Vivo 45 Ls Essential Performance; Guidance And Manufacturer's Declaration - Electromagnetic; Immunity - Breas Vivo 45 LS User Manual

According to IEC 60601-1-2:2014.
The performance of all functions of the ventilator is considered as essential perform-
ance for the purpose of immunity testing.
8.3.1

Vivo 45 LS Essential Performance

The ventilator will deliver ventilation at the patient-connection port within its published
accuracy specifications and within the alarm limits set by the operator, or generate an
alarm condition for high pressure, low pressure, high PEEP, low tidal volume, low
minute volume, low breath rate, high EtCO
power source, or power failure.
The ventilator will provide SpO
specifications and generate an alarm upon a low SpO
vide indication when the SpO
an alarm condition to indicate when the SpO
30 seconds.
The ventilator will provide EtCO
cations and generate an alarm condition upon high and low EtCO
Under the immunity test conditions, the following allowances are acceptable:
•
•
Additionally, the following shall not be allowed:
•
•
•
•
•
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.
Doc. 007301 K-1
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
ent immunity test exposure shall recover from any disruption within 30 seconds.
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.
, high and low FiO
2
and pulse rate values within its published accuracy
2
value or pulse rate is potentially incorrect, and generate
2
value update period has exceeded
2
and FiO values within its published accuracy specifi-
2 2
, EtCO or FiO
2 2
, obstruction, low last
2
condition. The ventilator will pro-
2
and FiO
2
performance following transi-
2
Technical Specifications
User manual
conditions.
2
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