Maintenance
• The Medical Device is a sophisticated high-tech product.
To ensure optimal performance and safe operating
conditions, we recommend, as part of a normal
maintenance program, to have an annual inspection
performed by technical staff authorized by OPTIKON
2000 S.p.A.
• To avoid a decrease in the safety of the Medical Device,
due to ageing, wear, etc. the institution operating the
device must ensure, in compliance with the applicable
national regulations, that regular safety checks have
been carried out on the prescribed schedule and on the
stipulated exent. The technical safety checks must be
carried out exclusively by the manufacturer or by
qualified personnel. The scope of the security
engineering controls should include at least the
following items:
– Availability of the user manual
– Visual inspection of the device and its
accessories to verify the absence of damage
and the readability of the symbols and labels.
– Protective earthing impedance test
– Current leakage test
– Functional test of all switches, buttons, outlets,
and indicator lamps of the Medical Device.
Modifications
WARNING Risk of injury to the patient's eye!
Modified products may break during application and
cause device malfunctions.
• Do not change the shape of the handpiece for
vitrectomy or the tip used with the
R-EVO SMART systems (e.g. do not bend, cut or
scratch).
WARNING Risk of injury to the patient's eye!
Changes due to the application of manual force on the
upper part of the infusion pole could result in an
incorrect level of the bottle and injury to the patient.
To Next Page
Loading...
