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.
Table of Contents EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING............................................ 1 Impedance Tabs [Stim>Impedance]......................................................................................................................17 Map Workspace................................................................................................................................. 17 Group Workspace...............................................................................
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.
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.
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.
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.
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.
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.
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.
• 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.
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.
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..
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.
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.
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
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%.
