ZIPThaw™ 202 System User Manual
Fremon Scientific, Inc.
5726 La Jolla Blvd., Suite 304, La Jolla, CA 92037USA
P
age 41 of 43
FDA
CLEARED
ZipThaw
™
20 2 System
User Manual
IEC 61000-3-3
Warning: This equipment/system is intended for use by
healthcare professionals only. This equipment/ system
may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to
take mitigation measures, such as re-orienting or
relocating the ZIPThaw
TM
202 or shielding the location.
Guidance and manufacturer’s declaration –
electromagnetic immunity
The ZIPThaw
TM
202 is intended for use in the electromagnetic environment specified below. The customer or the user
of the ZIPThaw
TM
202 should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment
–
guidance
Electrostatic
discharge
(ESD) IEC 61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 kV air
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
± 2 kV for power supply
lines
± 2 kV for input/output
lines
Mains power quality should be that of
a typical commercial or hospital
environment.
Surge IEC 61000-4-5
± 1 kV differential mode
± 2 kV common mode
± 1 kV differential mode
± 2 kV common mode
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 % U
T
(>95 % dip in U
T
)
for 0,5 cycle
40 % U
T
(60 % dip in U
T
)
for 5 cycles
70 % U
T
(30 % dip in U
T
)
for 25 cycles
<5 % U
T
(>95 % dip in U
T
)
for 5 sec
>95 % dip for 10ms
60 % dip for 100ms
30 % dip for 500ms
95 % dip for 5000ms
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the
ZIPThaw
TM
202 requires continued
operation during power mains
interruptions, it is recommended that
the ZIPThaw
TM
202 be powered from
an uninterruptible power supply.
Power frequency (50/60
Hz) magnetic field IEC
61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of a
typical
location
in
a
typical
commercial or hospital environment.
NOTE - U
T
is the AC mains voltage prior to application of the test level.
