General Information; Preface; Ce Conformity; Liability - Otto Bock E-MAG Active Instructions For Use Manual

Date of the last update: 2014-08-22
• Please read this document carefully.
• Follow the safety instructions.

1 General Information

1.1 Preface

Your orthotist has fabricated an individual leg orthosis for you.
The integrated E-MAG Active is a knee joint system with controled stance phase which allows
you to swing freely in the swing phase and lock the knee joint before heel strike for a secure
stance phase. The knee joint electronics determines the position of your leg and unlocks the
knee joint for the swing phase accordingly. Please read also the Quick Start Guide, 646D517.
The E-MAG Active is a sealed system, which means that the joint is less susceptible to contami-
nation and also prevents clothing from becoming trapped. Not only is this gentle on your clothing
but, above all, offers you enhanced safety.
Two clearly distinguishable switches on a button control unit allow you to electronically unlock
the joint (once) or engage the lock (permanently). In addition, the mechanical (temporary) unlock
feature supports a larger area of application, for example when cycling.
These Instructions for Use describe the functions and operation of the E-MAG Active as well as
how to charge it and care for it.
For technical questions, please ask your orthotist.

1.2 CE Conformity

The product meets the requirements of the European Directive for Medical Products 93/42/EEC.
Based on the classification criteria for medical products according to Appendix IX of the guide-
line, the product was classified as Class I. The declaration of conformity was therefore created
by Ottobock with sole responsibility according to appendix VII of the guidelines.

1.3 Liability

The manufacturer's warranty applies only if the product has been used under the conditions
and for the purposes described. The manufacturer recommends that the product be used and
maintained according to the instructions for use.
12 | Ottobock E-MAG Active