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Phone + 1-801-956-2400
Fax + 1-801-956-2401

This device complies with RSS 210 of Industry Canada. 
Operation is subject to the following two conditions: 
(1) this device may not cause interference, and 
(2)  this  device  must  accept  any  interference,  including  interference  that  may  cause  undesired
operation of this device. 

L’ utilisation de ce dispositif est autorisée seulement aux conditions suivantes: 
(1) il ne doit pas produire d’interference et 
(2)  l’  utilisateur  du  dispositif  doit  étre  prêt  à  accepter  toute  interference  radioélectrique  reçu,
même si celle-ci est susceptible de compromettre le fonctionnement du dispositif.

Caution: Exposure to Radio Frequency Radiation.

The installer of this radio equipment must ensure that the antenna is located or pointed such that
it  does  not  emit  RF  field  in  excess  of  Health  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
L7L 5N5 Burlington, Ontario
Canada
Phone + 1-800-665-3327

Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner
licensed by law of the State in which he/she practices to use or order the use of the device.

10 Appendices

11 Appendices

11.1 Symbols Used

Manufacturer

In some jurisdictions it is not permissible to dispose of these products with unsor­
ted household waste. Disposal that is not in accordance with the regulations of
your country may have a detrimental impact on health and the environment. Please
observe the instructions of your national 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 – sequential number

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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