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3 Intended use

3.1 Indications for use

The 8E550 Michelangelo Hand Transcarpal is to be used 

exclusively

 for upper limb exoprosthet­

ic fittings.

3.2 Conditions of use

The Axon-Bus prosthetic system was developed for everyday use and must not be used for unusu­
al  activities.  These  unusual  activities  include,  for  example,  sports  with  excessive  strain  and/or
shocks  to  the  socket  connection  (pushups,  downhill  racing,  mountain  biking,  ...)  or  extreme
sports (free climbing, paragliding, etc.). Furthermore, the Axon-Bus prosthetic system should not
be  used  for  the  operation  of  motor  vehicles,  heavy  equipment  (e.g.  construction  machines),
industrial machines or motor-driven equipment.
The product is intended 

exclusively

 for use on 

one

 patient. Use of the product by another person

is not approved by the manufacturer.
Permissible ambient conditions are described in the technical data (see page 13).

3.3 Indications

The 8E550 Michelangelo Hand Transcarpal can be used for unilateral or bilateral amputees from
a transradial to transcarpal amputation level or 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  conditions  which  contradict  or  go  beyond  the  specifications  listed  in  the  section  on
"Safety" and "Indications for use". 

3.5 Qualification

The fitting of a patient with the product may only be carried out by O&P professionals who have
been authorised with the corresponding Ottobock training.

4 Safety

4.1 Explanation of warning symbols

WARNING

Warning regarding possible serious risks of accident or injury.

CAUTION

Warning regarding possible risks of accident or injury.

NOTICE

Warning regarding possible technical damage.

4.2 Structure of the safety instructions

WARNING

The heading describes the source and/or the type of hazard

The  introduction  describes  the  consequences  in  case  of  failure  to  observe  the  safety  instruc­
tions. Consequences are presented as follows if more than one consequence is possible:
>

E.g.: Consequence 1 in the event of failure to observe the hazard

>

E.g.: Consequence 2 in the event of failure to observe the hazard

This  symbol  identifies  activities/actions  that  must  be  observed/carried  out  in  order  to  avert
the hazard.

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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