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Avoid  remaining  in  the  vicinity  of  visible  or  concealed  theft  prevention  systems  at  the
entrance/exit of stores, metal detectors/body scanners for persons (e.g. in airports) or other
sources of strong magnetic and electrical interference (e.g. high-voltage lines, transmitters,
transformer stations, computer tomographs, magnetic resonance tomographs, etc.).

When  walking  through  theft  prevention  systems,  body  scanners  or  metal  detectors,  watch
for unexpected behaviour of the prosthetic system.

CAUTION

Distance  to  HF  communication  devices  is  too  small  (e.g.  mobile  phones,  Bluetooth
devices, WiFi devices)

Injury due to unexpected behaviour of the prosthesis system caused by interference with internal
data communication.

Therefore, keeping the following minimum distances to these HF communication devices is
recommended:
• Mobile phone GSM 850/GSM 900: 0.50 m
• Mobile phone GSM 1800/GSM 1900/UMTS: 0.35 m
• DECT cordless phones incl. base station: 0.18 m
• WiFi (routers, access points,…): 0.11 m
• Bluetooth devices (third-party products not approved by Ottobock): 0.11 m

4.5 Information on Alignment/Adjustment

CAUTION

Operator errors during the adjustment process with the adjustment software

Injury due 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  access  to  the
adjustment  software. Additional  product  training  courses may  become  necessary to qualify
for software updates.

Do not share your unlock PIN.

Use the online help which is integrated into the software.

CAUTION

Incorrect electrode settings

Injury due to unexpected product behaviour.

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. If the interference cannot be elim­
inated or if you do not achieve the expected results by adjustment or selection of the appro­
priate control programme, please contact the Ottobock branch responsible for your country.

Set the electrode gain as low as possible in order to reduce interference from powerful elec­
tromagnetic  radiation  (e.g.  visible  or  or  concealed  theft  prevention  systems  at  the
entrance/exit of stores), metal detectors/body scanners for persons (e.g. in airports) or other
sources  of  strong  electromagnetic  interference  (e.g.  high-voltage  lines,  transmitters,  trans­
former stations, computer tomographs, magnetic resonance tomographs, etc.).

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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