Rehabtronics CSST1 StimRay User Manual

Rehabtronics Inc. StimRay

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CSST1 User Manual HTML Version

User Manual

 User Manual

CS-IFU-EN

Revision A (DRAFT)

2017-07-27

DRAFT

 
 
 
Table of Contents 
Introduction 4 
Device Description 4 
List of Symbols 5 
Safety Information 7 
Contraindications 7 
Warnings 7 
Precautions 8 
System Components 8 
STIM Component 8 
CHARGER Component 8 
ELECTRODE Component 9 
APP Component 9 
Using the StimRay System 11 
Overview 11 
ELECTRODES Fitting 13 
Preparing the Skin 13 
Configuring Stimulation Intensity 14 
Exercise Programs 15 
System Cleaning and Maintenance 16 
General System Maintenance 16 
ELECTRODES Maintenance 17 
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DRAFT

 
Disposal Information 18 
Troubleshooting 19 
Electrode Placement Troubleshooting 19 
Physical Reactions 20 
Pain or Discomfort 20 
Allergic Reactions 21 
Skin Irritation 21 
Device Use Troubleshooting 22 
General Troubleshooting 22 
Error Messages 22 
Technical Information 23 
Environmental Specifications 23 
Electrical Component Specifications 23 
Stimulation Specifications 24 
Wireless Specifications 25 
Electromagnetic Compatibility 26 
Contact & Re-ordering Information 30 
 
  
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DRAFT

Safety Information

Contraindications

●The system should not be used by anyone with a cardiac pacemaker,

implanted defibrillator, or other implanted metallic or electronic device.

Such use could cause electric shock, burns, electrical interference, or

death.

●The system should not be used by anyone with a pre-existing medical

condition that may be impacted by muscle stimulation, including

fractures, dislocations, heart problems, or severe osteoporosis.  Such

use can complicate the condition or lead to severe injury.

Warnings

●The system and Mobile Application are not intended to be used in

conjunction with therapy or treatment diseases of medical or medical

conditions of any kind.

●The long term effects of electronic stimulation are unknown.

Discontinue use and consult a medical professional if any adverse

effects are experienced.

●Never attempt to use the device to stimulate head or neck.

●Do not use the device on, or close to injured, swollen, infected, or

inflamed areas of the skin. Doing so may complicate the existing

condition or prolong healing.

●Long term use can cause skin irritation. Discontinue use if you

experience skin pain or a rash on your arm that doesn't fade within 1

hour.

●Do not immerse electrical components in water. Doing so may result in

electrical shock and damage to the device.

●Never attempt to disassemble, modify or repair any components of the

system. Doing so may result in electrical shock and damage to the

device

DRAFT

●Do not use if any component is visibly damaged. Connectors and

enclosures should be inspected for defects, breaks and obstructions

before every use.

●Do not use the device while sleeping.

●The system is to be used only with Stim and Electrode components

supplied by Rehabtronics Inc.

●Do not use electrodes without hydrogel

Precautions

●Safety of powered muscle stimulators for use during pregnancy has not

been established.

●Caution should be used over areas of the skin which lack normal

sensation.

●Some users may experience skin irritation or hypersensitivity due to

electrical stimulation. The irritation can usually be reduced by using an

alternate electrode placement or by changing the stimulation

parameters. If problems persist, discontinue use.

●Muscle soreness may occur, much like during regular exercise. Limit the

amount of usage per day according to exercise-related soreness.

●Replace Electrodes if they show signs of advanced wear and tear within

suggested replacement period.

●Ensure the skin is clean and free of any ointments, lotions and

cosmetics. The presence of other substances can have unknown effects

on stimulation delivery.

●Do not store or operate the device in conditions outside those listed.

Doing so can damage components.

●Caution when engaging in new or potentially dangerous activities.

List of Symbols

The following table lists the symbols that are used on the StimRay labels and in

this manual:

DRAFT

Symbol

Definition

Application to the StimRay System

Warning

Important information or instructions that

should be observed to avoid potential injury

or damage to the device.

Operating Instructions

Instructions for use can be referenced

detailing operating instructions.

Follow Instructions for

Use

The instructions for use contain critical

instructions necessary to use the device

safely.

IP22

Ingress Protection

Rating

The STIM enclosure is protected against

dripping water (e.g. light rain) and ingress of

finger-sized objects.

Non-Ionizing

Radiation Emitter

The STIM component uses low-energy radio

frequencies.

Model Reference

(Catalogue/Re-order

Number)

Reference the accompanying model number

next to this symbol when re-ordering

components.

Lot/Batch Number

Reference the accompanying batch number

next to this symbol if contacting support.

Type BF Applied Part

Components that make patient contact

have a degree of protection against electric

shock.

DRAFT

European Authorized

Representative

The contact information accompanying this

symbol can be used to contact a

representative in the European Community.

Waste Electrical and

Electronic Equipment

(WEEE)

Do not dispose electronics with regular

household waste.  Consult local waste

management authorities to determine the

acceptable means to dispose of electronic

equipment.

Transportation and

storage temperature

limits

Do not transport or store the StimRay

outside the temperature range indicated.

Transportation and

storage humidity

limits

Do not transport or store the StimRay

outside the humidity range indicated.

Transportation and

storage pressure

limits

Do not transport or store the StimRay

outside the pressure range indicated.

Introduction

Device Description

The StimRay system, used with StimRay Mobile Application, is intended for the

stimulation of healthy muscles in order  to improve or facilitate muscle

performance.

It is intended to supplement strengthening, massage and recovery of the

following muscle groups, during or after exercise:

DRAFT

●Abs

●Adductors

●Biceps

●Calves

●Deltoids

●Forearms

●Glutes

●Hamstrings

●Lats

●Lower-Back

●Pecs

●Quads

●Traps

●Triceps

The StimRay device and StimRay Mobile Application are not intended to be used

in conjunction with therapy or treatment diseases of medical or medical

conditions of any kind.

DRAFT

System Requirements

The StimRay system requires the following:

StimRay Components

(Included in system kit)

Other Requirements

(non-included)

- StimRay STIM (up to 2 can be

used simultaneously)

- StimRay CHARGER

- StimRay ELECTRODE (up to 2 can

be used simultaneously)

- StimRay ELECTRODE Hydrogel

Pads

- USB-to-microUSB cable

- Mobile device running iOS 10, or

later

- USB power supply (output: 5V,

1A-2A)

System Components

STIM Component

The StimRay STIM is a small, rechargeable battery-powered, stimulation device

that produces stimulation pulses when connected to a StimRay ELECTRODE

component, and can be controlled using a mobile device.

CHARGER Component

The StimRay CHARGER component is used to charge the STIM battery.  It is

USB-powered, and can connect to any compliant USB power-source with a

micro-USB cable.  It allows for up to two (2) STIM units to be charged

simultaneously.

ELECTRODE Component

The StimRay ELECTRODE is a 2-channel electrode that is placed over exercised

muscles groups.

DRAFT

It consists of a magnetic connection for a StimRay STIM, and replaceable

hydrogel pads.

MOBILE APP Component

The StimRay MOBILE APP component is a software program that is used to

control the STIM component.  It allows for selection and initiation of exercise

programs, and stimulation intensity adjustment.

It is compatible with Apple iOS devices, and can be freely downloaded from the

Apple App Store.

Before You Begin

Downloading and Installing the MOBILE APP

Download the “StimRay” app from the Apple App Store onto your mobile

device.

Using the STIM

Using the STIM is as simple as connecting it to an ELECTRODE, and then

controlling it with the MOBILE APP (see “Using the MOBILE APP”).

The STIM will automatically turn on when connected to an ELECTRODE or

CHARGER, and automatically turn off when not connected to anything.

The STIM battery requires periodic recharging using the CHARGER (see “Using

the CHARGER”).

DRAFT

STIM Indicators

The STIM contains a single LED to indicate its status, when connected to either

the CHARGER or an ELECTRODE.  The following table describes the meaning of

the LED states:

Stim LED

Meaning

No Activity

(Off)

The STIM is powered off.  All stimulation functions

and MOBILE APP connections are disabled.

The STIM will automatically turn off when it is not

connected to either an ELECTRODE or CHARGER.

Blinking Blue

(Standby)

When connected to a CHARGER, this means that:

●The STIM charging

●The STIM is waiting for MOBILE APP pairing

Solid Blue

(Ready)

When connected to a CHARGER, this means the the

STIM battery is fully charged.

When connected to an ELECTRODE, this means that

the STIM is on, and ready to start stimulating.

Orange

(Active



Stimulating)

The STIM is sending stimulation pulses to the

ELECTRODE.

This is only possible when the STIM is connected to

the ELECTRODE, and controlled with the MOBILE

APP.

Flashing Red

(Low



Battery)

The STIM battery has less than 10% capacity

remaining.

DRAFT

Solid Red

(Error)

An error has been detected.  Any stimulation will be

stopped, and functions will be disabled.  See

“Troubleshooting” section of this manual for details.

Using the CHARGER

The StimRay CHARGER serves two functions.  It is used to:

1. Recharge STIM batteries

2. Pair STIM units with a MOBILE APP (see “Using the MOBILE APP”)

Charging the STIM

Connect the CHARGER to a compliant USB power source, and then connect up

to two (2) STIM units.  Charging progress is monitored by observing the LED on

connected STIM units according to the following table:

Charging in Progress

Charging Complete

Charging Error

STIM LED

Status

Pulsing blue LED

Solid blue LED

Solid red LED

NOTE: Two STIM units can be charged separately or simultaneously.  Batteries

should be charged regularly.  When STIM units are not in use, it is

recommended that they be charged to avoid battery depletion.

Using the ELECTRODES

Replacing Hydrogel Pads

The StimRay ELECTRODES require replaceable hydrogel pads in order to stick to

the skin and stimulate as intended.

Hydrogel pads are intended to be changed after five (5) days of use, or

whenever the pads no longer effectively stick to the skin.

DRAFT

Replacement pads are available from Rehabtronics (see “Contact and

Re-ordering Information” section of this manual).

ELECTRODE hydrogel pads can be replaced as follows:

1. Peel off and discard previous hydrogel pads from the ELECTRODE.

2. Apply new hydrogel pads to the ELECTRODE pad areas.

DRAFT

Preparing the Skin

The skin over which the ELECTRODE(S) are placed must be clean, healthy, and

free of obstructions.  Perform the following preparation steps prior to fitting:

1. Ensure the skin is healthy and free of any cuts, irritations, infections,

or other injuries.

2. Ensure the skin is clean and free of any lotions, ointments or other

cosmetics.

3. Remove any personal items such as jewelry, watches, bracelets, etc.

that may obstruct ELECTRODE placement.

4. It may be necessary to trim any excess arm hair from the areas over

which the ELECTRODE(S) will be placed in order to ensure good

contact with the skin.

Applying ELECTRODES to the Body

ELECTRODES are applied to the body by using the sticky hydrogel pads, such

that the circular pads are placed over the desired muscle group.

●Abs

DRAFT

●Adductors

●Biceps

●Calves

DRAFT

●Deltoids

●Forearms

●Glutes

DRAFT

●Hamstrings

●Lats

●Lower-Back

DRAFT

●Pecs

●Quads

●Traps

DRAFT

●Triceps

The  MOBILE APP contains further instructions and images as to how to apply

ELECTRODES to specific areas.

Using the MOBILE APP

The MOBILE APP is what controls paired STIM units.  This section describes the

features and functions of the MOBILE APP, in particular:

●Pairing STIM units with the MOBILE APP

●Naming STIM units

●Selecting Muscle Groups

●Selecting Exercise Programs

●Running Exercise Programs and Configuring Intensities

Pairing STIM Units with the MOBILE APP

STIM units need to first be paired with your mobile device running the MOBILE

APP.  Up to two (2) STIM units can be paired with a given mobile device.

Pairing requires connection to the CHARGER, as follows:

DRAFT

1. Open the StimRay MOBILE APP on your mobile device

2. Connect the STIM to the CHARGER - The STIM’s LED will flash blue

3. Pairing Instructions

Select one of the default names

of the STIM that will appear on

the list of the STIM available to

pair and then Click “CONNECT”

A red text

“CONNECTING” will

appear

Then Blue text “CONNECTED”.

The default Name of the STIM

will appear at the bottom of the

screen

4.  To pair the second STIM, Click “ NEXT” and go through Step 3 again.

NOTE: Pairing must be done within three (3) minutes of connecting the STIM to

the CHARGER.  If pairing is unsuccessful, disconnect the STIM from the

CHARGER, then re-connect and try again.

NOTE: The MOBILE APP will remember paired STIM units, so the pairing process

only has to be done once for any given STIM unit and mobile device.

DRAFT

Naming STIM Units

The MOBILE APP allows paired STIM units to be assigned a name, so they can be

recognized easily in the future.

Naming / Renaming Instructions:

Click Bellow the text

“RENAME STIM”

Keyboard will appear,

name your STIM, then

click “ Done”

The new name of your

STIM will Appear

Selecting Muscle Groups

The MOBILE APP must be told what on parts of the body paired STIM units will

be acting.  This is done on the muscle-group selection screen.

(see above “Applying ELECTRODES to the Body”)

DRAFT

Selecting Exercise Programs

Depending on the muscle group selected, up to six (6) exercise modes will be

available within the MOBILE APP.  The following table describes the different

modes:

Choose the desired mode from the

mode selection screen on the

MOBILE APP.

Exercise Mode

Description

DRAFT

Endurance

Improves muscle endurance and resistance to a fatigue.

Assists in developing a higher absolute intensity over a

given volume at greater ease, improving muscle’s ability

to increase the rate of lactic acid removal.

Use up to 5 times a week per muscle group, before your

endurance workouts.

DURATION: 40-46 MINUTES

RECOMMENDED MUSCLE GROUPS:ADDUCTORS,

DELTOIDS, GLUTES, LOWER BACK, TRAPS, WRIST

FLEXORS/EXTENSORS

Long Resistance

Improves muscle ability to resist intense and prolonged

effort, muscle tone and definition. Assists in ability to

sustain higher intensities of exercise for short time

frames.

Use up to 4 times a week per muscle group, before or

after your Long Resistance workouts.

DURATION: 26-32 MINUTES

RECOMMENDED MUSCLE GROUPS:ABS,

ADDUCTORS, CALVES, DELTOIDS, GLUTES, LATS,

LOWER BACK, TRAPS, WRIST

FLEXORS/EXTENSORS

Short Resistance

Improves muscle ability to resist intense and prolonged

effort, increases muscle hypertrophy (muscle

cross-sectional area). Assists in creating strength gains

toward movement, speed, and ground reaction force on

the field or court.

DRAFT

Use up to 3 times a week per muscle group, in between

or after your usual workouts.

DURATION: 20-26 MINS

RECOMMENDED MUSCLE GROUPS: ABS, BICEPS,

CALVES, HAMSTRINGS, LATS, PECS, QUADS,

TRICEPS

Strengt

Improves muscle strength. Great in complementing

strength training sessions with the major focus on

pushing, pressing and pulling training.

Use up to 3 times a week per muscle group, in between

or after your strength training workouts.

DURATION: 20-26 MINS

RECOMMENDED MUSCLE GROUPS: BICEPS,

HAMSTRINGS, PECS, QUADS, TRICEPS

Explosive Strength

Focuses on rapid muscle strength development. Great

for overcoming plateaus in your strength or speed

training, complements well your plyometric workouts.

Use up to 3 times a week per muscle group, in between

or after your strength training workouts.

DURATION: 17-23 MINS

RECOMMENDED MUSCLE GROUPS: BICEPS,

HAMSTRINGS, PECS, QUADS, TRICEPS

Extreme Explosive

Focuses on rapid muscle strength development. Great

DRAFT

Strength

for overcoming plateaus in your strength or speed

training, complements well your plyometric workouts.

Use up to 3 times a week per muscle group, in between

or after your strength training workouts.

DURATION: 9-15 MINS

RECOMMENDED MUSCLE GROUPS: BICEPS,

HAMSTRINGS, PECS, QUADS, TRICEPS

Active Recovery

Reduces blood lactate accumulation and speeds up

muscle recovery after a hard training session.

Use within 2 hours after intensive training.

DURATION: 20 MINUTES

Potentiation

Increases muscle contraction speed and prepares

muscles for the maximum output. Potentiation Program

is a great warm-up tool.

Use as advanced warm up before important events and

competitions.

DURATION: 4 MINUTES

Massage

Temporarily increases blood circulation in the area

applied, promotes muscle relaxation. Great add-on for

your rest days.

Apply during your rest periods.

DRAFT

DURATION: 20 MINUTES

Short Message

Temporarily increases blood circulation in the area

applied, promotes muscle relaxation. Great add-on for

your rest days.

Apply during your rest periods.

DURATION: 11 MINUTES

Running Exercise Programs and Configuring Intensities

Once the muscle group and exercise mode have been selected, stimulation can

be started, stopped and paused using the MOBILE APP’s on-screen controls.

The timer will be set automatically based on the selected exercise mode.

While the exercise program is running, adjust the stimulation intensity to a

comfortable level using the on-screen controls.

MOBILE APP Indicators

The MOBILE APP has icons to indicate the STIM battery charge.

Battery Status Icon

Icon

Meaning

Charged - Fully charged

DRAFT

Discharging - Partially charged

Low Battery - Less than 20% charge remaining

DRAFT

System Cleaning and Maintenance

General System Maintenance

The following general maintenance guidelines should be followed to ensure safe

and effective use of the StimRay system:

●Inspect all components prior to use.  Do not use any components

showing signs of damage.

●Do not store or operate any of the system components outside their

specified operating and storage conditions (see “Environmental

Specifications” in the Technical Information section of this manual).

●All system components can be cleaned as necessary by wiping with a

soft cloth dampened with clean water.

WARNING: Do not immerse components in water or any other

liquid.  Doing so can permanently damage the electronics.

DRAFT

ELECTRODES Maintenance

ELECTRODE Body Replacement

The StimRay ELECTRODES should be replaced in either of the following cases:

1. If there is any noticeable damage or separation of materials;

2. After six (6) months of daily use.

For re-ordering information see “Contact & Reordering Information” at the end

of this manual.

Hydrogel Pad Replacement

The ELECTRODE hydrogel pads are intended to be replaced regularly to ensure

adequate adhesion to the skin, and reliable stimulation delivery.  Hydrogel pads

should be replaced in either of the following cases:

1. Hydrogel pads are dirty and/or no longer adhere well to the skin

2. After one (1) week of daily use.

The life of the electrodes varies depending on skin conditions, amount of use,

type of stimulation, storage and climate. Electrode life may be extended by

carefully following these tips on application, removal, and storage.

1- Avoid touching the Hydrogel Pad, lift a corner of the Electrode and slowly

peel the electrode off the skin, touching the adhesive gel as little as possible.

2- Place the electrodes back immediately after each use to its protective plastic

cover.

3- Return the electrodes back into  storage Bag and reseal tightly to prevent

Dry-out.

4- Store at room or cool temperature and keep out of direct sunlight

DRAFT

For re-ordering information see “Contact & Reordering Information” at the end

of this manual.

Disposal Information

Rehabtronics Inc. considers the environment in all aspects of the product

lifecycle, from design and engineering to packaging and recycling.  We

recommend that customers dispose of their used StimRay components in an

environmentally sound manner.

It is your responsibility to dispose of your waste equipment by handing it over to

a designated collection point for the recycling of waste electrical and electronic

equipment. The separate collection and recycling of your waste equipment at

the time of disposal will help to conserve natural resources and ensure that it is

recycled in a manner that protects human health and the environment. For

more information about where you can drop off your waste equipment for

recycling, please contact your local city office, your household waste disposal

service or the shop where you purchased the product.

CAUTION: Do not dispose of electronic components with normal

household waste.  Contact your local waste-management

services for information on how to best dispose of electronic

equipment.

DRAFT

Troubleshooting

Electrode Placement Troubleshooting

DRAFT

Physical Reactions

Pain or Discomfort

If used as directed, the StimRay should not cause any pain.  Mild discomfort may

be experienced when using the StimRay system, but is easily remedied in most

cases.  The following table describes possible sources of discomfort, and the

appropriate actions to take:

Source of Discomfort

Recommended Action(s)

Increase in sensitivity to

stimulation over time

Decrease stimulation intensities to comfortable

levels.  If discomfort persists, discontinue use and

consult your healthcare professional.

Fatigue or soreness

following prolonged use

Discontinue use until symptoms have cleared.  If

symptoms do not dissipate within a day of ceasing

use, consult your healthcare professional.

WARNING: If persistent pain is experienced, discontinue use

immediately and contact your healthcare professional.

DRAFT

Allergic Reactions

All StimRay materials have been selected and tested to ensure they are

biocompatible, hypoallergenic, and free of any toxic substances. Nevertheless, if

allergic reaction to materials is suspected, discontinue use immediately and

contact your healthcare professional.

Skin Irritation

Some reddening and indentation of the skin under electrodes is normal

following a period of use, and further mild skin irritation may be experienced

depending on factors such as the environment, duration of use, and

skin-sensitivity.

The following guidance should be followed to mitigate possible skin irritation:

●Limit wearing the ELECTRODES to a maximum of 2 hours a day.

●If any sort of skin irritation develops, discontinue use until the

symptoms have cleared.

WARNING: If persistent skin irritation is experienced that does

not clear within hours of removing the ELECTRODES, discontinue

use and contact your healthcare professional.

DRAFT

Device Use Troubleshooting

General Troubleshooting

Issue

Recommended Action(s)

Device performance

issues or unanticipated

behavior.

Discontinue use and contact customer support.

(see “Contact and Reordering Information” at the end

of this manual)

Error Messages

The following table lists possible error messages that may appear, and the

recommended actions to take:

DISPLAY Message

Potential Cause(s)

Recommended Action(s)

Low Battery on my

StimRay

Battery is low

Recharge the Lithium ion battery

High Temperature

fault on my

StimRay

internal heating of

components

Remove the StimRay from the

electrode holder, wait until it

cools down. Try it again. If the

fault persists contact

Rehabtronics.inc.

Electrode fault on

my StimRay

Electrode not making

good contact with skin

or Stimray not making

good contact with the

electrode connector.

Remove the electrode, reapply

the gel. remove and place back

the StimRay onto the electrode

holder. If problem persists change

the electrodes.

System Fault on

my StimRay

Component failure or

StimRay not making a

good contact with the

electrode holder.

Remove and place back the

StimRay unit to the electrode

connector. If problem persists

replace the electrode assembly. If

problem still not resolved, contact

Rehabtronics inc.

DRAFT

Technical Information

Environmental Specifications

Operating

Conditions

Temperature: +5 °C to +40 °C (41 °F to 104 °F)

Relative Humidity: 15% to 93% (non-condensing)

Pressure: 70 kPa to 106 kPa  (10.2 psi to 15.4 psi)

Transport &

Storage

Conditions

Temperature: -25 °C to +70 °C (-13 °F to 158 °F)

Relative Humidity: 5% to 100% (non-condensing)

Pressure: 70 kPa to 106 kPa (10.2 psi to 15.4 psi)

Electrical Component Specifications

CHARGER

STIM

Model Number

CSCG1

CSST1

Equipment Usage &

Type

Non Transit-Operable

Portable Equipment

Transit-Operable

Body-Worn Equipment

Mode of Operation

Continuous

Applied Part Type

N/A

BF Applied Part

Means of Supply

Mains Isolation

Direct plug-in adaptor

N/A

(battery-powered)

Power Specifications

USB Powered

5V, 1 - 2A

Internally Powered

3.7V, 310 - 330 mAh

Rechargeable Lithium Ion Battery

DRAFT

Stimulation Specifications

The following table provides technical details of the stimulation pulses delivered

by the StimRay system:

Stimulation Characteristic

StimRay Specification

Waveform Phase

Biphasic with passive recovery

Waveform Shape

Rectangular

Maximum Output Voltage (±10%)

80-100 mA (depending on pulse width)

Maximum Output Current (±10%)

100 mA @ 500 ohms

100 mA @ 2 kohms

0 mA @ 20 k Ohm (fault state)

Pulse Width

125 uS - 400 uS

Pulse Duration

1 mS

Pulse Frequency

1 Hz - 125 Hz

DRAFT

Wireless Specifications

The following table details the wireless specifications for the STIM:

Operating Frequency Range

2402– 2480 MHz

Operating Frequencies

2402,2426 and 2480 in advertising mode and other 37

channels in the range of 2402-2480 MHz

Data Rate

1 Mbps

Maximum Transmit Power

0  dBm

Modulation Scheme

GFSK

Modulating Signal Type

Binary Data

Modulation Baud Rate

1 MHz

RF Frequency Channels

40 Channels

Channel Spacing

2 MHz + channel hopping

Antenna Type

Printed F type PCB antenna with 5 dBi maximum gain.

Transceiver Duplex Scheme

Time Division Duplexing

Bit Error Rate

Less than 0.1%

Packet Error Rate

Less than 5%

Receiver Sensitivity

-96 dBm

Command Delay

Less than  1 Second

Transmitter Duty Cycle

Less than 0.2%

Operating Range

Up to 5 meters

NOTE: The Federal Aviation Administration rules require that all radio-transmitting devices be turned off

during flight.

DRAFT

FCC Regulator Statements

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1)

This device may not cause harmful interference, and (2) This device must accept any interference received,

including interference that may cause undesired operation.

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to

part 15 of the Federal Communication Commission (FCC) rules. These limits are designed to provide

reasonable protection against harmful interference in a residential installation. This equipment generates,

uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions,

may cause harmful interference to radio communications. However, there is no guarantee that interference

will not occur in a particular installation. If this equipment causes 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 doing one or more of the following measures:

●Reorient or relocate the receiving antenna.

●Increase the separation between the equipment and receiver.

●Connect the equipment into an outlet on a circuit different from that to which the receiver is

connected.

●Consult the dealer or an experienced radio/TV technician for help.

NOTE: THE GRANTEE IS NOT RESPONSIBLE FOR ANY CHANGES OR MODIFICATIONS NOT EXPRESSLY APPROVED

BY THE PARTY RESPONSIBLE FOR COMPLIANCE. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY

TO OPERATE THE EQUIPMENT.

RF Exposure Warning

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. In

order to avoid the possibility of exceeding the FCC radio frequency exposure limits, human proximity to the

antenna shall not be less than 5 mm during normal operation and must not be co-located or operating in

conjunction with any other antenna or transmitter.

IC Regulatory Statements

This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the

following two conditions: (1) this device may not cause interference, and (2) this device must accept any

interference, including interference that may cause undesired operation of the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de

licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de

brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le

brouillage est susceptible d'en compromettre le fonctionnement.

CAN ICES-3 (B)/NMB-3(B)

RF Exposure Information

This equipment complies with ISED RSS-102 radiation exposure limits set forth for an uncontrolled

environment. This transmitter must be installed to provide a separation distance of at least 5 mm from all

persons and must not be co-located or operating in conjunction with any other antenna or transmitter.

Cet équipement est conforme avec ISED RSS-102 des limites d'exposition aux rayonnements définies pour un

environnement non contrôlé. Cet émetteur doit être installé à au moins 5 mm de toute personne et ne doit

pas être colocalisé ou fonctionner en association avec une autre antenne ou émetteur.

DRAFT

Electromagnetic Compatibility

WARNING: The StimRay System should not be used adjacent to or stacked with

other equipment.  If adjacent or stacked use is necessary, the system should be

observed to verify normal operation in the configuration in which it will be

used.

WARNING:  Use of any system components other than those specified or

supplied by Rehabtronics Inc. may result in increased emissions or decreased

immunity of the equipment, and may cause the system to be non-compliant

with the electromagnetic compatibility requirements of IEC 60601-1-2:2007.

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The StimRay System and all its system components are intended for use in the electromagnetic

environment specified below. The customer or the user of the StimRay System should assure

that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic Environment - Guidance

DRAFT

Recommended separation distances between portable and mobile RF

communications equipment and the StimRay System

The StimRay System and all its system components are intended for use in an electromagnetic

environment in which radiated RF disturbances are controlled. The customer or the user of the

StimRay System can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the

components of the StimRay System as recommended below, according to the maximum

output power of the communications equipment.

Rated

maximum

output power

of transmitter

(W)

Separation distance according to frequency of transmitter

(m)

150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

DRAFT

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The StimRay System and all its system components are intended for use in the electromagnetic

environment specified below. The customer or the user of the StimRay System should assure

that it is used in such an environment.

Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic

Environment - Guidance

DRAFT

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The StimRay System and all its system components are intended for use in the electromagnetic

environment specified below. The customer or the user of the StimRay System should assure

that it is used in such an environment.

Immunity

Test

IEC 60601

Test Level

Compliance

Level

Electromagnetic Environment - Guidance

Contact & Reordering Information

For device support, or to reorder components, contact Rehabtronics Inc. via any

of the following channels:

Manufactured By:

Rehabtronics Inc.

#4352, 10230 Jasper Ave.

Edmonton, Alberta,

Canada T5J 4P6

Web: www.rehabtronics.com

Email: support@rehabtronics.com

Phone: 1-866-896-7277

If reordering components, please refer to the model (REF) number as indicated

in the table below, or on the component labels:

System Component Re-Ordering

System Component

Model (REF) /

Re-order Number

Recommended Re-order

Interval

(component service life)

Stim

CSST1

4 years

Charger

CSCG1

4 years

Electrode

CSED1

6 months

Hydrogel Pads

CSEP1

1 week

For inquires or re-ordering outside Canada, contact your local StimRay distributor.

For health-related concerns, contact your health care professional.

DRAFT

Rehabtronics CSST1 StimRay User Manual

Rehabtronics Inc. StimRay

User Manual

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