Bionet Cardio7 User manual

Copyright © 2023 Bionet CO., LTD. All Rights Reserved.
Electrocardiograph & Spirometer
Cardio7
Operation Manual
Ver. 1.37
2023.09.26
www.ebionet.com

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REVISION HISTORY
Revision No.
Date
Contents
Page
1.00
2015-12-24
1. Initial Release
All
-
1.35
2022-07-26
1. Added NTP warnings
75p
1.36
2023-02-27
1. Cardio7e and SpiroCare Manual
Integration
2. Model name Cardio7 unified
3. Add Accessories
4. Table of Contents Summary
5. Specification crystal
6. Reflection of translation
All
1.37
2023.09.26
1. Changed Doc Number
2. Edit Copyright text
3. Apply the latest manual format
All

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Warranty
-This product is manufactured through our strict quality control and inspection process.
Compensation standards for product repair and exchange follow the “Regulations of
Compensation for Consumer’s Damage” announced by the Fair-Trade Commission.
-Warranty period of this product is regulated to be 1 year while the warranty period of
accessories is six months.
-If a malfunction occurs under normal use, our service center will repair it free of charge
during the warranty period.
-If a problem occurs with the product during the warranty period, please notify us of the
model name, serial number, date of purchase, and malfunction details.
Caution
Federal law restricts this device to sale by or on the order of a physician
Note
The product does not have shelf life. Its expected use life is 10 years. After 10 years, though the product
still works normally, it is recommended to have it checked by Bionet.

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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.
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
Toll Free : 1-877-924-6638 / Fax : [phone]
E-mail : suppo[email protected]
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

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Paid Services
A fee will be charged for all services except for breakdowns, so be sure to read this
operation manual below before putting in a request.
- Usage description and simple inspection without
disassembly
- In case of reinstallation due to poor installation by
a distributor
Free the 1st time
Charged starting the 2nd time
- Inadequate installation or loosening due to physical
product movement, relocation, etc.
- When re-installing after the first installation
requested by the customer at the time of purchase
- When reinstallation is required due to inexperienced
installation by the customer
- When a service is requested due to the input of
foreign substances or improper cleaning
Charged starting the 1st time
1. Equipment cleaning, adjustment, and usage description are not product breakdowns.
(Unfeasible repairs are subject to separate standards.)
2. Breakdowns caused by consumer negligence
Breakdowns and damage due to careless handling by the customer or incorrect repair are
caused by:
- Using incompatible electric capacity.
- Mishaps such as dropping the product.
- Using the third party replacements or options not specified by our company.
- Non-Bionet technicians or agency technicians in the process of repair.
3. Other cases
- Breakdowns by natural disasters (fire, salt damage, flood damage, earthquake, etc.)
- When a consumable part has reached the end of its life (accessories)

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Warnings, Cautions, and Notes
⚫The following terms are used throughout this manual to emphasize important and critical
information. You must read these statements to help ensure safety and to prevent product
damage.
⚫The manufacturer or the product distributor is not liable for any loss or damage to the
product caused by incorrect use or negligence in product maintenance.
Warning
“Warning”Failure to follow this message may cause severe injuries, casualty or physical
damage to patients.
Caution
“Caution”Failure to follow this message may cause in non-life-threatening injury or damage
to the equipment.
Note
“Note”indicates some important information and tips, which are not dangerous, about
installation, operations and maintenance.

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General Precautions on Environment
DO NOT store or operate the equipment in the places listed below.
A place exposed to moisture
(DO NOT touch the
equipment with wet hands.)
A place under direct
sunlight
A place in areas with
highly fluctuating
temperatures.
A place in the vicinity of
Electric heater
A place with excessive
humidity rise or poor
ventilation
A place with sources
that cause excessive
shock or vibration
A place exposed to
chemicals or at risk of gas
leakage
Avoid the invasion of
small objects/ particles
such as dust, and
especially avoid metallic
material.
DO NOT disjoint or
disassemble the equipment.
(Bionet is not liable for
broken products caused by
attempted disassembly.)
DO NOT connect power
until the product is
completely installed.
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 Requirements) 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 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

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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.
Caution
Warning: MR Unsafe
Do not expose the device to a magnetic resonance (MR) environment.
•The device may present a risk of projectile injury due to the presence
of ferromagnetic materials that can be attracted by the MR magnet
core.
•Thermal injury and burns may occur due to the metal components of
the device that can heat during MR scanning.
•The device may generate artifacts in the MR image.
The device may not function properly due to the strong magnetic and
radiofrequency fields generated by the MR scanner.

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Safety Messages
The following messages are applied throughout the product. Certain statements may also
appear elsewhere in the manual.
Warning:
ACCIDENTAL SPILLS —If the equipment is penetrated with liquid, take it out of service and
have it checked by a service technician before using it again.
DO NOT allow liquids to enter the equipment to prevent electric shock or equipment
malfunction.
Warning:
BATTERY OPERATION - If the integrity of the electrical grounding is doubtful, use battery to
operate the equipment.
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 lead-wires.
Proper placement of defibrillator paddles in relation to the electrodes is required to ensure
successful defibrillation.
Use only recommended cables and leads to ensure adequate defibrillation protection.
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

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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.
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
60601-1-2 or Clause 16 of IEC 60601-1) 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.

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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 60601–1–2 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
60601–1–2 harmonized national standard.
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.

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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 Cardio7,
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
~
AC Power
Fuse
Conductor provides a connection between equipment and the potential
equalization bus bar of the electrical installation
ECG Patient Cable Connector

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Symbols
Contents
USB Connector
Spirometry Connector
Local Area Network (LAN) Connector
Power Off
Power On
Battery Operation Indicator
AC Power Connection Indicator
Manufacturer name and address
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.
MR Unsafe:
Do not use this device in all MR environment
No sterilization
Do not use if package is
damaged

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Symbols
Contents
Single Use Only
DO NOT reuse the
mouthpiece: it is a single time
use only.
Recycling: Dispose of
properly in accordance
with all state, province
and country regulations.
This way up:
For the duration of
shipping/delivery, the carton
should face upright
Fragile: Handle with care.
Use no hooks: Absolutely no
hand hooks should be
attached to pull the parcel.
Keep away from rain.
Medical Device

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Table of Contents
Chapter 1. General Information .............................................. 20
1) Product Overview.................................................................................. 20
2) Recording ECGs During Defibrillation .................................................. 23
3) Product Characteristics.......................................................................... 23
4) Product Configuration........................................................................... 25
5) System Installation ................................................................................ 44
6) System Start .......................................................................................... 47
Part I. Recording ECG................................................................. 53
Chapter 2. ECG Recording Preparation .................................. 53
1) Attaching the Electrodes....................................................................... 53
2) Connecting Electrodes .......................................................................... 54
3) Recording ECG ...................................................................................... 55
4) Basic Setup............................................................................................ 56
5) Disclosure .............................................................................................. 64
6) LCD Monitor display ............................................................................. 65
7) Real-time Printing (RHYTHM Key) ........................................................ 65
8) Record Mode Printing........................................................................... 66
9) Printing Form ........................................................................................ 67
10) Printing Diagnostic Copy (COPY key)................................................. 80
11) System Setup ...................................................................................... 81
Part II. Using Spirometer ........................................................ 113
Chapter 3. How to Install....................................................... 113
1) Connecting Spirometer Handle .......................................................... 113
2) Installing a Mouthpiece ...................................................................... 113
Chapter 4. How to Use .......................................................... 115

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1) Getting Started.................................................................................... 115
2) Entry of Patient Information ............................................................... 116
3) Forced Vital Capacity (FVC) Test......................................................... 120
4) Slow Vital Capacity (SVC) Test............................................................ 134
5) MVV(Maximum Voluntary Ventilation) Test ....................................... 139
6) Calibration ........................................................................................... 142
7) System Setup ...................................................................................... 147
Part III. Data & System Management................................. 151
Chapter 5. File management ................................................. 151
1) Display and function ........................................................................... 151
2) Data printing ....................................................................................... 152
3) Data deleting....................................................................................... 153
4) System Setup ...................................................................................... 154
5) Switching menu................................................................................... 156
6) Patient information ............................................................................. 157
7) Data search ......................................................................................... 157
8) Data transfer ....................................................................................... 158
9) Data import......................................................................................... 160
Chapter 6. Worklist management......................................... 162
1) Display and function ........................................................................... 162
2) Spiro/ECG Test .................................................................................... 163
3) Data deleting....................................................................................... 164
4) System Setup ...................................................................................... 165
5) Switching menu................................................................................... 165
6) Patient information ............................................................................. 166
7) Data search ......................................................................................... 167
Chapter 7. System Management........................................... 168
1) Maintenance and Cleanliness ............................................................. 168
2) Regular Check-up................................................................................ 169

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3) Trouble Shooting ................................................................................ 169
4) Manufacturer Declaration ................................................................... 175
Chapter 8) Specification......................................................... 178
Specifications and functions described in this manual are subject to change
without notice for product improvement.

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Chapter 1. General Information
1) Product Overview
Cardio 7 is a 12-channel ECG (Electrocardiogram) recording equipment that measures and records
the patient's ECG. It not only provides parameters necessary for diagnosis, patient's ECG record
and automatic diagnosis, but also increases chart management efficiency by providing ECG
records and printing reports when patient or user information is entered. At the same time, it can
transmit the saved data to a network-connected PC for file management. Its user-oriented design
enables ECG examination with a single push of a button. It saves, transfers and prints the data
that has been acquired by automatic diagnosis.
It provides the user with the necessary parameters and automatic diagnostics, which are necessary
for patient diagnosis, along with the spirometry record. After automatic diagnosis, you can print
out a report on A4/letter paper together with the spirometer record to efficiently manage the
patient's or user's chart. The stored data is forwarded to a network-connected PC that is in charge
of managing digital files. In addition, the battery pack, which can be stored inside as an optional
component, ensures high portability and makes it possible to inspect or use the equipment in an
emergency.
1-1) Intended Use
The Cardio7 ECG Analysis System is intended to acquire, analyze, display and record ECG
information from adult and pediatric populations. The system provides 12-lead ECG and
interpretive analysis.
The 12-Lead ECG interpretation algorithm provides analytical information about the patient's heart
condition, which must be confirmed by a qualified medical professional along with other relevant
clinical information.