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2.3 Therapy Event Detection
The device monitors breathing and detects apneas, hypopneas, and other therapy events (as available).
Event
Definition
Obstructed
Airway
Apnea/Clear
Airway Apnea
Detection
An apnea is detected when there is an 80% reduction in airflow from baseline for at least 10 seconds or
if there is no airflow detected for 10 seconds. During the apnea, one or more pressure test pulses are
delivered by the device. The device evaluates the response of the patient to the test pulse(s) and assesses
whether the apnea has occurred while the patient has a clear airway or an obstructed airway. The airway
is determined to be clear if the pressure test pulse generates a significant amount of flow; otherwise, the
airway is determined to be obstructed.
Note: If the device is in a mode that delivers its own backup breath, (S/T, PC, T, or AVAPS-AE mode),
then the device will NOT deliver the test pulse. Instead, it will use the machine back-up breath and
evaluate it for which (if any) type of apnea to score.
RERA
Detection
RERA (Respiratory effort-related arousal) is defined as an arousal from sleep that follows a 10 second
or longer sequence of breaths that are characterized by increasing respiratory effort, but which does not
meet criteria for an apnea or hypopnea. Snoring, though usually associated with this condition, need not
be present. The RERA algorithm monitors for a sequence of breaths that exhibit both a subtle reduction
in airflow and progressive flow limitation. If this breath sequence is terminated by a sudden increase in
airflow along with the absence of flow limitation, and the event does not meet the conditions for an apnea
or hypopnea, a RERA is indicated.
Periodic
Breathing
A persistent waning and waxing breathing pattern which repeats itself between 30 and 100 seconds. The
nadir of the breathing pattern is characterized by at least a 40% reduction in airflow from an established
baseline flow. The pattern must be present for several minutes before it can be identified as periodic
breathing.
Hypopnea
Detection
A hypopnea is detected when there is an approximately 40% reduction in airflow from baseline for at least
10 seconds.
Snore
Detection
Vibration snore is disabled at pressures greater than 16 cm H
2
O in CPAP mode. Vibration snore is disabled
at IPAP settings greater than 20 cm H
2
O or max pressure support (IPAP – EPAP) greater than or equal to
10 cm H
2
O in bi-level modes. It is also disabled during any machine triggered breaths when EPAP settings
are greater than or equal to 10 cm H
2
O.
Large Leak
The level of leak is so large, it is no longer possible to determine respiratory events with statistical
accuracy.
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