F-SZ09.24320068-01 V1.0 PCECG-500英文说明书 (LEPU) -2020.06.12

Copyright
Copyright© Shenzhen Carewell Electronics Co., Ltd. 2020.
Shenzhen Carewell Electronics Co., Ltd. (hereinafter short as Carewell) makes no warranty of
any kind with regard to this material, including, but not limited to the implied warranties of
merchantability and fitness for a particular purpose. Carewell assumes no responsibility for any
errors that may appear in this document, or for incidental or consequential damage in
connection with the furnishing, performance or use of this material.
No part of this document can be photocopied, reproduced or translated to another language

without prior written consent of Carewell.
Carewell will make continuous improvement in features and functions for future publication of
new equipment without prior notice. We beg your pardon for the inconvenience, if any.
Version
Version: V1.0
P/N: SZ09.24320068-01
Release date: May 2020
Responsibility of the manufacturer
Carewell only considers itself responsible for any effects on safety, reliability and performance
of the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

personnel authorized by us, and the electrical installation of the relevant room complies with
safety standards.
NOTE :
 This device is not intended for home use.
WARNING :
 This device is not intended for treatment.
I
Label guide
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
NOTE
A NOTE label advises against certain actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure.
II
Table of Contents
Chapter 1 Warnings and Notes ...................................................................................................... 1
1.1 Warnings and notes on the software ..................................................................................................1
1.2 Warnings and notes on the ECG ...........................................................................................................1
1.3 Warnings and notes on the acquisition box .....................................................................................1
Chapter 2 General Information ...................................................................................................... 2
2.1 Product introduction .......................................................................................................................................2
2.1.1 Intended use ...............................................................................................................................................2
2.1.2 Standard configuration ...........................................................................................................................2
2.1.3 About the software ...................................................................................................................................2
2.2 Installation requirement .................................................................................................................................3
2.2.1 Hardware requirement ............................................................................................................................3
2.2.2 Software requirement ..............................................................................................................................3
2.3 ECG patient cable connection ......................................................................................................................3
2.4 ECG electrode connection (CF Application Part) ...................................................................................4
2.4.1 Chest electrode connection...................................................................................................................6
2.4.2 Limb electrode connection ....................................................................................................................6
Chapter 3 Installation and Uninstallation ..................................................................................... 7
3.1 Installation of ECG Workstation 3.1............................................................................................................7
3.1.1 Installation of ECG Receiver ...................................................................................................................7
3.1.2 Installation of ECG Manager and ECG Manager & Acquirer .................................................. 11
3.2 Installation of dongle driver....................................................................................................................... 17
3.3 Installation of USB driver ............................................................................................................................ 18
3.4 System upgrade ............................................................................................................................................. 18
3.5 System uninstallation ................................................................................................................................... 19
Chapter 4 Communicate with ECG ............................................................................................... 21
4.1 Through COM ................................................................................................................................................. 21
4.1.1 Passive way ............................................................................................................................................... 22
4.1.2 Positive way .............................................................................................................................................. 24
4.2 Through Network (TCP/IP) ......................................................................................................................... 25
4.3 Through Router .............................................................................................................................................. 26
4.4 Through USB ................................................................................................................................................... 26
Chapter 5 Connecting with Acquisition Box .............................................................................. 27
Chapter 6 Operation Procedures ................................................................................................. 29
6.1 Startup ............................................................................................................................................................... 29
6.2 Setup .................................................................................................................................................................. 29
6.2.1 System setup............................................................................................................................................ 29
6.3 Patient information management ........................................................................................................... 33
6.3.1 Registration and edit ............................................................................................................................ 33
6.3.2 Delete ......................................................................................................................................................... 35
6.3.3 Search ......................................................................................................................................................... 35
6.3.4 Files import or export ........................................................................................................................... 37
6.4 Acquisition and communication through USB .................................................................................... 39
6.5 Acquisition through RS232 ........................................................................................................................ 41
III
6.6 Review ................................................................................................................................................................ 41
6.7 Measurement .................................................................................................................................................. 43
6.8 Median (Average waveform) interface ................................................................................................... 43
6.9 Report interface.............................................................................................................................................. 44
6.10 Print interface ............................................................................................................................................... 45
Chapter 7 Maintenance & Service ............................................................................................... 50
7.1 Maintenance .................................................................................................................................................... 50
7.2 Common trouble shooting ......................................................................................................................... 50
7.3 Service ............................................................................................................................................................... 51
Chapter 8 Accessories ................................................................................................................... 52
Appendix I Technical Specifications ............................................................................................ 53
IV
Chapter 1 Warnings and Notes
Chapter 1 Warnings and Notes
1.1 Warnings and notes on the software
WARNING :
 PCECG-500 is provided for the use of qualified physicians or personnel professionally trained
only. The operator is supposed to be familiar with the contents of this Operation Manual before
operation.
 Only patient cable and other accessories supplied by Carewell can be used. Otherwise the
performance or electric shock protection cannot be guaranteed.
 Keep the USB dongle connecting with PC during registration.
1.2 Warnings and notes on the ECG
Please refer to the ECG Operation Manual.
1.3 Warnings and notes on the acquisition box
WARNING :
 Do not transit the PC main unit or the display when it is powered on.
 Only patient cable and other accessories supplied by Carewell can be used. Otherwise the
performance or electric shock protection cannot be guaranteed.
 The acquisition box is supposed for the use of qualified physicians or personnel professionally
trained only. The operator is supposed to be familiar with the contents of this Operation
Manual before operation.
 Keep the USB dongle connecting with PC during registration.
NOTE :
 Avoid liquid splash and excessive temperature. The temperature must be kept between 5℃ to
40℃ while working, and between -20℃ to 55℃ during transportation, and between -10℃ to
40℃ during storage.
 Turn off the power before cleaning and disinfection. If mains supply used, the power cord should
be drugged out of the outlet also. Prevent the detergent from seeping into the equipment.
 Be sure that there is no intense electromagnetic interference source around the equipment, such
as radio transmitter or mobile phone etc. Large medical electrical equipment such as
electrosurgical equipment, radiological equipment and magnetic resonance imaging equipment
etc. are likely to bring electromagnetic interference.
1
Chapter 2 General Information
2.1 Product introduction
2.1.1 Intended use
Extract the human body's 12-lead synchronous ECG waveform for morphological and rhythmic analysis,
edit, store and print ECG waveforms and analysis results, helping physicians to analyze and diagnose
heart disease.
2.1.2 Standard configuration
Acquisition box, ECG workstation software, accessories (patient cable, limb electrodes and chest
electrodes), computer and printer.
2.1.3 About the software
Model: PCECG-500
Description: ECG workstation software
Desktop icon:
Functions: after installation of PCECG-500 in the PC, it transmits ECG waveforms to PC through USB
connection with Carewell acquisition box or ECG. HR, PR interval, QRS interval, QT/QTc interval, QRS axis,
P/T interval, RV5/SV1 range, etc can be analyzed, saved, edited, printed out through PC. It can also
transmit files saved in the ECG through RS232 connection. It provides 12*1, 6*2+1 or 4*3+1 printout,
exports files in XML, SCP, PDF, JPEG, DICOM, HL7 aECG, WORD, BITMAP OR MFER. There are 3 sections in
PCECG-500, namely ECG Receiver, ECG Manager and ECG Manager & Acquirer, which can be customized
according to specific clinical requirement. Please refer to relevant operation content in this manual for
the configured section as listed in below table.
Section Functionality description Reference content

ECG Receiver Receive data from ECG 3.1.1 ECG Receiver installation
Supporting multi-format conversion 3.2 Dongle driver installation
such as XML, SCP, PDF, JPEG, DICOM, 3.4 System upgrading
HL7 aECG, WORD, BITMAP, MFER, etc. 3.5 Software uninstallation
Supporting communication through 4.1 Communication through RS232
Ethernet and RS232 (the ECG should be port
configured with data transmission 4.2 Communication through
function) network port
4.3 Communication through router
ECG Manager Besides all the functions of ECG 3.1.2 ECG Manager installation
Receiver, it has following functions as 3.2 Dongle driver installation
well: 3.4 System upgrading
Data management: registration, edit, 3.5 Software uninstallation
delete, search 4.1 Communication through COM
2
Section Functionality description Reference content

Supporting communication through port
Ethernet and RS232 (the ECG should be 4.2 Communication through
configured with data transmission network port
function) 4.3 Communication through router
Review, analysis and measurement Chapter 6 Operation instructions
Browse, edit and printing of report (except 6.4)
ECG Manager & Acquirer Besides all the functions of ECG 3.1.3 ECG Manager & Acquirer
Manager, it has following functions as installation
well 3.2 Dongle driver installation
Supporting real-time communication 3.3 USB driver installation
through USB 3.5 Software uninstallation
Can be applied to acquisition box or Chapter 4 Communication with ECG
ECG (the ECG should be configured Chapter 5 Communication
with USB function) acquisition box
Analysis, measurement and algorithms Chapter 6 Operation instructions
2.2 Installation requirement
2.2.1 Hardware requirement
CPU: Pentium 1G Hz or above

RAM: 1G or above
COM: standard USB, RJ45 Ethernet port or RS232 port
Printer: laser printer, 600 dpi or above
Resolution: 1024*768 or above
2.2.2 Software requirement
Operation system: Microsoft windows XP/Vista/win7 (32bit & 64bit)
Authorization: USB dongle authorization
2.3 ECG patient cable connection

Patient cable includes two parts, main cable and lead wires with associated electrode connectors. The
electrode connectors can be distinguished from the color and identifier on them.
3
Figure 2-1 Patient cable
Connect ECG patient cable main cable: Plug the connector of main cable into the patient cable socket
on the right side of the ECG. Secure the knobs on sides of the socket.
WARNING :
 This product is CF classified and defibrillation protected only when the original patient cable is
used. However, as a safety precaution when possible, remove electrodes before defibrillation.
 It is strongly recommended that only Carewell patient cable be used when the ECG is using with
high frequency devices to avoid any possible signal interference.
2.4 ECG electrode connection (CF Application Part)
Chest electrode
Suction Bulb
Electrode
Metal Cup
Figure 2-2 Chest electrode
Limb electrode
Electrode
Reed
Clamp
Figure 2-3 Limb electrode
The identifier and color code of electrodes used comply with IEC requirements. In order to avoid
incorrect connections, the electrode identifier and color code are specified in Table 4-1. The
equivalent code of American standard is given too.
4
European American
Electrodes Identifier Color code Identifier Color code
Right arm R Red RA White
Left arm L Yellow LA Black
Right leg RF Black RL Green
Left leg F Green LL Red
Chest 1 C1 White/red V1 Brown/red
Chest 2 C2 White/yellow V2 Brown/yellow
Chest 3 C3 White/green V3 Brown/green
Chest 4 C4 White/brown V4 Brown/Blue
Chest 5 C5 White/black V5 Brown/orange
Chest 6 C6 White/violet V6 Brown/violet
Table 4-1 Electrodes, identifier and color code
The chest electrode should be placed on body surface as shown below.
C1
C4
C2
C6
C3
C5
Figure 2-4 Chest electrode positioning (Wilson system)
C1: Fourth intercostals space at right border of sternum

C2: Fourth intercostals space at left border of sternum
C3: Fifth rib between C2 and C4
C4: Fifth intercostals space on left midclavicular line
C5: Left anterior auxiliary line at the horizontal level of C4
C6: Left midaxillary line at the horizontal level of C4
The contacting resistance between the patient and the electrode will affect the quality of ECG
waveform greatly. In order to get a high-quality ECG waveform, the skin/electrode resistance must be
minimized while connecting electrodes.
5
2.4.1 Chest electrode connection
1. Ensure the electrodes are clean;

2. Align all lead wires of patient cable to avoid twisting, and connect the associated electrode
connectors with corresponding electrodes according to the color and identifier;
3. Clean electrode area on chest surface with alcohol;
4. Daub the round area of 25mm diameter on each electrode site with gel evenly;
5. Place a small amount of gel on the brim of chest electrode’s metal cup;
6. Place the electrode on chest electrode site and squeeze the suction bulb. Unclench it and then
the electrode is adsorbed on chest. Attach all chest electrodes in the same way.
2.4.2 Limb electrode connection
1. Ensure the electrodes are clean;

2. Align lead wires of patient cable to avoid twisting, and connect the electrode connectors to
corresponding electrodes according to the color and identifier;
3. Clean electrode area on a short distance above the ankle or wrist with alcohol;
4. Daub the electrode area on limb with gel evenly;
5. Place a small amount of gel on the metal part of limb electrode clamp;
6. Connect the electrode to limb, and be sure that the metal part be placed on the electrode area
above the ankle or wrist. Attach all limb electrodes in the same way.
WARNING :
 Be sure that all electrodes have been connected to the patient correctly before operation.
 Be sure that the conductive parts of electrodes and associated connectors, including neutral
electrode, should not contact with earth or any other conducting objects.
 There is no danger when using the ECG with electrical stimulation equipment. However, the
stimulation units should only be used at a sufficient distance from the electrodes. If in doubt, the
patient should be disconnected from the device.
 Electrodes with defibrillator protection should be used while defibrillating.
 Do not touch the ECG Shell case during defibrillation.
 Chest and limb electrodes can’t be used for defibrillation, but disposable electrodes can.
Figure 2-5 Wilson system
6
Chapter 3 Installation and Uninstallation
3.1 Installation of ECG Workstation 3.1
3.1.1 Installation of ECG Receiver
Insert the software installation CD into the PC CD/DVD ROM, double click “setup.exe” to start
installation.
Step 1 Installation of .NET Framework 2.0
 If .NET Framework 2.0 or above has been previously installed in the PC, please go forward to step
4.
 If .NET Framework 2.0 or above hasn’t been installed yet, please install it first as illustrated in
below Figure 3-1 and 3-2.
Figure 3-1 .NET Framework 2.0 installation
Step 2 Click “Accept” to continue installation.
7
Step 3 Installation of ECG Receiver
After installation of .NET Framework 2.0 or above，the system will automatically install main workstation
software driver as Figure 3-3.
Figure 3-3 Tips for ECG receiver workstation installation
Step 4 Choose installation locations
Click “Next” and comes to Figure 3-4 to choose the location where ECG Receiver is to be installed.
System default path is C：\Carewell\ECGWorkstation\. By clicking “Browse”you can change the path as
per your preference.
Figure 3-4 Choose installation locations
8
Step 5 Installation of ECG receiver workstation
Then click “Next”. The system will start installation of ECG workstation as Figure 3-5.
Figure 3-5 Installing ECG Receiver Workstation
Step 6 Language choice
During installation of ECG Receiver, the system will pop up a window asking for the dongle driver
language as Figure 3-6. Choose “English” and click “Next”.
Figure 3-6 Dongle driver language
9
Step 7 Dongle driver upgrading
If the dongle driver has been installed in the PC before, the system will pop up a window, checking the
dongle driver version. If the “Installed Version” is higher than the present version, please click “Yes”
to upgrade. Otherwise just click “No” as illustrated in Figure 3-7.
Figure 3-7 Dongle driver upgrading
Step 8 Dongle driver installation
Dongle driver has been installed in the PC as Figure 3-8.
Figure 3-8 Dongle driver installed
10
Step 9 Installation finished
Click “Finish” and continue installation of ECG workstation till it completes as Figure 3-9.
Figure 3-9 Installation finished
Step 10 ECG receiver setup
Click “Close” to finish installation.
After installation, users can run RS232 to Ethernet communication setup tools in the “start” menu.
Please refer to 4.2 for detailed information. You can also run ECG data receiver system setup tools in the
“start” menu. Please refer to 4.1 for detailed information.
3.1.2 Installation of ECG Manager and ECG Manager & Acquirer
The installation procedures of ECG Manager and ECG Manager & Acquirer are the same. In this manual,
we take the installation procedures of ECG Manager as an example.
Insert the software installation CD into the PC CD/DVD ROM, double click setup.exe to start installation.
Step 1 Installation of .NET Framework 2.0
 If .NET Framework 2.0 or above has been previously installed in the PC, please go forward to step
4.
 If .NET Framework 2.0 or above hasn’t been installed yet, please install it first as illustrated in
11
below Figure 3-10.
Step 2 Click “Accept” to continue installation.
Step 3 Installation of SQL Server 2005 Express Edition
After installation of .NET Framework 2.0，the system will automatically if SQL Server 2005 Express Edition
has been installed in local system. If not, please install SQL Server 2005 Express Edition as Figure 3-12.
12
Figure 3-12 Installation of SQL Server 2005 Express Edition
Step 4 Installation of ECG Manager
After .NET Framework 2.0 and SQL Server 2005 Express Edition have been installed, the system will
automatically install ECG Manager as Figure 3-13.
Figure 3-13 Installation of ECG Manager
Step 5 Choose installation locations
Click “Next” and comes to Figure 3-14 to choose the location where ECG Receiver is to be installed.
System default path is C：\Carewell\ECGWorkstation\. By clicking “Browse”you can change the path as
13
per your preference.
Figure 3-14 Choose installation locations
Step 6 Installation of ECG Manager
Then click “Next”. The system will start installation of ECG Receiver as Figure 3-15.
Figure 3-15 Installation of ECG Manager
14
Step 7 Language choice
During installation of ECG Receiver, the system will pop up a window asking for the dongle driver
language as Figure 3-16. Choose “English” and click “Next”.
Figure 3-16 Language choice
Step 8 Dongle driver upgrading
If the dongle driver has been installed in the PC before, the system will pop up a window, checking the
dongle driver version. If the “Installed Version” is higher than the present version, please click “Yes”
to upgrade. Otherwise just click “No” as illustrated in Figure 3-17.
Figure 3-17 Dongle driver upgrading
15
Step 9 Dongle driver installation
Dongle driver has been installed in the PC as Figure 3-18.
Figure 3-18 Dongle driver installed
Step 10 Installation finished
Click “Finish” and continue installation of ECG Receiver till it completes as Figure 3-19.
Figure 3-19 Installation finished
Step 11 ECG Manager setup
Click “Close” to finish installation. A shortcut icon will automatically appear on the PC desktop.
Double click the icon, or double click “PCECG.exe” from the installed programs to run ECG Manager.
16
3.2 Installation of dongle driver
Normally the system will automatically install dongle driver when ECG Workstation has been installed.
You can check if the driver has been successfully installed.
Right-click My Computer->System Properties->Hardware->Device Manager->USB Controllers as Figure

3-20.
Figure 3-20 Device Manager interface
In the USB controllers interface, you can see GrandDog USB Device UGRA as highlighted in Figure 3-21.
the dongle driver has been successfully installed.
Figure 3-21 Dongle driver successfully installed
If the GrandDog USB Device UPGA is not in the list that means the driver hasn’t been installed
successfully. You can install the driver manually. Double click C:\Carewell\ECGWorkstation\Support\
GrandDogRunTimeSystemSetup.exe, then click “Next”to finish installation.
17
3.3 Installation of USB driver
USB driver is for the acquisition box or ECG with USB function. When the acquisition box or ECG is
connected with PC through USB cable, the driver will be automatically installed. In the Device Manager
interface, you can click “Ports (COM & LPT)”and see “USB Serial Port (COM3)“. That means COM3 is
the activated COM port as Figure 3-22.
Figure 3-22 USB driver installation
If the above information is not in the list that means the driver hasn’t been installed successfully. You
can install the driver manually. Click “ Start>>All Programs>>Carewell ECG Workstation 3.1>>
Installation>>USB signal acquire driver” to install the USB driver.
If the acquisition box installation window is not closed automatically, but COM port already exists. That
means acquisition driver is already installed successfully and users can close the window manually.
NOTE :
 Different computer has different COM port. In other computers the COM ports maybe COM6,
COM8 or others.
 If the ECG Workstation is successfully installed, there is no problem installing USB driver.
 If the acquisition box driver doesn’t shut off for a long time, you can shut it off manually.
3.4 System upgrade
ECG Receiver can be upgraded to ECG Manager or ECG Manager & Acquirer. You need to uninstall ECG
Receiver first, then upgrade the software package and dongle driver.
ECG Manager can be upgraded to ECG Manager & Acquirer by upgrading the dongle driver. Click
“Start>>All Programs>>Carewell ECG Workstation 3.1>>Installation Tools” and click “Help” in the
dropdown menu. You can read the dongle upgrading document.
18
3.5 System uninstallation
Click Start->Control Panel->Add/Delete Program->Change/Remove Program, choose ECG Workstation

3.1 and click “Remove” as in Figure 3-23.
Figure 3-23 Uninstallation ECG Workstation 3.1
Figure 3-24 Uninstallation ECG Workstation 3.1
The system will ask if you want to uninstall the database.
Figure 3-25 Uninstallation database
19
Figure 3-26 Uninstallation database
The system will ask if you want to uninstall the dongle driver.
Figure 3-27 Uninstallation dongle driver
After uninstallation the dongle driver, the system will ask if you want to restart the computer. You can
choose “Restart later” till all related applications have been uninstalled.
20
Chapter 4 Communicate with ECG
There are 4 ways to establish communication with ECG: Ethernet, COM, Reuter and USB port.
4.1 Through COM
COM port has 2 kinds: RS232 (Figure 4-1) or RS232 to USB converter (Figure 4-2). If you use RS232 to
USB converter cable, we have to connect the COM port to the ECG’s COM port, with USB port to the
computer’s USB port.
Figure 4-1 RS232 cable Figure 4-2 RS232 to USB converter cable
In the Device Manager interface, you can click “Ports (COM & LPT)” as Figure 4-3. It has two
connection methods: passive and positive.
Figure 4-3
21
4.1.1 Passive way
You can transmit data to the workstation by operating the ECG unit.
Connect the computer which has installed ECG Workstation 3.1 and ECG with a RS232 cable. ECG data
captured by the ECG can be transmitted to the computer and exported in different format.
Click Start>>All Programs>>Carewell ECG Workstation 3.1>>System Settings>>ECG Receiver System

Settings as Figure 4-4.
Figure 4-4 ECG receiver system settings
Startup: start transmission of ECG data
Stop: stop transmission of ECG data
Default: return to last settings
Saving: save settings
Exit: exit system setting
Figure 4-5 File convert setting
22
In file convert setting interface, you can choose the file format to be saved. You can choose one or more
formats as per like. The saving path can be changed as well.
Figure 4-6 COMM setting
In COMM setting interface, choose COMM port. Please refer to device manager and find out the
activated COMM port in your computer as Figure 4-7 and choose right one in the dropdown menu.
Figure 4-7 Device Manager
After finishing all the settings, you can start transmit ECG data to your computer. ECG data can be saved
in the ECG and transmitted to PC anytime in need.
23
NOTE :
 After all settings above are saved, please restart the server to make it come into effect.
 If you choose default setting, which means the ECG file format and COMM setup will be the same
as the last effective setting.
4.1.2 Positive way
You can get ECG data by operating the ECG Workstation 3.1 if the ECG software version is 3.2 or less.
(When the ECG starts up, the software version will be displayed in the screen).
Connect the ECG and computer through RS232 cable. You need to setup the workstation prior to
operation as Figure 4-8.
Figure 4－8 Advanced settings
Generally the RS232 port is “COM1” in the computer. You can check the RS232 port in you computer
as Figure 4-9.
Figure 4－9 Check COM port
24
After setting of COM port, you can register a new patient then click “Capture” to start work. Please
refer to Chapter 6.5 for detailed information.
4.2 Through Network (TCP/IP)
NOTE :
 This way is suitable for laptop without RS232 port.
If the ECG supports Ethernet uploading, you can directly use one network cable to connect PC and ECG.
(For network setting, please refer to ECG operation manual).
If it doesn’t support Ethernet uploading, please prepare those materials before connection: one
network converter (we provide only), one network cable, one RS232 cable (we provide only), one ECG
main unit.
Connect the ECG and network converter with a RS232 cable, and then connect the network converter
and computer with a network cable. Make necessary settings as follows.

Click Start>>All Programs>>Carewell ECG Workstation 3.1>>System Settings>>SerialNetSetting.exe or
just double click it in the installation file as Figure 4-10.
Figure 4-10 Serial/Net ports convert setting
25
Make sure the computer is connected to internet and click “search”, the physical address of the
network converter will be in the list. Make necessary settings as Figure 4-11.
Figure 4-11 Network convert setting
Choose the right physical address and make following settings.
Remote port: 12340
Baud rate: 115200
Mode: TCP client
IP ADD: the same LAN (local area network) IP as the computer (right-click Local
Network>>Status>>Support), i.e. the first 3 digits are the same as your computer. E.g.: 192.168.0.x (x
means one value between 2~254)
Click “Write” to save the settings.
4.3 Through Router
As described in above 4.2, the network converter doesn’t connect with the computer directly; instead it
connects to a router. The router connects with the computer. In this case, after network converter
settings several ECGs can transmit data to the computer (according to the router port quantity).
4.4 Through USB
If the ECG has been configured with USB function, it can communicate with the computer directly.
Real-time ECG data can be transmitted to the computer. (please refer to 6.3-6.9 for ECG data
management).
26
Chapter 5 Connecting with Acquisition Box
24-bit acquisition box is a new product developed by our company. Compared with the old one, it’s
much easier to operate and faster to acquire signals.
Start/stop
Button
Indicator
Figure 5-1 24-bit acquisition box
27
The acquisition box communicates with ECG Workstation 3.1 directly through USB cable. You just need
to choose the right COM port. In the device manager interface, you can click “Ports (COM & LPT)”and
see “USB Serial Port (COM3)“ as Figure 5-3. That means COM3 is the activated COM port as Figure 5-2.
In the system setting interface you can choose the COM port as COM3.
Figure 5-2 Device Manager
Figure 5-3 System Setting
28
Chapter 6 Operation Procedures
6.1 Startup
There are 3 ways to startup ECG Workstation 3.1.
1. Double click the shortcut icon on your computer desktop.
2. Click Start>>All Programs>>Carewell ECG Workstation 3.1>>ECG Workstation.
3. Find the installation file and double click PCECG.exe.
NOTE
If the dongle is not connected to your computer, you can only read the demo information of ECG
Workstation 3.1. To start work, you have to install the dongle driver first.
6.2 Setup
6.2.1 System setup
 Common setting
Such parameters as saving time, sensitivity, wave speed, etc can set as Figure 6-1.
If users set “baseline automatic adjustment” with “YES”, the printout results will be not too tight
because of the automatic baseline print adjustment.
Figure 6-1 Common setting
29
Table 6-1 Common settings
Parameters Options
Default saving time 10s, 20s, 30s
Default sensitivity 5mm/mＶ, 10mm/mＶ, 20mm/mＶ, Auto
Default wave speed 12.5mm/s, 25mm/s, 50mm/s
Leads quantity 6, 12
Default patient cable type 6*2, 6*2+1, 3*4, 3*4+1, 12*1, etc.
Baseline automatic adjustment YES, NO
Print mode Normal, rotate, synchro, order
Default filter Low pass filter (None, Low75Hz, Low90Hz, Low 100Hz, Low165Hz)
Baseline (None, ADS 0.05, ADS 0.1, ADS 0.2, ADS 0.5)
EMG (None, EMG25, EMG35, EMG45)
Save path Users can choose as per interest
 Appearance setting
Waveform appearance can be set according to your preference. If you’re not satisfied with your setting,
you can click “Load default” to default setting as Figure 6-2.
Figure 6-2 Appearance setting
30
 Advanced setting
In advanced setting interface, you can set the correct COM port, rhythm lead, AC frequency, lead mode,
etc. Institution name will display on all printout reports, and it’s strongly recommended you properly
input the information. If the default language has been changed, the program will turn it off and restart
automatically.
Figure 6-3 Advanced setting

Table 6-2 Advanced settings
Parameters Option
1 COM port COM1, COM3, etc.
2 Rhythm lead Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6
3 AC frequency 50Hz, 60Hz
4 Lead mode Standard (Ⅰ, Ⅱ, Ⅲ, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6)
5 Record count int study list 100, 200, 300, 400, 500
6 Date format yyyy-MM-dd
7 Institution name Enter manually
8 Language Chinese, English, Spanish, Italian
9 File name format GUID, Patient ID, Date+ECG No., Date+Patietn ID
10 Automatically exported Click “√” in the frame
31
 Print setting
Figure 6-4 Print setting

Print setting as illustrated in the figure 6-4. The left window shows all the information that can be
selected, but the right window shows the information users want to print on the head of the report.
 “>”: Add information from the left window to the right window;
 “<”: Delete the selected item in the right window;
 “+”: Move the selected item upward one step;
 “－”: Move the selected item downward one step.
 “Default“: Restore the items order.
32
 Database setup
Click “Tool>>Database Setting” to add a dropdown menu as Figure 6-5.
Figure 6-5 Database setting
 "〇": Those items with "〇" mark can be modified, click it, then corresponding list will
display.
 "＋": Click the dropdown menu and then click “＋”in yellow, if you want to add. There
will be a line in the edit area. Input the item No, Name, Default and Sequence as desired.
 "╳”: Click it once to delete the selected items.
6.3 Patient information management
6.3.1 Registration and edit
Patient information registration is a must for each mission. Patient name, age, gender, etc are supposed
to be input properly as Figure 6-6 and Figure 6-7.
33
Figure 6-6 Main interface of registration
Figure 6-7 Patient information registration
Figure 6-6 is the main interface after registration. Highlight the registration information and click
“Edit” to revise the information if needed. Above the registration information list, there is a column
where you can browse the registration information. The sequence is
respectively first, previous, next, last.
34
Registered Patient Info
Figure 6-8 Main interface after registration
NOTE
All information above just can be input with half-width characters, otherwise it will automatically correct
it into half-width characters.
6.3.2 Delete
When a file is not in need anymore, you can delete it by clicking “Delete”. The file is not active in the
list. When you exit the program, this file will disappear in the list.
If you’ve wrongly deleted a file, you can recover it by clicking “File>>Recover Deleted File”. Also you
can permanently delete a file by clicking “File>>Deleted All Deleted Files”.
6.3.3 Search
In the main interface, you can search a file by clicking “Search”. In Search interface, you can set one or
more searching conditions, then click “OK” to confirm as Figure 6-9.
35
Figure 6-9 Search interface
Optional search modules: these modules can be added in Search module if needed. Input the module
name and click “Add” and the added condition will display in the dropdown menu of Search as Figure
6-10.
Figure 6-10 Add search module
36
6.3.4 Files import or export
① File import
Choose “File>>Import” and a window will pop up as 6-11.
Figure 6-11 File import
Choose one or more files, click “Open” and the file(s) will be imported to the ECG Workstation file list.
NOTE
The supporting format is .xml file(s).
② File export
ECG files can be exported to the computer in multi-formats. Click “Export” and a window will pop up
as Figure 6-12.
Figure 6-12 File export
You can choose the file format (you can choose one or more format(s)) and saving path as per
preference.
37
Figure 6-13 is the interface when a file is successfully exported. If the exportation fails, the system will
reminder you.
Figure 6-13 File export successful
If the exportation files are in other 8 format except .xls, then the check status must be Already Checked
or Report Finished, which means it is successfully exported and a hint will pop out. Patient information,
path, and file name of the successful exportation files will display.
Figure 6-14 is an exportation example in WORD format.
Figure 6-14 An exportation example in WORD format
38
6.4 Acquisition and communication through USB
After registration of patient information, you can return to the main interface and choose a patient
under registration status to start acquisition and communication through USB connection as Figure
6-15. Device that supports USB communication has 2 kinds: ECG with USB and 24-bit collection box.
Figure 6-15 Acquisition interface
In Figure 6-15, the ECG waveforms are real-time ECG waveforms. Acquisition time and heart rate
displays at top left area, length in 1s and filters applied display at bottom left area, and paper speed,
sensitivity, captured time display at bottom right area.
Paper speed, sensitivity, filter, or mode can be adjusted by click “Speed”, “Sens”, “Filter”, or
“Mode” drop-down menu.
No. Button Description
Acquisition interface: Start capturing and save the ECG waveforms

1 Start
Review interface: waveforms replay
Acquisition interface: Stop capturing ECG waveforms

2 Stop
Review interface: stop waveforms replay
The time length for capturing, there are 4 options: 10s, 20s, 30s and user
3 Time
defined.
4 CAL 1mV calibration in the waveforms
5 Reset Refresh current waveforms
6 Print Enter into print preview interface (valid only for Report Finished case)
39
No. Button Description
7 Meas. Enter measurement interface
8 Avg. Enter analysis interface
9 Report Enter report interface
10 Speed Sweeping speed: 12.5/25/50mm/s
11 Sens. Gain: 5mm/mＶ, 10mm/mＶ, 20mm/mＶ, auto
Low pass filter (off, Low75Hz, Low90Hz, Low 100Hz, low165Hz);

12 Filter
Baseline (ADS 0.05, ADS 0.1, ADS 0.2, ADS 0.5);
EMG (off, EMG25, EMG35, EMG45)

HUM: (50Hz, 60Hz, OFF)
13 Mode Mode setup: 12*1, 6*2+1, 4*3+1;
14 Re Capture After acquisition, if the waveforms are not ideal enough, click this button to
recapture.
15 Return Exit
Table 6-3 Acquisition& Review Interface Function List
Click “Start” to acquire ECG data and Figure 6-16 is the interface after acquisition completed.
Figure 6-16 Acquisition completed
Click “Start” to begin acquisition for ECG with USB unit. For 24-bit collection box, you can also press
the “start” button on the collection box to start acquisition. The waveforms will be blue at that time.
After acquisition, drag the scroll bars below to review the waveforms.
In the top left area are the heart rate and waveform intervals. In the top right area are major
40
measurement results, and in the bottom right area are analysis results. Analysis results will be
automatically saved and can be edited in diagnosis interface.
NOTE
If the button turns gray, which means the current interface or case can’t be used.
6.5 Acquisition through RS232
Set the RS232 COM port as described in Chapter 4.1.2, register a new patient, choose the file in the ECG
and press “Recall”. The file is waiting for transmission. Choose the patient just now registered and click
“Capture” to transmit as Figure 6-17.
Figure 6-17 Capture interface
After receiving of the ECG file, the system will close above window and turn to Review interface
automatically.
6.6 Review
Saved ECG files can be reviewed by click “Review” in the main menu. In Review interface, the
waveforms recycle by clicking “Start” as Figure 6-18. Speed, Sens, Filter and Mode are adjustable
under Review status.
41
Figure 6-18 Review interface
Click “Stop” to stop reviewing as Figure 6-19. In the top left area are the heart rate and RR intervals. In
the top right area are major measurement results, and in the bottom right area are analysis results.
Figure 6-19 Stop review interface
42
6.7 Measurement
After acquisition of ECG data, click “Measure” to enter measurement interface as Figure 6-20. There
will be a red line in the waveform area. Move the mouse to a specific point, right-click the mouse and
the red line will become black. The measurement results will display at top of the waveform. Move the
mouse and a red line will be coming with the cursor. Stop at any interested point and the value
difference between the two lines will display at the right side of the waveform. Click the blue “X” to
close the waveform.
Figure 6-20 Measurement interface
6.8 Median (Average waveform) interface
After acquisition, click “Median” and see Figure 6-21. Click any interested lead to observe the
waveform. Click “∑” to observe all leads waveforms. Click “Sens” to enlarge the waveform from
20/40/60/auto. On the right side displays measurement and analysis results.
Under full-lead waveform display, the marks are the positions of rhythm lead, which can be set in
“System Setting”. The default set of rhythm lead is Lead II. When the mark is moved, the system will
automatically analyze the ECG data. ECG data transmitted from ECG can be analyzed again through this
function.
43
Figure 6-21 Average waveform interface
6.9 Report interface
In main interface, acquisition interface, measurement interface or Median interface, click “Report” to
enter report interface as Figure 6-22.
Figure 6-22 Report interface
44
On the left of the interface are the analysis results and measurement values, while on the right are the
analysis modules. Analysis results and measurement values can be edited, saved in the database and
display in the interface.
After analysis, you can choose “Save” to save the file in the system or “Save printing” to print out
the file and save it in the system.
Click “Detailed measurement value” to view detailed value of each lead as Figure 6-23.
Figure 6-23 Detailed measurement value interface
If users have already selected “Automatically exported” in the “advanced setting”, then it will be
automatically exported after you save the report. Exported file format and save path can be modified in
the export interface.
6.10 Print interface
After measurement, you can click “Print” to view the printouts as Figures 6-25 to 6-30. You can set the
paper margin, sensitivity, printing speed, horizontal or vertical, etc.
45
Figure 6-24 Print Preview interface
Figure 6-25 2 12*1 vertical printout preview
46
Figure 6-26 12*1 horizontal printout preview
Figure 6-27 6*2+1 vertical printout preview
47
Figure 6-28 6*2+1 horizontal printout preview
Figure 6-29 3*4+1 vertical printout preview
48
Figure 6-30 3*4+1 horizontal printout preview
49
Chapter 7 Maintenance & Service
NOTE
You’re supposed to peruse this operation manual before operating the system.
7.1 Maintenance
The surface of the main unit and display can be wiped with a try soft cloth. Be sure the environment is
clean and well-ventilated.
7.2 Common trouble shooting
Failure Methods
Open the workstation, there are just 5 Please check the indicator of the USB software dongle in on or
buttons, and start, report, print and not. If it’s on, then enter “Device Manager” “Universal
export buttons are gray. Serial Bus Controllers” "GranDog USB Device UGRA". If there
is no "GranDog USB Device UGRA", please reinstall the
dongle driver as illustrated in chapter 3.2.
After connected with the acquisition Please close the acquisition box, enter “Device Manager”
box, the mouse cursor is always “PortS (COM&LPT)” “USB Serial Part”, right click the
jumping on the right top monitor. mouse to display properties and choose “Port Setting”
“Advanced” “Other items” to remove the " √ " of the
“Serial enumerator”.
Set HUM filter as 60Hz and start Please set HUM filter frequency as 50Hz.
acquisition. Then noise comes along.
Fail to transmit files to PC through Please refer to the Network port upload chapter for details.
network port. If the ECG setup is right, please check whether the software is
held up by the firewall or anti-virus software. Then close the
firewall and antivirus software, and add ECG workstation to its
white list of the firewall and antivirus software.
Fail to upload files through RS232 Please use the standard RS232 cable provided by our company
port. or replace it with a new one.
Hardware can’t be identified by the Please reinstall the USB driver as illustrated in chapter 3.3.
computer after insert the USB cable.
COM port don’t display after you Please check the USB connection between PC and acquisition
insert the USB cable. box or ECG. Furthermore, confirm that the acquisition device is
50
Failure Methods
turned on. If all the above steps conducted and the problem
still exists, please replace it with a new USB cable.
After connect the acquisition device Possible reason is that the COM port is not set correct. For
with USB cable, click “Start” but details, please refer to chapter 5.
can’t enter real-time acquisition
interface.
Fail to export .doc files Please install the Word 2003 software.
Fail to add new information in the When edit the default and No. content of the new list, please
“Database setting” and a dialogue input numbers under no input method status.
pops up shows “Input strings format
is wrong”.
Fail to add new information in the No. value can’t be repeated.
“Database setting” and a dialogue
pops up shows “unique”.
Table 7-1 Common trouble shooting
7.3 Service
Manufacturer address
Add: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District
518108, Shenzhen, P.R. China
Tel: +86-755-8617 0389 Fax: +86-755-8617 0478
Email: info@carewell.com.cn
After-sale service centre
Add: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District
518108, Shenzhen, P.R. China
Tel: +86-755-8617 0389 Fax: +86-755-8617 0478
Email: service-intl@carewell.com.cn
51
Chapter 8 Accessories
Chapter 8 Accessories
WARNING :
 Only patient cable and other accessories supplied by the manufacturer can be used. Otherwise
the performance and electric shock protection or defibrillator protection cannot be guaranteed.
 Do not use the accessory if any indication of damage is found. Refer to the accompanying
manual of the accessories for the replacement method and replacement cycle of the accessories.
No. Accessory Quantity
1 Patient cable 1
2 Chest electrodes 6 pcs
3 Limb electrodes 4 pcs
4 USB cable 1
5 Electrode pads 10 pcs
6 Software installation CD 1
7 USB dongle 1
Table 8-1 Accessories List
52
Appendix I Technical Specifications
MDD93/42/EEC Medical Device Directive
Medical electrical equipment - Part 1: General

IEC 60601-1: 2005+A1:2012
requirements for basic safety and essential performance
Safety Medical electrical equipment - Part 2-25: Particular

IEC 60601-2-25: 2011
requirements for the safety of electrocardiographs
Standards
Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance

IEC 60601-1-2: 2014
- Collateral Standard: Electromagnetic disturbances -
Requirements and tests
Anti-electric-shock type: Class II
Anti-electric-shock degree: Type CF with defibrillator protection
Degree of protection against Ordinary equipment (Sealed equipment without liquid
harmful ingress of water: proof)
Classification Degree of safety of
application in the presence Not suitable for use in the presence of flammable gas
of flammable gas:
Working Mode: Continuous operation
EMC: Group Ⅰ, Class A
Dimension Acquisition box: 168mm×120mm×31mm
Net Weight About 0.35kg
Transport Storage Operation
Temperature -20℃~+55℃ -20℃~+55℃ +5℃~+40℃

Environment
Relative Humidity 15%~95% 15%~95% 25%~85%
Atmospheric Pressure 700hPa ~1060hPa 700hPa ~1060hPa 700hPa ~1060hPa
53
Input Circuit Floating, protection against defibrillator effect
Lead 12 standard leads
Patient Leakage Current <10μA
Input Impedance ≥50MΩ (10Hz)
Calibration Voltage 1mV±3%
A/D Switch 24 bit
Sampling Rate 8000Hz（50Hz, 60Hz）
Measurement Range 20μV～4mV
＋０．４ｄＢ
Frequency Response 10Hz, (0.05～165Hz) －３．０ｄＢ
Time Constant ≥3.2s
Acquisition Box CMRR ≥115dB
50Hz/60Hz Filter ＞20dB
EMG Filter 25Hz(-3dB) / 35Hz(-3dB)
Sensitivity 5, 10, 20(mm/mV), Auto
Conversion Error ≤5%
Input Circuit Current ≤50nA
Rated Voltage d.c.5V, 250mA
Signal Input and Output USB
Depolarization Voltage ±500mV, ±5%
Noise ≤12.5μVp-p
54
Shenzhen Carewell Electronics Co., Ltd.
Manufacturer address: Floor 4, BLD 9, Baiwangxin High-Tech Industrial Park,
Songbai Road, Xili Street, Nanshan District 518108, Shenzhen, P.R. China
Tel: +86-755-8617 0389
Fax: +86-755-8617 0478
Web: www.carewell.com.cn
Email: info@carewell.com.cn

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Copyright© Shenzhen Carewell Electronics Co., Ltd. 2020.

No part of this document can be photocopied, reproduced or translated to another language

Release date: May 2020

Responsibility of the manufacturer

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by

Chapter 1 Warnings and Notes

1.1 Warnings and notes on the software

1.2 Warnings and notes on the ECG

Please refer to the ECG Operation Manual.

1.3 Warnings and notes on the acquisition box

Chapter 2 General Information

2.1 Product introduction

2.1.1 Intended use

2.1.2 Standard configuration

2.1.3 About the software

Section Functionality description Reference content

Section Functionality description Reference content

2.2 Installation requirement

2.2.1 Hardware requirement

CPU: Pentium 1G Hz or above

2.2.2 Software requirement

Operation system: Microsoft windows XP/Vista/win7 (32bit & 64bit)

Authorization: USB dongle authorization

2.3 ECG patient cable connection

Figure 2-1 Patient cable

2.4 ECG electrode connection (CF Application Part)

Figure 2-2 Chest electrode

Figure 2-3 Limb electrode

Electrodes Identifier Color code Identifier Color code

Right arm R Red RA White

Left arm L Yellow LA Black

Right leg RF Black RL Green

Left leg F Green LL Red

Chest 1 C1 White/red V1 Brown/red

Chest 2 C2 White/yellow V2 Brown/yellow

Chest 3 C3 White/green V3 Brown/green

Chest 4 C4 White/brown V4 Brown/Blue

Chest 5 C5 White/black V5 Brown/orange

Chest 6 C6 White/violet V6 Brown/violet

Table 4-1 Electrodes, identifier and color code

The chest electrode should be placed on body surface as shown below.

Figure 2-4 Chest electrode positioning (Wilson system)

C1: Fourth intercostals space at right border of sternum

2.4.1 Chest electrode connection

1. Ensure the electrodes are clean;

2.4.2 Limb electrode connection

1. Ensure the electrodes are clean;

Figure 2-5 Wilson system

Chapter 3 Installation and Uninstallation

3.1 Installation of ECG Workstation 3.1

3.1.1 Installation of ECG Receiver

Step 1 Installation of .NET Framework 2.0

Figure 3-1 .NET Framework 2.0 installation

Step 2 Click “Accept” to continue installation.

Figure 3-2 .NET Framework 2.0 installation

Step 3 Installation of ECG Receiver

software driver as Figure 3-3.

Figure 3-3 Tips for ECG receiver workstation installation

Step 4 Choose installation locations

per your preference.

Figure 3-4 Choose installation locations

Step 5 Installation of ECG receiver workstation