Related Manuals for Otto Bock Michelangelo Hand 8E500
Summary of Contents for Otto Bock Michelangelo Hand 8E500
- Page 1 Michelangelo Hand 8E500 Instructions for use (qualified personnel) ................
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Page 3: Product Description
These instructions for use provide you with important information on the use, adaptation and handling of the product. 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 far to the outside; this achieves a flat hand position with a completely opened thumb position. Opposition Power Grip The opening width makes it possible to hold cylindrical objects with large diameters and with an open thumb position.
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Page 5: Intended Use
2.2 Combination possibilities This product is to be combined exclusively with components in the Axon-Bus prosthetic system. Components of the Ottobock MyoBock system or components from other manufacturers cannot be used with this product. 3 Intended use 3.1 Indications for Use The Michelangelo Hand 8E500 is to be used exclusively for exoprosthetic fittings of the upper limbs. - Page 6 > E.g.: Consequence 2 in the event of failure to observe the hazard This symbol identifies activities/actions that must be observed/carried out in order to avert ► the hazard. 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.
- Page 7 4.4 Information on Proximity to Certain Areas CAUTION Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal detectors) Injury due to unexpected behaviour of the prosthesis system caused by interference with internal data communication. Avoid remaining in the vicinity of visible or concealed theft prevention systems at the ►...
- 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 Donning the prosthetic glove INFORMATION Do not use silicone spray when putting on the prosthetic glove. This impairs the secure fit of the glove and can limit the functionality of the product (hand). 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. -
Page 11: Maintenance
CAUTION Storage of the product in the closed state Injury due to faulty control or malfunction of the product as a result of damage to the sensors and mechanism. Store the product only in the neutral position or in the open state. ►... - Page 12 9.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. This product meets the requirements of the 2014/53/EU directive.
- Page 13 RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website http://www.hc-sc.gc.ca/rpb. Responsible party: Otto Bock Healthcare Canada Ltd. 5470 Harvester Road L7L 5N5 Burlington, Ontario Canada...
- Page 14 11.2 Technical data Ambient conditions Storage (with and without packaging) +5 °C/+41 °F to +40 °C/+104 °F Max. 85%relative humidity, non-condensing Transport (with and without packaging) -20 °C/-4 °F to +60 °C/+140 °F Max. 90% relative humidity, non-condensing Operation -5 °C/+23 °F to +45 °C/+113 °F Max. 95% relative humidity, non-condensing General information Reference number 8E500 Opening width...
- Page 16 R.O.C. Design Patent D 128 170; D 128 171 USA: Patent US D 595,854; D 597,672; D 694,189; D697 030 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.