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Section L

– Specifications

AirWave System Operator’s Manual

54

5. Electromagnetic Compatibility

The information contained in this section (such as separation distances) is in general specifically written with
regard to the SonarMed AirWave. The numbers provided will not guarantee faultless operation but should provide
reasonable assurance of such. This information may not be applicable to other medical electrical equipment; older
equipment may be particularly susceptible to interference.

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided in this document and the
remainders of the instructions for use of this device.

Portable and mobile RF communications equipment can affect medical electrical equipment.

Cables and accessories not specified within the instructions for use are not authorized. Using other cables and/or
accessories may adversely impact safety, performance and electromagnetic compatibility (increased emission
and decreased immunity).

Care should be taken if the equipment is used adjacent to or stacked with other equipment; if adjacent or
stacked use is inevitable, the equipment should be observed to verify normal operation in the configuration in
which it will be used.

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.

For further details regarding EMC, please refer to the

AirWave System Set-up and Maintenance Manual

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Содержание AirWave

Страница 1: ...Operator s Manual August 2019 Edition The foundation of airway management has just changed at the speed of sound ...

Страница 2: ...ill 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 mail obelis net References to SonarMed in this manual shall imply ...

Страница 3: ...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...

Страница 4: ...ubleshooting 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 ...

Страница 5: ...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 a...

Страница 6: ...ctice 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 ...

Страница 7: ... 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 co...

Страница 8: ...tter 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 mention...

Страница 9: ...n 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 ...

Страница 10: ...e 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 trach...

Страница 11: ...to the frequencies at which the ETT and airways behave as waveguides Operating in these frequencies creates a challenge for collecting echo signals that are not corrupted by the sounds typically found within a ventilator circuit such as respiratory sounds secretion sounds cuff leak sounds etc As a result the AirWave system uses a variety of data collection strategies to collect a clean echo signal...

Страница 12: ...the Alarm Silence button a second time reactivates audible alarms Navigation Arrows The navigation arrows are used to move between user selectable options on the screen and to change user editable values and parameters right left up down Enter Button The center button is used to select items or lock in changes when editing a field Function Buttons The function buttons provide specific contextual f...

Страница 13: ... the Monitor must be turned on Plugging in the AC power source to a Monitor that is turned off will not charge the battery AirWave Sensor Cable Port This connector accepts the SonarMed AirWave Sensor Cable Only connect the SonarMed AirWave Sensor Cable to this port Firmware Upgrade and Data Communication Port This connector accepts the Firmware Upgrade Cable supplied with the SonarMed AirWave Moni...

Страница 14: ... the one shown in Figure F 3 appear when the unit is first powered on If no AirWave Sensor is connected to the Monitor the system prompts to connect one Once a Sensor is connected the user is guided through the calibration process to the Patient Monitoring Screen Patient Monitoring Screen Section G 10 Patient Monitoring Home Screen This is the primary monitoring screen for the AirWave Monitor also...

Страница 15: ...g analyzed by the AirWave Figure F 5 Settings Screens Section G 3 Main Menu Selections 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 a...

Страница 16: ...ms becoming unmuted D Uncalibrated Indicator located in the upper center of the screen this indicates that a connected Sensor ETT pair has not yet been calibrated for use with the Monitor E Calibrated Indicator located in the upper center of the screen this indicator appears once a connected Sensor ETT pair has been calibrated for use with the Monitor The left value is the ID of the ETT the right ...

Страница 17: ...orresponding to the icon to begin continuous monitoring of the ETT Set Baseline Icon sets or resets the baseline the current ETT tip location and passageway size at the time the button is pressed from which deviations in ETT tip position and passageway size are measured Waveform Screen Icon changes display to the Patient Monitoring Waveform Screen Sensor Health Icon on the Waveform Screen provides...

Страница 18: ...l Monitor set up System Memory Erase Icon erases any data stored in system memory as a result of data logging activity 5 General Symbols Table F 5 Symbol Definition WARNING Refer to this user manual for specific warnings and precautions 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 r...

Страница 19: ...eld press the Enter button which turns the highlight from yellow to white Figure F 10 Modify the field value by using the up and down navigation arrows In some cases individual digits of a value are modified separately and the left and right arrows navigate between the digits To lock in the new value press the Enter button again This turns the highlight back to yellow At this point the navigation ...

Страница 20: ...nitor automatically senses if an AirWave Sensor is connected 2 Start Up Screens a If the Monitor is turned on without a Sensor connected to the Monitor the Monitor displays the screen below see Figure G 1 The only option is to access the Main Menu by pressing the top function key Gear Icon Figure G 1 b If an AirWave Sensor is connected to the Monitor the Monitor automatically recognizes the Sensor...

Страница 21: ...rtifact on ETT movement monitoring Set Carina Distance Allows the user to manually enter the distance from the ETT tip to the patient s carina based on a chest x ray This option only appears if a Sensor is connected to the system calibration is complete and a baseline has been set Modify ETT Length Allows the user to modify calibrated ETT length This option only appears if a Sensor is connected to...

Страница 22: ...r more alarms are disabled these alarms are restored to their prior values when the Monitor is powered back on The alarm values can be restored to their default values as set by authorized personnel in the Systems Settings Screen by selecting the Restore Defaults button middle function button shown in Figure G 4 The system prompts to accept or cancel restoring defaults as shown in Figure G 5 Selec...

Страница 23: ...ion NOTICE The AirWave system does not automatically detect the patient s carina The carina distance tracking feature depends on the one time manual input by the user Once the carina distance has been set the system shows the carina distance on the Patient Monitoring Screen please see Section G 10 and automatically tracks the distance from that point forward NOTICE Carina distance tracking is an o...

Страница 24: ...ound speed changes the timing of the AirWave s echoes and the system needs to compensate for these changes to provide accurate results Figure G 8 NOTICE For optimal accuracy the Sound Speed Correction needs to be set to the correct setting Two sound speed correction methods are available 1 O2 This manual correction method is intended for use in patients ventilated with oxygen such as in the ICU Wh...

Страница 25: ...actor d NOTICE When changing the sound speed correction settings from the Main Menu the process of verifying the factor involves switching back and forth between the 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 anesthe...

Страница 26: ... inside the middle red frame see Section D Principles of Operation for a more detailed explanation of this echo The waveform will update in real time as the speed factor is changed Figure G 11 If the tube tip echo is to the right of the window see Figure G 12 decrease the Speed Factor value This will be the case in the presence of a gas heavier than air such as anesthesia which causes the system w...

Страница 27: ...d 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 message listening to the microphone signals can help pinpo...

Страница 28: ...ming this operation f ETT Movement Smoothing The ETT Movement Smoothing feature is used when there is artifact in the movement echo This may be needed when the airway echo is flat or jumpy Note when this filter is on there will be time delay between gross movements of the ETT and when the AirWave shows the movement To engage ETT Movement Smoothing go to the Settings Screen Gear Icon use the downwa...

Страница 29: ...collecting data when troubleshooting or doing research Detailed instructions can be found in the Troubleshooting Section of the AirWave System Set up and Maintenance Manual Please contact your Biomedical or Clinical Engineering Team or SonarMed technical support for assistance i System Settings Selecting System Settings enters a password screen which leads to a set of screens where the LCD brightn...

Страница 30: ...en DO NOT USE Return the Sensor to 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 c Remove the standard adapter circuit adapter or hub that is connected to the ETT leaving just the ETT see Figure G 18 If assistance...

Страница 31: ...own in Figure G 19 Figure G 19 e Check that the ETT is securely connected to the Sensor 5 Connecting the AirWave Sensor to the Monitor a Connect monitor side of the Sensor cable to the matching port on the side of the AirWave Monitor see Figure G 20 Figure G 20 b Connect the sensor side of the cable with the micro USB connector to the Sensor as shown in Figure G 21 Figure G 21 Sensor ETT Connector...

Страница 32: ...to step d Figure G 22 c Select No X to continue using the previous calibration only if the following two conditions are true The previously calibrated Sensor has not changed same Sensor serial number The previous calibration was performed for the same model and size ETT Check that the current ETT matches the displayed diameter length and manufacturer Selecting No X will skip the remaining steps in...

Страница 33: ... the ETT tip is hovering in open space 2 A tubeless calibration can be completed when no calibration tube is available The user must hold the Sensor in open air away from any other objects or surfaces It is especially important for the Sensor connector to the ETT see Figure G 24 to remain unobstructed Figure G 24 e When ready to proceed with the calibration select the Next Screen Arrow The System ...

Страница 34: ...ailable options in the list using the Up Down Arrows then proceed by using the Next Screen Arrow and verifying the choice at the following prompt see Figure G 28 Figure G 28 NOTICE If an ETT type identical to the intubated ETT is not available in the list or if the ETT type being used cannot be identified then use Mallinckrodt as a substitute ETT for calibration It is very likely that the ETT leng...

Страница 35: ...atient as before i e if the original sensor was replaced If the calibration is for a new patient the user should select No X Figure G 30 k The Monitor now enters the Patient Monitoring Home Screen as shown in Figure G 31 The red UNCALIBRATED indicator at the top of the screen is replaced with green text showing the new ETT ID and length Figure G 31 l If calibration is not successful the system dis...

Страница 36: ...Wave Sensor c Secure the cable s path between the Monitor and the Sensor by attaching the cable to the ventilator tubing or by similar means WARNING Be sure to route the Sensor cable along a path that will not be easily disturbed by the operator patient or other persons Do not leave excess Sensor cable lying on the floor It is possible that the ETT can be moved or dislodged if the cable is pulled ...

Страница 37: ...tor must be adjusted manually To manually adjust the ETT length that was stored in the system during calibration access the Waveform Screen and press the left or right navigational arrows until the tube calibration indicator is highlighted in green see Figure G 33 Figure G 33 Press the Enter button to bring up the Modify ETT Length prompt shown in Figure G 34 Figure G 34 Change the value of the ET...

Страница 38: ...esponds to the ETT length stored within the system The ETT tip echo contains information related to the passageway size around the ETT tip see Section D Principles of Operation for a more detailed explanation of this echo It is important that this echo be positioned within the search window for the system to provide a reliable passageway size diameter If the ETT tip reflection is located within th...

Страница 39: ...ngth is too short In this case increase the ETT length until the tip reflection is located within the center frame Figure G 38 When an appropriate value has been reached exit the Modify ETT Length prompt by pressing the top function button Return Arrow and accepting the changes Alternatively the ETT length may be changed by accessing the Modify ETT Length option from the main menu which is reached...

Страница 40: ...Med 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 Once calibration is complete the Monitor enters the Patient Monitoring Screen also known as the Home Screen and begins taking periodic measurements This screen allows the user to set baseline and ...

Страница 41: ...ays the following screen see Figure G 42 Figure G 41 Baseline Movement Indicator Distance that ETT tip has moved from baseline Box color indicates alarm status Green when ETT tip position is within alarm limits Red when ETT tip position exceeds alarm limits Blue when system is analyzing data Carina distance is tracked if entered by the user Baseline Movement Direction Up down arrow lights indicati...

Страница 42: ...low a Pre Intubation In this state the Baseline Movement Indicator is disabled gray and the Passageway Size Indicator reads 0 mm in red indicating a large open area surrounding the ETT tip see Figure G 43 Any obstructions in the ETT will also be displayed Figure G 43 b Using the Device to Aid in Intubation Once the patient is intubated the Passageway Size Indicator shows the inner diameter of the ...

Страница 43: ...positioned as desired press the middle function button next to the GO Icon to proceed At this point the frequency of clicks from the Sensor is reduced since the ETT is in position and no longer being actively manipulated 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 ...

Страница 44: ...e G 47 Once the baseline is set all movement of the ETT tip will be measured from that point Figure G 47 Press the Set Baseline Button middle function button as shown in Figure G 47 The system asks to verify setting the baseline see Figure G 48 and upon verification plays a confirmatory tone Figure G 48 d Baseline Set The baseline position and passageway size are set see Figure G 49 All indicators...

Страница 45: ...nt Distance and direction that ETT tip has moved from baseline Color indicates alarm status Green when ETT tip position is within alarm limits Red when ETT tip position exceeds alarm limits Blue when system is analyzing data Obstruction Marker Shows percentage of ETT obstruction Color indicates alarm status Yellow when value is at least 20 Red when value exceeds alarm limit Passageway Size Shows s...

Страница 46: ... Airway contains the echo from the patient s airways This is the echo by which movement of the ETT tip is tracked The time difference between the current airway echo yellow and the baseline airway echo light blue is used by the system to track relative movements of the ETT tip In this example the current airway echo is occurring later in time compared to the baseline airway echo which means that t...

Страница 47: ...G 53 d Pressing the power button while in battery charging mode stops charging and powers down the Monitor e While in battery charging mode the Monitor automatically powers down when either the internal battery is fully charged or the AC DC Power Supply is disconnected NOTICE To charge the battery the Monitor must be connected to the AC DC Power Supply and the Monitor must be turned on Connecting ...

Страница 48: ...n the monitor housing CAUTION Improper cleaning methods or materials may damage the AirWave Monitor Do not use any other cleaning solutions or abrasive cleaning products as they may degrade the plastic Monitor Maintenance 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 c...

Страница 49: ...rnate airway management techniques error will clear when condition is corrected Large Passageway 1 The ETT is in a passage larger than the Passageway Size High alarm threshold Verify condition using alternate airway management techniques error will clear when condition is corrected Analyzing This message displays routinely as the Monitor is waiting to receive a clean microphone signal i e between ...

Страница 50: ...er protective microphone or speaker membranes It is normal for this error to occur occasionally for a few seconds If error persists suction protective membranes inside AirWave Sensor lumen to remove mucus If this does not clear the error then replace AirWave Sensor System Failures N A AirWave Sensor is not automatically detected when connected to the Monitor Contact SonarMed technical support Syst...

Страница 51: ...hree boxes show locations of the speaker and the two microphones within the Sensor along with a numeric representation of the performance of each When all three numbers are green the Sensor is functioning within acceptable limits When one or more of the numbers are red the Sensor may require cleaning Knowing which of the three components is affected allows the user to specifically target the lavag...

Страница 52: ...ge the setting to On on the screen that appears see Figure I 2 Exit and accept the changes Both the Home and Waveform screens will now display SM On to indicate the feature is enabled see Figure I 3 On the Home screen the indicator is located near the upper left corner of the screen on the Waveform screen the indicator is located above the airway waveform Figure I 3 To disable this smoothing filte...

Страница 53: ...Section I AirWave System Operation AirWave System Operator s Manual 49 ...

Страница 54: ...ace any AirWave Monitor found to be defective in accordance with this warranty free of charge for which SonarMed has been notified by the purchaser by serial number that there is a defect provided said notification occurs within the applicable warranty period This warranty shall be the sole and exclusive remedy by the purchaser hereunder for any AirWave delivered to the purchaser which is found to...

Страница 55: ... 0mm boxes of 5 or 10 AW S0014 Pediatric AirWave Sensor 5 5 6 0mm boxes of 5 or 10 AW S0015 Reusable Sensor Cable AW S0007 Sensor Suction Catheter Adapter for 2 5 mm Y connector AW S0010 Sensor Suction Catheter Adapter for 3 0 mm Y connector AW S0011 Sensor Suction Catheter Adapter for 3 5 mm Y connector AW S0008 Sensor Suction Catheter Adapter for 4 0 mm Y connector AW S0016 Sensor Suction Cathet...

Страница 56: ...gress Protection IPX1 Enclosure Leakage Current 300 μA at 240 VAC Applied Part Classification Type BF Defibrillation proof Power Classification Monitor Internally powered or powered from specified supply Power Supply Class II 2 AirWave Sensor Characteristics Functional Specification Single use Do not sterilize or re use Product contains no Latex or BPA N A Size 5 5 9 0 mm Sensor 3 375 x 1 125 x 1 ...

Страница 57: ... is 35 to 65 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 Temperature 20 to 50 C Relative Humidity 10 to 95 Atmospheric Pressure 50 to 106 kPa Monitor Temperature 40 to 70 C Relative Humidity 10 to 95 Atmospher...

Страница 58: ...cument and the remainders of the instructions for use of this device Portable and mobile RF communications equipment can affect medical electrical equipment Cables and accessories not specified within the instructions for use are not authorized Using other cables and or accessories may adversely impact safety performance and electromagnetic compatibility increased emission and decreased immunity C...

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