Ottobock 12K100N-50-S Instructions D'utilisation page 11

Das Produkt erfüllt die Anforderungen der RoHS-Richtlinie 2011/65/EU zur Beschränkung der Verwendung be-
stimmter gefährlicher Stoffe in Elektro- und Elektronikgeräten.
Das Produkt erfüllt die Anforderungen der Richtlinie 2014/53/EU.
Der vollständige Text der Richtlinien und Anforderungen ist unter der folgenden Internetadresse verfügbar: http://
www.ottobock.com/conformity
15 Angewandte Symbole
Date of last update: 2021-03-26
• Please read this document carefully before using the product and observe the safety notices.
• Please contact the manufacturer if you have questions about the product or in case of problems.
• 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.
Before fitting the patient with the DynamicArm 12K100N=50-S , please first read the
647G152=all_INT Instructions for Use !
1 Indications for use
1.1 Medical purpose
The DynamicArm 12K100N=50-S 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 DynamicArm 12K100N=50-S is suitable for unilateral and bilateral above-elbow amputees. The
DynamicArm 12K100N=50-S is to be used exclusively for the fitting of adults.
1.3 Application conditions
The DynamicArm 12K100N=50-S 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 DynamicArm 12K100N=50-S 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=all_INT Instruc-
tions for Use for the 112K100 DynamicArm .
Failure to follow the safety instructions mentioned below can lead to faulty control or malfunction of
the DynamicArm 12K100N=50-S and result in risk of injuries for the patient.
3 Service information
The DynamicArm 12K100N=50-S must be sent for examination to the authorized Ottobock Service after every
patient fitting. In the service the complete DynamicArm/DynamicArm Plus will be examined and possibly readjusted
and any wearing parts will be exchanged if necessary.
DynamicArm Service (Service/Test)
Medizinprodukt
English
Ottobock | 11