8.3. Reconditioning and periodic
maintenance
No periodic maintenance is required during
the expected service life of the device. In
order to continue using the device beyond its
expected service life, periodic maintenance
at a maximum interval of two years apart
must be performed until the device is
permanently decommissioned.
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.
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. Make sure there is good lighting
and preferably use a magnifying glass, as
small cracks can be difficult to detect on
black-painted 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the device must be withdrawn from service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.
Long-term storage of batteries
During longer periods of storage, the battery
is automatically disconnected after seven
days. The battery may also be forced into
unplugged mode by plugging a 9V power
supply (part number 804823) into the
charging socket and waiting for at least 5
seconds before disconnecting the power
supply. If the handheld controller is used,
all of the indicator lights will flash when
the battery is disconnected and the power
supply can then be disconnected.
40
Instructions for use for REAL 8000 PLUS Ophthalmology medical clinic chairs
Servicing & reconditioning
21-08997-EN-00
Summary of Contents for REAL 8000 PLUS
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