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12

Observe the instructions for use provided for the prosthetic glove and the process for putting it
on and taking it off described in the same.

6.3 Settings

Adjustments  to  the  product  can  be  made  via  Bluetooth  data  transmission  using  the  560X500=*
AxonSoft  software.  For  this  purpose,  a  wireless  connection  must  be  established  between  the
13E500 AxonMaster and the PC with the help of the 60X5 BionicLink PC.
For further information, see the instructions for use provided with the 13E500 AxonMaster and the
560X500=* AxonSoft software.

7 Cleaning

NOTICE

Improper product care

Damage to the product due to the use of incorrect cleaning agents.

Only clean the product with a damp cloth and mild soap (e.g. 453H10=1-N Ottobock Der­
maClean).

1)  Clean  the  product  with  a  damp  cloth  and  mild  soap  (e.g.  Ottobock  453H10=1-N  Derma

Clean) when needed.
Ensure that no liquid penetrates into the system component(s).

2)  Dry the product with a lint-free cloth and allow it to air dry fully.

8 Maintenance

Performing  regular  maintenance  (service  inspections)  every  24  months  is  recommended  to  pre­
vent injuries and maintain the quality of the product.
The grace period is no more than one month before or three months after maintenance is due.
In general, all products are subject to compliance with the maintenance intervals during the war­
ranty period. 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  can  be  billable  according  to  an  advance  cost
estimate, depending on the extent and validity of the warranty.
The following components must always be sent in for maintenance and repairs:
The  product,  battery  charger  and  power  supply.  The  shipping  container  for  the  loaner  unit  you
receive must be reused for sending back the components requiring inspection.

9 Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.

9.1 Liability

The manufacturer will only assume liability if the product is used in accordance with the descrip­
tions  and  instructions  provided  in  this  document.  The  manufacturer  will  not  assume  liability  for
damage  caused  by  disregarding  the  information  in  this  document,  particularly  due  to  improper
use or unauthorised modification of the product.

9.2 Trademarks

All  product  names  mentioned  in  this  document  are  subject  without  restriction  to  the  respective
applicable trademark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of
the respective owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justi­
fy the conclusion that the denotation in question is free of third-party rights.

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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