Bionet CardioCare 2000 User manual

CardioCare 2000
OPERATION MANUAL
Ver. 2.41
www.ebionet.com

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Terms of Warranty
-This product is manufactured and passed through strict quality control and
thorough inspection. Compensation standard concerning repair,
replacement, refund of the product complies with “Consumer’s protection
law”noticed by Ministry of Finace and Economy.
-EKG 2000 is warranted by Bionet Co., Ltd. to be free from defects in
material and workmanship for one year(two years in Europe) from date of
purchase.
-Warranty repair or replacement will be made by Bionet Service Center at
no charge for warranty period if properly used under normal condition in
accordance with the instructions for use.
-In the event of a malfunction or failure during warranty period, customer
should inform Bionet Co., Ltd. of the model name, serial number, date of
purchase and explanation of failure of the defective equipment.

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How to reach us …
The following are telephone numbers and addresses for contacting various service,
product supplies and sales personnel
Product and
Purchase
Inquiry
Bionet Co., Ltd.
Address #1101 11F E&C Venture Dream Tower3, 38-21,
Digital-Ro, 31-Gil, Guro-Gu, Seoul, 08376, REPUBLIC OF KOREA
REPUBLIC OF KOREA
Overseas sales dept.
Tel:++82-2-6300-6418
Fax : ++82-2-6300-6454
E-mail : [e-mail]
URL : http:// www.ebionet.com
※In the event of a malfunction or failure, contact Service Dept. of Bionet Co., Ltd along with
the model name, serial number, date of purchase and explanation of failure.
※If you need the supply circuit diagram, component list, description and calibration instruction
etc. you can contact us we will provide you with it.

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DefinitionofWarning,Caution,Note
For a special emphasis on agreement, terms are defined as listed below in
operation manual. Users should operate the equipment according to all the
Warning and Caution.
Manufacturer or Sales agency takes no responsibility for any kind of damage
or breakdown that is caused by misuse and failure to maintain the equipment. To
inform that it may cause no harm in life but lead to injury against the “Caution”sign.
Warning
To inform that it may cause serious injury or death to the patient, property
damage, material losses against the “Warning”sign.
Caution
To inform that it may cause no harm in life but lead to injury against the
“Caution”sign.
Note
To inform that it is not dangerous but important for proper installation,
operation, and maintenance of the equipment.

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Service Requirements
Refer servicing for equipment to Bionet Co., Ltd authorized service personnel. Any
attempt to repair equipment under warranty will void that warranty.
It is the responsibility of users requiring service to report the need for service to Bionet
Co., Ltd., or to one of their authorized agents.
Failure on the part of the responsible individual, hospital, or institution using this
equipment to implement a satisfactory maintenance schedule may cause undue
equipment failure and possible health hazards.
If there are any problems with the equipment, please follow the steps below:
Contact the Bionet Oversea Service Department immediately. After gathering the
model name, Serial Number, date of purchase, and description of the problem
contact Bionet with the information shown below.
Try to solve the problem over the phone with the service department personnel. If
the problem cannot be solved over the phone, the service personnel can came and
fix the problem directly.
Bionet or local distributor will make available on request circuit diagrams,
component part lists, descriptions, calibration instructions or other information
which will assist your appropriately qualified technical personnel to repair those
parts of equipment which are designated by Bionet as repairable.

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General Precaution on Environment
Do not keep or operate the equipment in the environment listed below.
Avoidplacing in an
area exposed to
moist.Donottouchthe
equipmentwithwet
hand.
Avoid exposureto
direct sunlight
Avoid placing in an
area where thereis a
highvariation of
temperature.
Operating
temperature
ranges from 10C
to 40C. Operating
humidity ranges
from 30%to 85%.
Avoid in thevicinity
of Electric heater
Avoidplacing in an
area where there is
an excessive
humidityriseor
ventilationproblem.
Avoidplacing in an
area wherethereis
anexcessiveshockor
vibration.
Avoid placing in an
area where
chemicals are
stored or where
there is danger of
gas leakage.
Avoid beinginserted
dust and especially
metalmaterialinto
the equipment
Donotdisjointor
disassemblethe
equipment.Bionet
Co.,Ltd. takes no
responsibilityfor it
Power off when
the equipment is
not fully installed.
Otherwise,
equipment could
be damaged.

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General Precaution on Electric Safety
Check the items listed below before operating the equipment.
-Be sure that AC power supply line is appropriate to use. (100 - 240V AC).
-Be sure that the entire connection cable of the system is properly and firmly fixed.
-Be sure that the equipment is completely grounded. (Otherwise, noise could result.)
Note
The equipment should not be placed in the vicinity of electric generator, X-ray, broadcasting
apparatus to eliminate the electric noise during operation. Otherwise, it may cause incorrect
result.
Self-power line and stabile grounding is important for EKG 2000.
To use same power source with other electric instruments may cause incorrect result.
Note
EKG 2000 is classified as listed below ;
This equipment conforms to Class I, Type-BF. The equipment should be grounded to
protect the patient from electrical shock.
Do not use the equipment in the vicinity of flammable anesthetics and solvents.
The equipment conforms to Class I according to IEC/EN 60601-1 (Safety of Electric
Medical Equipment)
This equipment conforms to Class A according to IEC/EN 60601-1-2 (Electromagnetic
Compatibility Requirements)
Note
Diagnosis has to be confirmed by the doctor.
Note
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards ( e.g. IEC 950 for data processing equipment
and IEC 601-1 for medical equipment ). Furthermore all configurations shall comply with the
system standard EN 60601-1-1:1993.
Everybody who connects additional equipment to the signal input part or signal output part
configures a medical system, and is therefore responsible that the system complies with the
requirements of the system standard IEC 601-1-1:1993. If in doubt, consult the technical
service department or your local representative. Diagnosis has to be confirmed by the
doctor.

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Safety Symbols
-The International Electrotechnical Commission (IEC) has established a set of
symbols for medical electronic equipment which classify a connection or warm of
any potential hazards. The classifications and symbols are shown below.
Save these instructions.
Symbols
contents
Isolated patient connection. (IEC 601-1-Type BF)
Device part switched off.
Device part switched on.
This symbol identifies a safety note. Ensure you understand the
function of this control before using it. Control function is described in
he appreciate operation manual.
Conductor provides a connection between equipment and the potential
equalization bur bar of the electrical installation
External Signal IN/OUT Port
EKG Signal Input Port
The following symbols are used inside the system :
Identifies the point where the system safety ground is fastened to the
chassis. Protective earth connected to conductive parts of Class I
equipment for safety purposes.

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Table of Contents
Table of Contents............................................................................9
Chapter 1. General Information ........................................... 11
1) Introduction ...............................................................................12
2) Features of the equipment........................................................12
3) Equipment description..............................................................13
Standard accessories....................................................................................13
Options..........................................................................................................13
Main Unit.......................................................................................................14
LCD Panel.....................................................................................................17
Control panel.................................................................................................18
AC Power......................................................................................................20
4) System Installation....................................................................21
Installation precautions..................................................................................21
Power cable connection ................................................................................21
Patient Cable Connection..............................................................................22
Recording paper installation..........................................................................22
5) Menu structure ..........................................................................23
6) System Setting ..........................................................................24
Initial setting ..................................................................................................24
Date and time................................................................................................25
User identification..........................................................................................26
Language ......................................................................................................27
Chapter 2. Preparation for ECGs recording ....................... 28
1) Electrode positions...................................................................29
2) Electrode connection................................................................30
Check before connection...............................................................................30
Connecting the Electrodes ............................................................................30
Connecting the Patient Cable........................................................................30
Lead-Off troubleshooting...............................................................................30

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Chapter 3. Recording of ECGs............................................. 31
1) Introduction ...............................................................................32
2) Basic setting..............................................................................33
General information.......................................................................................33
Signal Level Setting.......................................................................................33
Display speed setting ....................................................................................33
Filter Setting..................................................................................................34
Channel form setting .....................................................................................35
Rhythm channel setting.................................................................................35
Grid setting....................................................................................................36
Monitoring form setting..................................................................................37
Monitoring channel setting.............................................................................38
Diagnosis on/off setting.................................................................................39
Enter Patient Data.........................................................................................40
3) Monitor mode output ................................................................46
Output method...............................................................................................46
Output form ...................................................................................................46
4) Record mode output .................................................................47
10 seconds ECG recording ...........................................................................47
60 seconds ECG recording ...........................................................................48
Output form ...................................................................................................49
5) Copy mode output.....................................................................54
Chapter 4. System control.................................................... 56
1) Maintenance and Cleaning .......................................................57
2) Regular Inspection....................................................................58
3) Troubleshooting........................................................................58
Chapter 5. Specification ....................................................... 59

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Chapter 1. General Information
1) Introduction
2) Features of the equipment
3) Equipment description
Standard Accessories
Options
Main Unit
LCD Panel
Control Panel
AC Power
4) System Installation
5) Menu Structure
6) System Settings
Initial Setting
Date and Time
User Identification
Language

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1) Introduction
EKG2000 is 12ch ECGs equipment which measure and record ECGs of the patient.
EKG2000 provides users with ECGs record of the patient, measurement parameters for
diagnosis and auto analysis.
Patient information and user identification printed along with ECGs on the output report is
effective for hospital chart control.
For convenient operation, ECGs can be measured and recorded by pressing short key. Then,
ECGs is printed in A4 sized report form after applying filter, calculating the measurement
parameter and auto analysis.
In addition to an AC power, it can be continuously operated with a built-in rechargeable battery.
This enables the EKG2000 to be used in an ambulance, in a visit to patients or during patient
transportation.
2) Features of the equipment
12 channel ECGs is printed in a various channel form of 3ch+1rhy, 6ch+1rhy, 12ch rhy, 60s 1rhy
in A4 sized report form.
1. 1 channel rhythm is recorded for 60 seconds and printed in A4 sized report form.
2. 12 channel rhythms are printed simultaneously and continuously in real time..
3. Measurement parameters such as heart rate, PR interval, QRS duration, QT/QTc, P-R-T
axes required for diagnosis is printed along with ECGs on the output report after calculating
automatically.
4. Auto analysis enables 75 diagnosis.
5. For convenient diagnosis, ECGs can be printed after changing system setting such as filter,
signal level, printing speed, channel form, rhythm cannel of the recorded ECG data.
6. Easy to carry with built-in rechargeable battery.
7. Patient information and user identification can be entered and printed along with ECGs for
effective hospital chart control.

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3) Equipment description
EKG 2000 is composed of the items as follows.
Checks out all the listed accessories are available after opening the packaging
box. Also, check if the main unit and accessories are damaged or harmed.
Standard accessories
①EKG2000 Main unit
②Patient cable (1 EA)
③Limb electrode (1 SET)
④Chest electrode(1SET)
⑤Operation manual (1EA)
⑥ECG Gel (1 EA)
⑦Recording paper (1 EA)
⑧AC power cable (1 EA)
⑨Diagnosis guide book (1EA)
Options
①Cart
②Hanger
③Built-in Battery

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Main Unit
▣Front View
①Knob
②Printer door
③Printer door release button
④LCD
⑤Control panel
①
②
①
②
③
④
⑤

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▣Rear view
①Potential equalization stud
②Main power switch
③AC power socket
④RS-232C SERIAL port
⑤LAN port
▣Left side view
①
①Handle
①
②
①②
③④⑤

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▣Right side view
①
①Patient cable connection port
Warning
Do NOT disassemble the case of the equipment to avoid the electric shock. Refer servicing
to Bionet Co., Ltd qualified personnel or your local authorized dealer.

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LCD Panel
LCD panel displays system setting status after indicating the version of the system and
manufacturer name for 2 seconds when power is turned on.
Displayed items on the LCD are as follows.
①②③④
⑤⑥⑦
①Display ECG signal level out of 5, 10, 20, aut (Auto Gain)
②Display printing speed out of 12.5, 25, 50
③Display base line filter setting on or off
④Display EMG filter setting on or off
⑤Display heart rate
⑥Display channel form of the output report out of 3ch+1rhy, 6ch+1rhy, 12ch rhy,
60s 1rhy.
⑦Display rhythm channel setting out of I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5,
V6..
1
0
1
2
.
5
O
F
F
O
F
F
1
0
0
6
C
H
+
1
R
H
Y
a
V
R
①
②

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Control panel
▣Indicator lamp
Indicate the lead connection status.
If LED is illuminated green, connection status is good .
If LED is off, connection status is bad.
In this case, check off which one of lead connection is in lead-off status
through monitor mode output.
Caution: Start printing when LED is illuminated green.
Indicate the battery capacity status: Green and Red colors are used
to display 2 different statuses.
The battery indicator is red when the device is operational without having
an A/C power supply. When an A/C power is supplied, the battery
indicator will be either red or green depending on the charge level. No
color will be shown, if there is no battery installed in the device.
Indicate AC power is operated if LED is illuminated green and not in use if
LED is off.
▣Short keys
Select signal level(mm/mV) out of 5, 10, 20, aut
(I-aVF:10, V1-V6:5 )
Select printing speed(mm/sec) out of 12.5, 25, 50
Select on or off whether or not to activate the filter that eliminates base
line drift
Select on or off whether or not to activate the filter that eliminates EMG.
ECG signal can be distorted by applying this filter.
This key is excepted to use when network function is added ahead.

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Select channel form of the output report out of 3ch+1rhy, 6ch+1rhy,
12ch rhy, 60s 1rhy
Select rhythm channel
Call up the menu to enter patient ID, name, age, sex, height, weight
Display real-time ECGs from the patient continuously or monitoring the
patient ECGs for long time,
Record ECGs for 10 seconds by pressing key and prints in A4 sized
report form after calculating the measurement parameter of the recorded
ECGs
Print the same report as previously printed one in record mode or prints
after changing system setting such as filter, signal level, output speed,
channel form, rhythm cannel of previously recorded ECGs data in record
mode.
Exit during printing or recording of ECGs.
Except that, call up the menu or select menu.
Move the selected focus to the left in menu mode
Move the selected focus to the right in menu mode

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AC Power
When AC power is supplied to the equipment, AC power indicator lamp at the front side is
illuminated green and battery is being charged automatically.
If no battery is installed, battery indicator lamp will be off. Once a battery is plugged in and
the device is powered on, it will change its power mode to supply power to the battery. If
the device is running on the power from the battery, battery charge indicator lamp will light
up red color. If the battery is running low on power, three continuous buzzer alarms will
sound. If this occurs, turn off the device and connect the A/C power before turning the
device back on.
-Required time for charging : more than 4 hours
-Continuous battery operating time : 1 hour
Caution
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).
Battery charge
indicator lamp
AC Power
indicator lamp