Gima NEW CARDIO 7 ECG 12 channel User guide

Copyright © 2021 By Bionet CO., LTD. All rights reserved

Cardio7e/ Cardio7

(ECG)

Operation Manual

Ver. 1.31

2021.05.31

www.ebionet.com

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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.

Caution

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.

※ 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.

※ 'CE1434' only supports Cardio7e equipment.

Headquarters &
International
Sales & service

Bionet Co., Ltd.:

5F, 61 Digital-ro 31 gil, Guro-gu, SEOUL
08375, REPUBLIC OF KOREA
Tel : [phone] / Fax : [phone]
E-mail : [e-mail]
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 : [phone]
E-mail : [e-mail]

Website: www.bionetus.com

European
sales & service
representative

Bionet Europe GmbH :

2Li Bessemerstr. 51,
D-12103 Berlin, Germany
Tel : [phone]
E-mail : [e-mail]

Website: www.ebionet.com

Authorized
European representative

CMC Medical Devices & Drugs S.L.:

Horacio Legno N° 18, CP 29006, Malaga, Spain
Tel: [phone]/ Fax: [phone]
Email: [e-mail]
Website: http://www.cmcmedicaldevices.com/

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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
disassembling the product

- For reinstalling due to poor installa tion by the
retailer

Fee charged: From the

second time

Free of charge: One time

- For poor installation due to moving

- For reinstallation after initial installation due to
customer’s requirements.

- For reinstallation due to customer’s unskilled
installation

- For offering service when a foreign substance is
introduced or mis-cleaned by the customer

Fee charged

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
product with wet
hands.

Direct sunlight.

Place where the
temperature and
humidity condition
are extreme
(Use the equipment
between the ambient
temperature 10 to

40℃(50 to 104℉) and
humidity 30 to 85％.)

Near electronic
heaters

High humidity or
ill-ventilated place

Place where
excessive shock
or vibration
may occur

Place exposed to
flammable chemicals

or explosive gas.

Never introduce dust
or metal into the
product.

Do not disassemble
the product.
The product warranty
does not cover
problems resulting
from disassembling
the product.

Do not plug the
power supply cord
before installing the
product completely.
It may cause damage
to 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 - 240V AC)

• 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

Classification.

• 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 Re quirements) standard:

Classification

Description

Class A

The device or system is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power-supply network that supplies buildings used for domestic
purposes.

Mains power should be a typical commercial or hospital environment.

NOTE

Diagnosis provided by Cardio7e/Cardio7 must be confirmed by a qualified
medical professional.

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 Messages

The following messages apply to the product as a whole. Specific messages may also
appear elsewhere in the manual.

WARNING:

ACCIDENTAL SPILLS — If liquids enter a device, take the device out of service and have
it checked by a service technician before it is used again.
To avoid electric shock or device malfunction, liquids must not be allowed to enter the
device.

WARNING:

BATTERY OPERATION — If the integrity of the electrical ground is in doubt, operate the
unit from its battery.

WARNING:

CABLES — To avoid possible strangulation, route all cables away from the patient's
throat.

WARNING:

CONNECTION TO MAINS — This is class I equipment.
The mains plug must be connected to an appropriate power supply.

WARNING:

DEFIBRILLATOR PRECAUTIONS — Do not come into contact with patients during
defibrillation.
Otherwise, serious injury or death could result.
Patient signal inputs labeled with the CF symbols with paddles are protected against
damage resulting from defibrillation voltages.
To ensure proper defibrillation protection, use only the recommended cables and lead­wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to
ensure successful defibrillation.

WARNING:

ELECTRODES — Polarizing electrodes (stainless steel or silver constructed) may cause the
electrodes to retain a residual charge after defibrillation. A residual charge will block
acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-polarizing electrodes (silver or
silver chloride construction) for ECG monitoring.

WARNING:

MAGNETIC AND ELECTRICAL INTERFERENCE — 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.

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.

WARNING:

EXPLOSION HAZARD — Do NOT use in the presence of flammable anesthetics vapors or
liquids.

WARNING:

INTERPRETATION HAZARD — Computerized interpretation is only significant when used in
conjunction with clinical findings.
A qualified physician must verify all computer-generated diagnoses.

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WARNING:

OPERATOR — Medical technical equipment such as this system must be used only by
qualified and trained personnel.

WARNING:

SHOCK HAZARD — Improper use of this device presents a shock hazard. Strictly observe
the following guidelines. Failure to do so may endanger the lives of the patient, user,
and bystanders.
When disconnecting the device from the power line, remove the plug from the wall
outlet before disconnecting the cable from the device; otherwise, there is a risk of
coming into contact with line voltage by inadvertently introducing metal parts in the
sockets of the power cord.
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). Anybody connecting additional equipment to medical electrical
equipment configures a medical system and is therefore responsible that the system
complies with the requirements for medical electrical systems.
Attention is drawn to the fact that local laws take priority over the above-mentioned
requirements.
If in doubt, consult your local representative or the technical service department.

WARNING:

SITE REQUIREMENTS — Improper placement of the device and/or accessories may result
in a hazard to the patient, operator, or bystanders.
Do not route cables in a way that they may present a stumbling hazard.
For safety reasons, all connectors for patient cables and lead-wires are designed to
prevent inadvertent disconnection, should someone pull on them.
For devices installed above the patient, adequate precautions must be taken to
prevent them from dropping on the patient.

WARNING:

TREADMILLS — Avoid rapid changes in treadmill speed and/or grade during a stress test.

CAUTION:

PROPER LEADWIRE CONNECTION — Improper connection will cause inaccuracies in the
ECG.
Trace each individual lead-wire from its acquisition module label to the colored
connector and then to the proper electrode to ensure that it is matched to the correct
label location.

CAUTION:

ACCESSORIES (SUPPLIES) — Parts and accessories used must meet the requirements of
the applicable IEC 60601 series safety standards and essential performance standards,
and/or the system configuration must meet the requirements of the IEC 60601–1–1
medical electrical systems standards.
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.

CAUTION:

ACCESSORIES (EQUIPMENT) — The use of accessory equipment that does not comply
with the equivalent safety requirements of this equipment may lead to a reduced level
of safety of the resulting system.
Consideration relating to the choice of equipment shall include:

•Use of the accessory in the patient vicinity, and Evidence that the safety
certification of the accessory has been performed in accordance with the
appropriate IEC 60601–1 and/or IEC 60601–1–1harmonized national standard.

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CAUTION:

BATTERY POWER — If a device equipped with an optional battery pack will not be used
or connected to the power line for a period of over six months, remove the battery.

CAUTION:

BEFORE INSTALLATION — Compatibility is critical to safe and effective use of this device.
Please contact your local sales or service representative prior to installation to verify
equipment compatibility.

CAUTION:

DISPOSABLES — Disposable devices are intended for single use only. They should not be
reused as performance may degrade or contamination could occur.

CAUTION:

DISPOSAL — At the end of its service life, the product described in this manual, as well as
its accessories, must be disposed of in compliance with local, state, or federal guidelines
regulating the disposal of such products.
If you have questions concerning the disposal of the product, please contact bionet or
its representative.

CAUTION:

EQUIPMENT DAMAGE — Devices intended for emergency application must not be
exposed to low temperatures during storage and transport to avoid moisture
condensation at the application site.
Wait until all moisture has vaporized before using the device.
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.

CAUTION:

ELECTRIC SHOCK — To reduce the risk of electric shock, do not remove cover or back.
Refer servicing to qualified personnel.

CAUTION:

OPERATOR — Medical technical equipment such as this electrocardiograph system
must only be used by persons who have received adequate training in the use of such
equipment and who are capable of applying it properly.

CAUTION:

POWER REQUIREMENTS — Before connecting the device to the power line, check that
the voltage and frequency ratings of the power line are the same as those indicated on
the unit's label. If this is not the case, do not connect the system to the power line until
you adjust the unit to match the power source.
In the USA, if the installation of this equipment will use 240V instead of 120V, the source
must be center tapped, 240V single-phase circuit.
This equipment is suitable for connection to public mains as defined in CISPR 11.
Equipment connected to the ECG system and in the patient, environment must be
powered from a medically isolated power source or must be a medically isolated
device. Equipment powered from a non-isolated source can result in chassis leakage
currents exceeding safe levels. Chassis leakage current created by an accessory or
device connected to a non-isolated outlet may add to the chassis leakage current of
the ECG system.

CAUTION:

SERVICEABLE PARTS — This equipment contains no user serviceable parts.
Refer servicing to qualified service personnel.

CAUTION:

SUPERVISED USE — This equipment is intended for use under the direct supervision of a
licensed health care practitioner.

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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

Spirometry Connector

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 ............................................. 15

1) Product Overview ............................................................................. 16

2) Indication for use .............................................................................. 16

3) Recording ECGs During Defibrillation ......................................... 17

4) Product Features ............................................................................... 17

5) Product Configuration ..................................................................... 18

6) System Installation ............................................................................ 31

7) System Start......................................................................................... 34

Chapter 2. Preparation for Electrocardiography .............. 40

1) Location of Electrodes ..................................................................... 41

2) Electrode Connection ..................................................................... 42

3) Starting ECG recording.................................................................... 44

4) Basic Setup ......................................................................................... 45

5) LCD Monitor display ......................................................................... 56

6) Disclosure ............................................................................................ 57

7) Rhythm Mode Printing...................................................................... 58

8) Record Mode Printing ...................................................................... 59

9) Printing Form ....................................................................................... 60

10) Copy Mode Printing ....................................................................... 70

11) System Setup .................................................................................... 72

Chapter 3. ECG file management ....................................... 135

1) Display and function ...................................................................... 136

2) Data printing ..................................................................................... 137

3) Data deleting ................................................................................... 138

4) System Setup .................................................................................... 139

5) Switching menu ............................................................................... 141

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6) Patient information ......................................................................... 142

7) Data search ...................................................................................... 143

8) Data transfer ..................................................................................... 144

9) Data import ....................................................................................... 146

Chapter 4. ECG worklist management .............................. 149

1) Display and function ...................................................................... 150

2) ECG Test ............................................................................................. 151

3) Data deleting ................................................................................... 152

4) System Setup .................................................................................... 153

5) Switching menu ............................................................................... 154

6) Patient information ......................................................................... 154

7) Data search ...................................................................................... 155

Chapter 5. System Management ......................................... 156

1) Maintenance and Cleaning ........................................................ 157

2) Regular Check-up .......................................................................... 158

3) Trouble Shooting .............................................................................. 158

4) Manufacturer Declaration ............................................................ 162

Chapter 6. Specification ......................................................... 168

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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

Cardio7e/Cardio7 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 Cardio7e/Cardio7 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 Cardio7e/Cardio7 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
conjunction with ambulatory ECG monitoring, is of particular use in the diagnosis of
disorders of the cardiac rhythm and the evaluation of syncope.

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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 a rhythm from 1 channel for an extended time (1 minutes, 5 minutes, 10 minutes)

then print it 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, RR, QRS, QT and QTc widths and SV1/RV1/R+S
volumes from recorded signals automatically and print them on a report for use in rhythm
analysis.

- Get diagnostic reports using automatic detection functionality about Neonatal, pediatric,
adult.

- 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.

- Manage chart effectively by addition of patient and operator data on EKG printout.

- 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 and worklist Databases are strengthened.

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5) Product Configuration

The Cardio7e/Cardio7 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

①Cardio7e/Cardio7 body (1 EA) - Dimension 300(W) x 290(D) x 89.5(H) mm
②Patient cable (1 EA)- Length 3,700mm (Max)
③Limb electrodes (1 SET)
④Chest electrodes (1 SET)
⑤ECG paper (1 EA)
⑥Power cable (1 EA)- Length 2,500mm (Max)
⑦ECG Gel (1 EA)

NOTE

The model Cardio7e/Cardio7 only provides the ECG function as part of the
Cardio7 products.

③

⑤ ① ⑦

⑥ ② ④

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Optional components

① Battery (1 EA)

Caution

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 the battery: If the battery provided by us is not used, we are not responsible
for any problems arising from it. Be sure to use the battery provided by our company.

①

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Body Configuration

▣Top View

① ② ③ ④ ⑤

①Handle

②Printer Cover

③Printer Cover Switch

④LCD

⑤Control Panel

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▣Front View

①

①Printer Cover Switch

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▣Rear View

① ②

③ ④ ⑤

①Protective Ground Terminal

②Power Switch

③AC Power Connection Port (+ Fuse (250V, 3.15AL) x 2)

④USB Port

⑤RJ45 LAN Port

NOTE

Appliance inlet of separate power supply unit is used as mains disconnecting
device.

NOTE

For Cardio7, the following label is attached.

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▣Left Side View

①

①Handle

▣Right Side View

①

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

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

Rotary key

Power status

Battery status

Button

Graphic display window

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Graphic display LCD

The following descriptions explain data on the graphic LCD.

① ② ③ ④

⑤ ⑥ ⑦ ⑧

①Select one ECG recording mode (10s, 1m, 3m, 5m, or 10m (seconds, minutes))

②Displays the Heart Rate.

③Displays Patient ID.

④ Displays Battery Status or AC Power Connection Status.

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

⑥Displays Printing Speed with One Of 5, 12.5, 25, 50 And 100 (mm/sec).

⑦Modify the preferences of 6 items, i.e., Basic Setup, Network Setup, Hospital Setup, ECG

Setup, Record Setup and Service Setup

⑧Choose the menu where you want to move (ECG, File, Worklist or Spiro)

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Control Panel

① ② ③ ⑦

④ ⑤ ⑥ ⑧ ⑨

▣Button

①

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

②

10sec. and long-term readings (1min., 3min., 5min., 10min.) are
saved and are printed as an output form after processing.

③

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

④

It operates the product in the most frequently used operation
from the ECG diagnosis test to data saving.

⑤

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

⑥

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

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▣LED

⑦

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

⑨

Use when navigating or selecting menu items
(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>

WARNING

This equipment must be connected to a power supply with a protective earth.

▣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 while the power is

turned off

• 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.

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• Battery Type: Lithium-ion battery

The lithium-ion battery is rechargeable batteries with lithium-ion cells. Each battery
cell contains an electrical residual measurement circuit and a safety circuit.

WARNING

- The battery charging display will show correctly if the battery is operating normally.

- Old or defective batteries are significantly reduced capacity or operating time

NOTE

The battery charging display will take up to 15 seconds to reflect the actual capacity of

the internal battery if AC power is not supplied.

NOTE

- Bionet recommends replacing the lithium-ion battery after 24 months of use.

- Battery life depends on usage.

Continuing battery use will reduce battery life and increase the frequency of

replacement.

- Recharge the battery after it is discharged to prevent pre-discharge.

▣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 3BL335-BIO-4(10.8V, 3250mAh)

• 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.

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CAUTIONS

For the protection of environment, do NOT throw wasted battery away. Please
inquire at the biomedical engineering lab of the hospital and dispose according to
the appropriate procedure to the authorized place (according to national
regulations).

WARNING

Take care of the polarity when replacing the battery.
It is strongly recommended using the battery provided by the Bionet.
Using non-approved batteries may damage the equipment.

Effect of Lithium-ion Battery Technology on the Battery

This is explained about the lithium-ion battery technology.

The battery will discharge itself even though it is not connected to the equipment. Because

it is caused by the induced current in a circuit integrated with the lithium-ion battery, which

is own properties, it is self-discharged. The self-discharge rate increases by twice every 10°C

(18°F) increase in temperature.

Battery retention is more lost in the higher temperatures. Depending on battery life, the

volume of the full charge rate may decrease gradually or out of work. As a result, the total

amount of charge stored and available is reduced.

Inspection Instructions

Ensure battery performance by fully charging and discharging equipment every six months.

Storage Instructions

The battery must be stored between 20°C and 25°C (68°F and 77°F) from outside the

monitor. If the battery is connected to an AC power source in the system, the battery

temperature increases by 15°C to 20°C (59°F to 68°F) at room temperature and it shortens

the life of the battery

When AC power is connected in the monitor equipment, the battery doesn't work and

doesn't supply power. Battery life may be less than 12 months. Bionet recommends it should

be kept separate from the equipment during the moving.

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Battery recycles

Replace the battery when it is no longer charged. This battery is a regenerative product.

Remove the battery from the system and put it in a separate bin.

WARNING

Don't keep at high temperatures or burned of a battery due to there is a risk of explosion.

You can wear serious injuries resulting from the explosion.

Do not use and dispose of the battery if it is damaged, shocked and flooded externally.

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6) System Installation

Precautions For Installation

While installing Cardio7e/Cardio7, please pay attention to the following items:

- Use the equipment between the ambient temperature 10 to 40℃ (50 to 104℉) and

humidity 30 - 85％.

- Check the power cord is properly connected, and the probe carefully handled.

- Do not plug multiple cords in a power outlet.

- Install and operate Cardio7e/Cardio7 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 Cardio7e/Cardio7.

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

Cardio7e/Cardio7. Install EKG paper with the side to be recorded appearing on top.
Close the cover to finish the paper installation process.

WARNING

Use only those products provided by us for ECG records. Otherwise, the output is in poor
condition and may affect the diagnosis during a pseudo-verification. We are not
responsible for any problems caused by ignoring them.

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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.

Network Connection

- No one other than service personnel can connect this device to the network.
Consult with hospital IT staff in advance. It is recommended to follow IEC 80001-1
(Risk management of IT networks connected to medical devices)

LAN Network

- LAN networks are usually configured through a star topology. Individual devices can be
grouped together via a layer-n-switch. Other data traffic is separated by a separate
VLAN network. Configure the device's network settings according to this user guide and
network specifications.

- LAN connection specifications are described in the following standard specifications.

⚫ Wired network: IEEE 802.3
⚫ Wireless network: IEEE 802.11 (a, b, g, n)

- If the device is used as a layer-2-switch or layer-3-switch, the port settings must be

configured on the network switch. “Bionet device” must be configured so that the

network settings are compatible with the specifications of the operating organization.

- These devices exchange data with other medical devices over a LAN network. The
network must support the following transports and protocols.

⚫ TCP/IP
⚫ BROADCAST

VLAN Network

- If data is exchanged within a single network, an independent VLAN network must be
established for clinical information systems, such as a network dedicated to medical
devices in hospitals. In addition, it is necessary to establish a network system that detects
and defends against denial-of-service attacks by installing dedicated DDos defense
system.

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When using an inappropriate network

- If the network does not meet the requirements, the following situations can occur:

⚫ Without firewall and anti-virus software:

- Your data is not protected.

- Data is transmitted in an incomplete state or not transmitted at all.

- Data may be transmitted to the wrong server.

- Data may be blocked, forged or damaged.

⚫ in case there is no independent network environment or DDos defense system

- You may be subject to denial of service attacks (DDos). In this case, the deivce may
become slow or may not work properly. In rare cases, the boot may be delayed or

repeated reboots may occur.

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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.

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Menu

Description

Recording mode (marked as 10 s, 1 m, 3 m, 5 m and 10 m unit)

Heart rate mark

To Input or check the patient’s information

Barcode reader or USB Keyboard connection mark

Replaced by the icon when a network error occurs during
transfer to the PACS server. You can move to the Study Queue

screen by touching the icon.

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 or AC power connection status

Gain

To set up the size of the ECG waveform

Speed

To set up the speed for printing out the ECG waveform

Setup

To set up the various contents related to the equipment

Main

To skip to main page of ECG File management, ECG worklist
management and Spirometer

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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

Print

To print out the chosen data

Delete

To delete the chosen or all data

Setup

To set up the various contents related to the equipment

Main

To skip to main page of ECG, ECG worklist management and
Spirometer

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The following is the main page of ECG worklist management, shown when

selecting the ‘worklist’ menu.

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

page of ECG worklist 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

Exam

To start the test with the chosen data

Delete

To delete the chosen or all data

Setup

To set up the various contents related to the equipment

Main

To skip to main page of ECG, ECG worklist management and
Spirometer

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The following is the initial screen of the Study Queue Data Management, which is where

you will navigate to if you select the ‘Study Queue’ icon ( ). The Study Queue is
managing data errors when an error occurs during transfer to the PACS server.

Memorizing the following at the Study Queue Management screen will help more

convenient use.

NOTE

- This icon appears on the top right side when data transport is an error.

Menu

Description

Studies

Number of Study file marks

>>

To skip to previous page

<<

To skip to next page

Delete

To delete the chosen or all data

Retry

Re-transfer selected data or all data

Close

Close window

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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) LCD Monitor display

6) Disclosure

7) Rhythm Mode Printing

8) Record Mode Printing

10 seconds ECG recording

9) Printing Form

10) Copy Mode Printing

11) System Setup

Basic Setup
Network Setup
Hospital Setup
ECG Setup
Record 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 3rd 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.

- Please conduct an ECG test with the lead connection is correct.

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.

Lead Fault! All Leads.

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3) Starting ECG recording

- Input the patient’s information follow the entering procedure.

- Connect leads to the patient 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.

- 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 Cardio7e/Cardio7.

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

10sec. and long-term readings (1min., 3min., 5min., 10min.) 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, it is displayed top and down menu bars and graphic window
in the LCD screen.
Top menu bar shows a measurement mode, heart rate, patient information, the status of
the external connection and power state in, and down menu bar contains the output
speed, size of the signal and setup.

They can be modified in two ways.

These configuration values can be changed using either a rotary key or touch screen.

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, race

and smoking habit.

NOTE

- The patient's surname is available after changing the file version to 1.1 in the BMS

Server settings.

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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, regardless of whether

there is a multi-language set-up.

- 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, Birth, 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.

NOTE

- Pediatric diagnosis of the ECG is available from the first day of birth.

- If age is not entered, it will be diagnosed as an adult.

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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.

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When clicking the Race Line, the choices of White, Asian, Black will show up. After
selecting the data which you want to, 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 Race line will be set as Asian.

.

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You can decide whether or not to smoke by clicking Smoke. The default setting for Smoke
is “No.”

When you have completed inputting all information, you will see the window as shown
below. After checking all information then pressing OK button, the information will be
saved, while pressing cancel button will cancel the setting.

When pressing the ‘New’ button, all of the information will be initialized.

Note

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

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Entering patients information using a barcode reader

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

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

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 whether it is supported by Bionet.

• Input methods supported by Bionet: International standards, USB

• Products below are tested and confirmed by Bionet for Cardio7e/Cardio7.

No

Manufacturer

Product name

Product image

1

Symbol

LS-2208

2

ZEBEX

Z-3110

3

Honeywell

MS5145

Caution

It is must be 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.

NOTE

If Long Time function is set as 3min, 5min and 10min, output will result in

5.0mm/mV.

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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. 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.

- if Recording is set as Long time 3 min, 5 min and 10 min, the resulting output will
be in 12.5 mm/sec.

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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 is between 30 ~ 300 bpm, and the error range is ±3.

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6) Disclosure

The screen can be shifted to the 'Disclosure’ function by pressing and holding the LCD at

ECG main screen state for 3 seconds. ‘Disclosure’ function means data is buffered in the

Disclosure Buffer, and then is shown when running the Disclosure menu; 5-minute data
which is already saved is fully displayed at 1CH (refer to setting Print -> Rhythm ), and as the
square field for the 10-second section where the user can select it to perform diagnosis
output and data transfer.

The 10-second square field on the ‘Disclosure Window’ can be moved in 1-second
increments by using rotary right/left keys; front and back 5-second section of touch pointer
will be set by touching.

On this ‘Disclosure Window’, designated 10-second ECG data will be shown as 12­channel 10-second ECG data. If you press the 'All' button again, the screen will be
converted to a 5-minute full ECG screen; if you press the 'Close' bottom, the initial ECG
screen will return.

From the ‘Disclosure Window’, it is possible to output and transfer diagnosis by using
‘Record,’ ‘Auto’ and ‘Net’ key.

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7) 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.

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 for 1
second on the LCD:

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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8) 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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9) 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, 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. And 1 channel of rhythm will be recorded for 10 seconds
at the bottom.

- ‘6CH+1’: I, II, III, aVR, aVL and aVF will be recorded for the first 5 seconds and
V1, V2, V3, V4, V5 and 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, II, III, aVR, aVL, aVF, V1, V2, V3,
V4, V5 and V6 at the same time for 10 seconds.

- ‘3CH+3’: I, II and III will be recorded 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. And 3 channels of rhythm will be recorded for 10 seconds
at the bottom.

- 6CH+1(ST): I, II, III, aVR, aVL and aVF will be recorded for the f irst 4 seconds and
V1, V2, V3, V4, V5 and V6 for the next 4 seconds. And 1 channel of rhythm will
be recorded for 10 seconds at the bottom. The amplitude of the measured ST
wave is printed as an ST map. It is printed at 25mm/sec regardless of output speed

◼ 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.

- -ST Map (Dot): Prints the representative bit and each diagnostic parameter and

displays the amplitude of the ST wave as a point and a linear ST Map. It is printed at
50mm/sec regardless of output speed.

- ST Map (Bar): Prints the representative bit and each diagnostic parameter and displays

the amplitude of the ST wave as a bar ST Map. It is printed at 50mm/sec regardless of
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 (6 CH + 1 RHY (ST Map))

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Record Report Form (BEAT REPORT - TEXT)

Record Report Form (BEAT REPORT - VECTOR)

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Record Report Form (BEAT REPORT - GUIDE)

*

Record Report Form (BEAT REPORT –ST Map (Dot))

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Record Report Form (BEAT REPORT –ST Map (Bar))

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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: ST60ms Amplitude
◼ ST80A: ST80ms Amplitude

Note

The interval (duration, interval) of the parameters output to the Beat Report is in
ms, and the unit of height (amplitude) is in 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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10) 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:

Note

Copy function will become unavailable as data is considered as not existing if
Long time function was set after 10-second recording or before 10-second
recording. Copy function will become unavailable if the predetermined value of
Long Time is changed.

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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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11) 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, Record
Setup and 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.

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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, WORKLIST, ECG, SPIRO.

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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.

Device Name Setup

‘Device Name’ refers to the name of the device. The user can input the name of the

device in order to distinguish devices on PC easily.

‘Device ID’ cannot be revised by the user as it is a unique ID of the device and is used to

identify devices on a PC. ‘Device ID’ is automatically set for easy identification of devices
on the connected PC; therefore, it cannot be revised by user.

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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.

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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.

It allows selecting the server which is available to link with the equipment in the 'Connect
to' menu.

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

Note

- When setting up the connection to the PACS Server, the Device IP should be
entered manually (manual IP input) and used. When setting up as DHCP, the
Device IP can be changed; if the setting is different from the Device IP registered
in the PACS Server, it may prevent interworking with the server.

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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.

The patient's surname is available after changing the file version to 1.1 in the BMS Server

settings.

If you change the file version, all existing patient data will be deleted.

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:

If multiple IPs are displayed, choose one belonging to the PC to connect.

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.

Note

- If you change the file version, patient data and work list data will be deleted.

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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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PACS Server Setting

When selecting the PACS Server, the additional information should be set through the
Settings Menu.
The screen for related settings such as the AE Title, IP and Port of Cardio7e/Cardio7, Worklist
Server
and Store Server will appear.

When the input window of each item is selected, the keyboard window will appear:

Enter the applicable contents.

When entry is completed, click the “Verify” button so that the connection between the

Worklist Server and the Store Server can be confirmed.

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When successful, the “Verify: Success” message will appear; when it has failed, “Verify:

C-Echo Failed” will appear.

Set the PACS option by pressing the More button when connection to the server is

confirmed.

Spiro Exam Code

Enter the Exam Code of FVC, SVC and MVV for the Spiro test.

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Data Range

The range of dates when the worklist is brought can be set at the Worklist Server.

You can choose appropriate one from the options such as “Today,” “Yesterday ~
Tomorrow”, “One Week” and "A Week ago".

For today (today-today), both the start and end dates are set to today, and for today
(today-blank), only the start date is set to today to get the worklist.

Auto Update Worklist

If you tick the Auto Update Worklist, the Worklist update will be run automatically
whenever you enter the Worklist screen.

Auto Return Worklist

If you tick Auto Return Worklist, data will be transferred to the PACS Server and the
Worklist screen will re-appear automatically by using the Exam button after selecting the
patient to measure, or by using the NETWORK key or AUTO key after selecting the
patient to measure.

RGB Format

Select the RGB Format when converting the image to be transferred to the PACS Server.
The basic setting shall be “RGB”; if the Grid Color of the transferred file appears as
green, it will be converted to the red color when the "BGR" is set.

Window Width / Window Center

Set the Window Width and the Window Center for the file to be transferred to the PACS
Server.
If the image of the transferred file appears blurred, check the Window Width and
Center values which the PACS Server supports, and enter them.

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Data Format

Set the data format for the file to be transferred to the PACS Server.
You can select either “JPEG,” “PDF” or “RAW” after checking the format supported by
the PACS Server.

Retry Count

Select the number of Retransmission attempts when a communication error occurs
during transfer of data to the PACS Server.

Retry Interval

Select the interval for Retransmission attempts when a communication error occurs
during the transfer of data to the PACS Server.

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Character Set

By selecting the Character Set, multiple selections of language are available; it should
be selected according to the character set in order to present contents such as patient
information by language when transferring a DICOM file to the PACS Server.

Upon the completion of each setting, press the 'OK' button to save the changes or push
the 'Cancel' button or the 'ESC' button of the Operating Panel to cancel them.

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GDT Setting

When selecting GDT, it should be set additional information through the Setting menu.

It shows the menu screen for related settings such as Work type, GDT Directory,

Component name, File name, and Image type.

Work type

Set how the GDT function of the system works.

- Server: Cardio7e/Cardio7 receives requests and commands.

- Client: Cardio7e/Cardio7 sends requests and commands.

Directory

Enter the type format in which the shared folder information and date information to be

used by the GDT protocol.

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Component

For use GDT protocol, enter the EMR name and abbreviation and the name of

Cardio7e/Cardio7 and abbreviation.

File name

Select the name form of the file to be shared by the GDT protocol.

Image

Select the image format of the data file to share with the GDT protocol.

When it selects the Input window for each item, a keyboard window appears, and it can

type its contents. If the input is completed normally, a message about the connection

success is displayed at the top of the screen.

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WEB Setting

When selecting Web transmission, additional information must be set through the Setting

menu.

The screen for related settings such as DNS Server, URL, ID, PW, Path appears.

DNS Server

The IP of the server that supports the domain name system.

URL

Web address to access.

ID

User ID to be used in the web to be accessed.

PW

User password to use on the web to be accessed.

Path

Path within the server to which to send the file

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If you select the input window of each item, a keyboard window appears, and you can

enter the content.

After entering, you can check the connection between Worklist Server and Store Server by

pressing the “Verify” button.

The message “Verify: Success” is displayed on success, and the message “Verify: Fail” on

failure.

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Wireless Network Setting

1) Connect the USB to the USB port of Cardio7e/Cardio7, and check whether or not

the wireless icon ( ) appears in the Status bar on the top of the screen.

2) 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.

3) Select the “Search” 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

ipTIME

N100mini

N150UA

N150U

TP-LINK

TL-WN725N

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 Refresh : AP re-searching
 << : Page up
 >> : Page down

 Connect : Attempting to connect
 Close: Closing the window

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

security key.

6) Upon the completion of input, click the "OK" button; Connection will be attempted

and the message describing the connection status will appear.

7) 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 .

8) 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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9) 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.

Note

⚫ It is recommended connecting up to eight the same network under normal AP

status.

⚫ Due to the nature of wireless, connectivity may be poor depending on the

environment.

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.

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.

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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 6channels 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 12channels 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.