21
ENGLISH
Class Medical Device according to Directive
93/42/ECC and further modifications
ST905
Alternating pressure relief seat cushion
1. INTRODUCTION
Thank you for purchasing LEVITAS cushion by Moretti S.p.A. product range. This user's manual
provides some suggestions as how to correctly use the product you have chosen and gives some
valuable advice for your safety. Please read through the manual carefully before using the product.
Should you have any queries, please contact your retailer for advice and assistance. In case of doubts,
we recommend to contact the dealer who can help and advice you properly.
2. INTENDED USE
The cushion has been designed for the bedsore treatment and prevention, which may occur during
long period seated on a wheelchair.
WARNING!
• Do not use the product for a purpose not indicated in this manual
• Only qualified personnel or trained for the treatment and prevention of bedsore,
can operate with the device
• Moretti S.p.A. declines all responsabilities for any consequences resulting from an
incorrect use of this product and from unauthorized alteration to the frame of the
product
• The manufacturer reserves the right to change the information contained in this
document without previous notice
3. EC DECLARATION OF CONFORMITY
Moretti S.p.A. hereby declares, under its own exclusive responsibility, that the products
manufactured and sold by Moretti S.p.A. and belonging to the antidecubitus cushions category
are in compliance with the applicable provisions outlined in the Medical Devices Directive 93/42/
EEC and further modifications.
To this end Moretti S.p.A. guarantees and declares as follows, under its own responsibility:
1. The devices in question satisfy the essential requirements of Annex I of directive 93/42/ EEC
as prescribed by Annex VII of the above directive
2. The devices in question ARE NOT MEASUREMENT DEVICES
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION
4. The devices in question are sold in NON STERILE packing
5. The devices in question should be considered as belonging to class I
6. DO NOT use/install the devices in question for any other purpose than that expressly
indicated by Moretti S.p.A.
7. Moretti S.p.A. maintains and submits the documentation certifying conformity with
Directive 93/42/EEC to the proper authorities and further modifications
8. The products in question are manufactured using non dangerous materials in conformity
with the directive 2011/65/UE - ROHS2
