SOFTWARE INSTALLATION / REMOVAL
Contents
1. The face button allows displaying all ellipses corresponding to several recordings made on a same patient this helps in tracking changes for the patient The clock button displays the small crosses corresponding to every individual measurement in dynamic and chronological order this helps to track changes within the same recording session It is possible to display two hemodynamic crosses for two recordings on the same screen using the compare option in the patient explorer see above The individual measurements are displayed in blue crosses for the most ancient recording and green for the most recent recording Calibration Measurements The Calibration Measurements item in the Analysis menu opens a window displaying calibration results Results are listed together with the range of measurements considered normal for an adult at rest in supine position abnormal readings are highlighted with a star 26 Calibration measurements results Measurements Lower limit Normal value Upper limit Heart Rate bpm Stroke valume Index imlimz Cardiac Index liminfri i Systolic Arterial Blood Pressure mmHg 170 00 Diastolic Arterial Blood Pressure mmHg i 60 00 Systemic Vascular Resistance Index d siemb m i 2296 01 1600 00 7050 00 7500 00 Left Cardiac Work Index kg mim 4 78 3 00 4 00 5 00 Ejection Fraction estimated 9 38 39 50 00 67 00 75 00 ED ml 701 96 60 00 120 00 160 00 Thoracic Fluid Index2. Management of measurement averaging Profil Name Standard Profile v Default Calibration is performed over 30 consecutive heart cycles Acquisition measurements are averaged on Ti heart cveles e 15 seconds cma Clicking on Add a profile displays a very similar page but the name of the new profile has to be introduced 32 OVERALL SETUP 0 By clicking on the options you can modify some settings Management of Interfaces You can select another COM port as an incoming serial link if COMI is already used by another system for instance if you plan to use a USB Serial converter to connect PhysioFlow please refer to the user manual of the manufacturer Interface W PhysioFlow a COMI zk mul Interfaced Device of COMI kasi i ee PhysioFlow can be interfaced with automatic BP monitors allowing automatic importation of blood pressure measurement The compatible monitors are the Colin Pressmate BP8800C or BP8800 oscillometric measurement using cuff Colin CBM 7000 continuous measurement using arterial tonometry and Suntech Tango specifically designed for exercise testing PhysioFlow can be interfaced with the Central Monitoring Systems from HP Agilent Philips through a specific module called Viewlink Please contact us for more details It is necessary to configure the software to establish the communication between two units First tick in the box
3. PHYSIO FLOW PF 05 Labl Operating Instructions July 2009 Commercial Offices North America All other Countries VasoCom Inc Manatec Biomedical 2014 Ford Road Unit G 44 rue de Laborde Bristol PA USA 19007 75008 PARIS FRANCE e mail jim gunnerson vasocom net e mail physioflow yahoo com tel 215 826 9998 tel 38 1 48 87 88 13 fax 215 826 8102 fax 88 1 48 87 70 83 Manatec and PhysioFlow are registered trademarks TABLE OF CONTENTS PREAMBLE INTRODUCTION WORKING PRINCIPLE WARNINGS AND PRECAUTIONS INDICATIONS COUNTERINDICATIONS FUNCTIONS I SOFTWARE INSTALLATION REMOVAL II SUBJECT SETUP IIl CONNECTIONS IV CALIBRATION V MONITORING VI REVIEWING ACQUISTION VII EXPORT FUNCTION VIII EDITION OF PRINTOUTS IX EXIT X ADVANCED FEATURES XI MAINTENANCE AND STORAGE APPENDIX A SUMMARY TABLE OF MENUS APPENDIX B TOOLS BAR APPENDIX C PARAMETER DERIVATION PHYSIO FLOM USER MANUAL PhysioFlow PF 05 Labl For MS Windows XP Operating Systems Software version PF 106 PREAMBLE PhysioFlow is a noninvasive cardiac output measurement system that can be used on patients at rest or under exercise conditions If it is used on a treadmill please respect a moderated level of effort walking patients Remark Before using PhysioFlow please read the instructions of this manual thoroughly and carefully If you have any questions or require additional information about their significance or fo
4. bz T1 60 00 100 00 120 00 Early Diastolic Function Ratio 9 45 38 0 00 33 00 67 00 By using the compare option in the patient explorer it is possible to display two calibration measurements for two recordings on the same screen see above Table of Measurements The Table of Measurements item in the Analysis menu opens a window displaying table of measurements corresponding to elapsed time and time together with the description of event markers and a Q column containing information about signal quality artifacts etc Please note that the table is divided in two parts that can be displayed using the thumbnail Main Measurements and Other Measurements wasser ctm Ez T aci w i m Li ie FEET mem ll 42D uod rre Ep fasie runs Fi DOB go eho x By using the compare option in the patient explorer it is possible to display two tables of measurements for two recordings on the same screen see above 27 VI EXPORT FUNCTION Table of measurements can be exported into MS Excel spreadsheets or text txt files for those users who do not wish to use MS Excel or if MS Excel is not installed on your computer Direct export to MS Excel 2 co Conversion into text files Please note that if export into MS Excel files is direct 1f Excel is installed on your computer a new file is automatically created by opened the Excel program If you wish conversion into text files is a procedure c
5. HR Heart Rate SV Stroke Volume CO CI Cardiac Output Index cardiac index 1s cardiac output divided by the body surface area Signal Sisbiley Exercise Tor BN M M NN 1511 2004 05403 Bomme QAG BA dy poo mese word IIT rhesio nit for Wind SED s5 56S we By using the Parameters menu on the Tool Bar you can select or deselect parameters you want to display on screen OE Physiol korti for Windows E iy pee Preside ride Hit the space key bo add an seert marker ENEE as xl ps Signal Siabilev Exercise Tes SSO 082315 Pomare LA HAG p Do gy ff rtr Oeste ymortoater_ SENOS sa SHOE mn By clicking on the magnifying lens you can display the corresponding parameter on the full screen 20 Clicking on the hemodynamic cross button on the tools activates the corresponding screen 8 50 Elapsed Tire 00 0 1 40 Time 09 39 49 187 12004 033821 Hem A SI BA 3 gyros War GS ttre Part grertseher y 5 C EAD nn BU QAG oe Left Cardiac Work Index is plotted against Systemic Vascular Resistance Index Normal values at rest are displayed in the central area green square Yellow and red squares display two and three standard deviations from normal Every small green cross represents one measurement they are displayed in red if the corresponding measurement has been marked see below By pointing on a cross the operator can display the corresponding values elapsed time and time
6. Interfaced devices then select the desired COM port which can not be identical to the PhysioFlow then click on Parameters A list of possible interfaced systems 1s provided please select yours and confirm Interfaced Device Parametre EFSSOO Cancel vijelink CBM 7000 Suntech Tango 33 Parameters of Display You can modify display properties for instance colors associated with parameters or their range for displaying purposes in resting and exercising mode It allows user to select default parameters to be displayed on calibration acquisition and review screens Parameters of Display Mini Maxi ECG At Rest 3000 3000 Exercise Test 3000 3000 G a CI l min m2 EF 94 VET ms CTI ABP mmHg EDY ml SNR SNRi LCWi Directories You may change the directories used for the PhysioFlow software and recorded patients We recommend modifying only the latter if at all Please make a right click on the line then a left click on Modify and select a new target directory or create a new one Directories CPhysioFlow C PhysiaFlaw Patients CPhysioFlow Doctors Cr PhysioFlow Systern CUPhysiaFlawlLag CU PhysiaFlawtHelp Please do not try to modify other settings without first contacting our after sale service department 34 X MAINTENANCE AND STORAGE MAINTENANCE There are no parts in PhysioFlow which are serviceable by the customer or user of the device and
7. b Clean off the sites with an alcohol prep pad and dry with a paper towel Then rub the skin with Neuprep abrasive gel using gauze Remove the excess gel when done Skin color must turn bright pink c Apply the electrodes 6 in total to the proper locations on the left side of the subject s neck white and blue the middle of the sternum red the rib closest to V6 orange and along the center of the spine These two last electrodes can be placed on the xiphoid process green lead and laterally on the rib black lead as well but stability under exercise conditions is less optimal d IMPORTANT Please use Skintact FS50 or FS TB electrodes only Any other electrode will decrease the signal noise ratio and impair the performance of the device IMPORTANT Please make sure the electrodes are in good condition expiration date electrode bag not opened for more than a few days e When applying the electrodes ensure that the gel pad in the center of the electrodes contacts the skin before the rest of the electrode Do this by lifting up the sides of the electrode while placing the gel pad in the center flush against the 10 skin Then firmly push down on the sides of the electrode making sure no air pockets exist between the skin and the electrode Depending on the size and structure of the patient electrode positioning may need to be adjusted as follows When measuring a tall skinny subject or patient the V1 sternal manubrium
8. 1986 SV SVla dZ dT max dZ dT max cat TFIT eq TFIT BSA after calibration SVla k dZ dT max Zmax Zmin W TFIT ca during calibration where k is a constant and the subscript cal indicates the parameters measured during the calibration phase TFIT is a parameter related to VET TFIT is measured on the first derivative of the impedance signal dZ dT and is taken to be the time interval between the first zero value following the beginning of the cardiac cycle and the first nadir after the peak of the ejection velocity dZ dT max W TFIT ea is a weighting algorithm that takes into account TFIT ca HR and the quantity SAP DAP Charloux A A New Impedance Cardiograph Device for the Non Invasive Evaluation of Cardiac Output at Rest and During Exercise Comparison with the Direct Fick Method European Journal of Applied Physiology Volume 82 Issue 4 2000 pp 313 320 37
9. By Clicking on the Ellipse button measurements are displayed as an ellipse centered in the middle of the group of all measurements with one standard deviation distance from that center point This allows a better visual focusing of measurements if a number of them are displayed 21 During the monitoring phase you have the ability to mark events When you wish to indicate an event press the SPACEBAR A window appears and asks you for the text type comments if desired then Click OK or press enter to validate Then this event will appear as a vertical line on the screen Acquisition in progress TEST test Hit the space key to add an event marker Event Marker s Description Please Type Event Markers Description On this same window a Blood Pressure button appears if you have selected the manual input of blood pressure option This button allows the operator to enter blood pressure parameters manually during measurements same interface as during the calibration phase Emit at RB tif E a i a ii Hor sadi 8 Please enter Patient blood pressure values used far calculatians Only for maie accorate cacularion of SVRI and LOWI Swor HRS FE wea cw 7 I ooa Cwantoic 0 JE mm we ue mma On this same window a Break Resume button allows the operator to suspend computation of parameters without stopping the measurement in progress and with no need of re calibration To
10. bioelectrical activity In addition as the impedance of skin electrodes is very low at high frequency tissues will not endure any thermal effects and the patient feels nothing By detecting and measuring the difference of thoracic impedance over time PhysioFlow PF 05 measures in a noninvasive way the systolic volume the cardiac output and several other hemodynamic parameters By comparison thermodilution measures the differences in temperature function of the time for measuring the systolic volume and the cardiac output in an invasive way WARNINGS AND PRECAUTIONS WARNINGS FOR ACCURATE MEASUREMENTS IT IS VERY IMPORTANT THAT THE OPERATOR UNDERSTANDS THE DIFFERENCE BETWEEN ACCEPTABLE SIGNAL AND POOR SIGNAL QUALITY SEE CHAPTER IV In accordance with US federal regulations this device can be used only by a physician or under the order of a physician Explosion hazard do not use in the presence of flammable anesthetics The conductive gel of sensors must not be in contact with other conductive products of objects when patients are monitored Sensors must be positioned on the skin they must not be directly positioned on the heart Specific patient cables supplied with PhysioFlow have been designed for optimal protection against effect of defibrillators and electrosurgical devices Do not use any other type of cable with the device However patient cable should be unplugged from the device before any defibrillator shock is perfor
11. HALS6 C CORONASF C CORONABF Fl CI Demo dealers a C FAILUR28 C FROMENDS CI GOUDEPE3 C HAUTCOB6 C KLEBERO4 71 MFYFRM43 4 b At this stage a new folder can be created by clicking on the corresponding button Patients can be displayed in alphabetical or chronological order Alpha Order Chron Order A second click on the same button displays the list in reversed order 23 Searching for a patient in the database Search Sear eee e by name ID code C by comment C by date dd mm vyyy c x Patients can be found using keywords corresponding to the name ID code comment or by date Copy and delete functions allow managing patient files accordingly Copy Delete Please select patient or recording you want to copy or delete in the list Then click on the corresponding button and confirm To copy you have to define a target directory and or driver when asked by the system Copy function the system asks if you wish to copy the raw signal too The raw signal is the largest file and may take some space in your target memory Copy options Do you want to Copy the Raw Signal too Please click on exit if you wish to cancel patient database management Exit 24 Recordings can be displayed in several ways Trends constitute the default screen when a patient measurement is opened The hemodynamic cross as described above calibration results and a table of measurement
12. art of this phase Before proceeding to calibration make sure that signals are reproducible stable and without artifacts or interference 15 A signal stability sensor is present at the bottom of the screen The more squares that are displayed the better it is 8 squares ideally When stability is borderline squares turn to yellow and when signal stability is unacceptable squares are displayed in red color IMPORTANT If during the monitoring phase signal stability is not acceptable corresponding trends will be erayed Signal Stability Soo IMPORTANT the operator should check that heart rate results appear beat by beat on the dE dt signal light blue digits dark blue signal Similarly please verify that fiducial points of the dZ dt green signal are correctly detected the presence of red and yellow squares on the signal are necessary The yellow square must not appear at the end of the heart cycle If the signal analysis and quality are questionable the operator should try another derivation for the ECG red electrode on the right shoulder and orange electrode on the left hip for example and for the impedance horizontally move the pair of electrodes situated at the base of the thorax green and black IMPORTANT It is essential that the operator understands the difference between acceptable and unacceptable signals ACCEPTABLE SIGNAL QRS should be properly detected light blue lines and heart rate displayed
13. atient Interface with BP Monitor un i vo Last Name EST Manual Input of blood pressure values utomatic Calculation of Blood Pressure trends FirstName tet Automatic Calculation of Blood P trend m ss only For exercise best ris amp Age 35 years old or Date of Birth fi 11300 Natural ventilation e o C Mechanical ventilation f Height cm 175 fin 58 weight kg 68 b j 143 Exercise Test z Sex M F m Body Surface Area 1 82 m2 f Patient at Rest OK Cancel Use Tab Key to move between fields You can also click on Find to select a patient you have already measured modifications of parameters for instance weight are allowed Please select the appropriate measurement condition Manual input of BP value or interface with BP monitor If activated in the Options menu see below natural ventilation or mechanical ventilation exercise test or patient at rest You can fill optional fields in the Optional Parameters section You can go from a field to another field using the TAB key Patient ID Code D me EE Type of exam Prescripted by Last Name zip Code City First name Phone Comments Pathologies History of Exams Treatments given Lu li D qui T E m L m a Td L oO O Click on OK when ready 14 III CALIBRATION Please carefully read the calibration instruct
14. begin monitoring again simply hit the Resume button Click on End of Acquisition 1f you want to stop acquisition and confirm with OK when prompted 22 V REVIEWING ACQUISITION Acquisition review can be performed at two stages immediately after the monitoring is completed in that case screen freezes and displays trends or at any other time by clicking on the following button Patients are displayed in alphabetical order by the last name or a patient ID number and every measurement for each individual patient is displayed in chronological order Patient Database Management GOUDE patricia Choose Dir 20 04 2001 13 42 30 HAUTCOLIN REGE 06 10 01 AUGUE 06 10 2001 09 59 00 06 10 2001 10 02 42 FI KLEBER Paul emile patient2 Chron Order 28 02 2003 12 42 42 MEYER Marc Search 20 04 2001 14 08 18 20 04 2001 14 17 00 Copy F PNAN 14 29 24 sl a FI l Exit Compare The operator can open a recording by double clicking on the corresponding line or selecting a line and clicking on the open button below The compare button may be used when a recording is already displayed and when another recording has to be displayed simultaneously Several functions can be activated Selecting another directory where patients are recorded 5 Select a directory Choose Dir Slee PHY SIOFLOW Patients a I AKUETE23 CI ALK
15. ble amplitude of signal ECG s averaging the number of points used for the calculation of dE dt and the detection s threshold most important parameters The detection threshold should be increased in the case of a big T wave observed on dE dt 1f the wave T is taller than the QRS the operator should completely change the derivation of ECG derivation On the contrary if QRS has an irregular amplitude you must decrease the threshold to assure none of the QRS complexes escape detection These regulations could be made in real time and their effects are immediately visible on the signal The button ECG sensitivity increase increases the dE dt s dynamic and decreases the threshold The button Default parameters allows the user to return to the parameters by default 37 Enable Disable Signal Quality Alarms Allows activation or disabling of the alarms pop up windows when signal stability if poor Options To modify configuration of the software About Information about software version Window menu KUN j FI gd Ci W Tools Bar w Messages Bar Tools Bar view mask the tools bar Messages Bar view mask the message bar APPENDIX B Tools bar Direct export to MS Excel Conversion into text files mM cross B Mmm lecti file kun NI Enable disable kap qualitv alarms setup Exit ina i application Signal Stabilitv gauge Allows assessin
16. e Visible data wv HR HR heart rate bpm yi S SV stroke volume ml w CO CO cardiac output I min w CI CI cardiac index 1 min m CTI CTI contractility index no unit VET VET estimate of ventricular ejection time ms i EF estimate of ejection fraction 90 x EDV estimate of end diastolic volume in ml ue SAP svstolic arterial pressure mmHg BUE DAP diastolic arterial pressure mmHg SVR MAP mean arterial pressure mmHg LCWi SVRi systemic vascular resistance index d s cm m2 TFi SVR svstemic vascular resistance EDFR LOWI left cardiac work index kg m m TFI thoracic fluid index no unit EDER early diastolic function ratio 96 36 Analysis menu Seles Configuration Window Patients Explorer Patient ID and measurement conditions Displays patient information as they were typed by the operator Calibration measurements Displays data measured during calibration phase Hemodynamic Cross Displays the hemodynamic cross diagram Table of Measurements Displays the table of measurements Patient Explorer Opens the patient explorer 6 Configuration menu l Configuration Window Signal Setup Enable Disable Signal Quality Alarms Options Chrl Fe2 About Ctrl MajHA Signal Setup Allows the user to adjust the parameters of the detection of the QRS on the dE dt signal This is useful in cases of large T waves risk of a double counting and or of a varia
17. ermination is based on the following principles the biological tissues as the muscles bones fat and blood each have different electrical properties Among them all the blood is the most conductive body tissue in the thorax As the circulation is pulsatile and the arterial vessels are supple the differences of pulsatile blood volume are made at the level of thoracic arterial system mainly in the aorta in connection with the ventricular function This blood volume change makes an electrical conductivity change and consequently a change in the impedance of the thorax against the electrical current The differences in thoracic electrical impedance are essentially created by changes of velocity and of blood volume in the aorta Unlike other TEB systems PhysioFlow does not rely on impedance baseline measurements to compute parameters This tends to reduce the limitations of standard TEB PhysioFlow PF 05 uses a noninvasive technique to determine the TEB By performing the analysis of TEB recordings in association with the ECG signal PhysioFlow provides information related to the cardiac function PhysioFlow measures the change in impedance by injecting a high frequency alternating electrical current 75 kHz of low magnitude 3 8 mA rms towards the thorax between a pair of electrodes positioned on the neck and another pair positioned on xiphoid process The use of a high frequency current eliminates the risk of interference with heart and brain
18. g signal stabilitv green good signals vellow average red poor 39 PARAMETER DERIVATION The parameters that are derived by the two units are compared in the table below They are essentially the same with the main difference related to the different theory and calculation of Stroke Volume Table 4 Parameters ABP User Entered or Measured if connected to 510 k cleared blood Measured optional pressure monitoring devices BSA Haycock Wang BSA 007184 Height 7 Weight Haycock BSA 0 024265 x Height x Weight CO BSA ML LLL ai i i oe Jm C vm Entered or Measured NN connected to 510 k cleared blood easured optional pressure monitoring devices Measured as m fom H 0H QTM VET m vema pS m wmm 0 0 im Entered or Measured if connected to 510 k cleared blood easured optional pressure monitoring devices C O User Entered or Measured connected to 510 k cleared blood Measured optional pressure monitoring devices Modified Kubicek See notes Bour m pw wraca kera st is the inverse of TFI aa a ae 36 l SV L 425 VET dZ dT max Zo where L is the distance between the two sensing electrodes in cm Bernstein DP A New Stroke Volume Equation for Thoracic Electrical Bioimpedance Theory and Rationale Critical Care Medicine Vol 14 No 10 904
19. he spine corresponding to the same vertical position as the xiphoid process on the front middle to end of the sternum After all electrodes have been properly placed on the subject apply a small amount of conducting gel to the metal tops of the electrodes especially in case an exercise test is performed KY jelly can be used for this purpose This additional gel enhances signal conductance and stability throughout the duration of the test Connect the appropriately colored Physioflow probes on the patient cable to the electrodes on the subject A clicking noise indicates that the two have been connected correctly In case of an exercise test have the subject put on a Spandage shirt over their torso to ensure that the Physioflow probes and cable do not interfere with the subject s movement and ability to exercise The greatest amount of stability 1s achieved by placing the large rectangular center piece of the cable on the subject s right 11 shoulder Have the subject also place a smaller cut out piece of Spandage or 3M Coban wrap around their neck to secure the stability of the neck electrodes and probes Alternatively 3M Transpore tape can be use to solidify the probe cables on the skin like when an ECG holter is used but this does not ensure maximal stability during exercise especially on a treadmill Make sure that none of the probe cables run over any of the electrodes Overlap can interfere with the Physioflow signal Ens
20. ions on the Calibration Wizard screen Calibration 1s particularly important reliability and reproducibility of the system depends on it It is performed on 30 heart beats with best possible signal stability Precautions Measurements consist in 2 phases Calibration and Acquisition Calibration Position of electrodes as shown Introduction of Patient identidication data Recording of a series of calibration heart beats Patient staying still not speaking breathing normally Input of calibration blood pressure Computation and display of calibration results ui c g pur L Q ta Acquisition Acquisition starts Monitoring screens are displayed Connection with PhysioFlow OK At this stage the system informs you if the connection with the PhysioFlow is OK If not please check if the device is switched on if the serial cable is connected and if the PhysioFlow is connected to the suitable port see the Options section below Please proceed to signal preview by clicking on the appropriate button when ready It is necessary to proceed to simultaneous blood pressure measurement using manual or automatic blood pressure monitor in order to obtain blood pressure reference values they are used as a reference cardiac output computation and for blood pressure profile calculation during exercise ECG and impedance signals are displayed on the screen at the st
21. med Disposal of this product and or its accessories shall be made in accordance with all locally enforced laws PRECAUTIONS Some clinical circumstances may impair accuracy of measurements Such as Tachycardia with heart rate above 250 bpm Untimely movement of neck Patients running on treadmill Patients under 120cm 48 in Patients under 25 Kg 67 lbs Presence of aortic balloon pumps Presence of ultrafiltration systems Presence of pacemakers with external leads Open chest surgery Use of electrical cutlery and electrosurgical devices Morbidly obese patients such as those weighting over 600 pounds PhysioFlow PF 05 software should be re calibrated after 24 hours of continuous measurement on a patient Re calibration can take place at the same time that the electrodes are replaced as a function of normal nursing protocol As per US FDA s requirements please take note of the following graph comparing PhysioFlow cardiac output readings to Thermodilution cardiac output readings It shows that 8246 of readings are within bounds 20 margin of error of thermodilution PF CO L min K060387 PF CO vs TD CO PF 4 of 4 Manufacturer data 15 84 18 of data are outside bounds 2 4 6 8 10 12 TD CO L min Each PF reading was an average avg of 4 consecutive readings and each TD reading was an avg of the best 3 of 4 readings except that if the 2 extremes of the 4 TD reading
22. no parts have to be changed under normal wear and tear conditions If the system does not work properly please refer to the troubleshooting section If the problem remains please contact your authorized dealer the customer support 215 826 9998 within the USA or 33 1 43 87 88 13 outside the USA or support physioflow com STORAGE When not in use the PhysioFlow must be stored at an ambient temperature between 0 F and 100 F humidity below 70 96 35 APPENDIX A SUMMARY TABLE OF MENUS File Parameters Analysis Configuration Window File menu Stark a new measurement Ctrl M Open Recording Chrl 0 Close Ctrl FW Start a new measurement to begin a new acquisition Open Recording to load an old acquisition Close close displayed trends send to Excel save values as xls format Export save values as txt format Page Setup to modify margins header Page Setup footer of pages Print Preview displays printouts as they will be printed Printer Setup displays the configuration printer board Print prints the report Exit exit of the PhysioFlow software Printer Setup Exit Ctrl g Parameters menu Visible signals Parameters ana ECG ECG signal Z impedance signal dECG dt ECG signal first mathematical derivative dZ dt impedance signal first mathematical derivative d ECG d t ECG signal second mathematical derivative d2Z d t impedance signal second mathematical derivativ
23. omprising three steps 1 Giving a name to the file 2 Selecting a target folder 3 Confirmation Export Data Format Text File Ge 28 VII EDITION OF PRINTOUTS You can print a report using the print button A pop up window appears giving the possibility to type or modify a comment if needed Comments Print Previews are displayed three pages can be seen Calibration Results Hemodynamic Cross Trends and Tables of Measurements if selected using the button FOB FE me p Sie Fajo etl giie CYPRUS querweizlt dias t mik 8 OA Fhipal Tw Wem Tp nl n nomin xi vases rend hu i ee a qb i x ral mu i in E PN i ill a im ia E a 1 wn i 1 x I na u I 1 z L Lal ur I E i T Un Hm E fi T itti il 1 min i 1m Tt Wo i3 m xu z a 1 im 1 L a i imn T Ee d p ihi a ku a M Ci li n jii ia HI T Ly ar T m P mt is m ai E EE f 4 x 3 E im na ai a eee L L ru Ls fi E Er a II T T a ti mi Lm mu E L3 z im Titia CE Li T pm E E Ke 1 Er in i i LT T ace PTT x 2 a im x m g EI a T r a t wd a Tii a ur Li 223 hb ale fun ie Part 29 mix Printer Name DeskJet 95x Properties status Type HP DeskJet 885Cxi Where LFTI Comment Printto file Copies Number af copies fi Print range All C Pages from to f cel ee Collate Ta C Selection A window appea
24. r any further information please contact Manatec biomedical at the address indicated in the manual or your local distributor INTRODUCTION PhysioFlow PF 05 is an original system for noninvasive cardiac monitoring which provides hemodynamic parameters using analysis of thoracic electrical bioimpedance signals TEB More precisely PhysioFlow PF 05 PhysioFlow allows the assessment of the hemodynamic state and the ventricular function of patients by determining 15 hemodynamic parameters Besides this PhysioFlow PF 05 allows the operator to Monitor patient s trends Display store and analyze data Print reports of hemodynamic parameters Export data to text files Interface the system with other monitors Working Principle Thoracic electrical bioimpedance thoracic electrical impedance electric bioimpedance impedance cardiography and TEB have the same meaning in the literature In this manual the term thoracic electrical bioimpedance is used TEB is a technique which quantifies the heart s mechanical activity the circulation instead of its electrical activity ECG The fundamental theoretical principle of the TEB uses the direct measurement of the baseline impedance of the velocity index the acceleration index the ventricular ejection time and the heart rate of the early diastolic function ratio These measured parameters are used to compute other hemodynamic parameters The PF 05 s application for the hemodynamic parameters det
25. re similar information is given Signal Preview Please check signal quality and stability before starting calibration CALIBRATE Cancel 9 SIGNAL SETUP This icon allows adjustment of signal settings r Ecg Signal Activate graphic Filter hg Averaged over Computation of Threshold 4 dECG dt over 75 samples 5 samples KA al al al E l ba Automatic Reset after 10 seconds Default parametres ECG sensitivity increase ew l l Threshold is to be increased using the cursor when T wave is high and a double counting of heart rate is seen on display Threshold is to be decreased using the cursor when QRS amplitude is variable sample averaging and dECG dt averaging should be decreased in case of low ECG dynamic low QRS for instance in case of left bundle branch block clicking on ECG sensitivity increase does it automatically Default parameters allows returning to normal settings after a change All changes can be seen in real time on the signals beneath the pop up screen When signal is acceptable then click on Calibration to proceed Calibration in progress Calibration in progress Calibration over 30 heart beats NEN a analysed cycles Patient has to stay still and silent 18 Blood pressure measurement should be taken just prior to or in synchrony with the calibration phase Wait until calibration is finished 30 heartbeats and then type in s
26. rs and asks how many copies you want to print as well as the number of the pages that you want to print It is possible to edit screen copies during monitoring simply by clicking on the print screen key on your keyboard provided that a printer is connected and switched on 30 VH EXIT You can exit PhysioFlow software by clicking on the exit icon upper right side on the Tool Bar Then confirmation is requested CC ET Da you realy want to gut the application Thank you for using PhysioFlow 31 IX ADVANCED FEATURES PROFILES Every user of the PhysioFlow can define some functions according to his work preferences PhysioFlow is flexible and can be used by numerous people For selecting a profile you must click on the corresponding icon ME Standard Profile fed Standard Profile Beat Beat Only one default profile is available at first installation of the software For creating or modifying a profile you must click on the options button on the Tool Bar a pe Then go to the bottom of the page The following menu is available Management of measurement averaging standard Profile Edit Add Remove Editing a profile means displaying a previously recorded profile The following items can be modified default profile or not duration of calibration number of heart beats and averaging over several heart beats or several seconds Management of measurement averaging
27. s can also be displayed Trends During the acquisition phase default parameters are displayed on the screens It is possible to call additional parameters using the parameters menu see section It is also possible to display one parameter full screen using the magnifying lens see section Clicking on one point of any parameters waveform displays the corresponding numerical values of each parameter displayed and the elapsed time Ten 1 7004 141445 omma 13 DHA OD Proa word utu pm pharmaco frere e le 754 229 35 939 wis Double clicking on the time scale below each parameter converts the elapsed time into the real time 03 15 11 09 18 40 09 19 00 09 19 20 09 19 40 09 20 00 The magnifying lens nearby the chronometer allows zooming on the trends displayed then arrows appear to help navigation between the trends sections By clicking on the magnifying lens with a full size trends are displayed again 25 Scrolling on a section of the trend allows computing the average value of that section of the trend and the slope of the curve 15 11 2004 142601 ibimarer 88 B X OG W md nenne chance M Perle Hss rm Bf BOOMs tee US x It is possible to display two trends for two recordings on the same screen by using the compare option in the patient explorer see corresponding section Hemodynamic cross It looks very similar to the one displayed during monitoring however there are two additional features
28. s were equidistant from the avg the avg of all 4 was used e PFCO Identityline Upperbound Lower bound INDICATIONS PhysioFlow can be used on adults or teenagers at rest during cycloergometric exercise or during walking exercise on a treadmill PhysioFlow and accessories are made to be used in strict compliance with instructions specified in this manual PhysioFlow is to be operated with single use sensors which should be changed daily PhysioFlow is a class I type BF device European standards The patient cable circuit provides high level of insulation in case of grounding failure COUNTER INDICATIONS PhysioFlow must not be used on patients with pacemaker of minute ventilation type FUNCTIONS PhysioFlow measures the following parameters Thoracic Fluid Index Inverse of baseline impedance Contractility Index maximal rate of change of impedance waveform during systole Heart Rate Ventricular Ejection Time Early Diastolic Function Ratio PhysioFlow computes the following parameters e Stroke Volume Index e Cardiac Output Index e Systemic Vascular Resistance Systemic Vascular Resistance Index Systemic Vascular Resistance multiplied by the body surface area e Left Cardiac Work Index e jection Fraction e End Diastolic Volume I SOFTWARE INSTALLATION REMOVAL Software Installation Switch on your PC wait until MS Windows has booted Insert the PhysioFlow software installa
29. sternum electrode red with Lab 1 1 of 2 electrodes responsible for the ECG signal needs to be placed on the same level as the heart which tends to be on the upper half of the sternum When measusing a shorter heavier subject or patient the sternum electrode may need to be moved down to the bottom half of the sternum The goal is to have the sternum electrode on the same level as the heart segment with the largest diameter In general taller individuals tend to have more vertically aligned hearts while the hearts of shorter subjects tend to rest on a more horizontally tilted axis CAUTION in case of a wide QRS LBBB or pacemaker please place the mid sternum electrode V1 on the rib opposite side of the V6 electrode to create a horizontal line between the two The neck electrodes white and blue must be positioned so that they do not overlap and so that they both fit on the neck rather than one on the collar bone Best placement is achieved on the lateral triangle of the neck These electrodes have the greatest tendency to fall off due to their location near a high density of sweat glands and the higher probability of subject movement in that area The V6 electrode orange must be placed on the rib bone closest to the left ventricle for a proper ECG signal The spinal electrodes green and black must be placed on the midpoint of the spine To ensure proper placement have the subject stand or sit up straight and visualize the point on t
30. tion CD ROM Double click on My computer then on the icon representing the CD ROM player Display the content of this drive and double click on the installation program icon named setup US exe Installation starts Follow every step of the installation procedure clicking on the next and install button when appropriate It is recommended that you use the default installation settings Software is loaded in the C PhysioFlow newly created folder by clicking on browse it is possible to select another destination folder to install the software i Setup PhysioFlow English Release BI xl Select Destination Location D Where should PhysioFlow English Release be installed Q k p Setup will install PhysioFlow English Release into the following folder To continue click Next If you would like to select a different folder click Browse C PhysioFlow E NKPhysioFlow Browse Atleast 7 3 MB of free disk space is required lt Back Cancel When the software 1s loaded and you wish to start PhysioFlow please select launch PhysioFlow English release otherwise disable it Whatever the case press Finish in order to complete the procedure 4 Setup PhysioFlow English Release Setup has finished installing PhysioFlow English Release on your computer The application may be launched by selecting the installed icons Click Finish to exit Setup M Launch Physioflow English Release Soft
31. ure that the subject s mobility is maintained by having them rotate their torso left and right Adjust the probe cables as necessary if extra slack 1s needed or if the cables need to be repositioned If need be gauze pads can be inserted in between the Physioflow probes and the Spandage shirt to further increase probe stability 12 II CONNECTIONS Connect PhysioFlow to the mains CAUTION A grounded plug is mandatory Connect PhysioFlow to the serial port of your computer using the specific serial RS232 cable or USB to serial port converter whichever is available Connect patient cable on PhysioFlow front panel Connect patient using pre gelled PhysioFlow electrodes When ready start the PhysioFlow program either using the Start function of MS Windows or double clicking on the corresponding icon if you have created it During first use of the program you will be prompted to type the name of hospital and doctor who use the system Acquisition screen appears Click on the start a new recording Analysis ai E Management e ELS fie Recordings Recording Configuration The system asks you whether the patient has been recorded before or if it 1s a new patient If the patient has been measured before please select from the list Selection of Patient ce Introduce patient identification first name last name age or date of birth height weight and sex 13 Patient Identification Find P
32. ware Removal To remove the PhysioFlow software click on Start tool bar on the bottom of the screen Select Control Panel and then Add Remove software select PhysioFlow 1 06uk click on the Uninstall button and follow instructions ke Windows Update Programs gt Documents b BEI Control Panel id Network and Dial up Connections Search d EN 3 Printers d Hep B Taskbar amp Start Menu Run aj Shut Down Exi Add Remove Programs 7 i xl Currently instalied programa sotby Nmame ed 4 Physiofiow 1 05 uk Sie aime a Click here for support infor ration ped targiy Last Usied Cni Tales To change this program or reme it from your computer click Changae mormose harge er ED ii za Garima Clm Luis s gir 1m SAD Utility e Physiol bow E ripis Release Lira elli T Are you sure you want bo completely remove Phyaiotlow Sngith Release and all of its rem zl ew fi startji 52 E Sa Sa control Pane Efnadainemove Progr Mlapurappreszon p Physiortow English REN icc II SUBJECT SETUP 1 Subject Setup To ensure a stable signal and proper data acquisition during an exercise test it s critical that the electrodes and Physioflow probes be setup and configured correctly Follow these steps when setting up a subject refer to the diagram below a Shave the areas required for probe placement as seen above if need be with a disposable surgical razor
33. with every heart beat Colored squares on the dZ dt signal red to yellow should draw a curve oriented downwards during systolic phase EXAMPLEI EXAMPLE II EXAMPLE III 16 POOR SIGNAL EXAMPLE I No systolic curve during dZ dt squares are not regularly plotted EXAMPLE II Artifact on dZ dt curve occurring simultaneously to the QRS SOLUTION I Shave and clean the skin replace impedance electrodes Reposition impedance electrodes on the same horizontal level EXAMPLE III Electrical interference Static electricity on ECG and or impedance SOLUTION III If it permitted by law turn off the source of static electricity Blood ultra filtration systems using rotating pumps generate static electricity trough the plastic tubes connected to the patient These currents cross the patient thorax and return to the PhysioFlow through the patient leads SOLUTION II Shave and clean the skin replace impedance electrodes Reposition impedance electrodes on the same horizontal level EXAMPLE IV A majority of QRS are no properly detected and heart rate is wrong Often occurs in case of bundle branch block or pacemaker patients QRS large and of reduced dynamic SOLUTION IV Increase ECG sensitivity see Signal Setup on the tools bar Drop the red ECGI electrode at the level of the orange ECG2 on the other side of the thorax 17 Clicking on the question mark button leads to a section whe
34. ystolic and diastolic blood pressure when prompted by the software IT IS ESSENTIAL THAT BLOOD PRESSURE READINGS ARE TAKEN AS ACCURATELY AS POSSIBLE CONSIDERING THE MEASUREMENT CODITIONS THESE READINGS MUST BE TAKEN AT A TIME THAT IS SYNCHRONIZED WITH THE CALIBRATION PHASE AS MUCH AS POSSIBLE These readings are automatically retrieved form the blood pressure monitor if one is interfaced Modify default CVP and WP parameters if available for a more accurate computation of SVRI and LCWI When finished click on Validate You may verify Calibration results and click on start monitoring if they are correct Monitoring starts Computation of Calibration Results Please type blood pressure values used for computation of calibration results Only for more accurate calculation of SVRI and LCWI Systolic Z mm H3 cw E mm H3 Diastolik E mm Hg WP E mm Hg Calibration blood pressure v v c m oO d 3 Please note The basis of the upper lower limits of the calibration parameters are derived from a normal healthy supine patient at rest Parameters that exceed the normals will be shown in red those within the limits will be shown in green If the calibration looks questionable or numbers fail to appear in the boxes poor signal quality aberrant values you can start the calibration cycle again by clicking on Retry 19 IV MONITORING Monitoring screen appears
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