Guidance and Manufacturer’s Declaration - Emissions
The ClariVein
®
IC
is intended for use in the electromagnetic environment specified below. The user ensure that it
is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment – Guidance
RF Emissions CISPR 11
Group 1
The ClariVein
®
IC uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF Emissions CISPR 11
Class B
Harmonics IEC 61000-3-2
N/A
Flicker IEC 61000-3-3
N/A
The ClariVein
®
IC is suitable for use in all
establishments, including domestic, and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Guidance and Manufacturer’s Declaration – Immunity
The ClariVein
®
IC is intended for use in the electromagnetic environment specified below. The user
should ensure that it is used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level
Electromagnetic Environment –
Guidance
ESD
IEC 61000-4-2
±6kV Contact
±8kV Air
±6kV
Contact
±8kV Air
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the r/h should
be at least 30%
EFT
IEC 61000-4-4
±2kV Mains
±1kV I/Os
N/A
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV Differential
±2kV Common
N/A
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage Dips/Dropout
IEC 61000-4-11
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
N/A
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the ClariVein
®
IC requires continued operation during
power mains interruptions, it is
recommended that the ClariVein
®
IC be
powered from an uninterruptible power
supply or battery.
Power Frequency
50/60Hz
Magnetic Field
IEC 61000-4-8
3A/m
3A/m
Power frequency magnetic fields should be
that of a typical commercial or hospital
____________________________________________________________________
ClariVein
®
is a registered trademark of Vascular Insights
™
, LLC in the United States.
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