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AirWave™ Operator`s Manual

1. 28 G Cleaning Maintenance and Disposal cccccccccceecceeeeeeeeeeeeseeeeeeeeeeeeeeaeeeeeeeeeeesseeeeeeeeeeesseeeeeeeeeeeeseeaaeeseeeeessaaaaeeeeeeeeesaas 28 FU slo SING UNG m a E EE ERE A A EEA E E E EAA R EES 29 le ENO MESSIOS orre cc EEEE EEE EE EES 29 2 AirWave Sensor Health Metric ccccccccsssssecccceeeceeeeeeeceeeeeeeeeeeeeeeeeeeseeeseeeeeeeeseeeeseeceeeessseeeeeeeeeeesseuaeeeeeeeessaeaeeeeeeeeseaas 30 Bs Sensor 87219 Eee I0 AT Bo NOR ce 31 SOnhnarMED AirWave System Operator s Manual i Table of Contents ETT Movement SiO CHANG adic cence 33 l Service Support and Warranty sssssssesssssssssssseseeeeeeennnn eE re e nnn nnns ARER i ss ETE AEE pi RENEE Aere annis nana 34 J Pans and ACCCS 50 les NETT ES 35 ARIES eee eomm 36 l AN NENON O eR ORERRE 36 2 APNE OONO grer A E E A E RA R 36 S VENA A e e A E P M 37 4 Storage amp Operating CONITIONS cccccccccccsssssseeeeecceseesseeeeeecseeeuseeeeeeceeeauseeeeecseeeaaseeeeeesseeaaaseeeeeessseaasaeeesessssaaaaess 37 5 Electromagnetic Compatibilty ZR paniti 37 L mi ele meo eer c e PN EET ee ee eee ee eee EEE 38 SONarMED AirWave System Operator s Manual iii Section A System Description A System Description The SonarMed AirWave acoustic airway
2. P SO n a r MED AirWave System Operator s Manual 2 Section C Warnings and Precautions 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 Always ensure proper inflation of the ETT cuff Improper inflation may cause the system to give erroneous results or no results due to excessive noise Only connect the Firmware Upgrade Cable to the Monitor when the AirWave system is not connected to a patient Presence of high oxygen levels FiO gt 6096 or anesthesia gases changes the speed of sound Unless the AirWave system settings are modified as described
3. Alarm Settings on 25 o mm 30 mm high alarm threshold P eline Alarm Speaker Volume Control Restore Default Alarm Settings Passageway Size Low alarm threshold Passageway Size High alarm threshold Each alarm threshold can be customized to reflect the needs of individual patients Each alarm may be turned off temporarily by pressing the Down Arrow until the word Off is displayed for the corresponding alarm setting 1 While one or more alarms are disabled the Monitor displays the words An Alarm is Off at the bottom of the screen 2 If the Monitor is powered off while one or more alarms are disabled these alarms are restored to their prior threshold values when the Monitor is powered back on The alarm threshold 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 The system prompts to accept or cancel restoring defaults as shown below Select the appropriate function button to proceed SOnarMED AirWave System Operator s Manual 11 Section F AirWave System Operation Alarm Settings Restore Defaults m on mm ETT movement AC RT EC high alarm threshold Baseline Not set X The volume of the alarm speaker may be turned up or down as desired by the user 1 When the alarm volume is turned to zero 0 the Monit
4. sonarMED airWAVE Airway Monitoring System Operator s Manual June 2013 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 You must read and understand these instructions in their entirety prior to using the SonarMed AirWave System Because improvements to this manual and the products it describes will occur please check that you are using the most current version of this document by visiting www sonarmed com SonarMed Inc 12220 N Meridian Street Suite 150 Carmel Indiana 46032 USA Phone 855 240 0553 Fax 866 853 3684 support 2sonarmed 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 SP0610 I aiia sonarMED AirWave System Operator s Manual Table of Contents Table of Contents M i a BI eile or RR m 1 Be ALCNS 0 UTE o E E A EE E E E 2 We COO REDE e E EAE MP 2 2 For Best m ei 1U LERNTE TRDR 4 4 2 Warnings and Precautions RN 3 D Airwave Monitor Package Contents cccccccccccseseeececeeecaeeeeeceeeeeseeeeeeeeeeesesseeeeeeeeeessueeeeceeeeeseaessceeeessssaaseeeeeeessssaeeseeeees 4 E Displays Indicators and
5. NOTICE When possible the AirWave Sensor should be connected to the ETT before patient intubation Calibration can only be performed on an ETT clear of obstructions and with nothing blocking the distal patient end of the tube Improper calibration may cause the AirWave to give erroneous results If connecting the Sensor to an ETT that is already intubated in a patient follow the steps in Section F 6 ETT Calibration to calibrate the Sensor with another ETT prior to connecting the Sensor into the breathing circuit a Select the correct Sensor size to match the ETT inner diameter The size is found on the Sensor package label and also on the Sensor nozzle See AirWave Sensor IFU for details ETT ID mm AirWave Sensor Size 6 5 amp 7 0 Small S 7 5 amp 8 0 Medium M 8 5 amp 9 0 Large L b While wearing clean gloves remove the AirWave Sensor from the pouch and inspect it for visible damage If upon inspection the pouch is found to be torn or open DO NOT USE Return the Sensor to SonarMed for replacement WARNING Only connect an ETT to the 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 c Remove the standard adapter circuit adapter or hub that is connected to the ETT leaving just the ETT To assist with a difficult to remove adapter SonarMed provides the StART Standard Adapter R
6. ETT intubated cuff inflated Once the cuff has been inflated press the Cuff Inflated Button The system asks to verify that the cuff is inflated and upon verification plays a confirmatory tone see figure below F3 Lo tn Cuff LJ LH Inflated d Waiting to set baseline Once the system detects a stable ETT position a flashing Set Baseline Icon is displayed indicating that the system is ready to set the baseline ETT position and passageway size see figure below Once it has been verified that the ETT is in a satisfactory position e g via chest x ray or by other clinical means the baseline position can be set SOnhnarMED AirWave System Operator s Manual 25 Section F AirWave System Operation E r 25 20 15 10 a O cm e Set Baseline Press the Set Baseline Button The system asks to verify setting the baseline and upon verification plays a confirmatory tone Baseline f Baseline Set The baseline position and passageway size are set All indicators are now fully functional g 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 F 3 b Once set the system automatically tracks the distance during subsequent monitoring lcm SOnhnarMED AirWave System Operator s Manual 26 12 Patient Monitoring Waveform Screen Section F AirWave System Operation
7. If not already selected change the Correction Factor field to Factor Note that the FiO2 field becomes grayed out indicating that it is disabled Arrow down to the Factor field and change it to a new value smaller than 1 00 In the presence of a gas heavier than air such as anesthesia the system waveforms will stretch in time resulting in the tube tip echo see following figure falling to the right of the tube tip search window see Section L Principles of Operation for a more detailed explanation of this echo To check that the chosen Speed Factor value is appropriate check the waveform screen to see that the tube tip echo is roughly centered inside the window shown above Do this by selecting the Return Arrow and accepting the changes when prompted by the system then navigating to the Waveform Screen If the tube tip echo is still to the right of the window continue to decrease the Speed Factor value If the tube tip echo is to the left of the window increase the value slightly Continue this process until the tube tip echo is roughly centered in the window When finished the sound speed correction indicator top right shows the new setting d Monitor AirWave Microphones If an AirWave Sensor is connected to the system the menu item Monitor AirWave Microphones appears in the Main Menu list When this screen is selected the system plays the microphone signals directly through the Monitor loudspeaker This feature prov
8. to carina as measured from CXR Carina Distance MER cm 2 Use the up and down arrows to change the Carina Distance value to match the measurement obtained from the chest x ray WARNING The Carina Distance setpoint corresponds to the point where the ETT tip is at baseline position Setting the value incorrectly will result in inaccurate tracking of the carina distance during subsequent monitoring 3 Itis recommended to set the system baseline just before taking the chest x ray then setting the Carina Distance value based on the measurement obtained from the x ray If a change in tube position and or re baselining is required after this the system will automatically update the Carina Distance setting accordingly sonarMED AirWave System Operator s Manual 12 Section F AirWave System Operation 4 Once the distance has been set use the Return Arrow to exit the screen The system will prompt to accept or cancel the change c Sound Speed Correction Selecting Sound Speed Correction enters the Sound Speed Correction Screen which provides selection of the sound speed correction method and the corresponding parameter for that method These settings are used by the AirWave to compensate for changes in the speed of sound caused by high oxygen concentrations FiO2 or the presence of anesthesia gases Any changes in sound speed change the timing of the AirWave s echoes and the system needs to compensate for these changes to provide acc
9. Controls RENT 5 1 AirWave Monitor Controls Front Panel cccccccccccccccceseseeeeeeeeeceeeseeceeeeesaeeseceeeeeesseaseeeeeeesseueeaeeeeeessseaasseeeeeeessaaaeeeeeeees 5 2 Airwave Connections Right Side ioer eden npe c ases asn p eo Coo Jake ex p edO Cena exo PK D Dru Genbpuked oe eos un ME Re Ue CH E Ds cea dcEra dE 6 3 AirWave Monitor Screens ssssssssssssssssseeee nenne ennnnnnnn nnns sn nnnna nnn n iis ssssaa sisi sis ssssa giis isis ss ssa s sisi siis assa a sen n sis anna nnns 6 4 AirWave Monitor Indicators and lcons lsseesssssssssssesseseeeen nennen nnne nennen nnn e nnne nnns annee nnns nir n rennen nnns nnns nnns 7 WEE C0 el 901 06 Ree tie ee re rr a ery er T ee ee ed een ee eee 8 E red riueieEielseliiom E 9 F WAlnWave oy em OPE AON e 10 1 Powering On the AirWave Monitor cccccccssseececceseceeceeeeeeeecaeecececseseceeessaueceeeseaaeeeeeeseueceeeseaaeceesseaueeeessseneeeessaeeeees 10 MEME Cis DE gt NORTE ctc 10 Be CIN Ia Eel el tmm ee 10 E S cube dece m m 11 E40 I RPI Ie RN 12 Gz Sound SHSSO COM SCH OM MR 13 d Monitor AlrWave MICIODhOF Gs aures dccestceievesesdilccwetine Ye povevk denshiestie tuae ni gk bs Vepacs as ew stu rotg st c up St vadwerne d uud k af uu rte xl dne 14 e esi HN iuelipE Nem 15 MEME
10. This is a secondary monitoring screen for the AirWave Monitor which presents the underlying acoustic waveforms that the system analyzes to provide the indicators on the Patient Monitoring Home Screen This screen may be used for troubleshooting to verify that the waveform is free of artifact and that the system is properly identifying and tracking the ETT tip and airway echoes See Section L Principles of Operation for a more detailed description of the waveform features The Waveform Screen consists of the AirWave echo signals as shown in the figure below Passageway Size Shows size of passageway around the ETT tip Color indicates alarm status Green when value is within alarm limits Red when value exceeds alarm limits Tick Mark Distance Tick marks are used to measure effective distance between echoes Obstruction Marker Shows percentage of ETT obstruction Color indicates alarm status Yellow when value is at least 2096 Red when value exceeds alarm limit ETT Tip Echo Airway Echo Hiis creen System analyzes the System tracks the airway Baton echo yellow to determine relative ETT movement from the baseline echo blue amplitude of this echo to estimate size of passageway around the tip The portion of the waveform toward the left of the display represents the echo signal Baseline Movement Distance and
11. and Enter On the next screen change the value of the ETT length to the new length For example if the calibrated ETT is 29 6 cm and the intubated ETT is 28 7 cm modify the calibrated ETT length value by changing it to 28 7 cm Modify ETT Length Enter ETT Length To measure the intubated ETT length find the ETT length marking that is closest to the Sensor and measure the distance from the marking to the Sensor nozzle tip Add this measured distance to the distance on the marking to obtain the ETT length For example as shown in the figure below the distance between the 28 cm marking and the Sensor nozzle tip is 0 7 cm which results in an ETT length of 28 7 cm SONarMED AirWave System Operator s Manual 21 Section F AirWave System Operation Nozzle Tip Return to the Main Menu using the Previous Screen arrow and accept the changes when prompted After returning to the Patient Monitor Screen it is important to verify that the modified ETT length is correct by checking that the system is properly detecting the ETT tip Enter the Waveform Screen see Section F 11 Patient Monitoring Waveform Screen for a detailed description and observe the waveform region between the two red brackets as highlighted below These brackets denote a search window in which the system looks for the echo arising from the ETT tip The location of this search window corresponds to the ETT length stored within the
12. is for the Monitor only SOnhnarMED AirWave System Operator s Manual Section K Specifications 36 Section K Specifications 3 System Accuracy Accuracy 9596 Confidence ETT Tip Movement cm Passageway Diameter mm 2596 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 equipment older equipment may be particularly susceptible to interfer
13. not fully charged the Monitor screen powers back on with a message that sonarMED AirWave System Operator s Manual 5 Section E Displays Indicators and Controls the battery is charging The monitor can be turned off completely by pressing the power button one more time 2 Airwave Connections Right Side AC DC 19 Bc Power Port g m 4 Communication Port Airwave Adapter Port eS 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 PEHSOPEOH 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
14. occurs continuously for Menu Screen see Section F 3 c If the more than one minute then the Monitor is source is identified attempt to reduce the unable to collect data This is most likely noise level from the source If this is not due to excessive ventilator noise high feasible then monitoring on this patient may ventilation rates or excessive secretions in not be possible the airway Refer to Section F 10 for more information The airway echo amplitude is insufficient for It is possible that a small percentage of accurate tracking It is normal for this error patients may exhibit an airway echo of to occur occasionally for a few seconds inadequate amplitude that the system may WARNING While this error is present have difficulty tracking accurately In these the ETT movement indicator may provide patients it may be necessary to turn off the inaccurate readings ETT position tracking alarm The system is playing the microphone Exit Monitor AirWave Microphones signals directly over the Monitor speaker Screen Patient monitoring is disabled while this message is on Poor Signal Quality Microphone Monitor On SOnhnarMED AirWave System Operator s Manual 29 Section H Troubleshooting System Message Alarm Description JUserAction 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 ba
15. to a Monitor that is turned off will not charge the battery G Cleaning Maintenance and Disposal The Monitor enclosure and AC DC power supply may be cleaned 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 System Operator s Manual 28 Section H Troubleshooting H 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 dete
16. 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 SOnhnarMED AirWave System Operator s Manual 39 Section L Principles of Operation larger A compared to the ETT this would be the case for an ETT in the trachea If this echo were to change to a positive deflection then this would indicate that the ETT is located within a passageway that has a smaller A compared to the ETT This may correspond to an ETT that is in the esophagus or bronchus or that is clogged at the tip such as from mucus The last echo 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
17. Screen where the patient identification ID number can be modified Patient Info 1 Change the Patient ID as previously described in Section E 6 Basic Navigation and Editing Note that each individual digit is selected using the left right arrows and modified using the up down arrows 2 Once changes are complete press the Previous Screen button to exit the Patient Info Screen The system prompts to accept or cancel changes 3 Note that if Data Logging see Section F 3 g is active changing the Patient ID will erase all logged data g Data Logging selecting Data Logging enters the Data Logging Screen which provides options for collecting data when troubleshooting system problems with the help of SonarMed s technical support team 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 h System Settings 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 SOnhnarMED AirWave System Operator s Manual 15 Section F AirWave System Operation These settings are intended to be modified by authorized personnel only See AirWave System Set up and Maintenance Manual 4 Connecting an AirWave Sensor to an ETT
18. V 0 Rien e 15 d Daar ON RT m O 15 FMS I is 100 MENSES 15 4 Connecting an AirWave Sensor to an ETT ccccecccccccccecceeeseeeeeeeeecaeeeeeeceeeeeeeeeeeeeeeeessseeeeeeeeeeeseeeaeseeeeeesssaaaaeeeeeeessaaaasees 16 5 Connecting the AirWave Sensor to the Monitor cccccccseeseeecceeeceeeeeeeeeeeeeeeaeeeeeceeeessseeeeeeeeeeesesueeeeeeeeeessaeaaeeeeeeeeeeaas 17 MEME ETEO MD AION MEE E 17 7 Intubation with the AirWave Sensor Connected to an ETT cccccccccssseececceeeeeeeeeeeeeeeeeeaeeeeeeeeeeeseseeaeeeeeessseaaeeeeeeeeseaas 20 8 Connecting the AirWave Sensor to an Intubated ETT eeessssssssssssssssssseseene nennen nennen nnn n nnn nnns 20 9 Modifying the Calibrated ETT Length eeeeesssssssssssseesseeeeennn nennen nnne ee nnn nnn nsn nnn aan n nnns sss Enaip 21 10 Patient Monitoring Home Screen ccccceeecccccceccceeeseececeeeceeeeeeeeceeeeeeeeeseeeeeeeeeseeeseceeeeesseeeeeceeeessseeaseeeeeeesssaeseeeeeees 23 11 Transitioning to Patient Monitoring from a New Calibration sseeeeesseseeseeeeeeennn nennen 24 12 Patient Monitoring Waveform Screen cccccccccccsssseececeeeceeesseeeceeeeeeaeeeececeeeesaesseeceeeessaeeaseceeeeessaeaaeeeeeeesssaaaeeeeeeees 27 13 Powering ON the TAO T
19. and Controls Button Icon System Action When Pressed Set Baseline Icon sets or resets the baseline 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 a numeric and graphic indication of the sensor health green good red bad and provides access to the Sensor Health graphic Home Screen Icon returns to the Patient Monitoring Home Screen m Main Menu Icon enters the Main Menu to make changes to user defined parameters Previous Screen Icon 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 lcon 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 EN 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 gt The SonarMed Sensor is a defibrillation proof type BF applied part amp SO
20. 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 Sensor Health Button Provides access to the Sensor Health Screen and displays the lowest of the current sensor health readings when the sensor health is good Red when any one of the three sensor components performs below SonarMed specifications arising from within the ETT enclosed by the left red frame and at the tip of the ETT enclosed by middle red frame In this example the detected deflection in the echo signal indicates a partial obstruction of 2696 in the ETT The portion of the waveform toward the right of the display represents the echo signal arising from within the patient airway enclosed by the right red frame The time difference between the current airway echo and the baseline airway echo 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 suggests that the distance or echo travel time between the ETT and the lungs has increased i e the the trachea ETT tip has moved higher in If no baseline is set the system displays only the current yellow waveform Once the baseline position is set a second waveform light blue is displayed on the scr
21. e Sensor to the proper orientation with the SonarMed logo facing up The Sx Change Sensor message will likely remain in place for a little while until the protective membranes inside the Sensor have dried out Allow a few minutes for this process If the Sensor performance does not recover repeat the above procedure or replace the Sensor P aiia SO n a r M E D AirWave System Operator s Manual 32 Section H Troubleshooting 4 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 To enable this smoothing filter navigate to the Main Menu and select ETT Movement Smoothing Change the setting to On on the screen that appears Exit and accept the changes Both the Home and Waveform screens will now display SM On to indicate the feature is enabled 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 To disable this smoothing filter navigate to the Main Menu and select ETT Movement Smoothing Change the setting to Off on the screen that appears Exit and accept the changes NOTICE Once enabled the ETT Movement Smoothing filter will r
22. e SonarMed logo facing up Returning the Sensor to that position will let liquids to drain off the protective membranes and may allow the Sensor to recover without further intervention once the membranes dry out If the Sensor does not recover after a few minutes or if there is obvious evidence of mucus on the protective membranes the Sensor may be salvaged by lavaging and suctioning the interior of the Sensor lumen to remove any mucus buildup on the membranes NOTICE Please follow hospital guidelines and procedures for suctioning patients when suctioning the AirWave Sensor SOnhnarMED AirWave System Operator s Manual 31 Section H Troubleshooting a Begin by turning the Sensor upside down The writing THIS SIDE DOWN on the Sensor lumen should now be facing straight up b Introduce saline through the port on the in line suction catheter allowing the saline to fill the cavities inside the Sensor Sensor Cavities c Advance the suction catheter into the Sensor and initiate suction to remove secretions and saline from the inside of the Sensor This can be done on the way down or up or both Twist the catheter inside the lumen to fully clean the sensor paying particular attention to any cavity that was highlighted in the Sensor Health Graphic see Section H 2 Remember that once the saline has been introduced into the sensor lumen all three cavities will appear red in the graphic Suction Catheter Tip d Return th
23. e of each echo identifies approximately how much the corresponding A changed Muere eee i3 i3 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 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 F
24. eed by using the Forward Arrow and verifying the choice at the following prompt NOTICE If an ETT type identical to the intubated ETT is not available in the list then another ETT type can be used to calibrate the Sensor However due to differences in characteristics between some ETT manufacturers and models there is a chance that this may cause inaccuracies in the results returned by the Monitor Also it is likely that the ETT lengths will differ between the ETT being used and the calibration database entry requiring the user to manually change the ETT length in the system to avoid poor results For more information on changing the calibrated ETT length see Section F 9 Modifying the Calibrated ETT Length Once calibration is complete the Monitor plays a confirmatory tone and displays the following message for two seconds before proceeding 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 The user should select Yes v only if the Sensor is being used on the same patient as before i e if the old Sensor stopped working and had to be replaced If the calibration is for a new patient the user should select No X Previous Baseline Detected Use previous baseline The Monitor now enters the Patient Monitoring Home Screen as described in Section F 10 The red UNCALIBRATED indicator at the t
25. een The light blue waveform represents a snapshot of the baseline signal and is useful for comparison to the current signal The graph is labeled with a distance scale to provide a means for manually estimating distances between waveform features SOnarMED AirWave System Operator s Manual 2 Section F AirWave System Operation Three features contained within the waveforms are identified by the system ETT obstructions up to 2 with percent obstruction estimate ETT tip echo and passageway size Airway echo with relative movement estimate 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 c 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 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
26. emain in effect until turned off by the user NOTICE When the ETT Movement Smoothing filter is enabled there will be a time delay between gross movements of the ETT and when the AirWave shows the movement aiia sonarMED AirWave System Operator s Manual 33 Section Service Support and Warranty l 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 oonarMed warrants the AirWave Monitor for a period of three years from the date of purchase from an aut
27. emoval Tool a blue wedge shaped plastic tool Please refer to the StART Instructions for Use packaged with the tool for information on its use d e Check that the ETT is securely connected to the Sensor nozzle SO n a r MED AirWave System Operator s Manual 16 Section F AirWave System Operation 5 Connecting the AirWave Sensor to the Monitor a Connect the end of the Sensor cable to the matching port on the side of the AirWave Monitor b The Monitor automatically detects the Sensor and provides calibration options If the Monitor fails to detect the Sensor refer to the Table in Section H Troubleshooting 6 ETT 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 NOTICE For the most accurate results calibration should be performed with an ETT that is clear of obstructions and has an unblocked distal patient end i e the ETT is not intubated If the AirWave sensor is to be used on a previously intubated patient and no spare tube of the identical model and inner diameter is available for calibration the System can also be calibrated without an attached ETT a The AirWave retains calibration information for the previously calibrated Sensor ETT pair If the Sensor is accidently disconnected from the Monitor or if the Monitor is powered down and then back up the sys
28. ence 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 SOnhnarMED AirWave System Operator s Manual 37 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 Senso
29. ent Passageway Size Baseline Measurement Status Baseline Set Reset Press to set reset baseline Button is not available if system status is Analyzing Toggles on or off when the system completes taking a measurement and refreshes all indicators Arrows and value indicate the passageway size when baseline was set he system acquires acoustic measurements during quiet periods between patient breaths after which the indicators are updated Conditions that decrease the quiet periods during ventilation may make it difficult for the system to acquire clean measurements resulting in delays between indicator updates Such conditions may include SOnhnarMED AirWave System Operator s Manual 23 Section F AirWave System Operation e Ventilation at a high rate e Presence of significant noise from secretions in the ETT or airways e g airway crackle e Presence of ventilator noise between breaths e Patient coughing 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 F 3 d Patient monitoring continues until the Sensor cable is disconnected from the Monitor the Main Menu Screen is entered or the Monitor is powered off Monitori
30. ery 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 directly to the Sensor microphones via the Monitor speaker 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 System Operator s Manual 40
31. 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 Sound Speed Correction Select sound speed correction method and corresponding parameter SOnhnarMED AirWave System Operator s Manual 10 Section F AirWave System Operation Monitor AirWave Microphones Listen to AirWave microphone signals over Monitor loudspeaker this option only appears if a Sensor is connected to the system Modify ETT Length Modify calibrated ETT length this option only appears if a Sensor is connected to the system and has been calibrated Patient Info Enter unique patient identifier this option only appears if enabled in System Settings Data Logging Modify data logging settings for troubleshooting purposes this option only appears if enabled in System Settings System Settings Adjust LCD brightness Date Time and Alarm default settings this option is password protected and is intended for authorized personnel only see AirWave System Set up and Maintenance Manual To exit the Main Menu press the Previous Screen button a Alarm Settings Selecting Alarm Settings enters the screen shown below ETT Obstruction High alarm threshold ETT Movement High alarm threshold ETT Movement Low alarm threshold ETT movement Alarm Description Currently highlighted alarm setting
32. hanges 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 System Operator s Manual 9 Section F AirWave System Operation F AirWave System Operation This section describes the standard operation of the SonarMed AirWave system 1 Powering On the AirWave Monitor a b C d Press the power button to turn on the Monitor The Monitor emits an audible tone to test its sound circuitry The alarm LED flashes red once If any errors are detected during start up diagnostics refer to Section H Troubleshooting The Monitor automatically detects a connected AirWave Sensor 2 Start Up Screens a If the Monitor is turned on without a Sensor connected to the Monitor the Monitor displays the screen below The only option is to access the Main Menu by pressing the top function key or select options at right Connect an AirWave Sensor to the Monitor Once a Sensor is connected to the Monitor the Monitor automatically recognizes the Sensor and begins the calibration process 3 Main Menu Selections Entering the Main Menu presents a list of options from which to select Main Menu Select using arrow keys and Enter Alarm Settings Modify alarm threshold values Set Carina Distance Manually enter the distance
33. hen condition is corrected ETT tip is placed in a small passageway such as the esophagus ETT Too Low ETT Too High Obstruction Detected Small Passageway Prior to setting baseline Small Passageway After setting baseline The ETT is in a passage smaller than the Verify condition using alternate airway Passageway Size Low alarm threshold management techniques error will clear when condition is corrected The ETT is in a passage larger than the Verify condition using alternate airway Passageway Size High alarm threshold management techniques error will clear when condition is corrected This message displays routinely as the None required Monitor is waiting to receive a clean microphone signal i e between breaths An Alarm is Off At least one of the AirWave monitoring Re enable the alarms in the Alarm Settings alarms is disabled Screen or cycle the Monitor power T Large Passageway Analyzing Sensor Cable Disconnect AirWave Sensor cable is disconnected from Reconnect Sensor cable to Monitor Monitor during patient monitoring ETT Disconnected The ETT is disconnected from the AirWave Reconnect the ETT Sensor Excessive Noise Excessive noise detected in microphone To determine the noise source listen to the signals which is preventing collection of data microphone signals via the Monitor It is normal for this message to be displayed AirWave Microphones option in the Main occasionally If it
34. horized SonarMed distributor as follows oonarMed 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 kind whether statutory written oral or implied including
35. iagnostic 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 provides icon graphical and numerical representation of the status of the ETT including indicators for ETT tip movement passageway size and ETT obstruction The figure below details the various features of this screen 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 Obstruction Indicator Passageway Size Indicator The percentage of ETT obstructions up to 2 and the approximate locations in the ETT Color indicates alarm status Yellow when value is at least 20 Red when value exceeds alarm limit Cylinder and value indicate size of passageway around the ETT tip Color indicates alarm status Green when value is within alarm limits Red when value exceeds alarm limits ETT Ruler Distance markings cm from ETT distal tip to proximal end Baseline Movement Direction Up down arrow lights indicating ETT movement high low in trachea Refresh Time Waveform Screen Button Time since last measurem
36. ical practice and is not to be used as a stand alone diagnostic system It is intended for use with patients who use ETT inner diameters ID from 6 5 mm to 9 0 mm The SonarMed AirWave device should be used for patients with a weight gt 35 Kg 1 Contraindications Do not use the AirWave Monitor or leave the AirWave Sensor connected to the ETT in an MRI environment Do not use on a cuffless ETT The AirWave is intended for use only with a cuffed ETT Do not use on patients who require an ETT smaller than 6 5 mm ID Do not use on patients who require an ETT larger than 9 0 mm ID Do not use the AirWave with a dual lumen ETT 9o 9 Do not use the AirWave Monitor with any ETT adapter other than the AirWave Sensor the system will not function Do not use the AirWave on patients ventilated with Heliox Do not use in a setting other than in hospital Do not attempt to re use or sterilize the AirWave Sensor infection or cross contamination is possible Sterilizing the Sensor may cause damage to the internal components which can cause the SonarMed AirWave to produce erroneous results 2 For Best Results Use the largest ETT diameter that is clinically indicated for the patient Small ETT diameters relative to the patient s trachea diameter size can degrade AirWave system performance To maximize the lifespan of the Sensor keep the Sensor oriented such that the SonarMed logo faces up Logo Face Up
37. ides a means to listen to the AirWave microphones for troubleshooting purposes For example if the system is displaying an Excessive Noise message listening to the microphone signals can help pinpoint the origin of the noise see Section F 10 Patient Monitoring Home Screen for possible noise sources Or if the system is displaying Sx Change Sensor listening to both microphones can help determine if the signals are of equal amplitude and clarity If the microphone signals do not sound similar then this may indicate that excessive patient secretions have accumulated on the microphone membranes and SOnhnarMED AirWave System Operator s Manual 14 Section F AirWave System Operation degraded the sensor performance If this is the case please refer to Section H Troubleshooting for possible solutions Monitor Airwave Microphones select mic using arrow keys WARNING 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 e Modify ETT Length Selecting Modify ETT Length enters a screen where the calibrated ETT length can be manually modified for the case where the calibration ETT and patient ETT are different lengths Please see Section F 9 for detailed instructions on performing this operation f Patient Info Selecting Patient Info enters the Patient Info
38. igure 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 Obstruction Echo Echo Nozzle Echo 4 C Sound Pressure ETT Window lt 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
39. in Section F 3 c this will cause the AirWave to return potentially erroneous results 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 Calibration of the AirWave Sensor must be performed on a clean unintubated ETT Failure to do so may cause the AirWave to provide erroneous results If the AirWave Sensor is to be connected to an already intubated ETT calibration of the Sensor must first be performed on a clean unintubated ETT that is identical to the intubated ETT The AirWave Sensor cable must be routed and secured in a way that prevents accidental disturbance by the user patient or other persons The AirWave Sensor contains a small heating element to prevent water condensation on the acoustic sensors Using a Sensor in the ventilator circuit for more than 15 minutes without being connected to a powered Monitor may result in degradation of the acoustic sensors and the Sensor no longer being able to collect data However this poses no additional safety risk to the patient as an AirWave Sensor functions identically to a normal ETT adapter in providing a secure airway whether or not it is transmitting data to an AirWave Monitor If attaching the AirWave Sensor to an already intubated patient care must be taken not to dislodge the ETT while removing the standard ETT adapter and attaching
40. ld 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 2 When no calibration tube is available The user must hold the AirWave Sensor with the machine connector covered i e with a thumb The Sensor nozzle must remain unobstructed Sensor Nozzle waa Machine Connector When ready to proceed with the calibration select the Forward Arrow The system asks to verify the selected ETT size and upon verification plays a confirmatory tone e The Monitor briefly takes a series of acoustic measurements which sound like clicks to calibrate the oensor ETT pair The screen below is displayed during this process f If the System is being calibrated without a calibration tube the Monitor will next prompt the user for the type of ETT being used This enables the System to retrieve tube specific parameters from a database SOnhnarMED AirWave System Operator s Manual 18 Section F AirWave System Operation ETT Information Using Up Down arrow buttons select the ETT manufacturer and model to which the sensor will be connected and then press the arrow at right to continue Mallinckrodt Hi Lo Select the manufacturer model from the available options in the list using the Up Down Arrows then proc
41. 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 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 M SOnhnarMED AirWave System Operator s Manual 1 Section B Indications for Use B Indications for Use The SonarMed AirWave is used to assist in verifying placement of the ETT to assist in detecting movement of the ETT tip and to assist in detecting obstruction of the ETT The SonarMed AirWave is intended for use by qualified personnel to assist with artificial airway management for patients in an in hospital setting intensive care operating room and emergency department settings as well as intra hospital transport The SonarMed AirWave is to be used as an adjunct to normal clin
42. nd 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 being powered by the plugged into AC DC power supply Alarm Silence Indicator 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 the 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 selected 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 Button Icon System Action When Pressed Accept Changes Yes Icon Cancel Changes No Icon D Cuff Inflated Icon informs the system that the ETT cuff has been inflated sonarMED AirWave System Operator s Manual 7 Section E Displays Indicators
43. ng resumes after returning to the Patient Monitoring Screen Ifthe Sensor cable is disconnected from the Monitor the Monitor sounds an alarm and displays the following screen When the Sensor cable is reconnected the Monitor returns to the Calibration Screen see Section F 6 ETT Calibration 11 Transitioning to Patient Monitoring from a New Calibration 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 a Pre intubation In this state the Baseline Movement Indicator is disabled gray and the Passageway Size Indicator reads gt 25 0 mm in red indicating a large open area surrounding the ETT tip see figure below cm b ETTintubated cuff not inflated Once the ETT is intubated and its position is stable the Passageway Size Indicator shows the inner diameter of the passageway measured at the ETT tip and the Cuff Inflated Icon flashes see figure below SOnhnarMED AirWave System Operator s Manual 24 Section F AirWave System Operation H 7 EI FM 15 10 cm If the ETT tip is in a passageway smaller than the ID of the ETT such as the esophagus the Passageway Size Indicator shows a very small inner diameter measured around the ETT tip and the system displays and sounds a Small Passageway alarm see figure below cm c
44. nhnarMED AirWave System Operator s Manual 8 Section E Displays Indicators and Controls Use By date in the format YYYY MM Manufacturer symbol 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 items are selected from a list by using the Navigation Arrows and pressing the Enter button to enter that screen b 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 oh To edit the field press the Enter button which turns the highlight from yellow to white 21 60k 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 c
45. op of the screen is replaced with green text showing the new ETT ID and length SONarMED AirWave System Operator s Manual 19 Section F AirWave System Operation j If calibration is not successful the system displays one of four calibration failure messages A Clean and open ETT was not detected This message indicates that the system detected obstructions within the ETT or an ETT tip that is not sufficiently open Check that a clean ETT is connected to the Sensor and that the patient end is open and then retry calibration System detected an incorrectly configured AirWave Sensor This message indicates either that the Sensor nozzle is blocked or that the Sensor machine connector is uncovered Ensure that the machine connector is covered and the nozzle is open and then retry calibration AirWave Sensor is out of specification This message indicates that the acoustic components inside the AirWave Sensor are not operating properly If repeated calibration attempts fail contact SonarMed for assistance in troubleshooting AirWave Sensor is detecting excessive noise This message indicates that the system is having difficulty obtaining a clean acoustic signal due to excessive external noise Move to a quieter location and retry calibration 7 Intubation with the AirWave Sensor Connected to an ETT a After calibration is complete the ETT and attached AirWave Sensor may be placed within the patient per the appropria
46. or displays the words Alarm Sound is Off at the bottom of the screen Even with the alarm volume turned to 0 the monitor will continue to play confirmatory tones After changes are made press the Return Arrow button top function button to exit the Alarm Settings Screen The system prompts to accept or cancel the changes b Set Carina Distance Selecting Set Carina Distance enters the Set Carina Distance Screen which allows the user to manually enter the distance between the ETT tip and the patient s carina This option is only available once a Sensor has been attached to the system and calibrated and after the baseline has been set please see Sections F 5 F 6 and F 11 for more information Note 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 F 10 and automatically tracks the value from that point forward Note Carina distance tracking is an optional feature and leaving the carina distance undefined does not affect performance of the AirWave system 1 Upon entering the Set Carina Distance Screen the Carina Distance field will automatically be selected for editing and highlighted in white as it is the only editable field on the screen Set Carina Distance Enter distance from ETT tip
47. ort high pitched tones 3 User Action Required alarm 2 AirWave Sensor Health Metric When the AirWave Sensor is placed in the breathing circuit it is probable that secretions will occasionally occlude the acoustic components speaker and microphones 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 oystem 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 SOnhnarMED AirWave System Operator s Manual 30 Section H Troubleshooting To provide further guidance the System also provides a troubleshooting graphic to assist in determining which of the Sensor components are affected This visual aid 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 disappear 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 Sen
48. r speaker membranes It is normal for this error to occur occasionally for a few seconds AirWave Sensor is not automatically Contact SonarMed technical support detected when connected to the Monitor Sx Change Sensor EMEN System Failures System Error 3 Internal circuit or software error Power cycle Monitor and contact SonarMed for service if error persists One or more buttons on the keypad are Power down Monitor and contact SonarMed stuck in the pressed position for service if error persists 3 Internal memory to which data is being If this error persists power down monitor stored has malfunctioned and contact SonarMed for service Button Stuck Data Flash Error Alarm Speaker Failure 3 Test failed during power up that verifies Power down Monitor and contact SonarMed proper operation of alarm speaker for service 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 one Correct the entry in question Entry Error Internal Clock Fail Use Up Down Keys to Edit Invalid Date or Time 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 sh
49. r 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 the ETT tip within the trachea AirWave Monitor comer BN A SOP Speaker Microphones imm Input Sound mmi 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 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
50. remove adapter the supplied StART tool may be used Please refer to the StART Instructions for Use packaged with the tool for information on its use WARNING Be careful not to move or dislodge the ETT while removing the standard adapter c Slide the nozzle of the AirWave Sensor fully into the proximal end of the ETT as shown below SOnarMED AirWave System Operator s Manual 20 Section F 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 d Check that the ETT is securely connected to the Sensor nozzle e Connect the ventilator and other airway devices e g suction catheter ETCOS filter etc to the proximal end 15 mm connector of the AirWave Sensor f Secure the cable s path between the Monitor and the Sensor by attaching the cable to the ventilator tubing or by similar means 9 Modifying the Calibrated ETT Length If the intubated ETT is shorter longer than the ETT used for calibration then the calibrated ETT length stored within the Monitor must be adjusted manually If the ETT length is not adjusted appropriately the original ETT length will continue to be used by the system which may lead to erroneous results To manually adjust the ETT length that was stored in the system during calibration enter the Main Menu and select the option Modify ETT Length as shown below Main Menu select using arrow keys
51. rm 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 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 Alarm Silence This button is used to temporarily silence audible alarms Once 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 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 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 AC DC power supply and the battery is
52. rmining 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 If the user action doesn t remedy the problem please contact SonarMed technical support for assistance System Message Alarm Description 1 UserActin Calibration Monitoring Messages and Alarms Unable to Calibrate The AirWave cannot obtain a proper Follow the on screen prompts to correct the calibration signal condition causing the failure If failure persists replace the AirWave Sensor The ETT tip has migrated low in the trachea Verify condition using alternate airway beyond the ETT Movement Low alarm management techniques error will clear threshold when condition is corrected The ETT tip has migrated high in the trachea Verify condition using alternate airway beyond the ETT Movement High alarm management techniques error will clear threshold when condition is corrected An obstruction in the ETT has exceeded the Verify condition using alternate airway ETT Obstruction High alarm threshold management techniques error will clear when condition is corrected The ETT is in a passageway smaller than Verify condition using alternate airway the ETT ID This alarm is intended for use management techniques error will clear during intubation to provide feedback if the w
53. 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 the user enter the Patient Monitoring Waveform Screen 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 ev
54. sor Health icon center function button Since the waveforms may still provide useful troubleshooting information 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 may require cleaning Knowing which of the three components is affected allows the user to specifically target the lavage and suctioning see Section H 3 to the correct component which should make the cleaning process more effective Once the affected component is clean its number should return to green after the protective membranes have dried out 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 Sensor Lavage Suctioning When the Sx Change Sensor error message appears it is often the result of mucus or other fluids accumulating on the membrane that protect the acoustic components inside the Sensor The user should first check that the Sensor is in its optimal orientation with th
55. system The ETT tip echo contains information related to the passageway size around the ETT tip see Section L 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 the search window then the modified ETT length is appropriate and patient monitoring can continue If the reflection is located to the right or left of the search window then the modified ETT length is not appropriate and should be changed as follows SOnhnarMED AirWave System Operator s Manual 22 Section F AirWave System Operation Ifthe ETT tip reflection is located to the left of the search window then the modified ETT length is too long In this case return to the Modify ETT Length Screen and decrease the ETT length until the tip reflection is located within the search window Ifthe ETT tip reflection is located to the right of the search window then the modified ETT length is too short In this case return to the Modify ETT Length Screen and increase the ETT length until the tip reflection is located within the search window 10 Patient Monitoring Home Screen WARNING The SonarMed AirWave system is to be used to verify ETT placement movement and obstruction it is to be used as an adjunct to airway management only This device is not to be used as a stand alone d
56. te intubation procedure b After patient intubation 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 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 with sufficient force NOTICE The AirWave Sensor contains a small heating element to prevent water condensation on the acoustic sensors Using a Sensor in the ventilator circuit for more than 15 minutes without being connected to a powered Monitor may result in degradation of the acoustic sensors and the Sensor no longer being able to collect data However this does not pose any additional risk to the patient An AirWave Sensor functions identically to a normal ETT adapter in providing a secure airway whether or not it is transmitting data to an AirWave Monitor 8 Connecting the AirWave Sensor to an Intubated ETT a After completing calibration see Section F 6 ETT Calibration disconnect the clean unintubated ETT from the AirWave Sensor b Carefully disconnect the standard adapter from the intubated patient ETT To assist with a difficult to
57. tem provides the option to proceed using the previous calibration information b Ifthe system has a previous calibration in memory the following screen is displayed If there is no previous calibration proceed to step d oystem Calibration New Sensor 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 and length Using the previous calibration also causes the system to use the previous baseline information if it was set the baseline can be reset manually if desired see Section F 10 Patient Monitoring Home Screen If both of the above conditions are not true then a new calibration is necessary Select Yes v to continue with a new calibration d When performing a new calibration the following screen appears Enter the appropriate ETT inner diameter the system allows selection of tube sizes from 6 5 mm to 9 0 mm in half millimeter increments SOnhnarMED AirWave System Operator s Manual 17 Section F AirWave System Operation Callbrate New Sensor Hold AirvWave Sensor away from all surfaces select ETT Inner Diam using arrow buttons and then press arrow at right to continue J mm 1 When a calibration tube is available The ETT shou
58. th the Auto OR mode the AirWave system automatically assesses and corrects for the changing speed of sound Set up this mode by following the above instructions but selecting Auto ICU as the Correction Factor 3 FiO2 This manual correction method is intended for use in patients ventilated without anesthesia such as in the ICU When enabled two oxygen concentration range selections are provided 21 6096 and 61 100 a If not already selected change the Correction Factor field to FiO2 Note that the Speed Factor field becomes grayed indicating that it is disabled b Arrow down to the FiO2 field and change it to the range corresponding with the patient FiO2 c Select the Return Arrow and accept the changes when prompted by the system d The sound speed correction indicator top right shows the new setting 4 Speed Factor This manual correction method is intended for use in patients ventilated with anesthesia such as in an operating room This method gives the user the most control over the sound speed correction however it can be highly iterative and requires the user to frequently check the system SOnhnarMED AirWave System Operator s Manual 13 Section F AirWave System Operation waveforms see Section F 12 to verify that an appropriate factor was chosen Therefore in situations where the gas mixture is likely to change frequently during monitoring the Auto OR correction factor may be a better choice a C e
59. the AirWave Sensor While using the AirWave s feature for directly listening to the signals from the Sensor microphones system monitoring of ETT is discontinued until the system is returned to the patient monitoring screen 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 SOnhnarMED AirWave System Operator s Manual 3 Section D Airwave Monitor Package Contents D Airwave Monitor Package Contents 1 AirWave Monitor 1 Carrying strap AC DC Power Supply Hospital Grade Power Cord USB to RS232 Converter Cable 1 1 1 1 1 Software and Documentation CD 1 1 1 Firmware Upgrade Cable RS232 Connection 1 1 SonarMED AirWave System Operator s Manual 4 Section E Displays Indicators and Controls E 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 Speaker Display Screen Navigation Buttons sonar Power Button Function Buttons Alarm LED This LED flashes red when an ala
60. the reflected waves into an echo signal which is input into the Monitor s proprietary algorithms This echo signal consists of positive and negative deflections that represent positive and negative sound pressure waves respectively The use of two microphones to sense the acoustic waves allows the system to determine the direction from which echoes arrive As a result the system can selectively filter all echoes that arise from devices on the ventilator side of the Sensor such as closed circuit suction catheters y connectors ET CO2 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 SOnhnarMED AirWave System Operator s Manual 38 Section L Principles of Operation identifies the distance of the changing A that caused the echo The amplitud
61. ttery is fully charged If Monitor doesn t power on contact SonarMed technical support PNA Battery takes longer than 4 hours to charge Contact SonarMed technical support Battery Failure 3 Battery exceeded normal temperature or Power down Monitor and contact SonarMed voltage during charging or it exceeded the for service 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 EEE AirWave Sensor Failures Heater Failure Heater circuit inside AirWave Sensor is not Cycle Monitor power If error reoccurs try operating properly replacing AirWave Sensor Report error to SonarMed if it persists AirWave Sensor microphone s and or If error persists suction protective speaker are not operating correctly due to membranes inside AirWave Sensor lumen to electrical malfunction or mucus water remove mucus If this does not clear the deposition over protective microphone or error then replace AirWave Senso
62. urate results sound Speed Correction Correction Method EH atr speed Factor ET WARNING Without proper use of the Sound Speed Correction option the AirWave may return erroneous results Four correction methods are provided 1 Auto OR Auto OR mode is designed to be used with the various gas combinations encountered during anesthesia in the operating room In Auto OR mode the AirWave system automatically assesses the speed of sound and defines the appropriate correction factor accordingly This mode requires the least intervention from the user making it ideal for patients whose gas mix is changing frequently a If not already selected change the Correction Factor field to Auto OR Note that the FiO2 and Speed Factor fields become grayed out indicating that they are disabled b Select the Return Arrow and accept the changes when prompted by the system c The sound speed correction indicator top right shows the new setting the numeric value after the word Auto indicates the correction factor implemented by the system The correction factor represents the fraction of the sound speed in room air which the system is measuring and using to provide compensation to the echo signal For example a value of 0 80 indicates that the estimated sound speed is 0 80 times the sound speed in air 2 Auto ICU Auto ICU mode is designed to be used when the gas mixture is limited to changing oxygen concentrations without anesthesia As wi
63. warranties of fitness for a particular purpose or merchantability shall apply SOnarMED AirWave System Operator s Manual 34 Section Service Support and Warranty J Parts and Accessories The following parts and accessories are available for use with AirWave airway monitoring system Please contact oonarMed or 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 SOnhnarMED AirWave System Operator s Manual 35 K Specifications 1 AirWave Monitor 0 625 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 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 0z 119 g with cable 1 1 oz 32 g without cable PX 1 Water Ingress Protection rating
64. 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 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 System Operator s Manual 6 Section E Displays Indicators and Controls Waveform Screen 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 Battery Indicator located in the upper left corner of the screen the number of bars indicates charge level a

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