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
• DO NOT use this product or any available optional equipment without first completely
reading and understanding this instruction manual. If you are unable to understand the
warnings, cautions or instructions, contact a healthcare professional, dealer or technical
personnel before attempting to use this equipment, otherwise injury or damage may occur.
• Keep the packed bath chair away from heat sources.
• The product use limit is defined by the wear of the parts.
• ALWAYS keep hands and fingers clear of moving parts to avoid injury.
• DO NOT allow children to play on or operate the bath chair.
• 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