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Clinical Programmer
Model MN20700-03
User Manual
Copyright © 2012 Spinal Modulation, Inc. All rights reserved. Unauthorized duplication or use is prohibited.
AXIUM, SPINAL MODULATION and the Man in Circle Design are trademarks and/or registered trademarks
of Spinal Modulation, Inc.
Authorization to affix the CE mark
granted in 2011
Table of Contents
EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING............................................ 1
Impedance Tabs [Stim>Impedance]......................................................................................................................17
Map Workspace................................................................................................................................. 17
Group Workspace.............................................................................................................................. 17
INTRODUCTION...................................................................................................................................... 2
Lead Tabs [Group>Group Name]..........................................................................................................................17
Indications for Use............................................................................................................................... 2
Periodic Stimulation..............................................................................................................................................17
Description........................................................................................................................................... 2
TNS Rework Procedure [Utility>Rework]..............................................................................................................18
Warnings.............................................................................................................................................. 2
Hibernate [Utility>Hibernate].................................................................................................................................18
Precautions.......................................................................................................................................... 3
Stimulator Binding............................................................................................................................. 19
CLINICAL PROGRAMMER SYSTEM OVERVIEW.................................................................................. 4
Stimulator Unbinding......................................................................................................................... 20
Clinical Programmer Features............................................................................................................. 4
GUIDANCE AND MANUFACTURER’S DECLARATIONS..................................................................... 21
Magnet................................................................................................................................................. 5
Charging the Clinical Programmer Battery.......................................................................................... 5
Programmer Power Up........................................................................................................................ 5
MAIN MENU............................................................................................................................................. 6
Demo................................................................................................................................................... 6
Programmer Setup.............................................................................................................................. 6
Change the Date and Time.....................................................................................................................................7
Switch to FCE Programmer....................................................................................................................................7
Set Password..........................................................................................................................................................7
Establishing Communication with the NS Device................................................................................ 7
Back to Main Menu.............................................................................................................................. 8
NAVIGATION AND SCREEN ELEMENTS............................................................................................... 8
Neurostimulator Dashboard................................................................................................................. 8
Programmer Status Bar....................................................................................................................... 9
Workspace Navigation......................................................................................................................... 9
Temporary and Permanent Programming......................................................................................... 10
More on Editing Text Fields............................................................................................................... 10
USING THE WORKSPACES................................................................................................................. 10
Profile Workspace............................................................................................................................. 10
Patient Information Tab [Profile>Patient]............................................................................................................... 11
Clinic Information Tab [Profile>Clinic]....................................................................................................................12
Stimulator Information Tab [Profile>NS]................................................................................................................12
Leads Information Tab [Profile>Leads]..................................................................................................................13
System Information Tab [Profile>System].............................................................................................................13
Stim Workspace................................................................................................................................ 14
Stim Tabs [Stim>Target Name]..............................................................................................................................14
APPENDIX I: PROGRAMMABLE PARAMETERS AND VALUES.......................................................... 25
APPENDIX II: TROUBLESHOOTING.................................................................................................... 26
Explanation of Symbols on Product or Package Labeling
Introduction
The Clinical Programmer is part of the Spinal Modulation Axium 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.
Model Number
Serial Number
Indications for Use
Read the Manual
The Spinal Modulation Neurostimulator System is indicated for the management of chronic intractable
pain.
Consult the Manual
Description
Contents of Package are Non-Sterile
Manufacturing Date
Patients who are indicated for the Axium 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.
Manufacturer
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.
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
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 physician. 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 physician. 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
Store between -10°C and 50°C (14°F and 122°F)
The Warnings listed below pertain to the Clinical Programmer only:
Store between 0 and 93% humidity
• T
 he physician must be trained by Spinal Modulation personnel before using the Clinical Programmer.
The Clinical Programmer must be used and maintained in accordance with the information in this
manual.
The device is a radio transmitter
• D
 o not use the Clinical Programmer with a NS device that appears to be faulty or fails to properly
communicate.
Magnet. Shows the location of the Programmer magnet.
• Improper use of the Clinical Programmer may cause irreversible injury to the patient. All patients are
to be awake and conversant during the procedure to minimize the likelihood of any nerve damage
Authorized European Representative
• A
 lways 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.
Precautions
The following precautions should be taken to avoid damage to the Clinical Programmer and to ensure
proper function:
• D
 o not drop or mishandle the Clinical Programmer. Physical damage to the Clinical Programmer may
impair its function.
• D
 o 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.
• D
 o not attempt to open the case for the Clinical Programmer. Attempts to open the case may expose
the Clinical Programmer to elements that alter its function.
• T
 he 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.
• D
 o not operate the Clinical Programmer outside the specified temperature range of 5°C to 40°C.
Rapid temperature changes may affect proper device operation.
• Do not store the Clinical Programmer outside the specified temperature range of -10°C to 50°C.
Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept
any interference received, including interference that may cause undesired operation.
Clinical Programmer System Overview
The Axium 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 power supply provided and a power outlet.
The Clinical Programmer System includes:
• Clinical Programmer with Stylus
• Programmer Charger
• External Auxiliary Magnet
• Programmer Carrying Case
• Clinical Programmer User Manual (this document)
• Do not leave the Clinical Programmer in a car or other places where temperatures can exceed 50°C.
• D
 o 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.
• T
 he 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.
• D
 o not use the Clinical Programmer or NS in the presence of explosive or flammable gases as this
may cause serious injury.
• D
 o not use the Programmer Charger if the power cord is damaged, excessively worn or frayed. This
may cause injury or damage the Programmer.
Stylus
Programmer Charger
• F
 requent programming of the implanted device will cause the battery to deplete faster. Avoid
unnecessary programming.
Clinical Programmer Features
• If there is any concern regarding the proper function of the Spinal Modulation NS System, please
contact your Spinal Modulation representative.
With the Clinical Programmer, you can:
Clinical Programmer
• Turn OFF all stimulation.
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-MN20700-03
This device may not interfere with stations operating in the 400.150–406.000 MHz band in the
• 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.
• E
 nter patient and lead identification information, clinician and clinic name and contact information,
and clinician’s notes.
• C
 reate 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
Main Menu
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 Main Menu displays three primary functions:
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 or back on. (Refer to the “Workspace - Profile>System” section for
more information).
• Demo: Puts the system into a standalone 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,
and Manufacturing date are displayed.
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 the 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.
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.
1. Connect the power supply to a power outlet.
Input: 100-240 VAC, 50-60 Hz, 0.6A
Output: 5V
3.0A
2. Connect the Charger to the 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%.
The device is
charging when
the amber light
is on.
When the Clinical Programmer is connected to a power outlet as described above, it is being powered
by the outlet and will not use battery power. The battery can be expected to last at least 500 discharge
cycles with normal use. Connect the Clinical Programmer to the Charger and attach to an outlet regularly
to keep it charged.
Programmer Setup
Select “Programmer Setup” on the Main Menu to get the
setup screen.
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.
Change the Date and Time
To 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.
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.
6. M
 ove 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.
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.
7. F
 or the duration of the programming session keep the Clinical Programmer within 3 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
Set Password
A password may be set to limit access to the
Programmer.
The password is for the Programmer itself and is not
associated with any NS.
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. M
 ake 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.
If the serial number format is valid for a NS device, the
“Connect” button will be enabled.
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.
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.
Programmer Status Bar
Temporary and Permanent Programming
Located at the bottom of the Clinical Programmer screen, the Programmer Status Bar displays:
• Programmer-Stimulator 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.
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
appears in a red bold underlined font.
NOTE: The “temporarily active” state does not apply to the Group workspace.
Temporary programmed values or text data can be permanently programmed by pressing the program
button. The font color changes from red to black.
• Programmer Battery Level: Displays the Clinical Programmer battery charge level. It is
recommended that the Programmer be plugged in and charging when not in use. Plug in and
charge the Programmer before reaching 30% remaining life.
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.
• Programmer Clock: Displays the time. See User Manual section on Change the Date and Time.
NOTE: Parameters can be temporarily active on multiple tabs of the same Workspace.
Workspace Navigation
More on Editing Text Fields
Once the NS is connected, tabs are displayed for
the systems’ four main workspaces (“Profile”, “Stim”,
“Group”, and “Utility”). 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.
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: Selecting a text field will pop up a keyboard at the bottom of the screen. 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 indicates that editing is in progress.
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.
• Program button: programs all changes made within the current Workspace.
• ALL button: turns all stimulation off.
Using the Workspaces
NOTE: Returning to the Main Menu or turning off the Programmer will not change any of the
programmed NS settings.
NOTE: When programming is complete, select the “Exit” button to conserve power.
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
10
Patient Information Tab [Profile>Patient]
Clinic Information Tab [Profile>Clinic]
Enter or modify the patient information in the fields
provided:
Enter or modify the physician and clinic information in
the text fields provided:
• P
 atient Name: Enter the patient’s name using
the on-screen keyboard.
• Physician Name
• I D: Enter the patient’s unique identification using
the on-screen keyboard.
• Clinic After Hours Contact Phone Number
• Clinic Name
• Date of Birth: Enter the patient’s date of birth
using the drop-down calendar.
• Clinic Phone Number
• Primary and Secondary Diagnosis: Select the
patient’s diagnosis from a drop-down list (Refer
to Appendix I for selection set)
• Clinic Address
• Clinic Email
• Notes: Enter notes if needed.
NOTE: Pressing the “áü” button near the space
bar allows the use of accented characters.
Stimulator Information Tab [Profile>NS]
The NS tab provides a summary of information related
to the NS.
 ate of Implant: Enter the Stimulator date of
• D
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.
11
12
Leads Information Tab [Profile>Leads]
Stim Workspace
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.
Press the “Stim” tab to access the Stimulation Settings Workspace. The Stimulation Settings Workspace
is divided into five tabs which are used to:
• 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:
• Activate (turn on) up to four leads
• Adjust electrode configurations
• Measure impedance
• Set nominal values to begin stimulation
• Perform trial mapping
 ot #: Enter the Lot number found on the lead
• L
packaging.
• Model #: Enter the lead Model number.
• 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.
System Information Tab [Profile>System]
From the system tab the following system parameters
can be managed:
 eriodic Impedance Interval: Set the
• P
periodicity with which you want the system to
measure lead impedance.
 ollow-up Period: A calculated field which
• F
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
for impedance measurements.
• 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.
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 e.g. “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.
• Magnet Magnet Stim On/Off Time: Allows
you to control how long it takes before a
magnet held over the device switches off or
back on delivered therapy.
• Patient Refresh Impedance: This allows the impedance to be remeasured and used
for therapy on the Patient Programmer whenever the patient turns a Lead Enable from
OFF to ON. NOTE: the programmed Pulse Amplitude will be adjusted based on the
updated impedance to maintain a constant therapy voltage.
13
14
• E
 lectrode 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.
• Location: Enter the spinal level where stimulation therapy is delivered by this lead
• P
 ulse Parameters: To select and change pulse parameters, first press the desired increment
level: Fine(>), Medium(>>), Coarse(>>>).
▪ Amplitudes below 2.0 mA (>: 25 µA, >>: 50 µA, >>>: 200 µA)
▪ Amplitudes above 2.0 mA (>: 50 µA, >>: 100 µA, >>>: 400 µA)
1. S
 elect one of the four electrodes by
clicking on it using the stylus. Clicking
once will turn the electrode posi tive
(“+”), 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.
▪ Pulse Width (>: 20 µs, >>: 40 µs, >>>: 100 µs)
▪ Frequency (>: 2 Hz, >>: 4 Hz, >>>: 10 Hz)
▪ T
 he UP( Λ ) and Down( V ) 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:
2. C
 ontinue by setting each of the
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 to use this Instant Impedance
value for therapy delivery, press the “Transfer
Instant Impedance” button (“→“).
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
20 µs
300 µs
Pulse Frequency - PF (Hz)
4 – 80 Hz
2 Hz
2 0 Hz
(Depending on measured impedance)
NOTE: A transferred impedance value is
required before other stimulation parameters
can be selected.
• 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.
• E
 nable: Select “ON” to enable the lead so
that it provides stimulation therapy to the
patient. Select “OFF” if the lead is not being
used.
• 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. (E.g. Upper Back & Massaging → 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.
o W
 hen Enable is ON, the “ON” button
will turn the color green.
o W
 hen Enable is OFF, the “OFF”
button will turn the color black.
NOTE: When the lead electrode configuration
changes, the lead is disabled and the
amplitude is automatically changed to zero.
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. Lead
“Enable” must be “ON” before the amplitude
can be increased from 0 µA.
o T
 he 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.
15
NOTE: When restarting stimulation, increase the amplitude slowly until the desired effect is
achieved.
16
Impedance Tabs
[Stim>Impedance]
Rework Tabs
[Utility>Rework]
The Impedance Button (Ω) initiates impedance
measurements between adjacent electrode couples
in all of the configured leads and displays on the Imp
screen.
This screen provides one-button automation of the
normal TNS rework procedure:
The following steps are performed:
1. Impedance Check: Electrode impedances are
measured on all leads and compared against expected
load fixture values.
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
“Sitting”). 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.
NOTE: the user should connect the standard load
fixture prior to this test. If the fixture is not available,
this step can be ignored and the remaining two
steps will still occur.
2. Set Nominal values: all patient values are cleared in
the NS and therapy settings are set to nominal.
3. Perform NS self-check: a self-test is started on
the NS. Upon next connection, the Programmer Alert
screen will show any detected NS problems.
Lead Tabs [Group>Group Name]
Each Group can be configured by selecting the desired
tab.
• Name: The Group can be renamed here (freeform text entry)
 or Patient Use: The Group will be displayed
• F
on the Patient Programmer only if this box is
checked. Note that the currently active Group
must be checked/enabled.
• 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.
Additional: The ‘Exit Hibernate’ and ‘Battery Attach’ dates are provided to assist the user in determining
when the TNS battery should be replaced.
Hibernate Tabs
[Utility>Hibernate]
‘Hibernate’ is used to keep the NS in a low-power state
after manufacturing, while in storage, prior to initial
clinical use. When connecting a Clinical Programmer
to a device in Hibernation, the user will have the option
to exit Hibernation. ‘Hibernate’ is normally not needed
after initial clinical use.
Periodic Stimulation
Periodic Stimulation can be toggled On or Off (green button indicates On). When On, the clinician can
program Stimulation On and Off durations independently. Once programmed, therapy will turn on and off
according to the programmed durations when:
• out of session, or
• in session in the Group Workspace (this allows the clinician to evaluate and optimize On/Off durations)
When in session in the Stim Workspace, Periodic Stimulation will be inactive (stimulation will remain ON)
to allow the clinician to optimize pulse parameters.
17
18
Stimulator Binding
Stimulator Unbinding
The Binding process pairs a Patient Programmer to
a single NS. After the mandatory binding, the Patient
Programmer can only connect with that particular
NS. The NS can still communicate with other
Programmers.
On a bound Patient Programmer, press the Unbind
Stimulator button to remove the binding. This will free
the Patient Programmer to bind to another NS. The
Programmer will reboot upon completion..
To perform Binding from the Patient Programmer’s
Programmer Setup screen, select the desired
language then press the Bind Stimulator button.
Follow the sequence of prompts to enter the target
NS serial number and complete the Binding process.
The Programmer will reboot upon completion.
19
20
Guidance and Manufacturer’s Declarations 			
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
Electromagnetic Environment – Guidance
RF Emissions 1
Group 2
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
Class B
Harmonic emissions
IEC 61000-3-2
Class B
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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 Programmer Charger.
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.
IEC 60601 Test Level
Compliance
Level
Electromagnetic
Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
Pass
Mains power quality should be
that of a typical commercial or
home environment
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
NOTE UT is the a.c. mains
voltage prior to application of
the test level.
Mains power quality should be
that of a typical commercial or
home environment
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial, hospital, or home
environment.
Immunity
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
21
22
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
Radiated RF
IEC 61000-4-3
IEC 60601 Test
Level
Compliance
Level
3 Vrms
150 kHz to 80
MHz
3V
3 V/m
80 MHz to 2.5
GHz
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.
3 V/m
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:
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.
Separation distance according to frequency of transmitter
(m)
Rated maximum output
power of transmitter
(W)
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
0.01
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.
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.
23
24
Appendix I: Programmable parameters and values
Parameter
Programmable Values
Default
Pulse Amplitude
0 – 6000 µA
0-2000 µA (25 µA increments)
2000-6000 µA (50 µA increments)
0 µA
Maximum Pulse Amplitude
Same as Pulse Amplitude
0 µA
Pulse Width
40 – 720 µs (20µs increments)
300 µs
Pulse Frequency
4 – 80 Hz (2 Hz increments)
20 Hz
Data Field
Selectable Values
Diagnosis
(Primary and Secondary)
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; Peripheral Vascular Disease; Phantom Pain;
Post-Herpetic Neuralgia; Post Surgical Pain; Radicular Arm Pain;
Radicular Leg Pain; Thoracic Pain; Upper Extremity Neuropathic
Pain; Visceral Pain;
Appendix II: Troubleshooting
Pop-up Messages
Condition
Buttons
Resolution
All stimulation has been
turned OFF.
All stimulation turned off due to
data corruption.
“OK”
Contact your
Spinal Modulation
Representative.
Cancelled Connect
Request
Cancel was pressed with
connecting attempt in progress.
Changes since last
programming were lost
due to loss of connection
with the stimulator. Please
reconnect to stimulator.
Communication was lost prior
to programming attempt.
“OK”
Reconnect to stimulator
and re-enter program
changes.
Connected to stimulator.
Communication is poor.
All RF channels have noise
levels above the noise
threshold.
Connecting to stimulator...
“Connect” button on the main
menu was pressed.
Connection Established.
Connection attempt was
successful.
“OK”
Connection with
stimulator was lost.
Please reconnect.
Dropped RF connection.
“OK”
Do you want to program
changes?
A new Workspace or Exit button
was selected without saving
(programming) changes.
“Yes”
“No”
“Cancel”
Try moving to an area with
fewer sources of noise.
Periodic Impedance Interval
Off; 30 s; 1 min; 5 min; 20 min; 30 min; 1 h; 6h; 12 h; 1 days; 3 days;
7 days; 10 days; 30 days
Lead Model Number
MN0300; MN0400, MN10350, MN10450, MN20350, MN20450
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; Axilla; 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
Invalid FCE password.
Please try again.
Invalid FCE password was
entered.
“OK”
Only Spinal Modulation
representatives should
access the FCE mode.
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
Lead N detected a
Current Too High
condition.
During an impedance
measurement, the measured
current was too high.
“OK”
Repeat measurement. If
problem reoccurs, contact
your Spinal Modulation
representative.
Lead N impedance of
NNN Ω is out of range.
Lead impedance is out of range
“OK”
Repeat measurement or
accept as is.
Maximum stimulation
output has been reached.
Maximum stimulation output
has been reached (4.6V).
“OK”
Investigate lead integrity.
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
1 s; 2 s; 3 s; 4 s; 5 s; 6 s; 7 s; 8 s
The stimulator is in
hibernation.
Battery Voltage = xxx
Do you want to exit
hibernation?
25
26
Pop-up Messages (Cont.)
Condition
Buttons
Resolution
Pop-up Messages (Cont.)
Condition
Buttons
Resolution
Please specify a Stimulus
Response before programming
Attempt to program a set of
pulse parameters without a
Stimulus Response Name.
“OK”
Select stimulus
response.
Stimulator battery has reached
the Elective Replacement
Indicator (ERI).
Battery has reached ERI
voltage.
“OK”
Schedule replacement
of the Stimulator.
Programmer battery is low.
Please recharge.
PDA battery reaches 30%.
“OK”
Recharge as soon as
possible.
Hardware reset Button
on the PDA was pressed,
Programmer detected an
error or the Programmer is
launched for the first time.
The NS internal time is out
of sync with the Programmer
time.
“Yes”
“No”
Programmer is booting after
a reset. When you click OK
the Programmer will switch
off. Press the Power button to
restart.
Stimulator clock is HH:MM. Do
you want to update Stimulator
clock?
The stimulator has been set to
default values.
“OK”
Setup device
parameters as
desired.
Programmer storage space is
low. Please contact your Spinal
Modulation representative for
maintenance.
PDA storage is at full
capacity (log files are stored
on the PDA with each
significant operation such
as programming). Message
is displayed and file logging
continues by deleting old
log files to make room
for new log files. Normal
operation continues after user
acknowledgement.
“OK”
The Programmer has
encountered an NS with
unreadable or invalid data.
Parameters have been set and
programmed to default values.
The stimulator has unreadable
data. Please reconnect with
programmer in FCE mode or
contact your Spinal Modulation
representative
NS has unreadable data (such
as Trim data)
“OK”
Contact your
Spinal Modulation
Representative.
NS in Boot mode. All
stimulation is disabled.
“OK”
Contact your
Spinal Modulation
Representative.
Stimulation for one or more
leads has been turned OFF.
One or more leads turned off
due to Low Impedance.
“OK”
Perform impedance
measurement and reenable if within range.
Otherwise, investigate
lead integrity.
The stimulator is in Upgrade
Mode. Please reconnect with
programmer in FCE mode or
contact your Spinal Modulation
representative.
Unable to connect to
stimulator. Make sure the
programmer is close to the
stimulator and try again.
Can’t connect to the NS.
“OK”
Move the programmer
above the Stimulator
in circular motions.
Stimulation has been turned
OFF due to a magnet.
Stimulation can be turned
off by applying a magnet for
the duration specified by the
Magnet Stim On/Off Time
programmable parameter.
“OK”
Stimulation can be
turned back on by
applying magnet for
the same “Magnet
Stim On/Off Time”.
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.
“OK”
Stimulator battery has reached
End of Service (EOS).
Stimulation has been turned
OFF permanently.
Battery has reached EOS
voltage. Stimulation is
disabled in order to preserve
power for RF communication.
“OK”
27
Press Power button.
Contact your
Spinal Modulation
Representative.
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.
Schedule replacement
of the Stimulator.
28
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xmp.iid:5C874CE1180AE1119CA496D764F2E535, xmp.iid:F93C3406190AE1119CA496D764F2E535, xmp.iid:D8A0C51A190AE1119CA496D764F2E535, xmp.iid:7A4DFE29190AE1119CA496D764F2E535, xmp.iid:328E4C63190AE1119CA496D764F2E535, xmp.iid:1C271076190AE1119CA496D764F2E535, xmp.iid:395B11B7190AE1119CA496D764F2E535, xmp.iid:FC5076FA190AE1119CA496D764F2E535, xmp.iid:74AD5B091A0AE1119CA496D764F2E535, xmp.iid:6999F43A1A0AE1119CA496D764F2E535, xmp.iid:2984467E1A0AE1119CA496D764F2E535, xmp.iid:50E070A31A0AE1119CA496D764F2E535, xmp.iid:0C5BD81B1B0AE1119CA496D764F2E535, xmp.iid:C624BA761B0AE1119CA496D764F2E535, xmp.iid:A65DC4E71B0AE1119CA496D764F2E535, xmp.iid:DAAFEB2D1C0AE1119CA496D764F2E535, xmp.iid:EAC3AD431C0AE1119CA496D764F2E535, xmp.iid:CF8B1C4E1C0AE1119CA496D764F2E535, xmp.iid:A6C266551C0AE1119CA496D764F2E535, xmp.iid:C188E1B51C0AE1119CA496D764F2E535, xmp.iid:51D26EC41C0AE1119CA496D764F2E535, xmp.iid:688AADDD1C0AE1119CA496D764F2E535, xmp.iid:5A02DEE01C0AE1119CA496D764F2E535, xmp.iid:343A23F51C0AE1119CA496D764F2E535, xmp.iid:A09C8F0A1D0AE1119CA496D764F2E535, xmp.iid:079C501F1D0AE1119CA496D764F2E535, xmp.iid:9E9ABD4F1D0AE1119CA496D764F2E535, xmp.iid:E31B58521D0AE1119CA496D764F2E535, xmp.iid:D5DAA9761D0AE1119CA496D764F2E535, xmp.iid:A378E5C11D0AE1119CA496D764F2E535, xmp.iid:CE6361F71D0AE1119CA496D764F2E535, xmp.iid:3CAF75171E0AE1119CA496D764F2E535, xmp.iid:9C06F38B1E0AE1119CA496D764F2E535, xmp.iid:ABD77FB41E0AE1119CA496D764F2E535, xmp.iid:B128BA001F0AE1119CA496D764F2E535, xmp.iid:3B75014E1F0AE1119CA496D764F2E535, xmp.iid:EB3DE89B1F0AE1119CA496D764F2E535, xmp.iid:EEC76479200AE1119CA496D764F2E535, xmp.iid:CF83DD97200AE1119CA496D764F2E535, xmp.iid:AEE3DDBF200AE1119CA496D764F2E535, xmp.iid:36011FCE200AE1119CA496D764F2E535, xmp.iid:B602B3D5200AE1119CA496D764F2E535, xmp.iid:7DDA3E48210AE1119CA496D764F2E535, xmp.iid:1450E16E210AE1119CA496D764F2E535, xmp.iid:69BFE795210AE1119CA496D764F2E535, xmp.iid:3F9C4767950AE111B1E3B6D1450A1930, xmp.iid:ADFD4967950AE111B1E3B6D1450A1930, xmp.iid:EB95CE8E950AE111B1E3B6D1450A1930, xmp.iid:E2D56D9C950AE111B1E3B6D1450A1930, xmp.iid:D92BFCC1950AE111B1E3B6D1450A1930, xmp.iid:1D76CA2B960AE111B1E3B6D1450A1930, xmp.iid:FDCF434D960AE111B1E3B6D1450A1930, xmp.iid:080CC176960AE111B1E3B6D1450A1930, xmp.iid:3BD6A99C960AE111B1E3B6D1450A1930, xmp.iid:9BF49A0E970AE111B1E3B6D1450A1930, xmp.iid:E77D7B49970AE111B1E3B6D1450A1930, xmp.iid:58DB924D970AE111B1E3B6D1450A1930, xmp.iid:CFA9EA70970AE111B1E3B6D1450A1930, xmp.iid:FD0AA18F970AE111B1E3B6D1450A1930, xmp.iid:5087B0D0970AE111B1E3B6D1450A1930, xmp.iid:9788C10E980AE111B1E3B6D1450A1930, xmp.iid:F0D6574D980AE111B1E3B6D1450A1930, xmp.iid:8818328B980AE111B1E3B6D1450A1930, xmp.iid:1D7ADBB3980AE111B1E3B6D1450A1930, xmp.iid:AAFA59F2980AE111B1E3B6D1450A1930, xmp.iid:CCAB1730990AE111B1E3B6D1450A1930, xmp.iid:CDAB1730990AE111B1E3B6D1450A1930, xmp.iid:6FD59FA3990AE111B1E3B6D1450A1930, xmp.iid:48F352629A0AE111B1E3B6D1450A1930, xmp.iid:20A7227E9A0AE111B1E3B6D1450A1930, xmp.iid:30651F869A0AE111B1E3B6D1450A1930, xmp.iid:FA2ABB9D9A0AE111B1E3B6D1450A1930, xmp.iid:4F7166EB9A0AE111B1E3B6D1450A1930, xmp.iid:3F3BCB0F9B0AE111B1E3B6D1450A1930, xmp.iid:1FAA6F249B0AE111B1E3B6D1450A1930, xmp.iid:637E703D9B0AE111B1E3B6D1450A1930, xmp.iid:414E24489B0AE111B1E3B6D1450A1930, xmp.iid:E34DC4A59B0AE111B1E3B6D1450A1930, xmp.iid:A7B4D7D89B0AE111B1E3B6D1450A1930, xmp.iid:DBF152B79C0AE111B1E3B6D1450A1930, xmp.iid:955EB5D09C0AE111B1E3B6D1450A1930, xmp.iid:87187C339D0AE111B1E3B6D1450A1930, xmp.iid:DE8BA43E9D0AE111B1E3B6D1450A1930, xmp.iid:4E6881589D0AE111B1E3B6D1450A1930, xmp.iid:3D3772769D0AE111B1E3B6D1450A1930, xmp.iid:C2A67A0D9E0AE111B1E3B6D1450A1930, xmp.iid:0742828B9E0AE111B1E3B6D1450A1930, xmp.iid:4833BDE79E0AE111B1E3B6D1450A1930, xmp.iid:83BDF3769F0AE111B1E3B6D1450A1930, xmp.iid:1DD749899F0AE111B1E3B6D1450A1930, xmp.iid:3596419E9F0AE111B1E3B6D1450A1930, xmp.iid:80438420A00AE111B1E3B6D1450A1930, xmp.iid:5A8A3639A00AE111B1E3B6D1450A1930, xmp.iid:7613704BA00AE111B1E3B6D1450A1930, xmp.iid:A87F7052A00AE111B1E3B6D1450A1930, xmp.iid:BC9DB963A00AE111B1E3B6D1450A1930, xmp.iid:4352008BA00AE111B1E3B6D1450A1930, xmp.iid:5FEC9CBBA00AE111B1E3B6D1450A1930, xmp.iid:AFB91CF9A00AE111B1E3B6D1450A1930, xmp.iid:1CE201FFA00AE111B1E3B6D1450A1930, xmp.iid:037EB638A10AE111B1E3B6D1450A1930, xmp.iid:C030E556A10AE111B1E3B6D1450A1930, xmp.iid:5D490974A10AE111B1E3B6D1450A1930, xmp.iid:A1682BA3A10AE111B1E3B6D1450A1930, xmp.iid:33D619C1A10AE111B1E3B6D1450A1930, xmp.iid:279B29D4A10AE111B1E3B6D1450A1930, xmp.iid:FF49A4DEA10AE111B1E3B6D1450A1930, xmp.iid:462690E8A10AE111B1E3B6D1450A1930, xmp.iid:ECCD064EA20AE111B1E3B6D1450A1930, xmp.iid:3EFA687FA20AE111B1E3B6D1450A1930, xmp.iid:A4A4BADAA20AE111B1E3B6D1450A1930, xmp.iid:3C2116FDA20AE111B1E3B6D1450A1930, xmp.iid:3D2116FDA20AE111B1E3B6D1450A1930, xmp.iid:B5D7523EA30AE111B1E3B6D1450A1930, xmp.iid:119E8750A30AE111B1E3B6D1450A1930, xmp.iid:5926A466A30AE111B1E3B6D1450A1930, xmp.iid:B0E3F27AA30AE111B1E3B6D1450A1930, xmp.iid:72B52D97A30AE111B1E3B6D1450A1930, xmp.iid:13DDBEB8A30AE111B1E3B6D1450A1930, xmp.iid:1A916CE5A30AE111B1E3B6D1450A1930, xmp.iid:472E0EFEA30AE111B1E3B6D1450A1930, xmp.iid:81101206A40AE111B1E3B6D1450A1930, xmp.iid:34EE5A2FA40AE111B1E3B6D1450A1930, xmp.iid:9550583CA40AE111B1E3B6D1450A1930, xmp.iid:A7BDE447A40AE111B1E3B6D1450A1930, xmp.iid:90BC434AA40AE111B1E3B6D1450A1930, xmp.iid:EEA61054A40AE111B1E3B6D1450A1930, xmp.iid:A01D8B60A40AE111B1E3B6D1450A1930, xmp.iid:DA07C812A60AE111B1E3B6D1450A1930, xmp.iid:A0EAD31DA60AE111B1E3B6D1450A1930, xmp.iid:58AB7433A60AE111B1E3B6D1450A1930, xmp.iid:59AB7433A60AE111B1E3B6D1450A1930, xmp.iid:9F44D55FAA0AE111B1E3B6D1450A1930, xmp.iid:5C781A7FAA0AE111B1E3B6D1450A1930, xmp.iid:E95E6B95AA0AE111B1E3B6D1450A1930, xmp.iid:2FFCFB94AB0AE111B1E3B6D1450A1930, xmp.iid:167D6CA5AB0AE111B1E3B6D1450A1930, xmp.iid:C8B5611DAC0AE111B1E3B6D1450A1930, xmp.iid:CE4B6C29AC0AE111B1E3B6D1450A1930, xmp.iid:6964C72EAC0AE111B1E3B6D1450A1930, xmp.iid:F0455563AC0AE111B1E3B6D1450A1930, xmp.iid:1B1AE773AC0AE111B1E3B6D1450A1930, xmp.iid:A6FCA69DAC0AE111B1E3B6D1450A1930, xmp.iid:C82FE4B9AC0AE111B1E3B6D1450A1930, xmp.iid:17409A37AD0AE111B1E3B6D1450A1930, xmp.iid:D2ED9E64AD0AE111B1E3B6D1450A1930, xmp.iid:E3F39473AD0AE111B1E3B6D1450A1930, xmp.iid:F02BB898AD0AE111B1E3B6D1450A1930, xmp.iid:C0BCEAC9AD0AE111B1E3B6D1450A1930, xmp.iid:B826A9D5AD0AE111B1E3B6D1450A1930, xmp.iid:555CACEEAD0AE111B1E3B6D1450A1930, xmp.iid:2A2E8DFBAD0AE111B1E3B6D1450A1930, xmp.iid:8EDA0B59AE0AE111B1E3B6D1450A1930, xmp.iid:A653A671AE0AE111B1E3B6D1450A1930, xmp.iid:AC783976AE0AE111B1E3B6D1450A1930, xmp.iid:677C0F79AE0AE111B1E3B6D1450A1930, xmp.iid:ED951B1AAF0AE111B1E3B6D1450A1930, xmp.iid:3DAFB642AF0AE111B1E3B6D1450A1930, xmp.iid:089C6DA8AF0AE111B1E3B6D1450A1930, xmp.iid:E23C5C42B10AE111B1E3B6D1450A1930, xmp.iid:CBE77D80B10AE111B1E3B6D1450A1930, xmp.iid:F1976548B20AE111B1E3B6D1450A1930, xmp.iid:134B5B8EB20AE111B1E3B6D1450A1930, xmp.iid:8AD6FFE6B20AE111B1E3B6D1450A1930, xmp.iid:5A32CA69B30AE111B1E3B6D1450A1930, xmp.iid:225E28C2B30AE111B1E3B6D1450A1930, xmp.iid:75CE424FB40AE111B1E3B6D1450A1930, xmp.iid:7F1EC097720BE111B7A2951793522B0B, xmp.iid:37909D07740BE111B7A2951793522B0B, xmp.iid:3FBD3978740BE111B7A2951793522B0B, xmp.iid:BBBAF4AC750BE111B7A2951793522B0B, xmp.iid:B393FDBD750BE111B7A2951793522B0B, xmp.iid:C2AF0644760BE111B7A2951793522B0B, xmp.iid:46B1649B760BE111B7A2951793522B0B, xmp.iid:A59441C1760BE111B7A2951793522B0B, xmp.iid:6E835BD9760BE111B7A2951793522B0B, xmp.iid:8C4F5D40770BE111B7A2951793522B0B, xmp.iid:68DBA968770BE111B7A2951793522B0B, xmp.iid:396B1875770BE111B7A2951793522B0B, xmp.iid:3A7EA895770BE111B7A2951793522B0B, xmp.iid:822BEA9C790BE111B7A2951793522B0B, xmp.iid:FAF157077A0BE111B7A2951793522B0B, xmp.iid:D38AD1A87A0BE111B7A2951793522B0B, xmp.iid:D8DAA2177B0BE111B7A2951793522B0B, xmp.iid:E00F67457B0BE111B7A2951793522B0B, xmp.iid:CBD7D54F7B0BE111B7A2951793522B0B, xmp.iid:CCD7D54F7B0BE111B7A2951793522B0B, xmp.iid:220E073B7C0BE111B7A2951793522B0B, xmp.iid:AACA9D4D7C0BE111B7A2951793522B0B, xmp.iid:5E79A94F7C0BE111B7A2951793522B0B, xmp.iid:ACA8FCA77C0BE111B7A2951793522B0B, xmp.iid:CDE1C0CA7C0BE111B7A2951793522B0B, xmp.iid:BE41C22A7D0BE111B7A2951793522B0B, xmp.iid:420C663A7D0BE111B7A2951793522B0B, xmp.iid:176A94A77D0BE111B7A2951793522B0B, xmp.iid:125891C37D0BE111B7A2951793522B0B, xmp.iid:E66DA2CA7D0BE111B7A2951793522B0B, xmp.iid:E76DA2CA7D0BE111B7A2951793522B0B, xmp.iid:99DF23457E0BE111B7A2951793522B0B, xmp.iid:2B36F1557E0BE111B7A2951793522B0B, xmp.iid:98D3A7677E0BE111B7A2951793522B0B, xmp.iid:211DC7A57E0BE111B7A2951793522B0B, xmp.iid:CA2198B57E0BE111B7A2951793522B0B, xmp.iid:B039D7F67E0BE111B7A2951793522B0B, xmp.iid:71FED1107F0BE111B7A2951793522B0B, xmp.iid:B3F9C9187F0BE111B7A2951793522B0B, xmp.iid:F126261F7F0BE111B7A2951793522B0B, 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History When                    : 2011:11:08 15:13:36+02:00, 2011:11:08 15:16:03+02:00, 2011:11:08 15:16:03+02:00, 2011:11:08 15:16:43+02:00, 2011:11:08 15:18:43+02:00, 2011:11:08 15:22:14+02:00, 2011:11:08 15:25:41+02:00, 2011:11:08 15:41:37+02:00, 2011:11:08 15:42:15+02:00, 2011:11:08 15:44:52+02:00, 2011:11:08 15:46:31+02:00, 2011:11:08 15:46:52+02:00, 2011:11:08 15:47:38+02:00, 2011:11:08 15:51+02:00, 2011:11:08 15:53:01+02:00, 2011:11:08 15:55:21+02:00, 2011:11:08 15:56:45+02:00, 2011:11:08 15:57:20+02:00, 2011:11:08 15:58:32+02:00, 2011:11:08 16:10:31+02:00, 2011:11:08 16:14:11+02:00, 2011:11:08 16:16:07+02:00, 2011:11:08 16:16:56+02:00, 2011:11:08 16:17:58+02:00, 2011:11:08 16:19:29+02:00, 2011:11:08 16:21:39+02:00, 2011:11:08 16:25:03+02:00, 2011:11:08 16:25:41+02:00, 2011:11:08 16:27:21+02:00, 2011:11:08 16:27:27+02:00, 2011:11:08 16:28:36+02:00, 2011:11:08 16:33:18+02:00, 2011:11:08 16:33:46+02:00, 2011:11:08 16:34:43+02:00, 2011:11:08 16:35:02+02:00, 2011:11:08 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FCC ID Filing: Y8LMN20700-03

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