Appendix A—Troubleshooting and Maintenance
356 BD Alaris
TM
System with Guardrails
TM
Suite MX User Manual
Table 2
Electromagnetic Immunity
Immunity Test
IEC 60601-1-
2:2014
Test Level
Compliance
Level
Electromagnetic Environment -
Guidance
IEC 61000-4-2
Electrostatic Discharge
(ESD)
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete, or ceramic
tile.
If floors are covered with synthetic material,
relative hum
idity should be at least 30%.
IEC 6100
0-4-4
Electrical Fast
Transient, B
urst (EFT)
±2 kV for power
supply
lines
±1 k
V for input/
output lines
±2 kV for power
supply lines
±1 k
V for input/
output lines
Mains power quality should be that of a typical
comme
rcial or hospital environment.
IEC 61000-4-5
Power Line Surge
±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
comme
rcial or hospital environment.
IEC 61000-4-8
Power Frequency
M
agnetic Field
(50/60 Hz)
30 A/m 50 Hz or 60
Hz
30 A/m 50 Hz
30 A/m 60 Hz
Power frequency magnetic fields should be at
levels characteristic of a
typical location in a
typical commercial or hospital environment.
IEC 61000-4-11
Voltage Dips, Short
Interruptions,
and
Voltage Variations
0%
U
T
; 0.5
cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315°
0%
U
T
; 0.5
cycle
At 0°, 45°, 90°,
135°, 180°,
225°,
270° and 315°
Mains power quality should be that of a typical
comme
rcial or hospital environment.
If continued operation of the system is required
during power mains i
nterruptions, it is
recommended that the system be powered from an
uninterruptible power supply or a battery.
The system does employ an internal short duration
battery.
0%
U
T
; 1
cycle and 70%
U
T
;
25/30 cycles
Single phase: at 0°
0%
U
T
; 1 cycle
and 70%
U
T
; 25/30
cycles
Single phase: at 0°
0%
U
T
; 250/300
cycles
0%
U
T
;
250/300 cycles
NOTE:
The Alaris system may be affected by an electr
ostatic discharge through air at levels above 15kV or by
radio frequency radiation over 3 V/m. If the system is affected by this external interference, the system
will remain in a safe mode. The system will stop the infusion and alert the user by generating a
combination of visual and audible alarms. If any encountered alarm condition persists after user
intervention, it is recommended to replace that particular system and quarantine it until appropriately
trained technical personnel can address the problem.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site
survey should be considered. If the measured field strength in the location in which the system is used exceeds
the applicable RF compliance level above, observe the system to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the system.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V
1
] V/m.
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