Bioness StimRouter User manual

602-00630-001 Rev. E
11/2017
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Website: www.bioness.com
Rx Only
©2017 Bioness Inc.
StimRouter®, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc.
www.bioness.com
MP602-00630-001 Rev. E.indd 1 11/15/17 2:21 PM

®
MP602-00630-001 Rev. E.indd 2 11/15/17 2:21 PM

MP602-00630-001 Rev. E.indd 3 11/15/17 2:21 PM

Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Website: www.bioness.com
Copyright
©2017 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.
Registered Trademarks
StimRouter®, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc. |www.bioness.com
Patents Pending
This product is covered by one or more US and international patents. Additional patents pending. For more
information on patents visit the Bioness website at: www.bioness.com.
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.
Environmental Policy
Service personnel are advised that when changing any part of the StimRouter system, care
should be taken to dispose of those parts in the correct manner; where applicable, parts should be
recycled. When the life cycle of a StimRouter component has been completed, the product should
be discarded according to the laws and regulations of the local authority. For more information
regarding these recommended procedures, please contact Bioness Inc. Bioness is committed to
continuously seeking and implementing the best possible manufacturing procedures and servicing routines.
Conformity Certification
MP602-00630-001 Rev. E.indd 2 11/15/17 2:21 PM

iii
MP602-00630-001 Rev. E.indd 3 11/15/17 2:21 PM

iv
Table of Contents
Chapter 1: Introduction .................................................................................... 1
Chapter 2: Warnings and Cautions .................................................................. 3
Indications for Use .......................................................................................................... 3
Contraindications ............................................................................................................ 3
Warnings ......................................................................................................................... 4
Magnetic Resonance Imaging (MRI) Warnings and Precautions ................................ 4
StimRouter External Component Restrictions ............................................................ 5
MRI Safety Information ................................................................................................... 5
MRI Conditional .............................................................................................................. 5
Reduced RF Zone ...................................................................................................... 6
Using the Transmit Body RF Coil ................................................................................ 6
Using the Trasmit RF Body Coil and the Receive-Only RF Head Coil ......................... 7
Using the Transmit/Recieve RF Head Coil .................................................................. 7
Using the Transmit/Recieve RF Knee Coil .................................................................. 7
Using the Transmit/Recieve RF Hand/Wrist Coil ........................................................ 7
Using the Transmit/Recieve RF Foot/Ankle Coil ......................................................... 7
MRI-Related Heating of the StimRouter Lead: Supplemental Information ................ 14
1.5 T/64 MHz ...................................................................................................... 14
3 T/128 MHz ....................................................................................................... 15
Image Artifacts .......................................................................................................... 16
Induced Currents ...................................................................................................... 17
Potential Adverse Events .............................................................................................. 17
Pregnancy .................................................................................................................... 17
Long-Term Effectiveness of Neurostimulation .............................................................. 17
Programming ................................................................................................................ 17
Device Components ..................................................................................................... 17
Flammable Fuel, Chemicals or Environment ................................................................. 18
Driving and Operating Machinery .................................................................................. 18
Electromagnetic Compatibility Warnings ....................................................................... 18
MP602-00630-001 Rev. E.indd 4 11/15/17 2:21 PM

v
Medical Devices/Therapies ...................................................................................... 18
Electrosurgery Devices ............................................................................................. 19
High-Frequency Surgical Equipment ........................................................................ 19
Body-Worn Devices .................................................................................................. 19
Security Screening Devices ...................................................................................... 20
Cell Phones .............................................................................................................. 20
Precautions ................................................................................................................... 20
Post-Operative Care ................................................................................................. 20
Known or Suspected Heart Problems ....................................................................... 21
Implant Failure .......................................................................................................... 21
Postural Changes ..................................................................................................... 21
For Single Patient Use Only ...................................................................................... 21
Keep Out of Reach of Children ................................................................................. 21
Skin Abnormalities .................................................................................................... 21
Skin Irritation ............................................................................................................. 21
Sensations Caused by Stimulation ........................................................................... 22
StimRouter Electrode Expiration Date ...................................................................... 22
StimRouter Electrode Placement and Stimulation .................................................... 22
Storage and Handling ............................................................................................... 23
Adverse Effects ............................................................................................................. 23
Risks Related to the Implant Procedure .................................................................... 23
Risks Related to Stimulation ..................................................................................... 23
Additional Risks Related to the StimRouter System .................................................. 24
Chapter 3: Clinical Experience ....................................................................... 25
Safety ............................................................................................................................ 25
Effectiveness ................................................................................................................. 25
Chapter 4: Environmental Conditions that Affect Use ................................. 27
Storage and Handling ................................................................................................... 27
Radio Communication Information ................................................................................ 27
Electromagnetic Emissions ........................................................................................... 28
MP602-00630-001 Rev. E.indd 5 11/15/17 2:21 PM

vi
Chapter 5: StimRouter User Kit ...................................................................... 29
Chapter 6: Device Description ....................................................................... 31
StimRouter Lead ........................................................................................................... 31
StimRouter External Pulse Transmitter (EPT) ............................................................... 31
Charging Socket and Charging Light ........................................................................ 32
StimRouter Electrode .................................................................................................... 32
StimRouter Electrode Liner ....................................................................................... 33
StimRouter Electrode Carrying Case......................................................................... 33
StimRouter Patient Programmer ................................................................................... 34
Operating Buttons ..................................................................................................... 34
On/Off Button ...................................................................................................... 34
Mode Button ....................................................................................................... 34
Plus/Minus Buttons ............................................................................................. 35
Volume Buttons ................................................................................................... 35
Operating Modes ...................................................................................................... 35
Standby Mode ..................................................................................................... 35
Program Mode .................................................................................................... 35
Stimulation Mode ................................................................................................ 36
Indicator Lights ......................................................................................................... 36
Patient Programmer Indicator Light .................................................................... 36
Stimulation Indicator Light ................................................................................... 36
Program Mode Indicator Light ............................................................................. 36
Information Icons ..................................................................................................... 37
Patient Programmer Icon .................................................................................... 37
EPT Icon ............................................................................................................. 37
Radio Frequency (RF) Icon ................................................................................. 37
Digital Display .......................................................................................................... 37
Stimulation Intensity Level .................................................................................. 37
Program Selection .............................................................................................. 38
System Errors ..................................................................................................... 38
Charging Status .................................................................................................. 38
Audio Alerts .............................................................................................................. 39
MP602-00630-001 Rev. E.indd 6 11/15/17 2:21 PM

Charging Socket ....................................................................................................... 39
Connection Port ........................................................................................................ 40
Battery Compartment ............................................................................................... 40
Patient Programmer Neck and Wrist Straps ............................................................. 40
System Charger Set ................................................................................................. 41
Chapter 7: Set-Up Instructions ...................................................................... 43
Charging the Patient Programmer and EPT .................................................................. 43
Preparing the Skin ......................................................................................................... 45
Connecting the StimRouter Electrode and EPT ............................................................ 45
Adhering the StimRouter Electrode ............................................................................... 46
Chapter 8: Operating Instructions ................................................................. 49
Turning the Patient Programmer On/Off ........................................................................ 50
Adjusting the Volume of Audio Alerts ............................................................................ 51
Selecting a Stimulation Program ................................................................................... 51
Turning Stimulation On ................................................................................................. 52
Adjusting Stimulation Intensity ...................................................................................... 53
Saving a New Stimulation Intensity Level ...................................................................... 53
Turning Stimulation Off ................................................................................................. 54
Removing the StimRouter Electrode ............................................................................. 54
Removing the EPT from StimRouter Electrode ............................................................. 55
Chapter 9: Maintenance and Cleaning .......................................................... 57
Recharging the Patient Programmer Battery ................................................................. 57
Replacing the Patient Programmer Battery ................................................................... 57
Recharging the EPT Battery .......................................................................................... 59
Replacing the StimRouter Electrode ............................................................................. 59
Registering a New Component ..................................................................................... 60
Cleaning ........................................................................................................................ 61
Neck Strap and Wrist Strap ...................................................................................... 61
StimRouter Electrode Liner ....................................................................................... 61
StimRouter Electrode Carrying Case......................................................................... 61
Disinfecting ................................................................................................................... 62
vii
MP602-00630-001 Rev. E.indd 7 11/15/17 2:21 PM

viii
Electronic Components ....................................................................................... 62
Chapter 10: Troubleshooting ......................................................................... 63
Chapter 11: Technical Specifications ............................................................ 67
Chapter 12: Appendix - EMI Tables ................................................................ 73
Electromagnetic Emissions ........................................................................................... 73
MP602-00630-001 Rev. E.indd 8 11/15/17 2:21 PM

ix
User's Guide
List of Symbols
Caution
Warning
Class II Equipment (Double Insulated)
Type BF Applied Part(s)
Non-Ionizing Radiation
Date of Manufacture
Manufacturer
This Product Must Not Be Disposed of with Other Household Waste
Refer to Instruction Manual/ Booklet
Consult Instructions for Use
Re-Order Number
Lot Number
Serial Number
Complies with United States and Canadian Product Safety Standards
Single Patient Use
Storage Temperature
Humidity Limitation
Atmospheric Pressure Limitation
IPX3 Protection Against Ingress of Water
Keep Dry
Use By
Quantity
Prescription Only
MP602-00630-001 Rev. E.indd 9 11/15/17 2:21 PM

1
Chapter 1 - Introduction
1
Introduction
The Bioness StimRouter Neuromodulation System is intended to help manage your pain.
The StimRouter system works by providing electrical impulses to a target area in the body.
These impulses are intended to interrupt or change the pain signals, inducing the feeling
of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of
pain. The StimRouter system includes:
• An implanted lead.
• An External Pulse Transmitter (EPT).
• A StimRouter Electrode.
• A Patient Programmer.
This guide includes important safety information about your StimRouter system, describes
the external components of your StimRouter system that are used to stimulate the implanted
lead, and reviews how to set up and use your system. Be sure to read this guide before using
your StimRouter system. Ask your physician to explain and demonstrate any procedures
you do not understand.
StimRouter Electrode EPT Patient Programmer
Lead
MP602-00630-001 Rev. E.indd 1 11/15/17 2:21 PM

2
User's Guide
Note: Your StimRouter User Kit contains a Medical Device Identification (ID) Card. Complete
your card as soon as possible and carry it with you at all times. Your Medical Device ID
Card identifies you as a person with an implanted medical device.
You may need this card to bypass security screening devices, which are common at
airports, grocery stores, libraries, etc. You may also need this card if you require medical
treatment. This card includes the website address for Bioness. A copy of the StimRouter
User’s Guide is posted on the Bioness website.
MP602-00630-001 Rev. E.indd 2 11/15/17 2:21 PM

3
Chapter 2 - Warnings and Cautions
2
Warnings and Cautions
Be sure to follow your physician’s guidance. Use your StimRouter system only as instructed
in the User’s Guide.
Indications for Use
The StimRouter Neuromodulation System is indicated for pain management in adults who
have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other
modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the
craniofacial region.
Contraindications
The Bioness StimRouter Neuromodulation System is contraindicated for:
• Patients who have any active implanted device such as an implanted demand
cardiac pacemaker or defibrillator, or any metallic implant in the immediate area
intended for implant. Maintain a minimum safe separation distance of 15 cm
(6 in.) between the StimRouter Electrode with External Pulse Transmitter and
all other active implanted devices and metallic implants.
A risk/benefit determination should be performed before using the StimRouter system for:
• Patients exposed to diathermy. Shortwave, microwave and/ or therapeutic
ultrasound diathermy should not be used on patients who have a StimRouter
Neuromodulation System. The energy generated by diathermy can be transferred
through the StimRouter system components, causing tissue damage at the lead
site and potentially resulting in severe injury. Diathermy may also damage the
StimRouter system components, resulting in loss of therapy. Injury or damage
can occur during diathermy treatment whether neurostimulation is turned on or
off. All patients are advised to inform their health-care professionals that they
should not be exposed to diathermy.
MP602-00630-001 Rev. E.indd 3 11/15/17 2:21 PM

4
User's Guide
• Patients exposed to therapeutic ultrasound.
• Patients who are unable to operate the StimRouter system.
• Patients who are high surgical risks or poor surgical candidates in general.
• Patients who have a cancerous lesion present near the target stimulation point or
near to where the StimRouter Electrode will adhere.
• Patients with bleeding disorders or active anticoagulation that cannot be stopped
for a few days close to the time of the surgical procedure.
Warnings
Magnetic Resonance Imaging (MRI) Warnings and Precautions
• An MRI examination performed on a patient with an implanted StimRouter
Neuromodulation System Lead (i.e., StimRouter Lead) should only be done if
there is a valid indication as determined by the supervising physician, and then
only if all guidelines are carefully followed.
• All external components of the StimRouter system are contraindicated for the MR
system room. Therefore, the StimRouter Electrode, External Pulse Transmitter,
and Patient Programmer must be removed before the patient is allowed into the
MR system room.
• Do not conduct an MRI examination on a patient with an implanted StimRouter
Neuromodulation System Lead (i.e., StimRouter Lead) until you read and fully
understand the information in the Clinician’s Guide. Failure to follow all warnings
and guidelines related to MRI can result in SERIOUS INJURY to the patient.
• The implanted StimRouter Lead should not be within transmit RF body coil
unless the specific restrictions are followed for reduced radiofrequency (RF)
power deposition (i.e., WBA SAR or B1+RMS values) as presented in the Tables
2-1 and 2-2.
• Do not scan patients using a whole-body-averaged, specific absorption rate
(SAR) level that exceeds 2 W/kg (i.e., with the MR system operating in the
Normal Operating Mode). An MRI examination performed using a whole-body-
averaged SAR above 2 W/kg may increase the risk of MRI-related heating,
resulting in injury to the patient.
MP602-00630-001 Rev. E.indd 4 11/15/17 2:21 PM

5
Chapter 2 - Warnings and Cautions
StimRouter External Component Restrictions
All external components of the StimRouter system are contraindicated for the MR system
room. Therefore, the StimRouter Electrode, External Pulse Transmitter, and Patient
Programmer must be removed before the patient is allowed into the MR system room.
MRI Safety Information
MRI Conditional
Non-clinical testing demonstrated that the StimRouter Lead is MR Conditional. A patient
with an implanted StimRouter Lead can be scanned safely, immediately after implantation,
under the following conditions:
• Static magnetic field of 1.5 T or 3 T, only
• Maximum spatial field gradient magnetic field of 2,500 gauss/cm (25 T/m)
• Specific conditions (see below) must be followed to ensure patient safety relative
to the prevention of excessive heating of the StimRouter Lead
• If the entire StimRouter Lead is at least 50 cm away from the center of the bore
of the MR system and the center of the transmit RF body coil, the reported,
whole-body-averaged SAR must not exceed 2 W/kg at 1.5 T/64 MHz or a whole-
body-averaged SAR of 2 W/kg at 3 T/128 MHz in the Normal Operating Mode of
operation for the MR system
• The patient must be conscious. Maintain communication with the patient so that
the MRI examination can be terminated in the event of painful nerve stimulation
or other adverse or unusual event
Note: The precise anatomical position of the implanted StimRouter Lead is necessary to
know prior to the MRI exam. Therefore, before initiating an MRI exam, the supervising
clinician (e.g., the radiologist) should review the patient’s Medical Device Identification Card,
communicate directly with the implanting physician, and/or obtain an x-ray to determine
the precise anatomic location of the implanted StimRouter Lead in the patient’s body.
Additionally, the patient must undergo a proper MRI screening procedure to determine
the presence of a previously implanted (active or abandoned) medical device, including
leads, lead extenders, lead adapters, and passive implants.
MP602-00630-001 Rev. E.indd 5 11/15/17 2:21 PM

6
User's Guide
CAUTION: If the StimRouter Lead is at least 50 cm from the center of the bore of
the MR system and the center of the transmit/receive RF body coil, DO NOT perform an
MRI exam on the patient above a whole-body-averaged SAR of 2 W/kg in the Normal
Operating Mode for a 1.5 T/64 MHz or a 3 T/128 MHz MR system. For a StimRouter Lead
implant located inside the Reduced RF Zone (see Figures and Tables in this Guide) a
reduced value of the whole-body-averaged SAR or, alternatively, the value of the B1+RMS
must be utilized in order to ensure acceptable tissue temperature increases based on the
MRI conditions that are used for the MRI exam.
Reduced RF Zone
The “Reduced RF Zone” is defined as the anatomic area of the patient that will receive
the RF power deposition during an MRI exam. When all or part of the StimRouter Lead is
within a 50 cm distance from the center of the bore of the MR system and the center of
the transmit RF body coil, this is referred to as the “Reduced RF Zone.” A reduced value
of the whole-body-averaged SAR or, alternatively, the value of the B1+RMS must be utilized
in order to ensure acceptable tissue temperature increases based on the MRI conditions
that are used for the MRI exam. See Tables 2-1 and 2-2 for the acceptable whole-body-
averaged SAR and B1+RMS values.
To ensure safety for a patient with an implanted StimRouter Lead, MRI healthcare
professionals must adhere to the following conditions:
Using the Transmit Body RF Coil
When the entire StimRouter Lead is outside of the Reduced RF Zone and a receive-only
RF coil is being used (note, any type of receive-only RF coil is permitted for use under
these circumstances), the reported whole-body-averaged SAR must not exceed 2 W/kg at
1.5 T/64 MHz and 2 W/kg at 3 T/128 MHz (Figure 2-1). Do not perform MRI in patients using
a whole-body-averaged SAR level that exceeds 2 W/kg. An MRI exam scan performed
using a whole-body-averaged SAR level above 2 W/kg may increase the risk of unacceptable
MRI-related heating of the implanted StimRouter Lead.
When all or part of the StimRouter Lead is inside the Reduced RF Zone (Figure 2-1),
reduced values of the whole-body-averaged (WBA) SAR or the B1+RMS value must be used
to result in acceptable tissue temperature increases. See Tables 2-1 and 2-2 for the WBA
SAR or the B1+RMS recommended for use when all or part of the StimRouter Lead is within
the Reduced RF Zone during the MRI exam.
MP602-00630-001 Rev. E.indd 6 11/15/17 2:21 PM

7
Chapter 2 - Warnings and Cautions
Using the Transmit RF Body Coil and the Receive-Only RF Head Coil
When all or part of the StimRouter Lead is inside of the Reduced RF Zone and a receive-
only RF head coil is being used (Figure 2-2), reduced values of the whole-body-averaged
(WBA) SAR or the B1+RMS value must be used to result in acceptable tissue temperature
increases. See Tables 2-1 and 2-2 for the WBA SAR or the B1+RMS recommended for use
when all or part of the StimRouter Lead is within the Reduced RF Zone during the MRI
exam.
Using the Transmit/Receive RF Head Coil
Limit the head SAR to 3.2 W/kg using the Normal Operating Mode of operation for the
MR system if the StimRouter Lead is located in the patient’s shoulder or a lower anatomic
position (Figure 2-3).
Do not use the transmit/receive RF head coil if the StimRouter Lead is implanted above
the shoulder.
Using the Transmit/Receive RF Knee Coil
Limit the whole-body-averaged SAR to 2 W/kg using the Normal Operating Mode for
the MR system if the StimRouter Lead is located within the area of the transmit/receive
RF knee coil (Figure 2-4b). If the StimRouter lead is located outside of the RF coil, it is
unnecessary to adjust the SAR values for the MRI exam.
Using the Transmit/Receive RF Hand/Wrist Coil
Limit the whole-body-averaged SAR to 2 W/kg using the Normal Operating Mode for the
MR system if the StimRouter Lead is located within the area of the transmit/receive RF
hand/wrist coil (Figure 2-5b). If the StimRouter lead is located outside of the RF coil, it is
unnecessary to adjust the SAR values for the MRI exam.
Using the Transmit/Receive RF Foot/Ankle Coil
Limit the whole-body-averaged SAR to 2 W/kg using the Normal Operating Mode for the
MR system if the StimRouter Lead is located within the area of the transmit/receive RF
foot/ankle coil (Figure 2-6b). If the StimRouter lead is located outside of the RF coil, it is
unnecessary to adjust the SAR values for the MRI exam.
MP602-00630-001 Rev. E.indd 7 11/15/17 2:21 PM

8
User's Guide
Note: The StimRouter Lead is considered to be outside of the “Reduced RF Zone” if the
entire lead is located outside of the transmit RF body coil as shown in Figures 2-1 and
2-2, StimRouter Lead (A).
Note: The bore dimensions of clinical MR systems and associated transmit/receive RF
coils will vary according to the type of MR system used on the patient with the StimRouter
Lead.
Figure 2-1: The StimRouter Lead (A) is located outside of the Reduced RF Zone
and is more than 50 cm away from the center of the MR system’s bore and the transmit/
receive RF body coil. In this case, a whole-body-averaged SAR must not exceed 2 W/kg
at 1.5 T/64 MHz or a whole-body-averaged SAR of 2 W/kg at 3 T/128 MHz in the Normal
Operating Mode of operation for the MR system. The StimRouter Lead (B) is located inside
of the Reduced RF Zone. The use of reduced WBA SAR or B1+RMS values are required.
Center of MR
System’s Bore
Transmit/Receive
RF Body Coil
StimRouter Lead (B)
StimRouter Lead (A) Bore of MR System
50 cm 50 cm
Reduced RF Zone
MP602-00630-001 Rev. E.indd 8 11/15/17 2:21 PM

9
Chapter 2 - Warnings and Cautions
Figure 2-2: The transmit RF body coil and the receive-only RF head coil are
being used with the StimRouter Lead (B) inside of the Reduced RF Zone.
The use of reduced WBA SAR or B1+RMS values are required.
Center of MR
System’s Bore
StimRouter Lead (B)
StimRouter Lead (A)
Bore of MR System
Receive-only RF Head Coil
50 cm 50 cm
Reduced RF Zone
Transmit/Receive
RF Body Coil
MP602-00630-001 Rev. E.indd 9 11/15/17 2:21 PM