19-4 DELTA/DELTA XL/KAPPA VF8
19
ETCO2 (END-TIDAL CO2) MONITORING
General etCO
2
/Gas Analysis Precautions
Refer to the “Safety Considerations” section starting on page 6, at the beginning of these
Instructions for Use, for general precautions regarding safe device operation.
WARNING:
The safety and effectiveness of the respiration
measurement method in the detection of apnea,
particularly the apnea of prematurity and apnea of
infancy, has not been established.
Patient monitors that measure CO
2
, anesthetic agents,
and/or respiratory mechanics are not intended to be
used as an apnea monitor and/or recording device.
While these products provide an apnea alarm, that
alarm condition is initiated based on the elapsed time
since the last breath was detected. Clinical diagnosis
of a true apneic event, however, requires multiple
physiological signals.
CO
2
alarms do not activate until the first breath is
detected after turning on the monitor or discharging a
patient.
The accuracy of CO
2
and respiration rate measurements
may be affected by not applying the sensor properly, by
certain patient conditions and by certain environmental
conditions.
Incorrect, loose or damaged tubing connections may
compromise ventilation by allowing gas leaks which
may compromise measurement accuracy. To avoid this,
securely connect all components and check
connections for leaks according to standard clinical
procedures.