Zargis Cardioscan™ User Manual
Contents
1. If a murmur is detected in the diastolic interval the corresponding portion of the energy and timing profile will appear in red Areas of diastolic mid band frequency energy which Cardioscan does not identify as a murmur are depicted in blue NOTE The energy values do not correspond to murmur grade NOTE The energy scales are different for systole and diastole If the analysis algorithm detects murmurs at a site the average murmur onset and duration as a percentage of the systolic or diastolic duration are also shown In this case the Systolic or Diastolic Energy amp Timing Profiles show the average interval of the suspected murmur as a red colored bar overlaid on top of the energy profile If the energy profile has values greater than 18 dB in systole or 9dB in diastole the plot scales to the largest value in the profile and draws a yellow line marking the 18 dB or 9dB level Please be aware of this display change for interpreting the energy profile results 6 2 3 Site Level Class I Murmur Probability The Cardioscan algorithm calculates the probability that each recording contains a murmur that has auscultatory features that correspond to Class I indications for referral to echocardiography of an asymptomatic patient as defined by the American College of Cardiology American Heart Association ACC AHA Practice Guidelines for the Management of Patients with Valvular Heart Disease The ACC AHA guidelines define the Class I indications f2. by Cardioscan File Open Sample Files Select this option to open any sample files All sample including those purchased at Www zargis com will be located in this folder File Import Selecting this option opens the Import window where you can import zac files from anywhere on your PC File Export Selecting this option opens the Export window where you can export entire zac files to the location of your choice File Export Recording as wav Selecting this option opens the Export Recording as wav window File Zargistelemed com Selecting this option opens the Zargis Telemedicine Server File Printer Setup Selecting this option allows you to change the printer settings File Print Select this option to print the contents of the Recording Window in its current form File Recently Viewed This option displays the five most recently viewed files File Exit Select this option to exit out of the application ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 19 of 22 MED CAL 12 2 Tools Tools Settings Selecting this option opens the Settings window from where you can e Change the recording lead time e Set playback to go to your PC s audio output or the stethoscope e Indicate whether or not comments should be included when printing results e Choose Summary View or Detailed View as the default view for the Results Window Set the default setting for patient posture e S
3. cover the entire chest piece location of the stethoscope s Bluetooth antenna ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 7 of 22 MED CAL 2 4 Adding Comments to a Recording You can add comments to a file by clicking on the Comments icon located at the left of the screen A green check mark on this icon indicates that comments exist for the file 2 5 Adding a New Stethoscope To connect any Model 3200 stethoscope to any installation of Cardioscan for the first time you must launch the Add New Stethoscope window This window is accessible by selecting Manage Stethoscopes from the Tools menu or by selecting Add New Stethoscope from the pull down field below the Stethoscope Connection button 2 6 Connecting Your Stethoscope Once you ve added a stethoscope as described above the stethoscope can be connected to Cardioscan This connection can take place upon Cardioscan launch or by selecting your stethoscope from the pull down field to the right of the Stethoscope Connection button If your stethoscope is not connected the Stethoscope Connection button will display a red X instead of a green y NOTE Follow these tips to prevent lost wireless connections 1 Auscultate the patient as close to the PC as possible 2 Avoid having objects or people between the stethoscope and the PC 3 Avoid having your hand cover the entire chest piece location of th
4. is Cardioscan C Loop _ Play to PC Wy C Speed Global Scaling z Open file Comments A green dot indicates that Cardioscan Systolic Energy amp Timing 18 does not suspect a Posture Standing Patient ID 17596 Patient Name murmur at a given site A co Energy dB yellow dot J b 1 Heart Rate 95 3 beats min indicates that RR interval 700 91 ms Cardioscan Systolic interval 281 20 ms susp ects that a Diastolic interval 418 93 ms murmur exists at the site Cardioscan Findings Class Murmur Suspected Yes arteries 2R 2L 4L Ap uspecte Systolic ae MANAMA Suspected Diastolic Murmur Indicates Click to Wavelet view of Cardioscan display sound display Systolic Energy amp findings Systolic amp Timing Red Diastolic Energy amp Timing Graphs Diastolic Energy amp Timing Spectrogram view murmur of sound display Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 9 of 22 Red boxes highlight suspected murmurs Identifies the timing of the first and indicates suspected second heart sound The following is an example of the Cardioscan Summary View Connect to Stethoscope Start New telemedicine server Connection recording Indicator Zargis Cardioscan A Open file is wy Re recond Analyze Aew Filter sel
5. then Cardioscan did not find significant evidence for a murmur at that site When analyzed at the patient level Cardioscan s Murmur Detection algorithm demonstrated a sensitivity of 97 with a specificity of 70 ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 13 of 22 MED CAL If fewer than 3 complete heart beats were detected at a site then Cardioscan does not analyze the site for the presence of murmurs In this case Cardioscan will display question marks in the site level results boxes for that site 6 2 2 Energy and Timing The Systolic and Diastolic Energy and Timing Profiles for a site appear when you click on the Energy amp Timing button located to the left of the sound display The energy profiles are a normalized calculation of the median mid band frequency energy over the heart sound recording divided into systolic and diastolic intervals This profile provides a simple display of mid band frequency energy variation across systole and diastole The Systolic Energy amp Timing Profile illustrates the energy and timing results for the systolic interval If a murmur is detected in the systolic interval the corresponding portion of the energy and timing profile will appear in red Areas of systolic mid band frequency energy which Cardioscan does not identify as a murmur are depicted in blue The Diastolic Energy amp Timing profile illustrates the energy and timing results for the diastolic interval
6. wireless dongle plug the device into an open USB port on the PC on which the Cardioscan software has been loaded and activated ARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 5 of 22 MEDIC AL Anytime Cardioscan tries to connect to the stethoscope but does not detect a USB wireless dongle on the PC the following screen will be displayed USB Wireless Dongle Detection Window No wireless dongle detected Before you can connect to a stethoscope you must insert the dongle and then close and re launch Cardioscan Make sure to insert the wireless dongle before re launching Cardioscan want to review recordings without Make sure to maent the wreless dongle Connecting to the stethoscope before re launchang Cariosan 2 3 Pairing amp Connecting the Stethoscope with the Cardioscan Software After launching the Cardioscan software the following screens will help you connect Cardioscan to your stethoscope Launch Window Do you wish to wirelessly connect to your Model 3200 stethoscope now Yes connect now First make sure the a_i blue USB wireless dongle is inserted No do not connect Target Stethoscope I want to review Stethoscope to connect to recordings without the stethoscope I want to review recordings First make sure the blue USB without connecting to the wireless dongle is inserted stethocope C Do not show me this message again Car
7. Zargis Cardioscan User Manual Manufacturer Zargis Medical 2 Research Way Princeton NJ 08540 U S A Phone 609 488 4608 Fax 609 228 6100 ZCSsupport zareis com WWw zargis com EMERGO EUROPE Molenstraat 15 REP 2513 BH The Hague The Netherlands Caution Federal law restricts this device to sale by or on the order of a physician CAUTION Read this manual before using the device 2009 Zargis Medical Corp All Rights Reserved C 0086 ARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 1 of 22 MEDICAL TABLE OF CONTENTS 1 General Information 3 2 Getting Started 5 3 Upgrading to Multiple Users 8 4 Web enabled Collaboration via the Zargis Telemedicine Server 8 5 Instructions for Use 9 6 Reviewing Analysis Results 12 7 Saving Data 17 8 Opening Previously Recorded Data 17 9 Exporting amp Importing Data 18 10 Adjusting Acquisition Lead Time 18 11 Using Shortcut Keys 18 12 Navigating Menus 19 13 Understanding Recording Quality 20 14 Troubleshooting 22 15 Warranty Information 22 ARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 2 of 22 MEDIC AL 1 General Information The Zargis Acoustic Cardioscan device Cardioscan is designed to support physicians in analyzing cardiac sounds for the identification and classification of suspected murmurs When murmurs are detected by Cardioscan they are graphically displayed according to their
8. bilities associated with using storing and or transmitting such information including sound files electronically or otherwise This program does not require you to enter individually identifiable health information in order to function Records can be stored and recalled through the use of a timestamp or an arbitrarily assigned identifier If you choose to enter a meaningful Patient Name or Patient Identifier then you agree to assume any and all risks of and liabilities incurred with transmitting and storing such individually identifiable health information through the software including risks to the privacy and security of such individually identifiable health information 2 Getting Started 2 1 Installing Cardioscan Follow these steps to install Cardioscan on your computer 1 First insert the blue wireless dongle into your computer 2 Next insert the CD and follow the on screen instructions for installation and stethoscope connection If the installation program does not start automatically run the setup exe file directly from the CD 2 2 The Cardioscan USB Wireless Dongle The blue USB wireless dongle allows communication between the PC on which the Cardioscan software is installed and electronic stethoscopes that Zargis Medical Corp has approved for use with Cardioscan The USB wireless dongle receives and transmits data via the commonly accepted Bluetooth short range wireless connectivity standard To install the USB
9. can select causes beeping sound in screen resolution with Settings and select Disable cursor in stethoscope ear tips Cardioscan Wavelet Spectrogram playback Playback to stethoscope Same as above Same as above while viewing the Spectrogram or Wavelet causes the Bluetooth connection to drop Noisy recorded signal entitled The Cardioscan USB Wireless Dongle Excessive background noise Take actions to reduce the background noises heard in the auscultation environment See the Understanding Recording Quality section of this manual Signal shown in the Noisy recording See the Understanding Recording Quality section of this display plots is clipped manual Poor data quality reported Excessive background noise Take actions to reduce the background noises heard in the auscultation environment See the Understanding Recording Quality section of this manual Excessive stethoscope Hold the stethoscope with a steady hand firmly pressing motion against the patient s chest while recording See the Understanding Recording Quality section of this manual If you experience a problem with Cardioscan that is not addressed in this manual please review our support and Frequently Asked Questions page at www zargis com support If you are still unable to solve the problem please email a detailed description of the problem to ZCSsupport zargis com or contact Zargis at 609 488 4608 15 Warranty Inf
10. continue with an auscultation exam 8 A voice prompt reports the recording posture and prompts you to press OK when you are ready to begin recording When the patient is ready and you have the stethoscope turned on and placed on the patient s chest AND you can hear heart sounds click the OK button or press the M button 9 Listen to the patient s heart sounds at the indicated site Utilize the Signal Preview at the lower left portion of the window as a visual aid in gauging signal quality Once a recording begins you will see the waveform for the site in real time in the sound display corresponding to the recording site 10 It is preferable to auscultate on top of bare skin To reduce hand motion artifacts hold the stethoscope with a steady hand while recording 11 Continue the recording protocol for the remaining sites 12 Pressing the M button during a recording will re record the current site For additional information about conducting quality recordings see the section of this document entitled Understanding Recording Quality ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 11 of 22 MED CAL 5 3 Interrupting the Recording Sequence Between recordings during the protocol you may click on the red Interrupt button to pause a recording or cancel out of the protocol Clicking on the Interrupt button brings up a dialog window with the options to resume the sequence or cancel
11. decision The device is not intended for use on severely obese patients where the physician has difficulty auscultating with an acoustic stethoscope 1 3 Precautions Only qualified medical personnel should use the device Cardioscan is intended for use only with physician over read Cardioscan is not a diagnostic device Cardioscan is intended for use only on patients with heart rates between 50 and 120 beats per minute This manual provides instructions for use of the Cardioscan device and assumes that the user is familiar with the Windows operating system on PCs Zargis recommends that all personnel who operate the device thoroughly read and understand this manual The device is intended for use in a physician office setting As with normal auscultation the physician s office should have minimal background noise from the street telephones radio conversation and office clatter ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 3 of 22 MED CAL It is strongly recommended that the users of the Cardioscan software use computing and networking security features to protect patient data created and stored using this software Please consult your institution s data management or computer technical service personnel to implement appropriate security measures A WARNING CAUTION and NOTE used in this manual will be boxed and have the following significance WARNING Maintenance or operating procedures techni
12. dioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 6 of 22 Add New Scope Window To connect to a Model 3200 stethoscope for the first time you must follow the steps below to pair the stethoscope with Cardioscan Step 1 Fress M on the stethoscope Use and to select PAIR Then press the M button again A 4 digit PIN number will appear on the stethoscope LCD screen Step 2 Enter the PIN number here e Step 3 Create an ID for the stethoscope and enter it here Step 4 Example Dr Jones Click the Pair Now button below The screen below will appear each time you attempt to connect Cardioscan to your stethoscope Stethoscope Connection Window Press M on the stethoscope to select CONNECT and then press the M button again Indicates the Target Tips for Preventing Lost Wireless Stethoscope to which Connections Cardioscan is 1 Auscultate the patient as close to the PC attempting to connect as possible 2 Avoid having objects or people between Connecting to Stethoscope ALPHA the stethoscope and the PC Abort 3 Avoid having your hand cover the entire k chest piece location of the stethoscope s Bluetooth antenna fj Tips for Preventing Lost Wireless Connections 1 Auscultate the patient as close to the PC as possible 2 Avoid having objects or people between the stethoscope and the PC 3 Avoid having your hand
13. e stethoscope s Bluetooth antenna NOTE It 1s not possible to connect to a stethoscope that is actively connected to another PC 2 7 Registering Your Software To register your copy of Cardioscan click the Register option under the Help file menu and follow the instructions that appear 3 Upgrading to Multiple Users To upgrade your copy of Cardioscan so that it may used by multiple users either select Increase Stethoscopes under the Help menu option go to Www zargis com or contact Zargis via email at sales zargis com Upgrading to multiple user status allows the software to pair with more than one stethoscope at a time You must contact Zargis to upgrade to a greater number of users 4 Web enabled Collaboration via the Zargis Telemedicine Server Go to www zargis com or contact Zargis at sales zargis com to acquire access to www Zargis Telemed com Zargis telemedicine portal which allows you to share files with other physicians and or cardiologists for immediate second opinions ARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 8 of 22 MEDIC AL 5 Instructions for Use 5 1 Icons amp Buttons The following is an example of the Cardioscan detailed view Vertical Zoom Stethoscope Connection Indicator Connect to Class Start New recording telemedicine server Probability also increases Switch playback volume view Eok ar
14. ection Switch view C Play to PC E Interrupt A green dot indicates that Cardioscan does not suspect a murmur at the given site A yellow dot indicates that Cardioscan suspects that a murmur exists at the site Posture Standing Date 1115007 9 32 48 AM Y Patient ID 17596 Patient Hame Cardioscan Findings Class Murmur Suspected Yes 2R zL 4L Ap Suspected pl Systolic Murmur v Ki hal Suspected Diastolic Murmur Indicates Cardioscan findings Patient Information Heart Rate 95 3 beats min RR interval 700 97 ms Systolic interval 261 20 ms Diastolic interval 415 93 ms Red boxes highlight suspected murmurs Identifies the timing of the first and second heart sound 5 2 Methods for Proper Auscultation Please follow these instructions to properly run an auscultation protocol with the device 1 Ensure that the environment is as quiet as possible Listen carefully for background sounds such as that caused by traffic noises entering through open widows or by fans and air conditioners and eliminate these noises to the extent possible Make sure that there are no background conversations being conducted during recording 2 Prepare the patient as if the protocol were for any normal auscultation exam Before starting the protocol position the patient in the desired posture The patient should be instructed
15. ed View versions of the Results Window The Cardioscan algorithm analyzes each heart sound recording by detecting individual heart beats determining whether murmurs are present during systole or diastole and whether the detected beats are likely to reflect conditions that should be referred to a specialist for evaluation The results of the Cardioscan analysis are presented in textual and graphical form at the patient level and at the level of individual recordings site level 6 1 Patient Level Findings 6 1 1 Summary Hemodynamic Findings Cardioscan reports summary hemodynamic findings in the left panel under the torso model The median instantaneous heart rate is reported along with the standard deviation of the heart rate across the four auscultatory sites Also reported are the median and standard deviation values for the RR interval which is the interval between successive first heart sounds The summary findings also include the median and standard deviation of the systolic and diastolic intervals Note that the systolic and diastolic intervals sum to the RR interval ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 12 of 22 MED CAL 6 1 2 Patient level murmur classification The Cardioscan algorithm calculates the probability that the patient has a murmur that has auscultatory features that correspond to Class I indications for referral to echocardiography of an asymptomatic patient as defined by the Am
16. ed in the status box and also given through the voice prompts In addition the sound signal will be colored red as further indication that re recording needs to occur Required re recording will occur for Stethoscope Volume Too Loud Cardioscan automatically selects a gain level based upon the first two seconds of recording If the first two seconds of the recording are very soft Cardioscan could inappropriately increase the gain setting Make sure that the first two seconds are representative of the entire recording One cause for this indication is excessive background speech or hand motion artifacts Please record again with a steady hand in a quiet environment No or Low Signal Energy This can occur if the stethoscope gain is too low or the stethoscope is not well coupled to the patient s chest Cardioscan automatically selects a gain level based upon the first two seconds of recording A loud artifact noise in the first two seconds could cause Cardioscan to inappropriately decrease the gain setting Make sure that the first two seconds are representative of the entire recording Ensure that the stethoscope is properly positioned on the patient In some severely obese patients it may not be possible to obtain a satisfactory signal Average Energy Level of Recording Too High Can occur when the average energy level of the entire 20 second recording is deemed to be too high based on established thresholds Please record again with a s
17. erican College of Cardiology American Heart Association ACC AHA Practice Guidelines for the Management of Patients with Valvular Heart Disease The ACC AHA guidelines define the Class I indications for echo referral in an asymptomatic patient as being diastolic continuous holosystolic or late systolic murmurs or mid systolic murmurs of grade 3 or higher When the Cardioscan analysis algorithm has determined that a patient s suspected murmur has characteristics consistent with a Class I indication for referral to echocardiography the findings area of the software window displays Class I Murmur Suspected Yes under the Cardioscan Findings heading The patient level Class I Murmur referral decision in Cardioscan demonstrated a sensitivity of 97 with a specificity of 76 6 2 Site level Findings 6 2 1 Murmur detection Cardioscan analyzes each detected beat for the presence of systolic or diastolic murmurs The results are displayed in the site level findings checkbox see image below The results are defined as follows Suspected Systolic Murmur The analysis algorithm detected a sound consistent with a murmur in the systolic time interval Suspected Diastolic Murmur The analysis algorithm detected a sound consistent with a murmur in the diastolic time interval Site level Findings Checkbox 2R 2L 4L Ap Suspected TY Systolic Murmur vvv Suspected Diastolic Murmur If there is no check mark in either box at a site
18. et the default setting for the sound display e Adjust the length of the lead time or waiting period before Cardioscan begins recording at a site or set the recordings to start when the M button on the stethoscope is pressed Tools Manage Stethoscopes Selecting this option opens the Manage Stethoscopes window from where you can change stethoscope settings add a new stethoscope or delete stethoscopes 12 3 Help Help User Manual Selecting this option opens the Cardioscan User Manual Help Contact Zargis Medical Use this option to view contact information for Zargis and provide feedback about our products Helpl Register Cardioscan This will bring up the Registration window Help Increase Stethoscopes Select this option to enable your installation of Cardioscan to connect with additional stethoscopes Help About Cardioscan Select this option to view the product version number along with telephone numbers and addresses for requesting further information or making service inquiries 13 Understanding Recording Quality The quality of the recordings depends on user technique the environment and subject compliance High quality recordings will increase the accuracy of the analysis results There are three main factors that affect recording quality The acoustic environment Try to ensure that the auscultation procedure is carried out in a quiet environment Listen carefully for background sounds suc
19. f your sample files The Patient ID for these files will be the murmur type and the Patient Name will be Sample Additional sample files including S3 S4 opening snaps mid systolic clicks and additional systolic and diastolic murmurs of various types can be purchased from Www zargis com 9 Exporting amp Importing Data 9 1 Exporting Data By selecting Export Recording as wav from the file menu Cardioscan allows you to export an audio only version of a heart sound recording in the common wav file format to a USB flash drive the local hard drive of your computer or to a server When the Export Recording to wav window opens select the Recording Site s you would like to export and then select the Filter Mode Bell Diaphragm or Extended for each site By selecting Export from the file menu you can export the native zac file which includes the heart sound recordings and associated analysis results to any location on your PC Cardioscan also allows you to export the native zac versions of Cardioscan to the Zargis Telemedicine Server by selecting ZargisTelemed com from the File menu 9 2 Importing Data To import files from your PC into Cardioscan select the Import option from the file menu In the Open window that appears select the file s that you wish to import Once the import is complete you will be able to access these files as you would any other Cardioscan file 10 Adjusting Acq
20. ference and 2 This device must accept any interference received including interference that may cause undesired operation FCC NOTE THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS EQUIPMENT SUCH ARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 4 of 22 MEDIC AL MODIFICATIONS COULD VOID THE USER S AUTHORITY TO OPERATE THE EQUIPMENT 1 5 Patient Privacy The privacy and security of certain individually identifiable health information may be protected by state federal international and or foreign laws that regulate and restrict how such information can be used disclosed stored and transmitted In some instances you may even be prohibited from permitting any third party to access such information without first obtaining prior written authorization to do so You are solely and fully responsible for determining understanding and complying with any and all laws that affect how you may store and transmit any electronic individually identifiable health information through use of the Software If you determine that you are not able to comply with a law or restriction that applies to your use and disclosure including transmission of individually identifiable health information through the Software then you should not proceed to save such information By proceeding to save any information you hereby assume all risks responsibilities and lia
21. h as that caused by traffic noises entering through open windows or by fans and air conditioners and eliminate these noises to the extent possible Make sure that there are no background conversations being conducted during recording Take steps to prevent interruptions during the protocol Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 20 of 22 MED CAL The patient The patient should be properly prepared so that the recordings can be made with the stethoscope against bare skin The patient should be instructed to breathe in a normal and quiet manner The patient should be instructed to maintain a still and steady posture If there are digestive sounds present the recordings should be made after they have subsided The placement and handling of the stethoscope The stethoscope should be carefully and accurately position over the intercostal spaces to obtain best signal quality For the apex recording the point of maximum impulse should be palpated and the recording taken from that location The stethoscope should be held in position in a manner that minimizes motion artifact The Cardioscan system has some built in quality checks to detect conditions of low signal quality and to better ensure that only signals of good quality are accepted These quality checks may require that you re record at a given site immediately following the recording When Cardioscan determines that you must re record a notification message is display
22. he signal To play recordings back at half speed check the box next to 1 2 Speed and then click the Play button Once activated the 2 Speed setting stays activate until the box is unchecked 6 9 Playing Back a Specific Portion of a Recording To play back a specific portion of a recording simply click with your mouse on the area of the sound display where you want playback to begin and drag your mouse to the right to highlight the area of interest Once an area of the sound display has been highlighted in this way hit the Play button to listen to the specific section Note that you must select a segment of sound at least one second in duration in order for this feature to function Clear a highlighted area by left clicking anywhere on the sound display 6 10 Looped Playback The Loop option appearing at the top of the screen allows you to play back an entire recording or a specific portion of a recording in a loop that will continue until the Stop button is clicked To play a full recording in loop mode select the corresponding sound display by clicking on it then check the box next to Loop and then click the Play button To play a specific portion of a recording in loop mode use the cursor to highlight the area of interest on a sound display activate the Loop setting and then click the Play button Once activated the Loop setting stays activate until the check box is unchecked 6 11 Printing Results To print a co
23. intensity timing and location In addition Cardioscan indicates whether or not a suspected murmur meets the characteristics for classification as a Class I murmur according to the ACC AHA Recommendations for Echocardiography in Asymptomatic Patients With Cardiac Murmurs 1 1 Indications for Use The Zargis Acoustic Cardioscan is an electronic auscultatory device intended to provide support to the physician in the evaluation of heart sounds in patients The product will acquire and record the acoustic signals of the heart and analyze these signals The analysis procedure will identify specific heart sounds that may be present Identified sounds include S1 S2 and suspected murmurs The device is indicated for use in a clinical setting by a physician or by trained personnel who are acting on the orders of a licensed physician It is not intended as a sole means of diagnosis The interpretations of heart sounds offered by Cardioscan are only significant when used in conjunction with physician over read as well as consideration of all other relevant patient data 1 2 Contra Indications for Use Cardioscan is not intended to be a diagnostic device It does not supersede the judgment of the qualified medical personnel The device is intended to aid the physician in the evaluation of heart sounds The physician is responsible for reviewing and interpreting the results along with the auscultatory findings and medical history in making a referral
24. o the standard default view click the PCG wel icon that appears to the left of the display 6 5 2 Wavelet The wavelet decomposition is a different time frequency representation that also may be useful for viewing features of heart sounds Cardioscan uses the Morlet Wavelet which possesses ideal characteristics for heart sound analysis The x axis of the Cardioscan wavelet display represents the time index The y axis is a nonlinear frequency scale that extends from a low end of approximately 15 Hz to a high end of approximately 580 Hz The spacing of the wavelet channels is linear for the lower frequency range and logarithmic for the higher Wv frequencies To view a sound display in wavelet mode click the Wavelet kyi icon appearing to the left of the sound display 6 6 Signal Pan amp Zoom To zoom in or out on a sound display first select the chosen display by clicking on it then make use of either the Horizontal Zoom or Vertical Zoom buttons located at the top of the screen Zooming in provides more detail Zooming out provides less detail The mouse wheel may be used to perform horizontal zoom on a selected trace The Vertical Zoom will increase and decrease the volume of the recording as it affects the visual and the audible amplitude of the recording You can scroll along the analyzed heart sound signal by using the Pan buttons To move left select the chosen display by clicking on it and then make use of the Pan Left but
25. onding probability map Due to the fact that the ACC AHA guidelines classify all diastolic murmurs as Class I Murmurs Cardioscan does not provide a separate probability map for the diastolic interval Whenever a diastolic murmur is detected the patient should be considered to possess a Class I murmur at that site To view the Systolic Class I Murmur Probability Maps for all four recording sites click the Systolic Class I Murmur Probability Map icon appearing at the top of the screen 6 3 Color coding of Auscultation Site Markers on Torso Image Following analysis the four circles on the torso image are color coded as follows When a circle appears in green this indicates that Cardioscan does not suspect the presence of a murmur at the corresponding auscultation site When a circle appears in yellow this indicates that Cardioscan suspects that a murmur exists at the corresponding auscultation site and the findings are listed in the rectangular grid under the Cardioscan Findings heading 6 4 Heart Sound Display The heart sound recordings phonocardiograms are displayed in the four right hand panels one corresponding to each auscultatory site The recordings are analyzed to determine regions where noise artifacts have caused clipping of the signal any region that Cardioscan determined to contain signal clipping is displayed in yellow Yellow regions are deemed to be of poor quality and are not used in analysis The dis
26. or echo referral in an asymptomatic patient as being diastolic continuous holosystolic or late systolic murmurs or mid systolic murmurs of grade 3 or higher These site level murmur probabilities are aggregated to compute the patient level probability of Class I indications for murmur referral The probability that a detected systolic murmur has Class I indications for referral based on the timing and loudness of the murmur is displayed using a two dimensional probability map For each recording site the average timing and loudness of the systolic murmur is represented by a colored dot The murmur loudness is measured in decibels relative to the average energy of the ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 14 of 22 MED CAL signal and the timing is represented as the center of energy of the murmur Overlaid on this plot is a probability contour map that indicates the probability that given a systolic murmur is present it contains timing and loudness characteristics consistent with a Class I murmur in an asymptomatic patient The probability can be interpreted by the positioning of the dot in reference to the displayed contour lines When the dot falls within the gray area for a given recording site then Cardioscan has classified the systolic interval as possessing a suspected Class I murmur When Cardioscan s algorithm does not suspect that a murmur is present in a recording no dot will appear on the corresp
27. ormation Please refer to your Cardioscan End User License Agreement for the terms of your warranty Littmann is a registered trademark of 3M Windows is a registered trademark of Microsoft Bluetooth is a registered trademark of the Bluetooth SIG Inc ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 22 of 22 MED CAL
28. out of the protocol 5 4 Signal Quality Errors If Cardioscan deems a recording to be of acceptable quality a voice prompt indicates that the site recording is complete For more information on what constitutes a good heart sound recording please refer to the section of this manual entitled Understanding Recording Quality If Cardioscan rejects a recording it reports the error to you as a voice prompt a status window message and by coloring the recorded signal red Follow the prompts for the failure cause and suggested corrective action The program prompts you for an immediate re recording 5 5 Re recording an Auscultation Site If you want to re record a particular site after the protocol completes click on the circular Re record button at the top of the window A voice guided protocol guides you through a sequence of steps similar to those listed in the above section You can only re record a site before analyzing the file 6 Reviewing Analysis Results After successful completion of a recording protocol you may review the recorded data If the recorded data is satisfactory press the Analyze button at the top of the screen or press the M button on the stethoscope to initiate analysis of the recorded sounds When the analysis has completed the Results Summary window will appear on the screen The Switch View icon located at the top right of Results window allows you to toggle between the Summary View and Detail
29. play of the phonocardiograms often reveals the time structure of the heart sounds and a trained observer can detect individual heart beats In signals that are very noisy and of poor quality it can be difficult to discern individual heart beats The heart sound recordings reveal the results of the beat detection and murmur detection in detail Each signal annotated with S1 and S2 labels which correspond to the first heart sound and second heart sound respectively The labels appear directly over these identified heart sound events Detected murmurs are also indicated by colored display boxes that show the locations of suspected murmurs The left and right edges of the box indicate the onset and offset of the murmur and the height of the box indicates its amplitude 6 5 Spectrogram amp Wavelet Display Options 6 5 1 Spectrogram The spectrogram is a time frequency distribution presented as a two dimensional color plot of the heart sound energy distributed over time and frequency Black represents minimum energy ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 15 of 22 MED CAL while red is maximum energy The x axis represents the time index while the y axis is a linear frequency range of 0 500 Hz The spectrogram provides an additional perspective on the S recorded sound To view a sound display in spectrogram mode click the Spectrogram icon appearing to the left of the sound display To return a sound display t
30. py of the Cardioscan results window select Print under the File menu By default a copy of the corresponding Cardioscan User Comments amp Results Summary will also print each time a Cardioscan results window is printed This print setting can be turned off by going to Tools Settings and un checking the radio button that appears under Comments Printing 7 Saving Data The device software saves data files of heart sound recordings once the Analyze button is clicked If your computer has Vista saved files will be located in the following directory C Users Public Public Documents ZargisMedical ZargisCardioscan If your computer has XP saved files will be located in the following directory C Documents and Settings All Users SharedDocuments ZargisMedical ZargisCardioscan 8 Opening Previously Recorded Data Use the Open File icon or select the Open option under File to open a previously recorded and analyzed set of heart sounds Files in the Open window can be sorted by Patient ID Stethoscope ID Date of Recording or Patient Last Name Click on the recording of your choice and select Open to view the saved analysis ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 17 of 22 MED CAL 8 1 Sample Files Cardioscan comes pre loaded with a selection of natural heart sounds commonly encountered in clinical practice Select the Open Sample Files option under the File menu to view any o
31. ques etc that may result in possible injury death or other serious adverse reactions if not carefully followed CAUTION Maintenance or operating procedures techniques etc that may result in equipment malfunctions equipment failure or damage to equipment if not carefully followed NOTE Maintenance or operating procedure that is considered essential to emphasize 1 4 System Requirements To run version 2 0 of the Cardioscan software your system must meet these specifications Windows XP SP2 or later or Vista 32 bit 512MB of RAM minimun 1 0 GB recommended Intel Pentium 4 compatible or later 1024 x 600 graphic display or better USB 1 1 port or better The specifications of the blue USB wireless dongle are as follows Compliant with Bluetooth V1 1 V1 2 amp V2 0 Supporting profiles Networking Dial up Fax LAN access and Headset Operating systems Windows XP amp Vista Interfaces Compliant with USB 1 1 amp 2 0 Data transmission rate 3Mbps Working distance 5 10m FCC approval FCC ID WQ7I BTD 04 To minimize the potential for interference do not use the Cardioscan system within 5m of an active microwave oven Additionally the presence of multiple active WiFi networks may interfere with the wireless functionality of the system NOTE The USB Transceiver device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful inter
32. teady hand in a quiet environment and make sure that the first two seconds of the recording are representative of the entire recording so that Cardioscan adjusts the gain appropriately Recording Contains an Unacceptable Amount of Clipping Can occur when more than half the duration of the recording contains detected clipping Please record again with a steady hand in a quiet environment and make sure that the first two seconds of the recording are representative of the entire recording so that Cardioscan adjusts the gain appropriately ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 21 of 22 MED CAL 14 Troubleshooting Cannot connect to No USB wireless dongle Install USB wireless dongle See the section of this manual stethoscope installed USB wireless dongle not properly installed Stethoscope not paired Pair stethoscope See the Connecting Your Stethoscope section of this manual Each unique Stethoscope ID If your office has multiple stethoscopes make sure you are can only be connected to one trying to connect to the correct Stethoscope ID stethoscope Undetermined Turn off the stethoscope wait a few seconds and then turn the stethoscope back on Playback to stethoscope Older model PC or laptop Either while viewing the graphics cards cannot 1 Decrease the screen resolution of your PC OR Spectrogram or Wavelet support the PC s selected 2 Under the Tools Menu of Cardios
33. to remain still and breathe in a normal and quiet manner Finally follow the instructions of the voice guided protocol to complete the auscultation exam ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 10 of 22 MED CAL 3 Adjust the stethoscope so that the earpiece volume level is at a setting you find comfortable the volume level of recordings 4 Ensure that the User ID for the stethoscope you intend to use for the exam is listed under the Target Stethoscope heading at the top of the window To connect with a different stethoscope one which has already been paired use the pull down arrow beneath the Target Stethoscope heading For instructions on pairing a stethoscope with the software see the section of this manual entitled Pairing amp Connecting the Stethoscope with the Cardioscan Software 5 Click on the New button 6 Enter a patient ID in the Patient ID field Use an ID letter and or number combination that allows ready access to all patients under your care Patient ID names may contain any combination of letters and numbers up to 20 characters long Note that Cardioscan ONLY permits use of the following characters in patient IDs any letter any number the dash symbol and the underscore symbol 7 Select the appropriate patient posture from the pull down menu that appears under the Patient ID field and then click the OK button Click on Cancel if you do not want to
34. ton To move right select the chosen display by clicking on it and then make use of the Pan Right button Note It is also possible to pan left and right through the sound displays by using the Drag icon located on the toolbar Click this hand shaped icon and you have the ability to pan left or right through any of the sound displays in the results windows by placing the mouse cursor on a sound display and then dragging the cursor in the direction you wish to scroll Deactivate this feature by clicking the Drag 4 icon again 6 7 Playing Back a Recording To play back a portion of the analyzed heart sound signal click on the Play button It plays what you see in the graph Note that during playback a red cursor scrolls across the sound display in synchrony with the recording Click the Stop button to end the playback CAUTION The audio quality of heart sound recordings played back through a PC audio jack may not be suitable for use when making a diagnosis due to the PC s sound card and or the frequency response of the headphones speakers Zargis recommends using the electronic stethoscope when listening to recorded heart sounds with Cardioscan ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 16 of 22 MED CAL 6 8 Slow Playback of Heart Sounds The 2 Speed option located at the top of the screen allows you to play back recordings at half speed with no significant change in the spectral properties of t
35. uisition Lead Time A selection under Tools Settings allows you to adjust the length of the lead time or waiting period before Cardioscan begins recording at a site Lead time options 0 1 2 or 4 seconds You can also select Manual which will allow you to start recording when you press the M button on the stethoscope 11 Using Shortcut Keys The device is equipped with some shortcut keys that can help you move through options without using mouse selection Use the ENTER key for the OK option on all pop up dialog boxes Use the ESC key for the CANCEL or NO option on some of the dialog windows For some windows the mouse must be used to select the No option ZARGIS Cardioscan version 2 0 User Manual 001 LB 0001 Rev 17 Page 18 of 22 MED CAL The ALT key can be used to select the menu bar options Use the ALT key in conjunction with the arrow keys or underlined letter on the menu options to select an option and then press enter 12 Navigating Menus Cardioscan contains the following menu selections File Tools Help 12 1 File File Start New Recording Select this option to begin a new patient recording File Open Select this option to open or re analyze a previous recording Navigate by Patient ID or Analysis Date in the Open Patient Record window to locate the recording you are seeking and then click Open to view saved analysis results or select Re Analyze to have the file analyzed again
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