Ormesa 840100105074, Use And Maintenance Handbook

Page: 79 / 80

Page 77 of 77
CONDITIONS FOR DURABILITY, REUSE AND REASSIGNMENT TO
A NEW USER
Granted that Ormesa products should be selected, evaluated and ordered for the
needs of an individual user, reuse is however possible with the respect the
following conditions.
Based on the experience of other similar sold models, on technological progress,
on the guarantees of the Quality Management System certificated in 1998
according to ISO 13485, there is adequate confidence that the average lifespan of
the GRILLO is about 5 years, on condition that it is used according to the
directions given in the user manual.
Only when the conditions for storage and transport of chapter HOW TO STORE
AND TRANSPORT THE MEDICAL DEVICE” are followed, the periods in which the
product is stored at the dealer should not be considered in that time period
.
Factors unrelated to the product such as the development of the user, its
diseases, the use and the surrounding environment can make significantly lower
the duration of life of the product; on the contrary, if the indications on the use
and maintenance are properly observed, the reliability of the product can extend
well beyond the lifetime average above.
Prior to recycling or reassignment an already used Ormesa product, it is required
that:
1. A doctor or therapist verifies that the aid is appropriate and
adequate to meet the dimensional, functional and postural needs of
the new user, and if all its components are suitable / appropriate for
him. You should also consider that the CE marking and the
manufacturer's responsibility for safety requirements for the product
remain only if the original product still has not changed and only
original components or spare parts have been applied.
2. Qualified technical personnel of a company specialized in the
maintenance of technical aids for people with disabilities performs a
detailed technical inspection to verify its condition and wear, the
absence of any damage and failure of all components / adjustments,
the presence of the user’s manual, of the label with the date and
serial number. A copy of the manual and maintenance may be
always requested to the retailer that supplied the product or directly
to Ormesa.
3. The product has been thoroughly cleaned and disinfected following
the directions given in the “MAINTENANCE, CLEANING AND
DISINFECTION” Chapter.
We recommend you keep written records on all inspections performed
on the product before any assignment to the new user.
In case of doubt about the safety of the product or damage to parts or
components, you are urged to immediately discontinue use and contact
the Dealer who supplied you with the product; the Distributor or the
Manufacturer are at your disposal for any further doubt or assistance
.