24 Annex
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
85 / 92
Electromagentic immunity, IEC 60601-1-2: 2015, based on table 4
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment -
guidance
Electrostatic discharge
(ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV
± 15 kV
Floors should be made of wood
or concrete or covered with
ceramic tiles. If the floor is co-
vered with synthetic material,
the relative humidity must be at
least 30%.
Power frequency (50/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital envi-
ronment.
Electromagentic immunity, IEC 60601-1-2: 2015, based on table 5, 8
Electrical Fast transient/bursts
IEC 61000-4-4
± 2 kV for power
supply lines
100 kHz repe-
tition frequency
± 1 kV for input/
output lines
± 2 kV
-----------------
± 1 kV
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV
kine(s) to line(s)
± 2 kV
line(s) to earth
± 1 kV
differential mode
± 2 kV
line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short interruptions,
and voltage variations on power
supply input lines
IEC 61000-4-11
0% U
τ
; 1/2 period
at 0, 45, 90, 135,
180, 225, 270 and
315 degree
0% U
τ
; 1 period
and
70% U
τ
; 25/30
periods
Single-phase: at
0 degree
0% U
τ
; 250/300
periods
0% U
τ
; 1/2 period
at 0, 45, 90, 135,
180, 225, 270 and
315 degree
0% U
τ
; 1 period
and
70% U
τ
; 25/30
periods
Single-phase: at
0 degree
0% U
τ
; 250/300
periods
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Myopia Master® requires
continued operation during
power mains interruptions, it is
recommended that the Myopia
Master® be powered from an
uninterruptible power supply or
battery.
Note: U
τ
is the a.c. mains voltage prior to application of the test level
.
