Intended Use; Declaration Of Conformity; General Warnings; Symbols - Moretti ARDEA ONE Helios Smart CP770-40 Manual De Instrucciones

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3. INTENDED USE

This wheelchair is designed for the mobility of people with mobility problems and can be used
for self-propelling (if equipped with big rear wheels) or with the aid of an operator.

4. DECLARATION OF CONFORMITY

Moretti S.p.A. declares under its sole responsibility that the product made and traded by More-
tti S.p.A.and belonging to the group of WHEELCHAIRS – HELIOS ARDEA ONE complies with the
provisions of the regulation 2017/745 on MEDICAL DEVICES of 5 April 2017.
For this purpose, Moretti S.p.A. guarantees and declares under its sole responsibility what
follows:
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

• 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 using this equipment otherwise injury or damage may occur.
• Advise with physician or therapist to determinate the correct adjustment and the correct
use of the wheelchair.
• Keep the packed wheelchair away from heat sources.
• The wheelchair 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 wheelchair.
• Close the wheelchair before lifting it.
• DO NOT attempt to lift the wheelchair by any removable parts.
• 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