PLEASE NOTE! If the serial number label
and the date of manufacture are damaged
or destroyed, please contact your prescriber
or distributor in the first place for assistance
in identifying the device, see 1.1. Contact
details. Once the order number or serial
number is identified, contact Mercado Medic
for a replacement label.
The expected service life of accessories
supplied with a Mercado Medic device is
10 years unless otherwise stated in the
accompanying documentation.
The expected service life of the device
battery is 5 years when the device is charged
in accordance with these instructions for use,
see 2.3. Charging.
In markets outside Sweden and Norway
where a distributor has sold the device
directly to the user (where applicable), and
therefore there is no responsible prescriber,
periodic maintenance must be carried out at
least every other year throughout and after
the device’s entire expected service life.
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 shall be
carried out by authorised personnel of the
healthcare organisation if the device has
been prescribed and should at least take into
account:
• 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.
39
Instructions for use for medical work chairs in the REAL 9000 PLUS device range
Important safety information
21-08742-EN-01
Summary of Contents for REAL 9000 PLUS Series
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