Version 3.1 System Manual
Contents
1. 16 Patient View w M 17 Status and Error Messages inrer eA caseuavsisanvendasisdenesencnendcbonssustuuevendeslassuucavawend conus 18 b LENT C I Tus 20 Admitting and Discharging Patients 0 oorr an meta sn np avo sedan nu ro tu nb rk pau a aaa ng oro rk uaa dod 21 Automatic Admit and Discharge nreceerhai ete ore r nra nno nii nante nasa du baae ena rU EE eg 21 TABLE OF CONTENTS _ EEEE aay Clearing Date IWAN WAY RR 21 Interpreting RES UA soar aset ba eida bonc aO a O o RDUM URP ERE ERSS 22 Troubleshooting siesta debite i esa usd d uRac s EvadvpEO eiu Fx vir a a aeo DU dM M TIR ERE IAN UE 23 e Col dde ida in E 26 Appendix A Theory of OperatioNn seemmanennnnnsnnnnnsnnennssnnnosanennazenne 27 Algorithms for Calculating RRI Parameters ssssssessssssessesseossssscosssssessessesssesscsssssoesssseseese 27 QRS DA EET 27 Data Packaging wania ani ai rabini EOE audae 28 Data Conditioning Prior to Calculation of HRV sesccsciiseasisccttessrscanisccpeean ie wpinnececnccenstezdeanenauenney 28 Mathematical Analysis rione arisen Rai teas Na aaa 28 Histogram Based Parameters c usscnseteotescirn ved pln bss stai pec uiwtva dip beau otiam 28 Sample Asymmetry Analysis ieaieneci te aria deo exa sse pae venet2. To manually clear patient data click Discharge in the 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 21 TROUBLESHOOTING SaaS 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 in risk of sepsis relative to the general NICU population HeRO HRV data provides a new tool for clinical assessment so that standard diagnostic and therapeutic decisions are better founded 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 Patients with High HeRO Scores gt 2 0 are 6x more likely to develop sepsis in the next three days than patients with Low HeRO Scores lt 1 0 The HeRO system includes an alarm function to draw attention to these patients Refer to the section Alarms A randomized controlled trial of 3000 VLBW infants demonstrated that patients whose HeRO Scores were displayed to clinicians experienced 22 fewer de
3. the bed number the patient medical record number and name if a patient is assigned to the bed a five day trend of the HeRO Score a bar graph that shows the most recent HeRO Score a numeric display of the most recent HeRO Score an alarm symbol when appropriate and a status indicator that is green when the system is receiving RR intervals or heart rate data for the bed or gray otherwise The alarm is shown when the HeRO score is above 2 0 A flashing alarm can be paused by left clicking or tapping on touch screens anywhere on the Bed Icon Refer to the section Alarms for more information 16 USING HeRO ES As on the clicking on a will show the Patient View Note that if an alarm is active the first click will pause the alarm and the second click will open the Patient View The on the displays the same status and error messages as on the View 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 either the Plan View 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 Ina HeRO ES Enhanced system the Discharge button will only be available on the HeRO Viewing Stations not the iPC 17 USING HeRO ES ii Status and Erro
4. gaps in the Heart Rate trend Note 27 APPENDIX A THEORY OF OPERATION u M that subsequent data processing is not performed on data collected during time epochs in which the gaps occur nor data marked as invalid 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 Lasting more than 45 minutes heart rate less than 100 beats per minute 5 consecutive 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 interval is calculated on the raw data The RR intervals are filtered by subtracting a 2M 1 point moving average window M 1 RR Tp 24 n where n is 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 result is a set of high pass filtered normalized RR intervals with mean 0 and standard deviation 1 Mathematical Analysis Histogram Based Parameters From each set of 4096 High Pass filtered normalized RR intervals the 10 25 50 759
5. 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 anew HeRO Score may take up to 3 hours to be generated Ina 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 version information about HeRO ES 13 USING HeRO ES Viewing the HeRO Score on the HeRO viewing station only for HeRO ES Enhanced 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 with the most recent score to the right Dadelite DEMO A DEMO B Patients Beds Users ON BMCYVEBICYX Bo e810 B11 2 288 1 17 1 78 0 22 D272123 K453789 M727648 4769 H434989 G789453 G472189 T321986 Dde Kress Matson ri Hyde Greco Griffey Tra
6. where A Do BreVit B2eV BneVn and where V4 4 represent various measures of heart rate variability Fold Increase Score The model output score is scaled by a constant to 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 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 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 30 APPENDIX A THEORY OF OPERATION References Griffin MP Scollan DF Moorman JR The dynamic range of neonatal heart rate variability J Cardiovascular Electrophysiology 1994 5 112 124 3 Richman JS Moorman JR Physiological time series analysis using approximate entropy and sample entropy American Journal of Physiology 2000 278 H2039 2049 31 Appendix B Glossary E Appendix B Glossar
7. alessa alessakuwait com Web www alessakuwait com Saudi Arabia Gulf Neocare PO Box 365899 Riyadh 11391 Saudi Arabia PH 996 1464 8545 Web www gulfneocare com udi Manufacturer and for all other Countries Medical Predictive Science Corporation 2246 Ivy Rd Suite 17 Charlottesville VA 22903 USA T 1 434 220 0714 Fax 1 240 220 6098 E mail info heroscore com www heroscore com EC Authorized Representative Emergo European Authorized Representation Molenstraat 15 2513 BH The Hague The Netherlands Telephone 31 70 345 8570 Fax 31 70 346 7299 TABLE OF CONTENTS pu l Electronic Access to HERO System Manuals eee eese eese eese ee eene eene n nnne nsns aane sanas son 1 Contact INFOLMATION NP 2 Distributor LIST 72 E 2 ul Manufacturer and for all other Countries ccccccccsssssssssscccececeessssssnecceceeeceesesssanaeeess 2 EC Authorized Representative sivas cissciscsssssnnncsscivsesonveasesnsivan ORE FUE PKK ERO UNE CE PE UE PEREV ERROR KP 2 e gere Do aio a EE T E E E sieves tsvedasscca as O T T 5 Indications for Ua 6 Contraindications sssesssessseesssecosesosesesssessssssesosesossecssecosecesscessssesssssescssasssesssesosesesssessse 6 PrecautiOns ii uss coestedsstessesecdedceasedes veabcceasede seuss usb sceesedesdeeesedos 6 Using this Man al ner nrc
8. Contact Philips Technical Support 23 TROUBLESHOOTING Problem Description Problem Description Problem Description Comm Error message appears during normal use not monitor start up HeRO ES is unable to communicate with the Intellivue MX patient monitor Cause Resolution Intellivue and or iPC are starting Wait for HeRO ES to initialize up communication with the Intellivue up to 60 seconds Internal iPC network error Reboot the iPC Configuration error Contact MPSC Technical Support Hardware problem Contact MPSC Technical Support No Heart Rate message is displayed The system is not receiving heart rate data from the Intellivue MX patient monitor Cause Resolution Patient monitor is not attached to None necessary This is normal a patient or is not monitoring ECG behavior 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 Support correctly System Comm Error message is displayed during normal use not monitor start up The HeRO ES window application is not able to communicate with the services that acquire data and generate HeRO Scores Cause Resolution 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 Tech
9. ECG waveforms of certain artifactual signals caused by myoelectrical noise clinician interference or other spurious inputs When the signal to noise ratio of the true electrocardiograph drops below a certain level caused by poor lead placement inadequate electrode contact etc these spurious inputs can be mistakenly recognized as a QRS complex The criteria for RR interval validation discussed above ensure that the subsequent HRV analyses are only performed on valid interval data While the rules above will inevitably lead to the rejection of some valid QRS complexes and therefore to a bias toward reporting lower variability than actually exists the system is still able to perform its intended function of identifying reduced variability and transient decelerations The operator can gain insight into the operations of the QRS detection algorithm and validation rules by observing the trends on the screen On the ECG graph QRS complexes marked with a green triangle indicate the termination of a valid RR Interval Those with red marks indicate an invalid interval Those with no marks indicate QRS complexes that were not identified by the system and usually occur during or immediately after a spurious ECG signal The Heart Rate trend plots this information against time Points plotted in green represent valid RR intervals points in red represent invalid RR intervals while epochs of time in which QRS complexes were not identified are represented by
10. F OPERATION p ee ee ui Se ae 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 QRS Detection The QRS detector of the HeRO system has been tuned for quality not quantity As such observers may find that many seemingly valid QRS complexes are not identified by the system This is consistent with the intended use of the device which is to identify periods of transient decelerations and reduced baseline variability in the heart rate As such it is not as important that every single RR Interval be identified as it is that identified intervals be valid After the QRS detection algorithm identifies candidate QRS complexes the corresponding intervals are checked for validity Intervals that are outside of a range of 20 of the mean of the last fifteen intervals are discarded Also discarded are intervals whose difference from the previous interval is not within five standard deviations of the mean of the previous 512 differences These rules are justified by the presence on all
11. G Input B l QORSCapure BW Data Coverage B 12 07 2007 12 23 13 Figure 9 The remainder of the patient s stay in the NICU is marked by a low trend of HeRO Scores The patient is discharged home after 94 days in the NICU In this example the clinician is instructed to take no action based on the HeRO Score 44
12. HeRO ES Version 3 1 System Manual COPYRIGHT 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 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 future Electronic Access to HeRO System Manuals HeRO User Manuals are available in electronic form To access the electronic copies of the documents you will need a device connected to the Internet and have installed Adobe Acrobat Reader There is a link to obtain Adobe Acrobat Reader on the HeRO website You can access the HeRO website by clicking Help from a HeRO screen or by typin
13. MX series physiological monitor The iPC is a Windows PC that shares the screen and enclosure with the main patient monitoring hardware HeRO ES acquires 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 NBP 8 13 80 50 60 5 HeRO ES Solo NBP Pulse 100 80 50 60 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 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 Physiolagical pipes Vidiing Stations Monitors HeRO Server H
14. The system is receiving data from the physiological monitor serving the bed but no Name is specified for the patient admitted to the monitor MR Conflict The physiological mointors for the affected beds are reporting the same Medical Record Number for the admitted patient System Comm Error The HeRO ES window application is not able to communicate with the services that acquire data and generate HeRO Scores This message may appear for up to 60 seconds when the patient monitor is first powered up 18 USING HeRO ES ufu 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 data Heart Rate and or HeRO Score data is being updated 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 iPC 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 days This warning message indicates that the software license will expire in the indicated amount of time For more detailed informati
15. a tat eod eun nanii edes d adu Ausg deus 28 Sample ENEO Py 29 Mathematical Modeling iii 30 Foliis MEM m 30 FAINI SCONE PENNE E m S TEE 30 HeRO o p t 30 ROGER ONC OSS IA CUT oFU TRE DHL E DR FIO RDUM TEN TER E ETEN AMEN YN V E TEESE nE EEE PEU MM KR RUE 31 Appendix B GIOSSOIY RETE Cd 32 Appendix C Use of HeRO Score in the Assessment of Infection ccce eres 35 INTRODUCTION SaaS SSS 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 risk of sepsis 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
16. and go percentiles and the first second third and fourth moments are calculated 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 quantified through Sample Asymmetry analysis The first step is to construct a quadratic 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 minutes of data The Figure presents a function r x x m where x is the magnitude of an RR interval Z j and m is 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 respect to the median Given a series of 4 096 RR intervals x Xz X4096 We 28 APPENDIX A THEORY OF OPERATION _ SE compute r x r x if xm 0 otherwise and r2 x r x if x gt m 0 otherwise for each RR reading Xi Finally the R left asymmetry and R right asymmetry are computed as 4096 wn and g umi x respectively In other words R1 and R2 are non negative quantities that increase when 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
17. aths than patients whose HeRO Scores were not displayed to clinicians The computational methodology used to determine patient status is described in Appendix A Theory of Operation Appendix C Use of the HeRO Score in the Assessment of Infection provides numerous examples of HeRO trends around the time of clinically significant events 22 TROUBLESHOOTING penu EE Troubleshooting For Technical Support please contact the local distributor as listed on Page 2 of this manual Problem HeRO ES Solo Window is not visible Description Solo Window is not shown on the Intellivue MX screen Cause Resolution iPC window is not visible Change the screen layout on the Intellivue MX patient monitor to one that includes an iPC desktop window HeRO ES client application is not Manually start the HeRO ES running client application via Philips smart key XDS LaunchPad Windows desktop shortcut or Windows start menu iPC is not running Manually start the iPC 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 monitor is powered up Enter config mode then select Main Setup Hardware Internal PC Auto Start PC Enabled iPC XDS configuration error Reconfigure the XDS display settings to restore proper operation of the shared screen Contact Philips Technical Support if necessary iPC hardware problem
18. cally start the PC on power up To do this enter Config mode then select Main Setup Hardware Internal PC Auto Start PC Enabled 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 must activate the HeRO ES Patient Window by switching to an iPC 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 geo DEMO HeRO Trend Current HeRO Score Scrollbar Heart Rate Trend Help Button HeRO Icon Figure 3 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 Pausing an Alarm HeRO ES includes a high score alarm to warn clinicians if a patient s score rises above 2 0 When first activated the alarm displays a flashing symbol To pause the alarm and stop the flashing tap or click anywhere in the main area of the window away from the edges Refer to the section Alarms for more information Discharge Button Deletes all data for the currently displayed patient
19. cemia When neither the clinical score nor the HeRO Score is measured the fold increase in risk of illness is 1 0 The clinical score alone differentiates infants across a spectrum of risk as does the HeRO Score Knowledge of both allows greater refinement in the estimation of risk For example an infant with a clinical score of O generally has lower risk of illness but the concurrent finding of a high risk HeRO Score identifies a subset with 2 5 fold increase in risk For infants with 2 points or more that is with clinical findings of illness knowledge of the HeRO Score adds little and even a low risk HeRO Score does not cancel out the clinical presentation This is in keeping with the idea that the HeRO Score is adjunctive to clinical information and is not a standalone substitute for medical personnel Other than sepsis there are many reasons for an elevated HeRO Score It is believed that an elevated level of circulating cytokines early in sepsis causes the SA node of the heart to respond abnormally to the parasympathetic and sympathetic branches of the autonomic nervous system Hence any condition that is believed to result in cytokine release is also likely to cause elevated HeRO Scores These conditions include urinary tract infection necrotizing enterocolitis intraventricular hemorrhage and respiratory distress among others It is also well known that anesthetics and vasodilators affect the autonomic nervous systems Hence patients re
20. dina kh rni i cue Fu veu Fk Ru de EEEn Eron aO Fw dic d eva d Ra DV r ES 6 Gi a AT P EPETR 7 Server only for HERO ES Enhanced ecelesie eee eeee esee eene en sesenta nans tn ua 8 Network Data Acquisition Interface NDAI only for HeRO ES Enhanced 8 Viewing Stations only for HERO ES Enhanced eese 8 Using HERO b TOO TT ET 10 kaaa ITALI ete 10 Viewing the HERO Score iocanrn oit Orr ar eO EE IDEE ER HU Xr D xr FEX Hire R i pp b ri bU RR EU RER 11 The HERO ES Solo WindoW 5i Ex ign RE PER Ebo E RR s ERR Den Ua bee s ag QU ta dud e UE DENS 11 Activating the HERO ES Solo Window sese ener 12 Continuous HERO Monitoring retratos tnt banh a nono n aura 12 Window Position and SiZE cceceesesececeeeceesesseaececececeseeseeseeececsesceesesaeseseeeeeessseuaeaeeeeeens 12 HERO ES Patient WIRIOW idco va Fo bet OR FLY br nl bcr tna FIN Don v gud la e dac YR 12 Pausimp an Alarmi uie OR RUD ER VERA TR EODEM EN M RE Cr Mas UD EA UU Mad oA Ma RUPEE 13 Discharge sU uro PRSETER E 13 Serlvcmse 13 WI AA AA WA MM NA KA KA AAA AAA AAA WA AAA KA AAA 13 Viewing the HeRO Score on the HeRO viewing station only for HeRO ES Enhanced RE 14 Plan VIeW cedet tod esent UA AE tne 14 Pod View m
21. eRO ES amp nhanced HERO ES Enhanced only Figure 1 HeRO ES Enhanced Overview The HeRO Server acquires the heart rate and patient demographics from the physiological monitor through the iPC Server only for HeRO ES Enhanced The HeRO Server is a commercial server class PC that is typically installed in a data closet or other 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 only for HeRO ES Enhanced 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 Viewing Stations only for HeRO ES Enhanced 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 8 OVERVIEW io 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 LSE 21112 22252 1114 Using HeRO ES Setting Up The HeRO ES software shall be installed and configured by MPSC aut
22. ents When a new patient is transferred into the bed being 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
23. existing clinical observations such as increase in apneas and bradycardias increase in oxygen or ventilation feeding intolerance hypotonia lethargy temperature instability hypotension grunting vomiting jaundice shock petechiae purpura or abdominal distention HeRO Score Inter High a es mediate Not measured E Figure 1 Sepsis Risk Scorecard From Griffin 2007 Heart Rate Characteristics and Clinical Signs in Neonatal Sepsis Clinical Score 35 Appendix C Use of HeRO Score in the Assessment of Infection EE An elevated HeRO Score is not a diagnosis of sepsis it is an indication that sepsis is more likely While an elevated HeRO Score should arouse suspicion of sepsis diagnosis must be confirmed with other clinical signs laboratory work and or culture results Conversely a low HeRO Score does not rule out sepsis it indicates that sepsis is less likely A patient that has a low HeRO Score yet is exhibiting signs and symptoms of sepsis should be evaluated without regard to the low HeRO Score A low HeRO Score should not be used to withhold treatment Figure 1 shows a table for bedside use in estimating the risk of impending sepsis in the NICU using a clinical score and HeRO monitoring The clinical score assesses points for the following conditions used in diagnosing sepsis apnea increased ventilatory support temperature instability lethargy or hypotonia feeding intolerance I T ratio WBC and hypergly
24. g http www heroscore com Technical_Support htm from a web browser If you need help accessing the electronic copies of the documents or to request a printed copy at any time contact the appropriate representative on page 2 of this manual Single printed copies are available at no additional cost and will be delivered within seven days of receiving the request Document Number MPSC INS 1625 R1 10 EMERGO EUROPE EC Molenstraat 15 2513 BH The Hague C The Netherlands 0050 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 CONTACT INFORMATION Contact Information Distributor List Austria Connect Medizintechnik GmbH Gspanngasse 4 A 2130 Mistelbach Austria Ph 43 2572 32400 FAX 43 2572 20404 Email office connect medizintechnik at Web www connect medizintechnik at The Netherlands Medisize bv Edisonstraat 1 2181 AB Hillegom PH 31 0 252 576 888 Email info medisize com Web www medisize com United Kingdom SLE Ltd Twin Bridges Business Park 232 Selsdon Road South Croydon CR2 6PL UK Ph 44 0 208 6811414 ext 251 Fax 44 0 208 6498570 Web www sle co uk Kuwait Al Essa Medical amp Scientific Equipment Co W L L 118 Sector C Street 33 Shuwaikh Ind Area Kuwait PH 965 2 483 4510 FAX 965 2 484 0629 Email
25. ge 12 07 2007 12 21 36 Figure 7 At approximately seven weeks of age the patient s HeRO Score again spikes prior to diagnosis In this case the blood culture was positive for coagulase negative staphylococcus In this example the clinician is instructed to begin lab work at the first elevation of HeRO Score above 2 0 approximately 36 hours prior to the blood culture 42 Appendix C Use of HeRO Score in the Assessment of Infection M R _HeRO Monitor Patient View A1 OBTA dee e e e e e ee e dee e e e e eee e H e RO HRC Trend Fold Increase Heart Rate bpm ECG Input B m ii J GRSCapue B LE Data Coverage B 12 07 2007 12 22 21 Figure 8 At approximately eight weeks of age the patient exhibits a spike in HeRO Score that is not associated with any clinical event i e a False Positive In this example the clinician is instructed to begin lab work at the first elevation of the HeRO Score above 2 0 which would have led to an unnecessary heel stick presumably 43 Appendix C Use of HeRO Score in the Assessment of Infection ee _HeRO Monitor Patient View A1 O3 7 745 dee e e e e eee e 2 dee e e e e eee e H e RO HRC Trend Fold Increase Heart Rate bpm EC
26. he HeRO System note that the HeRO Scores were generated but not displayed to clinicians While the number of events experienced by this patient is unusual the course of stay offers a remarkably broad set of clinical scenarios for interpretation _HeRO Monitor Patient View de kkkkkkkkk k kkkkkkkkkxk A1 03774 o 2 Ej T E o D o a a Heart Rate bpm ECG Input BH SS QRS Capture f Data Coverage 12 07 2007 12 18 19 Figure 2 Patient presents as a Caucasian female 770 grams at birth 24 weeks gestational age HeRO Scores were generated for this patient but not displayed to clinicians Clinical annotations are marked in blue During the initial days in the NICU the HeRO Score trends low During the course of this example trend the clinician is instructed to take no action based on the HeRO Score although treatment should not be withheld if clinical signs of sepsis are present 37 Appendix C Use of HeRO Score in the Assessment of Infection O r ee _HeRO Monitor Patient View A 1 03774 dee e e e e eee e dee e e e eee e e H e RO HRC Trend Fold Increase Heart Rate bpm ECG input B BEEN m QRS Capture B Data Coverage B 12 07 2007 12 18 50 Figure 3 At approximately twelve days of age the patient exhibits episodes of reduced heart rate variability punctuated by transie
27. 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 and central monitoring while still displaying HeRO information on the physiological monitor INTRODUCTION pemu D 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 specialized HRV measurements and may detect arrhythmias that when combined with other risk factors can be used as an aid in assessing the risk of sepsis in infants The use of the HeRO monitoring improves survival in very low birth weight neonates HeRO ES acquires data from a user supplied ECG monitor and requires a monitor with an integrated PC Installation trai
28. horized 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 arise contact the hospital network administrator or the local distributor listed on page 2 of this manual 10 USING HeRO ES uu 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 patient is 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 signal is res
29. m Data Coverage i ECG Input i Eo EE QORSCapue B 12 07 2007 12 19 28 Figure 5 At approximately four weeks of age the patient again exhibits a loss of variability punctuated by transient decelerations resulting in a spike in the HeRO Score that begins approximately 36 hours prior to the diagnosis of Urinary Tract Infection with Klebsiella the blue line indicates the time the culture sample was taken In this example the clinician is instructed to begin lab work at the first elevation of the HeRO Score above 2 0 approximately 36 hours prior to the urine culture 40 Appendix C Use of HeRO Score in the Assessment of Infection _HeRO Monitor Patient View A1 OBRTA dee e e e e eee e 2 dee e e e e eee e H e RO HRC Trend Fold Increase Heart Rate bpm ECG Input B m TS QRS Capture B di 12 07 2007 12 20 21 Figure 6 At approximately six weeks of age the patient s HeRO Score again spikes in this case 3 to 5 hours prior to diagnosis of another UTI In this example the clinician is instructed to begin lab work at the first elevation of the HeRO Score above 2 0 approximately two hours prior to the urine culture 41 Appendix C Use of HeRO Score in the Assessment of Infection _HeRO Monitor Patient View A 1 EE ha dee e e e e e ee e dee e e e e eee e H e RO HRC Trend Fold Increase Heart Rate bpm ECG Input B Erw QRS Capture M D Data Covera
30. nical Support 24 Problem Description Problem Description Problem Description Problem Description TROUBLESHOOTING Error Processing Data message is displayed An error occurred while assigning heart rate data and HeRO Scores to a patient Cause Resolution Internal database error Reboot the iPC Verify that proper operation is restored Database corruption Contact MPSC Technical Support HeRO Failed to Start message is displayed The HeRO data processing services did not start Cause Resolution Internal iPC network error Reboot the iPC Configuration error Contact MPSC Technical Support Invalid License message is displayed The software license installed on the iPC has an invalid signature or is otherwise corrupt Cause Resolution License file has been tampered with or was otherwise damaged Contact MPSC Technical Support License Expired message is displayed The software license has expired Cause Resolution Expired license Contact MPSC Sales or Technical Support 25 CUSTOMER SERVICE Customer Service If network problems arise contact the hospital network administrator or Technical Support Complaints may be reported via telephone or submitted in writing to the local distributor as listed on page 2 of this manual 26 APPENDIX A THEORY O
31. ning 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 qualified to perform such duties Contraindications Patients with erratic accelerated or mechanically controlled irregular heart 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 A low HeRO Score should never be used to deny or reduce treatment on a patient that is exhibiting clinical signs of sepsis 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 is used in this manual and in the online help system to highlight warnings that could potentially affect patient care if not followed OVERVIEW uu Overview HeRO ES is a software application that runs on the Philips Integrated PC iPC option of the Philips Intellivue
32. nt decelerations This causes the HeRO Score to rise approximately 12 to 18 hours prior to an episode of clinical sepsis i e sepsis observed clinically and treated with antibiotics without confirmation by blood culture In this example if the HeRO Score were present the clinician is instructed to obtain the lab work when the HeRO Score first went above 2 0 eight hours prior to the culture time 38 Appendix C Use of HeRO Score in the Assessment of Infection ee _HeRO Monitor Patient View A1 O37 ha dee e e e e eee e z dee e e e e eee e H e RO ww Ej E s 2 o a o 4 Heart Rate bpm ECG Input B Put i T QRSCapue B a DataCoverage B 12 07 2007 12 19 12 Figure 4 At approximately three weeks of age the patient returns from surgery Anesthesia results in a complete loss of variability in the heart rate and a corresponding elevation in the HeRO Score Over the next 48 hours variability returns to the heart rate and the HeRO Score returns to normal In this example the clinician is instructed to ignore the elevated HeRO Score because it was caused by anesthesia 39 Appendix C Use of HeRO Score in the Assessment of Infection _HeRO Monitor Patient View de kkkkkkkkk k dede e e e e eee A1 03774 HRC Trend Fold Increase Heart Rate bp
33. on 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 Technical Support at the local representative listed on page 2 of this manual 19 USING HeRO ES Alarms The HeRO system includes a visual high score alarm that is designed to draw attention to patients with elevated risk The alarms activate when a patient s HeRO Score rises to or beyond a threshold value of 2 0 The alarm state is indicated by one of the two Alarm Symbols shown below State Appearance Off Symbol not shown Active N Symbol shown with exclamation points flashing Paused Symbol shown with exclamation points solid An active alarm may be paused by tapping or clicking on the flashing symbol or the surrounding area The alarm will now display the Paused symbol which will remain visible until the alarm resets When the patient s score drops below the threshold an Active or Paused alarm will reset to the Off state and the alarm symbol will disappear The alarm is automatically re armed such that it will activate if the threshold value is exceeded in the future The alarm system in HeRO is implemented in software and does not require separate testing If HeRO is operating the alarm system is functional 20 USING HeRO ES pup uuu Jn Admitting and Discharging Pati
34. 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 32 Appendix B Glossary E Logistic regression a regression model that fits binary outputs to the curve represented by a a e 1 e Model Output Results of mathematical equation 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 filter that averages a signal over a window of time Normalization Process by which a statistical moment is altered by subtracting the mean and dividing by the standard deviation so that the Mean 0 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 p
35. pp 4 LEX A6 A7 8 813 B14 B15 B16 0 32 1 46 0 43 0 14 0 25 0 31 9 19 8554276 M121658 231277 C982411 R231863 H921745 M148692 R422842 Sedillo McGarry Silver Campo Rabinowitz Hamer Mahon Roberts i HeRO 17 12 2013 14 25 26 Figure 4 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 4 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 an alarm symbol when appropriate 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 14 USING HeRO ES 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 The alarm is shown when the HeRO score is above 2 0 A flashing alarm can be paused by left clicking or tapping on touch screens anywhere on the Bed Icon Refer to the section Alarms for more information Clicking on a Bed Icon on the opens the Patient View screen for the patient assigned to that bed Note that if an alarm is active the first click on the Bed Icon will pause the alarm and
36. r 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 Message Description Comm Error There are two cases 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 monitor is first powered up If the message does not disappear there may be a hardware problem or a configuration error No Heart Rate The system is communicating with the Intellivue patient monitor but is not receiving heart rate data This typically indicates that the patient monitor is 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 No MR Number 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 No Name
37. result in R2 R1 MM V EM Figure 6 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 N is 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 for short data sets Sample entropy SampEn is calculated with m 3 r 0 2 using filtered normalized data bars are S D number of AY of length m 7 p number of matches of length m ApEn s In 1 Ay 1 E SampEn In A B For regular repeating data A B nears 1 and entropy nears D Figure 7 Sample Entropy 29 APPENDIX A THEORY OF OPERATION SS SS eS Se 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 pze 1 e
38. rocessing The process of breaking down an electrical signal into components that can be analyzed through a variety of algorithms 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 Sample Entropy 33 Appendix B Glossary E 34 Appendix C Use of HeRO Score in the Assessment of Infection ee Appendix C Use of HeRO Score in the Assessment of Infection HeRO Clinical Instructions The HeRO Score is to be used as another piece of adjunctive information in the assessment of sepsis The HeRO Score represents the fold increase in risk that a particular patient will develop sepsis in the next 24 hours For each patient monitored the HeRO Score is generated each hour based on the last 12 hours of heart rate data Abnormal Heart Rate Characteristics transient decelerations and reduced baseline variability are detected and quantified by the HeRO algorithms to render the HeRO Score The HeRO Score is considered Low if it is less than 1 0 Intermediate if it is between 1 0 and 2 0 High if it is above 2 0 The HeRO Score is to be used alongside
39. the second click will open the Patient View 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 Rt M DEMO NICU Maule DEMO B Patients Beds Users A1 D277123 Doe John A5 5554276 Sedillo Matthew e E SA tm NN v Ue E 2 xe t 9 A2 K453789 Kress Dennis A3 M727648 Matson Jeanette AA SP In ge A4 5324769 Sparks Alan 17 12 2013 14 28 08 Figure 5 Pod View Screen While the typically shows all beds in the unit the provides a more detailed view 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 are similar to the Plan View
40. tored 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 o L O U v 9 ra 1 E Alarm Indicator 01 03 02 03 Figure 2 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 p M MH pL SSS Activating the HeRO ES Solo Window Typically the Philips Intellivue MX monitor and iPC 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 iPC is running regardless of whether the HeRO ES Window is visible on the Intellivue screen Therefore it is perfectly acceptable to switch to other Intellivue screen layouts as needed without concern over disrupting HeRO monitoring However monitoring is interrupted while the iPC 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 automati
41. turning from surgery or after a routine eye exam will have elevated HeRO Scores The HeRO Score can also be driven artificially low Steroids are well known to suppress immune system activity and thus cytokines Patients on steroids have been observed to be in a state of super variability in heart rate thus driving their HeRO Scores down In most cases of sepsis the HeRO Score correlates with the clinical symptoms e g apneas and bradycardias are increased the patient is feeding intolerant the temperature is unstable and the HeRO Score is rising In very rare cases even in the presence of these other clinical abnormalities the HeRO Score will remain low However the power of the HeRO System lies in the fact that in most cases of sepsis the HeRO Score is an early manifestation of sepsis In such a case where the HeRO Score is high but the patient is clinically normal the clinician is instructed to obtain lab work and treat based on the results If the lab work returns normal the clinician should continue to observe the patient However if the lab work is abnormal the clinician should perform a sepsis work up and initiate broad spectrum antibiotic therapy The culture results should be used to guide or discontinue future therapy 36 Appendix C Use of HeRO Score in the Assessment of Infection EE Interpretation Examples The following screenshots from the HeRO System represent one patient s stay in the NICU while monitored by t
42. y 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 data 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 S and T waves are related to contraction of the ventricles Fiduciary point the single point representing the R wave in a QRS 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 Kurtosis The peakedness
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