Chemray 420 User Manual V1.0e
Chemray 420 User Manual V1.0e
Chemray 420 User Manual V1.0e
Rev 1.0e
User’s Manual for Chemray 420 Automated Chemistry Analyzer
Warning: When the user ignores this symbol and misuses the instrument,
casualties, serious injury or serious property loss may be caused
to the user.
Caution: When the user ignores this symbol and misuses the instrument,
injury, wrong output results or property loss may be caused to the
user.
Representation
Rayto 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 Rayto, no individual or organization may duplicate, modify or
translate the contents of the Manual.
Rayto will be responsible for the safety, reliability and performance of the product only when
all the following requirements are met:
● Assembly, re-debugging, expansion, improvement and repair should be conducted by
persons recognized by Rayto;
● The product is operated according to the Manual;
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Caution
● The instrument must be used by medical examination professionals or trained doctors,
nurses or laboratory technicians.
Warning
● If no satisfied maintenance/repair plan is achieved, the instrument may fail abnormally and
may endanger personal health.
● Ensure 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.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Temperature Limit
The temperature limit of the transport package.
Fragile Objects
The transport package contains fragile objects. Be careful in
handling.
Upward
The correct position of the transport package is straight up.
Prevent Rain
Protect the transport package against rain.
Prevent Sunshine
Avoid direct sunshine.
Do Not Roll
Do not roll the transport package.
Biohazard.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Table of Contents
CHAPTER 1 INTRODUCTION....................................................... 12
1.1 Introduction ................................................................................................ 12
1.1.1 Product Name Automated Chemistry Analyzer.............................................................. 12
1.1.2 Model Chemray 420 ..................................................................................................... 12
1.1.3 Features.............................................................................................................................. 12
1.2 Composition and Structure of the Instrument............................................. 13
1.2.1 Analysis Section ................................................................................................................ 13
1.3 Scope ........................................................................................................ 25
1.4 Technical Parameters ................................................................................ 25
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CHAPTER 7 TEST......................................................................... 84
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Chapter 1 Introduction
1.1 Introduction
1.1.1 Product Name Automated Chemistry Analyzer
1.1.3 Features
Chemray 420 is a discrete automated 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.
1) Automated, random, optional, discrete, priority given to emergency treatment, and
fully open analysis parameters and reagents;
2) Up to 78 colorimetric items and 3 ISE items (K, Na and Cl; optional) in progress at
the same time;
3) The analysis methods include end-point method, two-point method, kinetics method,
etc. Single/dual-wavelength test and three/four-reagent test support;
4) One point calibration, two-point calibration, multi-point linear calibration or nonlinear
calibration;
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
n Deionized Water: Main inlet of deionized water for the analysis section, connected to the
deionized water entry tube.
The layout of the connectors of the liquid lines on the back of the analysis section is
shown in the figure below.
Low High
Cleaning
Agent Concentration Concentration
Waste Liquid
Sensor Waste Liquid 1
Sensor Sensor
Low
Concentration
Waste Liquid 1
Deionized Low
Water Concentration
Waste Liquid 2
The serial ports and power jacks on the back of the analysis section are shown in the
figure below.
Serial Port
Power Jack
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Figure 1-4 Serial Port and Power Jack on the Back of Analysis Section
n Serial Port: Connected to the data cable, through which the analysis section is
communicated with the operation section;
n Power Jack: Connected to the electric cable.
The sample probe module is mainly used to analyze the collection and delivery of samples
for analysis and is composed of the sample probe, sample probe rocker arm, sample probe
drive shaft, sample syringe, corresponding liquid lines, etc.
Functions of Sample Probe Module
n Sample Collection: The sample probe module is mainly used to absorb quantitative
sample from the sample test tube and deliver the sample to the test cuvette, with the
sample size of:
Ø For biochemical items: 2μl~45μl, increasing progressively by 0.1μl;
Ø For electrolyte items: 70μl (blood serum or blood plasma), 140μl (diluted urine)
(added twice, 70μl each).
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
n Cleaning of Sample Probe: The sample probe module includes a cleaning system that
cleans the outer wall of the probe in the fountain type way, cleans the inner wall of the
probe with high pressure water, and supports strong acid and alkali cleaning;
n 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;
n 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.
Structure of Reagent Probe Module
Chemray 420 includes two reagent probe modules - R1 and R2 which have exactly the
same structure. They are mainly used to collect and deliver reagents. A reagent probe
module is composed the reagent probe, reagent probe rocker arm, reagent probe drive shaft,
reagent syringe, corresponding liquid lines, etc.
Functions of Reagent Probe Module
n Reagent Collection: The reagent probe module is mainly used to absorb quantitative
reagent from the reagent bottle and deliver the reagent to the test cuvette. The reagent
probe module moves repeatedly in the order of reagent bottle, reaction tray, and reagent
probe cleaning tank to complete reagent adding, in which,
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Ø R1 is used to absorb reagent No. 1(3), with the volume of 150μl~350μl, increasing
progressively by 1μl;
Ø R2 is used to absorb reagent No. 2(4), with the volume of 20μl~250μl, increasing
progressively by 1μl.
n Cleaning of Reagent Probe: The reagent probe module includes a cleaning system that
cleans the outer wall of the probe in the fountain type way, cleans the inner wall of the
probe with high pressure water, and supports strong acid and alkali cleaning;
n 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;
n 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 module mainly includes the sample tray and its drive system, sample
pot, sample barcode scanner, etc.
Functions of Sample Tray Module
n 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.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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 sample probe moves back and forth,
otherwise, the sample probe may be collided.
n The sample tray is divided into the outer, middle and inner circles. Each of the outer and
middle circles has 35 sample positions, and the inner circle has 30 sample positions;
n The sample tray has a total of 100 sample positions, in which, sample positions 97-100
are for ISE cleaning solution (D1), acid cleaning solution (D2), alkaline cleaning solution
(D3), and deionized water (W);
n Virtual Sample Tray: The Chemray 420 system software allows the setup of up to 7
virtual sample trays at the same time, one of which can be selected as the current
sample tray.
n Sample containers, such as original blood collection tube, centrifuge tube, plastic test
tube, small sample cup, etc., can be put on the sample tray. The following sample
containers are compatible with the sample tray:
Ø Standard Test Tubes: Ф12×68.5, Ф12×99, Ф12.7×75, Ф12.7×100, Ф13×75, and
Ф13×100;
Ø Original Blood Collection Tubes: Ф12×68.5, Ф12×99, Ф12.7×75, Ф12.7×100,
Ф13×75, and Ф13×100;
Ø Small Sample Cups: Ф10×37 and Ф12×3.
n The body of the sample tray can be picked and placed freely for you to replace the whole
tray of samples easily.
Ø Pick: Loosen the two fixing screws on the sample tray, hold the handle of the tray,
and lift and take it out vertically.
Ø Place: Hold the handle 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.
n The sample barcode scanner is optional.
Ø The sample barcode has 3~27 digits, supports the NCCLS standard, and is
compatible with various barcode application environments.
Ø You can set the format of sample barcode and select the barcode system.
Ø 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 Module
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
The reagent tray module mainly includes the reagent tray and its drive system, reagent
pot, reagent refrigeration system, reagent barcode scanner, etc.
Functions of Reagent Tray Module
n The reagent tray is a support where the reagent bottles are carried. Its drive system can
rotate each reagent bottle to the sampling position of the reagent probe according to the
system setting to wait for reagent absorption.
n The reagent refrigeration system is used to guarantee the reagent in the reagent bottle is
always stored in the low temperature environment to keep the reagent stable and reduce
volatilization.
n The reagent tray is divided into the inner and outer circles, each of which includes 40
reagent positions. The compatible reagent bottles are: Rayto outer circle bottle 25ml,
Rayto inner circle bottle 70ml, and Hitachi 60~70ml reagent bottle.
n The reagent tray has a total of 80 reagent positions, in which, reagent positions 79 and
80 are for strong cleaning solution (D) and deionized water (W);
n Any type of reagent (R1/R2/R3/R4) of a test item is allowed to be put at any reagent
position in the reagent tray;
n Two virtual reagent trays (80 positions) can be set. During a test, the system can
dynamically prompt for replacement of reagent tray;
n The reagent refrigeration system can provide 24-hour uninterrupted refrigeration, with
the storage temperature of 2~10℃;
n The body of the reagent tray can be picked and placed freely for you to replace the
whole tray of reagents easily.
Ø Pick: Loosen the two fixing screws on the reagent tray, hold the handle of the tray,
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User’s Manual for Chemray 420 Automated 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 Module
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
n For a single-reagent item test, M1 begins to mix the contents after the sample is added,
and M2 does not move;
n 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;
n 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;
n 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’s Manual for Chemray 420 Automated Chemistry Analyzer
1.3 Scope
Applicable to quantitative analysis of various samples with liquid reagents.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Sample
Optional fixed barcode scanner
Barcode
Sample
Automatic liquid level detection, tracking depending on volume, 3D
Adding
collision protection
Technology
Automatic
Equivalent, increment and decrement retests, and 3~150 times dilution
Sample
retest
Retest
Carry-over of
Cleaned automatically, carry-over ≤ 0.1%
Sample Probe
Reagent Two reagent probes for R1(R3) and R2(R4) respectively; liquid level
Probe detection, tracking depending on volume, 3D collision protection
Reagent
80 reagent positions
Position
Spec. of
Reagent 25ml and 70ml support; compatible with Hitachi reagent bottles
Bottle
Volume of
R1: 150~350μl, R2: 20~250μl, increasing progressively by 1μl
Reagent
Refrigeration
2~10℃, 24-hour uninterrupted refrigeration
of Reagent
Reagent
Optional fixed barcode scanner
Barcode
Carry-over of
Reagent Cleaned automatically, carry-over ≤ 0.1%
Probe
100 test cuvettes made of organic glass with the optical diameter of 5mm.
Test cuvette
Quartz test cuvettes of the same specification are compatible.
Volume of
Reaction 150~500μl
Liquid
Temperature
Control of Direct solid heating, free from daily maintenance
Reaction Tray
Temperature
Room temperature, 30℃, 37℃, temperature fluctuation ±0.2℃
of Reaction
Two mixers that begin to mix the contents after the sample and reagent
Way of Mixing
are added respectively.
Cleaning of 8-stage automatic cleaning, preheating of cleaning solution, warning of
Test cuvettes minimal volume of cleaning solution
Light Source Halogen lamp
Way of Light
Flat-field holographic concave grating, in the rear light splitting way
Splitting
Wavelength 12 wavelengths, precision ±2nm
Detector Photodiode array
Linear Range 0~2.5A
Input Branded PC, Chinese and English versions of multimedia analysis and
Equipment control software
Output
Wide-screen LCD, printer
Equipment
Interface RS232 serial port
Tube Connected to specific water machine, waste liquids of different
Connector concentrations discharged separately, with the minimal volume warning
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
function
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Packing Case
Analysis Section
Pallet
Foot Margin
2) Take out the accessories and check the objects against the accessories list. If any object
is missing, immediately inform Rayto’s After Service Unit or the retailer.
Caution: Keep the packing case for packing before long distance
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Caution:
u The normal working environment for the instrument is temperature of
10℃~30℃ and HR of 40%~85%.
u 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.
u It must be installed and moved by authorized professionals.
u Please dispose the waste liquid discharged by the system in
accordance with the local standards.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Warning:
Caution:
u Be sure to operate the system within the specified range of ambient
temperature and humidity, otherwise the results may not be reliable.
u If the ambient temperature and humidity exceed the specified range,
please use an air conditioning equipment.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Caution:
u The quality of water must meet the requirements of water supply,
otherwise the test results may be impacted due to insufficient purity of
water.
2.6 Installation
Max. 2m
Operation Section
Analysis Section
Min. 0.5m
Min. 0.5m
Min. 0.5m
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Cleaning
Concentration
Concentration
Water
Waste Liquid
Waste Liquid
Agent
Machine
High
Low
Figure 2-3 Liquid Line Connection
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Warning: Before mouting the test tube, confirm the system is in the
standby mode and the sample tray has stopped.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Connector
Reagent Pack
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Insert one end of the serial cable into the serial interface of the instrument and the other
end into the serial interface COM1 of the control computer (the port setting can be
changed to use other serial interfaces).
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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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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.
n Check that the three plate covers on the workbench have been closed;
n Check that there is no obstacle in the motion region of the various components
on the workbench;
n Check that the deionized water machine has been turned on;
n Check that the high concentration waste liquid tank and low concentration
waste liquid tank have been emptied;
n Check that the minimal volume of cleaning solutions (including the cleaning
solution for test cuvettes, cleaning solution in the reagent tray, and cleaning
solution in the sample tray) is sufficient;
n Check that the minimal volume of deionized water for the reagent tray and
sample tray is sufficient;
n Check that all tubes are correctly connected;
n Check that the serial control cables are properly connected;
n Check that the electric cables are properly connected.
2) Check whether the printing paper is sufficient and whether they are inserted in
place.
3) Keep the User’s Manual in a handy place.
4) Operate and maintain the computer according to the instructions of the computer.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Caution: The user name 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’s Manual for Chemray 420 Automated Chemistry Analyzer
n Units shaking hands: Test whether the status of the various units is normal.
n Sending parameters: Read system parameters from the middle computer.
n System reset: Conduct whole machine reset and liquid line filling to prepare for
testing.
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’s Manual for Chemray 420 Automated Chemistry Analyzer
tray, remaining test time, LIS connection status, ISE status, operator, and current
time.
n Help: Click the Help icon to display the About and Help selection box.
n Function Button Area: Displays the function buttons, including Sample, Reagent,
Calibration, QC, Status, Statistics, Parameter, Setup, Maintenance, and Off. Click a
function button, and the working page corresponding to the button will appear.
n Shortcut Button Area: Includes the Start, Pause, and Stop buttons. Click a shortcut
button to operate the system accordingly.
n Function Window Area: Displays the values and graphs of the parameters,
processes, results, etc. corresponding to the selected function button.
n Prompt and Alarm Message Display Area: Displays alarm, warning or error
messages. Click the Inquire button to inquire 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 screen 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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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Caution:
u 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.
u When Pre-Blank is selected, the start point and end point shall be in
the corresponding range. Input range for single-reagent tests: 10-150;
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
11) Measurement Time: To set the start time and end time of measurement respectively.
For single-reagent items, the range of measurement time is 20-600 seconds; for
double-reagent items, 20-300 seconds; for three-reagent items, 20-750 seconds; for
four-reagent items, 20-300 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 30
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:
n 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
n 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
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
determination results, the substrate exhaust limit (a certain absorbance) needs to be set
which should be exactly the critical point between linear zone and nonlinear zone in the
reaction curve, 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 indicates no judgment.
n 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.)
n 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.
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.
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
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
n Set the photometric points for prozone check [Q1], [Q2], [Q3], and [Q4]
n Set the prozone limit [PC] and lower limit of absorbance for prozone check [ABS]
n 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.
n Requirements of photometric point input:
Single-reagent items: 16<q1 <q2< q3< q4<= End point of reaction <= 76
Double-reagent items: 46<q1 <q2< q3< q4<= End point of reaction <= 76
Three-reagent items: 102<q1 <q2< q3< q4<= End point of reaction <= 176
Four-reagent items: 146<q1 <q2< q3< q4<= End point of reaction <= 176
n 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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User’s Manual for Chemray 420 Automated Chemistry Analyzer
The function is used to set the test priority of items. Select the item for which the test
sequence needs to be adjusted, use the Up and Down keys or the mouse to adjust it to the
proper position, and click the Save button after adjusting all items.
To restore the default test sequence, click the Restore button and save the setting.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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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User’s Manual for Chemray 420 Automated Chemistry Analyzer
about 2.5 minutes and then add the sample cleaning solution and mix the contents, and wait
about 10 minutes and then conduct the second cleaning. As the test cuvette has undergone
the special cleaning process of “automatic cleaning – add cleaning solution and soak -
automatic cleaning”, thus eliminates cross contamination between items.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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 substances used by the system.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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
substance in turn
4.3.2 Delete QC
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
Select the QC substance to be deleted from the QC substance list and click the Delete QC
button.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
n 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.
n Cumulation and QC: Whether the cumulation and rule are used. Select it to
cumulate the QC substance and make rule judgment.
n 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 cumulation and calculation, and 2.7S is
the QC limit H.
n 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.
n Empty Cumulative Sum: After calibration and correction of the out-of-control
instrument, click the Empty Cumulative Sum button to restart cumulation and QC.
After the cumulative sum is emptied, the current value of cumulative sum is 0.
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User’s Manual for Chemray 420 Automated Chemistry Analyzer
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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n Number: The unique number of the item. If the system adopts the barcode
scanning to obtain sample information, the item number must be consistent with the
definition of the information system, otherwise the sample information may be
wrong!
n Full Name of Item: The full name of the ISE item. It may be empty;
n Slope and Intercept: The linear correction coefficient for the test results of the
system. Results = Measured value * Slope + Intercept. In general, no correction is
needed: Slope = 1, Intercept =0;
n 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<;
n Unit of Results: The unit of results of the ISE item. It cannot be modified;
n Precision of Results: The precision of results of the ISE item. It cannot be
modified.
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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
substance in turn.
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Specify a QC substance 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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n 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.
n Cumulation and QC: Whether the cumulation and rule are used. Select it to
cumulate the QC substance and make rule judgment.
n 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 cumulation and calculation, and 2.7S is
the QC limit H.
n 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.
n Empty Cumulative Sum: After calibration and correction of the out-of-control
instrument, click the Empty Cumulative Sum button to restart cumulation and QC.
After the cumulative sum is emptied, the current value of cumulative sum is 0.
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n 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.
n Volume Used Each Time: To display the volume of the reagent used in each test
of the set item.
n 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”.
Caution: The reagent positions 79 and 80 are used for cleaning solution and
deionized water respectively. Other reagents are prohibited.
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n 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;
n Detect the minimal volume of reagent of all set reagents: Detect the minimal
volume of all set reagents in the current reagent tray.
n 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.
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Caution: Before reagent detection, input and save the Bottle Type
information corresponding to the reagent positions first. Otherwise
detection of minimal volume of reagent is impossible.
n Scan all positions: To scan all positions on the current reagent tray.
n 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.
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Click System Setup in the main menu to enter the System Setup page as shown in Figure
6-1:
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automatically when the test fails (for example, in case of collision of the sample
probe or reagent probe);
n Automatic Sleep Time: To set the automatic sleep time. As long as the idle time of
the system exceeds the set time, the system will enter the sleep mode automatically.
In the sleep mode, the light source protection function will be activated. To use the
machine again, execute the Awake operation;
n Automatic QC Setup: To set the interval of QC. 0 indicates no automatic QC is
conducted;
n Automatic Calibration Setup: To set the interval of calibration. 0 indicates no
automatic calibration is conducted;
n Upper Limit of No. of Dirty Cups: To set the maximum number of dirty test
cuvettes when you are prompted to replace the test cuvettes;
n 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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n Exceeding Upper Limit of Linear Range: When the test results exceed the upper
limit of linear range set for the item, the system will do a retest for the test with the
results exceeding the limit according to the retest method.
n Less than Lower Limit of Linear Range: When the test results are less than the
lower limit of linear range set for the item, the system will do a retest for the test with
the results exceeding the limit according to the retest method.
n No Calculation Interval: When the number of photometric points in the linear range
is less than 3 during the highly active enzyme inspection, the enzyme linear range
expansion 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.
n 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.
n Exceeding Max. Calibration Reactivity: When the reactivity tested exceeds the
reactivity of the calibration solution of the maximum concentration, the system will
do a retest for the test with the results exceeding the limit according to the retest
method.
n Less than Zero Concentration Calibration Solution: When the reactivity tested is
less than the reactivity of the calibration solution 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:
n Report Title: Set the title of the patient report, such as “Inspection Report of ××××
Hospital”.
n Report Annotation: Set the remark of the patient report, such as “Note: The
inspection results are for the sample only”.
n Printing Sequence Setup: Set the printing sequence of the items in the general
report.
n 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:
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From the type selection box, select the data dictionary entry to be observed and edited, and
all data 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 Bottle Type. The data dictionary entry is
character type, with the maximum length of 30 characters.
n Description: The description of a data dictionary entry, which indicates the meaning
of the data dictionary entry. It can be empty.
n Add: Select a data type, click the Add button, add a new entry to the selected data
type, and click the Save button;
n Modify: Select a data type, edit the related entry, and click the Save button;
n 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. 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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Operating Software
As the item name and number in the LIS system may be different from those in the
instrument, in order 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 character type, with the
length of 0~20 characters, which indicates the code of the item in the LIS host.
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wrong barcode. The barcode scanned will be discarded and will not be saved. The check bit
is not counted in the number of digits of a barcode. Do not input the check bit when manually
inputting a barcode.
n Total No. of Digits: The total number of digits of a sample barcode. Options: 10-30.
n Test Type: Regular and Stat. Options: 0 or 1 digit.
n Submission Date: Year-Month-Day. Options: 0, 6 or 8 digits.
n Sample No.: The number of the sample. Options: 0-10 digits.
n Sample Type: The sample type defined in the data dictionary (for example, blood
serum: 1; blood plasma: 2, etc.) Options: 0 or 1 digit.
n Profile No.: The number of the item profile. Test items are applied with profile
numbers. Options: 0-5 digits.
n Container Type: The specification of a sample container. Options: 0 or 1 digit.
n Default of sample barcode information:
Name Default
Test Type Regular
Submission Date Current day
Generated
Sample No.
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 and
obtain the information if any; detect whether there is setup
information at the scanning position 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
information obtained first and then clear the repeated information.
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Application of reagent barcodes in the operating system. All buttons related to the reagent
barcode function are active.
n Total No. of Digits: The total number of digits of a reagent barcode. Options:
10-30.
n Item Number: The number of the tested item. Options: 0-5 digits.
n Item Name: The name of the item. Options: 0-10 digits.
n Reagent Type: R1/R2/R3/R4. Option: 1 digit.
n Bottle No.: The number of the reagent bottle. Options: 0 or 3-5 digits.
n Bottle Spec.: The bottle specification defined in the data dictionary. Options: 0 or 1
digit.
n Batch No.: The production batch number of the reagent. Options: 0 or 3~5 digits.
n Expiry Date: Year-Month or Year-Month-Day. Options: 0, 4, 6 or 8 digits.
n Default of reagent barcode information:
Name Default
Item Number None
Item Name None
Reagent Type R1
Bottle 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
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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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repositioned through barcode scanning after the barcodes are input and saved.
n Sample No.: The maximum length of a sample number is 15 digits. The sample
number can be input manually or generated by the system automatically. If the
worksheet has not any sample, the system will generate 10-digit sample numbers
automatically, including 2-digit year number + 2-digit month number + 2-digit day
number + 1-digit worksheet number +3-digit serial number, such as 1109232001. If
the worksheet has samples saved, the system will generate new sample numbers
automatically according to the format of the existing sample number.
n Sample Container: The type of sample container used, including Standard Tube
and Small Cup.
n Sample Type: The options in the sample type are the options set in the data
dictionary.
n Sample Barcode: The barcode information of the sample which can be obtained
with the barcode scanning system or input manually.
n 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 reason, 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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n Display Details: Display all information on the sample for you to view and edit.
n Obtain Default: Obtain default information according to the default set in “Setup -》
Printing Setup”. For details, see Printing Setup.
n Save: Save the set information and return to the previous screen.
n Back: Return to the previous screen without saving the information.
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The default settings can be modified on the Item Options Setup screen. The meanings of the
test information are as follows:
n Sample Size: Set the sample size 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 size, dilution sample size and dilution ratio
according to the selected sample size mode. You can further adjust the above
information according to the specific needs.
n Test Sample Size: Specify the volume of sample used in a test. The default is
obtained according to Sample Size. You can further edit it as needed.
n Dilution Sample Size: Specify the volume of dilution sample used in a dilution test.
The default is obtained according to Sample Size. You can further edit it as needed.
n 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.
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n Dilution Ratio: Set the dilution ratio of sample in a test. The default is obtained
according to Sample Size. 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.
n Repeat Count: Set the times of repetition of a sample test. The default is 1. You can
further edit it as needed.
n 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.
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n 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:
n Scan All Positions: Select “Scan All Positions” and click the OK button, and the
system will scan positions 1-96 in the selected worksheet;
n 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”.
Caution:
u 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.
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u 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.
u 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 inquire 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:
n Updated Sample on the Current Day: The operating software will obtain all
sample information that has not been obtained on the current day from the LIS
system.
n All Samples on the Current Day: The operating software will obtain all sample
information on the current day from the LIS system.
n 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 operating software.
For the treatment of repeated information, see “LIS Setup” in “System Setup”.
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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.
Caution: Input any figures among 1-96 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:
u 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…
u When the application is finished, you can modify it manually.
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:
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n Sample Position: Set the position of the sample in the selected worksheet. The
range of editable positions is 1-96. Positions 97-100 cannot be edited, in which,
position 97 is for ISE cleaning solution, position 98 for acid cleaning solution,
position 99 for biochemical analyzer specific cleaning solution, and position 100 for
deionized water.
n Sample Container: The type of sample container used, including Standard Tube
and Small Cup.
n 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:
n Repeat Count: Set the times of repetition of a QC test. The default is 1. You can
further edit it as needed.
n Save: Save the setting and return to the previous screen.
n Next: Display the item information of the next QC sample position.
n Previous: Display the item information of the previous QC sample position.
n 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”.
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n Sample Position: Set the position of the sample in the selected worksheet. The
range of editable positions is 1-96. Positions 97-100 cannot be edited, in which,
position 97 is for ISE cleaning solution, position 98 for acid cleaning solution,
position 99 for biochemical analyzer specific cleaning solution, and position 100 for
deionized water.
n Sample Container: The type of sample container used, including Standard Tube
and Small Cup.
n 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:
n Repeat Count: Set the times of repetition of a standard test. The default is 1. You
can further edit it as needed.
n Save: Save the setting and return to the previous screen.
n Next: Display the item information of the next standard sample position.
n Previous: Display the item information of the previous standard sample position.
n Back: Return to the Sample Application page without saving the setting.
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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n Worksheet: Select the worksheet for which a test will be conducted soon. If the
system is conducting a test, the worksheet has been fixed.
n 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.
n Initial Test: To conduct initial test for the tests not finished or retests in the current
worksheet. If the system is conducting a test, this option is read only.
n Retest: To conduct 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.
n Calibration Selection: Select the calibration test required this time. Calibration
tests commenced cannot be edited.
n 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.
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Before confirming the commencement of the test, please confirm the above information and
check that the sample, calibration solution, QC solution, 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:
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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.
Prompt Description
Reagent Tray The setting of the selected virtual reagent tray does not
should be include the reagents required for the item test.
Reselected
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.
Caution: Test items with the prompt “Reagent Tray should be Reselected”
in the list will not be loaded as the selected virtual reagent tray
does not include the reagent for the item. After completing all
current tests, you can replace the reagent tray, press the Start
button again, and select the corresponding reagent tray to test it.
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button on the left bottom corner of the screen to enter the screen as shown in the figure:
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.
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n Worksheet: Including 7 test worksheets in the system, in which, the worksheet with
an asterisk (*) at the end is the current worksheet.
n Reagent Tray: Including 2 virtual reagent trays in the system, in which, the reagent
tray with an asterisk (*) at the end is the current reagent tray.
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n 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 Light green
pre-blank
E1 End point of Light green
pre-blank
S2 Start point of Light green
calculation
E2 End point of Light green
calculation
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n 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.
n Prim: The measured absorbance of the primary wavelength, indicated with red
points.
n Sec: The measured absorbance of the secondary wavelength, indicated with green
points.
n Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
n 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.
n Print: Print the reaction curve graph.
n Refresh Minimal Volume of Selected Sample Position: Cancel the missing sign
of the selected sample position.
n Refresh Minimal Volume of All Sample Positions: Cancel the missing sign of all
sample positions.
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n Refresh Minimal Volume of Specified Sample Position: Cancel the missing sign
of the sample positions in the specified range.
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:
n Sample Size: Set the sample size 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 size, dilution sample size and dilution ratio
according to the selected sample size mode. You can further adjust the above
information according to the specific needs.
n Test Sample Size: Specify the volume of sample used in a test. The default is
obtained according to Sample Size. You can further edit it as needed.
n Dilution Sample Size: Specify the volume of dilution sample used in a dilution test.
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The default is obtained according to Sample Size. You can further edit it as needed.
n Dilution Ratio: Set the dilution ratio of sample in a test. The default is obtained
according to Sample Size. 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.
The status information on the left side of the reagent tray graph is shown in the table below:
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n 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.
n New Reagent Position: Input the position that is empty on the reagent tray.
Caution:
u The deionized water and cleaning solution positions are fixed and
cannot be moved.
u If items corresponding to the reagent have been applied for, movement
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is prohibited.
n Refresh Minimal Volume of Selected Reagent Position: Cancel the missing sign
of the selected reagent position.
n Refresh Minimal Volume of All Reagent Positions: Cancel the missing sign of all
reagent positions.
n Refresh Minimal Volume of Specified Reagent Position: Cancel the missing sign
of the reagent positions in the specified range.
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volume of the reagent. When the detection is finished, the minimal volume displayed will be
refreshed, as shown in the figure.
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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 Black 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.
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Dirty test Earthy The blank value of the test cuvette exceeds the allowed
cuvette yellow lower limit. Maybe the test cuvette has not been
cleaned or has been stained.
Strong Purple The test cuvette is being strongly cleaned.
cleaning
n 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 Light green
pre-blank
E1 End point of Light green
pre-blank
S2 Start point of Light green
calculation
E2 End point of Light green
calculation
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n 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.
n Prim: The measured absorbance of the primary wavelength, indicated with red
points.
n Sec: The measured absorbance of the secondary wavelength, indicated with green
points.
n Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
n 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.
n Print: Print the reaction curve graph.
n Display Type: Select “Display All”, “Display Finished” or “Display Unfinished”, and
the system will automatically screen the test records as required.
n Reaction Curve: Select a test from the list and click the Reaction Curve button to
view the reaction curve corresponding to the test.
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n 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.
n Print: Print the results of a finished patient sample test.
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Reselected
Abnormal Any abnormality appears during the test of the item,
such as reagent missing or collision.
Caution: Test items with the prompt “Reagent Tray should be Reselected”
in the status will not be loaded as the selected reagent tray does
not include the reagent for the item. After completing all current
tests, you can replace the reagent tray, click the Start button again,
and select the corresponding reagent tray to test it.
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Click “Result” in the main menu to enter the Patient Record page as shown in the figure:
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Caution: Only operators with the “Result Editing” privilege may edit patient
test results.
Caution:
u Retested, manually added or modified test results are prompted with “*”
at the end.
u Results on the high side and low side are prompted with “↑” and “↓”
respectively.
u 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 inquire whether to
overwrite the existing patient information.
u 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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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.
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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Before printing the patient report for the first time, the report format should be set. Select the
Set button on the Patient Record screen, and the screen as shown in the figure will appear:
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.
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Input the inquiry criteria and click the OK button, and all test records meeting the criteria will
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Caution: Retested, manually added or modified test results are marked with
“*” at the end.
n 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
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n 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.
n Prim: The measured absorbance of the primary wavelength, indicated with red
points.
n Sec: The measured absorbance of the secondary wavelength, indicated with green
points.
n Prim-Sec: The absorbance of the primary wavelength minus that of the secondary
wavelength, indicated with blue points.
n 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.
n 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
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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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n 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.
n Print: Print the calibration curve graph.
n Send the Selected Item: Send the calibration parameters and results of the
selected item to the LIS host;
n Send All Items: Send the calibration parameters and results of all items in the list to
the LIS host.
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9.4 QC Inquiry
Function Brief: To view the test results in the specified time range of the specified QC
item.
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hold the Ctrl key). The Youden rule does not judge the QC results
automatically.
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.
n Real-time QC Graph: Draw all data. Each QC datum corresponds to the
X-coordinate value on the graph.
n 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 the X-coordinate value.
n Display QC Point Time: Select the Display QC Point Time option, and the QC test
time will be displayed on the QC point.
n Target Value and SD Value: The fixed target value and SD value set for the QC
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substance.
n Mean and SD Value: The mean and SD value obtained through statistics of data
actually tested for the QC substance.
n Out-of-control Prompt: Prompt the out-of-control QC solution according to the set
QC rule.
n Print: Print the QC graph.
Caution: The numbers on the right side of the cursor on the Wwstgard QC
graph and cumulation & rule 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.
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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.
On the Cumulation & 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.
n Cumulative Sum: Display the total cumulative sum of the QC substance.
n QC Limit H: Display the upper limit of cumulative QC of the QC substance.
n QC Limit L: Display the lower limit of cumulative QC of the QC substance.
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For the Youden rule, the mean and SD of the corresponding QC solution are displayed
on the left and upper sides of the QC graph respectively. Move the cursor on the QC point to
observe the specific data 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.
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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 solutions tested will be displayed. If two QC
solutions 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 solution lesser tested.
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n Send Selected Item: Send the QC data of the selected item to the LIS host;
n Send All Items: Send the QC data of all items in the list to the LIS host.
All items with reagent blank tested are displayed on the list on the left side. Click the item
to be inquired, and the historic reagent blank record will be displayed on the list on the right
side.
n Reaction Curve: View the reaction curve graph of the reagent blank test.
n Delete: Delete the selected reagent blank record in the list.
n Delete All: Delete all reagent blank records in the list.
n 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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n Last Results: Display the results of the last calibration, including calibration results
and calibration reagent.
n Historic Results: Inquire the historic calibration results in the date range.
n Inquire: Inquire the calibration results in a time period of the selected ISE item
according to the date range.
n Delete: Delete the specified ISE calibration results.
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n QC Graph: Display the QC graph according to the selected time and QC rule.
n Delete: Delete the selected QC data.
n Print: Print the QC data of the selected time.
n Send: Transmit the data of QC results.
Caution: The ISE Calibration Inquiry and ISE QC Inquiry pages are
displayed only when the ISE module has been installed in the
instrument.
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Chapter 10 Statistics
10.1 Worksheet 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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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.
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Caution:
u There is potential biological contamination on the surface of the
components of the instrument, proper safety measures should be taken
for operaiton and maintenance;
u Improper maintenance may cause damage of the insturment. Be sure to
conduct maintenance according to the instructions;
u If any failure or problem not listed in the instructions is encountered,
please contact Rayto’s User Service Department, and the professional
designated by Rayto will give suggestions on maintenance;
u Be sure to use the parts and components supplied by Rayto for
maintenance;
u If you have any question, please contact Rayto’s User Service
Department.
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a) Gently wipe the point of the probe with a gauze soaked with alcohol till the
surface becomes smooth and oil-free;
b) Clean the point of the probe with a gauze soaked with deionized water;
c) Turn on the power supply of the analysis section, enter the Maintenance – Daily
Maintenance page, and execute the Reset Whole Machine operation.
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3. Cleaning the barcode scanning window (with the optional fixed barcode scanning)
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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 a 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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pool.
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Caution: The replacement of wiping head and mixer must be allowed by the
engineer of Rayto.
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n 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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Export the patient sample test results in the specified time range. Data exported will be
saved in 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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n Daily cleaning
n 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;
n 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:
n On the low side L
n On the high side H
n Exceeding the lower linear limit A<
n Exceeding the upper linear limit A>
n Exceeding the linearity range (nonlinear) OL
n Substrate exhaust SE
n Less than the increment retest limit AR
n Greater than the decrement retest limit DR
n No linear interval NLN
n No calculation interval ENC
n Prozone check exceeding limit PRO
n Exceeding reactivity of zero concentration RRZ
n Exceeding reactivity of maximum calibration RRN
n Still abnormal after retest **
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will continue;
n Sample Probe Failure: When the sample probe is collided and cannot be restored or
the syringe of the sample probe is abnormal during the test, thus the sample probe
cannot be used for adding sample any longer, the software will prompt “Sample
Probe Failure” and enter the pause mode, but the test with sample added will
continue;
n 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;
n 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.
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Sample Probe 1001: Command error Stop Restart the instrument PC;
level Check whether the board
1002: Parameter error Stop matches with the program
level version; if, after the instrument
1003: Abnormality of Stop and software are restarted, the
self-check level failure still appears, contact the
1004: Communication failure Stop After Service Unit.
level
1005: Command cannot be Stop
executed normally level
1006: Abnormality of vertical Stop Check whether the cover of the
movement (in test cuvette, not level sample test rube is removed;
restored) Check whether the sample is
1007: Abnormality of vertical Pause missing in the sample cup;
movement (in sample cup, not level Check whether the covers of
restored) reaction tray and sample tray
1008: Abnormality of vertical Pause are closed;
movement (in cleaning pool, level Check whether there is any
not restored) foreign object on the movement
1009: Abnormality of vertical Pause trace of the sample probe;
movement (in ISE sample level Check whether the appearance
adding opening, not restored) of the sample probe is normal;
1010: Abnormality of vertical Pause Check whether the positions of
movement (other positions, level the sample probe are in the
not restored) center;
1011: Abnormality of vertical Cancel After the sample probe is
movement (restored) level vertically jacked up and
1012: Vertical probe collision Stop loosened, check whether the
(not restored) level sample probe can be reset
1013: Vertical probe collision Cancel freely.
(restored) level
1014: Vertical reset signal not Stop Turn off the power supply of the
detected level analysis section, hold the rocker
arm of the sample probe, and
move the sample probe to the
intermedial height. Then turn on
the power supply of the analysis
section. If, after the instrument
and software are restarted, the
failure still appears, contact the
After Service Unit.
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2013: Vertical reset signal not Stop Turn off the power supply of the
detected level analysis section, hold the rocker
arm of the reagent probe, and
move the reagent probe to the
intermedial height. Then turn on
the power supply of the analysis
section. If, after the instrument
and software are restarted, the
failure still appears, contact the
After Service Unit.
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Reagent 3001: Command error Stop Restart the instrument and PC;
Probe 2 level Check whether the board
3002: Parameter error Stop matches with the program
level version; if, after the instrument
3003: Abnormality of Stop and software are restarted, the
self-check level failure still appears, contact the
3004: Communication failure Stop After Service Unit.
level
3005: Command cannot be Stop
executed normally level
3006: Abnormality of vertical Stop Check whether the reagent
movement (in test cuvette, not level bottle cover is opened;
restored) Check whether reagent is
3007: Abnormality of vertical Pause missing in the reagent bottle;
movement (in reagent bottle, level Check whether the covers of the
not restored) reaction tray and reagent tray
3008: Abnormality of vertical Pause are closed;
movement (in cleaning pool, level Check whether there is any
not restored) foreign object on the movement
3009: Abnormality of vertical Pause trace of the reagent probe;
movement (other positions, level Check whether the appearance
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3013: Vertical reset signal not Stop Turn off the power supply of the
detected level analysis section, hold the rocker
arm of the reagent probe, and
move the reagent probe to the
intermedial height. Then turn on
the power supply of the analysis
section. If, after the instrument
and software are restarted, the
failure still appears, contact the
After Service Unit.
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Other Failures 14001: Photoelectric Stop Restart the instrument and PC;
acquisition error level Check whether the board
14002: Abnormality of Stop matches with the program
photoelectric data level version;
14003 Abnormality of Stop If, after the instrument and
photoelectric acquisition level software are restarted, the
communication failure still appears, contact the
After Service Unit.
14004: Cleaning solution Warning Check whether the cleaning
insufficient level solution is sufficient and the
tube is connected normally.
14005: Deionized water Warning Check whether the deionized
insufficient level water machine works normally
and the reading of the pressure
gauge is normal.
14006: High concentration Warning Empty the high concentration
waste liquid full level waste liquid.
14007: Low concentration Warning Empty the low concentration
waste liquid full level waste liquid.
Software 20001: Exceeding 4SD once Warning Check whether the QC setup
System level parameters are reasonable;
Failure Check whether the item setup
20002: Exceeding 3SD once Warning parameters are correct;
level Check whether the QC sample
20003: Exceeding 2SD once Warning is valid;
level Check whether the reagent is
20004: Two results in a row Warning valid;
exceeding 2SD level Check whether the calibration
20005: Three results in a row Warning results are accurate.
exceeding 2SD level
20006: Five results in a row Warning
on one side of the target value level
20007: Seven results in a row Warning
on one side of the target value level
20008: Invalid calibration Warning Check whether the standard
level setup parameters are correct;
Check whether the item setup
parameters are correct;
Check whether the standard
sample is valid;
Check whether the reagent is
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valid.
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Warning:
u In case of failure of the instrument, contact the agent immediately so as
to obtain technical support!
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or 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/T11363-2006 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/T11363-2006 standard.
2. Description of Mark
Environmental protection use 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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