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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.

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

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.

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.

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.

Summary of Contents for Michelangelo Hand 8E500

Page 1: ...Instructions for use qualified personnel 3 Michelangelo Hand 8E500...

Page 2: ...1 2 2...

Page 3: ...t into use in accordance with the information contained in the accompanying documents supplied 2 Product description 2 1 Function The Michelangelo Hand is a myoelectrically controlled gripping compone...

Page 4: ...mately 75 in 4 locking positions extension is 45 with 3 locking positions Flexion and extension are performed passively A flexible and a rigid mode are available according to the application situation...

Page 5: ...3 Indications Amputation level transradial and transhumeral For unilateral or bilateral amputation Dysmelia of the forearm or upper arm The user must be able to understand usage instructions and safe...

Page 6: ...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...

Page 7: ...tware 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 pas...

Page 8: ...nents e g the terminal device CAUTION Changing Axon Bus gripping components when switched on Injury due to faulty control or malfunction of the Axon Bus prosthetic system Power down the Axon Bus prost...

Page 9: ...magnetic data carriers Wiping of the data carrier Do not place the charging plug on credit cards diskettes audio or video cassettes 5 Scope of Delivery and Accessories 5 1 Scope of delivery 1 pc 8E500...

Page 10: ...nformation see the instructions for use provided with the 13E500 AxonMaster and the 560X500 AxonSoft software 7 Use 7 1 Changing the Axon Bus gripping component Attaching the Axon Bus gripping compone...

Page 11: ...n A pulsating beep sounds as it opens 2 Releasing the button immediately stops the process of opening the Axon Bus gripping component and turns the entire Axon Bus prosthetic system off 8 Maintenance...

Page 12: ...any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15...

Page 13: ...Canada limits for the general population consult Safety Code 6 obtainable from Health Canada s website http www hc sc gc ca rpb Responsible party Otto Bock Healthcare Canada Ltd 5470 Harvester Road L...

Page 14: ...N Gripping force Lateral Mode Approx 60 N Gripping force Neutral Mode Approx 15 N Load limits Maximum vertical load on the palm with locked wrist joint e g when holding a sphere 10 kg 22 1 lbs Maximu...

Page 15: ...15...

Page 16: ...663 339 US 8 690 963 European Patent EP 1962732 in AT DE FR GB IT NL SE TR EP 1962734 in AT DE FR GB IT NL SE TR EP 1962737 in AT DE FR GB IT NL SE TR EP 1962738 in DE FR GB TR EP 1971297 in AT DE FR...

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