Instructions For Use - Otto Bock 12K100N 50-S Instructions For Use Manual

Konformitätserklärung wurde deshalb von Ottobock in alleiniger Verantwortung gemäß Anhang VII der Richtlinie
erstellt.
Das Produkt erfüllt außerdem die Anforderungen der Richtlinie 1999/5/EG für Funkanlagen und Telekommunika-
tionsendeinrichtungen. Die Konformitätsbewertung wurde von Ottobock nach Anhang III der Richtlinie durchgeführt.
Eine Kopie der Konformitätserklärung kann unter der Adresse des Herstellers (siehe letzte Seite) angefordert werden.
Date of last update: 2014-01-24
• Please read this document carefully.
• Follow the safety instructions and the stated precautions 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).
Before fitting the patient with the 12K100N=50-S DynamicArm , please first read the 647G152

Instructions for Use !

1 Intended Use
1.1 Medical Purpose
The 12K100N=50-S DynamicArm is to be used solely for the duration of the service and for trial fittings for exo-
prosthetic fittings of the upper limbs.
1.2 Application
The 12K100N=50-S DynamicArm is suitable for unilateral and bilateral above-elbow amputees. The 12K100N=50-S
DynamicArm is to be used exclusively for the fitting of adults.
1.3 Application Conditions
The 12K100N=50-S DynamicArm has been developed for everyday use and must not be used for unusual activi-
ties such as extreme sports (free climbing, paragliding, etc.).
1.4 Prosthetist Qualification
The fitting of a patient with a 12K100N=50-S DynamicArm may only be carried out by prosthetists who have been
authorized by Ottobock based on completion of a corresponding training course.
2 Safety Instructions
Please learn the safety instructions as well as patient information from the 647G152 Instructions for
Use for the 112K100 DynamicArm .
Failure to follow the safety instructions mentioned below can lead to faulty control or malfunction of
the 12K100N=50-S DynamicArm and result in risk of injuries for the patient.
3 Service Information
The 12K100N=50-S DynamicArm must be sent for examination to the authorized Ottobock Service after every
patient fitting. In the service the complete DynamicArm will be examined and possibly readjusted and any wear-
ing parts will be exchanged if necessary.
4 Adjustment, Fittings, Application
Before fitting the patient with the 12K100N=50-S DynamicArm , please first read the 647G152 Instructions for
Use for the 12K100N DynamicArm . They include important additional information about the application of the
12K100N=50-S DynamicArm .
DynamicArm Service (Service/Test)
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