General Warnings; Service Life; Symbols - Mopedia RP729M-L Manual De Instrucciones

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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

• READ carefully the entire manual before using the device;
• Advise with physician or therapist to determinate the correct adjustment and the correct .
use of the walker;
• Make sure that the product is delivered complete and keep it packed away from heat sources;
• SERVICE LIFE- the device use limit is defined by the wear of the parts;
• DO NOT allow children to play or operate 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