User Manual - SensiCardiac
Contents
1. AHA ACC recommends echocardiography under the following conditions Class I SNSS2 50 UMAN 003 docx Page 23 of 34 1 Echocardiography is recommended for asymptomatic patients with diastolic murmurs continuous murmurs holosystolic murmurs late systolic murmurs murmurs associated with ejection clicks or murmurs that radiate to the neck or back 2 Echocardiography is recommended for patients with heart murmurs and symptoms or signs of heart failure myocardial ischemia infarction syncope thromboembolism infective endocarditis or other clinical evidence of structural heart disease 3 Echocardiography is recommended for asymptomatic patients who have grade 3 or louder mid peaking systolic murmurs Class III 1 Echocardiography is not recommended for patients who have a grade 2 or softer mid systolic murmur identified as innocent or functional by an experienced observer 4 3 2 Murmur Location The average relative energy distribution within a heartbeat is shown by means of energy distribution bar chart for S1 early systole ES mid systole MS late systole LS S2 early diastole ED mid diastole MD late diastole LD Signal Analysis Results Relative Energy for Average of Heart Beats Heart rate 76bpm Avg Systole 207 9 8ms Avg Diastole 442 16 5ms 3218 3 43 350 2 51 56 66 041 1 01 0 21 R R Interval 783 15 3ms l T T T a Er Si ES MS LS 52 ED MD LD Figure 15 Normal Heart Sound recorded2. able to perform any heart sound with limited functionality recordings Please visit www sensicardiac com and register as a user for more information Select the recording location Select a recording location on the image of the patient on the chest before and continue continuing Recording button disabled You did not register your software or obtained a valid for trial period on expiry product Product Key and Activation code You will not be able to perform any heart sound recordings Please visit www sensicardiac com and register as a user for more information UserManual pdf failed to The UserManual pdf file has been moved or deleted ARE Search for UserManual pdf on your PC Load the UserManual from the installation disc or if SNSS2 50 UMAN 003 docx Project Confidential Page 32 of 34 Make sure you have a back up of your current database After recovery the current database will be deleted permanently To start a heart recording please set the windows recording device microphone properties to stereo 2 channel 22050Hz and try again unsuccessful back up all your recordings and re install the software By selecting the database recover option your current database will be substituted by the backed up database The current database will be permanently removed and replaced by the backed up one Your audio settings are set to mono Connect the Audio Device to t
3. at the pulmonary location SNSS2 50 UMAN 003 docx Project Confidential Page 24 of 34 Figure 15 shows the relative energy distribution for a normal heart sound within the systole and diastole regions are relatively low indicating the absence of a murmur Signal Analysis Results Relative Energy for Average of Heart Beats Heart rate 80bpm Avg Systole 193 7ms Avg Diastole 410 29ms 71 69 37 54 16 9 22 66 0 03 0 03 0 06 AE SE een NE GA a 1 ES MS LS 52 ED MD LD R R Interval 742 26ms Figure 16 Pathological heart sound recorded at the tricuspid Figure 16 shows the relative energy distribution for a pathological heart sound indicating a systolic murmur SNSS2 50 UMAN 003 docx Page 25 of 34 5 Panels and Forms 5 1 SensiCardiac gt About The About form provides company and program version specific information 5 2 SensiCardiac gt User Account The User Account provides information about the registered user To change this information the user must log into the SensiCardiac account on www sensicardiac com and edit the user information 5 3 SensiCardiac gt Legal Notice This provides the Patient Privacy and confidential information 5 4 Settings gt Account Information The Account Information form provides information about the user subscription and the number of recordings remaining in the package for the current month 5 5 Settings gt Audio Devices This form all
4. connecting window SNSS2 50 UMAN 003 docx Project Confidential Page 14 of 34 3 Use Instructions 3 1 Icons Buttons and Controls Volume p o SNSS2 50 UMAN 003 docx Record amp Re record Button This button is selected to begin a recording at a selected location It can only be activated after all the patient s information has been completed and you have selected Continue The Step 1 Record at Aortic window appears with the Record button Apply all the recommendations stipulated and then select Record The Record button in the wizard is not active when the Start Auscultation icon is selected This button is selected to re record at a selected location Select the location on the image or within the patient explorer then select the Re record button For all new recordings the Auscultation sequence wizard should be followed Play Button When this button is selected the complete audio recording of the selected heart sound is played back NOTE Using the SensiCardiac with Littmann playback is only possible through the Bluetooth stethoscope Stop Button This button stops the recording or audio playback It is only visible while playing back a signal or recording a new signal Volume Control The volume of the heart sound can be controlled by means of the slide control Minimum volume intensity is at the left and maximum volume on the right If the volume is muted a red cross is indicated Clicking
5. Accept else select the appropriate heart rate range from the drop down menu e Default 50 90 bpm e Athlete 40 60 bpm e General 50 180 bpm e Specific 90 120 bpm e High 120 180 bpm If no correct heart rate could be calculated or if you are not satisfied with the recording you may re record the heart sound by selecting Re Record Select Cancel if you want to exit stop the session SNSS2 50 UMAN 003 docx Page 21 of 34 4 2 3 Record the remaining heart segments Figure 13 The recording locations Repeat the pervious two steps Record and Heart Rate Approval for each of the remaining heart sound locations e Pulmonary e Tricuspid e Apex SNSS2 50 UMAN 003 docx Project Confidential Page 22 of 34 4 2 4 Patient Findings Patient Findings Patient Cloete TT Analysis Classi Heart rate 74 bpm Analysed locations Aortic Pulmonary Tricuspid Mitral _ Figure 14 The patient findings window The findings for all four heart sound recordings are shown within the final window If all four recordings is indicated as green no echo cardiography referral is recommended Class III If any one of the recordings is indicated as amber echo cardiography is recommended Class I Select Download PDF if you want to save the findings to a PDF file 4 3 Interpretation of Findings 4 3 1 Class I vs Class Ill findings The American Heart Association and American College of Cardiology
6. EEE 9 krias aE AE EEA 10 PZ BENN PN 10 2 2 1 SensiCardiac With Littmann 3200 sssssssssssrsrsrrsrsrerrrrrrerererrrrene 10 25 BENENE 10 EEE EO EE sence 10 25 Stethoscope SEN 12 DIT P iring Your Littmann 3200 re 12 gt UCINI ON oasa RE E E E EEE E ES 15 Sil ORRE BENSON NE 15 4 The auscultation sequence wizard xuavannnnnnvnnnnnnnnennnnnnnnennnnnnnennn 18 Asd STN 18 4 2 Enter the patient information aruravnvnnnvnnnnnvnnnnnvnnnnnnnnnereuevereuevenene 19 SNSS2 50 UMAN 003 docx Page 3 of 34 4 2 1 Record Aortic Position ccc ccc cece cece cece eceecaceceaeueuaeueuanenuaneneanes 20 NA Selec le Neat Fale cova tancticunsensameaenbuwedanma EE 21 4 2 3 Record the remaining heart segments c ccc ce cece eee eee e eee eens 22 Wace Patent FONN vr 23 4 5 Interpretation of FINGINGS waiccivercvsreriererterranmanereworaneerwaneenmeneen ewes 23 4 3 1 Class I vs Class III findingsS rarnnnnnnannnnnnnennnnnnnennnnnnnennnnnnnennnnn 23 FE MT Nesen 24 3 PENNE 26 SL SANE NNN 26 Dee STN VE NON 26 Deo SENNA gt Legal NOUCE sr 26 5 4 Settings gt Account Information auannnnnnnvnnnnnneennnnnnennnnnnnennnnnnnnnnnnn 26 5 5 Settings gt Audio DEVICES Lure karse ernmeeese drekk ceceanitegedieenes 26 E TESE 27 OL TANN 27 bl FREI He 27 bh SPP NK 28 or EIT NE 28 6 5 Bluetooth Communication Error Messages anuuannnnnannnnnnnnnnnnnnnnnnnnunnen 31 60 Warning MESSE Leed ee 32 7 Warranty Information
7. SS2 50 UMAN 003 docx Project Confidential Page 12 of 34 e Use the button to scroll to the Pair option e Select this option by pressing M e The LCD will display the paring status e Select the Pair button as displayed in the figure below to proceed e Enter the required Pin number within the Windows environment Enter the pairing code in the software Select Pair on the Scroll to Pair on the Littmann 3200 set up stethoscope Menu and window and proceed window select On the Model 3200 depress and release the M button The MAIN menu will be displayed Use the button to scroll down to the PAIR option Select this option by pressing and releasing the M button The LCD screen will signal that pairing is in progress with the animation displayed below Figure 3 The Bluetooth pairing window SNSS2 50 UMAN 003 docx Page 13 of 34 If the devices were paired before select the stethoscope you want to connect to and press the Connect button e Depress and release the M button e Scroll with the button to the Connect option e Select Connect by pressing M e Select Connect within the window below How to connect Depress and release the M button Select the CONNECT option by again pressing and releasing the M button The LCD screen will signal that the Bluetooth link is active Press Connect button to setup the communications link with your stethoscope Figure 4 The Bluetooth
8. User Manual All names and diagnoses depicted in examples herein are fictitious No association with real persons is intended Complying with all applicable copyright laws is the responsibility of the user No part of this document may be reproduced or transmitted in any form or by any means or for any purpose without the express written permission of Diacoustic Medical Devices Pty Ltd Diacoustic may have patents patent applications trademarks copyrights or other intellectual property IP rights covering subject matter in this document The use of this document does not give anyone license to these patents trademarks copyrights or other intellectual property Caution Federal law restricts this device to be sold by or on the order of a physician CIACOUSTIC MEDICAL DEVICES Pry LID SNSS2 50 UMAN 003 docx Project Confidential Page 2 of 34 Table of Contents 1 FET M Me 5 bi EVNE 5 L2Z SENSICardiaC MOES Luse inden 5 Lo CONTEST Larvene eek 6 Le PRECAULIONS amp Warnings acctnex educa wise ceveucewstawseteexeeaisncedeiesaaneneas a 6 1 4 1 SensiCardiac General Warnings nannnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnenn 6 L STA PC arr 7 1 4 3 System RENNE 8 1 4 4 Required AccessorieS s sssssrnrerrrrrrnrrrrrrrrnrrrrrnrrnrrrnrrnrnrrrrrnnne 8 ED Privacy SONEN suntstuscsaveciiessansayuetagunnawersecaoyaunueniermneeeneqnneete 8 1 4 6 Licensing ENE 9 2 CEDI Cared ors An a E EA E 10 ZA Installing
9. cccccseeeceeeeseseeeeeeeseeeeeseueeeeetaugeettnaggengs 33 SNSS2 50 UMAN 003 docx Project Confidential Page 4 of 34 1 General Information 1 1 Indications for Use SensiCardiac is an electronic auscultation 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 trained personnel who are acting on the orders of a licensed physician It is not intended for use as the sole means of diagnosis The interpretations of heart sounds offered by the SensiCardiac are only Significant when used in conjunction with physician over read as well as consideration of all other relevant patient data NOTE e The device is not intended to be the sole means of diagnosis e Final judgment on the diagnosis still lies with the qualified medical personnel e The medical history and physical examination results must be taken into consideration during the decision making process e The software is intended for use in a quiet environment on patients with an audible heart sound 1 2 SensiCardiac Models SensiCardiac with Littmann 3200 SensiCardiac software is optimized to work with the Littmann 3200 electr
10. ce in use No information is lost Restart the application to resume 1 Check stethoscope volume setting 2 Check line In recording volume level During recording the signal display should be visible as a heart sound with distinguishable beats 3 Switch off all amplifications and ambient noise Page 27 of 34 reduction filter which alter the signal being recorded 4 If the detected S1 S2 peaks are incorrect selected the heart rate range for the recording that best matches the patient heart rate The diagnosis is dependent on correct S1 S2 locations 5 Also make sure that stethoscope is held firmly but with light pressure to minimise finger friction noises Table 1 List of possible sound recording troubles Notes For a reliable Bluetooth connection the distance between the computer and Littmann 3200 must not be more than 1 meter 3 feet 6 3 Sound Playback The recorded heart sounds do not In SensiCardiac Software select Settings play back properly gt Devices from menu Select correct output device from list of audio output devices Make Sure your headphones are plugged in and volume correct then click the Test button to make sure the hardware is correctly set up Set the playback volume to 100 Table 2 List of possible sound playback troubles NOTE Heart sounds are best heard using an electronic stethoscope If you intend to use speakers or headphones make sur
11. cedure to the current selected patient s auscultation history 4 2 Enter the patient information Patient information lt Unique identification code gt Name First lt Last name gt Birth date February 03 2014 Gender Male Female Contact number Address lt Optional contact address gt Figure 10 The patient information form Complete the patient information form and select continue The patient s ID Name and Birth date are compulsory SNSS2 50 UMAN 003 docx Page 19 of 34 4 2 1 Record Aortic Position Record at Aortic 2R Step 1 Recording Process 1 Calm patient until breathing easily 2 Do not speak while recording 3 quiet environment is preferable 4 Stethoscope should be positioned against bare skin and held very still while recording Recording duration EE Figure 11 Recording window Before selecting the recording button verify that the heart sound is clearly audible and the patient calm The recording duration should be selected to record at least 12 clear heart beats When ready press Record on the screen or M on the stethoscope SNSS2 50 UMAN 003 docx Project Confidential Page 20 of 34 4 2 2 Select the heart rate Heart Rate Approval 77 BPM Re Record Figure 12 The heart rate selection window Verify the calculated heart rate If the indicated heart rate is correct select
12. dentifiable information You are responsible for familiarizing yourself with any such laws practices and regulations and for making the necessary arrangements to implement appropriate security measures to control access to patient data Submitted created and stored in relation to the software SNSS2 50 UMAN 003 docx Project Confidential Page 8 of 34 In view of the above the software permits the disclosure or sharing of heart sound recordings without disclosing the patient s identity and no personal information is embedded within the heart sound files Accordingly you hereby assume all risks responsibilities and liabilities associated with the use storage disclosure and or transmission of information in relation to the software and Diacoustic is hereby indemnified from any claims losses or damages resulting from your actions or negligence in this regard Please consult your institution s information technology IT department or computer technician to implement appropriate security measures to protect access to patient data created and stored using this software 1 4 6 Licensing Agreement Installing this software on your computer for the first time allows you to use it for a 15 day evaluation period and makes you subject to our End User License Agreement After payment for the software and registration on the website of SensiCardiac www sensicardiac com you will receive a unique activation code This code is linked to t
13. e the frequencies response of the device supports the very low frequencies at which heart sounds are audible between 20 500Hz 6 4 Error Messages SNSS2 50 UMAN 003 docx Project Confidential Page 28 of 34 Heart sound signal quality test failed Less than 5 useful beats detected after beat filtering Heart sound signal could not be analysed correctly Signal length incorrect Recording stopped Please Re record the signal Stethoscope powered off or not connected Please select a beat from the Heart Sound to repeat The database directory does not exist Please try again SNSS2 50 UMAN 003 docx Initial 3 second quality test failed Follow the recording instructions Re record the heart sound The heart sound signal could not be analysed correctly Follow the recording instructions Re record the heart sound The signal variations were too large If the heart rate is fast reduce recording time Follow the recording instructions Re record the heart sound Follow the recording instructions Re record the heart sound Verify that all cables are connected correctly Verify that the stethoscope is switched on Follow the recording instructions Re record the heart sound Verify that the stethoscope is switched on and try again You have selected the Repeat button to play a single heartbeat continuously in a loop but did not se
14. he PC Open microphone recording device properties Select Advanced and set the default channels sample rate and bit depth to 2 channel 22050Hz 16bi t For help changing these settings see http Support microsoft com kb 935309 Table 5 List of possible warning messages 7 Warranty Information Consult the End User License Agreement for warranty information SNSS2 50 UMAN 003 docx Page 33 of 34 Sensi g SensiCardiac is a decision support software package intended to assist medical examiners in cardiac assessments The software will enable the medical examiner to make more accurate decisions on Class I and Class III cardiac murmurs by analyzing the acoustic heart signals captured with an electronic stethoscope Increase your auscultation confidence and gt Detect suspected heart murmurs gt Record and display auscultation sounds gt Playback and review of previously recorded sounds gt Print auscultation findings for your recording Consult the User Manual before using the software Minimum system requirements Microsoft WindowsQ 7 or 8 Diacoustic Medical Devices Pty Ltd Octo Place A3 Electron Rd Techno Park Stellenbosch 7600 South Africa T 27 0 21 880 2223 www sensicardiac com Diacoustic Medical Devices Pty Ltd All rights reserved SensiCardiac and Diacoustic are trademarks of Diacoustic Medical Devices Pty Ltd Windows is a registered trademark of Microsoft Littmann is a trademark
15. he serial number and registration code of the software You will be allowed to register the software on no more than three computers For each computer you will have to apply for a new unique activation code Diacoustic Medical Devices will not take responsibility for the misuse of this software package SNSS2 50 UMAN 003 docx Page 9 of 34 2 Getting Started 2 1 Installing SensiCardiac Download the SensiCardiac installation software from the SensiCardiac website www sensicardiac com and run the installation file If you do not agree with the licensing agreements select the I disagree option exit the installation process This version of SensiCardiac does require Net 4 5 to operate If it s not installed on your computer you will be directed to the appropriate installation files Complete the installation of Net 4 5 before proceeding with the installation of SensiCardiac After installing these programs your computer will be restarted and proceed with the installation process In the event that the installation process does not proceed automatically re run the downloaded installation executable file 2 2 Stethoscope Set up 2 2 1 SensiCardiac with Littmann 3200 See the Littmann 3200 stethoscope user manual before using this stethoscope For a reliable Bluetooth connection the Littmann 3200 and computer must not be separated by more than 1 meter 3 feet 2 3 Become a SensiCardiac User Go to www
16. lect a beat Select the heart sound beat you want to play within the heart sound window and press Repeat again The patient database directory does not exist within the user profile directory Make sure the current windows user profile is the Page 29 of 34 An error occurred while attempting to clean your database Please try again No recording is selected to export Please select a recording and choose this option again No patient is selected Please select a patient to export the desired records An error occurred while attempting to recover your database Please close all Windows Explorer directories that are open and try again The file that you selected must have a zip file extension Could not load or analyse recording Please go to File gt Database gt Clean to remove the dead link from the list SNSS2 50 UMAN 003 docx Project Confidential same as the user that installed the software Restart the program and try again If the error persists uninstall the software and re install it A process or program on your computer prevents access to the database file Close all programs and restart the program You ve selected the option to export a single recording but did not select a recording Select the recording you want to export within the patient tree view and select the export option again You ve selected the option to export a patient s recordi
17. ngs but did not select a specific patient Select the patient s data you want to export within the patient tree view and select the export option again Close all programs restart SensiCardiac and try again to recover your database Make sure you are selecting the correct back up files To import a heart sound the file must be in the correct format a zip file The file you want to import must have been exported or backed up by a SensiCardiac program The sound file was deleted from the programs database but is still displayed within the patient tree Select File gt Database gt Clean to remove the dead link from the list Page 30 of 34 Could not store recording The program was not able to store the current recording Restart the program and redo the recording Table 3 List of possible error messages 6 5 Bluetooth Communication Error Messages No stethoscope is connected You terminated the stethoscope connection steps You can review data and manage without successfully connecting to a valid patients but won t be able to stethoscope record or listen to sounds You will be able to access previous recorded patients data but will not be able to record or playback heart sounds Could not connect to sender Connecting via Bluetooth to the stethoscope was stethoscope Make sure the not successful Restart the SensiCardiac software stethoscope is waiting to be and tr
18. of 3M Bluetooth is a registered trademark of Bluetooth SIG ThinkLabs is a trademark of ThinkLabs Inc Caution Federal law restricts this device to sale by or on the order of a physician
19. on the red cross unmutes the audio for the Page 15 of 34 Playback speed Half a Normal Amplification __ 1 amp 2 _ Murmur Output Amplification J selected device Playback Speed Control Sets the speed at which the selected heart sound can be listened to Full speed is the speed at which the original recording of the heart was done At half speed the heart sound is slowed down to half the speed of the original recording Amplification of Heart S1 S2 amp Murmur Enables the amplification of different components of the heart sound S1 and S2 sounds are made more audible by amplifying the lower frequency band in which the S1 and S2 sound components are found by ignoring the higher frequency bands Similarly murmur amplification increases the audibility of the higher frequency sounds where the murmurs are more audible and suppresses the S1 and S2 sound components A tick will appear in the block of the component should you wish to amplify Amplification Playback speed 51 amp 52 Murmur Hat Normal Figure 5 The recording playback and amplification controls SNSS2 50 UMAN 003 docx Project Confidential Page 16 of 34 Patients My Patients AddNew Edit Delete Qy Smith Pete 730123 Last exam January 15 2014 July 07 1999 Figure 6 The current Patient List All the patients created within SensiCardiac will be displayed in the My Patients list The following functi
20. onic stethoscope Consult the user manual of this stethoscope for optimal performance SNSS2 50 UMAN 003 docx Page 5 of 34 1 3 Contra Indications for Use SensiCardiac is not a diagnostic tool but an aid for the physician in making a diagnosis while taking into account the whole medical history of the patient SensiCardiac is not to be used in a noisy environment Care should be taken that no external noise could influence the sound recording of the electronic stethoscope SensiCardiac should not be used on patients where the physician has difficulty to auscultate with an electronic stethoscope obese patients and patients with pulmonary noise 1 4 Precautions amp Warnings 1 4 1 SensiCardiac General Warnings A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death These warnings pertain only to the SensiCardiac software WARNING The information in this manual is a comprehensive guide to the operation of SensiCardiac For best results read this manual thoroughly before using the device WARNING SensiCardiac is designed for medical clinician use Only a trained clinician who knows how to auscultate should use this device WARNING SensiCardiac is not intended for use in environments that are not under the supervision of a health care practitioner WARNING SensiCardiac is not intended for contin
21. ons are available A new patient could be created Recordings could be performed ata later stage Existing patient information could be edited An existing patient could be deleted Session Procedures i Smith Pete Delete December 03 2013 Aortic Pulmonary Tricuspid Mitral 4 56 PM January 15 2014 Aortic Pulmonary Tricuspid Mitral 8 39 AM Figure 7 The patient session history All previous recording session will be displayed By selecting a session the session information will be loaded with the findings A selected session could also be deleted SNSS2 50 UMAN 003 docx Page 17 of 34 4 The auscultation sequence wizard The wizard bar contains all the steps to complete an auscultation sequence The steps have to be done in sequence to be completed successfully To start an auscultation sequence select the Start tab This could also be used to perform a new auscultation sequence for an existing patient Figure 8 The auscultation quick links 4 1 Start Auscultation The following window will appear on selecting the Start Auscultation tab Wizard Start New patient and session Patient Smith Pete Add new session Figure 9 The first form of the auscultation wizard Select SNSS2 50 UMAN 003 docx Project Confidential Page 18 of 34 e New patient and session if you want to perform the auscultation procedure on a new patient e Add new session if you want to add an auscultation pro
22. ows you to access the stethoscope pairing and connection settings SNSS2 50 UMAN 003 docx Project Confidential Page 26 of 34 6 Troubleshooting 6 1 Installation See the Getting Started part of this manual for troubleshooting after installation or at start up for the first time 6 2 Sound Recordings No recording of heart sounds Heart sound not recorded Heart sound signal saturates maximum and minimum Re installing SensiCardiac after evaluation period expired Not enough beats detected Program crash while setting sound properties within Windows Vista amp 7 When a recording fails or has an incorrect result SNSS2 50 UMAN 003 docx Open the sound properties and set the record settings for the audio device to default Set the recording volume level to 100 Set the recording sample rate and bit rate to 2 channels at 16bit 44kHz or 44100HZz SensiCardiac should be restarted since changing the driver settings halts the program For help changing these settings see http support microsoft com kb 935309 If you uninstall SensiCardiac after using it for the evaluation period and re install SensiCardiac again the evaluation period will remain expired Not enough heartbeats were recorded due to the fact that the heart rate may be slow and the recording duration to0 short Increase the recording duration Windows shows a warning that this might happen Devi
23. sensicardiac com and register as a user After successful login into your SensiCardiac user account subscribe for one of the subscription packages If you select the Free option you will be able to use SensiCardiac for 1 month 2 4 Log into SensiCardiac Within the SensiCardiac software use the username and password you create on sensicardiac com to login into the program SNSS2 50 UMAN 003 docx Project Confidential Page 10 of 34 Server Login Figure 1 SensiCardiac PC login screen If you are not a registered user select register and follow the instructions SNSS2 50 UMAN 003 docx Page 11 of 34 2 5 Stethoscope Set up 2 5 1 Pairing Your Littmann 3200 Littmann 3200 Setup Stethoscopes M3200 0009070000195120 M3200 0012050000873109 4 i pac Eem Se Figure 2 The Littmann 3200 set up window The computer s internal Bluetooth device or the external USB Bluetooth device shipped with the stethoscope could be used For optimal connection results the external Bluetooth device is recommended These windows are only relevant for the SensiCardiac with Littmann 3200 software After start up the Littmann 3200 Set up screen will appear If you have a new stethoscope and have not paired your computer with this stethoscope before select the Pair button and follow the instructions displayed e Press and release the M button on the stethoscope e The stethoscope s main menu will display SN
24. th the device and available through a legal supplier The use of accessories other than those specified may result in degraded performance or unsafe use of the software Caution Portable and mobile radio frequency RF communications equipment can affect the performance of the Bluetooth interface SNSS2 50 UMAN 003 docx Page 7 of 34 1 4 3 System Requirements To run SensiCardiac your computer system must meet the following requirements e Windows 7 or 8 32 64 bit e Minimum RAM 1 GB 2 GB recommended e Intel Pentium 4 compatible e 1024 x 768 graphics display or better e 40 Mb open hard drive space e Audio Interface o Internal or external Bluetooth connection for the SensiCardiac with Littmann 3200 model 1 4 4 Required Accessories Littmann 3200 Electronic Stethoscope For audibility of the heart sounds use headphones of good quality with a frequency range from 20 Hz to at least 10 kHz or higher 1 4 5 Privacy Statement The software is used to store personal clinical and medical information The use storage and disclosure of information submitted created or stored for the application of this software either electronically or otherwise is subject to all international national state provincial and local laws practices and regulations that are applicable to you in particular laws practices and regulations relating to privacy and data including the use storage disclosure and transmission of individually i
25. uous monitoring and must not be used as such Where continuous monitoring is required the appropriate equipment must be used WARNING To ensure patient safety use only accessories and supplies recommended for or supplied with SensiCardiac SNSS2 50 UMAN 003 docx Project Confidential Page 6 of 34 WARNING Do not use the SensiCardiac during magnetic resonance imaging MRI scanning WARNING Carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNING This device captures and presents data reflecting a patient s physiological condition When reviewed by a trained physician or clinician this data can be useful in determining a diagnosis However the data should not be used as the sole means for determining a patient s diagnosis or prescribing treatment 1 4 2 SensiCardiac Precautions A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss These cautions pertain only to the SensiCardiac software Caution If the accuracy of any measurement is in question check the patient s vital sign s with an alternative method and then check to verify if the device is functioning properly Caution For proper patient electrical isolation only use a computer isolated from the supply mains Caution Use only parts and accessories that are supplied wi
26. y again connected to and restart the application The stethoscope is already connected Select a different stethoscope Stethoscope battery level is low Replace the stethoscope battery Could not find the computer s The Bluetooth device was not detected Make sure Bluetooth antenna Make sure it is plugged into the computer oe EM POOR Mn niall DNG If computer s internal Bluetooth device is used in and Bluetooth is enabled verify that it is switched on Busy connecting please wait This may take a few seconds please wait Please select a stethoscope Select one of the stethoscopes listed SNSS2 50 UMAN 003 docx Page 31 of 34 Another stethoscope is already Terminate or disconnect current connection before connected attempting new connection Table 4 List of possible Bluetooth communication error messages 6 6 Warning Messages Warning Messages Reasons amp Actions Heart sound probably not The heart sound signal amplitude is detected as very audible check connectors soft If the heart sound is not audible re record the signal Heart sound distortion The heart sound signal amplitude is detected as very volume too loud loud If the heart sound is clipped re record the signal The software evaluation You did not register your software or obtained a valid period has expired You may product Product Key and Activation code continue using the software You will not be
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