Version 3.1 System Manual
Contents
1. Change the screen layout on the Intellivue MX patient monitor to one that includes an iPC desktop window Manually start the HeRO ES client application via Philips smart key XDS LaunchPad Windows desktop shortcut or Windows start menu Manually start the PC via the Philips menu Main Setup Internal PC Switch PC On Ensure that the Intellivue MX monitor is configured to automatically start the iPC when the monitoris powered up Enter config mode then select Main Setup Hardware Internal PC Auto Start PC Enabled Reconfigure the XDS display settings to restore proper operation of the shared screen Contact Philips Technical Support if necessary iPC hardware problem Contact Philips Technical Support 22 TROUBLESHOOTING AAA A A A AA Problem Comm Error message appears during normal use not monitor start up Description HeRO ES is unable to communicate with the Intellivue MX patient monitor CIO TN Intellivue and or iPC are starting Wait for HeRO ES to initialize communication with the Intellivue upto 60 seconds Internal iPC network error Reboot the PC Configuration error Contact MPSC Technical Support Hardware problem Contact MPSC Technical Support Problem No Heart Rate message is displayed Description The system is not receiving heart rate data from the Intellivue MX patient monitor Gauso eines Patient monitor is not attached None necessary Thisis normal to a p2. A AAA A AAA Activating the HeRO ES Solo Window Typically the Philips Intellivue MX monitor and PC are configured with a default screen layout that includes the HeRO ES Solo Window If this is not the case or if you have been using a different layout you may need to manually activate the HeRO ES Solo Window by pressing the HeRO smart key on the Philips monitor see Figure 1 Continuous HeRO Monitoring HeRO ES processes Heart Rate data and generates scores while the PC is running regardless of whetherthe HeRO ES Window is visible on the Intellivue screen Therefore itis perfectly acceptable to switch to other Intellivue screen layouts as needed without concern over disrupting HeRO monitoring However monitoring is interrupted while the PC or the entire patient monitor is powered off HeRO monitoring is active only when the Philips iPC is running The Intellivue MX patient monitor should be configured to automatically start the PC on power up To do this enter Config mode then select Main Setup Hardware Internal PC Auto Start PC Enable d Window Position and Size The typical HeRO ES configuration uses one or more dedicated Intellivue screen layouts that provide space for the HeRO ES Window to be shown alongside the other patient vital signs In this configuration the window cannot be moved or re sized HeRO ES Patient Window The HeRO ES Solo Window is not interactive In order to access interactive functions you
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4. arise contact the hospital network administrator or MPSC Technical Support toll free 1 800 394 1625 10 USING HeRO ES AAA ATAR Viewing the HeRO Score The HeRO ES Solo Window The HeRO Score is shown on the HeRO ES Solo Window which appears on the display of the Philips MX series monitor along with the other vital signs see Figure 1 The HeRO ES Solo Window displays the most recently computed HeRO Score as a numeric value and also shows a graph that trends the values over the last five days HeRO ES computes a new HeRO score for the patient at the beginning of each hour 1 00 2 00 etc When a new patientis admitted to the monitor it may take up to 3 hours for the first score to be shown HeRO ES will stop generating scores if the overall amount of data is insufficient or if there is not enough recent data to generate an accurate score These gaps in the HeRO score trend can occur if the patient leaves the bed or if the ECG signal is otherwise interrupted for 30 minutes or more When the ECG signalis restored HeRO ES will resume generating scores as soon as enough new data is available This may take up to an additional 3 hours Heart Rate Capture Indicator Patient Bed Info HeRO Score trend Current HeRO Score Figure 3 HeRO ES Solo Window The main window displays the HeRO score as a numeric value and as a graphical 5 day trend along with patient demographic information 11 USING HeRO ES
5. for the patient assigned to that bed The system can be configured to obscure all identifying patient information on the and Pod View In this case the identifying information will become fully visible when a user logs in to the system by pressing the button at the bottom right corner of the screen Click the button at the lower edge of the screen to display the help screen The may display informational or error messages to indicate problems or status changes These messages and their meanings are summarized below The messages differ based on the data acquisition method DAD or NDAI and for NDAI installations whether or not the interface is being used to provide patient admit discharge transfer information 15 USING HeRO ES DEMO NICU Payley Y DEMO B Patients Beds Users O A1 D277123 Doe John O A5 5554276 Sedillo Matthew 2 28 2 28 6 A6 M121658 McGarry Monique 1 46 id i EE five f f Sver O A3 M727648 Matson Jeanette ea OS O A4 5324769 Sparks Alan O A8 C982411 Campo Chris 0 14 Pro r Parts A X m A MTB o Figure 6 Screen While the typically shows all beds in the unit the provides a more detailedview of a small group of beds located in a particular section of the unit with the icons arranged in a grid A typical installation will be configured with multiple screens that collectively cover all of the beds in the unit The elements composing each ar
6. must activate the HeRO ES Patient Window by switching to an PC screen on the Intellivue that allows access to the Windows Taskbar and clicking on the HeRO icon 12 USING HeRO ES Patient Bed Discharge Button HeRO Trend Current HeRO Score Scrollbar Heart Rate Trend Help Button HeRO Icon Figure 4 HeRO ES Patient Window The main window displays the HeRO score as a numeric value and as a graphical 5 day trend along with patient demographic information and a heart rate trend Discharge Button Deletes all data for the currently displayed patient This feature is used to manually reset HeRO ES when the physiological monitor is connected to a new patient Typically this is done automatically when the new patient is admitted to the Intellivue MX physiological monitor but in some situations a manual clear function is useful See the following section Admitting and Discharging Patients for details You will be asked to confirm the Discharge operation before any changes are made Data collection will resume immediately and a new HeRO Score may take up to 3 hours to be generated In a HeRO ES Enhanced system the Discharge button will only be available on the HeRO Viewing Stations not the iPC Scrollbar The scrollbar can be used to review Heart Rate and HeRO trend data Click and drag the scrollbar button or use the arrows to navigate Help Displays the full user manual this document Displays v
7. HeRO ES Version 3 1 System Manual S D gt O 0 ane O A O Caution Federal law restricts this device to sale by or on the order of a physician COPYRIGHT 6 2015 BY MEDICAL PREDICTIVE SCIENCE CORP ALL RIGHTS RESERVED UNAUTHORIZED REPRODUCTION IS STRICTLY PROHIBITED Do not alter translate transfer disclose or use these materials or any part thereof in any form by any means except by prior written authorization from Medical Predictive Science Corporation For information on licensing for authorized use of these Materials contact Technical Publications Medical Predictive Science Corporation 2246 Ivy Rd Suite 17 Charlottesville VA 22903 Telephone 800 394 1625 Fax 240 220 6098 E mail info heroscore com Medical Predictive Science Corporation Inc makes no warranties express or implied regarding these materials including but not limited to any warranties of merchantability or fitness for a particular purpose Medical Predictive Science Corporation Inc makes these materials available solely on an as is basis Medical Predictive Science Corporation Inc accepts no responsibility for altered or edited versions of these Materials Medical Predictive Science Corporation Inc reserves the right to revise and improve its products as it sees fit This publication describes the state of the product at the time of this publication only and may not represent or describe the product at all times in the fu
8. a Demographics Statistical characteristics of the population in this case significant demographics include birth weight gestational age and post conceptional age ECG or EKG electrocardiogram Record of the electrical activity of the heart showing waves called P Q R S and T waves The Q R Sand T waves are related to contraction of the ventricles Fiduciary point the single point representing the R wave in a GRS complex Gestational age Prenatal age of fetus from conception to birth High pass filtering a signal processing technique that removes low frequency and DC components of a signal Histogram graph of frequency distribution by means of rectangles whose widths represent class R R intervals and whose areas are proportional to the corresponding frequencies HR Heart Rate HRV Heart Rate Variability 31 Appendix B Glossary AAA Kurtosis The peakedness or flatness of the graph of a frequency distribution especially with respect to the concentration of values near the mean as compared with the normal distribution Logistic regression a regression model that fits binary outputs to the curve represented by e 1 e Model Output Results of mathematical eguation computed hourly based on demographic data and or RRI parameters collected in the preceding 12 hours ex Demographic Risk Model HRV Score Moment the expected value of a positive integral power of a random variable Moving average window A f
9. a r A i 13 SCOOBA L a ee i a e al e 13 He Biusi keis akiai i ka a rs a i a i i i D i I i i a a 13 Viewing the HeRO Score on the HeRO viewing station HeRO ES Enhanced A NON 14 oi 14 tos 16 Patient VIEW L siusis asi a si ais a id 17 Status and Error Messages sscccccccsssssssssssssssccccssesscsssssecsccsssscsssssssssscsccsssssens 18 Admitting and Discharging Patients ooooooooomms 20 Automatic Admit and Discharge 44 id sa di iii dl id 20 Clearing Data Manual utis Sakyk ini si i ii ii i i a i 20 Interpreting PROS 11S sis CO a i i i k O ii 21 Troubleshooting seisein eE i i i i O i i 22 CUSTOMER SCIVICG iii aa ja a i i a sai 26 Appendix A Theory of DDEFd IOA sian i li a i i i 27 Algorithms for Calculating RRI Parametere ccccccccssssssscssssssssccssssscssssssees 27 Data P ackagiNg si sis i ii a i i i i a a ij 27 Data Conditioning Prior to Calculation Of HRV oooooccccconoccccnicocononononannnnccnnannnnnno 27 Mathematical Analysis o oooooooccnccccononnononannnononcnncnnnnn no nnnononncnnonnnnn no nnnnncnnaninnnnos 27 TABLE OF CONTENTS E e A TTT Histogram Based Parameters LL zkakininistusisaniiiuses sia i i i k 27 Sample Asymmetry Analysis ooooooooocccnccccncoonoonnnnnonocnononann no aaa aaa aaa 28 Sample EMOD ai i iii i i i i a i N E 28 Mathematical Modeling ooooooocoonoosinssiss 29 LOGISTIC FREGIES ON di i a a o a i a E 29 Fold Increase Score oococrionoi
10. atient or is not monitoring behavior ECG Patient monitor is not able to Check ECG lead placement and calculate heart rate lead pair selection HeRO services are not operating Contact MPSC Technical correctly Support 23 TROUBLESHOOTING AA A A A A A A A ATA Problem System Comm Error message is displayed during normal use not monitor start up Description The HeRO ES window application is not able to communicate with the services that acquire data and generate HeRO Scores ease resmin iPC is starting up Wait for HeRO ES to initialize up to 60 seconds Internal iPC network error Reboot the iPC Configuration error Contact MPSC Technical Support Problem Error Processing Data message is displayed Description An error occurred while assigning heart rate data and HeRO Scores to a patient ewe reson Internal database error Reboot the iPC Verify that proper operation is restored Database corruption Contact MPSC Technical Support Problem HeRO Failed to Start message is displayed Description The HeRO data processing services did not start Cause resonon Internal iPC network error Reboot the iPC Configuration error Contact MPSC Technical Support 24 TROUBLESHOOTING EET TTT TTT TTT TTT AAA Problem Invalid License message is displayed Description The software license installed on the iPC has an invalid signature or is otherwise corrupt cause TN License
11. d central monitoring while still displaying HeRO information on the physiological monitor INTRODUCTION AAA AAA AAN Indications for Use HeRO is intended to acquire store analyze and report on ECG data collected from infants HeRO is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment HeRO is intended to be used for the analysis of the variability in RR Intervals heart rate and to report measurements of the variability of heart rate data HRV The HRV measurements reported by HeRO are specialized in nature and intended to identify periods of transient decelerations and or reduced baseline variability in the heart rate HeRO is intended to provide only specialized HRV measurements and is not intended to produce any interpretation ofthose measurements or any kind of diagnosis The specialized HRV measurements produced by HeRO have not been approved by the FDA for any specific clinical diagnosis HeRO ES acquires data from a user supplied ECG monitor and requires a monitor with an integrated PC Installation training maintenance and support are to be performed by Medical Predictive Science Corporation employees or contractors who have been certified by Medical Predictive Science Corporation as qualifiedto perform such duties Contraindications Patients with erratic accelerated or mechanically controlled irregular hea
12. e HeRO ES Patient Window Finally click Yes to confirm the operation You must use one of the above methods of handling Admit and Discharge operations to ensure accuracy of the displayed scores 20 TROUBLESHOOTING E Interpreting Results HeRO results provide a quantitative assessment of characteristic RR variability patterns which may precede the clinical indications of developing illness Clinical research has shown that reduced baseline variability and transient decelerations of heart rate bradycardia are related to fetal and neonatal distress The HeRO Score is reported as a fold increase relative to the general NICU population HeRO HRV data provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are betterfounded As is customary with good medical practice the interpretation of any medical test should be made in conjunction with all other available medical history and diagnostic information about a patient The computational methodology used to determine patient status is described in Appendix A Theory of Operation 21 TROUBLESHOOTING Troubleshooting For Technical Support please contact MPSC at 1 800 394 1625 Problem HeRO ES Solo Window is notvisible Description Solo Window is not shown on the Intellivue MX screen Gauso esenion PC window is not visible HeRO ES client application is not running PC is not running PC XDS configuration error
13. e similar to the Plan View e the bed number e the patient medical record number and name if a patientis assigned to the bed e a five day trend of the HeRO Score e a bar graph that shows the most recent HeRO Score e anumeric display of the most recent HeRO Score and e a status indicator that is green when the system is receiving RR intervals or heart rate data for the bed or gray otherwise As on the Plan View clicking on a will show the Patient View 16 USING HeRO ES The on the displays the same status and error messages as on the Plan Viewl Refer to the previous section for more information Patient View The Patient View covers a single bed in the unit providing a much more detailed look at the HeRO Score than eitherthe or Pod View The on the HeRO Viewing Station is the same as the HeRO ES Patient Window Please refer to the instructions in the manual for HeRO ES Patient Window with the following exception In a HeRO ES Enhanced system the Discharge button will only be available on the HeRO Viewing Stations not the iPC 17 USING HeRO ES EE Z77777773 gt gt 77 Status and Error Messages The bottom section of the Main Window may display informational or error messages to indicate problems or status changes These messages and their meanings are summarized below No Heart Rate No MR Number MR Conflict System Comm Error There are two cases
14. ecutive minutes without detecting a heartbeat with valid RR interval values at which point the RR interval is reset The data from these sets are not included in the analysis Data Conditioning Prior to Calculation of HRV The mean RR intervalis calculated on the raw data The RR intervals are filtered by subtracting a 2M 1 point moving average window 1 M RR 2M 1 DPR Cn where nis the index of the RR interval 1 to 4096 and M 100 The standard deviation of the filtered RR intervals is calculated Then each RR interval is divided by the standard deviation The resultis a set of high pass filtered normalized RR intervals with mean O and standard deviation 1 Mathematical Analysis Histogram Based Parameters From each set of 4096 High Pass filtered normalized RR intervals the 10 25t 50 75 and 90 percentiles and the first second third and fourth moments are calculated 27 APPENDIX A THEORY OF OPERATION i i i i i EE Sample Asymmetry Analysis One characteristic of transient decelerations is a marked asymmetry of the distribution of RR intervals accompanied by an occurrence of large deviations especially to the right of the distribution median This phenomenon is guantified through Sample Asymmetry analysis The first step is to construct a guadratic function that will be used for weighting the deviation of each RR interval from a median computed on a data block containing 4096 beats approximately 25 minu
15. ersion information about HeRO ES 13 USING HeRO ES Viewing the HeRO Score on the HeRO Viewing Station HeRO ES Enhanced only There are three display screens on the HeRO viewing station the Plan View the Pod View and the Patient Detailed View In all cases a five day trend of the HeRO Score is plotted wherein the trend goes from left 5 days ago to right current leed DEMO A DEMO B Patients Beds Users A2 043 A4 1 78 3 09 Kros Mat Spark B15 0816 0 19 eA5 e A6 017 018 081 0 32 1 46 0 43 0 14 0 25 S HeRO Help Login 17 12 2013 14 25 26 Figure 5 Screen NOTE The names and medical record numbers used in this and subsequent figures are fictitious and do not represent real patients or users The Figure 5 is a custom designed view of the hospital unit Each consists of the following elements e the bed number e anumeric display of the most recent HeRO Score e the patient medical record number and name if a patient is assigned to the bed e a five day trend of the HeRO Score and 14 USING HeRO ES eO I a i e a status indicator that is green when the system is receiving RR intervals or heart rate data for the bed or gray otherwise In units that contain a large number of beds the HeRO system can be configured with multiple screens with each one covering a physical region within the unit Clicking on a on the opens the Patient View screen
16. file has been tampered Contact MPSC Technical with or was otherwise damaged Support Problem License Expired message is displayed Description The software license has expired CI CT Expired license Contact MPSC Sales or Technical Support 25 CUSTOMER SERVICE E Customer Service If network problems arise contact the hospital network administrator or MPSC Technical Support toll free 1 800 394 1625 Complaints may be reported via telephone or submitted in writing to the following address MPSC 2246 Ivy Road Suite 17 Charlottesville VA 22903 26 APPENDIX A THEORY OF OPERATION a TTT Appendix A Theory of Operation HeRO uses sophisticated mathematical modeling techniques to analyze Heart Rate data for characteristic patterns of variability In order to accomplish this raw data must be screened and converted into a statistically useful form Then significant relationships must be calculated to determine the relative degree of transient decelerations and reduced baseline variability present in the heart rate data Algorithms for Calculating RRI Parameters Data Packaging Sets of 4096 consecutive RR intervals are recorded and the start and stop times noted Each set represents 20 minutes at a heart rate of 200 beats min to 41 minutes at a heart rate of 100 beats min Sets with artifactual intervals are defined as m Lasting more than 45 minutes heart rate less than 100 beats per minute 5 cons
17. g monitored by HeRO ES it is necessary to clear the stored HeRO scores and heart rate data from the previous patient This ensures that the displayed numeric score and trend graph are based solely on heart rate data from the new patient Automatic Admit and Discharge HeRO ES can detect the name and Medical Record Number MRN of the patient currently admitted to the Intellivue MX patient monitor When HeRO ES detects a change in the demographic information it will automatically clear the old patient data and create records for newly admitted patients To take advantage of this automatic admit discharge functionality simply use the Admit and Discharge functions of the Philips Intellivue system When a patient moves into a bed Admit the patient to the monitor specifying a valid MRN one which is unique to that patient When the patient leaves the bed use the Discharge function to clear the patient data from the Intellivue Note that it is not necessary to Discharge a patient that is leaving the bed temporarily but will soon return e g for surgery Clearing Data Manually If your work flow does not make use of the Admit and Discharge functionality of the Philips Intellivue system that is you do not admit patients to monitors or you leave dummy patients admitted all of the time you must manually clear the HeRO ES patient data when moving a new patient into the monitored bed To manually clear patient data click Discharge in th
18. generated by taking the maximum of two Fold Increase scores each of which is ultimately derived from a Logistic Regression equation with unique coefficients Each of the sets of coefficients has been developed to address a specific Heart Rate pattern Combining the outputs of different sets of coefficients yields a more sensitive result then a single set of coefficients can Please see the section nterpreting Results for a discussion of the relevance of the HRV score References Griffin MP Scollan DF Moorman JR The dynamic range of neonatal heart rate variability J Cardiovascular Electrophysiology 1994 5 112 124 23 Richman JS Moorman JR Physiological time series analysis using approximate entropy and sample entropy American Journal of Physiology 2000 278 H2039 2049 30 Appendix B Glossary SSS SSeS Appendix B Glossary ANOVA Analysis Of Variance Area under Receiver Operating Characteristics a plot of sensitivity vs specificity at a variety of thresholds A totally random test produces an ROC area of 0 5 while a perfect test produces an ROC area of 1 0 Artifact or artefact Spurious signal not consistent with the expected results May be produced by a defective machine electrical interference patient movement or loose electrodes Bradycardia slow heart beat Cubic spline a commonly used interpolation technique Cumulative Distribution Function CDF the cumulative sum of the histogram of a set of dat
19. ilterthat averages a signal over a window of time Normalization Process by which a statistical momentis altered by subtracting the mean and dividing by the standard deviation so that the Mean O and the SD 1 P50 50 percentile data point Post conceptional age Current age of neonate from conception to present Reduced Baseline Variability epochs of heart rate data in which the trend has gone flat or has less variability in the baseline heart rate This is invariably linked to a decrease in the second moment standard deviation ROC Receiver Operating Characteristic R R Interval or RRI Interval between heartbeats RRI Parameter A statistic computed on an RRI set of 4096 interval ex M1 mean of RRI RRI Set 4096 consecutive heartbeats R R intervals SD Standard Deviation SEM Standard Error of the Mean Signal processing The process of breaking down an electrical signal into components that can be analyzed through a variety of algorithms ve Appendix B Glossary a a EE Skewness Lack of symmetry in a frequency distribution A symmetrical histogram has a skewness of 0 while a histogram with a tail of values larger than the median has a positive skewness Transient Deceleration epochs of heart rate data in which the trend indicates a deceleration of the heart rate for a period of roughly 30 100 heart beats transient period followed by an acceleration These patterns are reflected by a decrease in
20. is not able to communicate with the services that acquire data and generate HeRO Scores This message may appear for USING HeRO ES A A A E TTT A up to 60 seconds when the patient monitor is first powered up If the message does not disappear there may be a hardware problem or a configuration error Error processing data An error occurred while assigning heart rate data and HeRO Scores to a patient Updating patient Heart Rate and or HeRO Score data is being updated data for the current patient Updating scores HeRO ES is recalculating scores for the current patient Invalid License The HeRO ES software license installed on the PC has an invalid signature or is otherwise corrupt License Expired The HeRO ES software license for this patient monitor has expired HeRO ES will continue to generate scores for the current patient but will not generate scores for any patients admitted in the future License Expires in n This warning message indicates that the software days license will expire in the indicated amount of time For more detailed information about these messages and suggestions for diagnosing and resolving problems refer to the Troubleshooting section of this manual If the situation is not resolved by following the suggested steps contact MPSC Technical Support toll free 1 800 394 1625 19 USING HeRO ES i A Admitting and Discharging Patients When a new patient is transferred into the bed bein
21. mo 1 NBP 80 50 60 5 HeRO ES Solo e Man 0043 a 2 Window o i 35 80 50 0 2 3 n 0 Pause Calcu Chango raph Silence Alame HeRO Profiles Zero haar eee a Figure 1 HeRO ES on the Philips Intellivue MX800 Physiological Monitor In this example the HeRO ES window is displayed along with the other vital signs using a dedicated screen layout that reserves space for the iPC display Other screen layouts can be configured with or without the HeRO ES window The patient monitor is typically configured to show the HeRO score on the default screen users can change screens as needed in the course of patient care then return to the HeRO screen as needed HeRO Smart Key HeRO ES Enhanced is an optional configuration that enables additional functionality by the incorporation of a HeRO Server HeRO ES Enhanced consists of the iPC module installed in the physiological monitors a Server and one or more Viewing Stations In this installation the Server is configured to acquire data from the physiological monitor through the iPC OVERVIEW HeRO Physiological Viewing Stations Monitors He RO Server Hospital Clinical Network Options 1 and 2 l Option 2 Figure 2 HeRO ES Enhanced Overview The HeRO Server acquires the heart rate and patient demographics from the physiological monitor through the iPC Server The HeRO Server is a commercial server class PC that is typically installed in a data closet or other
22. nnnionidonono sa va ses aa koa sana aa k ses a aaa 29 FAS ROS CONC ii i seas a a a a aieesace 30 ROOF ausoninss asaskinniasunsaiissiasa ssss a davsansks ns is 30 Appendix B OBS ai a ia iii i i S a i i ii i 31 INTRODUCTION a a i Introduction HeRO provides an automated noninvasive method to detect transient decelerations and reduced baseline heart rate variability HeRO continuously acquires records measures and analyzes variations in RR Intervals and provides ongoing display of this information HeRO is used to Continuously acquire heart rate data from an existing physiological monitor Identify and determine the length of time between individual heart beats the R R Interval Calculate a set of measures from these R R Intervals to characterize the heart rate pattern Compute an index based on the degree of decelerations and reduced baseline variability in these patterns Calculate the HeRO Score which expresses the index as a fold increase relative to the overall NICU population and Provide this information to clinicians in a timely and intuitive fashion HeRO ES is a stand alone implementation of HeRO that processes heart rate data on the Philips Integrated PC iPC and shows the HeRO Scores at the bedside on the main display of the physiological monitor HeRO ES Enhanced is an optional upgrade that merges the functionality of HeRO Symphony and HeRO ES enabling a server based implementation an
23. r short data sets Sample entropy SampEn is calculated with m 3 0 2 using filtered normalized data 28 APPENDIX A THEORY OF OPERATION dy Y E Y bars are L SD rae A number of matches of length m 7 B number of matches of length m ApEn s In 1 A 1 B8 SampEn In A B For regular repeating data A B nears 1 and entropy nears O Figure 8 Sample Entropy Mathematical Modeling Logistic Regression Since no single measure will reliably detect all of the abnormal records multivariable predictive mathematical models are employed One such model is a logistic regression The mathematical model uses variables for HRV measures including standard deviation sample entropy and asymmetry function analysis These variables are inserted into a logistic equation of the form p e 1 e where A Bot BieVit B20V2 BneVn and where V represent various measures of heart rate variability Fold Increase Score The model output score is scaled by a constantto determine the Fold Increase Score Computing this score is analogous to dividing a particular Logistic Regression score by the average Logistic Regression score seen in the overall NICU population Thus any score less than 1 0 is below average while any score 29 APPENDIX A THEORY OF OPERATION SSS ee above 1 0 is above average The Fold Increase Score is graphed on a scale from 0 0 to 5 0 HeRO Score The HeRO Score is
24. rt rhythms are not suitable for HRV evaluation When shown the ECG waveform displayed on the computer screen is not to be used for analysis of cardiac function Precautions As is customary with good medical practice the interpretation of any medical data should be made in conjunction with all other available medical history and diagnostic information about a patient INTRODUCTION Using this Manual This manual is written for physicians clinicians nurses care extenders and hospital IT personnel who are familiar with basic Windows software operation Clickable menu items or button names are designated by a box around the name i e Help Labels of non interactive graphs or screen displays are indicated by bold type i e Main Menu The A symbol indicates a warning that could potentially affect patient care if not followed OVERVIEW Overview HeRO ES is a software application that runs on the Philips Integrated PC iPC option of the Philips Intellivue MX series physiological monitor The iPC is a Windows PC that shares the screen and enclosure with the main patient monitoring hardware HeRO ES acguires Heart Rate data from the patient monitor over a dedicated internal network connection computes hourly HeRO scores for the patient being monitored and displays the results on the shared screen HeRO has no applied parts Not Admitted 3 Mar 2014 11 22 Under 36 weeks BASIC HERO Pleth SSA Temp 430 O0iHeRO De
25. similar location It serves as the hub of the wheel it computes HeRO scores stores the main HeRO database coordinates patient transfers and stores settings for the other components of the HeRO system Network Data Acquisition Interface NDAI The Network Data Acquisition Interface NDAI is a software extension to HeRO ES that enables the Server to acquire heart rate data from the physiological monitor This interface can also perform Patient Admit Discharge and Transfer ADT operations based on information retrieved from the physiological monitors OVERVIEW Se Viewing Stations The Viewing Stations present the HeRO user interface to clinicians In a typical installation several dedicated viewing stations small form factor computers with monitors are deployed in various points throughout the NICU The system can also be configured to allow existing hospital PCs to access HeRO via web browser USING HeRO ES aa ss Using HeRO ES Setting Up The HeRO ES software shall be installed and configured by MPSC authorized technical personnel MPSC recommends that all Philips Integrated PCs iPCs that run HeRO ES be connected to a hospital intranet to facilitate license and software updates In the case that the HeRO ES Enhanced option is installed the iPC must be connected to the hospital intranet at all times If required additional network connections shall be the responsibility of hospital IT personnel If network problems
26. tes of data The Figure presents a function x x m where x is the magnitude of an RR interval and mis the median of the data The two branches of this parabola quantify deviations towards increase right half and decrease left half of an RR interval with respectto the median Given a series of 4 096 RR intervals x x2 Xs09e We compute r x r x if x lt m O otherwise and r x H x if x gt m O otherwise for each RR reading x Finallythe A left asymmetry and A right asymmetry are computed as 4096 f 1 4096 2 R 222 and R se 2 lx respectively In other words R1 and R2 are non negative quantities that increase when risk A the number and or the magnitude of large deviations from the median increases Intuitively a distribution of RR intervals that is skewed to the right will result in R2 gt R1 N A J Wi P7 Y V N SSL Figure 7 Sample Asymmetry Sample Entropy Sample Entropy is a measure of regularity in time series that is suitable to HRV analysis Sample Entropy m r N is the negative natural log of the conditional probability that two sequences similar within a tolerance r for m points remain similar at the next point where Nis the total number of points and self matches are not included A low value of SampEn is interpreted as showing increased regularity or order in the data SampEn is very similar to approximate entropy ApEn but has reduced bias especially fo
27. ture HeRO The Power to Predict and the MPSC logo are trademarks or registered trademarks of Medical Predictive Science Corporation Inc Microsoft and Windows are registered trademarks of Microsoft Corporation Philips and Intellivue are registered trademarks of Koninklijke Philips Electronics N V Document Number MPSC INS 1627 R1 10 TABLE OF CONTENTS ERA AAA A INTO CUCU ON ici V ia a B a i i A nia miele a s 4 Indications for U6G sisisisissnsisssssasssassinssskisasssnnssansonass kiss snssoa s satoa Inner 5 CONG BINGICANIONG uan 5 Procardia 5 Using this Manual cin ini a k 6 OVE IVI Wait ras Las 7 DO Vi a a s ossss s 8 Network Data Acquisition Interface NDAI cssssssssssssssssssssssscssssssssssesess 8 Viewing Stations inci ri A a i 9 Using HERO B RP 10 Setting Upa nin kki ai s su i sk ks is Ai i a 10 Viewing the HERO Score nissccasicsscsssssscssrssosscenseassosecsanscsssesscsensenacssssenceasscsocannssasoonss 11 The HERO ES Solo WindOW ooo ccccccncnononononnnonocononinnnnonononononnonnnnanononnnnnncnnonananonanoss 11 Activating the HERO ES Solo WiNdOW ooocccooocccccooonccccnononnonocononccoconononos 12 Continuous HeRO Monitoring usa sa i i a 12 Window Position and SiZe cccconnooononcnncnnccnonnnoannononoconononnnnononononoconanannnonanoss 12 HeRO ES Patient Window cccccccccccccsssssssscececececeesessaeeeceeseecsessesssseeeseeeenseeees 12 Discharge BUON arias ia a i i
28. where this error will apply With HeRO ES the system is unable to communicate with the Intellivue MX patient monitor With HeRO ES Enhanced the message will also appear when the HeRO Server is unable to communicate with the iPC In both cases No Heart Rate information is being collected and no HeRO Scores will be generated This message may appear for up to 60 seconds when the patient monitoris first powered up If the message does not disappear there may be a hardware problem or a configuration error The system is communicating with the Intellivue patient monitor but is not receiving heart rate data This typically indicates that the patient monitoris not able to calculate heart rate values due to an absent weak or noisy ECG waveform Check the leads or change the lead pair selection to improve the quality of the ECG waveform If this warning appears while the Intellivue is steadily displaying a numeric heart rate value there may be a hardware problem or a configuration error The system is receiving data from the physiological monitor serving the bed but no Medical Record Number is specified for the patient admitted to the monitor The system is receiving data from the physiological monitor serving the bed but no Name is specified for the patient admitted to the monitor The physiological mointors for the affected beds are reporting the same Medical Record Number for the admitted patient The HeRO ES window application
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