Declaration Of Conformity; General Warning; Symbols - ARDEA ONE CP100 Serie Manual De Instrucciones

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4. DECLARATION OF CONFORMITY

Moretti S.p.A. declares under its sole responsibility that the product made and traded by Moretti
S.p.A.and belonging to the group of MANUAL WHEELCHAIRS - ARDEA ONE complies with the provi-
sions 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 con-
formity 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 refe-
rences 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 WARNING

• For correct use of the device, carefully refer to the following manual
• For correct use of the device always consult your doctor or therapist
• Keep the packaged product away from any source of heat as the packaging it is made of cardboard
• The useful life of the device is determined by the wear of non-repairable and / or replaceable
parts
• Always pay close attention to the presence of moving parts which could cause limb entrapment
and personal injury
• Always pay attention to the presence of children
• Do not lift the wheelchair by removable parts which could accidentally come off during lifting
• The user and / or the patient must report any serious accident occurring in relation to the device
to the manufacturer and to the competent authority of the State in which the user and / or the
patient is established.

6. SYMBOLS

Product code
S N
Medical Device
CE mark
0197
Manufacturer
EC REP
Serial Number
Batch Lot
Unique Device Identification
Read the instruction manual
Conditions of disposal