MPSC HeRO solo System Manual
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MPSC HeRO solo System Manual

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HeRO
solo
®
&
HeRO
duet
®
Version 3.1
System Manual

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  • Page 1 HeRO solo ® & HeRO duet ® Version 3.1 System Manual...
  • Page 2 Document Number: MPSC-INS-1626 (R1.06) 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.

  • Page 3: Contact Information

    CONTACT INFORMATION Contact Information duet For HeRO technical support, information on licensing for authorized use of these materials, or complaints contact: Medical Predictive Science Corporation 1233 Cedars Court Suite 201 Charlottesville VA 22903 USA T: +1 434-220-0714 Fax: + 1 240-220-6098 E-mail: info@heroscore.com www.heroscore.com - 2 -...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Contact Information ......................2 Introduction ........................5 Indications for Use ......................6 Contraindications ......................6 Precautions ........................7 Environmental Requirements ..................8 Using this Manual ......................8 Overview ..........................9 Data Acquisition......................9 solo duet Using HeRO and HeRO ................
  • Page 5 Fold Increase Score....................32 HeRO Score ......................33 References: ........................33 Appendix B: Glossary..................... 35 - 4 -...

  • Page 6: Introduction

    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: ...

  • Page 7: Indications For Use

    INTRODUCTION 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.

  • Page 8: Precautions

    The HeRO Display is a Class I device and intended to be used only with the following power adapters: SINPRO, Inc. Model MPU50-105 12.0V, 3.75A Medical Power Supply, or MPSC supplied equivalent. Warning: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

  • Page 9: Environmental Requirements

    INTRODUCTION Warning: Other software applications should not be installed on the HeRO Display. 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...

  • Page 10: Overview

    OVERVIEW Overview solo duet HeRO and HeRO 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. solo duet duet Figure 1: HeRO...
  • Page 11 OVERVIEW HeRO Data Acquisition Device (AD2) are approved for installation in the patient environment. - 10 -...

  • Page 12: Using Hero Solo And Hero Duet

    HeRO and HeRO 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. duet...

  • Page 13: Powering Down

    TROUBLESHOOTING Powering down solo duet Please turn off the HeRO or HeRO 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 unit to shut down. - 12 -...

  • Page 14: Viewing The Hero Score

    TROUBLESHOOTING Viewing the HeRO Score solo Each HeRO displays the HeRO Score and trend for one patient. duet Each HeRO 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.

  • Page 15: Duet View (Only Available On Hero Duet )

    TROUBLESHOOTING duet duet View (only available on HeRO Patient MRN/Name Status Indicator Bed Designation Discharge Button Current HeRO Score HeRO Score trend Second Patient Help Button duet Figure 3. View Screen. HeRO Scores are shown for two beds labeled “Purple” and “Orange”. duet View provides the most recent HeRO Score and 5-day trend for two patients.

  • Page 16: Patient View (Hero Solo And Hero Duet )

    TROUBLESHOOTING solo duet Patient View (HeRO and HeRO Discharge Button Status Indicator ECG Waveform Heart Rate Trend Back Button Figure 4. Patient View Screen The Patient View covers a single bed, providing a more detailed look at the HeRO information. The Patient View contains the following elements: ...
  • Page 17 TROUBLESHOOTING 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. duet duet For HeRO , tap the Back button to return to the View.

  • Page 18: Activating Hero Solo And Hero Duet

    TROUBLESHOOTING solo duet Activating HeRO and HeRO solo HeRO 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. duet HeRO 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’...

  • Page 19: Status And Error Messages

    For more detailed information about these messages, and suggestions for diagnosing and resolving problems, refer to the Troubleshooting section of this manual. If the situation is not resolved by following the suggested steps, contact MPSC Technical Support . - 18 -...

  • Page 20: Interpreting Results

    TROUBLESHOOTING 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 .

  • Page 21: Troubleshooting

    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. - 20 -...
  • Page 22 Resolution License file has been tampered Contact MPSC Technical with or was otherwise damaged. Support License Expired Problem: message is displayed Description: The software license has expired. Cause Resolution Expired license Contact MPSC Sales or Technical Support - 21 -...

  • Page 23: Hero Technical Information And Installation Guidelines

    TECHNICAL INFORMATION HeRO Technical Information and Installation Guidelines The HeRO Display and Data Acquistion Device (AD2) are parts of the HeRO solo duet . The following information is provided for reference. For assistance with installation or reconfiguration, contact Technical Support. Site Location solo duet...

  • Page 24: Cleaning

    TECHNICAL INFORMATION 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.

  • Page 25: Description Of Markings

    TECHNICAL INFORMATION Description of Markings The following markings are used on the Data Acquisition Device (AD2) labeling: Marking Description Manufacturer Class II equipment Consult Operating Instructions before use Medical Safety Certification Certification of conformity to European Community directives Do not dispose of equipment in trash. Return to manufacturer to be repaired or recycled.

  • Page 26: Modifications

    HeRO 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.
  • Page 27 TECHNICAL INFORMATION IEC 61000-3-2 those directly connected to the public low - voltage pow er supply network that supplies Voltage fluctuations/ PASS buildings used for domestic purposes. flicker emissions IEC 61000-3-3 Guidance and manufacturer’s declaration – electromagnetic immunity 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 is used in such an environment.
  • Page 28 TECHNICAL INFORMATION Guidance and manufacturer’s declaration – electromagnetic immunity 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 is used in such an environment. test IEC 60601 Com pliance level...
  • Page 29 TECHNICAL INFORMATION Recommended separation distances between portable and mobile RF communications equipment and the HeRO System The HeRO System is intended for use in an electromagnetic environment in w hich radiated RF disturbances are controlled. The customer or the user of the HeRO System can help prevent electromagnetic interference by maintaining a minimum distance betw een portable and mobile RF communications equipment (transmitters) and the HeRO System as recommended below , according to the maximum output pow er of the communications equipment.

  • Page 30: Appendix A: Theory Of Operation

    APPENDIX A: THEORY OF OPERATION 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.

  • Page 31: Data Packaging

    APPENDIX A: THEORY OF OPERATION 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”...
  • Page 32 APPENDIX A: THEORY OF OPERATION 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 )=(x minutes of data).

  • Page 33: Mathematical Modeling

    APPENDIX A: THEORY OF OPERATION Figure A2. Sample Entropy Mathematical Modeling Logistic Regression Since no single measure will reliably detect all of the abnormal records, multivariable predictive mathematical models are employed. One such model is a logistic regression. The mathematical model uses variables for HRV measures including standard deviation, sample entropy, and asymmetry function analysis.

  • Page 34: Hero Score

    APPENDIX A: THEORY OF OPERATION 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.
  • Page 35 APPENDIX A: THEORY OF OPERATION assessors of neurological development were aware of patients’ medical history, which could have created bias, and the assessments have limited sensitivity for CP and delayed cognitive development. Stone ML, Tatum PM, Weitkamp JH, Mukherjee AB, Attridge J, McGahren ED, Rodgers BM, Lake DE, Moorman JR, Fairchild KD.

  • Page 36: Appendix B: Glossary

    APPENDIX B: Glossary 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.
  • Page 37 APPENDIX B: Glossary 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;...
  • Page 38 APPENDIX B: Glossary 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.

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