Mindray A8 - Page 281

Operator’s Manual of Anesthesia System E - 7
Electromagnetic Compatibility
ANESTHESIA SYSTEM'S ESSENTIAL
PERFORMANCE
ESSENTIAL
PERFORMANCE
TESTED DURING
EMC IMMUNITY
TESTS
CRITERIA DURING EMC
IMMUNITY
1. Oxygen flow under
all conditions except
the failure of the
oxygen supply
(pipeline or cylinder)
to the anesthetic
workstation or the
generation of a
technical alarm
condition
1.1 Oxygen
supply failure
protection device
1.1.1 Oxygen
supply failure
protection device
No false O
2
supply failure alarm
shall be activated and the fresh
gas flow shall be maintained
when the O
2
supply pressure is
within the rated input pressure
range.
1.2 Interruption
of the electrical
power supply
1.2.1 Power
management
The anesthesia system can run on
AC power supply and battery
supply, and
Battery in Use alarm of low
priority shall be indicated only in
case of AC power supply failure.
The ventilation shall be
maintained, and the control and
monitoring accuracy shall meet
the requirements of the
specification.
The fresh gas flow shall be
maintained, and the accuracy
shall meet the requirements of
the specification.
1.3 Oxygen flush / /
2. Delivery of a non-
hypoxic gas mixture to
the patient or
generation of a
technical alarm
condition
2.1 Alarm
condition for
power supply
failure
/ /
2.2 Internal
electrical power
source
2.2.1 Battery power
supply
The residual capacity of battery
power can be indicated normally
when battery power works.
2.3 Protection
against
hazardous
output
2.3.1 Control and
monitoring
accuracy
Control accuracy:
Tidal volume: 30±10 ml
Breath rate: 30± 1 bpm
Monitoring accuracy:
Tidal volume: 30±10 ml
Breath rate: 30± 1 bpmAirway
pressure: ±2.0 cmH
2
O or ±4% of
the actual reading, whichever is
greater
2.4 Reverse flow
and cross-flow
protection device
//
2.5 Gas mixers 2.5.1 Gas mixers Accuracy:
0.2±0.1 L/min
2.6 Oxygen flush
//
TABLE E-6 Anesthesia system's EMC essential performance