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Axium Clinical Programmer User Manual

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Clinical Programmer
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
Model MN20700-03
User Manual

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Summary of Contents for Axium Clinical Programmer

  • Page 1 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...

  • Page 2: Table Of Contents

    Clinical Programmer Features ......................4 GUIDANCE AND MANUFACTURER’S DECLARATIONS ..............21 Magnet ..............................5 APPENDIX I: PROGRAMMABLE PARAMETERS AND VALUES ............25 Charging the Clinical Programmer Battery ..................5 APPENDIX II: TROUBLESHOOTING ....................26 Programmer Power Up ........................5 MAIN MENU ............................6 Demo ..............................

  • Page 3: Explanation Of Symbols On Product Or Package Labeling

    The Clinical Programmer must be used and maintained in accordance with the information in this Store between 0 and 93% humidity manual. • Do not use the Clinical Programmer with a NS device that appears to be faulty or fails to properly The device is a radio transmitter communicate.

  • Page 4: Precautions

    • Do not use abrasive or caustic cleaning products on the Clinical Programmer. The Clinical Programmer System includes: • Do 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.

  • Page 5: Magnet

    Magnet Main Menu A magnet is built into the Clinical Programmer. It is located on the back side of the Programmer The Main Menu displays three primary functions: underneath the indent with the magnet symbol (shown below). • Demo: Puts the system into a stand- alone demo mode allowing you to use The NS system has the capability of detecting the presence of a magnet.

  • Page 6: Main Menu

    When a successful connection is established, the Programmer chimes and the NS device will be queried. NOTE: Establishing a connection updates the NS 7. For the duration of the programming session keep the Clinical Programmer within 3 feet of the NS device’s clock to the newly set time.

  • Page 7: Change The Date And Time

    The corresponding value or data selection appears in a red bold underlined font. 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 NOTE: The “temporarily active” state does not apply to the Group workspace.

  • Page 8: Patient Information Tab [Profile>Patient]

    Patient Information Tab [Profile>Patient] Clinic Information Tab [Profile>Clinic] Enter or modify the patient information in the fields Enter or modify the physician and clinic information in provided: the text fields provided: • Patient Name: Enter the patient’s name using • Physician Name the on-screen keyboard.

  • Page 9: Leads Information Tab [Profile>Leads]

    Leads Information Tab [Profile>Leads] Stim Workspace Lead 1 through Lead 4 are the default labels used to Press the “Stim” tab to access the Stimulation Settings Workspace. The Stimulation Settings Workspace identify the implanted leads in the “Stim” Workspace. is divided into five tabs which are used to: It is recommended that these names be changed into •...
  • Page 10 (off). There must level: Fine(>), Medium(>>), Coarse(>>>). be at least one positive and one negative electrode before the Clinical Programmer ▪ Amplitudes below 2.0 mA (>: 25 µA, >>: 50 µA, >>>: 200 µA) allows the amplitude to be adjusted and for the lead to be enabled.

  • Page 11: Impedance Tabs [Stim>Impedance]

    ‘Hibernate’ is used to keep the NS in a low-power state must be checked/enabled. after manufacturing, while in storage, prior to initial clinical use. When connecting a Clinical Programmer • Lead 1 through Lead 4: The Stimulus to a device in Hibernation, the user will have the option Response for each Lead within a Group can be to exit Hibernation.

  • Page 12: Stimulator Binding

    Stimulator Binding Stimulator Unbinding The Binding process pairs a Patient Programmer to On a bound Patient Programmer, press the Unbind a single NS. After the mandatory binding, the Patient Stimulator button to remove the binding. This will free Programmer can only connect with that particular the Patient Programmer to bind to another NS.

  • Page 13: Guidance And Manufacturer's Declarations

    Mains power quality should be purposes. and voltage 70% UT (30% dip in UT) that of a typical commercial or The Clinical Programmer is not intended to be connected to variations on for 25 cycles home environment CISPR 14-1 Complies other equipment except the Programmer Charger.
  • Page 14 GUIDANCE AND MANUFACTURER’S DECLARATION Recommended separation distances between portable and mobile RF communications Electromagnetic Immunity equipment and the Spinal Modulation Neurostimulation System The Spinal Modulation Neurostimulation System is intended for use in the electromagnetic The Spinal Modulation Neurostimulation System is intended for use in an electromagnetic environment environment specified below.

  • Page 15: Appendix Ii: Troubleshooting

    Appendix I: Programmable parameters and values Appendix II: Troubleshooting Parameter Programmable Values Default Pop-up Messages Condition Buttons Resolution Pulse Amplitude 0 – 6000 µA 0 µA All stimulation has been All stimulation turned off due to “OK” Contact your 0-2000 µA (25 µA increments) turned OFF.
  • Page 16 Pop-up Messages (Cont.) Condition Buttons Resolution Pop-up Messages (Cont.) Condition Buttons Resolution Please specify a Stimulus Attempt to program a set of “OK” Select stimulus Stimulator battery has reached Battery has reached ERI “OK” Schedule replacement Response before programming pulse parameters without a response.

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