Bioness StimRouter User manual

Clinician’s Guide

Copyright
©2016 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.
Manufactured for:
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone]
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
Consult Instructions for Use
Re-Order Number
Lot Number
Serial Number
Single Patient Use
Storage Temperature
Complies with the European Union Medical Device Directive
Humidity Limitation
Atmospheric Pressure Limitation
Keep Dry
Use By
IPX3 Protection Against Ingress of Water
Quantity

VI
Table of Contents
Chapter 1: Introduction........................................................................................................1
Chapter 2: Warnings and Cautions ................................................,................................. 3
Indications for Use .....................................................................................................................3
Contraindications ...................................................................................................................... 3
Implantation Setting .................................................................................................................. 4
Patient Screening .......................................................................................................................4
Warnings ................................................................................................................................... 5
Magnetic Resonance Imaging (MRI) Warnings and Precautions ........................................... 5
StimRouter External Component Restrictions ................................................................. 5
MRI Information............................................................................................................... 5
MRI-Related Heating: Supplemental Information ............................................................ 8
Image Artifacts ................................................................................................................ 9
Induced Currents ...........................................................................................................10
Potential Adverse Events ...............................................................................................10
Pregnancy ...........................................................................................................................10
Long-Term Effectiveness of Neurostimulation.....................................................................10
Programming .....................................................................................................................10
Device Components ...........................................................................................................10
Flammable Fuel, Chemicals or Environment ........................................................................11
Driving and Operating Machinery...........................................................................................11
Electromagnetic Compatibility Warnings .................................................................................11
Medical Devices/Therapies ................................................................................................11
Electrosurgery Devices........................................................................................................12
High-Frequency Surgical Equipment ..................................................................................12
Body-Worn Device................................................................................................................12
Security Screening Devices .................................................................................................12
Cell Phones ......................................................................................................................... 13
Precautions .............................................................................................................................13

VII
Physician Training ...............................................................................................................13
Post-Operative Care ...........................................................................................................13
Implant Location..................................................................................................................13
For Single Patient Use Only ...............................................................................................13
Postural Changes................................................................................................................13
Keep out of Reach of Children ............................................................................................14
Skin Abnormalities ..............................................................................................................14
Skin Irritation .......................................................................................................................14
Known or Suspected Heart Problems .................................................................................14
StimRouter Electrode Placement and Stimulation ...............................................................14
Expiration Date ....................................................................................................................15
Implant Failure.....................................................................................................................15
Storage and Handling .........................................................................................................15
Adverse Effects .......................................................................................................................15
Risks Related to the Implant Procedure ..............................................................................16
Risks Related to Stimulation.................................................................................................16
Additional Risks Related to the StimRouter System ............................................................16
Chapter 3: Clinical Experience .......................................... .......................................17
Chapter 4: Environmental Conditions that Affect Use........................................... 19
Storage and Handling...............................................................................................................19
Radio Communication Information ...........................................................................................19
Conformity Certification .......................................................................................................20
Chapter 5: Patient Components...................................................................................... 21
StimRouter Lead .................................................................................................................... 21
StimRouter External Plus Transmitter (EPT) ............................................................................ 21
StimRouter Electrode .............................................................................................................. 22
Patient Programmer ............................................................................................................... 23
Chapter 6: StimRouter Clinician Kit................................................................................ 27
Chapter 7: Device Description ........................................................................................ 29
Configuration Cradle ............................................................................................................... 29

VIII
Clinician’s Programmer ........................................................................................................... 29
Tester ......................................................................................................................................31
StimRouter Software ............................................................................................................... 32
Operating Modes...................................................................................................................32
Information Icon ...................................................................................................................33
Print Icon..............................................................................................................................33
Data Entry ........................................................................................................................... 33
Menu Bar and Menus .......................................................................................................... 34
Tabs .................................................................................................................................... 34
Navigation Buttons .............................................................................................................. 36
Intensity Level Bar................................................................................................................ 37
Program Bar......................................................................................................................... 37
Search Bars......................................................................................................................... 38
Stimulation Parameters ....................................................................................................... 38
Chapter 8: Clinician’s Programmer Set-Up .................................................................. 41
Connecting the Clinician’s Programmer and Configuration Cradle .......................................... 41
Charging the Clinician’s Programmer ...................................................................................... 41
Connecting the Patient Programmer and Configuration Cradle..................................................42
Logging into the StimRouter Software ..................................................................................... 43
Chapter 9: Software Records and History .................................................................... 45
Patient Records........................................................................................................................ 45
Adding a New Patient .......................................................................................................... 45
Copying a Record for an Existing Patient to an Unassigned System ................................... 46
Adding a Patient with an Assigned System ........................................................................ 47
Opening a Patient Record.................................................................................................... 48
Modifying a Patient Record ................................................................................................. 48
Removing a Patient Record ................................................................................................ 49
Searching for a Patient Record ........................................................................................... 50
Usage History .......................................................................................................................... 50
Viewing a Usage History ..................................................................................................... 50
Printing a Usage History....................................................................................................... 51
Session History........................................................................................................................ 52

IX
Viewing a Session History.................................................................................................... 52
Printing a Session History.................................................................................................... 53
Printing Multiple Sessions.................................................................................................... 53
Chapter 10: Patient Set-Up and Programming Instructions.......................................55
Preparing the Patient’s Skin .................................................................................................... 55
Connecting the StimRouter Electrode and EPT ....................................................................... 55
Adhering the StimRouter Electrode to the Skin ....................................................................... 56
Confirming Set-Up ................................................................................................................... 58
Removing the StimRouter Electrode ....................................................................................... 58
Programming Instructions ....................................................................................................... 59
Programming Stimulation Settings ...................................................................................... 59
Programming Time Settings ................................................................................................ 61
Programs ................................................................................................................................. 62
Adding a Program................................................................................................................ 62
Viewing a Program ..............................................................................................................62
Deleting a Program ............................................................................................................. 63
Printing a Program .............................................................................................................. 63
Chapter 11: Software Tools ............................................................................................. 65
Resetting the Patient Programmer and EPT ............................................................................ 65
User Administration.................................................................................................................. 66
Adding a User/Administrator................................................................................................ 66
Removing a User/Administrator........................................................................................... 68
Changing a User Password ................................................................................................ 68
Clinician’s Programmer Database Backup and Restore .......................................................... 68
Enabling Automatic Database Backup ................................................................................ 69
Manually Backing Up the Database..................................................................................... 69
Restoring the Database ...................................................................................................... 69
Bluetooth Printer Set-Up ..................................................................................................... 70
Chapter 12: Maintenance and Cleaning .................................................................. 75
Replacing StimRouter Electrode ............................................................................................. 75
Battery Replacement ............................................................................................................... 75

X
Replacing the Clinician’s Programmer Battery .................................................................... 75
Replacing the Patient Programmer Battery ......................................................................... 76
Cleaning ...................................................................................................................................77
Disinfecting .............................................................................................................................. 77
Electronic Components........................................................................................................ 77
Clinician Kit Carrying Case ................................................................................................. 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
Troubleshooting Tables ............................................................................................................ 84
Chapter 14: Technical Specifications .............................................................................. 89
Troubleshooting Wireless Technology ................................................................................... 91
Chapter 15: Appendix - EMI Tables ................................................................................ 93
Electromagnetic Emissions.................................................................................................... 93

XI Clinician’s Guide

1
1
Chapter 1 - Introduction
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
Configuration Cradle, 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

3
Chapter 2 - Warnings and Cautions
2
Warnings and Cautions
Physicians and patients should know the limitations, warnings and precautions associated with
the StimRouter Neuromodulation System. Physicians should review the warnings and precautions
and 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, then call Bioness at [phone] or
your local distributor.
The StimRouter programming system and patient-operated system should only be used under
proper medical guidance and as described in this StimRouter Clinician’s Guide and in the StimRouter
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

4Clinician’s Guide
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.
• Patient 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 who are known or suspected to have a nickel allergy. The handles of the
tunneling needle and tunneling needle stylet, used in the implant procedure, are nickel
plated.
• Patients with bleeding disorders or active anticoagulation that cannot be stopped for a
few days close to the time of the surgical procedure.
Implantation Setting
The StimRouter Lead should be implanted in an appropriately outfitted physician 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.
Bioness highly recommends the following screening procedure prior to StimRouter Lead
implantation:
• Nerve block using local anesthesia.
• Psychological screening using techniques traditionally used for similar types of
procedures and systems.

5
Chapter 2 - Warnings and Cautions
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 to electrical stimulation
applied to the skin.
Warnings
Magnetic Resonance Imaging (MRI) Warnings and Precautions
• When using a full body transmit radio frequency (RF) coil, do not scan patients
with a specific absorption rate (SAR) level exceeding 2 W/kg. A scan above 2 W/kg
may increase the risk of MRI-related heating.
• When using head transmit RF coil, do not exceed head SAR of 3.2 W/Kg.
• Do not place a local RF transmit coil directly over the implanted StimRouter Lead.
StimRouter External Component Restrictions
All external components of the StimRouter system are contraindicated for the MRI environment.
Therefore, the StimRouter Electrode, External Pulse Transmitter and Patient Programmer must
be removed before the patient is allowed into the MRI environment.
MRI Information
Non-clinical testing has demonstrated that the StimRouter Lead is “MR Conditional”. Patients
with an implanted StimRouter Lead can be scanned safely, immediately after implantation, in
MR cylindrical bore system that meets the following conditions:
• Static magnetic field of 1.5 Tesla (T) or 3 T; and
• Maximum spatial field gradient of 2500 gauss/cm (25 T/m); and
• To ensure patient safety, relative to potential heating of the StimRouter Lead,
either one of the two following scenarios must exist:
• When the entire StimRouter Lead is at least 50 cm (19.7in.) away from
the center of the MR system’s bore and at least 16 cm (6.3 in.) from the end of
the RF coil (See Figure 2-1), the reported whole body averaged specific
absorption rate (WB SAR) does not exceed 2W/kg at 1.5T or at 3.0T; or

6Clinician’s Guide
• When all or part of the StimRouter Lead is either (a) less than 50 cm (19.7 in.)
from the center of the MR system’s bore; or (b) less than 16 cm (6.3 in.) from
the end of the RF coil, whichever is the furthest distance from the center of the
bore (i.e., referred to as the “Reduced Zone”), reduced values of WB SAR and
B1 are utilized in order to result in acceptable tissue temperature increases of
2°C, 5°C, and/or 6°C, whichever is determined by the clinician to be
appropriate (See Tables 2-1 and 2-2).
• Communication is maintained with the patient so that the scan can be promptly
terminated in the event of painful nerve stimulation or other adverse event.
To clarify further, the StimRouter Lead is considered to be “outside the Reduced Zone” if the
entire lead is located outside of the Reduced Zone.
Figure 2-1: Figures show different relationships between the 50 cm measured
from the center of the MR bore and the 16 cm measured from the edge of the MR coil.
16 cm
16 cm
Isocenter
Bore
Lead (A)
16 cm
16 cm
50 cm
50 cm
Lead (B)
RF CoilBore
Lead (A)
50 cm
50 cm
Lead (B)
RF Coil

7
Chapter 2 - Warnings and Cautions
In Figure 2-1 the StimRouter Lead (A) implant is outside the “Reduced Zone.” The entire StimRouter
Lead is at least 50 cm away from the center of the MR system’s bore (the iso-center) and at least
16 cm outside of the MR coil measured from the edge of the MR coil. In Figure 2-1, the StimRouter
Lead (B) implant is inside the “Reduced Zone.” StimRouter Lead (A) is shown implanted in the
lower leg and StimRouter Lead (B) is shown implanted in the arm.
To ensure patient safety relative to potential heating of the implanted StimRouter Lead, clinicians
performing MR procedures on implanted patients should adhere to the following conditions:
When using full body transmit RF coil:
• When the entire StimRouter is outside of the Reduced Zone, the reported whole-
body-averaged SAR does not exceed 2 W/kg at 1.5 T and 2 W/kg at 3 T. Do not scan
patients with a SAR level exceeding 2 W/kg. A MR scan performed with a 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 Zone, reduced values
of WB SAR and B1 should be utilized in order to result in acceptable tissue
temperature increases of 2°C, 5°C, and/or 6°C. See Tables 2-1 and 2-2 for the WB
SAR and B1 values recommended for use when all or part of the StimRouter Lead
implant is within the Reduced Zone during the MR procedure.
When using head transmit RF coil:
• Limit head SAR to 3.2 W/Kg and otherwise follow normal operation procedures of the
MR system for patients when all or part of the StimRouter Lead implant is located at
the shoulder or at lower areas of the body.
• Do not use RF head transmit coil when all or part of the StimRouter Lead implant is
located above the level of the acromioclavicular joint.
• Under these conditions, the maximum calculated temperature rise at the implanted
StimRouter Lead did not exceed 0.1°C for the Lead implanted in either the shoulder or
any area of the body below the shoulder.
Information regarding the precise anatomical position of the implanted StimRouter Lead is necessary
for performing routine MRI procedures. Prior to initiating any MR procedure, the clinician 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
lead in the patient’s body.
Patients also must be screened for previously implanted (active or abandoned) medical devices,
leads, lead extenders or lead adapters.

8Clinician’s Guide
MRI-Related Heating: Supplemental Information
1.5 T/64 MHz
For situations where the entire StimRouter Lead is located outside of the Reduced Zone:
Temperature changes of the electrodes of the StimRouter Lead were measured at 1.5 T/64
MHz according to ASTM F2182 (GE Signa, 46- 258170G1, whole body transmit radio frequency
(RF) coil). With the lead in an orientation and a position in the phantom to produce worst-case
heating, the greatest measured temperature rise scaled to a background local SAR of 1 W/kg
was 3.9°C after six minutes of RF power application. This temperature change was with the lead
in an elongated, “straight” configuration (i.e., no curves), which produced the highest temperature
change. With the lead in curved or looped configurations, temperature changes were less.
A computer simulation that incorporated the worst-case measured temperature rise at several
anatomic locations and a whole-body averaged SAR of 2 W/kg predicts a worst-case heating
of an implanted StimRouter Lead in the patient during MRI of less than 2°C, provided that the
entire StimRouter Lead implant is outside of the Reduced Zone.
For a StimRouter Lead implant located inside the Reduced Zone, the worst-case Lead heating
was calculated for the following values of WB SAR and B1:
Path
RF Frequency = 64MHz
ΔT = 6°C ΔT = 5°C ΔT = 2°C
WB SAR
[W/kg]
B1
[µT]
WB SAR
[W/kg]
B1
[µT]
WB SAR
[W/kg]
B1
[µT]
Upper Arm 0.40 1.74 0.33 1.59 0.13 1.00
Intercostal 0.43 1.91 0.36 1.74 0.14 1.10
Lower Leg
(below the
knee)
0.24 2.68 0.20 2.45 0.08 1.55
Upper Leg
(knee and/
or thigh)
0.26 3.38 0.22 2.17 0.09 1.37
Table 2-1. Values of WB SAR and B1 in the Reduced Zone that will produce
a maximum in-vivo rise of 2°C, 5°C or 6°C @ 64MHz RF.

9
Chapter 2 - Warnings and Cautions
3 T/128 MHz
For situations where the entire StimRouter Lead is located outside of the Reduced Zone:
Temperature changes of the electrodes of the StimRouter Lead were measured at 3 T/128 MHz
according to ASTM F2182 (GE Signa, 3T HDx, Software Version 15/LX/MR, 15.0.M4.0910a).
With the lead in an orientation and a position in the phantom to produce worst-case heating, the
greatest measured temperature rise scaled to a local background SAR of 2 W/kg was 2.9°C after
six minutes of RF power application. This temperature change was with the lead in an elongated,
“straight” configuration (i.e., no curves), which produced the highest temperature change. With
the lead in curved or looped configurations, temperature changes were less.
A computer simulation that incorporated the worst-case measured temperature rise at several
anatomic locations and a whole-body averaged SAR of 2 W/kg predicts a worst-case heating
of an implanted StimRouter Lead in the patient during MRI of less than 1°C, provided that the
entire StimRouter Lead implant is outside of the Reduced Zone.
For a StimRouter Lead implant located inside the Reduced Zone, the worst-case Lead heating
was calculated for the following values of WB SAR and B1:
Path
RF Frequency = 128MHz
ΔT = 6°C ΔT = 5°C ΔT = 2°C
WB SAR
[W/kg]
B1
[µT]
WB SAR
[W/kg]
B1
[µT]
WB SAR
[W/kg]
B1
[µT]
Upper Arm 0.87 1.45 0.73 1.32 0.29 0.84
Intercostal 1.93 2.16 1.61 1.97 0.64 1.25
Lower Leg
(below the
knee)
0.70 2.61 0.58 2.38 0.23 1.51
Upper Leg
(knee and/
or thigh)
0.78 2.00 0.65 1.83 0.26 1.15
Table 2-2. Values of WB SAR and B1 in the Reduced Zone that will produce
a maximum in-vivo rise of 2°C, 5°C or 6°C @ 128MHz RF.
Image Artifacts
MR imaging quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the StimRouter Lead. Therefore, optimization of MR imaging
parameters to compensate for the presence of the StimRouter Lead may be necessary.

10 Clinician’s Guide
Induced Currents
The electric fields induced in the patient with the StimRouter Lead by the pulsed gradient fields
were calculated. The induced current will be less than the stimulation threshold if the StimRouter
Lead is located outside of the Reduced Zone.
Potential Adverse Events
Use of MRI could result in excessive heating of the StimRouter Lead if the MRI conditions of
use are not followed. Induced voltages in the lead may occur, possibly causing uncomfortable
levels of neurostimulation.
Note: The StimRouter Lead is not a life-sustaining device. It could be explanted prior to an MRI
procedure.
Pregnancy
The effects of electrical stimulation on pregnancy are not known. Do not use electrical stimulation
during pregnancy.
Long-Term Effectiveness of Neurostimulation
The long-term effectiveness of neurostimulation is not known.
Programming
The StimRouter components should only be programmed by the treating physician and/or under
proper medical guidance.
Device Components
The use of non-Bioness components with the StimRouter system may result in damage to the
system and increased risk to the patient.
No modification of this equipment is allowed.
The Patient Programmer and EPT can heat up to 43°C during operation in extremely hot areas/
rooms. If this occurs turn off stimulation, remove EPT and Patient Programmer, and set aside
until temperature is within operational conditions.

11
Chapter 2 - Warnings and Cautions
Flammable Fuel, Chemicals or Environment
The StimRouter is not intended to be used in oxygen-rich environments.
Advise patients to turn the StimRouter system (Patient Programmer and stimulation) off when
near a refueling station, flammable fuel, fumes or chemicals. The operation of the StimRouter
could cause the chemicals or fumes to ignite, causing severe burns, injury or death.
Driving and Operating Machinery
StimRouter stimulation should be off while driving or operating machinery.
Electromagnetic Compatibility Warnings
Medical Devices/Therapies
Operation of the StimRouter system in close proximity (e.g., 1 meter) to shortwave or microwave
therapy equipment may produce instability in the EPT output.
The following medical therapies or procedures may turn stimulation off, may cause permanent
damage to the external components and may injure the patient, particularly if used in close
proximity to the system components:
• Lithotripsy
• Electrocautery
• External defibrillation
• Ultrasonic scanning
• High-output ultrasound
•
Electromagnetic interference (EMI) from the following medical procedures is unlikely to
affect the StimRouter system:
• Computerized Axial Tomography (CT or CAT) scans
• Diagnostic ultrasound (e.g., carotid scan, Doppler studies)
• Diagnostic x-rays or fluoroscopy
Note: Advise patients to remove the StimRouter Electrode before undergoing medical therapies
or procedures.