Bioness StimRouter User manual

User Manual
StimRouter™ Implantable
Neurostimulator
Bioness Inc.
Rx Only
CAUTION: 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. shall not be liable for any injury or damage suffered by any person, either
directly or indirectly, as a result of the unauthorized use or repair of Bioness Inc.
products. Bioness does not accept any responsibility for any damage caused to its
products, either directly or indirectly, as a result of use and/or repair by unauthorized
personnel.
Enironmental Policy
Service personnel are advised that when changing any part of the StimRouter, care
should be taken to dispose of those parts in the correct manner; where applicable, parts
should be recycled. When the life cycle of the StimRouter has been completed, the
product should be discarded according to the laws and regulations of the local authority.
Registered Trademarks
StimRouter™, Bioness®, the Bioness Logo and LiveOn™ are trademarks of Bioness
Inc. | www.bioness.com
Use of the symbols ®and ™ herein refers to the registration status of trademarks in the
U.S. only. These trademarks may also be registered in other countries.
Manufacturer: Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355
19 Ha’Haroshet Street
PO Box 2500
Industrial Zone
Ra’Anana 43654, Israel
Bioness Customer Support:
Telephone: [phone]
Fax: [phone]
email: [email protected]
www.bioness.com

List of Symbols
Conformity Certification
The StimRouter complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions:
1This device may not cause harmful interference, and
2This device must accept any interference received, including interference
that may cause undesired operation.
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

1. Introduction 1
Your StimRouter User Kit . . . . . . . . . . . 1
Your Programming Session . . . . . . . . . . 1
User Registration Information . . . . . . . . . 2
Your Medical Device ID Card . . . . . . . . . 2
Bioness Customer Support . . . . . . . . . . 2
2. General Warnings and Cautions 3
Indications for Use . . . . . . . . . . . . . . . 3
Contraindications . . . . . . . . . . . . . . . . 3
Warnings . . . . . . . . . . . . . . . . . . . . . 4
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
Precautions. . . . . . . . . . . . . . . . . . . . 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
Adverse Effects . . . . . . . . . . . . . . . . . 8
Risks Related to Stimulation . . . . . . 9
Risks Related to the Device . . . . . . 9
3. User Kit Contents 11
4. Device Description 13
Implantable Lead . . . . . . . . . . . . . . . 14
Stimulation End . . . . . . . . . . . 14
Pick-Up End . . . . . . . . . . . . . 14
User Patch . . . . . . . . . . . . . . . . . . . 14
Design Features . . . . . . . . . . . 14
Two Surface Gel Electrodes. . . . 14
Integrated Battery . . . . . . . . . 14
External Pulse Transmitter Cradle 14
EPT Latching Mechanism . . . . . 14
Accessories . . . . . . . . . . . . . 15
User Patch Carrying Case . . . . 15
Patch Sleeves . . . . . . . . . . . 15
External Pulse Transmitter. . . . . . . . . . 15
Remote Control . . . . . . . . . . . . . . . . 15
Operating Modes . . . . . . . . . . . 15
Standby . . . . . . . . . . . . . . 15
Program . . . . . . . . . . . . . . 16
Stimulation. . . . . . . . . . . . . 16
Operating Buttons . . . . . . . . . . 16
On/Off . . . . . . . . . . . . . . . 16
Mode . . . . . . . . . . . . . . . 16
Plus/Minus. . . . . . . . . . . . . 16
Volume . . . . . . . . . . . . . . 17
On/Off Indicator Lights . . . . . . . . 17
Remote Control . . . . . . . . . . 17
Stimulation. . . . . . . . . . . . . 17
Program . . . . . . . . . . . . . . 17
Table of Contents

Digital Display. . . . . . . . . . . . . 17
Intensity . . . . . . . . . . . . . . 17
Program . . . . . . . . . . . . . . 17
Battery Charging . . . . . . . . . . 17
Battery Fully Charged . . . . . . . 17
Radio Frequency Registration Error .
18
Radio Frequency Registration
Complete. . . . . . . . . . . . . . 18
Radio Frequency Registration in
Progress . . . . . . . . . . . . . . 18
LEDs . . . . . . . . . . . . . . . . . 18
User Patch Icon . . . . . . . . . . 18
Radio Frequency (RF) Icon . . . . 18
Remote Control Icon . . . . . . . . 19
Visual Alerts . . . . . . . . . . . . . 19
Low Battery, Remote Control . . . 19
Low Battery, User Patch . . . . . . 19
Faulty Electrode Contact. . . . . . 19
Radio Frequency Failure. . . . . . 19
Component Malfunction . . . . . . 19
Audio Alerts. . . . . . . . . . . . . . 19
Beep . . . . . . . . . . . . . . . . 19
Battery Compartment . . . . . . . . . 20
Accessories . . . . . . . . . . . . . . 20
Remote Control Charger. . . . . . 20
Remote Control Neck Strap . . . . 20
Remote Control Wrist Strap . . . . 20
Remote Control Pouch. . . . . . . 20
5. Technical Specifications 21
6. Environmental Conditions that
Affect Use 25
Storage and Handling. . . . . . . . . . . . . 25
Radio Communication Information. . . . . 25
Security Screening Devices . . . . . . . . . 26
Cell Phones. . . . . . . . . . . . . . . . . . . 26
7. Set-Up Instructions 27
Charging the Remote Control . . . . . . . . 27
Preparing the Skin. . . . . . . . . . . . . . . 28
8. Operating Instructions 29
Overview . . . . . . . . . . . . . . . . . . . . 29
Attaching the EPT to a User Patch . . . . . 30
Applying the User Patch to the Skin . . . . 30
Turning On the Remote Control. . . . . . . 31
Adjusting the Volume of Audio Alerts . . . 32
Selecting a Stimulation Program . . . . . . 32
Turning Stimulation On. . . . . . . . . . . . 33
Adjusting Stimulation Intensity . . . . . . . 33
Saving a New Default Stimulation Intensity
Level . . . . . . . . . . . . . . . . . . . . . . . 34
Turning Stimulation Off. . . . . . . . . . . . 35
Taking Off the User Patch . . . . . . . . . . 36
Removing the External Pulse Transmitter. 36
9. Maintenance and Cleaning 39
Recharging the Remote Control Battery . 39
Replacing the Remote Control Battery . . 39
Registering a New Component . . . . . . . 40
Replacing the User Patch . . . . . . . . . . 42
Cleaning the Components . . . . . . . . . . 43
Cleaning the Patch Sleeves . . . . . . . . . 43
10. Troubleshooting 45
User Patch . . . . . . . . . . . . . . . . . . . 45
Faulty Electrode Contact . . . . . . . 45
Battery Low Charge . . . . . . . . . 46
Battery Failure . . . . . . . . . . . . 46
Remote Control . . . . . . . . . . . . . . . . 47
Battery Low Charge . . . . . . . . . 47
Battery Failure . . . . . . . . . . . . 47
Battery Discharges Rapidly . . . . . 47
Battery Charging Error . . . . . . . . 48
External Pulse Transmitter. . . . . . . . . . 48

Temperature Error . . . . . . . . . . 48
Component Malfunction . . . . . . . . . . . 48
Radio Communication Failure . . . . . . . 49

Introduction 1-1
CHAPTER
C HAPTER 1 I NTRODUCTION
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.
Your StimRouter User Kit
The StimRouter Model STR-5000 User Kit contains the external
components that supply and control your stimulation treatment. These
components are the user patch, external pulse transmitter and remote
control. Also included in your User Kit are accessories for these
components.
This manual describes your StimRouter system and explains how to
operate the external components to achieve maximum pain relief. Be
sure to read this manual before operating your StimRouter. Ask
your clinician to explain and demonstrate any procedures you do not
understand.
Your Programming Session
As part of your programming session, you will learn:
•How to set up and operate your StimRouter system

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•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.
User Registration Information
A User Registration Card is included in your StimRouter User Kit. The
purpose of this card is to maintain traceability of all StimRouter products
and to activate your StimRouter warranty. Fill out the registration card
and return it to Bioness Inc. by mail or by fax as soon as possible.
Your Medical Device ID Card
Bioness will send you a Medical Device Identification (ID) Card once we
receive your registration information. You should always have your
Medical Device ID card with you. The Medical Device ID card identifies
you as a person with an implanted medical device.
Bioness Customer Support
Bioness is dedicated to helping you achieve maximum effectiveness with
your StimRouter system. Our customer support representatives are
available to help you better understand how your StimRouter works and
to answer any questions you may have with its operation and care.
Bioness Customer Support:
Telephone: [phone]
Fax: [phone]
email: [email protected]

General Warnings and Cautions 2-3
CHAPTER
C HAPTER 2 G ENERAL W ARNINGS AND C AUTIONS
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: [phone].
The StimRouter should only be used under proper medical guidance and
as described in this manual.
Indications for Use
The StimRouter Implantable Neurostimulator provides electrical
stimulation via an implantable lead to a target stimulation point, for aid in
the management of chronic intractable pain.
Contraindications
The StimRouter should not be used if you have any of the following:
•An implanted cardiac pacemaker or defibrillator
•Any electrical or metallic implant in the area intended for implant

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•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. The energy generated by diathermy can be transferred
through the StimRouter, causing tissue damage at the lead site and
resulting in severe injury or death.
Diathermy may also damage the neurostimulation components, resulting
in loss of therapy and requiring additional surgery for lead replacement.
Injury or damage can occur during diathermy treatment whether the
neurostimulation system is turned on or off. All patients are advised to
inform their health-care professional that they should not be exposed to
diathermy.
Magnetic Resonance Imaging (MRI)
Patients implanted with the StimRouter Implantable Neurostimulator
should not be subjected to MRI. MRI exposure may dislodge the
implanted lead, heat the lead, damage the component electronics and/or
cause voltage induction through the lead.
Implanted Stimulation Devices
Neurostimulators, such as the StimRouter, may interfere with the
operation of implanted sensing stimulators such as pacemakers or

General Warnings and Cautions 2-5
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.
Electrosurgery Devices
Advise your health-care professional that electrosurgery devices should
not be used in close proximity to an implanted neurostimulation lead.
Contact between an active electrode of the electrosurgery device and an
implanted lead can cause direct stimulation of the nerve or other target
stimulation point and severe injury may result.
High-Frequency Surgical Equipment
Remove the user patch before medical treatment. Simultaneous
connection to the StimRouter and high-frequency surgical equipment
may result in skin burns where the gel electrodes adhere to the skin and
may damage the external pulse transmitter.
Driving and Operating Machinery
Turn off stimulation while driving and operating machinery.
Pregnancy
Avoid exposure to electrical stimulation for the entire duration of
pregnancy. The effects of electrical stimulation on pregnancy are
unknown.
Long-Term Effectiveness of Neurostimulation
The long-term effectiveness of neurostimulation is unknown.

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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.
Precautions
Medical Devices/Therapies
The following medical therapies or procedures may turn stimulation off,
or may cause permanent damage to the StimRouter lead and external
components and injury to the patient, particularly if used in close
proximity to the system components:
•Lithotripsy
•Electrocautery
•External defibrillation
•Radiation therapy
•Ultrasonic scanning
•High-output ultrasound
For Patient Use Only
Do not adhere the user patch to any other person or to any other part of
your body. The StimRouter user patch is meant to be worn only by the
patient for which it was prescribed and in the location where it was
prescribed.
Postural Changes
Turn off stimulation before making extreme posture changes or abrupt
movements such as stretching, lifting of arms overhead, or exercising.

General Warnings and Cautions 2-7
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. However, some patients
may experience skin irritation, an allergic reaction, or hypersensitivity to
the electrical stimulation or the electrical conductive medium. Persistent
redness, lesions or blisters are signs of irritation. Use of the StimRouter
should be temporarily halted until the inflammation is resolved. In some
cases, irritation can be avoided by changing the stimulation parameters.
Consult your treating clinician if irritation persists.
User Patch Placement and Stimulation
•Turn stimulation off before adhering, removing or handling the
StimRouter user patch.
•Do not activate stimulation until the user patch is in place.
•Do not handle the user patch with both hands while stimulation is
turned on; serious injury can result from electrical current passing
through the chest area.
•Only the treating clinician should determine user patch placement
and stimulation settings.
•Do not apply the user patch over any obstruction that would reduce
the designated electrode surface area. A smaller electrode surface
area could result in serious tissue injury during stimulation.

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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.
Care and Handling of Components
Handle all system components and accessories with care. Do not drop
components and accessories. Although reliability testing has been
performed to ensure quality manufacturing and performance, dropping
the components on hard surfaces, or other rough handling, can
permanently damage the components.
Storage and Operation Temperatures
Do not expose components to extreme temperature conditions or
moisture.
Expiration Date
Do not use a user patch with a use-by date that has expired.
Adverse Effects
Note: In the unlikely event that any of the following occurs, stop using the
StimRouter and immediately consult your treating clinician.

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.

2-10 StimRouter User Manual

User Kit Contents 3-11
CHAPTER
C HAPTER 3 U SER K IT C ONTENTS
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
Check to make sure that all of the above components are included in your
User Kit. If anything is missing, call Bioness Customer Support.

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