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Nano-Ditech Corporation
259 Prospect Plains Rd, Bldg K Cranbury, NJ 08512
Tel: 1-732-297-7877
Fax: 1-732-297-7878
ABA06-E101 2014-10-23
Table of Contents
Introduction
1. The Use of User Manual ..................................................................................................... 4
Product Description
1 Characteristics of Product .................................................................................................. 8
3 Execution ........................................................................................................................... 12
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Introduction
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1 The Use of User Manual
Labels and symbols shown below are used throughout the user manual.
Label Description
CE mark – To indicate that this product is appropriate for the standard of EU.
To indicate that this product should be stored within a certain temperature range.
*Ask your supplier or local agency for more information about separate collection and recycle
program.( This is only for EU member countries. Therefore, this may not be indicated according to
different regions and countries.)
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2. Please Be Well-informed before Using the Product
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.
④ To run the program and functions of this reader, follow test procedures guided in this user
manual. (Refer to Test Method)
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.
④ Avoid operating this reader nearby other equipment generating short waves or microwaves.
This condition may affect the result.
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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).
② To prevent electric shock, check if the power supply is connected to the ground.
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.
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
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.
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
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
Product and parts composition of Nano-Checker™ 710V Reader(v1) (Cat. No. ABA02)
▷ 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
▶ Product Connection
(ⅰ) Connect AC/DC adapter to the Nano-Checker™ 710V Reader(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 Reader(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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FRONT LED Configuration
RED Power cable is not connected but turns on the system(operated by battery).
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
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3 Execution
▶ 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 required 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
▶ Enter ID and Password and then click ‘Log in’ button to go to the main menu.
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▶ Click button to power off the reader.
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[Figure 4.] Main menu
Name Description
New Test 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 To administer registered operators and patients.
Setting To administer Network Configuration, LIS and Date/Time etc.
▶ If you want to log out and go back to log-in page, click button.
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3.2 Instrument Check
▶ 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.
▶ ‘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
▶ 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
show intensity of each parameter measured by the Nano-Checker™ 710V Reader(v1). The
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 Description
Parameter The parameter name matched for each parameter on the graph.
The standard value. The reference value is the fixed value, which has already
Ref. Value
been set by manufacturer.
The result shows validity of the measured value. If the measured value is in the
Result 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
▶ Click ‘New Test’ button to start the test, then ‘Test Information’ screen [Figure 10.] will
appear.
▶ 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 in 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.
▶ 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 Description
Images Test and control lines that are captured are shown.
▶ 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
1) 2) 3)
▶ 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.
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▶ If printer is not ready properly, Error message will appear. Please check the printer
status.
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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.
▶ 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.
3) Click ‘New Test’ button in [Figure 13.] and go back to the ‘Test Information’ screen to
do a new test.
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3.4 Test Report
▶ 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
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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.
▶ 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.
▶ 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.
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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.
▶ 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.
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3.5 Manager
▶ Click ‘Operator’ button to execute the ‘Operator Manager’. You can manage registered
operators and also register a new operator.
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⑴
⑵ ⑶ (4)
(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.
▶ 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
(3) Modify: Select an operator whose information you want to modify by clicking the
checkbox, and click ‘Modify’ button to modify the selected operator.
(4) Delete: Select an operator that you want to delete by clicking the checkbox, and click
‘Delete’ button to delete the selected operator.
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3.5.2 Patient Manager
▶ You can register new patients and manage previously registered patients. Click ‘Patient’
button to execute the ‘Patient Manager’.
⑵ ⑶ (4)
(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.
▶ 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.
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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.
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3.5.3 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.
▶ If you want to export all test files in the instrument, click ‘Select All’ button in
Instrument section and click ‘<’ button.
▶ If you want to export specific test file in the instrument, select the file and click ‘<’
button.
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▶ If you want to view the detail of test method file, select the test file and click ‘View’
button.
▶ If you want to remove any test file in the reader, select the test file and click ‘Remove
Test’ button.
* The USB Flash Drive is not provided. To use this option, please prepare a USB Flash
Drive for your own.
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3.6 Setting
▶ In the ‘Setting’, you can set network configuration, remote support, LIS connection,
barcode and so on.
▶ In the Main Menu, click ‘Setting’ button to go to the ‘Setting’ menu. Then you can
select ‘Network’, ‘Others’ and ‘Test’.
▶ In the ‘Setting’, before you set network configuration and the other menu please connect
LAN cable to the system.
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3.6.1 Network
▶ If you select Manual mode, you must input all information for network configuration
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▶ You can connect to LIS server, which is used to manage patients, specimens and test
results data in the laboratory for the diagnosis and treatment of a patient.
▶ To connect to LIS server, input the Device ID, address of LIS server, Port, and choose a
Mode (Custom/ASTM), then click ‘Enable’ button.
▶ If LIS server is connected properly, the ‘Enable’ button will be changed to ‘Disable’. Or
if the connection fails, ‘Enable’ will be displayed
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▶ If LIS is Enabled and ‘Notice’ is applied, a message for conforming to send will popup
when doing ‘New Test’ as [Figure 31-4].
▶ If you have any technical problem, you can get the remote support from our support
team.
▶ When the Internet is connected to the reader, you will see your ‘IP Address’ on the
screen. Give this ‘IP Address’ and ‘Port’ number to our support team and click ‘Remote
booting’ button to let us connect to your reader and support your technical problem.
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3.6.2 Others
▶ Click ‘Others’ button to set the language, Date/Time, checkup period, barcode and
printer.
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▶ You can set date format by choosing the format through dropdown menu.
▶ You can enable barcode reader support and set barcode type.
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▶ You can choose thermal printer or network printer(Remote). In the case of network
printer, you must input the IP address and port number of the printer.
▶ You can choose thermal printer or network printer(Remote). In the case of network
printer, you must input the IP address and port number of the printer.
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3.6.3 Test
⑴ (4)
(1) Lot Number – Fixed : ‘Lot Number’ in ‘New Test’ is will be filled up automatically.
(2) Patient Registration – Auto : Patient’s Name will be filled up automatically. Patient’s
Name will be prefixed. Ex) pt1, pt2, pt3 ...
(3) Patient Registration – Reg. Notice : if the patient’s name a user input is not registered, a
message will pop up.
(4) Organization Info. – Name : ‘Organization Name’ will be printed as a output format in
Thermal Printer.
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3.7 Thermal Printer
One print paper is installed in the system when the system is delivered. After use the paper and if you
need to replace paper new one, please follow the below procedure.
the housing.
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Insert edge of paper into the hall to make paper
rolling properly.
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4 Product Specification and After-sales Service
Parameter Description/Value
Weight 1.93 kg
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4.2 Product After-sales Service
(1) Failure
② Inactivated Program
④ Abnormal termination during operation or detection of any function not following this
manual.
③ Symptoms (details).
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