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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.

9.3 CE conformity

Otto  Bock  Healthcare  Products  GmbH  hereby  declares  that  the  product  is  in  compliance  with
applicable European requirements for medical devices.
This product meets the requirements of the 2014/53/EU directive.
The  full  text  of  the  regulations  and  requirements  is  available  at  the  following  Internet  address:
http://www.ottobock.com/conformity

9.4 Local Legal Information

Legal information that applies 

exclusively

 to specific countries is written in the official language

of the respective country of use in this chapter.

This  device  complies  with  part  15  of  the  FCC  Rules.  Operation  is  subject  to  the  following  two
conditions:
1) This device may not cause harmful interference, and
2)  This  device  must  accept  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 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment generates uses and can
radiate radio frequency energy and, if not installed and used in accordance with the instructions,
may  cause  harmful  interference  to  radio  communications.  However,  there  is  no  guarantee  that
interference will not occur in a particular installation. If this equipment does cause harmful inter­
ference  to  radio  or  television  reception,  which  can  be  determined  by  turning  the  equipment  off
and on, the user is encouraged to try to correct the interference by one or more of the following
measures:
—Reorient or relocate the receiving antenna.
—Increase the separation between the equipment and receiver.
—Connect  the  equipment  into  an  outlet  on  a  circuit  different  from  that  to  which  the  receiver  is
connected.
—Consult the dealer or an experienced radio/ TV technician for help.
Any  changes  or  modifications  not  expressly  approved  by  the  party  responsible  for  compliance
could void the user’s authority to operate the equipment.

Caution: Exposure to Radio Frequency Radiation.

This device must not be co-located or operating in conjunction with any other antenna or transmit­
ter.
Responsible party:
Otto Bock Health Care, LP
3820 West Great Lakes Drive
Salt Lake City, Utah 84120-7205 USA

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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