• Error of delivered volume and PEEP of individual breaths up to 35% and error of
the delivered volume and PEEP averaged over a one-minute interval up to 25%.
• Any temporary degradation of SpO
2
, EtCO
2
or FiO
2
performance following transi-
ent immunity test exposure shall recover from any disruption within 30 seconds.
Additionally, the following shall not be allowed:
• permanent damage or unrecoverable loss of function,
• changes in programmable parameters or settings,
• reset to default settings,
• change of operating mode,
• initiation of unintended operation.
8.3.2 Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The ventilator is intended for use in the electromagnetic environment specified below.
The customer or the user of the ventilator should assure that it is used in such an
environment.
Immunity Test
Compliance Level Electromagnetic Environ-
ment - Guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±8 kV contact±15 kV air The relative humidity should
be at least 5 %.
Electrical fast tran-
sient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines
Mains power quality should be
that of a typical commercial,
hospital and residential
environment.
Surge IEC 61000-4-
5
±1 kV line to line Mains power quality should be
that of a typical commercial,
hospital and residential
environment.
Power frequency
(50/60 Hz) mag-
netic field
IEC 61000-4-8
30 A/m
Power frequency magnetic
fields should be at levels char-
acteristic of a typical location
in a typical commercial, hospi-
tal and residential
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
0% UT, 0.5 cycle (multiple
phase analysis);
0% UT, 1 cycle;
70% UT, 25/30 cycles (50/
60 Hz);
0% UT, 250/300 cycles (50/
60 Hz);
Vivo 45 runs on internal bat-
tery during voltage dips, short
interruptions and voltage var-
iations on power supply input
lines.
Technical Specifications 153
Doc. 006149 D-3
Vivo 45 User manual
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