Medtronic, Inc.

Transcription

1 Recharging System Quick Guide for Chronic pain

2 Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: Toll-free: UC a EN 2013 Medtronic, Inc. Printed in USA. Recharging System Quick Guide for Chronic pain

3 NEUROSTIMULATION SYSTEMS FOR PAIN THERAPY Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure. Indication for Use: Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks. For full prescribing information, please call Medtronic at and/or consult Medtronic s website at USA Rx Only Rev 0313

4 Recharging System QUICK GUIDE FOR CHRONIC PAIN Note: This guide is a quick reference for recharging both your neurostimulator battery and your recharger battery. Please read the complete instructions in your user manual before using this guide. Parts of your recharging system AC Power Supply Charges the recharger using AC power. Plug one end into a wall outlet and the other end into the recharger. Antenna Establishes communication with the neurostimulator. Note: Adjust the dial to improve recharging efficiency between the recharger and the neurostimulator. neurostimulator on neurostimulator OFF Belt You will have a belt to keep the antenna directly over the neurostimulator during a Start charge/test KEY Begins recharging the neurostimulator. audio control KEY Turns the recharger ON. stop charge KEY Ends or interrupts the neurostimulator When the recharger is on, pressing the AUDIO CONTROL key again turns the audible status tones ON and OFF. Note: The recharger will automatically shut off after a period of non-use. Recharger Recharges the battery in the neurostimulator. The display screen provides information about the recharging system. Note: You are able to recharge both the neurostimulator battery AND the recharger battery at the same time. How to Check Your Battery Level Status Both the neurostimulator and the recharging device require recharging. You can check the status of your neurostimulator and recharger battery levels by using the recharger or the patient programmer. Charging your recharger battery and checking the battery level status 1. Plug the AC power supply cord into a wall outlet. A green light on the AC power supply indicates it has power. 2. Connect the other end of the AC power supply to the recharger. The recharger will automatically start to charge when connected to the AC power supply, and the recharger charging session screen will be displayed. Synchronizing the programmer and neurostimulator to check the battery charge level You can check your neurostimulator battery level by either placing your patient programmer over your implant or by using the programmer antenna. 1. Place the programmer or the antenna over the neurostimulator and press one of the three keys (ON, OFF, or SYNC) as shown below. Audio is ON or OFF Recharger battery status Indicates that your recharger is plugged into AC power Status row ON OFF SYNC Recharger battery charge level Recharge progress row Note: Using the NEUROSTIMULATOR ON key to synchronize also turns ON the neurostimulator. Using the NEUROSTIMULATOR OFF key to synchronize also turns OFF the neurostimulator. Needs charge Full charge 2. After synchronizing, the Therapy screen appears. The battery charge level of your neurostimulator is located on the top row of the display. Therapy Screen group Adjust Therapy Screen Battery status Needs charge Full charge continued on other side

5 How to charge the neurostimulator battery 1. Place the belt over your neurostimulator. 2. Attach and position the antenna. 3. Press the green START CHARGE/TEST key on the recharger. 4. You will see the Recharger Wait screen on the recharger display, indicating that the neurostimulator and recharger are trying to communicate. Recharger Wait screen 5. When recharging begins, you will see the Neurostimulator Recharging screen. This screen is used to: check the status and progress of the neurostimulator show you the battery status of your recharger. display a flashing battery icon for the neurostimulator, indicating that the battery is recharging. A Neurostimulator Recharging screen A Neurostimulator is ON ( ) or OFF ( ). B Audio is ON or OFF. B Note: After positioning the recharger over the neurostimulator, wait at least 10 seconds to determine if you have maximum efficiency. C STATUS row Displays information for the neurostimulator and the recharger. C D E Recharger Information Screens Information Screens What to do Neurostimulator Battery Screens Charge your neurostimulator The neurostimulator battery charge level is low. Stimulation will stop soon. Complete the neurostimulator charging session Finish charging the neurostimulator battery using the recharger. Neurostimulator recharging complete The neurostimulator battery is fully charged. Press the AUDIO control key to clear the message. Information Screens What to do Recharger Battery Screens Charge your recharger The recharger battery charge level is low. Charge the recharger battery using the AC power supply. Finish the recharger charging session The recharger battery is only partially charged. Finish charging the recharger battery using the AC power supply. Recharger charging complete The recharger battery is fully charged. Press the AUDIO control key to clear the message. D RECHARGE PROGRESS row Indicates the progress of the E RECHARGE EFFICIENCY row Indicates the efficiency of the recharging signal between the neurostimulator and the recharger (more black boxes mean better efficiency and shorter recharge duration). Note: The recharge efficiency (number of boxes filled) is dependent on the position of the antenna and the location and depth of your implant. In some cases, you may reach maximum efficiency with less than eight black boxes filled. Use the dial on the antenna to improve efficiency. 6. When your neurostimulator battery is almost full, you will see the Neurostimulator Charge Sufficient screen. Antenna Screens What to do Reposition antenna Communication between the recharger and the neurostimulator was interrupted or could not be established. Reposition the antenna over the neurostimulator, and press the START CHARGE/TEST key. Check antenna The antenna connection to the recharger is loose or the antenna is not connected. Check that the antenna and the recharger are making full contact. Connect or tighten the connection and retry. The antenna or the recharger might require service. Neurostimulator Charge Sufficient screen 7. When your neurostimulator battery is fully charged, the Neurostimulator Charge Complete screen will appear and the recharger will stop. Neurostimulator Charge Complete screen Warning Screens What to do Charge neurostimulator battery now The neurostimulator battery charge level is low. Stimulation has stopped. Press the START CHARGE/TEST key to clear the screen. Charge the neurostimulator battery now. Charge recharger battery The recharger battery charge is insufficient to charge the neurostimulator. Connect the recharger to the AC power supply to clear the screen. Charge your recharger now. Call clinician The system is not working correctly. Stimulation might have stopped. Write down the number displayed and call your clinician. Provide the specific error code shown on the recharger display. ERI (Elective Replacement Indicator) condition The neurostimulator needs to be replaced. Therapy will not be available soon. Call your clinician and provide the error message shown on the recharger display. For more information on using your recharging system, refer to the DVD packaged with the Post-Implant patient materials packet. See your recharger user manual for complete instructions and information on warnings, precautions, risks, and benefits. Rx only. AREA OF GLUE Recharging System QUICK GUIDE for chronic pain