Mopedia Tulipan MI100, Инструкция по эксплуатации, Страница: 23 / 60

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ENGLISH
I Class Medical Device
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 concerning medical devices
1. CODES
MI100 - Letto degenza a 1 manovella (TULIPANO)
MI110 - Letto degenza a 2 manovelle (TULIPANO)
MI120 - Letto degenza elettrico (TULIPANO)
MI130 - Letto degenza a 2 manovelle - largo 120 cm (TULIPANO)
MI140 - Letto degenza elettrico - largo 120 cm (TULIPANO)
2. INTRODUCTION
Thank you for choosing a MOPEDIA hospital bed by Moretti S.p.A. MOPEDIA hospital beds
manufactured by Moretti S.p.A. are designed to satisfy all your requirements for a practical,
correct and safe use. This manual provides some useful suggestions to correctly use the device
you have selected and offers valuable advices for your safety. We recommend carefully reading
the entire manual before using the hospital bed you have purchased. Should you have any
queries, please contact your retailer for proper advice or assistance.
Note:
Check all parts of the product have not been damaged during shipment. In case of
damage do not use the product and contact your dealer for further instructions
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.
3. INTENDED USE
MOPEDIA hospital beds are designed for people that have been hospitalized for health reasons
in institutes, hospitals and/or health assistance facilities or within a family context.
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 BEDS – TULIPANO 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.