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Research Manual (SCOR)

1. All Files Time Remaining 0 minutes 11 seconds Page 24 Step 9 When the software installation is finished the Installation Complete screen will appear Click Finish to exit the set up process SphygmoCor Cardiovascular Management Suite has been successfully installed Press the Finish button to exit this installation Cancel Page 25 4 2 INSTALLING USB ADAPTOR FOR WINDOWS XP WINDOWS 7 DRIVER INSTALLATION Step 1 step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Insert the SphygmoCor Installation CD and cancel the automatic SphygmoCor software install wizard Plug the USB to Serial Converter into a USB port at the rear of your computer Make sure that the Electronics Module is NOT connected Add New Hardware Wizard is activated Windows 7 may find the driver and install automatically Select Install from a list or a Specified Location Click Next to Continue Select Search for the Best Driver in these Locations Select Search Removable Media Floppy CD ROM Click Next to Continue Follow the prompts to complete the installation MANUALLY CONFIGURING SPYHGMOCOR Step 1 step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Step 8 Step 9 Step 10 Step 11 Step 12 Step 13 Step 14 Step 15 Step 16 Step 17 Right click MY COMPUTER and select properties Select the DEVICE MANAGER Tab For XP Select the Hardware Tab then DEVICE MANAGER
2. SphygmoCor AT THE HEART OF CARDIOVASCULAR MANAGEMENT Research Applications Manual Central Blood Pressure Using Pulse Wave Analysis Arterial Stiffness Using Pulse Wave Velocity Heart Rate Variability Continuous Central Blood Pressure Measurement Page i COPYRIGHT SphygmoCor Central Blood Pressure Assessment Pulse Wave Velocity Assessment Heart Rate Variability Assessment Continuous Central Blood Pressure Assessment Copyright 2010 AtCor Medical Pty Ltd Sydney Australia All rights reserved Under the copyright laws this manual cannot be reproduced in any form without prior written permission of AtCor Medical Pty Ltd DCN 101181 Rev 1 1 SphygmoCor Software Version 9 0 Head Office AtCor Medical Pty Ltd wal West Ryde Corporate Centre Suite 11 1059 1063 Victoria Rd C West Ryde NSW 2114 0120 Sydney Australia Telephone 61 2 9874 8761 Facsimile 61 2 9874 9022 Email inquiry atcormedical com Web www atcormedical com USA Office and US FDA Agent AtCor Medical Inc One Pierce Place Suite 295 East Itasca IL 60143 USA Telephone 1 630 228 8871 Facsimile 1 630 228 8872 Email atcorusa atcormedical com European Authorised Representative REP Advena Ltd Thorne Widgery House 33 Bridge Street Hereford HR4 9DQ United Kingdom Telephone 44 845 094 3307 Facsimile 44 0 156 862 0078 Page ii DISCLAIMER This manual has been validated
3. System Settings Check Module udy Report Find Module po Patient ID Database Manager Database Export As Text Printer Setup Epost In Database Batch Print SE Pack Exit Step 2 The SphygmoCor Export to Database window will open Choose the start and finish dates and click Get Studies The list of available reports will be displayed from the dates that you have selected Step 3 Select the studies from the Available Studies for Export panel and click on the study to highlight it To highlight more than one Study use the normal Windows conventions for highlighting multiple items in a list SphygmoCor Export To Database Select time window to select studies from A ae Selected Studies for Export 07 Jan 2010 21 47 42 Doe Jane Use these buttons to select individual or all studies LR 01 Feb 2010 12 42 38 West John 01 Feb 2010 15 35 57 West John Use these buttons to de select individual or all studies Ne Export All Export Selected Step 4 When you have completed your selection of studies click on the Export Selected button If you have previously exported a database you will be prompted to replace the existing database If you select yes a new database will be created If you select no the selected studies will be merged with the existing database Step 5 A notification window appears with details of your export to database The exported database will be located in
4. Com mation 5 4 2 SELECTING AN EXISTING PATIENT FROM THE DATABASE To identify previously entered patients within the database you may use either the Search or Patient tabs Using the Search tab enter the known patient details into any of the search fields Patient ID First Name Family Name and or Date of Birth Click Search The Search screen requires the patients complete name ie partial spelling of the name will not yield any results If only one 1 patient is found the patient will automatically be selected and the details will appear on the main portion of the patient screen e If multiple patients are found from the search criteria a list of patients will appear and you should select the correct patient by clicking on the corresponding row containing the patient s information Using the Patient tab you can select a specific patient by clicking on the row relating to that patient Note that the list of patients contains all patients in the database and may therefore be very long Use the scroll bar at the bottom of the search field to bring the other list headings into view Patient ID First Name Family Name Date of Birth Right Click on the patient list select Sort By and then Patient ID Date of Birth First name or family name to sort the list in alphabetical or numerical order Page 33 Use Search tab to enter a nll patient details Patient Search Patient ID Last Marne Fast Mama
5. Click on the Capture button to proceed 9 6 2 RECORDING PRESSURE AND ECG WAVEFORMS After entering the Data Capture Screen a horizontal trace will move across the screen in both the waveform windows The main window displays the last 5 seconds of data and the bottom window displays the last 11seconds of data IMPORTANT The SphygmoCor ECG cables and leads are designed for use with the SphygmoCor electronics module and should not be used with any other ECG device Only ECG cables supplied by AtCor Medical should be used with the SphygmoCor electronics module do not use any other ECG cables with SphygmoCor electronics module To maintain a clear noise free ECG signal avoid exposure to other medical equipment emitting large amounts of electronic noise eg MRI scanner X ray equipment etc The PWV measurement is taken in two steps a tonometry reading at Site A typically at the carotid artery followed by a subsequent tonometry reading at Site B typically at the femoral artery with an ECG signal simultaneously recorded ECG and tonometer placement and capturing the waveforms Ensure the ECG signal is free of noise and that the R wave on the ECG trace is the highest amplitude at each cardiac pulse You should make any adjustments necessary now to your ECG electrode placement to ensure a good quality signal The carotid measurement should be taken first e With the patient in a supine position the patient s head should be
6. Date OF Birth for Janry 1850 Search Reset to complete the Patient File Summary au Search Nuber OF Studies J Fee Study 23 Mew 2009 0527 Last Study 23 Mee 2009 09 31 Time Zeg Lang Study Paeis Search Patient Search Patient LastName foe OR Feste Data Of Birth 01 January 1850 Search Reset pre H multiple patients NS found click on the N required patient from the list of Patient File Summary EEN patients Number Of Studies D First Study n Lag Study ala Tene Since Last Siudy Use Patient mm tab to list all nt patients in Patients 2 the database Date Of Barth A Click on the desired patient Use scroll bar to see other search fields Patient ID Last Name First Name Date of Birth w 5 4 3 EDITING OR DELETING AN EXISTING PATIENT When the software is first opened the Patient screen will display in Browse mode To be able to edit a patient s details or delete the patient and their reports from the database you will need to enter the Edit mode Click on the Edit button When you have finished editing the patient information click the Browse button to return the software to Browse mode To edit the patient s details place the curser in any of the patient detail fields and make the required changes or additions Once a change is made to any field the Save and Cancel buttons will become active Click Save to
7. Would you like to try and detect the Electronics Module again No If the software is unable to establish communication with the electronics module a Warning window will appear If you require the software to communicate with the electronics module rather than work offline click Yes Warning Electronics Module Not Found Check the Electronics Module is connected bo Power Check the Communication Port connection Would you like to select a different Communication Port Ves No The SphygmoCor Configuration window will appear to allow you to select the Comms port Refer to Section 6 1 for more information on the SphygmoCor configuration settings Alternatively you can click No and then use the Find Module feature When the software opens select System then Find module from the main menu The software will automatically search all available communications ports on the computer to locate the electronics module A note will appear at the bottom of the screen indicating that the module has been found NOTE The Find Module procedure should only be used the first time you connect your electronics module Once the module has been successfully located you can select System then Check Module to test if communications are established If the message appears Module Not Found then refer to the troubleshooting section 7 5 2 Page 27 5 2 RECOMMENDED SPHYGMOCOR CONTROL CONDITIONS FOR STUDY PROTOCOLS To perform a Sphyg
8. Ea Link to Web Support C Browse Manuals Latest Clinical Articles SphygmoCor C Browse CD Version 9 Research Version AtCo www atcormedical com MEDICAL Step 2 When the Software License Agreement screen appears read the Terms of the Agreement and select Agree to continue the installation Software License Agreeme ms The Licence to use the SphygmoCor r software is conditional upon the customer hereafter referred to as you agreeing to the terms and conditions of this Software Licence Agreement You must not install or otherwise use the SphygmoCorfr software whatsoever until you have read and accepted all of the terms and conditions of this Software Licence Agreement and wish to become licensee ofthe software Acceptance shall bind you and all of your employees contractors and agents to the terms Installation or any other use of the SphygmoCorfr software by you will be deemed to be your acceptance of the following terms and conditions Ifyou do not wish to accept the terms and conditions of this Software Licence Agreement please return the software to AtCor Medical and any license fee you may have paid will be refunded to you Grant of License AtCor Medical grants you nonexclusive nontransferable license to use the enclosed program the Software according to the terms and conditions herein This License Agreement permits single user to use the Software on only one computer at one location at any one
9. If any of these criteria are not met regardless of the system s quality control parameters the recording should be repeated and strong consideration given to not retaining the data T1 Detailed Screen 80 ms lt T1 lt 150 ms Minimum Average Pulse Height Clinical Screen 80 units Maximum Pulse Height Variation Clinical Screen 5 Maximum Diastolic Variation Clinical Screen 5 Minimum Quality Index Clinical Screen 80 Augmentation Index Clinical Screen lt 50 Examples of typical good quality radial waveforms The detailed screen shows the 9seconds of recorded and analysed waveforms see Figure below These can be examined to assess overall consistency of the waveforms The series of waveforms should have consistent peaks and troughs and the contour of the waveform in particular the peak pressure and shoulder should be identical Captured raw peripheral top displayed with the derived aortic waveform bottom RADIAL RADIAL RADIAL RADIAL RADIAL mmHg S o 80 ey ee VEE EN TA BA G Ce LES ESCH FEN e Zn aR EEE 2 EN ees e EE ee ME 20 year old 30 year old 40 year old 50 year old 70 year old Radial waveforms of people with different vascular ages note that chronological age may differ substantially from vascular age Examples of poor raw waveform data The captured waveforms and their respective waveform overlay show some common examples of poor quality w
10. Practical Tips In order to meet the requirements for natural frequency and damping coefficient it is suggested that the following tips be followed O Minimise the length of the fluid filled catheter m Do not use soft tubing R Follow normal good practice to eliminate possibility of air bubbles in the fluid line m If the BP monitor has signal conditioning options for the pressure signal check that the most appropriate option is being used Page 66 7 Appendix 7 1 L t WARRANTY The SphygmoCor System excluding the tonometer is supplied with a full parts and labour warranty The length of this warranty varies based on statutory requirements in each country contact your distributor to determine the warranty for your device Any parts that fail during this warranty period will be repaired or replaced without charge at the discretion of AtCor Medical This excludes any damage to the instrument arising from operational wear and tear or from misuse The tonometer has a 120 day parts and labour warranty Service and technical support for the SphygmoCor system will be provided by AtCor Medical technical support group in Sydney with delivery to from Sydney by our international door to door courier service PRODUCT SUPPORT If you have any questions about the operation of your SphygmoCor System first consult the Operator s Manuals If you have additional questions after reviewing the manual contact your local A or M
11. Refer to individual flowchart for each mode Page 28 0 3 2 CENTRAL BLOOD PRESSURE MEASUREMENT USING PULSE WAVE ANALYSIS PWA PATIENT SCREEN Create New Patient Select Existing Patient using Search or Patient Tab Enter Last h ame First Mame DOB Sex Search by Patient ID Last Mame First Name DOB PWA STUDY SCREEN Obtain brachial blood pressure Enter SBP and DBP Click Capture measurement and height if reference age required jor press enter on keyboard PWA CAPTURE SCREEN Place tonometer over strongest pulse of radial artery Adjust tonometer to obtain consistent waveforms press lightly until a signal appears on screen using Guidance Bars for assistance Aute C h Or overide autocapture with spacebar on uto te ae e se edle 1 keyboard or foot pedal ee after 11seconds of quality wavefonms PWA REPORT SCREEN Review Quality Control Review patient report Print or Export Patient Results Use Repeat button to repeat if desired measurement f needed PWA ANALYSIS SCREEN ADVANCED FEATURE Review key measurements Print or Export Patient Result requires multiple studies amp waveforms available if desired Page 29 5 3 3 ARTERIAL STIFFNESS MEASUREMENT USING PULSE WAVE VELOCITY PWV PATIENT SCREEN Create New Patient Select Existing Patient using Search or Patient Tab Enter Last Name FirstName DOB Sex Search by Patient ID Last Name First Name DOB PWV STUDY
12. To select a different database than the one that is currently active click on the name of the database you wish to open it should now be highlighted and click on the Select button Click OK to open the database Remember to check on the bottom of your screen for the Active Database and confirm the one listed is the correct one Database Warning Do not open the SphygmoCor database with any other program as it may corrupt your data All database interactions should be performed using the SphygmoCor software For further advice contact AtCor Medical Product Support Page 60 6 4 2 6 4 3 6 4 4 Use the file manager to Enter name for the new database and a description of the database Click on Create New button This button will become active as soon as the name and description fields are completed The new database appears in the list and will be automatically selected the Description field and click on the Select button Use the drop down menu to select the drive locate a folder CREATE A NEW DATABASE Enter the name of the database you want in the Name field Spaces are not allowed Enter a description of the database in the Description field then click the Create New button to create the new database The new database will automatically be selected SphygmoCor Multiple Database Manager Description Defined Databases Selected Database EE DRJONES DATABASES Description diabetes clinic Date
13. o eet zm o J 3 E e o V2 E 9 lt O 1D lm 5 O z o 3 315 mip Ic m Z gt gt Z a SS 3 m Lee m 8 m Z O Se Z x lt Entered Diastolic Pressure Entered Mean Pressure Math s Data Revision SS End Date amp Time of Study Patient s Age on Date of Study m Body Mass Index Raw Data Sample Rate Ratio of Maximum to Minimum R to R Interval Difference between the Maximum and Minimum R to R Intervals Standard Deviation of R to R Intervals The most frequent R to R Interval Number of consecutive R to R Intervals differing by more than 50ms Percentage of consecutive R to R Intervals differing by more than 50ms METHOD Page 76 RV_TRIANGULAR_IND Number of Pulses Divided by the Maximum Height of the Histogram TINN The Width of the Histogram SEGMENT_LENGTH NUMBER_SEGMENTS Number of Segments S SDA Standard Deviation of the Means for each R to R Segment Segment Length in Minutes default 5 minutes RM Root Mean Square of the Difference of Successive R to R Intervals H D Mean of the Standard Deviations for each R to R Segment Highest Heart Rate Between the 5th and 25th Pulse During a Stand Manoeuvre SDNN Index Lowest Heart Rate Between the 21 STAND_HIGH STAND_LOW and 45 Pulse During a Stand Manoeuvre STAND_RATIO Ratio of Stand High to Stand Low VALSALVA HIGH Highest Heart Rate During a Valsalva SD NN Manoeuvre VALSALVA LOW VALSALVA_RATIO SPECTRUM
14. 09 29 42 23 Nov 2009 09 31 03 22 Jan 2010 19 50 14 27 Jan 2010 20 29 42 30 40 50 50 70 Operator Index Heart Rate Alert message area Displays the active database Click on Clinical tab to view the relevant report Aortic and brachial cuff blood pressure measurements Bar graphs of Aortic systolic pressure pulse pressure and augmentation in relation to population reference ranges Results are displayed in red if in the upper 5 of the normal Bar graph showing SphygmoCor Reference Age The blue bar is the patient s results e Aortic and brachial blood pressure measurements are shown for Systolic Pressure Diastolic Pressure Mean Pressure and Pulse Pressure The Aortic Pulse Pressure will be displayed in red if the value is gt 50 mmHg as central pulse pressure 2 50 mmHg has been shown to predict adverse cardiovascular disease outcomes Roman MJ Devereux RB Kizer JR et al High central pulse pressure is independently associated with adverse outcome The Strong Heart Study J Am CollCardiol 2009 54 1730 4 Page 38 e The patient s aortic Systolic Pulse and Augmentation Pressures are displayed on bar graphs The patients Augmentation Index and or Augmentation Index HR75 values are optional report settings refer to Configuration settings in Section 4 1 e The bar graphs indicate the normal range for individuals of the same age and gender at the pat
15. 5m 6ft away from the patient When using the SphygmoCor Electronics Module do not connect the power cable of the computer to multiple portable socket outlets or power boards which are connected to other devices Do not place the multiple portable socket outlet or power board on the floor while the SphygmoCor System is in use Do not connect any peripheral devices eg printer externally powered USB hubs to the computer while using the SohygmoCor System as they may breach the patient isolation requirements of IEC60601 1 amp IEC60601 1 1 When using an isolation transformer and a multiple portable socket outlet or power board to connect to the computer and the SphygmoCor System do not connect any other devices or equipment to the multiple portable socket outlet or power board When using the SohygmoCor System the operator should not touch the computer and the patient at the same time Do not connect or use any cables or sensors other than those specified for use with the SohygmoCor System Do not disassemble the SohygmoCor Electronics Module The SohygmoCor Electronics Module contains no serviceable parts Servicing shall be performed by qualified service personnel Only use accessories supplied or specified for use with this system Do not connect any device to the Auxiliary Input of the MM3 Module unless it is IEC60601 1 compliant or has patient isolation Contraindications General e Do not use mobile cellular phones or other
16. Connect the Tonometer s 12 pin socket to its matching 12 way connector in the module drawer Check to see that the orientation of the plug and socket is correct before connecting the two ends together The Tonometer is now locked into place DO NOT FORGE THE CONNECTORS TOGETHER MM2 Module MM3 Module Locate Connector Open Drawer After initialisation the READY light becomes orange you may now turn your computer on The READY light will change to Green when it first communicates with the SphygmoCor Software Step 2 You may now turn on your unit and commence the SphygmoCor software installation as described in Section 4 Page 18 3 2 3 PULSE WAVE VELOCITY These instructions only apply to the MM3 Module Step 1 Connect the Tonometer to the SohygmoCor Electronics Module The Tonometer will be connected to the module when factory shipped If it is not connected or you need to connect a replacement Tonometer and complete the following m Open the front tray and locate the Tonometer connector on the left Locate Connector Open Drawer QO Connect the Tonometer s 12 pin socket to its matching 12 way Panel Plug in the tray Check to see that the orientation of the plug and socket is correct before connecting the two ends together The Tonometer is now locked into place DO NOT FORCE THE CONNECTORS TOGETHER Step 3 Connect the ECG Cable Connect The ECG Cable to the connector labelled ECG on the front panel of the Module Ensur
17. Created 27 Jan 2010 DATA DRJONES DRSMITH Last Copied Copied To New Last Updated Updated From New Tas SphygmoCor Multiple Database Manaper Hame Description Defined Databases Selected Database 3 DRALLEN E DATABASES Description diabetes chte Date Created 27 Jan 2010 The description for DATA DRJONES gl Copied the new database DREMITH appears here Click the OK button to activate this database CHANGE THE DESGRIPTION OF AN EXISTING DATABASE Click on the name of the database you wish to change and click on Select Enter a new description in button This button becomes active once you press the COPYING A DATABASE You may wish to use this feature as a method of backing up your database or to transfer databases between computers Click on the name of the database you wish to copy and click the Select button When the Copy To window appears select the drive and folder to which the database is to be copied and click Ok Copy To Curent DAProgram FilesAtConsphygmotor Cvs ai d local xp sp3 ka Di gt Program Files a AtCor eee amp data Gate Click on the OK button a after you have selected the E system location for the database Caution When copying a database use caution when selecting the location to prevent copying over an existing database If this occurs the database will be corrupted and the records will not be recoverable 6 4 5 UPDATING A DATABAS
18. D weight Ml kg pressure gt TR er TERE Body Mass Index kg m measurem ent 0 r mean and diastolic Operator Enter additional information as required The patient s height must be entered in gt order for the SphygmoCor Reference Age to be ralrilated Select site for PWA measurement Check this box to enable data output from the electronics module during data capture Enable Output Mi Click on the Capture Data button when ready to proceed with the measurement The carotid transfer function has not been approved for clinical use in the USA The Carotid artery blood pressure waveform can be used in Aortic No Processing studies as an estimate to the central waveform When Aortic check box is selected no processing is done to the captured waveform 9 0 2 RECORDING A PRESSURE WAVEFORM CAPTURE DATA After entering the Data Capture Screen a horizontal tracing will move across the screen The main window displays the last 5 seconds of data and the bottom window displays the last 11 seconds of data Refer to Section 7 4 for information regarding acceptable PWA measurements Placement of the tonometer Placement of the tonometer is important to ensure quality waveforms e Remove the tonometer from either the tonometer storage tray or the temporary holder on the top of the electronics module Hold the tonometer base gently but firmly between the tip of your thumb and the fingers e Locate the patient s rad
19. Delta T Rejection Algorithm When the waveform signal processing has been completed and the Patient Report parameters have been calculated the data is passed to the Delta T Rejection Algorithm The algorithm reviews the beat to beat time differences Ats and rejects the data with extreme time variances according to the following procedure Calculate SD with recorded Ats Discard any At that is not within 90 of the SD Distribution Curve Re calculate SD using accepted Ats All the At onset pairs inside the 90 are labelled eon the Pulse Wave Velocity report while the rejected At onset pairs are labelled Page 45 5 6 3 2 REVIEW PATIENT S RESULTS The patient s results are presented in two ways on the PWV report e The pulse wave velocity value is displayed as PWV SEM standard error of the mean and is in metres second m s In general higher pulse Wave Velocity values are associated with stiffer arterial blood vessels Note The Normal ranges are based on a paper by McEneiry et al Therefore the values for normal range are only valid if the distance has been measured by subtracting the sternal notch carotid measurement from the sternal notch to femoral measurement 0 6 3 3 CREATE PWA MODIFY DELETE EXPORT AND PRINT The carotid waveforms and radial if performed of a particular measurement can be used to create a PWA report To do this click on the Create PWA button A confirmation window will appear click on the Ye
20. desired Proximal Body Mass Index kg m of 2 measurement Change the capture settings if required 10 sec Default is a carotid femoral i 20 sec measurement and capture Fomai D t 30 sec times of 10 seconds at each e PWV Algorithm Check this box to Enable Output M Pulse Height percent Select algorithm for PWV enable EE Sve ape is ee te Intersectin to the electronics Maximum 2nd Derivative tan ents is ie module during data g capture recommended setting Capture Data Active Database DATA Enter the diastolic and systolic blood pressure values or mean and diastolic values if available that have been obtained from the cuff sohygmomanometer or automatic blood pressure device Enter additional information into the study screen as desired Note Multiple methods exist for measuring the distance between the aorta and femoral artery for non invasive pulse wave velocity Itis recommended that the measurement be taken in a direct line between the supra sternal notch and the carotid artery for site A and then the supra sternal notch and the femoral artery for Site B The use of callipers is recommended in obese patients and in pregnant women In some instances you may need to position the tonometer in a different location than was used for the initial measurements In this instance you can re measure the proximal or distal distance and enter the new measurements after the reading has been performed
21. interval will be rejected when it is un characteristically too high or too low compared to previous intervals e The Histogram shows the frequency distribution of R to R intervals for the whole recording Page 54 e The Poincar Plot visually displays the scatter of adjacent R to R intervals e Three sets of statistical parameters are displayed o Key parameters Heart rate RMSSD HRV Index and PNN50 o HRV time parameters statistical values for the R R intervals of the whole recording o Segmented data parameters are calculated by dividing the whole recording into 5 minute segments This data is only available on recordings greater than 10 minutes Frequency Domain Analysis Frequency Domain Analysis assesses the ECG signal with respect to frequency rather than time as in time domain analysis Spectral analysis is performed on a series of R R intervals which separates the heart rate spectrum into various components and allows the quantification of sympathetic and vagal influences on the heart The Frequency Domain Report screen frequency tab provides the power spectrum graph showing a plot of R R interval signal power at various frequencies frequency pie chart showing the balance between LF and HF activity and the statistical parameters calculated from the power spectrum Click on the Frequency tab to view the Frequency Domain Analysis report SphygmoCor Cardiovascular Management Suite System Patient Study Rep
22. limbs as indicated on the lead wires Note Do not reuse electrodes Used and or dry electrodes will provide poor ECG signals For optimal ECG lead application prepare the patient s skin by wiping with an alcohol wipe Before applying the electrodes you may need to shave the area if excess hair prevents the electrodes from sticking Page 41 e Remove the tape from the back of the electrode and apply the electrode to the skin in either peripheral archest location as required and attached the leads as shown in the following diagram Place electrode on inside of wrist and connect left arm LA lead black clip Place electrode on inside of wrist and connect right arm RA lead white clip Place electrode on left leg above the ankle and connect left leg LL lead red plug Peripheral Limb Configuration Place electrode just below supra sternal notch and connect right arm RA lead white Place electrode on chest over sternum and connect left leg LL lead red plug klin Place electrode just above the left hip and connect left arm LA lead black clip Chest modified Lead II Location Allow the patient to rest approximately 5 minutes before taking a brachial blood pressure measurement to ensure heart rate and blood pressure are stable CAUTION ECG ELECTRODES Electrodes with dissimilar metals should not be used with this device The difference in potentials will cause polarisation an
23. measurement after Stand Manoeuvre The system uses a 3 lead ECG connected to the electronics module to non invasively record a continuous ECG waveforms From these measurements the SohygmoCor software is able to calculate parameters spectral and temporal related to ANS 24 THE SPHYGMOCOR PULSE WAVE MONITORING ASSESSMENT SYSTEM The SphygmoCor Continuous Aortic Blood Pressure Monitoring System enables continuous real time derivation of the aortic pressure waveform Key cardiovascular parameters are sampled every 5 seconds and trended The system allows reports to be generated at regular intervals or whenever required The SphygmoCor Continuous Aortic Blood Pressure Monitoring System utilises a continual radial artery pressure waveform input from either a radial artery catheter and blood pressure monitor or a non invasive radial artery pressure waveform monitor calibrated or non calibrated Page 14 3 Setting Up amp Hardware Installation 3 1 UNPACKING THE SPHYGMOCOR SYSTEM Carefully un pack your SphygmoCor System See the picture below for un packing the System 2 Remove the Electronics Module from the foam packing then remove the protective plastic bag 2 The Tonometer is pre packed in the tray of the module Remove any tapes securing the tray and Tonometer D A smaller carton contains all the accessories included with your system 3 1 1 COMPONENT CHECKLIST Confirm that you have received all the following items in you
24. of an electrocardiogram the numerical values given need to be checked visually according to quality of data entry and to physiological principles As an aid to deciding acceptability the SphygmoCor report contains the following features e The train of waves to be analysed is shown together with the reference point wavefoot for ensemble averaging The waves selected are overlaid in relation to the reference point and the variation in pulse height diastolic pressure pulse length variation and shape deviation is calculated and displayed These should correspond to respective variations normally less than 6 through one respiratory cycle Also shown are internal calibration and dP dT maximum for reference Low dP dI maximum less than 350mmHg sec indicates likelihood of stenosis of an artery between aorta and radial or artefact e On the ensemble averaged radial and aortic waves time and pressure markers are shown to indicate where physiologically important landmarks have been identified as follows a Ejection duration is calculated from the wavefoot to the incisura which marks the end of ventricular ejection and is identified by a vertical flagged line This should immediately precede an inflection on the radial pulse and normally corresponds to a slight inflection on the synthesised aortic pulse Ejection duration is inversely related to heart rate and normally varies from 250 4000msec Time T is identified by a marker diamo
25. of the AI P R P P T x100 reflected peak indicated by the second i i peak shoulder T2 with respect to the primary peak indicated by the first peak shoulder T4 Page 78 Primary Wave Pressure at The difference between the minimum pressure and PpP P H mmHg T the pressure at the 1st peak shoulder T4 i l Mean Pressure in Systole MP Sp ED mmHg Diastole This is the mean pressure between T to ED during K systole MP Sp i Tp n MP Dp gt This is the mean pressure between ED and the MP Dp end of the averaged pulse Tr during diastole End Systolic Pressure This is the pressure at the end of systole the ESp PED mmHg pressure at ED Buckberg Sub Endocardial Ratio of Diastolic Area min and Systolic Area min SEVR Viability Ratio Ad As Systolic Area min Tension Time Index TTI rm Diastolic Area min Diastolic Time Index DTI where TTI HRx MP Sp x ED T DTI HR x MP Dp x T ED 7 9 MAINTENANCE The SphygmoCor System does not require any regular maintenance service For repairs refer to qualified service personnel as instructed by AtCor Medical The device does not contain any serviceable or reusable parts Disassembly of the device by unauthorised personnel voids any warranty conditions Basic System Care Stability Place the Electronics Module gently onto a stable bench or trolley top Dropping the unit on to a desk can cause damage and result in the uni
26. one ov fan pp 0 00 00 0 gt ae RENE K ETE NE E E HR Graph D Heart Rate bpm NE E ee mr ee ee a ee ee et ee a ae ET KELGEEEEEGEEEEEEEEEEGSEEEEEECEGEEEEEEEEECEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEEGEEEEEEEEEEGEEEEEEEEEE aaa aaa STAND HIGH 91 bpm Stand Ratio Normals STAND LOW 69 bpm STAND RATIO 1 32 Capture Time 00 01 00 Number of Pulses 76 f Average Heart Rate 76 bpm Mean R to R 785 ms R to R Range 247 ms Abnormal population range for Stand ratio Active Database DATA Key Parameters Patient s Stand ratio with respect to age e The Stand Manoeuvre Graph shows beat to beat Heart Rate values of the Stand Manoeuvre recording e The Clinical Normals Graph is a plot of the Stand Ratio against the population normals Results in the white area are normal while the shaded area is below normal e An inconclusive message appears when 50 or more of the recorded R to R intervals were rejected because of abrupt changes in R to R intervals due to either noise or ectopic beats An inconclusive report should be discarded and the measurement repeated 5 10 SHOW ECG MODIFY DELETE EXPORT PRINT e The raw ECG signal last 3 minutes can be viewed on the time tab sheet of the HRV Calculation report the Valsalva Manoeuvre report and the Stand Manoeuvre report The signal is displayed by clicking Show ECG and hidden by clicking Hide ECG e Study details can be modified at this point in
27. respect to the normal Vagal Index Click on the Clinical tab to view the report Patient Information PA Patient ID Study Data 04 Mar 2010 8 12 11 PM SpiDp Mp Birth Date 02 Jan 1950 Age 60 Sex MALE Patients RMSSD value with respect to age Study Information Height Weight BMI Medications Normal Vagal Index range Notes Abnormal Vagal Index range Study Time 404 Mar 2 04 Mar 2010 20 12 11 04 Mar 2010 20 42 07 04 Mar 2010 20 54 16 04 Mar 2010 21 16 41 90 95 A D 10 De Page 55 e The Clinical Normals Graph is a plot of RMSSD against the population normals Values inside the coloured area are below the population normal Note The Clinical Normals Graph is only available on recordings of greater than 5 minutes e An Inconclusive message will appear at the bottom of the screen when o 50 or more of the recorded R to R intervals are rejected due to abrupt changes in R to R intervals due to either noise or ectopic beats o RMSSD more than 200 bom o PNN50 above 75 An Inconclusive report should be discarded and the measurement repeated 9 9 2 VALSALVA MANOEUVRE The most accurate way of assessing the Valsalva Manoeuvre is to assess changes to both heart rate and pulse pressure Most commonly the Valsalva manoeuvre is assessed by using the Valsalva Ratio which only observes changes in heart rate and thus has the benefit of eliminating the need for an arterial line T
28. taken using a manual or automatic sphygmomanometer The patient should be sitting or lying comfortably and allowed to rest approximately 5 minutes prior to taking the brachial blood pressure measurement to ensure stable haemodynamics At least2 minutes should elapse between taking the patient s brachial blood pressure and recording a pressure waveform using the tonometer e Enter the diastolic and systolic blood pressure values or mean and diastolic pressure if applicable obtained from the brachial blood pressure measurement in the corresponding fields on the Study Screen e Enter information in the Medication Notes and Operator field if required If the SphygmoCor Reference Age calculation is desired height must also be entered see Section5 5 3reviewing the patient report e Select the site of measurement by checking the relevant box radial carotid or aortic If either the radial or carotid boxes are checked the software will use the appropriate transfer function When the aortic box has been checked no processing is performed on the captured waveform e Check the Enable Data output box if output to external recording equipment is required during data capture Click on the Capture Data button to proceed Click on Study System en nt Stu dy Report FETE Help i button to enter patrene Analysis Privacy Sie systolic Be study details Patient Information i pressures from E ee ea brachial cuff blood Study Time
29. the Export directory with the filename Scor xyz 6 5 3 EXPORT ALL MEASUREMENTS FOR A PATIENT This option enables you to export all the Measurements for one Patient Note Waveform data is not exported with this option Step 1 In the Patient screen select the patient you require the measurements to be exported for by right clicking on the patient entry Page 64 6 9 4 6 6 Patients Search Patients 2 Patient ID Patient ID Date Of Birth 14 May 1976 Export Sort by Step 2 The Export window will open Use the Select button to choose the Windows folder and or file name for export Step 3 Click the Export button A progress bar shows you how much of the export has been completed At the end of the operation a status message appears in the Export window indicating how many records were exported Step 4 Click the Close button EXPORT A SINGLE REPORT FOR A PATIENT This option enables you to export a single report for a Patient Access this option from the Report Screen in the measurement mode you require Refer to Sections 5 5 3 3 0 and 0 for exporting a single report for a patient in PWA PWV HRV and PWM modes respectively FAST FLUSH TEST PWM MODE Catheter tubing transducer systems used in intensive care for frequencies less than 50Hz can be characterised by an underdamped second order dynamic system Second Order Systems A second order system can be characterised by three mechan
30. the recording in each type of HRV measurement click on the Start Session button The Add Marker and Abort buttons will become active once the session begins Use the Add Marker feature to electronically create a marker in the report to record a patient event during the measurement The Calculate button will appear after the minimum recording time for the measurement has been completed If you wish to cancel the measurement at any time and not save any data click the Abort button Click Start Session to start the HRV measurement Add Marker Calculate Abort Patient Name B A 00 02 10 904 66 Message alert area mf 5 ECG signal is refreshed every 5 earnnde Beat to Beat R R intervals chart extra data added every 5 seconds Verification of ECG Signal Quality Due to 50 or 60Hz mains power cables in typical operation environments the ECG signal is subject to mains artefacts Control circuitry in the ECG pre amplifier will eliminate mains artefacts if good electrical contact to the skin is made through the diagnostic ECG pads The presence of mains artefact indicates a problem with electrode application and the inability to obtain good electrical contacts to the skin The Left Leg Red electrode is the most sensitive electrode and is usually the source of mains artefacts To minimize artefacts ensure that the ECG cable is coiled and kept close to the patient IMPORTANT When using the system ensure it is ke
31. the studies click on the studies required and press the gt button or to select all studies press the gt button and then click Print Selected this button will become active when studies have been selected e For PWA reports the default report to print is the detailed report Check the Print Clinical Evaluations checkbox to batch print the clinical report The reference range reports are not available to be printed via batch printing Select a two week window ee After the start and end dates for studies to be selected for arog TEIE Set have been defined click the Sch S e Get Studies button to bring batch print SEN Available Studies for Printing GE Selected Studies for Printing up the studies performed within that timeframe H 07 J 010 21 49 oe Jane Studies performed within the Orden 2010 21 5215 D08 Jone nominated timeframe will appear here If individual studies are required click on the required study Studies selected for printing will appear here Ne Use these arrows to deselect individual studies or all studies Use these arrows to select individual or all studies for printing Check this box to print the Clinical report rather than gt FA Ten the detailed report PATIENT LISTING Using the Patient Listing feature you may obtain a list of patients in the current database with database Statistics To print a list of patients Step 1 Go to the Patient Screen F2 Ste
32. the unit Shutting down Do NOT switch the PC off until the SphygmoCor software and Windows have been exited Wait 4 seconds after turning the computer OFF before you turn it on again WARNING Exit the SohygmoCor software prior to shutting down your computer Page 79 Cleaning Instructions To clean the SphygmoCor Electronics Module first unplug the electronics module from the computer and using a damp cloth with mild detergent gently wipe the equipment If unsure of using a particular cleaning agent please contact AtCor Medical Ensure excess liquids or cleaning agents are wiped immediately from the equipment For further instructions on cleaning of the Tonometer refer to Tonometer Cleaning amp Disinfection section in this manual Notebook Batteries Ensure when using the SphygmoCor System on notebook computers running on rechargeable batteries that the batteries are fully charged Do not use the system on low battery power If the notebook is abruptly shutdown the SphygmoCor database may be corrupted Consult the notebook manufacturers user documentation regarding the safety and maintenance of the notebook rechargeable battery Tonometer Care The tip of the Tonometer is a delicate and sensitive device and can be easily damaged if dropped or misused Follow the guidelines below to ensure Tonometer lifetime is maintained Q When the tonometer is not in direct use with the patient protect the Tonometer by placing it in the module t
33. tilted slightly back and rotated laterally This is best achieved in the absence of a pillow Place tonometer over Place tonometer carotid artery for first over femoral measurement artery for second Page 43 measurement e Palpate for the strongest pulse point along the carotid artery and place the tonometer directly on top of the skin at this point e Ensure your forearm is resting on a stable surface to promote pressure and consistent measurement Do not rest your arm on patient chest as this will create artefact movements with his breathing e When you have a minimum of 11seconds of good quality waveforms click the OK button or press on the footswitch if used to capture the carotid measurement e A confirmation window appears to confirm readiness to proceed to Site B femoral artery If carotid measurement is acceptable click the Yes button otherwise click the No button to repeat taking a carotid measurement The femoral measurement is taken after the carotid measurement has been captured e The patient should be in a supine position and the patient s leg rotated laterally to expose the femoral artery Palpate to find the strongest femoral pulse e Place the tonometer directly on top of the skin and pressing down over the strongest pulse point to ensure a clear waveform signal e When you have a minimum of 11Seconds of quality waveforms click the OK button or press on the footswitch if use
34. time You may install and use the Software on your primary computer and make one additional copy for use on second computer you may have provided that 1 the additional copy is used only by you 2 Only one of the Software copies is in use at any one time at any one location and 3 the Software is not licensed and or labeled for educational Page 22 Step 3 Welcome to the SphyqmoCor Cardiovascular Management Suite CvMS Setup program This program will install the SphyqmoCor Cardiovascular Management Suite on your computer Itis strongly recommended that you exit all Windows programs and disconnect your Electonics Module from the computer before running this Setup Program Click Cancel to quit Setup and close any programs you have running Click Next to continue with the Setup program WARNING This program is protected by copyright law and international treaties Unauthorized reproduction or distribution of this program or any portion of it may result in severe civil and criminal penalties and will be prosecuted to the maximum extent possible under law Install Version 5 1 3 Cancel Step 4 On the Choose Destination location screen click Next to accept the suggested destination folder The default location is C AtCor SphygmoCor CvMS Vo To change the location enter an alternative folder name after the C AtCor directory Setup will install SphygmoCor Cardiovascular Management Suit
35. time by clicking Modify This allows the initial study details to be added or changed as necessary including making a change to or adding the cuff blood pressure values or adding additional information such as notes medication height and weight e The report can be deleted by clicking Delete A confirmation window will appear click Yes to delete the report and No to keep the report Note Only one 1 confirmation window will appear to ask if you wish to delete the report If you click on the Yes button the report will be deleted permanently Ensure you have the correct report and you are certain you wish to delete the report before proceeding e The Report screen can be exported as a graphic jpeg or a text txt by right clicking on the export button and selecting As text or As graphic from the pop up menu Clicking Export defaults to saving as a graphic file Click on the Select button to select the drive and folder on your computer to save to and click Export e To print a report click Print You may wish to select System then Printer Setup from the main menu first to select a printer To print a number of reports at the same time refer to Section 6 2 Page 57 6 Advanced Features 6 1 SPHYGMOCOR CONFIGURATION SETTINGS The SphygmoCor configuration window allows you to make modifications to report settings such as units of measurement from imperial to metric and enable or disable Guidance Bars and Auto C
36. transmitting devices within 10 metres 30 feet of the SphygmoCor System e The SphygmoCor System should not be used for patients with erratic accelerated or mechanically controlled irregular heart rhythms including patients with arrhythmias The SphygmoCor System should only be used with an AtCor Medical supplied Tonometer Do not use the Tonometer on moist or wet skin Do not use the SphygmoCor System on patients with aortic valve stenosis Any interpretations made from the SphygmoCor System measurements should be made in conjunction with all other available medical history and diagnostic test information about a patient e Since peripheral vasodilatation caused by arterial obstruction alters brachial wave transmission at least two minutes should elapse after use of the cuff sohygmomanometer before radial pressure waveform recordings are taken e Note additional warnings printed on the Electronics Module Central Blood Pressure PWA LI Tonometry should not be used on a patient s arm if there is a fistula present O The system is not applicable in generalised constriction or localised spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Reynaud s phenomena or intense cold 02 The SphygmoCor system should not be used on persons with significant aortic valve stenosis gradient gt 60mmHg Page 12 Pulse Wave Velocity PWV amp Heart Rate Variability HRV EC
37. using the patient s limbs as indicated on the cables Page v Step 4 Click the Capture Data button to proceed with the measurement The PWV measurement is taken in two steps A tonometry reading at Site A carotid artery followed by a tonometry reading at Site B femoral artery Ensure the ECG signal is of acceptable quality Place the tonometer on the carotid artery and gently press the tonometer down until you receive a consistent pressure waveform displayed on the data capture screen Once a minimum of 13seconds of consistent waveforms are seen click the OK button or press the footswitch if used c Place the tonometer on the femoral artery and gently press the tonometer down until you receive a consistent pressure waveform displayed on the capture screen Once a minimum of 13seconds of consistent waveforms are seen click the OK button or press the footswitch if used Step 5 The report s can now be reviewed To perform a measurement on a new patient click the Patient button and return to step 2 above Heart Rate Variability HRV Step 1 Click the Study button to enter study parameters a Select the tyoe of HRV measurement to be performed HRV Calculation Valsalva Manoeuvre or Stand Manoeuvre b All other fields on the study screen are optional If desired enter the diastolic and systolic blood pressure values and information in Medication Notes and Operator fields Check the Enable Data output check box if output f
38. zooming on the haemodynamic parameter trend graphs during session monitoring if required Step 4 Proceed with the data capture click Capture Data revere Mt ll may KS Analysis _Privacy Pulse Wave Monitoring Select time for snapshots Go NEE rd Minimum Window Lent mi Length of initial and incremental to be automatically taken 325 Fe 2010 0821 49 S during monitoring session Check either box for the respective waveforms to be sent to an analogue output increases of trend window Length of window in signal detail area Check to enable auto scale and zooming of trend graphs during monitoring session Page 48 Ae Enter updated blood pressure if required ane click Update button Signal pressure area Refer to legend below CAPTURING THE DATA After clicking on the Capture Data button the Data Capture Screen will automatically appear and only the Signal Detail area will be active Enter a note before taking a snapshot to include note in PWA report Actual and derived waveforms in real time Calculate Abort Snapshot Radial actual and aortic derived blood pressures Signal trend area graphs graph Step 1 Ensure you have a strong and accurate signal and adjust the tonometer sensor if necessary by viewing the signal on the SphygmoCor screen or the data acquisition device if using a calibrated device Step 2 Click Start Sessi
39. CALCULATION The standard HRV calculation provides both time and frequency domain parameters and also the Vagal Index Reference Range report Time Domain Analysis Time Domain Analysis measures the change in heart rate over time or the intervals between successive normal cardiac cycles The time interval between consecutive normal N beats Known as the NN interval is measured The NN intervals are then used to calculate time domain indices which are broken into two types of measurement statistical and geometric The time domain report screen Time Tab provides a plot of the RR intervals from the entire recording as well as statistical and geometric measures Click the Time tab to view the Time Domain Analysis report SphygmoCor Cardiovascular M ement Suit t Pati System Patient Study Repor Birth Date 02 Jan 1950 Age 60 Sex MALE Plot of R R intervals over entire recording Op Height Weight BMI Histogram Assessment 1 of 4 H Poincare plot 404 Mar 2010 20 12 11 04 Mar 2010 20 42 07 000 1 3 400 600 800 1 000 1 200 1 400 1 600 1 800 04 Mar 2010 20 54 16 RtoRn ms 04 Mar 2010 21 16 41 Statistical Parameters e The plot of R R intervals shows the beat to beat R to R intervals of the whole recording An interval marked with a red star indicates abrupt changes in R to R Intervals as a result of ectopic beats or noise These intervals are rejected and not used in the HRV calculation An
40. E Use this feature to restore a database to the most recent copy You should use this method if you are restoring a backup of the database Click on the name of the database you wish to update and click on the Select button Click on the Update button and when the Update From window appears select the drive and folder the saved copied database is located Click the OK button Caution This feature overwrites the current database with the backup copy of the database Any records added to the database since the last back up will be lost and are not recoverable 6 4 6 DELETING A DATABASE This feature is used to permanently delete a database All data will be permanenily deleted Caution As a precaution the SohygmoCor software will not let you delete a database if you have not first copied it Take a copy of the database as per section 7 4 4 above You will not be able to proceed until this has been performed Click on the name of the database you wish to delete and click the Select button Click the Delete button When the confirmation window appears click on the Yes button A second confirmation window will appear click the Yes button to proceed with deleting the database The database is now deleted Warning Messages Active Database You cannot delete the active database i e the database that was active when opening the Multiple Database Manager window If you try to delete the active database a Warning message will appear indicati
41. EEEEEEEEEEEEEEEEEEEEEEEEEEEE EEEE EEEEEEEEEEEEEEEEEEEEEEEEEEEEE 68 7 4 Assuring Quality of Pulse Wave Analysis Measurements cccceeeeeeeeeeeeeeenneeee eset eter etecceeaaeeeeeeeeeeeeegeccceaaeeeeeeeeeeeeseeeeeaas 69 79 TOUDE NTN 70 LO EE an een OE EEE REE EEE 72 TI BREE 74 78 Explanation of Parameters Indices PWA AND PWM ONLY ascccccccccccccccccccccccccececceceececeeeeececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeexes 77 dh WRU ANG hr 79 lt Ee 80 7 11 Electromagnetic Compatibility EMC Warnings A Declarations rerrrnnnnnrnnnnnrrrrnnnnnnnnnnnrrnnnnnrrrrnnnneennnnennnrrrrnnnnrrrrnnnneeentnernnnn 81 7 12 European Declaration of Conformity EE 82 Page viii Preface Congratulations on your purchase of the SohygmoCor System This powerful system provides leading edge technology in the study of the arterial pulse and haemodynamic analysis This manual assists in setting up and beginning to use your SphygmoCor System It also provides detailed information on configuring your system basic operations and care using the software and troubleshooting If you are a new user of the SohygmoCor System first read over the Introduction then Setting Up amp Hardware Installation sections to familiarise yourself with the systems features components and installation Then read the Operating instructions section for step by step instructions on using the SphygmoCor Software This manual covers the following software packages e
42. European Representative Advena Ltd Suite 11 Thorne Widgery House 1059 1063 Victoria Road 33 Bridge Street West Ryde NSW Hereford HR4 9DQ Australia United Kingdom Notified Body SGS United Kingdom Ltd Weston Super Mare Unit 202b Worle Parkway Weston Super Mare BS22 OWA United Kingdom 01 20 SphygmoCor Cardiovascular Management System CvMS The SphygmoCor CvMS consists of the following modes Central Pressure Analysis PWA Pulse Wave Velocity PWV Pulse Wave Monitoring PWM and Heart Rate lability HRV IEC EN 60601 1 IEC EN 60601 1 2 IEC EN 60601 1 4 IEC EN 62366 Tee i Description Standards Applied IEC EN 62304 Classification Class lla Rule 10 of Annex IX Conformity Assessment Route Annex Il excluding Section 4 93 42 EEC Products covered Serial number of first system shipped under annex II We herewith declare that the above mentioned products meet the provisions of the Council Directive 93 42 EEC as amended by 2007 47 EC all prior amendments and as transposed into national laws All supporting documentation is retained under the premises of the manufacturer John Abram Date Manager Regulatory Affairs and Quality Assurance AtCor Medical Pty Ltd Sydney NSW Australia DCN 100776 Rev 5 0 Page 82 INDEX A PT 59 Abbreviation ccccseseccccsssecceeeseseceesenececceeececseaneceesuuaeceeeesansees 77 Vo EEE AEE 79 EE EE 77 PRO
43. G O SphygmoCor PWV amp HRV should not be used for patients with the following conditions Atrio ventricular block 2nd or 3rddegree Sinoatrial depolarisation of lt 40 or gt 160 beats per minute Atrial fibrillation or flutter Unstable carotid plaques that might rupture upon massage Mentally disoriented or unaware patients who are unable to follow instructions Oh Use of medications affecting heart rate should be taken into consideration when interpreting results O For HRV only the Valsalva manoeuvre test is not recommended for use in patients with proliferative retinopathy and a systolic blood pressure of 160mmHg or higher or who have had laser treatment for retinopathy in the past 3 months LI Certain precautions should be observed to reduce the risk of personal injury or damage to the unit Refer to the general precautions and basic system care below CAUTION ECG ELECTRODES When placing ECG electrodes on the patient ensure that they are free of moisture or away from liquids WARNING PACEMAKER PATIENTS SphygmoCor PWV amp HRV should not be used for patients with pacemakers CAUTION DO NOT USE AS A HEART RATE MONITOR This system is not a Heart Rate Monitor Do not use the ECG functions of this device for heart rate monitoring purposes Ensure the device is used as per the intended purpose as described in this manual CAUTION DEFIBRILLATOR USE This system may not be used in conjunction with the use of an external defibri
44. Guidance Bars will also become green in colour Alternatively the keyboard space bar can be pressed at any time to override the Autocapture feature and capture the waveform If Auto Capture is disabled data capture can be completed by manually pressing the spacebar on the computer keyboard when at least 11 seconds of quality waveforms are observed if Guidance Bars are enabled all 3 Guidance Bars will become green in colour Page 36 Note Guidance Bars and Auto Capture are part of the Capture Guide feature in the software The default setting on the software includes enabling of both Auto Capture and Guidance Bars These features can be enabled or disabled from the System menu Section7 1SphygmoCor Configuration Settings 55 3 REVIEWING THE PATIENT REPORT After data capture is completed the Report screen will automatically be displayed All reports are automatically saved and can be viewed at any by selecting the patient from the Patient screen and pressing the Report button The most recent report is displayed If the patient has had more than one assessment clicking on any assessment allows viewing of the corresponding report The reports display both quality control parameters and the results of the measurement The quality control parameters should be assessed prior to reviewing the report The parameters will appear in green if they fall within the acceptable limits and in red if they are outside acceptable limits If any of t
45. NG VAY E 77 Aortic wa veform 77 MP 77 TN 12 PE E E E AE AE S A E EAEE 53 e 77 Arterial system 77 Augmentation see ugekeng S ier ENEE E EEN 78 AUO CALM eege 37 PI Alte 20 Average Pressure E 78 Averaged WaVefOIrsS cssseccccssssccccaeseceeceeeceeeauseceesaaaeceesuaaeess 77 B Barc RE 59 Blood Pressure Measurement eesssssssrrrrrsssrrrrrrrsererrrrrresrereres 35 NN 20 NOE 21 Buckberg Sub Endocardial Viability Ratio 79 C calculated Parameters urong 77 Capture 1 EEE 22 Capturing the waveforms for DWA 36 Carotidmeasurement for PWV rrrnnnnrrnnnnnnrrnnnnnnrrnnnnnrrrnnnnnssrnnnn 43 Caution Defibrillator USe r rrrrnnnnnnrrnnnnnnrrrnnnnnrrrnnnnnrrrnnnnnsssene 51 EIERE 16 Central Blood breseure rrrrrnannrrnnnnnnrrrnnnnnrrnnnnnnerrnnnnnsernnnnnnssene 14 Central haemodynamic parameters rrrnnrrrrrnnnnrrrrrnnnrrrnrnnnsernnnn 77 Communications DOME EE 17 ENN 18 20 Continuous Monitoring Input 20 Continuous Monitoring Outputs 21 Control Measurement rrarnnrnnnnnnnrnnnnnnnrnnnnnnernnnnnnnernnnnnssrnnnnnsssnne 28 D Database Change The Description Of 61 Copying Ee 61 Copying A Database Caution rrrronnrrnnnnnnrrrnnnnnrrnnnnnnrrnnnnnnsene 61 Create A New Database ossnnessseenessreesssreressreressreressreressee 61 Deleting A Database rrrrnnnnrrnnnnnnrrnnnnnnnrnnnnnnrrnnnnnssrnnnnnnssnnnnnee 62 Bega EE Le EE 62 Updating A Database ossnnnnsseenesseereesreressrrrrssreressrr
46. Nov 2009 09 29 42 plen aot Au pe 23 Nov 2009 09 31 03 e er Se cb Tr Aorti EAK ARER P2P1 Ix APPP HR75 MP Systo ole Di Se S 5 22 Jan 2010 19 50 14 Aae ous Modity Delete export Print Alert message area Displays the active database Ag seconds of captured radial waveform and corresponding derived aortic waveform B average of the captured radial waveforms C average of the derived aortic waveforms Aortic and brachial cuff blood pressure measurements Derived parameters taken from the aortic waveform The Clinical Report provides a number of key clinical parameters and highlights results that are considered to be outside normal limits and may indicate an increased risk of cardiovascular disease Dotted lines represent the aortic Augmentation Pressure Red lines indicate value isin upper 5 of normal range Click on Report button to display patient report s Patient Information bis Test Test i Radial Patient ID i Birth Date 02 Jan 1970 ge 40 EX gt Study Information Operator ey DEE eee ENEE Height Weight BMI 154cm Medications Aortic sr 94 1 mmHg Notes Aortic PP 22 43 mmHg Interpretation 8 re mmHg 2 15 Assessment 6 of 6 Study Time Si Average Pulse Height Pulse Height Variation Diastolic Variation Shape Variation 20 SphygmoCor Reference Age 23 Nov 2009 09 27 44 23 Nov 2009
47. Open PORTS COM amp LPT by clicking this plus symbol Note the ComPort number assigned to the ATEN USB TO SERIAL BRIDGE eg Com 3 You will need this number to use your SphygmoCor software If the ComPort number is 10 or greater i Double click on ATEN USB TO SERIAL BRIDGE ii Select the PORT SETTINGS Tab iii Click the ADVANCED button iv Open COM PORT NUMBER by clicking on the drop down menu arrow v All the Com Ports less than 10 will be labelled in use because other devices have used these numbers at some point and may be using them now You must select a Com Port less than 10 that is not currently being used by another device You will need this number to use your SphygmoCor software vi Click OK vii A warning will appear Click YES Connect the Serial Cable to the rear of the Electronics Module connect the free end to the USB to Serial Cable which is connected to the rear of your computer Connect the Power Cable to the Electronics Module Turn on the Electronics Module Run your SphygmoCor Software A window will pop up stating Electronics Module Not Found Would You Like To Try And Detect The Electronics Module Again Select NO Once the program is open go to the menu at the top of the window click SYSTEM and select SETTINGS Select the ComPort as observed in the previous section and click SAVE Go to the menu at the top of the page click SYSTEM and select CHECK MODULE At the bottom
48. POINTS LF POWER LF POWER NORMALIS Lowest Heart Rate Proceeding Valsalva High During a Valsalva Manoeuvre Ratio of Valsalva High to Valsalva Low Number of Frequency Spectrum Points default 128 Power in Low Frequency Range 0 04 0 15Hz Percentage of Low Frequency Power in the Low to High Frequency Range 0 04 0 4Hz Power in High Frequency Range 0 15 0 4Hz Percentage of High Frequency Power in the Low to High Frequency Range 0 04 0 4Hz LE HE RATIO Ratio of Low Frequency Power to High Frequency Power LE MAXIMUM Frequency of Maximum Power in the HF POWER NORMALIS Low Frequency Range HF MAXIMUM Frequency of Maximum Power in the High Frequency Range Maximum Power in the Low to High SPECTRUM MAXIMUM Frequency Rand TOTAL_POWER Total Power in the Power Spectrum 78 EXPLANATION OF PARAMETERS INDICES PWA AND PWM ONLY The SphygmoCor PWA amp PWM report screens and printed reports consist of key patient details at the top of the screen The raw peripheral waveform and the derived aortic waveform are displayed in full At the centre of the screen and print outs are the averaged recorded peripheral waveform left and the averaged derived aortic waveform right The bottom of the screen and print out displays the derived central haemodynamic parameters The following parameters apply to each averaged waveform Displayed Parameter Summary Heart Rate Period Ejection Duration P
49. SCREEN Obtain brachial blood pressure Enter distal amp proximal distances Connect ECG leads click on measurement enter SBP amp DBP fe dit site location and capture time if desired Capture button PWV CAPTURE SCREEN Site A hold tonometer on carotid Site B hold tonometer on femoral Adjust tonometer ECG leads as needed artery click Capture after 12 sec reading artery click capture after 11 sec reading to improve signal PWV REPORT SCREEN Review Quality Control Review patient report Print or Export Patient Results Modify button te change add study information if desired PWV ANALYSIS SCREEN ADVANCED FEATURE Review key measurements Print or Export Patient Result requires multiple studies trend graphs available if desired Page 30 5 3 4 PULSE WAVE MONITORING PWM PATIENT SCREEN Create New Patient Select Existing Patient using Search or Patient Tab Enter details of First Name Last Name DOB Sex Search by Patient ID First Name Last Name DOB PWM STUDY SCREEN Session Tab Control Tab Enter study details and select Define the capture screen and calibrated or uncalibrated frequency of snapshots PWM CAPTURE SCREEN Obtain radial artery waveform with tonometer or Ensure good waveforms and sensor Click Start Session to start use footpedal or click Calculate to finish Vv PWM REPORT SCREEN Click on Capture button or press enter on keyboard Revi
50. Serial to USB adaptor for USB Interface Classification of SphygmoCor System The SphygmoCor System is classified as follows o Class Il Double insulated Type CF Equipment Ordinary Equipment This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide o Continuous Equipment O O O The following symbols listed below with their meanings are used throughout this manual as well as on the equipment AN Attention consult accompanying documentation oO Double insulated wi Type CF Applied Part Standards The SphygmoCor System is designed tested and approved to the following standards IEC60601 1 1998 EN60601 1 AS NZS 3200 1 0 Medical electrical equipment with Amendments 1 amp 2 Part 1 General requirements for safety the International Electro Medical Safety Standard for medical equipment IEC60601 1 2 2000 amp A1 2004 EN60601 1 2 AS NZS 3200 1 2Medical electrical equipment Part 1 General requirements for safety Collateral Standard Electromagnetic compatibility Requirements and tests that also requires approval to LI Emissions CISPR11 LJ Immunity Electrostatic Discharge ESD IEC 61000 4 2 LJ Immunity Radiated RF Electromagnetic Fields IEC 61000 4 3 LJ Immunity Electrical Fast Transient EFT Bursts IEC 61000 4 4 LJ Immunity Surges IEC 61000 4 5 Q Immunity Conducted RF IEC 61000 4 6 LJ Immunity Voltage Dips Int
51. SphygmoCor Central Blood Pressure PWA e SphygmoCor Pulse Wave Velocity PWV e SphygmoCor Heart Rate Variability HRV e SphygmoCor Continuous Central Blood Pressure PWM INTENDED USE The SphygmoCor Pulse wave analysis PWA option provides a derived ascending aortic blood pressure waveform and a range of central arterial indices The SohygmoCor is used with a tonometer placed over a radial artery calibrated with a standard cuff blood pressure measurement It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits The SphygmoCor Pulse Wave Velocity PWV option is intended for use in obtaining PWV measurements The SphygmoCor Heart Rate Variability HRV option is intended for use in obtaining HRV measurements in response to controlled exercises Intended Patient Population The SphygmoCor System is intended to be used on adult patients only Intended Environment The SphygmoCor System is intended to be used in a Clinical or Research environment Page 9 MANUAL CONTENTS The SphygmoCor Research Application Manual covers the following areas related to setting up and running the SohygmoCor system R Procedures for using the SphygmoCor system including the installation and operation of the system O Software operation for all the modes of measurement including Centra
52. System Patient Study Report Analysis Mode Privacy Patient West John Print Select Export d SphygmoCor 96 or Medical Ko ALC e The Report screen can be exported as a graphic or image ie jpeg format by clicking on the Export button Click on Select to choose the drive and folder to which the file should be saved then click Export e To print a report click on the Print button 5 7 TAKING A MEASUREMENT IN PWM MODE 5 7 1 STUDY PRE CHECK If necessary perform a fast flush or step response to determine the natural frequency and damping coefficient of your catheter tubing transducer system Refer to the Section 6 6 for information relating to the Fast Flush Test Warning Before use operators should ensure there are no conditions present that would impair accuracy of blood pressure measurement in the radial artery The radial pulse should be identical in both arms within the perception of the examining physician and arterial pressure by cuff sohygmomanometry should be within 10 mmHg systolic prior to use Since peripheral vasodilatation as in reaction hyperaemia caused by arterial obstruction alters brachial wave transmission at least 2 minutes should elapse after use of the cuff sohygmomanometer before radial pressure waveform recordings are taken The system is not applicable in generalised constriction or localised spasm of muscular conduit arteries such as seen immediately after hypotherm
53. The Analysis screen is designed to allow you to view and compare multiple measurements for a patient This enables you to perform both long term and short term analysis for a patient for whom more than one study exists The analysis screen requires a minimum of 2 measurements When you have 2 or more measurements for a specific patient click the Analysis button to view a report for these measurements The Trend report is the default setting and can also be viewed by clicking on the Trend button The Trend report shows the aortic and brachial blood pressure measurements for Systolic Pressure Diastolic Pressure Mean Pressure and Pulse Pressure against time ie Study date and time Check or uncheck the pressure boxes to show or remove the various pressures from the graph The Augmentation Pressure is shown in a separate graph over time i e Study date and time The Waveform report can be viewed by clicking on the Waveform button Both the peripheral and aortic waveforms are shown in study date and time order To select specific waveforms to view on the graph click on the Select button and select or deselect the measurements by clicking on a particular study and using the arrow buttons to select one or select all Click the OK button to return to the waveform screen The Trend and Waveform screens can be Exported as a graphic or image ie jpeg file by clicking on the Export button on each screen Click on Select to select the drive and folder on
54. alculations Refer to the previous waveform graph for feature identification PARAMETER DESCRIPTION FORMULA SYMB UNITS Timing parameters Start of waveform This is the start of the waveform where the time at To msec the foot is used as To Time to 1st peak Aortic The duration from the start of waveform to the 1 T msec peak shoulder This is indicated by the first triangle from the left at the horizontal millisecond axis on each graph Time to 2nd peak Aortic The duration from the start of waveform to the 2 T msec peak shoulder This is indicated by the second triangle from the left at the horizontal millisecond axis on each graph End of waveform This is the end time of an averaged peripheral or a Tr msec derived aortic waveform Time to Reflection Time to return of the reflection wave of the aortic Tr is usually greater than T and Tr msec waveform always less than T Ejection Duration The ED is derived from the recorded peripheral msec waveform This point is indicated by a dotted line on the graph ED T incisura T The ED is the period of time from the start of the pulse for which the aortic valve is open To to the closure of the aortic valve incisura End of Systole Period This is the length of an averaged peripheral or a PD T T msec derived aortic waveform Heart Rate This is the patient s average heart rate over the 1000 Beats captured 10 sec data capture period HR m min Pressure par
55. ameters Peripheral Systolic and These are the maximum Sp and minimum Dp mmHg Diastolic Pressure pressures of the peripheral waveform Aortic Systolic and Diastolic These are the maximum Sp and minimum Dp mmHg Pressure pressures of the central waveform Mean Pressure Peripheral This is the average or mean pressure for the Tr mmHg and Aortic peripheral and aortic waveform DP NOTE This is a true mean not the 1 3 method as yp commonly used in many other monitoring systems n P Pressure points n Number of pressure points Pulse Pressure Peripheral The Pulse Pressure is the height of the peripheral MmHg and Aortic and aortic pulse This is determined by subtracting SC the minimum Dp pressure from the maximum PP Sp Dp Sp pressure Central Aortic Indices Augmentation Augmentation is a pressure calculated for the mmHg Aortic Waveform only The augmented pressure is the pressure difference between the 17 peak shoulder T and 2 peak shoulder T3 Augmentation Index Aortic Augmentation Index AG PP Fa There are 2 ratios used to calculate Al AG PP This value indicates the size of the increase or decrease in the pulse height as a result _ P P of the reflected wave Ee Sp P T SEH If the reflected peak is greater than the primary peak Al AG PP is positive If the reflected peak is less than the primary peak Al AG PP is negative P P P2 Pi This value indicates the size
56. and reviewed for accuracy The instructions and descriptions it contains are accurate for the AtCor Medical product models at the time of this manual s production However succeeding models and manuals are subject to change without notice AtCor Medical assumes no liability for damages incurred directly or indirectly from errors omissions or discrepancies between the product and the manual This Manual is produced on the assumption that the operator is an experienced user of the Windows XP Vista Business Windows 7operating Systems If the operator is not familiar with Windows operations please refer to the Online Help of Windows or the Windows User Manual TRADEMARKS SphygmoCor is a registered trademark of AtCor Medical Pty Ltd Millar IBM IBM PC Microsoft Windows and Excel are the registered trademarks of their respective holders DISPOSAL According to the Official Journal of the European Union WEEE Directive 2002 96 EC that requires the proper disposal of electrical and electronic equipment This device should be disposed of separately not as unsorted municipal waste To dispose of your device you should use appropriate collection reuse and recycling systems available in your region The use of these collection reuse and recycling systems is designed to reduce pressure on natural resources and prevent hazardous substances from damaging the environment If you need information on these disposal systems please contact you
57. apture in PWA mode To change the configuration settings select System and then Settings from the drop down menu This screen can only be accessed from the Patient or Study screens SphygmoCor Configuration This is the port the USB cable Determines limits for Quality Quality Control Comms Port is connected to on your control settings Minimum Pulse Height 80 COM 1 computer Maximum Pulse Height Variation 5 Maximum Diastolic Variation 5 geg raider eg Select one or both of the The pressure sensitivity is Augmentation Index Augmentation Index values set at the upper limit and Pressure Sensitivity F Augmentation Index HR75 you would like to have should not need to be Upper Limit 4000 Blind displayed on the patient report altered ee Select the type of report to be Select from metric ie kg or Measurement Units visible each time the report Clinical d screen is opened imperial Ib for the measurements units Metric C Imperial Capture Guide e Tonometer Serial Number Guidance Bars Enable or disable either one or both of these capture guide settings Enter your tonometer serial WV Auto Capture number if required To use the AtCor Medical default settings click on the Set Defaults button The values shown the Quality Control parameters set the limits for displaying the corresponding values on the report screen in red outside the limits or green within the limits The factory set def
58. ault settings are recommended to ensure acceptable quality waveforms Changes to these settings will not affect the Operator s Index an indicator of overall quality e The default setting for Pressure Sensitivity is set at the upper limit and should not need to be changed e To set the Measurement Units check either the Metric or Imperial button e Enter the Tonometer Serial Number to be displayed on the Report Screens for future measurements e You have the option when viewing the PWA Clinical Report to add the values for Augmentation Index and or Augmentation Index HR75 i e the augmentation index adjusted for a heart rate of 75bpm Check either one or both of the boxes to display the results e When the Report screen opens for the first time the Clinical Report will be displayed The next time the report screen is opened the report to be displayed will be the last type viewed i e It may be either the detailed clinical or reference range report To define the type of report to be displayed each time the Report screen opens check either the Detailed or Clinical checkbox e When taking a PWA measurement you have the option of using the Real Time Operator Feature using either Guidance Bars and or Auto Capture o Guidance bars are displayed horizontally above and below and vertically to the right of the waveform in the signal display area main 5 second window They provide a guide for the level of movement of the waveform on the sc
59. aveforms When the raw waveform signal appears as in the first two examples below it is due to the tonometer not being directly on top of the radial artery and the tonometer needs to be readjusted Variation in the peaks and troughs of the waveforms as shown in the third example indicates that a change in pressure was applied to the tonometer and the operator should aim to hold the tonometer steadier However this may also represent an Page 69 ti 7 9 1 9 2 unavoidable respiratory artefact In addition the diastolic portion of the waveform is flat indicating that the hold down pressure is too high and the artery is being occluded In each instance the measurements should be repeated TROUBLE SHOOTING GUIDE OVERVIEW See Section 7 6 for Product Support contact details The built in error checking and many error pop up windows solve most of the errors encountered within the SohygmoCor Software some of the more serious errors described in this chapter of the Trouble Shooting Guide however will refer the operator directly to AtCor Medical Technical Support If the procedure or action required by the user is not obvious contact AtCor Medical Technical Support for assistance ELECTRONICS MODULE Condition 1 The Electronics Module cannot be detected This error may appear at two places in the software a At the start of the software b Upon entry into the Capture Screen Check the following items 2 The Electronics Module
60. betwedss 78 Pressure At 2nd Peak REENEN 78 Pressure e ln EE 78 Pressure Sensitivity sicsssocenssoresenasascvenaveracnnss snnsenasetscanasenesaeavansances 58 FP 50 57 Print Panent EE meena 59 Printing Setup Screen EE 59 PHO COG Ol eia AEA ET N 28 Pulse Wave Analysis System cccccsseeccccessseeeeeeeeeeeeeeeseeessaesees 15 Pulse Wave Monitoring Introgduction 14 Pulse Wave Monitoring Setup 20 Pulse Wave Monitoring System ccccccssseececeseeeeseeeseeeeeeeeees 15 Pulse Wave Velochty rirerire itosi ar ei 14 Pulse Wave Velocity Setup 19 Pulse Wave Velocity System rrrrnnnnrnnnnnnnrrnnnnnnrrnnnnnnrrnnnnnnsrnnnnnee 15 luv 9 Analysis of Multiple Studies rrrrnrrrrnnnnnnrrnnnnnnrrnrnnnnrrnnnnnnernnnn 40 Clinical Patient Report 38 BEE GE 00 EE EE 35 Detailed Patient Report ccecccccsssseccccsseeeeeseeeeceesaeeeeeeaees 37 Enter Study Details siecivcdivacvcecaseabinduvsoreanaceabendatedvseratsabosdsaveues 35 Export as a Graphic or Text 40 PIG WY CANE EE RE EN EN EN 29 uleeft VAN UU 39 ett ee e TE ER D LE og a E 40 Reference Range Patient Report cccccccssseecceceseeeeseeeeees 39 Repeat a Measurement srnnrnnnvnnvnnnnnvenvnnnnnvnnvnannnnvnnuvnnennener 39 Taking a Measurement rnrnnnnnrnnnnnnrrnnnnnnrrnnnnnnernnnnnssvnnnnnsssennnn 35 Tonometer Placement for DWA 35 Tend Revver rene NNN 40 Waveform Repor E 40 PWM Calibrated or Uncalibrated Signal 47 Calibration Offset s
61. ccsccasccctsnacinssiasicateacdeiseatunicocsenaseusdancedestacees 47 Calibration Ratio E 47 Capturing W teg csisccitescrdsaciccsessnwstesarsactuostescednasieiersaiens 49 ONO EEE 48 Delete a Report 50 Entering Study Details 47 Export as Graphic OF Texhunansmesnunnaagdnaniamnie 50 Fast Flush Test 47 PR NN 49 LAE o NE EE EE 50 Report Generation Period 48 NTN 47 EEN 49 Study Pre check assevervarverenvannavensannennevannerensanverennannernnsannenenns 47 Taking a Measurement rrrnnnnnrnnnnnnrrnnnnnnrrnnnnnnrrnnnnnsrrrnnnnsssnnnnn 47 Trend Minimum Window Length 48 Trend Sample Period rrrrrrnnrrrrnnnnnrvnnnnnnnvnnnnnnrrnnnnnsrrrnnnnsssensnn 48 View AE ln wissssscarcisssibetassiaeetoessetsencassanssnaeoucnaseenesdenaee 50 PWV Analysis of Multiple Studies 46 Create a PWA EE sa 46 ECG Electrode Placement ccccsssseccceessececeeseeceeseeeeeesseaeees 41 IEE CR 43 Entering Study Details 41 Export as a Graphic or TOXE iciiacassiicacwssssnncsapsdenciessaiacespbavednsdeas 46 Ge as ebben eebe 30 Modify Study Detail 46 Patient Preparation EE 41 PENN 44 Pinta Report ENE 46 Taking a Measurement rrrnnnnornnnnnnrrnnnnnnrrnnnnnnrrnnnnnsrvnnnnnsssennnn 41 Tonometer Placement 43 PWV Millar Tonometer rrnvnrnnnnnnvrnnrnnnvsnnnnnnnrnnnnnnnsnnnvnnnsnnennnnsene 16 Q Quality Control FRP 45 EP eg 58 Quick Start ET iv R READYIight uk 17 19 Real Time Operator FeatureConfiguration Settings 58 Real Time Operator Feedbac
62. comes loose See section for the Input Signal specification and external device information BNC Cable attached to AUX INPUT connector WARNING Do not connect any device that is not IEC60601 1 approved or does not have an isolation transformer Step 2 Connecting the Continuous Monitoring Outputs If required to monitor output waveforms Connect two BNC signal cables to the connectors labelled Output 1 and Output 2 on the rear panel of the Module Ensure a good connection by rotating the connector clockwise until it is clicked in place You may remove the connector by genily rotating it counter clockwise until it becomes loose Page 20 Step 3 You may now turn on your unit and commence the SohygmoCor software installation as described in section Error Reference source not found BNC Cable attached to BNC Cable attached to Output 1 connector Output 2 connector 3 2 6 FOOTSWITCHES Your SphygmoCor System includes 1 footswitch to use while taking measurements with the MM3 Electronics Module The module also has the facility to connect a second footswitch which can be purchased separately CATUION Only connect footswitches supplied with your SphygmoCor System Do not connect these footswitches to any other device To use the footswitch Step 1 Unpack your footswitch and place it at a comfortable position on the floor for ease of access The footswitches are rated IPX8 1m ie they are sealed and may be used in wet area
63. d to capture the femoral measurement Click the OK button to l l capture the measurement ECG signal window Indicates the arterial site and Tonometry signal window the required capture time require minimum 11 seconds quality waveforms Displays the last 11 seconds of both ECG and tonometry signal Note Auto Guidance and Auto Capture is not available in PWV mode 0 6 3 EXAMINING THE PATIENT REPORT After you have completed the data capture for Site B femoral artery the Report screen will automatically be displayed All reports are automatically saved and can be viewed at any time by selecting the patient from the Patient screen and selecting the Report button The most recent report is displayed If the patient has had more than one measurement clicking on any measurement allows viewing of the corresponding report The report displays both quality control parameters and the results of the measurements The quality control parameters should be assessed prior to reviewing the report Page 44 SphygmoCor Cardiovascular Management Suite System Patient Study Report Analysis Privacy Help Patient Study Analysis Privacy Pulse Wave Velocity Patient Data Addre Patient Code Patient Information West John Study Data 14Feb 2010 8 17 53 PM Distance 400 mm Patient ID Sp Dp Mp 120 80 Algorithm Intersecting tangent Birth Date 02 Feb 1945 Age 65 Sex MALE Displays ECG _ tracing and to
64. d hence diminish ECG waveform quality We recommend the use of disposable electrodes to minimise the effects of large offset potentials due to polarization We do not recommend the use of bulb type electrodes Ensure when using disposable electrodes that they are used from a new packet Old and dried electrodes will provide poor ECG signals Check the quality of the electrodes before using them CAUTION LINE TRANSIENTS The device will detect and then reject irregular rhythms generated from line transients Ensure correct electrode and cable placements to minimise the effect of line transients IMPORTANT The SphygmoCor ECG cables and leads are designed for use with the SohygmoCor electronics module and should not be used with any other ECG device Only ECG cables supplied by AtCor Medical should be used with the SphygmoCor electronics module do not use any other ECG cables with SphygmoCor electronics module Page 42 Enter systolic and diastolic BP from cuff measurement SphygmoCor Cardiovascular Management Suite rivac ges Pulse Wave Velocity Patient Information i Distance in mm DA Height cm 120 PWY 300 m Assessments Study Time Mee E Enter distance measured s from patients supra sternal Proxima See notch to carotid and femoral arteries eS Fr Site A is site of 17 operator EE Sieg measurement Site B is site Radial Enter details in Seef Medications io G t these fields if Proximal
65. d in the manual CONVENTIONS This manual uses the following formats to describe identify and highlight terms and operating procedures Abbreviations On first appearance and whenever necessary for clarity abbreviations are enclosed in parentheses following their definition For example Read Only Memory ROM Message Notes Message Notes are used in this manual to bring additional information to your attention The message is identified as shown below Notes Additional relevant information is included in this area Keyboard Operation The computer keyboard keys are used in the text to describe many software operations A distinctive typeface identifies the key symbols as they appear on the keyboard For example ENTER identifies the Enter key Some operations require you to simultaneously use two or more keys We identify such operations by the key symbols separated by a dash sign For example Ctrl C means you must hold down Ctrl and at the same time press C If three keys are used hold down the first two keys and simultaneously press the third key Page 10 Most Controls on the screen buttons menus combo boxes etc can be activated through the keyboard A line appears underneath the letter that will activate that button Press Alt amp the specified key to perform the described function For Example To print press Alt T Display When procedures require an action such as clicking an icon button or entering tex
66. e in the following folder To install into a different folder under CYAtCor edit the destination folder You can choose not to install SphygmoCor Cardiovascular Management Suite by clicking Cancel to exit Setup Destination Folder CAAtCor SphygmoCor CvMS V9 Cancel Step 5 The Select Program Manager Group screen will appear The default folder name is SphygmoCor CvMS V9 Click Next to continue Enter the name of the Program Manager group to add SphygmoCor Cardiovascular Management Suite icons to AtConSphygmoCor CvMS V9 Accessories Administrative Tools Broadcom Wireless Brother CorelDRAW Graphics Suite 12 FileZilla FTP Client FolderSizes 4 Page 23 Step 6 The Start Installation screen will appear Click Next to copy the software to your computer Start Installation You are now ready to install SphyqmoCor Cardiovascular Management Suite Press the Next button to begin the installation or the Back button to reenter the installation information Step 7 Disconnect Module screen will appear Ensure the electronics module is not connected to the computer Click OK Disconnect Module Please ensure the Electronics Module is disconnected from this computer before proceeding Step 8 The Installing screen will appear showing the files being copied and installed on your computer eiss m Current File Copying file CA ASphygmoCor CvMS VS UNWISE EXE
67. e Wave Velocity Error Pulse Transit Time Standard Deviation Entered Tonometer Serial Number Site A Artery Location Site A No of 10sec data sets Site A Heart Rate Site A Mean At Site A Deviation Site A Pressure Pulse Height Site A Pressure Pulse Height Variation Site A Pressure Pulse Length Variation Site A Pressure Base Line Variation Site A ECG Pulse Height Site A ECG Pulse Height Variation Site A ECG Pulse Length Variation Site A ECG Base Line Variation Site B Artery Location Site B No Of 10 Sec Data Sets Site B Heart Rate Site B Mean At Site B Deviation Site B Pressure Pulse Height Site B Pressure Pulse Height Variation Site B Pressure Pulse Height Variation Site B Pressure Pulse Length Variation Site B Pressure Base Line Variation Site B ECG Pulse Height Site B ECG Pulse Length Variation Site B ECG Base Line Variation HRV Exported Fields Below is a list of the fields that are exported when a complete database export is performed x lt Entered Patient Notes Entered Systolic Pressure v m o z o lo lo w gt O z lolo vV d l lp lo lo jz lo l lo lo 5 z a 4 O Sa T gt gt 2 jg jg p o IS 12 12 15 x o 2 l gt e z o m m C sell Es o o o 0 gt gt jo 9 7 gt IZ 19153 D v lt y D A m gt 3 3 13 lo z 5 G 2 v 4 4 O H 13 Q 3 gt 9 3 EIE L 2 Im VU gt gt gt J Z OINS S ja z l8 CG v e 4 I T E D
68. e a good connection by aligning and fitting the ECG connector until the locking mechanism is securely engaged The connector contains a spring mechanism for ease of removal Gently pull the ECG connector to remove the cable again Step 4 Connect the Lead Wires to the ECG Cable Connect the supplied Lead Wires to the ECG cable Page 19 3 24 HEART RATE VARIABILITY These instructions only apply to the MM3 Module Step 1 Connect the ECG Cable Connect The ECG Cable to the connector labelled ECG on the front panel of the Module Ensure a good connection by aligning and fitting the ECG connector until the locking mechanism is securely engaged The connector contains a spring mechanism for ease of removal Gently pull the ECG connector to remove the cable again Step 2 Connect the Lead Wires to the ECG Cable s Se AG vat BE Fer Be a ai Connect the supplied Lead Wires to the ECG cable Step 3 You may now turn on your unit and commence the SphygmoCor software installation as described in section Error Reference source not found 3 2 5 PULSE WAVE MONITORING These instructions only apply to the MM3 Module Step 1 Connecting the Continuous Monitoring Input Connect the BNC signal cable to the connector labelled AUX INPUT on the front panel of the Module Ensure a good connection by rotating the connector clockwise until it is clicked in place You may remove the connector by gently rotating it counter clockwise until it be
69. e optional study gt fields if reauired Ensure checkbox is not checked if using an uncalibrated device such as a catheter Check the calibrated a checkbox if using a SSC PER device Device ec H Session Tab ardiovascular Mi anagement System Patient Study Report sis Mode J sessi Cular Suite port Anal Privacy en on Patient information BLA Height ME cm TT PE Enter blood pressure Session Start Time E Weight kg 2 Feb 2010 00 20 7 values from calibrated device gt Select tonometer to receive input from the tonometer auxillary to receive input from another device Select aortic or radial for the measurement site Calibrated Radial cd 74 Calibration Ratio 0 01 VimmHg Calibration Offset o V Select device or custom settings from drop down menu Enter the calibration ratio and offset of the device if using a custom setting If a known device is selected these values will be entered automatically Step 1 Check and select different times for the Trend Sample Period Report Generation Period and a Trend Minimum Window Length if required Step 2 Check the peripheral artery and or derived aortic signal boxes in the Output Channel Select window if either or both of these waveforms are required to be sent to an analogue output Step 3 Click on the Auto Scale Trends checkbox to enable
70. edical distributor or contact the AtCor Medical Technical Group at Telephone 61 0 2 9874 8761 Facsimile 61 0 2 9874 9022 Email support atcormedical com Website www atcormedical com support htmi FAQ www atcormedical com faq htmi Please quote your System Serial Number to your Product Support Representative This serial number can be found by opening the SohygmoCor software and selecting Help gt About from the Main Menu A window will appear and will contain the System Serial Number This window also contains the Version of software and the installed options When contacting by telephone please have your SphygmoCor System nearby as well as copy of the Operator s Manual open on your PC You should be prepared to give the following information if applicable System serial number e The error number and exact wording of any messages that appear The error number will appear in the corner of the error message window e What happened and what you were doing when the problem occurred e Any action that you took as a result of a warning error problem e The version of your SohygmoCor software Page 67 L DISCLOSURES AND LIMITATIONS The SphygmoCor Reports display the derived aortic pressure waveform beat by beat and as an ensemble averaged wave together with the measured radial waveform beat by beat and ensemble averaged from which the aortic wave was generated as shown in the Report Screen As with interpretation
71. eeey 14 SETTING UP amp HARDWARE INSTALLATION i sanuneervnnnnnnnnnnevvvnnnnnnnnnnnnennnnnnnnnnnnnevevnnnnnnnnnnr 15 3 1 UnPacking The SPT Tverr 15 32 NN 17 SOFTWARE INSTALLATION uvenn geadenndd end 22 4 1 installing TT 22 4 2 Installing USB Adaptor FOR Windows XP Windows 7 26 OPERA TING Eng ene LE 27 5 1 RS VSI E 27 5 2 Recommended Sphygmocor Control Conditions for Study Protocols ccccccccccceececeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeseeeeeseeenenness 28 53 Overview Of Modes Of Measurement scscsiincnnnninnansnwasansannsninnmienannes ainikhihnannnaannasalliniehhianannanassdhinahhhiamannanaasllniaeihiinannnan an 28 5 4 Patient Entry Select Or Enter A New Patient sccnscnnccecasscnnemeoonseeccniansmsniannennnaseessauansannnannaninasnnamansasianannnnnnanaenamansanmnmmianne 33 5 5 Conducting a Pulse Wave Analysis powa Asesesement ENEE 34 5 6 Conducting a Pulse Wave Velocity PWV assessment Luma 41 5 7 Taking A Measurement In PWM Mode eee 47 5 8 Taking A Measurement In Heart Rate Variability Mode HVT 51 5 9 Review The Patient PELS 54 5 10 Show Ecg Mo dify EN 57 ADVANCED FEATURES ne 58 6 1 SphygmoCor Configuration SOT NG EEE EN OE EE 58 6 2 Printer Settings And Batch Printing WE 59 br FN gt 59 6 4 ene E 60 6 5 EXPONE A he 63 66 Fast OF gO r A le E 65 Pe eh 67 7 1 Eee RE NE 67 T2 Product SUPPO EE 67 7 3 Disclosures And Limitations sssssssssesssseeseessssssresrrrrrrrrrrrrrrrrrrrttttttttttttttt ttt tt ttt E
72. eforms travelling across the screen e The guidance bars indicate the amount of variation of the waveforms Red indicates too much variation yellow indicates moderate variation and green indicates an acceptable level of variation Messages will appear at the bottom of the screen indicating the area of variation to guide in adjusting the position of the tonometer Adjust the tonometer slightly medially or laterally over the artery to obtain a clear strong signal e With Guidance Bars enabled all 3 bars will turn green when a quality waveform has been identified by the software The waveform tracing will change from white to green indicating all quality criteria have been met and data can be captured or saved Five second pressure va ET oe tinak Te Millis Gen OK Cancel waveform window The un Guidance bars display graph can be used to wm level of variation Each guide adjustments to the bar may be green good position of the syellow average or red tonometer poor All 3 bars become green when a quality waveform has been identified Eleven second pressure waveform window When the waveform fills the entire window 11 seconds of data is ED Waveform Capture Waveform capture can be performed either automatically or manually e If Auto Capture is enabled default setting the software will automatically capture the waveform when all of the quality parameters are met if Guidance Bars are enabled all 3
73. em ID Database ID Patient Number urname First Name p DATA_REV DATETIME AGE MEDICATION NOTES OPERATOR INTERPRETATION HEIGHT EIGHT BODY_MASS_INDEX AMPLE_RATE IMULATION_ MODE PX_DIST DT_DIST PWV_DIST PWV_DISTERR ALGORITHM System Serial Identification Number Database Identification Patient Number Entered Patient s Surname Entered Patient s First Name Entered Patient s Sex Entered Patient s Date of Birth Entered Patient Identification Entered Patient Code Entered Patient Notes Entered Systolic Pressure Entered Diastolic Pressure Entered Mean Pressure Math s Data Revision Date amp Time of Study Patient s Age on Date of Study Entered Medication Entered Notes Entered Operator Interpretation Entered Height Entered Weight Body Mass Index Raw Data Sample Rate Simulated Report Yes No Proximal Distance Distal Distance PWV Distance PWV Distance Error PP_DEVIATION PWV PWVERR PTT SD Tonometer Serial Number A_SUBTYPE A_NOF_10_SETS A_DEVIATION_DT A_TON_QC_PH A_TON_QC_PHV A_TON_QC_PLV A_TON_QC_BLV A_ECG_QC_PH A_ECG_QC_PHV A_ECG_QC_PLV A_ECG_QC_BLV B SUBTYPE B NOF 10 SETS B HR B MDT B DEVIATION DT B TON QC PH B TON QC PHV B TON QC PHV B TON QC PLV B TON QC BLV D ECG QC PH Pressure Waveform Algorithm Selected B ECG QC PLV Pulse Height Algorithm Percentage PH B ECG QC BLV Pulse to Pulse Mean At Page 75 Pulse to Pulse Deviation Pulse Wave Velocity Puls
74. eripheral Systolic and Diastolic Pressure Aortic Systolic and Diastolic Pressure Mean Pressure Peripheral and Aortic Pulse Pressure Peripheral and Aortic Time to 1st peak Aortic Time to 2nd peak Aortic Time to Reflection Central Aortic Indices Augmented Pressure Pressure at T Pressure at T2 Augmentation Index Ap P P2 P4 Primary Wave Pressure at T1 Buckberg Sub Endocardial Viability Ratio Ad As Mean Pressure in Systole Diastole End Systolic Pressure In its analysis of the derived aortic pressure waveform the SphygmoCor System extracts from the averaged waveform five time relative points described below and from these points further parameters relating to the heart and arterial system are determined see graph below The basic features of an arterial pulse are shown below After the foot of the pulse To indicating the onset of ejection the pressure wave rises to an initial peak where it forms a shoulder T4 This is the peak of the primary LV ejection pressure It then proceeds to a second shoulder T which is the peak of the arterial reflection wave Usually this constitutes the peak pressure in the elderly The end of ejection ED is point of closure of the aortic valve and time of End of Systole These timing points are the basis of the waveform analysis Features of the Arterial Pulse Radial Aortic The following is a detailed explanation of displayed parameters and those used for c
75. erruptions Variations IEC 61000 4 1 1 LJ Immunity Magnetic Fields IEC61000 4 8 Page 73 7 7 EXPORTED FIELDS PWA exported fields Below is a list of the fields that are exported when a complete PWA database export is performed em ID System Serial Identification Number Database Identification Patient Number Entered Patient s Surname Entered Patient s First Name Entered Patient s Sex Entered Patient s Date of Birth Entered Patient Identification Entered Patient Code Entered Patient Notes D LD 20 U UITUIUINITIN UTIT M v jax je 18 l z S 2 8 Is o lo lo o 13 lo p 2 3 3 3 lo z 2 2 18 Z IO lO lw 3 1 9 IZ o SE D Sls p 0 I e v OD Entered Systolic Pressure Entered Diastolic Pressure 5 o o SIS IS 4 3 m gt lt mic Entered Mean Pressure Math s Data Revision Date amp Time of Study Patient Age on Date of measurement gt O m Entered Medication Entered Notes Entered Operator Entered Interpretation Entered Height Entered Weight WEIGHT Body Mass Index Raw Data Sample Rate Simulated Report Yes No Entered Tonometer Serial Number Entered Artery Inconclusive Report Yes No Pulse Pressure Amplification Ratio Radial Central Peripheral Pulse Maximum dP dt Ejection Duration ms Calculated Ejection Duration ms Confidence Level of ED 3 Very Weak 2 Weak 1 Strong 0 Very Stron Peripheral Pulse Quality Control Pulse Height Per
76. essure waveform recorded at the radial artery Analysis of the waveform provides key parameters including central arterial pressures and indices of arterial stiffness which are also compared to population reference range values Measurements are performed by placing a pressure transducer tonometer over the radial artery and recording 11 seconds of quality radial waveforms 2 2 THE SPHYGMOCOR PULSE WAVE VELOCITY ASSESSMENT SYSTEM The SphygmoCor System also measures the pulse wave velocity of the blood pressure waveform travelling between any two arterial sites that can be measured non invasively The velocity of the blood pressure pulse waveform is dependent on the stiffness of the artery along which the pulse is travelling Measurements are normally performed by recording pressure waveforms at the carotid artery followed by the femoral artery with an ECG signal recorded simultaneously 2 3 THE SPHYGMOCOR HEART RATE VARIABILITY ASSESSMENT SYSTEM The SphygmoCor Heart Rate Variability System is a sophisticated system for non invasively assessing the Autonomic Nervous System ANS based on Heart Rate Variability HRV analysis HRV analysis is based on measuring variability in intervals between R waves ie R R intervals The SphygmoCor HRV system assesses sympathetic and parasympathetic autonomic function by providing stable and evoked measures of HRV a HRV measurement in Supine Resting State O HRV measurement after Valsalva Manoeuvre O HRV
77. ew PWM report trend graphs Review PWA reports if available PWM ANALYSIS SCREEN ADVANCED FEATURE Print or Export Patient Result if required Page 31 5 3 5 HEART RATE VARIABILITY HRV PATIENT SCREEN Create New Patient Select Existing Patient using Search or Patient Tab Fnter details of First Mame I ast Mame DOR Sex Search by Patient ID First Name ast Name DOR HRV STUDY SCREEN HRV EE Enter BP and other study information if Click on Capture button Stand Ets i required or press enter on keyboard HRV CAPTURE SCREEN Click Start Session to start Run for minimum 5 minutes when doinga Follow prompts for Valsalva Maoeuvre and Click Calculate to finish HRV Calculation StandManoeuvre HRV REPORT SCREEN Review HRV report HRY Calculation review Time and Frequency Valsalva and Stand Manoeuvre review reports as well as Clinical Report statiscal data and clinical normal values HRV REPORT SCREEN ADVANCED FEATURES View ECG Modify Print or Export Patient Result if required Page 32 5 4 PATIENT ENTRY SELECT OR ENTER A NEW PATIENT Create a new patient entry or select a previously entered patient open the Patient screen by clicking on the Patient button or pressing F2 on your keyboard function keys The procedure for entering or searching for a patient is identical for all modes of measurement If your patient has already had a measurement performed under any of the modes available there is
78. hange has been made then re measure the blood pressure and enter it in the study screen e Study details can be modified including changing cuff blood pressure values or adding additional information such as notes medication height and weight as well as adding an interpretation To use this feature click the modify button and enter or change the desired parameters as necessary then click the Modify button These sections can also be modified directly from the Report Screen by clicking inside the relevant field Page 39 5 5 3 4 The Report screen can be exported as a text or graphic file i e joeg format by right clicking on the Export button and selecting As text or As graphic Click on Select to choose the drive and folder on your computer to which you wish the file to be saved and click Export To print a report click on the Print button To print several reports at once click on the Patient button then select System then Batch Print from the main menu To search for reports to print select a start and end date within a 2 week window and click on Get Studies A number of available studies will appear If you wish to print all of the studies click on the Print All button Alternatively you may either select individual reports by clicking on that study and pressing the button or to select all studies for printing press the gt button and then click on Print Selected ANALYSIS OF MULTIPLE STUDIES
79. he Quality Control parameters appear in red the assessment should be repeated The patient s results are presented both numerically and graphically ls Report Screen BS Report Screen Patient Data Birth Date 02 Jan 1970 Age 40 Sex FEMALE Birth Date 10 Jan 1935 Age 75 Sex MALE mei Information Study Information Oper Operator Hei on Weight BMI Height Weight BMI 165cm 154cm Medications S Assessment 5 of 5 SphygmoCor Reference Age Study Time A 23 Nov 2009 09 27 44 23 Nov 2009 09 29 42 23 Nov 2009 09 31 03 22 Jan 2010 19 50 14 27 Jan 2010 20 29 42 Buckberg SEVR PTI Systole Dia Heart Rate Index wan Delete Eon Prin a aS Quality Control parameters are displayed in green when within acceptable limits Graph shows overlay of captured waveforms 9 0 0 1 QUALITY CONTROL PARAMETERS The Quality Control parameters are used to identify a valid reproducible waveform Any PWA measurements not considered of sufficient quality based on the following criteria should be repeated e Operator Index composite quality control parameter 2 80 acceptable 75 79 is considered borderline and lt 74 is considered unacceptable e Quality Indices reflect the degree of variation outside of acceptable limits Average pulse height 280 pulse height variation lt 5 diastolic variation lt 5 and shape variation 4 e The graph showing the overlay of captured waveforms sh
80. he Valsalva Ratio is calculated from the relationship of the largest RR interval after strain Phase IV to the shortest RR interval during strain Phase II E Show ECG Valsalva Manoeuvre 90 F Valsalva Manoeuvre Graph Heart Rate bpm Kl DN VALSALVA HIGH 86 bpm Valsalva Ratio Normals VALSALVA LOW 54 bpm VALSALVA RATIO 7 60 Eee SSS SEE EE a Capture Time 00 01 00 Number of Pulses 61 Average Heart Rate 62 bpm Mean R to R 961 ms e R to R Range 468 ms N Abnormal population range for Valsalva ratio Valsalva Ratio Oo Active Database DATA Key Parameters Patient s Valsalva ratio with respect to age e The Valsalva Manoeuvre Graph shows beat to beat Heart Rate values of the Valsalva Manoeuvre recording e The Clinical Normals Graph is a plot of the Valsalva Ratio against the population normals A ratio of 2 1 2 is considered normal and a result lt 1 2 is considered to be abnormal Results in the white area are normal while results in the shaded orange area are below normal e An Inconclusive message appears when 50 or more of the recorded R to R intervals were rejected because of abrupt changes in R to R intervals due to either noise or ectopic beats An inconclusive report should be discarded and the measurement repeated 9 9 3 STAND MANOEUVRE The basis of normal cardiac autonomic function is the shift from parasympathetic to sympathetic modulation in response to environmental or p
81. he main menu A warning message will appear reminding you to take a copy of your database as a back up before proceeding If you have already done so click on the Yes button The Patient screen will become active once the database optimisation has finished e The software will automatically generate a reminder prompting database optimisation If you have not performed a back up of your databases then click on No and perform a backup If you have recently performed a back up and no additional data has been added to the database then click the Yes button e The database optimisation only optimises the active database If you have multiple databases for the SohygmoCor system each database will need to be opened and optimised separately Page 62 6 5 EXPORTING DATA You can export data from the SphygmoCor system for use in other programs Data is exported in a Tab delimited text file format This format is easy to import into spreadsheet applications such as Microsoft Excel or statistical softwares The amount and type of data that can be exported as follows e All measurements in the database e All measurements for an individual patient e Asingle measurement for an individual patient e A single analysis for an individual patient DATABASE WARNING Do not open the SphygmoCor database with any other program as it may corrupt your data All database interactions should be performed using the SphygmoCor software For further advice contac
82. hen a clearer or stronger signal is required e Select the type of HRV measurement to be performed HRV Calculation Valsalva Manoeuvre or Stand Manoeuvre eAll other fields on the study screen are optional Enter the diastolic and systolic blood pressure values and information in Medication Notes and Operator field if desired e Check Enable Data if output is required from the electronics module during data capture SphygmoCor Cardiovascular Management Suite 3 Click on Study System Gert Study Report fas button to enter T pament P study Report analysis Privacy study details Enter additional information required capture nalysis Mode Privacy Help Enter systolic and diastolic blood pressure Patient Information if ired B A Height Mom IT required Assessment 1 of 1 B Study Time Weight kg e Sra contd Heart Rate Variability Body Mass Index kg m Operator mong if 5 Medications Select type of HRV g HRY Calculation measurement Valsalva Manoeuvre Stand Manoeuvre Check this box to enable data output from the electronics Enable Output 8 module during data Capture Data Active Database DATA Click Capture Data to proceed Page 52 9 8 2 RECORDING ECG SIGNAL After entering the Data Capture Screen a horizontal trace will move across the screen in the ECG Data window The display refreshes every 5 seconds To begin
83. hysiological stimuli A postural change from supine to standing is one such stimulus used to elicit a shift in cardiac autonomic balance When using the Stand mode in the SphygmoCor HRV system prompts will be provided for the patient to be resting in the supine position and when to stand Standing up from a lying position results in venous pooling and a transient decrease in cardiac output This triggers reflex activation of the sympathetic nervous system and a reduction in cardiac parasympathetic tone This is reflected by changes in the heart rate there is an immediate and sharp increase in heart rate to a maximum level at around the 15 heart beat after standing followed by a relative bradycardia that reaches its maximum level at around the 30 heart beat after standing Page 56 Show ECG Stand Manoeuvre Sse ceee halde zen de vesen ss ads seeks Veteranen Gerbereien koss helsa ger es Sse eo 4qeeser see sserssssess EN E eee ee See See eee See DE Dee ee E ee ke eee ee ee Bpf 9 p p p P P J J J rn pe te Ge A g ne EE oe Stand Manoeuvre on on diem om 0 Se ny Be 6 00 00 00 Gob Ge 00 ungan o0 00 00 000 po om oi 00 an 00 an on o0 00 en Se gt ang wee Vie ebben J Oe Gerber om om on om 0 00 1 gescheet Ze 0000 40 00 10 100 0 0 00 0060 A deen ll
84. ial artery with your index finger and identify the strongest pulse point e The best results are obtained if the patient s wrist is in a slight dorsiflex position on a stable surface You may wish to support the patient s wrist using your opposite hand or by placing a small pillow or rolled towel under the patient s wrist for support e When taking the measurement ensure that your eloow and wrist are supported on a flat surface and your hand presses gently but firmly against the patient s wrist to provide stability and minimise movement Page 35 e Gently place the tonometer over the strongest pulse point of the patient s radial artery until a waveform signal appears on the screen If too much pressure is applied the tracing will run across the top screen as a straight line If you press too lightly the tracing will run along the bottom of the screen e While holding the tonometer steadily over the patient s radial artery the waveform signal should automatically resize with optimal placement Watch the Capture Screen and make minor adjustments until waveforms uniform in shape and height travel horizontally at the same level across the screen Pressing the keyboard spacebar once 11 seconds of consistent waveforms are visible in the bottom screen will capture the data and save it to the patient s record e When the Guidance Bars are enabled red green or yellow bars will appear on the screen at the top bottom and sides of the wav
85. ic cardiopulmonary bypass surgery or accompanying Reynaud s phenomena or intense cold 5 7 2 ENTERING STUDY DETAILS Click on Study or press F3 on your keyboard The Study Screen allows you to enter the information pertaining to the study and the BP device you have connected to the electronics module in the Session Tab and information regarding the set up of the data capture screen in the Control Tab 5 7 2 1 SESSION TAB Step 1 Click on the radial artery check box to compare central and brachial pressure waveforms Step 2 Enter information into the Medication Notes and Operator fields if desired These fields are optional Step 3 For an uncalibrated signal such as a signal direct from a catheter ensure the Calibrated checkbox is not selected Select either tonometer or Auxiliary in the Input box Enter the diastolic and systolic pressures obtained from a brachial blood pressure measurement Step 4 For a calibrated signal i e the signal is being processed by another device ensure the Calibrated checkbox is selected Step5 Select the blood pressure device connected to the electronics module If the device is not listed select custom from the drop down menu and enter the Calibration Ratio Volts mmHg and Offset Volts of the connected blood pressure device If a known device is selected the Calibration Ratio and Calibration Offset will automatically be entered Page 47 5 7 2 2 CONTROL TAB Enter information into th
86. ical parameters O Elasticity the stiffness of the system normally caused by the transducer diaphragm this can be altered by air bubbles compliant tubing or other elastic elements in the system m Mass the fluid mass moving in the system usually in the catheter and interconnecting tubing and O Friction friction in the catheter and tubing as the fluid in them moves with each pulsatile change in blood pressure With the underdamped second order system the elasticity mass and friction determine two measurable parameters The natural or resonant frequency and the damping coefficient Natural frequency refers to how rapidly the system oscillates and the damping coefficient refers to how quickly the system comes to rest For clinical use underdamped catheter tubing transducer systems result in two major errors in blood pressure reading overestimation of systolic pressure frequency and amplification of artefact in the pulmonary artery The fast flush or step response method exposes the monitoring system to a sudden pressure change and is used to test the dynamics of the system i e measure the natural frequency and damping coefficient This method is superior to other techniques because it can be used to test the entire system from catheter tip to waveform recording system 2 Gardner RM Direct blood pressure measurement dynamic response requirements Anesthesiology1 981 54 227 236 3 McDonald s Blood Flow in Arter
87. ically be displayed Reports can also be recalled at any time by selecting the patient in the Patient screen and pressing the Report button The most recent report will be displayed If the patient has more than one assessment performed you can click on any of the other assessments to review the desired report Page 49 e Check the information in the patient and study data e Review the graphs showing trend lines for peripheral and central pressures as well as several central timing parameters SphygmoCor Cardiovascular Management Suite System Patient Study Report Trend graph of the individual recorded and This is the patient Patient Information SE derived blood pressures information entered on the S Session D Refer to legend below Patient screen Birth Date 02 Jan 1950 graph ge SE WE a a a Study Information Operator i a Height Weight BMI This information relates to nt this particular study and was entered in on the Study screen Medications Trend graphs of the individual key parameters heart rate SEVR ejection duration and augmentation Start index This patient has had 5 25 Feb 2010 08 20 17 measurements taken and Fo A are recorded by date and myrer time Click on one of the ae RE E ap Aortic Dp Radial Dp measurements to review the report Active Database DATA 0 7 4 1 VIEW PWA REPORTS DELETE EXPORT AND PRINT e Click on the Report button on the Too
88. ient When the patients measurement is in the upper 5 of the normal reference range the red section of the graph the value on the graph will be displayed in red e The SphygmoCor Reference Age for the patient is displayed on a bar graph as a blue band This value will only be calculated and displayed when the patient is over 18yrs old the patient s height has been entered and Augmentation Pressure has been calculated The blue bar represents the age range for the patient based on SphygmoCor aortic pressure parameters e The aortic Augmentation Pressure is indicated by the dotted lines on the aortic waveform These become red when the value is in the upper 5 of the normal range Reference Range Screen The Reference Range Screen displays the population statistical comparison graphs for aortic pulse pressure systolic pressure augmentation pressure augmentation index ejection duration and subendocardial viability index e The patient s position on each graph is indicated by the blue dot No indicator is present for the patient s position in the graphs when a carotid or aortic measurement is performed e The Alx graph will indicate the position for both the Alx and the AIx HR75 values for the patient e The Ejection Duration and SEVR are plotted by Heart Rate The second SEVR graph simply provides a representation of the cut off values for this measure e The reference range for the Aortic Systolic Pressure Aortic Pulse Pressure Aug
89. ies a Edition 1960 Arnold 4 Kleinman B Powell S Kumar P GardnerRM The fast flush test measures the dynamic response of the entire blood pressure monitoring system Anesthesiology1992 77 1215 1220 Page 65 The Fast Flush Test In the clinical setting the pulsating pressure waveform will be superimposed on the results therefore two or three flushes must be performed to facilitate measurement of the natural frequency and damping coefficient For Example if you are using a chart recorder the natural frequency can be determined by measuring the period of one cycle and applying the following equation Natural frequency Hz Paper Speed mm sec One cycle measured in mm The damping coefficient can be determined by measuring the amplitudes of two successive peaks from the response curve and then dividing the smaller amplitude by the larger amplitude This amplitude ratio can then be applied to the curve in the figure below and the corresponding damping ratio determined For Heart Rates less than 80 beats per minute a natural frequency greater than or equal to 16Hz is desirable with a damping coefficient range of 0 25 0 8 For Heart Rates greater than 80 beats per minute a natural frequency greater than or equal to 20Hz is desirable with a damping coefficient range of 0 35 0 65 The greater the natural frequency of the system the greater the latitude for the damping coefficient and greater reproducibility of the waveform
90. ions Operating Ambient temperature Operating Relative humidity Storage Ambient temperature Storage Relative humidity Power supply mains powered Physical Specifications 15 F to 30 C 59F to 86 F 20 to 80 10 F to 50 C 50 to 122 F 20 to 90 220 240 VAC 10 MIME BES ch 100 110 VAG 410 Supply Voltage MM3 Desktop 100 250 VAC 10 Supply Frequency 50 60Hz MM2 Desktop 12VA R C ti A wus Desktop 72VA MM2 Desktop T50mA Fuse Fuse MM3 Desktop T1A Fuse Protective Class IEC Class Il Type CF Power Connector IEC 320 Type 14 Appliance Inlet No Earth Enclosure Material MM3 Desktop Weight MM2 Desktop MM2 Desktop Polystyrene 1 5 kg 3 3 Ibs 2 5 kg 5 5 lbs MM3 Desktop 30 5 I x 26 1 w x 13 5 h cm Dimensions Input Signal Specifications Input Tonometer ECG MM3 Only Auxiliary Input MM3 Only Footswitch 1 amp 2 MM3 Only MM3 Desktop MM2 Desktop 12 I x 10 3 w x 5 3 h Specification Diffused semiconductor whetstone bridge sensor Sensitivity Contact Pressure Range Calibration Reference Pressure Frequency Range Sampling Rate Gain amp Offset Adjust Type Frequency Range Sampling Rate Gain amp Offset Adjust Connector Signal Range Frequency Range Sampling Rate Calibration Gain amp Offset Adjust Minimum Signal Level Allowable Pressure Range Input Signal Accuracy I
91. ipheral Pulse Quality Control Pulse Height Variation Peripheral Pulse Quality Control Pulse Length Variation Peripheral Pulse Quality Control Diastolic Variation Peripheral Pulse Quality Control Shape Deviation Calculated Operator Index Peripheral Systolic Pressure Peripheral Diastolic Pressure Peripheral Mean Pressure Adjusted Peripheral T4 Adjusted Peripheral T2 Peripheral Augmentation Index Calculated Peripheral T MEDICATION OPERATOR INTERPRETATION HEIGHT BODY MASS INDE X SAMPLE_RATE SIMULATION MODE Tonometer Serial Number SUB_TYPE PPAmpRatio P MAX DPDT CalcED QUALITY ED P QC PH P QC PHV P QC PLV P QC DV P QC SDEV Operator Index P MEANP P CalcT1 P CalcT2 Calculated Peripheral T Page 74 Peripheral Confidence Level of T1 P_QUALITY_T1 P QUALITY T2 Strong Central Augmented Pressure C AP HR75 Heart Rate Corrected Central Augmented Pressure C SVI Central Buckberg Sub Endocardial Viability Ratio SEVR Augmentation Load C ATI Augmentation Time Index 3 Very Weak 2 Weak 1 Strong 0 Very Strong Peripheral Confidence Level of T2 3 Very Weak 2 Weak 1 Strong 0 Very C QUALITY Ti C QUALITY T2 Central Confidence Level of T1 3 Very Weak 2 Weak 1 Strong 0 Very Strong Central Confidence Level of T2 3 Very Weak 2 Weak 1 Strong 0 Very Strong PWV Exported Fields Below is a list of the fields that are exported when a complete database export is performed yst
92. is connected to your computer 2 The Electronics Module is connected to power Q The Power light is on if it is off see When the power light is off D The correct communications port is selected in the configuration settings Refer to Section 6 1 Condition 2 When the POWER light is off Check the following items 2 The Electronics Module is connected to power Q Disconnect the Serial Cable and USB Adaptor if in use from the Electronics Module wait 2 3 seconds and reconnect At this time check that the Electronics Module runs through its initialisation sequence G If using a USB Adaptor ensure that the USB drivers have been installed on the computer Page 70 7 9 3 SOFTWARE SCREENS All conditions within this screen will be notified to the user by pop up windows If this is not the case or you require further explanation of any pop up window contact AtCor Medical Technical Support for assistance 7 5 4 PULSE CAPTURE SCREEN The Tonometer fails to respond Ensure that the Tonometer is connected to the connector in the tray of the Electronics Module Note Care is required when connecting the Tonometer Pins inside the connector can be easily bent or broken off Page 71 7 6 SYSTEM SPECIFICATIONS Product Configuration Mode PWA PWV HRV PWM Supported Inputs Modules Outputs Tonometer MM2 N A MM3 x1 Tonometer MM3 x2 ECG ECG MM3 x1 Tonometer MM3 x2 Auxiliary Physical and Environmental Specificat
93. ither end one end is female the other male Connect the male end to the Electronics Module and the female end to a spare communications port at the rear of your computer If you have used a serial to USB adaptor then connect the serial cable to the USB adaptor and then the USB adaptor to a free USB port Check to make sure all connections are secure Step 2 Connect the Power Supply to the Electronics Module Plug the 3 pin Electronics Module power cable into the power supply socket at the rear of the module Plug the Electronics Module power supply into the mains power Turn the Module on by switching the on off switch adjacent to the power supply socket from O to The green POWER light on the front of the module will illuminate to show power is connected to the Electronics Module See Picture below For the MM3 only Each of the Input amp Output indicators will turn on then off in sequence while the Module initialises then the READY light will show orange indicating that initialisation has completed MM2 Module Power Switch Power Connector Serial Connector MM3 Module noCor THE HEART OF MANAGEMENT Power Cable Power Switch Serial Cable Page 17 3 2 2 PULSE WAVE ANALYSIS You may set up the Pulse Wave Analysis system by using any one of the following Electronics Modules OQ MM2 a MM3 Step 1 Connect the Tonometer to the Electronics Module The Tonometer is found in the black tonometer case
94. k 37 RETICCLIER WEN 77 Regulatory AS NZS 3200120 ME 73 AS NZS 320012 E 73 EN ODOL eegene 73 UIT h 73 General requirements for safety rrrrrnnnnrrnnnnnnrrnnnnnnrrrnnnnnnene 73 IEC6G0G01 11998 EEE 73 1800 EO EE EEE EN 12 Page 85 FL aaran 12 IEC60601 1 22000 amp AT 2004 73 Rejection Algorithm cccccessssssssseeeceeeeeeeeeesssssesssnaseeeeeeeessesseegs 45 BA 01e g EE 77 S Safety Mobile Cellular Dhones 12 Second shoulder cccsseeecccceessecccceeseceeeeecceseeeseeeseueeeeeseeeeeeeeees 77 Sie e 16 17 Setting Up amp Installation COMPONE EEE 16 Un Packing REE ER EEEE VEETA 15 PN 18 Tov 27 Software Installation EEE EE ERE 23 SphygmoCor CVMS Installaton 23 Software CD ROM EE 16 Software License Agreement 23 Kehlen E 71 PN 77 SphygmoCor FANN 73 11610 REE EEE EEE seeieueiees 77 Systemi SET UP EEE saN ESE s VEE Eis 18 SphygmoCor Configuration Settings ccccccccssececeseeeeeeeeeeees 58 SphygmoCor Reference Age rrrrrnnnnrnrnnnnnnnrnnnnnnnrrnnnnnsernnnnsssnnnne 39 Stand ManoeuvrePatient Report 56 Stand Manoeuvre Mode ccccccsssecccceeseseccaeseceesaeeeceeseeseseesaees 54 KEN 12 68 E 77 VTM 18 VNR 79 e e 79 Magnetic TC EE 79 Ven TEE 79 Pressure or Impact DaMage ccsccssccssecnsecseccsseensceseceaees 79 EE EE EE 79 Tempera E EE EE 79 VP 79 VEN NE 59 System Serial Number 67 System SpecificationS rorrrrnnnrvrrnnnrvrnnnvnrnnnvvnsnnnvnrnnnnnv
95. k on the Export button e To print a report click on the Print button To print a number of reports at a time click on the Patient button to return to the Patient screen then select System then Baich Print from the main menu To search for reports to print select a start and end date within a two week period then click on the Gei Studies button To print all of the available studies click on the Print All button Alternatively individual reports may be selected by clicking on a specific study and pressing the button To select all studies for printing press the button and then click print on the Print Selected button 5 6 3 4 ANALYSIS OF MULTIPLE STUDIES The Analysis screen is designed to enable viewing and comparison of multiple studies for a patient At least two studies are required to use the Analysis feature To view multiple studies click on the Analysis button e The values for PWV Delta T Distance and Heart Rate are all shown in separate graphs over time To select specific study measurements to view on the graph click on the Select button and select or deselect the measurements by clicking on a particular study The arrow buttons may also be used to select one or select all studies Click the OK button to return to the analysis screen Page 46 3 Repor cua Pulse Wave Velocity Se the pA Se display the value for all time points Click on a single time point to display values for a specific study time and date
96. l Aortic Blood Pressure using Pulse Wave Analysis PWA Arterial Stiffness using Pulse Wave Velocity PWV Heart Rate Variability HRV and Continuous Pulse Wave Monitoring PWM m SphygmoCor Data Audit Trail software guide The primary sections are as follows Preface Provides an introduction to the SphygmoCor System the operating instructions and manual conventions General Precautions Describes the precautions needed to be observed to reduce the risk of personal injury or damage to the SphygmoCor System The section also describes system compliance with safety standards and regulatory approvals Introduction Describes the intended purpose of the SphygmoCor System the background to the technology and an overview of the system s features capabilities and options Setting up amp Hardware Installation Provides the instructions required to begin operating your SphygmoCor System Includes Setting up the Electronics Module and Tonometer ECG cables and leads and installation of the software Operating Instructions Includes instructions to use the system and the software to take measurements Advanced Features Provides instructions on performing advanced tasks within the software such as changing configuration settings and using multiple databases Troubleshooting Guide Provides helpful information on performing selected diagnostic tests and suggested courses of action if the system does not appear to function as describe
97. lbar menu to display any Pulse Wave Analysis PWA reports that were generated during the session either automatically or at a predetermined time interval and or manually from the Snapshot button during the measurement The PWA Report screen will appear To return to the main PWM Report screen click the Session button on the PWA screen Refer to Section 5 5 3 for information relating to reviewing PWA reports e The report can be deleted by clicking the Delete button A confirmation window will appear click Yes to delete the report and No to keep the report Note Only one 1 confirmation window will appear to ask if you wish to delete the report If you click on the Yes button the report will be deleted permanently Ensure you have the correct report and you are certain you wish to delete the report before proceeding with this procedure as delete report ca n not be retrieved e The Report screen can be exported as a graphic joeg only Click on the Export button to access the Export Window Click on the Select button to select the drive and folder on your computer that you wish the file to be saved to and click on the Export button To print a report click the Print button You may wish to select System then Printer Setup from the main menu first to select a printer Batch print is not available for multiple PWM reports but can be used to print the PWA reports generated during a PWM session Refer to Section 6 2 for details on batch prin
98. llator under any circumstances However should a defibrillator be used with this device it is strongly recommended that the use of the device is stopped AtCor Medical should be contacted for further advice CAUTION ELECTROSURGICAL EQUIPMENT USE This system may not be used in conjunction with the use of any electrosurgical equipment under any circumstances USA Privacy Rule This AtCor Medical product stores displays and exports patient health information which could affect HIPAA compliance It is the responsibility of the health care organisation that is subject to the Privacy Rule to ensure compliance with HIPAA regulations AtCor Medical does not make any claim with respect to compliance with HIPAA for its products The Privacy Rule also known as Standards for Privacy of Individually Identifiable Health Information is contained in Title 45 of the Code of Federal Regulations Part 160 and Subparts A and E of Part 164 Cybersecurity If the PC used with the SphygmoCor System is connected to a network or the internet the provider of services is responsible for ensuring the security of the information Page 13 2 Introduction Following is a brief overview of the SohygmoCor System 2 1 THE SPHYGMOCOR CENTRAL BLOOD PRESSURE ASSESSMENT SYSTEM The SphygmoCor System is a non invasive diagnostic tool for the clinical assessment of central blood pressure The SphygmoCor System can derive the central aortic pressure waveform using a pr
99. mentation Pressure and Augmentation Index is plotted by age and sex e The green line indicates the reference population mean 90 of the healthy population lies between the red lines e Clicking on a small graph will change the display so that the selected graph is displayed as the large graph on the screen Click on Reference Range tab to view the Reference Range report System Patient Study Report Analysis Each graph shows the patient s position as the black dot Red lines indicate the 90 confidence interval on either side of the mean green line ysis Privacy Pulse Wave Analysis Patient Information Test Test Click on any of the small graphs to make it the main graph Medications Notes Click on the SEVR graph to display the alternate graph Two graphs alternate between the SEVR plotted by heart rate and SEVR with the Repeat Modify Delete Export Print cut off values for this GR Sphygmocor dt measure 5 5 3 3 REPEAT MODIFY EXPORT AND PRINTFEATURES Additional features are available after reviewing the patient report e To repeat a measurement using the same study settings click the Repeat button to return to the Capture screen and use the tonometer to take a measurement CAUTION When performing a repeated PWA measurement via the repeat button in the report screen ensure that no change has been made which would affect the patient s blood pressure If a c
100. moCor control measurement PWA PWV HRV or PWM it is recommended that the subject should Abstain from alcohol at least 12 hours prior to the measurement 2 Abstain from tobacco and caffeine for at least 4 hours prior to the measurement m Fast for at least 6 hours prior to the measurement however if this can not be achieved a light meal before the measurement is allowed Rest seated or supine position for at least 5 minutes prior to the measurement Perform a SphygmoCor measurement at least 2 minutes after a cuff blood pressure measurement to enable the artery to refill with blood Co 5 3 OVERVIEW OF MODES OF MEASUREMENT When working in the Patient Screen the following measurement modes may be selected from the Mode Panel if purchased e PWA Central Pressure Analysis e PWV Pulse Wave Velocity e HRV Heart Rate Variability e PWM Pulse Wave Monitoring The following flowcharts provide an overview of the steps required to take a measurement on a patient and review the reports within each of the different modes of measurement 0 3 1 COMMON SCREEN FOR ALL MODES The Patient Screen is a common screen for all modes of measurement and the steps to creating a new patient or selecting an existing patient are identical PATIENT SCREEN reate New Faten Select Existing Patient using Enter details of First Name Last Name select PWA PWV PWM or D See i Search or Patent Tabs HRV mode STUDY SCREEN
101. nd on the time axis and corresponds to the secondary systolic peak or shoulder that is caused by wave reflection The pressure at this time interval is identified by a marker on the aortic pressure axis diamond on the pressure axis As for ejection duration ED visual inspection is required to ensure that Tis greater than T and less than ED Time T is identified by a marker diamond on the time axis and the pressure P1 at this point is also identified by a marker diamond on the pressure axis This time is meant to identify the peak of the pressure wave generated by ventricular ejection in the absence of wave reflection The time should correspond to the peak of flow in the aorta and so should be between 80 150msec T4 times of lt 80msec and gt 150 msec are suspect and so then are P and other indices determined from Ti augmented pressure augmentation index If there is a distinct inflection on the aortic synthesised waveform corresponding to the T flag and if T is in the range of 80 150 msec the calculation can be regarded as reliable However if there is no distinct inflection peak or shoulder on the synthesised aortic waveform within this time band then the values of P augmentation pressure and augmentation index cannot be calculated reliably Report Parameter Warnings Before use operators should ensure that there are no conditions present that would impair accuracy of blood pressure waveform measurement in the radial a
102. ng that you cannot delete the database for the reason that it was active If you wish to delete the currently active database you must close it and open a different database before proceeding Database Backup The SphygmoCor software prevents you from deleting a database that has had activity since it was last copied If any database operations have been performed such as adding or deleting a patient or measurement and a database deletion is attempted a Warning message will appear indicating that the database cannot be deleted If you still wish to delete this database then proceed with taking a copy of the database first and then proceed with deleting the required database 6 4 7 DATABASE OPTIMISATION PACKING A DATABASE You can perform a database optimisation at any time and if one has not been performed in a certain period of time the software will prompt you to perform one This feature optimises and repairs the database and is much like performing a disk clean up or defragmentation program on your computer Warning It is essential that a back up of all your databases is performed prior to performing a database optimisation Failure to do this may result in complete loss of data e lf aback up copy of the database has not been performed follow the steps in section 7 4 4 to make a copy e To perform the database optimisation click on the Patient button to return to the patient screen select System then Database then Pack from t
103. nnnrnnnnnnnrrnnnnnnsernnnnnee 44 e EE 74 75 76 eler ER Mandatory NN 35 Me 35 NO sesso ersite cadena E E E 35 Bin ET ER Bed 0 EE 35 W GLO Ae iivsnsaiasnnaddnacwactancsonssasbvandasntidacesdeosnuctapecbasddeonsussabesyudspettes 35 PIG CIAL EE 28 e AE ER Pl 29 Pl 31 EEE 30 eieiei glad Ce ER TE 77 FOOTSWILE EE 21 Pe 78 GL 16 H Haemodynamic Parameters 77 Head Office ii Heamodynamic Evaluations csssccccsesssececeeeseeeeseseceseeeeeeeees 9 Heart parameters sanere 77 Heart Rate Variability Luranscesaerrseasenamensmansesarndnsen 14 EN 77 lee 9 51 Clinical Report Vagal Index rrrronnrrnnnnnnrrrnnnnnrrnnnnnnrrnnnnnnnene 55 Delete a Patient Report 57 ECG Electrode Placement s nnossnnnssssenessreressreressreressreressserens 51 Entering Study Details 51 Export as a Graphic or Text 57 FOW CA asses ace ace EEN 32 Frequency Domain Analyse 55 HRV Calculation Patient Report 54 Mode of Measurement srerircicrersrisnrerireisereroreririici tnni 52 Modify Study Detail 57 Paene REDOT einan S 54 Recording ECG Signal 53 Show ECG on Patient Report 57 Time Domain Analyse 54 HRV Calculation Mode 53 I Lee EE EE NR 27 MATOS EE 58 KA PEE satcect eases AA O 77 Initial peak eee cesseccccesssececceeeeceseeeccecseeeececseaeecessueeeeeesaegnses 77 ao EE EEE EE EE EE NN ENE 20 ae geleet ge EEE EE EE 14 Central Blood Pressure rrrrrnannrrnnnnnnrrnnnnnnrrnnnnnnernnnnnssennnnnnsene 14 Heart Ra
104. no need to enter the patient details again simply search for the patient following the instructions below and proceed with the measurement 54 1 CREATE A NEW PATIENT ENTRY To create a new patient click on either of the New buttons e When the confirmation to create a new patient window appears click Yes e Enter the patient details as required Last Name First Name Date of Birth and Sex must be entered to proceed all other fields are optional Use the mouse or Tab key on your keyboard to move between the fields e Click Save when finished to add the details of the patient to the database Note Before creating a new patient entry please check if the patient already exists in the database as separate patient entries cannot be merged Click Patient to display patient screen Use this screen to Pulse Wave Analysis E gt Mode Last name Patient Search enter a new patient or pang aS search for an existing bat Nimes T Hest None Maki patient Fint ne ode Puy Add patient osoen l details to fields Search Reset as required Click on one of the New buttons labeled New to enter a new patient Click Save to enter patient into database Button will be active after clicking the New button Patient File Summary Te ast Click Yes when the Se hea confi rm ation window Humber CN Studies appears First Study 23 Noe 2009 09 27 Lat Study 23 Mow 2009 09 31
105. nometry waveform for carotid and femoral measurements Study Information Operator Height Weight BMI Medications Green dots indicate data sets used for calculation Red stars indicate data sets omitted from calculation Notes Statistical table Acceptable SD waveform pair values are displayed SECHER in green indicating 2 an 200 132 low variation 14 Feb 2010 17 04 37 414 Feb 2010 20 17 53 Bee H dili Displays results compared I i to age based reference NE E 2 range Active Database DATA e PWV value standard error of the Graphs individual time differences for carotid mean SEM and femoral measurement SR Values displayed in green indicate low variation CHECK THE QUALITY OF THE RECORDED PWV MEASUREMENT Review the Quality Control parameters on the report Measurements not considered to be of sufficient quality should be repeated e Confirm that the R wave is clearly defined and has the highest amplitude of the ECG signal e Confirm that the foot of the pressure waveform i e the initial upstroke is clearly identifiable e SD values displayed in a green indicate an acceptable level of variation Values in red indicate a high level of variation in this instance the measurements should be repeated The difference in heart rates between Site A and Site B measurements should not be more than 5 beats per minute bpm CO e Recorded Waves Quality Control Indices
106. nput Impedance Type IP Rating 5 uV V mmHg 0 300 mmHg Un calibrated Calibrate manually with Sphygnomoneter Atmosphere DC 40 Hz 128 Hz Auto 3 Lead modified Lead II 0 5 30 Hz PWV 128 Hz Auto HRV 1024 Hz BNC 5 to 5 V DC 40Hz 128 Hz Calibrated User adjustable V mmHg or Un calibrated Tonometer Input Auto 50mV 30 250 mmHg 1 30 50 mmHg 3 50 250 mmHg gt 720 kQ Micro switch IPX8 1 0m Page 72 Output Signal Specifications Output Specification Output 1 amp 2 Connector BNC MM3 Only Signal Range 5 to 5 V Frequency Range DC 30Hz Calibration Calibrated User adjustable V mmHg or Un calibrated Tonometer Input Gain amp Offset Adjust Auto Pressure Range 30 250 mmHg Output Signal Accuracy 1 30 50 mmHg 3 50 250 mmHg Output Impedance gt 100 kQ Maximum Intended Design Life The Maximum Intended Design Life of the Electronics Module is 5 Years The Maximum Intended Design Life of the Tonometer is 3 Years PC Interface Specifications Specification Minimum Computer PC or notebook computer with Requirements Pentium Processor P4 or greater 1 GB RAM 1024 x 768 256 colour XGA display smaller default text size 60GB initial free hard disc space CD ROM drive Windows standard printer drivers Dedicated USB port Windows XP Prof Vista Business or Windows 7 Prof Communication Interface RS 232 Serial Use supplied
107. nrnnnnnnsnnns 72 T EEE ENE EN 78 EE ENN EE EE 77 Tr 77 TENSION Time Index nenene aaa 79 TN 78 Time relative points 77 Timing poarameters 78 EEGEN EST ae 67 TononmeterDisconnectng 18 20 Tonometer CONNEC S re E E ET T 18 PWV Millar Tonometer 16 A E E vii Temporary Storage Holder V Tonometer Gog 115301 0 ERE EE EE EE EE EE 20 TonometerTemporary Storage Holder 39 TonometerTemporary Storage Holder 67 Toron acrais E 80 Tonometer Serial Number 58 E EE EEE EEE E E 77 TDN 19 TE NON 70 Electronics Module 70 NEVNT 70 TM 79 U VU NN 77 USA PRIVACY RUG sscuassaccinsasnetinadneniiwedoniaaietenteindaseuiiuadedeinedseieyiee 13 Page 86 V Valsalva ManeuverPatient Report 56 Valsalva Manoeuvre Mode rrrrrrnrnnnrnnnnnrrrrnnvrnnnnnrssnnsvnnnnsnsssnnnnn 53 W Warning Safety Leakage Currentzs 12 NON EE nese ste eerste emerson 12 EECHER ee 67 Waveform ETC 77 VWavetormsAveraged 77 SphygmoCor AT THE HEART OF CARDIOVASCULAR MANAGEMENT Head Office AtCor Medical West Ryde Corporate Centre Suite 11 1059 1063 Victoria Rd West Ryde Sydney NSW 2114 Australia Phone 61 2 9874 8761 Fax 61 2 9874 9022 USA office AtCor Medical inc One Pierce Place Suite 295 East Itasca IL 60143 USA Phone 630 228 8871 Fax 630 228 8872 Email inquiry atcormedical com Web www atcormedical com SphygmoCor is a registered trademark of AtCor Medical Pty Ltd Page 87
108. ny electronic components of the system by not over spraying or allowing detergent to run 7 10 REFERENCES Refer to our website www atcormedical com publications html for a current list of SohygmoCor publications Page 80 7 11 ELECTROMAGNETIC COMPATIBILITY EMC WARNINGS amp DECLARATIONS O The SphygmoCor System needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual 2 Portable and mobile RF communications equipment can affect the SohygmoCor System O Operation of the SphygmoCor System during capture below the minimum digital unit signal amplitude Pulse Height specified below may cause inaccurate results O PWA Capture Pressure Pulse Height 80 O PWV Capture Pressure Pulse Height 80 ECG Pulse Height 80 Oo HRV Capture ECG Pulse Height 80 02 Use of tonometers accessories and cables other than those specified or supplied by AtCor Medical may effect EMC compliance of the SohygmoCor System Warning The SphygmoCor System is intended for use by healthcare professionals only The SphygmoCor System may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to take mitigation measures such as reorienting or relocating The SphygmoCor System or shielding the location Page 81 7 12 EUROPEAN DECLARATION OF CONFORMITY Declaration of Conformity Manufacturer AtCor Medical Pty Ltd
109. on to begin data capture The Signal Pressure and Signal Trend areas will become active Step 3 If a time was defined for report generation on the Study screen PWA reports will 5 7 4 automatically be generated at the specified time A PWA report can also be generated manually at any time by clicking on the Snapshot button To include a note on a manually or an automatically generated snapshot type the desired text in the Note field prior to the snapshot being taken The section above the signal area will turn green when a snapshot is being taken SphygmoCor Pulse Wave Monitoring mmm fee abort Fee Step 4 When an uncalibrated device is being used updated blood pressures can be entered in the relevant fields if required Enter the new blood pressure values and click on the update button Step 5 If an Output Channel has been selected Click on the Event Marker button to indicate a specific event that occurred during the session SphygmoCor Pulse Wave Monitoring Enter or lt Snapshot gt to generate a PWA Report Notes Event Abort Step 6 Click on the Calculate button when the measurement is complete to save the data and generate any reports that are available Note The measurement can be cancelled at any time by clicking on the Abort button No data will be saved and no reports will be available REVIEW THE PATIENT REPORT After clicking on Calculate button during the data capture the Report screen will automat
110. onics module 5 8 1 ENTERING STUDY DETAILS Open the Study Screen by clicking on the Study button or pressing the F3 button on your keyboard This screen will allow you to enter the study details and to proceed to Capture data The patient should be lying down comfortably with their arms by their side Attach the three ECG electrodes and leads to the patient Note Do not reuse disposable electrodes Old and dried electrodes will provide poor ECG signals Wipe the skin with an alcohol wipe where the electrodes will be placed If excess hair prevents the electrodes from sticking shave the location of the electrodes Remove the tape from the back of the electrode and place the electrode on the skin in either the peripheral orchest configuration as required and attach the leads as shown in the following diagram Page 51 Place electrode on inside of wrist and connect left arm LA lead black clip Place electrode on inside of wrist and connect right arm RA lead white clip Place electrode on left leg above the ankle and connect left leg LL lead red plug Peripheral limb location most frequently used Place electrode just below supra sternal notch and connect right arm RA lead white clip Place electrode on chest over sternum and connect left leg LL lead red plug NS Place electrode just above the left hip and connect left arm LA lead black clip Chest location w
111. ort Privacy Help Patient Study AUO Mi Heart Rate Variability Time Frequency Clinical Patient Information DA Low Frequency To High Frequency Ratio Patient ID GO Li EE E E EE EE EE Birth Date 02 Jan 1950 j d d Age 60 Sex MALE KR mee H GG w Frequency pie Power Spectrum Chart Graph Operator Height Weight BMI Medications Notes 005 04 015 02 03 035 04 045 05 75 1 LF MW 24 9 HF Iz 0 25 Frequency Hz Low Frequency Maximum Hz Low Frequency Power Normalised Absolute Low Frequency Power ms 04 Mar 2010 20 42 07 04 Mar 2010 20 54 16 High Frequency Maximum Hz High Frequency Power Normalised Absolute High Frequency Power ms 04 Mar 2010 21 16 41 HRV frequency parameters LFIHF Ratio Total Power ms wa Derete export Se H e The Power Spectrum Graph is a plot of R to R Interval signal power at various frequencies The Grey regions represent Very Low Frequencies and Very High Frequencies The Blue region represents the Low Frequency LF range 0 04 0 15 Hz and the Black region represents the High Frequency HF range 0 15 0 4 Hz e The Frequency Pie Chart visually displays the balance between LF and HF activity e The HRV Frequency Parameters are statistical parameters calculated from the Power Spectrum Clinical Report The RMSSD variable for the patient is plotted against age expressed as Vagal Index and is displayed with
112. ould have minimal variation between each waveform Note Ensure you consider all the quality control data when making an assessment of data quality Do not discard any measurements on the basis of one value alone Page 37 Ehe Detailed Report REVIEW PATIENT REPORT The Detailed Report provides all of the patient s results in a detailed report which includes captured and derived waveforms as well as the numerical values for all of the key parameters as shown in the example below Contains patient information entered in on the Patient screen Information relates to this particular study entered in on the Study screen Number of assessments taken and recorded by date and time Click on one of the measurements to review the report Clinical Report Click on Detailed tab to view the Detailed Report screen SphygmoCor Cardio ular Management Suite System Patient Study Report Analysis Mode Privacy Help Seel se Detailed Clinical Reference Range Pulse Wave Analysis Patient Information Test Test Patient ID Birth Date 02 Jan 1970 Age 40 Sex FEMALE Patient Data Address Patient Code Study Data 27 Jan 2010 8 29 42 PM Quality Control A Study Information Operator T 800 1 000 Assessment 5 of 5 e Height Weight BMI 154cm Medications Notes Interpretation Study Time 23 Nov 2009 09 27 44 23
113. p 1 Turn your computer on Locate the SohygmoCor Software Suite CD ROM into the CD ROM drive of your computer Step2 A Micromedia Flash Player screen should automatically appear Select Install SohygmoCor Software Start Here to begin the installation process Step3 When the Software License Agreement screen appears read the terms of the agreement and select Agree to continue the installation Step4 On the Welcome screen click Next to continue Step5 On the Choose Destination location screen click Next to accept the suggested destination folder C AtCor SphygmoCor CvMS V9 To change the location enter an alternative folder name location Steo6 The Select Program Manager Group screen will appear The default folder name SphygmoCor CvMS V9 will appear Click Next to continue The Start Installation screen will appear Click Next to copy the software to your computer Step7 The Disconnect Module screen will appear Ensure the module is not connected to the computer Click OK Page iv Step 8 The Installing screen will appear showing the files being copied and installed on your computer Step 9 When the software installation is finished the Installation Complete screen will appear Click Finish to exit the set up process 3 Hardware Installation The tonometer is connected to the electronics module and can be accessed by opening the tonometer drawer e Connect the footswitch if desired by inserting the connector on
114. p 2 Select Patient Listing by clicking Patient then Listing or by pressing F2 Step 3 A confirmation window will appear to confirm if you would like to proceed with the listing Click Yes to proceed Click No if you don t wish to proceed Note For large databases the listing may take some time to complete Ensure that the printer is ready Page 59 6 4 6 4 1 Step 4 A preview of the report will be displayed e Patient Listing E T n ul 5 al ga EE SphygmoCor Patient Listing Patients 25 Studies 35 Surname First Name Date Of Birth Studies First Study Last Study Compliant Artery 23 Jul 197 2 23 Aug 1999 25 Oct 1999 Patient E 25 Dec 1943 2 29 Sep 1999 09 Jul 2001 Patient 5 01 Jan 1964 1 29 Sep 1999 29 Sep 1999 Patient S 01 Jan 1967 1 30 Sep 1999 30 Sep 1999 Patient J 13 Jan 1937 1 30 Sep 1999 30 Sep 1999 Step 5 Click on the printer button on the tool bar at the top to print DATABASE MANAGER Database Manager allows you to create new databases change between different SphygmoCor databases and to copy databases You may have the need for more than one database if multiple clinics or doctors are using the same system and would like their patients to be in their own databases Click System then Database from the main menu A SphygmoCor Multiple Databases Manager window will appear This menu option is only available when you are in the Patient Screen SELECTING A DIFFERENT DATABASE
115. pt away from equipment that may emit excessive noise such as an MRI or X ray and hence affect the quality of the ECG signal ECG placement and signal Ensure the ECG signal is steady and clear and that the wave z on the ECG trace is the largest amplitude of each waveform R HRV Calculation mode Click on the Start Session button to begin recording the ECG signal The beat to beat R to R intervals chart the bottom window is activated and updated every 5 seconds Values relating to Elapsed Time Number of Pulses Average R to R Interval and Average Heart Rate will also be activated and updated every 5 seconds Click Calculate to complete the session and capture the data It is recommended that a minimum of 5 minutes of ECG recording is captured particularly if the Vagal Index Normals report graph is required Valsalva Manoeuvre Mode Allow the patient to sit comfortably and breathe at a normal pace for a minimum of 5 minutes prior to the start of the measurement The Prepare to hold breath prompt will be displayed in the message alert area Ask your patient to breathe normally but be prepared to blow against the strain gauge when the measurement starts Click Start Valsalva to begin the measurement Page 53 e The prompt Blow against 40mmHg Now will now appear and will remain for 15 seconds The patient must blow exhale air into the mouth piece of a manometer to a pressure of 40 mmHg for 15 seconds e The promp
116. r SohygmoCor System Product Code Px D em ee Inc Software Guides Serial Cable 2m 1 0 gt USB Adaptor Ooo o ECG Cable Conmed D8314ll 06 2m ECG Leads Conmed DL24 03ll 0 5m Power Cable 2m a a i AtCor Medical reserves the right to modify the design and specifications contained within without prior notice The product or component pictures shown in this manual may vary compared to the system supplied to you Page 15 The picture below shows the contents of the SohygmoCor system Note that items shown vary depending on the configuration you purchase The picture below shows the main items in the Px D system Software CD Operators Serial Cable Tonometer Electronics Power Cable Manuals Module The picture below shows the SphygmoCor PVx amp PHx system TU Mi Sieg TILL somrer Se Page 16 Oe SYSTEM SET UP To prepare the system for operation follow the instructions below for the particular configuration you want to set up AC POWER amp SERIAL CABLE Step 1 Connect the SphygmoCor Electronics Module to the Computer Use the Electronics Module Serial Cable which has 9 way D connectors on e
117. r local waste administration The crossed bin symbol invites you to use these disposal systems If you require information on collection and disposal of your AtCor Medical device please contact AtCor Medical Head Office or local distributor REGULATORY CAUTION Federal USA law restricts this device to sale by or on the order of a physician or properly licensed practitioner Page iii SphygmoCor Quick Start Guide QUICK START GUIDE This Quick Start Guide will briefly explain how to install the SohygmoCor System its accessories and software Please consult the manual following the quick guide for detailed instructions as well as other important information and tips 1 Unpacking SphygmoCor System Open the carton and carefully unpack the SohygmoCor System Inspect the contents of your system including all accessories and documentation Check to ensure you have all of the following items in your SohygmoCor system e SphygmoCor Electronics Module e Tonometer SPT 304 e Software CD ROM Includes software guides e Serial Cable e USB Adaptor e Footswitch e ECG electrodes cable and leads located in cardboard accessories box in the shipping carton 2 Software Installation The SphygmoCor Software Suite CD ROM supplied with your system contains the installation software to install the SphygmoCor software on your computer Complete the software installation prior to connecting the module to your computer Ste
118. r study parameters Step 2 Click the Session tab a Select either the radial artery or aortic check box depending on the location of the tonometer sensor or catheter Enter information into the Medication Notes Operator and Anthropometric fields if desired b If an uncalibrated signal will be used ensure the Calibrated checkbox is not checked and click the checkbox for either Tonometer or Auxiliary c Ifa calibrated signal will be used check the Calibrated checkbox and select the blood pressure device that will be connected to the electronics module If the device is not listed select Custom and enter the Calibration Ratio and Calibration Offset of the connected blood pressure device Step3 Click the Control tab a Check and select desired times for the Trend Sample Period Report Generation Period and a Trend Minimum Window Length if desired b Check the peripheral artery and or derived aortic signal boxes in the Output Channel Select window if either or both of these waveforms are required to be sent to an analogue output c Click on the Auto Scale Trends checkbox to enable zooming on the haemodynamic parameter trend graphs during session monitoring if desired Page vi Step 4 Click the Capture Data button to proceed with data capture Ensure that a consistent pressure waveform is displayed on the data capture screen Step5 Click the Start Session button to begin the measurement Click on the Calculate button to comple
119. ray or in the temporary storage holder in the front of the module Q Do NOT use this Tonometer with any other instrumentation other than that supplied by AtCor Medical m This Tonometer is intended to be used in conjunction with the AtCor Medical Electronics Module only which has a floating isolated grounding system O The Tonometer should be cleaned routinely every month or when it becomes dirty Users who record waveforms at the Femoral artery site should clean the Tonometer between patients Disinfection Instructions The SphygmoCor product is considered a non critical device Therefore a low level disinfection method has been provided to assist users to disinfect the tonometer which is the only patient contacting component of the SohygmoCor system see below Use a 70 Isopropyl Alcohol IPA impregnated wipe or spray for low level disinfection Allow a contact time of at least 5 minutes CAUTION Do not immerse the tonometer in IPA or any liquid as this could damage the tonometer electronics Do not use coarse cloths for wiping the tonometer as this will damage the sensitivity of the transducer Cleaning Instructions The best choice for cleaning is a neutral or near neutral pH detergent solution as these solutions generally provide the best material compatibility profile and good soil removal Gently wipe the enclosure and cables with a soft cloth and detergent CAUTION Ensure detergent does not ingress into a
120. reen Green bars indicate low variation yellow bars medium variation and red high variation o Auto Capture will capture the waveforms when there have been at least 11 continuous seconds good quality waveforms e The COMM port or communications port is the port that the serial cable from SphygmoCor has been connected to your computer Page 58 6 2 6 3 PRINTER SETTINGS AND BATCH PRINTING When the Print option is used on any of the screens the software will automatically print to the location as per any settings defined in the Printer Setup window To check the printing settings select System then Printer Setup from the main menu The Printer setup window will appear and you can check or correct any settings prior to printing Click OK to confirm the settings Note Printing in SphygmoCor has been optimised for A4 printing changing to any other setting may produce un desirable results Paper Orientation has been set to Portrait SohygmoCor will not allow any setting other than Portrait To print a number of reports at once in either PWA or PWV mode click on the Patient button then select System then Batch Print from the main menu The Batch Print window will appear To search for reports to print select a start and end date within a 2 week window and click on Get Studies The available studies will appear in the left hand window e To print all of the studies that have been listed click Print All e To print some of
121. ressserens 62 Updating A Database Caution 62 VP 60 MA pa EEO E 70 MV E 62 Database access ertror 70 Page 83 Database corruption rrrrnnnnrrrnnnnnnrrrnnnnnvnnnnnnrsrnnnnnsrrnnnnssrnnnnnnee 70 Database Manager 60 Database Optimisation geueuges un eeen eegen 62 Deleting A Patient Entry ssccccsssssccsssssscesscssssesscsssscssesssess 34 Delta T Rejection Algorithm rrrnnnrnnnnnrnrrnnnnnrrrnnnnnnrrnnnnnnrrnnnneene 45 Desktop Systems 15 Detecting Module 70 Diastolic Time Index 79 Double Insulated is ege EEN 73 D EEE EEE lave Sarena EE EEE 77 EEE EEE 79 E EE ERE EE 20 ECG CAD EE Segeetbegieuegege 20 ECG Electrodes NN 42 51 ECG Signal TC 53 DEE EEE E ETE 77 de EE 77 FEIN DUNN eoria Erne OERE EERS 77 78 Electronics lege 16 27 Floating isolated ground ceeeecccececeesseecceeeeeeeeeeeeeeeeeeeees 80 MING 17 Power Cabile 17 Power supply Socket rrrrnnnnnnrrnnnnnnrrnnnnnnernnnnnnrrnnnnnssrnnnnnsssensnne 17 Trouble Shooting savannen 70 Enable Re ENE EE EE EE EEE 35 Error eu A 70 Geer De EATE E E PET ganas A E ies 70 PN 77 European Regulatory Office ii Export All Measurements ccccssssecceceeeceeceseeceeseeeeceeseeeeeeesaeaeeeeeeas 63 Mel 74 75 76 PAN 64 Single Measurement rrrnnnnrnnnnnnrrnnnnnnrrnnnnanernnnnnnernnnnnnsennnnnnseee 65 Export t Data ase Laupsa 64 EXO MIRED Abe vr vl EG 63 F Fast Flush Test 65 Femoral Measurement For PWV rrrnnnnnnnrnnn
122. rm shape will remain the same For example the effects of aging are seen in the waveform of a middle aged person as an increase in amplitude of the second systolic shoulder and a decrease in amplitude of the pressure waveform during diastole The discussion and illustration below provide guidance for review of the radial waveform to assure good data quality 1 A sharp nearly linear initial upstroke of the pressure 3 waveform for at least 80 msec Bumps or noise in the upstroke will be incorrectly interpreted by the analysis software as the end of the initial pressure wave 2 A peak in some cases an inflection point or shoulder between 80 and 150 msec 3 A late systolic shoulder between the first peak and incisura The location of this shoulder will differ depending on the age and disease In older persons this shoulder may in fact be a second peak In very young people this may not be detectable 4 The incisura marked on the sample waveform at left by a 5 vertical dotted line will be located after the late systolic shoulder and immediately before an inflection of the radial pressure waveform 5 The pressure through diastole should smoothly decrease to approximately the same pressure as at the beginning of the waveform It should nowhere be flat Waveform Criteria The following criteria should be applied to waveform data available on the SphygmoCor Clinical and Detailed Report Screens as a means of assuring data quality
123. rom the electronics module to external recording equipment is desired during data capture Step 2 Attach the three ECG electrodes and leads to the patient in a modified Lead II configuration or using the patient s limbs as indicated on the cables Step3 Click the Capture Data button to begin the measurement To begin data capture click the Start Session button a For an HRV Calculation measurement a minimum recording time of 5 minutes is recommended Click the Calculate button to complete the measurement session and save the data b Fora Valsalva Manoeuvre or Stand Manoeuvre measurement follow the prompts as they appear on the screen Click the Calculate button after a minimum of 60 seconds to complete the measurement session and save the data Step 4 To begin the measurement session in each HRV measurement modality click Start Session Steo5 The Add Marker and Abort buttons will become active once the Start Session button has been clicked During the Stand Manoeuvre and Valsalva Manoeuvre measurements prompts will appear in the message alert area for you to follow The Calculate button will become active once the minimum required recording time has been completed Step6 The report s can now be reviewed To perform a measurement on a new patient click Patient and repeat this procedure or use the Search feature to search for an existing patient Continuous Central Blood Pressure Monitoring PWM Step 1 Click the Study button to ente
124. rtery The radial pulse should be identical in both arms within the perception of the examining physician and arterial pressure by cuff sohygmomanometry should be within 10 mmHg systolic prior to use Since peripheral vasodilatation as reactive hyperaemia caused by arterial obstruction alters brachial wave transmission at least 2 minutes should elapse after use of the cuff sphygmomanometer before radial pressure waveform recordings are taken The system is not applicable in generalised constriction or localised spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud s phenomena or intense cold The SphygmoCor system should not be used on persons with significant aortic valve stenosis gradient gt 60mmHg Values of parameters determined from ejection duration when ejection duration values are outside the range 200 450 msec should be disregarded Values of parameters determined from P1 and T1 should be viewed with caution when T1 is outside the range 80 150 msec AtCor recommends repeating the measurement and where T1 is consistently outside the range strong consideration should be given for not retaining the data Page 68 1 4 ASSURING QUALITY OF PULSE WAVE ANALYSIS MEASUREMENTS Features of the Radial Artery Pressure Waveform that Identify a Good Quality Waveform Certain features of the radial artery pressure waveform may vary in position but overall wavefo
125. s Step 2 Connect the footswitch at the rear of the MM3 Electronics Module see below Connect the 1 footswitch in the Footswitch 1 position This will allow you to use the footswitch to capture the waveform when in the Capture Screen You may also connect the 2 footswitch at this time Connect Footswitch 1 Step 3 Place the footswitch on the floor To use the 1 footswitch when in the Capture Screen press the footswitch gently to active the capture request in any mode This is equivalent to pressing the space bar on the keyboard Page 21 4 Software Installation The SphygmoCor Software Suite CD ROM supplied with your system contains the software needed to install the SphygmoCor software on your computer Complete the software installation prior to connecting the module to your computer If the SohygmoCor Software is pre installed on a notebook supplied by AtCor Medical you may proceed to the Operating Instructions in this Manual 4 1 INSTALLING SPHYGMOCOR Turn your computer on Locate the SphygmoCor Software Suite CD ROM in the accessories box and insert the disk into the CD ROM drive of your computer Step 1 A Micromedia Flash Player screen should automatically appear Select Install SohygmoCor Software Start Here to begin the installation process d men EE bh SphygmoCor 4 THE HEART org CARDIOVASCU Ai MANAGEMENT C Install SphygmoCor Software Start Here C Install Acrobat Reader Software
126. s button to generate the PWA report A second confirmation window will appear for the carotid waveforms click on the Yes button to use the carotid transfer function or the No button for the waveform to have no processing applied The PWA report can be viewed by clicking on the Patient button to return to the patient screen and then clicking on the PWA button to return to PWA mode Click on the Report button to go to the report screen and select the study using the date and time stamp of the PWV measurement Refer to Section 3 4 3 for information on examining a PWA report and reviewing the Quality Control parameters Note for the correct calibration of the Carotid Waveform the SohygmoCor software requires the mean arterial pressure MAP and diastolic blood pressure DBP values not the SBP and DBP values Use the modify button to delete the SBP value and add the MAP value A typical method for calculating the MAP is to add diastolic pressure and 1 3rd of pulse pressure e Study details can be modified by clicking on the Modify button Brachial blood pressure values notes medications height weight carotid femoral measurements and site location can be modified e The Report screen can be exported as a text or graphic file i e jpeg format by right clicking on the Export button and selecting As text or As graphic Click on the Select button to select the drive and folder on your computer to which the files should be exported and clic
127. save the changes or Cancel to ignore the changes A confirmation window will appear click Yes to proceed with the changes To delete the patient s details and reports if any are available click Delete Two separate confirmation windows will appear asking you to confirm that you wish to delete the patient and any reports associated with the patient permanently from the database Click Yes to confirm CAUTION Deleted data is permanently removed from the database and cannot be retrieved Active Database DATA Click Edit to make changes to a patient s details or to enable the Delete button Click Browse to return to Browse mode to prevent any unanticipated d changes Active Database DATA Edit Mode Click Delete to delete a patient from Indicates that you are in Edit Click Save to save the changes the database This action will Mode and changes can be made to the patient s details This permanently delete the patient details made to the patient s details button will become active during Edit and any available reports from the mode after a change has been database made 5 5 CONDUCTING A PULSE WAVE ANALYSIS PWA ASSESSMENT Page 34 0 0 1 ENTERING STUDY DETAILS Open the Study screen by clicking on the Study button or pressing the F3 button on your keyboard This screen will allow you to enter the study details and to proceed to the Capiure Data screen e A brachial blood pressure measurement should be
128. t Relax and Breath at a Normal Rate will appear The patient should relax and breathe normally until the end of the measurement e Click Calculate when it becomes active after 45 pulses to capture the data It is recommended however to keep recording for a maximum of 60 seconds for valid results Stand Manoeuvre Mode The patient should be supine and breathing at a normal pace for a minimum of 5 minutes prior to the start of the measurement When asked to stand the patient should be able to move their legs off the bed and stand easily swiftly and smoothly without being tangled in bed sheets or ECG cables The Prepare to Stand prompt will be displayed in the message alert area Ask your patient to breathe normally but be prepared to stand when the measurement starts Click Start Stand to begin the measurement e The prompt Stand Up Now will appear and the patient should go from a full supine to a full upright position The patient should remain standing until the end of the measurement e Click Calculate when the prompt Calculate Stand Manoeuvre Now appears after 60 seconds The Calculate button will become active after 45 pulses 9 9 REVIEW THE PATIENT REPORT After pressing the Calculate button the Report Screen automatically opens The report that automatically appears relates to the measurement you have just taken You should check data as explained in the following sections on the Report screen 9 9 1 HRV
129. t the icon s name or the text you are to type in is represented in this type face ENTER Page 11 1 4 ELECTRICAL SAFETY WARNINGS of the following warnings associated with conformance of the SphygmoCor System to IEC60601 1 are applicable 02 IEC60601 1 1compliance is the responsibility of the end user To ensure compliance to IEC60601 1 1 the SphygmoCor System must meet the following conditions 02 The PC and peripherals e g USB hubs must comply with IEC60950 or equivalent and must not be located within 1 5m approx 6ft from the patient AND 1 The enclosure leakage current from any device within the patient environment including any parts of equipment which extend into that environment is not more than 0 1mA in normal condition and 0 5mA in the single fault condition of interrupting an earth conductor in any single power supply cord for the U S A the single fault limit is reduced to 0 3mA The required low enclosure leakage current may be achieved by powering the PC and peripherals from an isolation transformer Connecting the SphygmoCor system to other non isolated monitoring equipment or communication networks is not recommended It is the end user s responsibility to ensure compliance with IEC60601 1 and IEC60601 1 1 IEC60601 1 1 SAFETY WARNINGS Ensure that only the SphygmoCor Electronics Module Tonometer ECG Cables and footswitch are within reach of the patient The computer and other devices should be at least 1
130. t AtCor Medical Product Support Whenever you select export data the following window will appear SphygmoCor Export E BIK Export file D VA C D rh Sp hygm o Co r Cy MS VEE po tl I DATA O SMar2 Se e ct Export All Measurements 6 5 1 EXPORT ALL MEASUREMENTS IN THE DATABASE Step 1 From the Patient screen select System then Database then Export As Text from the main menu Check Module Find Module Patient ID Database Export As Text Frinter Setup ppor tio Utaha Batch Print SE Hack Exit Step 2 The Export window will open Use the Select button to choose the Windows folder and or file name for export Step 3 Click the Export button progress bar shows you how much of the export has been completed At the end of the operation a status message appears in the Export window indicating how many records were exported Step 4 Click the Close button Page 63 6 5 2 EXPORT TO DATABASE PWA ON This function allows you to export selected reports from within a 1 month period to a database Each time you export to this database you will be given the option of replacing the reports previously exported or adding to them In this way you can create a database of selected reports from various patients over various time periods Step 1 From the Patient screen select System then Database then Export To Database from the main menu Study Report Ana Patient lysis Mode Privacy Help
131. t not operating correctly Choose a good location clear of clutter and other high activity areas Pressure or impact damage Do not apply heavy pressure to the Electronics Module or subject it to strong impact Excessive pressure or impact can damage electronic components or otherwise cause malfunctions Temperature The room in which the System is used or stored should have an ambient temperature of 15 30 C 50 85 F and relative humidity of 20 80 WARNING Do not expose the unit to dirt moisture or dust Exposing the unit to dust or moisture could cause it to fail Don t place the unit in direct sunlight If you place the unit near a window leave it inside your car or take it outside in direct sun it may overheat and damage internal components Magnetic fields Magnets television sets radios large electric motors or any other source of strong magnetic fields will effect the operation or may cause it to fail WARNING Do not place any components near strong magnetic fields Liquids Liquids on or inside any components of the System can cause irreversible damage WARNING Do not spill liquids on any component Weight Weight applied to the top of the Electronics Module may cause the unit enclosure to crack and other parts to be damaged WARNING Do not place any objects on top of the Electronics Module Movement Sudden jolts can cause damage to the unit or the Tonometer if it isn t restrained WARNING Do not shake or drop
132. te Variability orrorrnnnnnrrrnnnnnrrrnnnnnnrrnnnnnnrrnnnnnssrnnnnne 14 Pulse Wave Velochtwy 14 L Lead Wies ceecccccsssscceceesscccecceesececeeeecessueecessuaecessuaneceeessagsses 20 M Maximum Pressure pl 78 METER 78 Measurement Mode E 28 Measurement Units sicesicwesseciscnassacsscceninasesanuisesersaborccanseawedanmesaces 58 MAN seca EE E E encswena A A 58 Minimum Pressure Dp 78 RE 16 18 VE 54 16 18 TEEN 77 N Vleit SE Notebook PT 80 Pre Installed Software 23 Page 84 O Operating Instructions wiccsscsssscsccutsesiscsnsacunsanensdnpsaussscceaunssensaxceens 27 General 27 Heart Rate Variability Assessment rrrrrrrnnnnrrrrnnnnnrrrnnnnnnrrnnnn 51 Preparation ECG Electrodes cccccesececeseeeeeseceeeeeceeenes 42 51 Operator MOEK ee 37 ML 21 MUMLER 21 Gil En ee 21 D E 77 EE 77 Packing A Database nnneeseenneseeenn See Database Optimisation Paper ENNO ee 59 PN 78 Parameter SUIMMANY LuarsaeaeseeasGss Gea Gneis 77 Gel 77 Patient Create New Patient Ent 33 TUE 34 e GEN 34 Search For Existing Patient 33 Patient Entry NPE 33 FT 33 Petr 59 PN 77 Peripheral Wavetorm 77 Peripheral Wavetorm 78 Portable Systems scssscncsssadensssassancdvrsdiaesberaandeneddanserebanctaaacetonces 15 POUL E 59 eg hhv 16 17 POT 70 Poll 17 POWER Sokkel EE 17 PUD REE EN EE EEE SE NE TT 77 PLOCAULIONS eebe 13 Pressure At 1st PEAK casccissscrswevcasavesvetaatenveasavesectabiweredsaveeeetea
133. te the measurement and save any reports that have been generated Step 6 The report s can now be reviewed To perform a measurement on a new patient click the Patient button and return to step 2 above 5 Shut Down Step 1 The software automatically saves all reports To close the software click on System from the main menu and then click on Exit Step 2 Place the tonometer in the module tray for storage Page vii Contents E lee EEE ii DEAN EN Ve lil Ree a lil Disposals a aaa iii Regulatory eran iii BI 6 GST IE 10 0 REE EA O E rT TERE eR eR Te ee Tr err iv REENEN H 1 1 veret JJ 9 t2 Manual Se RR 10 T3 e ein cere cece cesarean ec eecececcennenenneeeeqccmeeccenneeaenaseie ce cecenaccennesasae tec ccecencecnnesasnnete ce cere cecennesesnne ee deeeneeecennaxeeanneresanneeeee 10 Te ENN NNN 12 INTRODUC TION usage 14 2 1 The SphygmoCor Central Blood Pressure Assessment System cccccceeeee eee eeceeeneeee eee eeeeeeeeceeeaaeeeeeeeeeeeeeeeeececieeeeeeeeeeeesy 14 2 2 The SphygmoCor Pulse Wave Velocity Assessment System rnnnnrrrnnnnnnnnnnnnrnnnnnnrrrnnnnnnnnnnnrrnnnnnrrrrnnnenernnnerrnnnnnrrrrnnenerennneennnn 14 2 3 The SphygmoCor Heart Rate Variability Assessment System rrnnrrrnnnnnnnnnnnrrnnnnnnrrrnnnnnnnrnnrrrnnnnnrrrrnnnenernnnrrrnnnnrrrrnnenerrrtnernnnn 14 2 4 The Sphygmocor Pulse Wave Monitoring Assessment System ccccceee eect ee eeeeeeeeeee eee eee e eter eeteeeeaaaeeeeeeeeeeeeeeeceeceeeeeeeeee
134. the tonometer down until you see a consistent pressure waveform displayed on the data capture screen If Auto Capture is enabled see Note below the system will automatically save the measurement To manually save the measurement for analysis press the soacebar on your keyboard or step on the footswitch if used Note When the Capture Guide is enabled default setting Guidance Bars are displayed in red yellow or green green indicating waveform data within quality control parameters and the waveform will automatically become green when 11 seconds of waveform data meets all quality control parameters The waveforms will automatically be captured for analysis and a report will be generated Step 3 If a repeat measurement is required with the same study parameters click the Repeat button to return to the Capture Data screen and repeat the measurement as outlined in Step 2 above Step 4 To perform a measurement on a new patient click the Patient button and return to Step 2 above Arterial Stiffness Measurement Using Pulse Wave Velocity PWV Step1 Click the Study button to enter study parameters Step2 Enter brachial pressure taken from a calibrated sohygmomanometer and the distance measured for the distal and proximal sites from the supra sternal notch Medication Notes Operator and Anthropometric fields may be entered if desired Step 3 Attach the three ECG electrodes and leads to the patient in a modified Lead II configuration or
135. the end of the footswitch into the footswitch socket on the rear of the electronics module e Connect the power cable to the electronics module Connect the electronics module to your computer using the serial cable A USB Adaptor has also been supplied to be used if no serial ports are available The instructions for installing the USB Adaptor are contained in section Installing USB Adaptor You are now ready to start using your SphygmoCor system 4 Operating Instructions Step 1 Open the SphygmoCor software by via the shortcut on your Windows desktop by double clicking on the icon Step 2 Click Patient to activate the Patient Screen To enter a new patient into the database click the New button then click Yes to confirm you would like to enter a new patient Enter Patient details such as Last Name First Name DOB and Sex mandatory fields Click the Save button to advance to the next step Step3 Click on the appropriate available mode PWA PWV HRV or PWM button to perform the desired measurement Central Blood Pressure Measurement Using Pulse Wave Analysis PWA Step 1 Click the Study bution to enter study parameters Enter the brachial pressure taken from a calibrated sphygmomanometer and any other details you with to include Step2 Click the Capture Data button to proceed with a measurement Palpate the patients radial artery to identify the strongest pulse point Place the tonometer over the strongest pulse point Gently press
136. the window is displayed MODULE FOUND SUCCESSFULLY This shows that your system is now ready for use If the words MODULE NOT FOUND appear contact AtCor Medical for technical support Note To Set the Comms Port click the drop down menu arrow and select from COM1 to COM9 or SIMULATION If you are using a USB to Serial Converter select the corresponding COM port Page 26 5 Operating Instructions 5 1 GENERAL Ensure the Electronics Module is connected to the computer and the green Power and orange Standby indicators are illuminated You can start the SphygmoCor software from the Windows Start menu by clicking once on the Start button on the Windows taskbar then navigate your mouse to the SphygmoCor program as follows select All Programs gt AtCor gt SphygmoCor CvMS V9 gt SphygmoCor CvMS V9 Alternatively if you have a shortcut to the SohygmoCor software on your Windows desktop just double click the Se icon The SohygmoCor software displays a splash screen while the software is loading The first screen to appear will be the Patient screen If a Notification window appears stating the electronics module not found check the USB connection to the PC and on the electronics module and click Yes to have the software get a connection with the electronics module Notification Electronics Module Not Found Check that Power is applied to the Electronics Module Also check the communication connection to your PC
137. ting Page 50 9 8 TAKING A MEASUREMENT IN HEART RATE VARIABILITY MODE HRV CAUTION DEFIBRILLATOR USE This system may not be used in conjunction with the use of an external defibrillator under any circumstances However should a defibrillator be used with this device it is strongly recommended that the use of the device is stopped AtCor Medical should be contacted for further advice CAUTION ECG ELECTRODES Electrodes with dissimilar metals should not be used with this device The difference in potentials will cause polarisation and hence diminish ECG waveform quality We recommend the use of disposable electrodes to minimise the effects of large offset potentials due to polarization We do not recommend the use of bulb type electrodes Ensure when using disposable electrodes that they are used from a new packet Old and dried electrodes will provide poor ECG signals Check the quality of the electrodes before using them CAUTION LINE TRANSIENTS The device will detect and then reject irregular rhythms generated from line transients Ensure correct electrode and cable placements to minimise the effect of line transients IMPORTANT The SphygmoCor ECG cables and leads are designed for use with the SohygmoCor electronics module and should not be used with any other ECG device Only ECG cables supplied by AtCor Medical should be used with the SphygmoCor electronics module do not use any other ECG cables with SphygmoCor electr
138. your computer that you wish the file to be saved to and click the Export button Page 40 Right click anywhere in the graph to display the study time and date Left click anywhere in the graph to display the heart rate value Suite SphygmoCor Cardiovascular Management jystem Patient Study Report Analysis M Privacy Help GF _f Patient study Report Analysis PrivacyN Er Analysis 5 P L Arteries P P Waveform Export Click anywhere in the graphs to display the pressure value for all time points Click on a single time point to display pressure values for that pressure i e Peripheral SP Check or uncheck boxes to display or remove pressures from graph Position the cursor over the curves to display the study time and date below the graph Patient study alysis Privacy Pulse Wave Analysis Patient Test Test int Select Export AtCor Mecical ANALYSIS TAB WAVEFORM e To print a report click on the Print button 9 6 CONDUCTING A PULSE WAVE VELOCITY PWV ASSESSMENT 5 6 1 ENTERING STUDY DETAILS Open the Study Screen by clicking on the Study button or by pressing the F3 button on your keyboard This screen will allow you to enter the study details and to proceed to Capture data The patient should be resting supine with their arms by their side Attach the three ECG electrodes and leads to the patient in a modified Lead II configuration or using the

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