Rehabtronics CSST1 StimRay User Manual

Rehabtronics Inc. StimRay

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 2 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 3 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 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 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: 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 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. 6 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: 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) 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. 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 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”). 10 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. 11 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. 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 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 14 DRAFT
●Adductors ●Biceps ●Calves 15 DRAFT
●Deltoids ●Forearms ●Glutes 16 DRAFT
●Hamstrings ●Lats ●Lower-Back 17 DRAFT
●Pecs ●Quads ●Traps 18 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: 19 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. 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 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”) 21 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 22 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. 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: 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 24 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. 25 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 26 DRAFT
Discharging - Partially charged Low Battery - 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: ●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. 28 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 29 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. 30 DRAFT
Troubleshooting Electrode Placement Troubleshooting 31 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. 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 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. 33 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. 34 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 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 35 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 36 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. 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 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. 38 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 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. 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 40 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 41 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. 42 DRAFT

Navigation menu