MPSC HeRO solo Guida utente

HeRO

solo

HeRO

duet

Version 3.1

System Manual

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: +1 434-220-0714

Fax: + 1 240-220-6098

E-mail: info@heroscore.com

www.heroscore.com

TABLE OF CONTENTS

- 3 -

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

- 4 -

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

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