Declaration Of Conformity - ORTHOSERVICE RO+TEN extra-S 15 Mode D'emploi

Please read the instructions carefully and thoroughly

DECLARATION OF CONFORMITY

As the manufacturer, ORTHOSERVICE AG declares with sole responsibility that this
product is a Class I medical product and has been manufactured in accordance with
the basic requirements of the directives 93/42/EEC and 2007/47/EEC. These operating
instructions were created in accordance with the specification of the above-mentioned
directives. They aim to ensure the safe and correct use of the medical product.
TRADEMARKS OF MATERIALS
Velcro is a registered trademark of Velcro Industries B.V.
®
SELECTION/SIZE
Item right REF. E113 15° REF. E115 30°
Item left REF. E114 15° REF. E116 30°
Size S M L
Forearm length cm* < 34 35/39 > 40
*Measurement taken from elbow to end of closed fist
Colour: black
specify right or left
C H A R A C T E R I S T I C S A N D M A T E R I A L S
• Cussion made from high-density foam. The fabric that comes into direct contact
with the body has silver fibres woven into it
• Neck protection sleeve
• Covering and sleeve with a nylon gauze on the outside to facilitate the Velcro
• Buckle straps and adjustable Velcro fastening
®
• Option of extra rotation of 15° or 30°
• Rehabilitation ball
• Thumb support
• Arm support pocket made of breathable material
I N D I C A T I O N S
• Post-operative care (extra rotation) after operations on the rotator cuff, the joint of the
glenoid labrum, capsular stabilisation, operations to the soft tissue of the shoulder
• Conservative treatment of initial stages of a luxation of the glenohumeral joint
C O N T R A I N D I C A T I O N S
Currently no known
grip
®