Instructions for Use 1 Safety and Certifications
2660021169042 Rev. A 2018-03 1.5 Operator Training and Equipment Maintenance
2660021169042 Rev. A 2018-03 27 / 246
1.5 Operator Training and Equipment Maintenance
1.5.1 Operator Training
WARNING!
Incorrect use of equipment
could result in damage to patients or equipment.
ü Only personnel who have undergone appropriate training and
instruction may use this device.
u Operating personnel must be appropriately trained and
instructed.
u Operating personnel must read and understand the User
Manual.
u The User Manual must be made available to operating
personnel at all times.
u To facilitate access for all operating personnel: Request
additional copies of user documentation as required from
ZEISS.
u Specify the competencies for handling the device and state
who is authorized for what tasks.
u Determine the reporting obligations for instrument error and/or
damage and make them known.
u Regularly review the applicable legal regulations regarding
accident prevention, health and safety in the country of use.
1.5.2 Equipment Maintenance
CAUTION!
Lack of regular safety inspections
could result in a decrease in device safety, increase in the possibility
of device damage, and/or inaccurate results.
ü Regular technical safety inspections must be carried out as
specified for this device by any and all applicable national
regulations.
ü Equipment inspections may only be performed by Zeiss or Zeiss-
qualified personnel.
u Comply with the specified maintenance intervals.
u Carry out all inspections fully.
u Minimally, local system inspections must include the following:
ð Availability of the Instructions for Use
ð Visual inspection of system and accessories for damage and
legibility of labels
ð Current leakage current test
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