Declaration Of Conformity - ORTHOSERVICE RO+TEN lumbopull70 Mode D'emploi

Please read the instructions carefully and thoroughly
The images shown serve solely explanatory purposes.

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.
®
MAINTENANCE
do not bleach
do not iron
Washing instructions: Remove the metal frame from the back section as described.
Washing in hand-hot water (max. 30° C) with a neutral soap, rinse carefully and
dry away from heat sources.
Do not dispose of the product or any of its components into the environment
PRECAUTIONS
It is advised that the pressure exerted by the product does not act on parts of the body
suffering from wounds, swelling or lumps. The product should not be tightened too firmly so
as to avoid the development of pressure points or compression of the nerves or blood vessels
underneath. It is advisable to wear the product over a garment, avoiding direct contact with
the skin. If in doubt about how to apply, contact an orthopaedic technician. The device should
not be worn in the vicinity of open flames or strong electromagnetic fields.
WARNINGS
The product may only be used in the event of medical indication or when prescribed by a
physician and must be applied by an orthopaedic technician, the competent authority figure
for the application as well as for information on the safe use, according to individual needs.
To ensure the effectiveness, tolerability, and correct operation, it is necessary that the device
is put on with the utmost care. Any changes to the structure or adjustment of the device must
be prescribed by a physician and performed by an orthopaedic technician. Under no
circumstances should the adjustment made by the physician/orthopaedic technician be
altered. Use of the product is recommended for a single patient. With hypersensitive patients,
direct contact with skin may cause redness or irritation. In the case of onset of pain, swelling,
lumps or any unusual reaction, immediately contact your physician.
no chemical cleaning
do not tumble-dry