MPSC HeRO solo User guide

®
®
HeRO solo
&
HeRO duet
Version 3.1
System Manual

COPYRIGHT © 2019 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 HeRO 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-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.

CONTACT INFORMATION
- 2 -
Contact Information
For HeRO duet 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: [phone]
Fax: + 1 240-220-6098
E-mail: [e-mail]
www.heroscore.com

TABLE OF CONTENTS
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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
Using HeRO solo and HeRO duet .............................................................................11
Setting Up ....................................................................................................................11
Powering down ............................................................................................................12
Viewing the HeRO Score ............................................................................................13
duet View (only available on HeRO duet )............................................................14
Patient View (HeRO solo and HeRO duet )...........................................................15
Activating HeRO solo and HeRO duet ..................................................................17
Continuous HeRO Monitoring................................................................................17
Status and Error Messages....................................................................................18
Interpreting Results.........................................................................................................19
Troubleshooting...............................................................................................................20
HeRO Technical Information and Installation Guidelines ...........................................22
Site Location................................................................................................................22
Cabling..........................................................................................................................22
Cleaning........................................................................................................................23
Description of Markings..............................................................................................24
Modifications................................................................................................................25
Environmental Impact .................................................................................................25
Electrical Isolation.......................................................................................................25
Electromagnetic Compatibility...................................................................................25
Appendix A: Theory of Operation .................................................................................29
Algorithms for Calculating RRI Parameters..............................................................29
QRS Detection (where applicable) .......................................................................29
Data Packaging........................................................................................................30
Data Conditioning Prior to Calculation of HRV....................................................30
Mathematical Analysis ............................................................................................30
Mathematical Modeling ..............................................................................................32
Logistic Regression.................................................................................................32

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Fold Increase Score................................................................................................32
HeRO Score.............................................................................................................33
References: ..................................................................................................................33
Appendix B: Glossary.....................................................................................................35

INTRODUCTION
- 5 -
Introduction
HeRO provides an automated, noninvasive method to detect transient
decelerations and reduced baseline heart rate variability. HeRO continuously
acquires, records, measures and analyzes variations in RR Intervals, and provides
ongoing display of this information.
HeRO is used to:
Continuously acquire heart rate data from an existing physiological monitor
Identify and determine the length of time between individual heart beats
(the R-R Interval)
Calculate a set of measures from these R-R Intervals to characterize the
heart rate pattern
Compute an “index” based on the degree of decelerations and reduced
baseline variability in these patterns,
Calculate the HeRO Score, which expresses the index as a fold-increase
relative to the overall NICU population, and
Provide this information to clinicians in a timely and intuitive fashion.
HeRO solo 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 solo or HeRO duet refer to the HeRO Display and, as
applicable, the HeRO Data Acquisition Device (AD2).

INTRODUCTION
- 6 -
Indications for Use
HeRO®is intended to acquire, store, analyze, and report on ECG data
collected from infants. HeRO is intended to be used by trained operators
under the direct supervision of a licensed health care practitioner in a
hospital neonatal or pediatric ICU environment.
HeRO is intended to be used for the analysis of the variability in RR
Intervals (heart rate) and to report measurements of the variability of heart
rate data (HRV). The HRV measurements reported by HeRO are
specialized in nature, and intended to identify periods of transient
decelerations and/or reduced baseline variability in the heart rate.
HeRO is intended to provide only specialized HRV measurements and is not
intended to produce any interpretation of those measurements or any kind of
diagnosis.
The specialized HRV measurements produced by HeRO have not been approved
by the FDA for any specific clinical diagnosis.
HeRO acquires data from a user-supplied ECG monitor, and requires a user-supplied
local area network.
Installation Training and Maintenance
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
HeRO is not intended for use with patients more than 180 days old or weighing
over 5000g. Patients with erratic, accelerated, or mechanically controlled irregular
heart rhythms are not suitable for HRV evaluation. When shown, the ECG
waveform displayed on the computer screen is not to be used for analysis of
cardiac function.

INTRODUCTION
- 7 -
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 solo and HeRO duet are not suitable for use in the presence of flammable
anesthetic in mixture with air, oxygen, or nitrous oxide.
The HeRO Data Acquisition Device (AD2) is a Class II 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 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.
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).
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 solo 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.

INTRODUCTION
- 8 -
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
Temperature
0:r50:
-30:r 60:
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 are indicated by bold type, i.e.
Patient View.
The 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
- 9 -
Overview
HeRO solo 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 solo 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 solo 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. Both the HeRO Display and the

OVERVIEW
- 10 -
HeRO Data Acquisition Device (AD2) are approved for installation in the patient
environment.

TROUBLESHOOTING
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Using HeRO solo and HeRO duet
Setting Up
HeRO solo and 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 solo hardware 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 solo cabling is identical except for the omission of the second,
orange patient cable. RS-232 installations omit the HeRO Data Acquisition Device (AD2) entirely.

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

TROUBLESHOOTING
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Viewing the HeRO Score
Each HeRO solo 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 patient is 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.

TROUBLESHOOTING
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duet View (only available on HeRO duet )
Figure 3. duet View Screen. HeRO Scores 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 Icon are:
the bed designation (Purple or Orange for HeRO Data Acquisition Device
(AD2) systems, the Bed Label of the monitor for RS-232 systems),
The Name and MRN of the patient (RS-232 systems only)
a five-day trend of the HeRO Score,
a bar graph that shows the current HeRO Score,
a numeric display of the current HeRO Score, and
a status indicator that is green when the system is receiving heart rate data
for the bed, and dark otherwise.
Tapping on a Bed Icon will bring up 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.
Bed Designation
Current HeRO Score
HeRO Score trend
Status Indicator
Second Patient
Discharge Button
Help Button
Patient MRN/Name

TROUBLESHOOTING
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Patient View (HeRO solo and HeRO duet )
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:
the bed identifier (Purple or Orange for HeRO Data Acquisition Device (AD2)
systems, the Bed Label of the monitor for RS-232 systems),
The Name and MRN of the patient (RS-232 systems only)
a five-day trend of the HeRO Score,
a bar graph that shows the HeRO Score,
a numeric display of the HeRO Score,
a 30-minute Heart Rate trend,
a real-time ECG Waveform (when using the HeRO Data Acquisition Device
(AD2); see warning below)
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.
Status Indicator
Discharge Button
ECG Waveform
Heart Rate Trend
Back Button

TROUBLESHOOTING
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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.
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.

TROUBLESHOOTING
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Activating HeRO solo and HeRO duet
HeRO solo 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:
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 as long as possible.
A Discharge operation must be completed any time the HeRO solo or duet
is moved from one physiological monitor to another, or when a new patient
is connected to the monitor.
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.

TROUBLESHOOTING
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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.
Message
Description
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 monitor is first powered up. If the 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
want to discharge bed
(Purple/Orange)?
This message is displayed when the Discharge on the
Patient View is clicked. No patient data has been
changed at this point. You may choose to continue or
cancel the operation.
Discharging bed
(Purple/Orange)
A Discharge operation has been confirmed and is
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
bed (Purple/Orange)
A Discharge operation has failed. Scores from the
previous patient may still be displayed. Restart the
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 suggested steps, contact
MPSC Technical Support .

TROUBLESHOOTING
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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 distress1-7. The HeRO
Score is reported as a fold increase relative to the general NICU population.
HeRO HRV data provides a new tool for clinical assessment so that standard
diagnostic and therapeutic decisions are better founded. As is customary with
good medical practice, the interpretation of any medical test should be made in
conjunction with all other available medical history and diagnostic information
about a patient.
Warning: A low HeRO score should never be used to deny or reduce treatment on a
patient that is exhibiting clinical signs of sepsis.
The computational methodology used to determine patient status is described in
Appendix A: Theory of Operation.