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LABTECH LTD. MADE IN HUNGARY

Resting ECG System

Cardiospy® User manual

for EC-12R; 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 RESTING ECG SYSTEM

2 V5.03_2014_11 LABTECH LTD.

1 Introduction

Dear customer!

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

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

Resting ECG System and computer programs appropriately, please read the manuals

carefully. A basic knowledge of computers and Windows based applications is 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 Resting ECG System?

Connected to a PC, the small sized and compact ECG device makes a complete 12-

Channel Resting ECG system with the software attached.

How to use a Resting ECG System?

During an examination made by the Resting ECG system, a record of 5 to 60 seconds is

made of a patient and this recording is analysed by the software.

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

can be operated in network and all the patient data is managed in 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.

RESTING 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 RESTING 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 Principles of Operation ................................................................................. 10

3.3 Warnings and Contraindications: ................................................................. 11

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

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

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

4.3 EC-12S (Bluetooth) Recorder Components ................................................ 15

4.4 Database management interface ................................................................... 16

4.4.1 Toolbar ..................................................................................................... 16

4.4.2 List of patients .......................................................................................... 20

4.4.3 Records toolbar ........................................................................................ 21

4.4.4 List of records .......................................................................................... 22

4.4.5 Selected System ....................................................................................... 22

4.4.6 Filters ....................................................................................................... 23

4.4.7 Search ....................................................................................................... 23

4.4.8 Database information ............................................................................... 23

4.5 How to start a new recording? ...................................................................... 24

4.5.1 Connecting the ECG device (USB type) .................................................. 24

4.5.2 Connecting the ECG device (Bluetooth type) .......................................... 24

4.5.3 Patient preparation ................................................................................... 24

4.5.4 New recording in resting mode ................................................................ 28

4.6 Resting ECG mode display .......................................................................... 29

4.7 Toolbar ......................................................................................................... 32

4.7.1 Start monitoring ....................................................................................... 32

RESTING ECG SYSTEM TABLE OF CONTENTS

LABTECH LTD. V5.03_2014_11 5

4.7.2 Mode ......................................................................................................... 32

4.7.3 ECG leads ................................................................................................. 32

4.7.4 Filters ........................................................................................................ 34

4.7.5 Settings ..................................................................................................... 35

4.7.6 Print Report ............................................................................................... 36

4.7.7 Print current sample .................................................................................. 36

4.7.8 Export the Report ...................................................................................... 36

................................................................................................................... 36

4.7.9 Automatic report ....................................................................................... 37

4.7.10 Print and export settings ....................................................................... 38

4.7.11 Help ...................................................................................................... 40

4.7.12 Paper speed ........................................................................................... 40

4.7.13 Amplitude ............................................................................................. 40

4.7.14 Record length ....................................................................................... 40

5 EDITING AND MEASUREMENT POSSIBILITIES ......................................... 42

5.1 Arrhythmia analysis in resting and stress test ECG systems ......................... 42

5.2 Edit and delete ectopic events ....................................................................... 43

5.3 Ruler .............................................................................................................. 44

6 ERROR CORRECTION, MAINTENANCE ........................................................ 45

6.1 USB-02 signs and error messages ................................................................. 45

6.2 ECG Recorder signs and error messages ...................................................... 46

6.3 General and communication failure .............................................................. 46

7 TECHNICAL SPECIFICATION ......................................................................... 51

PREPARATIONS RESTING ECG SYSTEM

6 V5.03_2014_11 LABTECH LTD.

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 Resting ECG System.

New

Code No. Code No. Specification

EC

-12

R

EC

-12

R

(Blu

eto

oth

)

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 1 1

CAS-

00IRD-01

12RS-V1-

01

Case for

holding the

IRDA and Old

type recorders

1 - 1 - -

ACC-

0SWCD-

01

12RS-V5-

02

CD with

installation

software

1 1 1 1 1

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

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

GUIDANCE ON THE INSTALLATION OF THE SYSTEM.

RESTING ECG SYSTEM PREPARATIONS

LABTECH LTD. V5.03_2014_11 7

New


EC

-12R

EC

-12R

(Blu

eto

oth

)

EC

-12R

/S

EC

-12 R

/S

(Blu

eto

oth

)

EC

-12S

(Blu

eto

oth

)

Picture

DEV-

0USBA-

02

12RS-V5-

03-A

USB-02/A

Bluetooth

Interface Unit

(rest and stress;

holter

monitoring)

- 1 - 1 1

DEV-

012RS-04

12RS-V5-

04-A

ECG recorder

unit (EC-12R/S) - - 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

DEV-

012RS-04

12RS-V5-

04-A

EC-12R ECG

recorder unit

1 - - - -

DEV-

012RS-05

12RS-V5-

04-D

EC-12R ECG

recorder unit

(BT)

- 1 - - -

CUF-

00LAC-

31

LAC-3.1

Stress BP cuff,

Adult (25-

35cm)

- - - - 1


8 V5.03_2014_11 LABTECH LTD.

New


EC

-12R

EC

-12R

(Blu

eto

oth

)

EC

-12R

/S

EC

-12 R

/S

(Blu

eto

oth

)

EC

-12S

(Blu

eto

oth

)

Picture

BAG-

012RS-01

12RS-V5-

05-A

Recorder bag

(EC-12R, EC-

12RS, non-

wireless)

1 - 1 - -

BAG-

012RS-02

12RS-V5-

05-B

Recorder bag

(EC-12R, EC-

12RS, EC-12S,

wireless)

- 1 - 1 1

CHA-

0004X-01

12RS-V5-

07

Battery charger

MAXI - 1 - 1 1

BAT-

00000-02

12RS-V5-

08

1.2V

Rechargeable

batteries (AA)

- 4 - 4 4

CAB-

00ECG-

03

12RS-V5-

09-A

12 CH standard

patient cable

(D-SUB -

Banana

connector)

1 - - - -

CAB-

00L12-06

12RS-V5-

09-B

12 CH standard

patient cable

(HDMI-Banana

connector)

- 1 - - -

CAB-

00L12-05

12RS-V5-

09-C

12 CH standard

patient cable

(HDMI-Snap

connector)

- - - 1 1

CAB-

00ECG-

01

12RS-V5-

09-D

12 CH standard

patient cable

(D-SUB - Snap

connector)

- - 1 - -


LABTECH LTD. V5.03_2014_11 9

New


EC

-12R

EC

-12R

(Blu

eto

oth

)

EC

-12R

/S

EC

-12 R

/S

(Blu

eto

oth

)

EC

-12S

(Blu

eto

oth

)

Picture

ELE-

CLAMP-

01

12RS-V5-

10-A

Adult clamp

electrodes (1

pack / 4 pcs) 1 1 - - -

ELE-

CHEST-

01

12RS-V5-

10-B

Adult chest

electrodes (1

pack / 6 pcs)

ELE-

00000-01

12RS-V5-

11

Single-use ECG

electrodes 1 1 1 1 1

CAB-

00USB-

03

12RS-V5-

12-B

PC USB cable,

5m (USB A -

USB B)

1 - 1 1 1

CAB-

00USB-

06

12RS-V5-

16

USB-SIO cable

(USB A - D-

SUB, for

ergometer,

treadmill)

- - 1 1 1

BEL-

00000-01

12RS-V5-

06 Waist belt - - 1 1 1

CAB-

00USB-

01

12RS-V5-

15

Extension cable

for USB-02 - 1 - 1 1

USR-

00000-01

12RS-V5-

15-A

Installation and

Update Guide

1 1 1 1 1

USR-

00000-04

12RS-V5-

15-B

User manual for

rest and stress

systems


10 V5.03_2014_11 LABTECH LTD.

New


EC

-12R

EC

-12R

(Blu

eto

oth

)

EC

-12R

/S

EC

-12 R

/S

(Blu

eto

oth

)

EC

-12S

(Blu

eto

oth

)

Picture

BAG-

012RS-04

12RS-V5-

17

Patient cable

bag - - 1 1 1

PAD-

00000-01

12RS-V5-

15-A Mouse pad 1 1 1 1 1

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

3.2 Principles of Operation

Resting ECG examinations are useful in the case of patients known to have a

cardiovascular disease or who are at increased risk of developing one. The examination

may provide useful information regarding diagnosis and prognosis and it also supports

making rational decisions, including risk analysis before a medical and surgical

intervention.

It also gives useful information regarding the presence or absence of arrhythmias,

conduction defects, chamber enlargement, myocardial hypertrophy, myocardial

ischemia, myocardial necrosis, pericardial inflammation and electrolyte

disturbance.Figyelmeztetések és ellenjavallatok a Nyugalmi EKG rendszerhez

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


LABTECH LTD. V5.03_2014_11 11

3.3 Warnings and Contraindications:

Never use the recorder:

- in the presence of flammable anaesthetics or explosive surroundings

- in strong heat

- in strong electrostatic field

- in wet conditions (the recorder is not waterproof)

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

be serviced by users

- Do NOT immerse the recorder in any fluid

- Always use non-aggressive fluids to clear the patient cables and the recorder.

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.

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 withnon-implanted

defibrillators!

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.

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

AND DISCONNECT THE UNIT FROM THE PATIENT.


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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

RESTING ECG SYSTEM INSTRUCTIONS

LABTECH LTD. V5.03_2014_11 13

4 Instructions

4.1 EC-12R (Bluetooth) Recorder Components

FRONT VIEW

REAR VIEW

ECG recorder

Patient cable

- easy to replace -

Recorder status

indicating lamp

Symbols

Recorder ’s

configuration type

Serial

number

Battery cover Battery

EC-12R

INSTRUCTIONS RESTING ECG SYSTEM

14 V5.03_2014_11 LABTECH LTD.

4.2 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


EC-12R/S


LABTECH LTD. V5.03_2014_11 15

4.3 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



16 V5.03_2014_11 LABTECH LTD.

4.4 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.

4.4.1 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

4.4.2 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

4.4.3 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.

4.4.4 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.

4.4.5 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

4.4.6 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.

4.4.7 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.

4.4.8 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.

4.5 How to start a new recording?

4.5.1 Connecting the ECG device (USB type)

After the installation of the Cardiospy software, connect the ECG device to the PC by

connecting one end of the USB cable to the device and its other end to an available USB

slot on the computer. A flashing green light indicates proper connection between the

computer and the ECG device.

4.5.2 Connecting the ECG device (Bluetooth type)

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

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.

4.5.3 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

The ECG 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.

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.


LABTECH LTD. V5.03_2014_11 25

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.

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.


26 V5.03_2014_11 LABTECH LTD.

Standard 2

IEC label AHA








L LA Left arm.

R RA Right arm.

F LL Left leg.

N RL Right leg.


LABTECH LTD. V5.03_2014_11 27

5 leads

IEC label AHA








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.

* The only white chest electrode can be placed anywhere between C1 and C6

positions.


28 V5.03_2014_11 LABTECH LTD.

4.5.4 New recording in resting mode

Create a new patient or select one from the database. Click on Start Recording.

Select the number of record: you can set the suitable number of records here: Settings

menu – Number of rest records

Set the lenght of record: you can choose to create 5, 10, 20 seconds or 60 minutes

long rest records in the upper menu.

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

Start the examination by clicking on the button on the top left corner of the display.

In case you chose to make several records, click on buttons , , and to save each

record.

The automatic interpretation can be modified by clicking on the Edit Interpretation

button.

In case you chose to make a Long Rest record, clicking on Start rec button starts the

recording. The records is stopped and saved automatically after 60 minutes, in case you

would like to stop it earlier click on the End Rec button.

The software automatically saves the record to the database, then makes interpretation

and calculates some parameters - all of these are displayed on the screen.

Placing Freeze and Mark signals for arrhythmia events (only in case of 60 m,inute

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).

Making an emergency recording

In emergency cases, you can make recordings without giving any specific

data about the patient. Click on the “Emergency Patient” icon below the

Selected systems menu. In this case, the patient is named Emergency

000x in the database, where the 000x indicates a sequence number. Such

patient data can be edited later.


LABTECH LTD. V5.03_2014_11 29

4.6 Resting ECG mode display

R1 Toolbar: The toolbar contains buttons that give you fast access to the most

common tasks in the program.

R2 Select patient: Select patient to load previous records or make new ones,

and also you can add new patients to the database here.

R3 Select patient / Database page: Manage patients, export and import ECG

records and archive data.

R4 Patient’s Name: Name of the current patient.

R5 Click to choose the previous or next record of the patient.

R6 Click to delete the currently selected record.

R7 ECG Devices Connection Status Window: Move the mouse here to check

the right operation between the ECG devices and the PC.

R8 Current Heart Rate: Displays current value for Heart Rate of the patient.


30 V5.03_2014_11 LABTECH LTD.

R9 Global Parameters/Intervals: Displays Intervals and Axes.

R10 Displays the interpretation.

R11

Edit interpretation: You can add information to the resting ECG, like a

description of any arrhytmia that has occured. This comment will be

saved with the record and also appear in print. The length of the comment

cannot exceed 50 characters.

R12 Medians: ECG Averages.

R13 Amplitude: Set to 5, 10 or 20 mm/mV.

R14 ECG record leads: Displays the ECG leads.

R15 Show/hide medians: Click to show/hide the ECG averages.

R16 Scrollbar: Move it to see the requested part of the Record.

R17 Continuous Playback: Click on for continuous playback.

R18 Comparison: Compare a patient's two rest ECG's.

R19 ST Calculation: the actual value of ST calculation is shown

R20 Time Scale: Long-resting records’ time and marks of the events are

shown

R21 BMI / BMI Prime: indicates the BMI index of the patient

R22 Test time: Shows the elapsed time.


LABTECH LTD. V5.03_2014_11 31

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

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

record can be selected in the drop-down menu.


32 V5.03_2014_11 LABTECH LTD.

4.7 Toolbar

4.7.1 Start monitoring

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

started.

4.7.2 Mode

The software can be used in three operating modes:

- Resting ECG mode

- Continous ECG mode

- Stress test mode

4.7.3 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.


LABTECH LTD. V5.03_2014_11 33

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

invert any of the leads.

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.


34 V5.03_2014_11 LABTECH LTD.

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.

4.7.4 Filters

Here you can switch on/off the filters.

• Smoothing

• Baseline

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

Switch on all filters!

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.


LABTECH LTD. V5.03_2014_11 35

4.7.5 Settings

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

in this menu.

Settings / Interpretation of the Resting ECG:

- All: The whole text of the automatic diagnosis is displayed on the screen.

- Presumptive: Only the sure part and presumptive diagnosis is displayed.

- Sure: Only those parts of the diagnosis are displayed which contain correct,

certain statements.

- None: No text of the diagnosis is displayed at all.

The automatic interpretation can be modified by clicking on the Edit Interpretation

button.

You can modify the text of the interpretation by pressing the Edit interpretation button.

Please note that once you modify the interpretation, Sure option will not be available

anymore.

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

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

diagnosis settings as well.


36 V5.03_2014_11 LABTECH LTD.

4.7.6 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.

4.7.7 Print current sample

Prints the ECG you actually see on your PC screen.

4.7.8 Export the Report

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


LABTECH LTD. V5.03_2014_11 37

4.7.9 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.


38 V5.03_2014_11 LABTECH LTD.

4.7.10 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.

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.


LABTECH LTD. V5.03_2014_11 39

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:


40 V5.03_2014_11 LABTECH LTD.

4.7.11 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.

4.7.12 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.

4.7.13 Amplitude

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

4.7.14 Record length

The length of the record can be set for 5, 10, or 20 seconds, or Long record

(max. 1 hour). This function is available only in Resting mode.


LABTECH LTD. V5.03_2014_11 41

List of parameters

The list of parameters does not only appear on the printed report, but we can also

examine it on the PC’s screen. Once the resting record is finished, Details button

becomes active on the right side. Clicking on it displays the list of parameters.

EDITING AND MEASUREMENT POSSIBILITIES RESTING ECG SYSTEM

42 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.

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

Settings / Parameters.

RESTING ECG SYSTEM EDITING AND MEASUREMENT POSSIBILITIES

LABTECH LTD. V5.03_2014_11 43

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.

EDITING AND MEASUREMENT POSSIBILITIES RESTING ECG SYSTEM

44 V5.03_2014_11 LABTECH LTD.

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.

RESTING ECG SYSTEM ERROR CORRECTION, MAINTENANCE

LABTECH LTD. V5.03_2014_11 45

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.

ERROR CORRECTION, MAINTENANCE RESTING ECG SYSTEM

46 V5.03_2014_11 LABTECH LTD.

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


LABTECH LTD. V5.03_2014_11 47


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.


48 V5.03_2014_11 LABTECH LTD.


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.


LABTECH LTD. V5.03_2014_11 49


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


50 V5.03_2014_11 LABTECH LTD.

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.

RESTING ECG SYSTEM TECHNICAL SPECIFICATION

LABTECH LTD. V5.03_2014_11 51

7 Technical specification

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

(Bluetooth)

EC-12R/S

(Bluetooth)

EC-12S (Bluetooth)

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 USB cable Bluetooth (wireless type)

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

Power supply /

Can be exchanged

during recording!

/

USB cable

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 125 x 70 x 33 mm

Weight ~ 100 g ~ 110 g ~ 200 g

TECHNICAL SPECIFICATION RESTING ECG SYSTEM

52 V5.03_2014_11 LABTECH LTD.

Software specification

Simple, user friendly software with multiple functions

Precise QRS classification

Built-in expert system,

Short and long resting ECG record

SAECG

Various printable reports

Customizable alarm and stop criteria

Comparing measurements

DICOM, GDT, MFER, HL7

Local and network operation

Export and import functions

Arrhythmia analysis

Pacemaker detection

RESTING ECG SYSTEM TECHNICAL SPECIFICATION

LABTECH LTD. V5.03_2014_11 53

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

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