3
ENGLISH
Class I Medical Equipment
according Directive 93/42/EEC and subsequent amendment
1. CODES
RCA136 Oxygen bottle holder
CPA606 Oxygen bottle holder
2. INTRODUCTION
Thank you for choosing an accessories manufacturer by MORETTI S.p.A. Their design and
quality are a guarantee of comfort, safety and reliability. The accessory by MORETTI S.p.A.
is designed and built to meet all your demands for a practical, correct use. This user manual
provides some suggestions to correctly use the accessory you have chosen and offers a lot
of valuable advice for your safety. Please read carefully through the manual before using the
accessory. Should you have any queries, please contact your retailer for advice and assistance.
3. INTENDED USE
The Oxygen bottle holder is primarily intended for people who have mobility and respiratory
problems. However they are adaptable both in hospitals and home.
NOTE: Check that the product has not been damaged during shipment. In case of damage do
not use it and contact your dealer for further instructions
WARNING!
• Do not use the product for a purpose not indicated in this manual.
• Moretti S.P.A. declines all responsibilities 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.
4. 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 wheelchairs and aid accessories
range are in compliance with the applicable provisions outlined in the Medical Devices
Directive 93/42/ EEC and further modifications. For this purpose 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 full list of the devices at issue are specified in Annex A in declaration.
3. The devices in question ARE NOT MEASUREMENT DEVICES.
4. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATION.
5. The devices in question are sold in NON STERILE packing.
6. The devices in question should be considered as belonging to class I.
7. DO NOT use/install the devices in question for any other purpose than that expressly
indicated by Moretti S.p.A.
8. Moretti S.p.A. maintains and submits the documentation certifying conformity with
Directive 93/42/EEC and further modifications to the proper authorities.
4.1 Standards and guidelines reference
Test di sicurezza prescritti dalla norma UNI EN 12182:2001