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Instructions for use (qualified personnel) ...........................................................................

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8E70=*, 8E71=*, 8E72=*

Summary of Contents for 8E70

Page 1: ...Instructions for use qualified personnel 3 8E70 8E71 8E72...

Page 2: ...2...

Page 3: ...t is the operat or of the product according to the IEC 60601 1 2005 A1 2012 standard 2 Product description 2 1 Design The product consists of the following components 1 Distal phalanx 2 Middle finger...

Page 4: ...thumb is opposite the palm Tripod grip The index finger and middle finger are closed simultaneously with the thumb until the three fingers touch Ring and little fingers con tinue to close until they...

Page 5: ...maining fingers The object is released from the hand Application examples this grip can be used for example to operate spray bottles Pinch grip For this grip only the index finger and thumb meet while...

Page 6: ...asps the index finger sideways This makes it possible to secure and release flat objects with the thumb without movement of the remaining fingers Application examples this grip can be used to hold thi...

Page 7: ...signal Vibration signal Approx 1 second Switching between primary and secondary grips 1x short after releasing the program switch 1x short after releasing the program switch Between 2 and 3 seconds S...

Page 8: ...ment and replaced by a dif ferent terminal device with the same quick dis connect unit 8E71 bebionic hand Short Wrist Low profile connection for users with a long forearm or transcarpal amputation The...

Page 9: ...ions of use The product is intended exclusively for use on one user Use of the product by another person is not approved by the manufacturer The product was developed for everyday use and must not be...

Page 10: ...arried 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 Ob...

Page 11: ...uct an external visual inspection to verify that all parts of the product are undamaged In case of damage have the product repaired promptly CAUTION Penetration of product with dirt and humidity Injur...

Page 12: ...ttobock product training course is required prior to initial use Addition al product training courses may become necessary to qualify for software updates Transfer the setting changes to the terminal...

Page 13: ...internal data communication Therefore keeping a minimum distance of 30 cm from HF communication devices is recom mended CAUTION Operating the product in very close proximity to other electronic device...

Page 14: ...a result of a malfunction The product was developed for everyday use and must not be used for unusual activities These unusual activities include for example sports with excessive strain and or shock...

Page 15: ...are not included in the scope of delivery and must be supplied for operation bebalance 1 4 560X12 V1 4 or higher adjustment software Bluetooth adapter Bluetooth Long Range Dongle B33061 757B35 3 MyoEn...

Page 16: ...The thumb position is secured with an Allen screw on the bebionic hand small and a number 2 slotted screw on the bebionic hand medium The medial end stop can be adjusted with the screw when the thumb...

Page 17: ...sition the gaiter 10 Switch the terminal device on and test it with the user Thumb contact point The adjustment option makes it possible to optimise the contact point of the thumb with the opposite in...

Page 18: ...se of the adjustment software for information about the adjustment soft ware installation and establishing a connection to the product INFORMATION Cybersecurity Keep your operating system up to date a...

Page 19: ...s the thumb from getting caught in clothing and therefore reduces breaking of the thumb For information about the use putting on and taking off and care of the prosthetic glove please refer to the ins...

Page 20: ...hand on 1 Press and hold the program switch on the back of the hand for no longer than 2 to 3 seconds 2 After releasing the program switch a single short feedback signal is generated see page 28 INFO...

Page 21: ...able control of the switching mode is only possible with two good myo signals However the co contraction cannot be used as the switching mode between the hand and hand rotation The settings can be con...

Page 22: ...General workshop supplies Finger chain 9S296 Included in the tool kit Proceed as follows to replace the finger chain 1 Open the terminal device and bring the thumb into opposition 2 Switch off the pro...

Page 23: ...ck the flexion of the finger The finger chain has been replaced and the product can be used again INFORMATION Replacement of the finger chain by an authorised Ottobock Service Centre If the finger cha...

Page 24: ...bject 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...

Page 25: ...n 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 Phone 1...

Page 26: ...ransverse force on single finger static 44 N Force on chassis static supporting the hand 500 N Force with closed hand static carrying a bag 152 N Forces on thumb static 40 N Data transfer Wireless tec...

Page 27: ...equirements under the Radiocommunications Act AUS Non ionising radiation In some jurisdictions it is not permissible to dispose of these products with unsor ted household waste Disposal that is not in...

Page 28: ...product error are generated even when the feedback signals have been turned off Beep signal Vibration signal When Signal can be deactivated Function 1x short 1x short After releasing the program swit...

Page 29: ...sions Interference meas urements Compliance Electromagnetic environment directive HF emissions accord ing to CISPR 11 Group 1 class B The product uses HF energy exclusively for its internal functionin...

Page 30: ...Line against line IEC 61000 4 5 0 5 kV 1 kV Conducted interfer ence induced by high frequency fields IEC 61000 4 6 3 V 0 15 MHz to 80 MHz 6 V in ISM and amateur frequency bands between 0 15 MHz and 8...

Page 31: ...0 to 960 GSM 800 90 0 TETRA 800 iDEN 820 CDMA 850 GSM 800 90 0 LTE band 5 Pulse modu lation 18 Hz 2 0 3 28 1 720 1 845 1 970 1 700 to 1 990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Puls...

Page 32: ...ck com The product is covered by the following patents Canada CA 2 767 121 USA US 9 101 499 US 9 592 134 European Patent EP 2510906 in AT CH DE FR GB IT SE Patents pending in Canada and EPA Caution Fe...

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