Bioness StimRouter User manual

Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Website: www.bioness.com
602-00631-001 Rev. F
08/2018
Rx Only
©2018 Bioness Inc.
StimRouter®, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc.
in the United States or other countries. | www.bioness.com

Clinician’s Guide
®

Copyright
©2018 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.
Trademarks
StimRouter®, Bioness, the Bioness Logo®and LiveOn®are trademarks of Bioness Inc. in the
United States or other countries. |www.bioness.com
Bioness Patents
This product is covered by one or more US and international patents. Additional patents pending.
For more information on patents visit Bioness web site at: http://www.bioness.com/Patents.php
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
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or 661.362.4850
Website: www.bioness.com

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
Not Reading Instructions Can Cause Hazard
Consult Instructions for Use
Re-Order Number
Lot Number
Serial Number
Complies with United States and Canadian Product Safety Standards
Single Patient Use
Single Use
Storage Temperature
Complies with the European Union Medical Device Directive
European Authorized Representative
Humidity Limitation
Atmospheric Pressure Limitation
IPX3 Protection Against Ingress of Water
Keep Dry
Use By
Quantity
Prescription Only

VI
Table of Contents
Chapter 1: Introduction ........................................................................ 1
Chapter 2: Warnings and Precautions ................................................ 3
Indications ......................................................................................................... 3
Contraindications ............................................................................................... 3
Implantation Setting ........................................................................................... 4
Patient Screening .............................................................................................. 4
Warnings ........................................................................................................... 5
Magnetic Resonance Imaging (MRI) Warnings and Precautions ................... 5
StimRouter External Component Restrictions ............................................... 6
MRI Safety Information ...................................................................................... 6
MRI Conditional ................................................................................................. 6
Using the Transmit Body RF Coil ................................................................... 8
Using the Trasmit RF Body Coil and the Receive-Only RF Head Coil ............ 8
Using the Transmit/Receive RF Head Coil .................................................... 8
Using the Transmit/Receive RF Knee Coil ..................................................... 8
Using the Transmit/Receive RF Hand/Wrist Coil ........................................... 9
Using the Transmit/Receive RF Foot/Ankle Coil ............................................ 9
MRI-Related Heating of the StimRouter Lead: Supplemental Information ... 13
1.5 T/64 MHz ......................................................................................... 13
3 T/128 MHz .......................................................................................... 13
Image Artifacts ............................................................................................ 14
Induced Currents ......................................................................................... 14
Potential Adverse Events ................................................................................. 14
Pregnancy ........................................................................................................ 14
Long-Term Effectiveness of Neurostimulation ................................................. 15
Programming ................................................................................................... 15
Device Components ........................................................................................ 15
Flammable Fuel, Chemicals or Environment ................................................... 15
Driving and Operating Machinery ..................................................................... 15
Electromagnetic Compatibility Warnings ........................................................ 16
Medical Devices/Therapies ......................................................................... 16
Electrosurgery Devices ............................................................................... 16
High-Frequency Surgical Equipment ........................................................... 16
Body-Worn Devices ..................................................................................... 17

VII Clinician’s Guide
Security Screening Devices ......................................................................... 17
Cell Phones ................................................................................................. 17
Precautions ...................................................................................................... 17
Physician Training ....................................................................................... 17
Post-Operative Care .................................................................................... 18
Implant Location .......................................................................................... 18
For Single Patient Use Only ........................................................................ 18
Postural Changes ........................................................................................ 18
Keep out of Reach of Children ..................................................................... 18
Skin Abnormalities ....................................................................................... 18
Skin Irritation ............................................................................................... 18
Known or Suspected Heart Problems .......................................................... 19
StimRouter Electrode Placement and Stimulation ....................................... 19
Expiration Date ............................................................................................ 19
Implant Failure ............................................................................................. 19
Storage and Handling .................................................................................. 20
Adverse Effects ................................................................................................ 20
Risks Related to the Implant Procedure ....................................................... 20
Risks Related to Stimulation ........................................................................ 20
Additional Risks Related to the StimRouter System .................................... 20
Chapter 3: Clinical Experience .......................................................... 23
Safety .............................................................................................................. 23
Effectiveness ................................................................................................... 23
Chapter 4: Environmental Conditions that Affect Use .................... 25
Storage and Handling ...................................................................................... 25
Radio Communication Information ................................................................... 25
Conformity Certification ............................................................................... 26
Chapter 5: Patient Components ......................................................... 27
StimRouter Lead .............................................................................................. 27
StimRouter External Plus Transmitter (EPT) .................................................... 27
Charging Socket and Charging Light ........................................................... 28
StimRouter Electrode ....................................................................................... 28
Patient Programmer ......................................................................................... 29
Operating Modes ......................................................................................... 30
Standby Mode ....................................................................................... 30
Program Mode ...................................................................................... 31

VIII
Stimulation Mode ................................................................................... 31
Charging Socket and Connection Port ......................................................... 31
Chapter 6: StimRouter Clinician Kit ................................................... 33
Chapter 7: Device Description ........................................................... 35
Programmer Connector Cable ......................................................................... 35
Clinician’s Programmer .................................................................................... 35
Operating Buttons ....................................................................................... 36
Micro SD Slot .............................................................................................. 36
Touchscreen Display ................................................................................... 36
Connector Port ........................................................................................... 36
Clinician’s Programmer Micro SD Card ....................................................... 36
Clinician’s Programmer Charger ................................................................. 36
Tester .............................................................................................................. 37
StimRouter Software ........................................................................................ 37
Operating Modes ......................................................................................... 37
Online .................................................................................................... 37
Offline .................................................................................................... 37
Information Icon ........................................................................................... 38
Print Icon ..................................................................................................... 39
Save Icon .................................................................................................... 39
Drop-Down Lists ......................................................................................... 39
Menu Bars and Menus ................................................................................ 40
Exit ........................................................................................................ 40
Patients ................................................................................................ 40
Programs .............................................................................................. 40
History .................................................................................................. 40
Tools ..................................................................................................... 40
Tabs ............................................................................................................ 40
Navigation Buttons ...................................................................................... 42
Intensity Level Bar ....................................................................................... 43
Program Bar ................................................................................................ 43
Add Program Icon ................................................................................. 43
Delete Program Icon .............................................................................. 43
Program Bar Arrows .............................................................................. 43
Search Bars ................................................................................................. 43
Stimulation Parameters ............................................................................... 44

IX Clinician’s Guide
Chapter 8: Clinician’s Programmer Set-Up ....................................... 47
Connecting the Clinician’s Programmer and Programmer Connector Cable .... 47
Charging the Clinician’s Programmer .............................................................. 47
Connecting the Patient Programmer and Programmer Connector Cable ......... 48
Logging into the StimRouter Software .............................................................. 48
Chapter 9: Software Records and History ......................................... 51
Patient Records ............................................................................................... 51
Adding a New Patient .................................................................................. 51
Copying a Record for an Existing Patient to an Unassigned System ........... 52
Adding a Patient with an Assigned System .................................................. 53
Opening a Patient Record ........................................................................... 53
Modifying a Patient Record .......................................................................... 54
Removing a Patient Record ......................................................................... 54
Searching for a Patient Record .................................................................... 55
Usage History .................................................................................................. 55
Viewing a Usage History .............................................................................. 56
Printing/Saving a Usage History .................................................................. 56
Session History ................................................................................................ 57
Viewing a Session History ........................................................................... 57
Printing/Saving a Session History ................................................................ 58
Printing/Saving Multiple Sessions ............................................................... 58
Chapter 10: Patient Set-Up and Programming Instructions ............ 59
Preparing the Patient’s Skin ............................................................................. 59
Connecting the StimRouter Electrode and EPT ............................................... 59
Adhering the StimRouter Electrode to the Skin ................................................ 60
Confirming Set-Up ........................................................................................... 62
Removing the StimRouter Electrode ................................................................ 62
Programming Instructions ................................................................................ 63
Programming Stimulation Settings .............................................................. 63
Programming Time Settings ........................................................................ 65
Programs ......................................................................................................... 66
Adding a Program ....................................................................................... 66
Saving a Program ........................................................................................ 66
Deleting a Program ...................................................................................... 67
Printing a Program ....................................................................................... 67
Chapter 11: Software Tools ................................................................ 69

X
Resetting the Patient Programmer and EPT .................................................... 69
User Administration ......................................................................................... 70
Adding a User/Administrator ........................................................................ 70
Removing a User/Administrator ................................................................... 71
Changing a User Password ......................................................................... 71
Clinician’s Programmer Database Backup and Restore .................................. 71
Enabling Automatic Database Backup ........................................................ 72
Manually Backing Up the Database ............................................................. 72
Restoring the Database ............................................................................... 72
Chapter 12: Maintenance and Cleaning ............................................ 75
Replacing StimRouter Electrode ...................................................................... 75
Replacing the Patient Programmer Battery ................................................. 75
Cleaning .......................................................................................................... 76
Disinfecting ...................................................................................................... 77
Electronic Components ............................................................................... 77
Chapter 13: Troubleshooting ............................................................. 79
Patient Forgets Patient Programmer ................................................................ 79
Using a Clinic Patient Programmer .............................................................. 79
Registering the Patient Programmer/EPT ................................................... 80
Patient Forgets EPT ......................................................................................... 82
Patient Loses EPT ........................................................................................... 82
Patient Brings New EPT and New Patient Programmer ................................... 82
Copying Patient Data to New Components .................................................. 82
Testing the EPT ............................................................................................... 83
Troubleshooting Tables ................................................................................... 84
Chapter 14: Technical Specifications ................................................ 89
Wireless (RF) Communications Specifications ................................................ 89
Troubleshooting Wireless Technology ............................................................. 90
Privacy of StimRouter Wireless Communication .............................................. 90
Chapter 15: Appendix - EMI Tables .................................................... 91
Electromagnetic Emissions .............................................................................. 91
Guidance and Manufacturer’s Declaration Electromagnetic Emissions ....... 91
Guidance and Manufacturer’s Declaration Electromagnetic Immunity ........ 93
Recommended Separation Distances for Device ........................................ 96

XI Clinician’s Guide

Chapter 1 - Introduction 1
1
Introduction
The Bioness StimRouter Neuromodulation System is intended to help relieve
chronic pain of peripheral origin. The Bioness StimRouter Neuromodulation System
consists of the following:
• An implantable multi-electrode lead with integrated receiver in loader.
• Surgical tools for implantation of the StimRouter Lead.
• A clinician programming system with a Clinician’s Programmer and
charger, a Programmer Connector Cable, a Tester and accessories.
• A patient-operated system with a rechargeable External Pulse
Transmitter (EPT), an external Patient Programmer, a system charger
and accessories.
• Disposable StimRouter Electrodes.
This guide describes the clinician programming system components of the
StimRouter Neuromodulation System, which are provided in the StimRouter
Clinician Kit. The clinician programming components are used to program the
patient’s External Pulse Transmitter (EPT) and Patient Programmer.
Refer to the StimRouter Procedure Manual for a description of the StimRouter
Implantable Lead and Lead Introducer Kit, package contents, device specifications
and the StimRouter implant procedure.
Refer to the StimRouter User’s Guide for a full description of the StimRouter User
Kit, StimRouter Electrode, External Pulse Transmitter (EPT), Patient Programmer,
external accessories, package contents, device specifications and instructions
for use.

2Clinician’s Guide

Chapter 2 - Warnings and Cautions 3
2
Warnings and Precautions
Physicians and patients should know the limitations, warnings, and precautions
associated with the Bioness StimRouter Neuromodulation System. Physicians
should review the warnings and precautions and the instructions for use with the
patient. If at any time the physician or patient is concerned about the safety or
effectiveness of the StimRouter System, they should call Bioness at 800.211.9136
or their local distributor.
The StimRouter Clinician Programmer and the patient-operated system consisting
of the StimRouter Patient Programmer, StimRouter External Pulse Transmitter
(EPT), and the StimRouter Electrode, should only be used under proper medical
guidance and as described in the StimRouter Clinician’s Guide and in the StimRouter
User’s Guide.
Indications
The StimRouter Neuromodulation System is indicated for pain management in
adults who have severe, intractable chronic pain of peripheral nerve origin and
as an adjunct to other modes of therapy (e.g., medications). The StimRouter is
not intended to treat pain in the craniofacial area.
Contraindications
The Bioness StimRouter Neuromodulation System is contraindicated for:
• Patients who have any active implanted devices such as an implanted
demand cardiac pacemaker, implantable cardioverter defibrillator (ICD),
other implanted, active devices, or any metallic implant in the immediate
area intended for implant.
Note: Maintain a minimum safe separation distance of 15 cm (6 in.) between the
StimRouter Electrode with External Pulse Transmitter (EPT) and all other active
implanted devices and metallic implants.

4Clinician’s Guide
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.
• Patients exposed to therapeutic ultrasound.
• Patients who are unable to operate the StimRouter Neuromodulation
System.
• Patients who are high surgical risks or who are poor surgical candidates
in general.
• Patients who have a cancerous lesion near the target stimulation point or
near where the StimRouter Electrode will adhere.
• Patients with bleeding disorders or active anticoagulation that cannot be
stopped for a few days prior to the time of the surgical procedure.
• Do not use the transmit/receive RF head coil if the StimRouter Lead is
implanted above the shoulder.
Implantation Setting
The StimRouter Lead should be implanted in an appropriately outfitted physician’s
office, outpatient surgical center, or hospital surgical center. Fluoroscopy and/or
ultrasound should be available if deemed necessary and be used at the implanting
physician’s discretion.
Patient Screening
Candidates for the StimRouter Neuromodulation System should be appropriately
screened for selection and fully informed about the therapy risks and benefits, the
surgical procedure, system operation, and self-treatment responsibilities.
Select patients carefully to ensure that:
• Their symptoms are of an anatomical and/or physiological origin.
• They are appropriate candidates for surgery.
• They can properly operate the StimRouter system.

Chapter 2 - Warnings and Cautions 5
Bioness recommends the following optional screening procedure prior to
StimRouter Lead implantation:
• Transcutaneous electrical nerve stimulation (TENS) to determine
the patient’s tolerance of stimulation near the anticipated site for the
StimRouter Electrode. Please note that some individuals are very
sensitive to the sensation of electrical stimulation applied to the skin.
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.

6Clinician’s Guide
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
• Limit B1 and or SAR to values in Table 2.1 if the entire StimRouter is not
at least 50 cm from the center of the MRI bore. (This is the Reduced RF
Zone.)
• 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
• Skin above StimRouter must not be in direct contact with the wall of the
MRI bore. Use insulating padding of at least 1 cm thickness between the
skin above StimRouter and the wall of the bore.
• Legs of patient do not touch each other.
• Arms of patient are not in contact with each other or the side of the body.
• MR system is in Normal Operating Mode for gradient magnetic fields.

Chapter 2 - Warnings and Cautions 7
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.
Position WBA SAR
1.5 T
WB SAR
3 T
B1 +rms
1.5 T
B1 +rms
3 T
Upper Arm 0.4 0.6 1.2 0.7
Intercostal 0.4 0.6 1.2 0.7
Lower Leg 0.2 0.6 1.2 0.7
Upper Leg 0.4 0.6 1.2 0.7
Table 2.1. Whole body SAR and B1+rms limits for StimRouter inside
the Reduced RF Zone, i.e. within 50 cm of center of the RF body coil.
If B1+rms is not displayed on the MR system console, the
whole bodySAR limit is to be used.
WARNING: 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.
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.

8Clinician’s Guide
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 B
1+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 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. Do not use the transmit RF
Body Coil if the StimRouter Lead is implanted above the shoulder.
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).
As previously mentioned in the contraindication section, do not use the transmit/
receive RF head coil if the StimRouter Lead is implanted above the shoulder.
Please refer to Chapter 2 for a complete list of contraindications.
Using the Transmit/Receive RF Knee Coil
MRI scans with the Transmit/Receive RF Knee Coil may be performed provided
that StimRouter Lead is outside the coil and at least one coil radius away from
the edge of the coil.

Chapter 2 - Warnings and Cautions 9
Do not scan if StimRouter is inside the coil or less than a coil radius away from
the edge.
Using the Transmit/Receive RF Hand/Wrist Coil
MRI scans with the Transmit/Receive RF Knee Coil may be performed provided
that StimRouter Lead is outside the coil and at least one coil radius away from
the edge of the coil.
Do not scan if StimRouter is inside the coil or less than a coil radius away from
the edge.
Using the Transmit/Receive RF Foot/Ankle Coil
MRI scans with the Transmit/Receive RF Knee Coil may be performed provided
that StimRouter Lead is outside the coil and at least one coil radius away from
the edge of the coil.
Do not scan if StimRouter is inside the coil or less than a coil radius away from
the edge.
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.