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EDAN Agile PLM Electronic Signature Information

--Signatures related to this document and performed in EDAN Agile PLM.

文件名称(Document Name):Holter分析软件说明书_英文
文件编号(Number):01.54.456516
版本(Version):2.0
产品型号(Product Model):SE-2003;SE-2003A;SE-2012;SE-2012A
项目编码(Project Code):2410C005

签批信息(Signature):
作者(Originator) : 张 妞 (zhangniu) 2023-01-13 11:06:19
审核人(Reviewers) : 魏 丹莉 (weidanli) 2023-01-13 14:56:17
审核人(Reviewers) : 黄 炜乐 (huangweile) 2023-01-13 15:46:56
审核人(Reviewers) : 夏 欢欢 (xiahuanhuan) 2023-01-13 18:22:37
批准人(Approvers) : 肖 玉华 (xiaoyuhua) 2023-01-16 15:07:03

版权©深圳理邦诊断科技有限公司(Copyright©Edan Diagnostic.Ltd.)
About this Manual

P/N: 01.54.456516

MPN: 01.54.456516020

Release Date: Jan. 2023

© Copyright EDAN INSTRUMENTS, INC. 2014-2023. All rights reserved.

Statement

This manual will help you understand the operation and maintenance of the product better. It is
reminded that the product shall be used strictly complying with this manual. User’s operation
failing to comply with this manual may result in malfunction or accident for which Edan
Instruments, Inc. (hereinafter called EDAN) cannot be held liable.

EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.

Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information are contained in this manual, the user
shall not disclose such information to any irrelevant third party.

The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.

EDAN holds the rights to modify, update, and ultimately explain this manual.

Responsibility of the Manufacturer

EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by


persons authorized by EDAN, and

The electrical installation of the relevant room complies with national standards, and
The instrument is used in accordance with the instructions for use.

I
Terms Used in this Manual

This guide is designed to give key concepts on safety precautions.

WARNING

A WARNING label advises against certain actions or situations that could result in personal
injury or death.

CAUTION

A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.

NOTE

A NOTE provides useful information regarding a function or a procedure.

II
Table of Contents
Chapter 1 Safety Guidance ........................................................................................................... 1
1.1 Indications for Use/Intended Use ...........................................................................................1
1.2 Warnings and Cautions .......................................................................................................... 1
1.2.1 Safety Warnings ........................................................................................................... 2
1.2.2 General Cautions ..........................................................................................................2
1.2.3 Protecting Personal Information .................................................................................. 2
1.3 List of Symbols ...................................................................................................................... 4
Chapter 2 About the Manual ........................................................................................................ 7
2.1 Application of the Manual ................................................................................................... 7
2.2 Applicable Object .................................................................................................................7
2.3 Product Reference ................................................................................................................ 7
2.4 Legend and Name ................................................................................................................ 7
Chapter 3 Introduction ..................................................................................................................8
3.1 Components ..........................................................................................................................8
3.2 Features ................................................................................................................................ 8
3.3 System Installation and Running Requirements .................................................................. 9
3.4 Software Installation .......................................................................................................... 10
3.5 Main Screens ......................................................................................................................14
3.6 Basic Functions .................................................................................................................. 14
3.7 Advanced Functions ...........................................................................................................15
Chapter 4 Patient Record Management .................................................................................... 16
4.1 Main Menu ......................................................................................................................... 16
4.2 Registering Patient Information ......................................................................................... 19
4.3 Scanning ECG Data ........................................................................................................... 19
4.3.1 Scan ............................................................................................................................ 20
4.3.2 Import .........................................................................................................................20
4.4 Archiving a Patient Record ................................................................................................ 20
4.5 Restoring a Patient Record .................................................................................................21
4.6 Exporting a Patient Record ................................................................................................ 21
Chapter 5 ECG Data Analysis .................................................................................................... 22
Chapter 6 ECG Data Editing ...................................................................................................... 26
6.1 Editing Patient Information ................................................................................................26
6.2 Editing Template ................................................................................................................26
6.2.1 Template Analysis ......................................................................................................26
6.2.2 Editing Superimposed Graph ..................................................................................... 31
6.2.3 Editing Histogram ...................................................................................................... 32
6.2.4 Editing RR Bird View ................................................................................................33
6.2.5 Editing Poincare Plot ..................................................................................................34

III
6.2.6 Editing Poincare Plot and Superimposed Graph ........................................................35
6.2.7 Keyboard Operation and Other Useful Operations ....................................................36
6.3 General ECG View Window ..............................................................................................40
6.3.1 Inserting Beats ............................................................................................................41
6.3.2 Deleting Beats ............................................................................................................ 42
6.3.3 Modifying Beats .........................................................................................................42
6.3.4 Modifying Successive Beats ...................................................................................... 42
6.3.5 Inserting Beats in Batch ............................................................................................. 43
6.3.6 Measuring ECG ..........................................................................................................43
6.3.7 Quick Browse of ECG ............................................................................................... 44
6.3.8 Saving ECG Strip .......................................................................................................44
6.3.9 Relocating R Waves ...................................................................................................45
6.3.10 Printing ECG ..............................................................................................................45
6.3.11 Defining an Arrhythmia Event ...................................................................................45
6.3.12 Display Options ..........................................................................................................46
6.4 STe ..................................................................................................................................... 47
6.4.1 ST Event List ..............................................................................................................48
6.4.2 HR Trend ....................................................................................................................49
6.4.3 ST Trend .....................................................................................................................49
6.4.4 ST Reanalysis .............................................................................................................50
6.5 Events .................................................................................................................................51
6.6 Strips .................................................................................................................................. 54
6.7 Page Scan ........................................................................................................................... 55
6.8 Trend .................................................................................................................................. 56
6.9 Tabular ............................................................................................................................... 56
6.10 HRV ............................................................................................................................... 57
6.10.1 HRV Histogram ......................................................................................................... 59
6.10.2 HRV Table ................................................................................................................. 59
6.10.3 Power Spectrum Graph .............................................................................................. 61
6.11 QT .................................................................................................................................. 61
6.12 Pacing Electrophysiology ...............................................................................................62
6.12.1 Pacing Event Definition ............................................................................................. 62
6.12.2 Pacing Histogram ....................................................................................................... 63
6.12.3 Pacing Trend .............................................................................................................. 64
6.12.4 Pacing Events ............................................................................................................. 64
6.13 Statistic Information .......................................................................................................65
6.14 Report .............................................................................................................................65
Chapter 7 System Settings ...........................................................................................................67
7.1 Common Setting .................................................................................................................67
7.2 Workflow Setting ............................................................................................................... 67

IV
7.3 Analysis Setting ................................................................................................................. 68
7.4 View ................................................................................................................................... 69
7.5 Maintenance ....................................................................................................................... 69
7.6 GDT ....................................................................................................................................70
7.7 File Output Setting ............................................................................................................. 71
Chapter 8 System Tips .................................................................................................................72
Chapter 9 Maintenance ............................................................................................................... 73
Chapter 10 Accessories ................................................................................................................ 74
Chapter 11 Warranty and Service ..............................................................................................75
11.1 Warranty .........................................................................................................................75
11.2 Contact Information ....................................................................................................... 75
Appendix 1 Abbreviations ...........................................................................................................76

V
SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

Chapter 1 Safety Guidance


This chapter provides important safety information related to the use of SE-2003&SE-2012
Series Holter System analysis software.

1.1 Indications for Use/Intended Use

The SE-2003&SE-2012 Series Holter System (including recorder and analysis software) is
intended to record, analyze, display, edit and generate report of ambulatory ECG. The Holter
System is intended to be used by trained personnel under the direction of doctors. The analysis
results are offered to doctors on an advisory basis only. The Holter System is intended for adult,
pediatric patients including infants weighing less than 10 kg.

It can be used for the following indications:

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.


2. Evaluation of patients for ST segment changes.
3. Evaluation of drug response in patients taking anti-arrhythmic medications.
4. Evaluation of patients with pacemakers.

1.2 Warnings and Cautions

In order to use the software safely and effectively, and avoid the possibility of system failure,
firstly be familiar with the operation method of Windows, and read the user manual in detail
and be sure to be familiar with the proper operation method of SE-2003&SE-2012 Series
Holter System analysis software and Holter System Recorder. The following WARNING and
CAUTION must be paid more attention to during the operation of the system.

NOTE:

1. This system is not intended for home use.


2. The pictures and screens in this manual are for reference only.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

1.2.1 Safety Warnings

WARNING

1. Failure to follow the safety instructions for operating the instrument and system could
endanger the patient. The manufacturer accepts no liability for damages resulting
from improper use.
2. The system should be installed by qualified service engineers. Do not switch on the
power until all cables have been properly connected and verified.
3. The user should get professional training and read this manual in detail before using
the system.
4. This system is not intended for treatment.
5. Do not move the main unit or the monitor while working.
6. Only accessories supplied or recommended by the manufacturer can be connected to
the system.

1.2.2 General Cautions

CAUTION

1. Federal (U.S.) law restricts this device to sale by or on the order of a physician.
2. Do not bend or press the CD.
3. Keep the CD away from direct sunlight and high temperature. Otherwise, the CD may
become deformed.
4. Do not touch the disk surface of the recorded side. If the surface becomes
contaminated with any foreign substance such as fingerprints, reading data may be
impossible.
5. Clean the CD with a disk cleaner. Do not use organic solvents such as acetone.
6. This CD-ROM disk is not an audio CD, and cannot be played with an audio CD player.
7. Avoid liquid splash and excessive temperature. The temperature must be kept
between 5 ºC and 45 ºC during operation.
8. Do not use the system in a dusty environment with bad ventilation or in the presence
of corrosive. Avoid vibration.
9. Do not handle the CD while smoking or eating.
10. Do not get the CD wet.

1.2.3 Protecting Personal Information

Protecting personal health information is a major component of security strategy. To protect


the personal information and ensure the proper device performance, the user should take
necessary precautions in accordance with local laws and regulations and institution’s policies.
Manufacturer recommends health care organizations or medical institutions to implement a
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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

comprehensive and multifaceted strategy to protect the information and systems from internal
and external security threats.

To ensure the patients’ safety and protect their personal health information, the user should
implement practices or measures that include:

1. Physical safeguards - physical safety measures to ensure that unauthorized personnel do not
have access to the system.
2. Operational safeguards - safety measures during operation.
3. Administrative safeguards - safety measures in management.
4. Technical safeguards - safety measures in technical field.
CAUTION
1 The access/operation of the system is restricted to authorized personnel only. Assign
only staff with a specific role the right to use the system.

2 Ensure that all device components maintaining personal information (other than
removable media) are physically secure (i.e. cannot remove without tools).

3 Make a backup of data on a periodic basis.

4 Ensure that the system is connected only to the device authorized/approved by


manufacturer. Users should operate all system deployed and supported by
manufacturer within specifications authorized by manufacturer, including the software,
software configuration, security configuration, etc. approved by manufacturer.

5 Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s
service personnel are allowed to modify the Maintenance settings.

6 Anti-virus measures such as USB device virus scanning should be carried out prior to
using USB flash drive.

7 When connecting the system to a shared network, data security issues of the network
topology and configuration must be considered. Since the patient sensitive data are
not encrypted and might be transmitted from the system to the network, the medical
institution should be responsible for the network security. Firewalls and/or other
security devices should be in place between the medical system and any externally
accessible systems. It’s recommended to use Windows defender firewall or any other
firewall that can defend against Dos and DDos attacks, and keep it up to date.

8 Dos and DDos protection of the router or switch must be turned on for defensing
against attacks.

9 When the system is returned for maintenance, disposed of, or removed from the
medical institution for other reasons, it is necessary to ensure that all patient data are

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

removed from the system.

10 For security, disable all unused USB and network ports.

11 When deploying the network, it is recommended to isolate the network and the
Intranet system of the hospital by using VLAN so as to ensure the network security.
Only trusted devices are allowed to join the VLAN network.

12 Please protect the privacy for the information and the data displayed on the screen,
and for the information and the data stored in the system.

13 When building the networking environment: 1) If a wireless router is used, please turn
on the MAC address filtering function of the wireless router and add the MAC address
of the system to the rule list. The wireless router only allows devices in the rule list to
access the wireless network. 2) It is suggested to build a VLAN, assign the LAN ports
where the approved switch port and the system are into the same VLAN, and isolate
them from other VLANs.

14 It is advised not to establish administrator and guest accounts.

15 The system does not support file or file folder sharing which will cause irreversible
data lost or damage.

16 Destroy the sensitive information in the idle or scrapped device.

17 It is recommended that you activate Windows password strategy.

1.3 List of Symbols

NO. Symbol Description

1 Caution

2 Consult operating instructions

3 General symbol for recovery/recyclable

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

4 Part Number

5 SERIAL NUMBER

6 Date of manufacture

7 MANUFACTURER

8 CE marking

AUTHORISED REPRESENTATIVE IN THE EUROPEAN


9
COMMUNITY

10 Disposal method

Caution: Federal (U.S.) law restricts this device to sale by or


11
on the order of a physician.

12 This way up

13 Fragile, handle with care

14 Keep away from rain

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Safety Guidance

15 Stacking limit by number

16 Handle with care

17 Do not step on

18 Front

19 Medical Device

20 Unique Device Identifier

NOTE: The user manual is printed in black and white.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual About the Manual

Chapter 2 About the Manual


2.1 Application of the Manual

The manual mainly introduces functions of analysis software and the way to operate it.

2.2 Applicable Object

The manual is applicable to clinical professionals and other authorized users.

2.3 Product Reference

In this manual:

♦ A computer running analysis software is called "Analysis Host”.


♦ Holter System analysis software is shortened to “analysis software”.
♦ Ambulatory ECG recorder is called "Holter System Recorder" or "Recorder".
♦ Menu options to start a new process, open window/menu or input information by clicking
your mouse in the active windows called "Buttons".

2.4 Legend and Name

All legends provided in the manual are just for examples.

All names shown in examples and legends are imaginary. It is coincidence if somebody
happens to have the same name with that in the manual.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

Chapter 3 Introduction
The SE-2003&SE-2012 Series Holter System is intended to be used in hospitals and clinics. It
should be used by trained personnel under instructions of physician to evaluate long-term
ambulatory ECG data. The analysis results generated by the system are only reference for
physicians to make clinical diagnoses and treatment. The exact diagnosis decision and therapeutic
procedures lie with the physician.

WARNING

Operators should familiarize themselves with the clinical operating procedures of


Holter prior to use.

3.1 Components

The SE-2003&SE-2012 Series Holter System has the following components:

♦ Holter System Recorder that has four models: SE-2003, SE-2012, SE-2003A, and
SE-2012A.
The analysis software is only intended to analyze ambulatory3/12-channel ECG data from
recorder manufactured by Edan Instruments, Inc.

To avoid errors, check and enter the patient data carefully. For details, please refer to
SE-2003&SE-2012 Series Holter System Recorder User Manual.
♦ Patient Cables
♦ Holter System Analysis Software

3.2 Features

♦ Supporting multi-channel beat detection


♦ Accurate classification of QRS morphology
♦ Supporting automatic detection of arrhythmia
♦ Supporting re-analysis
♦ Reviewing, editing, and saving strips
♦ Supporting full disclosure of ECG
♦ Template analysis, event analysis, ST analysis, pacing analysis, HRV
time-domain/frequency-domain analysis, and QT analysis
♦ Customizing workflows

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

3.3 System Installation and Running Requirements

CAUTION

1. This system can only be operated at secure networks. Otherwise, patients’


information and health conditions may leak.
2. Install anti-virus software in the PC that runs this system and update the software
timely.
3. If the PC is not purchased from our company, we will not be held responsible for the
maintenance of the PC hardware or the operating system.
4. Sharing of files or file storage folders on the network is not supported by the
SE-2003&SE-2012 Series Holter System Analysis Software and may cause
irreversible data lost or corruption.
5. Install the SE-2003&SE-2012 Series Holter System Analysis Software in dedicated
PC to ensure the Holter System Analysis Software runs properly.

NOTE:

1. This system can only be operated at secure networks. Otherwise, patients’


information and health conditions may leak.
2. Install anti-virus software in the PC that runs this system and update the software
timely.
3. If the PC is not purchased from our company, we will not be held responsible for the
maintenance of the PC hardware or the operating system.

System installation and running requirements are given in the table below.

Item Configuration Requirements


CPU Intel P4 2.6G Hz or above
Memory 2G or above
Hard Disk 100G or above
Main Board The main board of Intel chipset is recommended
19' TFT or above, 16 bit actual color, regular icon and
PC hardware Display: font setup
Supported resolution: 1366×768, 1440×900, 1920×1080
Printer HP LaserJet printer (Resolution: 600 dpi or above)
FLASH card-reader using USB port
Others At least 2 free USB ports
24x or above CD-ROM
Windows XP SP3
PC software PC system
Windows 7, 32 bits/64 bits
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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

Windows 8, 32 bits/64 bits


Windows 10, 32 bits/64 bits

Operating voltage 220±22 V~


Power
requirements
Operating frequency 50±1 Hz

Temperature 5°C to 45°C

Working
Relative humidity 10% RH to 95% RH (non-condensing)
environment
Atmospheric
70 kPa to 106 kPa
pressure

3.4 Software Installation

The procedure for installing the analysis software are as follows:

1. Insert the installation CD into CD-ROM, and double-click on setup.exe . The


following windows will be displayed.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

2. Click on the Next > button and the following window will be displayed.

3. Click on the Next > button to install the analysis software to the default folder.
Or click on the Browse… button to choose the installation path, and then click on the Next >
button to continue. The following window will be displayed.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

4. Click on the Install button to continue.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

5. Click on the Finish button. The analysis software is installed successfully.

NOTE:

1. Insert the dongle before starting the analysis software.


2. It is recommended to shut down other applications before using the software.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

3.5 Main Screens

To perform automatic analysis and create a report, you may enter the following screens in a
workflow.

Screen Description

The main menu is displayed when you start the analysis


Main menu software and it provides access to functions like Register
Patient Info and Recorder DB.

Patient information input Input patient information.

Set analysis parameters before automatic analysis of a


Analysis setting
patient record.

Review, edit and report analysis results after completion


Record editing and analyzing
of automatic analysis
Report preview/printing Preview report before printing.

3.6 Basic Functions

♦ Patient Information Registration.


Input, modify, or delete the patient information, including name, age, gender, and record
time etc.
♦ Archive, restore, import, and export patient records.
♦ Automatic analysis
1) The system uses three channels for analysis to ensure all the heartbeats are detected.
2) Arrhythmia analysis
Automatically analyzes ECG data, identifies and marks the beats as N (normal), V
(ventricular), S (atrial), aP (atrial pacing), vP (ventricular pacing), and avP (AV dual pacing)
etc.
Automatically identifies arrhythmia events such as isolated VE, VE couplet, VE runs, VE
bigeminy, VE trigeminy, bradycardia, tachycardia, pause, isolated SVE, SVE couplet, SVE
bigeminy, SVE trigeminy, atrial fibrillation/flutter, abnormal ST segment, pacing
FTC/FTS/FTO, etc.
3) HRV analysis
Displays RR histogram, Poincare plot, power spectrum graph, and SDNN trend.
4) QT interval analysis
Displays the QT list, QT histogram, and QTc percentage.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Introduction

5) ST analysis
Displays the ST trend of 12 leads.
After resetting the ST measurement points, you can refresh the results without reanalyzing.
Calculate myocardial ischemia load.
♦ Replay
Replay ECG waveforms and HR trend throughout the record. Automatically read patient
information from the Recorder.
♦ Event
Identify the events marked by the patient.
Add, modify, and delete events, and display the ECG strip when an event occurs.
♦ Statistics
Count the number of arrhythmia events, HR, and ST deviation and allow you to edit the
value.
♦ Beat editing
View, merge, and reclassify beats in the Template tab.
Insert, delete, and modify beats in the ECG view window, with event types and related
statistical data synchronized automatically.
Edit beats by means of histograms. More than 20 types of histograms are available.
♦ Allow you to define an ECG strip as an event. The ECG strip can be printed vertically or
horizontally.
♦ Report printing
Print diagnosis report, statistical charts, strips, trend charts, histograms, ECG full disclosure,
and Poincare plot etc.
Provide various types of comment and select what you want to be shown in the diagnosis
report.

3.7 Advanced Functions

The following advanced functions are configurable:

♦ T wave alternans analysis


♦ SAECG analysis
♦ VCG analysis
♦ Waterfall plot analysis

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

Chapter 4 Patient Record Management


CAUTION

Please ensure that patients’ ECG data are completely imported to Holter analysis
software before using this software.

4.1 Main Menu

Double click on the Holter icon on the desktop to start the program.
The main menu of Holter Analysis System is displayed as below:

3 2

Region 1 Main Toolbar

The main toolbar contains the following options:

Option Description

Search Enter patient name, ID, and diagnostic conclusion to search for ECG data.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

About Obtain software information.

Lead View lead placement.

Register Register patient information.

Scan Load data from the Recorder or other external memory.

Edit Modify the patient information and ECG data of the selected record.

Analyze Analyze the selected examination record.

Delete patient records. If the record is deleted from the Recycle folder, the
Delete
data will be deleted permanently.
If a record is archived, only its diagnosis report remains. The original ECG
Archive data and analysis data will be stored in the specified memory. In this way,
more system storage space will be available.

Restore Recover the archived data.

Export Export data to other memories.

Import Import data from other memories.

Settings Set system parameters.

Region 2 Patient Record List

A patient record can be in the following status:

: Newly imported record

: Analyzed record

: Diagnosed record

: Archived record

You can only see the patient information and diagnosis report if a record has been archived.

If a record is marked with RDF in the Report column, it indicates that a report has been
generated for the record.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

If a record is marked with PM in the Pacing column, it indicates that pacemaker analysis has
been performed for the record.

Right click on the patient record list, a menu will be displayed. The menu contains the
following options.

Option Description

Select All Select all the records.

Reset All Not Select any record.


Cancel analysis task for the patient records that are
Cancel Task
waiting in line.
Move to… Move the record(s) to another folder.
Copy to… Copy the record(s) to another folder.
View conclusion Display the manually input comment.
Collection Add the record(s) to the Favorites folder.
Report Review the report.

Region 3 Storage Folders

The three storage folders are used to:

♦ Register DB: store registered patient information.


♦ Recorder DB: store data from the Recorder.
♦ Recycle: store data deleted from Recorder DB.
♦ Favorites: store the collection of data.

Right click on a storage folder, a menu will be displayed. The menu contains the following
options.

Option Description
Set the selected folder as the default folder.
Default Folder
Imported data will be stored in this folder automatically.
Create a new data folder.
New Folder The name of the new folder cannot be the same as those of the existing
folders.
Rename the selected folder.
Rename
The name of the four folders provided by the system cannot be modified.
Delete the selected folder. Data in the deleted folder will be transferred to
Delete
the Recycle folder automatically.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

CAUTION

Data that are deleted are unable to be restored. Please make a backup before deleting
the data.

Users should make a backup of historical data on a periodic basis.

4.2 Registering Patient Information

A patient can be registered before ECG recording. Click Register on the main toolbar, the
following window will be displayed.

On this window, you can:

Input patient information and click Save to save the patient information to the Register DB, or
click Register to save the patient information to the Recorder.

Click Print to print an Events Card for the patient to record daily activities and symptoms.

Click Notes to edit the notes to be printed on the Events Card.

4.3 Scanning ECG Data

After ECG recording, you have to import the data to the Holter Analysis Software. There are
two ways of data import: scan and import.
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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

4.3.1 Scan

To import a single record:

1. Click Scan on the main toolbar. The system automatically enters the Single Import
window and scans the sampled data.
2. Click Next Step. The sampled data will be stored in the Recorder DB, and the system
automatically enters the analysis setup screen.

To import records in batch:

1. Click Scan > Batch Import.


2. Set scan path.
System will go through the chosen disk or given path for ECG data. If data are stored in
the SD or CF card, click Removable Disk for search.
3. Click Scan to start data search.
The search path will be remembered by the system. All found data will be listed in a
window.
4. Select the data to be imported. Click Import.
5. When data is successfully imported, remove the external memory.

4.3.2 Import

Import records that have been exported from Holter analysis software before.

1. Click Import on the main toolbar.


2. Select records in arc and zarc format. Click Open. They will be listed in the import
window.
3. Click the check box before records that you want to import and select the storage folder
from the drop-down list.
4. Click Import. Records are successfully imported.

4.4 Archiving a Patient Record

To save system storage space, patient records are archived, which means you transfer ECG
data in patient records to external memories (hard disk or compact disk), leaving only patient
information and diagnosis report in the system.

To archive a patient record:

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Patient Record
Management

1. Click the check box before a record in the Recorder DB. Click Archive on the main
toolbar.
2. Select the saving path and click Archive. System will transfer ECG data to the target
memory.
3. Status of the record is changed to be archived.

NOTE: Please ensure the external memory is marked and stored for the possibility of
future use.

4.5 Restoring a Patient Record

To restore a patient record:

1. Click the check box before an archived record. Click Restore on the main toolbar. The
Restore window will be displayed.
2. Select the memory where the record has been archived and click Restore. The system
automatically searches for and restores all ECG data of the record.

4.6 Exporting a Patient Record

Copy ECG data of a patient record to other memories. To export a patient record:

1. Click the check box before the patient record(s) to be exported. Click Export on the
main toolbar. The Export window will be displayed.
2. Set the export path.
3. Exported record will be named by the system by default unless you change it.
4. Click Export. ECG data of the record are copied. The data file is in arc format. If
Compress data is clicked, it will be zarc format.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual ECG Data Analysis

Chapter 5 ECG Data Analysis


System will automatically analyze the ECG data after they are scanned and enter the analysis
screen below. In this screen, you can set the analysis parameters. If you need to reanalyze the
ECG data, go to the Pat. Info tab, click Reanalyze.
ST Setting

Parameter
Setting

Pacing
Channel Setting
Setting

Analysis Start Analysis End

This screen contains the following options.

Option Description

Analysis channels include one important channel and two ancillary


channels. Data analysis is based on the important channel. But if the signal
of this channel is weak, ancillary channels will be used for analysis.
♦ Important channel. We recommend that you pull the scroll bar to
quickly browse the entire ECG, and select a channel with good
Channel
signals, large QRS amplitude, and ectopic beat waveform as the
Setting
important channel.
♦ Ancillary channels. They are used only when multi-channel analysis is
activated. Exclude channels with poor signal quality and small signal
amplitude. Choose a channel with large T wave amplitude and good
signal quality for QT analysis.

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♦ Click << and >> buttons to move E point (baseline), J point, and ST
point.
ST Setting
♦ To move the vertical indication line: place the cursor onto the line,
and keep your left mouse button pressed to move the line.

Noise Level See Chapter 7 System Settings.

Child mode Use pediatric algorithm to analyze ECG data.

Auto remove Enable the system to automatically remove ECG interference signals and
interfer. not to analyze them.
Multi CHAN
To activate this function, see Chapter 7 System Settings.
analyze
Click the check box before Pacemaker analysis. Select pacemaker type
Pacing Setting
from the drop-down list. Choose to do pacing event analysis or not.

Set the following rhythm parameters.

Isolated VE Early ventricular beat followed by a non-ventricular beat

VE Couplet Two consecutive ventricular beat

VE Runs Three or more consecutive ventricular beats

VE Bigeminy V-N occurs in couple for specified times

VE Trigeminy V-N-N occurs in couple for specified times


Parameter Number of heartbeats less than or equal to the predefined
setting Bradycardia heart rate is continuously greater than the specified
number

Number of heartbeats more than or equal to the


Tachycardia
predefined heart rate is continuously greater than the
specified number
Long RR
Longer than the specified RR interval
interval(PAUS
Note: The default value is 2000ms.
E)
A premature or escape beat from an atrium or node
(functional); or an abnormal atrial premature beat.
Atrial Set the percentage of prematurity, number of beat as
reference, compensatory pause, HR variation range, and
RR interval.

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PAC Couplet Two consecutive atrial cardiac beats

Atrial
Three or more consecutive atrial cardiac beats
Tachycardia
Atrial When SN occurs in couple for consecutive specified
Bigeminy number of times
Atrial When SNN occurs in couple for consecutive specified
Trigeminy number of times
Set the number of QRS to be involved in the mean value
calculation.
Max./Min. HR You can select whether to allow ectopic heartbeat
(including pacing) to be involved in calculation of
maximum and minimum heart rates.
In lowering events, ST depression is greater than the
specified value and its duration longer than the specified
time.
ST
In raising events, ST elevation is greater than the
specified value and its duration longer than the specified
time.
The pacing event analysis function is available only
when Pacemaker analysis is enabled.
♦ FTS: When the spacing between the initial pacing
value and former beat is less than the specified
Pacing value.
♦ FTC: when beat is not detected for more than a
specified time after initial pacing value.
♦ FTO: When RR interval or RP interval is greater
than the specified value.
Set the length of analysis, high frequency range, low
HRV frequency range, and very low frequency range for
HR variability.
Click some point on the ECG where the signal is good as the start of
analysis. Click Start. And another good point behind as the end of
Analysis start
analysis. Click End. ECG data between the start and end points will be
and end
analyzed while the other data out of this range are excluded. The length of
time out of the range is also deducted from record duration in the report.
Set to remove
Set ECG segments as interference and not to be analyzed.
interference

After setting the above parameters, click Analyze to conduct analysis. When analysis is done,
the template editing screen is displayed.

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Heart rate calculation

• Heart rate of a single beat is calculated by the formula: HR = (60*1000 / RR + 0.5), in which
RR means the RR interval (in ms) of the beat.

Maximum and minimum heart rate

The maximum and minimum HR events are calculated every five minutes. The most
appropriate events are selected by the software by default. You are also allowed to select from
them. The events you selected will present the maximum and minimum HR and be displayed
in the report.

Average heart rate calculation

• Select the RR interval that meets the conditions: the type of the previous heartbeat and the
next heartbeat are the same, this value is non-artifact and does not exceed 2500ms;

• Taking the average RR interval to calculate the average heart rate needs to meet two
conditions: one is to select the number of RR intervals that meet the conditions to be greater
than or equal to 10. Second, the value should be greater than or equal to 1/4 of the total number
of heartbeats.

• If the above conditions are not met, then relax the conditions (i).

• If there is no RR interval that meets the conditions, the average heart rate is 0.

R-R interval(PAUSE)calculation

R-R interval is the duration of two adjacent R waves. The criteria for judging a long R-R
interval can be configured in the settings.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual ECG Data Editing

Chapter 6 ECG Data Editing

6.1 Editing Patient Information


Click on the Pat. Info tab. The patient information page is displayed. On this page you can do the
following:
♦ Input patient’s basic information. Click Save.
♦ Click Diary. Input information about the patient's daily activities.

6.2 Editing Template

6.2.1 Template Analysis


Template analysis includes template review/edit and beat review/edit/modify. Click on the
Template tab. Template analysis screen is displayed as below.

1 2

3 4

Region 1: Analysis Toolbar

The analysis tools are Poincare plot, RR histogram, focus (superimposed graph), and RR bird
view.

Button Description

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Click this button to display the Poincare plot of all


beats.
Click this button to display RR histogram of all beats.
Click this button to display superimposed graph of
beats of a type of templates.
♦ If N is chosen, what is shown is the superimposed
graph of N templates. But if there are templates are
classified as non-N templates under the category of
N type templates, the superimposed graph will not
count in such templates.
♦ If P is chosen, the superimposed graph will count
in the templates which are the same type with the
first template shown on the top.

♦ If O is chosen, will turn grey which


indicates not functioning.
Click this button to display RR bird view.

Region 2: Common Toolbar

Option/Button Description
Select all the beats of a group of marked templates.
[A] Select All This can also be done by pressing Ctrl+A on your
keyboard.
From a group of marked templates, select all the beats
[R] Reverse Select other than that selected before. This can also be done
by pressing Ctrl+R on your keyboard.
Select all the beats on the present page. This can also
[P] Select Page
be done by pressing Ctrl+P on your keyboard.
From the present page, select the beat(s) other than that
[Q] Reverse Page Select selected before. This can also be done by pressing
Ctrl+Q on your keyboard.
Single-Beat Display Display every single beat individually in Region 4.
Multi-Beat Display Display strips of beat in Region 4.
Click the arrow beside the gain to change its setting.
Change gain setting When changed, the ECG waves will show this change
in Region 4 Beat View.
Click on the arrow button to select a lead from the
Lead selection
drop-down menu. The main lead is shown by default.
Click this button to not to display the ECG view
window. Click once more to display. When the window
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is open, ECG is displayed right below Region 4. When


it is closed, ECG is not displayed and beats shown in
Region 4 will extend to this area, so more beats are
shown.
Use this brush to mark beats with type. To mark beat
types, click this button to display a menu, which lists
types of beats as in Table 6-1. Select a type and a brush
accompanied with the type mark is displayed. Use this
brush to mark beats in region 4. Select None from the
menu to stop brushing.
With this option you can set the analysis parameters of
atrial beats, especially premature beats.
Cancel the last modification to beats.
Configure the escape analysis setting. After
ESC Anls
configuration, click OK to start analysis.

Region 3: Template View

1. Templates are classified as N (normal), V (ventricular), S (atrial), P (pacing), X (artifact),


D (deleted), and O (others) types.
2. Click one of the above types. All the templates of this type can be viewed in the area
right beside it.
3. In this area, press ↑ and ↓ to scroll up and down. Press → and ← to scroll through beats.
4. Press Ctrl and click your left mouse button to select multiple templates. After selection,
click your right mouse button, a menu will pop up.
5. In this menu, the options are beat types, Poincare plot, focus, HIST., and Poincare plot +
focus.
♦ See Table 6-1 for specific types of beat.
♦ Select a type of beat to mark the templates.
♦ Select Poincare Plot to enter the Poincare plot (excluding 24-h and hourly plot) of
templates.
♦ Select Focus to enter the superimposed graph of templates.
♦ Select HIST. to enter the histogram of templates.
♦ Select Poincare Plot + Focus to enter the Poincare plot and superimposed graph of
templates.
6. Keep Alt and your left mouse button pressed to move templates out from the right

window to a new type on the left. When moving, the cursor is shaped like .

7. Keep your left mouse button pressed to drag templates with the same type mark so that

they are put together. When dragging, the cursor is shaped like . Differently marked
templates cannot be put together.

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8. Use letter keys and number keys on the keyboard to modify beat type of a template.

Region 4: Beat View

In the beat view, all beats in the selected templates are displayed.
The first beat is by default focused. If beats covers more than one page, do the following to
view them:

♦ Click on the arrow buttons on the scroll bar to switch from one page to another.
♦ Click scroll bar or the blank space to switch from one page to another.
♦ Press Page Up or Page Down on your keyboard to switch from one page to another.
♦ Scroll your mouse wheel to switch from one page to another.

To select a beat(s):

♦ Press the arrow keys on your keyboard to switch from one beat to another.
♦ Keep your left mouse button pressed to drag a beat(s).
♦ Press Ctrl and your left mouse button to select or not to select beats.
♦ Press Shift and your left mouse button to select two beats and the beats between them.

To modify type of a beat:


♦ Press Alt and your left mouse button to drag one beat to the target template type. When

dragging, the cursor is shaped like .


♦ You can also use letter keys and number keys on the keyboard to modify beat type

Select a beat and click you right mouse button, a menu will pop up. The options available are
beat types, match QRS by type, match QRS by premature, classify QRS by delay, classify
ECG waves in low amplitude as artifacts, select all, reverse select, page select, reverse page
select and so on.

♦ For specific beat types, see Table 6-1.


♦ The sub-menu of Match QRS by Type includes the above beat types.
♦ The sub-menu of Match QRS by Premature includes ventricular (V) and atrial (S).
♦ The sub-menu of Classify QRS by delay includes atrial escape (W), ventricular escape
(E), and junctional escape (G).
♦ Classify ECG waves in low amplitude as artifacts: Beats that are less than or equal to the
amplitude of the selected beat will be classified as artifacts. They will form a new X
group and finally move to template X in the Template View.

To display the full disclosure of ECG, double click on any beat or press Enter.

Table 6-1 Beat Types

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Type Description
N Mark the current QRS wave as normal beat.
V Mark the current QRS wave as ventricular ectopic beat.
S Mark the current QRS wave as atrial ectopic beat.
J Mark the current QRS wave as junctional premature
beat.
A Mark the selected QRS wave as aberrant conduction
beat.
Af Mark the current QRS wave as atrial fibrillation.
AF Mark the current QRS wave as atrial flutter.
R Mark the current QRS wave as R on T.
aP Mark the selected QRS wave as atrial paced beat.

vP Mark the selected QRS wave as ventricular paced beat.

avP Mark the selected QRS wave as atrial-ventricular paced


beat.
aE Mark the selected QRS wave as atrial escape beat.

vE Mark the current QRS wave as ventricular escape beat.

nE Mark the selected QRS wave as nodal escape beat.

Mark the selected QRS wave as left bundle-branch


LB.
block.
Mark the selected QRS wave as right bundle-branch
RB.
block.
fP Mark the selected QRS wave as pacing fusion beat.

F Mark the selected QRS wave as ventricular fusion beat.

I Mark the selected QRS wave as interpolated premature


beat.
X Mark the selected QRS wave as artifact beat.
D Delete the selected QRS wave.

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6.2.2 Editing Superimposed Graph

By superimposing heartbeats, you can check the analysis accuracy and sort again the beats by

type. This will reduce detection mistakes and failures. To edit this graph, click in the
template analysis toolbar. See the following editing screen.

1 2

Region 1: Superimposed Graph View

In this region, you can see superimposed heartbeats and separate beats into four areas coded 1,
2, 3, and 4.

♦ Scroll your mouse wheel to zoom in/out the whole superimposed graph. Keep your
mouse wheel pressed to drag the graph.
♦ Click on the arrow button. A drop-down list is displayed. You can switch from one
template type to another or one lead to another.
♦ Keep your left mouse button pressed to mark beats you want to separate with a white
rectangle. Press a number key (1, 2, 3, and 4) to separate the beats to the corresponding
coded area below. In the same way, you mark beats and press number key 0 to move
beats back up.
♦ To relocate the QRS: mark beats in the way mentioned above. Click your right mouse
button. Select Relocate R waves. The central lines of R waves will be aligned.

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♦ To toggle between single-beat superimposition and multiple beats superimposition, click

.
♦ In the case of multiple beats superimposition, you can align the superimposition with the

beat in the far left or right by clicking or .

Region 2: Strip View

Strips of heartbeats from a coded area of superimposed graph view are displayed in this region.
To display single lead or three leads in each strip, select System Settings > View > Leads
displayed in templates.

♦ To cancel the last modification to beats, click .

♦ To select the superimposed beats in a white square, click . To select the superimposed
beats in curves, click .
♦ To change the gain of strips, click the drop-down arrow beside the gain. Select the gain
you want.

6.2.3 Editing Histogram

Use an RR histogram to edit heartbeats within a specified RR interval. The RR histogram is


useful in the following cases.

♦ Based on the feature that the RR interval of a supraventricular beat is short, use the
histogram to search for unidentified atrial premature beats in N-type templates or search
for normal beats in S-type templates.
♦ Based on the feature that the RR interval of an artifact beat is short, use the histogram to
rule out artifact beats.

Click in the template analysis toolbar to enter the histogram editing screen. This screen
contains the following operations:

♦ Hold down the left-mouse button to select RR intervals within a certain range on the
histogram. The beat strips just within the range will be displayed. To edit the beats, select
a strip and then click your right mouse button. Select the option you want from the
pop-up menu.
♦ Right click on a histogram column. Modify beat types by selecting the desired type from
the pop-up menu. From this menu, you can also select where to insert the beat (before or
after), what type of beat to insert, and insert in batch. If you want to insert beats in batch,
from the sub-menu you can select the ways of inserting: by rescanning with a lead or by
R-R guess.
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6.2.4 Editing RR Bird View

RR bird view is a supplement to RR histogram which cannot be edited in time sequence. With
a RR bird view you can quickly select over a period of 24 hours or longer the beats that are

within abnormal RR intervals, such as atrial, ventricular, and long RR. Click in the
template analysis toolbar to enter the RR bird view editing screen below.

On the top is the RR bird view where the X-axis indicates time and Y-axis indicates RR
interval. RR intervals are sorted by colors. Green indicates normal, red indicates VE, and
purple indicates SVE. This histogram contains the following operations:

♦ Keep your left mouse button pressed to select QRS at any RR interval and any time with
a blue rectangle. Then it will be displayed in the strip window. In this window, you can
modify QRS type, use type brush and four selection options etc. After modification, click
Update at the bottom of screen to update QRS.
♦ To display a specified type of RR intervals, right click the RR bird view and a menu will
pop up. Select a type from the sub-menu of View mode. Then only this type of RR
intervals is displayed in the histogram.
♦ To vertically zoom in/out on the histogram, hold down the Ctrl key and scroll the mouse
wheel. Or right click the histogram, select Zoom in or Zoom out from the pop-up menu.

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♦ After zooming in, if you want to vertically drag the histogram, hold down the mouse
wheel to move the histogram up or down.
♦ Template synchronization. When QRS is modified to a type that is new to the previous
classification, it will be placed separately in the template view.

6.2.5 Editing Poincare Plot

Poincare plot is R-R interval scatter plot, also called as Lorenz Plot. It is used to reflect
adjacent R-R interval changes.

Poincare plot is created by plotting successive pairs of sinus R-R intervals as coupling point.
Plot the RRn interval (ms) as X value in the horizontal coordinate and the RRn+1 interval as Y
value in the vertical coordinate. Then plot RRn+1 interval (ms) as X value and the RRn+2
interval (ms) as Y value. Repeat the operation to create a plot over a time period.

Click in the template analysis toolbar to enter the Poincare plot editing screen below.

1
2

Region 1: Poincare Plot View

♦ Click All to select the beat types to be displayed in the plot.


♦ Click the drop-down arrow beside All to display the Poincare plot over hours.

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♦ Click to close or open ECG view window and click again to cancel.

♦ Click to determine how to select the plots. The default way of selection is random
curve. You can click this button again to switch your option between random curve and
rectangle.

♦ Click to display the equal heart rate line. Click this button again to hide the line.

♦ Click to display the heart rate differential line. Click this button again to hide the
line.

♦ Click to display the focus graph (superimposed graph). Click this button again to
hide the graph

♦ Click to cancel your last operation on beats. Such operations include modifying beats
(by clicking your right mouse button), modifying beats (by pressing keys on your
keyboard), matching QRS by type or by premature. This button is valid for operation on
superimposed graph, Poincare plot, sequential Poincare plot, ECG strip, and ECG view
window.
♦ If no area is selected by random curve or rectangle, or the selected area has no beats,
when you click your right mouse button, you have two options: Lorenz plot, and
Difference scatter plot. You can only select one of them to display.
♦ When you have selected beats in this plot, you can modify the selected beats to the
desired type from the pop-up menu by clicking your right mouse button...
♦ Scroll your mouse wheel to zoom in/out the Poincare plot.
♦ After zooming in, hold down the mouse wheel to drag the plot.
♦ Place the cursor anywhere on the plot, values in horizontal coordinate and vertical
coordinate at that point is displayed right below the cursor.

Region 2: Strip View

Strips of selected beats from the Poincare plot are displayed.

Region 3: Sequential Poincare Plot View

♦ Both 24-hour and 1-hour sequential Poincare Plots are displayed.


♦ A green rectangle displayed on the 24-hour plot is 1-hour long. It is commensurate with
the 1-hour sequential Poincare Plot.

6.2.6 Editing Poincare Plot and Superimposed Graph

This is a combination of Poincare plot and superimposed graph. By such a combination


heartbeat analysis becomes easier and faster.

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Select templates from the template view window. Right click the templates. A menu will pop
up. Select Poincare Plot + Focus to enter the editing screen shown below.

Region 1: Superimposed Graph View

♦ Superimposed waveforms of one-hour scattering points are displayed by default. If


specific scattering points are selected from the Poincare plot view, then superimposed
waveforms of such points are displayed.
♦ There are two areas for waveform separation.

♦ Click the arrow . You can modify beat type from the drop-down list.

Region 2: Poincare Plot View

♦ RR intervals of heartbeats from selected templates are displayed.


♦ Select a scattering point(s). Right click the mouse. Modify beat type with the pop-up
menu.

Region 3: Strip View

Strips of superimposed waveforms are displayed.

6.2.7 Keyboard Operation and Other Useful Operations

The following operations and information are helpful for template editing.
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Keyboard Operation

The following table lists the hot keys for modifying beats. This is applicable to template
analysis screen, histogram editing screen, Poincare plot editing screen, RR bird view editing
screen, Poincare plot + focus editing screen, and ECG view window.

NOTE: Hot keys of the numeric pad may not be available on your laptop.

Hot Key Function

N or 1 Mark the current QRS wave as normal beat (N).

V or 2 Mark the current QRS wave as ventricular beat (V).

S or 3 Mark the current QRS wave as atrial beat (S).

X or 0 Mark the selected QRS wave as artifact beat (X).

A or 7 Mark the selected QRS wave as aberrant conduction beat (A).

H or 6 Mark the selected QRS wave as atrial-ventricular paced beat (avP).

P or 5 Mark the selected QRS wave as ventricular paced beat (vP).

O or 4 Mark the selected QRS wave as atrial paced beat (aP).

W Mark the selected QRS wave as atrial escape beat (aE).

G Mark the selected QRS wave as nodal escape beat (nE).

E Mark the current QRS wave as ventricular escape beat (vE).

L Mark the current QRS wave as left bundle branch block (LB.)

B Mark the current QRS wave as right bundle branch block (RB.)

R Mark the current QRS wave as R on T (R)

K Mark the current QRS wave as atrial fibrillation (Af)

M Mark the current QRS wave as atrial flutter (AF)

Q Mark the current QRS wave as fused pacing (fP)

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J Mark the current QRS wave as junctional premature (J)

F Mark the current QRS wave as ventricular fusion (F)

I Mark the current QRS wave as interpolated premature (I)

Delete or D Delete the selected QRS wave.

QRS Type and Color Indication

Color Mark QRS Type


N Normal Sinus QRS
V Premature ventricular contraction
S Premature atrial contraction
J Junctional premature beat
X Artifact
LB./RB. Left/right bundle branch block
A Intra-ventricular aberrant conduction beat
aP Atrial pacing
vP Ventricular pacing
avP AV dual pacing
fP Fused pacing
aE Atrial escape beat
nE Nodoventricular escape beat
vE Ventricular escape beat
R R on T
Af Atrial fibrillation
AF Atrial flutter
F Ventricular fusion
I Interpolated premature beat
Del Deleted beat

The difference between deleting a beat and defining a beat as an artifact is:

You delete a beat when the beat is misclassified. After deletion, beats are automatically
connected, thereby forming new RR interval which will be included in arrhythmia analysis.

You define a beat as an artifact when the beat is poor in quality and its QRS cannot be
identified. The artifact will be excluded from arrhythmia analysis.

6.2.7.1. Quick Browse of All QRS in Template


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Beats with the same QRS morphology make up a group of templates marked with the same
beat type. You can use the scroll bar to quickly browse all QRS from the templates. Operation
steps are as follows:

1. Select a template.
2. Click or drag the scroll bar at the bottom of the template pane.
3. QRS wave will be displayed in sequence in the template pane.
4. ECG view window will simultaneously respond and display ECG of this beat.
5. Click or drag scroll bar in the ECG view window to scroll ECG backward and forward.

6.2.7.2. Changing the Type of Template

If a template is changed to another type, then all beats bound to this template will be changed
to that type too. This is used to quickly correct type of massive QRS. Operation steps are as
follows:

1. Select one or more template(s) to be changed.


2. Right click on the template. A menu will pop up.
3. Select the target type from the menu. Type of QRS is changed.

6.2.7.3. Merging Templates

Beat(s) in several templates of the same type can be merged into one template. This is used to
reduce the number of templates and ease the editing of patient data. Operation steps are as
follows:

1. Select the template to be merged, press and keep your left mouse button pressed.
2. Move mouse (drag the template) onto the target template (must be of the same type).
Release your left mouse button.
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3. Wait until merging is finished.

6.3 General ECG View Window

There is a general ECG view window in most tabs. The window is shown as below:

ECG Display and Edit

Thumbnail Scrollbar Function Buttons

The ECG view window consists of the ECG display/edit area, thumbnail, and function buttons.

Thumbnail

♦ To switch from one lead to another, right click on any point of thumbnail and select the
target lead from the shortcut menu.
♦ The QRS thumbnails with a rectangle marker are shown in the ECG display area.
♦ Left click any point in the thumbnail, then its corresponding ECG will be marked with a
rectangle and shown in the display area.

Function Buttons

Button Function
Instantly print current ECG in the window, with the cursor-placed point as the
start.
You can select Preview before printing to preview the ECG to be printed.
Save the selected strip. Click this button, a picture frame will be displayed.
Move this frame to select a strip. Then select the label of strip and set the
property of it. Click OK. The strip is saved. It can be found in the Strips tab.
Strips shown in this tab will be included in the report.
Turn on/off the measurement

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Turn on/off the calipers.


When turned on, boundary lines of the RR intervals will be displayed in the
ECG display area. The RR interval and HR value of the selected beat will also
be displayed on the right side of calipers. Move the cursor to the parallel jaws
of calipers, an arrow will be displayed. Drag this arrow to change the width of
calipers.

Move the ECG waveforms of the selected lead longitudinally.


SVE automatic edit.
After marking a beat with S, click on this button to judge if the subsequent
beats have equal RR intervals. If yes, they will be automatically marked with S
too. And an atrial tachycardia event is created.

Gain.
This is to vertically scale up or down the ECG amplitude. The options are 5
mm/mV, 10 mm/mV, 20 mm/mV, 40 mm/mV, 80 mm/mV, and 160 mm/mV.
The default value is 10 mm/mV.
Speed.
This is to horizontally scale up or down the ECG. The options are 6.25mm/s,
12.5 mm/s, 25 mm/s, 50 mm/s, 100 mm/s, 200 mm/s, and 400 mm/s. The
default value is 25 mm/s.
Lead.
Press this button to enter the Lead Select window. Select the lead(s) you want
to display and the lead(s) to invert.
Click the check box before Lock to synchronize ECG view with full disclosure
view. The same leads will be displayed in both.
Click the check box before Tile in the window to display the leads you have
selected in the ECG view window.
Zoom in on ECG waveform. Click this button, and select any lead in the view.
You can get a closer look at the lead at most 10 times of the original size. To
exit, click this button again.

The following sections will describe regular operations in the ECG view window.

6.3.1 Inserting Beats

It is able to insert beat marked with designated type at any position of ECG. Operation steps
are as follows:

1. Click on the position where a new beat is to be inserted, and then a cursor line will be
displayed in the ECG view window.
2. Click your right mouse button, and then the beat type menu will pop up.
3. Select a type from the menu, and then a new beat of this type will be inserted.

NOTE:
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1. The position to insert QRS has to be at least 200ms away from the nearest QRS.
2. After completion of inserting beats, the system will automatically recalculate rhythm
events.

6.3.2 Deleting Beats

You can delete any marked beat. Operation steps are as follows:

1. Click on a marked beat to be deleted, and then a rectangle marker will appear in the ECG
display area.
2. Click your right mouse button, and select Delete the mark of QRS complex. Or you
can press D on the keyboard to delete the beat.

NOTE: After beats are deleted, the system will automatically recalculate rhythm events.

6.3.3 Modifying Beats

You can modify any marked beat on ECG. Operation steps are as follows:

1. Click on a marked beat to be modified, and then a rectangle marker will appear around
the beat.
2. Click your right mouse button, and a menu will pop up.
3. Select the target type from the pop-up menu. Then the type of the selected beat will be
modified.

Or you can use hot keys on the keyboard to modify beats. For information about the hot keys,
please refer to section 6.2.7 Keyboard Operation and Other Useful Operations.

NOTE: After beats are modified, the system will automatically recalculate rhythm events.

6.3.4 Modifying Successive Beats

If the successive beats to be modified are in the scope of current ECG window:

1. Place the cursor ahead of the first beat, then press and hold down left-mouse button. A
blue rectangle will appear. Drag the mouse until the rectangle covers all beats to be
modified, then release left-mouse button, a menu will pop up.
2. From the menu select Classify all QRS as. Select a beat type from the sub-menu. All
beats will be modified.

If the successive beats to be modified are outside the scope of the ECG window:

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1. Move the cursor to the first beat. Click your right mouse button and select Select the
start.
2. Move the cursor to the last beat. Click your right mouse button and select Select the
end.
3. In the pop-up menu, select Classify all QRS as from this menu. And in the sub-menu,
select the beat type you want. All beats are modified.

NOTE: After beats are modified, the system will automatically recalculate rhythm events.

6.3.5 Inserting Beats in Batch

In the ECG view window:

Keep your left mouse button pressed to select a range, release your mouse button and a menu
will be displayed. Select Insert batch and in the submenu you can choose to insert beats by
rescanning with a lead or by R-R guess.

In the Events tab:

1. Click Long R-R from the available patterns. Select one or more ECG episodes
displayed.
2. Right click on the mouse, and select Insert batch. In the submenu, you can choose to
insert beats by rescanning with a lead or by R-R guess.

6.3.6 Measuring ECG

You can measure R-R interval and amplitude of ECG at any time in the ECG view window.
Operation steps are as follows:

1. Click the button.

2. Click your left mouse button, and the current position will be marked as the starting
point of measurement.
3. Drag the mouse to the end point of measurement. Along with the movement of the
mouse, there will be a small prompting window in the status bar to display the interval
(ms) and the amplitude differential (mV) between the current mouse position and the
starting point.
4. Release your left mouse button. The time interval (ms) and the amplitude differential
(mv) between the starting and end points are displayed in the small prompting window.
5. Move your mouse to drag the whole window.
6. Click your left mouse button to exit the measurement window.

7. Click the button again to exit measurement.


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6.3.7 Quick Browse of ECG

You can use ECG view window to quickly display ECG.

Scroll your mouse wheel to scroll the ECG.

There is also a scroll bar at the bottom of ECG view window and its length is equivalent to the
duration of ECG. The ECG will scroll along with clicking or dragging of scroll bar.

In the case of 12-lead ECG, you can use the scroll bar on the right side of this window to
display the lead you want. Alternatively, you can click the button to disaplay or cancel the
display of the ECG lead.

6.3.8 Saving ECG Strip

You save an episode of ECG wave as an ECG strip so that it will be part of the report.
Operation steps are as follows:

1. Save an ECG strip in one of the following ways:


 Click and move your left mouse button mouse to select the ECG waves you want.
Select Save ECG strip from the pop-up menu.
 Click your right mouse button on the ECG waves... Select Mark Range from the
pop-up menu. Choose the start and end of the ECG. Select Save ECG strip from
the pop-up menu.
 Click your right mouse button on the ECG waves. Select Save ECG strip from the
pop-up menu.

 Click the function button to save an ECG strip.

2. To set the type of the strip, the options are:

♦ 3 strips per page: 3-lead ECG strip in optional length. The default length is7s.
♦ Single lead per page: single-lead ECG strip of 63s.
♦ Full leads per page: Full leads ECG in optional length.

3. Select the leads you want to display.


4. Set the length of strip.
5. Set the gain and speed.
6. Choose whether to enable Beats type, R-R (ms), and R-R (bpm). They are enabled by
default.
7. Set the label of the strip. You can select a label from the drop-down list or customize it.
A customized label will be automatically added to the drop-down list.
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8. Click OK to save the ECG strip. And this ECG strip can be found and printed out in the
Strips tab.
9. Click Cancel to not to save the strip.

6.3.9 Relocating R Waves

Click the QRS marker or the beat type in the ECG View window. Hold and drag to the end.
Select Relocate R Waves in the pop-up menu. When the R waves are relocated, the RR
intervals and heart rate will be updated.

6.3.10 Printing ECG

In the ECG view window you can print out any episode of ECG. Operation steps are as
follows:

1. Click your left mouse button and keep it pressed to drag along the ECG. Release your
left mouse button. Select Print from the pop-up menu.

Or after marking range (for operations, see section 6.3.4 Modifying Consecutive Beats),
select Print from the pop-up menu.

Or right click on the ECG view window. Select Print from the pop-up menu.

Or click on button on the right side of the window (to print out the episode only
shown in the window).

2. A print setting window will pop up. Select page style, lead, gain, and speed etc.
3. Click Print to print out the episode.

6.3.11 Defining an Arrhythmia Event

In the ECG view window you can define any episode of ECG waves as an arrhythmia event.
Operations are as follows:

♦ Click your left mouse button and keep it pressed to drag along the ECG. Release your left
mouse button. Select Define Event from the pop-up menu. Select an arrhythmia type
from sub-menu to define an arrhythmia event.
♦ You can also mark range (for operations, see section 6.3.4 Modifying Successive Beats).
Select Define Event from the pop-up menu. And then select an arrhythmia type from the
sub-menu to define an arrhythmia event.

NOTE: In addition to defining an arrhythmia event, you can also modify beats or print out
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ECG in an episode.

6.3.12 Display Options

You can decide what to be displayed on the bar at the top of ECG view window. Right click on
the bar, the options are as follows:

Click the checkbox before an option to display it on the bar. Click once more to hide on the bar.

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6.4 STe

In this tab you can:

♦ Review the ST events automatically identified by the system.


♦ Remove the ST events misidentified due to interference or artifacts.
♦ View the ST trend.
♦ Define new ST events.

The above STe tab contains the following options:

♦ Switch leads to view the ST trends of all leads.


♦ Switch the trend types to be displayed. Trend types available are ST, T wave peak, and J.
♦ Accept, delete, edit, and add ST event.
♦ Full disclosure view of ECG.
♦ Automatically scan to display the synchronicity between trend charts and ECG.
♦ Select duration of the trend charts shown in horizontal coordinate. There are 6 hours, 12
hours, and 24 hours duration.

All leads will be subject to ST analysis.


Threshold can be reset to measure ST segment changes.
In the report, ST depression and elevation with their occurring time are described one by one.
Both HR and ST segment change of every single heart beat are displayed.

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6.4.1 ST Event List

In the ST event list, you can see the starting time, duration, ST elevation or depression.

Function buttons and their descriptions are as follows:

Button Function
View To display ST events, you can select to either show all or hide deleted events.
If Hide Deleted is selected, the deleted event will not be displayed in the event
list.
Accept Set a deleted ST event as normal.
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Delete Delete the selected ST event.


Edit Edit the selected ST event.
If multiple ST events are selected, the last selected event will be edited.
Add Add a new ST event manually.
Reanalyze Reanalyze the ECG record.
All CH. Select one lead or all leads (channels) to be analyzed. The default setting is All
CH..
<< Return to the original size of event list.

You can press Ctrl/Shift + left mouse button to select multiple ST events.

Right click on any event, the options available are: delete, delete all, modify, add, accept,
accept all, save strip, unsave, select all, and unselect all.

6.4.2 HR Trend

In the HR trend chart, you can do the following operations:

♦ Click your right mouse button to display grids.


♦ Double click your left mouse button to display ECG of all leads, and then double click
again or press Esc to return to HR trend screen.
♦ Press the left or right arrow keys on your keyboard to move the mark line by minute.

6.4.3 ST Trend

In the ST trend charts, you can do the following operations:

♦ Switch leads: right click on the chart, select the lead you want to see from the pop-up
menu.
♦ Delete event: Keep you left mouse button pressed and drag along the chart. Right click
on the chart, select Delete Event from the pop-up menu.
♦ Add event: Keep you left mouse button pressed and drag along the chart. Right click on
the chart, select Add event from the pop-up menu. The Add ST Event window is
displayed. Enter ST elevation/depression in mV. Select slope (from J point to ST point)
as horizontal (0), downsloping (-), or upsloping (+). An event will be added.
♦ Delete an area: Keep you left mouse button pressed and drag along the chart to select an
area. Right click on the chart, select Reject selected area from the pop-up menu. ST
elevation/depression of this deleted area will be 0 mV as shown in the report.
♦ Restore the deleted area: Keep you left mouse button pressed and drag along the deleted
area. Right click on the chart, select Accept drag area from the pop-up menu.
♦ Event mark: ST events are marked with orange blocks in the horizontal coordinate.
Double click on the mark to edit the ST event.
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6.4.4 ST Reanalysis

If the ST measurement points are incorrect, you have to reanalyze. Click Reanalyze in the
center of STe tab and the ST Reanalyze screen will be displayed as below.

Region 1: Measurement Point Adjustment

To adjust the ST measurement points:

1. Right click on the region and select a lead from the pop-up menu.
2. Move the cursor to the beat display area. Press Tab and use the arrow keys on your
keyboard to change the position of ISO. Press Tab again. Use the arrow keys on your
keyboard to change the position of J point. And in the same way to change the position
of ST point.
3. Scroll your mouse wheel or drag the scroll bar to switch from one beat to another. ST
differential of the present beat is shown on the left side.
4. Reset the following threshold values to reanalyze.

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ISO: baseline indicator which is between P and R. Suggest to position it in the middle of P-R
interval.

JP: J point indicator which is behind R wave.

J+80 (60): ST point indicator which is varied depending on heart rate.

♦ J+80 msec, if heart rate < 100 bpm


♦ J+72 msec, if 100 bpm ≤ heart rate < 110 bpm
♦ J+64 msec, if 110 bpm ≤ heart rate < 120 bpm
♦ J+60 msec, if heart rate ≥ 120 bpm

T wave offset: the end of T wave, used to calculate the magnitude of T wave.

Region 2: ST Trend

After the measurement points are adjusted, ST trend will be updated automatically.

6.5 Events

After editing the templates and updating events, you need to confirm the identified events and
select the strips to be printed.

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1 2

Region 1 Event List

Number in "( )" is the number of events.

Number in "[ ]" is the parameter value of the event. Take Max. HR for example. The number in [ ]
indicates the highest heart rate in the unit of bpm.

You can do the following operations:

♦ Click on an event type from the list. The related strips will be displayed in region 2. The
“$” sign indicates that the event has been viewed.
♦ Parameter setting. Events will be automatically updated after parameters are modified.

Region 2 Strip View

Strips of an event type are displayed.

An event can be accepted or deleted. A deleted event will not be counted in the event list. Its
strips can be saved or not.

To select a strip, you have the following options:

Button/Key Function
PgUp or PgDn buttons Turn pages up or down.

Page Up or Page Down keys on Turn pages up or down.


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the keyboard

Mouse wheel (scrolling


up/down)
or keys on the keyboard
Select a single strip horizontally.
or keys on the keyboard
Select a single strip vertically.

Left mouse button Select a single strip.

Ctrl + left mouse button Select multiple strips.

Ctrl+A or Select All Select all the strips of the event type.

Ctrl+P or Select Page Select all the strips displayed on the current page.

Click your right mouse button, the options are:

Option Description

Delete Delete the current strip.

Delete All Delete all strips of the event type.

Accept Accept an event strip that have been rejected.

Accept All Accept all the strips that have been rejected.

Save Strip Save the selected strip to the Strips screen

Unsave Delete the selected strip from the Strips screen

Sort Set the sort conditions for the events.

Leads Select the leads to be displayed.


Insert beats in batch by rescanning with a channel or by RR
Insert batch
guess.
Modify beat Change the strip to a new type.

To operate with special events:

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There is only one Max. HR event and one Min. HR event. Each of them has 200 strips but only
one is selected. The first strip is selected by default, but you can select another strip to be
calculated.

NOTE: Calculation will be automatically synchronized with modification on events.

6.6 Strips

In the Strips tab you can confirm again the strips to be printed.

The strips in this tab are created in the following ways:

♦ Automatically created at the end of automatic analysis based on the parameter setting.
♦ Manually selected and saved with the Save ECG strip option in the general ECG view
window.
♦ Manually selected and saved with the Save Strip option in the Events tab.

1 2

Region 1: Strip List

♦ The type and the number of strips are displayed.


♦ Click on a strip type and its distribution histogram will be displayed in Region 2.

Region 2: Strip Distribution Histogram

♦ Display strips in time sequence.

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♦ To select multiple histograms, press Ctrl + left mouse button, or keep your left mouse
button pressed to drag along the histograms.
♦ Click on a histogram, the corresponding strips will be displayed in Region 3.

Region 3: Strip View

♦ This strip view consists of a group of small strip windows, which can be selected
multiply by dragging the mouse or pressing Ctrl + left mouse button.
♦ To move strips, hold down your left mouse button on the strip and move it to the desired
position in this region.
♦ Double click on a small strip window to display ECG full disclosure view.
♦ Right click on a strip, a menu will be displayed. Select operations from the pop-up menu.
With the Property option you can set the name and other parameters of the strip.

Region 4: Toolbar

Button Description
Click this button to display the ECG view below the strip
view.
Property Click this button to enter the strip property configuration
window.
Del All, Del Page, Del Slct Delete all strips, one page of strips, or selected strips.
Print All Print all the strips.
Print Page Print all the strips displayed on the current page.
Print Slct Print the selected strips.
PgUp, PgDn Turn pages.

6.7 Page Scan

2
1

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Region 1: Thumbnail

♦ Set time to start scanning: enter starting time to the input box or click on the start point
on the thumbnail.
♦ CHAN: select the lead to scan.
♦ Gain: click + or – to set the gain of thumbnail.

♦ Scan and pause: click on button to scan the thumbnail. Click on button to
stop scanning or when the predefined conditions are met it stop scanning automatically.

Click on button to scan from the beginning of thumbnail.

♦ Scanning speed: use bar to control the scanning speed.

♦ Display: click on button to select the displaying rate of beats per page. It
is to display 4 min per page by default.
♦ Print: print out 15-min thumbnail on present channel.

Region 2: Pause Scan Condition

♦ Set the conditions of pause: heart rate, ventricular, and supraventricular are available for
setting.
♦ When the above conditions are met, the system will stop scanning automatically.
♦ The reason of stop will be displayed at the top right corner. The event will be marked
with a small rectangle in the thumbnail and displayed in the middle of ECG view
window.

Region 3: HR Trend View

The HR trend is displayed by default to help you find out where the atrial fibrillation occurs.

Region 4: Superimposed Graph View

♦ On the left is two superimposed normal waveforms over 5 minutes.


♦ On the right is two superimposed ventricular waveforms over 5 minutes. If there are not
ventricular waveforms, it is blank on the right.

6.8 Trend

In the Trend tab, trends of heart rate, ST, ventricular beat (number calculation per hour), atrial
beat (number calculation per hour), and SDNN are displayed. In the ST trend view, right click
your mouse button to switch from one lead to another.

6.9 Tabular
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The Tabular tab displays parameters and the number of events per hour.

6.10 HRV

Cardiac rhythm varies according to time and body condition. The physiological phenomenon of
variation in the time interval between heartbeats is called heart rate variability (HRV). To detect
HRV, time-domain and frequency-domain methods are commonly used.

Time-domain methods

Use time as independent variable to measure the change in N-N interval. There are long-period
and short-period analysis. In the case of long period, we recommend 24 hours. And for short
period, it should be at least 5 min. The following variables are used.

♦ SDNN, standard deviation of N-N intervals calculated over a period, in the unit of ms.
The calculation formula is:

♦ SDANN, the standard deviation of the average N-N intervals calculated over 5 min, in
the unit of ms. The calculation formula is:

♦ RMSSD, the square root of the mean of the squares of the successive differences between
adjacent N-Ns, in the unit of ms. The calculation formula is:

♦ SDNN index, the mean of standard deviation of N-N intervals calculated over every 5
min, in the unit of ms. The calculation formula is:

♦ NN50, the number of pairs of successive NNs that differ by more than 50 ms.
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♦ TINN triangular index, the number of maximum N-N interval divided by the total
number of N-N intervals.

Frequency-domain methods

A complicated curve can be divided into sine curves of different frequency, of different
amplitude, and of different phases. These curves are converted to spectrums for analysis.

Power spectral density (PSD) as an analysis method provides basic information on the power
distribution across frequencies in N-N intervals. The algorithm used is FFT (fast Fourier
transform).

Bands of frequency used in 24-hour recording are:

Total power (TP): variation in all R-R intervals, ≤ 0.4 Hz

Ultra low frequency (ULF): ≤ 0.003 Hz

Very low frequency (VLF): 0.003 Hz to 0.04 Hz

Low frequency (LF): 0.04 Hz to 0.15 Hz

High frequency (HF): 0.15 Hz to 0.4 Hz

Bands of frequency used in 5-min recording are:

Very low frequency (VLF): ≤ 0.04 Hz

Low frequency (LF): 0.04 Hz to 0.15 Hz

High frequency (HF): 0.15 Hz to 0.4 Hz

(The above parameters are expressed in the unit of ms2.)

LF normalization (Lfnorm): LFx100/TP

HF normalization (Hfnorm): HFx100/TP

The power spectrum of HRV over a short period is very sensitive to ectopic beat, undetected beat,
and artifact beat. So prior to PSD analysis, check carefully the recording data over 5 min to
obtain useful data on N-N interval for 5-min analysis.

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6.10.1 HRV Histogram

2 3 4

Click on button to switch from General Tools to Complex Tools. The first
tab shown is HRV HIST as above.

Region 1: HR trend view

Region 2: RR interval histogram

Left click on the histogram. Click < or > buttons to display the ECG of all selected beats.

Region 3: RR difference histogram

Region 4: Poincare plot

6.10.2 HRV Table

Use the HRV Table tab to view HRV analysis result. The tab is displayed as below.

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Region 1: List of Frequency-Domain Analysis in 5-minute Length

The bands of frequency are as follows:

Very low frequency (VLF): ≤ 0.04 Hz

Low frequency (LF): 0.04 Hz to 0.15 Hz

High frequency (HF): 0.15 Hz to 0.4 Hz

(The above parameters are expressed in the unit of ms2.)

LF normalization (Lfnorm): LFx100/TP

HF normalization (Hfnorm): HFx100/TP

Region 2: List of Time-Domain Analysis in 5-minute Length

Region 3: Trend of Frequency-Domain Analysis in 5-minute Length

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6.10.3 Power Spectrum Graph

2 3

Region 1: Power Spectrum Trend View

Use FFT to calculate 5-minute HRV to obtain its power spectrum. Superimpose all such power
spectrums over 24 hours and use colors to indicate power levels in a graph. With this graph,
you can easily observe power distribution across frequencies.

In the above color card, 0 indicates the lowest power and 60 indicates the highest power.

Click on a specific time in the trend view to display power spectrum at that time in region 2
and RR trend in region 3.

6.11 QT

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2 3

In the QT tab, you can see:

Region 1: QT List

Region 2: QT Histogram

Left click on a beginning position of the histogram. Click on or buttons to display


ECG at QT intervals.

Region 3: QTc Percentage

6.12 Pacing Electrophysiology

Click More Clinic… and select Pacemaker Tools from the drop-down list to enter the analysis
screen of pacing electrophysiology.

6.12.1 Pacing Event Definition

♦ FTO (Fail to output)


Pacemaker does not deliver electrical impulses at the time it ought to no matter what the
problem is. This is expressed on the ECG that all of the P-P, R-P, and R-R intervals are
greater than the predefined value.

♦ FTC (Fail to capture)

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After electrical impulses are delivered, there is no electrocardial reaction. This is


expressed on the ECG that P-R interval is greater than the predefined value.

♦ FTS (Fail to sense)


Pacemaker cannot sense normal P waves or QRS complexes and still delivers electrical
impulses at its regular interval. This is expressed on the ECG that R-P interval is smaller
than the predefined value. A sensing failure is caused by poor sensing or excessive
sensing while FTS is mainly caused by poor sensing. And excessive sensing leads to
FTO. Both excessive sensing and FTO have the same expression on ECG.

6.12.2 Pacing Histogram

Region 1: PM-PM Interval Histogram

Histogram of intervals between two successive adjacent pacing spikes (no beats in between)

Region 2: PM-R Interval Histogram

Histogram of interval between a pacing spike and its nearest beat

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To set the FTO, FTS, FTC, and fusion beat distribution can help evaluate the performance of
pacemaker.

6.12.3 Pacing Trend

In the Pacing Trend tab, you can see:


1 Atrial pacing trend,


2 Ventricular pacing trend, and


3 Atrial-ventricular pacing trend.

6.12.4 Pacing Events

In the Pacing Events tab, you can see the number of pacing events as classified and strips of
each event.

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6.13 Statistic Information

In the Statistic Info. tab, you can see statistics for HR, VE, atrial, junctional, HRV, atrial
fibrillation/flutter, ST segment, and pacing. You can edit such statistics and click Save to save
your modification.

6.14 Report

After data editing, you will need to print a report. Use the Report tab to edit and print the report.
The Report tab contains the following options:

Option Description
Comment Automatically To add a comment, double click a type of comment you
want from the list on the right. Then the comment will be
added.

To delete a comment, keep your left mouse button


pressed to select the comment you want to delete. Press
Backspace or Delete buttons on your keyboard.

First letter associating input is supported.


Comment Style Click Edit to display types of comment. You can modify
the content of comment by direct input. Double click a
field on the right to add statistics to the comment. The
statistics is represented by <$field$>. After modification,
click OK to save your modification.
Comment Manually To edit glossary, click Edit on the right of Glossary. A
txt file will be displayed. Edit the file and save it. Close
the file. Click Update on the right of Glossary. The
glossary will be updated.

To add glossary to comment, double click the glossary


you want. Then the glossary will be displayed in the
manual comment.

After manually editing the comment, click Save.


Full Disclosure Click the check box before Full Disclosure to activate
this function.

Click the check box before the time to select at which


one-hour interval the ECG is shown in the report.

Click the box before the lead to select in which lead the
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ECG is shown in the report.

Choose the print mode between 60s per line and 30s per
line.
Print/Preview To preview a report before printing, click Print/Preview.
The report is displayed. Press Ctrl and scroll your mouse

wheel to zoom in/out. Or click on or buttons


to zoom in/out. Press the arrow keys on your keyboard or
click on the arrow buttons to quickly turn pages.

Click on button to print a report. The system will


print all pages of the report by default. You can also set
the page scope to print.

In addition to black and white, reports allow color


printing by selecting Color.

The comment generated automatically and manually will be both shown in the report.

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Chapter 7 System Settings


You can customize Holter analysis software to your own preference. To open the settings, click
Settings on the main toolbar in the main menu.

7.1 Common Setting

The Options tab contains the following options.

Option Description
Hospital name, address, If you have entered these information, they will be
telephone, and website shown in the printed report.

Set Hospital Logo With this option, you can add the hospital logo to the
report and determine where to be shown (limited to the
top of report).
System Language With this option, you can select the language in which
the system is displayed.

Date Format With this option, you can determine how the date is
displayed. You can choose between yy/mm/dd,
dd/mm/yy, and mm/dd/yy.
Height/Weight unit With this option, you can select the unit in which
patient’s height and weight are expressed. You can
choose between cm and inch for height, and kg and lb.
for weight.
ECG Color Setting With this option, you can change the color of the beats to
display and preview the result.

7.2 Workflow Setting

The Workflow tab contains the following options.

Option Description
General Tools, Complex Tools, The workflow of these four modules cannot be modified.
Pacemaker Tools, and Resting
ECG

Customize 1, 2, 3 and 4 You can customize the workflow of these modules. The
functions available to select are patient information,
template, ST evaluation, events, strips, page scan, trend,
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SE-2003&SE-2012 Series Holter System Analysis Software User Manual System Settings

tabular, HRV histogram, HRV table, spectrum, QT,


pacing histogram, pacing trend, pacing table, pacing
events, average ECG, time ECG, report, and etc.
You can set a customized workflow as default.
You can select a customized workflow to edit ECG data.

7.3 Analysis Setting

The Analysis tab contains the following options.

Option Description
Multi CHAN Analyze With this option, the system uses ancillary channels to
help detect heart beat without omissions.
If this option is not selected, system will only analyze
data from the important channel.

Noise Level You can choose between high, medium, low or none.
With this option, the system will automatically delete the
ECG with bad signal. The heart beats in the deleted ECG
will not be counted. The higher the noise level, the more
ECG will be deleted. None means not to automatically
delete artifact beats.
Note: Noise level setting is valid only when Multi
CHAN analysis is activated.
Child Mode Use pediatric algorithm to analyze ECG data.

Notch Filter You can choose between 50Hz, 60Hz, or off.


If AC interference is strong, it is recommended that you
activate this function and select a value and reanalyze
ECG data.

DFT Filter With this option, you can filter out baseline wander and
guarantee that the ECG is on the baseline.
Note: Please set off DFT filter when evaluating ST
segment changes.
Lowpass Filter Lowpass Filter restricts the bandwidth of input signals.
Not selected by default.

ECG Waveform Smoothing Make the ECG waveforms look smooth. Not selected by
default.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual System Settings

OSA Analysis Obstructive sleep apnea (OSA) screening based on the


ECG recording during sleep.

NOTE:
This analysis takes a long time, so needs your
patience.
Print Setting You can choose between black and white, and color.
With this option, you can select a way appropriate for
your printer to print the report. Improper selection may
affect the printing effect.

7.4 View
Option Description
Comment area is visible Comment of a report is divided into automatically
generated and manually generated. You can determine
whether the manually input comment is visible or not in
the report. If this option is selected, the manually input
comment and the automatic one will be put together in
the printed report.
Separate manual conclusion This option can be selected only when Comment area is
visible is selected.

With this option, the manually input comment will be


displayed in an individual page, following the first page
of the report.
Grid With this option you can enable or disable the displaying
of grid in the ECG View window.

Style of ECG View Window You can choose between Displayed on one line and
Displayed on multiple lines. The default setting is
Displayed on one line.
Leads displayed in templates You can choose between Single Lead and Three leads.
The default setting is Single Lead.

Only one lead is displayed in the Beat View for template


analysis if Single Lead is selected. But three leads are
displayed in the Beat View with multi-beat display if
Three Leads is selected.

7.5 Maintenance

Use the Maintenance tab to set the ECG storage path, passwords, and reconstruct database.
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SE-2003&SE-2012 Series Holter System Analysis Software User Manual System Settings

Option Description
Choose ECG storing path Choose the location to store ECG data.

Reconstruct database Create a database that contains all files of the storage
location.

Set system password Enter the password before you access the settings.

Set login password Enter the password before you start this analysis
software.
Set analysis password Enter the password before you access the analysis screen.

7.6 GDT
Option Description
Enable GDT This option is disabled by default. Once it is selected, the
system can read information from GDT in the case of
registering patient information or scanning a single
record.

GDT Path The default GDT path is C:\gdt. You can enter the path
or click Browse to set the path.

Suffix GDT is the default suffix. With this option, you can
select the suffix of files to be searched in the GDT path.
You can choose between .GDT and .001.
Input File Name With this option, you can specify the name of files sent
from the GDT server. The file name is “Holter_EKG” by
default.
Output File Name With this option, you can specify the name of files
exported from Holter system. The file name is
“Holter_EDP” by default.
ECG ID With this option, you can specify the name of local port.
“EKG” is the default name.

EDP ID With this option, you can specify the name of GDT
server. “EDP” is the default name.

Output when making diagnosis With this option, you can enable or disable the output of
GDT file after you click Confirm Diagnosis in the
Report tab.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual System Settings

NOTE: To use GDT protocol for communications, you need to make sure that the Holter
system is operated at secure networks. Otherwise, patients’ information and health
conditions may leak.

7.7 File Output Setting


Option Description
File Name Setting With this option, you can specify how to name a patient
record. A record name consists of first name and last
name of the patient by default.

PDF Setting With this option, you can enable or disable the output of
PDF report after confirming diagnosis. This option is
disabled by default.
Output Path With this option, you can set the path of exporting
patient records.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual System Tips

Chapter 8 System Tips


This system will provide you with helpful tips during operation. Please see the table below.

Tips Probable Cause


“No sentinel detected.” Dongle is removed during system operation.

“No correct sentinel have been Dongle is not inserted or wrong dongle is inserted into
detected. Do you want to enter the PC.
DEMO mode?”
“Incorrect password!” Incorrect password is typed in when entering the DEMO
mode or logging in to system setting.

“No file is found under the GDT GDT file is unavailable under the GDT path.
path!”

“Different template can’t be You try to put differently marked templates together.
combined.”
“The length must be larger than 5 You select a segment of ECG which is less than 5s and
seconds.” define it as an ST episode.

“Less than two beats are found in You select a segment of ECG which contains less than
the designated areas.” two beats and define it as maximum or minimum heart
rate.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Maintenance

Chapter 9 Maintenance
You should be familiar with all the operation methods of this system. Read this user manual in
detail, and don't use this system before understanding the whole operation process.

Holter System analysis software just needs simple maintenance during the operation process. But
only the right operation method can guarantee the system's long-time and steady working. So you
must strictly comply with the notice and maintenance presented by the manufacturer.

WARNING

Turn off the power before cleaning.

CAUTION

Avoid pouring liquid on the equipment while cleaning, and do not immerse any parts of the
equipment into any liquid.

Maintenance of the Main Unit and the Monitor

1) Keep the main unit and the monitor clean. The main unit case can be cleaned with a soft
cloth dampened with water. If necessary, use a mild detergent but carefully remove any
residue. Use water very sparingly to prevent liquid from seeping into the equipment.
2) The main unit and the monitor should be placed in a dry and well-ventilated place. Avoid
placing them in a dusty and humid environment. The air path for cooling the system should
be kept well ventilated.

Maintenance of the CD

1) Do not bend or press the CD. Do not put heavy substances onto the CD. Protect it against
crushing.
2) Keep the CD away from high temperature and humidity, direct sunlight, and dust.
3) Do not touch the disk surface on the recording side. Avoid fingerprints or scratch.
4) Clean the CD with a disk cleaner. Do not use organic solvents such as acetone.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Accessories

Chapter 10 Accessories
We recommend you use the following accessories to help operation of the Holter system analysis
software.

Accessory Part Number


USB Cable 01.57.471456
Installation CD 02.01.211447
Dongle 02.01.211263

The following printers are recommended.

Model Number Manufacturer


HP P2035, HP P2010 Hewlett Packard Enterprise in USA
CANON iP1980 Canon Inc. in Japan

WARNING

Only accessories or spare parts supplied by the manufacturer can be used. The use of
third-party products may compromise system performance and safety.

The Holter System analysis software and accessories are available by contacting the manufacturer
or your local distributor.

NOTE: The part name may vary depending on context, but the part number is unchanged.

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Warranty and Service

Chapter 11 Warranty and Service

11.1 Warranty

EDAN warrants that EDAN's products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within warranty period.

The warranty is void in cases of:

a) Damage caused by mishandling during shipping.


b) Subsequent damage caused by improper use or maintenance.
c) Damage caused by alteration or repair by anyone not authorized by EDAN.
d) Damage caused by accidents.
e) Replacement or removal of serial number label and manufacture label.

If a product covered by this warranty is determined to be defective because of defective materials,


components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.

11.2 Contact Information

If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.

Alternatively, you can send an email to EDAN service department at: [email protected].

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SE-2003&SE-2012 Series Holter System Analysis Software User Manual Abbreviations

Appendix 1 Abbreviations
Abbreviation Full Description
LCD Liquid Crystal Display
ECG Electrocardiogram/Electrocardiograph
HR Heart Rate
AC Alternating Current
USB Universal Serial Bus

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