Moretti SKEMA FORM, Instruction Manual

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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
MI481 1 step stool 150 Kg
MI482 2 steps stool 150 Kg
2. INTRODUCTION
Thank you for choosing a step stool from the SKEMAFORM by MORETTI S.p.A. Their design and
quality are a guarantee of comfort, safety and reliability. The step stools from the SKEMAFORM
by MORETTI S.p.A. are designed and built to meet all your demands for a practical, correct use.
This user manual provides for some suggestions as to how correctly use the item you have
chosen and offers a lots of valuable advice for your safety. Please read carefully through the
manual before using the step stools. Should you have any queries, please contact your retailer
for advice and assistance.
3. INTENDED USE
The step stool by SKEMAFORM is a device designed to help people to easily get on and off onto medical
examination bed.
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
If you should have any doubts please contact your dealer who will help and advice you correctly.
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 STEP STOOL 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.