Breas Medical Vivo 45, Руководство пользователя

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187 Technical Specifications
Vivo 45 User Manual
Doc.006149 En Y-2
8.3 Emission and Immunity Declaration
According to IEC 60601-1-2:2014.
The performance of all functions of the Vivo 45 is considered as essential
performance for the purpose of immunity testing.
Vivo 45 Essential Performance
The Vivo 45 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
2
, high and low FiO
2
, obstruction, low last power source, or power
failure.
The Vivo 45 will provide SpO
2
and pulse rate values within its published
accuracy specifications and generate an alarm upon a low SpO
2
condi-
tion. The Vivo 45 will provide indication when the SpO
2
value or pulse
rate is potentially incorrect, and generate an alarm condition to indicate
when the SpO
2
value update period has exceeded 30 seconds.
The Vivo 45 will provide EtCO
2
and FiO
2
values within its published
accuracy specifications and generate an alarm condition upon high and
low EtCO
2
and FiO
2
conditions.
Under the immunity test conditions, the following allowances are accept-
able:
- 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 transient 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.