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Idiomas disponibles
Idiomas disponibles
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
1. CODES
TB030X
TIBODA front drive for wheelchairs, power 300W
TB040X
TIBODA front drive for wheelchairs, power 400W
TB075X
TIBODA front drive for wheelchairs, power 750W
TB100X
TIBODA front drive for wheelchairs, power 1000W
2. INTRODUCTION
Thank you for choosing a TIBODA by ARDEA MOBILITY di MORETTI S.p.A. front drive. It is
designed and specified for unbeatable comfort, safety and reliability. This user manual contains
useful information for using your product properly and safely. Please read this manual in full before
you use the product. Should you have any queries, please contact your dealer for suitable advice and
assistance. The manual is part of the product and must be kept with care and included with it if it is
transferred to another user. The manual is intended for operators, owners, users and maintenance
staff. The manual provides information on: use, technical specifications, transport, keeping,
maintenance, disposal and safety. Any modifications to the manufacturer's instructions which affect
the safety of the patient or operator will be communicated to the owner of the product by Moretti
S.p.A. as it deems suitable. Any non-substantial modifications and additions to the product will not
be notified by the manufacturer.
3. INTENDED USE
The TIBODA by ARDEA MOBILITY di MORETTI S.p.A. front drive is an electric drive for wheelchairs,
fitted with a quick mounting, which will revolutionise your urban mobility by eliminating the need for
you to push the wheelchair yourself.
WARNING!
•
Do not use the product for any purpose other than that specified in this manual.
•
Moretti S.p.A. declines any and all liability for damages resulting from improper use
of the device or any use other than that specified in this manual.
•
The manufacturer reserves the right to modify the device and its relevant manual
without prior notice, in order to improve the product's features.
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 FRONT WHEELCHAIR DRIVE 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.
I Class Medical Device
of 5 April 2017 concerning medical devices
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