Guidance And Manufacturer's Declaration - Electromagnetic Immunity - HemoCue Plasma/Low Hb Manual De Funcionamiento

Guidance and manufacturer's declaration – Electromagnetic immunity
The HemoCue systems are intended for use in the electromagnetic environment specified below. The customer or user of the HemoCue
systems should assure that it is used in such an environment.
Immunity test IEC 60601 test level
Electrostatic discharge (ESD) ±6 kV contact
IEC 61000-4-2
±8 kV air
Electrical fast transient/burst ±2 kV for power supply lines
IEC 61000-4-4 ±1 kV for input/output lines
Surge ±1 kV differential mode
IEC 61000-4-5
Voltage dips, short interrup- < 5 % U (> 95 % dip in U) for
tions and voltage variations a 0.5 cycle
on power supply lines
40 % U (60 % dip in U) for
IEC 61000-4-11 5 cycles
70 % U (30 % dip in U) for
25 cycles
< 5 % U (> 95 % dip in U) for
5 seconds
For explanation of U see
NOTE 1
Compliance level Electromagnetic environment — guidance
±6 kV contact Floors should be wood, concrete or ceramic tile. If
floors are covered with synthetic material, the rela-
±8 kV air tive humidity should be at least 30 %.
2 kV for power sup- Mains power quality should be that of a typical
ply lines commercial or hospital environment.
±1 kV for input/
output lines
±1 kV differential Mains power quality should be that of a typical
mode commercial or hospital environment.
< 5 %U (> 95 % dip Mains power quality should be that of a typical
in U) for a 0.5 cycle commercial or hospital environment.
40 % U (60 % dip in If the user of the HemoCue systems requires con-
U) for 5 cycles tinued operation during power mains interruptions,
it is recommended that the HemoCue systems be
70 % U (30 % dip in powered from an uninterruptible power supply or
U) for 25 cycles a battery.
< 5 % U (> 95 % dip
in U) for 5 seconds
30