MPSC HeRO solo User manual

®
®
HeRO solo
&
HeRO duet
Version 3.1
System Manual

COPYRIGHT © 2022 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-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.

CONTACT INFORMATION
- 2 -
Contact Information
Distributor List
Australia
Device Technologies
1 Garigal Road
Belrose NSW 2085
Australia
PH: [phone]
E-mail: [e-mail]
Web: www.device.com.au
Bahrain
Mohammed Fakhroo & Bros.
P.O. Box 439
Manama, Kingdom of Bahrain
PH: ([phone]
E-mail: [e-mail]
Web: www.fakhroo.com
Canada
Canadian Hospital Specialties Ltd.
2810 Coventry Rd, Oakville, Ontario
L6H 6R1 Canada
PH: 1-905-825-9300
E-mail: [e-mail]
Web: www.chsltd.com
Hong Kong
Sunshine Medical Supplies Ltd
Rm 5A, 1/F, Transport City Building,
1-7 Shing Wan Road, Shatin
Hong Kong
PH: [phone]
E-mail: [e-mail]
Austria
Connect Medizintechnik GmbH
Gspanngasse 4
A-2130 Mistelbach
Austria
Ph: [phone]
E-mail: [e-mail]
Web: www.connect-medizintechnik.at
Belgium
Tomorrow Medical
Linnaeuslaan 75
3571 TV Utrecht
The Netherlands
PH: [phone]
E-mail: [e-mail]
Web: www.tomorrow-medical.com
Egypt
Egyptian Engineering & Industrial Office
18 Hoda Shaarawi Street
Cairo 11511
Egypt
PH: [phone]
E-mail: [e-mail]
Web: www.eeiomedical.com
Hungary
Polaris Medical Ltd
Vezer u. 30
Budapest 1141
Hungary
PH: [phone]
E-mail: [e-mail]
Web: www.polarismedical.hu

CONTACT INFORMATION
- 3 -
Iran
Armaghan Salamat Kish Co., Ltd
No. 18, 4th Floor, Farhad Bldg
Amir Kabir Sq.
Kish Island, Iran
PH: ([phone]
E-mail: [e-mail]
Web: www.arsak.co
Jordan
Sadaf Medical Supplies
P.O. Box 4412 Postal Code 11953
Amman, Jordan
Complex 67 - Amer Bin Malek Street –
1st Floor
PH: [phone]
E-mail: [e-mail]
Malta
Associated Equipment Ltd
11 Lourdes Square
Rihan Avenue
San Gwann SGN 2010, Malta
PH: ([phone]
E-mail: [e-mail]
Web: www.associated-equipment.com
Jamaica
Medical Technologies (Meditech) Limited
Shop 1 & 2, Northside Plaza,
Liguanea, Kingston 6
Jamaica
PH: [phone]
E-mail: [e-mail]
Web: www.meditechjm.com
Kuwait
Al-Sareh International Company
Universal Tower, 8th Floor
Ahmed Al Jaber Street
Sharq, Kuwait
PH: [phone]
E-mail: [e-mail]
Web: www.alsarehkw.com
The Netherlands
Tomorrow Medical
Linnaeuslaan 75
3571 TV Utrecht
The Netherlands
PH: [phone]
E-mail: [e-mail]
Web: www.tomorrow-medical.com
Oman
Muscat Pharmacy & Stores LLC
Building No. 51, Block No. 144
Al Senaeyah Street
Al Wadi Al Kabir
P.O. Box 438, P.C. 100,
Muscat, Sultanate of Oman
PH: [phone]
E-mail: [e-mail]
Web: www.muscatpharmacy.net
Pakistan
Global Clinical Cura
18 Mian Iqbal Rd
Westrige 1
Rawalpindi Pakistan
PH: [phone]
E-mail: [e-mail]
Web: www.gcc-health.com
South Africa
Kiara Health
89 Elevation Avenue
Randjesfontein, Midrand
South Africa
E-mail: [e-mail]
Web: www.kiarahealth.com

CONTACT INFORMATION
- 4 -
Poland
Viridian Polska Sp. z.o.o.
ul Morgowa 4
04-224 Warszawa, Poland
PH: [phone]
E-mail: [e-mail]
Web: www.viridian.com.pl
Romania
Abb Medtec SRL
Str. GAROFITEI 2
Rasnov, Brasov
Romania
PH: [phone]
E-mail: [e-mail]
Web: www.abbmed.ro
South Korea
N Tech Medical Co., Ltd.
#308, Digital-ro 33-gil 55
Guro-gu, Seoul
152-719, Korea
PH: [phone]
E-mail: [e-mail]
United Kingdom
SLE Ltd
Twin Bridges Business Park
232 Selsdon Road
Croydon CR2 6PL, UK
Ph: [phone]
E-mail: [e-mail]
Web: www.sle.co.uk
United Arab Emirates
MDC Care Medical Trading
Office 506, Sobha Sapphire Tower,
Burj Khalifa Area,
Dubai, United Arab Emirates
PH: [phone]
E-mail: [e-mail]
Web: www.mdccare.com

CONTACT INFORMATION
- 5 -
M Manufacturer and for all
other Countries
Medical Predictive Science Corporation
1233 Cedars Court Suite 201
Charlottesville VA 22903 USA
T: [phone]
Fax: [phone]
E-mail: [e-mail]
www.heroscore.com
P EC Authorized Representative
Telephone: [phone]
Fax: [phone]

TABLE OF CONTENTS
- 6 -
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........................................................................................................11
Overview...........................................................................................................................12
Data Acquisition...........................................................................................................13
Using HeRO solo and HeRO duet .............................................................................14
Setting Up ....................................................................................................................14
Powering down ............................................................................................................15
Viewing the HeRO Score............................................................................................16
duet View (only available on HeRO duet )...........................................................17
Patient View (HeRO solo and HeRO duet ).........................................................18
Activating HeRO solo and HeRO duet ..................................................................20
Pausing an Alarm ....................................................................................................20
Continuous HeRO Monitoring................................................................................20
Status and Error Messages....................................................................................21
Alarms...........................................................................................................................22
Interpreting Results.........................................................................................................23
Troubleshooting...............................................................................................................24
HeRO Technical Information and Installation Guidelines ...........................................26
Site Location................................................................................................................26
Cabling..........................................................................................................................26
Cleaning........................................................................................................................27
Description of Markings..............................................................................................28
Modifications................................................................................................................29
Environmental Impact .................................................................................................30
Electrical Isolation.......................................................................................................30
Electromagnetic Compatibility ...................................................................................30
Appendix A: Theory of Operation ..................................................................................34
Algorithms for Calculating RRI Parameters..............................................................34

TABLE OF CONTENTS
- 7 -
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......................................................................................................39
Appendix C: Use of HeRO Score in the Assessment of Infection.............................42

INTRODUCTION
- 8 -
Introduction
HeRO provides an automated, noninvasive method to detect transient
decelerations and reduced baseline heart rate variability. HeRO continuously
acquires, records, measures and analyzes variations in RR Intervals, and provides
ongoing display of this information.
HeRO is used to:
Continuously acquire heart rate data from an existing physiological monitor
Identify and determine the length of time between individual heart beats
(the R-R Interval)
Calculate a set of measures from these R-R Intervals to characterize the
heart rate pattern
Compute an “index” based on the degree of decelerations and reduced
baseline variability in these patterns,
Calculate the HeRO Score, which expresses the index as a fold-increase
risk of sepsis relative to the overall NICU population, and
Provide this information to clinicians in a timely and intuitive fashion.
HeRO 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
- 9 -
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 solo 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 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 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:

INTRODUCTION
- 10 -
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,
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.
Warning: The 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.
Warning: Other software applications should not be installed on the HeRO
Display.

INTRODUCTION
- 11 -
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.
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
- 12 -
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, HeRO duet configured to acquire the analog ECG
waveform from the Defib/Sync jacks on two monitors using line-in acquisition or the optional HeRO
Data Acquisition Device (AD2). Below, a HeRO solo configured to acquire RS-232 heart rate data
directly into the HeRO Display.

OVERVIEW
- 13 -
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.
This adaptor connects between one or two cables and to the pink colored
input on the bottom of the HeRO Display.
2) 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.
3) The HeRO Display can be connected directly to the RS-232 port on certain
physiological monitors. When connected via RS-232, HeRO will use the
ECG-derived heart rate.
Both the HeRO Display and the HeRO Data Acquisition Device (AD2) are approved
for installation in the patient environment.

USING HeRO solo and duet
- 14 -
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 patient monitors, one with
a purple cable and the second with an orange cable, that are connected to the
HeRO duet as shown in Figure 2. HeRO solo hardware appears identical, omitting
the orange patient cable. RS-232 configurations, meanwhile, omit the HeRO Data
Acquisition Device (AD2) entirely.
Figure 2a. HeRO duet cabling when using the duet ECG input adaptor. The purple patient cable
is connected into the purple lead, and the orange cable into the orange lead. The ECG input
adaptor plugs into the pink colored port on the bottom of the HeRO Display.

USING HeRO solo and duet
- 15 -
Figure 2b. HeRO duet 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
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. Not shown, RS-
232 installations omit the HeRO Data Acquisition Device (AD2) entirely.
Powering down
Please turn off the HeRO solo or HeRO duet before unplugging any of the power
cords connected to the unit. Some units have a circular power button on the
bottom of the unit that is illuminated green when powered on. Other units have a
circular power button on the back of the HeRO Display. For both units, press
the button for approximately 1 second and wait for the unit to shut down.

USING HeRO solo and duet
- 16 -
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.

USING HeRO solo and duet
- 17 -
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 ECG input 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,
an alarm symbol, when appropriate, and
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 Pause
Alarm from the pop-up menu. Refer to 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.
Bed Designation
Current HeRO Score
HeRO Score trend
Status Indicator
Second Patient
Discharge Button
Alarm Indicator
Help Button
Patient MRN/Name

USING HeRO solo and duet
- 18 -
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,
an alarm symbol, when appropriate,
a 30-minute Heart Rate trend,
a real-time ECG Waveform (disabled when using RS-232; 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.
Alarm Symbol
Status Indicator
Discharge Button
ECG Waveform
Heart Rate Trend
Back Button

USING HeRO solo and duet
- 19 -
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 symbol or the surrounding
bar graph area. Refer to 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.
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.