Bionet Cardio P1 User manual

Copyright © 2023 By Bionet Co., Ltd. All rights reserved
Cardio P1
SERVICE MANUAL
Version 1.01
www.ebionet.com

V 1.01
2023. 05 2/ 53 Doc. # : BN_CP1_SCM_305
Revision History
Edition
Date
Page
Comment
Ver. 1.00
2022-02-08
All
Initial Release
Ver. 1.01
2023-05-17
All
Change Logo

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- TABLE OF CONTENTS –
Section 1. General Information...............................................................................................4
1-1. Introduction......................................................................................................................................................................4
1-2. Features of the equipment...................................................................................................................................... 4
1-3. Equipment description .............................................................................................................................................. 5
1-4. System Installation .....................................................................................................................................................13
1-5. Terms of Warranty.......................................................................................................................................................15
1-6. Specification .................................................................................................................................................................16
Section 2. Troubleshooting.....................................................................................................18
2-1. Power.................................................................................................................................................................................18
2-2. Wave Printing ................................................................................................................................................................19
2-3. Diagnosis .........................................................................................................................................................................23
2-4. Filter ....................................................................................................................................................................................24
2-5. Trouble Shooting Guide ..........................................................................................................................................26
Section 3. Adjustment .............................................................................................................29
3-1. Lead Fault........................................................................................................................................................................29
3-2. Filter Setting....................................................................................................................................................................30
Section 4. Block Diagram/Description ................................................................................31
4-1. Circuit Block Diagram..............................................................................................................................................31
4-2. Size and Weight ...........................................................................................................................................................32
Section 5. Disassembly and Assembly................................................................................33
5-1. Module Description ...................................................................................................................................................33
5-2. Block Diagram & Cable..........................................................................................................................................35
5-3. Disassembly...................................................................................................................................................................37
5-4. Assembly.........................................................................................................................................................................44
Section 6. Replaceable Parts List and Accessory.............................................................45
6-1. Replaceable Part List................................................................................................................................................45
Section 7. Base Board Connector ........................................................................................46
7-1. Power Connector........................................................................................................................................................46
7-2. Patient Cable Connector.......................................................................................................................................46
Section 8. PCB Part disposition ..............................................................................................47
8-1. Base Board .....................................................................................................................................................................47
Section 9. Software Install.......................................................................................................48
9-1. Software Minimum Requirement........................................................................................................................48
9-2. How to install the Software ....................................................................................................................................49

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Section 1. General Information
1-1. Introduction
The CardioSync system is a system to measure and record ECG of a patient as an ECG
recording machine with 12 channels.
In addition to providing the user with the parameters and automatic diagnosis required
for the patient's ECG recording and diagnosis, when the patient's and user's information
is entered, a report is output to the PC along with the ECG record, which can be
effectively used for chart management and stored data can be managed as digital files.
The CardioSync is installed on a standalone PC. For all configurations, an independent
PC is used that can be positioned for patient convenience. For device to ECG
measurement is Cardio P1.
1-2. Features of the equipment
- Waves of ECG in 12 channels are configured with various channels in 3 channels + 3
rhythms, 3 channels + 1 rhythm, 6 channels + 1 rhythm and 12 channels and reports are
printed on the PC.
- Rhythm in 1 channel is acquired for a long time (1, 3, 5, 10, 20 and 30min) and reports
are printed on the PC.
- Print 12 channel rhythm continuously on a real time basis at a time.
- Heart rate, PR interval, RR interval, QRS interval, QT interval, QTc interval, P-R-T axis,
SV1/RV1/R+S size needed for the diagnosis are automatically calculated and printed on
the report with ECG.
- Provide automatic diagnosis results of ECG of pediatrics and adults.
- Provide real-time detection for 13 rhythm diagnoses.
- Provide disclosure function to save and show ECG data up to 30 minutes.
Disclosure function helps diagnose arrhythmia.
- It is possible to print after changing the filter setup, sign size, printing speed, channel
configuration and rhythm setup on ECG that is saved once helping diagnose.
- It is available to enter and show on screen patient or user information making it feasible
to efficiently manage the chart.
- The number of patient data stored varies depending on the PC capacity, and the stored
data can be moved to another PC. In addition, additional storage and data movement
are possible in USB memory.
- It supports various protocols to be connected with hospital computer network (EMR,
PACS, etc.) reinforcing the file or worklist DB functions.

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1-3. Equipment description
The CardioSync system is comprised of the following components.
CardioSync System
1) CardioSync
- Software that analyzes and records the measured ECG
- Installed on a PC.
2) Cardio P1
- Device to ECG measurement

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Cardio P1 Basic Configuration and Accessories
Make sure to open the package box and see if the following components are contained.
In addition, make sure to see if body or components are damaged.
①Body (1EA) - Cardio P1 90.75(W) x 103.5(H) x 24.93(D)mm
②Patient Cable (1EA) - Length 1,400mm (Max)
③Power (USB Data) Cable (1EA) - Length 2,450mm (Max)
④Limb Electrodes (1SET)
⑤Chest Electrodes (1SET)
⑥Hanger (1EA)
⑦Silicone Pad (1EA)
⑧USB Lock Key (1EA)
⑨ECG Gel (1EA)

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Main Unit
▣Top View
①Indication Part (LED) : Part showing the power connection status of a product
②Indication Part (LED) : Part that informs the lead connection status
③Function Switch : Start record (push more than 3 seconds), event marker key
▣Bottom View
①ID Label : Part to attach ID Label

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▣Side View
①Power (USB Data) Cable Connection Port
▣Rear View
①ECG Cable Connection Port
Warning
If a stand for anchoring the device is damaged, or if a product is not anchored,
there is a risk of electrocution. Make sure to immediately stop using the product
and request manufacturer or seller for the repair.
Notes
Do not open the cover of the device to avoid electronic shock. Device can
only be disassembled by qualified personnel of service of our company.

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Initial Screen
After completing all installation and running the program, you will see a menu to select the
system version, company name, 'ECG', 'Patient', 'Worklist', and 'File' on the screen.
To select an ECG, find the menu box and click the selection box on the screen.
: ECG
: Patient
: Worklist
: File

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ECG Graphic Window
①Button for expand/collapse Quick Menu
②6CH display button
③Disclosure button
④Display the current date or time
⑤Menu button for indicating patient ID and name and entering patient information
⑥Display the real-time diagnosis name display
⑦Indicate study queue (sending failure list management) icon
⑧Access status of external devices (barcode reader)
⑨Access status of Cardio P1
⑩Menu button for network connection status and setup
⑪Button for expand/collapse Side Menu
⑫Quick Menu bar
1) Button for moving to ECG
2) Button for moving to Patient list
3) Button for moving to Worklist
4) Button for moving to File
5) Print button
6) Print setup menu button
7) Setup menu button
8) Display manual button
9) Show manual

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10) Show contact us
11) Logout button
12) Close button
⑬Side Menu bar
1) Indicate heart rate
2) AUTO button
3) Menu button for indicating ECG record mode (one of the 10s, 1m, 3m, 5m, 10m,
20m and 30m) and setup
4) Menu button for indicating or setting up signal size
5) Menu button for indicating or setting up print speed
Notes
The heart rate is between 30 and 300 bpm and the error range is ±3 bpm.

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Function Key Panel
⚫Push Buttons
①
Auto / Event.
1. Long Press (more than 3 seconds)
Perform the operation that is the most frequently
performed in the saving, transmission, and printing of data
in the ECG diagnosis test with one key
2. Short Press
Performed to mark as a marker when abnormalities such as
arrhythmias were felt in the ECG diagnostic test
⚫Indication lamp
②
Indicates the lead fault status when the patient cable is
connected. The red LED is lit when in a lead fault
condition. When everything is connected, the blue LED
indicator lights up.
③
Indicate the DC power connection status. blue LED light
turns on when DC power is connected on the
equipment body.
①
②
③

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1-4. System Installation
Notes of Attention for Installation
Care has to be taken on the followings when installing CardioSync system.
- Make sure to use the equipment within the ambient temperature of 10∼40℃and
humidity of 30∼85％.
- Confirm the connection status of power code and carefully handle patient handle.
- Do not put multiple cords in one outlet.
- Connect to the ground in case of noise.
- Do not use the electronic code to cause connection noise.
- Care has to be taken for the vulnerability of destruction from impact.
- Make sure to install in consideration of ambient temperature and humidity and also
install away from flammable substances.
Power Connection
Plug the power (USB data) cable into the USB port of the PC and the side connection
cord of the Cardio P1 and the device will work.
Patient Cable Connection
- Connect the patient cable to the patient cable connection port located on the
bottom of the main unit.
- Make sure to connect limb electrode to the terminals in RL(N), LL(F), RA(R) and LA(L) of
the patient and the chest electrode to the terminals in V1(C1), V2(C2), V3(C3),
V4(C4), V5(C5) and V6(C6).
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.

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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.
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.
Network Security
⚫It must be ensured that appropriate security measures are installed to protect the
transmission of data.
⚫Security of the network is the sole responsibility of the network operator.
⚫In order to guarantee the security of the network, Bionet recommends the
following:
-defining access authorization for the configuration of the host system so that no
unauthorised alterations of the system are possible.
-installing the latest antivirus/firewall programs to prevent malware from
affecting the system.
-regularly installing security and software updates.
-apply “Risk management of IT-networks” according to IEC 80001-1.

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1-5. 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 finance and economy.
-Cardio P1 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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1-6. Specification
ECG Leads
Simultaneous 12 channel ECG and acquisition
Recording
Channel
3CH+3RHY, 3CH+1RHY, 6CH+1RHY, 12CH, 6CH+ST map
1CH Long Time (1min, 3min, 5min,10min, 20min, 30min)
and
Special Beat Report (Text, Guide, Vector, ST map)
Gain
2.5, 5, 10, 20, Auto (I~aVF: 10, V1~V6: 5) mm/mV
Printing Speed
5, 12.5, 25, 50, 100 mm/sec
Sampling Rate
Analysis Sampling Rate - 500Hz
Digital Sampling Rate - 8,000Hz
Filters
AC (50/60 Hz, -20dB or better),
Muscle (25~35Hz, -3dB or better),
Baseline Drift (0.05Hz, 0.1Hz, 0.2Hz, -3dB or better),
Low Pass Filter(off, 40Hz, 100Hz, 150Hz)
Patient Data
ID, Name, Birthday, Age, Gender, Height, Weight,
Race, Smoke, Department, Room No., Study Desc.,
Accession No., Referring Physician
Basic
Measurement
Heart Rate (30~300bpm, ±3bpm), PR/RR Int, QRS Dur,
QT/QTc Int,
P-R-T axis, SV1/RV5/R+S Amp
Electrical
Internal Noise : 20uV(p-p)max
Input Impedance : ≥ 50MΩ
Input Voltage Range : ±5mV
CMRR : > 105dB
DC Offset Voltage : ≥ ±400mV
Patient Leakage Current : < 10uA
Frequency Response : 0.05~200 with in –3dB
Isolated, Defibrillation and ESU Protected
Signal Quality
Control
Pacemaker Pulse Detection
Lead Fault Detection, Signal Saturation Detection
Input Power
5VDC (USB), Max. 0.5A
Communication
USB data communication (to PC)
Safety Conformity
Class I, Type CF applied parts: ECG electrodes
Environ
mental
Operatio
n
Ambient temperature: 10 to 40ºC
Relative humidity: 30 to 85%
Atmospheric pressure: 70 to 106KPa

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Storage/
Ship
Ambient temperature: -10 to 60℃
Relative humidity: 20 to 95%
Atmospheric pressure: 50 to 106KPa
Dimensions
Body
- 90.75(W) x 103.5(D) x 24.93(H)mm
- Approx. 110g
Standard
Accessory
Patient Cable (1EA), Limb Electrodes (1SET),
Chest Electrodes (1SET), Power (USB Data) Cable (1EA),
Hanger (1EA), Silicone Pad (1EA), ECG Gel (1EA),
ECG Diagnosis Guide (1EA), USB Lock Key (1EA)
Warning
Do not touch patient cable or equipment when using heart ventricles
defibrillation machine
Warning
Make sure not to have conductive parts or grounds contact the connector
if connecting electrode or patient cable. Especially, care has to be taken
not to have conductive parts or ground contact when attaching each
electrode to the patient body.
Warning
Make sure to use the provided ECG patient cable only for measurement of
ECG without measuring the respiration.
Caution
Make sure to use biocompatibility certificate authorized with international
standards or provided for electrodes
Caution
Make sure to have the experts (health care professional) present when
using CardioSync system for patients who had surgery with heart aiding
machines

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Section 2. Troubleshooting
2-1. Power
Problem
Solution
Case1.
The Cardio P1
open will turn
on and off
frequently.
Case2.
Power will not
turn on.
< General Checking >
1. Check the power (USB data) cable is connected with DC power
terminal at the side of the device.
2. Check the power source of the PC with connection to the power
(USB data) cable. (If power is connected, power indicator is lighted.)
If not, please contact Bionet.
Case1:
Check if the soldering of J5 on the base board (DC Power + base
board connector) is poor. →Re-solder the connector.
● When applying power to Cardio P1, the voltage of pin2 of J5 should
always be 5V.
1) Is the pin’s voltage is 5V→Yes →replace the base board.
2) Is the pin’s voltage is 5V→No →contact Bionet

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2-2. Wave Printing
Problem
Resolution
1-1. The wave pattern changes from the
flat line on the left to the wave forms on
the right.
1-2. Some wave patterns are not shown in
V1~6.
1. The normal wave patterns will
show if output is requested
after the patient is stabilized by
showing the ECG wave on the
CardioSync display.
2. Check connection of the limb
and the chest electrodes to
the patient body parts.
3. If used on the dry skin or in the
winter season, connectivity
may be degraded. In that
case, used water or ECG gel.
The electrode must be washed
after using ECG gel. Otherwise,
the electrode will be rusted
and corroded.

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Problem
Resolution
2-1. The thick noise is made on the wave
patterns.
2-2. The wave output looks like the noise
and are not properly shaped.
1. This problem occurs when the
filter value is not corrected.
2. Since the noise occurs as in
problems 2-1, if the AC filter is
turned off or set at different
frequency from the power
source, the system must be set
at 50Hz or 60Hz to correspond
to the input power. (It is
different each country) The
AC filter status is shown at the
left bottom of the printout.
3. Problems 2-2 occurs when the
BASE filter is set at OFF.
Change it to ON. Also the
BASE filter status is shown at
the left bottom of the printout.