User Manual StimRouter™ Implantable Neurostimulator CAUTION: Bioness Inc. Rx Only United States federal law restricts this device to sale by or on the order of a physician.
Copyright ©2009 by Bioness Inc. All Rights Reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system or translated into any language or any computer language, in any form or by any third party, without the prior written permission of Bioness Inc. Guarantees Bioness Inc. reserves the right to modify, without prior notice, information relating to its products to improve their reliability or operating capacity. Disclaimer Bioness Inc.
List of Symbols Symbols Definition Type BF Applied Part Electronic Testing Lab, indicates product meets U.S. and Canadian product safety standards. This device complies with UL 60601-1 and CSA C22.2 No. 601-1-M90. Non-Ionizing Radiation Class II Equipment Manufacturer Date of Manufacture Warning Conformity Certification The StimRouter complies with Part 15 of the FCC Rules.
Table of Contents 1. Introduction 1 Expiration Date . . . . . . . . . . . . . 8 Your StimRouter User Kit . . . . . . . . . . . 1 Adverse Effects . . . . . . . . . . . . . . . . . 8 Your Programming Session . . . . . . . . . . 1 Risks Related to Stimulation . . . . . . 9 User Registration Information. . . . . . . . . 2 Risks Related to the Device . . . . . . 9 Your Medical Device ID Card . . . . . . . . . 2 Bioness Customer Support . . . . . . . . . . 2 2. General Warnings and Cautions 3 3.
Digital Display. . . . . . . . . . . . . 17 7. Set-Up Instructions 27 Intensity . . . . . . . . . . . . . . 17 Charging the Remote Control. . . . . . . . 27 Program . . . . . . . . . . . . . . 17 Preparing the Skin. . . . . . . . . . . . . . . 28 Battery Charging . . . . . . . . . . 17 Battery Fully Charged . . . . . . . 17 8. Operating Instructions 29 Radio Frequency Registration Error . 18 Overview . . . . . . . . . . . . . . . . . . . . 29 Radio Frequency Registration Complete. . . . . . . .
Temperature Error . . . . . . . . . . 48 Component Malfunction . . . . . . . . . . . 48 Radio Communication Failure . . . . . . .
C HAPTER INTRODUCTION CHAPTER1 Congratulations! Your physician has prescribed the StimRouter Implantable Neurostimulator to help manage your pain. The first step is to have the StimRouter lead implanted where neurostimulation will give you the most pain relief. After the lead is implanted and the skin above the implant site is healed, you can start your stimulation treatment.
• Where to place the user patch • How to attach the external pulse transmitter to the user patch • How to select a stimulation program • How to fine-tune stimulation intensity The clinician will program your StimRouter system with a series of stimulation settings that best fits your pain-management needs. The programs will be stored on your StimRouter remote control for you to access at home. Your clinician will explain how the programs differ, and when and how to choose which program to use.
C HAPTER GENERAL WARNINGS AND CAUTIONS CHAPTER 2 Before using your StimRouter system, be certain to read, understand and practice the precautionary and operating instructions in this manual. Know the limitations and hazards associated with your StimRouter. Discuss any questions you have with your clinician. If at any time you are concerned about the safety or the effectiveness of your StimRouter, consult your treating clinician or Bioness Customer Support Representative: Telephone: (800) 211-9136.
• A cancerous lesion near the target stimulation area or near to where the user patch will adhere • A fracture or dislocation near the target stimulation area or near to where the user patch will adhere The StimRouter should not be used if you may require: • Diathermy treatment • Magnetic resonance imaging Warnings Diathermy Shortwave, microwave and/or therapeutic ultrasound diathermy should not be used on patients who have a StimRouter Implantable Neurostimulator.
cardiovascular defibrillators. The effects of implanted sensing stimulators on neurostimulators are unknown. Flammable Fuel or Chemicals Turn the StimRouter (remote control and stimulation) off when near a refueling point, flammable fuel, fumes or chemicals. The operation of the StimRouter could cause the chemicals or fumes to ignite, causing severe burns, injury or death.
System Programming Only the treating clinician should program the StimRouter. System Components Use only Bioness components with your StimRouter. Use of non-Bioness components may damage your system and cause injury to you.
Changes in posture or abrupt movements may decrease or increase your perceived level of stimulation. Keep out of Reach of Children Keep all StimRouter components out of the reach of children. Skin Abnormalities Do not adhere the user patch to sites that are swollen, infected or inflamed, or that have skin eruptions such as phlebitis, thrombophlebitis and varicose veins. Skin Irritation It is normal for the areas under the user patch to be red. The redness should disappear in approximately one hour.
X-Ray Examinations Do not wear the StimRouter user patch during x-ray examinations. Known or Suspected Heart Problems Consult your physician if you have or suspect you have a heart condition. Physicians should use caution when treating patients with suspected or diagnosed heart problems. Device Failure Leads can fail at any time because of random component failure or lead breakage. If stimulation is no longer effective, contact your treating clinician or Bioness Customer Support.
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.
2-10 StimRouter User Manual
C HAPTER USER KIT CONTENTS CHAPTER3 The StimRouter STR-5000 User Kit contains the external components and accessories of the StimRouter implantable neurostimulation system for pain therapy: • Remote Control • Remote Control Charger • Remote Control Neck Strap • Remote Control Wrist Strap • Remote Control Pouch • User Patch (4) • User Patch Carrying Case • External Pulse Transmitter (EPT) Also included: • User Manual • User Instruction Card • User Registration Card • Warranty Card
3-12 StimRouter User Manual
C HAPTER DEVICE DESCRIPTION CHAPTER4 Your StimRouter system consists of four key components: • An implantable lead • An external user patch • An external pulse transmitter (EPT) • A portable remote control FIGURE 4-1. FIGURE 4-1. Your StimRouter system components.
Implantable Lead The StimRouter lead is about 6 inches long. It has a stimulation end and a pick-up end. The entire lead is implanted. Stimulation End Stimulates the treatment area. Pick-Up End Receives (picks up) the stimulation signal from the external pulse transmitter and sends it to the stimulation end. The pick-up end can usually be felt by palpating the skin in the area of implant.
Accessories User Patch Carrying Case Designed to carry an extra user patch or store a worn user patch. The case is small and portable and holds one user patch. Patch Sleeves Designed to help secure the user patch to the skin. External Pulse Transmitter The StimRouter external pulse transmitter (EPT) sends pain-relieving electrical stimulation to the implanted lead. The external pulse transmitter fits into the user patch and responds to wireless commands from the remote control.
FIGURE 4-2. StimRouter remote control operating buttons. On/Off Button Mode Button Volume Buttons Plus/ Minus Buttons Program In program mode, the available stimulation programs are accessible. To choose a stimulation program, use the plus/minus buttons. Stimulation In stimulation mode, the StimRouter system is on; it is stimulating the target treatment area. Stimulation intensity can be fine-tuned using the plus/minus buttons. Operating Buttons On/Off Used to turn the remote control on and off.
Volume Used to increase or decrease sound level of the audio indicators. On/Off Indicator Lights Remote Control On/Off button flashes green when the remote control is on. Stimulation Mode button flashes yellow when stimulation mode is on. Program Mode button glows yellow when program mode is on. Digital Display Shows stimulation intensity in stimulation mode, program selected in program mode, charging status, radio frequency registration status and system errors.
FIGURE 4-3. StimRouter remote control digital display and LEDs. Radio Frequency (RF) Icon User Patch Icon Digital Display Remote Control Icon Radio Frequency Registration Error “E” appears in the digital display. Radio Frequency Registration Complete “C” appears in the digital display. Radio Frequency Registration in Progress A green arch alternates in the digital display.
Remote Control Icon • Flashes yellow: low battery • Glows red: component malfunction or battery charging error Visual Alerts Low Battery, Remote Control • Remote control icon flashes yellow Low Battery, User Patch • User patch icon flashes yellow Faulty Electrode Contact • User patch icon flashes red • Stimulation intensity number flashes green Radio Frequency Failure • Radio frequency icon flashes red Component Malfunction • Remote control or user patch icon glows red • “E” appears in the dig
• A button has been pressed • The stimulation mode’s duration has elapsed • The remote control battery charge level is low • The remote control battery is depleted • The remote control battery is full • The electrode contact is faulty • The user patch battery is low • The EPT is malfunctioning • The remote control charger is connected • The remote control charger is disconnected Battery Compartment The battery compartment contains a rechargeable AAA battery (installed).
C HAPTER TECHNICAL SPECIFICATIONS CHAPTER5 Specifications, StimRouter User Patch Classification Battery Type Dimensions Internally powered, continuous operation, Type BF applied part(s) 2 AAA 1.5-V, lithium batteries Height 14 mm (0.551 in.) Width 40 mm (1.574 in.) Length 115 mm (4.527 in.
Specifications, StimRouter External Pulse Transmitter Dimensions Height 9 mm (0.354 in.) Width 35 mm (1.377 in.) Depth 38 mm (1.496 in.) Weight 10 grams (0.352 oz.) Environmental Ranges Transport and Storage Temperature -20°C to 60°C (-4°F to 140°F) Operational Conditions Temperature 5°C to 40°C (41°F to 104°F) Charging Temperature 5°C to 40°C (41°F to 104°F) Relative Humidity 25% to 85% Atmospheric Pressure 0.9 kPA to 1.
Specifications, StimRouter Remote Control Digital Displays Relative stimulation intensity Program selected Error or status (charging, registration) On/Off Indicator Lights Remote Control Stimulation Program Audio Alerts Beep System errors Mode changes (stimulation and program) Volume changes Carrying Options Neck strap, wrist strap, belt pouch, pocket Dimensions Height 71 mm (2.8 in.) Width 46 mm (1.8 in.) Depth 17.5 mm (0.7 in.) Weight 45 grams (1.5 oz.
Specifications, Wireless Link Frequency Band Transmission Power 2.4 GHz, ISM band Complies with FCC 15.247 (for U.S.
C HAPTER ENVIRONMENTAL CONDITIONS THAT AFFECT USE CHAPTER6 Storage and Handling All StimRouter components should be kept dry and protected from extreme changes in temperature and humidity. Do not use or store your components where they could come in contact with water, such as by sinks, bathtubs and shower stalls. Do not expose your StimRouter components to weather conditions such as rain or snow, or to any other source of water.
for a Class B digital device, pursuant to Part 15 (Radio Frequency Devices) of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential environment. This equipment generates, uses and can radiate radio frequency energy and, if not operated and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular environment.
C HAPTER SET-UP INSTRUCTIONS CHAPTER7 Charging the Remote Control The remote control comes with a rechargeable AAA battery already installed, and a charger. The battery should be charged daily and when the remote control icon flashes yellow. A new remote control battery supports at least 24 hours of typical usage before needing to be recharged. WARNING: The remote control can be operated while it is being charged. Use only the charger included in the StimRouter User Kit.
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. Charge Level Low Charge Level High Battery Charged FIGURE 7-1. When the remote control is turned off, the digital display continuously shows the charging status.
C HAPTER OPERATING INSTRUCTIONS CHAPTER8 Use only the Bioness components designed and manufactured for the StimRouter. Do not substitute any components for those supplied in the StimRouter User Kit.
Before operating the StimRouter, read the previous sections of this manual that describe the components and their features. To gain the maximum benefit from your StimRouter, carefully follow your clinician’s instructions. If you have any questions or problems, or experience any new symptoms or painful areas, contact your treating clinician for appropriate diagnosis and treatment. Your clinician is familiar with your specific situation and the best source of additional guidance.
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 body hair from the skin area with scissors. Do not use a razor. A razor can irritate the skin.
To turn the remote control on: 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 button will flash green. Note: The remote control turns on in standby mode. The default stimulation intensity level will appear as a number in the digital display.
To select 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.
CAUTION: this level will be most appropriate for use. Stimulation intensity can be adjusted, however, using the plus/minus buttons. Be careful not to set the stimulation intensity too high. Pain can result. To temporarily adjust stimulation intensity: 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.
The saved level will be the default level whenever the stimulation program is started or until a new default level is saved. Turning Stimulation Off To turn stimulation off: Stimulation Off 1 Stimulation On Press the mode button briefly. The remote control will return to standby mode and the mode button will turn off. Stimulation will stop. Remote Control Off Remote Control On 2 Or, turn the remote control off. The remote control can be turned off at all times.
Taking Off the User Patch Note: Remove the user patch before bathing, when the battery wears out and when the gel adhesive, with or without the assistance of a patch sleeve or strap, can no longer keep the user patch in place. Periodically, the user patch will also need to be removed to allow the skin to breathe. Skin irritation can result from prolonged contact with the surface gel electrodes. To remove the user patch: 1 Stop stimulation and turn the remote control off.
Operating Instructions 8-37
8-38 StimRouter User Manual
C HAPTER MAINTENANCE AND CLEANING CHAPTER9 CAUTION: Do not attempt to repair any of the components supplied in the StimRouter User Kit. If a component malfunctions or is lost, contact Bioness Customer Support. Recharging the Remote Control Battery The remote control battery should be charged daily, after extended storage and when the remote control icon flashes yellow. The battery must be charged for stimulation to be effective and comfortable. See “Charging the Remote Control” on page 7-27.
3 WARNING: Remove the old battery.Insert a new rechargeable AAA NiMH 1.2V battery, orienting it to match the polarity marks on the battery socket. Use only a rechargeable 1.2-V NiMH AAA battery. Use of a nonrechargeable battery can damage and overheat the remote control, and may lead to tissue injury or burns. 4 Reattach the battery cover. 5 Tighten the screw. 6 Reattach the label. 7 Dispose of the old battery according to your local environmental regulations. FIGURE 9-1.
To perform the registration procedure, both the remote control and the external pulse transmitter must be operational. Make sure the remote control is charged and that the external pulse transmitter is attached to a user patch with a working battery. Note: Please read all of the instructions below before beginning the registration procedure. To register the remote control and the external pulse transmitter: 1 If necessary, charge the remote control.
Registration Connected Registration Error 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, registration was successful. Note: If the readout displays the letter “E” (meaning error) and the radio frequency icon turns red for a few seconds, an error has occurred and the procedure must be repeated.
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. Note: To ensure proper electrical stimulation, the external pulse transmitter must be connected to the user patch properly. Cleaning the Components • All StimRouter components may be cleaned by carefully wiping with a damp cloth. • StimRouter electronic components are not waterproof; do not immerse them in water to clean.
9-44 StimRouter User Manual
C HAPTER TROUBLESHOOTING CHAPTER10 Should a technical problem occur that is not covered in this section, contact Bioness Customer Support: Telephone: (800) 211-9136. Note: Do not attempt to repair any of your StimRouter components. User Patch Faulty Electrode Contact Indicators • Beep • User patch icon flashes red • Intensity level flashes in digital display Corrective Actions 1 Turn off the remote control. 2 Remove the user patch from the body.
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 Indicators • Beep • User patch icon flashes yellow Corrective Actions 1 Change the user patch. 2 If the problem persists, contact Bioness Customer Support.
Remote Control Battery Low Charge Indicators • Beep • Remote control icon flashes yellow Corrective Actions 1 Charge the remote control battery. 2 If the problem persists, replace the battery. Battery Failure Indicator • When the remote control is turned on, none of the icons lights up; no self test is performed Corrective Actions 1 Charge the battery. 2 If the problem persists, replace the battery.
Battery Charging Error Indicator • While charging, the letter “E” appears on the digital display and the remote control icon glows red Corrective Actions 1 Reconnect the charger cable to the remote control. 2 If the problem persists, replace the battery in the remote control. 3 If the problem persists, contact Bioness Customer Support.
Radio Communication Failure Indicators • Beep • The radio frequency icon flashes red Corrective Actions 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.
10-50 StimRouter User Manual
Index M A A-H 32 airports 26 antitheft devices mute 32 26 P patient ID card B battery discharges rapidly 47 battery loses its charge 42 R rain or snow 25 rechargeable AAA battery 27 Registration Connected 42 Registration Error 42 Registration in Progress 41 remote control and user patch icons start flashing red in succession 48, 49 remote control icon flashes yellow 27 remote control icon turns red 48 Remote control indicator flashes yellow 47 Remote control indicator is constantly red 48 remote con
