Abilia Emfit Epilepsy Alarm, Manual, Page: 29 / 36

29
Guidance and manufacturer’s declaration – electromagnetic immunity
The Emfit Tonic-Clonic Seizure Monitor is intended for use in the electromagnetic
environment specified below. The customer or the user of the equipment should
assure that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level Electromagnetic environment
Electrostatic
discharge
(ESD) IEC
61000-4-2 ±6 kV contact
±8 kV air IEC-60601-
1-2 test level Floors should be wood, 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 ±2 kV for
power supply
lines ±1 kV for
input/output
lines IEC-60601-
1-2 test level Mains power quality should be that of a
typical commercial or hospital
environment.
Surge IEC
61000-4-5 ±1 kV line(s)
to line(s) IEC-60601-
1-2 test level 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 <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 IEC-60601-
1-2 test level Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Emfit
epileptic seizure alarm enquires
continued operation during power
mains interruptions, it is recommended
that the Emfit Tonic-Clonic Seizure
Monitor be powered from an
uninterruptible power supply or battery
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8 3 A/m IEC-60601-
1-2 test level Power frequency 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.