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: