Related Manuals for Hasomed RehaMove3
Summary of Contents for Hasomed RehaMove3
- Page 1 RehaMove3 Instructions for Use Read the Instructions for use (IFU) before you use the device Version 1.0 / 2017-07 / ©HASOMED GmbH...
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Page 2: Table Of Contents
................................. 27 4.2.2 4.2.2.1 Science Mode ..........................27 Electrode error detection ................................. 28 4.2.3 5 Maintenance and Service Instructions 5.1 Cleaning and Disinfection ................................. 29 5.2 Stimulator Battery ................................. 29 Charging ................................. 29 5.2.1 Version 1.0 / 2017-07 / ©HASOMED GmbH... - Page 3 ................................. 31 6.1.2 Button and LED Management ................................. 32 6.1.3 6.1.3.1 Usage Buttons ..........................32 6.1.3.2 Status LED ..........................32 6.1.3.3 Stimulation LED ..........................32 6.2 Complaint form for unwanted events ................................. 34 Version 1.0 / 2017-07 / ©HASOMED GmbH...
- Page 4 Release date: July 2017 Language: English HASOMED GmbH Paul-Ecke-Str. 1 39114 Magdeburg Germany Phone: +49 (0) 391 - 61 07 650 E-Mail: info@rehamove.de Webpage: www.hasomed.de Subject to Modifications ©HASOMED GmbH...
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Page 5: Safety Notes
The RehaMove3 is classified as a medical device class IIa. An inspection of the device must be carried out by the HASOMED service staff only. You are not allowed to open the device. The repair of the RehaMove3 must be performed only by the manufacturer. -
Page 6: Symbols And Labels
RehaMove3 Instructions for Use Symbols and Labels The following symbols and labels are used on the RehaMove3. The rating plate stating the exact model name, CE mark and corresponding number of the notified body, date of manufacture, and power supply details are located on the head of the stimulator. -
Page 7: Dangers
Users of RehaMove3 have to consider the risk of strangulation when using electrode cables. Prevent the equipment from immersion in water or other liquids. The RehaMove3 is not waterproof. -
Page 8: Warnings
Electrical muscle stimulators shall be used exclusively with the electrodes and cables recommended by the manufacturer. Use only the connection systems that have been tested for compatibility with RehaMove3. Version 1.0 / 2017-07 / ©HASOMED GmbH... - Page 9 The safety of patients, users, third parties and equipment cannot be guaranteed if components of the RehaMove3 are not connected directly to the mains power supply. Therefore, do not connect the RehaMove3 to the mains power supply using an extension cable or a multiple socket outlet.
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Page 10: Cautions
Place the RehaMove3 in such a way that it is easy to disconnect it from the mains power supply, but make sure that the power supply cord cannot be accidentally disconnected by a person or object (no trip hazards). - Page 11 HASOMED gives no warranty for obvious misuse. The stimulation parameter setting should be made only after consultation with a healthcare professional.
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Page 12: Electromagnetism
Electromagnetism 1.6.1 Electromagnetic Emission The RehaMove3 is intended for use in the electromagnetic environment specified below. The user of the RehaMove3 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment - guidance The RehaMove3 uses RF energy only for its internal function. -
Page 13: Electromagnetic Immunity
Safety Notes 1.6.2 Electromagnetic Immunity The RehaMove3 is intended for use in the electromagnetic environment specified below. The user of the RehaMove3 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment -... -
Page 14: Guidance And Manufacturer´s Declaration
RehaMove3 Instructions for Use 1.6.3 Guidance and manufacturer´s declaration The RehaMove3 is intended for use in the electromagnetic environment specified below. The user of the RehaMove3 should assure that it is used in such an environment. Immunity IEC 60601 test Compliance... - Page 15 RF transmitters an electromagnetic site survey should be considered. If the measured field strength in the location in which the RehaMove3 is used, exceeds the applicable RF compliance level above, the RehaMove3 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be ary, such as reorienting or relocating the RehaMove3.
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Page 16: Recommended Separation Distances
1.6.4 Recommended separation distances The RehaMove3 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The user of the RehaMove3 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the RehaMove3 as recommended below, according to the maximum output power of the communication equipment. -
Page 17: General Information
General Information RehaMove3 at a glance The RehaMove3 is a portable electrical stimulation device that generates impulses, on up to 4 channels nearly simultaneously, to activate paralyzed muscles via surface electrodes. The RehaMove3 can be used for training and rehabilitation applications. Numerous parameters concerning power and temporal sequence of the impulses can be adjusted individually for each channel. -
Page 18: Responsible Organisation
Only authorized people can have access to the device. A list of authorized users is kept for the device. Make sure that unauthorized people do not tamper with the device The information in this user manual shall be strictly observed in full and without restriction Version 1.0 / 2017-07 / ©HASOMED GmbH... -
Page 19: Declaration Of Conformity
General Information 2.2.2 Declaration of Conformity HASOMED confirms that RehaMove3 is appropriate to the essential requirements for safety and health of all relevant European guidelines. The declaration of conformity is base of the CE-Mark of RehaMove3. HASOMED declares the compliance to follow the ‘ElektroStoffV’ of 09.05.2013 and to consider the RoHS (Restriction of Hazardous Substances). -
Page 20: Correct Usage
3.1.3 Description of function The stimulator RehaMove3 is a device for functional electrical stimulation and generates electrical pulses in order to stimulate muscles via surface electrodes on up to 4 channels simultaneously. The stimulator is battery operated, so it can be used network-independent and mobile. -
Page 21: Contraindications
Fractures: Unhealed fractures exclude the application of the RehaMove3 until they are healed Wounds: Unhealed wounds exclude the application of the RehaMove3 until they are healed Additional contraindications for arm training:... - Page 22 Allergic reaction to the gel used in the electrodes (ask your medical supplier) The stimulation can be interrupted immediately by press and holding the on/off-button of RehaMove3 or by disconnecting of an electrode or electrode cable. The electrode detection ensures that stimulation stops due to the interrupted connection of RehaMove3 and the electrode.
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Page 23: Electrode Application
Not later than after 30 sessions, After a maximum utilization time of 3 months, If a problem occurs during the product specific use, If skin irritations occur or The electrodes exceeded the use-by date indicated on the package. Version 1.0 / 2017-07 / ©HASOMED GmbH... -
Page 24: Side Effects
In known allergies against electrode material, be careful when making your choice. Electrodes must not be placed on excoriations or gashes. Using the RehaMove3 can cause additional adverse reactions: Allergies to electrodes must be taken into consideration when choosing them Skin irritation or lesions can result from poor electrode contact with the skin or incorrectly set electrical parameters. -
Page 25: Device Description
Enviroment conditions +5 °C to +34 °C; RH 15% to 93%, not In use condensating -20°C bis +45°C; RH 0% - 80%, not Transporting/storing condensating (recommended to ensure battery life cycle) Stimulator/Controller Display/Interface keypad Version 1.0 / 2017-07 / ©HASOMED GmbH... - Page 26 Range of atmospheric pressure 700 to 1060 hPa IP classification IP XO Protection class Application part Typ BF Medical device according to EU guidelines MDD 93/42/EWG Version 1.0 / 2017-07 / ©HASOMED GmbH...
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Page 27: System Components
The transport case mandatory includes: 1 stimulator 3 electrode cables 1 power supply unit for the stimulator 4 sets of electrodes 1 Instructions for Use Version 1.0 / 2017-07 / ©HASOMED GmbH... - Page 28 RehaMove3 Instructions for Use 4.2.1.1 RehaMove3 RehaMove3 provides 4 operation buttons. The back of the stimulator shows the type label. A belt clip can be added optionally. On the right side of the stimulator, the following connections can be found:...
- Page 29 Inverting the connections can damage the stimulator and cause unwanted reactions. 4.2.1.2 Electrode Cables RehaMove3 provides three electrode cables with 1 or 2 channels each. All cables are color coded to avoid wrong application. CAUTION! Do not pull on cables to unplug electrodes.
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Page 30: Type Label
RehaMove3 using an external device (e.g. PC or similar devices). ScienceMode enables the communication between a controlling device and the RehaMove3 via USB using a virtual serial interface (FTDI) to control all stimulation tasks. RehaMove3 with ScienceMode offers two advanced layers for high scientific FES performance. -
Page 31: Electrode Error Detection
4.2.3 Electrode error detection To ensure that the electrodes are conductively connected the RehaMove3 uses a biphasic test pulse right in front of the stimulation pulse. The test pulse is applied independently of the communication protocol. The amplitude is 15 mA and the pulse duration is 15 µs. -
Page 32: Maintenance And Service Instructions
Maintenance and Service Instructions Cleaning and Disinfection Clean the RehaMove3 regularly for hygienic reasons. Use a dry or slightly moist cloth. If there are persistent stains, you can also soak the cloth in alcohol or a universal (BMF) cleaner. Never use strong detergents, soaps or solvents. -
Page 33: Maintaining The Technical Safety
The manufacturer recommends for the stimulator a maintenance interval of 2 years in order to guarantee the safety standards for further use. Hence, please send your RehaMove3 on your own account to the manufacturer. HASOMED will examine the adherence to technical parameters and the function of the monitoring elements. -
Page 34: Main Functions
Check that the supply voltage of the unit matches with your line voltage. Only connect the RehaMove3 with the main outlet if the values match. If they do not match or damages to the power supply occur, please contact the manufacturer HASOMED GmbH. -
Page 35: Button And Led Management
Green – slow blinking Low rechargeable battery (11-20%); Low battery Orange – slow blinking Please connect power supply. Very low rechargeable Very low battery Red – slow blinking Battery (<11%); Please connect power supply. Version 1.0 / 2017-07 / ©HASOMED GmbH... - Page 36 LED state Description After the first initialization, the LED is switched Yellow On, Off, blinking on during the stimulation (at least one channel is active). Fast blinking Electrode error at least on one channel. Version 1.0 / 2017-07 / ©HASOMED GmbH...
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Page 37: Complaint Form For Unwanted Events
All devices must be monitored since the first placing on the market to ensure a highest level of usability and user safety. Appearing complaints must be reported, documented and evaluated immediately by HASOMED. Complete specifications of the user, device details and the complaint are mandatory. Please complete the following document in the event of an error.
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