Biocare iE 101, User Manual

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Appendix C EMC-Guidance and manufacture’s declaration
-- 66 -- User Manual for Electrocardiograph
C.2 Guidance and manufacture’s declaration-electromagnetic immunity for all
EQUIPMENT and SYSTEMS.
Guidance and manufacture’s declaration-electromagnetic immunity
The ECG machine is intended for use in the electromagnetic environment specified below. The customer of the user of the ECG
machine should assure that it is used in such an environment
Immunity test IEC60601 test level Compliance level Electromagnetic environment
guidance
Electrostatic discharge
(ESD)
IEC61000-4-2
±6KV contact
±8KV air
±6KV contact
±8KV air
Floors should be wood, concrete or
ceramic tile. If floor are covered with
synthetic material, the relative
humidity should be at least 30%
Electrical fast
transient/burst
IEC61000-4-4
±2KV for power supply lines
±1KV for input/output lines
±1KV for power supply
lines
±1KV for input/output lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge IEC61000-4-5 ±1KV differential mode
±2KV common mode
±1KV differential mode
±2KV common mode
Mains power quality should be that of
a typical commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variation power
supply input lines
IEC61000-4-11
<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 cycles
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
for 0.5 cycle
40% UT
for 5 cycle
70% UT
for 25 cycles
<5% UT
for 5 sec
Main power quality should be that of
a typical commercial or hospital
environment. If the user of the ECG
machine requires
Continued operation during power
mains interruptions, it is
recommended that the ECG machine
be powered from an uninterruptible
power supply or a battery.