USER MANUAL
(Instruction for Use)
SW 2.9
EMC Guidance and Manufacturer’s Declaration
Version 2.9.7 dated 2020-12-23
Page 73 of 75
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12.2
Essential Performance
Basic safety and essential performance:
According to the intended use the purpose of the Carriazo-Pendular is to create a corneal flap in
LASIK and to shave the cornea prior to lamellar transplant.
Table 4: ESSENTIAL PERFORMANCE ACCORDING TO IEC 60601-1-2 (2014) clause 5.2.1.1 b)
Essential performance
Foreseeable
hazard
if
essential performance is lost
or degraded due to EM
disturbances.
Protective Measure
Control of the cutting head for
oscillation of the blade.
Damage of the eye, loss of
visual acuity and cicatrisation.
Protective
system
for
observation of the motor
current
of
the
blade
oscillation. Test function
before treatment start.
.
Control of the cutting head for
integrated feed of the cutting
head.
Damage of the eye, loss of
visual acuity and cicatrisation.
Protective
system
for
observation of the motor
current
of
the
blade
oscillation. Test function
before treatment start.
Control of the vacuum pump
for control of the suction
pressure at the eye.
Loss of vacuum, damage of
the eye.
Low vacuum is acoustically
reported to the surgeon.
