FCC ID: QIQCSST1 StimRay

User Manual CS-IFU-EN Revision A (DRAFT) 2017-07-27 DRAFT Introduction Table of Contents Device Description List of Symbols Safety Information Contraindications Warnings Precautions System Components STIM Component CHARGER Component ELECTRODE Component APP Component Using the StimRay System Overview ELECTRODES Fitting Preparing the Skin Configuring Stimulation Intensity Exercise Programs System Cleaning and Maintenance General System Maintenance ELECTRODES Maintenance 2 4 4 5 7 7 7 8 8 8 8 9 9 11 11 13 13 14 15 16 16 17 DRAFT Disposal Information Troubleshooting Electrode Placement Troubleshooting Physical Reactions Pain or Discomfort Allergic Reactions Skin Irritation Device Use Troubleshooting General Troubleshooting Error Messages Technical Information Environmental Specifications Electrical Component Specifications Stimulation Specifications Wireless Specifications Electromagnetic Compatibility Contact & Re-ordering Information 3 18 19 19 20 20 21 21 22 22 22 23 23 23 24 25 26 30 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 Such condition that may be impacted by muscle stimulation, including fractures, dislocations, heart problems, or severe osteoporosis. use can complicate the condition or lead to severe injury. Warnings The system and Mobile Application are not intended to be used in The long term effects of electronic stimulation are unknown. conjunction with therapy or treatment diseases of medical or medical conditions of any kind. Discontinue use and consult a medical professional if any adverse effects are experienced. Long term use can cause skin irritation. Discontinue use if you 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. 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 Never attempt to disassemble, modify or repair any components of the electrical shock and damage to the device. system. Doing so may result in electrical shock and damage to the device 4 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 Do not use electrodes without hydrogel supplied by Rehabtronics Inc. Precautions sensation. been established. Safety of powered muscle stimulators for use during pregnancy has not Caution should be used over areas of the skin which lack normal Some users may experience skin irritation or hypersensitivity due to Muscle soreness may occur, much like during regular exercise. Limit the Replace Electrodes if they show signs of advanced wear and tear within Ensure the skin is clean and free of any ointments, lotions and 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. amount of usage per day according to exercise-related soreness. suggested replacement period. cosmetics. The presence of other substances can have unknown effects on stimulation delivery. Doing so can damage components. Do not store or operate the device in conditions outside those listed. 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:

5 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 STIM enclosure is protected against The dripping water (e.g. light rain) and ingress of finger-sized objects. Non-Ionizing Radiation Emitter STIM The frequencies. component uses low-energy radio 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. 6 DRAFT European Authorized Representative Waste Electrical and Electronic Equipment

(WEEE) The contact information accompanying this symbol can be used to contact a representative in the European Community. 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 Transportation and storage pressure limits Do not transport or store the StimRay outside the humidity range indicated. 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 performance. It is intended to supplement strengthening, massage and recovery of the following muscle groups, during or after exercise:

to improve or facilitate muscle 7 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. 8 DRAFT System Requirements The StimRay system requires the following:

StimRay Components

(Included in system kit) 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

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-

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Other Requirements

(non-included)

- Mobile device running iOS 10, or later USB power supply (output: 5V,

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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. 9 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 Download the StimRay app from the Apple App Store onto your mobile device. MOBILE APP STIM MOBILE APP ELECTRODE, and then

(see Using the MOBILE APP). is as simple as connecting it to an Using the STIM Using the controlling it with the The ELECTRODE CHARGER, and automatically turn off when not connected to anything. The the CHARGER). will automatically turn on when connected to an battery requires periodic recharging using the CHARGER STIM STIM or

(see Using 10 DRAFT STIM Indicators STIM The the or an CHARGER the LED states:

Stim LED No Activity

(Off) Blinking Blue

(Standby) Solid Blue

(Ready) Orange

(Active - Stimulating) Flashing Red

(Low Battery) contains a single LED to indicate its status, when connected to either The following table describes the meaning of ELECTRODE. is powered off. Meaning STIM The MOBILE APP and The STIM connected to either an When connected to a All stimulation functions connections are disabled. will automatically turn off when it is not CHARGER. ELECTRODE CHARGER, this means that:

or MOBILE APP pairing CHARGER, this means the the The The STIM STIM charging is waiting for STIM STIM battery is fully charged. When connected to a STIM When connected to an the The ELECTRODE. This is only possible when the the APP. STIM The remaining. ELECTRODE, this means that is on, and ready to start stimulating. is sending stimulation pulses to the ELECTRODE, and controlled with the STIM is connected to MOBILE battery has less than 10% capacity 11 DRAFT Solid Red

(Error) Any stimulation will be An error has been detected. stopped, and functions will be disabled. Troubleshooting section of this manual for details. See 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 CHARGER Connect the units. to two (2) STIM connected STIM units according to the following table:

to a compliant USB power source, and then connect up Charging progress is monitored by observing the LED on STIM LED Status Charging in Progress Pulsing blue LED Charging Complete Solid blue LED Charging Error Solid red LED Batteries STIM STIM Two When units can be charged separately or simultaneously. NOTE:

should be charged regularly. units are not in use, it is recommended that they be charged to avoid battery depletion. Using the ELECTRODES Replacing Hydrogel Pads The StimRay 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. ELECTRODES require replaceable hydrogel pads in order to stick to 12 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. 13 DRAFT Preparing the Skin The skin over which the free of obstructions. ELECTRODE(S) are placed must be clean, healthy, and Perform the following preparation steps prior to fitting:

or other injuries. cosmetics. 1. Ensure the skin is healthy and free of any cuts, irritations, infections, 2. Ensure the skin is clean and free of any lotions, ointments or other 3. Remove any personal items such as jewelry, watches, bracelets, etc. that may obstruct It may be necessary to trim any excess arm hair from the areas over 4. which the contact with the skin. will be placed in order to ensure good ELECTRODE(S) placement. ELECTRODE 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 14 DRAFT Adductors Biceps Calves 15 DRAFT Deltoids Forearms Glutes 16 DRAFT Hamstrings Lats Lower-Back 17 DRAFT Pecs Quads Traps 18 DRAFT Triceps MOBILE APP contains further instructions and images as to how to apply The ELECTRODES to specific areas. Using the MOBILE APP The MOBILE APP is what controls paired STIM units. 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 This section describes the units need to first be paired with your mobile device running the Up to two (2) units can be paired with a given mobile device. Pairing STIM Units with the MOBILE APP STIM APP. Pairing requires connection to the CHARGER, as follows:

STIM MOBILE 19 DRAFT 1. Open the StimRay 2. Connect the STIM 3. Pairing Instructions MOBILE APP to the CHARGER on your mobile device

- The STIMs LED will flash blue Select one of the default names STIM of the that will appear on the list of the available to STIM pair and then Click CONNECT STIM, To pair the second A red text CONNECTING will appear Then Blue text CONNECTED. The default Name of the STIM will appear at the bottom of the screen CHARGER. Click NEXT and go through Step 3 again. Pairing must be done within three (3) minutes of connecting the from the If pairing is unsuccessful, disconnect the 4. NOTE:

the CHARGER, then re-connect and try again. NOTE:

only has to be done once for any given STIM unit and mobile device. will remember paired STIM MOBILE APP STIM The units, so the pairing process STIM to 20 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 then click Done STIM, 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.

(see above Applying ELECTRODES to the Body) This is done on the muscle-group selection screen. 21 DRAFT Selecting Exercise Programs Depending on the muscle group selected, up to six (6) exercise modes will be The following table describes the different available within the MOBILE APP. modes:

Choose the desired mode from the mode selection screen on the MOBILE APP. Exercise Mode Description 22 DRAFT Endurance Long Resistance Short Resistance Improves muscle endurance and resistance to a fatigue. Assists in developing a higher absolute intensity over a given volume at greater ease, improving muscles ability to increase the rate of lactic acid removal. Use up to 5 times a week per muscle group, before your endurance workouts. DURATION:

RECOMMENDED MUSCLE GROUPS:ADDUCTORS, DELTOIDS, GLUTES, LOWER BACK, TRAPS, WRIST FLEXORS/EXTENSORS 40-46 MINUTES 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 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. 23 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:

CALVES, HAMSTRINGS, LATS, PECS, QUADS, TRICEPS ABS, BICEPS, 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. Strengt 20-26 MINS DURATION:

RECOMMENDED MUSCLE GROUPS:

HAMSTRINGS, PECS, QUADS, TRICEPS BICEPS, 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:

HAMSTRINGS, PECS, QUADS, TRICEPS BICEPS, Extreme Explosive Focuses on rapid muscle strength development. Great 24 DRAFT Strength Active Recovery Potentiation Massage 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:

HAMSTRINGS, PECS, QUADS, TRICEPS BICEPS, Reduces blood lactate accumulation and speeds up muscle recovery after a hard training session. Use within 2 hours after intensive training. DURATION:

20 MINUTES 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 Temporarily increases blood circulation in the area applied, promotes muscle relaxation. Great add-on for your rest days. Apply during your rest periods. 25 DRAFT Short Message DURATION:

20 MINUTES 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 APPs 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 MOBILE APP Indicators The Battery Status Icon has icons to indicate the STIM battery charge. Icon Meaning Charged

- Fully charged 26 DRAFT Discharging Low Battery

- Partially charged

- Less than 20% charge remaining 27 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:

Do not use any components Inspect all components prior to use. 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:

liquid. Do not immerse components in water or any other Doing so can permanently damage the electronics. 28 DRAFT ELECTRODES Maintenance ELECTRODE Body Replacement The StimRay ELECTRODES should be replaced in either of the following cases:

If there is any noticeable damage or separation of materials;

1. 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 Dry-out. 4- Store at room or cool temperature and keep out of direct sunlight storage Bag and reseal tightly to prevent 29 DRAFT For re-ordering information see Contact & Reordering Information at the end of this manual. We Disposal Information Rehabtronics Inc. considers the environment in all aspects of the product lifecycle, from design and engineering to packaging and recycling. 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. Do not dispose of electronic components with normal CAUTION:

household waste. services for information on how to best dispose of electronic equipment. Contact your local waste-management 30 DRAFT Troubleshooting Electrode Placement Troubleshooting 31 DRAFT The following table describes possible sources of discomfort, and the Physical Reactions Pain or Discomfort Mild discomfort may If used as directed, the StimRay should not cause any pain. be experienced when using the StimRay system, but is easily remedied in most cases. appropriate actions to take:

Source of Discomfort Increase in sensitivity to stimulation over time Recommended Action(s) Decrease stimulation intensities to comfortable levels. If discomfort persists, discontinue use and consult your healthcare professional. Discontinue use until symptoms have cleared. If symptoms do not dissipate within a day of ceasing use, consult your healthcare professional. Fatigue or soreness following prolonged use WARNING:

immediately and contact your healthcare professional. If persistent pain is experienced, discontinue use 32 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 to a maximum of 2 hours a day. If any sort of skin irritation develops, discontinue use until the ELECTRODES symptoms have cleared. WARNING:

not clear within hours of removing the use and contact your healthcare professional. If persistent skin irritation is experienced that does ELECTRODES, discontinue 33 DRAFT Device Use Troubleshooting General Troubleshooting Issue Device performance issues or unanticipated behavior. Recommended Action(s) 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) Low Battery on my Battery is low StimRay Recommended Action(s) Recharge the Lithium ion battery Remove the StimRay from the electrode holder, wait until it cools down. Try it again. If the fault persists contact Rehabtronics.inc. Remove the electrode, reapply the gel. remove and place back the StimRay onto the electrode holder. If problem persists change the electrodes. 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. High Temperature fault on my StimRay internal heating of components Electrode not making good contact with skin or Stimray not making good contact with the electrode connector. Component failure or StimRay not making a good contact with the electrode holder. 34 Electrode fault on my StimRay System Fault on my StimRay DRAFT Technical Information Environmental Specifications Operating Conditions Transport &

Storage 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) 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) STIM CSST1 Transit-Operable Body-Worn Equipment Continuous BF Applied Part N/A

(battery-powered) Internally Powered 3.7V, 310 - 330 mAh Rechargeable Lithium Ion Battery CHARGER Electrical Component Specifications Model Number Equipment Usage &

Mode of Operation Applied Part Type Means of Supply Mains Isolation Non Transit-Operable Portable Equipment Direct plug-in adaptor Continuous CSCG1 Type N/A Power Specifications USB Powered 5V, 1 - 2A 35 DRAFT Stimulation Specifications The following table provides technical details of the stimulation pulses delivered by the StimRay system:

StimRay Specification Biphasic with passive recovery Rectangular 80-100 mA (depending on pulse width) 100 mA @ 500 ohms 100 mA @ 2 kohms 0 mA @ 20 k Ohm (fault state) 125 uS - 400 uS 1 mS 1 Hz - 125 Hz Stimulation Characteristic Waveform Phase Waveform Shape Maximum Output Voltage (10%) Maximum Output Current (10%) Pulse Width Pulse Duration Pulse Frequency 36 DRAFT Wireless Specifications The following table details the wireless specifications for the Operating Frequency Range 2402 2480 MHz STIM:

Operating Frequencies 2402,2426 and 2480 in advertising mode and other 37 channels in the range of 2402-2480 MHz Data Rate 1 Mbps dBm Modulation Scheme GFSK Maximum Transmit Power 0 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 Less than 0.1%

Less than 5%

-96 dBm Less than Less than 0.2%

Operating Range Up to 5 meters Bit Error Rate Packet Error Rate Receiver Sensitivity Command Delay Transmitter Duty Cycle The Federal Aviation Administration rules require that all radio-transmitting devices be turned off 1 Second NOTE:

during flight. 37 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 USERS 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 prsent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes: (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme 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 quipement est conforme avec ISED RSS-102 des limites d'exposition aux rayonnements dfinies pour un environnement non contrl. Cet metteur doit tre install au moins 5 mm de toute personne et ne doit pas tre colocalis ou fonctionner en association avec une autre antenne ou metteur. 38 DRAFT Electromagnetic Compatibility The StimRay System should not be used adjacent to or stacked with If adjacent or stacked use is necessary, the system should be WARNING:

other equipment. observed to verify normal operation in the configuration in which it will be used. Use of any system components other than those specified or WARNING:

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 Manufacturers 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 Electromagnetic Environment - Guidance that it is used in such an environment. Emissions Test Compliance 39 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. Separation distance according to frequency of transmitter

(m) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz Rated maximum output power of transmitter

(W) 40 DRAFT Guidance and Manufacturers 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. Electromagnetic Environment - Guidance Immunity Test IEC 60601 Test Level Compliance Level 41 DRAFT Guidance and Manufacturers 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. Compliance Level Electromagnetic Environment - Guidance IEC 60601 Test Level Immunity Test 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 Stim Charger Electrode Hydrogel Pads CSST1 CSCG1 CSED1 CSEP1 Recommended Re-order

(component service life) Interval 4 years 4 years 6 months 1 week For inquires or re-ordering outside Canada, contact your local StimRay distributor. For health-related concerns, contact your health care professional. 42 DRAFT