USER MANUAL (Instruction for Use) SW 6.1
AppendiXes
Version 6.1.6 dated 2020-01-31 EN Page 199 of 201
12.4.2 Essential Performance
Basic safety and essential performance:
According to the intended use the purpose of the AMARIS EXCIMER LASER is to ablate corneal
tissue using an excimer laser beam with defined energy and positioning.
Table 5: ESSENTIAL PERFORMANCE ACCORDING TO IEC 60601-1-2 (2014) clause 5.2.1.1 b)
Essential performance Protective Measure Foreseeable hazard if
essential performance is lost
or degraded due to EM
disturbances.
Control of the laser energy of
the excimer laser (working
laser)
Protective system with
independent energy
monitoring and inducing of
the safe state.
Exposure of too high output
energy of the working laser
Exposure of laser radiation Protective system Shutter. Unintended activation of the
laser beam.
Positioning of the laser beam Protective system with
monitoring of the scanner
positioning, eye tracking and
data transfer and inducing of
the safe state.
Wrong positioning of the
laser beam.
Calculation of the shot
patterns.
Diverse checkup of shot list
calculation
Wrong calculation or usage
of wrong parameters (e.g.
eye tracker offsets, energy
values)
Gas supply of the excimer
laser
Appropriate design layout
and protective system with
control of pressure
Uncontrolled emersion of
toxic gas
Aiming laser Protective system within the
laser diode module to limit
the laser power or shutdown
of the laser diode.
Exposure of too high laser
power of the aiming laser
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