Rehabtronics CSST1 StimRay User Manual
Rehabtronics Inc. StimRay
User Manual
AF User Manual CS-IFU-EN Revision A (DRAFT) 2017-07-27 Table of Contents Introduction Device Description List of Symbols Safety Information Warnings Precautions System Components STIM Component CHARGER Component APP Component ELECTRODE Component AF Contraindications 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 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 22 Error Messages 22 23 23 Electrical Component Specifications 23 Environmental Specifications AF Technical Information General Troubleshooting Stimulation Specifications 24 Wireless Specifications 25 Electromagnetic Compatibility 26 Contact & Re-ordering Information 30 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 ● ● ● ● ● AF ● 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 ● ● ● ● ● 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 ● ● ● ● ● ● ● AF ● 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: 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. 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 Application to the StimRay System AF IP22 Definition The STIM component uses low-energy radio frequencies. Symbol 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. 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. AF Do not transport or store the StimRay outside the pressure range indicated. Transportation and storage pressure limits European Authorized Representative 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: ● ● ● ● ● Abs Adductors Biceps Calves Deltoids ● ● ● ● ● Forearms Glutes Hamstrings Lats Lower-Back ● ● ● ● Pecs Quads Traps Triceps AF 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. System Requirements The StimRay system requires the following: StimRay Components (Included in system kit) STIM Component Mobile device running iOS 10, or later USB power supply (output: 5V, 1A-2A) System Components 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 AF Other Requirements (non-included) 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. 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 Using the STIM AF Download the “StimRay” app from the Apple App Store onto your mobile device. 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 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: Solid Blue (Ready) The STIM will automatically turn off when it is not connected to either an ELECTRODE or CHARGER. When connected to a CHARGER, this means that: ● ● Blinking Blue (Standby) The STIM is powered off. All stimulation functions and MOBILE APP connections are disabled. The STIM charging The STIM is waiting for MOBILE APP pairing AF No Activity (Off) Meaning When connected to a CHARGER, this means the the STIM battery is fully charged. Stim LED When connected to an ELECTRODE, this means that the STIM is on, and ready to start stimulating. The STIM is sending stimulation pulses to the ELECTRODE. Orange (Active - Stimulating) Flashing Red (Low Battery) This is only possible when the STIM is connected to the ELECTRODE, and controlled with the MOBILE APP. The STIM battery has less than 10% capacity remaining. 11 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 STIM LED Status Charging Complete Charging Error Solid blue LED Solid red LED Charging in Progress AF 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: Pulsing blue 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 Replacement pads are available from Rehabtronics (see “Contact and Re-ordering Information” section of this manual). ELECTRODE hydrogel pads can be replaced as follows: AF 1. Peel off and discard previous hydrogel pads from the ELECTRODE. 2. Apply new hydrogel pads to the ELECTRODE pad areas. 13 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: AF Applying ELECTRODES to the Body 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. ● Abs ELECTRODES are applied to the body by using the sticky hydrogel pads, such that the circular pads are placed over the desired muscle group. 14 Adductors ● Biceps ● Calves AF ● 15 Deltoids ● Forearms ● Glutes AF ● 16 Hamstrings ● Lats ● Lower-Back AF ● 17 Pecs ● Quads ● Traps AF ● 18 ● Triceps Using the MOBILE APP AF The MOBILE APP contains further instructions and images as to how to apply ELECTRODES to specific areas. 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 A red text “CONNECTING” will appear 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” AF 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 I nstructions 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 Naming STIM Units The MOBILE APP allows paired STIM units to be assigned a name, so they can be recognized easily in the future. AF Naming / Renaming Instructions: Click Bellow the text “RENAME STIM” Keyboard will appear, name your STIM, then click “ Done” Selecting Muscle Groups The new name of your STIM will Appear 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 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: AF Choose the desired mode from the mode selection screen on the MOBILE APP. Exercise Mode Description 22 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 AF 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. Long Resistance RECOMMENDED MUSCLE GROUPS:ADDUCTORS, DELTOIDS, GLUTES, LOWER BACK, TRAPS, WRIST FLEXORS/EXTENSORS 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 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. AF Use up to 3 times a week per muscle group, in between or after your strength training workouts. DURATION: 20-26 MINS Explosive Strength RECOMMENDED MUSCLE GROUPS: BICEPS, HAMSTRINGS, PECS, QUADS, TRICEPS 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 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. AF Use within 2 hours after intensive training. Potentiation 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 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 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 AF 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 Discharging - Partially charged AF Low Battery - Less than 20% charge remaining 27 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: ● WARNING: Do not immerse components in water or any other liquid. Doing so can permanently damage the electronics. AF ● 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. ● 28 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 AF 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 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. AF 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 Troubleshooting AF Electrode Placement Troubleshooting 31 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: 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. AF Source of Discomfort WARNING: If persistent pain is experienced, discontinue use immediately and contact your healthcare professional. 32 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. AF 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 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: Potential Cause(s) Low Battery on my StimRay Battery is low Recommended Action(s) DISPLAY Message AF Recharge the Lithium ion battery internal heating of components Electrode fault on my StimRay Electrode not making good contact with skin or Stimray not making good contact with the electrode connector. System Fault on my StimRay Component failure or StimRay not making a good contact with the electrode holder. High Temperature fault on my StimRay 34 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. 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 Mode of Operation Applied Part Type Means of Supply Mains Isolation Power Specifications CSCG1 Non Transit-Operable Portable Equipment Continuous N/A AF Equipment Usage & Type Model Number STIM CHARGER Direct plug-in adaptor USB Powered 5V, 1 - 2A 35 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 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) 100 mA @ 500 ohms Maximum Output Current (±10%) 100 mA @ 2 kohms 0 mA @ 20 k Ohm (fault state) 125 uS - 400 uS Pulse Duration 1 mS AF 1 Hz - 125 Hz Pulse Frequency Pulse Width 36 Wireless Specifications The following table details the wireless specifications for the STIM: Data Rate Maximum Transmit Power Modulation Scheme Modulating Signal Type Modulation Baud Rate RF Frequency Channels Channel Spacing Antenna Type Transceiver Duplex Scheme Bit Error Rate Packet Error Rate Receiver Sensitivity Command Delay Transmitter Duty Cycle Operating Range Operating Frequencies 2402– 2480 MHz 2402,2426 and 2480 in advertising mode and other 37 channels in the range of 2402-2480 MHz 1 Mbps 0 dBm GFSK Binary Data 1 MHz 40 Channels 2 MHz + channel hopping Printed F type PCB antenna with 5 dBi maximum gain. Time Division Duplexing Less than 0.1% Less than 5% -96 dBm Less than 1 Second Less than 0.2% Up to 5 meters AF Operating Frequency Range NOTE: The Federal Aviation Administration rules require that all radio-transmitting devices be turned off during flight. 37 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. RF Exposure Warning AF 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. IC Regulatory Statements 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. 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 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 AF 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 Recommended separation distances between portable and mobile RF communications equipment and the StimRay System AF 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 Rated (m) maximum output power 80 MHz to 800 MHz 150 kHz to 80 MHz 800 MHz to 2.5 GHz of transmitter (W) 40 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity AF 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 Immunity Test IEC 60601 Test Level Compliance Level Environment - Guidance 41 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 IEC 60601 Compliance Electromagnetic Environment - Guidance Test Test Level Level Contact & Reordering Information Web: w ww.rehabtronics.com Email: support@rehabtronics.com Phone: 1-866-896-7277 AF Manufactured By: Rehabtronics Inc. #4352, 10230 Jasper Ave. Edmonton, Alberta, Canada T5J 4P6 For device support, or to reorder components, contact Rehabtronics Inc. via any of the following channels: 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 CSST1 Charger CSCG1 Electrode CSED1 Hydrogel Pads CSEP1 Recommended Re-order Interval (component service life) 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
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