FS-301 Introduction
FS-301 Introduction
Introduction
Analyzer
Introductio
n
Structure Introduction
Test by original tube , puncture tube to get sample
Convenient and fast touch screen
Buffer
chamber
Reagent
Automatic cleaning of card
mixing cup chamber
Consumables door
Preset emergency
4 projects, 40 samples on Waste card collection to
position and
the machine at the same prevent biological
protective cover
time contamination
Accessories Introduction
Sample rack (use 2ml blood collection tube)
Instrument
Product name
setting
Dry Fluorescence Immunoassay
Analyzer
Light source
Excitation
LED
Center wavelength λ0=470nm
spectrum
( Model : FS-301 ) Receiving Center wavelength λ1=525nm
Methodology Fluorescence immunoassay spectrum
Detection channel 20 detection channels
Display system 12-inch touch color screen
Sample tube Original blood collection tube Software system Linux operation system
Single sampling Results
40 samples 20,000 results can be stored
amount management
Multi-item test simultaneously, fully Temperature The incubation and reaction zone includes a
automatic operation mode: automatic Control System temperature control system
Work mode shaking of blood collection tube, get
sample by puncture, mix, drop, incubate, Support built-in laser scanner and external
Scan system
detect, discard the card scanner
Printing system External USB printer
Emergency position Include emergency position Communication
USB interface, serial port, Ethernet interface
hardware
Support test reagent Support LIS connection, computer
4 kinds Communication
cards simultaneously connection, external scanner connection,
support
external printer connection
Test speed 80 tests/hour
Power input 3P power port
Size 700×600×500mm(L×W×H)
Weight About 70kg
Reagent
Precautions
Reagent packaging(old
Remove the packing)
protective sleeve of Package specification:
the soft rubber 50 persons/bag
plug 100 persons/box
ID chip: 1/box
Buffer: 2 bottles/box
Package specification:
25 persons/bag
100 persons/box
ID chip: 1/box The baffle
Buffer: 4 bottles/box spring is
too tight.
Desiccant
Note: don’t insert in the wrong direction. scattering
Reagent Parameters
Sample Type and Reaction Reference
Test Item Detection Range Clinical Significance
Sample Volume Time Range
0.1~0.5 ng/mL: Local bacterial infection, early bacterial infection
whole blood:75 µL or viral infection; 0.5~2 ng/mL: It is likely to be systemic bacterial
PCT 15 min 0.1~100 ng/mL 0~0.5 ng/mL infection; 2~10 ng/mL: Systemic bacterial infection (sepsis); >10
serum/plasma:50 µL
ng/mL: Severe sepsis or septic shock ;
CRP: CRP: >10 mg/L: Possible bacterial or viral infection ;
whole blood:8.5µL 0~10 mg/L hs-CRP: 1~3 mg/L: Moderate risk of cardiovascular disease ,
hs-CRP + CRP 3 min 0.5~200 mg/L
serum/plasma:5µL hs-CRP: 3~10 mg/L: High risk of cardiovascular disease; >10 mg/L: Acute
0~1 mg/L inflammation; Newborn: >2 mg/L: Acute inflammation.
0.5~1.5 ng/mL: Low risk of thrombosis; 1.5~3 ng/mL: moderate
whole blood:15µL
D-Dimer 3 min 0.1~10 mg/L 0~0.5 mg/L risk; 3~5 ng/mL: High risk; >5 ng/mL: High risk (increased
plasma:10µL
mortality)
Whole bllod:75µL >450 ng/L: It indicates the risk of heart failure, and it should be
NT-proBNP 15 min 18~35000 ng/L 0~300 ng/L
Serum/plasma:75µL judged according to the patient's age and other factors
Whole blood:75µL
cTnI 15 min 0.03~50 ng/mL 0~0.3 ng/mL >0.3ng/mL: Indicating the risk of myocardial infarction
Serum/plasma:75µL
Whole blood:75µL
Myo 15 min 2.4~400 ng/mL 0~58 ng/mL >58ng/mL: Indicating the risk of myocardial infarction
Serum/plasma:50µL
Whole blood:75µL
CK-MB 15 min 0.32~80 ng/mL 0~5 ng/mL >5ng/mL: Indicating the risk of myocardial infarction
Serum/plasma:70µL
cTnI 0.1-50ng/mL
cTnI/Myo/CK- Whole blood:75µL Same as each
15 min CK-MB 0.3-100ng/mL Same as each item
MB Serum/plasma:75µL item
Myo 2-400ng/mL
Storage Conditions
Installation Procedure
Unpackaging and
Communication Layout preparation
check
Unpackage
Installation Procedure
Check
Installation Procedure
Layout
Installation Procedure
Preparation
Installation Procedure
Reagent
( old )
Installation Procedure
Reagent ( new
)
Installation procedure
Training
Installation procedure
Add
consumables
Installation procedure
Query
result
Operation procedure of QC
2. Click 【 Start 】 button , apply for QC test
1. 【 Function 】 - 【 QC 】 - 【 QC gather 】 -
Setting : sample type : QC - sample amount
【 Add 】
- item type ( QC information ) - QC lot
Setting : QC lot number- validity time-
number – QC level
item - level ( 1/2/3 ) - target value -
Click 【 confirm 】 - 【 add 】 - 【 start 】, start QC
upper - lower
test
Operation procedure of QC
Four Note: Pay attention to whether the blood sample volume of the
blood collection tube is sufficient
Component
s
Control——Slave control board
Cleaning solution
Slave control board and buffer
(2.5 mL)
deionized water
and sample
(250μL)
Core Board
Expansion Board
Main Control Board
Expansion Board
Core Board
NB module
Touch screen Power ( 1
2V )
cable
Fluorescent
USB line
Signal line
Serial port
Main board
battery ( CR
Network 1220 )
port
CPU
Touch Screen Connection
Touch screen
cable Signal line
Fluorescent
line
Autosampler Unit
The micro switch
Function:
1. Detect whether the longitudinal sample
injection tube rack is pushed to the position,
and give a signal to the longitudinal sample
injection to reset it
2. Give the lateral injection a signal to work
Autosampler Unit
Shaking Z
limit position
optocoupler
Shaking Y limit
position optocoupler
Shaking Z initial
position
optocoupler Shaking Y initial
position optocoupler
Positive side Reverse side Lateral side
Autosampler Unit
Test tube clamping optocoupler
optocoupler checking
whether sample tubes exist
Function:
1. optocoupler checking whether
sample tubes exist : Determine
whether there is a test tube. If
there is a test tube, give the claw a
ready instruction.
2. Test tube clamping optocoupler:
Determine whether the tube is
pinched.
Consumables Unit
Reagent stock Buffer stock
Reagent stock Y motor
Reagent stock Y motor
initial optocoupler
Consumables Unit
Card feeding component module
trumpet
Card feeding
initial
optocoupler
Sampling Unit
Z Sampling motor
initial optocoupler
Sampling belt
Isolation pool
Function: 1. Blow bubbles.
2. Isolate samples to prevent
contamination.
Injection
Waste liquid pump Function: inhale and exhale Negative pressure tank
Function: To provide power system fluid with sample and Function: Collect and
for discharging waste liquid buffer by up and down motion store waste liquid
Reaction Platform Unit
Discarding card
component
AD acquisition
board
Restoration
optocoupler
Counter
optocoupler
Light source
acquisition initial
position optocoupler
Blue light collects T/C values and red light reads bar codes
Temperature Control Unit
Hardware:
phillips screwdriver, hexagon screwdriver(No. 3), tweezers,
cutting pliers, flat pliers
Software:
single instruction, compound instruction, parameter setting,
other functional tests
Accessories:
optocoupler (4 kinds), screw (3 kinds), swab, filter, two-way valve,
cable tie, adhesive buckle
Fault
Modularizatio
n Analysis
Autosampler
Unit
Autosampler Unit
microswitch
Phenomenon 2: Shaking claw keep walking and do not stop with abnormal
sound.
Analysis 1: The limit position optocoupler of the shaking Y motor is
broken.
Analysis 2: The optocoupler baffle is too short and the optical coupler
cannot sense.
Analysis V: The reagent cards in the old reagent card box are
disordered, which causes that the card cannot be pushed or cannot
be pushed.
Analysis VI: Push the empty card, the software setting is abnormal
with the actual placement, or the spring is not elastic enough to
spring up.
Analysis VII: The black rubber plug is forgot to remove , which is
stuck between the bell mouth and the inlet
Analysis VIII: Abnormal installation of card feeding components
Analysis IX: The card feeding push block is too long, so it is blocked
by screws and cannot be reset.
Analysis X: The limit screw does not have a sleeve, resulting in
excessive height. Or too low after casing.
Consumable Unit
Initial optocoupler of reagent
reagent stock Y motor stock Y
motor
V1 Mixing cup
Swab waste liquid V11
0 waste liquid
V Negative
filter Isolation pool 1
pressure
swab mixing cup tank
The reagent
card has
hemolysis
Analysis:
1. Valve 10 or valve 11 is blocked, or the valve is burnt
2. The bottom of the mixing cup is blocked by the debris
Hemolysis of the test tube cap, causing the water cannot be drained
Waveform
recognition
Principle
During detection, the object to be detected in the
sample forms an immune complex with the
fluorescently labeled antibody, and undergoes a
chromatographic process and solidifies in the
detection area and quality control area,
respectively. When the reagent card is transported Photoelectric converter
to the detection area, the LED blue light source of
the analyzer shines to the detection area of the Light source
reagent card and the fluorescent immune complex
Fluorescent signal
in the quality control area to excite the
fluorescence to emit light, the light waves emitted
by the fluorescent matter are collected by the
signal acquisition board and converted into
electrical signals, the strength of the electrical
signal depends on the concentration and number
of fluorescent molecules, analyzer calculates the
concentration of the analyte in the sample to be
measured according to the strength of the
feedback signal.
Value
The final concentration value is determined according to the functional relationship between the
T/C value and the concentration
Waveform recognition
1. CRP waveform
CRP waveform
consists of two
waves, C wave and T
wave, T wave in the
front and C wave in
the back. The peak T
range of T wave is
200~400, and the C
peak range of C wave
is 400~600.
Waveform recognition
2. PCT waveform
3 、 Waveform of
cTnl/CK-MB/MYO
Waveform of cTnl/CK-
MB/MYO is four-segment
waves, one C wave and
three T waves, the C
wave in the front and the
T wave in the back. The T-ck
peak range of C wave is
0~150, the peak range T-CTnI
of T-CK wave is C T-MYO
150~300, the peak
range of T-CTnl wave is
300~450, and the peak
range of T-MYO wave is
450~600.
Waveform recognition
4 、 NT-proBNP
waveform
NT-proBNP
waveform consists
of two waves, C
wave and T wave, C
wave in the front
and T wave in the
back. The peak T
range of C wave is C
200~400, and the
peak range of T
wave is 400~600.
Waveform recognition
5 、 cTnl
waveform
cTnl waveform
consists of two
waves, C wave and T
wave, C wave in the
front and T wave in T
the back. The peak
range of C wave is
C
200~400, and the
peak range of T wave
is 400~600.
Waveform recognition
6 、 DD
waveform
DD waveform
consists of two
waves, C wave and
T wave, C wave in T
the front and T wave C
in the back. The
peak range of C
wave is 200~400,
and the peak range
of T wave is
400~600.
Waveform position offset
The T and C lines of the waveform have corresponding value intervals (segment points). Within the corresponding inte
CRP as an example, T2 peak interval: 201-400, C peak interval: 401-580), take out the abscissa of maximum fluorescen
the peak position of the T line and the C line. If the waveform position shift range is too large, the T peak and C peak a
out of the value range, which will lead to wrong T peak and C peak value in the original value range, and the result of T
wrong. The concentration of the fluorescence value inversely calculated from the wrong T2/C and calibration curve will
The range and width of the T line and C line of FS-301 items are different (see the appendix for the value range). There
avoid abnormal results due to the offset of the waveforms of other items, the peak position needs to be controlled with
range. Taking the CRP project as an example, the two peak positions should be controlled at 300±20(T2) and 500±20(C
Schematic
diagram