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13

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.
The  full  text  of  the  regulations  and  requirements  is  available  at  the  following  Internet  address:
http://www.ottobock.com/conformity

10 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

Charging the battery

+5 °C/+41 °F to +40 °C/+104 °F
Max. 85%relative humidity, non-condensing

General information

Reference number

8E550=L-M or 8E550=R-M

Opening width

120 mm/4.72 inch

Weight of Michelangelo Hand without prosthet­
ic glove

approx. 460 g/16 oz

Length: 12 mm (in
scope of delivery)

Length: 14 mm (in
scope of delivery)

Approved screws for connecting Michelangelo
Hand with socket

501S101=M4X12

501S84=M4X14

Product service life

5 years

The following gripping forces and load limits apply only when the battery of the Axon-Bus pros­
thetic system is fully charged and at room temperature.

Maximum gripping forces 

Gripping force "Opposition Mode"

Approx. 70 N

Gripping force "Lateral Mode"

Approx. 60 N

Gripping force "Neutral Mode"

Approx. 15 N

Load limits

Maximum vertical load on the palm (e.g. when
holding a sphere)

10 kg/22.1 lbs

Maximum load on the actively driven fingers
(index finger, middle finger) in the fully open
hand position (e.g. holding a plate)

10 kg/22.1 lbs

Maximum load on the actively driven fingers
(index finger, middle finger) in the closed hand
position (e.g. carrying bags)

20 kg/44.1 lbs

Maximum vertical load on the knuckles (e.g.
bracing oneself on the fist)

60 kg/132 lbs

Содержание Michelangelo Hand Transcarpal 8E550

Страница 1: ...Instructions for use qualified personnel 3 Michelangelo Hand Transcarpal 8E550...

Страница 2: ...2...

Страница 3: ...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 Function The Michelangelo Hand is a myoelectrically controlled gripping c...

Страница 4: ...on setting can be adjusted within a range of 15 see page 11 see fig 8 Opposition Power Grip The opening width makes it possible to hold cylindrical objects with large diameters and with an open thumb...

Страница 5: ...in the case of dysmelia of the forearm The patient must fulfil the physical and mental requirements for perceiving visual acoustic sig nals and or mechanical vibrations 3 4 Contraindications All cond...

Страница 6: ...not open the power supply unit adapter plug or battery charger Do not expose the power supply unit adapter plug or battery charger to extreme loading conditions Immediately replace damaged power supp...

Страница 7: ...to unexpected product behaviour Participation in an Ottobock product training course is mandatory prior to using the product During this product training course you will receive a password giving you...

Страница 8: ...mperature range see page 13 CAUTION Penetration of dirt and moisture in the Axon Bus components Injury due to faulty control or malfunction of the Axon Bus prosthetic system Ensure that neither solid...

Страница 9: ...rging plug on credit cards diskettes audio or video cassettes 5 Scope of Delivery and Accessories 5 1 Scope of delivery 1 pc 8E550 L R M Michelangelo Hand Transcarpal 1 pc 10S550 M lamination ring Inc...

Страница 10: ...nd and gives the Transcarpal prosthesis a natural appearance The recommended alignment is to be used as a guideline for the prosthetic alignment Before the lamination ring is laminated the position of...

Страница 11: ...o short use longer screws Please see the section Technical data for approved screws see page 13 6 1 2 Connecting the Michelangelo Hand with the socket 8 9 10 Once the socket has been completed the rot...

Страница 12: ...riod This is the only way to maintain full warranty cover Additional services such as repairs may be provided in the course of maintenance These addi tional services may be provided free of charge or...

Страница 13: ...on Reference number 8E550 L M or 8E550 R M Opening width 120 mm 4 72 inch Weight of Michelangelo Hand without prosthet ic glove approx 460 g 16 oz Length 12 mm in scope of delivery Length 14 mm in sco...

Страница 14: ...authority pertaining to return and collec tion Declaration of conformity according to the applicable European directives Serial number YYYY WW NNN YYYY year of manufacture WW week of manufacture NNN s...

Страница 15: ...15...

Страница 16: ...th Korea KR 101 131 692 KR 101 169 834 KR 101 178 679 KR 101 178 646 USA US 7 867 287 US 8 016 969 US 8 257 446 US 8 188 835 US 8 579 991 Patents pending in Australia Brazil Canada China EPA Germany I...

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