35
MIR Spirolab (UK version) | User Manual
Manufacturer’s recommendations and declarations - electromagnetic immunity
The Spirolab device can be used in the following electromagnetic environments.
The Spirolab customer or end user must ensure that the device is used in such an environment.
Immunity test
Test level
IEC 60601
Level of
conformity
Electromagnetic environment - guide
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be made of wood, cement or ceramic tiles.
If floors are covered with synthetic materials, Relative Hu-
midity must be at least 30%. In the event of an electrostatic
discharge occurring during an oximeter test, the device will
recover its functionality within 30 seconds (in accordance
with ISO 9919)
High speed data
transmission lines
IEC 61000-4-4
±1 kV per
input/output
line
The main type of power supply must be that present in com-
mercial or hospital settings.
power surges
IEC 61000-4-5
±1 kV
differential
mode
±2 kV common
mode
Not applicable
The main type of power supply must be that present in com-
mercial or hospital settings.
Drops in voltage, short
interruptions and voltage
variations in the power
supply feed line
IEC 61000-4-11
<5 % UT
(>95 % gaps in
UT)
for 0.5 cycles
40 % UT
(60 % gaps in
UT)
for 5 cycles
70 % UT
(30 % gaps in
UT)
for 25 cycles
<5 % UT
(>95 % gaps in
UT)
for 5 seconds
Not applicable
Frequency of magnetic field
(50/60 Hz)
IEC 61000-4-8
3 A/m
3 A/m
The magnetic field values must correspond with those
present in a
commercial or hospital setting.
NOTE: UT is the mains voltage before the application of the test voltage.
Appendix:
Information about the correct use of device in an electromagnetic environment
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