Mopedia MP165, Instruction Manual

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ENGLISH ENGLISH
Class I medical device
according Directive 93/42/EEC and subsequent amendments
1. CODES
MP165 - Aluminum bedside rails with support on the ground
MP167 - Aluminum reversible telescopic bedside rails
2. INTRODUCTION
Thank you for choosing an accessory MOPEDIA by Moretti. The bedside rails have been
designed and built to meet all your needs for a practical use, correctly and safely. This manual
contains some suggestions for proper use of the accessory of your choice and valuable tips
for your safety. You should read carefully all of this manual before using the bedside rails.
CAUTION!
• Do not use the following device for purposes other than those described in this manual.
• Moretti S.p.A. disclaims any liability for damage resulting from improper use
of the device or use other than that described in this manual.
• We reserve the right to make changes to the device and this manual without notice
in order to improve the characteristics.
• Always pay close attention to the presence of moving parts that could cause
limb entrapment and injury.
• Always pay attention to the presence of children.
3. INTENDED USE
The bedside rail is a universal accessory designed to prevent an accidental fall of a person
from a any bed. It may provide a useful support to facilitate the raising and the seat from the
bed and can be placed, optionally on both sides of the bed.
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 the support aids 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 full list of the devices at issue are specified in Annex A to the 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 to the proper authorities and further modifications.