General Precautions; Symbols Used - Moretti Levitas ST625 Serie Manual Del Usuario

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To this end, MORETTI SpA guarantees and declares as follows, under its own exclusive responsibility:
1. The devices in question satisfy the general safety and performance requirements set out in
Annex I to Regulation (EU) 2017/745, as prescribed by Annex IV to said regulation.
2. The devices in question ARE NOT MEASUREMENT INSTRUMENTS.
3. The devices in question ARE NOT INTENDED FOR CLINICAL INVESTIGATIONS.
4. The devices in question are sold in NON STERILE packing.
5. The devices in question should be considered as belonging to class I, in accordance with the
rules set out in Annex VIII to said regulation.
6. MORETTI SpA maintains and provides to the competent authorities, for at least ten years
from the date of manufacture of the last production lot, the technical documentation
proving conformity with Regulation (EU) 2017/745.
Note: The complete product codes, the manufacturer's single registration number (SRN),
the basic UDI-DI code and any references to standards used are indicated in the EU Declaration
of Conformity that MORETTI SPA issues and provides through its own channels.

5. GENERAL PRECAUTIONS

• Please consult this manual carefully for correct use of the device
• Always consult your doctor or therapist for correct use of the device
• Use by one user only is recommended
• Use and store in the horizontal position
• Always sanitise the device before any reuse
• The devices are extremely sensitive to air and light
• Any fading of the colour does not alter the efficacy of the mattress
• The lifetime of the device depends on wear and tear of non-repairable and/or
non-replaceable parts
• Store and use the device away from open flames and sources of heat
• Always take care when children are present
• Do not place the patient in direct contact with the mattress. Always use a full cover
• The user and/or patient must report any serious incident that has occurred in relation to the
device to the manufacturer and to the competent authority of the Member State in which the
user and/or patient is established.

6. SYMBOLS USED

Product code
S N
Unique device identification
CE marking
0197
Manufacturer
EC REP Batch Lot
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