Instructions for use for medical bariatric work chairs
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 device's main components
consist of a base, brake, lifting mechanisms,
seat frame, backrest mechanism and
width adjustment U-bars for armrests.
The inspection must include welds,
lockable functions and settings.
When checking the base, always inspect
the welds 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the device must be withdrawn from service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
www.mercado.se
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 https://shop.mercado.se/.
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.
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Servicing & reconditioning
there are various forms
21-08861-EN-04