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8.3
Emission and Immunity Declaration
8.3.1
Vivo 65 Essential Performance
The Vivo 65 will deliver ventilation at the patient-connection port within its published accu-
racy specifications and within the alarm limits set by the operator, or generate an alarm con-
dition for high pressure, low pressure, high PEEP, low inspired tidal volume, low expired
tidal volume, low inspired minute volume, low breath rate, high EtCO
obstruction, low last power source, or power failure.
The Vivo 65 will provide SpO
tions and generate an alarm upon a low SpO
The Vivo 65 will provide indication when the SpO
rect, and generate an alarm condition to indicate when the SpO
exceeded 30 seconds.
The Vivo 65 will provide EtCO
and generate an alarm condition upon high and low EtCO
Under the immunity test conditions of IEC 60601-1-2 4th Ed., the following allowances are
acceptable:
•
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
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
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
Electrical fast transi-
ent/burst
IEC 61000-4-4
Surge IEC 61000-4-
5
Doc. 006150 M-1
and pulse rate values within its published accuracy specifica-
2
condition.
2
and FiO
values within its published accuracy specifications
2
2
, EtCO
2
Compliance Level
±8 kV contact±15 kV air
±2 kV for power supply lines
±1 kV for input/output lines
±1 kV line to line
, high and low FiO
2
value or pulse rate is potentially incor-
2
value update period has
2
and FiO
conditions.
2
2
or FiO
performance following transient
2
2
Electromagnetic Environ-
ment - Guidance
The relative humidity should
be at least 5 %.
AC Power (Mains) quality
should be that of a typical
commercial, hospital and resi-
dential environment.
AC Power (Mains) quality
should be that of a typical
commercial, hospital and resi-
dential environment.
Technical Specifications
,
2
139
User manual
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