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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 9001, there is adequate confidence that
the average lifespan of the BIRILLO 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
-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 accessories or spare
parts have been applied
2. qualified technical personnel of a company specialized in the
maintenance of technical aids for disabled people 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 a specialized service center in the maintenance of
mechanical aids for disabile, or directly ORMESA
Summary of Contents for Birillo
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