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1 Foreword

English

INFORMATION

Date of last update: 2022-02-07

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 8E550=R/L Michelangelo Hand Transcarpal is referred to as the product / Axon-Bus terminal
device / Michelangelo Hand below.
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 Function

The  Michelangelo  Hand  is  a  myoelectrically  controlled  gripping  component  in  the  modular
Ottobock Axon-Bus prosthetic system. The complex gripping kinematics combined with the ana­
tomical  appearance  and  low  weight  support  the  patient  in  his  or  her  daily  activities,  thereby
providing the highest rehabilitation value.
The Michelangelo Hand is equipped with two drives to achieve a natural motion pattern. The main
drive  is  responsible  for  the  gripping  movements  and  gripping  force.  The  thumb  drive  facilitates
the two gripping modes 'Opposition Mode' and 'Lateral Mode'. Actively driven components are
thus the thumb, index finger and middle finger. The ring finger and little finger passively follow the
movements.

Gripping modes of the Michelangelo Hand

The following gripping options are possible:

Neutral Position

Natural, physiological appearance in the rest position.

Lateral Power Grip

The thumb moves laterally to the index finger; this laterally fixates medium-
sized objects when the thumb is in the half-open position.

3

Summary of Contents for Michelangelo Hand Transcarpal 8E550

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

Page 2: ...2...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 15: ...15...

Page 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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