Emissions And Immunity Declaration - Breas Clearway 2 User Manual

Emissions and Immunity Declaration

Note: The 'Essential Performance' of the Clearway 2 is defined as follows:
Clearway 2 Essential Performance
The Clearway 2 will deliver therapeutic treatment via the patient-connection
port (outlet) at the set pressure (+/- 10% of full scale).
Under the immunity test conditions of IEC 60601-1-2 4
following allowances are acceptable:
• If the SpO
2
SpO readings within its published accuracy specifications or, indicate
2
abnormal operation. Any temporary degradation of SpO
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, or change of operation
71 Technical Specifications
Clearway 2 User Manual
sensor accessory is connected, the Clearway 2 will provide
Edition, the
th
performance
2
DOC-001000 Ver 6