User Manual Nano Checker Cardiac Biomarker Analyzer
Short Description
User Manual Nano Checker Cardiac Biomarker Analyzer...
Description
User Manual Nano-Checker 710V Reader(v1)
Nano-Ditech Corporation 259 Prospect Plains Rd, Bldg K Cranbury, NJ 08512 Tel: 1-732-297-7877 Fax: 1-732-297-7878
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Table of Contents Introduction 1. The Use of User Manual ................................................................. ..................................................................................................... .................................... 4 2.
Please Be Well-Informed before Using the Product ........................................................ 5
Product Description 1
Characteristics of Product .............................................................. .................................................................................................. .................................... 8
2
Product Components and Installation Methods ........................................................... .............................................................. ... 9
3
2.1
Product Components ............................................................... ................................................................................................... .................................... 9
2.2
Installation Methods ................................................................ .................................................................................................. .................................. 10
Execution ........................................................................................................................... 12
3.1
Initial Execution Execution and Main Main Page .......................................................... ................................................................................. ....................... 12 3.1.1
Initial Execution .......................................................... ............................................................................................ .................................. 12
3.1.2
Starting the Program .............................................................. ..................................................................................... ....................... 14
3.2
Instrument Check ........................................................ ...................................................................................................... .............................................. 17
3.3
Starting Test ................................................................. .............................................................................................................. ............................................. 21
3.4
Test Report ................................................................... ................................................................................................................ ............................................. 28
3.5
Manager ..................................................................................................................... 33
3.6
3.5.1
Operator Manager .................................................................. ......................................................................................... ....................... 33
3.5.2
Patient Manager Manager .......................................................... ............................................................................................ .................................. 36
3.5.3
Test File Manager .................................................................. ......................................................................................... ....................... 39
Setting ........................................................................................................................ 42 3.6.1 Network ........................................................... ......................................................................................................... .............................................. 43
3.7 4
2
3.6.2
Others ............................................................................................................ 46
3.6.3
Test ................................................................................................................ 49
Thermal Thermal Printer ................................................................................................................... 50
Product Specification and After-sales Service .............................................................. ................................................................ 52
4.1
Product Specification Specification .............................................................. ................................................................................................ .................................. 52
4.2
Product After-sales After-sales Service ................................................................ ....................................................................................... ....................... 53
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Introduction Thank you for purchasing Nano-Checke 710V Reader(v1). Reader(v1) . In order to prevent damage or loss of property, please read instructions and safety guidelines in this user manual and be well-informed before using this reader. reader. Always have this user manual at hand in case of need.
▶
Copyright© all rights reserved.
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1
The Use of User Manual
Labels and symbols shown below are used throughout the user manual.
Label
Description
To indicate the direct current (DC). CE mark – mark – To To indicate that this product is appropriate for the standard of EU. To indicate instruction manual. The catalog number of this product. The serial number of this product. To indicate the manufacturer. Biohazard – Biohazard – To To indicate that biological substances may damage your health. Warning – To indicate that a user should read and consult accompanying instruction. Authorized representative in the European Community. To indicate suitability of all in-vitro medical diagnostic equipment for entering Europe market. To indicate that this product should be stored within a certain temperature range. range. To indicate the date of manufacture.
*Ask your supplier or local agency for more information about separate collection and recycle program.(
This is only for EU member member countries. countries. Therefore, this may not be indicated according according to
different regions and countries.)
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2. Please Be Well-informed before before Using the Product Precautions on Installation and Storage
CAUTION: Please read this user manual carefully and follow instructions for installation.
(1) Appoint an administrator and let the administrator install and run this system. An administrator should be medical professional, researcher or skilled operator with responsibilities. If the administrator is a non-medical professional, the person is required to keep confidentiality. (2) Installation Method ① Check the rated voltage and connection of the power cord. ② Check the connection between the cable and the connector. ③ Press power button to turn on the system.
- After the power is on, check the Power LED to see if it is working properly. - If the system does not turn on, check the condition of the connector. ④ To run the program and functions of this reader, follow test procedures guided in this user
manual. (Refer to Test Method) (3) Cautions during Installation ① Install this product in a place where voltage, frequency and electric power consumption are
supplied appropriately. - Use the adapter provided. - The product may be damaged, in the case of an overvoltage or low voltage. ② Check the ground connection for grounding-type bipolar outlet. ③ Be careful of reader malfunction, if there is a possible inflow of electromagnetic waves. ④ Avoid operating this reader nearby other equipment generating short waves or microwaves.
This condition may affect the result. ⑤ Check Location of Installation.
Install the reader in a place with humidity less than 90%.
Install the reader in a well-ventilated well-ventilated place with minimal dust.
Avoid any place where physical and chemical effect is possible.
Avoid direct sunlight.
Install the reader on a flat surface.
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If room temperature is too high, an error may arise. (Optimal operating temperature: +10~+40℃)
The use of this reader with explosive, inflammable or putrefactive substances is prohibited.
The use of this reader in a place with radiation, a magnetic field or a vacuum is prohibited.
The use of this reader in a place with extreme electric noise is prohibited.
The Calibrator may be discolored under direct sunlight. It is recommended that the calibrator is stored in a dark place.
Be careful not to extremely tilt or drop the reader during transfer.
Notice
This product optically analyzes the reaction between specific pathogenic organism and reagent in the diagnostic process of specimen, and quantifies degree of the reaction This system is for quantitative analysis of lateral flow immunochromatographic devices. The system can be operated by a person of a non-medical field, but the result should be interpreted and analyzed by medical professionals. You can buy supplies like the calibrator and test devices from your supplier. Supplies should be tested for adaptability with the system before it is actually used for the test. Information about applicable supplies is available by contacting Nano-Ditech Corporation.
CAUTION: If you need an accurate result or have an important test to be done, wait about 30 minutes after turning the system on and do the calibration before the test(Refer to 3.2 Instrument Check). ① Use this reader on a flat surface avoiding direct light. ② To prevent electric shock, check if the power supply is connected to the ground. ③ Use supplies only from Nano-Ditech Corporation to prevent product damage. ④ Be careful not to block the air passage on the back of the reader. ⑤ Be careful not to get burnt from the heat produced by the reader due to long-term use. ⑥ Do not use this reader in a place with shock and vibration. ⑦ To prevent contamination of the reader, wait until all samples are absorbed into the RDT
(Rapid Diagnostic Test) device before you insert the device in the system. ⑧ While you are operating the reader with the object of testing, prevent any vibrations that affect
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the system. ⑨ If there is any vibration affecting the system during the test, abort the process and restart the
test from the beginning. ⑩ Do not open the tray during the test. If the device is exposed to the outside during the test,
abort the process and restart the test. ⑪ When the test is completed, exit the program and turn off the system. If you turn off the
system before the program normally ends, it could affect the program and unexpected errors could be generated. ⑫ Be careful not to contaminate the reader when taking the device out of the reader.
Notice on Copyrights ① All rights are reserved by Nano-Ditech Corporation. ② This user manual cannot be copied without permission. If it is used without authorization, the
user has to take legal responsibilities. ③ We are not responsible for the damage occurred by not using appointed standardized parts or
using other software, which is not provided in the product package. ④ Specifications of this product can be changed due to company’s action for improving
convenience and product performance. ⑤ You may not be compensated if it is not mentioned by manufacturer. ⑥ Any problem occurred by not using equipment from the manufacturer cannot be compensated. ⑦ We are not responsible for any damage of the product caused by not following cautions and
warnings in this user manual.
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Product Description 1. Characteristics of Product Nano-Checker™ 710V R eader(v1), developed by Nano-Ditech Corporation, gives you quantitative assessment by capturing and analyzing images of lateral flow immunochromatography. When the Rapid Diagnostic Test (RDT) device is inserted into the tray, an internal camera captures and saves the image, and data is automatically collected to be converted to a graphical analysis. Accurate and reliable rapid diagnosis is possible since this product provides quantitative and qualitative analysis through highly sensitive image analysis based on LED and the high quality image sensor. Convenient management of patient information is also possible by saving and transporting patient information through a USB port. And the system provides printing function using built-in thermal printer and network printer, you can print out test result through this function. Intuitive user interface using touch pad controller with 10” color LCD makes it easy to access and use.
Main Features
-Qualitative and quantitative analysis of various applications for POCT -Support LIS -Remote access for support -Bar code & QR code
Convenient Features
-Data management -Data printing -User management -Patient record management
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2. Product Components and Installation Methods
2.1 Product Components
Components provided in the product package are as following.
Product and parts composition of Nano-Checker™ 710V Reader(v1) (Cat. No. ABA02) ▷ AC/DC Adapter (12V, 5A output; Cat. No. ABA061) ▷ Power Cable (Cat. No. ABA062) ▷ Touch Pen (Cat. No. ABA063) ▷ Calibrator: for QC purpose only (Cat. No. ABA064) ▷ User manual
*If you have any questions or missing components, please contact Nano-Ditech Corporation customer services ((Tel : 1-732-297-7877, Fax : 1-732-297-7878)
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2.2 Installation Methods
CAUTION: Install this system on a flat surface. Be cautious with connection of AC/DC adapter.
▶ Product Connection
(ⅰ) Connect AC/DC adapter to the Nano-Checker™ 710V R eader(v1). (ⅱ) Connect power cable to AC/DC adapter. (ⅲ) Put the plug in the 100-240V socket.
▶ Powering on/off
Reset Button The power button is located on the front side of the Nano-Checker™ 710V R eader(v1). Press the power button to start the program or shut down the reader.
Reset button is located on the rear side of the unit, if the system does not work during operation please press this reset button by inserting narrow rod into the hole.
To turn off the power of the system completely, please remove Adaptor cable from the unit or disconnect the plug from the socket.
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F RONT L E D Configuration The system has indication function using LED. During operation, it illuminates different colors. Please refer to the following color indications.
LED illumination part
LED color
Indication
No light
No power connection.
GREEN
Power cable is connected but not turns on the system.
YELLOW
Power cable is connected and turns on the system.
RED
Power cable is not connected but turns on the system(operated by battery).
BLUE
Sample is measuring.
Operation by Battery The lithium ion battery is built-in inside of system. The purpose of the battery is for emergency back up in case of shut down of electric power system, it is not for normal operation. If the system is operated by battery only, USB output does not work. The maximum operation time by battery is less than 1 hour. If the electric power is shut down by accident, please finish the operation and save data.
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3 Execution
3.1 Initial Execution and Main Page
3.1.1 Initial Execution
[Figure 1.] Registration Window
▶ When executing
Nano-Checker™ 710V Reader(v1) for the first time, a registration
window appears. Users can input the reader information and get customer support and product updates. The information that users enter is not provided to any other company or institution. ▶ For the registration of the reader, the serial number of the product is required. After
filling the blanks with serial number, name, country, organization, department, phone number, email, set the Date/Time to your local date and time. Click ‘Register’ button to register information. (The blanks indicated with ‘*’ are required information.)
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[Figure 2.] Supervisor Registration ▶ To execute the program, the supervisor’s registration is required. Enter the supervisor’s
ID and click ‘Register’ button to check if the ID is available. Unless the entered ID already exists, you will see the message “Enter your password.” Enter other req uired information (password and confirm password) and optional information (name, organization and department) as well. Then click ‘Register’ button to register the supervisor. * The first person registered in the system is designated as a supervisor. You can also register additional supervisors or operators afterwards. ▶ After completing the registration, the ‘Log in’ screen appears. Log in the system with
registered ID and password to start the program.
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3.1.2 Starting the Program
[Figure 3.] Log in Window
▶ Enter ID and Password and then click ‘Log in’ button to go to the main menu.
▶ Click
button to check model name and software version.
[Figure 3-1.] Program Information
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▶ Click
button to power off the reader.
[Figure 3-2.] Click ‘Power Off’ button
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[Figure 4.] Main menu Name New Test
Description
To start a new test.
Test Reports
To view previously tested results.
Instr. Check
Calibrate the reader with the calibrator for an accurate result.
Manager Setting
To administer registered operators and patients. To administer Network Configuration, LIS and Date/Time etc.
▶ If you want to log out and go back to log-in page, click
button.
[Figure 4-1.] Click to Log out
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3.2 Instrument Check
[Figure 5.] Click Instrument Check Button ▶ ‘Instr. Check’ is a calibration function to check optimization of Nano-Checker ™ 710V
Reader(v1). On the main menu, press ‘Instr. Check’ button to execute the ‘Instrument Check’. ▶ To conduct ‘Instrument Check’ function, a calibrator, provided in the product package,
is required.
[Figure 6.] Check Instrument – First Time ▶ If it is the first time measuring the calibrator, you will see the screen shown above.
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▶ But if you have measured calibrator previously, you will see the previous measurement
data on the screen. You can see the screen with the previous measurement data as shown in [Figure 6-1].
* You can always go back to ‘Main Menu’ by clicking
button on the screen.
[Figure 6-1.] Check Instrument with Data
▶ ‘Date/Time’, ‘Operator ID’, and ‘Result’ of previous measurement are in the Table. If it
is the first time measuring the calibrator, the table will be empty as shown in [Figure 6.]. ▶ Click ‘Run’ button to start scanning process. Again, you will see the screen as [Figure
7.] if it is the first time of measurement, and [Figure 7-1.] when there is previous measurement data.
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[Figure 7.] Scanning Calibrator – First Time of Measurement
▶ The scanning is processing.
[Figure 7-1.] Scanning Calibrator – with Previous Data
▶ You can see the previous data table and the running of scanning process.
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[Figure 8.] Result of Check Instrument ▶ When the scanning process is complete, you can see the result of measurement.
▶ You can see the graph and captured image of calibrator’s five test lines. The graph will ™ 710V R eader(v1) . The show intensity of each parameter measured by the Nano-Checker
x-axis stands for the relative location of each test line on the device. The y-axis stands for measured intensity value. ▶ Check descriptions for the ‘Parameter’, ‘Value’, ‘Reference Value’ and ‘Result’ in the
Table.
Name Parameter Value Ref. Value Result
Description
The parameter name matched for each parameter on the graph. Measured value The standard value. The reference value is the fixed value, which has already been set by manufacturer. The result shows validity of the measured value. If the measured value is in the pre-set range of reference value, the result will call ‘Pass’. But the measured value is out of pre-set range of reference value, the result will call ‘Fail’.
Note: Calibration is required to optimize measuring ability of reader. For more accurate result, regular calibration is required. If the calibrator is damaged or lost, contact the place of purchase immediately. 3.3 Starting New Test
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3.3 Starting New Test
[Figure 9.] Starting New Test ▶ Click ‘New Test’ button to start the test, then ‘Test Information’ screen [Figure 10.] will
appear.
[Figure 10.] Test Information ▶ Enter patient ID. If the patient has a history of test, click the ‘Search’ button to search
the patient. After click ‘Search’ button, you can see the ‘Search Patients’ screen as shown in [Figure 10-1.] below. ..* You can register the patient information (ID, Name, Birthday and Gender) through the ‘Manager’ in main menu.
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[Figure 10-1.] Search Patients ▶ When the ‘Search Patients’ screen appears, select one option i n the ‘Search Filter’ drop
down menu, input the ‘Filter Text’ and click ‘Search’ button. ▶ Select a patient and press ‘OK’ button, then the ‘Test Information’ screen will appear
as shown in [Figure 11.] below.
[Figure 11.] Test Information – after searching patients ▶ Select an appropriate sample type in drop down menu and enter the Lot Number, and
then you can select a year and month of the test device’s expiration date. The ‘expiration date’ is not a required input.
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▶ When you select the test file from the ‘Test Name’, the test file’s information will be
shown under the selected test file name. All test file information is described in the table below. * The test files have been preset for testing the test device.
Name Images
Description
Test and control lines that are captured are shown.
Description
Types of diseases that can be tested with the device.
Incubation
Total duration of the test, including the incubation time. The test can be done in a given time frame but user can also set the time for the test. ▷Select ‘Default’ to start measuring the test after a certain time, which is already set by each test file. ▷Select ‘Skip’ to start measuring the test immediately. ▷Select ‘Set Time’ to manually setup incubation time.
[Figure 12.] Click Run Button ▶ Click the down arrow button next to the ‘Test Name’ to select the test file. After
selecting ‘Incubation’ condition, click ‘Run’ button to start measurement.
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[Figure 12-1.] Abort Button
▶ You can click ‘Abort’ button to stop the scanning process.
1)
2)
3)
[Figure 13.] Test Result ▶ When the scanning is successfully complete, the ‘Test Result’ screen appears. The test
information and the measured values are presented. The left side of the image shows test and control lines of the test device, captured by the internal camera of the reader.
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▶ To check the detailed information of test result. Click
button.
[Figure 14.] Derailed Information of Test Result
1) Click ‘Print’ button in [Figure 13.] to print the result.
[Figure 15.] Print
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▶ If printer is not ready properly, Error message will appear. Please check the printer
status.
[Figure 15-1.] Print Error
2) Click ‘Share’ button in [Figure 13.] to export the result.
[Figure 16.] Share
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▶ When you click ‘Email’ button, you can send the test result in PDF by e-mail. ▶ Type the e-mail address where you want to receive the test result in the ‘Receive E -
Mail Address’ section. In ‘Send E-Mail Address’, ‘Password’, ‘SMTP Server’ and ‘SMTP Port’, you can input sender’s e-mail information.
[Figure 16-1.] Send e-mail ▶ When you click ‘USB’ button, you can save the test result PDF file in the USB. Type
the file name and click ‘USB Export’ button to save the test file in the USB. * The USB is not provided. To use this option, please prepare a USB for your own.
[Figure 16-2.] Typing File Name 3) Click ‘New Test’ button in [Figure 13.] and go back to the ‘Test Information’ screen to do a new test. ABA06-E101 2014-10-23
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3.4 Test Report
[Figure 17.] Click Test Reports ▶ Click ‘Test Reports’ button on the main menu to execute the Test Report menu. You
can review all previous test results. Also you can delete, export, and print previous test reports.
⑴
⑵
⑶
[Figure 18.] Test Report Main Screen
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(1) View: If you want to view details of a previous test report, check the check box and
click ‘View’ button. You can check more than one test report. When you click the column header of checkbox column, all checkbox will be checked. When you click it again, all checkbox will be unchecked.
[Figure 18-1.] Review the Test Result
▶ You can review the selected test result. You can also print the result and save it as a
PDF file.
▶ With
and
buttons in both sides of table, you can review other selected test
results, which are selected from the list in the Test Report main screen in [Figure 18.].
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▶ To check the detailed information of test result. Click
button.
[Figure 18-2.] Review Details of a Test Result ▶ Click
button in the upper left corner of screen to close the ‘Test Result’ screen
and go back to the Test Report main screen. (2) Delete: Select a result that you want to delete and click ‘Delete’ button to delete the result.
[Figure 18-3.] Confirmation Message of Deleting Results ▶ Click ‘Yes’ button to confirm deleting test results.
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(3) Export : Select a result that you want to save as a SAM file or an Excel file, then click ‘Export’ button to save the selected result.
[Figure 18-4.] Save as SAM File
[Figure 18-5.] Save as Excel File ▶ Click ‘Export’ button to confirm saving the test results in your USB as a SAM
file/Excel file.
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▶ If USB flash drive is not inserted, error popup will be displayed. Please insert USB
flash drive before copying the result.
[Figure 18-6.] Export Error
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3.5 Manager
[Figure 19.] Click Manager ▶ In the ‘Main Menu’, click ‘Manager’ button to execute the ‘Manager’. ▶ You can manage registered operators and patients, and register new operators and
patients, also you can transfer test file by connecting a USB flash memory. 3.5.1 Operator Manager
[Figure 20.] Click Operator in Manager Main Screen ▶ Click ‘Operator’ button to execute the ‘Operator Manager’. You can manage registered
operators and also register a new operator. ABA06-E101 2014-10-23
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⑴
⑵
⑶
(4)
[Figure 21.] Operator Manager (1) Search: To search a registered operator, select the ‘Filter Type’ between ‘ID’ and ‘Name’, type the operator’s ID or name and click ‘Search’ button.
* You can always go back to previous screen by clicking
button on the screen.
(2) New: Click ‘New’ button to register a new operator.
[Figure 21-1.] Registration of New Operator
▶ Input a new ‘ID’, ‘Password’, ‘Name’, ‘Organization’ and ‘Department’ and select the
‘Authority’. And then click ‘Register’ button to complete registration.
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○ Information on Manager’s Authority Authority Supervisor Operator
Possible Operation
Every operation is possible. Every operation except modification and deletion of data is possible
(3) Modify: Select an operator whose information you want to modify by clicking the checkbox, and click ‘Modify’ button to modify t he selected operator.
[Figure 21-2.] Modify Operator (4) Delete: Select an operator that you want to delete by clicking the checkbox, and click ‘Delete’ button to delete the selected operator.
[Figure 21-3.] Delete Operator
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3.5.2 Patient Manager
[Figure 22.] Click Patient in Manager Main Screen ▶ You can register new patients and manage previously registered patients. Click ‘Patient’
button to execute the ‘Patient Manager’.
⑴
⑵
⑶
(4)
[Figure 23.] Patient Manager
(1) Search: To search a registered patient, select the ‘Filter Type’ between ‘ID’, ‘Name’, ‘Gender’, etc., type the patient’s ID, name, etc. and click ‘Search’ button.
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(2) New: Click ‘New’ button to register a new patient.
[Figure 23-1.] Registration of New Patient ▶ Input a new ‘ID’, ‘Name’ and ‘Birthday’ for the patient, and select the ‘Gender’ of the
patient. And then click ‘Resister’ button to complete registration. (3) Modify: Select a patient whose information you want to modify by clicking the checkbox, and click ‘Modify’ button to modify the selected patient.
[Figure 23-2.] Modify Patient
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(4) Delete: Select a patient that you want to delete by clicking the checkbox, and click ‘Delete’ button to delete the selected patient.
[Figure 23-3.] Delete Patient
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3.5.3 Test File Manager
[Figure 24.] Click Test Files in Manager Main Screen ▶ Click ‘Test’ button to execute the ‘Test File Manager’.
⑴ ⑵
[Figure 25.] Test File Manager ▶ You can import new test methods and manage stored test methods.
▶ If you want to import all test files in USB flash drive, click ‘Select All’ button in USB
section and click ‘>’ button.
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▶ If you want to import specific test file in USB flash drive, select the file and click ‘ >’
button.
[Figure 26.] Import Test File
▶ If you want to export all test files in the instrument, click ‘Select All’ button in
Instrument section and click ‘
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