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11

WARNING

Use of the product while handling a firearm.

Injury due to unexpected product behaviour.

The product may not be used for handling firearms.

WARNING

Skin contact with leaking lubricants due to mechanical defects 

Injury due to skin irritation.

Avoid contact between leaking lubricants and the mouth, nose and eyes.

The product must be inspected by an authorised Ottobock Service Center.

CAUTION

Signs of wear on the product

Injury due to faulty control or malfunction of the product

In  the  interest  of  patient  safety  and  in  order  to  maintain  operating  reliability,  the  terminal
device has to be inspected by an authorised Ottobock Service Centre in case of noticeable
restrictions of functionality.

Note  that  the  functionality  of  the  terminal  device  may  be  limited  if  the  battery  charge  level
gets too low.

CAUTION

Use of a damaged product

Injury due to loss of product functionality.

Prior to use, conduct 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

Injury due to unexpected product behaviour or malfunction.

Ensure that neither solid particles nor liquids can penetrate into the product.

CAUTION

Independent manipulation of the product or product components

Injury due to faulty control or malfunction of the product due to manipulation 

Manipulations to the product other than the tasks described in these instructions for use are
not permitted.

Opening and repairing the product and any damaged components, and removing the back
of the hand, is reserved exclusively for authorised, qualified Ottobock personnel.

CAUTION

Insufficient skin contact of the electrodes

Injury due to faulty control or malfunction of the product.

The electrodes are to be placed on intact skin only and with as much electrode-skin contact
as possible.

In  the  case  of  strong  interference  from  electronic  devices,  the  position  of  the  electrodes
should be checked and changed if necessary.

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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