Infopia SelexOn User manual

Contents
Intended Use
Background
Device Settings
QC Test (Quality Control)
Memory
Quick Test (Quick Measurement)
Patient Test (Basic Measurement)
Code Registration
Main Menu
Caution
Product Components
Product Overview
Power Supply
Names of Parts
3
4
42
31
25
19
14
12
11
10
9
7
5
3
SelexOn .1

Intended Use
SelexOn is an in-vitro diagnostic device that measures the concentra-
tion of biomarkers within blood. It is used for diagnosis.
This device uses an anticoagulant-treated (EDTA-treated) venous whole
blood sample and should be operated by experts in the laboratory or
hospital.
<IMPORTANT>
Please read this manual carefully prior to the initial use of the product.
Product Overview
SelexOn meter is easy to use. After injecting the collected venous blood
sample into the sensor on the test strip, the strip changes its color
depending on the concentration of the analyte. This reaction is then
quantitatively measured to calculate the results.
The meter should be used only with the provided adapter. If a different
adapter is used, incorrect results may be obtained.
Product Principle
The test contains two monoclonal antibodies specific to analyte. The
antibodies form a sandwich complex with the analyte in the blood.
Following removal of erythrocytes from the sample, plasma passes
through the detection zone in which the gold –labelled analyte sandwich
complexes and the positive signal is displayed as a reddish line (the test
line). Excess gold-labelled antibodies accumulate along the control line,
signaling that the test was valid. The intensity of the test line increases
in proportion to the analyte concentration. The optical system of the
SelexOn instrument detects the two lines and measures the intensity of
the test line. The integrated software converts the signal intensity to a
quantitative result and showed it in the display.
SelexOn .3
49
ID Input
Barcode Scanner
Troubleshooting
Battery
Printer
Appendix
PC Sync Software
Contents
SelexOn .2
53
63
60
58
55
57

Product Components
Components
Meter Components
SelexOn Meter 1 Meter
1 User's Manual
1 External power adapter
1 Fan filter
1 Standard strip
SelexOn .5
Background
Lateral Flow Immunoassay
The lateral flow immunoassay is also known as a sandwich assay.
In this quantitative measurement method, by using an antigen, a gold
nanoparticle-labelled detection antibody is combined with an antibody
specific to disease markers.
The antigen concentration within blood appears as the thickness of the
red band on the test line. Through this correlation, the antigen concen-
tration can be measured by using the standard curve.
SelexOn .4

Names of Parts
SelexOn Meter
SelexOn Test Strip
SelexOn .7
Product Components
Optional
You can purchase the optional components from your nearest dealer.
For details, please contact the store or visit our web site
(www.infopia21.com).
Optional Components
SelexOn test strip
SelexOn printer
Barcode scanner
SelexOn battery
Data cable
Quantity
1 Box
1 ea.
1 ea.
1 ea.
1 ea.
SelexOn .6
Strip Handle
Measuring Window
Blood Inlet area
Strip Code

Caution
Precautions
1. Please read this manual carefully prior to use.
2. Prior to the initial use, please set the current year, month and day in
'SetUp' mode.
If the date is incorrect, an error related to exceeding the expiration date of
a strip may occur.
3. In order to prevent any infection or contamination, please wear gloves.
4. The meter must be used on a flat, stable surface and should not be moved
during its operation.
5. If the RFID information on the sensor container and the code information
of the sensor do not match, an error will occur. Please replace the strip
with the same code information on both sensor container and sensor.
6. Please routinely run QC (Quality Control) mode.
7. Wipe off any contaminants such as blood spots or dust on the blood inlet
prior to use.
8. Since a strong impact may cause the device to fail, avoid external shock.
9. Use the meter at a stable temperature range (18 - 32℃).
10. Avoid the electric and magnetic field.
11. Use the only SelexOn strip.
Storage After Use and Maintenance
1. Do not arbitrarily disassemble or alter the device.
2. Store the device in a dry place.
3. Avoid dust and high humidity / water when storing or operating the device.
4. Store the device in a stable, level location without vibration or shock.
5. Do not store near chemical storage or a place that generates gas.
6. Avoid direct sunlight.
7. Clean the meter with a soft cloth or tissue only if there are any contami-
nants such as blood spots or grease on the device after use.
8. Be careful not to insert the different materials in the meter.
9. Please dispose of used strips or meter in accordance with the waste dis-
posal regulations by your local authorities.
SelexOn .9
Names of Parts
Port Panel
<CAUTION!>
The USB port is exclusively used by the manufacturer. If this port is
used for other than the intended use, the product may have a problem.
Name
1. Printer port
2. Barcode scanner port
3. USB port
4. Power adapter port
5. Power switch
SelexOn .8
1 2 3 4 5

Main Menu
After the system initialization, the Main Menu appears on the meter LCD.
Icons for each mode appear on the LCD.
Memory
Runs the memory
mode.
QC Test
Runs the QC Test mode.
SetUp
Runs the SetUp mode.
Patient Test(Normal Test)
Runs the normal
measurement mode.
SelexOn .11
Power Supply
Meter Power Supply
1. Check that the "Power Switch" is Off.
2. Plug the power plug into the wall outlet.
3. Connect the "External
Power Adapter" to the
"Power Adapter Port"
on the back of the
SelexOn meter.
4. Flip the
"Power Switch" 'ON'.
5. Briefly press the
"Power Button" on
top of the meter.
6. After the system
initialization, the Main
Menu appears.
SelexOn .10
Quick Test
Runs the quick
measurement mode.

Code Registration
Step 3
Hold the label until the RFID information appears.
When the RFID code registration succeeds, the screen below appears.
Confirm if the "Marker", "Code" and "Exp. Date" information on the RFID
label of the strip box match with the RFID information displayed on the
LCD.
If they do not match, rerun the code registration. If the problem persists,
contact the nearest dealer.
<NOTE>
Please refer to 'Troubleshooting' if an error message appears.
<CAUTION!>
Ensure that the RFID code is registered when using a new strip box.
SelexOn .13
Code Registration
RFID Code Registration
The RFID must be registered prior to use when performing a test with a
new strip.
The RFID code needs to be registered once prior to use of a new strip
box.
Step1
In 'SetUp' mode, press the 'RFID' icon in order to run the RFID commu-
nications.
Step2
Place the RFID label of the strip box onto the "RFID Reader" on top of
the meter.
SelexOn .12

Patient Test (Normal Measurement)
Step 3
Take one strip out of the strip storage box.
The test strip must be used immediately after opening the pouch.
<CAUTION!>
Avoid any foreign substances contaminating the strip code label, blood
inlet and measuring window.
Contaminants may cause an error in the results.
Step 4
Hold the strip handle and insert the strip into the strip insertion port on
the left side of the meter.
Push the strip to the end.
SelexOn .15
Patient Test (Normal Measurement)
Step 1
Press 'Patient Test' on the Main Menu.
Step 2
A screen to insert a strip appears.
SelexOn .14
Strip Handle
Strip Code
Blood Inlet
Measuring Window

Patient Test (Normal Measurement)
Step 7
When the LCD instructs to apply sample, inject 100 ul of the sample into
the blood inlet by using a pipette. Press 'OK'. (①->②->③)
Step 8
The measurement runs automatically and the measurement time is dis-
played on the LCD.
3
1
2
SelexOn .17
Patient Test (Normal Measurement)
Step 5
The strip marker and code are displayed on the LCD.
Confirm if the marker and code information on the RFID label of the strip
box match with those on the screen.
When the strip is recognized, the meter automatically runs 'System
check'.
Step 6
When the 'System check' is complete, the meter automatically runs
'Heating'.
SelexOn .16

Quick Test (Quick Measurement)
Step 1
Take one test strip out of the strip storage box.
The test strip must be used immediately after opening the pouch.
<CAUTION!>
Avoid any foreign substances contaminating the strip code label, blood
inlet and measuring window.
Contaminants may cause an error in the results.
Step 2
Inject 100 ul of whole blood into the blood inlet on the strip by using a
pipette.
SelexOn .19
Patient Test (Normal Measurement)
Step 9
When the measurement is complete, the results appear on the LCD.
Remove the strip.
The results are automatically saved. (Please refer to 'Device Settings'
for changing the settings.)
Press 'Delete' to delete the results.
Press 'Print' to print the results on the 'SelexOn Printer'.
Press or to return to the Main Menu.
<NOTE>
If the results for CK-MB are displayed with an inequality sign such as '>
40 ng/mL' or '< 3 ng/mL', the results are out of the measurement range.
Please refer to the strip instruction for the measurement range and
Cutoff concentration.
Single Strip
Triple Strip
SelexOn .18
Strip Handle
Strip Code
Blood Inlet
Measuring Window

Quick Test (Quick Measurement)Quick Test (Quick Measurement)
Step 3
Press'Quick Test' to display the timer selection screen.
SelexOn .20 SelexOn .21
Icon Description
10 Min Select if the strip reaction time is 10 minutes
Select to proceed to the next step without
setting the timer
20 Min Select if the strip reaction time is 20 minutes
<NOTE>
Select an appropriate timer after confirming the reaction time on the
strip manual.
If the timer is selected, the remaining time is displayed in the 'Remaining
Time' field. When the time is up, the next step is automatically executed.
If 'SKIP' is pressed, the timer stops and the next step is executed.
<CAUTION!>
You must proceed to the next step after the reaction time specified in
the strip manual is passed by using the timer.
SKIP

Quick Test (Quick Measurement)
Step 6
The strip marker and code are displayed on the LCD.
Confirm if the marker and code information on the RFID label of the strip
box match with those on the screen.
The measurement will automatically start.
Step 7
When the measurement is complete, the results appear on the LCD.
Remove the strip.
The results are automatically saved. (Please refer to 'Device Settings'
for changing the settings.)
Press 'Delete' to delete the results.
Press 'Print' to print the results on the 'SelexOn Printer'.
Press 'Continue' to return to Step 4 and to measure another strip.
Press or to return to the Main Menu.
SelexOn .23
Quick Test (Quick Measurement)
Step 4
A screen to insert a strip appears.
Step 5
Hold the strip handle and insert the strip into the strip insertion port on
the left side of the meter.
Push the strip to the end.
SelexOn .22

Memory
Press ''Memory’ on the Main Menu and press ''Patient’ in order to view
the result list.
The user can view and manage the results.
Up to 1000 measurements are saved.
The latest results appear at the top of the list.
By using the ▲/▼ icons, the previous or next result can be viewed.
SelexOn .25
Quick Test (Quick Measurement)
<NOTE>
If the results for CK-MB are displayed with an inequality sign such as '>
40 ng/mL' or '< 3 ng/mL‘, the results are out of the measurement range.
Please refer to the strip instruction for the measurement range and
Cutoff concentration.
Single Strip
Triple Strip
SelexOn .24

Memory
Press each icon in order to sort the data
accordingly.
Displays the current page / all pages.
Selects the results. Moves the page.
SelexOn .26
Icon Function
Print Prints the selected results on the SelexOn Printer.
Del Deletes the selected results.
All Select Selects all results on the current page.
Displays the test type.
[P]: Patient Test / [Q]: Quick Test
Memory
Press 'Memory' on the Main Menu and press 'QC' in order to view the
QC result list.
Press 'Control Solution' in order to view the Control Solution Test
results.
Up to 1000 results can be saved.
The latest results appear at the top of the list.
By using the ▲/▼ icons, the previous or next result can be viewed.
SelexOn .27

Memory
Press each icon in order to sort the data
accordingly.
Displays the current page / all pages.
Selects the results. Moves the page.
SelexOn .28
Icon Function
Print Prints the selected results on the SelexOn Printer.
Del Deletes the selected results.
All Select Selects all results on the current page.
Memory
Press 'Memory' on the Main Menu and press 'QC' in order to view the
QC result list.
Press 'Standard Strip' in order to view the Standard Strip Test results.
Up to 1000 results can be saved.
The latest results appear at the top of the list.
By using the ▲/▼ icons, the previous or next result can be viewed.
SelexOn .29

QC Test
Meter Quality Control Management
Please inspect if the SelexOn meter operates properly by using the
standard strip.
Standard Strip
-SelexOn Standard Strip LOW : Standard1
-SelexOn Standard Strip HIGH : Standard2
Storage
-Store the standard strip in its container.
-Avoid direct sunlight.
-Store the standard strip between 10 - 35℃(50 - 95℉).
-Store the standard strip between 10% - 85% humidity.
-Since a standard strip damaged from external shock may affect the
results, safely store the standard strip.
<CAUTION!>
Do not use an expired standard strip.
Do not use a standard strip damaged due to external shock, scratch, or
contamination.
SelexOn .31
Memory
Press each icon in order to sort the data
accordingly.
Displays the current page / all pages.
Selects the results. Moves the page.
SelexOn .30
Icon Function
Print Prints the selected results on the SelexOn Printer.
Del Deletes the selected results.
All Select Selects all results on the current page.
1
[ 1]

QC Test
How to use the standard strip
Step 1
Press 'QC Test' on the Main Menu.
Step 2
Press 'Standard Strip Test'.
SelexOn .33
QC Test
When to test the standard strip
-Prior to the sample measurement
-When the results are deemed to be inaccurate
-When the QC alarm appears (Weekly, Monthly)
<NOTE>
Store the standard strip in its container when it is not in use.
(It may be deformed due to direct sunlight or other sources of light.)
SelexOn .32

QC Test
Step 5
The results are displayed.
- PASS: indicates that the meter operates properly.
- FAIL: indicates that the meter may be used but the results may be
inaccurate.
Please rerun the QC test if FAIL appears. If FAIL persists, stop using
the meter and contact your local representative for technical support.
Step 6
After completing the test, remove the standard strip from the meter.
Store the standard strip in its storage container while avoiding direct
sunlight.
SelexOn .35
QC Test
Step 3
Select the level of the standard strip.
- LOW : Standard1
- HIGH : Standard2
Step 4
Insert the standard strip of the relevant level.
Push the strip to the end.
If an RFID is required, register the RFID tag on the standard strip storage
container.
SelexOn .34

QC Test
How to use the control solution
Step 1
Press 'QC Test' on the Main Menu.
Step 2
Press 'Control Solution Test'
SelexOn .37
QC Test
Strip Quality Control Management
SelexOn Control Solution verifies the accuracy of the SelexOn test
strip.
Control Solution
The control solution is a solution that verifies the accuracy of the test
strip.
For details regarding the control solution, please refer to the manual
provided with the control solution.
When to run the control solution test
- Prior to the sample measurement
- When the results are deemed to be inaccurate
- When the QC alarm appears (Weekly, Monthly)
<CAUTION!>
Do not reuse the strip that was used for the control solution test.
Do not use an expired control solution.
<NOTE>
For details regarding the control solution, please refer to the control
solution manual.
SelexOn .36