Related Manuals for Otto Bock 757M20 Series
Summary of Contents for Otto Bock 757M20 Series
- Page 1 757M20=* Instructions for use (qualified personnel) ................
- Page 2 Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device.
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Page 3: Product Description
Only put the product into use in accordance with the information contained in the accompanying documents supplied. According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operat or of the product according to the IEC 60601-1:2005/A1:2012 standard. -
Page 4: Intended Use
Explanation of symbols 1. Donning direction (left/right) The arrow has to point towards the hand. 2. Charging receptacle 3. Alignment for the patient's ulna 4. Electrode position (1–8) 3 Intended use 3.1 Indications for use The product is to be used exclusively for exoprosthetic fittings of the upper limbs. 3.2 Conditions of use The product is to be used exclusively for the period of end user evaluation and training. - Page 5 4.2 Structure of the safety instructions WARNING The heading describes the source and/or the type of hazard The introduction describes the consequences in case of failure to observe the safety instruc tions. Consequences are presented as follows if more than one consequence is possible: >...
- Page 6 CAUTION Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal detectors) Injury due to unexpected behaviour of the product caused by interference with internal data communication. Avoid remaining in the vicinity of visible or concealed theft prevention systems at the ►...
- Page 7 NOTICE Insufficient skin contact of the electrodes Insufficient information about the suitability of the muscle signals to use MyoPlus ► Makes sure that the contact surfaces of the electrode domes are placed on intact skin only and have full-surface contact during a test. NOTICE Shifting of the electrodes Insufficient information about the suitability of the muscle signals to use MyoPlus...
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Page 8: Preparing The Product For Use
→ The product is switched off automatically. → The charging process starts. 2) Disconnect the battery charger from the product after the charging process is complete. 7 Preparing the product for use 7.1 Determine electrode position 1) Pull the product over the end user's forearm. 2) Position the product 6 to 7 cm distal of the olecranon. - Page 9 8 Myo Plus app With the Myo Plus app, the user can view and evaluate their signals and the fre quently used functions together with the O&P professional. The repeatability of movements can be trained with the app. When combined with the product, the app permits the simulation of bebionic hands or MyoBock hands.
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Page 10: Cleaning And Care
9 Use 9.1 Evaluating muscle signals in the MyoPlus app To perform an evaluation of the muscle signals or for training, the following steps have to be completed: 1) Press the charging receptacle button and hold for one second. → The product is switched on. →... -
Page 11: Legal Information
11.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic devices. -
Page 12: Technical Data
Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmit ter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA Phone + 1-801-956-2400 Fax + 1-801-956-2401 This device complies with RSS 210 of Industry Canada. - Page 13 Ambient conditions Storage between subsequent applications -25 °C/-13 °F to +35 °C/95 °F 15% to 90% relative humidity, non-condensing +35 °C/95 °F to +70 °C/158 °F Water vapour pressure up to 50 hPa Operation +5 °C/41 °F to +40 °C/104 °F 15% to 90% relative humidity, non-condens ing; air pressure 533 hPa to 1060 hPa Charging the battery 0°C/+32°F to +45°C/+113°F General...
- Page 14 Declaration of conformity according to the applicable European directives Manufacturer In some jurisdictions it is not permissible to dispose of these products with unsor ted household waste. Disposal that is not in accordance with the regulations of your country may have a detrimental impact on health and the environment. Please observe the instructions of your national authority pertaining to return and collec...
- Page 15 Event Cause Required action rectly configured in the app. General fault • Turn the Myo gaiter off and back on again Unexpected display of the No contact between • The Myo gaiter has to fully contact the recognised movement in the electrodes and residual limb case of unfavourable resid...
- Page 16 Phenomenon EMC basic standard Interference immunity test level test procedure IEC 61000-4-5 Surges ± 0.5 kV, ± 1 kV Line against line IEC 61000-4-6 Conducted interfer 3 V ence induced by high- 0.15 MHz to 80 MHz frequency fields 6 V in ISM and amateur frequency bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz Voltage drops IEC 61000-4-11...
- Page 17 Test fre Frequency Radio ser Modulation Maximum Distance Interfer quency band vice power [W] ence [MHz] [MHz] immunity test level [V/m] 2,450 2,400 to Bluetooth Pulse modu 2,570 WLAN 802.1 lation 1 b/g/n, 217 Hz RFID 2450 LTE band 7 5,240 5,100 to WLAN 802.1 Pulse modu 5,800 1 a/n lation...
- Page 20 The product is covered by the following patents: USA: US 9,566,016 B2 Patents pending in: Germany Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 info.austria@ottobock.com · www.ottobock.com...
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