User Manual MUT_RD_009H_GB Page
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The maintenance operations shall be done by technicians trained and qualified by EYE TECH
CARE. EYE TECH CARE shall not be held responsible if the user refuses maintenance operations
by a trained and qualified technician, or if he does it by himself.
Switch off the electrical mains and disconnect the system from the mains supply before
cleaning or inspection.
CE 0459 identification is placed on the medical device to indicate that the medical device was
produced in compliance with the current European Directives on medical devices
The EyeOP1 medical device is not intended for domestic use. If it is not installed in compliance
with the instructions for use, it can cause interference that could damage other more sensitive
equipment or be disrupted by their possible excessive radio-electric emissions. It may be
necessary to take mitigation measures, such as reorientation or installation of the EyeOP1
control unit in another room, or shielding of the location.
Moreover, cellular phones and other mobile communication equipment must not be used
close to the medical device, since they could affect it. Any other device used close to the
EyeOP1 device must comply with the IEC 60601-1-2 standard.
When an error message appears, it is recommended to read and understand the message, to
write it down in order to make the technical diagnostic easier, to discontinue treatment if the
procedure is not described in the present manual, and to rapidly inform EYE TECH CARE (or
the local distributor).
If unusual events persist
or if unidentified problems occur, do not try to dismantle the medical
device. Take note of the problem and contact the technical department of EYE TECH CARE at
, or the local representative
The procedure to be followed for collecting, discarding, destroying or recycling the
equipment, its sub-assemblies, associated accessories and single-use devices, shall comply
with the regulation in force in the country and/or hospital where it is being used (if necessary,
contact the local agent or distributor).
The EYEOP-PACK single-use consumable must be discarded immediately after use in the
appropriate container (contaminated waste).
The end-of-life EyeOP1 Control Unit being considered as an electric/electronic
waste (WEEE), EYE TECH CARE will recover and dispose of it according to the
WEEE waste collection and recycling procedure. To this end, contact the local
representative. By doing so, the user acts positively for the environment,
preservation of natural resources and health protection.
3.2.2
Main warnings on treatment
Only a properly trained and qualified users shall use the EyeOP1 control unit, its associated
accessories and EYEOP-PACK consumables described in the present manual.