Codes; Introduction; Intended Use; Declaration Of Conformity - Moretti MOPEDIA NEFTI BI100 Manual Del Usuario

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

1. CODES

BI100 Shower trolley NEFTI HYDRAULIC, max weight (water included) 180 kg
BI110 Shower trolley NEFTI ELECTRIC, max weight (water included) 200 kg
BI180 Shower trolley pediatric NEFTI SMALL HYDRAULIC, max weight (water included) 180 kg
BI200 Shower trolley pediatric NEFTI BIG ELECTRIC, max weight (water included) 325 kg

2. INTRODUCTION

Their design and quality ensure the maximum comfort, safety and reliability. MOPEDIA
shower trolleys Nefti by Moretti S.p.A are designed and manufactured to meet all your needs
for a practical, correct and safe use. This manual contains small suggestions for proper use of
the device you have chosen and valuable advice for your security. You may read the complete
manual before using the shower trolley. In case of doubts please contact your dealer, who will
help and advice you properly.

3. INTENDED USE

MOPEDIA shower trolleys Nefti by Moretti S.p.A are intended for patients care during
washing/showering when horizontally oriented or inclined (up to a maximum of 5°, 7° only
BI200), with the help of an assistant that operates commands and executes the washing
operations. It cannot be used by a single person.
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. 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 SHOWER TROLLEYS 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
3