SonarMed AirWave Manuel utilisateur

Operator’s Manual

August 2019 Edition

The foundation of airway management has just changed…

at the speed of sound.

AirWave System Operator’s Manual

Caution: US federal law restricts this device to sale by or on the

order of a physician.

You must read and understand these instructions in their

entirety prior to using the SonarMed AirWave System.

Because improvements to this manual and the products it describes will occur, please check that you are using

the most current version of this document by visiting www.sonarmed.com.

SonarMed, Inc.

12220 N. Meridian Street, Suite 150

Carmel, Indiana 46032

USA

Phone: (855) 240-0553

Fax: (866) 853-3684

support@sonarmed.com

www.sonarmed.com

Obelis s.a.

Boulevard General Wahis 53

1030 Brussels, Belgium

+32 3 732 59 54

[email protected]

References to “SonarMed” in this manual shall imply SonarMed, Inc. “SonarMed” is a registered trademark, and

“AirWave” is a trademark of SonarMed, Inc.

SP0610_P

 
Table of Contents 
 
 
 
AirWave System Operator’s Manual 
ii 
 
Table of Contents 
A. System Description...........................................................................................................................................................1 
B. Indications for Use............................................................................................................................................................2 
1. Contraindications ..........................................................................................................................................................2 
C. Warnings and Precautions................................................................................................................................................3 
D. Principles of Operation......................................................................................................................................................4 
E. Airwave Monitor Package Contents..................................................................................................................................7 
F. Displays, Indicators, and Controls ....................................................................................................................................8 
1. AirWave Monitor Controls –Front Panel.......................................................................................................................8 
2. AirWave Connections –Right Side...............................................................................................................................9 
3. AirWave Monitor Screens............................................................................................................................................10 
4. AirWave Monitor Indicators and Icons.........................................................................................................................12 
5. General Symbols......................................................................................................................................................... 14 
6. Basic Navigation and Editing.......................................................................................................................................15 
G. AirWave System Operation............................................................................................................................................. 15 
1. Powering On the AirWave Monitor..............................................................................................................................16 
2. Start-Up Screens......................................................................................................................................................... 16 
3. Main Menu Selections.................................................................................................................................................17 
a. Alarm Settings ........................................................................................................................................................ 18 
b. Set Carina Distance................................................................................................................................................19 
c. Sound Speed Correction......................................................................................................................................... 20 
d. Monitor AirWave Microphones................................................................................................................................ 23 
e. Modify ETT Length ................................................................................................................................................. 24 
f. ETT Movement Smoothing.....................................................................................................................................24 
g. Patient Info.............................................................................................................................................................. 25 
h. Data Logging ..........................................................................................................................................................25 
i. System Settings...................................................................................................................................................... 25 
4. Connecting an AirWave Sensor to an ETT.................................................................................................................. 25 
5. Connecting the AirWave Sensor to the Monitor ..........................................................................................................27 
6. Sensor Calibration....................................................................................................................................................... 28 
7. Intubation with the AirWave Sensor Connected to an ETT .........................................................................................32 
8. Connecting the AirWave Sensor to an Intubated ETT................................................................................................. 32 
9. Modifying the Calibrated ETT Length.......................................................................................................................... 33 
10. Patient Monitoring –Home Screen.........................................................................................................................36 
11. Transitioning to Patient Monitoring After Set-Up.....................................................................................................38 
a. Pre-Intubation.........................................................................................................................................................38 
b. Using the Device to Aid in Intubation......................................................................................................................38 
c. Ready to Set Baseline ............................................................................................................................................40 
d. Baseline Set............................................................................................................................................................ 40 
e. Set Carina Distance................................................................................................................................................41 
12. Patient Monitoring - Waveform Screen...................................................................................................................41 

 
Table of Contents 
 
 
 
AirWave System Operator’s Manual 
iii 
 
13. Powering Off the Monitor........................................................................................................................................ 43 
H. Cleaning, Maintenance and Disposal .............................................................................................................................44 
I. Troubleshooting..............................................................................................................................................................45 
1. Error Messages........................................................................................................................................................... 45 
2. AirWave Sensor Health Metric.................................................................................................................................... 47 
3. Sensor Suctioning....................................................................................................................................................... 47 
4. ETT Movement Smoothing..........................................................................................................................................48 
J. Service, Support, and Warranty...................................................................................................................................... 49 
K. Parts and Accessories.................................................................................................................................................... 50 
L. Specifications..................................................................................................................................................................51 
1. AirWave Monitor.......................................................................................................................................................... 51 
2. AirWave Sensor..........................................................................................................................................................51 
3. System Accuracy ........................................................................................................................................................ 52 
4. Storage & Operating Conditions.................................................................................................................................. 52 
5. Electromagnetic Compatibility..................................................................................................................................... 53 
 

Section A–System Description

AirWave System Operator’s Manual

A. System Description

The SonarMed AirWave acoustic airway monitoring system consists of an AirWave Monitor, (Monitor) which is

used in conjunction with a single-use AirWave Sensor (Sensor) and a reusable cable (see Figure A-1).

Figure A-1

The Monitor contains signal-generating and echo-processing circuitry that uses proprietary software to monitor

the position and patency of an endotracheal tube (ETT) via the AirWave Sensor. The Monitor is powered from an

external power supply and has a battery backup that will allow the device to function for approximately 120

minutes without external power. The Monitor has a color display, which is used to present information about the

ETT status. This information can be used in an adjunctive manner to assist with management of the patient’s

artificial airway.

In order to attach the Sensor to the ETT, the standard 15-mm connector (also known as the “hub”) is removed

and replaced with the AirWave Sensor (see Figure A-2).

Figure A-2

AirWave Sensors

Cable

AirWave Monitor

Standard

Connector (Hub)

AirWave Sensor

ETT

Section B–Indications for Use

AirWave System Operator’s Manual

B. Indications for Use

The SonarMed AirWave is used to assist in verifying placement of the ETT, to assist in detecting movement of the

ETT tip, and to assist in detecting obstruction of the ETT and assist with listening to breath sounds.

The SonarMed AirWave is intended for use by qualified personnel to assist with artificial airway management for

patients in an in-hospital setting (intensive care, operating room, and emergency department settings, as well as

intra-hospital transport).

The SonarMed AirWave is to be used as an adjunct to normal clinical practice, and is not to be used as a stand-

alone diagnostic system.

The AirWave can be used for patients intubated with a 2.5 mm ETT up to a 9.0 mm ETT.

1. Contraindications

Do not use the AirWave Monitor or leave the AirWave Sensor connected to the ETT in an MRI environment.

For ETT ID sizes between 4.0 mm and 9.0 mm, do not use on a cuffless ETT. The AirWave is intended for

use only with a cuffed ETT for this size range.

Do not use on patients who require an ETT smaller than 2.5 mm ID.

Do not use the AirWave on patients ventilated with Heliox.

Do not use in a setting other than in-hospital.

Do not attempt to re-use or sterilize the AirWave Sensor; infection or cross-contamination is possible.

Sterilizing the Sensor may cause damage to the internal components, which can cause the SonarMed

AirWave to produce erroneous results.

Section C–Warnings and Precautions

AirWave System Operator’s Manual

C. Warnings and Precautions

The SonarMed AirWave Monitoring System (Monitor and Sensor) is not to be used as a diagnostic

tool; it is to be used as an adjunct to airway management only.

The SonarMed AirWave is to be used by properly trained personnel only.

Do not use an AirWave Sensor if its pouch is open or damaged.

Do not use the AirWave Monitor if it is damaged.

The AirWave Monitor is rated IPX1 for water ingress protection, which means the Monitor is resistant

to water dripping vertically onto the device. Other types of water exposure (e.g. sprays, submersion)

should be avoided.

Only the SonarMed AC-DC power supply may be used with the SonarMed Monitor. Use of another

power supply may put the patient at risk of an electrical hazard. Warning: To avoid the risk of electric

shock, this equipment must only be connected to a supply mains with protective earth.

When the Alarm Silence button is pressed, the Monitor speaker is disabled for two (2) minutes even if

a new alarm should occur during that period.

Some AirWave alarms may be manually disabled by the user. The Monitor will display the message

“An Alarm is Off” when this is the case. All alarms that have been disabled are reactivated to their

previous settings if the Monitor is powered off and back on.

Only upgrade firmware when the AirWave system is off the patient.

Presence of high oxygen levels (O2> 40%) or anesthesia gases affects the speed of sound. For best

results, it is important to modify the settings as described in Section G.c.

When using the SonarMed AirWave device in conjunction with a high frequency oscillatory ventilator

(HFOV), the manufacturer’s safety information and recommendations should be followed.

Only connect an ETT to an AirWave Sensor nozzle specified for that ETT ID. Failure to do so may

result in an unsecure fit between the Sensor and ETT and/or may cause the AirWave to provide

erroneous results.

The AirWave Sensor cable must be routed and secured in a way that prevents accidental disturbance

by the user, patient, or other persons.

If attaching the AirWave Sensor to an already intubated patient, care must be taken not to dislodge

the ETT while removing the standard ETT adapter and attaching the AirWave Sensor.

While using the AirWave’s feature for directly listening to the signals from the Sensor microphones,

system monitoring of ETT is discontinued until the system is returned to the patient monitoring

screen. This feature is used to both troubleshoot and listen to the patient’s breath sounds.

Improper cleaning methods or materials may damage the AirWave Monitor.

This device is a precision electronic instrument and must be repaired by qualified technical

professionals. Field repair of the device is not possible. Do not attempt to open the case or repair the

electronics. Opening the case may damage the device and voids the warranty.

Section D–Principles of Operation

AirWave System Operator’s Manual

D. Principles of Operation

The AirWave System

The SonarMed AirWave Monitoring System, as shown in Figure D-1, consists of an AirWave Sensor connected to

the proximal end of an ETT, and a Monitor to which the Sensor is connected via a cable.

Inside the AirWave Sensor are embedded a miniature speaker, for emitting sound waves into the ETT, and

microphones, for sensing the returning acoustic echoes. The amplitudes and timing of the echoes are analyzed

by the Monitor to provide the following information:

•location and size of ETT obstructions

•size of the passageway around the ETT tip

•relative movements of the ETT tip within the trachea

Figure D-1

SonarMed AirWave System

During use of the AirWave, an option is provided via the Patient Monitoring Waveform Screen to view the echo

signal to provide a means to the user to verify that the signal is free of artifact and that the algorithm is properly

identifying and tracking the ETT and the patient’s airway echoes. This primer is intended to help the user to

better understand and interpret the AirWave echo signals.

Acoustic Reflectometry

The SonarMed AirWave employs the technique of acoustic reflectometry which consists of emitting acoustic

waves into an unknown object (or in this case, an intubated ETT), detecting the returning acoustic reflections

(echoes), and examining their timing and amplitudes to infer characteristics of the object in question.

As mentioned above, the AirWave Sensor contains a speaker, for generating acoustic waves which travel into the

ETT and airways, and two microphones (separated by a small distance), for converting the reflected waves into

an echo signal which is input into the Monitor’s proprietary algorithms. This echo signal consists of positive and

negative deflections that represent positive and negative sound pressure waves, respectively.

The use of two microphones to sense the acoustic waves allows the system to determine the direction from which

echoes arrive. As a result, the system can selectively filter all echoes that arise from devices on the ventilator

side of the Sensor, such as closed-circuit suction catheters, y-connectors, ETCO2sensors, filters, etc. This

selective filtering is critical for obtaining a clean echo waveform from the ETT and airways that is free of ventilator

circuit echoes.

Section D–Principles of Operation

AirWave System Operator’s Manual

Origin of Echoes inside Tubes

A key property of an acoustic wave propagating in a tube is that a fraction of the wave’s energy will undergo a

reflection each time it encounters a change in cross-sectional area (A). If the changing A is from larger to smaller

(as depicted in (a) in Figure D-2), a positive pressure wave is reflected (showing up as a positive deflection in the

echo signal). Conversely, if the changing A is from smaller to larger (see (b) in Figure D-2 below), a negative

pressure wave is reflected (showing up as a negative deflection in the echo signal). The delay time of each echo

identifies the distance of the changing A that caused the echo. The amplitude of each echo identifies

approximately how much the corresponding A changed.

Figure D-2

Reflection or echo signals that arise from a tube with (a) changing A from large to small and (b) changing A from small to large.

Echoes in the ETT and Airways

The human airways consist of a network of bifurcating branches that start at the trachea and terminate at the

alveoli (small sacs where oxygen-carbon dioxide exchange takes place). An interesting property of the airways is

that even though the A of each individual segment decreases as the branching depth increases, the total A

(adding As of all parallel segments) undergoes a rapid increase after several generations of airway branching.

Considering this morphology, the airways behave acoustically like a horn with a bell at the end. Therefore,

acoustic waves traveling down the airways, or the analogous horn model, will be reflected at the rapid increase in

total A. The negative pressure wave from this bell-shaped region is used as a reference to which changes in ETT

tip position are tracked. The bell begins around the 6th branching generation which is approximately 5 cm past

the carina in adults and about 2-3 cm past the carina in neonates. It is worth noting that there are no echoes of

significance that arise from the carina, since the additive A of the two mainstem bronchi is approximately equal to

the trachea A.

To illustrate the relationships between cross-sectional area, amplitude, and time delay, refer to Figure D-3

depicting an intubated ETT with a corresponding echo signal (pressure amplitude on y-axis and time delay on x-

axis). For each deflection in the echo signal, an arrow denotes the corresponding region in the ETT and airways

from which that echo arises.

Section D–Principles of Operation

AirWave System Operator’s Manual

Figure D-3

Relationship of AirWave Sensor and intubated ETT (top) to the corresponding echo signal recorded by the AirWave system

(bottom).

Description of Echoes

In Figure D-3, the first (leftmost) echo (1) is a positive deflection (positive pressure) which indicates an A change

within the Sensor ETT connector from larger to smaller. This corresponds to the diameter change within the

connector (for example, from 3.5 to 3.0 mm ID in the 3.0-mm Sensor).

The second echo (2) is a positive deflection immediately followed by a negative deflection which indicates an A

change from larger to smaller and then back to larger. This echo could be from a small obstruction within the

ETT, a kink in the ETT, or a patient biting on the ETT. If the echo amplitude were larger, this would correspond to

a larger obstruction. The AirWave system estimates the obstruction size from the echo amplitude and the

obstruction location from the echo delay time.

The third echo (3) is a negative deflection which indicates an A change from smaller to larger. This echo, referred

to as the ETT tip echo, is analyzed by the AirWave system to estimate the passageway size (effective diameter)

around the ETT. A negative deflection echo indicates that the ETT is located within a passageway that has a

larger A compared to the ETT (this would be the case for an ETT in the trachea). If this echo were to change to a

positive deflection, then this would indicate that the ETT is located within a passageway that has a smaller A

compared to the ETT. This may correspond to an ETT that is in the esophagus or bronchus, or that is clogged at

the tip, such as from mucus.

The last echo (4), referred to as the airway echo, arises from the aforementioned bell-shaped region in the

airways. The AirWave system tracks the time delay of the airway echo to estimate relative changes in the

distance between the ETT tip and the airway echo region. For example, if the time delay between the ETT tip

echo and the airway echo is decreasing (airway echo moves to the left), then this indicates that the ETT tip is

getting closer to the airway echo region, or that the ETT is migrating down the trachea.

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