Đgfok
Đgfok
1805800
Warning: Indicates when the user ignores this symbol and misuses the instrument,
casualties, serious injury or serious property loss may be caused to the user.
Caution: Indicates when the user ignores this symbol and misuses the instrument, injury,
wrong output results or property loss may be caused to the user.
Representation
Linear Chemicals, S.L.U. reserves the right for the final explanation of the User’s Manual.
The illustrations in the Manual give typical examples only and may not be completely consistent with
the actual displaying on the product. Take practicality as standard. Never use the illustrations for other
purposes.
Without written consent of Linear Chemicals, S.L.U., no individual or organization may duplicate,
modify, or translate the contents of the Manual.
Linear Chemicals, S.L.U. will be responsible for the safety, reliability, and performance of the product
only when all the following requirements are met:
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Caution:
● The instrument must be used by medical examination professionals or trained doctors, nurses, or
laboratory technicians.
Warning
● If no satisfying maintenance/repair plan is achieved, the instrument may fail abnormally and may
endanger personal health.
● Be sure to use the instrument in the conditions specified in the Manual. Otherwise, it may cause the
instrument’s failure to function normally and unreliable measurement results, damage the
components of the instrument, and endanger personal safety.
Revision
Rev. 02 · 2023
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
This way up
The symbol means the instrument packaged should not be
upended at any time.
Keep dry.
Indicates a medical device that needs to be protected from
moisture
Do Not Roll
Do not roll the transport package.
Biological risks
Indicates that there are potential biological risks associated with
the medical device.
Caution
Indicates that caution is necessary when operating the device or
control close to where the symbol is placed, or that the current
situation needs operator awareness or operator action in order to
avoid undesirable consequences.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Equipotential
Manufacturer
Indicates the medical device manufacturer.
CE mark
Indicates that the device complies with the EU 2017/746.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Warning: Read the following precautions carefully before using the instrument.
⚫ In case of peculiar smell, smog, or abnormal noise during use, immediately turn off
the power and remove the plug from the socket, and immediately apply for
inspection with the dealer or our agent. If you continue to use the instrument in
that case, fire, electric shock, or casualties may be caused.
⚫ Prevent blood, reagent, or metal pieces, such as staple, etc., from entering the
instrument. Otherwise, short circuit or fire may be caused. In case of abnormality,
immediately turn off the power and unplug the plug from the socket, and
immediately apply for inspection with the dealer or our agent.
⚫ Do not touch the electronic circuit in the instrument. Particularly, touch with wet
hand may cause electric shock.
⚫ Wear rubber gloves and use the specified tools, parts and components when
maintaining and inspecting the instrument. When the operation is ended, wash
hands with disinfectant. Otherwise, the part of skin in contact with blood may be
infected or scalded or get an electric shock.
⚫ Be very careful when treating samples. Be sure to wear rubber gloves, otherwise
infection may be caused. In case the sample enters the eye or wound, immediately
rinse with plenty of clear water and receive examination by a doctor.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Table of Contents
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Chapter 1 Introduction
1.1 Introduction
1.1.1 Product Name: Automatic Clinical Chemistry Analyzer
1.1.3 Features
LIDA 800 is a discrete Auto chemistry analyzer that tests sample data with the colorimetry,
turbidimetry, ion electrode (optional) method, etc. for quantitative analysis of chemical composition of
clinical samples of blood serum, blood plasma, urine, cerebrospinal fluid, etc.
⚫ Auto, random, optional, discrete, priority given to emergency treatment, and fully open analysis
parameters and reagents.
⚫ Up to 60 colorimetric items and 3 ISE items, i.e., K, Na and Cl (optional), in progress at the same
time.
⚫ The analysis methods include the end-point method, two-point method, kinetics method, etc.
Single/dual-wavelength test and three/four-reagent test support.
⚫ One point calibration, two-point calibration, multi-point linear calibration or nonlinear calibration.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Figure 1-4 Serial Port and Power Jack on the Back of Analysis Section
The serial port, network port, and power jack on the back of the analysis section are shown in the
figure below.
Figure 1-5 Serial Port, Network Port, and Power Jack on the Back of Analysis Section
◼ Serial Port: Connecting the data cable, through which the analysis section is communicated with
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
The sample probe assay is mainly used to analyze the collection and delivery of samples under
analysis and is composed of a sample probe, a sample probe rocker arm, a sample probe drive shaft, a
sample syringe, the corresponding liquid path, etc.
Functions of Sample Probe Assay
◼ Sample Collection: The sample probe assay is mainly used to absorb quantitative sample from the
sample test tube and deliver the sample to the test cuvette, with the sample volume of:
➢ For biochemical items: 2μL~30μL, increasing progressively by 0.1μL.
➢ For electrolyte items: 60μL (blood serum or blood plasma), 200μL (diluted urine).
◼ Cleaning of Sample Probe: The sample probe assay includes a cleaning system that cleans the
outer wall of the probe in the “oblique spray” way, cleans the inner wall of the probe with high
pressure water flow, and supports intensive cleaning with acid and alkali.
◼ Anti-collision Test: The sample probe has the horizontal and vertical collision protection function.
When it encounters an obstacle in the horizontal or vertical direction, the anti-collision function
will be started to prevent the sample probe from being damaged.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
◼ Liquid Level Detection and Tracking Depending on Volume: The sample probe can detect the liquid
level automatically and determine the depth of the sample probe below the liquid level according
to the volume of liquid absorbed to realize the function of tracking depending on volume.
◼ Plugging function: The sample probe has a probe blocking function. When the probe is detected,
the sample loading will stop, and two second of cleaning, Stop the addition of the sample three
times in a row, and invalidate the test of the sample.
Structure of Reagent Probe Assay
LIDA 800 includes two reagent probe assays - R1 and R2 which have exactly the same structure.
They are mainly used to collect and deliver reagents. A reagent probe assay is composed of a reagent
probe, a reagent probe rocker arm, a reagent probe drive shaft, a reagent syringe, the corresponding
liquid path, etc.
Functions of Reagent Probe Assay
◼ Reagent Collection: The reagent probe assay is mainly used to absorb quantitative reagent from
the reagent vial and deliver the reagent to the test cuvette. The reagent probe assay moves
repeatedly in the order of reagent vial, reaction tray, and reagent probe cleaning tank to complete
reagent adding, in which,
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
➢ Probe R1 is used to absorb Reagent 1(3), with the volume of 20μL~350μL, increasing
progressively by 0.5μL.
➢ Probe R2 is used to absorb Reagent. 2(4), with the volume of 20μL~350μL, increasing
progressively by 0.5μL.
◼ Cleaning of Reagent Probe: The reagent probe assay includes a cleaning system that cleans the
outer wall of the probe in the “oblique spray” way, cleans the inner wall of the probe with high
pressure water flow, and supports intensive cleaning with acid and alkali.
◼ Anti-collision Test: The reagent probe has the horizontal and vertical collision protection function.
When it encounters an obstacle in the horizontal or vertical direction, the anti-collision function
will be started to prevent the reagent probe from being damaged.
◼ Liquid Level Detection and Tracking Depending on Volume: The reagent probe can detect the liquid
level automatically and determine the depth of the reagent probe below the liquid level according
to the volume of liquid absorbed to realize the function of tracking depending on volume.
The sample tray assay mainly includes a sample tray and its drive system, a sample pot, a sample
barcode scanner, etc.
Functions of Sample Tray Assay
◼ The sample tray is a support where the sample test tubes are carried. It can rotate
counterclockwise according to the set position when it is driven by its drive system. During the
work, each sample test tube rotates to the sampling position of the sample probe to wait for the
sample probe to absorb the sample.
Caution: To add sample during the operation of the whole machine, be sure to stop the
rotation of the sample tray first, and do not add sample to the rail where the
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
sample probe moves back and forth, otherwise, the sample probe may be
collided.
◼ Sample containers, such as original blood collection tubes, centrifuge tubes, plastic test tubes,
small sample cups, etc., can be put on the sample tray. Sample containers with the following
specifications are compatible with the sample tray:
➢ Standard Test Tubes: Ø12×68.5, Ø12×99, Ø12.7×75, Ø12.7×100, Ø13×75, Ø13×100.
➢ Original Blood Collection Tubes: Ø12×68.5, Ø12×99, Ø12.7×75, Ø12.7×100, Ø13×75,
Ø13×100.
➢ Small Sample Cups: Ø10×37, Ø12×37
Minimal Volume of Sample:
➢ The liquid level of samples (serum) should be higher than 5mm.
◼ The body of the sample tray can be picked and placed freely for you to replace the whole tray of
samples easily.
➢ Pick:
Inner Tray: Loosen the two fixing screws on the sample tray, hold the handles of the tray, and
lift and take it out vertically.
Outer Tray: Hold the handles of the tray and directly lift and take out the tray.
➢ Place:
Inner Tray: Hold the handles of the sample tray, aim the pin hole on the tray at the pin position
on the tray base, place down the tray vertically, and tighten the two fixing
screws on the tray.
Outer Tray: Hold the handles of the tray and directly place the tray aiming at the pin.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
◼ The sample tray assay can be used with the sample barcode scanner (optional).
➢ The sample barcode has 3~27 digits, supports the NCCLS standard, and is compatible with
various barcode application environments.
➢ You can set the format of sample barcode information and select a barcode system.
➢ When the fixed barcode scanning fails, the handheld barcode identification system can be
used for supplementary scanning or manual barcode input can be used to perfect the
scanning of sample barcode.
Structure of Reagent Tray Assay
The reagent tray assay mainly includes a reagent tray and its drive system, a reagent pot, a reagent
refrigeration system, a reagent barcode scanner, etc.
Functions of Reagent Tray Assay
◼ The reagent tray is a support where the reagent vials are carried. Its drive system can rotate each
reagent vial to the sampling position of the reagent probe according to the system setting to wait
for reagent absorption.
◼ The reagent refrigeration system is used to guarantee the reagent in the reagent vial is always
stored in the low temperature environment to keep the reagent stable and reduce volatilization.
◼ One Reagent Disk has one Reagent Position circle, which have 50 reagent positions, each reagent
position can use 20mL Clonatest reagent bottle, 40mL Clonatest reagent bottle and 62mL
Clonatest reagent bottle, also it can be compatible with Hitachi analyzer’s 60-70mL Reagent
bottles.
◼ This Analyzer has R1 and R2 reagent disk, which has 100 reagent positions in total. Each reagent
disk has 50 reagent position, Reagent Pos. 48(W), 49(D1), 50(D2) are separately placed with De-
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ionized water, Strong Washing solution and preservative liquid (Incubation Bath Liquid).
◼ Reagent Tray R1 is specific to Reagents R1 and R3 only; Reagent Tray R2 is specific to Reagents R2
and R4 only.
◼ The reagent refrigeration system can provide 24-hour interrupted refrigeration, with the storage
temperature of 2~10℃.
◼ The body of the reagent tray can be picked and placed freely for you to replace the whole tray of
reagents easily.
➢ Pick: Loosen the two fixing screws on the reagent tray, hold the handles of the tray, and lift
and take it out vertically.
➢ Place: Hold the handles of the reagent tray, aim the pin hole on the tray at the pin position
on the tray base, place down the tray vertically, and tighten the two fixing screws on the tray.
◼ The reagent tray assay uses a reagent barcode scanner.
➢ The reagent barcode has 10~30 digits, supports the NCCLS standard, and is compatible with
various barcode application environments.
➢ You can set the format of reagent barcode information and select a barcode system.
➢ When the fixed barcode scanning fails, the handheld barcode identification system can be
used for supplementary scanning or manual barcode input can be used to perfect the
scanning of reagent barcode.
1.2.1.2 Mixing and Reaction System
The mixing and reaction system is used to promote the full mixing of the sample and reagent and
provides a constant temperature reaction environment. The system includes a mixer assay, a reaction
tray assay, etc.
Structure of Mixer Assay
LIDA 800 has two mixer assays, i.e., M1 and M2, which have the same structure. A mixer assay is
mainly composed of a mixer, a rocker arm, and a drive shaft.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
When the mixing is finished, the mixer automatically moves to the mixer cleaning pool for cleaning to
prevent carrying contaminants.
Functions of Mixer Assay
◼ For a single-reagent item test, M1 begins to mix the contents after the sample is added, and M2
does not move.
◼ For a double-reagent item test, M1 begins to mix the contents after the sample is added, and M2
begins to mix the contents after reagent 2 is added.
◼ For a three-reagent item test, M1 begins to mix the contents after the sample is added, and M2
begins to mix the contents after reagents 2-3 are added.
◼ For a four-reagent item test, M1 begins to mix the contents after the sample is added, and M2
begins to mix the contents after reagents 2-4 are added.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
◼ The liquid pump and syringe assay in the liquid path system provide driving force for liquid delivery.
◼ The valves in the liquid path system are mainly used to control the direction of liquid or air.
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Cleaning of Test 8-stage automatic cleaning, preheating of cleanser, warning of minimal volume
cuvettes of cleanser
Light Source Halogen lamp
Way of Light
Flat-field concave grating, in the rear light splitting way
Splitting
Wavelength 13 wavelengths, precision ±2nm
Detector Photodiode array
Linear Range 0~2.5A
Input
Branded PC, English versions of multimedia analysis and control software
Equipment
Output
Wide-screen LCD, printer
Equipment
Connector RS232 serial port, Ethernet port
Connected to the specific water machine, waste liquids of different
Tube Connector
concentrations discharged separately, with the minimal volume warning function
Power Supply AC 220V, 50Hz
Peak Water
≤ 35L/H
Consumption
Working
Temperature: 10℃~30℃; RH: ≤85%, no condensation
Environment
Storage Well-ventilated environment with temperature of 0℃~40℃, RH ≤ 85%, without
Environment corrosive gas
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
2) Take out the accessories and check the objects against the accessories list. If any object is missing,
immediately inform Linear Chemicals, S.L.U. After Service or the Official Distributor.
Caution: The accessories packed should be consistent with the packing list. If any
component is missing or damaged or inconsistent with the packing list, please
contact the retailer.
Caution: Keep the packing case for packing before long distance transport. The
instrument must be put on a level operation desk, rather than angular surface.
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Caution:
◆ After installation, try to avoid frequent movement. To move the instrument, use a
stable cart. The angle of inclination should not be greater than 15° when the instrument
is being moved.
◆ It must be installed and moved by authorized professionals.
◆ Please dispose the waste liquid discharged by the system in accordance with the
local standards.
Warning:
◆ The AC power supply must be grounded properly (zero to earth voltage< 5 V).
◆ Check that the input voltage complies with the requirement of the instrument. The
AC power supply must be stable. Sharing a power supply with high power electrical
appliances is prohibited. It’d be better to be equipped with a regulated power supply.
◆ Before connecting the electric cable, check that the switch of the instrument is off.
◆ In case of smog, peculiar smell, or abnormal noise, immediately turn off the power
and contact the retailer.
◆ To unplug the electric cable, grasp the plug, rather than the cord.
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Caution:
◆ Be sure to operate the system within the specified range of ambient temperature
and humidity, otherwise the results may not be reliable.
◆ If the ambient temperature and humidity exceed the specified range, please use air
conditioning equipment.
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2.6 Installation
2.6.1 Space Requirement
Please place the analysis section and operation section as shown in the figure below. The gap
between the analysis section and wall must not be less than 0.5m.
Min. 0.5m
Max. 2m
Operation Section
Analysis Section
Min. 0.5m
Min. 0.5m
Min. 0.5m
Water
Machine
水机
Concentration
高浓
Waste Liquid
度废
High
Warning: When connecting the drain tube, do not fold or compress the drain
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tube.
Caution: The high concentration waste liquid outlet joint on the back of the
analysis section must be inserted in place, otherwise the automatic cleaning
system will overflow.
Biohazard: Be sure to wear gloves and work clothes during operation to prevent
infection.
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Warning: Before mounting the sample tray, check that the system is in the
standby mode and the tray has stopped.
Caution: Before the system runs, check that the sample tray cover has been
closed, otherwise the sample probe may be damaged. When placing the tray
cover, make sure the positioning boss clicks into place.
Biohazard: Be sure to wear gloves and work clothes during operation to prevent
infection.
Warning: Before mounting the reagent tray, check that the system is in the
standby mode and the reagent tray has stopped.
Caution: Before the system runs, check that the reagent tray cover has been
closed, otherwise the reagent probe may be damaged. When placing the tray
cover, make sure the positioning boss clicks into place.
Biohazard: Be sure to wear gloves and work clothes during operation to prevent
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infection.
Warning: Before mounting the test tube, check that the system is in the standby
mode and the sample tray has stopped.
Caution: Do not use test tubes of specifications other than specified.
Biohazard: Be sure to wear gloves and work clothes during operation to prevent
infection.
Warning: Before mounting the reagent vial, check that the system is in the
standby mode and the reagent tray has stopped.
Caution: Do not use reagent vials of specifications other than specified.
Biohazard: Be sure to wear gloves and work clothes during operation to prevent
infection.
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Connector
Reagent Pack
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of the analysis section, turn on the computer, and turn on the instrument control software.
◼ Turn off the instrument: Turn off the instrument control software and then turn off the
control switch and power switch of the analysis section of the instrument.
2.7 Correction
Standard can be used to correct the instrument. The instrument needs not to be calibrated for
each test. However, for items requiring calibration, at least one calibration test is needed. The
changes in the system environment may impact the tests to a certain extent, so a calibration test
is suggested each time the machine is switched on to ensure the accuracy of test results.
For the calibration test method, refer to “Chapter 4 Parameter Setup” and “Chapter 7 Tests”.
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Chapter 3 Start
3.1 Precautions before Starting the Machine
Before you start the machine each time, pay attention to the following to ensure the system is
ready:
1) Check the status of the instrument before starting the machine.
◼ Check that the five plate covers on the workbench have been closed.
◼ Check that there is no obstacle in the motion region of the various components on the
workbench.
◼ Check that the deionized water machine has been turned on.
◼ Check that the high concentration waste liquid tank has been emptied and the low
concentration waste liquid tank has been handled in a normal way.
◼ Check that the thermostatic bath liquid of the reagent trays is sufficient (the
thermostatic bath liquid is stored at Position D2 on the two reagent trays).
◼ Check that the minimal volume of cleansers (including the cleanser for test cuvettes,
Position D1 of cleanser in the two reagent trays, and Positions D1 and D2 of cleanser in
the sample tray) is sufficient.
◼ Check that the minimal volume of deionized water for the reagent trays and sample tray
is sufficient.
◼ Check whether sufficient cleanser is placed at the cleanser position on the tabletop.
◼ Check that the sample probe is pollution-free and not bent. If the sample probe is
polluted, wipe it; if the sample probe is bent, replace it.
◼ Check that Reagent Probe 1 is pollution-free and not bent. If Reagent Probe 1 is polluted,
wipe it; if Reagent Probe 1 is bent, replace it.
◼ Check that Reagent Probe 2 is pollution-free and not bent. If Reagent Probe 2 is polluted,
wipe it; if Reagent Probe 2 is bent, replace it.
◼ Check that the reagent mixer is pollution-free and not bent. If the reagent mixer is
polluted, wipe it; if the reagent mixer is bent, replace it.
◼ Check that the sample mixer is pollution-free and not bent. If the sample mixer is
polluted, wipe it; if the sample mixer is bent, replace it.
◼ Check that all tubes are correctly connected.
◼ Check that the serial port (or network port) control cables are properly connected, and
that the connection port is consistent with the setting. The default is COM1.
◼ Check that the electric cables are properly connected.
2) Check whether the printing paper is sufficient and whether they are inserted into place.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Caution: The username of the system administrator is “Admin”, and the initial password
is “888888”. You can change the password freely. Please keep the changed
password in mind!
After login, the system will enter the initialization screen and conduct self-check and initialization
automatically, as shown in the figure:
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
Caution: Each time the power is switched on, it takes 30 minutes for the light source to
become stable. If the test is commenced before the light source becomes
stable, the accuracy of the results may be impacted.
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
◼ Shortcut Button Area: Includes the “Start”, “Pause”, and “Stop” buttons. Click a shortcut
button to operate the system accordingly.
◼ Function Window Area: Displays the values and graphs of the parameters, processes, results,
etc. corresponding to the selected function button.
◼ Prompt and Alarm Message Display Area: Displays alarm, warning, or error messages. Click
the “Search” button to search the details of the alarm, warning, or error messages.
3.5 Help
Function Brief: When you encounter any question during the use of the software, you can find the
information on the instrument in the help file.
Click the Help icon on the main interface to enter the About and Help selection box. Click the “Help”
button, and the help file will pop up, as shown in the figure:
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Input “10” to indicate a 10 times dilution, i.e., 1 part of sample + 9 parts of diluent; input “1”
to indicate no dilution.
6) Sample Volume - Decrement:
◼ Test Sample Volume: The volume of sample to be added during a decrement test. Range: 2-
30μL, increasing progressively by 0.1μL.
◼ Dilution Sample Volume: The volume of original sample used for dilution during a decrement
dilution test. Range: 2-36μL, increasing progressively by 0.1μL.
◼ Dilution Ratio: The dilution ratio of the original sample during a decrement dilution test.
Input “10” to indicate a 10 times dilution, i.e., 1 part of sample + 9 parts of diluent; input “1”
to indicate no dilution.
7) Reagent Volume: Input the volume of reagent used. (Input 0 for a reagent not used.)
8) Method Type: Select End-Point Method, Two-Point Method, or Kinetics Method.
9) Main/Secondary Wavelength: Set the wavelength used according to the instructions of the
reagent. If the single-wavelength test is adopted, set wavelength 1 only, and select None for
wavelength 2. However, in order to eliminate external interference, it is suggested to use the dual-
wavelength test.
10) Blank Test: Select None, Reagent Blank, Sample Blank, or Pre-Blank.
◼ None: The blank value needs not to be reduced.
◼ Reagent Blank: The measurement method is using reagent and sample volumes for normal
tests and substituting the sample with deionized water.
◼ Sample Blank: The measurement method is using reagent and sample volumes for normal
tests and substituting the reagent with deionized water.
◼ Pre-Blank: The pre-blank measurement point should be set. The blank value of the set
measurement point should be reduced from the measurement results.
Caution:
◆ With the end-point method, the absorbance value of the reagent blank test is
reduced; with the two-point method and kinetics method, the variation per
minute of the reagent blank test is reduced.
◆ When Pre-Blank is selected, the start point, and end point shall be in the
corresponding range. Input range for single-reagent tests: 5-59; input range for
double-reagent tests: 72-270; input range for three-reagent tests: 284-743; input
range for four-reagent tests: 815-1013.
11) Measurement Time: To set the start time and end time of measurement respectively. For single-
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reagent items, the range of measurement time is 9-530 seconds; for double-reagent items, 9-324
seconds; for three-reagent items, 9-530 seconds; for four-reagent items, 9-324 seconds. With
respect to the two-point method and kinetics method, the interval between the start time and
end time should not be less than 60 seconds.
12) Calculation Method: Select the corresponding calculation method according to the actual needs.
When the Factor Method is selected, you can input factor values provided in the instructions of
the reagent.
Caution: The signs of the factors of items tested with the kinetics method reflect the
change directions of the curve. If it is downward reaction, the factor is negative,
otherwise the factor is positive.
13) ABS Range: To set the measurement range of absorbance value, with a maximum range of -30000
~ 30000. Input 0 to indicate this judgment is not made.
14) Linear Range: Test range of the instrument or reagent. When the test results exceed the range,
the results are unreliable and should be marked to prompt you for dilution retest, decrement
retest or increment retest. Input 0 to indicate this judgment is not made.
15) Reagent Blank: The valid range of reagent blank. When the reagent blank exceeds the range, the
system will treat the reagent as failure. The unit is 1/10000 absorbance.
16) Linear Limit (Linearity Limit): Effective for the kinetics method only. The system calculates the
linearity in the test period automatically. When the linearity of the reaction curve exceeds the set
range, the results will have the corresponding sign. The setup range of linearity limit is 0-300. The
default is 20. The calculation formula of linear limit is:
◼ Number of test points > 9
Linearity = 100* (Change rate of the first 6 points - Change rate of the last 6 points)/
Change rate of all points
◼ 4 ≤ Number of test points ≤ 8
Linearity = 100* (Change rate of the first 3 points - Change rate of the last 3 points)/
Change rate of all points
17) Substrate Exhaust Limit: Effective for the two-point method and kinetics method only. Some high
concentration (active) samples exhaust the substrate, which makes the reaction no longer a kinetic
method reaction. In order to correctly reflect the determination results, the substrate exhaust
limit (a certain absorbance) needs to be set and such absorbance should be exactly the critical
point between linear zone and nonlinear zone in the reaction curve, i.e., the minimum (the
reaction curve bends downward) or maximum (the reaction curve bends upward) absorbance
value before the substrate is exhausted within the reaction time. The substrate exhaust limit of an
item is closely related to the reagent kit used. The unit is 1/10000 absorbance. The setting 0
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User Manual: LIDA 800 – Automatic Clinical Chemistry Analyzer
indicates no judgment.
◼ No Linear Interval: Number of points with no substrate exhausted in the measurement time
< 3. (The check is started only when the substrate is exhausted.)
◼ No Calculation Interval: Number of points with no substrate exhausted including the delay
time < 3. (The check is started only when there is no linear interval.)
18) Increment Judgment: Increment judgment is a judgment limit in the increment test. When the
absorbance is less than (the reaction curve bends upward) or greater than (the reaction curve
bends downward) the limit after the reaction is ended, the increment test is conducted
automatically.
The input range of increment judgment is -30000 ~ 30000; input 0 to indicate this judgment is not
made.
Caution: Be sure to set the increment sample before setting increment judgment.
19) Decrement Judgment: Decrement judgment is a judgment limit in the decrement test. When the
absorbance is greater than (the reaction curve bends upward) or less than (the reaction curve
bends downward) the limit after the reaction is ended, the decrement test is conducted
automatically.
The input range of decrement judgment is -30000 ~ 30000; input 0 to indicate this judgment is not
made.
Caution: Be sure to set the decrement sample before setting decrement judgment.
20) Unit of Results: To set the unit of test results. The options displayed are the information set in
“System Setup” -> “Data Dictionary” -> “Unit of Results”.
21) Precision of Results: To select the number of decimal places of the results of the items in the
general report to be printed, with a maximum of 3 decimal places.
22) Correction Factor: Linear correction factor of system test results: Result = Measurement result *
Slope K + Intercept B. In general, no correction is needed: K=1, B=0. However, for items tested with
the factor method, the factor can be used to correct the error of the instrument.
23) Prozone Check: Q1, Q2, Q3 and Q4 are the photometric points for prozone check; PC is the
prozone limit; ABS is the absorbance limit for prozone check. The above prozone parameters are
valid only when “Prozone Check” is selected.
The reaction rate method is adopted in the prozone check, that is, the antibody excess reaction
curve can reach balance and the antigen excess reaction curve cannot reach balance in the same period
time. The specific judgment method is as follows:
◼ Set the photometric points for prozone check [Q1], [Q2], [Q3], and [Q4]
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◼ Set the prozone limit [PC] and lower limit of absorbance for prozone check [ABS]
◼ Calculate the PCM value of the sample: PCM = Change slope [Q3, Q4]/Change slope [Q1, Q2].
If PCM > PC, the “Prozone Check Exception” warning sign is given.
◼ Requirements of photometric point input:
Single-reagent items: 16<q1 <q2< q3< q4<= End point of reaction <= 34
Double-reagent items: 63<q1 <q2< q3< q4<= End point of reaction <= 134
Three-reagent items: 180<q1 <q2< q3< q4<= End point of reaction <= 299
Four-reagent items: 227<q1 <q2< q3< q4<= End point of reaction <= 299
◼ The prozone check is no longer conducted in the following two cases:
Absorbance of end point of sample A < abs.lowlimit (upward reaction) or A > abs.lowlimit
(downward reaction)
Absolute value of reactivity of sample R > RCMAX (Absolute value of reactivity of standard of
maximum concentration)
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Caution: The special cleaning consumes the normal test cycle; therefore the testing
speed of the instrument will be lowered. Unless it is necessary, do not set the
special cleaning!
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Click the “Add Standard” button, input the Number, Batch Number and Expiry Date on the screen that
appears, and select OK to save the setting. Add the calibration items included for the standard in turn.
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Specify a standard and click the “Add Item” button. Select Add or the calibration item to be modified
on the screen that appears, input the reference value, and click the “Save” button.
4.3 QC Setup
Function Brief: To set parameters of QC materials used by the system.
Select the QC Setup page as shown in the figure:
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4.3.1 Add QC
Click the “Add QC” button, input the Number, Batch Number and Expiry Date on the screen that appears,
and click OK to save the setting. Add the QC items included for the QC material in turn.
4.3.2 Delete QC
Select the QC material to be deleted from the QC material list and click the “Delete QC” button.
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◼ Westgard Multi-rule QC: Select the QC warning rule for the item from the 7 rules and click
the “OK” button to save the selection.
◼ Cumulative Sum QC: Whether the cumulative sum rule is used or not. Select it to make
cumulative sum rule judgment of the QC material.
◼ Cumulation Rule: To set the QC rule for cumulative sum, such as CS (1.0S:2.7S), in which, 1.0S
is the threshold K that starts cumulative sum calculation, and 2.7S is the QC limit H.
◼ Cumulation Method: For daily QC chart, Real-time Single-point Cumulation means the
cumulative data are the actual results of each test; Daily Mean Cumulation means the
cumulative data are the mean of test results of every day.
◼ Empty Cumulative Sum: After calibration and correction of the out-of-control instrument,
click the “Empty Cumulative Sum” button to restart the cumulative sum QC. After the
cumulative sum is emptied, the current value of cumulative sum is 0.
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Click the “Add Profile” button, input the name and number of the new profile, and click the “OK” button.
Select the items to be included in the profile and click the “Save” button.
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Intercept =0.
◼ Measurement Range: The test range of the ISE item. When the test results exceed this range,
the corresponding results will be marked with the sign A> or A<.
◼ Unit of Results: The unit of results of the ISE item. It cannot be modified.
◼ Precision of Results: The precision of results of the ISE item. It cannot be modified.
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Specify a QC material and click the “Add Item” button. Select Add or the QC item to be modified on the
screen that appears, input the target value and SD, and click the “Save” button.
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◼ Westgard Multi-rule QC: Select the QC warning rule for the item from the 7 rules and click
the “OK” button to save the selection.
◼ Cumulative Sum QC: Whether the cumulative sum rule is used or not. Select it to make
cumulative sum rule judgment of the QC material.
◼ Cumulation Rule: To set the QC rule for cumulative sum, such as CS (1.0S:2.7S), in which, 1.0S
is the threshold K that starts cumulative sum calculation, and 2.7S is the QC limit H.
◼ Cumulation Method: For daily QC chart, Real-time Single-point Cumulation means the
cumulative data are the actual results of each test; Daily Mean Cumulation means the
cumulative data are the mean of test results of every day.
◼ Empty Cumulative Sum: After calibration and correction of the out-of-control instrument,
click the “Empty Cumulative Sum” button to restart cumulative sum QC. After the cumulative
sum is emptied, the current value of cumulative sum is 0.
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◼ Expiry Date of Reagent: The expiry date of the reagent. When the expiry date of the reagent
has passed, the “Reagent Setup” and “Test Status – Reagent Tray” screens will prompt you
with yellow.
◼ Volume Used Each Time: To display the volume of the reagent used in each test of the set
item.
◼ No. of Items Tested with Minimal Volume: The number of items that can be tested with the
minimal volume of reagent calculated according to “Minimal Volume of Reagent” and
“Volume Used Each Time” of reagent item testing.
Caution: Reagent Positions 48(W), 49(D1) and 50(D2) are used for deionized water,
cleanser and thermostatic bath liquid respectively. Other reagents are prohibited.
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◼ Detect the minimal volume of reagent at the selected position: Detect the minimal volume
of reagent at the selected position in the reagent list for the current reagent tray. If no reagent
information is set at this position, it cannot be detected.
◼ Detect the minimal volume of reagent of all set reagents: Detect the minimal volume of all
set reagents in the current reagent tray.
◼ Detect the minimal volume of reagent of set reagents in the specified range: Detect the
minimal volume of set reagents in the specified range in the current reagent tray.
Caution: Before reagent detection, input and save the Vial Type information
corresponding to the reagent positions first. Otherwise, detection of minimal
volume of reagent is impossible.
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◼ Scan all positions: To scan all positions on the current reagent tray.
◼ Scan the specified position range: You can input the start and end reagent positions, and the
system will scan the specified reagent position range. The “Scan the specified position range”
radio must be selected before you can input the start and end positions. When the input is
finished, the end reagent position must be greater than the start reagent position. Scanning
range is Pos. 1-47. Reagent Pos. 48/49/50 are defaulted occupied, cannot been scanned.
Caution: When any position cannot be scanned normally during the scanning of reagent
barcode, view the prompt message at the bottom of the screen to search the
abnormal reagent position and the cause of scanning failure.
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Choose the Reagent Pos. and then click “Priority Use” button, then it will show * for Priority Use column.
If the reagent test Times or Reagent volume is zero, it will further use the same type of reagent on
other reagent position to continue testing.
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Click System Setup in the main menu to enter the System Setup page as shown in Figure 5-1:
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the light source protection function will be activated. To use the machine again, execute the
Awake operation.
◼ Automatic QC Setup: To set the interval of QC. 0 indicates no automatic QC is conducted.
◼ Automatic Calibration Setup: To set the interval of calibration. 0 indicates no automatic
calibration is conducted.
◼ Upper Limit of No. of Dirty Test Cuvettes: To set the maximum number of dirty test cuvettes
when you are prompted to replace the test cuvettes.
◼ Alarm Limit of Minimal Volume of Reagent: To set the minimal volume of reagent when the
reagent tray marks the corresponding reagent as “Reagent Insufficient”.
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function will be activated. In such case, when the number of all photometric points including
the delay time is less than 3, the system will do a retest for the test with the results exceeding
the limit according to the retest method. It is effective for the kinetics method only.
◼ Prozone Check Exceeding Limit: When prozone appears during the reaction, the system will
do a retest for the test with the results exceeding the limit according to the retest method.
It is effective for the end-point method only.
◼ Exceeding Max. Calibration Reactivity: When the reactivity tested exceeds the reactivity of
the calibration standard of the maximum concentration, the system will do a retest for the
test with the results exceeding the limit according to the retest method.
◼ Less than Zero Concentration Calibration Standard: When the reactivity tested is less than
the reactivity of the calibration standard of zero concentration, the system will do a retest
for the test with the results exceeding the limit according to the retest method.
Select the Printing Setup page to enter the screen as shown in the figure:
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The meanings of the various functions on the Printing Setup page are as follows:
◼ Report Title: Set the title of the patient report, such as “Inspection Report of ×××× Hospital”.
◼ Report Annotation: Set the remark of the patient report, such as “Note: The inspection
results are for the sample only”.
◼ Printing Sequence Setup: Set the printing sequence of the items in the general report.
◼ Patient Information Setup: Set the default, printing display setup, and printing sequence
setup of patient information newly recorded.
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Select the User Management page to enter the screen as shown in the figure:
Caution: Only the administrator “Admin” can add, delete and modify user privilege.
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Select the Data Dictionary page to enter the screen as shown in the figure:
From the type of selection box, select the data dictionary item to be observed and edited, and all data
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of the selected type will appear in the data list, including Unit of Results, Sample Type, Specimen
Character, Blood Type, Qualitative Results, Clinical Diagnosis, Nation, Patient Type, Charge Type,
Inpatient Area, and Reagent Vial Type. The data dictionary item is character type, with the maximum
length of 30 characters.
◼ Description: The description of a data dictionary item, which indicates the meaning of the
data dictionary item. It can be empty.
◼ Add: Select a data type, click the “Add” button, add a new entry to the selected data type,
and click the “Save” button.
◼ Modify: Select a data type, edit the related entry, and click the “Save” button.
◼ Delete: Select a data type, select the entry to be deleted, and click the “Delete” button.
Caution: On the Data Dictionary screen, the system will pre-input some entries of the
data dictionary. If Prohibit Deletion or Prohibit Modification is selected for
the pre-input entry, deletion or modification will be prohibited.
Select the LIS Setup page to enter the screen as shown in the figure:
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to correctly match the items during sample application information obtaining and results transmission,
the correspondence of item parameters between the LIS system and instrument must be set, with the
corresponding code as the link.
From the corresponding item list, select an item and directly edit the code in the corresponding “LIS
Item Code” column. The information input is the character type, with the length of 0~20 characters,
which indicates the code of the item in the LIS host.
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◼ Obtain from Sample Barcode: After scanning the barcode, the system will automatically
obtain the sample information according to its constituent fields. When the information is
being obtained, any invalid constituent information will cause failure of sample barcode
scanning. Take the profile number as an example: all profile numbers of barcodes must be
profile numbers predefined in the operational software.
Name Default
Test Type Regular
Submission Date Current day
Sample No. Generated automatically
Sample Type Blood serum
Profile No. Empty
Container Type Standard tube
Caution: During information obtaining, the system will first obtain sample information
from the sample barcode source; detect whether there is setup information
of the barcode in the current worksheet or not and obtain the information if
any; detect whether there is setup information at the scanning position or not
and obtain the information if any. If no necessary sample information is
obtained, the system will fill the missing necessary information with the
default. If the information obtained is repeated, the system will save the
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Caution: If “Apply Reagent Barcode” is selected, when the system is scanning a reagent,
it will obtain reagent information from the reagent barcode.
◼ Total No. of Digits: The total number of digits of a reagent barcode. Options: 10-30.
◼ Item Number: The number of the tested item. Options: 0-5 digits.
◼ Item Name: The name of the item. Options: 0-10 digits.
◼ Reagent Type: R1/R2/R3/R4. Option: 1 digit.
◼ Vial No.: The number of the reagent vial. Options: 0 or 3-5 digits.
◼ Vial Spec.: The vial specification defined in the data dictionary. Options: 0 or 1 digit.
◼ Batch No.: The production batch number of the reagent. Options: 0 or 3~5 digits.
◼ Expiry Date: Year-Month or Year-Month-Day. Options: 0, 4, 6 or 8 digits.
◼ Default of reagent barcode information:
Name Default
Item Number None
Item Name None
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Reagent Type R1
Vial Type 25mL
Batch No. Empty
Expiry Date Current day
Caution: During information obtaining, the system will first obtain reagent information
from the reagent barcode information; detect whether there is setup information
of the barcode in the current reagent tray or not and obtain the information if
any; detect whether there is setup information at the scanning position or not
and obtain the information if any. If no necessary reagent information is
obtained, the system will fill the missing necessary information (except the item
name and item number of the reagent) with the default. If the information
obtained is repeated, the system will save the information obtained first and then
clear the repeated information.
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Chapter 7 Test
7.1 Sample Application
Function Brief: To set test items for samples according to the editing of the worksheet.
Click Sample Application in the main menu to enter the Sample Application screen as shown in the
figure:
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year number + 2-digit month number + 2-digit day number + 1-digit worksheet number +3-
digit serial number, such as 1303191001. If the worksheet has samples saved, the system will
generate new sample numbers automatically according to the format of the existing sample
number.
Caution: No matter whether the sample number is input manually or generated by the
system automatically, it must have at least three digits and the last three
digits must be figures.
◼ Sample Container: The type of sample container used, including Standard Tube and Small
Cup.
◼ Sample Type: The options in the sample type are the options set in the data dictionary.
◼ Sample Barcode: The barcode information of the sample which can be obtained with the
barcode scanning system or input manually.
◼ Test Item: The test item table includes all items that can be tested on the instrument,
including, from top to bottom, items set in Item Setup, item profile, and ISE items. For items
that cannot be applied for due to certain reasons, this option will be disabled. When an item
profile is selected, the corresponding items will all be selected. When an item of the item
profile in the item list is cancelled, the profile will also be deselected. As long as an item in
the item profile is disabled, the profile will be disabled. The ISE item list is displayed only
when the ISE module has been installed in the instrument, otherwise, the ISE item list is
invisible.
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◼ Display Details: Display all information on the sample for you to view and edit.
◼ Obtain Default: Obtain default information according to the default set in “Setup ->> Printing
Setup”. For details, see Printing Setup.
◼ Save: Save the set information and return to the previous screen.
◼ Back: Return to the previous screen without saving the information.
The default settings can be modified on the Item Options Setup screen. The meanings of the test
information are as follows:
◼ Sample Volume: Set the sample volume mode in item testing, including Standard, Dilution,
Increment, Increment Dilution, Decrement, and Decrement Dilution (displayed only when the
related test information has been set in Item Parameter Setup). The system will read the test
sample volume, dilution sample volume and dilution ratio according to the selected sample
volume mode. You can further adjust the above information according to the specific needs.
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◼ Test Sample Volume: Specify the volume of sample used in a test. The default is obtained
according to Sample Volume. You can further edit it as needed.
◼ Dilution Sample Volume: Specify the volume of dilution sample used in a dilution test. The
default is obtained according to Sample Volume. You can further edit it as needed.
◼ Sample Blank: You may select to test or not to test sample blank. The default is “Not To Test”.
You can further edit it as needed.
◼ Dilution Ratio: Set the dilution ratio of sample in a test. The default is obtained according to
Sample Volume. You can further edit it as needed. Input “10” to indicate 10 times dilution,
i.e. 1 part of sample + 9 parts of diluent. Input “1” to indicate no dilution.
◼ Repeat Count: Set the times of repetition of a sample test. The default is 1. You can further
edit it as needed.
◼ Set All Items: To select the same sample blank or set the same repeat count for all items
applied for the sample, tick and set the corresponding options, and click OK to realize batch
setup.
◼ Source Worksheet: Select the worksheet where the sample to be moved is located.
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◼ Sample Position: Select the position of the sample to be moved. Multiple positions can be
input according to the prompt of the system, such as 1-9, 11, and 60.
◼ Destination Worksheet: Select the new worksheet to which the sample is to be moved.
◼ Sample Position: Input the start position in the new worksheet to which the sample is to be
moved. The samples will be inserted to the destination worksheet in turn according to the
start position.
7.1.5 Scan
Click the “Scan” button to pop up the Sample Scanning dialogue box. It is used to scan the sample
barcode in the sample tray, as shown in the figure:
◼ Scan All Positions: Select “Scan All Positions” and click the “OK” button, and the system will
scan Positions 1-96 in the selected worksheet.
◼ Scan Specified Position Range: Select “Scan Specified Position Range, and the “Start” and
“End” fields will be available. The range of input is Positions 1-96, and the start position must
be less than or equal to the end position. Click OK, and only the sample positions in the range
input will be scanned.
After the barcode is scanned, the corresponding sample information will be obtained according to
“Sample Information Source” in Barcode Setup. For details, see “Barcode Setup”.
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Caution:
◆ During barcode scanning, when the barcode scanned is the same as one in another
worksheet, a prompt message will be given, and the saving of the barcode scanned will
be given up.
◆ When the barcode scanned is the same as one in the current worksheet, the system
will move the repeated barcode in the current worksheet to the current scanning
position and save the information obtained according to the barcode.
◆ If, during sample barcode scanning, there is any position where scanning is
abnormal, please view the prompt message at the bottom of the screen to search the
abnormal sample position and cause of scanning failure.
7.1.6 Get
“Get” can be operated when the system is ready and has been connected to the LIS host, and the
communication mode has been set to Two-way in “LIS Setup”. Click the “Get” button to pop up the
Sample Scanning dialogue box. It is used to scan the sample barcode in the sample tray, as shown in
the figure:
◼ Updated Sample on the Current Day: The operational software will obtain all sample
information that has not been obtained on the current day from the LIS system.
◼ All Samples on the Current Day: The operational software will obtain all sample information
on the current day from the LIS system.
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◼ Specified Barcode Sample: Select this option, and the sample barcode textbox below it will
be available. Input a valid barcode, and the LIS system will retrieve the sample information
of the barcode and send it to the operational software.
For the treatment of repeated information, see “LIS Setup” in “System Setup”.
Caution: Items that cannot be applied for due to certain reasons are disabled. When the
cursor floats over such items, the reasons why the item cannot be selected
will be displayed.
Caution: Input any figures among 1-136 at the sample position, and the sample editing
information will be displayed automatically. If the sample position has not
been defined, the system will generate a new sample number automatically.
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Step 3: Input the start sample position and end sample position and click the “OK” button.
Step 4: Finish the batch sample application.
Caution:
◆ In batch sample application, the rule for the system to automatically generate
sample numbers increasingly is starting with the sample number input and increasing in
turn. For example, when ***018 is input, the sample numbers in batch application are
***018, ***019, ***020…
◆ When the application is finished, you can modify it manually.
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7.2 QC Application
Function Brief: To edit the QC test information and apply for QC test items for sample testing.
7.2.1 QC Application
Click “Sample Application” in the main menu to enter the sample application screen. Select the QC
Application page as shown in the figure:
◼ Sample Position: Set the position of the sample in the selected worksheet. The range of
editable positions is 1-137. Positions 138-140 cannot be edited, in which, Position 138(D1) is
for acid cleanser; Position 139(D2) is for alkaline cleanser; Position 140(W) is for deionized
water.
◼ Sample Container: The type of sample container used, including Standard Tube and Small
Cup.
◼ Test Item: The test item table includes all items that can be tested on the instrument,
including items set in Item Setup and ISE items. Items that cannot be applied for due to
certain reasons are disabled. The ISE item list is displayed only when the ISE module has been
installed in the instrument, otherwise, the list is invisible.
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The default settings can be modified in the Item Options setup screen. The meanings of test
information are as follows:
◼ Repeat Count: Set the times of repetition of a QC test. The default is 1. You can further edit
it as needed.
◼ Save: Save the setting and return to the previous screen.
◼ Next: Display the item information of the next QC sample position.
◼ Previous: Display the item information of the previous QC sample position.
◼ Back: Return to the Setup page without saving the setting.
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Caution: Items that cannot be applied for due to certain reasons are disabled. When the
cursor floats over such items, the reasons why the item cannot be selected
will be displayed. ISE items can be applied for only when the ISE QC
parameters are set in “ISE Setup”.
◼ Sample Position: Set the position of the sample in the selected worksheet. The range of
editable positions is 1-137. Positions 138-140 cannot be edited, in which, Position 138(D1) is
for acid cleanser; Position 139(D2) is for alkaline cleanser; Position 140(W) is for deionized
water.
◼ Sample Container: The type of sample container used, including Standard Tube and Small
Cup.
◼ Test Item: The test item table includes all items that can be tested on the instrument Items
that cannot be applied for due to certain reasons are disabled.
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The default settings can be modified in the Item Options setup screen. The meanings of test
information are as follows:
◼ Repeat Count: Set the times of repetition of a standard test. The default is 1. You can further
edit it as needed.
◼ Save: Save the setting and return to the previous screen.
◼ Next: Display the item information of the next standard sample position.
◼ Previous: Display the item information of the previous standard sample position.
◼ Back: Return to the Sample Application page without saving the setting.
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Caution: Items that cannot be applied for due to certain reasons are disabled. When the
cursor floats over such items, the reasons why the item cannot be selected
will be displayed.
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◼ Worksheet: Select the worksheet for which a test will be conducted soon. If the system is
conducting a test, the worksheet has been fixed.
◼ Reagent Tray: Select the reagent tray for which a test will be conducted soon. If the system
is conducting a test, the reagent tray has been fixed.
◼ Initial Test: To conduct an initial test for the tests not finished or retests in the current
worksheet. If the system is conducting this option, this option is read only.
◼ Retest: To conduct a retest for the finished tests the results of which need retest in the
current worksheet. If the system is conducting a test, “Retest” cannot be selected.
◼ Calibration Selection: Select the calibration test required this time. Calibration tests
commenced cannot be edited.
◼ QC Selection: Select the QC test required this time. QC tests commenced cannot be edited.
Caution: If the selected reagent tray does not include the reagents required for
calibration and QC item tests, the calibration and QC items will be disabled.
Before confirming the commencement of the test, please confirm the above information and check
that the sample, calibration standard, QC liquid, reagent, etc. have been put at the correct positions.
To modify them, click the “Cancel” button. Or click the “OK” button, and the Test Sequencing screen
will appear, as shown in the figure:
◼ Test All Samples: Select all samples the test of which has not been finished for testing.
◼ Test Specified Samples: Specify which samples for which the test has been applied for will be
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tested. Multiple sample positions can be input according to the prompt of the system, such
as 1-9, 11, and 60.
◼ Detection of Minimal Volume of Reagent: Detect the minimal volume of the items applied
for in this test. If the reagent is insufficient, a prompt box will pop up to prompt that some
reagents are missing and whether to continue the test or not. Select Yes to continue the test;
select No to give up the test.
◼ Clear Tested Sample Results: Clear the sample results tested in the current worksheet and
restart all sample tests.
◼ Clear Tested Standard Results: Clear the standard results tested in the current worksheet and
restart all standard tests.
◼ Clear Tested QC Results: Clear the QC results tested in the current worksheet and restart all
QC tests.
◼ No. of Tests: Prompt the total number of tests, including finished, loaded, and unloaded
items.
The meanings of the Status and Prompt columns in the list are shown in the table below:
Status Description
Unloaded Test applied for and unloaded.
Loaded Test applied for and loaded.
Finished Test applied for and finished.
By default, the system uses the sequence specified in “Test Sequence Setup” (see “Item Setup”). To
adjust the sequence, click the “Sort by Item” button or “Sort by Sample” button or drag the tests in the
list. After the test sequence is adjusted, click the “OK” button to start the test, or click the “Cancel”
button to give up the test.
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Confirm the test sequencing, and the system will test all samples according to the new sequence.
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Confirm the test sequencing, and the system will test all samples according to the new sequence. All
stat samples will be tested first.
7.7 Pause
During a test, click the “Pause” button on the left bottom corner of the screen, and the system will
enter the Pause for Adding Sample mode. All tests not started will be suspended, but all tests in
progress will continue. To restore the test, click the “Start” button again.
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◼ Worksheet: Including the 7 test worksheets in the system, in which, the worksheet with an
asterisk (*) at the end is the current worksheet.
◼ Reagent Tray: Including the 2 reagent trays in the system, in which, Reagent Tray 1 is for
Reagent 1 and Reagent 3; Reagent Tray 2 is for Reagent 2 and Reagent 4.
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◼ Stage Prompt Line: The current stage of the curve data. The meanings of the stage prompt
lines are as follows:
Stage Line Meaning Color
S Add sample Light red
R2 Add Reagent 2 Light blue
R3 Add Reagent 3 Light blue
R4 Add Reagent 4 Light blue
S1 Start point of pre- Light green
blank
E1 End point of pre-blank Light green
S2 Start point of Light green
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calculation
E2 End point of Light green
calculation
◼ Analysis Line: When the cursor is at a test point, the red prompt line of the point will appear,
and the current number of periods and OD value will be displayed on the right side of the
cursor.
◼ Prim: The measured absorbance of the primary wavelength, indicated with red points.
◼ Sec: The measured absorbance of the secondary wavelength, indicated with green points.
◼ Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
◼ Reaction Data: Click this button to pop up the Reaction Curve Data prompt box which
displays the reaction data corresponding to the current reaction curve.
◼ Print: Print the reaction curve graph.
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Caution: If any sample is missing during a test, the system will automatically skip all tests
corresponding to the sample. Execute “Minimal Volume Refreshing”, and the
system will automatically continue the test of the sample.
8.1.4 Retest
Select a tested sample in the sample tray status graph and click the “Retest” button to pop up the Retest
dialogue box as shown in the figure:
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The status information on the left side of the reagent tray graph is shown in the table below:
Status Color Description
Empty position Grey No reagent is put.
Deionized water Light blue For deionized water
Cleanser Light green For cleanser
Thermostatic Bath Light blue Thermostatic bath additive
Liquid
Reagent Green For reagent
Reagent insufficient Red The minimal volume of reagent is insufficient to finish
the test or less than the alarm limit set.
Expired reagent Yellow The reagent has expired.
◼ Original Reagent Position: The reagent position of the reagent selected in the reagent tray
status graph on the current reagent tray. It is a read only field.
◼ New Reagent Position: Input the position that is empty on the reagent tray.
Caution:
◆ The deionized water, cleanser and thermostatic bath liquid positions are fixed and
cannot be moved.
◆ If items corresponding to the reagent have been applied for, movement is prohibited.
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◼ Refresh Minimal Volume of Selected Reagent Position: Cancel the missing sign of the
selected reagent position.
◼ Refresh Minimal Volume of All Reagent Positions: Cancel the missing sign of all reagent
positions.
◼ Refresh Minimal Volume of Specified Reagent Position: Cancel the missing sign of the
reagent positions in the specified range.
Caution: If any reagent is missing during a test, the system will automatically skip all
tests corresponding to the reagent. Execute “Minimal Volume Refreshing”,
and the system will automatically continue the test of the reagent.
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The meanings of the status information on the left side of the reaction tray graph are shown in the
table below:
Status Color Description
Prediluted Light yellow Prediluted in the test cuvette
Testing Light green Testing in the test cuvette
Finished Dark blue The test in the test cuvette is finished, and the test cuvette is
pending cleaning.
Cleaning Light blue The test cuvette is being cleaned. After the water blank is
tested, the test cuvette can be used again.
Cancelled Red The test in the test cuvette has been cancelled, and the test
cuvette is pending cleaning.
Empty Light grey The clean test cuvette can be added for testing.
Missing Green The blank value of the test cuvette exceeds the allowed upper
limit. Maybe the test cuvette has not been put.
Unknown Dark grey When the machine is started, the test cuvette has not been
cleaned or the status of the test cuvette is not detected. The
test cuvette can be used only after it is cleaned.
Dirty test Earthy yellow The blank value of the test cuvette exceeds the allowed lower
cuvette limit. Maybe the test cuvette has not been cleaned or has
been stained.
Intensive Purple The test cuvette is being intensively cleaned.
cleaning
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◼ Stage Prompt Line: The current stage of the curve data. The meanings of the stage prompt
lines are as follows:
Stage Line Meaning Color
S Add sample Light red
R2 Add reagent 2 Light blue
R3 Add reagent 3 Light blue
R4 Add reagent 4 Light blue
S1 Start point of pre- Light green
blank
E1 End point of pre-blank Light green
S2 Start point of Light green
calculation
E2 End point of Light green
calculation
◼ Analysis Line: When the cursor is at a test point, the red prompt line of the point will appear,
and the current coordinate position will be displayed on the right side of the cursor.
◼ Prim: The measured absorbance of the primary wavelength, indicated with red points.
◼ Sec: The measured absorbance of the secondary wavelength, indicated with green points.
◼ Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
◼ Reaction Data: Click this button to pop up the Reaction Curve Data prompt box which
displays the reaction data corresponding to the current reaction curve.
◼ Print: Print the reaction curve graph.
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◼ Display Type: Select “Display All”, “Display Finished” or “Display Unfinished”, and the system
will automatically screen the test records as required.
◼ Reaction Curve: Select a test from the list and click the “Reaction Curve” button to view the
reaction curve corresponding to the test.
◼ Retest: Select the results to be retested from the list and click Retest to mark the selected
record as “Retest”. For the detailed retest setup, see 7.1.3. If the system is conducting a test,
tests marked with “Retest” will be added automatically; otherwise, in the next test, the
system will automatically respond to the Retest request.
◼ Print: Print the results of a finished patient sample test.
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Chapter 9 Report
9.1 Patient Record Search
Function Brief: To search the patient records meeting the specified criteria. The basic information
and test results of the selected patient can be edited and viewed one by one.
Click “Report” in the main menu to enter the Patient Record page as shown in the figure:
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Input the search criteria and click the “OK” button, and the list will display all patient records meeting
the criteria. If “Submission Date” is not ticked, the results of items tested on any submission date that
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Caution: Only operators with the “Result Editing” privilege may edit patient test results.
Caution:
◆ Retested, manually added or modified test results are prompted with “*” at the end
of the test results, and the background is yellow. If the results are abnormal, the
background is red.
◆ Results on the high side and low side are prompted with “↑” and “↓” respectively.
◆ The test date of the newly added patient is the current day. The sample number of
the newly added patient must not be the existing patient sample number on the day of
test, otherwise the system will ask you whether to overwrite the existing patient
information or not.
◆ When the system is saving test results, if there is no patient information of the
sample number on the current day, the system will automatically generate a new patient
according to the sample number and test date.
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system will delete the specified patient record and all corresponding test records and save the deletion
record in the log.
From the patient record list, select the audited patient record or “Select All”, and click the “Audit”
button to finish the audit of the selected patient.
In the audited information list, the “Audited” column will have a “√” mark.
Caution: In order to protect the validity of the audit, after finishing the audit, the auditor
should timely enter the Setup screen to log out.
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Caution: The report settings will be saved automatically after the operation, and the
report needs not to be set each time before it is printed.
From the patient record list, select the patient record to be printed or “Select All” and click the “Print”
button. The system will generate the patient report automatically. In the audited information list, the
“Printed” column will have a “√” mark.
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Input the search criteria and click the “OK” button, and all test records meeting the criteria will appear
in the list.
Caution: Retested, manually added, or modified test results are marked with “*” at the
end.
◼ Stage Prompt Line: The current stage of the curve data. The meanings of the stage prompt
lines are as follows:
Stage Line Meaning Color
S Add sample Light red
R2 Add Reagent 2 Light blue
R3 Add Reagent 3 Light blue
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◼ Analysis Line: When the cursor is at a test point, the red prompt line of the point will appear,
and the OD value corresponding to the current test period will be displayed on the right side
of the cursor.
◼ Prim: The measured absorbance of the primary wavelength, indicated with red points.
◼ Sec: The measured absorbance of the secondary wavelength, indicated with green points.
◼ Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
◼ Reaction Data: Click this button to pop up the Reaction Curve Data prompt box which
displays the reaction data corresponding to the current reaction curve.
◼ Print: Print the reaction curve graph.
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Caution: After the calibration data are deleted or modified, the system will calculate the
new calibration parameter automatically. The system will automatically set
the newly calculated calibration parameter as the default calibration
parameter of the item and refresh the display of the calibration parameter list.
If the calculation fails, the system will give the prompt “Calibration invalid.
Parameter calculation impossible” at the right bottom corner.
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◼ Analysis Line: When the cursor is at a position, the red prompt line of the point perpendicular
to the X axis will appear, and the concentration and corresponding OD value of the
intersection of the current prompt line and standard curve will be displayed on the right side
of the cursor.
◼ Print: Print the calibration curve graph.
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◼ Send the Selected Item: Send the calibration parameters and results of the selected item to
the LIS host;
◼ Send All Items: Send the calibration parameters and results of all items in the list to the LIS
host.
9.4 QC Search
Function Brief: To search the test results in the specified time range of the specified QC item.
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Caution: When the Youden rule is selected, 2 QC liquids must be selected (to select
multiple QC liquids in the QC list, press and hold the Ctrl key). The Youden rule
does not judge the QC results automatically.
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The screen displays the target value and SD value of the QC item as well as the statistical results
of the selected data: mean, SD, and CV. The system can change the QC graph automatically according
to the drawing method specified by you. Click the “Print” button to print the QC graph shown on the
Graph screen.
◼ Real-time QC Graph: Draw all data. Each QC datum corresponds to an X-coordinate value on
the graph.
◼ Daily QC Graph: Average the data for the same day and draw the point corresponding to the
mean for each day only. The mean for each day corresponds to an X-coordinate value.
◼ Display QC Point Time: Select the Display QC Point Time option, and the QC test time will be
displayed on the QC point.
◼ Target Value and SD Value: The fixed target value and SD value set for the QC material.
◼ Mean and SD Value: The mean and SD value obtained through statistics of data tested for
the QC material.
◼ Out-of-control Prompt: Prompt the out-of-control QC liquid according to the set QC rule.
◼ Print: Print the QC graph.
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Caution: The numbers on the right side of the cursor on the Westgard QC graph and
cumulative sum QC graph are the X-coordinate and Y-coordinate data of the
current QC point. Youden QC graph may have multiple QC points on the same
Y-coordinate, therefore the numbers on the right side of the cursor are the X-
coordinate and Y-coordinate data of the current cursor. When viewing the
data points on the Youden QC graph, locate the cursor following the
corresponding QC point to view its coordinate data.
On the Westgard multi-rule QC graph, the X-coordinate is the serial number of the QC point, and
the Y-coordinate is the concentration. For QC test points violating the QC rule, in addition to prompting
which rules are violated in “Out-of-control Prompt”, the out-of-control QC points will be displayed in
pink. The values on the right side of the cursor are the X-coordinate and Y-coordinate values of the
current QC point.
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and click “QC Graph”. The Cumulative Sum Rule QC graph will appear:
On the Cumulative Sum Rule QC graph, the X-coordinate is the serial number of the QC point, and
the Y-coordinate is the specific value corresponding to the cumulative sum of the QC point. For QC test
points violating the QC rule, in addition to prompting which rules are violated in “Out-of-control
Prompt”, the out-of-control QC points will be displayed in pink.
◼ Cumulative Sum: Display the total cumulative sum of the QC material.
◼ QC Limit H: Display the upper limit of cumulative QC of the QC material.
◼ QC Limit L: Display the lower limit of cumulative QC of the QC material.
Caution: The cumulation method of the real-time QC graph is real-time single point
cumulation. The cumulation method of the daily QC graph is daily mean
cumulation. For the meanings of real-time single point cumulation and daily
mean cumulation, see 4.3.5 Set QC Rule.
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For the Youden rule, the mean and SD of the corresponding QC liquid are displayed on the left and
upper sides of the QC graph respectively. Move the cursor on the QC point to observe the specific value
of each point in the graph. In the two boxes under the QC graph, the statistical data of the X-coordinate
item are displayed on the left side, and the statistical data of the Y-coordinate item are displayed on
the right side.
Caution: If the Youden rule has been selected, when the Youden QC graph is viewed, the
QC results will not be judged, and no out-of-control prompt will appear. For the
QC point Youden graph for a day, only points with both QC liquids tested will
be displayed. If two QC liquids are tested multiple times in a day, the number
of points displayed on the Youden real-time QC graph are the number of points
of the QC liquid lesser tested.
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◼ Send Selected Item: Send the QC data of the selected item to the LIS host.
◼ Send All Items: Send the QC data of all items in the list to the LIS host.
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All items with reagent blank tested are displayed in the list on the left side. Click the item to be
searched, and the historic reagent blank record will be displayed in the list on the right side.
◼ Reaction Curve: View the reaction curve graph of the reagent blank test.
◼ Delete: Delete the selected reagent blank record in the list.
◼ Delete All: Delete all reagent blank records in the list.
◼ Print: Print all reagent blank records in the list.
Caution: Blank results exceeding the reagent blank range are marked with “OR”.
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◼ Last Results: Display the results of the last calibration, including calibration results and
calibration reagent.
◼ Historic Results: Search the historic calibration results in the date range.
◼ Search: Search the calibration results in a time period of the selected ISE item according to
the date range.
◼ Delete: Delete the specified ISE calibration results.
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◼ QC Graph: Display the QC graph according to the selected time and QC rule.
◼ Delete: Delete the selected QC data.
◼ Print: Print the QC data of the selected time.
◼ Send: Transmit the data of QC results.
Caution: The ISE Calibration Search and ISE QC Search pages are displayed only when
the ISE module has been installed in the instrument.
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Chapter 10 Statistics
10.1Worksheet Statistics
Click “Statistics” in the main menu to enter the Statistics page as shown in the figure:
Select the worksheet for which statistics will be conducted from the pull-down list, and the statistical
results of the worksheet will be displayed in the list below. The statistical results include Total, Finished,
On the High Side, On The Low Side, Abnormality Rate, Mean, SD, and Variable Coefficient.
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10.3Workload Statistics
Select the Workload Statistics page as shown in the figure:
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Specify the time range and click the “Statistics” button. The system will conduct statistics of workload
of each submitting doctor, testing doctor and auditing doctor in the statistical time respectively.
10.4Cost Statistics
Select the Cost Statistics page as shown in the figure:
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Caution:
◆ There is potential biological contamination on the surface of the components of the
instrument, proper safety measures should be taken for operation and
maintenance.
◆ Improper maintenance may cause damage of the instrument. Be sure to conduct
maintenance according to the instructions.
◆ If any failure or problem not listed in the instructions is encountered, please contact
LiNEAR’s User Service Department, and the professional designated by LiNEAR will
give suggestions on maintenance.
◆ Be sure to use the parts and components supplied by LiNEAR for maintenance.
◆ If you have any question, please contact LiNEAR’s User Service Department.
12.2Regular Maintenance
12.2.1 Daily Maintenance
1. Check deionized water connection:
◼ Check that the water machine or other external water container has sufficient deionized
water.
◼ Check that the tubes are correctly connected and are not bent or leaking.
◼ Check that the switch of the water machine is on.
2. Check waste liquid connection:
◼ Check that the tubes are correctly connected and are not bent or leaking.
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Warning: Properly dispose the removed waste components according to the local laws.
Before mounting/removing the reagent pack, ensure the power supply of the
instrument has been turned off.
Caution: Please use the consumables recommended by LiNEAR, otherwise the
performance of the system may reduce.
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a) Gently wipe the point of the probe with gauze soaked with alcohol till the surface
becomes smooth and non-oily.
b) Clean the point of the probe with gauze soaked with deionized water.
c) Turn on the power supply of the analysis section, enter the Maintenance – Daily
Maintenance screen, and execute the Reset Whole Machine operation.
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3. Cleaning the barcode scanning window (with the optional fixed barcode scanning)
1) Make sure the power supply of the analysis section has been turned off.
2) Remove the sample tray cover and reagent tray cover and take out the sample tray and
reagent tray.
3) Clean the glass window with gauze soaked with deionized water.
4) Mount the reagent tray and sample tray, and close the tray covers.
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4) Clean the sample bin and reagent bin with a cloth soaked with cleaning agent.
5) Mount the reagent tray and sample tray, and close the tray covers.
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respectively.
2) Enter the Maintenance – Daily Maintenance screen, execute the Intensive Cleaning operation
to realize intensive cleaning of the sample probe, reagent probe and test cuvettes. Then
execute the “Intensive Cleaning of Test Cuvette” command.
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2) Grasp the rocker arms of the sample probe, reagent probe and mixer by hand respectively
and move them out of the respective cleaning pool.
3) Wipe the inside and outer side of the cleaning pool with soft gauze soaked with alcohol to
ensure the cleaning pool is clean.
4) After the wiping, move the sample probe, reagent probe and mixer over the cleaning pool.
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4) Wipe the surface of the steel probe and wiper with soft gauze soaked with deionized water.
5) Check whether the surface of the wiper is smooth or not. If it is worn, replace it.
6) Mount the automatic cleaning mechanism onto the support and adjust the position to make
the steel probe and wiper at the centre of the test cuvette.
7) Fix the nut.
Warning: Operate carefully. Do not overexert yourself when rotating the wiper.
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Warning: Operate carefully. During the process, do not touch other components (probe
or mixer) on the machine.
Caution: When mounting a new test cuvette, do not touch the optical surface of the test
cuvette.
After the mounting, check whether any test cuvette is missing or not and
whether the bottoms of the test cuvettes are parallel and level or not.
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Caution: The replacement of wiper and mixer must be allowed by the engineer of LiNEAR.
12.5Maintenance Guide
12.5.1 Liquid Path Check
◼ Whether the air tightness of the connection between the probe and syringe and the tube is
good or not.
◼ Whether the air tightness of the connection between the steel probe and tube of the
automatic cleaning station is good or not.
◼ Whether the tube connection is consistent with the graph on the rear panel or not; whether
the tube is bent or not.
◼ Whether the waste liquid tank is full or not.
◼ Whether the deionized water machine works normally or not.
◼ Whether the cleanser is sufficient or not.
◼ Whether the liquid in the cleaning pool flows evenly and smoothly or not.
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When manual operation is needed during the use of the instrument, enter the Maintenance - Daily
Maintenance screen as shown in the figure:
◼ Instrument Temperature Inquiry: Display the current temperature status of the system.
◼ Component Status: Display the status of the various units and components. Select any unit
and click the “Failure Restoration” button to restore the operation.
◼ Maintenance Operation: When the instrument is in the non-testing mode, you can select the
desired maintenance operation and click the “Execute” button.
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To make backup or restore data, enter the Maintenance - Data Maintenance screen as shown in the
figure:
◼ Data Deletion
Used to delete the specified type of data in the database. The data type can be selected according
to the actual needs. Once deleted, the data cannot be restored!
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the specified directory. When they are needed, the patient sample test results in the specified
time range can be imported from the file.
12.5.7 Log
Record the user login log and major failure log of the instrument.
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◼ Daily cleaning
◼ After starting the machine, enter the Maintenance – ISE Maintenance screen for
maintenance every day to execute the Cleaning Period operation and execute “Two-point
Calibration”. When the test is finished or the number of samples with the ISE test finished
exceeds 50 samples, an ISE Cleaning operation is required. You can also enter the System
Setup - ISE Setup screen to make the corresponding setup to make the software complete
the above operations automatically.
◼ Pump Calibration
After starting the machine, enter the Maintenance – ISE Maintenance screen every day to
execute the Pump Calibration Period operation.
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Invalid Test Cuvette Blank: During the cleaning of cuvette, deionized water is poured into the cuvette
after the sixth cleaning is finished. When the cuvette is passing the photoelectric acquisition position,
the water blank of the cuvette is measured. If the water blank value exceeds the set range, the system
will prompt you that “the blank of x# cuvette is invalid” and give up the use of the cuvette automatically.
When the test results are abnormal, the system will prompt you with a sign. For abnormal results, you
can conduct manual retest or recheck. If the automatic retest rule has been set, the system will finish
the retest automatically. Abnormalities of test results include:
◼ On the low side L
◼ On the high side H
◼ Exceeding the lower linear limit A<
◼ Exceeding the upper linear limit A>
◼ Exceeding the linearity range (nonlinear) OL
◼ Substrate exhaust SE
◼ Less than the increment retest limit AR
◼ Greater than the decrement retest limit DR
◼ No linear interval NLN
◼ No calculation interval ENC
◼ Prozone check exceeding limit PRO
◼ Exceeding reactivity of zero concentration RRZ
◼ Exceeding reactivity of maximum calibration RRN
◼ Still abnormal after retest **
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syringe of the sample probe is abnormal during the test, thus the sample probe cannot be
used for sample adding any longer, the software will prompt “Sample Probe Failure” and
enter the pause mode, but the test with sample adding finished will continue.
◼ Mixer Failure: When the mixer cannot work normally during the test, the software will
prompt “Mixer Failure” and enter the pause mode, but the test with mixing finished will
continue.
◼ Automatic Cleaning Unit Failure: When the automatic cleaning unit cannot work normally
during the test, the software will prompt “Automatic Cleaning Unit Failure” and stop the
adding of R1, but the test having been started will continue.
l unit
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Reaction tray
module’s Exit the operational software and turn off the test
command switch. 5S later, turn on the test switch and
execution operational software again. If this failure appears 3
603 prohibited STOP times in a row, contact the After Service
The command sent
to the sample
tray’s lower Exit the operational software and turn off the test
computer is not switch. 5S later, turn on the test switch and
responded or the operational software again. If this failure appears 3
701 response is wrong. STOP times in a row, contact the After Service
Time out executing Exit the operational software and turn off the test
command of switch. 5S later, turn on the test switch and
sample tray’s operational software again. If this failure appears 3
702 lower computer STOP times in a row, contact the After Service
Reaction tray 1
module’s Exit the operational software and turn off the test
command switch. 5S later, turn on the test switch and
execution operational software again. If this failure appears 3
703 prohibited STOP times in a row, contact the After Service
Time out sending Exit the operational software and turn off the test
command to switch. 5S later, turn on the test switch and
sample tray 2 operational software again. If this failure appears 3
751 module STOP times in a row, contact the After Service
Time out executing Exit the operational software and turn off the test
command of switch. 5S later, turn on the test switch and
sample tray 2 operational software again. If this failure appears 3
752 module STOP times in a row, contact the After Service
Sample tray 2
module’s Exit the operational software and turn off the test
command switch. 5S later, turn on the test switch and
execution operational software again. If this failure appears 3
753 prohibited STOP times in a row, contact the After Service
The command sent
to reagent tray 1’s
lower computer of Exit the operational software and turn off the test
is not responded switch. 5S later, turn on the test switch and
or the response is operational software again. If this failure appears 3
801 wrong. STOP times in a row, contact the After Service
Time out executing Exit the operational software and turn off the test
command of switch. 5S later, turn on the test switch and
reagent tray 1’s operational software again. If this failure appears 3
802 lower computer STOP times in a row, contact the After Service
Reagent tray 1
module’s Exit the operational software and turn off the test
command switch. 5S later, turn on the test switch and
execution operational software again. If this failure appears 3
803 prohibited STOP times in a row, contact the After Service
Time out sending Exit the operational software and turn off the test
command to switch. 5S later, turn on the test switch and
reagent tray 2 operational software again. If this failure appears 3
851 module STOP times in a row, contact the After Service
Time out executing Exit the operational software and turn off the test
command of switch. 5S later, turn on the test switch and
reagent tray 2 operational software again. If this failure appears 3
852 module STOP times in a row, contact the After Service
Reagent tray 2
module’s Exit the operational software and turn off the test
command switch. 5S later, turn on the test switch and
execution operational software again. If this failure appears 3
853 prohibited STOP times in a row, contact the After Service
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4501 Command error STOP times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
operational software, and continue to try to
execute this command. If this message appears 3
4502 Parameter error STOP times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
Abnormality of off and then on the test switch, restart the
4503 self-check STOP operational software, and continue to try to
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5003 unit STOP message appears again, contact the After Service
Communication Reset the power supply of the control section again
failure of Reagent and restart the operational software. If this
5004 Tray 1 unit STOP message appears again, contact the After Service
Command of Turn off and then on the power supply of the
Reagent Tray 1 analysis section and restart the software. If this
unit cannot be message appears 3 times in a row, contact the After
5005 executed normally STOP Service
Exit the operational software and turn off the test
Reagent Tray 1 switch. 5S later, turn on the test switch and
unit cannot be operational software again. If this failure appears 3
5006 reset PAUSE times in a row, contact the After Service
Lost step in Exit the operational software and turn off the test
movement of switch. 5S later, turn on the test switch and
Reagent Tray 1 operational software again. If this failure appears 3
5007 unit PAUSE times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
Reagent Tray 2
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Abnormality of Exit the operational software and turn off the test
cleaning agent switch. 5S later, turn on the test switch and
temperature operational software again. If this failure appears 3
10014 sensor WARNING times in a row, contact the After Service
Exit the operational software and turn off the test
Temperature of switch. 5S later, turn on the test switch and
whole machine operational software again. If this failure appears 3
10015 cleanser too high WARNING times in a row, contact the After Service
Abnormality of
whole machine Exit the operational software and turn off the test
cleanser switch. 5S later, turn on the test switch and
temperature operational software again. If this failure appears 3
10016 sensor WARNING times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
operational software, and continue to try to
execute this command. If this message appears 3
10501 Command error STOP times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
operational software, and continue to try to
execute this command. If this message appears 3
10502 Parameter error STOP times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
operational software, and continue to try to
Abnormality of execute this command. If this message appears 3
10503 self-check STOP times in a row, contact the After Service
Conduct the whole machine reset operation on the
Maintenance screen. If this failure continues, turn
off and then on the test switch, restart the
Refrigeration Unit
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Calibration
standard A in ISE
11021 unit has air CANCEL
Calibration
standard A in ISE
11022 unit has air CANCEL
Cleanser in ISE unit
11023 has air CANCEL
No liquid in tube
11024 of ISE unit CANCEL
Calibration failure
11025 of ISE unit CANCEL
Calibration value
storage error of
11026 ISE unit CANCEL
Failure of bubble
detector of ISE
11027 unit LIMIT
Command
execution error of
11028 ISE unit CANCEL
Reagent module of
ISE unit does not
11029 exist LIMIT
Command error of
sample barcode
12001 unit LIMIT
Parameter error of
sample barcode
12002 unit LIMIT
Sample Barcode Unit
Abnormality of
self-check of
sample barcode
12003 unit LIMIT
Communication
failure of sample
12004 barcode unit LIMIT
Barcode check
error of sample
12005 barcode unit CANCEL
Barcode
information error
of sample barcode
12006 unit CANCEL
Command error of
reagent barcode
13001 unit LIMIT
Parameter error of
reagent barcode
Reagent Barcode Unit
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of reagent barcode
unit
Check whether the QC setup parameters are
reasonable or not.
Check whether the item setup parameters are
correct or not.
Check whether the QC sample is valid or not.
Check whether the reagent is valid or not.
Reagent blank Check whether the calibration results are accurate
20000 exceeding range WARNING or not.
Check whether the QC setup parameters are
reasonable or not;
Check whether the item setup parameters are
correct or not;
Check whether the QC sample is valid or not;
Check whether the reagent is valid or not;
Exceeding 4SD Check whether the calibration results are accurate
20001 once WARNING or not.
Check whether the QC setup parameters are
reasonable or not;
Check whether the item setup parameters are
correct or not;
Check whether the QC sample is valid or not;
Check whether the reagent is valid or not;
Software System Failure
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Scanning failure.
Profile number
20020 cannot be judged! WARNING
Scanning failure.
Container type not
20021 matching! WARNING
Scanning failure.
Total length of
barcode not
matching with
20022 system setup! WARNING
Scanning failure.
Abnormality of
20023 barcode scanning! WARNING
Scanning failure.
Item number type
20024 not matching! WARNING
Scanning failure.
Reagent type
20025 cannot be judged! WARNING
Scanning failure.
Reagent type > 4.
Judgment
20026 impossible! WARNING
Scanning failure.
Reagent vial type
20027 cannot be judged! WARNING
Scanning failure.
Reagent vial type
not matching with
data dictionary.
Judgment
20028 impossible! WARNING
Scanning failure.
Expiry date format
error. Judgment
20029 impossible! WARNING
Scanning failure.
Expiry date format
error. Judgment
20030 impossible! WARNING
Scanning failure.
Item number not
matching with
20031 item name! WARNING
Scanning failure.
Reagent type
information not
matching with
reagent setup of
20032 item! WARNING
Minimal volume
20033 detection failure! WARNING
Scanning failure.
Item number and
item name of this
barcode do not
20034 exist in item setup! WARNING
Scanning failure.
No reagent item
information
20035 obtained! WARNING
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Cumulative sum
control is out of
control. Please find
cause of out-of-
control. After
correction, clear
cumulative sum in
20036 QC rule setup. WARNING
ISE electrode
exceeds rated
total number of
20037 tests! WARNING
ISE electrode
exceeds rated
20038 total time of tests! WARNING
20039 Reagent missing! WARNING Replace the reagent and conduct the test again
Time out detecting
reagent. Detection Check whether the reagent is correctly placed or
20040 terminated! WARNING not
Dirty test cuvettes
exceed limit.
Please replace test
20041 cuvettes WARNING
Warning:
◆ In case of failure of the instrument, contact the agent immediately to obtain
technical support as soon as possible.
◆ Only professionals recognized by LiNEAR may repair the instrument. To replace
accessories, contact the manufacturer or agent.
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Elements
Shell × ○ ○ × ○ ○
Display × ○ ○ ○ ○ ○
Photoelectric
× ○ ○ ○ ○ ○
components
Internal
electronic ○ ○ ○ ○ ○ ○
wire
Accessories × ○ ○ ○ ○ ○
○: Indicates the content of the toxic/hazardous substance in all homogeneous materials of the component
is below the limit specified in the SJ/T11363 standard.
×: Indicates the content of the toxic/hazardous substance in at least one homogeneous material of the
component exceeds the limit specified in the SJ/T11363 standard.
2. Description of Mark
Environmental protection uses period mark.
Meaning of the mark: The electronic information product contains certain toxic/hazardous substances,
with the environmental protection use period of 20 years. You can use it within this period. When this
period expires, the product should enter the recycling system.
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