MPSC HeRO solo Manual
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MPSC HeRO solo 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-1621 (R1.21) 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 Distributor List Australia Austria Device Technologies Connect Medizintechnik GmbH 1 Garigal Road Gspanngasse 4 Belrose NSW 2085 A-2130 Mistelbach Australia Austria +61 2 9975 5711 +43 2572 32400 E-mail: customers@device.com.au E-mail: office@connect-medizintechnik.at Web: www.device.com.au Web: www.connect-medizintechnik.at Bahrain Mohammed Fakhroo &...
  • Page 4 CONTACT INFORMATION Iran Jamaica Armaghan Salamat Kish Co., Ltd Medical Technologies (Meditech) Limited No. 18, 4 Floor, Farhad Bldg Shop 1 & 2, Northside Plaza, Amir Kabir Sq. Liguanea, Kingston 6 Kish Island, Iran Jamaica (+98)21-49205000 +1 876 618-1373 E-mail: info@arsak.co E-mail: customerservice@meditechjm.com Web: www.arsak.co Web: www.meditechjm.com...
  • Page 5 CONTACT INFORMATION Poland United Arab Emirates Viridian Polska Sp. z.o.o. MDC Care Medical Trading ul Morgowa 4 Office 506, Sobha Sapphire Tower, 04-224 Warszawa, Poland Burj Khalifa Area, +48 22 844 13 33 Dubai, United Arab Emirates E-mail: viridian@viridian.com.pl +971 4368 3055 Web: www.viridian.com.pl E-mail: info@mdccare.com...

  • Page 6: M Manufacturer And For All Other Countries

    CONTACT INFORMATION EC Authorized Representative Manufacturer and for all other Countries Medical Predictive Science Corporation 1233 Cedars Court Suite 201 Charlottesville VA 22903 USA Telephone: +31.70.345.8570 T: +1 434-220-0714 Fax: +31.70.346.7299 Fax: +1 240-220-6098 E-mail: info@heroscore.com www.heroscore.com - 5 -...

  • Page 7: Table Of Contents

    TABLE OF CONTENTS Contact Information ......................2 Distributor List ....................... 2 M Manufacturer and for all other Countries ............... 5 P EC Authorized Representative................5 Introduction ........................8 Indications for Use ......................9 Contraindications ......................9 Precautions ........................9 Environmental Requirements ..................11 Using this Manual ......................
  • Page 8 TABLE OF CONTENTS QRS Detection (where applicable) ............... 34 Data Packaging......................35 Data Conditioning Prior to Calculation of HRV............ 35 Mathematical Analysis .................... 35 Mathematical Modeling ....................37 Logistic Regression....................37 Fold Increase Score....................37 HeRO Score ......................38 References: ........................38 Appendix B: Glossary......................

  • Page 9: 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 10: 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 11 SINPRO, Inc. Model MPU50-105 12.0V, 3.75A Medical Power Supply, EDAC Model EM10681V 19V, 3.78A Medical AC Adaptor, 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 12: Environmental Requirements

    INTRODUCTION Environmental Requirements The following environmental requirements apply to the hardware components of HeRO solo and HeRO duet (i.e. the display and AD2-DAD devices with their associated cabling, if present). 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.

  • Page 13: 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 14: Data Acquisition

    OVERVIEW Data Acquisition HeRO solo and duet support three modes of data acquisition depending on the configuration purchased: 1) Using cables provided with the device, the analog signal output from the physiological monitor can be connected to the provided ECG input adaptor.

  • Page 15: 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 16: Powering Down

    USING HeRO solo and duet duet Figure 2b. HeRO cabling when using the HeRO Data Acquisition Device (AD2). The purple patient cable is inserted into the Channel 0 port, and the orange cable into the Channel 1 port. An solo Ethernet cable connects the HeRO Data Acquisition Device (AD2) to the HeRO display.

  • Page 17: Viewing The Hero Score

    USING HeRO solo and duet Viewing the HeRO Score Each HeRO solo 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).

  • Page 18: Duet View (Only Available On Hero Duet )

    USING HeRO solo and duet duet duet View (only available on HeRO Patient MRN/Name Status Indicator Bed Designation Discharge Button Current HeRO Score Alarm Indicator HeRO Score trend Second Patient Help Button duet Figure 3. View Screen. HeRO Scores are shown for two beds labeled “Purple” and “Orange”.

  • Page 19: Patient View (Hero Solo And Hero Duet )

    USING HeRO solo and duet solo duet Patient View (HeRO and HeRO Discharge Button Status Indicator Alarm Symbol 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.
  • Page 20 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.

  • Page 21: Activating Hero Solo And Hero Duet

    USING HeRO solo and duet 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.

  • Page 22: Status And Error Messages

    USING HeRO solo and duet Status and Error Messages duet The top section of each bed in the 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.

  • Page 23: Alarms

    USING HeRO solo and duet 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.

  • Page 24: Interpreting Results

    INTERPRETING RESULTS 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 25: 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. - 24 -...
  • Page 26 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 - 25 -...

  • Page 27: 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 28: 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 29: Description Of Markings

    TECHNICAL INFORMATION Description of Markings The following markings are used on the Data Acquisition Device (AD2) labeling: Marking Description Manufacturer Serial number  Product Name  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.

  • Page 30: 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 31: Environmental Impact

    TECHNICAL INFORMATION Environmental Impact solo duet HeRO 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.
  • Page 32 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 33 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 34 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 35: 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 36: 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 37 APPENDIX A: THEORY OF OPERATION 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). The Figure presents a function , where is the magnitude of an RR interval...

  • Page 38: 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 39: 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 40: 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 41 APPENDIX B: Glossary 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 filter that averages a signal over a “window”...
  • Page 42 APPENDIX B: Glossary 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.

  • Page 43: Appendix C: Use Of Hero Score In The Assessment Of Infection

    APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 44 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 45 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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 HeRO lies in the fact that in most cases of sepsis, the HeRO Score is an early manifestation of sepsis.
  • Page 46 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 47 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 48 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 49 APPENDIX C: Use of HeRO Score in the Assessment of Infection Figure C5 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).
  • Page 50 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 51 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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.
  • Page 52 APPENDIX C: Use of HeRO Score in the Assessment of Infection 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).
  • Page 53 APPENDIX C: Use of HeRO Score in the Assessment of Infection Figure C9 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.

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