Sleep Therapy Devices

Clinical Guide

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AEONMED Auto CPAP Algorithms Clinical Manual V1.0
 Statement

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liable for any typographical errors in the specification, or any damage caused
by improper installation or operation. Xiaoniu does not provide other parties
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party’s rights.

The contents contained in the specification may be changed without

notice.

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Table of Contents

Statement ......................................................................................................................................... 2
1 Overview................................................................................................................................... 4
2 Algorithm Description............................................................................................................... 4
2.1 Automatic Pressure Adjust Algorithm ...................................................................... 4
2.2 Definition and algorithm description of respiratory events ................................... 5
2.2.1 Sleep Apnea .................................................................................................... 5
2.2.2 Obstructive Sleep Apnea............................................................................... 5
2.2.3 Central Apne ................................................................................................... 6
2.2.4 Snoring ............................................................................................................ 7
2.2.5 Hypopnea ........................................................................................................ 7
2.2.6 Airflow Limitation ............................................................................................ 7
2.3 Expiratory Pressure Release (ELEX) ...................................................................... 8
2.4 Manual Titration .......................................................................................................... 9
2.5 Calculation of Abnormal Air Leakage of Mask ....................................................... 9
2.6 AUTOS ...................................................................................................................... 10
2.7 Rise Slope .................................................................................................................... 10
2.8 Triger ........................................................................................................................... 11

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1 Overview

AEONMED Sleep Therapy devices include CPAP and BiPAP. CPAP have CPAP and
AutoCPAP . BiPAP have CPAP , AUTOS,S,ST,T and VGPS.
AEONMED Auto CPAP is an automatic pressure adjusting sleep breathing treatment
machine. The internal flow and pressure sensors are designed to monitor the gas flow and
pressure in the airway, and the breathing air and breathing state of the patients are
derived by the algorithm. After the start of the machine, the breathing airflow of the airway
was detected in real time, and then the normal breathing air amplitude (A) data was
extracted and maintained (as in Figure 1). As a reference standard for abnormal breathing
events in patients, we call this reference a standard breathing air flow.

Figure 1 Standard Airflow Waveform of the Patient

The device can detect five kinds of abnormal breathing events, namely
obstructive apnea, central apnea, snoring, hypoventilation and airflow
limitation. The working principle of the AEONMED Auto CPAP algorithm and
the automatic voltage regulation mechanism for five kinds of respiratory
abnormal events are described in detail below.

2 Algorithm Description

2.1 Automatic Pressure Adjust Algorithm

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 Figure 2 Auto CPAP Automatic Pressure Adjust Diagram

AEONMED worked with the clinical consulting team to develop the

AEONMED Auto CPAP algorithm. To improve the patient's comfort, this
algorithm filters the frequency interference and noise of the original signal at
the signal acquisition end. The time window is set up with 60s, and the
standard breathing air flow is established by using the pressure and flow data
of normal breathing state in the time window (Figure 1. Note: Only the part of
the waveform in 60S indicated.) The respiratory flow, airway resistance and
lung compliance of the patients are calculated in real time, and compared with
the standard breathing air flow, so thatthe respiratory events and their types
were differentiated are as per related standards of sleep disorders. Then the
algorithm will adjust the pressure between the set maximum and minimum
treatment pressure according to the current respiratory event type, shown as in
Figure 2.
AEONMED Auto CPAP Pressure adjust algorithm:
1） Every 60 seconds, the algorithm inserts a time window with a width
of 60s in the data set, and takes the value and calculation in the
time window.
2） Every 60 seconds, the algorithm will detect all the respiratory
events occurring in the time window.
3） Every 60 seconds, the algorithm will identify the respiratory events
detected in the time window, and then increase, decrease, or
maintain the current therapy pressure according to the results.

2.2 Definition and algorithm description of respiratory events

The following detailed definition of each respiratory event is described in

details. Breathing events are detected by the AEONMED Auto CPAP algorithm,
and the pressure response is based on the type of respiratory events.
2.2.1 Sleep Apnea

Sleep apnea refers to intermittent respiratory arrest in the course of sleep.

Two types are classified : Obstructive Sleep Apnea(OSA) and Central
Apnea(CA)
2.2.2 Obstructive Sleep Apnea

Definition: The device detected that the inspiratory flow amplitude of the
patient was less than 20% of the standard airflow, and lasted more than 10s,
shown as in Figure 3.

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 Figure 3 Schematic Diagram of Respiratory Airflow Waveform of
Obstructive Apnea

Response: Once An apnea event is judged, the algorithm will increase the
treatment pressure at 0.5hPa per 60s until no events are detected. After
breathing smoothly, the algorithm will decrease treatment pressure at 0.1hPa
per 60s. During the pressure decreasing, if no respiratory events are
detected, the treatment pressure will continue to decrease till the set minimum
treatment pressure. Once breathing events are detected during the decreasing,
pressure shall increase to eliminate the event.
2.2.3 Central Apne

Definition: Breathing air flow paused and last more than 10s, without chest
abdominal breathing movement. Central Apnea is caused by Central Nervous
System.
How to detect: Central apnea is detected by a shock wave that is 2hPa
higher than the current pressure when an apnea detected. The duration of the
shock wave is 2s; which the rise period is 0.3s, the platform period is 1.4s, and
the decline period is 0.3s. The working process of each time period is as
follows:
1） Rise period: Timing of shock wave output time, the given shock
ware pressure increases in proportion to the current accumulative
time (y=kx), calculate air way resistance by lung compliance.
2） Platform period: Timing of shock wave output time, the constant
2hPa pressure is given (y=k), calculate air way resistance by lung
compliance Decline period: Timing of shock wave output time, the
pressure is given according to the current accumulative
concussion time decreased (y=2-kx). When the cumulative time
of shock reached 2s, calculate mean air way resistance by lung
compliance And iteratively update.
If there is an obstructive apnea, and the mean airway resistance
calculated during the duration of the shock pressure (2s) is lower than 2hPa, it
is judged to be a central apnea event. Central apnea is caused by nervous
system disorder (severe loss of function), and excessive pressure can lead to
injury. Therefore, the AEONMED Auto CPAP algorithm does not rise the
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pressure for Central Apnea.
2.2.4 Snoring

Definition: Snoring refers to the obstruction of upper respiratory tract in the

patient's sleep. When inhaling, with the increase of the negative pressure in
the lungs, the upper airway begins to collapse and produces low frequency
vibration. The flow / time curve shows the saw tooth wave at the platform
period, and the amplitude of the air flow is small.
Response: Once snoring is detected in the time window, and it lasts for
10s, the algorithm will increase the treatment pressure at 0.3hPa per 60s, until
no events are detected. After breathing smoothly, the algorithm will decrease
treatment pressure at 0.1hPa per 60s. During the pressure decreasing, if no
respiratory events are detected, the treatment pressure will continue to
decrease till the set minimum treatment pressure. Once breathing events are
detected during the decreasing, pressure shall increase to eliminate the event.
.
2.2.5 Hypopnea

Definition: The device detects the expiratory flow amplitude of the patient
is less than 40% of the standard airflow, and lasts more than 10s, shown as in
Figure 4.

Figure 4 Airflow Waveform of Hypopnea

Response: Once Hypopnea is detected in the time window, and it lasts for
10s, the algorithm will increase the treatment pressure at 0.3hPa per 60s, until
no events are detected. After breathing smoothly, the algorithm will decrease
treatment pressure at 0.1hPa per 60s. During the pressure decreasing, if no
respiratory events are detected, the treatment pressure will continue to
decrease till the set minimum treatment pressure. Once breathing events are
detected during the decreasing, pressure shall increase to eliminate the event.
2.2.6 Airflow Limitation

Definition: Airflow limitation refers to the partial closure of the respiratory

airway in the patient. When inhaling, the upper airway begins to collapse with
the increase of the negative pressure in the lungs; the flow / time curve shows
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a multi peak in the stage of the inhalation platform, or the flat center part of the
platform, shown as in Figure 5.

Figure 5 Airflow Waveform of Airflow Limitation

Airflow limited detection includes platform determination and multimodal

decision. It is described in detail as follows:
Platform determination: Within one inspiratory phase time, if platform time
is greater than 50% of the total inspiratory phase; a flow limitation event is
defined.
Multimodal decision: The number of peak values in the stage of the
inspiratory phase is calculated. If the number of peaks in the suction phase is
greater than 3, and the fluctuation range of each peak is greater than 75ml/s, a
flow limited is defined.
Response: when the device detected 5 or more consecutive airflow
limitation, the algorithm will increase the treatment pressure at 0.3hPa per 60s,
until no events are detected. After breathing smoothly, the algorithm will
decrease treatment pressure at 0.1hPa per 60s. During the pressure
decreasing, if no respiratory events are detected, the treatment pressure will
continue to decrease till the set minimum treatment pressure. Once breathing
events are detected during the decreasing, pressure shall increase to
eliminate the event.

2.3 Expiratory Pressure Release (ELEX)

Definition: The device identifies the patient's breathing flow from the
inspiratory phase to the expiratory phase through an algorithm, and reduces
the treatment pressure and assists the patient's breathing, shown as in Figure
6.
The setting parameters of specific expiratory pressure release are as
follows:
1） ELEX-OFF: The algorithm does not control the device in expiratory
phase to reduce the pressure of treatment.
2） ELEX-1: 0.5hPa Pressure is reduced during expiration phase.
3） ELEX-2: 1.0hPa Pressure is reduced during expiration phase.
4） ELEX-3: 1.5hPa Pressure is reduced during expiration phase.
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 5） ELEX-4: 2.0hPa Pressure is reduced during expiration phase.
6） ELEX-5: 2.5hPa Pressure is reduced during expiration phase.
7） ELEX-6: 3.0hPa Pressure is reduced during expiration phase.
8） ELEX-7: 3.5hPa Pressure is reduced during expiration phase.
9） ELEX-Patients: The patient can adjust the expiratory release level
in the patient settings menu, and the release effect is based on the
release level set by the patient.
10） Note: If the expiratory release level is not set “Patient” according to
5, it can only be set by the doctor in the clinical menu.

Figure 6 Pressure Release Grade Flow Pattern

2.4 Manual Titration

Definition: During therapy model, the physician could adjust the Pressure
of the device according to the real time data shown without stop the therapy.
Description: After setting the parameters of manual titration, the physician
starts the device. The device output pressure according to the set of treatment
pressure; meanwhile, the algorithm detects respiratory abnormal events in
different time windows. In addition, the physician can adjust the therapeutic
parameters according to the real-time monitoring of airflow and pressure to
help determine the treatment pressure and achieve the best therapeutic effect.

2.5 Calculation of Abnormal Air Leakage of Mask

The abnormal air leakage of the mask is calculated by the total flow rate
collected by the flow sensor to reduce the breathing flow rate of the person and
the flow rate of the exhaust hole of the mask.
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2.6 AUTOS
After the device starts the autos mode, when the patient inhale, the device
is triggered from the exhalation pressure to the inspiratory pressure; when the
patient expiratory, the device is triggered from the inspiratory pressure to the
expiratory pressure. If the device detects a respiratory event, the inspiratory
pressure and the expiratory pressure will be increased by an equal amount
according to the type of respiratory event. The judgment of respiratory event is
based on 2.2 respiratory event definition and algorithm description.

Figure 7 AUTOS
2.7 Rise Slope
After the patient inhale or exhale, the device will be triggered to switch
between the breath pressure and the inspiratory pressure. Different Rise Slope
settings, the speed of booster or hypotension, and the comfort of the patient
are different. Corresponding to different Rise Slope individual comfort feelings
vary from person to person. Equipment design 1-6 Rise Slope. 1- Boost or
depressurize fastest ,6- Boost or depressurize slowest.

Figure 8 Rise Slope

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2.8 Triger
When the device starts AUTOS、S、ST or VGPS mode, when the patient
inhale, the device will be triggered from expiratory pressure to inspiratory
pressure; when the patient exhales, the device will be triggered from
inspiratory pressure to expiratory pressure. In order to achieve good
interpersonal synchronization, the device designed 6 sensitivities 1-6. The
trigger sensitivity is the highest, and the switch of breathing and breathing can
be triggered by a small trigger flow rate.
2.9 VGPS

After the device starts VGPS, the device starts working with the MINIPAP
as the inspiratory pressure. The device monitors and calculates the tidal
volume of the patient through a flow sensor. If the monitored tidal volume is
less than the set target tidal volume, the device will increase the Inhalation
pressure until the monitored tidal volume reaches the set target tidal volume. A
breathing cycle boost or depressurization of 0.5hPa, the maximum inspiratory
pressure does not exceed MAXIPAP set.

Figure 8 VGPS

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