Moretti MOPEDIA MI094, Instruction Manual

Page: 16 / 36

4
ENGLISH
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.
4.1 Standards and guidelines reference
Safety tests required by UNI CEI 60601-2 -52
5. GENERAL WARNINGS
WARNING! PAlways pay close attention to the presence of moving parts that could
cause limb entrapment and injury.
• For proper use of the device refer to this manual.
• For proper use of the device consult your doctor or therapist.
• Keep the packaged product away from any source of heat because the packaging
is made of cardboard.
• The shelf-life of the accessory is determined by the wear of parts that cannot
be repaired and / or replaced.
• Be careful when children are nearby.
• Do not exceed the maximum payload.
• 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
Unique Device Identification
CE mark
EC REP
0197
S N
Manufacturer
Batch Lot
Read the instruction manual
Medical Device
Conditions of disposal