Otto Bock 12K110N-50-S Instructions For Use Manual page 11

14 CE-Konformität
Hiermit erklärt Otto Bock Healthcare Products GmbH, dass das Produkt den anwendbaren europäischen Vor-
gaben für Medizinprodukte entspricht.
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
Medizinprodukt
Date of last update: 2021-04-15
• 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 12K110N=50-S DynamicArm Plus , please first read the
647G526=all_INT Instructions for Use !
1 Intended use
1.1 Medical purpose
The 12K110N=50-S DynamicArm Plus is to be used solely for the duration of the service and for trial fittings for
exoprosthetic fittings of the upper limbs.
1.2 Application
The 12K110N=50-S DynamicArm Plus is suitable for unilateral and bilateral above-elbow amputees. The
12K110N=50-S DynamicArm Plus is to be used exclusively for the fitting of adults.
1.3 Application conditions
The 12K110N=50-S DynamicArm Plus has been developed for everyday use and must not be used for unusual
activities such as extreme sports (free climbing, paragliding, etc.).
1.4 Prosthetist qualification
The fitting of a patient with a 12K110N=50-S DynamicArm Plus 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 647G526=all_INT Instruc-
tions for Use for the 12K110N DynamicArm Plus .
Failure to follow the safety instructions mentioned below can lead to faulty control or malfunction of
the 12K110N=50-S DynamicArm Plus and result in risk of injuries for the patient.
3 Serviceinformation
The 12K110N=50-S DynamicArm Plus 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
wearing parts will be exchanged if necessary.
DynamicArm Plus Service
English
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