PANTONE 2945C
PANTONE 2945C
8
ENGLISH
I Class Medical Device according to
Directive 93/42/EEC and further modifications
CODE
ST323
- PVC water cushion with central hole
ST324
- PVC water cushion
INTRODUCTION
Thank you for purchasing a LEVITAS water cushion by Moretti S.p.A. 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
NOTE
CHECK ALL PARTS FOR SHIPPING DAMAGES AND TEST BEFORE USING.
IN CASE OF DAMAGE, DO NOT USE THE DEVICE. CONTACT YOUR DEALER FOR
FURTHER INSTRUCTIONS
INTENDED USE
The water cushion have been designed for bedsore care
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. are compliant with the applicable provisions out-
lined 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 said 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 and further modifications to the proper authorities
GENERAL WARNINGS
• DO NOT use this product or any available optional equipment without first completely
reading and understanding this instruction manual. If you are unable to understand the
warnings, cautions or instructions, contact a healthcare professional, dealer or technical
personnel before attempting to use this equipment otherwise injury or damage may occur
• Advise with physician or therapist to determinate the correct adjustment and
the correct use of the cushion
• Keep the item away from heat sources