Younes Medical Technologies 100013000 User Manual
Operator Manual – ORP System
Revision: 05
Effective Date: 17-Dec-15
Document Number: YST-UDoc-OPM-05
109 of 116
Table 6 – Table 7 – IEC 60601-1-2:2007 Table 2 Requirements
The Prodigy Sleep Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of the Prodigy Sleep Monitor should assure that it is used in such an environment.
Immunity Test
Immunity Test
IEC 60601 Test Level
Compliance Level
Electromagnetic
environment – Guidance
environment – Guidance
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV Air
±8 kV Air
±6 kV Contact
±8 kV Air
±8 kV Air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical Fast
Transient/Burst
IEC 61000-4-4
Transient/Burst
IEC 61000-4-4
±2 kV for power supply
lines
lines
±2 kV for power supply
lines
lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
IEC 61000-4-5
±1 kV line(s) to line(s)
±1 kV line(s) to line(s)
Mains power quality
should be that of a typical
commercial or hospital
environment.
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
short interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95 % dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
(>95 % dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95 % dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
(>95 % dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the Prodigy Sleep
Monitor requires
continued operation
during power mains
interruptions, it is
recommended that the
Prodigy Sleep Monitor
be powered from an
uninterruptible power
supply or a battery.
should be that of a typical
commercial or hospital
environment. If the user
of the Prodigy Sleep
Monitor requires
continued operation
during power mains
interruptions, it is
recommended that the
Prodigy Sleep Monitor
be powered from an
uninterruptible power
supply or a battery.
Power Frequency
Magnetic Field
(50/60 Hz)
IEC 61000-4-8
Magnetic Field
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
Power frequency
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
magnetic fields should be
at levels characteristic of
a typical location in a
typical commercial or
hospital environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.