Intended Use; Safety Instructions - Otto Bock 8E38 9 Instructions For Use Manual

in die Klasse I eingestuft. Die Konformitätserklärung wurde deshalb von Ottobock in alleiniger
Verantwortung gemäß Anhang VII der Richtlinie erstellt.
16 Anhänge
16.1 Betriebszustände/Fehlersignale
Ladezustand des Akkus
Ein intelligentes Akkumanagement informiert den Patienten über den abnehmenden Ladezustand
des Akkumulators, indem die Hand immer langsamer wird bzw. weniger Griffkraft aufbaut. Der
Akkumulator wird gleichzeitig vor schädlicher Tiefentladung geschützt.
Ein zweiter geladener Akkumulator sollte zum Wechseln bereitgestellt werden.
Date of the last update: 2015-09-22
• Please read this document carefully.
• Follow the safety instructions and the precautions specified in this accompanying document.
• If assistance is required during the start-up, use or maintenance of the product, as well as
in the event of unexpected operating behaviour or circumstances, contact the manufacturer
(see manufacturer's address on the back of this accompanying document).

1 Intended use

1.1 Medical Purpose
The MyoHand VariPlus Speed (8E38=9, 8E39=9, and 8E41=9) are to be used solely for the
exoprosthetic fitting of the upper extremities.
1.2 Application
The MyoHand VariPlus Speed (8E38=9, 8E39=9, and 8E41=9) can be used for unilateral or
bilateral amputees.
1.3 Conditions of use
The MyoHand VariPlus Speed (8E38=9, 8E39=9, and 8E41=9) have been developed for everyday
use and must not be used for unusual activities such as extreme sports (free climbing, paraglid-
ing, etc.).
The MyoHand VariPlus Speed (8E38=9*, 8E39=9* and 8E41=9*) is designed exclusively for use
on one patient. Use of the product by other persons is not approved by the manufacturer.
1.4 Prosthetist qualifications
The fitting of a patient with the MyoHand VariPlus Speed (8E38=9, 8E39=9, and 8E41=9) may
only be carried out by prosthetists who have been trained and certified by Ottobock for the use
of MyoBock components.

2 Safety instructions

Non-observance of safety instructions
Non-observance of the following safety instructions can lead to product malfunction or
defects and result in a risk of injury to the patient.
• Do not use silicone spray when putting on the cosmetic glove; silicone spray does not allow for
a proper fit. We recommend using Procomfort Gel (633S2) as a mounting aid.
8E38=9, 8E39=9, 8E41=9
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