Cardiotouch3000 Operation Manual

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CardioTouch3000

Operation Manual

Ver. 7.00
2019.05.23

www.ebionet.com
CardioTouch3000 Operation Manual

Warranty

- This product was made through strict quality control and examination. The repair and
compensation standards follow the consumer damage compensation regulations of the
Ministry of Finance and Economy.

- The warranty for this product runs for 1 year. (2 years in EU) But the warranty for
accessories runs for 6 months.

- This product is guaranteed against faulty workmanship for a period of 1 year. Under this
warranty, we undertake to repair free of charge at our service centers.

- When having troubles during this period, please provide us with the model name, serial
number, date of purchase and a description of the problem you are experiencing.

CAUTIONS

Federal law restricts this device to sale by or on the order of a physician

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Contact Bionet

If you have any questions or comments relating to our products or purchasing,


please contact the telephone numbers or E-mail below. You can talk to our sales
people. Bionet always welcomes your enquiries. Please contact us.

Contact Us Bionet Co., Ltd.

• Address: 5F, Dreammark1 Data center 61 Digital-ro 31 gil,


Guro-gu, SEOUL 08375, REPUBLIC OF KOREA

• Tel: +82-2-6300-6410

• Fax: +82-2-6499-7789

• E-mail: [email protected]
[email protected]

• URL: http://www.ebionet.com

※ In the event of a malfunction or failure, contact Service Dept. Of Bionet Co., Ltd.

along with the model name, serial number, date of purchase and explanation of
failure.

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Fee-Based Service

If you wish to make a claim when the product is damaged through misuse, we
charge repair fees. Please read the manual before you make a claim.

- For simple inspection without giving instruction or


Fee charged: From the
disassembling the product
second time
- For reinstalling due to poor installation by the
Free of charge: One time
retailer

- For poor installation due to moving


- For reinstallation after initial installation due to
customer‘s requirements.
- For reinstallation due to customer‘s unskilled Fee charged
installation
- For offering service when a foreign substance is
introduced or mis-cleaned by the customer

1. The warranty does not cover cleaning, adjusting and instruction for use.
(Separate standard will apply when repair is impossible)

2. Fault of customer
When the product is damaged or broken due to customer‘s improper use or
misuse
- When the power cord is replaced improperly by the user
- When the user drops the product while moving, after the initial installation
- When the user uses unauthorized accessories
- When the product is repaired by unauthorized person

3. Others
- When the product is damaged by a natural disaster (fire, flood or earthquake)
- When lifespan of accessories ends

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Definition of WARNING, CAUTIONS and NOTE

 In order to stress the contents of this manual, we define the terms as below.
Please follow the warning and cautions instruction.

 The manufacturer or service agents are not responsible for damage resulting
from inappropriate use or carelessness.

WARNING

There may be serious injuries, fatal accidents or financial damages if you violate
this instruction

CAUTIONS

There may be slight injuries or reduced damages if you violate this instruction

NOTE

There may not be any dangerous events, but it is important to note this
instruction for installation, use, maintenance or repair

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Environment Instructions

 Please do NOT use or place the product in such environments explained below.

Steamy environment.
Do not use the
Direct sunlight.
product with wet
hands.

Place where the


temperature and
humidity condition
are extreme
(Recommended Near electronic
temperature and heaters
humidity range
for Storage/Transport
are 5~40C and
10~90%, respectively.)

Place where
High humidity or excessive shock
ill-ventilated place or vibration
may occur

Place exposed to Never introduce dust


flammable chemicals or metal into the
or explosive gas. product.

Do not disassemble
the product. Do not plug the
The product warranty power supply cord
before installing the
does not cover
product completely.
problems resulting It may cause damage
from disassembling to the product.
the product.

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Safety Instructions for Electricity

Please note the following precautions before using the product.


• Is the power supply cord proper? (100-240Vac)
• Is every cord connected properly to the product?
• Is the grounding connected correctly? (Otherwise, noise can occur.)
• There is a risk of electric shock if the Rest stand of the equipment is damaged or
can not be fixed to the product. Do not use the product and immediately ask
the manufacturer and the seller for repair

NOTE

Magnetic and electrical fields are capable of interfering with the proper
performance of the device. For this reason, make sure that all external devices
operated in the vicinity of the device comply with the relevant EMC requirements. X-
ray equipment or MRI devices are possible sources of interference as they may emit
higher levels of electromagnetic radiation.

NOTE

This device is classified as follows, in accordance with IEC60601-1.


Its classification against electric shocks is Class Ⅰ, Type CF defibrillation -
proof applied part.
Degree of protection against harmful ingress of water: Ordinary
It is not proper to use this product near a flammable anesthetic or solvent.
Continuous operation.
IEC/EN60601-1-2 (Electromagnetic Compatibility Requirements) standard :
Class A

NOTE

Diagnosis provided by CardioTouch3000 must be confirmed by a qualified


medical professional.

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NOTE

Additional equipment connected to medical electrical equipment must comply


with the respective IEC or ISO standards (e.g. IEC 60950 for data processing
equipment). Furthermore all configurations shall comply with the requirements for
medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3 Ed. of IEC
60601-1, respectively).

WARNING

When using AC power with multi-tap, be sure to use grounding type.

WARNING

Do not contact the patient's connector pin with the patient at the same time.

WARNING
Do not contacts with the patient while operate the machine It may cause serious
danger to the users. Use only the provided cable.
A warning that other cables and accessories may negatively affect EMC
performance.

NOTE

This product is a Class A product with EMC4 version and is suitable for professional
healthcare facility environment.

NOTE
Exposing this product to EM interference may cause the equipment to
malfunction.

WARNING

Use of this equipment adjacent to or stacked with other equipment should be


avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they
are operating normally.

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WARNING
Use of accessories, transducers and cables other than those specified or
provided by the manufacturer of this equipment could result in increased
electromagnetic emissions or decreased electromagnetic immunity of this
equipment and result in improper operation.

WARNING
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the [ME EQUIPMENT or ME SYSTEM], including cables specified by
the manufacturer.

NOTE
The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential
environment (for which CISPR 11 class B is normally required) this equipment might
not offer adequate protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating or re-orienting
the equipment.

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Safety Symbols

Symbols Contents

ATTENTION :
Consult accompanying documents

Consult instructions for use:


This symbol advises the reader to consult the operating instructions for
information needed for the proper use of the device.
Safety Sign :
To signify that the instruction manual must be read.
Reading the instruction manual before starting work or before operating
equipment.

General prohibition sign

Defibrillation –proof type CF APPLIED PART

Type B APPLIED PART

~ Alternating Current Power

Fuse

Conductor provides a connection between equipment and the potential


equalization bus bar of the electrical installation

ECG Patient Cable Connector

USB Connector

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Symbols Contents

Local Area Network(LAN) Connector

Power Off

Power On

Battery Operation Indicator

AC Power Connection Indicator

Manufacturer name and address

Authorized European representative

Waste of electrical and electronic equipment must not be disposed as


unsorted municipal waste and must be collected separately.
Please contact an authorized representative of the manufacturer for
information concerning the decommissioning of your equipment.

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Contents
Chapter 1. General Information ............................................. 14
1) Product Overview ............................................................................. 15
2) Indication for Use .............................................................................. 15
3) Recording ECGs during Defibrillation.......................................... 16
4) Product Features ............................................................................... 16
5) Product Configuration ..................................................................... 17
6) System Installation ............................................................................ 27
7) System Start......................................................................................... 28

Chapter 2. Preparation For Electrocardiography .............. 31


1) Location of Electrodes ..................................................................... 32
2) Electrode Connection ..................................................................... 33
3) Starting ECG recording.................................................................... 35
4) Basic Setup ......................................................................................... 36
5) LCD Monitor display ......................................................................... 44
6) Rhythm Mode Printing...................................................................... 44
7) Record Mode Printing ...................................................................... 46
8) Printing Form ....................................................................................... 47
9) Copy Mode Printing ......................................................................... 55
10) System Setup .................................................................................... 57

Chapter 3. ECG File Management ........................................ 93


1) Display and function ........................................................................ 94
2) Data printing ....................................................................................... 95
3) Data deleting ..................................................................................... 96

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4) System Setup ...................................................................................... 97


5) Switching menu ................................................................................. 99
6) Patient information ......................................................................... 100
7) Data search ...................................................................................... 100
8) Data transfer ..................................................................................... 101
9) Data import ....................................................................................... 103

Chapter 4. System Management ......................................... 105


1) Maintenance and Cleaning ........................................................ 106
2) Regular Check-up .......................................................................... 106
3) Trouble Shooting .............................................................................. 107
4) Manufacturer Declaration ............................................................. 111

Chapter 5. Specification ..........................................................117

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Chapter 1. General Information


1) Product Overview

2) Indications for Use

3) Recording ECGs during Defibrillation

4) Product Features

5) Product Configuration
Basic Components and Accessories
Optional Components
Body Configuration
Front Panel
Graphic Display LCD
Control Panel
Power

6) System Installation
Precautions For Installation
Power Connection
Patient Cable Connection
Paper Installation

7) System Start

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1) Product Overview

CardioTouch3000 is an electrocardiogram (ECG) device capable of measuring and


recording 12 channels of cardiac signals of patients. The device enables operators to
record cardiac signals, review them using various viewing modes, and perform automatic
detection of cardiac conditions.
In addition, the device allows operators to enter patient information for it to be printed
alongside cardiac signals, so that operators can sort and manage charts conveniently. It is
also possible to manage the digital files by transferring the stored data to a networked PC.
Furthermore, user convenience has been further enhanced by addition of a functionality
that can initiate ECG recording & saving, filter enhancing, parameter sorting and
automatically detecting cardiac signal all at once by pressing one key.
A battery (optional) can be added to the device so that the device can be operated
conveniently during bedside visits or emergency conditions.

2) Indication for Use

The CardioTouch3000 ECG Analysis System is intended to acquire, analyze, display and
record electrocardiographic information from adult and pediatric populations.
Basic systems deliver 12 lead ECG‘s, interpretive analysis, vector loops, and can be
upgraded to provide software analysis options such as high resolution signal averaging of
QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG
data to and from a central ECG cardiovascular information system is optional.
The CardioTouch3000 is intended to be used under the direct supervision of a licensed
healthcare practitioner, by trained operators in a hospital or medical professional‘s facility.

Indications
The ECG has proven to be among the most useful diagnostic tests in clinical medicine.
The ECG is now routine in the evaluation of patients with implanted defibrillators and
pacemakers, as well as to detect myocardial injury, ischemia, and the presence of prior
infarction as well. In addition to its usefulness in ischemic coronary disease, the ECG, in
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conjunction with ambulatory ECG monitoring, is of particular use in the diagnosis of


disorders of the cardiac rhythm and the evaluation of syncope.
Contraindications
No absolute contraindications to performing an electrocardiogram, other than patient
refusal, exist. Some patients may have allergies, or more commonly, sensitivities to the
adhesive used to affix the leads; in these cases, hypoallergenic alternatives are available
from various manufacturers.

3) Recording ECGs during Defibrillation

This equipment is protected against the effects of cardiac defibrillator discharge to


ensure recovery, as required by test standards. The patient signal input of the acquisition
module is defibrillation-proof. Therefore, it is not necessary to remove the ECG electrodes
prior to defibrillation.
When using stainless steel or silver electrodes a defibrillator discharge current may cause
the electrodes to retain a residual charge causing a polarization or dc offset voltage. This
electrode polarization will block acquisition of the ECG signal. To avoid this condition, use
non-polarizing electrodes (which will not form a dc offset voltage when subjected to a dc
current) such as silver/silver-chloride types if there is a situation where there is a likelihood
that a defibrillation procedure will be necessary.
If polarizing electrodes are used, we recommend disconnecting the lead-wires from the
patient before delivering the shock.
Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace to
return after defibrillation. We recommend using non-polarizing disposable electrodes with
defibrillation recovery ratings as specified in AAMI EC12 4.2.2.4. AAMI EC12 requires that the
polarization potential of an electrode pair does not exceed 100mV, 5 seconds after a
defibrillation discharge.

4) Product Features

- Print 12-channel (ch) cardiac signals with reports in: 3ch+1 rhythm, 3ch+3 rhythms,
6ch+1 rhythm, and 12ch rhythm patterns on A4 or Letter size printing paper.
- Record and print 12 channel rhythms continuously and simultaneously.
- Calculate heart rate, P-R-T axis and PR, QRS, QT and QTc widths from recorded signals
automatically and print them on a report for use in rhythm analysis.
- Get diagnostic reports using automatic detection functionality.
- Able to modify filter setting, signal sensitivity, printing speed, channel view settings and
rhythm settings, and print on previously recorded EKG signals to aid data analysis.
- Able to attach a battery so that the device can become portable.
- More than 200 patient‘s data can be saved and transferred to a PC through LAN as
well as through USB Memory.
- It offers various protocols to make it possible to link with hospitals‘ computing networks.
Also File Databases are strengthened.

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5) Product Configuration

The CardioTouch3000 system consists of the items below. Unpack the package and check
the items below are included. Also, be sure to check for any damage to the body and
accessories.

Basic Components and Accessories

① CardioTouch3000 Body (1 EA) – Dimension: 290(W)× 300(D) × 97.5(H)mm

② Patient Cable (1 EA) – Length: 3,700mm (Max)

③ Limb Electrodes (1 SET)

④ Chest Electrodes (1 SET)

⑤ ECG Paper (1 EA)

⑥ Power Cable (1 EA) – Length: 3,000mm (Max)

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Optional Components

① Battery (1 EA) – Replaceable and Rechargeable, Lithium ion, 11.1V, 2600mA

② Hanger (1 EA)

③ Cart (1 EA)

CAUTIONS

You may have distortion or signal noise when you use nonstandard or other brand
accessories. We strongly recommend you use only the authorized accessories which we
supply.

WARNING

How to replace battery: Please make sure you use the right battery we show here.

Otherwise we are not liable for any damages and/or explosion/fire caused by using the
wrong battery.

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Body Configuration

▣ Top View

① ② ③ ④ ⑤

① Handle

② Printer Cover

③ Printer Cover Switch

④ LCD

⑤ Control Panel

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▣ Front View

① Printer Cover Switch

▣ Rear View
① ②

③ ④ ⑤

① Protective Ground Terminal

② Power Switch

③ AC Power Connection Port ( Fuse : 250V , 5A ( High breaking type ))

④ USB Port

⑤ RJ45 LAN Port

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▣ Left Side View

① Handle

▣ Right Side View

① Patient Cable Connection Port

WARNING

There is a risk of electric shock if the Rest stand of the equipment is damaged or can
not be fixed to the product. Do not use the product and immediately ask the
manufacturer and the seller for repair

NOTE

To avoid an expected electric shock, do not open the equipment cover or


disassemble the equipment. Refer servicing to Bionet, Inc.

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Front Panel

Graphic display window

Battery status Power status

Button Rotary key

During device boot up, you can see the system software version and the Bionet name.

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Graphic display LCD


The following descriptions explain data on the graphic LCD.

① ② ③ ④ ⑤

⑥ ⑦ ⑧ ⑨

① Displays The Heart Rate.

② Displays Patient ID.

③ Displays USB Connection Status (USB Memory, Barcode)

④ Displays Network Connection Status.

⑤ Displays Battery Status or AC Power Connection Status.

⑥ Displays ECG Sensitivity with One of 2.5, 5, 10, 20, and Auto (mm/mV).

⑦ Displays Printing Speed With One of 5, 12.5, 25, 50 And 100 (mm/sec).

⑧ Basic Setup, Network Setup, Hospital Setup, ECG Setup, Record Setup and Service Setup.
Modify the preferences of 5 items, i.e.,
⑨ Choose the menu where you want to move (ECG, File)

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Control Panel
⑦ ⑧

① ② ③

④ ⑤ ⑥ ⑨
▣ Button

① Print out the rhythm data on A4 size or continuous paper.

② 10sec.are saed and are printed vas an output form after processing.

Process the recorded data with or without revision and print them

out.

It operates the product in the most frequently used operation



from the ECG diagnosis test to data saving.

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⑤ It transfers the test data, or saved data to the server PC.

Cancel commands or change into the former mode for main menu

printing.

▣ LED

A light indicator lets you know that the battery is on and shows your
current battery charging status. A red light indicator lets you know

that the battery is charging and a green light indicator lets you know
the batter is fully charged.

⑧ Green light indicates connection with an AC adapter.

▣ Rotary Switch

Use when navigating or selecting menu items


⑨ (Same functionalities can be achieved by touching menu
items on the screen).

Power

▣ AC Power

When AC Power is connected to the device, power LED light will be green; if the battery
is installed, charging will commence.

<AC Power> <Battery Power>

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▣ Battery Power

The device will get its power from the battery and the unit will display the battery power
icon (shown above), when the system is powered on, the battery is connected to the
device and the AC power is disconnected. When the battery power is low, an alarm
sound will ring from the device speaker and LCD display will show a ―Battery Low‖ message.
Connect the AC power immediately or the device will automatically shut down in 1minute.
• Time to complete full recharge after full discharge: Max. 3 hours
• Duration of continuous usage after full recharge: if running ECG record in 12 channel
format by choosing to set successive function for about 360 min. at 25mm/s and
10mm/mV or in the absence of ECG record, it is possible to record a max. of 200
ECG.

▣ Display Battery Power Status

 : Battery Fully Charged

 : Battery Charge Half-Full

 : Battery Charge Low

 : Battery Almost Fully Drained

▣ Replacing Battery

When replacing battery for this device, the same type of battery should be used.
• Type: Lithium-ion battery 3ICR19/65 ( 11.1V-2600mAh )
• When to replace: Battery will automatically be charged when the device is
connected to AC power, and cannot be charged when separated from the device.
Battery is designed to have a charging cycle of 300 times or more. If the device only
lasts 20 minutes or less on battery power, the battery needs to be replaced.
Additionally, when a battery pack is damaged or leaking chemicals, replace it
immediately. Do not use damaged battery packs with the device.

WARNING

EXPLOSION HAZARD —

DO NOT incinerate the battery or store at high temperatures. Serious injury or death
could result.

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6) System Installation

Precautions for Installation


While installing CardioTouch3000, please pay attention to the following items:
- Use the equipment between the ambient temperature 5 to 40℃ and humidity 10 - 90%.
- Check the power cord is properly connected, and the probe carefully handled.
- Do not plug multiple cords in a power outlet.
- Install and operate unit on a flat surface.
- If you experience noise, ground the device.
- Do not use a power cord that may make a connection noise.
- Device settings will be recorded in the internal memory even when it is off.
- Prevent any shock or excessive force that may cause damage to the device.
- Place the device away from any dust or flammable materials.

Power Connection
The equipment needs electrical power to operate. Plug in one end of the power cable
to wall socket and the other to CardioTouch3000.

Patient Cable Connection


- Connect the patient cable to the patient cable connection port on the right side of the
body.
- Connect limb electrodes to RL (N), LL (F), RA(R), and LA (L) leads of the patient cable and
chest electrodes to V1 (C1), V2 (C2), V3 (C3), V4 (C4), V5 (C5), and V6 (C6), respectively.

Paper Installation
- Push the printer cover release switch to the right to open the printer door of the
CardioTouch3000. Install EKG paper with the side to be recorded appearing on top. Close
the cover to finish the paper installation process.

WARNING

No modification of this equipment is allowed.

Do not modify this equipment without authorization of the manufacturer.

If this equipment is modified, appropriate inspection and testing must be conducted to


ensure continued safe use of equipment.

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7) System Start

When every preference is set, the company name will be displayed when the switch is
turned on, and then after approx. 10 seconds, the initial menu selection will appear on the
screen, as shown in the figure below.

You can move to the main page of the chosen menu by touching the menu on the
screen or rotating the key on the control panel.

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The following is the main page of ECG menu.

If you remember the information shown below, it will be easier for you to use the main
page of ECG.

Menu Description

Heart rate mark

To Input or check the patient‘s information

Barcode reader or USB Keyboard connection mark

USB memory connection mark

Network status mark (wired : , wireless : ).


Move to the Network Setup screen by touching the icon.

: The error icon will appear in the event of an IP conflict

Display battery status

To set up the size of the ECG waveform

To set up the speed for printing out the ECG waveform

To set up the various contents related to the equipment

To skip to main page of ECG or File management

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The following is the main page of ECG file management, shown when selecting
the ‗File‘ menu.

If you remember the information shown below, it will be easier for you to use the main
page of ECG file management.

Menu Description

Going to Patient List

To skip to previous page

To skip to next page

To check the patient‘s information

To search the data by inputting what you want to find

To print out the chosen data

To delete the chosen or all data

To set up the various contents related to the equipment

To skip to main page of ECG, file management

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Chapter 2. Preparation For Electrocardiography


1) Location of Electrodes

2) Electrode Connection
Patient Cable Connection
How to Attach Electrodes
Countermeasures for Bad Lead Connection

3) Starting ECG recording

4) Basic Setup
General
Patient Information Input
Sensitivity Setup
Printing speed Setup

5) Screen Printing

6) Rhythm Mode Printing

7) Record Mode Printing


10 seconds ECG recording

8) Printing Form

9) Copy Mode Printing

10) System Setup


Basic Setup
Network Setup
Hospital Setup
ECG Setup
Service Setup

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1) Location of Electrodes

Attach electrodes to the patient‘s body to record an electrocardiogram of twelve


standard leads [ I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6 ], as shown below.

Limb electrodes are located as follows.


- RL (N): Right Leg
- LL (F): Left Leg
- RA (R): Right Arm
- LA (L): Left Arm

Chest electrodes are located as follows.


- V1 (C1): Fourth Intercostal Space At The Right Border Of The Sternum
- V2 (C2): Fourth Intercostal Space At The Left Border Of Sternum
- V3 (C3): Midway Between Location V2 and V4
- V4 (C4): At The Mid-Clavicular Line In The Fifth Intercostals Space
- V5 (C5): At The Another Axillary Line On The Same Horizontal Level As V4
- V6 (C6): At The Anterior Axillary Line On The Same Horizontal Level As V4 and V5

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2) Electrode Connection

* Check Points

- Check the status of equipment and attachment to patient‘s body before measuring.
- Check for any mechanical danger.
- Check cables and accessories connected to the outside.
- Check all the devices to measure the patient .

Patient Cable Connection

Connect the device cable to the patient cable connection port on the right side of the
main body, and then connect electrodes for extremities to the terminal of patient cable RL
(N), LL (F), RA(R) and LA (L), while you can connect electrodes for the chest to the terminal
of ‗V1 (C1), V2 (C2), V3 (C3), V4 (C4), V5 (C5) and V6 (C6).

How to Attach Electrodes

Lay down the patient on the bed and let the patient relax. Attach the electrodes
cleaned with water or antiseptic alcohol to the patient‘s body. If it is hard to attach
the electrodes due to the patient‘s hairs or curves of the body, apply the ECG gel.
Please make sure the electrodes are attached correctly as explained above. When
using the gel, please remove the gel after use as it may cause noise of the ECG
signals.

WARNING
Use only electrodes and patient cables provided from Bionet, Inc. Bionet
America, Inc. will take no responsibility for any accidents involving 3 rd party
accessories.

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Countermeasures for Bad Lead Connection

After turning on the power switch, enter the ECG test to check waveforms of all leads.
On this menu, operators can check waveforms of all leads and their noise, and may see
―Lead Fault‖ message displayed on the LCD screen.

NOTE

Message will be displayed when Lead fault is set to ON in System Setup, and will
NOT be displayed when set to OFF..

Lead Fault! All Leads.

The following two cases could cause a lead fault error.


- First case, leads are detached from the patient‘s body. In this case, re-attach leads
normally.
- Second case, signal conductivity between leads and the patient‘s body is low. In this
case, replace the electrodes.

If the two above cases have been performed and the operator is still experiencing
noise or lead fault conditions, the patient cable may be faulty. Please contact the Bionet
service center.

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3) Starting ECG recording

- Connect leads to the patient, and then turn on the device in accordance with the
preparation steps for measuring electrocardiogram.
- Check the setting for filter, size of signals, printing speed, channels and rhythm. Set up
the new values if you want to modify them.
- Input the patient‘s information
- If the waveform displayed on the LCD is abnormal or has excess noise, follow the
instruction of ―Countermeasures by Bad Lead Connection‖.
- If the waveform displayed on the LCD is normal, press the ‗RECORD‘ key to record the
electrocardiogram of the patient.
- Press the ‗COPY‘ button to print out the previously saved 10-second data or modified
data.
- Press the ‗RHYTHM‘ key to monitor the ECG waveform through the printer not through
the LCD.
- Press the ‗ESC‘ key to stop the operation while printing or recording.

The following buttons will be most commonly used when operating CardioTouch3000.

Print out the rhythm data on A4 size or continuous paper.

10sec. are saved and are printed as an output form after processing.

Process the recorded data with or without revision and print them out.

It operates the product in the most frequently used operation from


the ECG diagnosis test to data saving.

It transfers the test data, or saved data to the server PC.

Cancel commands or change into the former mode for main menu
printing.

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4) Basic Setup

General
When turning on the system, LCD will display component values set by the current
system in order of heart rate, patient information, connection status of external device,
power state, size of ECG signal and output speed.
They can be modified in two ways.
First, these configuration values can be changed using either a rotary key or touch
screen. Second, with the rotary key, the desired menu and changed configuration values
can be set easily.
Same functionality can also be achieved with the touch screen by pressing and
changing the desired information on the LCD.

Changing The Configuration Value With The Rotary Key


In this case, please follow these steps: enter Menu Mode, navigate and select Menu and
then change values.

- Entering Menu Mode

The rotary key is supposed to rotate clockwise. When the user selects the ECG
Main, the initial focus will point to the ‗patient‘ item. The following is the page you
will see when you rotate the key clockwise and click it to enter the speed menu.

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- Menu Navigation
Operate by rotating the rotary key. Menu movement will occur in the same direction
as the direction of the key‘s rotation.

- Menu Selection
Initiate by pressing the rotary key. Menu box for setting of the selected menu will be
displayed.

- Modifying setting values


Move to desired setting, then modify & select values in the same manner as menu
movement shown above. When you select either 5mm/sec, 12.5mm/sec,
25mm/sec, 50mm/sec or 50mm/sec at the ‗Speed Setting‘ POP-UP, the POP-UP
window will disappear.

Using the touch screen to modify the information


When using the touch screen, only two procedures, menu selecting and
information modification, are required.

- Select Menu
Press the menu on the screen. Unlike the rotary key, the menu box you want
to set up will show at the same time.

- Change the value


Press the chosen item on the screen after moving to the page.

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Patient Information Input


In this menu, operators can input the patient‘s ID, name, age, sex, height, weight.

When the user selects the line of ID, NAME, Department , a keyboard will show up on the
screen. The default of every line is a blank and if there is a certain figure on the line, it
should be shown exactly when loading the keyboard window.
When the user wants to set the data after inputting, the user can press OK button on the
keyboard and if the user wants to cancel the setting, pressing ESC button will do it and the
keyboard window will disappear.

NOTE

When entering an ID, it is impossible to enter special characters such as ―, <, >, ?, /, *,
|, :, \, etc. (these invalid characters are set to be inactive)
When entering an ID, an English keyboard will be displayed.
When entering an ID by connecting to an external keyboard, proceed by using
general alphabet and numbers only. If you enter an ID using Latin extended characters
and Russian, an error may occur when transferring files via PC and USB.

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When the user selects the line of Age, Height or Weight, a keypad will show up on the
screen. The default of every line is a blank and if there is a certain figure on the line, it
should be shown exactly when loading the keypad window.

Enter an age and select the year of birth for >1 year old; enter age in the form of week or
day for 1< year old. Automatic diagnosis is available from postnatal day 1 for pediatrics.
When the user wants to set the data after inputting, the user can press OK button on the
keypad and if the user wants to cancel the setting, pressing ESC button will do it and the
keypad window will disappear.

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When clicking the Gender Line, the letter Male or Female will be shown respectively.
After selecting the data which you want, input all the information of the patient. When
pressing OK button, the information will be saved, while pressing cancel button will cancel
the setting. The default of the Gender line will be set as a Female.

NOTE

Patient information will be initialized if the language preference is changed during the
system setup.

NOTE

Patients‘ ID can be registered using a barcode scanner. Patients‘ ID will be entered


automatically when the user scans the barcode on ECG main screen.

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Normally barcode scanners are compatible with all products. However, because of
inconsistencies in barcode scanner manufacturers implementation of input methods, you
need to verify the scanner is supported by Bionet.

• Input methods supported by Bionet : International standards, USB


• Products below are tested and confirmed by Bionet.

No Manufacturer Product name Product image

1 Symbol LS-2208

2 ZEBEX Z-3110

3 Honeywell MS5145

CAUTIONS

You must read the user manual of the barcode scanner to get complete information
about it. The initialization codes for various products would be included. You must run the
initialization after verifying the input type.

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Sensitivity Setup
This is a functionality that can modify sensitivity of the output signal, when the outputting
signal‘s amplitude is too large and causes overlap with neighboring signals, or too small so
that signal diagnosis is difficult.
Users can set all 12 channels to 2.5mm/mV, 5mm/mV, 10mm/mV or 20mm/mV. Users
can also set it to Auto which will automatically set the sensitivity level for each channel; for
example limb electrodes(I, II, III, aVR, aVL, aVF) to 10 mm/mV and chest electrodes(V1, V2,
V3, V4, V5, V6) to 5mm/mV. Note that 10mm/mV means printing 1mV signal as 10mm in
amplitude on the printing paper.

The left side of the graph display will show the channel name and a bar graph, so users
can notice recently changed values easily. However, for 20mm/mV, the size of signal is set
to be shown for 6 signals only to avoid overlapping signal size displays.

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Printing speed Setup


This is a function to adjust the width of the printing signal. The values are available
in 12.5mm/sec, 25mm/sec and 50mm/sec, 100mm/sec. If you set 25mm/sec up, the
ECG signal will be recorded in 25mm for one second. Therefore, the 12.5 mm/sec width
is equal to half of the 25 mm/sec width; the 5 mm/sec with is equal to 1/5 of the 25 mm/sec
width.
The 50mm/sec width is equal to twice that of the 25mm/sec width; the 100mm/sec width
is equal to twice that of the 50mm/sec width. Therefore, if you want to have a wide
signal, set up the bigger value.

NOTE

When monitoring is set to ‗Mon Size‘ -> ‗A4‘, the printing speed is 25mm/s.

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5) LCD Monitor display

Monitor mode display shows the currently measured electrocardiogram signal in real
time. The monitor mode display function is used for the following two purposes: One is to
check whether the signals from all channels are coming out properly; the other one is to
see the status of the electrocardiogram of the patient for an extended time.

The printing speed can be selected to 5mm/s, 12.5 mm/s, 25 mm/s, 50mm/s and 100
mm/s, and the sensitivity can be selected to 2.5 mm/mV, 5 mm/mV, 10 mm/mV, 20
mm/mV, and Auto.
Displayed heart rate is the average of 4 heartbeats

NOTE

The heart rate detection range is 30 to 300 bpm, and the error range is ± 2.

6) Rhythm Mode Printing

In rhythm mode printing, the measured ECG signals would be printed in real-time.
Rhythm mode printing allows operators to perform the following two functions: one is to
verify that signals in all channels are active before recording ECGs, and the other is to print
the ECGs rhythm status of the patient for a longer duration.

Printing speed can be set to 5mm/s, 12.5 mm/s, 25mm/s, 50mm/s, 100mm/s and signal
level can be set to 2.5mm/mV, 5mm/mV, 10mm/mV, 20mm/mV, and Auto.
When pressing the ‗RHYTHM‘ key on the control panel, you will see the message as
shown below and printing will start in accordance with the speed you set up.

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Press ‘ESC‘ key to stop printing the ECG rhythm. After pressing the key, the system will
stop printing and the display system setting after indicating the following message.

NOTE

Even if ECG output speed is set as 100 mm/sec, it is not supported when outputting
monitoring.

NOTE

You should avoid connecting or disconnecting a USB device while printing out, as it
could cause the printer module to rattle.

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7) Record Mode Printing

For the record mode display, save the electrocardiogram in the memory first, and apply
the filter which is set up by the user to the saved electrocardiogram, and then extract the
parameters for the heart rate, PR interval, QRS duration, QT/QTc, and P-R-T axes. Then, print
out the heart rate according to the sensitivity, printing speed, and channel form that are
set up by the user.

10 seconds ECG recording


When one of 3ch+1rhy, 6ch+1rhy, 12ch, 3ch+3rhy and beat is selected for the channel
form, press the 'RECORD' key to display the saving time as below and save the 10-second
data.

After saving the 10-second data and the parameters for diagnosis will be
extracted, it will show the message as shown below and printing will begin.

Enter 'ESC' key on the operation panel in order to stop while obtaining or printing out
data. In this case, display the following message on the screen; cancel ECG recording if
saving, otherwise end output while printing out.

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8) Printing Form

In this section, descriptions and samples of various printing forms are provided.

 Rhythm Printing Form


- 3CH printing: To print 3 channels at the same time (I ~ III / aVR ~ aVF / V1 ~ V3 /
V4 ~ V6)
- 6CH printing: To print 6 channels at the same time (I ~ aVF / V1 ~ V6)
- 12CH printing: To print 12 channels at the same time (I ~ V6)

 Record Printing Form


- ‗3CH+1‘: I, II and III will be recorded for the first 2.5 seconds, V1~V3 for the next
2.5 seconds, V4~V6 for the next 2.5 seconds and 1 channel of rhythm will be
recorded for 10 seconds at the bottom.
- ‗6CH+1‘: I~ aVF will be recorded for the first 5 seconds and V1~ V6 for the next 5
seconds. And 1 channel of rhythm will be recorded for 10 seconds at the bottom.
- ‗12CH‘: 12-channel rhythm will be recorded as I~ V6 at the same time for 10
seconds.
- ‗3CH+3‘: I~ III will be recorded for the first 2.5 seconds, aVR ~ aVF for the next 2.5
seconds, V1~V3 for the next 2.5 seconds and V4~V6 for the next 2.5 seconds. And
3 channels of rhythm will be recorded for 10 seconds at the bottom.

 Form of Beat Report Output


- Choose an additional output form after printing out diagnosis; either Text, Guide or
Vector.
- Text: to output representative beat and each diagnostic parameter. Output will come
at 50mm/sec if the output speed is set at ‗5, 12.5 and 25 mm/sec‘, whereas it will come
at 100 m/sec if set at ‗50 and 100mm/sec‘.
- Guide: to output representative beat and each diagnostic parameter, with diagnostic
guide for arrhythmia. Output will come at 50 mm/sec regardless of the output speed.
- Vector: to output representative beat and each diagnostic parameter and Vector of
QRS, as indicated by the arrow. Output will come at 50 mm/sec regardless of the
output speed.

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Rhythm Report Form (3CH)

Rhythm Report Form (6CH)

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Rhythm Report Form (12CH)

Record Report Form (3CH + 1 RHY)

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Record Report Form (3 CH + 3 RHY)

Record Report Form (6 CH + 1 RHY)

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Record Report Form (12 CH)

Record Report Form (BEAT REPORT - TEXT)

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Record Report Form (BEAT REPORT - VECTOR)

Record Report Form (BEAT REPORT - GUIDE)

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Beat Report Parameters

 PR : PR Interval
 PA : P Amplitude
 PD : P Duration
 QA : Q Amplitude
 QD : Q Duration
 RA : R Amplitude
 RD : R Duration
 SA : S Amplitude
 SD : S Duration
 QRSD : QRS Duration
 QRSA : QRS Amplitude
 TA : T Amplitude
 STA : ST Amplitude
 QTc : collect Q-T Interval
 ST60A : ST 60ms Amplitude
 ST80A : ST 80ms Amplitude

NOTE

The unit of the interval of the parameter output(duration, Interval) in the Beat
Report is 'ms', and the unit of amplitude is 'uV'.

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NOTE

Dextrocardia

The human heart is normally located on the left side of the chest. However, in rare
cases it is located on the right side chest, which is a condition called Dextrocardia.

There is potential for dextrocardia if:


- P, QRS and T are all reversed on Lead I.
- aVR and aVL as well as lead II and III are switched with each other.
- As you proceed from V1 to V6, R wave is reducing on Chest lead.

For patients with dextrocardia, the result of a normal automated diagnosis can be
obtained if measurement is conducted by switching electrodes over, as follows:
- Switch between Right hand (R) and Left hand (L) electrodes.
- Attach chest leads starting from the left side, rather than from the right.

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9) Copy Mode Printing

Copy Mode Printing is a function to print out the same report as the previously printed
report. In Copy Mode, users can also print out the same previous data but with changed
settings such as filter type, sensitivity, printing speed, channel form, and rhythm number if
more than one rhythm is recorded.
Copy Mode can be entered by pressing the ‗COPY‘ key following an EKG recording.
After pressing the COPY Key, the following message will be displayed on the LCD screen,
and the printing process will start:

If Copy Mode Printing is called without performing an EKG recording, there would be no
EKG data to copy. In this case, the following message box will be displayed:

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If you change the filters on a previously saved ECG, it will adapt to the new filter.
When the new filter is adapted completely, it will start printing after showing the
message as below.

When printing is abnormally completed, the state of the system setting will be
displayed after showing the message as shown below for a second.

If you want to stop the process of printing, press the ‗ESC‘ key. Then the process
will stop and you will see the ECG Main page after the message shown for a second
as below.

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10) System Setup

Choose the 'Setup' button on the initial ECG main screen to change preferences.
Setup menu consists of Basic Setup, Network Setup, Hospital Setup, ECG Setup, Service
Setup and you can change the setting at each window. The main page shows Basic Setup.
After finishing the settings, press 'OK' to save the new information or press 'Cancel' to
cancel it. You can choose 'Exit' or 'ESC' button to exit from the setup menu.

‗Default‘ button is used to default every setting.

Basic Setup

When choosing Basic menu at the left side of the Setup page, you will see the page for
Basic Setup.
Basic Setup consists of Date, Time, Touch screen, Start Option, Unit, Date Type and
Device Name menus.

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Setup date and time

After choosing the Setup menu, press the Basic button then the focus will go to the 'Date'
item.

By using the touch screen or rotating the rotary switch, choose the Date (yyyy/mm/dd) or
Time (hr/min/sec), then the keypad will show up. You can set up the information by using
this keypad.
The Focus will go ‗year  month  day  hour  minute  second‘ consecutively.

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Touch Setup

This is a menu to set up the coordinates of the touchpad. When selecting the 'Touch'
menu at the Basic Setup page, setup page will disappear and the coordinates for setting
calibration will appear as shown below. Follow the instructions shown on the screen, and
then the coordinates will be set up.

Please input the information in the right place, otherwise the touchpad may not work
properly.

NOTE

When the user selects the Touch Setup menu, all windows will disappear and the
touch screen setup will start. No keys will be operational until the Touch Setup is
complete.

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Language

As shown below, when selecting 'Language menu at the Basic Setup page, you can
choose the language among
English, French, German, Italian, Korean, Polish, Portuguese, Rumanian, Russian, Spanish
and Turkish.
Select the language you want to use and click the OK button and then you can use
the service in the chosen language.

NOTE

Patient information previously entered will be initialized if the language preference


is changed.

NOTE

If language preference is set as ―KOR,‖ only the menu on the LCD screen will be
shown as Korean, whereas the output will be in English when printing out.

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Start Option

You can set up the index page shown at the time of initial boot up, according to the
common dialog.
When clicking the ‗Start Option‘ button, a small menu window will appear and you can
select the initial page you want to have among MAIN, FILE, ECG.

Units

This menu is to select the units for height and weight of the patient. When you click ‗Units‘
button, cm/kg or Inch/Lbs will be shown.

If you select Inch/Lbs unit, the patient‘s height information will be expressed in *** Ft (Feet)
*** Inch.

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Date Type

As seen in the figure below, the date format on the top of the paper can be changed
while printing out monitoring and recording results if you choose 'Date Type' from the Basic
Setup menu. Choose the date format to be used, and then click the 'OK' button; the date
format is converted to the one selected and can be seen on the output.

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Color Setup

The device offer two type of LCD screen for easy reading of wave form. In case of
choosing "Black" color, it reflect wallpaper as black color and wave color turn to green
color. In case of choosing "White" color, the wallpaper reflect white, wave color turn to
black.

[Black& Green Color]

[White& Black Color]


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Network Setup

When connecting the equipment with LAN to interface with the outside PC, network
setup is needed. Network IP is required and DNS is not used.

When selecting the Network menu at the left side of the System Setup page, Network
Setup page will show up at the right side.

The mode of network connection can be selected as Wired or Wireless in ‗Net Device‘
setup.

The automatic IP(DHCP) or fixed(Manually) can be selected through the 'Configure'.


If the Configure is setup as automatic IP(DHCP), the Device IP, Subnet Mask, Gateway
value is received automatically from the DHCP server on your network. If the Configure is
set to manually, the user has to enter the Device IP, Subnet Mask, Gateway directly.
When selecting one of the ‗Device IP‘, ‗Subnet Mask‘, ‗Gate Way‘, the keypad will show
up. Then, input the information required and press 'OK' button to save or 'ESC' to cancel the
information.

The server interlocking device can be selected as BMS Server of Bionet.


After selecting the type of interlocking server, select the 'Setting' button; an appropriate
setup window to the choice of server will be displayed.

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BMS Server Setting

IP setup on BMS Server-installed PC can be performed by choosing either Automatic IP


(DHCP) or Fixed IP (Manually) in 'Configure‘ setup.

If ‗DHCP‘ is chosen, the IP of the BMS Server-installed PC will be shown on the input box.
Choose the IP of the PC you intend to connect as the IP of a BMS Server-installed PC; At
that time, IP will be shown on the input box only if BMS Server is running on the PC.
If no IP of the intended BMS Server to connect is shown on the input box, choose 'Search'
button to conduct an additional search.
If no IP of the intended BMS Server to connect is shown on the input box, choose 'Manual'
mode to perform manual input.
Upon completion of BMS Server IP setup, the Ping Test can be conducted to check
successful network connection. If choosing ‗Ping‘ button, ―Ping : 100% Succeeded‖
message will be shown for a successful connection, whereas ―Ping : Failed‖ message will
be shown for connection failure.

NOTE

Wired usage is recommended for a BMS Server-installed PC network.


When setting BMS Server, directly enter the IP of the BMS Server-installed PC by
selecting "Manually" if searching with DHCP has failed.

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Wireless Network Setting

Connect the USB wireless LAN card to the USB port of CardioTouch3000, and check

whether or not the wireless icon ( ) appears in the Status bar on the top of the screen.

1) Navigate to System Setup -> Network, and Set the Device as ―Wireless‖.
When selection is done properly, the "Survey" button on the bottom will be
activated.

2) Select the ―Survey‖ button to search for the AP.


The AP is to be searched automatically when the ―Search‖ button is pressed;
the searched AP will appear in the list upon the completion of the search.

Specifications of Wireless Network USB Adapter Support

Company Name Product Name


N100mini

ipTIME N150UA

N150U

TP-LINK TL-WN725N

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 : AP re-searching

 : Page up

 : Page down

 : Attempting to connect

 : Closing the window

3) Select the AP to be connected by using the rotary key or touching.


Click the ―Connect‖ button. At that time, the security key input window will appear
if the ―Encrypt‖ field is ―On‖.

NOTE

The user should set the AP Search and Security Key in order to use the wireless network.
If there is no security set on the AP to be connected, it will be connected
automatically without Security Key setting.
In the event that there is an automatic connection to the AP without Security Key
setting, the safety of network communication is not guaranteed.

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4) After clicking the Key Value input line by using the rotary key or touching, enter the
security key.

5) Upon the completion of input, click the "OK" button; Connection will be attempted
and the message describing the connection status will appear.

6) When the message reporting a proper connection appears, click the "Close"
button.

When connection is successful, the wireless icon on the status bar at the bottom of

the screen will be changed into .

7) If connection fails, connection can be re-attempted by pressing the "Retry" button.


If connection keeps failing, check the AP and the USB-TO-WLAN status.

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8) When connection with the AP is successful, set the Device IP, Subnet Mask,
Gateway, etc. by selecting manually or Configuring with DHCP.
Refer to the Network Setup part of the User Manual for more details.

NOTE

It is recommended to use English for the name of the AP wireless network (SSID). If it is
entered in Korean or other languages, Mojibake or illegible characters can appear.

Hospital Setup

When selecting the ‗Hospital‘ menu at the left side of the Setup page, Hospital Setup
page will show up at the right side. You can input the names of the hospital and doctor.
Moreover, for classifying with the other devices in hospital, it is offer to make " Device
Hospital Setup menu, user can set up hospital name and doctors name. But "Device ID" is
innate ID and user can not adjust. Automatically, " Device ID" is generated.
When clicking the area to input the information, the keypad will show up. Then you can
input the information required and press OK button to save or ESC to cancel the
information.

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ECG Setup
When selecting the ‗ECG‘ menu at the left side of the Setup page, ECG Setup page will
show up at the right side. In ECG Setup menu, there is 'AUTO' button to set up and change
set up related automatic diagnosis.

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Printing channel setting [Print Setup]

[Monitoring Form]

Set up real time-printout form. Click ‗Mon Form,‘ and then a POP-UP window for channel
list will be displayed. Default is set as ‗12CH‘.

- 3CH printing: To print 3 channels at the same time (I ~ III / aVR ~ aVF / V1 ~ V3 /
V4 ~ V6) If you want to change the channel, press ‗RHYTHM‘ on the control panel.
- 6CH printing: To print 6 channels at the same time (I ~ aVF / V1 ~ V6) If you want
to change the channel, press ‗RHYTHM‘ on the control panel.
- 12CH printing: To print 12 channels at the same time (I ~ V6)

NOTE

At 3CH and 6CH setup, ‗RHYTHM‘ key will become active only if ‗Mon Size‘ is set as
‗Continue.‘

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[Monitoring Size]

You can set up the real time printing size. When you click the ‗Mon Size‘ menu, ‗Report‘
will be selected and when clicking it again, ‗Continue‘ will be selected. Default is set as
‗Continue‘.

- ‗Report‘ : To print out 10-second data in the form of Report.


- ‗Continue‘: The leads will be printed out continuously until you press the ‗ESC‘ key on the
control panel.

NOTE

Output speed will be 25.0mm/sec if ‗Mon Size‘ is set as ‗Report.‘

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[Grid]

If general fax paper is used for printout, it needs to be marked with a grid. A 5mm X 5mm
grid must be in a solid line with the point mark on the 1mm X 1mm location. If using
standard ECG recording paper instead of general fax paper(thermal paper), undo the grid
marking setup as the recording paper will already have it.
The grid marking setup can be done using output format selection mode. Press rotary key
or touch the intended field to select among the Grid selection items, and then the setup
will be modified as ON or OFF. If ON, the grid marks will be printed out; if OFF, it will not be
printed out.

[Recording Form]

You can set up the recording form.

If you choose the ‗Rec Form‘ menu, a small POP-UP menu will appear below; once you
choose either 3CH+1, 6CH+1, 12CH or 3CH+3, the POP-UP menu will disappear. The default
is ‗3CH+3'.

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- ‗3CH+1‘: 10-second ECG will be recorded as I, II and III for the first 2.5 seconds, aVR,
aVL and aVF for the next 2.5 seconds, V1, V2, V3 for the next 2.5 seconds
and V4, V5, V6 for the next 2.5 seconds. 1 channel of rhythm will be
recorded for 10 seconds at the bottom.
- ‗6CH+1‘: 10-second ECG will be recorded as I, II, III, aVR, aVL and aVF for the first 5
seconds and V1, V2, V3, V4, V5 and V6 for the next 5 seconds. 1 channel
of rhythm will be recorded for 10 seconds at the bottom .
- ‗12CH‘: 12-channel rhythm will be recorded as I, II, III, aVR, aVL, aVF, V1, V2, V3, V4,
V5 and V6 at the same time for 10 seconds.
- ‗3CH+3‘: 10-second ECG will be recorded as I, II and III for the first 2.5 seconds, aVR,
aVL and aVF for the next 2.5 seconds, V1, V2, V3 for the next 2.5 seconds
and V4, V5, V6 for the next 2.5 seconds. 3 channels of rhythm will be
recorded for 10 seconds at the bottom.

The set value will be displayed on the screen, and when you choose ‗3CH+1‘, 3
Channels + 1 Rhythm Report will be shown at the top of the printing form, ‗6CH+1‘
for 6 Channels + 1 Rhythm Report, ‗12CH‘ for 12 Channels Rhythm Report, ‗3CH+3‘
for 3 Channels + 3 Rhythm Report will be shown.

[Paper Size]

You can set up the paper size. When you click the ‗Paper Size‘ menu, ‗A4‘ will be
selected and when clicking it again, ‗Letter‘ will be selected. Default is set as ‗A4‘.

- ‗A4‘ : to output at 297mm for A4 Size printout.


- 'Letter' : to output at 279 mm for Letter Size printout.

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[Print Line]

You can set the line thickness of the printouts. Three setting options are available; ―Thin‖,
―Normal‖ and ―Thick‖.

[Beat Form]

You can set up the additional beat report printing.

When you select the ‗Beat Form‘ menu, a small POP-UP menu will appear at the
bottom and it will disappear when choosing OFF, Text, Vector or Guide.
Default is set as ‗OFF‘.
Beat report will be attached to the printing form of channels of ‗3CH +1‘, ‗6CH +1‘,
‗12CH‘ and ‗3CH +3‘. It will record every important result by marking the
representative waveform of each form.

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[Rhythm]

You can set up the rhythm leads for printing out the diagnosis of 3CH+1, 6CH+1, 3CH+3
and Long Time(1,3,5,10 Minute). You can choose 3 rhythm leads and when ‗3CH+3‘ is
chosen, you can use all of the 3 leads, while when ‗3CH+1‘, ‗6CH+1‘ or ‗Long Time‘ is
chosen, you can use the first value only.
Default is set as ‗II, V1, V5‘, so when 3CH+1, 6CH+1 is chosen, you can use the lead ‗II‘
and 3CH+3 for lead ‗II, V1, V5‘.
If you choose ‗Rhythm‘ menu, ‗Rhythm Channel‘ window will be displayed as shown
below.

At that time, select either the ‗CH1,‘ ‗CH2‘ or ‗CH3‘ menu; and then choose one from
Lead I ~ V6 in the select menu.

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[Quick Print]

Set up the Quick Print Options. Output time can be saved by using the buffering function
during selection of 0 - 10 seconds.

NOTE

If setting up as ON, diagnosis button should be used only after signalling is stabilized.
Upon ON setup, diagnosis and output can be affected if the saved data is not
stabilized; this is because the data is retained before use for as long as the time set
up.

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[Filter Setup]

The signal output generated by the device may contain extra unwanted signals in
addition to the EKG wave such as AC noise, base line drift caused by respiration, noise
generated by an electrical field nearby, etc. Applying filters could help to reduce or
remove those unwanted signals from the output of the device.
To change filter information, enter the Filter Setup Menu either by moving the selection
block over and select it using the rotary key or by touching the menu on the touch screen.

Upon selection, the Filter Setup menu, shown below, will appear. Use either the rotary key
or touch screen to navigate and select menu items to edit. After editing, OK must be
selected in order to apply the changed value.

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Base line drift is caused by the patient‘s breathing. It can be seen as ECG signals being
overlapped on a large parabola. The BASE LINE filter provides 0.05Hz, 0.1Hz and 0.2Hz, and
its set values will appear as Base:0.05Hz, Base:0.1Hz and Base:0.2Hz at the bottom of the
Output Form.

There are three types of an AC power noise filter; 60Hz, 50Hz and OFF. When set to
OFF, the filter will not be applied. If the filter is set to 50Hz or 60Hz, then the AC filter will
remove 50Hz or 60Hz power noise correspondingly. In the U.S., the AC filter should be
set to 60Hz. Check the properties of your power source before setting AC filter
properties.
The status of the AC filter can be checked on the bottom part of the printout -
indicating AC 60Hz, AC 50Hz or AC OFF

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If the recorded EKG signal contains a lot of noise, Low Pass Filter (LPF) may help to clear it.
For Low Pass Filter, 40Hz, 100Hz, 150Hz and OFF option is offered. Here, 40Hz option means
the filter will remove any unwanted signal with frequencies above 40Hz. Low Pass Filter
values will appear on the bottom of the printout form; if LPF setting is OFF then as LPF: Off; if
the LPF setting is 40Hz then as LPF: 40Hz; if LPF setting is 100Hz then as LPF: 100Hz; if LPF
setting is 150Hz, then as LPF: 150Hz.

Select 'ON' when applying ‗EMG‘ filter; otherwise, select 'OFF.' Setup values will be shown
on the bottom of the printout form as ‗EMG:On‘ or ‗EMG:Off‘ when applying the filter.

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Lead fault Signal Display Setting

When the connection between the patient and Leads is improper, lead fault can
occur. In that case, you can choose whether to have the lead fault message on the
ECG Main page or not. Selecting ‗Lead Fault‘ menu will switch between ON and OFF in
the menu, with ON turning on the message display and OFF switching off the message
display.

The following message for Lead Fault will be shown with affected channels:

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NOTE

If ‗RA‘ Lead becomes Fault, the wave types of all Leads will not be indicated.
If ‗LA‘ Lead becomes Fault, the wave types of I and V1-V6 Leads will not be
indicated.
If ‗RA‘ Lead becomes Fault, Lead Fault message might not be shown and the wave
types of all Leads might be indicated.
If ‗LL‘ Lead becomes Fault, the wave type of II and V1-V6 Leads will not be indicated.
If a Lead Fault occurs during monitoring or recording, a buzzer alarm will sound and
the message box will pop up.
No pacemaker signal may be detected. Additionally, if a Lead Fault occurs, please
re-measure the EKG as it could have affected the measurement by the device.

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Pacemaker signal printing

In case of using the pacemaker signals, you can choose whether to print out the
location of the pacemaker when monitoring or recording .

You can select ON or OFF by clicking the ‗Pacemaker‘ item. When it is on, the
location of the pacemaker will be printed out, while when it is off, it will not be
printed out.

NOTE

It is recommended to set the pacemaker off for normal use and only when the
patient uses a pacemaker, set it on.

When having a Lead Fault, the Pacemaker signals may not be detected.

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QRS Sound Setup

In this menu, users can set the device to ring an alarm sound when a QRS beat has
generated while it is in waiting mode. Users can either set the alarm ON or OFF by selecting
the menu with ON turning on and OFF turning off the alarm sound.

NOTE

No sound will ring while printing even when the QRS sound is set to ON.

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Demo Mode Setting

This menu puts CardioTouch3000 in demo mode. When it is set to ON, 60bpm Sinus
Normal Rhythm signal will be displayed on the device and DEMO sign will appear on the
upper part of the LCD screen. Users can test rhythm, diagnostic, copy printing functions as
well as PC communication and other miscellaneous functions.

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‘AUTO’ key setting

When the ‗Store‘ menu has the focus, click it to set up ‗Yes‘ or ‗No‘.
When ‗Yes‘ is selected, you can operate the ECG test by pressing the ‗AUTO‘ key
on the control panel and the ECG data will be automatically saved, but when ‗No‘
is selected, the ECG data will not be saved. Default is set as ‗Yes‘.

When the ‗Print Out‘ menu has the focus, click it to set up ‗Yes‘ or ‗No‘.
When ‗Yes‘ is selected, you can operate the ECG test by pressing the ‗AUTO‘ key
on the control panel and the ECG data will be automatically print out, but when
‗No‘ is selected, the ECG data will not be printed out . Default is set as ‗Yes‘.

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When selecting the ‗Export‘ menu, a small menu window as below will appear and
it will disappear when selecting one of None, Server, USB.
If it is ‗None,‘ ECG data will not be externally transferred; if is 'USB,' ECG data will be
automatically saved to the external USB memory. In addition, if it is set up as ‗Server,‘ data
will be automatically transferred to PC Server IP among Network options. (Default : None)

NOTE

When you remove the external device after sending to USB Memory, you

should click icon that is correct to each device on top of the main
screen and remove the device.
Otherwise data can be damaged.

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Service Setup

If ‗Service‘ menu on the left of the Setup screen is selected, the other Setup screen
related to ‗User Security Set‘ and ‗Manufacture Set‘ will appear.
At ‗User Security Set‘ setup, it is possible to change Factory Setting and User Password.
At ‗Manufacture Set‘ setup, it is possible to change Upgrade and Device Options;
please contact the Bionet Service Center.

Factory (Reset Settings)

In order to reset to factory conditions, press the ‗Factory‘ button and enter the Password.
Reset will proceed, with the message below appearing on the LCD screen for 1 second.

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The initialized values are as follows.

Contents Setting Value

Gain 10mm/mV

Speed 25mm/s

Start Option Main

Unit Height : cm, Weight : kg

Date Type YYYY-MM-DD

Patient Info (File) Delete

Device Name CardioTouch3000

Net Device Wired

Configure Manually

Device IP 192.168.30.224

Subnet Mask 255.255.255.0

Gate way 192.168.30.1

BMS Server 0.0.0.0

Hospital blank

Doctor blank

Quick Print Off

Lead Fault On

Pacemaker Off

QRS sound Off

Demo Off

Mon Form 12ch

Mon Size Continue

Grid Off

Rec Form 3ch + 3

Paper Size A4

Print Line Normal

Beat Form Off

Rhythm II, V1, V5

Base Filter On

For ENG and KOR language, ‗60Hz‘


AC Filter
For other languages, ‗50Hz‘

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Low Pass Filter 150Hz

EMG Filter Off

ECG Store Yes

Print Out Yes

Export None

Target PC

Method Manual

Format EKG

Delete Yes

JPEG Size 1024 x 768

Patient information initialized

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Data Erase

All data in Files will be deleted.

Change PW

User Password can be configured. User Password is the number entered for Factory and
Data Erase. The password should be a 4-digit number.

NOTE

The default User Password is ‗1234‘. If you forget the password, enter ‗1234‘ and reset.

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CAUTIONS

Do not touch patient cables or equipment when using the ventricular defibrillator.

CAUTIONS

When connecting electrodes, patient cables, etc., ensure that the connector does
not touch conductive areas or ground. In particular, be careful not to touch the
conductive parts or ground when you attach each electrode to the patient's body.

CAUTIONS

The supplied ECG patient cable should be used only for ECG measurements and
not use for breathing.

CAUTIONS

Use electrodes with products such as those provided or with a biocompatibility


certificate certified by international standards.

CAUTIONS

Use CardioTouch3000 in the presence of a specialist(health care professional) for


use by patients undergoing cardiac assist device surgery.

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Chapter 3. ECG File Management

1) Display and Function

2) Data Printing

3) Data Deleting

4) System Setup

5) Switching Menu

6) Patient Information

7) Data Search

8) Data Transfer

9) Data Import

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1) Display and Function


ⓛ ② ③ ④ ⑤ ⑥ ⑦ ⑧

⑨ ⑩
① Page information
- For example, [1/20] means that you see the first page among total 20
pages. 1 Page contains 24 lines of Data.
If Rotary is selected, the focus will be moved to Data list.
② Button to skip to the previous page
③ Button to skip to the next page
④ Button to check the patient‘s information of the chosen data saved
⑤ Button to search the data you want
⑥ State of USB connection
⑦ State of Network connection
⑧ State of battery or AC power connection
⑨ Button to print out the chosen saved data
⑩ Button to delete the data
⑪ Button to set up the environment of ‗File Management‘
⑫ Button to move to other main screen from ‗File Management‘

At the initial file management page, the first data of the list has the focus. The
focus will automatically move to the menu bar at the bottom of the screen, when
you click the data by touching the screen or rotating the rotary key on the control
panel.
If there is no data in the page, the focus can be found on [Print] button.
When there is no patient information you want to select, please press [<] or [>]
button or the ‗Search‘ menu to move to other pages.
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- Menu direction (Rotary Key‘s right spin)


Print  Delete  Setup  Main  Page information  [<]  [>]  Info  Search  Print

- Menu direction (Rotary Key‘s left spin)


Print  Search  Info  [>]  [<]  Page information  Main  Setup  Delete  Print

2) Data Printing

When selecting a saved data at the ECG file management page by using rotary
key or touch screen, the focus will appear at the data list.

Press the ‗Print‘ button to print out the data. Then you will see a message as shown
below.

NOTE

You should avoid attaching and detaching a USB device while printing out, as it could
cause the printer module to rattle.

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3) Data Deleting

When pressing the ‗Delete‘ button, a small pop-up menu will show up. You can
choose to press the ‗select‘ or ‗all‘ button.

When you press the ‗Select‘ button, one data will be deleted, but if you press the
‗All‘ button, all data in the list will be deleted.

In order to help the user not to make a mistake when deleting the data, a
message shown as below will appear to reaffirm whether you really want to delete
the data.

CAUTIONS

Please think carefully before selecting the ‗All‘ button, as it will permanently
delete all of the ECG data.

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4) System Setup
When clicking the ‗Setup‘ button at the ECG data file management page, you
will see a ‗System Setup‘ window as shown below.

‗PAT Info.‘ menu is to set up whether the patient information is retained or not, when
you move the main screen of the ECG. When you click the menu, ‗Retain‘ will be set
up and when clicking the menu again, ‗Delete‘ will be set up. Default is set as
‗Delete‘.
- ‗Delete‘: To set up the patient information is deleted, when you move to main
screen of the ECG.
- ‗Retain‘: To set up the patient information is retained, when you move to main
screen of the ECGThis may result in more than one record for the same patient.

NOTE

The steps for Network, Hospital and Service Setting are identical with the steps
for ECG Main setting.

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When clicking the ‗Export‘ button, you will see ‗Export‘ window as shown below.

When clicking the ‗Target‘ button, a POP-UP window will show up and it will
disappear when selecting one of BMS Server or USB.
- BMS Server : To save the data in the BMS Server or USB memory.

When clicking the ‗Method‘ button, a small line window will show up and it will
disappear when selecting Manual, Select, All or All New.
- Manual : menu window allows user to select either ‗Selected, All, All New, Cancel‘ or
‗Selected, Cancel‘ whenever transferring data
- Select : To transfer the selected data
- All : To transfer all data
- All New : To transfer the newly saved data

When clicking the ‗Format‘ button, a line window will show up and it will
disappear when selecting EKG, MFER(ECG), XML(ECG), JPEG, PDF. ‗Format‘ menu is
used to select the user‘s options when transferring the data.

- EKG: To save the data by type of ECG Raw Data(*EKG)


- MFER: To save the data by type of ‗***.mwf'
- XML: To save the data by type of ‗***.xml'
- JPEG: To save the data by type of ‗***.jpg'
- PDF: To save the data by type of ‗***.pdf'

When clicking the ‗Delete‘ button, a line window will show up and it will disappear
when selecting Yes or No. ‗Delete‘ menu is used to select the user‘s options after the
data has transferred.
- Yes: To delete the data after it has transferred
- No: To not delete the data after it has transferred

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NOTE

If ‗Format‘ menu has only ‗EKG‘ options, it is possible to select 'All' or 'All New' in
'Method‘ menu; for other formats, ‗Selected‘ is the only option.

5) Switching Menu

When selecting the ‗Main‘ button at the main page of ‗File management‘, a line window
will show up. You can choose ECG to go to the chosen page.
But it depends on the setting value of ‗PAT Info.‘ menu when skipping to ‗ECG‘ main
screen.

- ECG : Skip to ECG main screen

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6) Patient Information

When selecting a saved data at the ECG file management page by using a rotary
key or a touch screen, the focus will appear at the data list.

Press the ‗Info‘ button. Then you will see a ‗Patient Information‘ window as shown
below. Information other than patient name cannot be changed.

7) Data Search

When clicking the ‗Search‘ button at the ECG data file management page, you
will see a ‗Patient Search‘ window as shown below. If you rotate the rotary key, the
‗search condition‘ button will have focus. Press the ‗Find‘ button after inputting the
information about ID, Name, Date or Age.

When the search takes a long time, a message will show up to let you know the
progress. After searching, you will see a data search r esult page.

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8) Data Transfer

You can transfer the saved data to the external device at the ECG data file
management page by using the ‗NETWORK‘ key on the control panel.

When pressing the ‗NETWORK‘ key, a message will show up, asking which menu
you want to select.

If you transfer a selected data, a message with progress speed or other


information will be shown as below.

If you transfer all of the data, a message with progress speed or other information
will be shown as below. In this case, the total number of files and the file being
transferred currently will be displayed.

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NOTE

When transmitting multiple sets of data to PC after saving, a network error could occur
which may cause transmission halt and subsequent loss of data. Therefore, we
recommend users to practice following procedures to minimize such loss.

1. In EKG Main, press [NETWORK] button to transmit data to PC immediately after


measuring..
2. When transmitting multiple sets of measurements, rather than sending all data at
once, we recommend users to transmit individual records after each
measurement.

NOTE

If the system boots up without having LAN cable connected, the network function may
not work properly. In this case, enter [System] -> [Network] -> [OK] then press ‗NETWORK‘
button to attempt running the network function again. Please refer Network Setup part of
the manual to get more information regarding IP configuration setup.

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9) Data Import

You can import the saved data from the external device at the ECG data file
management page by using the ‗RECORD‘ key on the control panel.

When pressing the ‗RECORD‘ key, 'Import File List‘ screen will be shown as below.

If the external device is not connected to CardioTouch3000, the error message will
be shown as below.

If you select the ‗Selected‘ menu in the ‗Import File List‘ screen, after receiving the
selected data from the external device a system message will be shown as below.

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If you select the ‗All‘ menu in the ‗Import File List‘ screen, a system message with
progress speed will be shown as below.

After receiving all data from the external device, a system message will be shown
as below.

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Chapter 4. System Management

1) Maintenance and Cleaning

2) Regular Check-up

3) Trouble Shooting

4) Manufacturer Declaration

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1) Maintenance and Cleaning

There are many ways to clean CardioTouch3000, but it is best to use our
recommendation to avoid damage or sanitary issues.

The warranty does not cover problems resulting from the use of harmful substances
(unauthorized substances).

CAUTIONS

After cleaning the product, check the hardware and the electrodes.
Do not use the product if it is damaged or worn.

Rub the product with gauze damp with alcohol about once a month to clean the
product as well as the electrodes. Do not use lacquer, thinner, ethylene or oxide.
Make sure there is no dust or dirt on the cables and limb and chest electrodes
and clean them with wet gauze (40˚C/104˚F) after use and clean it with clinical
alcohol once a week.

Do not submerge the product or the ECG cable into any liquid or detergent. Also
make sure there is no liquid in the product or the cable.

Disposal of your old appliance

1. When this crossed out wheeled bin symbol is attached to


a product it means the product is covered by the European
Directive 2002/96/EC.
2. All electrical and electronic products should be disposed of
separately from the municipal waste stream via designated
collection facilities appointed by the government or the local
authorities.
3. The correct disposal of your old appliance will help pre vent potential negative
consequences for the environment and human health.
4. For more detailed information about disposal of your old appliance, please
contact your city office, waste disposal service or the shop where you
purchased the product.

2) Regular Check-up

Like every other medical product, CardioTouch3000 requires a regular check-up once
a year. Please refer to the Service manual for the information on the check-up.

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3) Trouble Shooting

 Printing was not successful:

The cover may not be closed properly. Please close the cover and print again.

 When using the battery power, there was a beep for more than 3 times and a
message came as shown below:

The battery is low. Please connect to the AC power to use.

 The signal is printed out with noise:

First, check that you set up the AC power filter. If it still makes noise with the AC
power supply, please connect grounding line to the grounding electrode of
the system.
The grounding should not be used with the AC power‘s grounding and please
connect it to the metal around the patient‘s bed or the building.

 When The external USB keyboard is not working properly:

Connect the external USB keyboard to the USB port before you turn on the
power of CardioTouch3000. If you connect the external USB keyboard to the
USB port after you turn on the power of CardioTouch3000, you should turn off
the power of CardioTouch3000 and turn on again.

If it is still not working, please contact our customer service center.

 System messages

The following system messages may occur while you are operating this system.
You may be required to perform some action. If you perform the recommended
actions and the condition still remains, contact authorized service personnel.

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No. System message Cause Solution


Please contact CS (Customer
Please check Internal coin battery is Support) team of Bionet to
1
date and time discharged. replace old coin type battery with
new one
When wrong network
Address is not Check the right network address
2 address(IP, SM, GW) is
valid before input
entered

When wrong character is Please input valid character such


Invalid value.
3 entered at time of as 0~9, A to F in number and
[Use: 0~9, A~F]
inputting Mac address alphabet respectively

There is no patient When you implement


Please enter patient ID in patient
4 ID. Please enter AUTO or NET button
information window to implement
patient ID. without patient ID

Wrong password.
When wrong password is
5 Please re-enter Check and input right password
entered
your password.
Enter password
When wrong number of
length error. Please check and input valid and
6 characters is entered as
Please re-enter correct password
password
your password
The internal
memory is full.
Please erase When over 200 files are
7 Erase files in File menu
other files or stored at internal memory
transfer to
external storage.
USB memory device has Remove unnecessary files from
Not enough free
8 insufficient space to USB memory (Minimum 500KB
disk space
receive files. space is needed to export 1 file)
Please check and insert USB
When USB memory stick is memory stick in right position.
Please check the
9 not inserted, or is out of Note that USB memory file format
USB memory.
order supports FAT, FAT32 only (this can
be checked on PC)
There is no Access
There is no wireless access
10 Point. Please Check AP and retry
point detected.
check the AP

Fail, connecting.
When wireless AP - Press Retry button
11 Do you want to
connection is failed - Retry after checking AP
retry?

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- Check System setup and


When there is connecting network
12 Ping : Failed failure between network - Check PC network setup
and PC with BMS Server -Check LAN cable or wireless
environment
Please contact ‗Network Team‘ to
The devices IP address is
IP address check IP address, and set right IP
13 already in use on the
conflict. in turn of System setup and
network
Network
Connection Error.
Please check LAN cable
Check lan cable,
When there is failure of connection, network setting,
14 network setting
network connection server PC‘s networking and
and relevant
related S/W programs
program.
When file transmission to Check server PC‘s networking
15 File Trans Fail!! server PC or USB memory conditions, and USB memory, and
fails retry

When the battery level is Please connect power cable or


16 Recharge Battery!
Low charge battery

Printer stops working due


17 Printer: Time out. to technical problem of React the printer
device

Printer: Busy When the wrong printer


18 React the printer
continue data were input

When the Printer gets


Printer: Please stop the use of printer for
19 heated due to long and
Temperature high at least one minute and try again
continuous use of printer

Printer: Paper When the printing paper is Please put new roll of printing
20
empty completely out paper for use

When there is no ‗ready‘


Printer: Printer not
21 answer from printer React the printer
ready
module

Printer: Unknown When the wrong protocol


22 React the printer
data was put into the printer

When the printer was


23 Abnormal End! abnormally forced to stop Re-start printing
during printing

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When the lead is off from Please reattach the electrode on


24 Lead Fault!
the patient body patient body

When the conductivity


Apply some water to reusable
between patient body
electrodes, and reattach them
and electrode is weak
When the user tries to
Try make copy after recording
No ECG execute copy printing
25 data by ―RECORD‖, ―AUTO‖, and
Recorded Data! without any recording
―NET‖ button
data

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4) Manufacturer Declaration

Electromagnetic Compatibility Information

Basic EMC
Phenomenon standard or test Test level/requirement
method
Mains terminal
CISPR 11 Group1, Class A
disturbance voltage
Radiated disturbance CISPR 11 Group1, Class A

Harmonic Current Emission IEC 61000-3-2 Class A


Pst: 1
Voltage change, Plt: 0.65
Voltage fluctuations and IEC 61000-3-3 Tmax:0.5
Flicker Emission dmax: 4%
dc: 3.3%
Electrostatic Discharge ± 8 kV/Contact
IEC 61000-4-2
Immunity ± 2, ± 4, ± 8, ± 15 kV/Air
Radiated RF 3 V/m
Electromagnetic Field IEC 61000-4-3 80 MHz - 2.7 GHz
Immunity 80% AM at 1 kHz
Immunity to Proximity Fields
Table 9 in
from RF wireless IEC 61000-4-3
IEC 60601-1-2: 2014
Communications Equipment

± 2 kV, 100 kHz


Electrical Fast repetition frequency
IEC 61000-4-4
Transient/Burst Immunity ± 1 kV, 100 kHz
repetition frequency
Line to Line
± 0.5 kV, ± 1 kV
Surge Immunity IEC 61000-4-5 Line to Ground
± 0.5 kV, ± 1 kV,
± 2 kV
3V
Immunity to Conducted 0.15 MHz - 80 MHz
Disturbances Induced by IEC 61000-4-6 6 V in ISM bands
RF fields Between 0.15 MHz and 80 MHz
80% AM at 1 kHz
Power Frequency Magnetic 30 A/m
IEC 61000-4-8
Field Immunity 50 Hz and 60 Hz
0 % UT: 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
0 % UT; 1 cycle
Voltage dips IEC 61000-4-11 and
70 % UT; 25/30
cycles
Single phase: at 0º

Voltage interruptions IEC 61000-4-11 0 % UT; 250/300 cycle

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Electromagnetic compatibility - Guidance and manufacturer's declaration

Guidance and manufacturer’s declaration – electromagnetic emissions

The CardioTouch3000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CardioTouch3000 should assure that it is used in such an
environment.

Emissions test Compliance Electromagnetic environment - guidance


The CardioTouch3000 uses RF energy only for its
RF emissions internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions The CardioTouch3000 is suitable for use in all
Class A
CISPR 11 establishments other than domestic, and may be
used in domestic establishments and those
Harmonic emissions directly connected to the public low-voltage power
Class A
IEC 61000-3-2 supply network that supplies buildings used for
domestic purposes, provided the following
warning is heeded:

Warning: This equipment/system is intended for


use by healthcare professionals only.
Voltage fluctuations/
This equipment/ system may cause radio
flicker emissions Complies
interference or may disrupt the operation of
IEC 61000-3-3
nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or
relocating the CardioTouch3000 or shielding the
location.

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Guidance and manufacturer’s declaration – electromagnetic immunity

The CardioTouch3000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CardioTouch3000 should assure that it is used in such an
environment.
IMMUNITY IEC 60601 Electromagnetic
Compliance level
test test level environment - guidance
Floors should be wood,
Electrostatic
concrete or ceramic tile.
discharge ± 6 kV contact ± 6 kV contact
If floors are covered with
(ESD)
synthetic material, the
± 8 kV air ± 8 kV air
relative humidity should be
IEC 61000-4-2
at least 30 %.
± 2 kV for power ± 2 kV for power supply
Electrical fast supply lines lines Mains power quality should
transient/burst be that of a typical
commercial or hospital
± 1 kV for ± 1 kV for input/output
IEC 61000-4-4 environment.
input/output lines lines
Mains power quality should
Surge ± 1 kV line(s) to line(s) ± 1 kV line(s) to line(s)
be that of a typical
commercial or hospital
IEC 61000-4-5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth
environment.
Mains power quality should
Voltage dips, <5%UT <5%UT
be that of a typical
short (>95%dip in UT) (>95%dip in UT)
commercial or hospital
interruptions for 0,5 cycle for 0,5 cycle
environment.
and 40 %UT 40 %UT
If the user of the
voltage (60 %dip in UT) (60 %dip in UT)
CardioTouch3000 requires
variations for 5, 6 cycles for 5, 6 cycles
continued operation during
on power 70 %UT 70 %UT
power mains interruptions,
supply (30 %dip in UT) (30 %dip in UT)
it is recommended that the
input lines for 25,30 cycles for 25,30 cycles
CardioTouch3000 be
<5%UT <5%UT
powered from an
IEC 61000-4- (>95%dip in UT) (>95%dip in UT)
uninterruptible power supply
11 for 5 s for 5 s
or a battery.
Power Power frequency magnetic
frequency fields should be at levels
(50/60 Hz) 3 A/m 3 A/m characteristic of a typical
magnetic field location in a typical
commercial or hospital
IEC 61000-4-8 environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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Guidance and manufacturer’s declaration – electromagnetic immunity

The CardioTouch3000 is intended for use in the electromagnetic environment specified below.
The customer or the user of the CardioTouch3000 should assure that it is used in such an
environment.
IEC 60601 Compliance Electromagnetic environment -
IMMUNITY test
test level level guidance
Portable and mobile RF
communications equipment should be
used no closer to any part of the
CardioTouch3000, including cables,
Conducted RF 3 Vrms 3 V rms than the recommended separation
IEC 61000-4-6 150 kHz to 80 MHz distance calculated from the equation
applicable to the frequency of the
transmitter.

Recommended separation distance

80 MHz to 800 MHz


Radiated RF 3 V/m
3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz

800 MHz to 2,5 GHz


where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation distance in
meters (m).

Field strengths from fixed RF


transmitters, as determined by an
a
electromagnetic site survey, should be
less than the compliance level in each
b
frequency range.

Interference may occur in the vicinity of


equipment marked with the following
symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected

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by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the CardioTouch3000 is used exceeds the
applicable RF compliance level above, the CardioTouch3000 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary,
such as re-orienting or relocating the CardioTouch3000.
b
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m

Recommended separation distances between


portable and mobile RF communications equipment and the CardioTouch3000
The CardioTouch3000 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CardioTouch3000 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the CardioTouch3000 as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
[m]
800 MHz to
Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz
2,5 GHz
power of transmitter

[W]

V1= 3 Vrms E1= 3 V/m E1= 3 V/m

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

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For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.

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Chapter 5. Specification
ECG Leads Simultaneous 12 Leads Resting ECG

Recording Channel 3CH+1RHY, 3CH+3RHY, 6CH+1RHY, 12CH,


1CH Long Time (1min) and Beat Report

Gain 2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: 5)mm/mV

Printing Speed 5, 12.5, 25, 50, 100mm/sec

Sampling Rate Analysis Sampling Rate – 500sample/sec


Digital Sampling Rate - 8,000sample/sec

Filters AC (50/60Hz, -20dB or better),


Muscle (25~35Hz, -3dB or better),
Base Line Drift ( 0.05, 0.1, 0.2Hz, -3dB or better),
Low Pass Filter (off, 40Hz, 100Hz, 150Hz)

Display 272 x 480 Pixel Resolution, 4.3‖ Color TFT Wide Display
12 Channels Preview, ID, HR, Gain, Speed, Power Status

User Interface Touch Screen, Rotary Push-knob

Printer Resolution Thermal Print Head, Roll Paper


Report Paper
- Width: A4/Letter – 215mm (8.5‖)
- Length: A4 – 297mm (11.7‖)
Letter – 279mm (11‖)
Resolution: 8dot/mm (0.125mm pitch)

Patient data ID, Name, Age, Gender, Height, Weight

Basic Measurement Heart Rate: 30~300bpm (±2bpm)


PR, QRS, QT/QTc, P-R-T axis, SV1/RV5/R+S amp.

ECG Data Storage Internal Storage for 200 ECGs: Built- in Memory

Electrical Internal Noise: 20uV(p-p)max


Input Impedance: More than 50MΩ
Input Voltage range: ±5mV
CMRR: Greater than 105dB
DC offset Voltage: ≥ ±400mV
Patient Leakage Current: < 10uA
Frequency Response: 0.05~150 with in –3dB
Isolated, Defibrillation and ESU Protected

Signal Quality Pacemaker Pulse Detection


Control Lead Fault Detection, Signal Saturation Detection

Line Power Input: 100-240Vac, 1.5-0.75A, 50-60Hz, Output: 15Vdc, 4.2A

Battery type Replaceable and Rechargeable, Lithium ion, 11.1V, 2600mA

Battery Capacity 360 minutes of continuous operation without recording or

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200 ECGs in 12 channel format at 25mm/s and 10mm/mV


with a battery charged during approximately 3 hours from total
discharge (with display off)

Communication LAN, WIFI (option)

Safety Conformity Class I, Type CF Defibrillation-proof applied Part.

Environmental Operating Temperature: 5~40℃


Operating Humidity: 10~90%RH
Atmospheric Pressure: 70~106KPa

Dimensions 290(W)× 300(D) × 97.5(H)mm, Approx. 3.5kg (Main Body)

Standard Accessory Patient Cable (1 EA), Limb Electrodes (1 SET),


Chest Electrodes (1 SET), ECG Paper (1 EA),
Power Cord (1 EA)

Options Rechargeable Battery (1 EA),


Cart(1 EA), Hanger (1 EA)

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Warranty

Product Name Electrocardiograph

Model Name CardioTouch3000

License Number

License Date

Serial Number

Warranty period 1 year from the date of purchase

Date of purchase (yyyy/mm/dd)

Hospital:
Address:
Customer
Name:
Contact No:

Seller‘s Name

Manufacturer‘s Name

※ Thanks for purchasing CardioTouch3000.


※ This product is a medical machine.
※ This product meets the strict quality requirements thoroughly.
※ The repairing and compensation standards follow the consumer damage
compensation regulations of the Ministry of Finance and Economy.

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International Sales & service


Bionet Co., Ltd. :
5F, Dreammark1 Data center 61 Digital-ro 31 gil,
Guro-gu, SEOUL 08375, REPUBLIC OF KOREA
Tel : +82-2-6300-6410 / Fax : +82-2-6499-7789 / e-mail: [email protected]
Website: www.ebionet.com

U.S.A sales & service representative


Bionet America, Inc. :
2691, Dow Ave, Suite B
Tustin, CA 92780 U.S.A.
Toll Free: 1-877-924-6638 / Fax: 1-714-734-1761 / e-mail: [email protected]
Website: www.bionetUS.com

European sales & service representative


MGB Endoskopische Gerä te GmbH Berlin :
Schwarzschildstraße 6
D-12489 Berlin, Germany
Tel: +49(0)-30-6392-7000 / Fax: +49(0)-30-6392-7011 / e-mail: [email protected]
Website: www.mgb-berlin.de

Bionet Co., Ltd


Model Name: CardioTouch3000

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