Declaration Of Conformity - Orthoservice Ro+Ten Genufit 08 Handbuch

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 XS S M L
Thigh circ. taken
15 cm above 33/39 39/45 45/52 52/58
mid-patella cm
Length cm 34 34 34 34
black · fits right and left
New, very soft
and seamless
popliteal insert
made of Soft-X fabric
XL XXL
58/66 66/75
34 34
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
• New anatomical, tight-fit design allows
flexible movement and adjusts optimally to the joint
• Breathable, skin-friendly AirX™ fabric
• New, very soft and seamless popliteal insert made of Soft-X fabric
for pleasant wearing comfort
• New soft elastic border
• Genufit 08/15 only: Patella opening with foam stabiliser
• Genufit 08A/15A only: New front opening for easier application: internal
fastening system for prefixing and external fastening system for final fixing.
Patella cut-out
• Redesigned fastening system
(European Patent)
and elastic insert for the adjustment of optimal pressure settings
• Genufit 08/08A only: New, flexible, flat plastic sleeves for splint and strap attachment
• Genufit 08/08A only: Spiral-shaped lateral support splints
• Genufit 15/15A only: Flat polycentric hinged bars
I N D I C A T I O N S
• REF. G1108 · G1108A only: Initial gonalgia after sprain trauma
with mild residual collateral ligament slackness (knee inoperable)
• REF. G1115 · G1115A only: Gonarthrosis or the after-effects of distorsions
with residual instability of the collatoral ligaments (inoperable knee)
• REF. G1108 · G1115: Mild latero-medial instability of the patella
• REF. G1108 · G1115 only: Femoro-patellar arthrosis
C O N T R A I N D I C A T I O N S
Currently no known
: Stabilizing straps with buckles