Stress Test ECG System - Meditech · During an examination made by the Stress Test ECG system, ... The recorder may be used simultaneously with a high frequency surgical device, in

LABTECH LTD. MADE IN HUNGARY

Stress Test ECG System

Cardiospy® User Manual

for EC-12R/S; EC-12S recorder

LABTECH LTD.

Address 4031 Debrecen Vág utca 4. HUNGARY

E-mail [email protected]

Tel +36-52-310-128

Fax +36-52-412-023

INTRODUCTION STRESS TEST ECG SYSTEM

2 V5.03_2014_11 LABTECH LTD.

1 Introduction

Dear Customer,

Thank you for purchasing our 12 Channel Stress Test ECG System. We sincerely wish

that our product would help your diagnostic and therapeutic work. Please, read the user

manual carefully regarding the use of the ECG System and the computer programs! You

can also read this User Manual in the software in several languages (in Help menu). A

basic knowledge of computers and Windows based applications is expected.

What is a Stress Test ECG system?

The small sized, compact built ECG device with the attached Software connected to a

PC builds a 12-Channel Stress Test ECG system. You also need a loading device and

blood pressure monitor to make a Stress Test examination.

How is a Stress Test ECG system used?

During an examination made by the Stress Test ECG system, the patient is examined for

about 15-20 minutes. During this time, the patient has to do some exercises on a loading

device (ergometer, treadmill or master step) in order to significantly increase his heart

rate.

The evaluation of data is aided by the interpretation system of the software. The devices

can be operated in network and the patient data are available from a common database..

Quality certifications

The CE mark indicates that it meets the essential

requirements of European Council Directive 93/42/EEC

concerning medical devices.

Labtech operates a quality system certified to ISO 9001:2008

and ISO 13485:2003.

STRESS TEST ECG SYSTEM INTRODUCTION

LABTECH LTD. V5.03_2014_11 3

We wish you success in the use of our resting ECG system.

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

LABTECH LTD.

Address 4031 Debrecen Vág utca 4. HUNGARY

E-mail [email protected]

Tel +36-52-310-128

Fax +36-52-412-023

TABLE OF CONTENTS STRESS TEST ECG SYSTEM

4 V5.03_2014_11 LABTECH LTD.

2 Table of contents 1 INTRODUCTION ................................................................................................................. 2

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

3 PREPARATIONS ................................................................................................................. 6

3.1 List of accessories ........................................................................................................ 6

3.2 Instructions for starting a Stress Test ECG recording ................................................ 10

3.3 Warnings and Contraindications: ............................................................................... 10

4 INSTRUCTIONS ................................................................................................................ 13

4.1 EC-12R/S (Bluetooth) Recorder Components ........................................................... 13

4.2 EC-12S (Bluetooth) Recorder Components ............................................................... 14

4.3 Database management interface ................................................................................ 16

4.3.1 Toolbar.................................................................................................................. 16

4.3.2 List of patients ...................................................................................................... 20

4.3.3 Records toolbar ..................................................................................................... 21

4.3.4 List of records ....................................................................................................... 22

4.3.5 Selected System .................................................................................................... 22

4.3.6 Filters .................................................................................................................... 23

4.3.7 Search ................................................................................................................... 23

4.3.8 Database information ............................................................................................ 23

4.4 How to start a new recording ..................................................................................... 24

4.4.1 Connecting ECG device ........................................................................................ 24

4.4.2 Connecting the stress device ................................................................................. 24

4.4.3 Patient preparation ................................................................................................ 27

4.4.4 New recording in stress test mode ........................................................................ 30

4.5 Stress test ECG mode display .................................................................................... 32

4.6 Toolbar ...................................................................................................................... 36

4.6.1 Start monitoring .................................................................................................... 36

4.6.2 Mode ..................................................................................................................... 36

4.6.3 ECG leads ............................................................................................................. 36

4.6.4 Filters .................................................................................................................... 38

STRESS TEST ECG SYSTEM TABLE OF CONTENTS

LABTECH LTD. V5.03_2014_11 5

4.7 Settings ...................................................................................................................... 39

4.7.1 Print Report ........................................................................................................... 41

4.7.2 Print current sample .............................................................................................. 41

4.7.3 Export the Report .................................................................................................. 41

................................................................................................................................ 41

4.7.4 Automatic report ................................................................................................... 42

4.7.5 Printing and export settings ................................................................................... 43

4.7.6 Help ....................................................................................................................... 47

4.7.7 Paper speed ........................................................................................................... 47

4.7.8 Amplitude ............................................................................................................. 47

5 EDITING AND MEASUREMENT POSSIBILITIES ....................................................... 48

5.1 Arrhythmia analysis in resting and stress test ECG systems ...................................... 48

5.2 Edit and delete ectopic events .................................................................................... 50

5.3 Ruler .......................................................................................................................... 51

5.4 Weber function classification ..................................................................................... 51

5.5 Bayes' theorem in the analysis ................................................................................... 52

5.6 Duke – nomogram ..................................................................................................... 52

5.7 Borg rank ................................................................................................................... 54

5.8 QRS frontal axis......................................................................................................... 54

5.9 Exercise and condition plan ....................................................................................... 54

6 ERROR CORRECTION, MAINTENANCE ...................................................................... 56

6.1 USB-02 signs and error messages .............................................................................. 56

6.2 ECG Recorder signs and error messages ................................................................... 57

6.3 General and communication failure ........................................................................... 57

7 TECHNICAL SPECIFICATIONS (EC-12R/S; EC-12S) .................................................. 62

8 HOT KEYS .......................................................................................................................... 65

PREPARATIONS STRESS TEST ECG SYSTEM

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3 Preparations

The table below shows which recorders can be used with each system.

EC-12R EC-12R/S EC-12S

Resting ECG X X X

Continuous ECG X X

Stress ECG X X

3.1 List of accessories

Please check the listed units and accessories before installing the Stress ECG System.

New

Code

No.

Code

No. Specifications

EC

-12

R/S

EC

-12

R/S

(Blu

eto

oth

)

EC

-12

S

(Blu

eto

oth

)

Picture

CAS-

012RS-

01

12RS-

V5-01

Case for

holding the

rest and stress

system

1 1 1

CAS-

00IRD-

01

12RS-

V1-01

Case for

holding the

IRDA and Old

type recorders

1 - -

ACC-

0SWCD-

01

12RS-

V5-02

CD with

installation

software

1 1 1

NOTE: BEFORE STARTING TO USE THE STRESS ECG SYSTEM YOU ARE EXPECTED TO

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

GUIDANCE ON THE INSTALLATION OF THE SYSTEM.

STRESS TEST ECG SYSTEM PREPARATIONS

LABTECH LTD. V5.03_2014_11 7

New

Code

No.

Code

No. Specifications

EC

-12

R/S

EC

-12

R/S

(Blu

eto

oth

)

EC

-12

S

(Blu

eto

oth

)

Picture

DEV-

0USBA-

02

12RS-

V5-03-A

USB-02/A

Bluetooth

Interface Unit

(rest and

stress; holter

monitoring)

- 1 1

DEV-

012RS-

04

12RS-

V5-04-A

EC-12R ECG

recorder unit 1 - -

DEV-

012RS-

05

12RS-

V5-04-B

ECG recorder

unit (EC-

12R/S

Bluetooth)

- 1 -

DEV-

0012S-

05

12RS-

V5-04-C

ECG recorder

unit (EC-12S

Bluetooth)

- - 1

BAG-

012RS-

01

12RS-

V5-05-A

Recorder bag

(EC-12R, EC-

12RS, non-

wireless)

1 - -

BAG-

012RS-

02

12RS-

V5-05-B

Recorder bag

(EC-12R, EC-

12RS, EC-

12S, wireless)

- 1 1

BEL-

00000-

01

12RS-

V5-06 Waist belt 1 1 1


8 V5.03_2014_11 LABTECH LTD.

New

Code

No.

Code

No. Specifications

EC

-12

R/S

EC

-12

R/S

(Blu

eto

oth

)

EC

-12

S

(Blu

eto

oth

)

Picture

CHA-

0004X-

01

12RS-

V5-07

Battery

charger MAXI - 1 1

BAT-

00000-

02

12RS-

V5-08

1.2V

Rechargeable

batteries (AA )

- 4 4

CUF-

00LAC-

31

LAC-

3.1*

Stress BP cuff,

Adult (25-

35cm)

- - 1

CAB-

00ECG-

01

12RS-

V5-09-D

12 CH

standard

patient cable

(D-SUB -

Snap

connector)

1 - -

CAB-

00ECG-

03

12RS-

V5-09-A

12 CH

standard

patient cable

(D-SUB -

Banana

connector)

- - -

CAB-

00L12-

05

12RS-

V5-09-C

12 CH

standard

patient cable

(HDMI-Snap

connector)

- 1 1

ELE-

00000-

01

12RS-

V5-11

Single-use

ECG

electrodes

1 1 1


LABTECH LTD. V5.03_2014_11 9

New

Code

No.

Code

No. Specifications

EC

-12

R/S

EC

-12

R/S

(Blu

eto

oth

)

EC

-12

S

(Blu

eto

oth

)

Picture

CAB-

00USB-

03

12RS-

V5-12-B

PC USB

cable, 5m

(USB A -

USB B)

1 1 1

CAB-

00USB-

01

12RS-

V5-15

Extension

cable for

USB-02

- 1 1

USR-

00000-

01

12RS-

V5-15-A

Installation

and Update

Guide 1 1 1

USR-

00000-

04

12RS-

V5-15-B

User manual

for rest and

stress systems

CAB-

00USB-

06

12RS-

V5-16

USB-SIO

cable (USB A

- D-SUB, for

ergometer,

treadmill)

1 1 1

BAG-

012RS-

04

12RS-

V5-17

Patient cable

bag 1 1 1

PAD-

00000-

01

12RS-

V5-21

Mouse pad

1 1 1

*The manufacturer maintains the right to change at any time.

* Children size LAC-1.1


10 V5.03_2014_11 LABTECH LTD.

Small adult size LAC-2.1

Adult size LAC-3.1

Adult + size LAC-4.1

Adult ++ size LAC-5.1

3.2 Instructions for starting a Stress Test ECG recording

A regular stress test is considered in the following circumstances:

Patients with symptoms or signs those are suggestive of coronary artery diseases

(CAD), with significant risk factors for CAD or with old or new ECG abnormalities.

- To evaluate exercise tolerance when patients have unexplained fatigue and

shortness of breath.

- To evaluate blood pressure response to exercise in patients with borderline

hypertension.

- To look for exercise-induced serious irregular heartbeats.

The examination is carried out by defined internationally accepted loading protocols –

using ergometer, treadmill, Master-step or Walking.

During the examination the physician pays particular attention to the heart rate, blood

pressure, changes in the ECG pattern, irregular heart rhythm, and the patient's

appearance and symptoms and even stops the test before the planned period of time –

which is generally 8-12 minutes, individualized according to the chosen protocol and to

the patient’s personal parameters – age, weight, etc.

The results of the test may help confirm or rule out a diagnosis of heart disease, perform

prognostication after myocardial infarction. In patients with known coronary artery

disease, the test will help confirm that the patient is in a stable state, or that a new

blockage is developing.

Contraindications of Stress Testing:

Unstable angina, untreated hypertonia, known serious coronary disease, danger of

serious arrhythmia, significant abnormalities in the Resting ECG records.

3.3 Warnings and Contraindications:

General warnings

Never use the recorder:

- in the presence of flammable anaesthetics or explosive surroundings

- in strong heat

- in strong electrostatic field

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


LABTECH LTD. V5.03_2014_11 11

- in wet conditions (the recorder is not waterproof)

Do NOT immerse the recorder in any fluid, it causes electrical failure!

Do NOT remove recorder covers - the recorder does not contain any parts which

could be serviced by users. Do not try to repair it, and do not repair it with someone

who has not received service-training or not authorized to do service.

Usage with other devices:

The system 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.

The ECG recorders are not defibrillator-protected! Never use with

non-implanted defibrillators!

Warnings and contraindications to blood pressure measurement:

- Do not use on patients known to be susceptible to bruising

- Do not attach the cuff to a limb being used for IV infusions. Pumping up the

cuff can block the flow of the infusion liquid which can harm the patient.

- If you change the accessories (Korotkoff microphone, balloon, pneumatic tube,

etc.) to any other than the ones which come from the manufacturer it can cause errors in

the measurements.

- The patient should be instructed on proper and safe removal of the cuff, in case

it fails to deflate.

- Check during test that the device is not causing long-term damage in the

patient’s blood circulation.

- Avoid compression or restriction of pneumatic tubes.

Possible Adverse Reactions:

- Allergic Exanthema (symptomatic eruption) in the area of the cuff Urticaria

(allergic reaction including raised edematous patches of skin or mucous membranes and

intense itching) caused by the fabric material of the cuff.

- Petechia (a minute reddish or purplish spot containing blood that appears in the

skin).

- Rumple-Leede phenomenon (multiple petechia) on the forearm.

- Idiopathic thrombocytopenia (spontaneous persistent decrease in the number of

platelets associated with hemorrhagic conditions).

- Phlebitis (inflammation of a vein).


12 V5.03_2014_11 LABTECH LTD.

Environmental conditions of storage and operation:

Temperature-range: -10-50oC

Relative humidity: 10-95% non-condensing

Air pressure-range: 700-1060 hPa

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.

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

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

CF type on patient‟s side

Date of manufacturing

Manufacturer

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

AND DISCONNECT THE UNIT FROM THE PATIENT.

STRESS TEST ECG SYSTEM INSTRUCTIONS

LABTECH LTD. V5.03_2014_11 13

4 Instructions

4.1 EC-12R/S (Bluetooth) Recorder Components

FRONT VIEW

REAR VIEW

Recorder status

indicating lamp Patient cable

- easy to replace -

- easy to replace -

Symbols

Recorder ’s

configuration type

Serial

number

Battery cover Battery

EC-12R/S

INSTRUCTIONS STRESS TEST ECG SYSTEM

14 V5.03_2014_11 LABTECH LTD.

4.2 EC-12S (Bluetooth) Recorder Components

FRONT VIEW

REAR VIEW

Recorder status

indicating lamp Patient cable

- easy to replace -

- easy to replace -

BP measurement

cuff with KO

microfone

Symbols

Recorder ’s

configuration type

Serial

number

Battery cover Battery


LABTECH LTD. V5.03_2014_11 15

The EC-12S Stress Test System offers built-in auscultation blood pressure

measurement, high precision sampling and quality ECG curves, automatic load control

and monitoring of HR, ST, ABP, MET, etc. parameters. The user-friendly analysing

program offers efficient and reliable measurements.

The EC-12R/S and EC-12S device could be fixed on the Loading device directly, in

order to make the Stress Test more comfortable to the patient:


16 V5.03_2014_11 LABTECH LTD.

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.

4.3.1 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


LABTECH LTD. V5.03_2014_11 17

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.


18 V5.03_2014_11 LABTECH LTD.

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.

- Select systems:


LABTECH LTD. V5.03_2014_11 19

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.


20 V5.03_2014_11 LABTECH LTD.

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

4.3.2 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.


LABTECH LTD. V5.03_2014_11 21

4.3.3 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.


22 V5.03_2014_11 LABTECH LTD.

- 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.

4.3.4 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.

4.3.5 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.


LABTECH LTD. V5.03_2014_11 23

4.3.6 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.

4.3.7 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.

4.3.8 Database information

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

and size of records contained, etc.


24 V5.03_2014_11 LABTECH LTD.

4.4 How to start a new recording

4.4.1 Connecting ECG device

After the installation of the Cardiospy software, connect the USB-02 interface into an

available USB slot on the computer (you can also use the extension cord for the USB-

02). A flashing green light indicates proper connection between the computer and the

ECG device.

If the USB-02 is connected to the computer you just need to check the connection with

the ECG device.

After connecting the ECG device to the computer, attach the electrodes to the patient

and connect the patient cable to the device. Please proceed to read the guide of electrode

placement (in chapter 2.3.1)

4.4.2 Connecting the stress device

Our Stress Test ECG system is developed with a general algorithm. It means that it is

able to control virtually any kind of ergometer, treadmill or master step available on the

market because the software is able to use several types of protocols.

The loading device must be installed according to the relevant user manual before using

it with this software.

You can select the type of the loading device you wish to use by the

Settings/Select Stress Device and Protocol… menu in the program.

Here you can test if the EC12 software found the ECG device and if so, what type of

device it is.


LABTECH LTD. V5.03_2014_11 25

Loading devices

Here you can select (by choosing „New”) which device you want to carry out the Stress

Test with. You can choose an ergometer, a treadmill, a Master-Step or a Walking.

Walking possibility: free walking, or PC Controlled Walking - which requires the five 5

boxes with leds to determine the patient's walking speed and the PC Controller device.

We built in two Master-Step loading methods, the conventional MS-Normal, and the

newly developed MS-RAMP, both of them are fully MET-oriented loading methods

The software is able to communicate with almost any kind of loading device. Please

select the type of your device from the list.

THE SELECT STRESS DEVICE AND PROTOCOL… MENU CAN BE USED IN PASSWORD-

CODED MODE AS WELL :

PASSWORD: 12345

CHANGING THE LOADING DEVICE AND THE PROTOCOL IS RECOMMENDED FOR

EXPERIENCED USERS, SO PLEASE BE CAREFUL DURING PERFORMING CHANGES.

HERE YOU MAY CHOOSE A SPECIAL ENDLESS RECORDING, WHICH GIVES YOU THE

POSSIBILITY FOR SEVERAL HOURS’ RECORDING WITHOUT USING STRESS DEVICES, WITH

BLOOD PRESSURE MEASUREMENTS AND HR, ST TRENDS DISPLAYING.


26 V5.03_2014_11 LABTECH LTD.

Loading Protocols

Here you can choose the protocol according to which you want to conduct the test. You

can choose a protocol from a predefined list (e. g. conventional) or use a user-specified

protocol (e.g. Custom, Special), which you can modify.

Preselected printing: You can set the intervals of the record that had been taken during

the test. You can set the printing during the test process. (In the end of printing interval,

the in end of the stages)

Blood Pressure Meter settings:

Here you can choose the blood pressure meter to be used. You can set the starting

protocol of the automatic blood pressure meters.

The Blood Pressure Monitor can be a separate one or an integrated part of the loading

device or the ECG device (EC-12S) as well.


LABTECH LTD. V5.03_2014_11 27

In case of selecting the “Manual Only” measurement mode, you can start a BP

measurement at any given time during the stress examination.

Pressing the BP Start (after start BP Stop to stop) button enables starting

measurements manually both in monitoring and is stress phases ( Manual loading panel

is on the right side).

Manual loading panel:

The manual loading panel is at the right botton of the screen, under the graphs. With the

plus / minus buttons you can change the level of loading, while the “Hold” button is for

keeping the current level.

By pressing the green button (before loading starts!) the manual load’s possible settings

are displayed:

4.4.3 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

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.


28 V5.03_2014_11 LABTECH LTD.

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

can be applied only on injury-free skin.

In the case of EH (only for one use) electrodes always use good quality, CE marked

electrodes, in this way you can ensure the appropriate quality, stable contact, and also

prevent the infection of the patient’s skin. Do not use expired, dry or used electrodes,

because they deteriorate the record’s quality.

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

instructions shown on the electrode’s package.

Standard 1

IEC label AHA

label Electrode placement

C1 V1 Fourth intercostal space at the right sternal border.

C2 V2 Fourth intercostal space at the left sternal border.

C3 V3 Midway between C4 and C2.

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


LABTECH LTD. V5.03_2014_11 29

IEC label AHA

label Electrode placement

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

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

C6 V6 Mid-axillary line on the same horizontal level as C4 and C5.

L LA Slightly below left clavicle, far from main muscles.

R RA Slightly below the right clavicle, far from main muscles.

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

the left mid-clavicular lines.

N RL Lower edge of the rib cage, or at the level of the umbilicus at

the right mid-clavicular lines.

Step 4: Correct installation of the blood pressure cuff (Only EC-12S recorder), in

order to get usable Korotkoff-signs

Please choose the cuff-size carefully, because if it's not fit to the patient, it could cause

incorrect measurement results.

In order to avoid reducing the pressure fluctuation caused by the moving made the

patient; the patients should avoid excess movement during blood pressure

measurements. They should hold their arm loose, slightly away from their chest.

Step 5: Connect the patient cable to the electrodes.

Step 6: Fix each cable separately under the electrodes in loop shape with plasters to 4-

5 cm distance from the electrode.

Yellow


30 V5.03_2014_11 LABTECH LTD.

4.4.4 New recording in stress test mode

Create a new patient or select one from

the database. Click on Start Recording.

Select a loading device with which you

would like to perform the examination in the

System configuration... menu.

Set a protocol of which you would like to

perform the examination in the System

configuration… menu as well.

Start monitoring by clicking on the start monitoring icon at the top left corner.

The Start Load or „N” (next) button shows the ongoing phase of the stress test. You

can start the next phase with this button. The stress test builds up by five phases,

marked with roman numbers.

Resting phase (before stress)

Warm up phase ( static stress)

Stress phase (increasing stress)

Deduce phase (decreased stress)

Relief phase (after stress)

The stress test stops automatically as the adjusted Rest (Relief) phase time (V) has

finished. The end of the stress is indicated by acoustical signal with 10sec length. If you

would like to finish earlier the ongoing phase, please click on Start Load / ongoing

phase ( I, II, III, IV, V ) as many you phases would like to be skipped.

Reason for finishing of stress:

The stop/finishing of the stress phase is possible by accessing the adjusted value of

Settings/Alarming and stop criterias.

If the adjusted criterias reach the stop value, the phase of the stress will finish

automatically and the program steps forward to phase .


LABTECH LTD. V5.03_2014_11 31

If the stress phase was stopped manually the >> window will appear after phase.

You can select here the reason of stress test stop or write short notice in the textbox. In

case of you would not want to stop just step forward to the next phase, than please

select the Cancel button for continuing the stress test.

You can register the frequently appeared causes by clicking on Customize than Add

button. You can modify the sequence too.

After this you can select the Other reason list item. Please press the „three dots” at the

end of Notes field for opening the Reason men. After selection, press on OK button and

the stress test will stop and the reason of stop will appear on the record as well.

Adding Freeze and Mark signals for arrhythmia events (only in case of 60 minute

long records)

In case an arrhythmia is discovered during the stress measurement, it can be indicated

by the space button. In this case you will be able to check these marked deviations after

finishing the test.

You can also add markers after the resting test or while you are examining the record

(Replay).

During the stress test you can create marks in case of disorder by pressing space button.

You can give names on the records and the reason of marking will be indicated in the

ECG view too. You can select default marking by opening the scroll bar, or define a

new one.

Please use the right-left navigating buttons on the keyboard for navigating between the

markers or delete button for deleting the event. The program indicates the events which

can be inspected later at a place where it is appropriate for you.


32 V5.03_2014_11 LABTECH LTD.

4.5 Stress test ECG mode display

S1 Toolbar: The toolbar contains buttons that give you easy acces to the most

common tasks in the program.

S2 Select patient: Select patient to load previous or make new records and

also you can add new patients to the database here.

S3 Select patient / patient panel: Manage the patients, export and import ECG

records and archive your data.

S4 Patient’s Name: Name of the current patient.

S5 Step to Next or Previous Record: Click to choose the previous or next

record of the patient.

S6 Delete Currently Selected Record: Click to delete the currently selected

record.

S7 ECG Devices Connection Status Window: Move the mouse here to check

the right operation between the ECG devices and the PC.

S8

Current Heart Rate: Displays the current heart rate, indicate the achieved

precentage of the current and target Heart Rate, and also shows the target

Heart rate itself in b/min.

S9 Here you can switch the Info-Box, HR, ST, Colour-coded ST, AVG,


LABTECH LTD. V5.03_2014_11 33

SPO2, Lead-off, Event and MasterStep diagrams on or off. To hide any or

all diagrams only click the buttons again, the order of the diagrams can be

changed also by clicking them on or off.

S10 Here you can switch the HR, Load, MET, Bpa and BPm graphs on or off.

S11

MET: "metabolic equivalent," represents the approximate rate of oxygen

consumption, the best index of exercise capacity and maximal

cardiovascular function. One MET is equal to a unit of basal oxygen

consumption measuring approximately 3.5 ml O2 /kg/min. As a rough

reference, the maximal oxygen uptake of the normal sedentary adult is

approximately 30 ml O2 /kg/min (8.5 METS) and the minimal level for

physical fitness is 40 ml O2 /kg/min (11 METS). External work directly

correlates to oxygen consumed to achieve the applied work level. The

program displays the achieved precentage of the current and predicted

MET, and also shows the predicted MET value itself.

VO2max: is the maximum capacity of an individual's body to transport

and utilize oxygen during incremental exercise, which reflects the physical

fitness of the individual. The name is derived from V - volume per time, O2

- oxygen, max - maximum. VO2 max is expressed either as an absolute rate

in litres of oxygen per minute (l/min) or as a relative rate in millilitres of

oxygen per kilogram of bodyweight per minute (ml/kg/min), the latter

expression is often used to compare the performance of endurance sports

athletes.

S12

Displays HR, Load, MET, BP graphs. You can see the Date and Time in

the HR Graph window. At Replay (examining an older record) it shows

the time of starting, and during the Test you can see the actual time.

S13

Automatic Blood Pressure Systole/diastole: Shows the actual blood

pressure of the patient. Systolic blood pressure should rise with increasing

workload. Diastolic blood pressure usually remains about the same. It can

be automatically measured by the built-in blood pressure meter in the EC-

12S or you can type it into the appropriate boxes manually.

S14 Load: Displays the current load (Watt; km/h, %; Round; stb.)

S15 Exercise time: Shows the elapsed time.

S16

Protocol: A specific set rules and conventions that determine how the

excercies ECG is performed. The program offers a number of well-known

protocols that you can use. In this window you can see the current

protocol which was chosen before starting the stress test.

S17

Manual Blood Pressure: Displays the current blood pressure in mmHg. In

case, there is no automatic blood pressure measurement function built into

the ECG device, when entering a new stage, the BP fields will be

automatically activated and let you enter the BP values manually. First

type the Systole value, then press TAB or Enter, then type the Diastole

http://en.wikipedia.org/wiki/Incremental_exercise

http://en.wikipedia.org/wiki/Physical_fitness

http://en.wikipedia.org/wiki/Physical_fitness

http://en.wikipedia.org/wiki/Volume

http://en.wikipedia.org/wiki/Time

http://en.wikipedia.org/wiki/Oxygen

http://en.wikipedia.org/wiki/Litre

http://en.wikipedia.org/wiki/Kilogram


34 V5.03_2014_11 LABTECH LTD.

value and press Enter again. The values you type are automatically

displayed on the HR diagram on the right side of the screen.

If the ECG device or the loading device has built-in blood pressure

measurement function the BP fields will be filled automatically. Of course

this may be overridden by the physician and it is possible to enter BP

values manually.

S18 Amplitude: adjustable value: 5; 10; 20 mm/mV

S19

Median: ECG average

The current median is indicated in black, the original one made during

resting phase is indicated in blue.

S20 ECG diversion: Several ECG diversion configuration can be selected in

the Settings/ Diversion menu.

S21 Click on the arrow for the next ST Trend selection.

S22 Enlarge or zoom out of the graph by clicking on the button.

S23 ST Trend: visualize in graph or colour coded format.

S24 Display or hide median you can display or hide the medians by clicking on

the arrow.

S25 Scrollbar: moving of the scrollbar the most important part of the record

can be inspected.

S26 Continuous play: for continuous record playing press on double arrow.

S27

Phase time: displays the elapsed time of the ongoing phase. As an option

the countdown until the end of stress stair/grade. The last 10 ms is

indicated in red.

S28 ST calculation: Displays of the current value of ST calculations.

S29 ST Loop: Displays ST value of the stress and sedation in function of HR.

S30 Colour coded ST: percentage display of ST changes

S31 Manual mode: Stress increasing, decreasing, level keeping during the test

S32 Manual BP start: manual start/stop of blood pressure measuring in

monitoring or test phase.

S33 Manual emergency stop: If the patient feels unwell the stress test can be

stopped, ECG and BP measurement is possible for 60 sec.

S34 BMI / BMI Prime: indicates the BMI index of the patient

S35 SPO2 diagram: displays the patient’s oxygen saturation during the test.

S36 Event tablet displays atrial and ventricular events.

S37 Electrode placement: shows the advanced EH ECG placement and contact

failure

S38 Info-box: test information in bigger size, to be visible even from distance

During Stress/Continuous/Stress recording a whole view displays all previously taken

record divided to one minute intervals, under ECG displaying. This view enables

checking of arrhythmic events detected previously. It displays in 5 minutes intervals and


LABTECH LTD. V5.03_2014_11 35

the scrollbar in the right ensures the navigation within the record. The view of the

record can be selected in the drop-down menu.


36 V5.03_2014_11 LABTECH LTD.

4.6 Toolbar

4.6.1 Start monitoring

Pressing this button to start monitoring the patient before the recording is

started.

4.6.2 Mode

The software can be used in three operating modes:

- Resting ECG mode

- Continous ECG mode

- Stress test mode

4.6.3 ECG leads

In this menu point: you can modify the leads displayed on the screen, the

ST calculation and measuring methods; view displaying from 1column to 2

columns or make display the mean curve and setup the ECG contrast and

millimetre paper.

The renewed Leads menu gives more possibilities and the ECG leads wanted to be

appeared on the screen during recording, and analyzing are more flexible. From now on

seven users can setup and rename the views. Moreover Cabrera and Cabrera +

Pericordial arrangements become default.

You can select if you would like to display the lead in Full view or in Freeze. You can

invert any of the leads.


LABTECH LTD. V5.03_2014_11 37

View menu: here you can modify the display of ST calculation during record taken, or

identification of the measurement point (possible setup of J point: 0, 30, 40, 60, 80 ms)

and the amplitude unit of ECG sign.

You can modify the display of ECG leads here. It is possible to switch between the

common one column display to two column display (standard + unipolar and 6 chest-

separately) by pressing “D” on the keyboard. You can abolish the overlaps of main

curve taken during the stress and resting test.


38 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.

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.

4.6.4 Filters

Here you can switch on/off the filters.

• Smoothing

• Baseline

• Mains (50/60 Hz) –available only at resting mode

Switch on all filters!

Preview: Here you can see the effects

before activating the settings.

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.


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4.7 Settings

You can set the various parameters of the software influencing the analysis

in this menu.

Choosing of loading device:

Endless EKG

Ergometer

Runners

MasterStep

Walking

<< select the loading device used during

the stress test

System configuration …:

Select the stress test device and stress protocols used during the stress test. See details in

User Manual, chapter 2.1.3.

Emergency and termination criteria:

You can setup emergency and termination criterias that make alarming or red lightening

as the critical value have been reached or automatically stop the stress test.

Definition and selection of heart target HR became optional in the stress

test/investigation. You can select the convention 220- ages or the percentage of it (85 %,

90 %) or other settings. The selected value will appear in the information box during

recording and on the Summary after recording.


40 V5.03_2014_11 LABTECH LTD.

You can parameterize the marking of event by clicking on rhythm analyzing tab.

Reason of stress test terminating:

Dialog box for the list up the possible reasons of stress test termination that can be

switch on/off.

Colour settings…:

You can find, modify and delete the colouring combinations displayed on the screen of

the program here. Aside from the recommended colour designs you can adjust personal,

user colour combinations from Custom1 to Custom5 and save them by clicking the Save

button.

Lead-off warning:

The displaying methods can be chosen:

Lead-off warning >>

Opportunities for display:

- Always on toolbar: the program gives a warning sign on the toolbar in the

moment of the electrodes’ lead-off.

- •Always in window: the program gives a warning sign in a window appearing

in the middle of the screen in the moment of the electrodes’ lead-off.

- Once in window: the program gives a warning sign of the electrode’s lead-off

once and if you close the appearing window it won’t pop up again.

- Never: the program does not display the electrode’s lead-off.

New analysis

Used to analyse the previous records with new settings (for example: J+ … changes.

Service… :

Here you can find the information about the type of software used during the

measurements, the serial number of the ECG recorder, the actual Firmware version and


LABTECH LTD. V5.03_2014_11 41

the currently chosen record’s settings. Here you can follow the stressing records’

diagnosis settings as well.

4.7.1 Print Report

You can print the record on display by clicking on the printer icon, it will

display a print preview window. In this window you can set the parameters

of printing, like the leads to be printed, printing mode, printing colour,

number of reports and pages to be printed, and the printer itself can be

selected also.

4.7.2 Print current sample

Prints the ECG you actually see on your PC screen.

4.7.3 Export the Report

Export the record into PDF, image formats, DICOM or GDT.


42 V5.03_2014_11 LABTECH LTD.

4.7.4 Automatic report

Print out/export your reports automatically from print out/export settings

menu/automatic report tab. Select the function which would be necessary for you and if

required select the export library as well. The reports can be printed per sheets, or per

groups. It is possible to arrange into libraries, using patient ID and recording time.

It is possible to print out automatically, PDF, JPEG and DICOM export.

You can modify the output format under the Export tab. You can modify here the

resolution of output picture.

Here you can setup that the program arranges the stress and rest records in a different

file.


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4.7.5 Printing 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.

Printing possibilities:

ECG samples: In the case of 5, 10 and 20 second long records it means printing the

whole record, while with 60 minute long records it means printing only the samples of

the intervals which were given previously

Marked ECG samples: Prints the events related to the Marker.

Parameters of marked ECG samples: Prints the parameters of the events related to

the Marker.

ECG for selected lead: Prints the ECG of the selected lead.

Print current sample: This function can be reached in the Toolbar. Press button and

the currently displayed ECG section will be printed.


44 V5.03_2014_11 LABTECH LTD.

Print settings:

Leads: You can choose which leads you would like to print (Standard > I, II, III;

Unipolar > aVR, aVL, aVF; Standard and Unipolar; Precordial > V1-V6 and 12 leads.)

Selected Printer: You can select the default printer by clicking on Setup. You can

select local and network printers as well. The software will always save your last

selection.

Printing Colour: Colour or Black & White.

If the amplitude of the ECG is too large and does not have enough space on the report

display, you can modify it by ECG vertical offset scroll bar in the printing setup.

Each curve will appear correctly:

During the stress test and continuous reporting you can put marks on report in the

detailed summarization report for printing.


LABTECH LTD. V5.03_2014_11 45

Setup: Printing setup > Special setup.

. .

. .

. .


46 V5.03_2014_11 LABTECH LTD.

The time interval became adjustable on page of stress summary and detailed summary.

Summary page:

- Default

- according to MET stages

Detailed summary page

You can setup the intervals using the slide cursor in Printing/Setting/ Miscellaneous,

moreover you can expanse the list by modifying MET stages and the marked samples.


LABTECH LTD. V5.03_2014_11 47

4.7.6 Help

In this menu it is possible to invoke the built-in user manual, change the

language of the software or have a look at the Keyboard Usage window.

User Manual

The User Manual is available in different languages. By changing the language of the

software, the user manual (help) will be shown in the same language, as well. However,

if the user manual is not available in the chosen language yet, the English manual will

be shown.

You need to install Adobe

Reader

application to see the User Manual, this is

automatically installed along with the Cardiospy software.

Languages

Here you can select the language of the software. However if the program is not

available in the chosen language yet, the English program version will be worked.

Multilanguage Translator…

The Multilanguage Translator menu offers a great help to translate the text of the

software into any language. This menu can be used only with the password provided by

the manufacturer.

4.7.7 Paper speed

Set here the speed of the paper (mm/sec) to the measurement. The paper

speed can be set for 12.5, 25 or 50 mm/sec.

4.7.8 Amplitude

You can change the amplitudes (mm/mV) here.

EDITING AND MEASUREMENT POSSIBILITIES STRESS TEST ECG SYSTEM

48 V5.03_2014_11 LABTECH LTD.

5 Editing and measurement possibilities

5.1 Arrhythmia analysis in resting and stress test ECG systems

Real-time arrhythmia analysis is available in the software, this means that the VES and

SVES.. events are detected during the resting and stress test monitoring. We can also

add various stop and alarms criteria for such events.

Re-analysing older ECG records (Settings/New analysis) detects and displays V and SV

events.

The info boxes contain the V and SV ectopic rates.

A new panel on the left side displays the V-SV events; we can activate this panel by

pressing the EVN button.

We can set the Arrhythmia and V ectopic rate among the Alarm and stop criteria in

Settings / Parameters.

Clicking on the Rhythm analysis tab the parameters of each event can be specified.

STRESS TEST ECG SYSTEM EDITING AND MEASUREMENT POSSIBILITIES

LABTECH LTD. V5.03_2014_11 49

The events panel is now displayed on the stress test summary, this way we can keep

track of the V - SV events which occurred the examination.


50 V5.03_2014_11 LABTECH LTD.

5.2 Edit and delete ectopic events

Arrhythmia analysis first appeared in Cardiospy version v5.02.00., now this function

has been extended with various additional functions. VES and SVES beats are not only

detected but can be edited during and after recording. It is possible to delete groups of

events in case it was a false event. The summary table displays the number of ectopic

beats and their frequency in percentage, in comparison to all the beats during the record.

Editing and modifying events can be conducted in the ECG view as well. Use the left

button of the mouse to select beats, and the right button to modify their type.


LABTECH LTD. V5.03_2014_11 51

5.3 Ruler

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.

5.4 Weber function classification

You can setup the Weber function classification in System configuration window/ Other

tab. Please switch the loadability from Morris function to Weber functional

classification. After this, please move the cursor to the MET value in the upper menu of

the program and the chart will be appear. The classification will appear in the Summary

report and in Automatic report as well.

Base on the value of MET reached during the stress analysis; the severity of the disease

will be classified:


52 V5.03_2014_11 LABTECH LTD.

5.5 Bayes' theorem in the analysis

Based on the results population and diagnostic tests and with using Bayes’ theorem it is

possible to give positive or negative predictive (PPV; NPV) value of the test.

You can reach the value in the automatic report. The program calculates regarding the

patient’s sex, age and the type of chest pain reported before the inspection.

general sensitivity: 68%; general specificity: 77%

(Source: AHA 2002 guideline update, Table 7)

P = Pretest probability of positive (N Engl J Med. 1979;300:1350-8.)

PPV = P / (1 - P) * 2.957 / (P / (1 - P) * 2.957 + 1)

NPV = (1 - P) / P * 0.416 / ((1 - P) / P * 0.416 + 1)

You can type into the characteristic of chest pain have the patient had; by pressing F8

key after starting the stress inspection. In case of mistaken type selection you can

modify it anytime, during the stress inspection by repressing F8 key.

5.6 Duke – nomogram

Duke nomogram is a graphical risk assessment procedure.


LABTECH LTD. V5.03_2014_11 53

http://circ.ahajournals.org/content/99/17/2345/F1.expansion.html

The program makes a nomogram as separately printable report. Information about the

type of the chest pain is important for nomogram creating. You can enter it by pressing

F8 key, than select the time of stress test and type of the pain. If the pain is too high,

you can stop the stress inspection by clicking the square before ’Stop Stress test’, then

click on OK button. You can write comments in connection with the pain, and you can

find among the marked samples.

Duke Treadmill Score = METs - 5x(excercise-induced ST depression in mm) -

4x(treadmill angina index)

Treadmill angina index = 0 if no agnina, 1 if angina occurred during test, 2 if angina

was the reason for stopping

http://circ.ahajournals.org/content/99/17/2345/F1.expansion.html


54 V5.03_2014_11 LABTECH LTD.

5.7 Borg rank

The patient can evaluate by himself the hardness of ongoing loading on a scale of 6-20.

The loading can be recorded in several times in HR/BP diagram, and it is indicated on

the printed out report. The value can be registered by pressing B key during the stress

test.

5.8 QRS frontal axis

During stress test the program displays the QRS frontal axis in degree. You can set this

if you would like to see this value during the examination in the Inbox.

5.9 Exercise and condition plan

The Hungarian exercise plan template was made based on, 2001year (the latest) AHA’ s

protocols for investigation stress test and heart disease patients. You can reach it by

entering diagnosis editor/ import automatic expertise button.

Template example

Exercise and conditioning plan: Initial exercise intensity: light to moderate, 3,2-4,7 MET

Initial target heart rate: 110,4 - 120,6 bpm

Activities corresponding to your initial intensity range: walking 3.0 mph (4.8 km/h); golf, not carrying

clubs; walking 3.4 mph (5.5 km/h); bicycling, <10 mph (16 km/h), leisure, to work or for pleasure; swimming, slow


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Maximal exercise intensity: hard, 4,8-6,7 MET

Maximal target heart rate: 133,35 bpm

Activities corresponding to your target intensity range: bicycling, stationary, 100 watts; swimming,

moderately fast; jogging, 4.5 mph (7.2 km/h); bicycling, 10 mph (16 km/h); hiking Increase exercise intensity gradually once comfortable at a particular level. Intensity may be increased as heart

rate response to exercise decreases with conditioning.

Exercise frequency: 3 to 6 sessions/week Session duration: 30 to 60 minutes

If the following symptoms occur, obtain medical consultation before continuing exercise: 1)Discomfort in the upper body, including the chest, arm, neck, or jaw during exercise. 2)Faintness accompanying the exercise.

3)Shortness of breath during exercise.

4)Discomfort in bones and joints either during or after exercise.

Although the above-mentioned symptoms are the most important, any symptom should be clarified and

discussed with your physician.

Non-cardiac medical conditions and cardiac conditions not detected during the stress test session may impose additional limitations on exercise ability.

--- AUTOMATICALLY GENERATED EXERCISE PLAN, NOT VALIDATED BY QUALIFIED

HEALTH-CARE PROFESSIONAL. --- --

ERROR CORRECTION, MAINTENANCE STRESS TEST ECG SYSTEM

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6 Error correction, maintenance

Before going through this chapter please read the Installation and Update Guide

carefully in which we detail how you should install and operate the program and the

devices. If you cannot solve the problem based on these manuals, then read the

information below.

6.1 USB-02 signs and error messages

Light Description Countermeasure

red Power LED

USB-02connected to

the PC but it does not

operate

Terminate the USB connection. After 5-

10 ms reconnect it to the PC. If the USB -

02 is still red, follow the below

instruction:

Install the USB-02 drivers again by

deleting and reinstalling the Cardiospy

program. Go to Start menu / Programs /

Labtech Ltd / Uninstall Cardiospy –

Wizard: put checkmark in the Remove

USB-02 drive switch and dele the

program. Terminate the USB-02 device

during the reinstallation process.

green Power LED

USB-02 connected to

the PC and operates

properly

-----

Wireless LED in

orange flashing

USB-02 sign offline

status.

The recorder is not connected to the

device. Switch on the (insert full charged

batteries) EC-12R / EC-12R/S / EC-12S

for the communication connection.

Wireless LED in

green flashing

Bluetooth

communication

between ECG

recorder.

You can start recording.

red Wireless LED

Bluetooth module has

failure in USB-02

interface.

Please contact the service support.

STRESS TEST ECG SYSTEM ERROR CORRECTION, MAINTENANCE

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6.2 ECG Recorder signs and error messages

Light Description Countermeasure

NO light

sign ----

Please check the status of the batteries or change

them for new charged ones. If the problem is still

exists despite of using new charged batteries, please

contact service support.

Orange

flashing

Three pieces of

short beep after

inserting charged

batteries

Offline operation. Start the Cardiospy program to

enable the connection to USB-02 interface. The

light of the recorder becomes green.

Green

flashing

Two pieces of

short beep

Normal operation, the recorder and the USB-02

interface are connected with each other, you can

start the recording.

Continuous

red

Continuous

beeping

See the General communication failure: NO 1. The

ECG led lights in red, and beeping

* The light sign of the recorder means the Led sign on the front side of the device.

6.3 General and communication failure

NO Error / Symptom Countermeasure

1.

THE ECG LED

LIGHTS IN RED

AND BEEPING

Discharged battery charged status. Please use properly

charged batteries or use new fully charged batteries.

Please insert the batteries into the charger and wait until

the charging time finished. If beeping does not finish

after batteries changing, the recorder has been damaged.

POWER LED

WIRELESS LED


58 V5.03_2014_11 LABTECH LTD.


Please contact service support.

2. NO OR BROKEN

ECG DRAWING

Distance between USB-02 interface and recorder should

not be more than 6 meters. For proper communication

between USB-02 interface and recorder (in linear

distance) should not be an object that makes radio

frequency interfere. Using the lengthened cable put the

USB-02 interface a well visible place. For better

communication you can stick it to the monitor or to a

stand.

3. *

CANNOT START

THE BLOOD

PREASSURE

MEASUREMENT.

PROGRAM SHOWS

THE

MEASUREMENT

STARTED BUT

THE DEVICE DOES

NOT MEASURE

Check the battery status (Status display or

Setup/service/battery status menu). Open the record and

navigate to the Service menu.

Properly charged batteries: marked with green line.

Battery voltage only slightly decreases during blood

pressure measurement.

Improperly charged or old batteries: give high voltage at

the first measurement. Please charge the batteries and

check their status. If the symptom is the same please

change the batteries to new ones.


LABTECH LTD. V5.03_2014_11 59


If the batteries has not got problem, but not able to

measure the blood pressure then please check the

drawing. If it is broken that might indicate a Bluetooth

connection failure. Distance between USB-02 interface

and recorder should not be more than 6 meters. For

proper communication between USB-02 interface and

recorder (in linear distance) should not be an object that

makes radio frequency interfere. Using the lengthened

cable put the USB-02 interface a well visible place.

4. *

NO CONNECTION

WITH THE BLOOD

PREASSURE DEVICE

OR NOT SELECTED

Check if the proper blood reassure device is selected in

System Configuration menu and if the device

application is switched.

Check the connection of the devices.

If you use different type blood pressure monitor, you can

enter the data manually into the SW by the manual blood

pressure.

5. *

SOFTWARE

MESSAGE:

MICROPHONE IS

NOT CONNECTED

Check the connection of the KO microphone’s

connector to the ECG device. It connects from the BP

cuff with a black cable to the ECG device.


60 V5.03_2014_11 LABTECH LTD.


6.

**

STRESS TEST

DEVICE

CONNECTION

FAILURE

Check the connection between the computer and the

stress test device (connection of communication cable),

and the charging status (if the stress test device’s main

switch is on), and if under the System Configuration

menu/Loading device menu is the right loading device

was selected. In case of treadmill: check if the

Emergency Stop button is ejected. Perform chapter 4.1.3

in the Installation and Update Guide.

7. NOISY ECG SIGN

Examine if all the ECG electrodes were attached to the

patient appropriately. To produce high quality record the

electrodes should be attached carefully by qualified

staff.

8. PRINTOUT DOES

NOT START

Check if the selected printer is switched on. If you have

selected a local printer, then examine if the connection

to the PC is appropriate (connection of communication

cable).

* in case of EC-12S built-in blood pressure ECG device

** EC-12R/S, EC-12S Stress ECG systems


LABTECH LTD. V5.03_2014_11 61

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.

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! Length of patient cable: 65-85 cm

BP cuff cleaning

Before cleaning of textile cuff please take off the rubber hose and Korotkoff-

microphone.

Wipe or wash the cuff off with moderate effect (not aggressive) and temperature (max.

30 °C) antiseptic or cleaning agent. After its dry on room temperature put back the

rubber hose and Korotkoff-microphone.

Validation

Blood Pressure device validation in accordance with the requirements of the applicable

standards and as the validation term expired.

TECHNICAL SPECIFICATIONS (EC-12R/S; EC-12S) STRESS TEST ECG SYSTEM

62 V5.03_2014_11 LABTECH LTD.

7 Technical specifications (EC-12R/S; EC-12S)

Technical specification EC-12R/S EC-12S

Leads I, II, II, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

BP measurement method - Auscultational

BP interval of measurement -

30-260 mmHg; Device’s

measuring limit: 20-280

mmHg

BP measurement’s accurary - ± 3 mmHg

PC connection Bluetooth (wireless type)

Patient protection EN 60601 (IEC-601-1), CF type

Power supply / Can be exchanged

during recording! /

2 x 1,2 V rechargeable batteries

(or 2 x 1.5 V AA alkaline battery)

Dynamic interval ±20 mV

DC offszet range ±1000 mV

Frequency response 0.05 Hz … 150Hz

Sampling rate 1000 Hz

A/D resolution 16 bit

Input impedance ≥100 MΩ

Size 125 x 70 x 25 mm (non-wireless type)

125 x 70 x 33 mm (wireless type)

Weight

~ 100 g (non-

wireless type)

~ 110 g (wireless

type)

~ 200 g

STRESS TEST ECG SYSTEM TECHNICAL SPECIFICATIONS (EC-12R/S; EC-12S)

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Software specification

Simple, user friendly software with multiple functions

Precise QRS classification

Built-in expert system,

Short and long resting ECG record

BP measurement based on auscultation method

colour-coded ST level, slope and ST loop graphs

SAECG

MET computation

HR, BP, LOAD, MET graphs

Various printable reports

Customizable alarm and stop criteria

Ergometer and treadmill database

Comparing measurements

DICOM, GDT, MFER, HL7

Local and network operation

Export and import functions

Arrhythmia analysis

Weber function classification

Bayes theorem in the analysis

Duke-nomogram

Borg rank

QRS frontal axis

Exercise and condition plan

Pacemaker detection

TECHNICAL SPECIFICATIONS (EC-12R/S; EC-12S) STRESS TEST ECG SYSTEM

64 V5.03_2014_11 LABTECH LTD.

Software minimum configuration

Processor: Min. Core 2 Duo (2 Ghz)

RAM: Min. 1,5 GB (Windows XP) recommended: 2 GB

Min. 2 GB (Windows Vista, Windows 7)

HDD: 200 GB

Display: min: 19” display 1024X768 resolution, Color XGA

recommended 22” display 1680X1050 resolution

Interface: 1 USB port for EC-ABP

2 USB ports for EC-1-12H

Printer: Laser or LaserJet (Min 15-20 pages/minutes)

Operating

systems:

Windows XP ( Service Pack 2 )

Windows Vista

Windows 7

( 32 and 64 bit ) with Windows Update enabled

STRESS TEST ECG SYSTEM HOT KEYS

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8 Hot keys

1. Tab In case of stress test it is used to switch between the manual BP

measurement’s Systole / Diastole windows

2. N – Next Starts stress test or moves to the next step of stress test

3. Space Stops the drawing of the ECG lead which was selected previously and

places a Marker sign during the stress test measurement

4. Enter By pressing you can fix the BP measurement values entered manually

5. Del – Delete Deletes the Freeze and Marker signs

6. Left, Right Used for navigation between Freeze and Marker signs

7. Numeric keypad For entering BP measurement values manually

8. F10 Manual start and stop of BP measurement 9. D Switch between the 4 possible ECG displays

10. Num. – and + Increases and decreases the load in case of manually controlled

stress test

11. F2 Opens the Patient’s database

12. C Switch between the ECG lead’s displays

13. I Displays/Hides the larger automatic BP measurements and HR boxes

14 (A) Coloured EKG curve

15. (B) Entering Borg value during stress test

16. (F8) Pain in the chest

Stress Test ECG System - Meditech · During an examination made by the Stress Test ECG system, ... The recorder may be used simultaneously with a high frequency surgical device, in

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