Guidance And Manufacturer's Declaration - Electromagnetic Immunity - Breas Vivo 3 Clinician Manual

Vivo 3 Essential Performance
The Vivo 3 will deliver ventilation at the patient-connection port within its published
accuracy specifications and within the alarm limits set by the operator, or generate any
of the following alarms:
• High pressure
• Low pressure
• Low inspired minute volume
• high inspired minute volume
• Low breath rate
• High leakage
• Low last power source
• Power failure
• Disconnection
• High EPAP
• Low EPAP
The Vivo 3 will provide SpO2 and pulse rate values within its published accuracy speci-
fications and generate an alarm upon a low SpO2 condition. TheVivo 3 will provide
indication when the SpO2 value or pulse rate is potentially incorrect, and generate an
alarm condition to indicate when the SpO2 value update period has exceeded 30
seconds.
Under the immunity test conditions, the following allowances are acceptable:
• Temporary degradation of performance that does not adversely affect basic safety or
essential performance.
• Any temporary degradation of SpO2 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
• negative false alarm condition
9.7.1 Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Vivo 3 is intended for use in the electromagnetic environment specified below. The
customer or the user of the Vivo 3 should assure that it is used in such an environment.
124 Technical Specifications
Vivo 3 Clinician's Manual
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