8.3. Reconditioning and periodic
maintenance
The device does not require periodic
maintenance in cases where it has a
responsible prescriber in the healthcare
sector. The prescriber and healthcare
organisation are expected to follow up the
prescription during the lifetime of the device
according to the healthcare procedures.
During this follow-up, it is important to
question the performance of the device and
any perceived changes. Where the device is
sold by a distributor directly to the user and
does not have the responsible prescriber,
periodic maintenance at intervals of a
maximum of 2 years must be carried out
throughout and after the expected service
life according to the following reconditioning
instructions.
Reconditioning in these instructions for
use does not refer to a full restoration
or complete refurbishment in the sense
referred to in the Medical Devices
Regulation (EU) 2017/745, MDR, with a
view to putting the device on the market
again with a renewed expected service life.
Reconditioning in these instructions for
use aims instead at a more comprehensive
review and service of the device, but where
serial numbers are retained and expected
service life remains unaffected. The purpose
of this reconditioning may be, for example, to
make the device suitable for prescribing to a
new user.
Inspection during reconditioning
Reconditioning must include a thorough
visual inspection of the device’s main
components in order to guarantee patient
safety. The main components of the device
include base, brake, lifting mechanism, seat
frame, back recliner and U-bars for armrests.
The inspection must include welds, lockable
functions and settings.
When checking the PLUS base, always
inspect the weld between the base’s front
and rear legs. Any indication of cracks in
the material or paint in this area should be
regarded as reason to replace the base,
or the device. Ensure good lighting and
preferably use a magnifying glass, as small
cracks can be difficult to detect on black
lacquered bases.
In case of reduced braking action, check both
the stability of the base and the condition of
the brake rubber. If the device is not resting
on all four wheels in the unbraked position,
the device must be withdrawn from service
immediately. Check the balance of the base
in several locations and in several directions
to exclude any influence from the floor.
Replacement of components
On
there are various forms
of substrate for changing components,
such as exploded diagrams, assembly
instructions, connection guides and digital
item search. Installation instructions can
also be used to disassemble the device's
components. For accessories and spare
parts please visit our webshop
Warning! Installation, connection
or dismantling is not risk-free.
If components are handled
incorrectly, for example, crushing
damage may occur. This type of
work may therefore only be carried
out by a Mercado Medic authorised
technician.
Warning! All parts of the device
must be installed and fixed so
that there is no risk of small parts
coming loose. All cables must
be secured with cable ties to the
device's structure to minimise the
risk of strangulation.
49
Instructions for use for medical work chairs in the REAL 9000 PLUS device range
Servicing & reconditioning
21-08742-EN-01
Summary of Contents for REAL 9000 PLUS Series
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