Declaration Of Conformity - ORTHOSERVICE 500 Bedienungsanleitung

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
Size S M L
Shoe size 35/39 39/44 > 44
Colour: grey
fits right and left
Option: REF. 501 Wedges for the heel, specify right or left
REF. 505 Diabetic Set, fits right and left
Option:
REF. 501
Wedges for the
heel, specify
right or left
Option: REF. 510
REF. 505 short version
Diabetic Set,
fits right and 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
• Reinforcing shells on the front and back, for higher stability
• Inflatable air pads for optimum wearing comfort and improved stabilisation
• Structure in lightweight, sturdy plastic
I N D I C A T I O N S
• Conservative treatment of ankle fractures
• Severe sprains (3rd degree)
• Post-operative phase after osteosynthesís of ankle fractures
• Stabilisation of ligament injuries of the ankle and Achilles tendon
• Stable foot, ankle, tibia and fibular distal fractures
C O N T R A I N D I C A T I O N S
The application of this protector is advised only when it is documented that the fracture
is stable and there are acceptable limits of angular and rotational misalignments.