Introduction; Purpose And Use Of Devices In The Line Genu; Essential Performance; Responsibilities Of Easytech - easytech Isokinetic Genu Iso User Manual

1. INTRODUCTION

This manual applies to the equipment:
GENU-Iso
GENU-Plus 1936

1.1 PURPOSE AND USE OF DEVICES IN THE LINE GENU

The devices in question are medical devices within the meaning of Article 1, paragraph 2
of Directive 93/42/EEC and subsequent amendments and additions, as it was intended
to be used on humans for the purpose of rehabilitation therapy using dynamic action
(motion isokinetic, hydrodynamic, isotonic, eccentric) or static (isometric).
The devices are intended for physical therapy in the field of rehabilitation and has been
designed to allow the assessment and rehabilitation of the functions of flexion and
extension of the muscles and knee joint.
In particular, on the basis of the definitions of the All. IX, Rule 9 of the Directive, it is:
•
GENU-Iso: Medical treatment of class I.
•
GENU-Plus: Any active medical device therapeutic class IIb.
Therefore it is a device to be used under direct medical supervision.
The devices are manufactured in compliance with Directive 93/42/EEC and subsequent
amendments and additions.

1.2 ESSENTIAL PERFORMANCE

The device has no life support function for the patient. Non of its functions is
indispensable expept those of movement control event in the event of single fault.

1.3 RESPONSIBILITIES OF EASYTECH

Easytech reserves the right to make changes and/or improvements to this manual and
its products without prior notice. At the same time the manufacturer declines any
whatsoever responsibility for damages or inconveniences arising from typographical
errors contained in this manual.
Easytech declines any responsibility regarding the safety and functionality of Isokinec
Devices, if:
Easytech s.r.l. – Genu Iso/Plus User's Manual
rev. C
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