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LW C100plus Auto Chemistry Analyzer Operation Manual
LW C100plus Auto Chemistry Analyzer Operation Manual
Operation Manual
Copyright
©Shenzhen Landwind Industry Co., Ltd..All rights reserved.This manual and the information
contained herein are confidential information of Shenzhen Landwind Industry Co., Ltd.No
information contained in this manual without the prior wiitten permission of Shenzhen Landwind
Industry Co., Ltd.The manual is intended for users who are authorized to use such manual as a
part of the product purchased from Shenzhen Landwind Industry Co., Ltd.Use of this manual by
merchantability and fitness for for a particular purpose.Although every effort has been made to
ensure the accuracy of the information contained in this manual, Shenzhen Landwind Industry
Co., Ltd.assumes no liabilities for any errors or omissions and reserves the right to modify the
product to improve its reliablity,function or desigh without further notice. Shenzhen Landwind
Industry Co., Ltd.may modify or improve the product or program described herein at any time.
Statement
Shenzhen Landwind Industry Co., Ltd. has the right to explain the manual.
Authorized EC Representative
Foreword
Thank you for purchasing Landwind’s auto chemistry analyzer.
In order to use the product correctly,please read this manual carefully. After
Safty Symbols
The following table explains the safety symbols used in this manual.
Symbols Description
This symbol means to note. What the symbol indicates may damage
your analyzer or lead to unreliable test results.
This symbol means biohazard. What the symbol indicates may cause
biological contamination.
This symbol means electric shock. What this symbol indicates may get
you electrically shocked.
This symbol means corrosion. What this symbol indicates may cause
corrosive damage.
This symbol means high temperature. What the symbol indicates may
cause personal injury.
This symbol means strong light. What the symbol indicates may hurt
your eyes.
This symbol means personal injury. What this symbol indicates may
cause personal injury.
I
Foreword
Labels
The following table explains the safety symbols used in this manual.
Labels Description
Power on
Power off
Graphics
All graphics in this manual are for illustration only and must not be used for any other
purposes.
II
Contents
Foreword .................................................................................................................................. I
Contents................................................................................................................................. III
Chapter 1 Precautions on Safety and Use ................................................................................. 1
1.1 Safety Precautions ................................................................................................. 1
1.2 Precautions on Use ................................................................................................ 2
Chapter 2 Installation ..................................................................................................................... 6
2.1 Installer ..................................................................................................................... 6
2.2 Installation Requirements ...................................................................................... 6
2.3 Connecting Purified Water Bucket ....................................................................... 7
2.4 Connecting Waste Bucket ..................................................................................... 7
2.5 Installing or Removing Reagent/Sample Disk .................................................... 7
2.6 Installing or Removing Sample Tubes ................................................................. 8
2.7 Installing or Removing Reagent Bottles .............................................................. 8
2.8 Installing or Removing Cuvettes........................................................................... 9
2.9 Installing Software .................................................................................................. 9
Chapter 3 System Structure and Functions ............................................................................. 13
3.1 Analyzing Unit ....................................................................................................... 13
3.1.1 Overall Structure ........................................................................................... 13
3.1.2 Top View......................................................................................................... 13
3.1.3 Rear View ...................................................................................................... 14
3.1.4 Left View ........................................................................................................ 14
3.1.5 Right View ...................................................................................................... 15
3.2 Functional Modules .............................................................................................. 15
3.2.1 Reagent/Sample Dispenser Assembly ...................................................... 15
3.2.2 Mixer Assembly ............................................................................................. 16
3.2.3 Auto washing System .................................................................................. 17
3.2.4 Reaction Disk ................................................................................................ 17
3.2.5 Reaction Compartment ................................................................................ 18
3.2.6 Reagent/Sample Disk .................................................................................. 18
3.2.7 Reagent Refrigerator.................................................................................... 19
3.2.8 Acid/Alkaline Wash Position........................................................................ 19
3.2.9 Optical System .............................................................................................. 20
Chapter 4 Interface and Operations .......................................................................................... 21
4.1 Screen Structure ................................................................................................... 21
4.1.1 Menu Hierarchy............................................................................................. 21
4.1.2 Shortcut Buttons ........................................................................................... 28
4.1.3 Status Buttons ............................................................................................... 29
4.1.4 Status Area .................................................................................................... 30
4.2 Software Operations ............................................................................................ 31
4.2.1 General Setting ............................................................................................. 31
4.2.2 Test Setup ...................................................................................................... 38
III
4.2.3 Statistics and Inquiry .................................................................................... 50
4.2.4 Maintenance .................................................................................................. 56
4.2.5 System Help .................................................................................................. 57
4.2.6 Calibration Request ...................................................................................... 58
4.2.7 Testing Request ............................................................................................ 59
4.2.8 Fast Mode Request ...................................................................................... 61
4.2.9 Starting Analysis............................................................................................ 62
4.2.10 Pausing Analysis........................................................................................... 63
4.2.11 Stopping Analysis ......................................................................................... 64
4.2.12 Viewing Test Results .................................................................................... 64
4.2.13 System Status ............................................................................................... 68
4.2.14 Exiting the System ........................................................................................ 68
4.2.15 Emergency Exit ............................................................................................. 68
4.2.16 Hiding/Displaying Menus ............................................................................. 69
4.2.17 Viewing Temperature Curve ........................................................................ 69
4.2.18 Sample Disk .................................................................................................. 70
4.2.19 Reagent Disk ................................................................................................. 70
4.2.20 Reaction Disk ................................................................................................ 72
4.2.21 Early Warning and Warning Messages ..................................................... 72
Chapter 5 General Operation Procedures ...................................................................................... 74
5.1 Basic Operations .................................................................................................. 74
5.2 Operation Procedure of New Item Analysis ...................................................... 77
5.3 Routine Operation Procedure ............................................................................. 78
Chapter 6 Analysis Principles and Calculation Methods ........................................................ 83
6.1 Analysis Principles ............................................................................................... 83
6.2 Analysis Procedure .............................................................................................. 83
6.2.1 Actions............................................................................................................ 83
6.2.2 Action Positions ............................................................................................ 84
6.2.3 Testing Flow................................................................................................... 84
6.2.4 Measuring Point ............................................................................................ 84
6.3 Analytical Methods ............................................................................................... 85
6.3.1 Endpoint ......................................................................................................... 85
6.3.2 Two-point ....................................................................................................... 86
6.3.3 Kinetic ............................................................................................................. 86
6.4 Absorbance and Response ................................................................................. 87
6.4.1 Absorbance ................................................................................................... 87
6.4.2 Response ....................................................................................................... 87
6.5 Calibration.............................................................................................................. 89
6.5.1 Calibration Methods ..................................................................................... 89
6.5.2 Calibration Parameters ................................................................................ 89
6.6 Concentration ........................................................................................................ 90
6.7 QC........................................................................................................................... 90
6.7.1 QC Rules ....................................................................................................... 90
6.7.2 QC Types ....................................................................................................... 91
IV
6.7.3 QC Plot ........................................................................................................... 91
6.8 Other Calculations ................................................................................................ 93
6.8.1 Calibration Curve .......................................................................................... 93
6.8.2 Substrate Depletion ...................................................................................... 94
6.8.3 Linearity Check ............................................................................................. 94
6.8.4 Prozone Check ............................................................................................. 95
6.8.5 Reaction Equilibrium Check ........................................................................ 97
6.8.6 Lamp Status Check ...................................................................................... 97
6.8.7 Cuvette Status Check .................................................................................. 97
Chapter 7 Maintenance ............................................................................................................... 98
7.1 Preparation of Tools ............................................................................................. 98
7.2 Daily Maintenance ................................................................................................ 98
7.2.1 Cleaning Panels of Analyzing Unit ............................................................. 98
7.2.2 Cleaning Sample Probe and Mixer ............................................................ 98
7.2.3 Cleaning Wash Probes and Nozzle ........................................................... 99
7.2.4 Checking Reagent/ Sample Syringe........................................................ 100
7.2.5 Checking Purified Water Tank .................................................................. 101
7.2.6 Checking Waste Tank and Tubing............................................................ 101
7.3 Weekly Maintenance .......................................................................................... 103
7.3.1 Cleaning Primary Filter of Purified Water ................................................ 103
7.3.2 Cleaning Waste Tank ................................................................................. 103
7.3.3 Cleaning Reagent/Sample Disk Refrigerator ......................................... 104
7.4 Monthly Maintenance ......................................................................................... 104
7.4.1 Cleaning Wash Pools ................................................................................. 104
7.4.2 Cleaning Reaction Compartment ............................................................. 105
7.4.3 Cleaning Rotors .......................................................................................... 106
7.5 As-Needed Maintenance ................................................................................... 106
7.5.1 Unclogging Sample Probe and Reagent Probe ..................................... 106
7.5.2 Replacing Sample Probe ........................................................................... 107
7.5.3 Replacing Mixer .......................................................................................... 108
7.5.4 Replacing Lamp .......................................................................................... 108
7.5.5 Replacing Syringe ...................................................................................... 110
7.5.6 Replacing Secondary Filter of Purified Water ........................................ 111
7.6 List of Replacement Apparatus ........................................................................ 112
7.6.1 List of replacement apparatus for User ................................................... 112
7.6.2 List of replacement apparatus for Servicing engineer........................... 112
7.7 Maintenance Log Sheets................................................................................... 112
Chapter 8 Appendices ............................................................................................................... 115
8.1 Terminology ......................................................................................................... 115
8.1.1 AD Value ...................................................................................................... 115
8.1.2 Dark Current ................................................................................................ 115
8.1.3 Water Blank ................................................................................................. 115
8.1.4 Measuring Point .......................................................................................... 115
8.1.5 Absorbance ................................................................................................. 115
V
8.1.6 Reaction Curve ........................................................................................... 116
8.1.7 Response ..................................................................................................... 116
8.1.8 Calibration .................................................................................................... 116
8.1.9 Calibration Curve ........................................................................................ 116
8.1.10 Calibration Parameter ................................................................................ 116
8.2 Technical Parameters ........................................................................................ 116
8.3 Transport and Storage ....................................................................................... 117
VI
Chapter 1 Precautions on Safety and Use
Ignorance of these symbols may get you into the risks of death or injury. The symbols are
STRONG LIGHT
1 The light transmitted by the bar code reader may hurt your eyes.
2 The light transmitted by the lamp may hurt your eyes. Do not stare at the lamp
when the system is in operation.
FLAMABILITY
1 Do not use flammable substances around the system, such as alcohol and ether.
EXPLOSION
1 Do not use explosive substances around the system.
HIGH TEMPERATURE
1 Before replacing the lamp, please switch off the Main Power and then wait at
least 30 minutes till the lamp cooling down.
2 Do not touch the print head or the metal part near it; otherwise you may get
burned.
ELECTRIC SHOCK
1 When the Main Power is ON, the panels, side cover or rear cover of the analyzer
are not allowed to be opened unless by qualified personnel.
2 Please make sure that no liquid spillage spatters on the panels. In case liquid
goes inside analyzer, just turn off the power supply and contact Landwind as soon
as possible.
PERSONAL INJURY
1 The sharp components of the analyzer can cause puncture wounds. To prevent
injury, please exercise caution when working around the reagent probe, sample
probe, mixer and steel pipe of the wash unit.
2 When the analyzer is in operation, do not touch such moving parts as sample
probe, reagent probe, mixer, wash unit, fan, and etc.
BIOHAZARD
1 All test samples, such as calibrator and control, are infectious. If necessary,
please wear gloves when working with these samples.
2 All waste liquids should be considered infectious. Please wear gloves when
working with waste liquids.
3 Those components that have been attached with the reagent probe, sample
probe, mixer, wash unit, waste tubing and waste tank are infectious. Please wear
gloves when working with them.
CORROSION
1 The wash solution and certain reagents are strongly acid or alkaline. While using
them, exercise caution and prevent direct contact with your hands or clothes. In
case your hands or clothes contact the wash solution or reagents, wash them off
immediately with soap and clean water.
2 In case they spill into your eyes, rinse them with much water and consult an
oculist.
INTENDED USE
1 The LW C100plus is a fully-automated and computer-controlled chemistry analyzer
designed for in vitro quantitative determination of clinical chemistry parameters in
serum, plasma, urine in medical institutions.
2 To draw a clinical conclusion, please also refer to the patient’s clinical symptoms
and other test results.
OPERATOR
1 The LW C100plus is to be operated only by personnel trained and authorized by
Landwind or Landwind-authorized distributors.
ENVIRONMENT
1 Please install and operate the system in an environment specified by this manual.
Installing and operating the system in other environment may lead to unreliable
results and even equipment damage.
2 To relocate the system, please contact Landwind or your local distributor.
ELECTROMAGNETIC NOISE
1 Electromagnetic noise may interfere with operations of the system, or even lead to
unreliable test results and misoperation. Do not use such devices as electric drill,
mobile phones or radio transmitters near the system.
2 The system may generate electromagnetic wave during operation. Do not install or
use electrosensitive equipment near the system.
GROUNDING
1 Make sure the power socket is grounded correctly. Improper grounding may lead to
electric shock.
2 The grounding resistance must be lower than 10Ω. Improper grounding may lead to
unreliable test results and risk o f enclosure leakage and even electric shock.
LIQUID LEAKAGE
1 Please check the tubing connectors carefully before starting tests. Leakage may
cause inaccurate aspiration or dispensing.
2 Do not place reagents or samples on the panels of the analyzer; otherwise liquid
spray or leakage may occur.
PROBE BLOCKAGE
1 Check the reagents and samples carefully for insoluble matters, such as fibrin and
protein; otherwise the reagent probe or sample probe may be blocked.
WATER
1 The water used should meet the requirements of the CAP Type II water.
SYSTEM USE
1 Operate the system strictly as instructed by this manual. Inappropriate use of the
system may lead to unreliable test results or even equipment damage or personal
injury.
2 Before using the system for the first time, run the calibration program and QC
program to make sure the analyzer is in proper state.
3 Be sure to run the QC program every time you use the system, otherwise the result
may be unreliable.
4 Do not open the cover of the reaction disk when the analyzer is in operation
5 Please install the reaction disk cover,reagent/sample disk cover before start the
analyzing.
6 Be sure that there is no obstacle in the moving paths of the probe and mixer during
analyzing
7 For safety,please don’t touch the reaction disk or reagent/sample disk When it is in
operation.
8 The operating software installed on the operation unit is specified by
Landwind.Please do not install any other software or hardware,otherwise it may
affect the system..Do not run other software when the system is in operation.
9 Do not use this computer for other purposes. Inappropriate use of it will probably
introduce computer virus, which may spread through floppy disks, software or
network, into the system.
SYSTEM MAINTENANCE
1 Maintain the system strictly as instructed by this manual. Inappropriate
maintenance may lead to unreliable results or equipment damage or personal
injury.
2 Replacement of such major parts as photometer, probe, mixing bar and syringe
plunger assembly must be followed by a calibration.
3 In the case that the analyzer discontinue use because of error or other reason and
needs repair or disposal,please contact Landwind,meanwhile
Please take other measures to avoid delay in results,for example,use other
machines or other methods to continue to finish the test.
Take out the reagent bottle in the analyzer and store it in accordance with the
reagent kit. for example,put the reagent back in the refrigeratory to keep it
from spoilage.
SAMPLES
1 Use serum samples that are completely separated from blood clots or urine
samples that are free from suspended matter. If fibrin exists in the serum samples
or suspended matter exists in the urine samples, the probe may be blocked.
2 Medicines, anticoagulants or preservative in the samples may lead to unreliable
results.
3 Hemolysis, jaundice or chylomicron in the samples may lead to unreliable test
results. Sample blank analysis is recommended.
4 Store the samples properly. Improper storage may change the compositions of the
samples and lead to unreliable results.
5 Sample volatilization may lead to unreliable results. Do not leave the sample open
for a long period.
6 The system has a specific requirement on the sample volume. Refer to this manual
for proper sample volume.
7 Load the sample to proper tube position on the sample disk before the analysis
begins; otherwise you will not obtain correct results.
PARAMETERS
1 Incorrect analysis parameters may cause erroneous test results. Please consult
Landwind or your reagent supplier for correct parameters.
DATA BACKUP
1 The system can store data to the hard disk of the PC automatically. However, data
loss is still possible due to deletion or physical damage of the hard disk. We
recommends you to back up the data to portable storage device regularly.
DISPOSING OF ANALYZER
1 Some materials of the analyzer are subject to contamination regulations. Dispose
of the analyzer in accordance with your local or national guidelines for waste
disposal.
Chapter 2 Installation
2.1 Installer
The LW C100plus should be installed by Landwind or its authorized agent only. Proper
environment and proper room is needed for installation. If the analyzer needs to be
relocated, please contact Landwind or your local agent.
Item Requirements
The bearing ground should be level with gradient less than 1/200. It should
be hard enough to bear weight.
Installation site The installation site should be free of dust, corrosive and flammable gas, no
heat and wind source, neither mechanical vibration.
It shall not be exposed in direct sun light and should be well ventilated.
Space
Environment 10℃-30℃
Temperature
Relative 30%~85%
humidity
Atmospheric 86.0 kPa-106.0kPa
pressure
Well-ventilated to the outside with the analyzer not exposed directly to the
Ventilation
wind source.
Electromagnetic Away from brush-type motors and electrical-contacts equipments which are
wave powered on and off frequently.
Diameter of the particle in water shall be less than microns.
Resistivity of water shall be greater than 0.5MΩcm.
Water
The colony count shall be less than 10cfu/ml.
The dissolved silicon shall be less than 0.1mg/L.
Waste liquid Waste liquid shall be disposed of compliantly with local regulations.
NOTE:The purified water bucket must be placed around the analyzer to ensure that
the purified water inlet tube absorb the water in the bucket.
NOTE: The waste bucket should be lower than the analyzer waste liquid connector.
2. To remove reagent/sample disk,hold the handle and pull the disk upward to remove it.
Partial
Enlarged
Drawing
WARNING
1 Before installing/removing reagent/sample disk,make sure that all moving parts
have been stoped,such as probe 、mixer、reaction disk and reagent/sample disk.
BIOHAZARD
1 Wear gloves and lab coat and, if necessary, goggles.
CAUTION
1 Make sure that the cover of the reagent/sample disk is closed,otherwise cooling
effect of the refrigerator will be degraded and the sample/reagent probe may be
demaged.
2 The reagent/sample disk and the reagent/sample compartment may be
contaminated when being used.If samples or reagents spill on the
reagent/sampled disk or in the reagent/sample comparement,wipe them with cloth
soaked with water or disinfector after placing the Power to OFF.
2.To remove sample tubes,grab the tube and pull it upward to remove it from the tube
holder.
WARNING
1 Before installing/removing sample tubes,make sure the probe and
reagent/sample disk have been stopped. Do not use sample tubes which is
beyond the specific specification.
BIOHAZARD
1 Wear gloves and lab coat and, if necessary, goggles.
2.To remove the reagent bottles,grab the bottle and pull it upward to remove it from the
bottle holder.
WARNING
1 Before installing/removing reagent bottles,make sure the probe and
reagent/sample disk have been stopped. Do not use reagent bottles which is
beyond the specific specification.
BIOHAZARD
1 Wear gloves and lab coat and, if necessary, goggles.
2.To remove cuvettes, open the reaction disk cover, grab the cuvette segment by the
middle of its buckle,pull it upward to remove it form the cuvette holder.
WARNING
1 Before installing/removing reagent bottles,make sure the probe 、mixer and
reagent/sample disk have been stopped.
BIOHAZARD
1 Wear gloves and lab coat and, if necessary, goggles.
NOTE
1 Do not touch the optical surface at the lower part of the cuvette when installing
the cuvette ,otherwise it may affect the cuvette’s color comparison and the
accuracy of the test result.
2 The optical surface should not contact the cuvette holder when installing the
cuvette,otherwise it may scratch the covette and affect the accuracy of the test
result.
If the software is installed for the first time,it needs to configure .NET Framework
4.0,see the screen below.It may take some time,please wait patiently.
And then:
In the above screen,you can choose the detination folder by using the
button”Browse”.And then click “Next”, the following screens are displayed.
And at last,shows the following screen.At this time, the software has already been
successfully installed.Click the icon in the desktop and you can start the software.
Note
1 The ”v.x.x.x” shows the version information of the
. The version is usually expressed with
numbers.
3 2
4
Reagen/sample Probe
b. Specifications
c. Actions
The probe moves up and down at the following positions in the order presented
below.
1 2 3
Reagent bottle Cuvette Wash pool
1 2 3
Sample tube Cuvette Wash pool
Mixer
Wash Probe
a. Functions
Wash cuvettes automatically.
b. Actions
The wash probe moves up and down,finishes the actions of draining the reaction liquid
and filling in the water.
a. Functions
The reaction disk holds cuvettes, in which the sample and reagent react at a constant
temperature of 37℃ and then measured directly by colorimetry.
b. Specifications
Cuvettes: 81
c. Actions
LW C100plus Operation Manual 17
Chapter 3 System Structure and Functions
a. Functions
b. Specifications
Fluctuation: ±0.1℃
a. Functions
The sample disk holds reagent bottles/sample tubes, and rotates to carry each of
them to the specified position for reagent/sample aspirating.
b. Specifications
Round disk, with three circles, hold 40 sample positions, and 40 reagent positions.
NOTE
(1) The No.39 reagent position is specified for the wash solution only. Please use only
the wash solution supplied by Landwind to wash cuvettes, Otherwise, you may not
obtain expected results.
(2) The wash solution supplied by Landwind is WASH WI.
c. Actions
a. Functions
The reagent refrigerator holds the reagent disk and the sample disk and provides a
refrigerated environment for the reagents.
b. Specifications
a. Functions
The acid/alkaline wash position is for acid/alkaline wash solution which is used to
wash probe and mixer.
b. Specifications
NOTE
Landwind recommends you to use the following acid/alkaline wash solution:
(1)acid wash solution:0.1mol/L HCl;
(2)alkaline wash solution: sodium hypochlorite solution containing 0.5% active
chlorine
NOTE
Landwind recommends you to use the acid/alkaline wash solution alternately,eg:use
the acid wash solution one day ,and use the alkaline wash solution the next day.
NOTE
Please use the acid/alkaline wash solution recommended by Landwind, Otherwise,
you may not obtain expected results.
The photometer measures the absorbance of the reaction liquid in the cuvette while
the reaction disk is rotating.
b. Specifications
The main menu includes General Setting, Test Setting, Stat./Search, Maintenance and System
Help.
The shortcut buttons include Calibration Request, Testing Request, Fast Mode Request, Start,
Pause, Stop, Results, Exit, Emergency Exit, Hide/Display Menu, Temp. Curve, Sample Disk, Reagent
The status buttons include:temperature,lamp status, status of purified water, status of waste
liquid,running status(in testing,standby and test forbidden,indicated with different color and rotation
software.
Indicates that communication with the main unit fails and testing is
forbidden.
Indicates that the distilled water tank has run out of water. The icon is
dynamic.
1. Explanation of fields
Field Description Operation
hospital name Name of the hospital Enter it in the edit box.
hospital principal Contact person of the Enter it in the edit box.
hospital.
hospital address Area of the hospital. Enter it in the edit box.
Tel Telephone number of the Enter it in the edit box.
hospital.
Website Website of the hospital. Enter it in the edit box.
Population Population of the hospital. Enter it in the edit box.
Total Dept. number Number of departments in the Enter it in the edit box.
hospital.
Remark Comments and notes about Enter them in the edit
the hospital. box.
1. Explanation of fields
Field Description Operation
Serial No Sequence number of the Enter it in the edit box.
department.
Name Name of the department. Enter it in the edit box.
Principal Contact person of the Enter it in the edit box.
department.
Population Population of the department. Enter it in the edit box.
Tel Telephone number of the Enter it in the edit box.
department.
Remark Comments and notes about Enter it in the edit box.
the department.
4 To save the information you have entered, click Save; otherwise, click
Cancel.
Deleting a department
1 Select a department you want to delete from the Department Details
List.
2 Click the Delete button.
3 To delete the department, click Yes; otherwise, click No.
1. Explanation of fields
Field Description Operation
Department Select a department of which Select it from the
you want to edit the doctor pull-down list box.
information.
Number Sequence number of the Enter it in the edit box.
doctor.
Name Name of the doctor. Enter it in the edit box.
Position Position of the doctor. Enter it in the edit box.
Tel Telephone number of the Enter it in the edit box.
doctor.
Email Email address of the doctor. Enter it in the edit box.
Add. Address of the doctor. Enter it in the edit box.
Remark Comments and notes about Enter them in the edit
the doctor. box.
1 Select a department from the pull-down list box for which you want to
add a doctor.
2 Click the Add button.
3 Enter the doctor information in corresponding edit boxes.
4 Click Save to save your settings.
Editing doctor information
1 Select a department from the pull-down list box.
2 Select a doctor you want to Edit from the Doctor Details List.
3 Click the Edit button.
4 Enter the doctor information in corresponding edit boxes.
5 To save the information you have entered, click Save; otherwise, click
Cancel.
Deleting a doctor
1 Select a department from the pull-down list box.
2 Select a doctor you want to delete from the Doctor Details List.
3 Click the Delete button.
4 To delete the doctor, click Yes; otherwise, click No.
1. Explanation of fields
Field Description Operation
Login Name User name used to log in the Enter it in the edit box.
system.
Name Name of the user. Enter it in the edit box.
Company Name of the company to Enter it in the edit box.
which the user is dedicated.
Tel Telephone number of the Enter it in the edit box.
user.
1. Explanation of fields
Field Description Operation
Login User name used to Click >> or << to select the desired user
Name log in the system. name.
Name Name of the user. Click >> or << to select the desired user
name.
1. Explanation of fields
Field Description Operation
User Name User name used to log in the Select a user name from the
system. pull-down list box.
Original Old password used to log in Enter it in the edit box.
password the system.
New New password of the user to Enter it in the edit box.
password log in the system.
Confirm New Password entered to confirm Enter it in the edit box.
password the previous new one.
1. Explanation of fields
Field Description
Serial item number.
number
Item Abbreviation of the item.
3 Click OK to save your adjusting, and the print order of results will follow
the adjusted order.
4 Click cancel to abandon your adjusting.
1. Explanation of fields
Field Description Operation
Unit Name Name of item unit. Enter it in the edit box.
Remark Comments or notes about the Enter them in the edit box.
unit.
1. Explanation of fields
Field Description Operation
Item Number Sequence number of the item Generated by the system automatically and
cannot be changed.
Abbreviation Abbreviation of the item. Enter it in the edit box.
Full Name Full name of the item. Enter it in the edit box.
Decimal Digits Number of decimals in the test Select 0, 1, 2 or 3 from the pull-down list box.
result.
Result Unit Unit of the result. Select it from the pull-down list box.
Test Unit Online setup of item units. Click to enter the test unit setting window.
Setting
Price Cost price for a single test of Enter it in the edit box.
the current item.The default
value is 0.
Testing Testing method of the current Select it from the pull-down list box. The options
Method item. include endpoint, two-point and Kinetic.
Direction Changing direction of the Select it from the pull-down list box. The options
absorbance during the reaction include ascending and descending.
process.
Pri. Wave. Primary wavelength used for Select it from the pull-down list box. The options
testing. include 340, 405, 450, 510, 546, 578, 630 and
670.
Secon. Wave. Secondary wavelength used Select it from the remaining wavelength in the
for testing. pull-down list box.
Sample Amount of sample dispensed Enter it in the edit box. It should be within 2 to 48
Volume for normal analysis. The unit is at the increment of 0.1.
μl.
1. Explanation of fields
Field Description Operation
Calibrator Name of the calibrator. Enter it in the edit box.
Name
Calibration Position of the calibrator on the Set it by clicking a position on the calibrator
Disk Pos calibrator disk. disk on the left of the window.
Item Conc. Concentration of the calibrator Enter them in the edit boxes.
Setting for various items.
Display Area
3 Enter new calibrator information in corresponding edit boxes. If you want to relocate the
calibrator, click a new position on the sample disk graph, and then click Save. Please
note the new position you should be empty.
4 To save your changes, click Save; otherwise, click Cancel.
Deleting a calibrator
1 Select a calibrator you want to delete in the Calibrator Display Area.
2 Click the Delete button.
3 Click Yes to delete the selected calibrator; or click No to abort.
4.2.2.3 QC Setup
1. Explanation of fields
1. Explanation of fields
Field Description Operation
Abbr. Abbreviation of the calculation Enter it in the edit box.
test.
Full Name Full name of the calculation Enter it in the edit box.
test.
Result Unit Unit of the calculation test Select it from the pull-down list box. It can
result. also be left blank.
Decimal Digits Number of decimals in the Select 0, 1, 2 or 3 from the pull-down list
calculation test result. box.
Reference Enter the default reference Enter the upper and lower limits in the two
Range range of test result. edit boxes.
Details Click this button to set up Click this button. The following window is
reference ranges for patients displayed.
1. Explanation of fields
Field Description Operation
Profile No. Sequence number of the Generated by the system automatically and
profile cannot be changed.
Abbr. Abbreviation of the profile. Enter it in the edit box.
Full Name Full name of the Profile. Enter it in the edit box.
1. Explanation of fields
Field Description Operation
Automatic The conditions for Select it from the pull-down list box.Including
dilution automatic dilution substrate depletion,above linear range upper limit and
conditions antigen excess.
Multiple Dilution ratio Follow the software instruction.It ranges from 2.5 to
100.
Original The original sample Follow the software instruction.It ranges from 2 to
Volume volume 100ul.
5 Click Reaction Curve. The following window pops up, displaying the reaction curve of
the reagent blank test.
Click Data Details >> to view the absorbance of each measuring point.
6 To print the details of the selected reagent blank record, click Plot Print.
3 Click the Search button. All qualified cuvette blank records are displayed in the Search
Result Display Area in the upper-right part of the window. In the Cuvette Blank Search
Distributing Chart Display Area, the trend of cuvette blank is illustrated with each dot
indicating a cuvette blank test.
1. Explanation of fields
Field Description Operation
Operator The operator who is going to Select it from the pull-down list box.
summarize the workload.
Sample Type Sample type for workload statistics. Select it from the pull-down list box.
Time Start and end date for statistics. Select it from the pull-down list box
or enter it with the keyboard.
All Tests Selecting it means to summarize the Clicking once means to select the
tests of all items. item, and clicking again means to
deselect it.
4.2.4 Maintenance
The LW C100plus provides you with a maintenance function, which enables you to wash
cuvettes,clear unfinished requests, save sample results in the history database, perform cuvette blank
and inquire error logs The following sections introduce the maintenance operations in detail.
Click Ok to start to wash cuvettes automatically.,or click Cancel to return to the main screen.
Note
(1) The replacement cycle of the semi-permanent cuvette is 3 months.After
using the cuvtte for over 3 months,please replace the cuvettes according
to chapter 2.8
(2) When the cuvettes is replaced,exit the program,re-login and select to test
water blank.
Click Yes to delete the uncompleted sample requests; or click No to abort and return to the main
screen.
4.2.4.3 Saving Sample Results to History Database
On the LW C100plus, you are allowed to transfer manually the sample test results to the history
database. Select Maintenance> Save Analyzing Data to History. The following prompt appears.
Click Yes to transfer the sample results to the history database; or click No to abort and return to
the main screen.
4.2.4.4 Inquiring Error Logs
By selecting Maintenance>Analyzer Running Error Log, you can search for history error logs of the
system occurring during certain period.
After setting up the inquiry conditions, click Search to search for desired error logs. To delete the
selected error log, click Delete Current Error Info; to delete all the error logs, click Clear All Errors Info.
To return to the main screen, click Return.
1. Explanation of fields
Field Description Operation
Sample ID Sequence number of Enter it in the edit box.
the sample.
Batch Number of samples Enter the number of samples requested for the same test
Request requested for the items.
same test items.
Sample Sequence number of Select it from the pull-down list box.
Disk the sample disk.
There are 4 virtual
sample disks in total.
Sample Position of the sample Enter it in the edit box; or click the Position Remained View
Position on the selected button and select one from the remaining positions.
sample disk. There
are 40 positions on
each sample disk.
Position Used to view the Click this button. The following window appears, displaying
Remained empty positions on all remaining positions on the current disk. To select a
View the current sample position, click the number button and click OK.
disk.
Dilution Select method for Select from the pull down list.It includes manual
test dilution test. dilution,auto-dilution and auto retest. When calculating
results,the system will multiply the set dilution ratio
automatically.
Mutiple Dilution ratio .It ranges from 2.5 to 100.If the dilution test is manual
dilution or auto-dilution,follow the software instruction to
input Mutiple.if the dilution test is auto retest,no input is
needed.
Original The original sample It ranges from 2 to 100ul,If the dilution test is auto dilution,
volume volume follow the software instruction to input Volume.If the the
dilution test is manual dilution or auto rest,no input is
need.The total volume after dilution ranges from 150 to
500ul.And the original volume of reaction liquid(without
dilution) is between 150 and 450ul.
Sample Type of the sample. Select it from the pull-down list box.
Type
STAT Used to set the When selected, the sample is STAT and should be
sample as STAT. analyzed immediately.
Sample Select to test sample When selected,the sample will be used to test sample
Blank blank.Sample blank is the test using H20 as reagent and
Blank. sample applied to be tested as sample.
NOTE
1. In case of requesting samples in batch, the sequence No. and tube position on
the sample
disk are determined increasingly from the start sample No. and position.
2. Batch request and single-sample request can be performed simultaneously.
The operation procedures of fast mode request are the same as those of routine sample request. See
section 4.2.7 for details.
NOTE
Fast mode request is applicable to single-reagent items only.
1 If you want to analyze the samples quickly, mark the checkbox in front of Fast Mode.
If not, proceed to the next step.
2 Select a reagent disk (No.1-No.5) and sample disk (No.1-No.4) to run the tests.
3 To run a reagent blank automatically for each item, mark the checkbox in front of
Auto Reagent Blank Test. Then proceed to the next step.
4 If you want to run a reagent blank for certain items, click the Reagent Blank Test
button, select desired reagents in the pop-up window, and then click OK. Please note
clicking once means to select the item, and clicking again means to deselect it.
5 If QC tests are included in the current batch, click the QC Test button. Clicking once
means to select it, and clicking again means to deselect it.
6 Click the Routine Test button; then enter the start and end sample No. in the
following edit boxes. Void means to run all routine tests.
7 Click OK to start the analysis.
NOTE
The LW C100plus can run the reagent blanks, QC tests and routine samples
simultaneously, which are given with the following priority.
1. Reagent blank tests
2. QC tests
3. Routine samples
NOTE
1. Once the Reagent Blank Test, Calibration Test and QC Test buttons are selected,
all such
tests currently requested will be run.
2. As for routine samples, you can specify the sample number and analyze desired
samples.
If you only enter the start sample number, all samples following it will be
analyzed; if
you only enter the end sample number, all samples before it will be analyzed; if
you
enter neither of them, all the requested samples will be analyzed.
Click “continue” to start pause function and the analyzer will be in a status of pause.See the
figure below.Click “cancel” if you don’t want to start pause function.
After the wait time of the pause is finished,a prompt screen pops up as below.At this time,the
reaction disk is the only moving part that continues moving.Probe and reagent/sample disk are both
stopped and you can add sample and reagents.Click “start” to return to normal test,click “cancel” to stay
in pause status.
Note:
When in the status of pause,the probe and reagent/sample disk are still in
operation.For safety,please add sample and reagents only when the pause is
finished.
1. Explanation of fields
Field Description Operation
Patient Name of the Enter it in the edit box.
patient.
Sex Gender of the Select it from the pull-down list box.
patient.
Age Age of the Enter the age in the first edit box and select a unit from the
patient. pull-down list box.
Register Medical record Enter it in the edit box.
No. number of the
patient.
Admiss. Admission Enter it in the edit box.
No. number of the
patient.
Sent The department Enter the code or name of the department.
From where the
patient is
treated.
Bed No. Bed number of Enter it in the edit box.
the patient.
Diagnosi Clinical Select it from the pull-down list box or enter it with your keyboard.
s diagnosis of the
patient.
Sender The doctor who Enter the code or name of the doctor.
issues the
inspection sheet
for the patient.
Send The time when Select it from the pull-down list box or enter it with your keyboard.
Time the sample is
Used to delete
all routine
samples that are Click Delete All. The following prompt pops up. Click OK to delete
not analyzed all the samples.
and associated
items, as well as
Delete All those finished
samples.
Search
Sample
Used to delete
single test result
of current
sample
Delete
2 To print the test results of the selected sample, select The Current Selected Sample
radio button and then click Print.
3 To print the specified test results, select the Select Sample radio button, enter the
sample number in the following edit box and then click Print.
After selecting the Exit Emergently icon in the shortcut buttons area, the above prompt pops
up. Click OK.
To increase or decrease the Y-coordinate, move the scroll bar upwards or downwards in ;
;
Click Return to close the temperature curve window and return to the main screen.
1 Select desired reagent disk tab on the Reagent Disk Position Setting screen.
Click Reagent Volume Check to display a new window. Select a reagent that you
2
want to check the inventory, and then click OK.
NOTE
1. In case of a double-reagent item, you are required to position both R1 and R2
on the same reagent disk.
2. You are allowed to check reagent inventory only when the system is in standby
status.
Click Return to close the window and return to the main screen.
To view the history alarm messages, see Inquiring Error Logs in section 4.2.4.5 Inquiring Error
Logs.
3. Select an control you want to delete and click Delete to display a prompt.
4. Click Yes.
1. Click the Show Menu shortcut button on the main screen to show the menu
bar.
Adding a 2. Select Test Setting and then select Calibration Setting in the pull-down
calibrator menu. The Calibration Setting Management screen is displayed.
3. Click Add, and then set the calibrator parameters properly, including
calibrator name, SD for each item, and position on the calibrator disk.
4. Click Save.
1. Click the Show Menu shortcut button on the main screen to show the menu
bar.
Modifying 2. Select Test Setting and then select Calibration Setting in the pull-down
calibrator menu. The Calibration Setting Management screen is displayed.
information 3. Select a calibrator you want to modify, click Modify, and then change the
calibrator parameters properly, including calibrator name, SD for each item,
and position on the calibrator disk.
4. Click Save.
1. Click the Show Menu shortcut button on the main screen to show the menu
bar.
Deleting a 2. Select Test Setting and then select Calibration Setting in the pull-down
calibrator menu. The Calibration Setting Management screen is displayed.
3. Select an calibrator you want to delete and click Delete to display a prompt.
4. Click Yes.
1. Click the Reagent Disk shortcut button on the main screen. The Reagent
Disk Position Setting screen is displayed.
Setting up 2. Select desired reagent disk tab.
reagent 3. Select a reagent you want to locate. Note that you need to select both R1
positions and R2 for a double-reagent item.
4. Double-click an empty position on the reagent disk graph. The selected
reagent is positioned.
1. Click the Reagent Disk shortcut button on the main screen. The Reagent
Disk Position Setting screen is displayed.
Changing
2. Select desired reagent disk tab.
reagent
3. Select a reagent you want to relocate on the reagent disk graph.
position
4. Double-click an empty position on the reagent disk graph. The selected
reagent is relocated.
1. Click the Reagent Disk shortcut button on the main screen. The Reagent
Disk Position Setting screen is displayed.
Releasing a
2. Select desired reagent disk tab.
reagent
3. Select a reagent position that you want to release.
position
4. Click the Delete button to display a prompt.
5. Click Yes.
3 Add calibrators for the item or set up the concentrations of existing calibrators for it.
4 Add controls for the item or set up the target values and SDs of existing controls for it.
7 When calibration tests are finished successfully, request QC tests and start running them.
8 If the system is surely under control after the QC analysis, start running routine samples.
LW C100plus Operation Manual 77
Chapter 5 General Operation Procedures
Note
Reagen blank test is a must for the first calibration of a new item.
2 Powering on
Switch on the power in the sequence as presented below:
a) Switch the main power to ON, which is at the right side of the rear panel of the
analyzing unit
b) Press the power switch on the right panel of the analyzing unit. The indicator is on.
c) Turn on the monitor of the computer.
d) Turn on the computer.
e) Turn on the printer.
e) Wash cuvettes.
f) Measure the water blank
g) Check the lamp status.
NOTE: Alarm and Dirty Cuvettes
1. When an alarm occurs during the startup process, click the Warning Messages button
on the main screen to view the alarm message and corresponding corrective actions.
2. When the analyzer starts up,it will monitor the lamp status automatically.If it indicates
that the lamp intensity is weak,please replace the lamp immediately.
4 General setting
a) Set up the information of hospital, departments and doctors.
b) Set up user name, initial password and operation privileges.
c) Set up information of item printing order and result unit.
5 Item parameters setting
Set up the item parameters properly according to the reagent package insert.
NOTE: Parameters
Incorrect analysis parameters may cause erroneous test results. Please consult
Landwind or your reagent supplier for correct parameters.
7 Calibration setup
a) Add one or more calibrators.
b) Set up positions of the calibrators on the calibrator disk.
c) Set up the concentration of the calibrators for each item.
8 QC Setup
a) Adding one or more controls.
b) Set up the target value and standard deviation of the controls for each item.
c) Set up the cumulative sum check rule of the controls for each item.
9 Testing request
1 Request reagent blank tests.
2 Request calibration tests.
3 Request QC tests.
4 Request routine samples.
reagent.
b) Place the correct calibrators in their assigned positions on the sample disk.
c) Place the correct controls in their assigned positions of the sample disk.
d) Place the correct samples in their assigned positions of the sample disk.
NOTE: Probe Blockage
1. Check the reagents and samples carefully for insoluble matters, such as
fibrin and protein; otherwise the reagent probe or sample probe may be
blocked.
2. If the samples include insoluble matters, extract the supernatant and transfer
it to a clean tube.
11 Starting analysis
a) Click the Start shortcut button on the main screen.
b) Select desired test type.
c) Set the sample range for analysis.
d) Click OK to start analysis.
NOTE
The LW C100plus can run the reagent blanks, QC tests and routine samples
simultaneously, which are given with the following priority.
1. Reagent blank tests.
2. QC tests.
3. Routine samples.
b) Select Stat./Search and then select Calibration Search in the pull-down menu. The
c) Set the start and end date for inquiry, select an item in the Search Item Selection Area, and
then click Search. All qualified calibration records are displayed in the Search Result
d) To view the detailed information of a calibration record, select a test result in the Search
2. Viewing QC status
a) Click the Result Check button on the main screen.
b) Click a control name in the lower-left part of the screen. All requested items of the control
are displayed. To view the reaction curve and data of an item, select a finished item and
b) Click a sample number in the left part of the screen. All requested items of the sample are
displayed. To view the reaction curve and data of an item, select a finished item and then
c) To set up the patient information of a sample, select the sample number, enter the patient
information in the upper part of the screen, and then click Save.
d) If you want to rerun an item, mark the Rerun checkbox to the right of the test result, and
14 Shutdown
Click the Exit button on the main screen. The system performs the shutdown procedure as
follows, which may take about 55 min.
a) Wash all cuvettes.
b) Fill the cuvettes with purified water.
c) If it is “Long-leave mode”,it will drain out the water of all cuvettes.
d) Exit the operating system
15 Power-off
Switch off the power in the sequence as presented below:
a) Place the Power of the analyzing unit to OFF.
b) Turn off the computer.
c) Turn off the monitor.
d) Turn off the printer.
NOTE
1. The main power of the LW C100plus is located in the lower part of the rear panel
and shall not be turned off if not specially required.
2. To turn off the main power, place the power switch to OFF.
a) Take out samples, calibrators and controls from the sample disk.
b) Cap the reagent bottles.
c) Wipe the front panels of the analyzing unit.
d) Remove the stains and water on the sample probe and mixer.
C100plus measures the absorbance of the reaction liquid at each measuring point during the
reaction process, and calculates the concentration or activity of the analytes with corresponding
calibration parameters or calculation factors according to the absorbance change before and
6.2.1 Actions
The LW C100plus finishes all the tests by performing the following steps repeatedly:
The reaction disk rotates to carry the cuvettes to the first set of wash probes and wash them
automatically.
The reaction disk rotates 87 cuvettes positions (during rotating the absorbance of the reaction
liquid is measured) and then pauses; rotates to R1 dispensing position, pauses; rotates 90
During the 1st and the 81st period, R1, sample and R2 are dispensed and the reaction is
In the 81st period, the cuvettes are carried to the first set of wash probes and then washed.
each of which takes 24 seconds in fast mode and 36 seconds in routine mode. See the figure below.
49 measuring points during the whole reaction process, and the interval between two is 24s in fast
analytical methods: endpoint, two-point and Kinetic. The following sections introduce these three
methods in detail.
6.3.1 Endpoint
With the analytical method of endpoint, the sample & reagent mixture reacts completely; all
analytes are changed to products under monitoring; the absorbance of the reaction liquid does not
change any more; the absorbance change before or after the reaction is directly proportional to
6.3.2 Two-point
With the analytical method of two-point, the reaction velocity is directly proportional to the
concentration of the analytes within a specific period. Since the analytes are consumed
continuously, the reaction velocity decreases, and so does the change rate of the absorbance.
During this period, the absorbance change is directly proportional to the initial concentration of the
analytes.
6.3.3 Kinetic
With the analytical method of Kinetic, the reaction velocity reaches the maximum and keeps
unchanged within a specific period; the reaction liquid are changed to products evenly at the
maximum speed; the absorbance of the analytes decreases or increases evenly and the change
rate (△ A/min) is directly proportional to the concentration or activity of the analytes. This method
6.4.1 Absorbance
On the LW C100plus, the calculation formula of absorbance is as follows:
Absorbance = Log(ADwater - ADdark) / (ADliquid - ADdark)
Where,
transmitted light.
3. ADdark is the AD value when the lamp is off;;ADwater is the AD value when the cuvette is
filled
with purified water.; ADliquid is the AD value when the reaction cuvette is filled with reaction
mixture.
4.The absorbance data on the reaction curve is 20000 times of the data calculated by using
the above
formula.
6.4.2 Response
On the LW C100plus, response refers to the absorbance change or change rate within the
start and end reaction points. It is a crucial intermediate factor and indispensible for calculating
calibration parameters and concentration. The calculation method of response varies with
1. Endpoint analysis
Response = Absorbance at end point – (Absorbance at start point × Volume correction
LW C100plus Operation Manual 87
Chapter 6 Analysis Principles and Calculation Methods
factor)
Where,
The start and end points can be defined on the Test Setting> Item Parameter screen.
To correct the response with sample blank, you should request sample blank test separately,
whose response( R Sb )is same as the above. The response after being corrected by sample
R' R RSb
blank is .
2. Two-point analysis
Response =(Absorbance at end point – Absorbance at start point)/(T2-T1)
Where,
The start and end points can be defined on the Test Setting> Item Parameter screen.
T2 is the time of the reaction end point,T1 is the time of the reaction start point.
3. Kinetic analysis
Response = Absorbance change rate per minute within the start and end points
Where,
The start and end points can be defined on the Set Tested Item Parameter screen.
6.5 Calibration
includes one-point, two-point and multi-point, which are mainly used for items determined by
detail.
K=Rstd/Cstd
Where, Cstd is the concentration of calibrator, and Rstd is the response of calibrator.
k= (R2-R1) /(C2-C1)。
Where, C1 and C2 are the concentration of calibrators 1 and 2; R1 and R2 are the response
of calibrators 1 and 2.
4. Logit-4P
-(a+blnC)
Formula: R=R0+K/[1+e ], with 4 parameters, e.g. R0, K, a and b. This method
requires at least 4 calibrators. The concentration (or activity) of calibrator 1 is 0, and the
corresponding R is equal to R0. Other parameters are calculated with iterative method.
5. Logit-5P
-(a+blnC+c*C)
Formula: R=R0+K/[1+e ], with 5 parameters, e.g. R0, K, a, b and c. This method
requires at least 5 calibrators. The concentration (or activity) of calibrator 1 is 0, and the
corresponding R is equal to R0. Other parameters are calculated with iterative method.
6. Exponential-5P
[alnC+b(lnC)2+c(lnC)3]
Formula: R=R0+Ke , with 5 parameters, e.g. R0, K, a, b and c. This
method requires at least 5 calibrators. The concentration (or activity) of calibrator 1 is 0, and the
corresponding R is equal to R0. Other parameters are calculated with iterative method.
7. Polynomial-5P
method requires at least 5 calibrators. The concentration (or activity) of calibrator 1 is 0, and the
corresponding R is equal to R0. Other parameters are calculated with iterative method.
8. Spline
This method requires at least 2 calibrators. The calibration parameters are calculated with
iterative method.
6.6 Concentration
1. With the analytical method of Kinetic, calibration can be neglected. You should enter the
calculation factor F. The concentration is the product of response R and F. For other types of
items, you should run calibration tests first. The concentration will be calculated with the
2. For the calibration methods of linear, Logit-4P or Polynomial-5P, the concentration can be
3. For the calibration methods of Logit-5P, Exponential-5P or Spline, the concentration can be
calculated with the dichotomy method based on the response R and calibration parameters.
6.7 QC
6.7.1 QC Rules
The LW C100plus takes Westgard multi-rule as the default.
The Westgard multi-rule includes 6 sub-rules, which are listed in the table below:
Symbol Explanation QC Conclusion
22S Two consecutive control values for one level Out of control (system
exceed ±2 standard deviations. error)
R4S The difference between two consecutive Out of control (random
control values exceeds 4 standard error)
deviations.
41S Four consecutive control values for one level Out of control (system
exceed ±1 standard deviation. error)
10X Ten consecutive control values for one level Out of control (system
lie on one side of the mean. error)
6.7.2 QC Types
The LW C100plus provides three QC types, which are real-time, daily and day-to-day. QC
judgment is made according to the set QC rule.
Real-time QC: 10 consecutive QC data are collected on the same day for judgment.
Daily QC: All QC data are collected on the same day for judgment.
Day-to-day QC: All QC data are collected on different days for judgment.
6.7.3 QC Plot
The LW C100plus provides three types of QC plots: Levey-Jennings (L-J), cumulative sum
check and Twin Plot.
1. L-J plot
The measured QC values are the Y-coordinates. A horizontal line is leaded from the target
LW C100plus Operation Manual 91
Chapter 6 Analysis Principles and Calculation Methods
value, with +1SD, +2SD and +3SD marked above it, and -1SD, -2SD and -3SD marked below it.
Based on the six values, six straight lines are drawn in parallel with the target value line and
marked with ±1SD, ±2SD and ±3SD. The L-J plot is formed by connecting the adjacent points of
The cumulative sum of a control is calculated and taken as the Y-coordinate, and the test time
is the X-coordinate. A horizontal line is leaded from 0 and another two straight lines are drawn in
parallel with it at the control limit h above and below it. The control limit is calculated automatically
according to the QC rule you have set up. The cumulative sum plot is formed by connecting the
adjacent points of cumulative sums marked in the coordinate system. Any point beyond the two
According to the set target value and SD of each control, the measured value of the
low-concentration control is the X-coordinate and that of the high-concentration control is the
Y-coordinate. The average of the two values is used to draw the center line. The ±1SD, ±2SD and
±3SD are adopted to draw lines parallel to the X-/Y-axis. The measured results of the two controls
at each time constitute a point, which is marked in the coordinate system. An example of Twin-Plot
is shown below.
3SD
2SD
1SD
-1SD
-2SD
-3SD
The figure above can reflect system and random errors. The data within the blue frame
(±2SD) means in control; the data between the red and blue frames in the first or third quadrant
means system error; the data between the red and blue frames in the second or fourth quadrant
Rij Ri
N n
' 2
i 1 j 1
SD=
Nn 2
Where, Rij is certain response of calibrator i; Ri is the response calculated based on the
calibration curve; N is the number of calibrators; n is the number of valid tests.
Logit-4P
Rij Ri
N n
' 2
i 1 j 1
SD=
Nn 4
Where, Rij is certain response of calibrator i; Ri is the response calculated based on the
calibration curve; N is the number of calibrators; n is the number of valid tests.
Logit-5P
Rij Ri
N n
' 2
i 1 j 1
SD=
Nn 5
Where, Rij is certain response of calibrator i; Ri is the response calculated based on the
calibration curve; N is the number of calibrators; n is the number of valid tests.
Exponential-5P and polynomial-5P
Rij Ri
N n
' 2
i 1 j 1
SD=
Nn 5
Where, Rij is certain response of calibrator i; Ri is the response calculated based on the
calibration curve; N is the number of calibrators; n is the number of valid tests.
Spline
Rij Ri
N n
' 2
i 1 j 1
SD=
Nn 4
Where, Rij is certain response of calibrator i; Ri is the response calculated based on the
calibration curve; N is the number of calibrators; n is the number of valid tests.
Cij C Rij R
N n
2 2
i 1 j 1
R2
Cij C Rij R
N n N
2 2
i 1 j 1 i 1
NOTE
On the LW C100plus, each calibrator is tested for 3 times. The
concentration is the average of the two values rather than the most
deviated one. Therefore, n is constantly 2.
high-concentration (activity) samples cause the substrate to deplete quickly, and the reaction
velocity is deviated from the expected one (zero-order or first-order reaction). To ensure reliable
test results, judgment of substrate depletion is required. See the introduction below.
1. Ascending reaction
If the absorbance at any one or more points is greater than the set value within the start and
2. Descending reaction
If the absorbance at any one or more points is lower than the set value within the start and
linearity of the reaction curve is checked against the set value according to the measured value at
1. If there are more than 9 measuring points within the start and end reaction points,
2. If 4 ≤ Number of measuring points within the start and end reaction points ≤ 8
The absorbance change rate is lower than 0.006/min, or the difference of absorbance
Reagent blank tests, sample blank tests or blank calibrators are run.
closely related to the proportion between antigen and antibody. When antigen and antibody is
proportioned properly, maximum amount of insoluble compound is generated, that is, least light is
passed and absorbance is the highest. Otherwise, amount of insoluble compound is reduced,
more light is passed, and absorbance is decreased. See the figure below. Without prozone check,
Ag/Ab
compound
Equilibrium
Ab surplus zone Ag surplus
Ag
The LW C100plus performs prozone check with the following methods.
1. Double-reagent endpoint analysis
See the figure below. L is the start reaction point, M is the end reaction point, N and P are
LW C100plus Operation Manual 95
Chapter 6 Analysis Principles and Calculation Methods
prozone check points. The four points should meet the following equation:
10≤L<19≤N<P<M≤49
reaction reaches equilibrium at the end point according to the absorbance measured at each
measuring point.
1. The difference between the absorbance measured at three consecutive measuring points at
2. If all the differences are less than 0.01, the reaction has reached equilibrium, and vice versa.
3. If the end reaction point exceeds 47, the system will not perform the equilibrium check.
2. When the light intensity at 340nm is less that 50% of the initial value, the warning information
will comes out to remind you that the light intensity is insufficient and please replace the
lamp in time. At this time,you are allowed to continue the test, but the warning information
will comes out each time before you start the test to remind you that the insufficient light
intensity may affect the test result. ; when the light intensity at 340nm is less than 30% of the
initial value. it will remind you the light intensity is so insufficient that you have to replace the
lamp immediately.At this time,you are not allowed to continue the test and you have to
measure the water blank after you replace the lamp and run the software again.
to around 50000 before delivery of the analyzer. and it should not be less than 45000.The 40% of
the initial value is used as the limit value for determining dirty cuvette.If it is lower than the limit
value,the system will warn that the cuvette is dirty.Judgements of dirty cuvette will be made each
time when testing the ADwater.And the judgement is based on the ratio of minimum ADwater to
initial ADwater.
Chapter 7 Maintenance
In order to achieve the best performance, reliability and service life of the system, please
1 Wipe the panels with a wet towel dipped with wash solution until all stains are
removed.
2 Wipe the panels again with a wet towel dipped with disinfectant.
3 After a quarter, dry the wet towel and use it to wipe off the disinfectant from the
panels.
NOTE: Corrosion
Wash solution is chemically corrosive. Please wear gloves when
working with wash solution.
NOTE: Biohazard
The panels should be considered infectious. Please wear gloves when
working around the panels.
2 Use a clean cotton swab dipped with absolute ethyl alcohol to gently wipe the
sample probe tip until no attachment is found.
NOTE: Flammability
Ethanol is flammable and may be fired. While doing the cleaning,
please ensure the analyzer has been powered off and no more than
10ml ethanol is used near it.
NOTE: Biohazard
All parts should be considered infectious. If necessary, please wear
gloves when working with them.
NOTE
Cotton fibrin may stay between the dispense probe and aspirate probe.
Exercise caution while cleaning the probes and remove the remained
cotton fibrin if any.
NOTE: Flammability
Ethanol is flammable and may be fired. While doing the cleaning,
please ensure the analyzer has been powered off and no more than
10ml ethanol is used near it.
NOTE: Biohazard
All parts should be considered infectious. If necessary, please wear
gloves when working with them.
NOTE: Biohazard
All waste liquids should be considered infectious. If necessary, please
wear gloves when working with waste liquids.
NOTE
When putting back the primary filter, ensure it reaches the tank bottom;
otherwise, unreliable test results may be caused.
NOTE: Biohazard
All waste liquids should be considered infectious. If necessary, please
wear gloves when working with waste liquids.
NOTE: Biohazard
All stains should be considered infectious. If necessary, please wear
gloves during operation.
NOTE: Biohazard
All stains should be considered infectious. If necessary, please wear
gloves during operation.
4 Hold two sides of the reaction disk, and take it out to the upright direction, as the below
figure:
5 Wipe the inside of the reaction compartment with clean gauze or a wash solution-dipped
cotton swab until no stain is found, and then dry it with clean gauze. See the figure
below.
NOTE: Biohazard
All stains should be considered infectious. If necessary, please wear
gloves during operation.
3 Disconnect the Teflon tube from the probe. See the figure below.
4 Disconnect the cable from the liquid level detection board as shown below.
7 Use a 0.3mm stainless steel wire to unclog the probe from the tip upwards. Repeat your
operations for several times.
8 Connect a single-use syringe to the fluid connector with soft tubing and inject water to the
tubing. If you see water spray in line from the probe tip, the probe is clean.
9 Install the probe and the arm cover.
10 Move the sample probe back to their wash pools.
NOTE: Biohazard
The sample probe and reagent probe should be considered infectious.
If necessary, please wear gloves when working around it.
2 Move the probe to a proper position, remove the arm cover, disconnect the
Teflon tube from the sample probe and then unplug the sensor cable from the
liquid level detector
3 Loosen the retaining spring and remove the probe.
4 Install the new probe and then the retaining spring, connect the tubing to the
fluid connector, insert the sensor cable to the level detection board, and then
install the arm cover.
5 Move the sample reagent probe back to their wash pools.
NOTE: Biohazard
The sample probe and reagent probe should be considered infectious.
If necessary, please wear gloves when working around it.
NOTE: Biohazard
The mixer should be considered infectious. Please wear gloves when
working around it.
7 Install the new lamp, tighten the retaining screws and connect the power cord.
6 Install the reaction disk and tighten its retaining screws.
7 Install the wash probes and tighten the retaining knob.
8 Install the reaction disk cover.
3 Remove the syringe and T-piece by grabbing the metal part of the upper
syringe part and unscrewing it counterclockwise.
4 Install the new syringe with its thread part inserted into the T-piece and then
screw it clockwise to tighten it.
5 Tighten the retaining screws on upper and lower part of the syringe.
6 Close the window.
______Year____Month
Maintenance Records
Daily Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning Panels of
1
Analyzing Unit
Maintenance Records
Weekly Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
______Year____Month
Maintenance Records
Monthly Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Cleaning Reaction
2
Compartment
3 Cleaning Rotors
Maintenance Records
As-Needed Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
3 Replacing Mixer
4 Replacing Lamp
5 Replacing Syringe
Replacing Secondary
6
Filter of Purified Water
Chapter 8 Appendices
8.1 Terminology
8.1.1 AD Value
The light that reaches the detector generates current, which is amplified and then transferred
to photovoltage (analog signals) after passing through the fixed resistor. The photovoltage is
converted to corresponding numeric value via the AD (analog-digital) converter. The obtained
transmitted. It is equivalent to the circuit background and should be subtracted during absorbance
calculating.
relative concept and based upon the standard absorbance value. In the LW C100plus,the
absorbance of the water blank is 0 and should be subtracted for calculating any other absorbance.
a numeric value. Each measuring point is strictly determined and closely related with one another.
In the LW C100plus, each reaction process is divided into 49 measuring points. The interval
8.1.5 Absorbance
Absorbance is the logarithm of minus quotient between the transmitted light intensity and the
input light intensity. In the LW C100plus, transmitted light intensity is the AD value of a reaction
cuvette filled with distilled water; the final absorbance is the product of the calculated value ×
20000.
Absorbance
Measuring Point
8.1.7 Response
Response refers to the absorbance change before and after the reaction, or the absorbance
8.1.8 Calibration
Calibration is a sample measurement, during which one or more samples (or calibrators) with
given concentration (or activity) are measured to get its response. According to the set calibration
method (linear or nonlinear), an optimal curve is fit based on the given concentration and the
calculated response and used to generate an equation. By using the curve, a sample can be
measured to get its response, which is then employed to calculate its concentration or activity.
calibration formula.
Light Source Tungsten-halogen lamp; 12V, 20W; current small and light
stable
Light Array Full-sealed array of Interference Filters, away from mildew
Wavelength 8 wavelengths
Dimension(lengthXwidthXheight
855X620X545
in mm)