EQUIL MTM-I - Page 126

Equil
TM
Insulin Patch Pump System
121
IEC 60601-1-2：Table 202
Guidance and manufacturer's declaration ‒ electromagnetic immunity
Immunity Test IEC 60601 Compliance Electromagnetic environment ‒
Test Level Level guidance
The device is intended for use in the electromagnetic environment specified below. The
user of the device should ensure that it is used in such an environment.
Electrostatic
discharge (ESD)
IEC 60601-4-2
Electrical fast
transient burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
±
6 kV Contact
±
8 kV Air
±
2 kV
±
1 kV
for input/
output lines
±
1 kV
Differential mode
±
2 kV
Common mode
<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 s
3 A/m
±
8 kV Contact
±
15 kV Air
±
2 kV
±
1 kV
for input/
output lines
±
1 kV
Differential mode
±
2 kV
Common mode
<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 s
400 A/m
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality shoul
d be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment. If the user of the device
requires continued operation during
power mains interruptions, it is
recommended that the device be
powered from an uninterruptible power
supply or a battery.
The power frequency magnetic field
should have the characteristics of power
frequency magnetic field level at a
typical place in a typical commercial and
hospital e
nvironment