In order to continue using the product
beyond its expected service life, you must
make sure that periodic maintenance at
intervals no more than two years apart are
performed until the device is permanently
decommissioned. Maintenance should be
carried out according to these instructions for
use, see page 8. Servicing and reconditioning,
in addition to the overall assessment below.
After the expected service life, Mercado Medic
cannot guarantee the suitability and safety of
the device, as Mercado Medic has no control
over how the device has been used and its
wear and tear. After the expected service
life, Mercado Medic AB cannot guarantee the
provision of spare parts.
Overall assessment
After the expected service life, it is important
to make an overall assessment of the device
before continuing to use it. The overall
assessment of the device must be carried
out by authorised personnel and should,
as a minimum, take the following into
consideration:
• how the device has been used,
• what condition the device and its
components are in,
• whether the device has been
reconditioned and serviced,
• when reconditioning and servicing have
been carried out,
• what has been remedied on the above
occasions,
• and the reason for the above remedial
measures.
After the expected service life, periodic
maintenance at intervals of a maximum of
2 years shall be carried out according to
these instructions for use, see 8. Servicing
and reconditioning, in addition to the overall
assessment below.
6.4. Reporting of adverse events and
incidents
As a manufacturer of medical devices in
the EU, Mercado Medic is obliged to have a
system to monitor how our devices work in
practical use.
Before our devices are CE-marked and
placed on the market, we have taken into
account the risks that may be present with
them and taken measures to reduce the risks
as far as possible. Nevertheless, accidents
and incidents can occur when the devices
are used. If this happens, it is important that
this is reported to both Mercado Medic and
the national relevant authority. Use contact
details in these instructions for use for
reporting, see 1.1. Contact details. Feel free
to use email to enable faster handling.
31
Instructions for use for REAL 8000 PLUS Ophthalmology medical clinic chairs
Important safety information
21-08997-EN-00
Summary of Contents for REAL 8000 PLUS
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