Infopia SelexOn Manuel utilisateur
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
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