AirWave™ Setup and Maintenance Manual
Contents
1. Obstruction Echo Sound Pressure wm ETT Window Airway Window Time Delay gt Relationship of AirWave Sensor and intubated ETT top to the corresponding echo signal recorded by the AirWave system bottom The first leftmost nozzle echo is a positive deflection positive pressure which indicates an A change within the nozzle from larger to smaller This corresponds to the diameter change within the nozzle from 9 to 8 mm ID The second echo 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 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 SONarMED AirWave Setup and Maintenance Manual 25 Sect2. a clean unintubated ETT Failure to do so may cause the AirWave to provide erroneous results Do not use abrasive cleaning products on the Monitor as this will damage the clear screen cover and degrade visibility of system information 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 C Airwave Monitor Package Contents 1 AirWave Monitor 1 Carrying strap 1 AC DC Power Supply 1 Hospital Grade Power Cord 1 Firmware Upgrade Cable RS232 Connection 1 USB to RS232 Converter Cable 1 Software and Documentation CD SONarMED AirWave Setup and Maintenance Manual 2 Section D Displays Indicators and Controls D Displays Indicators and Controls This section describes the displays indicators and controls for the SonarMed AirWave Monitor 1 AirWave Monitor Controls Front Panel Alarm LED Alarm Silence Button Display Screen Navigation Buttons Speaker Power Button Function Buttons Alarm LED This LED flashes red when and alarm condition is present The LED flashes even if the audible alarms are silenced Display The display screen of the AirWave Monitor is a color LCD Screen Alarm Silence This button is used to temporarily silence audible alarms Onc
3. a period of three years from the date of purchase from an authorized SonarMed distributor as follows SonarMed shall repair or replace 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 be defective in any manner whether such remedies be in contract tort or by law 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 The AirWave is a precision electronic instrument and must be repaired by qualified technical professionals Accordingly any sign or evidence of opening the AirWave field service by non authorized personnel tampering or any kind of misuse or abuse of the AirWave shall void the warranty in its entirety All non warranty work shall be done according to SonarMed standard rates and charges in effect at the time of delivery to SonarMed Disclaimer Exclusivity of Warranty The express warranties set forth in this manual are exclusive and no other warranties of any k
4. 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 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 the Figure below 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 ETT Tip
5. emits an audible tone to test its sound circuitry The alarm LED flashes red once c If any errors are detected during start up diagnostics refer to Section H Troubleshooting 2 Modifying System Settings a Access the Main Menu by pressing the top function key as shown below or select options at right b From the Main Menu select System Settings as shown below to advance to the Password Screen Note that the options displayed in the Main Menu may differ from those shown depending on the selected settings and whether a Sensor is present or not Main Menu select using arrow keys and Enter c Inthe Password Screen enter the password using the Navigation Arrows in the following order left up right sonarMED AirWave Setup and Maintenance Manual 8 Section E System Set up Password D 2 1 3 b CRC 1174147460 d Inthe System Setting Screen shown below the following settings can be modified system Settings Patient ID Data Logging Screen Brightness 1 low to 10 high Date MM DD YY format Time 24 hour time format 12 00 11 59 PM represented as 12 00 23 59 gt e Patient ID Enables access from Main Menu to Patient Info Screen If this option is enabled set to Y then all data collected within the Monitor are stamped with a patient identification number which is accessible from the Patient Info Screen Data Logging Enables access from Main Menu to the D
6. sec Electromagnetic Environment Electromagnetic environment Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be kept at levels to reduce electrostatic charge to suitable levels Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Equipment which emits high levels of power line magnetic fields in excess of 3A m should be kept at a distance to reduce the likelihood of interference Mains power should be that of a typical commercial or hospital environment If user requires continued operation during power mains interruptions ensure that batteries are installed and charged Ensure that battery life exceeds longest anticipated power outages or provide and additional uninterruptible power source This equipment is intended for use in the electromagnetic environment specified below The customer or the user should assure that it is used in the specified environment Portable and mobile RF communications equipment should be used no closer to any part of the SonarMed Airway Monitoring System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter as below SonarMED AirWave Setup and Maintenance Manual 22 Section L Principles of Operation Immunity te
7. 2 Voltage fluctuations flicker IEC 61000 3 3 Electromagnetic Immunity Compliance according to Electromagnetic environment The equipment uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class A The SonarMed Airway Monitoring System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Not applicable Not applicable This equipment is intended for use in the electromagnetic environment specified below The user of this equipment should assure that it is used in the specified environment Immunity against electrostatic discharge ESD IEC 61000 4 2 electrical fast transients bursts IEC 61000 4 4 surges on AC mains lines IEC 61000 4 5 power frequency magnetic field 50 60 Hz IEC 61000 4 8 voltage dips and short interruptions on AC mains input lines IEC 61000 4 11 IEC 60601 1 2 test level Compliance level of this device contact discharge 6 kV air discharge 8 kV power supply lines 2 kV longer input output lines 1 kV Common mode 2 kV differential mode 1 kV dip gt 95 0 5 periods dip 60 5 periods dip 30 25 periods gt 95 0 5 per 60 5 per 30 25 per dip gt 95 5 seconds gt 95 5
8. SonarMED airwave Airway Monitoring System Setup and Maintenance Manual June2013 Edition The foundation of airway management has just changed at the speed of sound Caution Federal law restricts this device to sale by or on the order of a physician This Set up and Maintenance Manual is an addendum to the Operator s Manual supplied with the Airwave system and focuses on technical aspects of the system For information regarding the use of the AirWave in a clinical setting refer to the Operator s Manual WARNING The instructions in this addendum will allow the user to change the default settings of the Airwave Monitor 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 References to SonarMed in this manual shall imply SonarMed Inc SonarMed is a registered trademark and AirWave is a trademark of SonarMed Inc SP0621_D S ee SONarMED AirWave Setup and Maintenance Manual Table of Contents Table of Contents OO W ech D om Ek o hb sch ie y ech St z n e SN Se EE 1 WY UII and Wee le 2 Airwave Monitor Package Content cccccccccsssseeccceeeeaeeeseceeeeese
9. Wave Sensor is placed in the breathing circuit it is probable that secretions will occasionally occlude the acoustic components of the Sensor Such occlusions can degrade the performance of the System and eventually result in erroneous feedback to the user To avoid this the AirWave System continually checks the quality of the acoustic signals and suspends patient monitoring if signal quality drops too much In this situation the System displays the error message Sx Change Sensor SONnarmMED AirWave Setup and Maintenance Manual 14 Section H Troubleshooting To provide further guidance the System also provides a troubleshooting graphic to assist in determining where within the sensor to focus the suctioning cleaning efforts This visual aide looks as follows Sensor Health The system is detecting mucus buildup on the protective membranes shown in red Please lavage and suction the corresponding membrane until its status returns to green When the Sx Change Sensor error is active this graphic will automatically be overlaid onto the Patient Monitoring Screen to further alert the user to the condition of the Sensor It will only go away after the Sensor health has returned to an acceptable level to resume monitoring The Sensor Health graphic is also accessible at any time from the Waveform Screen by selecting the Sensor Health icon center function button Since the waveforms may still provide useful troubleshooting inform
10. aeeeeeeeeeeeseeeeeeeeeeeeesaesseeeeeeeseseeeseeeeeeesseueseeeeeesssaeaeeeeeeeesaaaasees 2 Displays Indicators and Controls seaicaccmunicasccnanantucnseswdsondaeienannsaiasmnaeeataaniuies dvrnnidincemesinenaosesneesicodaene iendabademeddisnuemasutandinesisanaieduewies 3 AirWave Monitor Controls Front Panel NEE 3 Airwave Connections Right SIde nx ccccc cccsaceeciccessendcanssiedesasdesasdnontececedsextamecseadesuevenee nocbeuleendeeedenadclandaanedensecaoebaeuedeendemessioedenases 4 AirWave Monitor ScreenS acta sssatinge wacatee eset ce acennecaauenecab steneaeeeeetedcnnteeessaeeenasettoes shesene tae ch aceenaeeeuannte tee eeeseeetaceteGueeseeneenetetnouee tee 4 AirWave Monitor Indicators And ICONS ccccceeeeeeee eee eee cece eee ee eee seen eee eee e ances eee eae sees eae eee eeaaaaeeeesaeaaeeeeeaaaeeeeesaaaeeeeeseeeeeeesaaes 5 EE lee eee eee ee ae a ee eee E ee eee eee 6 Basic Navigation and COMING detncicetetersccndsertcetersetnuahindecedeteeianshsweiesdeaisieesbinticubebeeteneecmerdetaedenenibiitecedeiseleoeseantuadeieeiaeshieeueeiedestee 7 SEEE e E E E O E E E E E E E E E E E E E E EE E A EEA 8 Powering On the AirWave Montor 8 Modifying System GS CTING EE 8 Powering Off the Monttor t nrrEnn n AAEE SAEEEEArEEEE An EEEn nn Eren anrr en ennenen 10 Updating Monitor Fi EE 11 INSC SSS AE EE 11 Windows Software Installation EE 11 Firmware Upgrade eee cecessenmvcisemrenceids e r a oar EE e E oer A E OER E A O a O AEE E O EE 11 Cleaning Main
11. and the recommended user action If the user action doesn t remedy the problem please contact SonarMed technical support for assistance System Message __ Alarm Description Cer Action Calibration Monitoring Messages and Alarms Unable to Calibrate Obstruction Detected Analyzing An Alarm is Off I Small Passageway Prior to setting baseline Small Passageway After setting baseline Large Passageway The AirWave cannot obtain a proper calibration signal The ETT tip has migrated low in the trachea beyond the ETT Movement Low alarm threshold The ETT tip has migrated high in the trachea beyond the ETT Movement High alarm threshold An obstruction in the ETT has exceeded the ETT Obstruction High alarm threshold The ETT is in a passageway smaller than the ETT ID This alarm is intended for use during intubation to provide feedback if the ETT tip is placed in a small passageway such as the esophagus The ETT is in a passage smaller than the Passageway Size Low alarm threshold The ETT is in a passage larger than the Passageway Size High alarm threshold This message displays routinely as the Monitor is waiting to receive a clean microphone signal i e between breaths Follow the on screen prompts to correct the condition causing the failure If failure persists replace the AirWave Sensor Verify condition using alternate airway manag
12. ata Logging Screen If this option is enabled set to Y the monitor can be set up for various data collection operations to facilitate troubleshooting see Section H Troubleshooting for details e When modifications are complete return to the Main Menu by pressing the Previous Screen Icon or advance to the Default Alarm Settings Screen by pressing the Next Screen Icon If changes were made the system prompts to confirm or cancel the changes before moving to the next screen f Inthe Default Alarm Settings Screen shown below the default alarm values can be modified as follows e ETT Tip Movement High and low thresholds may be set separately in increments of 0 1 cm Passageway Diameter High and low thresholds may be set separately in increments of 5 ETT Obstruction This threshold may be set in increments of 5 Main Alarm Tone To provide a distinct alarm tone that will differentiate the AirWave alarm from nearby alarms the alarm tone is selectable from four sequences A through D While editing this field pressing the up down arrow buttons plays each alarm tone SONarMED AirWave Setup and Maintenance Manual 9 Section E System Set up Default Alarm Settings ETT Tip Hi cm Movement Lo cm Passageway Hi Yo Diameter Lo of Main Alarm Tone OB Note that these are the default alarm settings to which the system will revert if the user presses the Restore Defaults button in the Alarm Settings Screen g W
13. ation even while monitoring is suspended the Sensor Health graphic will not automatically appear on the Waveform Screen The Sensor Health graphic depicts a representation of the AirWave Sensor when seen through the lumen from below The three 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 requires cleaning Knowing which of the three components is affected allows the user to specifically target the lavage and suctioning to the correct component which should make the cleaning process more effective Once the affected component is clean its number should return to green It is possible that cleaning suctioning will not allow the Sensor health numbers to recover sufficiently to resume monitoring If this is the case it will be necessary to replace the Sensor 3 Data Logging The AirWave contains nonvolatile memory into which monitoring data can be logged at selected intervals Data logging provides a means for SonarMed technical service personnel to remotely troubleshoot AirWave operation If the AirWave is frequently displaying error messages or is not performing as expected it is recommended that data logging be activated and the data be periodically downloaded from the AirWave and sent to SonarMed for analysis The da
14. c 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 ETCO2 sensors 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 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 of the Figure below 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 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 SONnarmMED AirWave Setup and Maintenance Manual 24 Section L Principles of Operation distance of the changing A that caused the echo The amplitude of each echo identifies approximately how much the corresponding A changed el Ash ds 3 Echo Echo a b 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
15. de a Connect RJ 11 side of Firmware Update Cable to the Airwave Monitor This is the connector that looks like a telephone jack To place Monitor in firmware update mode start with Monitor turned off and hold down speaker mute button while pressing power button The alarm LED rapidly blinks yellow and the LCD remains off If this does not occur power down the Monitor and retry It is ok to run the Monitor off battery power while updating the firmware Even if the Monitor loses power while updating the previous firmware version will remain intact Run Start gt All Programs SonarMed gt AirwaveFirmwareUpdater on PC Select the Upload Firmware bution SONarMED AirWave Setup and Maintenance Manual 11 Section G Cleaning Maintenance and Disposal f Select the firmware image X Idr and select Open g The status window and progress bar shows programming progress Programming is complete when the Monitor reboots and executes the new firmware image If the cable accidently becomes disconnected during programming power down the Monitor by holding down the power button quit the AirwaveFirmwareUpdater program and repeat from step b h Goto the System Setting Password Screen on the Monitor to verify that the system has been updated to the correct firmware version The version number and CRC should match the firmware image filename G Cleaning Maintenance and Disposal The Monitor enclosure and AC DC power supply may be clean
16. e if the drivers for the USB to RS232 Adapter haven t previously been installed then install them by going to Start All Programs gt SonarMed gt USB RS232 Drivers and selecting the appropriate installation file WIN98 XP 2000 or Vista Win7 Allow driver to install Connect the USB to RS232 Converter Cable to PC and allow driver to finish installing Connect Firmware Update Cable to USB to RS232 Converter Cable if not already done Data Download Procedure Connect RJ 11 side of Firmware Update Cable to the Airwave Monitor This is the connector that looks like a telephone jack Power on the Monitor if it is not already on It is ok to run the Monitor off battery power while downloading data However large amounts of data may take several minutes to download so connecting the power cord may be desirable if the battery is very low Run Start gt All Programs SonarMed gt AirwaveDownloader on PC Select the Download Patient History button Select a location to save the data file and hit OK The status window and progress bar show downloading progress and the Monitor screen will show Log download in progress The download is complete when the file name bin is displayed over the progress bar If the cable accidently becomes disconnected during programming quit the AirwaveDownloader program and repeat this procedure select the Download Error Log button Select a location to save the data file and hit OK T
17. e is insufficient for accurate tracking It is normal for this error to occur occasionally for a few seconds WARNING While this error is present the ETT movement indicator may provide inaccurate readings The system is playing the microphone signals directly over the Monitor speaker Patient monitoring is disabled while this message is on To determine the noise source listen to the microphone signals via the Monitor AirWave Microphones option in the Main Menu Screen see Section F 3 c of the AirWave Operator s Manual If the source is identified attempt to reduce the noise level from the source If this is not feasible then monitoring on this patient may not be possible It is possible that a small percentage of patients may exhibit an airway echo of inadequate amplitude that the system may have difficulty tracking accurately In these patients it may be necessary to turn off the ETT position tracking alarm Exit Monitor AirWave Microphones Screen AirWave Setup and Maintenance Manual The ETT is disconnected from the Reconnect the ETT AirWave Sensor 13 Section H Troubleshooting System Message Alarm Description Ir eer enpon Power and Battery Failures N A Monitor does not power on Connect Monitor to AC DC power supply and press on button If Monitor powers on leave connected until battery is fully charged If Monitor doesn t power on contact SonarMed technical support EE l Ba
18. e pressed the Monitor silences Button alarm sounds for two minutes including if a new alarm is triggered during that time If an alarm condition still exists after two minutes the audible signal resumes Note Pressing the Alarm Silence button a second time DOES NOT reactivate audible alarms Navigation The navigation arrows are used to move between user selectable options on the screen and Buttons to change user editable values and parameters The center button also referred to as the Enter button selects and locks in changes Speaker The speaker plays audible alarm tones when an alarm condition exists The speaker is also used to play the real time signals sensed by the AirWave Sensor microphones Function The function buttons provide specific contextual functionality as indicated by the currently Buttons display screen icons Icons appear to the left of these buttons to indicate their current function Power Button Pressing the power button once turns on the AirWave Monitor Pressing and holding the power button for one 1 second turns the AirWave Monitor off discontinuing all monitoring functions After turning the Monitor off if the Monitor is plugged into AC power and the battery is not fully charged the Monitor screen powers back on with a message that the battery is SONarMED AirWave Setup and Maintenance Manual 3 Section D Displays Indicators and Controls Control Description charging The monitor can be turned
19. ed by lightly rubbing their surfaces with a standard hospital cleaning wipe or a soft cloth dampened with 70 isopropyl alcohol and then allowed to dry The Monitor enclosure should be cleaned per the above method between each use from one patient to the next Do not use any other cleaning solutions as they may degrade the plastic WARNING Do not use abrasive cleaning products as this will damage the clear screen cover and degrade visibility of system information 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 The Monitor must be disposed of in accordance with facility standards and local laws The Sensor is labeled for single use only Dispose of the Sensor after use following hospital biohazard policies and local regulations There are no user serviceable parts in the Monitor Repairs must be made by SonarMed authorized personnel only SONarMED AirWave Setup and Maintenance Manual 12 Section H Troubleshooting H Troubleshooting 1 Error Messages When the AirWave system 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 possible system failures modes the associated system message if applicable if the failure is associated with an audible alarm
20. ement techniques error will clear when condition is corrected Verify condition using alternate airway management techniques error will clear when condition is corrected Verify condition using alternate airway management techniques error will clear when condition is corrected Verify condition using alternate airway management techniques error will clear when condition is corrected Verify condition using alternate airway management techniques error will clear when condition is corrected Verify condition using alternate airway management techniques error will clear when condition is corrected At least one of the AirWave monitoring Re enable the alarms in the Alarm Settings alarms is disabled Screen or cycle the Monitor power Sensor Cable Disconnect 3 AirWave Sensor cable is disconnected Reconnect Sensor cable to Monitor from Monitor during patient monitoring ETT Disconnected Excessive Noise Poor Signal Quality Microphone Monitor On SonarMED Excessive noise detected in microphone signals which is preventing collection of data It is normal for this message to be displayed occasionally If it occurs continuously for more than one minute then the Monitor is unable to collect data This is most likely due to excessive ventilator noise high ventilation rates or excessive secretions in the airway Refer to Section F 10 of the AirWave Operator s Manual for more information The airway echo amplitud
21. ensor is not automatically Contact SonarMed technical support detected when connected to the Monitor Sx Change Sensor ee System Failures System Error 3 Internal circuit or software error Power cycle Monitor and contact SonarMed for service if error persists Button Stuck One or more buttons on the keypad are Power down Monitor and contact SonarMed stuck in the pressed position for service if error persists Data Flash Error Internal memory to which data is being If this error persists power down monitor and stored has malfunctioned contact SonarMed for service Alarm Speaker Failure 3 Test failed during power up that verifies Power down Monitor and contact SonarMed proper operation of alarm speaker for service Entry Error Internal Clock Fail Use Up Down Keys to Edit Invalid Date or Time Incorrect value entered in system setup Retry entry using correct value Internal clock malfunction Power down Monitor and contact SonarMed for service The wrong button was used to edit a Use the up and down keys only parameter An inappropriate value was entered for Correct the entry in question one of the parts of the date or time 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 User Action Required alarm 2 AirWave Sensor Health Metric When the Air
22. he user enter the Patient Monitoring Waveform Screen refer to the AirWave System Operator s Manual for further information to compare the baseline and present airway echoes to confirm the current echo has shifted in time moved left right compared to the baseline echo and that the baseline and current airway echoes have similar shapes 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 tubes 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 during ventilation When connected to a patient the system collects a majority of its measurements during the quiet period of ventilation between end expiration and inspiration Therefore the AirWave Monitor provides updates to the ETT status approximately every patient breath depending on the level of noise present between breaths For cases where excessive noise interferes with acoustical measurements such that the ETT status is not updating it is recommended that the user enter the Listen to AirWave Microphones Screen to listen d
23. he download is complete when the file name txt is displayed over the progress bar Sending Data to SonarMed Compress data files bin and txt into a zip file zip Email the data file to support sonarmed com along with a description of the reason for logging the data SONarMED AirWave Setup and Maintenance Manual 17 Section Service Support and Warranty I Service Support and Warranty WARNING 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 void the warranty A return authorization number is required before returning any product to SonarMed To obtain this return authorization number contact SonarMed Customer Support 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 Warranty SonarMed Incorporated SonarMed warrants to the purchaser for a period of one year from the date of purchase each AirWave Monitor battery pack SonarMed warrants to the purchaser that the AirWave Sensor will calibrate on a clean unused endotracheal tube a minimum of one 1 time when used before the expiration date listed on the package and if the original packaging is not damaged sonarMed warrants the AirWave Monitor for
24. hen modifications are complete return to the System Setting Screen by pressing the Previous Screen Icon or advance to the Main Menu by pressing the Next Screen Icon If changes were made the system prompts to confirm or cancel the changes before moving to the next screen 3 Powering Off the Monitor a 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 c Ifthe 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 For new units it is recommended to fully charge the battery before placing the device into service Battery Charging In Progress Press Power button to discontinue charging 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 Note To charge the battery the Monitor must be connected to the AC DC Power Supply and the Monitor must be turned on either in normal mode or battery charging mode Connecting the AC DC Power Supply to a Monitor that is turned off will not charge the battery SONarMED AirWave Setup and Maintenance Manual 10 Section G Cleaning Maintenance and Disposal F Updating Monitor Fi
25. ind whether statutory written oral or implied including warranties of fitness for a particular purpose or merchantability shall apply SONarMED AirWave Setup and Maintenance Manual 18 Section J Parts and Accessories J Parts and Accessories The following parts and accessories are available for use with AirWave airway monitoring system Please contact your distributor representative for pricing and to place an order Part Description Part Number AirWave Sensor Small box of 10 AW S0001 AirWave Sensor Medium box of 10 AW S0002 AirWave Sensor Large box of 10 AW S0003 AC DC Power Supply with Power Cord AW X0007 Firmware Upgrade Cable AW X0005 RS232 to USB Converter Cable AW X0006 Monitor Carrying Strap AW X0004 Standard Adapter Removal Tool StART AW X0001 Monitor Post Rail Mount Swivel Tilt AW X0008 Monitor Post Rail Mount Gooseneck AW X0009 SONarMED AirWave Setup and Maintenance Manual 19 K Specifications 1 AirWave Monitor 9 625 x 4 5 x 2 25 Applied Part Classification Power Classification Monitor Internally powered or powered from specified supply Power Supply Class II 2 AirWave Sensor Characteristics Functional Specification Do not re sterilize or re use Size 3 5 x 1 x 1 25 8 9 x 2 5 x 3 2 cm with airway connectors 2 125 x 1 x 1 25 5 4 x 2 5 x 3 2 cm without airway connectors Weight 4 2 oz 119 g with cable 1 1 oz 32 g without cab
26. ion L Principles of Operation 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 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 All Lungs Are Not the Same Accurate tracking of the airway echo by the system assumes that the echo shape remains consistent over the duration of patient monitoring Significant changes in the echo shape may result in the system reporting a change in ETT position when the actual position has not changed It is possible that the airway echo shape may change due to airway changes that affect the geometry of the airway echo region Some examples of airway changes that may affect the airway echo shape include mucus plugs in a bronchus or a significant change in middle airway A due to bronchoconstriction or dilation Therefore when the system indicates ETT movement it is recommended that t
27. ipment 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 SONarMED AirWave Setup and Maintenance Manual 21 Electromagnetic Emissions Section L Principles of Operation This equipment is intended for use in the electromagnetic environment specified below The user of this equipment should assure that it is used in the specified environment RF emissions CISPR 11 CISPR Emissions Classification Harmonic emissions IEC 61000 3
28. irectly to the Sensor microphones via the Monitor speaker refer to the AirWave System Operator s Manual for further information This assists the user in determining the noise source so they can rectify it if possible Examples of noise sources may include a leaky ETT cuff secretions in the airway and or ETT a high respiratory rate a nebulizer and patient coughing SONarMED AirWave Setup and Maintenance Manual 26
29. le 1 PX 1 Water Ingress Protection rating is for the Monitor only SONarMED AirWave Setup and Maintenance Manual Section L Principles of Operation 20 Section L Principles of Operation 3 System Accuracy Accuracy 95 Confidence ETT Tip Movement cm Passageway Diameter mm 25 1 Percentage is absolute For example if actual obstruction is 50 of ETT cross sectional area then accuracy is 35 to 65 2 Passageway cross sectional area is represented as effective passageway diameter Actual passageway geometry may not have a circular cross section 3 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 amp Operating Conditions When not in use the SonarMed AirWave is to be stored under the following conditions e Temperature 40 to 70 C e Relative Humidity 10 to 100 e Atmospheric Pressure 50 to 106 kPa The Monitor may be used under the following conditions e Temperature 10 to 40 C e Relative Humidity 30 to 75 e Atmospheric Pressure 70 to 106 kPa 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 equ
30. n returns to the last screen that was displayed Next Screen Icon moves to the next screen in a sequence Return to Defaults Icon resets the Monitor s alarm settings to the default values default values are selected during initial Monitor set up typically by the hospital s Biomedical Engineering Department System Memory Erase Icon erases any data stored in system memory as a result of data logging activity 5 General Symbols WARNING Refer to this user manual for specific warnings and precautions Bei 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 S The SonarMed Sensor is a defibrillation proof type BF applied part Kh Manufacturer symbol CR Use By date in the format YYYY MM SONarMED AirWave Setup and Maintenance Manual 6 Section D 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 and as indicated by the icons displayed to the left of the buttons Selecting from a list On the Main Menu Screen item are selected from a list by using the Navigation Arrows and pressing the Enter button t
31. o enter that screen Certain screens of the AirWave Monitor contain fields that can be edited Navigation between these fields occurs by using the navigation arrows The active field is designated by a yellow highlight Yo To edit the field press the Enter button which turns the highlight from yellow to white 21 60 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 arrows move the focus to different fields to make changes When exiting the screen usually by using the Return Arrow function button the system prompts to accept or cancel any changes Accept Changes selecting the green checkmark confirms all modifications made on the screen the Monitor also plays a confirmatory tone Selecting the red X returns all values on the screen to their previous values SONarMED AirWave Setup and Maintenance Manual 7 Section E System Set up E System Set up This section describes how to access and modify the AirWave Monitor system settings screen brightness date time default alarm thresholds alarm tone and patient data requirements 1 Powering On the AirWave Monitor a Press the power button to turn on the Monitor b The Monitor
32. off completely by pressing the power button one more time 2 Airwave Connections Right Side AC Power Port Ze PC 4 Communication H Gay i Port Airwave Adapter Port E AC Power Port This connector accepts the SonarMed AC DC power supply 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 Plugging in the AC power source to a Monitor that is turned off will not charge the battery AirWave This connector accepts the SonarMed AirWave Sensor SES TON Only connect the SonarMed AirWave Sensor to this port The system will not function if another adapter is connected PC This connector accepts the Firmware Upgrade Cable supplied with the SonarMed AirWave Communication Monitor which is used to upgrade system firmware Port Only connect the Firmware Upgrade Cable to the Monitor when the AirWave system is not connected to a patient Only use the Firmware Upgrade Cable supplied by SonarMed 3 AirWave Monitor Screens System Start up Screens These screens 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 Sc
33. on distance for transmitters in these frequency ranges Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the system is used exceeds the applicable RF compliance level above the system should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the system Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m Recommended separation distances between portable and mobile RF communications equipment and the equipment Rated maximum separation distance according to frequency of transmitters in meters output power of transmiter 150 kHz 80 MHz 80 MHz to 800MHz 800 MHz to 2 5 GHz d 1 2 P d 1 2P d 2 3VP For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separa
34. r when this symbol is present near the upper left corner of the screen the alarms on the AirWave Monitor have been muted using the Alarm Silence button The symbol begins to flash ten seconds prior to the alarms becoming unmuted 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 this Monitor 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 value is the calibrated length of the ETT Sound Speed Correction Indicator located in the upper right corner of the screen this indicator shows the current user defined setting that the AirWave is using to compensate for changes in the speed of sound caused by high oxygen concentrations FiOz or the presence of anesthesia gases LCD Brightness Symbol Time Date Symbol Button Icon System Action When Pressed Accept Changes Yes Icon SONarMED AirWave Setup and Maintenance Manual 5 Section D Displays Indicators and Controls Button Icon System Action When Pressed Cancel Changes No Icon Screen Pixel Test Icon when pressed sets all LCD pixels to white to allow examination for dead pixels Main Menu Icon enters the Main Menu to make changes to user defined parameters RM Previous Screen Ico
35. reen Patient Monitoring Screen Home screen This is the primary monitoring screen for the AirWave Monitor It provides icon graphical and numerical representation of the status of the ETT including indicators for ETT tip movement passageway size and tube obstruction sonarMED AirWave Setup and Maintenance Manual 4 Waveform Screen Section D Displays Indicators and Controls This screen provides an alternative visual representation of the information displayed on the Patient Monitoring Screen in the form of the acoustic waveforms being analyzed by the AirWave System Set Up Screens These screens accessed through the Main Menu 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 and sound speed correction settings 4 AirWave Monitor Indicators and Icons Indicators if applicable are presented on all screens Icons appear next to the function keys to provide specific functionality depending on the current screen or action being performed Indicator ee Battery Indicator located in the upper left corner of the screen the number of bars indicates charge level and the bars blink during charging External Power Indicator when this symbol is present near the upper left corner of the screen the AirWave monitor is plugged into AC power Alarm Silence Indicato
36. rmware In an effort to continually improve the performance of the AirWave system and provide new system features SonarMed will periodically release new versions of the Monitor firmware This section provides instructions for upgrading the Monitor firmware Note The Monitor firmware version and its unique CRC number is displayed at the bottom of the Password Screen when System Settings is selected in the Main Menu Password D 2 1 3 b CRO 1174147460 1 Necessary items Firmware Update Cable DB 9 to RJ 11 USB to RS232 Converter Cable connected to Firmware Update Cable Note If necessary refer to the Parts and Accessories section of this manual for ordering information software and Documentation CD Firmware Image File X Idr e g M_1 2 1_CRC149712653 ldr 2 Windows Software Installation 3 Insert the Software and Documentation CD into PC drive Open the Firmware Updater folder and execute setup exe to install software on the PC After installation is complete if the drivers for the USB to RS232 Adapter haven t previously been installed then install them by going to Start gt All Programs gt SonarMed gt USB RS232 Drivers and selecting the appropriate installation file WIN98 XP 2000 or Vista Win7 Allow driver to install Connect the USB to RS232 Converter Cable to PC and allow driver to finish installing Connect Firmware Update Cable to USB to RS232 Converter Cable if not already done Firmware Upgra
37. st IEC 60601 1 2 Compliance Recommended separation distance test level level Conducted RF coupled 150 kHz 80 into lines MHz IEC 61000 4 6 Radiated RF 80 MHz 2 5 d 1 2VP 80 MHz to 800MHz IEC 61000 4 3 GHz d 2 3VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the recommended separati
38. system prompts the user to confirm prior to erasing WARNING Erasing the system memory causes a permanent loss of the data Any data stored in the system should be downloaded prior to erasing see Section HA for additional details Note The amount of memory remaining is displayed in the Monitor s upper right corner while data logging is enabled This number will be yellow if Logging is set to Off and green if it is set to Periodic or Continuous The Monitor will alarm when the system memory is almost full If the memory becomes full then data logging will stop f Once Data Logging parameters are set exit to the Main Menu by selecting the Return Arrow The system will prompt the user to confirm changes 4 Downloading Data In order for SonarMed technical personnel to analyze logged data the data must be downloaded from the Monitor and sent to SonarMed a Necessary Items Firmware Update Cable DB 9 to RJ 11 USB to RS232 Converter Cable connected to Firmware Update Cable Note If necessary refer to the Parts and Accessories section of this manual for ordering information e Software and Documentation CD SONarMED AirWave Setup and Maintenance Manual 16 Section H Troubleshooting Windows Software Installation Insert the Software and Documentation CD into PC drive Open the AirWave Downloader folder and execute setup exe to install software on the PC After installation is complet
39. ta logging feature is enabled in System Settings See Section E 2 a To access the Data Logging Screen to set the logging parameters select Data Logging from the Main Menu SONarMED AirWave Setup and Maintenance Manual 15 Section H Troubleshooting Data Logging Noise Logging Data logging is Off b The Logging mode can be set to one of three options No logging takes place Periodic The system records individual measurements at pre set intervals Continuous The system records every measurement note that memory will fill up quickly in this mode c If using the Periodic logging mode the user can choose from a selection of time intervals ranging from 5 seconds to 3 minutes Based on the logging period and the amount of free memory the text below the parameter box will provide an estimate of the time remaining until the memory becomes full d Ifthe Noise Logging feature is turned on the system will automatically record noise related data data stream when the Excessive Noise message is encountered This can assist SonarMed technical personnel in identifying the cause of the message since noise can originate from a number of sources both inside and outside the patient Since a data stream uses a large amount of memory 10 only one automatic recording is taken in a 12 hour period unless the Monitor is powered down which resets the clock e The system memory can be erased by pushing the bottom function key The
40. tenance and Dispooszal 12 BU ce 6 0 15 pelo EE 13 EOF NIOS AOR EE 13 AirWave Sensor Health te 14 ibe OIG WEE 15 POW NEN A WE 16 BEMVICSs SUDO la VV E a cateda cade E E E E E E P E E E E E E EEA tebe detdeued acess 18 Klee PNG Ca EE 19 PECE O ege 20 AIW ANS MONIO E 20 PMY AVS SSNS EE 20 SE Ee E 21 Storage amp Operating Conditions ccccccceeeeeecccceecceeeeeeceeeeeeaaeeeeeeeeeeesaaeeeeceeeeeeeeeeseeeeeeeeeseeaeeeceeeeesseeeaeeeeeeeesaaaaeeeeeesesaaaaeess 21 Electromagnetic Compatibility cccccccccccccccccceseeeeeeeeeceaeeseeeeeeesseeeeseeeeeeeeseeeseeceeeeeeeeeeseceeeesseeeaseeeeeeesseeeaececeeeesssaeeeeeeeeeeeaas 21 PRC TONS OF Oe e EE 24 SONarMED AirWave Setup and Maintenance Manual ii Section A System Description 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 Adapter and cable Sensor 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
41. the ETT tip within the trachea AirWave Monitor sonarMED Speaker Microphones iz Input Sound demm Echoes ETT AirWave Adapter 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 refer to the AirWave System Operator s Manual for further information 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 acousti
42. tion distance for the higher frequency range applies NOTE 2 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz NOTE 3 An additional factor of 10 3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas NOTE 4 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people SONarMED AirWave Setup and Maintenance Manual 23 Section L Principles of Operation L Principles of Operation The AirWave System The SonarMed AirWave system as shown in the Figure below 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 echoes The amplitudes and timing of the echoes are analyzed by the Monitor to provide the following information e location and size of ETT obstructions e size of the passageway around the ETT tip e relative movements of
43. to assist with management of the patient s artificial airway The Sensor replaces the standard 15 mm connector also known as the hub that typically comes with each ETT AirWave Monitor AirWave Sensor and Cable SOnarmMED AirWave Setup and Maintenance Manual 1 Section C Airwave Monitor Package Contents B Warnings and Precautions The SonarMed AirWave 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 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 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 Pressing the Alarm Silence button a second time does not reactivate the speaker 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 connect the Firmware Upgrade Cable to the Monitor when the AirWave system is not connected to a patient Calibration of the AirWave Sensor must be performed on
44. ttery takes longer than 4 hours to Contact SonarMed technical support charge Battery Failure 3 Battery exceeded normal temperature or Power down Monitor and contact SonarMed voltage during charging or it exceeded for service the time during which it should have fully charged System is running on battery and 20 or Connect Monitor to AC DC power supply to less charge is remaining recharge internal battery The Monitor can remain connected to a SonarMed Sensor and collect data during battery charge System is running on battery and 15 or Connect Monitor to AC DC power supply to less charge is remaining System will recharge internal battery The Monitor can automatically shutdown in 60 seconds remain connected to a SonarMed Sensor and collect data during battery charge Charge Battery Low Battery GN AirWave Sensor Failures Heater Failure Heater circuit inside AirWave Sensor is Cycle Monitor power If error reoccurs try not operating properly replacing AirWave Sensor Report error to SonarMed if it persists AirWave microphone s and or speaker If error persists suction protective are not operating correctly due to electrical membranes inside AirWave Sensor lumen to malfunction or mucus water deposition remove mucus If this does not clear the error over protective microphone or speaker then replace AirWave Sensor membranes It is normal for this error to occur occasionally for a few seconds AirWave S
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