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Guidance and Manufacturer’s Declaration – Immunity All
ME Equipment and ME Systems
The sam is intended for use in the electromagnetic environment
specified below. The customer or user of the sam should ensure
that it is used in such an environment.
Immunity Test IEC 60601 Compliance Electromagnetic
Test Level Level Environment - Guidance
ESD
+
6kV Contact
+
6kV Contact Floors should be wood, concrete
IEC 6100042
+
8kV Air
+
8kV Air or ceramic tile. If floors are
synthetic, the r/h should be at
least 30%.
EFT 2kV Mains
+
2kV Mains Mains power quality should be
IEC 61000044
+
1kV IOs
+
1kV IOs that of a typical commercial
or hospital environment.
Surge
+
1kV Differential
+
1kV Differential Mains power quality should be
IEC 6100045
+
2kV Common Common NA that of a typical commercial or
(no ground) hospital environment.
Voltage >95% Dip for >95% Dip for Mains power quality should be
Dips/Dropout 0.5 Cycle 0.5 Cycle that of a typical commercial or
IEC 61000411 60% Dip for 60% Dip hospital environment. If the user
5 Cycles 5 Cycles of the sam requires continued
30% Dip for 30% Dip for operation during power mains
25 Cycles 25 Cycles interruptions, it is recommended
>95% Dip for >95% Dip for that the sam be powered from
5 Seconds 5 Seconds an uninterruptible power supply
or battery.
Power 3A/m 3A/m Power frequency magnetic fields
Frequency should be that of a typical
5060Hz commercial or hospital
Magnetic Field environment.
IEC 6100048