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1 Foreword

English

INFORMATION

Date of last update: 2022-02-09

Please  read  this  document  carefully  before  using  the  product  and  observe  the  safety
notices.

Instruct the user in the safe use of the product.

Please contact the manufacturer if you have questions about the product or in case of prob­
lems.

Report each serious incident related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.

Please keep this document for your records.

The  products  "8E70=*  bebionic  hand  EQD,  8E71=*  bebionic  hand  Short  Wrist  and  8E72=*
bebionic hand Flex" are referred to as the product/terminal device/hand in the following.
These  instructions  for  use  provide  you  with  important  information  on  the  use,  adaptation  and
handling of the product.
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.

2 Product description

2.1 Design

The product consists of the following components:

1. Distal phalanx
2. Middle finger joint 
3. Finger chain
4. Program switch (see page 7)
5. Back of the hand
6. Wrist joint
7. CMC joint of the thumb
8. Gaiter
9. Distal thumb joint

2.2 Function

The product is a myoelectrically controlled and multiarticulating hand prosthesis. 
The  product  enables  objects  to  be  gripped,  pushed,  pulled  and  carried  with  multiarticulating
functionality.  The  product  is  designed  to  resemble  the  anatomical  structure  and  weight  of  a
human hand.
The thumb can be set to two different positions (opposition and lateral), allowing for 14 different
grips (see page 3). Eight grips can be preconfigured using the adjustment software.
A finger chain that protects the drive serves as overload protection for the 4 actively powered fin­
gers. In case of overloading, the corresponding finger cannot be flexed anymore since the con­
nection to the drive was severed. The finger chain can be replaced without disassembling the ter­
minal device (see page 22).

Essential performance of the product

No essential performance according to IEC 60601-1

3

Содержание 8E70

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

Страница 2: ...2...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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