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Idiomas disponibles
Idiomas disponibles
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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 STOOLS complies with the provisions of the regu-
lation 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.
5. GENERAL WARNINGS
For all matters concerning a proper use of the product, please refer to this user manual:
• Keep the packing away from any heat source because it is a cardboard box
• The service life of the device is determined by the wear of its non-repairable and/or spare
parts
• Please, pay attention to moving parts that may trap limbs or cause personal injuries
• Always pay attention to children
• The user and/or the patient will have to report any serious accident that have occurred
related the device to the manufacturer and appropriate authority of the State which the
user and/or patient belongs to.
6. SYMBOLS
Product code
S N
Unique Device Identification
CE mark
0197
Manufacturer
Batch Lot
EC
REP
Read the instruction manual
Medical Device
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