45
APPENDIX
EMC
Table 1
Table 2
Alarm state
Alarm state delay
Alarm signal generation delay
Low battery alarm
60 s
5 ms
Over-limit alarm for SpO
2
1 s
5 ms
Over-limit alarm for pulse rate
1 s
5 ms
“Sensor Off” alarm
16 ms
5 ms
ENGLISH
Guidance and manufacturer’s declaration –electromagnetic emission
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The
purchaser or the user of the device should assure that it is used in such environment.
Emission test
Compliance
RF emissions CISPR 11
Group 1
RF emissions CISPR 11
Class B
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration-electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The pur-
chaser or the user of the Pulse Oximeter should assure that it is used in such environment.
Immunity test
IEC60601 test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8kV contact
±15 kV air
±8kV contact
±15 kV air
Electrical fast transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1 kV for input/output line
±2kV for power supply lines
Not Applicable
Surge IEC 61000-4-5
±1 kV lines to lines
±2 kV lines to earth
±1 kV lines to lines
Not Applicable
Voltage dips, 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 cycle
70%UT(30%dip in UT)
for 25 cycle
<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 cycle
70%UT(30%dip in UT)
for 25 cycle
<5%UT(>95%dip in UT)
for 5 sec
Power frequency (50 / 60Hz)
magnetic field IEC 61000-4-8
30 A/m
30 A/m