1. Scope 1.1
This Standard addresses monitors intended for the detection of interruptions of
the patient's breathing gas during controlled ventilation in anaesthesia by
monitoring pressure in the breathing circuit. It does not address monitors
based on gas composition, flow, or exhaled volume.
Notes:
(1) Applications for critical care ventilation are not considered but may be
included in future revisions.
(2) Physiological monitors are not addressed, with the exception of parameters
associated with lung mechanics, but may be included in future revisions.
(3) Situations involving manually-controlled ventilation or some spontaneous
breathing are not considered by this Standard.
(4) Low-flow anaesthesia applications are not included in this Standard.
(5) Not all possible clinical situations are simulated by the scenarios
outlined in this Standard. Users are encouraged to develop test conditions
relevant to their own clinical situations. 1.2
This Standard outlines a series of performance tests intended to evaluate
isolated and intergrated monitors. 1.3
It is fundamentally assumed that the manufacturer provides a means for the
operator to establish a set of "normal conditions" at startup to ensure the
proper operation of the monitor.