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LABTECH LTD. MADE IN HUNGARY

ECG Holter System

Cardiospy® User Manual

for EC-2H; EC-3H; EC-12H; EC-3H/ABP recorder

LABTECH LTD.

Address 4. Vág street Debrecen 4031 Hungary

E-mail [email protected]

Phone +36-52-310-128

Fax +36-52-412-023

INTRODUCTION ECG HOLTER SYSTEM

2 V5.03_2014_11 LABTECH LTD.

1 Introduction

Dear Customer!

Thank you for purchasing our Cardiospy ECG Holter System. We sincerely hope that

our product will help you with your diagnostic and therapeutic work. To be able to use

Holter System and computer programs appropriately, please read the manuals carefully.

A basic knowledge of computers and Windows based applications are required. We

appreciate any comment you might have on the use of the System. Please, turn to us

with confidence: our colleagues and representatives will be pleased to help you, even in

person if need be.

What is a Holter?

A Holter is a non-invasive, long-term ambulatory ECG device that is capable of

recording up to 24 (or even 48-72) hours of ECG signals.

How to use Holter monitoring?

The Holter recorder is worn by the patient for 24 hours, and records during normal daily

activities, including sleep periods. After 24 hours, the readings are downloaded to a

computer for analysis, where a qualified expert reviews and, if necessary, edits the data.

What is the main idea of Holter Monitoring?

Holter monitoring is a tool in the evaluation of patients with symptoms of various forms

of heart disease, or in situations where the physician suspects cardiac pathology in the

absence of symptoms. Holter monitoring is an ideal test because the patient assumes

normal daily activities, increasing the likelihood that he or she will experience the

precise situations that can trigger symptoms or cardiac events. This allows correlation of

any rhythm problems or abnormalities with activities and/or symptoms. In the opposite

sense, Holter monitoring can also be used to "rule out" cardiac causes of patients'

symptoms.

ECG HOLTER SYSTEM INTRODUCTION

LABTECH LTD. V5.03_2014_11 3

Does this system have any quality certifications?

The CE mark indicates that the product meets the essential

requirements of European Council Directive 93/42/EEC

concerning medical devices.

Labtech Ltd. also operates a quality system certified to ISO

9001:2008 and ISO 13485:2003. Made in Hungary by

Labtech Ltd.

We wish you success in using our ECG Holter Systems!

Should you have any questions, ideas, partnership suggestions please contact us:

LABTECH LTD.

Address 4. Vág street Debrecen 4031 Hungary

E-mail [email protected]

Phone +36-52-310-128

Fax +36-52-412-023

TABLE OF CONTENTS ECG HOLTER SYSTEM

4 V5.03_2014_11 LABTECH LTD.

2 Table of contents

1 INTRODUCTION ................................................................................................... 2

2 TABLE OF CONTENTS ........................................................................................ 4

3 PREPARATIONS FOR USING THE HOLTER SYSTEM .................................. 7

3.1 List of accessories for EC-2H; EC-3H; EC-12H * ......................................... 7

3.2 List of accessories for EC-3H/ABP .............................................................. 10

3.3 Principles of Operation ................................................................................. 13

3.4 Warnings and Contraindications of using Holter System ............................. 14

4 INSTRUCTIONS FOR STARTING HOLTER MONITORING ........................ 16

4.1 Recorder Components (EC-2H; EC-3H; EC-12H) ....................................... 16

4.2 Recorder components (EC-3H/ABP) ........................................................... 17

4.1.1 Signs and alarms of EC-3H/ABP ............................................................. 18

4.3 Database management interface ................................................................... 21

4.1.2 Toolbar ..................................................................................................... 21

4.1.3 List of patients .......................................................................................... 25

4.1.4 Records toolbar ........................................................................................ 26

4.1.5 List of records .......................................................................................... 27

4.1.6 Selected System ....................................................................................... 27

4.1.7 Filters ....................................................................................................... 28

4.1.8 Search ....................................................................................................... 28

4.1.9 Database information ............................................................................... 28

How to start a New Recording? ................................................................................. 29

4.1.10 Patient preparation ............................................................................... 29

4.1.11 New Recording .................................................................................... 40

4.1.12 Holter monitoring settings ................................................................... 41

4.1.13 Starting a recording from the computer ............................................... 41

4.1.14 Starting a recording without a computer .............................................. 43

4.1.15 Patient’s event log printing .................................................................. 44

ECG HOLTER SYSTEM TABLE OF CONTENTS

LABTECH LTD. V5.03_2014_11 5

Reading a Record........................................................................................................ 45

5 ANALYSIS WITH THE CARDIOSPY SOFTWARE .......................................... 46

Views .......................................................................................................................... 46

5.1.1 Main window ............................................................................................ 46

5.1.2 ECG window – large window ................................................................... 50

5.1.3 Templates window .................................................................................... 52

5.1.4 HRV window ............................................................................................ 54

5.1.5 QT Summary window ............................................................................... 58

5.1.6 3.1.6 Pacemaker window .......................................................................... 59

5.1.7 Ectopic Trends Window ........................................................................... 61

5.1.8 Summary window ..................................................................................... 62

5.1.9 Vectorcardiography: ................................................................................. 63

5.1.10 BP (EC-3H/ABP) ................................................................................. 63

Toolbars ...................................................................................................................... 67

5.1.11 Database ............................................................................................... 67

5.1.12 ECG leads ............................................................................................. 67

5.1.13 Report ................................................................................................... 68

5.1.14 Sequence of tasks ................................................................................. 68

5.1.15 Print ...................................................................................................... 68

5.1.16 Printing of screen section ..................................................................... 69

5.1.17 Export ................................................................................................... 69

5.1.18 Export Current Samples ....................................................................... 69

5.1.19 Settings ................................................................................................. 69

5.1.20 Automatic report .................................................................................. 73

5.1.21 Print and export settings ....................................................................... 74

Editing and measuring options ................................................................................... 75

5.1.22 Automatic and manual analysis ............................................................ 75

5.1.23 Sequence of tasks ................................................................................. 76

TABLE OF CONTENTS ECG HOLTER SYSTEM

6 V5.03_2014_11 LABTECH LTD.

5.1.24 Template window ................................................................................ 76

5.1.25 ECG window ....................................................................................... 80

5.1.26 Event window ...................................................................................... 81

5.1.27 HRV window ....................................................................................... 83

5.1.28 ST, QT, QTc graph .............................................................................. 86

5.1.29 AF graph .............................................................................................. 87

5.1.30 Deleting T alternans sections ............................................................... 88

5.1.31 Noise window ...................................................................................... 89

Calculation and Evaluation methods - EKG .............................................................. 90

Calculation and Evaluation methods - BP.................................................................. 96

6 TROUBLESHOOTING AND MAINTENANCE ................................................ 98

7 TECHNICAL SPECIFICATIONS ..................................................................... 109

Specification table of holter recorders (EC-2H; EC-3H; EC-12H) .......................... 109

Specification table of holter recorders (EC-3H/ABP) .............................................. 110

Recording time ......................................................................................................... 113

Basic functions of different holter systems .............................................................. 114

Additional functions of different holter systems ...................................................... 116

8 PATIENT DIARY ............................................................................................... 117

ECG HOLTER SYSTEM PREPARATIONS FOR USING THE HOLTER SYSTEM

LABTECH LTD. V5.03_2014_11 7

3 Preparations for using the Holter System

3.1 List of accessories for EC-2H; EC-3H; EC-12H *

Please check the listed units and accessories before installing the ECG Holter System

New

Code

Old code

No. Specification Qa.

EC-

2H

EC-

3H

EC-

12H Picture

CAS-

00000-

01

3HV5-01 Case for holding

the systems 1 x x x

ACC-

0SWCD-

01

3HV5-02

CD with

installation

software

1 x x x

DEV-

0USBB-

02

3HV5-03-

B

USB-02

Bluetooth

interface unit

1 x x x

DEV-

02HLC-

05

3HV5-04-

A

EC-2H ECG

recorder unit 1 x

DEV-

03HLC-

05

3HV5-04-

B

EC-3H ECG

Holter Recorder

(Bluetooth)

1 x

DEV-

12HLC-

05

3HV5-04-

C

EC-12H ECG

holter recorder

unit (BT)

1 x

NOTE: BEFORE STARTING TO USE THE HOLTER SYSTEM YOU ARE EXPECTED TO FOLLOW

LABTECH LTD.’S INSTALLATION AND UPDATE GUIDE, WHICH PROVIDES GUIDANCE ON

THE INSTALLATION OF THE SYSTEM.

PREPARATIONS FOR USING THE HOLTER SYSTEM ECG HOLTER SYSTEM

8 V5.03_2014_11 LABTECH LTD.

New

Code

Old code


EC-

2H

EC-

3H

EC-

12H Picture

BAG-

0012H-

01

3HV5-05

Recorder bag

(EC-2-3-12H

V5, attachable to

patient’s

waistbelt)

1 x x x

BAG-

0012H-

02

3HV5-06

Recorder bag

(EC-2-3-12H

V5, attachable to

patient’s neck)

1 x x x

CHA-

0002X-

01

3HV5-07

Battery charger

MINI

1 x x x

BAT-

00000-

01

3HV5-08

1.2V

Rechargeable

batteries (AAA)

2 x x x

CAB-

00L02-

06

3HV5-09-

B

2 CH bipolar

patient cable

(HDMI-Snap,

45cm)

1 x

CAB-

00L03-

06

3HV5-10-

B

3 CH bipolar

patient cable

(HDMI-Snap,

45cm)

1 x

CAB-

00L12-

05

3HV5-11

12 CH standard

patient cable

(HDMI-Snap

connector)

1 x


LABTECH LTD. V5.03_2014_11 9

New

Code

Old code


EC-

2H

EC-

3H

EC-

12H Picture

CAB-

00LNE-

06

3HV5-12-

B

NEHB patient

cable (HDMI-

Snap, 45cm)

1 x

CAB-

00USB-

01

3HV5-13

Extension cable

for USB-02

1 x x x

CAB-

00REC-

05

3HV5-14

Data transfer

cable (USB A -

HDMI)

1 x x x

USR-

00000-

01

3HV5-15-

A

Installation and

Update Guide

1 x x x

USR-

00000-

02

3HV5-15-

B

User manual for

holter recorders 1 x x x

ELE-

00000-

01

3HV5-16-

A

Single-use

electrodes (1

pack / 30 pcs)

1 x x x

PAD-

00000-

01

3HV5-18 Mouse pad 1 x x x


10 V5.03_2014_11 LABTECH LTD.

NOTE: PLEASE REFER TO THE CODE NUMBER ABOVE WHEN PLACING AN ORDER.

*The manufacturer reserves the right to change prices at any time.

**The accessories highlighted in grey in the chart will be given as accessories for

the recorders as well.

3.2 List of accessories for EC-3H/ABP

New

Code

Old code


EC-

3H/ABP Picture

CAS-

00ABP-

01

3HA-V5-01 Case for holding the

recorder and accessories 1 x

ACC-

0SWCD-

01

3HA-V5-02

CD with installation

software

1 x

DEV-

0USBB-

02

3HA-V5-03-

B

USB-02/B

Bluetooth Interface Unit

(monitoring and

evaluation)

1 x

DEV-

3HABP-

05

3HA-V5-04

EC-3H/ABP ECG and

ABPM recorder unit

(BT)

1 x

BAG-

3HABP-

02

3HA-V5-05

Recorder bag (EC-ABP

V5, EC-3H/ABP V5,

attachable to patient’s

waistbelt)

1 x


LABTECH LTD. V5.03_2014_11 11

New

Code

Old code


EC-

3H/ABP Picture

CHA-

0004X-

01

3HA-V5-06 Battery charger MAXI 1 x

BAT-

00000-

02

3HA-V5-07

1.2V Rechargeable

batteries (AA)

4 x

CAB-

00L03-

06

3HA-V5-08-

B

3 CH bipolar patient

cable (HDMI-Snap,

45cm)

1 x

CAB-

00USB-

01

3HA-V5-09

Extension cable for

USB-02

1 x

CAB-

00REC-

05

3HA-V5-10

Data transfer cable

(USB A - HDMI)

1 x

USR-

00000-

01

3HV5-15-A Installation and Update

Guide 1 x

USR-

00000-

02

3HV5-15-B User manual for holter

recorders 1 x

ELE-

00000-

01

3HV5-16-A Single-use electrodes (1

pack / 30 pcs) 1 x

ELE-

00000-

02

3HA-V5-12 Single-use electrodes

for cuff fixing 1 x


12 V5.03_2014_11 LABTECH LTD.

New

Code

Old code


EC-

3H/ABP Picture

BEL-

00000-

01

3HA-V5-13 Waist belt 1 x

CUF-

00SUN-

02

3HA-V5-14-

B

ABPM cuff, Adult (23-

33cm) 1 x

PAD-

00000-

01

3HA-V5-15 Mouse pad 1 x

*The manufacturer reserves the right to change prices at any time.

**The accessories highlighted in grey in the chart will be given as accessories for

the recorders as well.


LABTECH LTD. V5.03_2014_11 13

3.3 Principles of Operation

Holter monitoring is a tool in the evaluation of patients with symptoms of various forms

of heart disease, or in situations where the physician suspects cardiac pathology in the

absence of symptoms. Symptoms such as lightheadedness, palpitations, or fainting may

be caused by disturbances in the electrical signals that control the heart muscle

contractions. These disturbances can be random, spontaneous, sleep-related, emotion- or

stress-induced.

Holter monitoring is an ideal test because the patient assumes normal daily activities,

increasing the likelihood that he or she will experience the precise situations that can

trigger symptoms or cardiac events. This allows correlation of any rhythm problems or

abnormalities with activities and/or symptoms. In the opposite sense, Holter monitoring

can also be used to "rule out" cardiac causes of patients' symptoms.


14 V5.03_2014_11 LABTECH LTD.

3.4 Warnings and Contraindications of using Holter System

Never use the recorder:

- in wet conditions (the recorder is not waterproof)

- in strong heat

- in explosive surroundings

- in strong electrostatic field

- in the presence of flammable anaesthetics

- Do NOT remove recorder covers

- Do NOT immerse the recorder in any fluid

- the Holter is not defibrillator-protected, do not use with not-implanted defibrillator

Usage with other devices:

Holters may be used safely in patients with pacemakers, Implanted Cardiac Defibrillator

(ICD) or other implanted devices. The implanted devices will not disrupt or be

influenced by the operation of the recorder, as well as the recorder will not be

influenced by the operation of the above devices.

The recorder may be used simultaneously with a high frequency surgical device, in this

case make sure that the ECG electrodes are placed as far as possible away from the

surgical field.

Environmental conditions of storage and operation:

Temperature-range: -10-50oC

Relative humidity: 10-95% non-condensing

Air pressure-range: 700-1060 hPa

To achieve good and safe connection, to take care of the patient’s skin and to avoid

infection use only good quality single-use electrodes that are marked with the CE sign.

Do not use electrodes with expired warranty or dry or used ones from old, previously

opened packages because it will result in bad recording quality.

As in all Holter systems, noise and artefact may produce false positive ECG events.

Therefore, patient data must be reviewed and edited by a qualified technician.

Opening the enclosure by unauthorized person may invalidate warranty. Modification

of the ME equipment can only be performed by the manufacturer. In case of problems

contact a professional repair shop.

NOTE: IF ANY ABNORMALITY OCCURS IN THE UNIT, SUSPEND THE OPERATION

IMMEDIATELY AND DISCONNECT THE UNIT FROM THE PATIENT.


LABTECH LTD. V5.03_2014_11 15

Symbols:

This equipment meets the requirements of Directive 93/42/EEC Annex II

(excluding section 4).

Do not dispose of this product and batteries as unsorted municipal waste.

Prepare this product for reuse or separate collection as specified by

Directive 2002/96/EC of the European Parliament and the Council of the

European Union on Waste Electronic and ElectricalEquipment (WEEE).

MDD classification IIa. EMC class B. EMC group 1.

Bluetooth Wireless Communication Technology

Not ionizing radiation – Device including Bluetooth based RF transmitter.

Pay special attention to the part, marked with the exclamation mark.

CF type on patient’s side

Date of manufacturing

Manufacturer

INSTRUCTIONS FOR STARTING HOLTER MONITORING ECG HOLTER SYSTEM

16 V5.03_2014_11 LABTECH LTD.

4 Instructions for starting Holter Monitoring

4.1 Recorder Components (EC-2H; EC-3H; EC-12H)

FRONT VIEW

REAR VIEW

LCD Display

Patient cable

- Easy to replace -

Event Button

- Use this button

for patient events -

Battery

1 pc type AAA Battery Cover

Serial

Number

Symbols

Recorder

Configuration type

Patient Cable

Record reading

indicator lamp

ECG HOLTER SYSTEM INSTRUCTIONS FOR STARTING HOLTER MONITORING

LABTECH LTD. V5.03_2014_11 17

4.2 Recorder components (EC-3H/ABP)

FRONT VIEW

Patient cable

- Easy to replace -

Cuff

Pneumatic tube

Event Button

Event LED


18 V5.03_2014_11 LABTECH LTD.

4.1.1 Signs and alarms of EC-3H/ABP

The recorder contains a single RGB LED with which you can indicate several colours

and hues.

Light signal Description What should we do?

The LED light is

red.

Hardware error After detecting the hardware error it waits

a few seconds and restarts automatically.

If it’s not then you should restart the

recorder by removing the batteries and

taking them back. If the problem still

occurs it requires repair.

The LED is red

and flashing.

The battery has run

out.

Battery exchange required.

The LED light is

green.

The recorder connects

to the PC through the

USB data transfer

cable and it works

properly.

-

The green LED

light flashes

quickly.

The recorder connects

to the PC through the

USB data transfer

cable and and there is

data transfer between

the PC and the

recorder.

The rythm of the

flashing is

syncronized with the

rythm of data transfer.

-

The green LED

seldom flashes

The recorder is ready

to start recording

(doesn’t contain any

unread records, the

self-test and

-


LABTECH LTD. V5.03_2014_11 19

Light signal Description What should we do?

initialization was

successfully

completed).

The yellow LED

flashes.

The device is

recording.

-

A crimson LED

flashes

The recorder contains

unread record.

You should read the last record from the

recorder, otherwise you cannot start the

next record and the device won’t turn on

the Bluetooth modul.

Blue LED seldom

flashes

There is Bluetooth

connection between

the PC and recorder.

-

Blue LED flashes

quickly

There is data transfer

between the PC and

recorder.

-

The recorders include a zümmer which can operate in different frequencies. By this the

recorders are able to display the different statuses and errors.

Signal Rhythm,

tune Status description

One high-pitched short beep Push-button event on the recorder

or on the PC (Start/Stop BP).

One short beep in deep voice The device was removed from

the USB.

One high-pitched long beep Start of recording.

Stop of recording.

The recorder beeps for some

seconds on a high-pitched voice.

Hardware error.


20 V5.03_2014_11 LABTECH LTD.

Signal Rhythm,

tune Status description

Two high-pitched short beep Cannot start recording (no patient

data).

Push-button event, but there is no

function related to pushing the

Push-button in the current state of

the recorder (for example: the

recorder connects to the USB).

Two short beep in deep voice The device was connected to

USB.

Two short beep with rising melody Bluetooth connection was

created.

Two short beep with descending

melody

Bluetooth connection was

broken.

Three high-pitched short beep After the battery was put in the

initialization, selftest was

successfully completed.

Four high-pitched short beep Discharged battery.


LABTECH LTD. V5.03_2014_11 21

4.3 Database management interface

The database management interface enables us to add physicians and patients by name

and ID number (e.g., social security number), which can be sorted and filtered

according to different criteria. The interface also offers a search option by name or ID.

The database management interface displays the list of patients and the pertaining

number of records. Here we can view previous records and start new recordings as

well.

4.1.2 Toolbar

The toolbar contains buttons which provide access to the most often used functions in

the software.

New patient: Here you can add new patients to the list. Patient’s first and last names,

birth dates and patient IDs are fields which need to be filled in. The

software allows only unique patient IDs to be entered into the database,

which is the reason why it is recommended to use this field for entering the social

security number of each patient (or any other code which uniquely identifies a person).

Entering address and height is optional when registering a patient.

Modify: Patient data can be edited by clicking on the Modify button. The interface

allows every field to be edited except patient ID (social security number)

2.2.2

2.2.8

2.2.5

2.2.6

2.2.1

2.2.4

2.2.7 2.2.3


22 V5.03_2014_11 LABTECH LTD.

Medical record: This function gives a summary about the medical record. This

summary can be edited and we can also add explanations and

observations.

Delete: Click on the Delete button for deleting patients. When patient is deleted, all of

its corresponding records are deleted as well. After deleting, there is no

way to restore data.

Settings:

- Select physician: In this menu the physician performing

the current test can login to the software, and also select to

view the records of other physicians whose records are not

password protected.

- Change password: By selecting this option, the physician

performing the current test can change his/her password.

- Administration: Selecting this menu point, we can see

names of Test Physicians. Other names can be added to the

list in this menu point by clicking on “New” button; data of

existing physicians can be edited by clicking on “Modify”,

and “Delete” serves to delete the physician (a physician can

only be removed if there are no records relegated to his/her

name). Security settings and administrator rights can be set under this menu point.

Further information on modifying user authorization can be found in Cardiospy

Installation and Update Guide.

- Select database: In this menu, you can choose to create a new database or to use a

different one. These databases operate independently of each other, so a patient created

in one does not appear in another. The software always uses the database set for the

previous operation.

TO INSERT YOUR OWN INSTITUTION’S LOGO INTO THE PRINTED REPORT, ADD THE DESIRED

LOGO UNDER SETTINGS / ADMINISTRATION TO THE DOCTOR YOU WISH TO USE IT WITH.

EACH THE LOGO HAS TO BE ADDED TO EACH DOCTOR WE WISH TO USE THE LOGO WITH,

ONE BY ONE.


LABTECH LTD. V5.03_2014_11 23

Clicking on the Add button creates a new

database. If you need to work with a

different one, select it and click on OK.

There are three possible ways to create a

database:

Local database folder: The database is

stored in a local directory on your

computer. Network drives are not

supported. Optimal for single computer

usage. Select the directory for the

database and it is ready.

- Network mode- Microsoft SQL Server:

SEE DESCRIPTION IN INSTALLATION AND

UPDATE GUIDE’S CHAPTER 4.3.

SQLite database: SEE DESCRIPTION IN

INSTALLATION AND UPDATE GUIDE’S

CHAPTER 4.2.

- File names as: The order of first and last name can be set in this menu.

- Input devices: Barcode readers and magnetic card readers can be set here.

- FTP settings: SEE DESCRIPTION IN INSTALLATION AND UPDATE GUIDE’S CHAPTER 5.1.

- Communication: HL7 communication protocol can be started here.


24 V5.03_2014_11 LABTECH LTD.

- Select systems:

Here you can select the ECG systems you

wish to use. Inactive systems will not

appear in the field of Selected Systems. A

system is inactivated by removing the

green tick from the box to its left.

Help:

- User manual: Choose the system in the Select systems

panel (further description in point 2.2.5). Once you click on

User manual button, the user manual of the currently

selected system will appear.

- Installation and update guide: The guide on software

installation and system configuration also contains a

description of the software update process.

- What’s new: The novelties of the current software version can be found in this option.

- Languages: The software offers a choice of several languages, from which you can

select the one you wish to work in.

- Multilanguage translator: This function enables the user to translate each term

appearing in the software into the desired target language. A password is necessary to

enter this menu point. In case you would like to use this function, turn to your

distributor for a password.

- About: Information on software version, the operational system and copyrights can be

found here.


LABTECH LTD. V5.03_2014_11 25

ECG Device Connection Status Indicator: This indicator shows the current

connection status of the devices (the USB-02 interface, the ECG recorder, the blood

pressure monitor and the stress device).

The ECG Device Connection Status Indicator has three types: the first one is used with

the Holter, ABP and Resting Test systems. The second type is used with the Stress Test

systems, and the third type with the Continuous ECG systems.

1

2

1

2 3 4 5

1

2

.

3 5

1. Status of Bluetooth or direct connection

2. Status of connection with Holter ECG recorder /ABP recorder / Resting ECG

recorder / Test ECG recorder

3. Status of connection with blood pressure monitor

4. Status of connection with loading machine

5. Status of connection with Pulse Oximeter (this section is only available when Pulse

Oximeter is activated under System Configuration menu)

Colour codes for the ECG Devices Connection Status Window:

green - The device is properly connected

yellow - Manual operation, the device is not connected to the computer

red – No connection with the device

grey – No connection is needed for recording

4.1.3 List of patients

This menu point lists the patients in the database. Clicking on the appropriate tab of the

header sorts the available data by patient’s first or last name, date of birth, ID number,

or date of the last record.


26 V5.03_2014_11 LABTECH LTD.

4.1.4 Records toolbar

This is a toolbar for managing existing records.

Load record: Opens the selected record from the list. Once the record

is open we can edit, analyze or print it.

Import / export: In this menu point we can save the current record to the directory of

our choice. This directory can be on a network drive or on a

portable drive (e.g., USB stick). The name of the exported

record will include the first and last name of the patient, the

date of recording and patient ID, separated by low lines. We

can also import any previously saved (exported) record from

any directory. The imported record is automatically saved to

the current database.

- Import selected records: With this function we can import

records from a directory of our choice. Should you need to

import more records at a time, select records while holding

the CTRL key, then press Import selected records.

- Import records by date: Imports all the records of a selected directory which were

recorded in a given interval.

- Download from FTP: We can download records from the given FTP server. We can

see all the available directories and Cardiospy files in the appearing window, the left

side column is for navigation among folders, the right one is for Cardiospy files. The

files can be arranged according to their Names, IDs, Record dates and Upload dates, and

a search bar is also available to help find the necessary record. Holding the Ctrl button

enables highlighting and downloading multiple records at a time. Records can be

deleted by pressing the Delete button, and triggering the “Delete downloaded records”

automatically erases all records after downloading them.


LABTECH LTD. V5.03_2014_11 27

- Export selected records: With this function we can export records selected in the list

of records. Should you need to export more records at a time, select records while

holding the CTRL key, then press Export selected records.

- Export records by date: Exports all the records which were recorded in a given

interval.

- Export records of selected patients: Holding CTRL while clicking on several patients

enables the multiple selections of patients. This option saves all the records of the

selected patients.

- Upload to FTP: We can select multiple records from a single patient and upload them

to the given FTP server.

- Upload to FTP by date: Every record is uploaded which fits to all the criteria given

and was recorded within a given period.

- Upload to Labtech: In case you have any problem with the interpretation of a record,

or you face any difficulties you can upload the record to the Labtech server.

- Print rest records by date: Prints every rest record which was made with the given

conditions and recorded in a given interval.

- Import sample data: In case a CD was used for installing the Cardiospy software and

there are no sample records in the database, you can import them by pressing this

button.

Delete selected record: This buttons deletes every selected record from the database.

After deleting, there is no way to restore data. Should you need to

delete more records at a time, select records while holding the

CTRL key, then press Delete selected records.

Delete records by date: Deletes every record recorded in the

given interval according to the criteria selected.

4.1.5 List of records

Displays the records of the patient selected in List of patients (point 2.2.2). Here you

can search among the records. Should you need to select more records at a time, you can

do so while holding the CTRL key.

4.1.6 Selected System

Here you can select the ECG systems you wish to use, configure systems, add new

recorders before you start recording. You can also start Demo recording in this field.

Please keep in mind that a demo recording can only be started if the USB-02 device is

not connected to the PC.


28 V5.03_2014_11 LABTECH LTD.

4.1.7 Filters

This field provides a number of filters which enable the filtering of records by different

criteria. Once the database is filtered, List of patients displays only those who fit the

criteria.

You can filter records by:

- Physician: When this filter is used, List of patients displays those patients whose

records have been made by the doctor selected.

- Date: When this filter is used, List of patients displays those patients who have

records made today / in the last 2 days / in the last 7 days / this month / this year.

- Status: When this filter is used, List of patients displays those patients who have

temporary / pre-evaluated / evaluated / approved records.

- Record type: When this filter is used, we can view all types of records or only those

pertaining to the system currently selected in Select system field.

- Pacemaker: When this filter is used, we can view patients who have and those who do

not have a pacemaker in separate lists.

4.1.8 Search

The Search (name or ID) field is used for narrowing down the list of patients

displayed. Once we enter a letter or a number in the field, List of patients will only

display patients whose first or last name, or the ID begins with the pertinent letter or

number. The more letters we type in the field, the more we narrow down the number of

patients appearing in the list. Clicking on the Reset button cancels the filtration and the

default List of patients will appear, where every patient and every record is displayed.

4.1.9 Database information

This field contains general information about the database, such as access path, number

and size of records contained, etc.


LABTECH LTD. V5.03_2014_11 29

How to start a New Recording?

4.1.10 Patient preparation

Step 1: Place the case of the recorder unit on the right side of the patient and fix it on

the belt on his/her waist. Although the case is washable, it is recommended to avoid

skin-contact.

Step 2: Clean the surface of the skin thoroughly using:

- razor /in case it is necessary/

- abrasive preparation pad and

- alcohol swab

The Holter System is designed for external skin-surface ECG recording. The electrodes

can be applied only on injury-free skin.

Step 3: Attach the single-use electrodes as it is indicated below and by keeping to the

instructions shown on the electrode’s package.

Step 4: Connect the patient cable to the attached electrodes.

Step 5: Secure the cables below the electrodes one by one by making a loop on each

of the cables and secure them to the skin by adhesive plaster.

NOTE: A NOISE-FREE RECORD CAN BE OBTAINED ONLY IF ALL THE STEPS OF PATIENT

PREPARATION HAVE BEEN FOLLOWED ACCORDING TO THE INSTRUCTIONS. DO NOT START

THE RECORDING IF ECG SIGN IS NOISY.

FOR MORE INSTRUCTIONS PLEASE CHECK THE PATIENT’S PREPARATION INSTRUCTIONS.

Yellow


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3 lead placement (1 CH)

Standard 1

AHA Label IEC Label Electrode Placement

CH1+ CH1+ 6th intercostal space at the anterior axillary's line

CH1- CH1- Right clavicle, lateral to the mid-clavicle line

RL N Lowest rib on right side of chest


LABTECH LTD. V5.03_2014_11 31


Standard 1




CH2+ CH2+ Approximately 1 inch right of Xiphoid Process on the

rib.

CH2- CH2- Left clavicle, lateral of sternum border



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Standard 2


CH1+ CH1+ 4th intercostal space at left border of sternum






LABTECH LTD. V5.03_2014_11 33


Orthogonal

AHA Label IEC Label Electrode placement

CH1+ CH1+ 5th intercostal space at the mid line of left axillary

CH1- CH1- 5th intercostal space at the mid line of right axillary

CH2+ CH2+ Lowest rib on left side of chest




34 V5.03_2014_11 LABTECH LTD.


Standard 1




CH2+ CH2+ Approximately 1 inch right of Xiphoid Process on the

rib.


CH3+ CH3+ 6th intercostal space on left midclavicular line

CH3- CH3- Manubrium sternum



LABTECH LTD. V5.03_2014_11 35


Standard 2


CH1+ CH1+ 4th intercostal space at left border of sternum





CH3- CH3- Manubrium sternum



36 V5.03_2014_11 LABTECH LTD.


Orthogonal


CH1+ CH1+ 5th intercostal space at the mid line of left axillary

CH1- CH1- 5th intercostal space at the mid line of right axillary



CH3+ CH3+ Approximately 1 inch left of Xiphoid Process on the

rib.

CH3- CH3- 8th intercostal space at the center of the back,

opposite the CH3+ electrode



LABTECH LTD. V5.03_2014_11 37


Standard 1


V1 C1 Fourth intercostal space at the right sternal border.

V2 C2 Fourth intercostal space at the left sternal border.

V3 C3 Midway between C4 and C2.

V4 C4 Mid-clavicular line in the fifth intercostal space.

V5 C5 Anterior axillary line on the same horizontal level as C4.

V6 C6 Mid-axillary line on the same horizontal level as C4 and

C5. LA L Slightly below left clavicle.

RA R Slightly below the right clavicle

LL F Lower edge of the rib cage, or at the level of the

umbilicus at the left and right mid-clavicular lines. RL N


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NEHB placement

Standard 1


Slightly below left clavicle.

Slightly below the right clavicle

Lower edge of the rib cage, or at the level of the

umbilicus at the left and right mid-clavicular lines.


LABTECH LTD. V5.03_2014_11 39

NEHB placement

Standard 2


V1 C1 Nst – 2nd rib at the right sternal border

V2 C2 Nax - 5th intercostal space on the left posterior

axillary line directly opposite (on the back,) from 3

(Nap) V3 C3

Nap- 5th intercostal space mid-clavicular line (cardiac

apex) equates to (V4 / C4)

RL N On the middle line of midaxillary, on the position of

ribcage


40 V5.03_2014_11 LABTECH LTD.

4.1.11 New Recording

Before starting a new recording, you have to add the recorder you wish to record with.

Please follow the steps below:

1/ Press the System configuration icon to add a new recorder. Press the Add new

recorder button.

2/ Connect the recorder via USB cable to your PC, if the connection is stable, you

will see the following window:

3/ Disconnect the recorder from your PC, connect a patient cable to the recorder,

choose from the list the serial number of the recorder you wish to use and press

Start monitoring with the selected recorder.

When you have added a new recorder or chosen a registered one, you may start the

recording in one of two ways:

- from the computer: when starting the recording from the computer, it is possible to

check the ECG signal before the start.


LABTECH LTD. V5.03_2014_11 41

- by pressing the button on the recorder: it is more convenient when the patient cannot

go to a computer, e.g., in case of a bed-ridden patient.

4.1.12 Holter monitoring settings

Patient tab: When start of ABP recording there is an opportunity in the program to

enter the name of the doctor who requested the examination and the medication and

symptoms of the patient. The information will be put in the record and will be available

if you scan it on another PC. If you import automatic report then the symptoms and

medication field’s content will be imported to the report, as well. The doctor’s name

will be imported to every report’s letterhead.

At the Measurement tab you can find the

setting of waking period you can modify

it after the record was read, as well. You

can also set the frequency of the BP

measurement the maximum pressure of

the cuff and right after the output of the

recorder it is able to measure.

Miscellaneous tab: Here you can find the

miscellaneous settings. Monitoring and

reading (Loading record after reading: If

you connect the recorder to the PC the

record will be imported to the database

and automatically loads in.) Length of

recording (Here you can set the length of

record). QRS signal: the program sign the

QRS beat arrival with sound signal during

the monitoring process. Recording (setup

of the length of the record, frequency of

sampling, see detailed in Chapter 7.2)

Filters (base line and muscle contraction filtering are switched on during the monitoring

process).

4.1.13 Starting a recording from the computer

Please follow the steps below:

a) Select the patient from the database whom you wish to

make a record of.

b) Click on the Holter ECG icon in the Selected System

menu point.

c) Click on Start Recording button to start monitoring.


42 V5.03_2014_11 LABTECH LTD.

- The USB-02 Bluetooth interface unit should be connected to your PC.

d) Check the quality of the ECG signal.

e) Start a test record with the Start BP command in the right bottom corner

f) If you find it acceptable, start monitoring by clicking on YES, START Recording

indicated on the screen.

You will see a confirmation that the recording has been started succesfully:


LABTECH LTD. V5.03_2014_11 43

4.1.14 Starting a recording without a computer

Use this method only in situations when patient is limited in his/her movement (e.g.,

due to his/her illness).

a) Select the patient from the database whom you wish to make a record of.

b) In case you have not done so yet, disconnect the USB-02 interface device from PC.

c) Connect the recorder to theh USB reader cable.

d) Click the Start without PC button to start recording. As soon as it starts, the recorder

saves the patient’s data and the parameters of the recorder. If the procedure is successful

you will see the following window.

d) Take the recorder to the patient place the electrodes as it was shown before.

Push the event button until you hear a long beep signal (approximately 3 sec.) to start

recording.

The program saves the starting and ending times as well as the duration of the

monitoring.


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4.1.15 Patient’s event log printing

After pressing ‘start record’ button the pop up window offer the printing of the patient’s

event log. The verification of Personal data is possible or making modification if needs.

The printed out event log can be hand out to the patient for making notes about his/her

complaint, uncommon activities and medication.


LABTECH LTD. V5.03_2014_11 45

Reading a Record

The recording stops automatically after 8-24-48-72-168 hours or when the batteries go

flat or when they are removed.

Continuous record: During recording it is possible to replace flat batteries so longer

recording can be made (IN CHAPTER 6 IN SPECIFICATIONS TABLE it is shown how many

batteries are needed for one recording) , the patient cable can be detached as well during

recording; when reattached recording continues automatically.

It is advisable to remove the batteries first and then the cables from the electrodes.

Otherwise the end of the recording cannot be analyzed because of lead-off error. For

reading a record, please follow the steps below:

a) Remove the batteries from the recorder unit (this ends the recording, if the preset time

has not expired yet, otherwise the recording automatically stops at the preset time

b) Take off the recorder-case from the patient and remove the electrodes from him/her.

c) Start the Cardiospy program on the computer. Then select the holter system.

d) Attach the recorder to the USB reader cable. Then reading starts automatically.

BEFORE READING THE RECORDING YOU HAVE THE OPTION TO SET THE AUTOMATIC

SENDING OF RECORDING TO THE FTP SERVER IN THE SYSTEM CONFIGURATON WINDOW

UNDER THE SETTINGS TAB. THIS WAY, AFTER READING THE RECORD IS AUTOMATICALLY

UPLOADED TO THE PRESET FTP SERVER.

ANALYSIS WITH THE CARDIOSPY SOFTWARE ECG HOLTER SYSTEM

46 V5.03_2014_11 LABTECH LTD.

5 Analysis with the Cardiospy Software

Views

We can view the recorded ECG curve and its calculated parameters in several forms.

The following chapter is dedicated to listing these views in the order they appear in the

software interface.

5.1.1 Main window

The Main window has three fields, all of which vary according to the tab selected at the

left side. The graphs are colour-coded, which means that areas suspected to be

pathological are highlighted in different colours.

HR, BP, ACL

The uppermost section of the Main window displays the heart rate graph, which shows

us heart rate calculated from the ECG signal (for the definition of Avg Hr, go to chapter

3.4), motion intensity, and in case the recorder comes with an integrated ABPM

component, this graph shows blood pressure values as well. With the two arrows below

the tabs this component can be removed, giving more space to the middle part. The

heart rate graph is able to display the time distribution of events selected in Events

menu. The temporal occurrence of individual events is indicated by small vertical lines.

Customisation of the upper HR graph is possible at the Holter record investigation

ECG HOLTER SYSTEM ANALYSIS WITH THE CARDIOSPY SOFTWARE

LABTECH LTD. V5.03_2014_11 47

which makes more visible of the HR graph:

- Default (0-200) ordinary enlargement

- Optimized: enlarging the range between the minimum and maximum value

- 50-150 range display

- 50-200 range display

QT/ST

The algorithm calculates ST and QT values from normal beats and right- or left bundle

branch blocks. The displayed value is calculated from the averages of beats within a

ten-second range of the given ruler position. In case a section of ECG does not contain

any right- or left bundle branch blocks, then ST is not calculated or displayed. The ST

level is calculated from the J+ point (see Settings/Parameters/ECG-ST). We can also

edit QT, QTc and ST values in the software (see chapter 3.3).

The scaling of the ST chart (the ST levels) can be changed with the zoom

button found in the upper menu, if the ST level does not fit into the 1X

range then you can set it to 0,5X range, and if the ST levels are too small

you can set it to 2X range to zoom in.

Events

By selecting Events from the tabs on the left side, we can see a summary containing

events of the entire record. The graph has three columns: the left column contains Event

types; the second column displays their time distribution and the third one, on the right

side, shows the aggregate number of each event. Each type of event can be selected by a

single left-click of the mouse, which changes background color and broadens the

selected line.

You can edit the list of events (e.g. delete a single or a group of events. See also chapter

3.3). Under the menu of Settings / Events it can be configurated. You can set the order

of events, can place events into and out of the view.


48 V5.03_2014_11 LABTECH LTD.

Full View

In this menu we can overview a longer section of the ECG curve. The window displays

the number of ECG channels selected in the ECG field. Depending on the ECG paper

speed, ECG intervals of either 30 seconds or 60 seconds can be displayed here. The

ECG field in the lower section displays the sub-section which we select in the middle

section by left-clicking the mouse. If you turn off the channels and set the amplitude in

the upper menu, and remove the HR chart with the two arrows then you will see a

longer section of ECG on your screen.

Atrial Fibrillation

This tab displays the graph of NN Intervals, which helps us check the correct detection

of Atrial Fibrillation. You can edit the AF intervals (e.g., insert AF intervals, delete a

single or a group of AF intervals. See also chapter 3.3)

Noise

The significance of this function is that it enables us to mark any section as noise, either

from the HR or ECG field. Conversely, sections of noise can also be marked as normal

in this function. (See chapter 3.3) Apart from this, the intervals marked as noise by the

software’s automatic noise detector are indicated by a different background colour.

ECG – normal window

The ECG field displays the selected channels in the desired degree of magnification.

Clicking on Median button in the lower left corner displays the median pertaining to the


LABTECH LTD. V5.03_2014_11 49

selected ECG section. Both the median and the ECG curve can be measured in terms of

time and amplitude. Editing is enabled in the ECG field (e.g., insert, delete or classify

QRS. SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS)

Service

The Service field illustrates the technical details of the recording. It displays the lead-on

and lead-off intervals of each electrode, and the state of battery. You can see here what

version of recorder was used for the loaded recording.


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5.1.2 ECG window – large window

The ECG window displays the ECG curve in a larger screen-space. You can view the

ECGs in two columns.

You can edit in the ECG field (e.g., insert, delete or classify QRS. SEE ALSO CHAPTER

EDITING AND MEASURING OPTIONS)

T alternans


LABTECH LTD. V5.03_2014_11 51

In the HR field the time interval is marked with red lined, where the SW detected T

alternans. The detection is completed for each holter channel, that is why the event line

belongs to that channel, which was chosen in the ECG field.

To T alternans events the amplitude belongs as well, which shows the alternans’s

amplitude size in the uV.

The SW offers the editing possibility as well: deleting of T alternans intervals (SEE

ALSO CHAPTER EDITING AND MEASURING OPTIONS)

The meaning of alternans’s amplitude:

X [uV]

𝐴 = 𝑋

2.

On the picture the QRS with

even indexes are marked with

blue, the odd ones are marked

with red.


52 V5.03_2014_11 LABTECH LTD.

5.1.3 Templates window

The analysis software classifies each heartbeat (N, S, V) and clusters similar formations.

Filter templates by function in the upper right corner serves to display QRS complexes

of different types altogether or individually.


LABTECH LTD. V5.03_2014_11 53

Meaning of the information on cluster pictures:

Cluster cleanness measuring circle (homogeneity)

Clean cluster

Somewhat mixed cluster

Extremely mixed cluster

If a cluster is marked with green circle, it means that the QRS complexes belonging to

the cluster show very similar forms to the cluster QRS shape. The red area in a circle

signifies the percentage of non-similar QRS shapes.

The validation of a type of cluster means the affirmation of the type. If you click on a

template the program automatically puts a yellow check mark as a default setting. This

is good to see in which template you have already been. You can switch off the

automatic check mark under the menu of Settings (Automatic check mark, choosing

form). If you want to confirm the automatic checking you can click on the yellow check

mark which will turn green as proof of that the template has been searched thoroughly.

Not validated type.

Automatic marking

Validated type by user

SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS

Number of

beats Beat type

Cluster

cleanness Cluster

validation


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5.1.4 HRV window

The HRV window provides detailed information on time and frequency parameters of

RR variability.

Time Distribution

Three graphs are displayed in this section: RR Intervals, RR Differences and Lorenz

plots. We can also edit data in the RR Intervals graph, for example we can validate or

revalidate the intervals (see chapter 3.2).Data edition is convenient, because the ECG

pertaining to each selected interval is displayed immediately in a lower section. Next to

the ECG-display we can see the Patient Risk graph, which is calculated from the HRV

parameters. To check the exact meaning of each parameter, CALCULATION AND

EVALUATION METHODS

To check data edition possibilities, SEE ALSO CHAPTER EDITING AND MEASURING

OPTIONS


LABTECH LTD. V5.03_2014_11 55

Histogram and Table

The first row of this graph displays SDNN values by a 5-minute division, the second

one contains SDNN calculated for 1 hour, the last two rows contain rMSSD and

PNN50% values. In the lower part of the screen we can see these values in table format.

To check the exact meaning of each parameter, see CALCULATION AND EVALUATION

METHODS


56 V5.03_2014_11 LABTECH LTD.

NN Intervals hourly: This graph displays NN intervals in an hourly division in 3d.

Frequency: In the representation of frequency range, three graphs are displayed: one

showing the period when the patient is awake, one when s/he is asleep, one for the total

period of the measurement time, represented in a 3D HRV frequency graph. The latter

can be represented in a 2D format as well. To check the exact meaning of each

parameter, SEE ALSO CHAPTER EDITING AND MEASURING OPTIONS


LABTECH LTD. V5.03_2014_11 57

RR Graphs: Here you can see the RR Max and Min ECG views and the diagram shows

the distribution of the RR intervals.

HR Turbulence: This menu point displays the HR turbulence both in graph and table

formats. To check the exact method for calculating HRV turbulence SEE ALSO CHAPTER

EDITING AND MEASURING OPTIONS.


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5.1.5 QT Summary window

The values of the QT analysis are shown in the form of a distribution graph and a table.

We can choose to display QT or QTc values by selecting one of them at the left side of

the distribution graph, while the table displays both values.


LABTECH LTD. V5.03_2014_11 59

5.1.6 3.1.6 Pacemaker window

Pacemaker Histograms: This menu displays eight graphs according to what follows

below:

a-PMI The time distribution between the stimulation of the atrium and

the heart beat (induced by the heart on this stimulation).

v-PMI The time distribution between the stimulation of the ventricle and

the heart beat (induced by the heart on this stimulation).

d-PMI The time distribution between the stimulation of the atrium and

the ventricle and the heart beat (induced by the heart on this

stimulation).

N-PMI The distribution graph of the normal and PM induced beats.

V-PMI The distribution graph of the ventricular and PM induced beats.

PMI-N The distribution graph of the PM induced and normal beats.

PMI-V The distribution graph of the PM induced and ventricular beats.

PMI-PMI The distribution graph of consecutive PM induced beats.


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Pacemaker Summary

Here you can view a table summary of the pacemaker analysis. The number of beats

induced by the PM is presented in the table in groups based on the type of the induction

in an hourly division. The table shows the failure of electric capture and failure to sense

events detected by the program as well.

The failure to capture (FTC) means that the pacemaker spike appears at the right time,

but it is not followed by QRS. The failure to sense (FTS) refers to premature pacemaker

stimulation, in which case the pacemaker produces a stimulus, without being stimulated

by the patient’s heart.


LABTECH LTD. V5.03_2014_11 61

5.1.7 Ectopic Trends Window

Ventricular: Represents the frequency of events related to V beats on the time axis.

The last graph shows the frequency of V episodes (consecutive V beats by length).

SupraVentricular: Represents the frequency of events related to S beats on the time

axis. The last graph shows the frequency of S episodes (consecutive S beats by length).


62 V5.03_2014_11 LABTECH LTD.

5.1.8 Summary window

This menu displays the most important findings in the automatic summary of the

monitoring in two formats.


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5.1.9 Vectorcardiography:

Vectorcardiographic display mode is available with records made with EC12H

recorders using 3-channel patient cables in orthogonal electrode placement. The

medians of the ECGs are displayed in 2D and 3D coordinate systems. Their display is

colour-coded which makes it easy to keep track of the QRS in the vectorcardiogram.

The assigning of ECG channels to axes is displayed by the software.

5.1.10 BP (EC-3H/ABP)

HR, BP graph

The graph presents Heart Rate and Blood Pressure measured by the ABPM device.


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Table

The table displays all the BP results in a chronological order. We can validate /

invalidate each result by ticking / un-ticking the relevant checkbox in the column

marked “Valid”.

We can add short remarks to each measurement in the Comment column (double click).

Charts

The software represents systole and diastole values in the form of pie-charts.


LABTECH LTD. V5.03_2014_11 65

Graphs

The software shows BP burdens in the upper graph, while in the second graph Systole,

Diastole, MAP and HR values are displayed.

Histograms

In this part Systole, Diastole and Map values are represented in the form of histograms.


66 V5.03_2014_11 LABTECH LTD.

Statistics

Statistical parameters calculated from the validated Blood Pressure and Heart Rate

values are shown in a table format.

Scatter

In this function, the cohesive systole-HR, diastole-HR and Systole-Diastole points are

displayed.


LABTECH LTD. V5.03_2014_11 67

Toolbars

5.1.11 Database

This function gives you the possibility to go back to database or to

complete some operations in the database.

5.1.12 ECG leads

It is recommended to use this function in the case of 12-channel

recordings, when only three channels can be displayed in the ECG field.

Here we can select the channels to be displayed.

Millimeter paper setting

This window is active in stress and holter system, by clicking view menu, Millimetre

paper menu. Adjustment of millimetre paper size correlating to the monitor is possible.

It is possible to setup real, 1:1 scale appearance of the millimetre paper on screen.

Manual setting: setting

manually how many pixels

match for 1 mm.

Automatic setting: the cube

underneath is symbolising the

monitor, showing the resolution

and display size. The resolution of

the monitor is defined by the

system setup, but the display size

must be set by rolling the cursor

above the cube. Finalise the new

setting by pressing "Set to

recommended" button. Then press

the set button, and the program

sets the size on 1:1 scale, if the

monitor shows 10mm it will be the

same size in reality too.


68 V5.03_2014_11 LABTECH LTD.

Contrast modification of ECG curves

The modification of waves on the monitor is possible. Modify separately the line

stickiness of VES, SVES, normal beat curves. The program enables default settings to

distinguish each event. Modify the settings in Setting menu, ECG contrast tab.

5.1.13 Report

When selecting this menu, a movable text-box appears where the

physician can enter his/her comments. The patient data and the automatic

report generated by the program can be copied into this window by

clicking on the Import Automatic Report button.

You can display any window from the View menu, while the Report text-window is

still displayed, which is convenient as you can see your remarks and the necessary

information simultaneously. The text written in this window can be printed on a

separate page.

5.1.14 Sequence of tasks

The status of the record also appears in the database interface, which can

be used as a filtering option. See chapter 3.3.1.

5.1.15 Print

We can select to print the pages generated by the program in black-and-

white or in colour mode. We can also choose from the print settings.

More information in chapter 3.2.11.


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5.1.16 Printing of screen section

This function gives you the possibility to print the ECG section, which

can be seen on the screen.

5.1.17 Export

In this menu you can go through the pages completed by the program and

export separately (JPG, BMP, PDF). We can choose from the print

settings as well. More information in chapter 3.2.11.

5.1.18 Export Current Samples

There is an opportunity to directly export the selected ECG section on the

screen.

5.1.19 Settings

In this menu it is possible to set the various parameters of the program,

such as parameters relevant to the analysis, colours of the screen, graphs

to be displayed in the Main/Events menu.

In case we run a new analysis of the record, default settings will be restored, so all

previous editing will be lost.

Meaning of parameters

Time

Here we can set asleep and awake periods (related to the ECG and to blood pressure

measurement) and add special time intervals (only related to blood pressure

measurement).

ECG-Rhythm

Here we can find the settings of the ECG rhythm analysis. For the meaning of each

parameter go to chapter 3.3.

ECG-ST

Here we can set the limits of ischemic burden.

ECG-HR turbulence

Here we can set the parameters used for calculating turbulence and classifying patient

risk. For the meaning of each parameter go to chapter 3.3.


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ECG-Misc

Here we can turn ECG filters on and off. A modification triggers the automatic analysis,

after which all previous editing will be lost.

We can also select each channel to be viewed in an inverted position. A modification

triggers the automatic analysis, after which all previous editing will be lost.

Blood Pressure

Here we can set parameters used for statistical calculations and measurement ranges

used for automatic pre-filtering. Here you can set the parameters for the analysis of

blood pressure measurement. Limits for children and adults can be adjusted separately.

Statistical limit: You can set the normal systole and diastole limits in every interval

separately. If the patient’s result exceeds this limit the program indicates that it is in a

high range (with red colour). Valid measurement range: The program’s analysis accepts

BP values within these ranges. If the results of certain measurements are outside of this

range the program takes the measurements out of the evaluation.

ECG contrast: In this menu you can set the ECG curve’s thickness displayed on the

screen, Normal, VES, SVES beats separately

Refreshing / method of analysing: You can choose from two methods, if you use an

older computer (low memory, weak processor) choose the:

Use of refresh button method. In this case the analysis does not run again and again

after every editing step, just when changing screens and if you click on the Refresh

button displayed on the screen.

The other method is ’validation of changes immediately’ which means that after each

completed editing operation the analysis runs. This is recommended for faster

computers.


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Basic set events lists

It is possible to make several lists. Thus you need not change the list if you want to

differ from the usual event view you only need to set a new group and you will reach it

by pressing a button. In the upper toolbar you can step between groups. If you change

group, the events under event flap will be altered according to the changed group. You

can make 3 basic set event groups. You can include different events into all 3 groups

and make different layouts.


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Automatical analysing after read-in

The automatic analysing read-in method selection is an innovated part of the program. It

is possible to select from ‘never’ (no automatic analysing after read-in), ‘ask me every

time’ and ‘always’ (automatic analysing after read-in) options. Standard setting is

record automatic analysis.

Speed of Continuous playing

It is possible to modify the speed of continuous playing of the Holter ECG records.

Setting>continuous playing menu>select the proper speed from 1 to 9.


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5.1.20 Automatic report

The selected reports automatic printout/export is possible in Printing/Export Setting

menu by clicking Automatic printing button.

This function is inactive until activating any of automatic modes in Print

preview/Settings menu.

Please activate this function in Printing Review>Setting menu>select an automatic

mode.

Possibilities for printing are: automatic printout, PDF, picture and DICOM export.

TOOLBARS ECG HOLTER SYSTEM

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5.1.21 Print and export settings

ECG drawing: Here we can set the graph paper, the

EKG curve, the VES and the SVES curve’s

thickness on the print findings.

Cutting of noisy ECG: In the whole ECG view the

program completely cuts the noisy sections and they

do not appear on the finding.

Page layout: It is allowed to put a logo in the

finding’s headpiece; you can attach the expert’s

report to the Summary II finding or you can display

it as a separate finding. You can take off the

automatic expert’s report from the finding Summary

I.

Quality: Printer-specific settings. You can select

high-resolution or low resolution quality. You can send the findings to the printer in

vector graphic or raster graphic modes. The colouring method can be set as black and

white or coloured. Furthermore you can change the line smoothing and the contrast here

as well for the print findings.


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Editing and measuring options

5.1.22 Automatic and manual analysis

This function can be found in Settings menu / Refresh/analysis mode.

Apply changes immediately: The software runs the automatic analysis every time we

edit the record, this way we’ll see the results on the screen immediately. This function is

only recommended for modern and fast computers.

Use refresh button: The software does not run the automatic analysis each time the

record is edited, the analysis only runs when the user presses the refresh

button or change the screen. It is recommended for computers with slow CPU

or insufficient RAM. Refresh button can be found in the middle of the screen,

next to the horizontal slide.

EDITING AND MEASURING OPTIONS ECG HOLTER SYSTEM

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The results of the automatic analysis can be edited and checked by means of the

program’s editing and measuring options.

The program contains all the options with the help of which a record can be quickly and

precisely evaluated.

5.1.23 Sequence of tasks

The current status of the record also appears in the database

interface, which can be used as a filtering option.

The status of each record can be as follows:

Temporary: the recording has been read from the recorder, but

no automatic analysis has been performed yet.

Pre-evaluated: the recording has been automatically analyzed at

least once, and Evaluated by physician still has at least one un-

ticked box.

Evaluated: automatic analysis has been performed and all boxes

in Evaluated by physician are ticked.

Closed: a record can only be closed when status of record has

been evaluated.

5.1.24 Template window

Using the Highlight function

If this function is on, QRS complex displayed in the ECG window will be marked by a

continuous line in the Demix window.

The function is off The function is on


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Manual demix

The purpose of this function is to clear the cluster of the inappropriate QRS complexes

and artefacts.

This function enables us to select one or more QRS complexes in order for them to be

moved to a new cluster.

Select cluster (it is going to be a parent cluster)

Mark a rectangle in Demix window in any channel by pressing left mouse button.

All QRS complexes can be moved to a new cluster (it is going to be a child cluster),

which has at least one point within the rectangle.

The program automatically modifies and creates the QRS image characteristic of the

given cluster.

The created child cluster is marked in red.

The marking remains on the parent cluster until a new cluster is marked.


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Auto demix

In the Auto Demix function we can “clean” the marked clusters of each channel. If a

new cluster is created, the focus moves to the new cluster. The original cluster is

marked with a red frame.

Edition of Cluster’s type

The type of a cluster can be changed by right-clicking the template. The chosen type

will automatically appear next to each heartbeat of a cluster.

Contraction of Clusters

All the similar cluster types can be contracted manually or by the drag-and-drop method

familiar from Windows. This means that with the left mouse button we mark the cluster

and while holding this button just move the marked cluster to the one with which we


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wish to contract it, then release the button. The program allows contracting only similar

types of clusters, e.g. N can be contacted with N, V with V etc.

Before completing the contraction, it is advisable to display only one particular type of

group in the “Filter templates by” drop-down menu.

Cluster group operations

We can select all the clusters for group operations by holding the right mouse button,

then choosing Select all.

We can select the specified multiple clusters for group operations by pressing and

holding the Shift button while clicking the left mouse button at one point and pulling the

cursor the desired clusters.

The selected clusters can be contracted, or their types can be modified together.

The function of the Fix button

By clicking on the Fix button, a certain type of QRS can be fixed in the marked cluster.

Marking a new cluster invalidates all the previously set cluster types.

It is advisable to use this button, if we would like to modify the type of a complex

cluster, with the exception of some QRS complexes.

Determination of QRS clusters

After selecting the desired QRS by right-clicking in the ECG window and clicking on

the ’Forms’ tab, the focus will go to the cluster in which there is the appropriate QRS.


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5.1.25 ECG window

Modification of unique QRS types

Right-click the relevant QRS and choose the appropriate QRS type from the list offered

by the program.

Modification of group QRS types

Moving the mouse by holding the left mouse button mark all those QRS, which are

found next to each other and the type of which you would like to modify.

Then by pressing right mouse button on any of the QRS you can modify the type of all

the marked QRS. The marking can be terminated if we click using right mouse button

on any of non-marked QRS or if navigate to another time.


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Using the ECG ruler - measurement

We can measure time and amplitude by holding the left mouse button while moving the

cursor, this way you select a certain section of the ECG curve. Time: Represents the

elapsed time of the record. Selected intervall: Represents the intervall since the mouse

was pressed in the blue box provided in ms. Indicated RR intervall: Here we can see

the number of beats, the length of the section between the first and last QRS and the

average HR measured in the intervall from the selected section. Amplitude is measured

by calculating the difference of the two points where the first and second ruler intersects

the ECG curve.

Insertion of QRS

Move the cursor to the point at which you intend to insert the selected QRS. While

holding the left mouse button press the “I” or the “Insert” key. Choose the appropriate

QRS type from the list offered by the program.

Removal of QRS

Choose the relevant QRS by the right mouse button, then choose Removal of the QRS

from the list offered by the program.

Remove the QRS or mark the QRS as noise

As a result of QRS removal, the relevant QRS disappears from the QRS list, while it

remains when marked as noise. We should remove QRS, if there is an artefact between

the two QRS complexes of a real pause, which hinders pause detection. When the

artefact has been removed, the pause becomes detectable. If several artefacts follow

each other, it is advisable to rename them as noise, because their removal can create a

pause.

5.1.26 Event window

The events can be displayed in one of two menu points: one is Main/Events, the other is

the ECG window next to Main menu point. In this window we can delete the individual

events or event groups.


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Delete an individual event

In the selected event type, we can delete the currently displayed event by pressing the

button. When the event has been deleted, all the QRS complexes belonging to this

event type will automatically be renamed as noise.

Delete a group of events

In the selected event type, we can delete all events by pressing the button. When the

event has been deleted, all the QRS complexes belonging to the pertinent event will

automatically be renamed as noise.

Using the Fix button

Using the Fix button is used when deleting a group of events. By pressing the Fix

button, you can fix the selected events, that is, by pressing the button we delete all

events which have not been fixed.

After fixing the events, depending on their occurrence/number we can choose to delete

the fixed or the unfixed events. So in the events list we can fix events with the help of

the Fix button (X).

Keeping the obtained group, the other events get deleted from the event group.

The group obtained this way will be deleted from the event list and the other

unfixed events will remain.


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Selecting actual samples for printing

You can select intervals in the program with the help of this button and these samples

will appear on the printed report as well. The samples can be named and own default

titles can be prepared which can be set easily.

The length of the sample selected for printing can also be modified with the help of the

slider.

5.1.27 HRV window

In the HRV window we can validate or invalidate RR or NN intervals individually or as

a group.

Choose the Intervals graph to edit intervals. The displayed intervals can be RR, NN, or

invalid intervals.

The intervals are represented in a 10-ms histogram.

Fixation of RRmin, RRmax, NNmin, NNmax

These parameters will appear in the reports and in other calculations as well. That is

why it is important to have their precise values.


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The HRV window enables a fast editing of these values. To edit the MinRR, choose

“RR intervals”. With the left mouse button move the cursor above the ruler in the graph

of HRV intervals, then move the ruler to the left side of the graph. Then moving right

by pressing the button or with the help of the ruler, choose the interval which can

be accepted as RRmin. When pressing the button, the interval becomes a valid

RRmin interval. The intervals shorter than this one will automatically be invalidated by

the program.

The same procedure must be followed for editing the RRmax, NNmin, NNmax.

Invalidation of individual intervals

The currently displayed interval can be invalidated by clicking on the button.

Invalidation means that intervals of the given types are ignored by all algorithms during

the evaluation. The QRS complexes belonging to the given interval retain their original

type.

Invalidation of groups of intervals

By continuously pressing the ’Shift’ button you can select a wider interval if you left-

click.


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Use of Fix button

The Fix button’s use has a role in

collective cancellations. It can fix the Min

and Max intervals. Search for the

appropriate place and click on the Fix

Min or Max button.

Recovery of invalid intervals

The invalid intervals can be displayed by selecting ’Invalid intervals’. There are

opportunities to validate individually or collectively as well by pressing the and

Shift+ left mouse button we can restore more units.


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5.1.28 ST, QT, QTc graph

Invalidate selected interval

We can select an interval in the QT, QTc and AT graphs by pressing and holding the

Shift button while clicking the left mouse button at one point of the ECG curve and

dragging the cursor to the desired point. When the selection has been made, these

intervals can be invalidated. This action has no effect on intervals which have already

been invalidated.

Result of the invalidation:

Restoring invalidated intervals

We can select an interval in the QT, QTc and AT graphs by pressing and holding the

Shift button while clicking the left mouse button at one point of the ECG curve and

dragging the cursor to the desired point. When the selection has been made, these

invalidated intervals can be restored. This action has no effect on valid intervals.

Deleting Min, Max values

We can select the desired parameter in the Event menu point, then click on the

button in case the selected value is not acceptable. Deleting can be repeated until an

acceptable result is received.


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5.1.29 AF graph

Deleting AF sections

There are multiple options to delete AF sections.

One option is to delete by using the and the buttons. Clicking on the button

deletes the AF section on which the ruler is placed at the moment, while clicking on the

button deletes all AF sections.

Another option is to select a desired interval by pressing and holding the Shift button

while clicking the left mouse button at one point of the ECG curve and dragging the

cursor to the desired point. When the selection has been made, the software prompts us

to answer a question concerning what to do with the selected section next. In case we

decide to mark the selected section not as fibrillation, all the corresponding AF sections

will be deleted. The automatic analysis stops indicating AF on manually deleted AF

sections, but we can rename any section as AF manually.

Rename section as AF

Select a desired interval by pressing and holding the Shift button while clicking the left

mouse button at one point of the ECG curve and dragging the cursor to the desired

point. When the selection has been made, the software prompts us to answer a question

concerning what to do with the selected section next. All manually selected AF sections

can be deleted.


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5.1.30 Deleting T alternans sections

There are multiple options to delete T alternans sections.

One option is to delete by using the and the buttons. Clicking on the button

deletes the T alternans section on which the ruler is placed at the moment, while

clicking on the button deletes all T alternans sections.

Another option is to select a desired interval by pressing and holding the Shift button

while clicking the left mouse button at one point of the ECG curve and dragging the

cursor to the desired point. When the selection has been made, the software prompts us

to answer a question concerning what to do with the selected section next. In case we

decide to mark the selected section not as T alternans section, all the corresponding T

alternans sections will be deleted. On the manually deleted T alternans sections the

automata analyses does not show more T alternans, but manually the T alternans may be

marked to any place.

Insert the T alternans sections

Select a desired interval by pressing and holding the Shift button while clicking the left



concerning what to do with the selected section next. If we choose this section, as T

alternans section, the T alternans mark will appear on it. Manually marked T alternans

section may be deleted according to ones demand.


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5.1.31 Noise window

Invalidate selected interval

We can select an interval by pressing and holding the Shift button while clicking the left



concerning what to do with the selected section next. In case we decide to mark the

selected section as noise the software marks all pertaining QRS complexes as noise,

which means they will be excluded from further analysis.

Result:

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Restoring invalidated intervals

We can select an interval by pressing and holding the Shift button while clicking the left



concerning what to do with the selected section next. In case we decide to mark the

selected section as not noise the software restores all pertaining QRS complexes, which

means that they will be included in further analysis.

Calculation and Evaluation methods - EKG

Heart rate (HR graph, Avg HR min, Avg HR max, ECG widow)

𝐴𝑣𝑔 𝐻𝑅 =1000 ∗ 60

∑ 𝑅𝑅𝑖10𝑠

AvgHR is computed from RR intervals in every 10s interval.

𝐴𝑐𝑡 𝐻𝑅 =1000 ∗ 60

∑ 𝑅𝑅𝑖𝑤𝑖𝑛𝑑𝑜𝑤

ActHR is computed from the ECG stream on display.

Corrected QT (Bazett formula)

𝑄𝑇𝑐 =𝑄𝑇

√𝑅𝑅

ST level

ST = ECG[J+] - ECG[Izo]

Turbulence calculation

Determining valid VES beats

There are at least 3 sinus beats before the VES

There are at least 20 sinus beats after the VES

RR0 <= 0.8 * RR-1,

RR1 >= 1.2 * RR-1,


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The heart rate in the pertinent section falls into the HR range which can be set

in the Settings menu

Calculation of Reference RR: RRref = ∑ 𝑅𝑅𝑖

20𝑖=15

5

VES is omitted when any RR interval (except RR0 and RR1) is

< 300ms,

2000ms,

RRi-RRi-1 > 300ms,

RRi / RRref > 1.2 or RRi / RRref < 0.8

Averaging RR intervals

Average RR intervals are computed from RR intervals before and after the valid VES

beats in every hour.

Calculating Turbulence onset

𝑇𝑢𝑟𝑏𝑢𝑙𝑒𝑛𝑐𝑒 𝑜𝑛𝑠𝑒𝑡 = (𝑅𝑅1 + 𝑅𝑅2) − (𝑅𝑅−2 + 𝑅𝑅−1)

(𝑅𝑅−2 + 𝑅𝑅−1)

RR-2 RR-1 RR0 RR1 RR2

N N N V N N

Calculating Turbulence slope

The maximal positive slope of an average of 5 sinus beats occurring after RR1

(compensatory pause) applied to one beat.

Mathematical methods applied for calculating multiple parameters

Calculation criteria for VES and SVES events

VE – Ventricular Beat (V)

One ventricular beat.

VCPL – Ventricular Couplet

Two successive ventricular beats where the heart rate is bigger than or equal to the

ventricular tachycardia parameter set in the Settings / Parameters / ECG-Rhythm menu.

VRUN – Ventricular Run

Three successive ventricular beats where the heart rate is bigger than or equal to the

ventricular tachycardia parameter set in the Settings / Parameters / ECG-Rhythm menu.

VBIG – Ventricular Bigeminy


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A series of subsequently alternating ventricular and dominant beats.

VTCH – Ventricular Tachycardia

Four or more successive ventricular beats where the heart rate is bigger than or equal to

the ventricular tachycardia parameter set in the Settings / Parameters / ECG-Rhythm

menu.

RonT

The ventricular beat is closer to the preceding non-ventricular beat than the parameter

set in the Settings / Parameters / ECG-Rhythm menu.

SVE – Supraventricular beat (S)

Premature heartbeat which occurs earlier than the average RR interval calculated from

the five preceding dominant beats. (The limit can be set in Settings / Parameters / ECG-

Rhythm menu’s SVPB limit parameter. The bigger the value, the fewer SVE events we

get.)

SVCPL – Supraventricular Couplet

The heart rate calculated from the interval of two consecutive heartbeats is bigger than

or equal to the Paroxismal Tachycardia parameter set in the Settings / Parameters /

ECG-Rhythm menu and it has increased by the value of Paroxismal Tachycardia

Increase set in the Settings / Parameters / ECG-Rhythm menu .

SVRUN – Supraventricular Run

The heart rate calculated from the interval of three consecutive heartbeats is bigger than

or equal to the Paroxismal Tachycardia parameter set in the Settings / Parameters /

ECG-Rhythm menu and it has increased by the value of Paroxismal Tachycardia

Increase set in the Settings / Parameters / ECG-Rhythm menu .

SVTCH – Paroxismal Supraventricular Tachycardia

The heart rate calculated from the interval of four or more consecutive heartbeats is

bigger than or equal to the Paroxismal Tachycardia parameter set in the Settings /

Parameters / ECG-Rhythm menu and it has increased by the value of Paroxismal

Tachycardia Increase set in the Settings / Parameters / ECG-Rhythm menu .

PAUSE

The time between two heartbeats reaches or exceeds the Pause limit set in the Settings /

Parameters / ECG-Rhythm menu.


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Interpretation of HRV time domain parameters

(Reference: Circulation 1996, 93:1043-1065, 1996 American Heart Association Inc.)

NN interval

The interval between two consecutive normal beats. The dominant QRS complexes are

interpreted as Normal-N beats.

NN min

The shortest NN interval measured in the record.

NN max

The longest NN interval measured in the record.

NN avg

The sum of NN intervals divided by the number of normal beats.

N-Normal beats

The number of normal beats during in the record.

SDNN

The standard deviation of NN intervals in relation to the total recording time. The

individual NN intervals must be counted during measurement time. The NN

distribution function is obtained by representing these values, by calculating the

standard deviation of which the SDNN values measured in ms are obtained. As the

SDNN value greatly depends on measurement time, it is recommended to calculate it

for 24 hours every time. In addition, it is the only way to interpret properly the

comparison of the data with normal values represented in the reference, because these

values refer to 24-hour recordings. (Normal range for 24 hours is: 102 – 180 ms)

SDANN

Standard deviation of the averages of NN intervals in every 5-minute segment of the

entire recording. The NN intervals are averaged for every five minutes, and the

distribution function is obtained by representing the frequency of the averages. The

SDANN parameter is obtained by calculating the standard deviation. (Normal range for

24 hours: 92 - 162 msec)

RMSSD

The squares of the differences between consecutive NN intervals are added up, divided

by the number of the intervals, and taken the square root of.

This value is the RMSSD calculated for the total measurement time. (Normal range for

24 hours: 15 - 39 msec)


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SDNNi

The standard distribution of NN represented is calculated for every five minutes; the

values are added up and averaged for the total measurement time.

SDSD

Standard distribution of differences between consecutive NN intervals.

The distribution of the difference between consecutive NN intervals is represented, the

SDSD parameter is obtained by calculating the standard deviation, which is interpreted

for the total measurement time.

pNN50

The value of pNN50 parameter in percentage is obtained by counting the consecutive

NN interval couplets having a difference greater than 50 msec, dividing it with the total

count of NN intervals, and multiplying by 100.

HRVTi

Approaching the RR distribution linearly represented with a triangle that covers the

given distribution as fully as possible. The HRVTi parameter is obtained by calculating

the differences between the intersections of the given triangle and the time axis.

Interpretation of HRV frequency range parameters

(Reference: Circulation 1996, 93:1043-1065, 1996 American Heart Association Inc.)

Total power [ms2]:

Efficiency spectrum 0.03125 – 0.40625 Hz

LF [ms2]:

Efficiency spectrum in the low frequency range 0.03125 – 0.15625 Hz

HF [ms2]:

Efficiency spectrum in the high frequency range 0.15625 – 0.40625 Hz

Normalized values

𝐿𝐹𝑛[%] =100 ∗ 𝐿𝐹

𝐿𝐹 + 𝐻𝐹

𝐻𝐹𝑛[%] =100 ∗ 𝐻𝐹

𝐿𝐹 + 𝐻𝐹

The parameters are calculated according to the Wavelet Packets method.


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Mathematical methods applied for calculating parameters

Standard deviation

𝑆𝐷 = √∑ (𝑋𝑖 − 𝑀)2𝑁

𝑖=1

𝑁

Root Mean Square

𝑅𝑀𝑆 = √∑ (𝑋𝑖)2𝑁

𝑖=1

𝑁

Pacemaker report automatic detection

The program automatically detect s pacemaker record, it is detects the pacemaker pins

even if the type of the pacemaker was not set in the database. The user can accept this or

revise the report as not pacemaker record.

The program detects that if the record does not contain pacemaker data but the

pacemaker device has selected in patient data. In this case the program offering setting

modification

If the modification has been accepted, the settings of pacemaker device changes and a

new analyzing will be performed.

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P-curve analyse

The Cardiospy is able to detect the P-curve ave hence new functions became available.

Calculation and Evaluation methods - BP

Pulse Pressure

〖PPi= Sys〗_i- 〖Dia〗_i

Medium Arterial Pressure

〖〖MAP〗_i=Dia〗_i+(〖Sys〗_i- 〖Dia〗_i)/3

Diurnal Index

Diurnal Index= (〖Data〗_(Awake,mean)-〖Data〗_(Asleep,mean))/〖Data〗_(Awake,mean)

where Data: Sys, Dia.

Hyperbaric Impact

Hyperbaic Impact=24* (∑_(i=1)^N▒〖〖(Data〗_i- 〖Norm〗_i)* 〖Time〗_i

〗)/(∑_(i=1)^N▒〖Time〗_i )

where Datai: Sysi, Diai

Normi the normal value related to the measurement (set in Settings)

Timei the represented time of the measurement


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〖Time〗_i= (〖(T〗_i-T_(i-1))+ 〖(T〗_(i+1)-T_i))/2

where Ti = the time of the measurement

Double Product

Double Product=Sys*HR

Dipper Status

Dipper[%]= 100*(1-〖Sys〗_(Asleep,mean))/〖Sys〗_(Awake,mean)

Meaning:

Dipper Dipper Status

< 0 Reverse Dipper

0-10% Non-Dipper

10-20% Dipper

>20% Extreme Dipper

Morning Surge

Morning Surge is medically defined as the difference in systolic blood pressure during

the first two hours after awakening and the lowest level recorded during the day. The

greater the difference the more likely is the risk of stroke.

(Article Source: http://EzineArticles.com/3086388)

AASI (Ambulatory Arterial Stiffness Index)

AASI=1-Slope

where Slope = Diastole – Systole graph (Scatter) steepness of the regressive line.


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6 Troubleshooting and Maintenance

Error / Event What to do?

BATTERY ERROR Batteries are not properly charged in the

recording unit. Please use well-charged

batteries.

LEAD OFF ERROR

Please place the lead back properly.

COMMUNICATION ERROR Please check if the connection between the

recorder unit and computer is working

properly.

NOISE ARTIFACTS ON ECG

SIGNAL

Please check if all the electrodes are

securely attached to the patient. The

electrodes must be applied with sufficient

care and expertise in order to make good

quality recording.

SELECTED PAGE CAN NOT BE

PRINTED

Check if the printer selected is turned on. If

you have selected a local printer, check if it

is connected to the computer.

RECORDER DOES NOT RECORD

FOR 24 HOURS

Please make sure that you use well-charged

batteries. Recharge the batteries only with

the supplied battery charger according to the

enclosed instructions. Please use batteries

only of the same type and capacity.

Please connect the patient cable to the

Recorder.

Please Read the latest record.

Please connect the appropriate patient cable

to the recorder unit.

Please check if the batteries are charged

properly.

ECG HOLTER SYSTEM TROUBLESHOOTING AND MAINTENANCE

LABTECH LTD. V5.03_2014_11 99


Please connect the appropriate patient cable

to the recorder unit. The compatibility of

cables depends on the type of recorder being

used.

The recorder is connected to the USB port.

Recording has started successfully.

Recording has stopped.

Please read the latest record.

You cannot start new recording unless you

have read the latest record.

It is the start-up screen of the recorder,

indicating the recorder configuration type.

ECG sign, which appears on the recorder’s

display during the monitoring process.

The recorder starts.


100 V5.03_2014_11 LABTECH LTD.


A message which appears in the upper part

of LCD in case of informing.

A message which appears in the upper part

of LCD in case of warning.

You may see this screen when the recording

is in progress.

This error appears when the recorder is

connected to the PC with flat or no batteries.

Please disconnect the recorder from PC,

place well-charged batteries in the recorder.

After clicking on the Scan and fix line, the

program will automatically fixes this

problem and the message will not appear

any more.

In cases of reading failure, card error,

message of invalid record please put full-

charged battery into the device and wait till

the recorder fixes the card. then, repeat the

reading process.


LABTECH LTD. V5.03_2014_11 101

Further steps

If the above description does not solve the problem, please send an e-mail with the

following

PLEASE DESCRIBE THE FAULT:what has happened.

- SEND A BLACKBOX: Cardiospy Blackbox: after the installation you can find a

Generate black box shortcut under the Start Menu / Labtech / Cardiospy/ . Please send

the blackbox file to our e-mail address.

- SEND A REPORT ABOUT THE FAULT: Export the report from Cardiospy program

(Patient menu – Import Export – export record), and send us the record. If the record is

too big (more than 2-4mb) ask for our ftp details via our e-mail address

-SEND SCREENSHOT ABOUT THE FAULT: You can make it with Print Screen

button, then import it to Paint with CTRL+Vand save the file.

Maintenance and Calibration

If the ECG device is used according to the preset parameters as prescribed, there is no

need for calibration or maintenance.

The case of the recorder unit may be cleaned, if necessary.

The accuracy of controls is assured by using long lasting parts and techniques that are

able to preserve their accuracy during the life cycle of the product.

Calibration of the ABPM (blood pressure) has to be carried out from time to time as

prescribed by the relevant standards. To ensure calibration is performed according to the

relevant standards, please return the device to Labtech Ltd. where we will perform

calibration free of charge.

The accuracy of controls is assured by using long lasting parts and techniques that are

able to preserve their accuracy during the life cycle of the product.

Suggestions to preparing a measuring set and carrying out calibration:

Place well-charged batteries into the device.

Place the cuff on an artificial arm (for example on a plastic pipe with a

diameter of 6-12 cm).

Connect a manometer as a reference device to the recorder according to the

figure below. It is essential that the manometer should be calibrated and able to

take measurements within the range of 0-300 mmHg (used at blood pressure

measuring)


102 V5.03_2014_11 LABTECH LTD.

Select a patient in the Holter program (Database / Patients), then press New

Record button

Place the INFRA window of the recorder in front of the USB INFRA interface

unit then press BP START button

Wait until the device inflates the cuff

During deflation, please read and write down the pressure values shown by the

Holter program and the reference device. Since the ABPM deflates gradually

you can read the values of the same step from both displays.

By comparing the pressure values you can determine whether the accuracy of

the ABPM is satisfactory or not.

If non-accurate the calibration has to be done by the manufacturer.


LABTECH LTD. V5.03_2014_11 103

The device inflates the cuff normally to 160 mmHg. If you would like to calibrate at a

higher pressure, you have to knock the cuff continuously by hand during the inflation

process so as to cheat on the device as if the systolic value were high. This way the

device will inflate the cuff with higher pressure.

The case of the recorder unit may be cleaned or washed if necessary.

Cleaning of device and patient cable

Do not dip the device in liquid, for device-cleaning use moistened wipes with a

moderate acting (not agressive) disinfectant or cleaning agent. Liquid getting inside of

the device can cause electric failures! All cleaning agents are suitable for cleaning

which are also suitable for cleaing human skin. Length of patient cable: 65-85 cm.


104 V5.03_2014_11 LABTECH LTD.

Directive and manufacturer declaration on electromagnetic disturbance emission

EC-1H, EC-2H, EC-3H, EC-12H devices were produced to be used under the enlisted

electro-magnetic. The buyer or user of EC-1H, EC-2H, EC-3H, EC-12H devices

should assure that it should operate under such condition

Disturbance emission test Conformity Electromagnetic environment

directive

RF emissions

CISPR 11

2. group EC-1H, EC-2H, EC-3H,

EC-12H devices intentionally

emit electromagnetic energy

during operation. It can disturb

the electronic

RF emission

CISPR 11

B class EC-1H, EC-2H, EC-3H,

EC-12H is suitable to be used

in all kind of environment,

including houses and facilities

supplying housings, directly

related to public low voltage.

harmonic emission

IEC 61000-3-2

Not applicable

Voltage changes/flicker

emission

IEC 61000-3-3

Not applicable


LABTECH LTD. V5.03_2014_11 105





Disturbance

emission test

IEC 60601

test level

Conformity

level

Electromagnetic

environment directive

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 6 kV contact

± 8 kV

breakdown

± 6 kV contact

± 8 kV

breakdown

The floor must be wooden,

concrete or ceramic. If the

floor is covered with

synthetic material, the

relative humidity must be

minimum

Network

frequency (50/60

Hz) magnetic field

IEC 61000-4-8

3 A/m 3 A/m The network frequency

magnetic field level should

be equal with the

commercial or hospital

level


106 V5.03_2014_11 LABTECH LTD.





Disturb

ance

emissio

n test

IEC 60601

test level

Confor

mity

level

Electromagnetic environment directive

Transmi

tted RF

IEC

61000-

4-3

3 V/m

80 MHz –

2,5 GHz

3 V/m Portable and mobile RF devices must not be

used in the defined in the protective distance

depending on the formula based on EC-1H,

EC-2H, EC-3H, EC-12H, their cabling and the

transmitter.

Recommended protective

d = 1,17 . P

0,5 80 MHz – 800 MHz,

d = 2,33 . P

0,5 800 MHz – 2,5 GHz,

P is the largest transmitting performance given

by the manufacturer in Watt (W), and is the

recommended protective distance in meter (m).

The field strength defined by site measurement

and emerging from installed RF should be lower

than the conformity level defined for the

frequency range. The below marking indicates

eventual disturbance.

1. NOTE: IN CASE OF 80 MHz AND 800 MHz the higher frequency range should be

applied


LABTECH LTD. V5.03_2014_11 107

2. NOT These directives cannot be applied in all cases. Electromagnetic expansion is

influenced by the absorption and reflexion caused by buildings, objects and people.

a Fixed, installed transmitters (cell/wireless) mobile phones and land mobile radio base

stations, amateur radios, AM and FM radio and TV broadcast field strength cannot be

forecasted exactly in a theoretical. In order to know the electromagnetic environment

of installed RF transmitters you need measurement on the spot. In case the measured

field strength of EC-1H, EC-2H, EC-3H, EC-12H exceeds the relevant RF conformity

you should control whether the system operates. In case disturbance can be

experienced, you should take measures, like turning the EC-1H, EC-2H, EC-3H, EC-

or installing it on another location.

b In the range above 80 MHz the field strength should be lower than V/m.


108 V5.03_2014_11 LABTECH LTD.

Recommended protective distances between portable and mobile RF

telecommunication devices and EC-1H, EC-2H, EC-3H, EC-12H

EC-1H, EC-2H, EC-3H, EC-12H were made to be used in such electromagnet

environment, in which the RF disturbances are under control The user or customer of

EC-1H, EC-2H, EC-3H, EC-12H can help to avoid electromagnetic disturbance by

defining the smallest protective distance between portable, mobile and RF transmitters

and EC-1H, EC-2H, EC-3H, EC-12H depending on the largest output

the largest output

performance of

the transmitter

W

Protective distance depending on transmitter

m

150 kHz – 80

MHz

d = 1,17 . P

0,5

80 MHz – 800

MHz

d = 1,17 . P

0,5

800 MHz – 2,5

GHz

d = 2,33 . P

0,5

0,01 0,12 0,12 0,23

0,1 0,37 0,37 0,74

1 1,17 1,17 2,33

10 3,70 3,70 7,37

100 11,70 11,70 23,30

In case of transmitters that are not included in the table with given output frequency the

recommended protective distance (m) “d” be defined by an equation where P is the

largest given output transmitter performance in Watt (W).

1. NOTE: In case of 80 MHz and 800 MHz the higher (upper) frequency range should

be applied

2. NOTE: These directives cannot be applied in all cases. Electromagnetic expansion

can be influenced by absorption and reflexion caused by buildings, objects and people.

ECG HOLTER SYSTEM TECHNICAL SPECIFICATIONS

LABTECH LTD. V5.03_2014_11 109

7 Technical Specifications

Specification table of holter recorders (EC-2H; EC-3H; EC-12H)

Type of Holter Recorders EC-1H EC-2H EC-3H EC-12H

Bipolar ECG Channels 1 1, 2 1, 2, 3 1, 2, 3

Other ECG Channels - - +PM,

NEHB

+PM

Classic 12

CH,

NEHB,

Frank

Number of snap type Leads 3 3,5 3, 4, 5, 7 3, 4, 5, 7, 10

Recording Period (hours) 24,48, 72 h

1 week

24, 48, 72

h

24, 48, 72 h 24, 48 h

The accumulator can be

changed during recording

Yes

Dynamic Bandwidth (min) ±20 mV

DC Offset Range (min) ±800 mV

Frequency Response (max) 0.05 Hz … 150Hz

Sampling Rate 256 Hz … 2048 Hz

Recording Rate 128 Hz … 1024 Hz

Common Mode Rejection

Ratio (min)

120dB

A/D Resolution 16 bit

Input impedance (min) 100 M

Power Source 1x1.2 V AAA NiMH accumulator

(or 1x1.5 V AAA alkaline battery)

Battery Life (min) 24 hours

Storage Card Capacity 2GB (uSD)

SPECIFICATION TABLE OF HOLTER RECORDERS (EC-3H/ABP) ECG HOLTER SYSTEM

110 V5.03_2014_11 LABTECH LTD.

Type of Holter Recorders EC-1H EC-2H EC-3H EC-12H

Internal Voltage (max) 3.3 V

Display LCD (Grey Scale 160x100 pixels) or LED

Movement detection-3D Yes

Monitoring ECG On PC via Bluetooth and if available, on LCD as well

Reading Record via USB 2.0

International Protection

Rating Against Water: IPX4

Yes

Size 53 mm * 67.5 mm * 18.5 mm

Weight ~ 50 g

Specification table of holter recorders (EC-3H/ABP)

Technical specification I.

Bipolar ECG Channels 1, 2, 3

Other ECG Channels NEHB +PM

Number of snap type Leads 3, 4, 5, 7

Recording Period (hours) 24, 48, 72 h

The battery can be changed

during recording Yes

Dynamic Bandwidth (min) ±20 mV

DC Offset Range (min) ±800 mV

Frequency Response (max) 0.05 Hz … 150Hz

Sampling Rate 256 Hz … 2048 Hz

Recording Rate 128 Hz … 1024 Hz

Common Mode Rejection

Ratio (min) 120dB


LABTECH LTD. V5.03_2014_11 111

Technical specification I.

A/D Resolution 16 bit

Input impedance (min) 100 M

Power Source

2 x 1.2 V AA rechargeable batteries of minimum

2500 mAh capacity or 2 x 1.5V AA high quality

alkaline batteries

Battery Life (min) 24 hours

Storage Card Capacity 2GB (uSD)

Internal Voltage (max) 3.3 V

Movement detection-3D Yes

Monitoring ECG On PC via Bluetooth

Reading Record via USB 2.0 ( USB A – HDMI )

International Protection

Rating Against Water: IPX4 Yes

Size Approx. 125 x 70 x 33 mm

Weight Approx. 250 g (incl. Batteries)

Technical specification II.

BP measurement

method:

Oscillometric with step deflation, Diastolic values correspond to

Phase 5 Korotkoff Sounds

BP measurement

range: 25 – 260 mmHg (max inflate 300 mmHg)

Pressure

Transducer

Accuracy:

± 3 mmHg

Pulse Rate

Range: 30 – 220 BPM (Beats Per Minute)

SPECIFICATION TABLE OF HOLTER RECORDERS (EC-3H/ABP) ECG HOLTER SYSTEM

112 V5.03_2014_11 LABTECH LTD.

Pulse Rate

Accuracy: ± 2% or ±3 BPM, whichever is greater

Calibration: The device should be verified on a yearly interval.

Safety Systems:

Max. inflation pressure is limited to 300 mmHg;

Auto safety release valve for power failure.

Maximum cuff inflation time is limited to 75 seconds.

Duration of blood pressure reading is limited to 130 seconds.

Clinical

Accuracy:

Meets accuracy requirements of ANSI/AAMI

SP10:2002(R)2008, EN1060-4:2004 and ISO

81060-2:2009.


LABTECH LTD. V5.03_2014_11 113

Recording time T

yp

e o

f E

CG

ca

ble

Sample rate frequency

128Hz 256Hz 512Hz 1024Hz M

ax

imu

m

len

gth

of

reco

rdin

g

Req

uir

ed

ba

tter

ies

Ma

xim

um

len

gth

of

reco

rdin

g

Req

uir

ed

ba

tter

ies

Ma

xim

um

len

gth

of

reco

rdin

g

Req

uir

ed

ba

tter

ies

Ma

xim

um

len

gth

of

reco

rdin

g

Req

uir

ed

ba

tter

ies

1CH 168 h 4 pc 24 h 1 pc 24 h 2 pc 8 h 1 pc

2CH 72 h 2 pc 24 h 1 pc 24 h 2 pc 8 h 1 pc

NEHB 72 h 2 pc 24 h 1 pc 24 h 2 pc 8 h 1 pc

3CH 72 h 2 pc 24 h 1 pc 24 h 2 pc 8 h 1 pc

12CH 48 h 2 pc 24 h 2 pc 24 h 2 pc 8 h 1 pc

BASIC FUNCTIONS OF DIFFERENT HOLTER SYSTEMS ECG HOLTER SYSTEM

114 V5.03_2014_11 LABTECH LTD.

Basic functions of different holter systems

Functions EC-1H EC-2H EC-3H EC-12H

Compatible Holter Recorders

(Channels)

1 1, 2 1, 2, 3 1, 2, 3, 12

Features without USB-02 Bluetooth interface

- Make new record using

recorder display

- Raw ECG visualization after

reading to PC

- Send Raw and receive evaluated

record

- Visualization of evaluated

record on PC

- Archiving

- Printing

+ + + +

Features with non-validated USB-02/A Bluetooth interface

- Make new record using

recorder display

- Raw ECG visualization after

reading to PC

- Send Raw and receive evaluated

record

- Visualization of evaluated

record on PC

- Archiving

- Printing

+ + + +


LABTECH LTD. V5.03_2014_11 115

Features with validated USB-02/B Bluetooth interface

- Make new record and read

record to PC

- ECG Filtering

- QRS Detection

- HR and ST Graphs

- Arrhythmia Analysis (N,S,V)

- Full ECG Visualization

- Event Viewer

- Colour-coded event marking

- Detailed ECG Visualization

- Adjustable parameters for

analysis

- Report Edition

- Archiving

- Printing

- Database

- Interfaces – GDT, DICOM, HL-

7

- Editing Options:

measuring possibility on the

ECG

insert and delete QRS

rename QRS

mark noisy intervals

delete single/group events

+ + + +

ADDITIONAL FUNCTIONS OF DIFFERENT HOLTER SYSTEMS ECG HOLTER SYSTEM

116 V5.03_2014_11 LABTECH LTD.

Additional functions of different holter systems

Function EC-1H EC-2H EC-3H EC-

3H/ABP

EC-12H

Motion Detection + + + + +

QRS Template

Classification

+ + + +

QT Analysis + + + +

HRV Time Domain + + + +

HRV Frequency Domain + + +

Pacemaker Analysis + + +

Atrial Fibrillation Analysis + + +

Vector cardiography + + +

T Alternant +

HR Turbulence Analysis +

Breathing Detection +

ECG HOLTER SYSTEM PATIENT DIARY

LABTECH LTD. V5.03_2014_11 117

8 Patient Diary

Institution (name, address):

Consultant:

Patient’s Name:

Date of Birth: Day: Month: Year:

Please keep the following rules during holter monitoring:

- Do not take off the device during the recording.

- Avoid any work causing intensive perspiration.

- Keep away the electrodes and the recording unit from water and intensive heat.

- Do not take the device in explosive surrounding.

- Do not use the device in strong electric field.

- In case of dizziness or any other complaint, push the event button and make a note in

the diary.

- Please diarize the events as detailed as possible! Please write into the appropriate row

the number of activity at that time and if you had complaints, then write that number,

too. If the activity or complaint is not listed under the table, then please write it into the

table in legible form.

- The time of taking drugs, the name and quantity should be written in the following

table as well.

HOW TO FILL IN THE DIARY: In case you feel any complaint, please put a number

from the Activity and from the Complaint column in the table below. The chosen

numbers should reflect your current activity and complaint. Put them in the line which

shows the current time. The time should be obtained from the digital clock on the

monitor and not the patient’s watch or any other clock.

ADDITIONAL FUNCTIONS OF DIFFERENT HOLTER SYSTEMS ECG HOLTER SYSTEM

Page: 118 / 118 2011-v5.01

CHOOSE

Activities

and

Complaints

Activity Complaint

1. Work at workplace 1. Breathlessness

2. Housework 2. Quick heartbeats (Tachycardia)

3. Walking 3. Irregular heartbeats

4. Sleeping 4. Dizziness

5. Travelling 5. Nausea

6. Rest 6. Chest pain

7. Other (please, name it) 7. Other (please, name it)

Time Daily Activity Complaints

800

-900

900

-1000

1000

-1100

1100

-1200

1200

-1300

1300

-1400

1400

-1500

1500

-1600

1600

-1700

1700

-1800

1800

-1900

1900

-2000

2000

-2100

2100

-2200

2200

-2300

2300

-000

000

-100

100

-200

200

-300

300

-400

400

-500

500

-600

600

-700

700

-800

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