13
ENGLISH
I Class Medical Device according to directive 93/42/EEC
and subsequent amendments
1. CODE
RP689
4-wheel steel rollator – DYONE 1.0
2. INTRODUCTION
Thank you for purchasing the rollator, MOPEDIA by MORETTI S.p.A., realized to help people with
movement difficulty inward and outward, during voyages or in everyday life. The production has been
made according to the highest quality and safety standards in accordance with European Directive
on Medical devices (93/42/EEC). This instruction manual gives you suggestion for a correct use and
for your safety. We recommend you to read carefully this instruction manual before using. In case of
doubts, please contact your dealer.
Note:
Check all parts to verify it won’t be any shipping damage. In case of shipping damages, do not
use. Contact the dealer for further instructions.
WARNING!
• Do not use the product for a purpose not indicated in this manual.
• Moretti Spa declines all responsibilities for any consequences resulting from an incorrect
use of this product and from unauthorized alteration to the frame of the product.
• The manufacturer can modify the device or the instruction manual without prior
notification.
3.INTENDED USE
This rollator fit for people with movement problems. Can be used as assistance to facilitate ambulation
or even servo-assisted ambulatory. Anyway, it can’t be used by people with evident malfunction of the
hand or the arm, even by people with balance problems. The rollator can be used inward and outward. We
recommend using on flat surface where the wheels can reach the land. It can’t be used on rock ground or
on slanted area as the rollator can be unstable. The device is not intended to carry people or things.
4. EC DECLARATION OF CONFORMITY
Moretti S.p.A. declare under sole responsibility that the product made and traded by Moretti S.p.A. and
belonging to rollator range are in accordance with the European Directive on Medical devices (93/42/EEC).
Moretti S.p.A. guarantees and declared under sole responsibility what follow:
1. The devices under discussion satisfy the essential requisites requested by the I enclosure
directive 93/42/CEE as laid down by the VII enclosure of the above mentioned Directive.
2. The devices under discussion ARE NOT MEASURING INSTRUMENTS.
3. The devices under discussion ARE NOT MADE FOR CLINICAL PROBES.
4. The devices under discussion are traded with NON STERILE BOX.
5. The devices under discussion belong to class I.
6. IT IS NOT ALLOWED to use and install devices except for the use provided by Moretti S.p.A.
7. Moretti S.p.A maintains and provides for authorities, the technical documentation
proving the accordance to European Directive on Medical devices (93/42/EEC).
5. WARNINGS
5.1 General warnings
• Do NOT install or use the device before reading and understanding this manual;
If you are unable to understand the warnings, cautions or instructions, contact a healthcare
professional dealer or technical personnel before attempting to install this equipment
to avoid injure or damage;
