Otto Bock Michelangelo Hand Transcarpal 8E550 Instructions For Use Manual
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- Instructions for use manual (152 pages)
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Summary of Contents for Otto Bock Michelangelo Hand Transcarpal 8E550
- Page 1 Michelangelo Hand Transcarpal 8E550 Instructions for use (qualified personnel) ................
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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 Lateral Pinch The thumb moves laterally to the index finger; this laterally fixates flat objects when the thumb is in the closed position. Open Palm In the open palm position, the thumb is positioned all the way out; this allows for a flat hand position with a completely opened thumb position. The degree of mobility for internal and external rotation of the forearm depends on the length of the residual limb.
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Page 5: Intended Use
3 Intended use 3.1 Indications for use The 8E550 Michelangelo Hand Transcarpal is to be used exclusively for upper limb exoprosthet ic fittings. 3.2 Conditions of use The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusu al activities. - Page 6 4.3 General safety instructions WARNING Non-observance of safety notices Personal injury/damage to the product due to using the product in certain situations. Observe the safety notices and the stated precautions in this accompanying document. ► WARNING Operating the prosthetic system near active implanted systems Interference with active implantable systems (e.g., pacemaker, defibrillator, etc.) due to electro...
- Page 7 Avoid remaining in the vicinity of visible or concealed theft prevention systems at the ► entrance/exit of stores, metal detectors/body scanners for persons (e.g. in airports) or other sources of strong magnetic and electrical interference (e.g. high-voltage lines, transmitters, transformer stations, computer tomographs, magnetic resonance tomographs, etc.). When walking through theft prevention systems, body scanners or metal detectors, watch ►...
- Page 8 4.6 Information on Use CAUTION Improper use Injury due to malfunction and resulting unexpected prosthesis actions. Instruct the patient in the proper use of the product. ► CAUTION Mechanical stress on the product Injury due to faulty control or malfunction of the product. Do not subject the product to mechanical vibrations or impacts.
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Page 9: Scope Of Delivery And Accessories
4.7 Information on the Power Supply/Battery Charging CAUTION Charging the product with soiled or damaged contacts Injury due to unexpected behaviour of the product caused by insufficient charging. Make sure that the contacts are always clean and free of grease. ►... -
Page 10: Preparing The Product For Use
6 Preparing the product for use 6.1 Alignment INFORMATION The Axon-Bus prosthetic system cannot be used as long as the charging plug is connected to the charging receptacle. The Axon-Bus prosthetic system is deactivated for the duration of char ging. Please observe the following points during alignment of the Michelangelo Hand Transcarpal: Flexion and ulnar deviation The Michelangelo Hand Transcarpal is designed in such a way that the hand is positioned in a... - Page 11 3) (see fig. 5) If extra reinforcement is required, use double-sided adhesive tape to affix carbon fibre cloth to the first layer of the Perlon stockinette as a frame structure. 4) Pull the second layer of Perlon stockinette downwards over the carbon fibre cloth. →...
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Page 12: Maintenance
Observe the instructions for use provided for the prosthetic glove and the process for putting it on and taking it off described in the same. 6.3 Settings Adjustments to the product can be made via Bluetooth data transmission using the 560X500=* AxonSoft software. -
Page 13: Technical Data
9.3 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 14 Load limits Weight of objects (typical diameter 18 kg/39.6 lbs 19 mm/0.75 inch) before they slide out of the hand ("Power Grip" grip type) 11 Appendices 11.1 Symbols Used Manufacturer In some jurisdictions it is not permissible to dispose of these products with unsor ted household waste.
- Page 16 Patent US D 595,854; D 597,672; D 694,189 Design Patents pending in India. Michelangelo is a tradename of Otto Bock Healthcare GmbH. Michelangelo is a registered trademark in many countries of the world, beside others registered at the US Patent and Trade mark Office, Reg.–No. 4008171.