User Manual
Table Of Contents
- User Manual
- CAUTION:
- 1. Introduction 1
- 2. General Warnings and Cautions 3
- Diathermy 4
- Magnetic Resonance Imaging (MRI) 4
- Implanted Stimulation Devices 4
- Flammable Fuel or Chemicals 5
- Electrosurgery Devices 5
- High-Frequency Surgical Equipment 5
- Driving and Operating Machinery 5
- Pregnancy 5
- Long-Term Effectiveness of Neurostimulation 5
- System Programming 6
- System Components 6
- Medical Devices/Therapies 6
- For Patient Use Only 6
- Postural Changes 6
- Keep out of Reach of Children 7
- Skin Abnormalities 7
- Skin Irritation 7
- User Patch Placement and Stimulation 7
- X-Ray Examinations 8
- Known or Suspected Heart Problems 8
- Device Failure 8
- Care and Handling of Components 8
- Storage and Operation Temperatures 8
- Expiration Date 8
- Risks Related to Stimulation 9
- Risks Related to the Device 9
- Stimulation End 14
- Pick-Up End 14
- Design Features 14
- Accessories 15
- Operating Modes 15
- Operating Buttons 16
- On/Off Indicator Lights 17
- Digital Display 17
- LEDs 18
- Visual Alerts 19
- Audio Alerts 19
- Battery Compartment 20
- Accessories 20
- Faulty Electrode Contact 45
- Battery Low Charge 46
- Battery Failure 46
- Battery Low Charge 47
- Battery Failure 47
- Battery Discharges Rapidly 47
- Battery Charging Error 48
- Temperature Error 48
- Chapter
- Chapter
- 2
- Indications for Use
- Contraindications
- Warnings
- Precautions
- Medical Devices/Therapies
- For Patient Use Only
- Postural Changes
- Keep out of Reach of Children
- Skin Abnormalities
- Skin Irritation
- User Patch Placement and Stimulation
- X-Ray Examinations
- Known or Suspected Heart Problems
- Device Failure
- Care and Handling of Components
- Storage and Operation Temperatures
- Expiration Date
- Adverse Effects
- Chapter
- Chapter
- Chapter
- Chapter
- Chapter
- 7
- Charging the Remote Control
- WARNING:
- 1 Open the cover over the charging socket on the bottom of the remote control.
- 2 Insert the charger cable connector into the charging socket.
- 3 Plug the charger into a power socket.
- 4 Monitor the remote control digital display to verify that the remote control is charging. When the remote control battery is charging and the remote control is in standby mode, a small green loop will circle in the digital display. The loop will ci...
- 5 The charging process should last approximately four hours.
- 6 When the remote control battery is fully charged, a horizontal green line will appear in the digital display.
- 7 Unplug the charger cable from the power socket and from the charger socket. Store the charger in the User Kit.
- WARNING:
- Preparing the Skin
- CAUTION:
- 1 Locate the area where the pick-up electrode is implanted. If necessary, palpate the area until the pick-up electrode can be felt.
- 2 Clean the skin above the pick-up electrode with an alcohol swab or wet washcloth and dry. If the area has been treated with lotions or oils, then clean the skin with soap and water, rinse well and dry.
- CAUTION:
- Chapter
- 8
- CAUTION:
- Overview
- Attaching the EPT to a User Patch
- Applying the User Patch to the Skin
- WARNING:
- 1 Locate the area where the pick-up electrode is implanted. If necessary, palpate the area until the pick-up electrode can be felt.
- 2 Clean the skin above the pick-up electrode with an alcohol swab or wet washcloth and then dry the skin area. If the area has been treated with lotions or oils, then clean the skin with soap and water, rinse well and dry. If necessary, remove excess...
- 3 Hold the user patch between the index finger and thumb, with the gel electrodes facing toward the site of adhesion.
- CAUTION:
- CAUTION:
- WARNING:
- Turning On the Remote Control
- 1 Press the on/off button once and release. The remote control will beep and start a self test. All display indicators will light up briefly. When the self test is finished, the remote control will beep again, the lights will turn off, and the on/off...
- 2 Press the on/off button once and release. The remote control will beep and turn off. The on/off button will stop flashing. (The remote control turns off automatically after 5 minutes of disuse.)
- Adjusting the Volume of Audio Alerts
- Selecting a Stimulation Program
- 1 From standby mode, press and hold the mode button for at least three seconds, until the remote control beeps and the mode button glows yellow. A letter will appear in the digital display, indicating the active program.
- 2 Press the plus or minus button to change the active program. The new active program will appear in the digital display.
- 3 Press the mode button briefly to return to standby mode. The remote control will beep, the mode button will turn off, and the default stimulation intensity level will appear in the digital display.
- Turning Stimulation On
- 1 From standby mode briefly press the mode button. The remote control will beep and the mode button will start flashing yellow.
- 2 Few a few seconds, the digital display will alternately show the active program and active stimulation intensity level.
- 3 After a few seconds, the digital display will show only the stimulation intensity level.
- 4 After a few minutes, the digital display will go dark.
- Adjusting Stimulation Intensity
- CAUTION:
- 1 Either from standby mode or while stimulating in stimulation mode, press the plus or minus button once for each level of change. The remote control will beep and the new level will show on the digital screen.
- 2 Allow time for the system to demonstrate a change in setting before making another change.
- CAUTION:
- CAUTION:
- Saving a New Default Stimulation Intensity Level
- 1 Select a stimulation program (“Selecting a Stimulation Program” on page 8-32).
- 2 Return to standby mode.
- 3 Adjust the stimulation intensity level to the desired level (“Adjusting Stimulation Intensity” on page 8-33).
- 4 From standby mode, press and hold the minus button for at least three seconds. The remote control will beep and the new default intensity level will flash on the digital display for a few seconds while saving.
- Turning Stimulation Off
- Taking Off the User Patch
- 1 Stop stimulation and turn the remote control off.
- 2 If a patch strap or sleeve was used, take the strap off.
- 3 Grasp the tab on the user patch and gently pull the patch away from the skin.
- 4 Place the electrode cover over the gel electrodes.
- 5 If the user patch is still operational, store the patch in the user patch carrying case.
- 6 If the user patch is no longer operational, remove the external pulse transmitter (EPT) from the user patch and dispose of the patch according to local regulations.
- Removing the External Pulse Transmitter
- Chapter
- 9
- CAUTION:
- Recharging the Remote Control Battery
- Replacing the Remote Control Battery
- 1 Remove the screw from the battery cover on the back of the remote control. The screw is under a label. Gently peel up the corner of the label, taking care not to damage the label.
- 2 Remove the battery cover.
- 3 Remove the old battery.Insert a new rechargeable AAA NiMH 1.2- V battery, orienting it to match the polarity marks on the battery socket.
- WARNING:
- Registering a New Component
- 1 If necessary, charge the remote control.
- 2 Ensure that the remote control is turned off (the on/off button should not be flashing green).
- 3 Attach the external pulse transmitter to a user patch with a working battery.
- 4 Place the remote control and user patch with external pulse transmitter attached close together on a table. Make sure the remote control and the external pulse transmitter are no more than a few inches apart and not touching.
- 5 Make certain that any other external pulse transmitter is at least 10 feet away from the components to be registered.
- 6 Simultaneously press and hold for three seconds the mode and minus buttons on the remote control to start the registration process. You should hear a beep, indicating the registration process has begun.
- 7 The remote control digital readout should display two alternating green arches, indicating registration is in progress.
- 8 When the readout displays the letter “C” (meaning connected), and the radio frequency icon turns green for a few seconds, registration is complete. The system will automatically turn on. If the radio frequency icon is not flashing red, registra...
- Replacing the User Patch
- 1 Stop stimulation and turn the remote control off.
- 2 If a patch sleeve was used, take the sleeve off.
- 3 Grasp the patch tab and gently pull the patch from the skin.
- 4 Place the electrode cover over the gel electrodes.
- 5 Gently pull the latching mechanism back and away from the external pulse transmitter (EPT) and lift out the EPT.
- 6 Open a new user patch.
- 7 Hold the EPT with the label facing toward the new user patch.
- 8 Align the gold connector on the EPT with the connector’s port on the user patch. Push the EPT forward into the port. Press the EPT toward the patch to lock the latching mechanism.
- Cleaning the Components
- Cleaning the Patch Sleeves
- Chapter
- 10
- User Patch
- Faulty Electrode Contact
- 1 Turn off the remote control.
- 2 Remove the user patch from the body.
- 3 Check to see that the electrode cover was removed from the patch.
- 4 Make sure that nothing is on the electrodes or on the skin that would interfere with electrode contact with the skin.
- 5 Check to see that the external pulse transmitter is snugly attached to the user patch.
- 6 Re-adhere the user patch to the skin.
- 7 If the problem persists, adhere a new user patch.
- 8 If the problem persists, contact Bioness Customer Support.
- Battery Low Charge
- Battery Failure
- Faulty Electrode Contact
- Remote Control
- External Pulse Transmitter
- Component Malfunction
- Radio Communication Failure
- 1 Make sure that the remote control and the external pulse transmitter (EPT) are within 10 feet of each other.
- 2 Make sure that the remote control battery is charged.
- 3 If the components are within range and working properly, turn the remote control off and then back on.
- 4 Check to see that the external pulse transmitter is snugly attached to the user patch.
- 5 Replace the user patch: use a new user patch and connect the external pulse transmitter to the new patch.
- 6 If the problem persists, reregister the components.
- 7 If the problem still persists, contact Bioness Customer Support.
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General Warnings and Cautions 2-9
Risks Related to Stimulation
• Operation of the StimRouter may cause increased pain in an area(s)
other than the implant site. The pain may be caused by stimulation
of the tissue surrounding the lead (skin, fascia and muscle).
• You may feel undesirable or unpleasant sensations related to
stimulation because of cellular changes in tissue surrounding the
lead.
• You may experience an undesirable motor response during
stimulation.
Risks Related to the Device
• Migration of the lead may cause changes in stimulation.
• While very unlikely, a tissue reaction to any of the implanted
materials may occur.
• External electromagnetic interference may cause the StimRouter to
malfunction and may affect stimulation.
• Magnetic resonance imaging may result in heating of the lead,
image artifact, induced voltages on the lead or lead movement.
• You may experience persistent pain at the implant site of the lead.
• The lead may fail or malfunction, requiring that the lead be
explanted and a new lead be implanted.
• Rarely, the skin overlying the lead may erode.
• Portable and mobile radio frequency communications equipment
can affect medical electrical equipment.