Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODE
MP393
Three-jointed electric dual "Trendelenburg" hospital bed,
variable height GARDENIA 2.0
2. INTRODUCTION
Thank you for choosing the three-jointed electric hospital bed of MORETTI S.p.A. The de-
sign and quality guarantees unbeatable comfort, safety and reliability. The three-jointed
electric hospital bed in the MOPEDIA range by MORETTI S.p.A. have been designed and
manufactured to satisfy all your needs for practical and correct use. This user manual
contains some suggestions on how to use the bed properly and safely. Please read this
manual in full before you use the device. Should you have any queries, please contact your
dealer for suitable advice and assistance.
3. INTENDED USE
MOPEDIA hospital beds are intended for patients admitted for health reasons at hospitals
and/or healthcare structures and entities or for use at home.
WARNING
• 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.
4. DECLARATION OF CONFORMITY
Moretti S.p.A. declares under its sole responsibility that the product made and traded
by Moretti S.p.A.and belonging to the group of MEDICAL BEDS - MOPEDIA complies with
the provisions of the regulation 2017/745 on MEDICAL DEVICES of 5 April 2017. For this
purpose, Moretti S.p.A. guarantees and declares under its sole responsibility what follows:
1. The devices satisfy the requirements of general safety and performance requested by
the Annex I of regulation 2017/745 as laid down by the Annex IV of the above mentioned
regulation.
2. The devices ARE NOT MEASURING INSTRUMENTS.
3. The devices ARE NOT MADE FOR CLINICAL TESTS.
4. The devices are packed in NON-STERILE BOX.
5. The devices belong to class I in accordance with the provisions of Annex VIII of the
above mentioned regulation
6. Moretti S.p.A. provides to the Competent Authorities the technical documentation to
prove the conformity to the 2017/745 regulation, for at least 10 years from the last lot
production.
Note: Complete product codes, the manufacturer registration code (SRN), the UDI-DI code
and any references to used regulations are included in the EU declaration of conformity
that Moretti S.p.A. releases and makes available through its channels.
I Class Medical Device
of 5 April 2017 concerning medical devices
3
