopped. Please contact
your Spinal Modulation representative
for maintenance.
Pop‐up Messages (Cont.)
"Yes"
"No"
"Cancel"
“OK”
“OK”
“OK”
“OK”
Hardware reset Button on the PDA
was pressed or the Programmer is
launched for the first time.
PDA storage is full. After user
“OK”
acknowledgement, normal operation
continues.
Condition
Only Spinal Modulation
representatives should
access the FCE mode.
Repeat measurement.
If problem reoccurs,
contact your Spinal
Modulation
representative.
Repeat measurement
or accept as is.
Investigate lead
integrity.
Select stimulus
response.
Recharge as soon as
possible.
Press Power button.
Contact your Spinal
Modulation
Representative.
Buttons Resolution
37
Programmer storage space is low.
Please contact your Spinal Modulation
representative for maintenance.
Stimulation for one or more leads has
been turned OFF.
PDA storage is nearing full capacity
(log files are stored on the PDA with
each significant operation such as
programming). Message is displayed
and file logging should continue.
Normal operation continues after
user acknowledgement.
One or more leads turned off due to
Low Impedance.
Stimulation has been turned OFF due to Stimulation can be turned off by
a magnet.
applying a magnet for the duration
specified by the Magnet Turnoff Time
programmable parameter.
Stimulation has been turned OFF.
Stimulation can be turned off, either
by the “All Stim OFF” software button
on the INS programmer, or the Off
switch on the TNS.
Stimulator battery has reached End of
Battery has reached EOS voltage.
Service (EOS). Stimulation has been
Stimulation is disabled in order to
turned OFF permanently.
preserve power for RF
communication.
Stimulator battery has reached the
Battery has reached ERI voltage.
Elective Replacement Indicator (ERI).
Stimulator clock is HH:MM. Do you
The NS internal time is out of sync
want to update Stimulator clock?
with the Programmer time.
The stimulator has been set to default
The Programmer has encountered an
values.
NS with unreadable or invalid data.
Parameters have been set and
programmed to default values.
The stimulator has unreadable data.
NS has unreadable data (such as Trim
Please reconnect with programmer in
data)
FCE mode or contact your Spinal
Modulation representative
The stimulator is in Upgrade Mode.
NS in Boot mode.
Please reconnect with programmer in
FCE mode or contact your Spinal
Modulation representative.
Unable to connect to stimulator. Make Can’t connect to the NS.
sure the programmer is close to the
stimulator and try again.
“OK”
Contact your Spinal
Modulation
Representative.
“OK”
Perform impedance
measurement and re‐
enable if within range.
Otherwise, investigate
lead integrity.
“OK”
“OK”
“OK”
Schedule replacement
of the Stimulator.
“OK”
Schedule replacement
of the Stimulator.
“ Yes”
“No”
“OK”
Setup device
parameters as desired.
“OK”
Contact your Spinal
Modulation
Representative.
“OK”
Contact your Spinal
Modulation
Representative.
“OK”
Move the programmer
above the Stimulator in
circular motions.
Error messages may contain additional troubleshooting information such as “Error Code: 04‐
123, BadParameterValue”. This is an aid for Spinal Modulation engineers to debug errors.
38

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