192 Technical Specifications
Vivo 65 users manual
Doc. 006088 En-US U-1b
8.3 Emission and Immunity Declaration
Vivo 65 Essential Performance
The Vivo 65 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 inspired tidal volume, low expired tidal volume, low
inspired minute volume, low breath rate, high EtCO
2
, high and low FiO
2
,
obstruction, low last power source, or power failure.
The Vivo 65 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 65 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 65 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 of IEC 60601-1-2 4th Ed., the fol-
lowing 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
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