4
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
•
Please refer to this manual carefully for proper use of the device.
• Check that the product has been delivered to you intact and keep it packed away from heat
sources.
•
The service life of the device is determined by the wear of parts that cannot be repaired and/
or replaced.
•
Always pay attention to the presence of children.
•
Always consult your physician or therapist for proper use of the device.
• 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
EC
REP
Batch Lot
Read the instruction manual
Medical Device
Conditions of disposal
Do not bleach
Wash by hand; Maximum temperature: 30°C
Do not dry clean