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1 Foreword

English

INFORMATION

Date of last update: 2022-02-14

Please  read  this  document  carefully  before  using  the  product  and  observe  the  safety
notices.

Instruct the user in the safe use of the product.

Please contact the manufacturer if you have questions about the product or in case of prob­
lems.

Report each serious incident related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.

Please keep this document for your records.

The  8E500=R/L  Michelangelo  Hand  is  referred  to  as  the  product  /  Axon-Bus  terminal  device  /
Michelangelo Hand below.
These  instructions  for  use  provide  you  with  important  information  on  the  use,  adaptation  and
handling of the product.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operat­
or of the product according to the IEC 60601-1:2005/A1:2012 standard.
Only put the product 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  component  in  the  modular
Ottobock Axon-Bus prosthetic system. The complex gripping kinematics combined with the ana­
tomical  appearance  and  low  weight  support  the  patient  in  his  or  her  daily  activities,  thereby
providing the highest rehabilitation value.
The Michelangelo Hand is equipped with two drives to achieve a natural motion pattern. The main
drive  is  responsible  for  the  gripping  movements  and  gripping  force.  The  thumb  drive  facilitates
the two gripping modes 'Opposition Mode' and 'Lateral Mode'. Actively driven components are
thus the thumb, index finger and middle finger. The ring finger and little finger passively follow the
movements.

Gripping modes of the Michelangelo Hand

The following gripping options are possible:

Neutral Position

Natural, physiological appearance in the rest position.

Lateral Power Grip

The thumb moves laterally to the index finger; this laterally fixates medium-
sized objects when the thumb is in the half-open position.

3

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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