Declaration Of Conformity - ORTHOSERVICE RO+TEN iper35 Instructions

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 S+ M M+
Pelvic circumf. cm 60/75 60/75 75/90 75/90 90/105 90/105 105/115 105/115
Height
hyperextension
brace cm 32/38 38/44 35/41 41/50
* measured from the proximal side of the corpus sterni to the upper edge of the pubic bone (tuberculum pubicum)
Colour: grey
Dorsolumbal
pelotte, can
be positioned
horizontally and
vertically
L L+ XL XL+
37/44 44/52 40/46 46/55
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
• Telescopic: The screws do not have to be removed, but only loosened for adjustment
• Pelvic band made from flexible polymer. A new fixation mechanism permits
a quick and safe change
• Possibility of blocking the spring oscillation using polymer wedges
• Newly designed pin fasteners for easy closing by the patient
• Strap can be adjusted with ratchet closure
• Removable PE foam pads, attached with snap fasteners, covered with synthetic PU
material on the outside and blended elastane fabric on the inside
• Base structure made from light aluminium alloy, frame construction
• Movable sternal plate
• Dorsolumbal pelotte, can be positioned horizontally and vertically
• Plus-closure made of light, robust composite material with safety lock
• Protective axilla pads made from hypoallergenic, non-toxic material
I N D I C A T I O N S
• Traumatic fractures (T10-L1/L2)
• Osteoporotic or metastatic-related compression fractures of the thoracic spine
and the dorsolumbar transition (T10-L1/L2)
• Osteomalacia with fractures
• Dorsolumbar osteoarthritis
• Substitute for plaster corset
C O N T R A I N D I C A T I O N S
Currently no known