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User Manuals - HeRO by MPSC

1. sseeeeeseeenasnneesenaneesensensssnnnn n 25 Lhispep eire Die 26 Environmental Impact s ssseseeeeeeeeeenensnseseeensns e 26 Electrical ru 26 Electromagnetic Compatibility eee ee eere esee eese ee eene eerie nenne nennen te tran 26 Appendix A Theory of ODGFaLblO I eic ener tart seen res n GER rera Lp r Y eS YR Pe eR urge ed eEa E Re cca 30 Algorithms for Calculating RRI Parameters eee eee eeee ee eerte nenne 30 3 TABLE OF CONTENTS Be a R QRS Detection where applicable eene 30 Data Packaging ii AA E tee d uei dod im iine utet bem DUCTA in NId 31 Data Conditioning Prior to Calculation of HRV sssssseeeee 31 Mathematical Analysis 0 cccccccccccccccescsesesseceeeccceceesesssaeeeceeeceseeesersaaeeeseeseseeeeas 31 Mathematical Modeling ooi nieto er seno RE Fee Run EO tese S UN DERE Gun DE EH ORENSE o Gu US REESE EGER DR Un REDE 33 LOGISTIC RE EE Ia 33 Fold Increase SODEPO eris x oret be pec EU pn a REV pY e SEAUINR TEE rutas Oo die FERA QUIE E EM DURER E 33 HeRO ee er T PPP 34 RAS P NNEITTELT T tisuasconsseacosnsbtecs eucbuccadedssasnacseneceaasaes 34 Appendix B GLOSS AI e
2. A Warning This equipment is intended for use by healthcare professionals only Warning The HeRO Data Acquisition Device AD2 requires a minimum ECG waveform amplitude at the ECG monitor Defib Sync port of 1 volt i e 2 volts peak to peak for correct operation Operation with lower amplitude input signals may cause inaccurate results Warning HeRO so o and HeRO duet are classified as Medical Electronic Equipment As such they require special precautions regarding Electromagnetic Compatibility EMC Refer to the HeRO Technical Information and Installation Guidelines section for more information A Warning Other software applications should not be installed on the HeRO Display INTRODUCTION Environmental Requirements The following environmental requirements apply to the hardware components of the HeRO system i e the Server computer dedicated Viewing Stations and AD2 DAD devices with their associated cabling if present Parameter Operating Range Storage Transport Range Temperature o c 50 C 30 C 60 C Relative Humidity 30 80 RH 10 95 RH Altitude 0 m 5000 m 0 m 12000 m 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 ar
3. USING HeRO solo and duet E RU ME er Viewing the HeRO Score Each HeRO so o displays the HeRO Score and trend for one patient Each HeRO duet displays the HeRO Score and trend for up to two patients as shown in in Figure 3 The HeRO Display shows the most recently computed HeRO Score for each patient as a numeric value and also shows a graph that trends the values over the last five days HeRO computes a new HeRO Score for each patient at the top of each hour 1 00 2 00 etc When a new patientis connected to the monitor it may take up to 3 hours for the first score to be shown HeRO will stop generating scores for an individual patient if there is an insufficient amount of heart rate data or if there is not enough recent heart rate data to generate an accurate score These gaps in the HeRO Score trend can occur if the patient leaves the bed if the heart rate signal is otherwise interrupted for 30 minutes or more or for patients with low heart rates due to cooling When valid heart rate signal is restored HeRO will resume generating scores as soon as enough new data is available This may take up to an additional 3 hours 13 USING HeRO solo and duet Patient MRN Name Discharge Button duet View only available on HeRO quet Status Indicator Bed Designation PURPLE 123458789 Smith gt Hel 13 10 13 23 31 37 p Help Button Figure 3 duet View Screen HeRO Sc
4. 35 Appendix C Use of HeRO Score in the Assessment of Infection 38 INTRODUCTION 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 intuitivefashion HeRO so o and HeRO duet are self contained implementations of HeRO and are built upon the same technology platform The monitors share a hardware platform with the difference being in the number of patients monitored Each processes ECG data from one solo or two duet patient monitors and shows HeRO Scores for the monitored bed s In this document HeRO so o or HeRO duet refer to the HeRO Display and as applicable the HeRO Data Acquisition Device
5. 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 34 APPENDIX B Glossary SSS 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 movementor 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 fi
6. Trend Fold Increase t a 2 2 2 E 5 Data Coverage I QORSCapwe B 12 07 2007 12 21 36 ECG Input f ui Figure C7 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 46 APPENDIX C Use of HeRO Score in the Assessment of Infection CO EG AT ka ES RE dee de e e e ee e e HRC Trend Fold Increase t a 2 2 c E 5 3 Data Coverage Ii QRS Capture E 12 07 2007 12 22 21 ECG Input f si Figure C8 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 47 APPENDIX C Use of HeRO Score in the Assessment of Infection SAO EG AT TELA le aa dee ee e ee e e e HRC Trend Fold Increase E 2 2 w c t E Ej LES ECG Input B Data Coverage T 12 07 2007 12 23 13 Figure C9 The remainder of the patient s stay in the NICU is marked by a low trend of HeRO Scores The patientis discharged home af
7. ammonia or alcohol solutions e The surface finish will be permanently damaged by strong chemicals and solvents such as acetone and trichloroethylene Do not use steel wool or other abrasive material to clean the mounting assembly Damage caused by the use of unapproved substances or processes will not be covered by warranty We recommended that you test any cleaning solution on a small area of the mounting assembly that is not visible to verify compatibility e Never submerge the roll stand or allow liquids to enter the mounting assemblies Wipe any cleaning agents off the mounting assembly immediately using a water dampened cloth Dry all mounting assemblies thoroughly after cleaning 24 TECHNICAL INFORMATION Description of Markings The following markings are used on the Data Acquisition Device AD2 labeling Manufacturer Class ll equipment Consult Operating Instructions before use Medical Safety Certification Certification of conformity to European Community directives Do not dispose of equipmentin trash Return to manufacturer to be repaired or recycled Contact information for European Community Representative The following markings are used on the HeRO Display labeling Manufacturer Medical Safety Certification Certification of conformity to European Community directives Do not dispose of equipmentin trash Return to manufacturer to be repaired or recycled FCC Approved Equipment Authoriza
8. and unit displays application by double tapping the Windows desktop Client Windows desktop shortcut or application is not running by selecting itin the Windows start menu HeRO Display will not start Restart HeRO Display by unplugging and replugging the monitor Ensure that both the power cord for the HeRO Display and the Data Acquisition Device AD2 are both plugged in to an energized power outlet Problem System Communication Error message is displayed during normal use not monitor start up Description The HeRO window application is not able to communicate with the services that acquire data and generate HeRO Scores Cause Resolution HeRO is starting up Wait for HeRO Display to initialize up to 5 minutes Configuration error Contact MPSC Technical Support 21 TROUBLESHOOTING _ _ E_ See ee Problem HeRO Failed to Start message is displayed Description The HeRO data processing services did not start Internal PC error Reboot HeRO Display by unplugging and replugging the power cable Configuration error Contact MPSC Technical Support Problem License is not valid message is displayed Description The software license has an invalid signature or is otherwise corrupt Cause Resolution License file has been tampered Contact MPSC Technical with or was otherwise damaged Support Problem License Expired message is displayed Description The software license has expire
9. 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 HeRO so o and HeRO duet are not suitable for use in the presence of flammable anesthetic in mixture with air oxygen or nitrous oxide INTRODUCTION The HeRO Data Acquisition Device AD2 is a Class ll device and intended to be used only with the following supplied power adapter GlobTek Inc Model GTM21089 1305 T2 5 0V 2 6A Medical Power Supply The HeRO Display is a Class device and intendedto be used only with the following power adapters SINPRO Inc Model MPU50 105 12 0V 3 75A Medical Power Supply or MPSC supplied equivalent A Warning To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth A Warning The SINPRO power supply must only be plugged into the HeRO Display through the power port on the bottom Attaching this power supply to the HeRO Data Acquisition Device AD2 may cause damage to the HeRO Data Acquisition Device AD2
10. message does not disappear there may be a hardware problem or a configuration error Check power to the HeRO Data Acquisition Device AD2 and reseat all communication cables to the HeRO Display HeRO is starting The HeRO data processing services are starting HeRO monitoring should begin within 5 minutes HeRO failed to start HeRO data processing services could not be started This may indicate a hardware problem or a configuration error Are you sure that you This message is displayed when the Discharge on the want to discharge bed Patient View is clicked No patient data has been Purple Orange changed at this point You may choose to continue or cancel the operation Discharging bed A Discharge operation has been confirmed and is Purple Orange under way The message will be cleared when the operation completes and only indicates an error condition if the message does not disappear within 60 seconds Failed to discharge A Discharge operation has failed Scores from the bed Purple Orange previous patient may still be displayed Restartthe HeRO Display unit and perform the operation again if necessary License is not valid The software license is not valid License Expires The software license has expired 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 suggest
11. present 44 APPENDIX C Use of HeRO Score in the Assessment of Infection Sd OFC ATM te RUNE dee e e e e e ee e HRC Trend Fold Increase t a 2 2 T c 5 3 ECG Input B QRS Capture B xm Data Coverage ii 12 07 2007 12 18 50 Figure C3 At approximately twelve days of age the patient exhibits episodes of reduced heart rate variability punctuated by transient 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 42 APPENDIX C Use of HeRO Score in the Assessment of Infection EOS AS ERE dee se e e e ee e e HRC Trend Fold Increase 09 19 19 30 Heart Rate bpm ECG Input B EINE QRS Capture B 12 07 2007 12 19 12 pec Figure C4 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 anesthesi
12. 20 6098 E mail info heroscore com www heroscore com CONTACT INFORMATION 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 alessa alessakuwait com Web www alessakuwait com Saudi Arabia Gulf Neocare PO Box 365899 Riyadh 11391 Saudi Arabia PH 996 1 464 8545 Web www gulfneocare com Egypt Egyptian Engineering amp Industrial Office 18 Hoda Shaarawi St Cairo 11511 Egypt PH 20 2 23951195 Web www eeiomedical 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 E a REA Contact IN OMIM Wa 2 Distributor dE T an n 2 ul Manufacturer and for all other CountrieS ss eesesememenenemanensenwa 2 EC Authorized Representative eeeeee eee eee esee eee ee eee eene nenne eter enoa 2 MOG ONES WOM Ritter mem FN M DR PRI op Mt RH RES 5 Indications for USES e 6 CONT AINGICATONG vii ciciscassencivadccsdvcasstecivedcccexinadensedenscstebossdnanscewcsvasctucieessecexvesteuesvsscaseencs 6 Pr ca ti S E AC KI 6 Environmental Requirements ccssssssssccceccssssssssssccccecssssssssnc
13. AD2 INTRODUCTION E A A eee 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 HeRO monitoring improves survival in very low birth weight neonates HeRO so o and HeRO duet acquire data from a user supplied ECG monitor Initial training 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 Assembly relocation and ongoing maintenance are the responsibility of the user Contraindications Patients with erratic accelerated or
14. HeRO so o amp HeRO duet Version 3 1 System Manual The Power To Predict COPYRIGHT 2015 BY MEDICAL PREDICTIVE SCIENCE CORP ALL RIGHTS RESERVED UNAUTHORIZED REPRODUCTION IS STRICTLY PROHIBITED Do not alter or translate 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 HeR
15. O Display and the HeRO Data Acquisition Device AD2 are approved for installation in the patient environment 10 USING HeRO solo and duet EEUU u c Ec nq Using HeRO so o and HeRO duet Sett ng Up HeRO soloand HeRO duet are configured by MPSC prior to shipment Instructions for assembly are included in the packing box and can be completed by hospital personnel Relocation and ongoing maintenance are the responsibility of the user facility Below is an example of a HeRO duet with cables for two patients one purple and one orange that are connected to the HeRO Data Acquisition Device AD2 as shown in Figure 2 HeRO sofohardware appears identical omitting the Channel 1 orange patient cable RS 232 configurations meanwhile omit the HeRO Data Acquisition Device AD2 entirely Figure 2 HeRO duet cabling The purple patient cable is inserted into the top port and the orange cable in the second port An Ethernet cable connects the HeRO Data Acquisition Device AD2 to the HeRO display HeRO so o cabling is identical except for the omission of the second orange patient cable RS 232 installations omit the HeRO Data Acquisition Device AD2 entirely 11 USING HeRO solo and duet Powering down Please turn off the HeRO sofoor HeRO duet before unplugging any of the power cords connected to the unit To do this press the circular power button on the back of the HeRO Display and wait for the unitto shut down 12
16. O screen or by typing 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 1621 R1 08 EMERGO EUROPE Molenstraat 15 EC 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 Distributor List Austria Connect Medizintechnik GmbH Gspanngasse 4 A 2130 Mistelbach Austria Ph FAX 43 2572 32400 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 al 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 2
17. RS 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 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 actu ally 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 Patient View screen On the ECG graph QRS complexes marked with a green triangle indicate the termination of a valid RR Interval Tho
18. a 43 APPENDIX C Use of HeRO Score n the Assessment of Infection dO EG T TAA nd odo cdit dee e e e e ee e e E a m 2 s o PE E o a EE Heart Rate bpm QRS Capture B um Data Coverage f ECG input E 12 07 2007 12 19 28 mE Figure C5 At approximately four weeks of age the patient again exhibits a loss of variability punctuated by transient decelerations resultingin 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 44 APPENDIX C Use of HeRO Score in the Assessment of Infection EOS AS RE dee ee e e ee e e HRC Trend Fold Increase t a 2 2 7 c e 5 3 Data Coverage I ORS Capture B 12 07 2007 12 20 21 ECG Input m Rr Figure C6 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 45 APPENDIX C Use of HeRO Score in the Assessment of Infection EOS AS AER dee de e e e e e e e HRC
19. d Cause Resolution Expired license Contact MPSC Sales or Technical Support 22 TECHNICAL INFOHMATION LLL el HeRO Technical Information and Installation Guidelines The HeRO Display and Data Acquistion Device AD2 are parts of the HeRO so o and duet The following information is provided for reference For assistance with installation or reconfiguration contact Technical Support Site Location HeRO so o and HeRO duet are installed in the NICU HeRO is approved for use within the patient vicinity that extends within 1 5 meters of the patient The HeRO Data Acquisition Device AD2 is an optional part of HeRO Individual cables are run from the physiological monitors to the HeRO so o or duet The HeRO Data Acquisition Device AD2 is not approved for installation in close proximity to or stacked with other equipment that is sensitive to Radio Frequency RF or Electromagnetic Interference EMI emissions or that generates significant RF or EMI emissions Cabling HeRO requires the following connections and cable types Connection Cable Type Maximum Notes Length ECG signal input Proprietary 5 meters e The cable end at the Defib Sync from Defib Sync or RS 232 jack isa or RS 232 jack on manufacturer specific physiological connector monitor HeRO is intended to connect to one so o and up to 2 duet ECG monitors Data Acquisition 0 5 Device AD2 to meters HeRO Display Data Acquisition 2 wir
20. e 6 meters The Data Acqusition Device AD2 Device AD2 power cord uses an external medical grade Power provided power supply rated for 110 240VAC input voltage It is not approved for use with any other power supply The Data Acquisition Device AD2 is a CISPR11 Class A device and is not approved for use in buildings used for domestic purposes or in other locations that directly connect TECHNICAL INFOHMATION Connection Cable Type Maximum Notes Length to the public low voltage power supply network that supplies buildings used for domestic purposes HeRO Display 3 wire 6 meters The HeRO Display uses an external power cord medical grade power supply rated provided for 110 240VAC input voltage It is not approved for use with any other power supply Connections using unapproved cable types or lengths may result in increased RF or EMI emissions or decreased immunity to these types of emissions Cleaning The hardware components of HeRO so oor duet may be cleaned as needed per the instructions below HeRO Display Data Acquisition Device AD2 and cables e Disconnect this equipment from any AC outlet before cleaning The equipment can be wiped or dusted with a damp cloth Do not use liquid or spray detergents for cleaning HeRO roll stand desk stand and wall mount e The mounting assembly may be cleaned with most mild non abrasive solutions commonly used in the hospital environment e g diluted bleach
21. e indicated by bold type i e Patient View 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 EE Overview HeRO so o and HeRO duet are standalone monitoring systems that acquire heart rate data from an existing physiological monitor or monitors HeRO Scores for the patient s being monitored are computed hourly and displayed on the HeRO Display Figure 1 HeRO so o and duet Overview Above a HeRO duet configured to acquire the analog ECG waveform from the Defib Sync jacks on two monitors using the optional HeRO Data Acquisition Device AD2 Below a HeRO so o configured to acquire RS 232 heart rate data directly into the HeRO Display Data Acquisition The HeRO Data Acquisition Device AD2 is used to gather ECG waveform data from an existing physiological monitor and perform mathematical algorithms to determine patterns of HRV The HeRO Data Acquisition Device AD2 is a small brick sized device that is connected to an analog signal output on the physiological monitor and to the HeRO Display Alternately the HeRO Display can be connected directly to the RS 232 port on certain physiological monitors and the HeRO Data Acquisition Device AD2 is not needed When connected via RS 232 HeRO will use the ECG derived heart rate if available or the SpO2 derived OVERVIEW ee R pulse otherwise Both the HeR
22. e 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 CN Mathematical Analysis Histogram Based Parameters From each set of 4096 High Pass filtered normalized RR intervals the 10t 25t 50t 75th and 90 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 31 APPENDIXA THEORY OF OPERATION a ii ii atiii through Sample Asymmetry analysis The first stepis to construct a guadratic function that will be usedfor 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 xJ x m where x is the magnitude of an RR interval Z 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 xz X405 We compute 7 xJ r x if x lt m O otherwise and r2 x 7r x if x gt m 0 otherwise for
23. each RR reading x Finallythe A left asymmetry and Az right asymmetry are computed as R y n x and p EE uus 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 skewedto the right will resultin R2 gt R1 N S lt 2 AN Figure A1 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 especiallyfor short data sets Sample entropy SampEn is calculated with m 3 0 2 using filtered normalized data 32 APPENDIXA THEORY OF OPERATION bars are SD A number of matches of length mt B number of matches of length m ApEn s In 1 A 1 B8 SampEn In A B Far regular repeating data A B nears 1 and entropy nears D Figure A2 Sample Entropy Mathemat cal Model ng Logistic Regression Since no single measure will reliably detect all of the ab
24. econd moment standard deviation D OC 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 36 APPENDIX B Glossary Skewness Lack of symmetry in a frequency distribution A symmetrical histogram has a skewness of O 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 37 APPENDIX C Use of HeRO Score n the Assessment of Infection pum 4 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
25. ed steps contact MPSC Technical Support 18 USING HeRO solo and duet P I E 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 The alarm state is indicated by one of the two Alarm Symbols shown below Appearance Symbol not shown Active N Symbol shown with exclamation points flashing Paused f Symbol shown with exclamation points solid An active alarm may be paused by tapping 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 19 INTERPRETING RESULTS aa aa aa 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 hear
26. eececcecsssessssnaceeeeees 8 Using this MANU e 8 OV SSW X O U OO Y 7H e U C e 9 Data ACQUISITION mL SJASO 9 Using HERO so o and HERO Gye iia ra Ee Lebe poi erp net io ee manna 11 oaiae RU ne 11 Powering GOWN M KIA 12 Viewing the HERO Score vccisccscccescecescecccasscnssccscnssvsncdxosccnesiastuasespecussepennsscencvsascusocanccues 13 duet View only available ON HERO QhLueft sss 14 Patient View HeRO solo and HERO JUeGt wmmamamanamamamamamama 15 Activating HERO solo and HERO qQlet essere 17 Pausini an PAIN iii 17 Continuous HERO MonlteDrag usedeiueie iuvene tA v cte eo crds cu Devas uod CoL rre US MA rae Erit u vids 17 Status and Error MesSBOQes uoo Ipetusn devenue de soE DVDs eu uU dU eu v E URN TERRAE SU e EU Ur e EUER 18 IA mede er E d v 19 iicgeruiEi cloccfe P EEO 20 TOUS SHOOTING AA tuve ib made nnecet ove dL E Lv vU mi dEU uda bI eMe DUE 21 HeRO Technical Information and Installation GuidelineS lt 23 STO LOCA OM e 23 ANN e 23 LE api ee cc c NOU 24 Description of Markings
27. 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 itis lessthan 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 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 Not Low Inter High measured mediate Not measured inical Score CI Figure C1 Sepsis Risk Scorecard From Griffin 2007 Heart Rate Characteristics and Clinical Signs in Neonatal Sepsis 98 APPENDIX C Use of HeRO Score in the Assessment of Infection pu M M 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 patientthat has a low HeRO Score yet is exhibiting signs and symptoms of sepsis should be evaluated without regard to the low HeRO Sc
28. ines t 1 kV for input output Lines t 1 kV line s to 2kV line s to earth lt 5 96 Ur gt 95 dip in Ur for 0 5 cycle for 0 5 cycle 40 96 Ur 60 dip in Ur for 5 cycles for5cycles 70 Yo Ut 30 96 dip in Ur 30 96 dip in Ur for 25 cycles 5 Ur for 25 cycles 5 Yo Ut 295 dip in Ur 295 96 dip in Ur for 5s Pow er freguency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Ur is the a c mains voltage prior to application of the tes 27 for5s tlevel Electromagnetic environment Guidance Floors should be w ood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains pow er quality should be that of a typical commercial or hospital environment Mains pow er quality should be that of a typical commercial or hospital environment Mains pow er quality should be that of a typical commercial or hospital environment typical commercial or hospital environment If the user of the HeRO Systemrequires continued operation during pow er mains interruptions itis recommended that the HeRO systembe pow ered froman uninterruptible pow er supply or a battery Pow er frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment TECHNICAL INFORMATION Guidance and manufacturer s declaration electromagnetic immunity The HeRO sy
29. ltering 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 R Heart Rate HRV Heart Rate Variability 95 APPENDIX B Glossary EEUU 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 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 filterthat 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 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 s
30. normal 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 te 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 33 APPENDIXA THEORY OF OPERATION T a 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 fora discussion of the relevance of the HeRO Score References Griffin MP Scollan DF
31. ore A low HeRO Score should not be used to withhold treatment Figure C1 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 T ratio WBC and hyperglycemia 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 elevate d 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 parasympathe
32. ores are shown for two beds labeled Purple and Orange The duet View provides the most recent HeRO Score and 5 day trend for two patients The elements composing each Bed lcon are e the bed designation Purple or Orange for HeRO Data Acquisition Device AD2 systems the Bed Label of the monitor for RS 232 systems e The Name and MRN of the patient RS 232 systems only e a five day trend of the HeRO Score e a bar graph that shows the current HeRO Score e anumeric display of the current HeRO Score e an alarm symbol when appropriate and e a status indicator that is green when the system is receiving heart rate data for the bed and dark otherwise The alarm is shown when the HeRO Score is above the alarm threshold A flashing alarm can be paused by tapping anywhere on the Bed Icon or by choosing from the pop up menu Referto the section Alarms for more information Tapping on a Bed Icon will bring up the Patient View Note that if an alarm is active the first tap on the Bed Icon will pause the alarm and the second tap will open the Patient View Tap the Help button to display the online help this manual When the help screen is displayed the button label will change to Back Tap the button again to return to the duet View 14 USING HeRO solo and duet Patient View HeRO so o and HeRO quet Status Indicator 0 PURPLE 123475678 Smith 2 28 13 10 13 23 32 35 Back Button Figure 4 Patient Vie
33. plicable to the frequency of the transmitter w here Pis the maximum output pow er rating of the transmitter in w atts W according to the transmitter manufacturer NOTE 1 At80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fromstructures objects and people 29 APPENDIXA THEORY OF OPERATION T a 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 where applicable 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 Q
34. predicted theoretically w ith accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in w hich the HeRO systemis used exceeds the applicable RF compliance level above the HeRO systemshould be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the HeRO system b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 28 TECHNICAL INFORMATION Recommended separation distances between portable and mobile RF communications equipment and the HeRO system The HeRO systemis intended for use in an electromagnetic environment in w hich radiated RF disturbances are controlled The customer or the user of the HeRO systemcan help prevent electromagnetic interference by maintaining a minimum distance betw een portable and mobile RF communications equipment transmitters and the HeRO systemas recommended below according to the maximum output pow er of the communications equipment Separation distance according to frequency of transmitter Rated maximum output power m of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 2VP d 1 2VP d 2 3VP at a maximum output pow er not listed above the recommended separation distance din metres m can be estimated using the equation ap
35. s 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 40 APPENDIX C Use of HeRO Score in the Assessment of Infection g Interpretation Examples The following screenshots from the HeRO System represent one patient s stay in the NICU while monitored by the 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 sod A iioo zi dee de e e ee ee e HRC Trend Fold Increase t a 2 2 7 2 E 5 3 Data Coverage Ii 12 07 2007 12 18 19 ECG input f ORSCapue J Figure C2 Patient presents as a Caucasian female 770 grams at birth 24 weeks gestational age HeRO Scores were generatedfor this patient but not displayed to clinicians Clinical annotations are marked in blue Duringthe 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
36. s long as possible e A Discharge operation must be completed any time the HeRO so oor duet is moved from one physiological monitorto another or when a new patient is connected to the monitor Pausing an Alarm HeRO so o and duet include a high score visual alarm to warn clinicians if a patient s score rises above an alarm threshold 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 bed icon away from the edges Refer to the section Alarms for more information Continuous HeRO Monitoring HeRO processes heart rate data and generates scores while the HeRO Display is running However monitoring is interrupted while the HeRO Display or the HeRO Data Acquisition Device AD2 is powered off HeRO monitoring is active only when HeRO Display and HeRO Data Acquisition Device AD2 are running 17 USING HeRO solo and duet c M e Pl Status and Error Messages The top section of each bed in the duet View and the Patient View may display informational or error messages to indicate problems or status changes These messages and their meanings are summarized below Comm Error The HeRO Display 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 monitoris first powered up If the
37. s used in such an environment Compliance Electromagnetic environment guidance RF emissions Group 1 The HeRO systemuses RF energy CISPR 11 only for its internal function Therefore its RF emissions are very low andare notlikely to cause any interference in nearby electronic equipment CISPR 11 The HeRO systemis suitable for use Class A D in all establishments other than domestic and IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 TECHNICAL INFORMATION RE EURRESUNTTIIIIIIL ILICE aT those directly connected to the public low voltage pow er supply network that supplies buildings used for domestic purposes Guidance and manufacturer s declaration electromagnetic immunity The HeRO systemis intended for use in the electromagnetic environment specified below The customer or the user of the HeRO systemshould assure that it is used in such an envir MMUNITY fes 6060 ompliance leve test level t 6kV contact Hectrostatic t 6kV contact discharge ESD 8kV air IEC 61000 4 2 t 2kV for pow er transient burst supply lines IEC 61000 4 4 1 kV for input output Lines IEC 61000 4 5 2kV line s to earth lt 5 96 Ur 795 dip in Ur Voltage dips short interruptions and voltage variations on pow er supply input lines 40 96 Ur 60 Yo dip in Ur IEC 61000 4 11 70 Yo Ur 1kV line s to t line s line s onment t 8kV air t 2kV for pow er supply l
38. se with red marks indicate an invalid interval Those with no marks indicate QRS complexes that were not identified by the system and 30 APPENDIXA THEORY OF OPERATION Ls 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 gaps in the Heart Rate trend Note 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 setrepresents 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 intervalis 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 RR 2M 1 D n j where n is the index of the RR interval 1 to 4096 and M 100 Th
39. stemis intended for use in the electromagnetic environment specified below The customer or the user of the HeRO systemshould assure that it is used in such an environment MMUNITY test 0060 ompliance leve Electromagnetic environment test level Es IEC 61000 4 6 m Ke to 80 MHz should be used no idea any part of the HeRO system including cables than the recommended separation distance calculated fromthe equation Radiated RF 3 V m applicable to the frequency ofthe transmitter IEC 61000 4 3 80 MHz to 2 5 GHz Re com mended separation distance d 1 2VP d 1 2VP 80 MHz to 800MHz d 2 3VP 800 MHz to 2 5GHz w here Pis the maximum output pow er rating of the transmitter in w atts W according to the transmitter manufacturer and dis the recommended separation distance in metres m Field strengths fromfixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked w ith the follow ing symbol 9 e higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection fromstructures objects and people a Field strengths fromfixed transmitters such as base stations forradio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be
40. symbol or the surrounding bar graph area Referto the following section Alarms For HeRO duet tap the Back button to return to the duet View Discharge Button Deletes all data for the currently displayed patient and clears the HeRO Scores from the duet View and the Patient View Use this when connecting a new patient to the physiological monitor this process will occur automatically when the serial RS 232 interface is used and HeRO detects a new Medical Record Number from the monitor You will be asked to confirm the Discharge operation before any changes are made Data collection will resume immediately but it may take up to 3 hours before the first HeRO Score is generated 16 USING HeRO solo and duet EE LEE ULL Activating HeRO so o and HeRO duet HeRO so o is delivered configured to collect data from one physiological monitor In order to begin generating HeRO Scores the purple cable must be connected to the patient s physicological monitor HeRO duet is delivered configured to collect data from two physiological monitors In order to begin generating HeRO Scores the purple and orange cables must be connected to the patients physiological monitors In both cases please note the following e The typical time to generate the first HeRO Score for a new patient is 3 hours and that HeRO utilizes up to the last 12 hours of heart rate data for each score generation Thus HeRO should remain dedicated to a patient bed for a
41. t 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 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 Patients with high HeRO Scores 22 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 Referto the section Alarms A randomized controlled trial of 3 003 VLBW infants demonstrated that patients whose HeRO Scores were displayedto clinicians experienced 22 fewer deaths 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 20 TROUBLESHOOTING Ui ii a Troubleshooting Problem HeRO Main Window is not visible Description Main Window is not shown on the HeRO Display HeRO application screen does Manually start the HeRO not appear
42. ter 94 days in the NICU In this example the clinician is instructed to take no action based on the HeRO Score 48
43. tic 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 returning 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 39 APPENDIX C Use of HeRO Score in the Assessment of Infection qup M the presence of these other clinical abnormalities the HeRO Score will remain low However the power of HeRO 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 result
44. tion 25 TECHNICAL INFORMATION a mi Modifications HeRO so o and duet are not user serviceable and must not be modified in any way Defective units must be returned to MPSC for replacement HeRO is designed for continuous operation the user should not turn off the device or take any other steps in order to reduce environmental impact Environmental Impact HeRO so o and duet are designed to minimize impact on the environment Due to the continuous nature of HeRO monitoring it is not recommended that the system or its components be powered down at any point to conserve electricity Follow the instructions on disposal above when removing HeRO from service Electrical lsolation The HeRO Data Acquisition Device AD2 is electrically isolated via the provided medical grade power supply specified below It is not approved for use with any other type of power supply e GlobTek Inc Model GTM21089 1305 T2 5 0V 2 6A Medical Power Supply The HeRO Display is electrically isolated via the provided medical grade power supply specified below It is not approved for use with any other type of power supply e SINPRO Inc Model MPU50 105 12 0V 3 75A Medical Power Supply Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic emissions The HeRO System is intended for use in the electromagnetic environment specified below The customer or the user of the HeRO System should assure that it i
45. w Screen The Patient View covers a single bed providing a more detailed look at the HeRO information The Patient View contains the following elements e the bed identifier Purple or Orange for HeRO Data Acquisition Device AD2 systems the Bed Label of the monitor for RS 232 systems e The Name and MRN of the patient RS 232 systems only e a five day trend of the HeRO Score e a bar graph that shows the HeRO Score e anumeric display of the HeRO Score e an alarm symbol when appropriate e a 30 minute Heart Rate trend e areal time ECG Waveform when using the HeRO Data Acquisition Device AD2 see warning below e a status indicator that is green when the system is receiving heart rate data for the bed The scroll bar and the four arrow buttons allow the user to navigate through several days worth of data The 30 minute heart rate trend the bar graph and the numeric representation will display data from the currently selected time epoch When historical data is being viewed a yellow cursor in the HeRO Score trend indicates the location of the current time epoch 15 USING HeRO solo and duet The ECG waveform when displayed by HeRO should not be used as a diagnostic ECG In addition due to latency in the waveform display this ECG trace should not be used as a trigger for defibrillation The alarm is shown when a patient s HeRO Score goes above the alarm threshold A flashing alarm can be paused by tapping the alarm

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