Bionet Cardio7-S User manual

Cardio7-S
Operation Manual
Ver. 1.11
2017.01.13
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.
- Indications for Use
The SPM-300 Spirometer is intended for prescription use only to conduct diagnostic
spirometry testing of adults and pediatric patients in general practice, speciality
physician, and hospital settings.
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.
Contact Us
Bionet Co.,Ltd.
•Address: 5F, Shinsegae I&C Digital Center 61 Digital-ro 31 gil,
Guro-gu, SEOUL 08375, REPUBLIC OF KOREA
•Tel: [phone]
•Fax: [phone]
•E-mail: [e-mail]
[e-mail]
•URL: http://www.ebionet.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 installation 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 instructions 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
(Recommended
temperature and
humidity range
for use are
10~40C and 30~85%,
respectively.)
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.)
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.

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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:
CONNECTION TO MAINS —This is class I equipment.
The mains plug must be connected to an appropriate power supply.
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.
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 60601-1-1 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

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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.
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.
To ensure patient safety, use only parts and accessories manufactured or
recommended by bionet.
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 60601–1–1 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.
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.
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:
SUPERVISED USE —This equipment is intended for use under the direct supervision of a
licensed health care practioner.

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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
Contents.....................................................................12
Chapter 1. General Information...............................15
2) Indication for use ......................................................................15
1) Product Overview .....................................................................16
2) Indication for use ......................................................................16
3) Product Features .......................................................................17
4) Product Configuration ..............................................................18
Basic Components and Accessories .......................................................18
Body Configuration ....................................................................................21
Spirometer Configuration ..........................................................................24
Front Panel ..................................................................................................28
Control Panel ..............................................................................................30
Power...........................................................................................................31
5) System Installation ....................................................................32
Precautions For Installation .......................................................................32
Power Connection .....................................................................................32
Paper Installation........................................................................................32
System Start.................................................................................................33
Chapter 2. Installing Spirometer...............................34
1) Connecting Spirometer Handle...............................................35
2) Installing Mouthpiece...............................................................35
Chapter 3. Using Spirometer.....................................37
1) Start ............................................................................................38
2) Entry of Patient Information ......................................................39
3) FVC(Forced Vital Capacity) TEST.............................................44
FVC Test.......................................................................................................44

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FVC+(PRE-POST Bronchodilator Comparison) Test..................................56
4) SVC(Slow Vital Capacity) TEST.................................................59
5) MVV(Maximum Voluntary Ventilation) TEST ...........................64
6) Calibration.................................................................................69
7) System Setup.............................................................................74
Basic Setup.................................................................................................75
Network Setup ............................................................................................81
Hospital Setup ............................................................................................92
SPIRO Setup ...............................................................................................93
Calibration Setup........................................................................................97
Service Setup ..............................................................................................98
Chapter 4. Spiro file management ........................103
1) Display and function...............................................................104
2) Data printing............................................................................105
3) Data deleting ..........................................................................106
4) System Setup ..........................................................................107
5) Switching menu.......................................................................109
6) Patient information..................................................................110
7) Data search.............................................................................111
8) Data transfer............................................................................112
9) Data import..............................................................................113
Chapter 5. Spiro worklist management.................116
1) Display and function...............................................................117
2) Spiro Test..................................................................................118
3) Data deleting ..........................................................................119
4) System Setup...........................................................................120
5) Switching menu.......................................................................121
6) Patient information..................................................................121

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7) Data search.............................................................................122
Chapter 6. System Management...........................123
1) Maintenance and Cleaning ..................................................124
2) Regular Check-up ..................................................................125
3) Trouble Shooting .....................................................................125
4) Manufacturer Declaration......................................................130
Chapter 7. Specification .........................................134

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Chapter 1. General Information
1) Product Overview
2) Indication for use
3) Product Features
4) Product Configuration
Basic Components and Accessories
Body Configuration
Spirometer Configuration
Front Panel
Control Panel
Power
5) System Installation
Precautions For Installation
Power Connection
Paper Installation
System Start

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1) Product Overview
Cardio7-S is a Spirometer device capable of measuring and recording lung capacities
of patients. Upon entering information on the patient, users can get not just lung capacity
of patients measured by Cardio7-S, but also record of automatic detection of
abnormalities, which Cardio7-S calculated using measurements and patient information.
In addition, the device allows users to have patient information to be printed alongside
spirometer reports, so that users can sort and manage charts confidently.
Furthermore, user convenience has been enhanced by digital file management
function in which users can retrieve saved data on the device from connected PCs. A
battery (optional) can be added to the device so that device can be operated
conveniently during bedside visits or emergency conditions.
2) Indication for use
The Spirometer is intended for prescription use only to conduct diagnostic spirometry
testing of adults and pediatric patients in general practice, speciality physician, and
hospital settings.
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.
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.

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3) Product Features
- Can perform real time monitoring of Lung Functionality testing progress and results via
the device’s LCD screen; best result out of 3 trials will be automatically selected as
outcome.
- Get diagnostic reports using automatic detection by entering patient information
- Results of the lung function test can be saved on a long term basis by transferring them
to the connected PC, and a hard copy can be retained after printing it out with a
general PC printer.
- Unlike competitors’ mouthpieces (screen or turbine modules) which needs to be washed
and disinfected after each use due to potential germ and bacteria growth, Cardio7-S’
mouthpiece uses patented SmarTube™ technology which is disposable and does not
require such efforts by users.
- Effective management of charts is enabled, as patient information and user information
are available to be entered and printed out.
- Able to attach a battery so that the device can become portable
- Up to 200 recordings can be saved on device memory, and saved data can be
reprinted.

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4) Product Configuration
The Cardio7-S 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
▣Main Body
①Cardio7 body (1 EA)
②ECG Paper (1 EA)
③User Manual (1 EA)
④Power Cable (1 EA)
②
①
③
④

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▣Spirometer
①Spirometer Handle (1 EA)
②Handle Dock (1 EA)
③Disposable Mouthpiece (2 EA)
④Nose clip (1 EA)
⑤Mouthpiece Adapter (1 EA)
⑥User Manual & Diagnosis Guide (1 EA)
⑦Disposable Mouthpiece (100 EA)
③
①
②
④
⑤
⑥
⑦

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▣Options
①Battery (1 EA)
②Hanger (1 EA)
③Cart (1 EA)
④Disposable Sensor (100 EA)
⑤Reusable Adaptor (2 EA)
⑥PFT Filter (100 EA)
⑦Calibration Syringe[3L] (1 EA)
Caution
You may have distortion or signal noise when you use nonstandard or other brand's
accessories. We strongly recommend you use only the authorized accessories which we
supply.
WARNING
How to replace battery: Please make sure you use the right battery we show here.
Otherwise we are not liable for any damages and/or explosion/fire caused by using the
wrong battery.
①
②
③
④
⑤
⑥
⑦