Axium Clinical Programmer User Manual Download Page 10

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 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 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.

2.   Continue by setting each of the 

implanted leads with at least one 

positive and one negative electrode for 

each body region to be treated.

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   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 (“→“).

NOTE:

 A transferred impedance value is 

required before other stimulation parameters 

can be selected.

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 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.

o   When Enable is ON, the “ON” button 

will turn the color green.

o   When Enable is OFF, the “OFF” 

button will turn the color black.

o   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: 

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.

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 Location:

 Enter the spinal level where stimulation therapy is delivered by this lead

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 Pulse  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)

▪  Pulse Width (>: 20 µs, >>: 40 µs, >>>: 100 µs)

▪  Frequency (>: 2 Hz, >>: 4 Hz, >>>: 10 Hz)

▪   The 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:

Specifications

Range

Step Size

Default Value

Pulse Amplitude - PA (µA)

(Depending on measured impedance)

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 – 

72

0 µs

20 µs

300 µs

Pulse Frequency - PF (Hz)

4 – 80 Hz

2 Hz

2 0 Hz

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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. (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.

NOTE:

 When restarting stimulation, increase the amplitude slowly until the desired effect is 

achieved.

Summary of Contents for Clinical Programmer

Page 1: ...thorized duplication or use is prohibited AXIUM SPINALMODULATION and the Man in Circle Design are trademarks and or registered trademarks of Spinal Modulation Inc Clinical Programmer Model MN20700 03 User Manual Authorization to affix the CE mark granted in 2011 ...

Page 2: ... 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 Impedanc...

Page 3: ...ds 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 t...

Page 4: ... concern regarding the proper function of the Spinal Modulation NS System please contact your Spinal Modulation representative 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 pow...

Page 5: ...cycles with normal use 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 func...

Page 6: ... telemetry connection is cancelled 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 ...

Page 7: ...e programmed NS settings NOTE When programming is complete select the Exit button to conserve power 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 appears in a red bold underlined font NOTE The temporarily active ...

Page 8: ...ng the áü button near the space bar allows the use of accented characters 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 t...

Page 9: ...the device switches off or back on delivered therapy 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 speci...

Page 10: ...st 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 Location Enter the spinal level where stimulation therapy is delivered by this lead Pulse Parameters To select and change pulse parameters first press the desired increment level Fine Medium Coarse A...

Page 11: ...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 Rework Tabs Utility Rework This screen provides one button automation of the normal TNS rewo...

Page 12: ...tient 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 Stimulator Unbinding On a bound Patient Programmer press the Unbind Stimulator button to remove the binding This will free the Patient Programmer t...

Page 13: ... of the test level Mains power quality should be that of a typical commercial or home environment 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 Guidance and Manufacturer s Declarations GUIDANCE AND MANUFACTURER S DECLARATION Electromagnetic Emi...

Page 14: ...cy 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 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 electromagne...

Page 15: ... 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 1 s 2 s 3 s 4 s 5 s 6 s 7 s 8 s 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 C...

Page 16: ...FF 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 Schedule replacement of the Stimulator Pop up Messages Cont Condition...

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