Bioness bioventus StimRouter User manual

LBL-000709
602-00724-001 Rev. A
08/2022
©2022 Bioventus LLC
Bioventus and the Bioventus logo are registered trademarks of Bioventus LLC.
StimRouter and Bioness are trademarks of Bioness Inc. | StimRouter.com
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355
USA
Telephone: [phone] or [phone]
Website: StimRouter.com
Rx Only
User’s Guide
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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 Customer Service. Bioventus is committed to continuously
seeking and implementing the best possible manufacturing procedures and servicing routines.
Bioness Inc.
25103 Rye Canyon Loop
Valencia, CA 91355 USA
Telephone: [phone] or [phone]
Website: StimRouter.com
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Table of Contents
Chapter 1: Introduction......................................................................................1
Chapter 2: StimRouter User Kit ....................................................................... 3
Chapter 3: Warnings and Cautions ..................................................................5
Indications for Use ......................................................................................................... 5
Device Use and Suitability ............................................................................................. 5
Device Materials ............................................................................................................ 5
Essential Performance .................................................................................................... 6
Contraindications ........................................................................................................... 6
Warnings ....................................................................................................................... 6
Magnetic Resonance Imaging (MRI) Safety Information .......................................... 7
Pregnancy .................................................................................................................... 7
Programming ................................................................................................................. 7
Flammable Fuel, Chemicals or Environment ................................................................. 7
Driving and Operating Machinery .................................................................................. 8
Electromagnetic Compatibility Warnings ....................................................................... 8
Medical Devices/Therapies ....................................................................................... 8
Electrosurgery Devices ............................................................................................. 8
High-Frequency Surgical Equipment ........................................................................ 9
Body-Worn Devices .................................................................................................. 9
Security Screening Devices ...................................................................................... 9
Cell Phones ............................................................................................................... 9
Precautions .................................................................................................................. 10
Post-Operative Care ............................................................................................... 10
Known or Suspected Heart Problems ..................................................................... 10
Implant Failure ........................................................................................................ 10
Postural Changes .................................................................................................... 10
For Single Patient Use Only .................................................................................... 10
Keep Out of Reach of Children ................................................................................ 11
Skin Abnormalities .................................................................................................... 11
Skin Irritation ............................................................................................................ 11
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
Single Patient Multiple Use
MR Conditional
Storage Temperature
Humidity Limitation
Atmospheric Pressure Limitation
IP68 Protection Against Ingress of Water
Keep Dry
Use By
Quantity
Prescription Only
MD Medical Device
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Sensations Caused by Stimulation .......................................................................... 11
Gel Electrode Expiration Date .................................................................................. 11
Gel Electrode Placement and Stimulation ................................................................ 11
Adverse Effects ........................................................................................................... 12
Risks Related to the Implant Procedure .................................................................. 12
Risks Related to Stimulation ................................................................................... 12
Additional Risks Related to the StimRouter System ............................................... 13
Temperature ................................................................................................................ 13
Chapter 4: Environmental Conditions that Affect Use................................. 15
Storage and Handling .................................................................................................. 15
Radio Communication Information .............................................................................. 15
Electromagnetic Emissions ......................................................................................... 16
End-Of-Life Waste Management .................................................................................. 16
Chapter 5: Device Description ...................................................................... 17
StimRouter Lead .......................................................................................................... 17
StimRouter External Electric Field Conductor (E-EFC) ............................................... 17
Charging Socket ...................................................................................................... 18
Light ........................................................................................................................ 18
Gel Electrode ............................................................................................................... 19
Gel Electrode Liner ................................................................................................. 20
Electrode Carrying Case.......................................................................................... 20
System Charger Set ................................................................................................ 21
StimRouter Plus Mobile Application (MAPP)................................................................ 21
Chapter 6: Set-Up Instructions .......................................................................23
Charging the E-EFC .................................................................................................... 23
Preparing the Skin ....................................................................................................... 24
Connecting the Gel Electrode and E-EFC ................................................................... 25
Adhering the Gel Electrode ......................................................................................... 25
Chapter 7: Operating Instructions ................................................................ 29
Using the StimRouter Plus MAPP ............................................................................... 30
E-EFC Setup ........................................................................................................... 30
Controls ................................................................................................................... 32
Activity ...................................................................................................................... 34
More ........................................................................................................................ 34
Turning Stimulation On ................................................................................................ 35
Adjusting Stimulation Intensity ..................................................................................... 35
Turning Stimulation Off ................................................................................................ 36
Tracking StimRouter Usage .......................................................................................... 37
Select a Stimulation Program.................................................................................... 37
Duration..................................................................................................................... 37
Intensity..................................................................................................................... 38
Time Period............................................................................................................... 38
Changing Date Ranges............................................................................................. 38
Update StimRouter Firmware ...................................................................................... 39
Removing the Gel Electrode ........................................................................................ 39
Removing the E-EFC from Gel Electrode .................................................................... 40
Replacing the Gel Electrode ......................................................................................... 41
System Errors .............................................................................................................. 42
Selecting a Stimulation Program ................................................................................. 42
Registering a New Component .................................................................................... 42
Registering a Replacement E-EFC ............................................................................... 43
Chapter 8: Cleaning ........................................................................................ 45
Cleaning ...................................................................................................................... 45
Gel Electrode Liner ................................................................................................. 45
Electrode Carrying Case ......................................................................................... 45
Disinfecting .................................................................................................................. 45
Electronic Components ........................................................................................... 45
Chapter 9: Troubleshooting ........................................................................... 47
Incident Reporting ....................................................................................................... 48
Chapter 10: Technical Specifications ........................................................... 49
E-EFC Charger Specifications...................................................................................... 49
User's Guide
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Chapter 1 - Introduction
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E-EFC Specifications.................................................................................................... 49
Gel Electrode Specifications......................................................................................... 51
System Characteristics.................................................................................................. 51
Privacy of StimRouter Wireless Communiation............................................................. 52
Chapter 11: Appendix - EMI Tables ............................................................... 53
Electromagnetic Emissions ......................................................................................... 53
Guidance and Manufacturer’s Declaration Electromagnetic Emissions....................... 54
Guidance and Manufacturer’s Declaration Electromagnetic Immunity......................... 55
Recommended Separation Distances Between Portable and Mobile
RF Communications Equipment and the StimRouter System.......................................58
Introduction
The StimRouter Neuromodulation System is intended to be operated by patients to help
manage their pain. The StimRouter Neuromodulation System works by providing electrical
impulses from an implanted neurostimulator 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 is made up of implanted components from the StimRouter Implanted Lead and
Lead Introducer Kit (ST2-1000) and external components from the StimRouter User Kit
(ST2-5050). The StimRouter System includes:
• An implanted lead
• An External Electric Field Conductor (E-EFC)
• A Gel Electrode
• A downloaded Mobile Application (MAPP)
This guide includes important safety information about your StimRouter system, describes
the external components of your StimRouter system that are used to activate 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 doctor to explain and demonstrate any procedures
you do not understand.
Gel Electrode E-EFC
Lead
User's Guide
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Chapter 2 - StimRouter User Kit
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2User'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 StimRouter. A copy of the StimRouter
User’s Guide is posted on the StimRouter website.
StimRouter User Kit
Your StimRouter User Kit includes the following:
• External Electric Field Conductor (E-EFC)
• System Charger Set
• Gel Electrode Carrying Case
• User’s Guide
• User’s Reference Card
• Medical Device Identification Card
• Mesh Tote Bag
External Electric Field
Conductor (E-EFC) Gel Electrode Carrying Case
System Charger Set
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Chapter 3 - Warnings and Cautions
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4User's Guide
Warnings and Cautions
Be sure to follow your doctor’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.
Device Use and Suitability
The StimRouter Neuromodulation System is designed to reduce pain in patients with
chronic pain of peripheral nerve origin. Components of the StimRouter Implantable Lead
and Lead Introducer Kit and StimRouter Clinician Kit are for use by trained clinicians,
and components of the StimRouter User Kit are for use by individual patients. Additional
information, including clinical safety and performance, can be found at www.StimRouter.com.
The StimRouter Neuromodulation System may not be suitable for treatment of acute pain,
for pain that is not of peripheral nerve origin, or for patients whose required stimulation
parameters cannot be met by the StimRouter Neuromodulation System. The StimRouter
Neuromodulation System implant procedure may be performed in any sterile surgical setting.
Device Materials
Materials in the StimRouter User Kit that may contact the patient during device use include:
• Hydrogel
• Plastic
Both materials have been tested to verify biocompatbility.
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Chapter 3 - Warnings and Cautions
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Essential Performance
The StimRouter System does not have Essential Performance as there is no performance
necessary (as defined by IEC 60601) to avoid unacceptable risks, in that all sources of
identified risk have been mitigated (through application of appropriate risk control measures)
to the greatest extent possible and to an acceptable degree. There are no sources of
residual risk which outweigh the benefits accrued from the use of the device and which
would thus be deemed unacceptable.
Contraindications
The StimRouter Neuromodulation System is contraindicated for:
• Patients who are unable to operate the StimRouter system.
• Patients who are poor surgical candidates.
• Patients who have a cancerous lesion present near the target stimulation point or
near to where the Gel 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.
• Patients who are unable to remove the E-EFC.
• Patients who are unable to communicate a device malfunction from device use.
Warnings
• The StimRouter Neuromodulation System may interfere with other implanted
devices such as cardiac pacemakers, defibrillators, and other implanted
stimulators. The effect of other implanted devices, including but not limited
to implanted drug pumps and other stimulation devices on the StimRouter
Neuromodulation System is unknown.
A risk/benefit determination should be performed before using the StimRouter Neuromodulation
System for:
• Patients exposed to diathermy. Shortwave, microwave and/ or therapeutic
ultrasound diathermy should not be used on patients who have a StimRouter.
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.
Magnetic Resonance Imaging (MRI) Safety Information
The StimRouter Neuromodulation System is MR Conditional. A person implanted with
this device can be safely scanned with MRI only under very specific conditions. Scanning
under different conditions may result in severe injury or device malfunction. Full MRI
safety information is available in the MRI Guidelines Manual, which can be obtained at
www.StimRouter.com or by calling 800-211-9136. An MRI examination of a patient with
a StimRouter Neuromodulation System should not be conducted until the information in
the MRI Guidelines is read and understood.
All external components of the StimRouter system, including the Gel Electrode, E-EFC,
Clinician’s Programmer, and Clinician’s Programmer Charger are MR Unsafe and
contraindicated for the MR environment. Do not bring them into the MR system room.
Pregnancy
The effects of electrical stimulation on pregnancy are not known. Do not use electrical
stimulation during pregnancy.
Programming
Only a trained clinician should program the StimRouter system.
Flammable Fuel, Chemicals or Environment
The StimRouter is not intended to be used in oxygen-rich environments.
Turn off stimulation when you are near a refueling station, flammable fuel, fumes or chemicals.
If your system is on, it could ignite the chemicals or fumes, causing severe burns, injury
or death.
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Chapter 3 - Warnings and Cautions
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Driving and Operating Machinery
Turn off stimulation while driving or operating machinery.
Electromagnetic Compatibility Warnings
Medical Devices/Therapies
Operation of the StimRouter system in close proximity (e.g., 1 meter or 3 feet) to shortwave
or microwave therapy equipment may produce instability in the E-EFC output.
The following medical therapies or procedures may turn stimulation off. They may also
permanently damage the StimRouter external components and may cause injury, particularly
if used close 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: Turn off stimulation and remove the Gel Electrode before undergoing a medical
procedure.
Electrosurgery Devices
If you require electrosurgery, tell your doctor you have an implanted StimRouter
Neuromodulation System. Electrosurgery devices should not be used close to an implanted
StimRouter lead. Contact between an active electrode of the electrosurgery device and
the StimRouter lead can stimulate the receiver and cause severe injury.
High-Frequency Surgical Equipment
Remove the Gel Electrode before medical treatment. If you are connected to the StimRouter
system and high-frequency surgical equipment, you may experience a skin burn where
the Gel Electrodes adhere. The StimRouter E-EFC may also become damaged.
Body-Worn Devices
Although unlikely, body-worn medical devices may interfere with the RF communication
used in the StimRouter system. Stimulation control may be delayed. Examples of a body-
worn device are a pain pump or an insulin pump and a monitoring device. To minimize
interference, maintain a minimum safe separation distance of 15 cm (6 in.) between the
StimRouter system and all other electronic devices. See the “Troubleshooting” section for
help. See the “Appendix” for more information.
The StimRouter system’s wireless technology may cause EMI to other body-worn medical
devices. Refer to the instructions for use for those devices for information on recommended
minimum separation distances.
Security Screening Devices
Certain types of security devices may affect stimulation. Examples include those used at
the entrances and exits of public buildings such as libraries, airports and retail stores. Ask
for help to bypass the device. Show your Medical Device Identification Card if you must
pass through the device:
• Turn off your StimRouter system.
• Pass through the security screening device quickly.
• Stay as far from the emitter as possible. Walk, for example, in the center of a
pass-through security gate.
Cell Phones
There is potential for interference between electronic devices, including cell phones.
Stimulation control may be delayed. If interference is suspected or anticipated,
distance yourself from the source of interference. To minimize interference, maintain
a minimum safe separation distance of 15 cm (6 in.) between the StimRouter system
and all other electronic devices.
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Chapter 3 - Warnings and Cautions
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Precautions
Post-Operative Care
After the implant procedure, check the incision site for infection, possible device rejection
or other possible adverse effects.
Contact your physician immediately if you have:
• Excessive redness or discharge around the incision site.
• Prolonged pain at the incision site.
• Warmth and swelling of the incision site.
• Fever
• Dizziness
• Bleeding
Known or Suspected Heart Problems
Consult your doctor if you have or suspect you have a heart condition. Doctors should use
caution when treating patients with suspected or diagnosed heart problems.
Implant Failure
Implanted receivers may fail at any time. If a StimRouter fails or breaks, then the StimRouter
system may need to be removed or replaced. It is possible that small fragments of the
lead could remain at the implantation site after removal, which will indefinitely prevent you
from being eligible for certain procedures, such as diathermy, therapeutic ultrasound, or
MRI in the affected area. Immediately contact your doctor if implant failure is suspected.
Postural Changes
Changes in posture or abrupt movements may change the stimulation you feel. Turn off
stimulation before stretching or exercising.
For Single Patient Use Only
Do not adhere the Gel Electrode to any other person or any other part of your body.
Keep Out of Reach of Children
Keep all StimRouter components out of the reach of children.
Skin Abnormalities
Do not adhere the Gel Electrode to skin that is swollen, infected or inflamed or to skin
that is broken. Do not adhere the Gel Electrode over veins that are swollen or inflamed.
Skin Irritation
It is normal for the skin under the Gel Electrode to become red. The redness should
disappear about one hour after you remove the Gel Electrode.
Some people may be allergic or hypersensitive to the electrical stimulation or the gel
on the Gel Electrode. Persistent redness, lesions or blisters are signs of irritation. Stop
using the StimRouter system until the irritation is gone. To avoid irritation, remove the Gel
Electrode every three to four hours for 15 minutes. Talk to your doctor if irritation persists.
Sensations Caused by Stimulation
As with other nerve stimulation devices, the StimRouter Neuromodulation System achieves
pain relief by causing different sensations to be felt in the area of treatment. These sensations
(also referred to as “paresthesia”) include tingling and numbness. While these sensations
are normal during StimRouter use, stimulation should not proceed to the point of being
painful.
Gel Electrode Expiration Date
Do not use a Gel Electrode with a “Use by” date that has expired.
Gel Electrode Placement and Stimulation
• Only use Gel Electrodes supplied by Bioventus.
• Only your doctor should decide where to place the Gel Electrode.
• Only your doctor should program your StimRouter system.
• Turn off stimulation before adhering, removing or handling the Gel Electrode.
• Do not adhere the Gel Electrode across your chest or near your heart. Electrical
stimulation of the heart may disturb heart rhythm.
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Chapter 3 - Warnings and Cautions
12 User's Guide
• Apply Gel Electrode only to the areas recommended by your doctor. Avoid
placing the Gel Electrode across the head, directly on the eyes, covering the
mouth, or on the front of the neck (especially the carotid sinus).
• Do not adhere the Gel Electrode over anything other than skin. Do not adhere
it over an adhesive bandage, for example. The Gel Electrode must be in full
contact with the skin or the stimulation could cause serious injury.
• Do not place the Gel Electrode over skin folds, scarred tissue, irritated skin,
uneven skin surfaces or broken skin.
• Always check the Gel Electrode gel pads before use. Do not use the Gel
Electrode if the gel appears dry, worn, dirty or irregular.
• Remove the clear protective cover from the Gel Electrode before using.
• Do not handle the Gel Electrode with both hands while stimulation is on. Serious
injury can occur if electrical current passes through your heart.
• Do not apply the Gel Electrode to anyone else or any other part of the body than
that determined by your doctor.
Adverse Effects
In the unlikely event that any of the following occurs, stop using your StimRouter system,
remove the Gel Electrode and immediately contact your doctor.
Risks Related to the Implant Procedure
If the lead is not placed properly, it may need to be removed or your therapy may need to
be adjusted. Nerve injury is possible, although unlikely. Possible surgical complications
include infection and device rejection. Contact your physician immediately if you experience
fever, swelling, bleeding or prolonged pain at the implant site.
Risks Related to Stimulation
• Stimulation of skin and muscles surrounding the lead may cause increased pain.
• You may have undesirable movements during stimulation. If this occurs please
contact your physician.
If you experience any discomfort during stimulation, or notice any skin abnormalities:
• Stop stimulation immediately.
• Remove the Gel Electrode.
• Notify your physician.
Additional Risks Related to the StimRouter System
• If the lead moves, it may change the stimulation effectiveness.
• While very unlikely, the tissue around the lead may react to the implanted
materials.
• External electromagnetic interference (EMI) may cause the StimRouter
components to malfunction. EMI may also affect stimulation.
• You may have persistent pain at the implant site.
• Although rare, the skin overlying the lead may erode.
• Portable and mobile radio frequency communications equipment can affect
medical electrical equipment.
• The StimRouter external components could overheat if the components fail.
Overheating could cause burning.
Temperature
The StimRouter E-EFC can heat up to 43°C during operation in extremely hot areas/
rooms. If this occurs turn off stimulation, remove E-EFC, and set aside until temperature
is within operational conditions.
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Chapter 4 - Environmental Conditions that Affect Use
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14 User's Guide
Environmental Conditions that Affect Use
Storage and Handling
Keep all StimRouter components dry and protect them from extreme changes in temperature
and humidity. Do not use or store your components where they could come in contact
with water, such as by sinks, bathtubs and shower stalls. Do not expose them to weather
conditions such as rain or snow. Do not store your StimRouter components in a car where
they can be exposed to extreme hot or cold temperatures.
Place your StimRouter components in an air-tight plastic bag before moving them from hot
to cold temperatures. Let them adjust slowly (for at least two hours) to the new temperature
before use.
Changes to the StimRouter system not approved by Bioventus could void your authority
to operate the equipment.
Gel Electrode Storage Temperature Range: 5°C to 27°C (41.0°F to 80.6°F)
External Electric Field Conductor (E-EFC) Storage Temperature Range: -25°C to
+60°C (-13°F to +140°F)
Radio Communication Information
Several components of the StimRouter system use radio communication. They have
been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 (Radio Frequency Devices) of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference in a residential environment.
This equipment generates, uses and can radiate radio frequency energy. If not used
as instructed, this equipment may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur. If this equipment does
cause harmful interference to radio or television reception, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the interference
by one of the following measures:
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Chapter 5 - Device Description
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16 User's Guide
• Move or adjust the receiving antenna.
• Move the equipment farther from the receiver.
• Contact the dealer or an experienced radio/television technician for assistance.
The antenna for each transmitter must not be near to or operating with any other antenna
or transmitter.
Electromagnetic Emissions
The StimRouter system is medical electrical equipment and was tested for electromagnetic
compatibility (EMC) in accordance with International Electrotechnical Committee (IEC)
60601-1-2. The StimRouter system should be configured and used in accordance with
the instructions provided in this manual.
End-Of-Life Waste Management
WEEE Regulations place an obligation on distributors to offer consumers a take-back
system where WEEE items can be disposed of free of charge.
Device Description
CAUTION: Do not attempt to repair any of the components in your StimRouter User
Kit. If a component does not work, contact Customer Service or your local distributor.
Unauthorized repair can void your warranty. Use only StimRouter components with your
StimRouter system.
This section describes the StimRouter Lead, E-EFC, Gel Electrode, and Electrode Carrying
Case, System Charger Set, and StimRouter Plus Mobile Application ( MAPP).
StimRouter Lead
The StimRouter Lead is flexible and approximately 15 cm (6 in.) in length. The
lead has a stimulation end and a receiver end. The lead implantation places the
stimulation end near or at the targeted peripheral nerve. The StimRouter lead
receives the signal from the E-EFC and conducts the stimulation pulse through
the lead to the stimulation end. See Figure 5-1.
Figure 5-1: The StimRouter Lead.
StimRouter External Electric Field Conductor (E-EFC)
The StimRouter E-EFC generates the trancutaneous signal and transmits the signal via
the Gel Electrode/skin interface to the StimRouter lead. The E-EFC snaps onto the Gel
Electrode (See Figure 5-2) and responds to wireless commands from the MAPP. The
E-EFC has three buttons: power, plus, and minus.
Lead
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Chapter 5 - Device Description
18 User's Guide
Figure 5-2: The E-EFC attached to the Gel Electrode.
Charging Socket
The E-EFC charging socket is located on the front panel of the E-EFC. When the E-EFC is
charging a green charging light will appear on the side panel of the E-EFC. See Figure 5-3.
Figure 5-3: The E-EFC charging socket and charging light location.
Light
The E-EFC light illuminates the Power button on the E-EFC. Light colors indicate the
status of the E-EFC:
• WHITE –
Solid: E-EFC is off and is fully charged – Connected to USB
Blinking: E-EFC is off and is currently charging – Connected to USB
• GREEN –
Solid: E-EFC is in standby mode and is fully charged – Connected to USB
Blinking: E-EFC is in Standby mode.
Fast Blinking – E-EFC is in stimulation mode
• YELLOW –
Blinking: Battery is Low
• RED –
Blinking: Information signal that action is required.
Solid Red: E-EFC encountered a non-recoverable error.
E-EFC Charging Socket
Location of Charging Light
E-EFC
Gel Electrode • BLUE –
Blinking: E-EFC is in pairing mode, ready to make Bluetooth connection with
MAPP or CPS
Gel Electrode
Gel Electrode features: (See Figure 5-4)
• Two gel pads that adhere the Gel Electrode to the skin. The gel pads also
transmit the stimulation signal from the E-EFC to the StimRouter lead.
• Two snaps for E-EFC placement.
• Two tabs for removing the Gel Electrode from the skin.
• A liner to protect the gel pads on the back of the Gel Electrode.
Figure 5-4: Gel Electrode (top and bottom views).
The Gel Electrode is disposable and can be reused while the gel pads are intact. The Gel
Electrode is designed to fully adhere to the skin or for a maximum of four days.
The typical lifespan of the Gel Electrode is two to four days, depending on:
• The number of hours of use.
• The number of times the Gel Electrode is adhered to and removed from the skin.
• Hygiene and skin care in the area of Gel Electrode placement.
Gel Pads
Snaps
Tabs
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Chapter 5 - Device Description
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Gel Electrode Liner
Every Gel Electrode is supplied with an electrode liner. See Figure 5-5. The liner is used
to keep the gel pads on the Gel Electrode from drying out.
Figure 5-5: Gel Electrode liner.
Always store the Gel Electrode with the liner attached. Store the liner in the Electrode
Carrying Case between uses, to keep the liner clean and protected.
A liner can be reused for as long as it can stick to the entire surface of the gel pads on
the back of the Gel Electrode.
Electrode Carrying Case
The Electrode Carrying Case is used to store the E-EFC, Gel Electrode, and the Gel
Electrode liner. See Figure 5-6.
Figure 5-6. Inside of the Gel Electrode Carrying Case.
System Charger Set
The system charger set is a plug-in AC/DC adapter that connects to a main power supply and
includes a USB C cable, a charger, and interchangeable blades for U.S. and international
outlets. The system charger set is used to charge E-EFC battery. See Figure 5-7.
Figure 5-7: System charger set.
CAUTION: Use only the charger included in your StimRouter User Kit. Using other
chargers could damage the system.
CAUTION: The AC/DC adapter portion of the system charger set must be disconnected
from the main power supply to completely disconnect the power input.
StimRouter Plus Mobile Application (MAPP)
The StimRouter system is an optional mobile application that can be used to control the
StimRouter system. Please download the MAPP from your device’s application store by
searching for “StimRouter Plus”. The app logo is:
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Chapter 6 - Set-Up Instructions
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22 User's Guide
The StimRouter Plus MAPP communicates wirelessly to the StimRouter E-EFC. The
StimRouter Plus MAPP is used to:
• Turn Stimulation on and off.
• Adjust stimulation intensity
• Select a stimulation program
Please ensure that the StimRouter Plus MAPP has been downloaded on your mobile device.
Set-Up Instructions
Charging the E-EFC
The StimRouter E-EFC comes with a rechargeable Lithium Polymer battery installed.
Charge the E-EFC daily, or when the E-EFC battery is low. Low battery is indicated by
the MAPP or by yellow or red lights on the E-EFC.
Note: Charge the E-EFC for at least two hours immediately before a programming session.
WARNING: Use only the medical-grade charger included in the StimRouter User Kit.
Use of any other charger could result in serious injury.
WARNING: The E-EFC battery is not replaceable. Do not attempt to remove or
replace the E-EFC battery.
To charge the E-EFC:
1. Open and assemble the System Charger Set. The System Charger set comes
with interchangeable blades for U.S. and international outlets. Select the
appropriate blade that fits the chosen power outlet and slide the blade onto the
end of the charger. Then connect the USB C cable to the charger cable.
2. Connect the USB C cable to the E-EFC. See Figure 6-1.
3. Plug the charger into a power outlet.
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Figure 6-1: Charging set-up.
4. The E-EFC should fully charge within 8 hours.
Note: The E-EFC will not allow stimulation to start while the E-EFC is charging and
connected to the USB C cable. Please remove the E-EFC from the charger before beginning
stimulation.
Preparing the Skin
The skin below the Gel Electrode should be clean, dry, and free from irritation, infection
or injury. It is important to develop a good skin care daily routine and to follow the steps
listed in this section. Always check your skin before using the StimRouter system. If you
have any concerns, contact your doctor.
CAUTION: Skin inflammation in the region of the Gel Electrode may be aggravated
by pressure from the electrode. If the skin is inflamed or swollen, do not use your
StimRouter system until the inflammation is gone. If the skin has a cut or scrape, do not
adhere the Gel Electrode.
To prepare the skin:
1. Clean the skin where the Gel Electrode will adhere with a wet washcloth.
If any lotions or oils are on the skin, then clean with soap and water. Rinse well
and dry.
2. If necessary, remove excess body hair from the skin area using scissors. Do not
use a razor because it can irritate the skin.
3. Always check the skin for redness or a rash.
Connecting the Gel Electrode and E-EFC
To connect the Gel Electrode and E-EFC:
1. Obtain a new Gel Electrode or one with gel pads that can still fully adhere to the
skin.
2. Check the “Use by” date on the Gel Electrode box.
3. Do not remove the liner at this time.
4. Set the Gel Electrode on a flat surface with the gel pads facing down.
5. Snap the E-EFC onto the Gel Electrode. See Figure 6-2.
Note: To ensure proper stimulation, the E-EFC must be connected to the Gel Electrode
properly.
Figure 6-2: StimRouter E-EFC connecting to Gel Electrode.
Adhering the Gel Electrode
A Gel Electrode can be reused as long as the gel pads are intact and can fully adhere to
the skin or for a maximum of four days of use.
WARNINGS:
• Do not touch the gel pads of the Gel Electrode with both hands while stimulation
is on. Serious injury can occur if electrical current passes through your heart.
• Turn stimulation off before adhering, removing or handling the Gel Electrode.
• Do not pinch or stretch the skin while adhering the Gel Electrode.
E-EFC
Gel Electrode
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• If the gel pads start to peel off at the edges or detach from the Gel Electrode,
immediately dispose of and get a new Gel Electrode.
To adhere the Gel Electrode:
1. Remove the liner and store it in the Electrode Carrying Case. See Figure 6-3. Do
not bend the liner. Keep the liner clean and protected so it can be reused when
the Gel Electrode is removed from the skin.
2. Visually inspect the gel pads on the back of the Gel Electrode. Make sure the gel
is smooth and the gel pads are not dry, worn or dirty.
3. Using the index finger and thumb, grasp the edges of the E-EFC attached to the
Gel Electrode so the gel pads face downward. See Figure 6-4.
Figure 6-3: Remove the Gel Electrode liner.
Figure 6- 4: Grasp the edges of the E-EFC attached to the Gel Electrode.
4. Align the Gel Electrode directly over the end of the StimRouter lead. The center
of the gel pad should be above the StimRouter. See Figure 6-5.
E-EFC
Figure 6-5: Correct stimulation position. (Illustration not to scale.)
Note: The effectiveness of the stimulation is sensitive to the alignment and rotation of
the Gel Electrode in relation to the StimRouter lead. If the alignment or rotation of the Gel
Electrode changes, the stimulation intensity may need to be adjusted.
5. Firmly adhere the Gel Electrode to the skin. Make sure the Gel Electrode is in
full contact with the skin. If the Gel Electrode is not firmly adhered to the skin and
moves, stimulation may become uncomfortable or ineffective.
Charging port
on E-EFC
Gel Electrode
Lead
Skin
Gel Pad
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Operating Instructions
CAUTION: Use only the components designed and manufactured for the StimRouter
system. The use of other components may damage your system and cause injury.
This section includes instructions on how to operate your StimRouter system,
including instructions for:
• Using the StimRouter Plus Mobile Application.
• Selecting a Stimulation Program.
• Turning stimulation On.
• Adjusting Stimulation Intensity.
• Turning stimulation Off.
• Tracking StimRouter Usage.
• Updating StimRouter Firmware.
• Removing the Gel Electrode.
• Removing the E-EFC from the Gel Electrode
Before you operate your StimRouter system, be sure to read the previous sections of
this guide. Important safety information and features of your StimRouter components are
described. If you have any questions, problems, or experience any new symptoms or
painful areas, contact your doctor for appropriate diagnosis and treatment. Your doctor is
familiar with your specific situation and the best source of additional guidance.
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Using the StimRouter Plus MAPP
Click the icon on your mobile device to open the StimRouter Plus MAPP. The StimRouter
Plus MAPP has four main screens: E-EFC Setup, Controls, Activity and More.
E-EFC Setup
Users can connect new E-EFCs and modify connected E-EFCs from the E-EFC Setup
screen.
Connect a New E-EFC
Simultaneously, press and hold the plus (+) and minus (-) buttons on the E-EFC until the
blue light flashes. Click the “Connect New E-EFC” button from the “Setup” tab of the MAPP.
If you experience any issues when connecting the E-EFC to the MAPP, please contact
Technical Support at 800-211-9136.
Re-connection to Same E-EFC
Restarting the MAPP will automatically re-connect to the E-EFC that has been previously
connected.
Modify Connected E-EFC(s)
Click the box of a connected E-EFC. The box will expand and allow the user to:
• Verify the E-EFC connection Status.
Figure 7-1: Verify E-EFC Connection Status.
• Change stimulation intensity of the currently selected therapy program by
pressing the plus or minus buttons
Connection Status
Figure 7-2: Stimulation Intensity Adjustment.
• Turn E-EFC audio cues on or off by pressing the audio icon
Figure 7-3: Audio Cues On/Off.
• Change the name of the selected E-EFC by pressing “Edit Name”.
Figure 7-4: Edit E-EFC Name.
Audio Icon
Plus and Minus Buttons
Edit Name
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