Codes; Introduction; Intended Use; Declaration Of Conformity - Mopedia RP200 Manual De Instrucciones

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

1. CODES

RP200 Chest strap
RP210 Girdle chest belt
RP215 Butterfly-shaped girdle chest belt
Full pelvic belt
RP220
RP225 Separate pelvic belt
RP240 Wrist strap

2. INTRODUCTION

Thank you for choosing an aid in the MOPEDIA range by Moretti. The KOALA restraint systems
by Moretti have been designed and constructed to satisfy all your needs for practical, correct
and safe use. This manual contains useful suggestions for using your device properly and safely.
Please read this entire manual carefully before you use the device. Should you have any queries,
please contact your dealer for suitable advice and assistance.
Check to ensure that no parts of the product have been damaged during shipment.
NOTE:
Do not use the product if it is damaged and contact the retailer for further instructions.
Do not use the product for any purpose other than that specified in this manual.
Moretti S.p.A. declines any and all liability for damages resulting from improper use
of the device or any use other than that specified in this manual. The manufacturer
reserves the right to modify the device and its relevant manual without prior notice,
in order to improve the product's features.

3. INTENDED USE

The KOALA restraint systems by Moretti are used to avoid slipping forwards and as a restraint for
patients seated in a wheelchair or on a commode chair. These aids are particularly comfortable,
thanks to the padded fabric used in their manufacture. They have a length-adjustable tape
and clip closures that allow quick and correct positioning for any build and on all wheelchair,
commode chair or high chair models, and also quick release in the case of an emergency.

4. DECLARATION OF CONFORMITY

MORETTI SpA declares, under its own exclusive responsibility, that the products manufactured
and sold by MORETTI SpA in the RESTRAINT SYSTEMS product family conform with the
applicable provisions of Regulation (EU) 2017/745 of 5 April 2017 on MEDICAL DEVICES.
To this end, MORETTI SpA guarantees and declares as follows, under its own exclusive responsibility:
1. The devices in question satisfy the general safety and performance requirements set out
in Annex I to Regulation (EU) 2017/745, as prescribed by Annex IV to said regulation.
2. The devices in question ARE NOT MEASUREMENT TOOLS. 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, in accordance with the
rules set out in Annex VIII to said regulation.
6. MORETTI SpA maintains and provides to the competent authorities, for at least ten years
from the date of manufacture of the last production lot, the technical documentation proving
conformity with Regulation (EU) 2017/745.
Class I medical device
of 5 April 2017 on medical devices
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