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4.3 General safety instructions

WARNING

Non-observance of safety notices

Personal injury/damage to the product due to using the product in certain situations.

Observe the safety notices and the stated precautions in this accompanying document.

WARNING

Operating the prosthetic system near active implanted systems

Interference with active implantable systems (e.g., pacemaker, defibrillator, etc.) due to electro­
magnetic interference of the prosthetic system.

When  operating  the  prosthetic  system  in  the  immediate  vicinity  of  active  implantable  sys­
tems, ensure that the minimum distances stipulated by the manufacturer of the implant are
observed.

Make sure to observe any operating conditions and safety instructions stipulated by the man­
ufacturer of the implant.

WARNING

Use of damaged power supply unit, adapter plug or battery charger

Risk of electric shock due to contact with exposed, live components.

Do 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 supply units, adapter plugs or battery chargers.

CAUTION

Independent manipulation of the product

Injury due to malfunction and resulting unexpected prosthesis actions.

Manipulations to the product other than the tasks described in these instructions for use are
not permitted.

The product and any damaged components may only be opened and repaired by authorised,
qualified Ottobock personnel.

CAUTION

Signs of wear on the product

Injury due to faulty control or malfunction of the product.

In the interest of the patient's safety and in order to maintain operating reliability, the product
should be serviced at regular intervals.

4.4 Information on Proximity to Certain Areas

CAUTION

Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention
systems, metal detectors)

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

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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