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SonarMed AirWave Operator's Manual

Airway monitoring system
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Operator's Manual
August 2019 Edition
has just changed...
The foundation of
airway management
at the speed of sound.

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Summary of Contents for SonarMed AirWave

  • Page 1 Operator’s Manual August 2019 Edition has just changed… The foundation of airway management at the speed of sound.
  • Page 2 Boulevard General Wahis 53 1030 Brussels, Belgium +32 3 732 59 54 mail@obelis.net 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 AirWave System Operator’s Manual...

  • Page 3: Table Of Contents

    Connecting the AirWave Sensor to the Monitor ......................27 Sensor Calibration ............................... 28 Intubation with the AirWave Sensor Connected to an ETT ..................32 Connecting the AirWave Sensor to an Intubated ETT ....................32 Modifying the Calibrated ETT Length .......................... 33 Patient Monitoring –...
  • Page 4 Powering Off the Monitor ............................43 Cleaning, Maintenance and Disposal ..........................44 Troubleshooting ................................45 Error Messages ................................45 AirWave Sensor Health Metric ............................ 47 Sensor Suctioning ............................... 47 ETT Movement Smoothing............................48 Service, Support, and Warranty ............................49 Parts and Accessories ..............................50 Specifications ..................................

  • Page 5: System Description

    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.

  • Page 6: Indications For Use

    (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.

  • Page 7: Warnings And Precautions

    (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.

  • Page 8: Principles Of Operation

    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.
  • Page 9 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. AirWave System Operator’s Manual...
  • Page 10 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).

  • Page 11: Airwave Monitor Package Contents

    AirWave Sounds are Audible While a majority of medical devices that employ acoustics do so in the ultrasonic frequency range, the AirWave operates in the audible range below 8 kHz due to reasons related to the frequencies at which the ETT and airways behave as waveguides.

  • Page 12: Displays, Indicators, And Controls

    Power Button Pressing the power button once turns on the AirWave Monitor. While the Monitor is on, pressing and holding the power button for one (1) second turns the Monitor off, discontinuing all monitoring functions. After turning the Monitor off, if it is plugged into the AC-DC power supply and the battery is not fully charged, the Monitor screen powers back on with a message that the battery is charging.

  • Page 13: Airwave Connections - Right Side

    This connector accepts the SonarMed AC-DC power supply. Port 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. Note: To begin charging the battery, the Monitor must be connected to the AC power source, and the Monitor must be turned on.

  • Page 14: Airwave Monitor Screens

    Displays, Indicators, and Controls 3. AirWave Monitor Screens This section provides a brief description of the screens that make up the user interface of the AirWave System. Additional details, including more pictures, are included in subsequent sections. System Start-up Screens (Sections G.2 - Start-Up Screens and G.6 - Sensor Calibration) Figure F-3 These screens, beginning with the one shown in Figure F-3, appear when the unit is first powered on.
  • Page 15 These screens are accessed through the Main Menu (see Figure F-6) by pressing the Gear Icon found on most of the other AirWave screens and provide the interface for editing system parameters. These parameters include alarm limits for ETT tip movement, passageway size, and obstruction, a patient identification number, an ETT length setting, as well as settings for airway movement smoothing, data logging, and sound speed correction.

  • Page 16: Airwave Monitor Indicators And Icons

    External Power Indicator – when this symbol is present near the upper left corner of the screen, the AirWave Monitor is being powered by the plugged into AC-DC power supply.
  • Page 17 Accept Changes / Yes Icon Cancel Changes / No Icon Monitoring Readiness Icon – Appears when the ETT is connected to the AirWave Sensor and the Monitor detects what appears to be an intubated ETT. Press the button corresponding to the icon to begin continuous monitoring of the ETT.

  • Page 18: General Symbols

    Prohibited – Refer to the Contraindications Section of this manual for a complete list of system limitations Single Use Only – the SonarMed AirWave Sensor may not be reused due to risk of infection and/or cross-contamination The SonarMed Sensor is a defibrillation-proof type BF applied part “Use By"...

  • Page 19: Basic Navigation And Editing

    Displays, Indicators, and Controls 6. Basic Navigation and Editing a. Navigation from screen to screen of the AirWave Monitor occurs in one of two ways:  Using the Function Buttons – These buttons provide specific contextual functionality for the current screen as indicated by the icons displayed to the left of the buttons.

  • Page 20: Powering On The Airwave Monitor

    (Gear Icon Figure G-1 If an AirWave Sensor is connected to the Monitor the Monitor automatically recognizes the Sensor and prompts the start of the calibration (see Figure G-2). Section G.6 - Sensor Calibration provides full details about the calibration process.

  • Page 21: Main Menu Selections

    Alarm Settings – Allows the user to modify alarm threshold values.  Monitor AirWave Microphones – Allows the user to listen to AirWave microphone signals. This feature is used to both troubleshoot the Sensor and listen to the patient’s breath sounds.

  • Page 22: Alarm Settings

    Section G – AirWave System Operation a. Alarm Settings Selecting Alarm Settings enters the screen shown below (Figure G-4). ETT Obstruction Alarm Speaker High alarm threshold Volume Control ETT Movement High alarm threshold Restore Default Alarm Settings ETT Movement Passageway Size...

  • Page 23: Set Carina Distance

    NOTICE! Carina distance tracking is an optional feature, and leaving the carina distance undefined does not affect performance of the AirWave system. The Carina distance will reflect the distance of the ETT tip from the carina at the time it is set. Any movement of the ETT tip of the tube will automatically increase or decrease the carina distance based on the corresponding movement of the ETT tip.

  • Page 24: Sound Speed Correction

    (> 40%) or the presence of anesthesia gases. Any change in sound speed changes the timing of the AirWave’s echoes and the system needs to compensate for these changes to provide accurate results.
  • Page 25 Sound Speed Correction Screen and the Waveform Screen. This process is iterative and may require several repetitions. NOTICE! When the AirWave is used with anesthesia gases, the Speed Factor may require frequent adjustments if the anesthesia gas composition changes frequently.
  • Page 26 Section G – AirWave System Operation c. To determine an appropriate Speed Factor value, verify that the tube tip echo (highlighted by the light blue circle in the Figure G-11) is roughly centered inside the middle red frame (see Section D –...

  • Page 27: Monitor Airwave Microphones

    Sensor are used by the system to receive the returning echo. This echo is not audible to the human ear. The Monitor AirWave Microphones feature can be used to assist in listening to the patient’s breath sounds. This feature also provides a means to listen to the AirWave microphones for troubleshooting purposes. If the system is displaying an “Excessive Noise”...

  • Page 28: Modify Ett Length

    Section G – AirWave System Operation Figure G-14 NOTICE! Acoustic monitoring of the ETT and patient airway by the AirWave system is suspended when in this screen. Return to the Patient Monitoring Screen by selecting the Previous Screen arrow twice to resume patient monitoring.

  • Page 29: Patient Info

    Selecting System Settings enters a password screen which leads to a set of screens where the LCD brightness, Date-Time, Patient ID on/off, Alarm Sound selection, and Alarm default settings can be modified. These settings are intended to be modified by authorized personnel only (See AirWave System Set-up and Maintenance Manual).
  • Page 30 SonarMed for replacement. WARNING! Only connect an ETT to the AirWave Sensor 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.

  • Page 31: Connecting The Airwave Sensor To The Monitor

    Figure G-18 NOTICE! The StART is currently only available for the Larger Pedi/Adult size ETTs. Slide the proximal end of the ETT fully over the ETT Connector of the AirWave Sensor, as shown in Figure G-19. 6.5 – 9.0 mm Sensor 2.5 –...

  • Page 32: Sensor Calibration

    Sensor, refer to the Table in Section I – Troubleshooting. 6. Sensor Calibration NOTICE! The AirWave System must be calibrated prior to use. When a Sensor is plugged into the Monitor, the System automatically enters the calibration sequence.
  • Page 33 Section G – AirWave System Operation Figure G-23 1. When a calibration tube is available: The ETT should now be attached to the Sensor. To ensure a clean calibration signal, the ETT tip must not have any objects within 3 inches of it in all directions. For best results during the calibration, the user should be holding the Sensor in such a way that the ETT tip is hovering in open space.
  • Page 34 Section G – AirWave System Operation The Monitor briefly takes a series of acoustic measurements (which sound like clicks) to calibrate the Sensor. The screen below (Figure G-26) is displayed during this process. Figure G-26 The Monitor will next prompt the user for the type of ETT being used (see Figure G-27). This enables the System to retrieve tube-specific parameters from a database.
  • Page 35 Section G – AirWave System Operation Once calibration is complete, the Monitor sounds a confirmatory tone and displays the following message (Figure G-29) for two seconds before proceeding: Figure G-29 If calibration occurs with an ETT of the same diameter and similar length (± 0.5 cm), the system will prompt whether the baseline information from the most recent calibration should be used (see Figure G-30).

  • Page 36: Intubation With The Airwave Sensor Connected To An Ett

    StART Instructions for Use packaged with the tool for information on its use. WARNING! Protect the ETT position while removing the standard adapter. Slide the ETT connector of the AirWave Sensor fully into the proximal end of the ETT, as shown below in Figure G-32.

  • Page 37: Modifying The Calibrated Ett Length

    Section G – AirWave System Operation WARNING! When connecting the AirWave Sensor to an ETT that is already intubated, be careful not to move or dislodge the ETT. Check that the ETT is securely connected to the Sensor. Connect the ventilator and other airway devices (e.g. suction catheter, ETCO2, filter, etc.) to the proximal end (15 mm connector) of the AirWave Sensor.
  • Page 38 Section G – AirWave System Operation 1.1 cm Connector Tip Figure G-35  Before accepting the new ETT length, it is important to verify that the modified ETT length is correct by checking that the system is properly detecting the ETT tip.
  • Page 39 Section G – AirWave System Operation  If the ETT tip reflection is located to the left of the search window (see Figure G-37 , then the modified ETT length is too long. In this case, decrease the ETT length until the tip reflection is located within the center frame.

  • Page 40: Patient Monitoring - Home Screen

    10. Patient Monitoring – Home Screen WARNING! The SonarMed AirWave system is to be used to verify ETT placement, movement and obstruction; it is only to be used as an adjunct to airway management. This device is not to be used as a stand-alone diagnostic system.
  • Page 41 If the system is having difficulty acquiring measurements, an “Excessive Noise” message may appear in conjunction with infrequent indicator updates. To assist in determining the source of the noise, listen directly to the microphone signals using the Monitor AirWave Microphones option in the Main Menu (see Section G.d).

  • Page 42: Transitioning To Patient Monitoring After Set-Up

    Section G – AirWave System Operation Figure G-42 When the Sensor cable is reconnected, the Monitor returns to the Calibration Screen (see Section G.6 – Sensor Calibration). 11. Transitioning to Patient Monitoring After Set-Up When entering the Patient Monitoring Home Screen following a new calibration, the level of information displayed for each indicator is dependent on progression through the steps outlined below.
  • Page 43 NOTICE! When using a cuffed ETT, the cuff should be inflated at this point in order to obtain the most accurate results from the AirWave System. When the system is being used with a 2.5mm, 3.0mm or 3.5mm Sensor, the Monitor will remind the user to adjust the tube length used by the system in case the ETT has been shortened (see Figure G-46).

  • Page 44: Ready To Set Baseline

    Section G – AirWave System Operation c. Ready to Set Baseline A flashing Set Baseline Icon is displayed indicating that the system is ready to set the baseline ETT position and passageway size (see Figure G-47). Once the baseline is set, all movement of the ETT tip will be measured from that point.

  • Page 45: Set Carina Distance

    Section G – AirWave System Operation e. Set Carina Distance If the distance from the tube tip to the patient’s carina is known, the user may enter it manually from the Main Menu Screen (see Section G.b). Once set, the system automatically tracks the distance during subsequent monitoring (see Figure G-50).
  • Page 46 Section G – AirWave System Operation Figure G-51 The Waveform Screen shows the AirWave echo signals as highlighted in Figure G-52. The waveform is visually separated into three colored frames, which delineate the echoes arising from the ETT, ETT tip, and patient airways.

  • Page 47: Powering Off The Monitor

    Section G – AirWave System Operation 13. Powering Off the Monitor Press and hold the power button for at least one second. The Monitor displays “Power Down In Progress” for one second and then the screen goes black. If the internal battery is not fully charged and the AC-DC Power Supply is still connected, then the Monitor screen powers back on into the battery charging mode.

  • Page 48: Cleaning, Maintenance And Disposal

    The Monitor contains two batteries: one lithium ion rechargeable battery pack and one coin cell battery used to power the internal clock. These batteries are not user replaceable; contact SonarMed for service. There are no user serviceable parts in the Monitor. Repairs must be made by SonarMed authorized personnel only.

  • Page 49: Troubleshooting

    I. Troubleshooting 1. Error Messages When the AirWave system signals an alarm or experiences a failure, it displays informational/error messages to assist the user in pinpointing the cause of the problem and determining how to resolve it. The table below lists system alarms and failures modes, the associated system message (if applicable), if the alarm/failure mode is associated with an audible alarm, and the recommended user action.
  • Page 50 (e.g. month = 13 or hour = 26) 1 – User selectable alarm sound sequence (see AirWave System Set-up and Maintenance Manual for details on selecting alarm type) 2 – Urgent alarm (short, high-pitched tones) 3 –...

  • Page 51: Airwave Sensor Health Metric

    2. AirWave Sensor Health Metric When the AirWave Sensor is placed in the breathing circuit, it is possible that secretions may periodically impact the speaker of the Sensor. These secretions can degrade the performance of the System. To avoid this, the AirWave System continually checks the quality of the acoustic signals and suspends patient monitoring if signal quality is too low.

  • Page 52: Ett Movement Smoothing

    In the event that there is artifact in the echo waveform from the patient airway, the ETT movement indicator may display “jumpy” results. In extreme cases, this may result in nuisance alarms for high or low tube tip movement. The AirWave provides a feature to smooth out these jumpy readings. and select “ETT Movement Smoothing”.
  • Page 53 – Section AirWave System Operation AirWave System Operator’s Manual...

  • Page 54: Service, Support, And Warranty

    This warranty excludes cost of delivery to and from SonarMed. All repaired units shall be received by the purchaser at SonarMed's place of business. SonarMed reserves the right to charge a fee for a warranty repair request on any AirWave that is found to be within specifications.

  • Page 55: Parts And Accessories

    Section K – Parts and Accessories K. Parts and Accessories The following parts and accessories are available for use with AirWave airway monitoring system. Please contact SonarMed or your distributor representative for pricing and to place an order. Table K-1...

  • Page 56: Specifications

    2.125” x 1.125” x 1.125” / 5.4 x 2.9 x 2.9 cm (without airway connectors) 2.5 – 5.0 mm Sensor: 2.438” x 0.688” x 1” / 6.2 x 1.7 x 2.5 cm (with airway connectors) 1.375” x 0.688” x 1” / 3.5 x 1.7 x 2.5 cm (without airway connectors) AirWave System Operator’s Manual...

  • Page 57: System Accuracy

    2 – Percentage of passageway diameter. For example, if actual diameter is 10.0 mm, then accuracy is 7.5 mm to 12.5 mm. 4. Storage & Operating Conditions When not in use, the SonarMed AirWave is to be stored under the following conditions: Sensor: •...

  • Page 58: Electromagnetic Compatibility

    It is intended for all qualified personnel using the SonarMed AirWave to leave the plastic surround installed around the Monitor’s perimeter at all times.

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