Operator s Manual - China Care Medical

Five-Part-Diff Auto Hematology Analyzer

5500 Operator’s Manual

I

NOTE:

1) Carefully read this manual before first operating the analyzer.

2) Inspect the electrical requirements of the analyzer before power on, and properly connect the grounding wire.

3) Turn off the power to the analyzer and disconnect the power cord if the analyzer is idle for a long time.

4) Do not run the analyzer if it’s in an abnormal or damaged condition.

5) There is potential biohazard of the reagents and samples; operator should follow proper biosafety practices. Dispose of waste reagent and sample in accordance with local, national regulations.

I

Contents

Chapter 1Introduction ..........................................................................................................1 1.1 Overview .................................................................................................................1 1.2 Hazard Sign ............................................................................................................1 1.3 Guidance.................................................................................................................3 1.4 Parameters .............................................................................................................4

Chapter 2 Safety Information for Operation .........................................................................6 2.1 Overview .................................................................................................................6 2.2 Special Requirements .............................................................................................6 2.3 General Requirements............................................................................................6 2.4 Electromagnetism Security .....................................................................................7 2.5 Installation ...............................................................................................................7 2.6 Antipollution ............................................................................................................8 2.7 Reagent ..................................................................................................................8 2.8 Maintenance ...........................................................................................................9 2.9 Laser .......................................................................................................................9 2.10 Consumables ......................................................................................................10 2.11 Security Sign .......................................................................................................10 2.12 Operators ............................................................................................................ 11 2.13 Computer Virus ...................................................................................................12

Chapter 3 System and Function ........................................................................................13 3.1 Overview ...............................................................................................................13 3.2 Parameter .............................................................................................................13 3.3 Structure................................................................................................................15 3.4 Counting Operation Screen ..................................................................................23 3.5 Reagent, Control and Calibrator ...........................................................................24 3.5.1Diluent .................................................................................................................25 3.5.2 Sheath ................................................................................................................25 3.5.3 Lyse....................................................................................................................26 3.5.4 Detergent ...........................................................................................................26 3.5.5 Probe Detergent ................................................................................................26 3.5.6 Control and Calibrator .......................................................................................27

Chapter 4 Installation .........................................................................................................28 4.1 Overview ...............................................................................................................28 4.2 Unpacking and Inspection ....................................................................................28 4.3 Space Requirements ............................................................................................29 4.4 Power Supply Requirements ................................................................................29 4.5 Environment Requirements ..................................................................................29 4.6 Waste Requirements ............................................................................................30 4.7 System Installation ................................................................................................30 4.7.1 Computer Installation .........................................................................................30 4.7.2 Tubing Installation ..............................................................................................31 4.7.3 Printer Installation ..............................................................................................32

II

4.8Transport and Storage Requirement .....................................................................32 Chapter 5 Principles of Operation ......................................................................................33

5.1 Overview ...............................................................................................................33 5.2 Sample Aspiration .................................................................................................33 5.3 Sample Dilution .....................................................................................................33 5.3.1 Whole Blood Automated (Batch) Sampling Mode .............................................34 5.3.2 Whole Blood Single (Emergency) Sampling Mode. ..........................................35 5.4 WBC Test Principle ...............................................................................................36 5.4.1Four-Angle Laser Light Scatter Technology .......................................................36 5.4.2 White Blood Cell Differential ..............................................................................39 5.5 Hemoglobin Concentration Test Principle ............................................................40 5.5.1 Colorimetry Principle .........................................................................................40 5.5.2 HGB Parameter .................................................................................................41 5.6 Red Blood Cell /Platelet Test Principle .................................................................41 5.6.1 Electrical Impedance Principle ..........................................................................41 5.6.2 Volumetric Metering ...........................................................................................42 5.6.3 Red Blood Cell Parameters ...............................................................................43 5.6.4 Platelet Parameters ...........................................................................................44

Chapter 6 Settingss ...........................................................................................................45 6.1 Overview ...............................................................................................................45 6.2 Time Setting ..........................................................................................................45 6.3 System Maintenance ............................................................................................46 6.4 Dictionary Maintenance ........................................................................................50 6.5 Barcode Information .............................................................................................52 6.6 Sampler .................................................................................................................53 6.7 Display Setting ......................................................................................................54 6.8Print Setting ...........................................................................................................56 6.9 Transfer Setting ....................................................................................................56 6.10 Group Parameters ..............................................................................................58 6.10.1 Limit Review ....................................................................................................58 6.10.2 Limit Modification .............................................................................................60 6.11 User Management ..............................................................................................60 6.12 Permission ..........................................................................................................62

Chapter7 Daily Operation ..................................................................................................64 7.1 Overview ...............................................................................................................64 7.2 Preparations..........................................................................................................64 7.3. Startup ..................................................................................................................65 7.4 Quality Control ......................................................................................................67 7.5 Collection of Blood Samples .................................................................................67 7.5.1 Whole blood collection .......................................................................................67 7.5.2 Sample stability ..................................................................................................68 7.6 Information Input ...................................................................................................68 7.7 Sample Counting ..................................................................................................70 7.7.1 Mode ..................................................................................................................70

III

7.7.2 Counting and Analysis .......................................................................................71 7.8 Data Query and Output ........................................................................................71 7.8.1 Data Query.........................................................................................................71 7.8.2 Data Selection ...................................................................................................73 7.8.3 Data Deletion .....................................................................................................75 7.8.4 Precision ............................................................................................................75 7.8.5 Trend Graph .......................................................................................................76 7.9 Reticulocyte Analysis ............................................................................................77 7.9.1 Principles of Operation ......................................................................................78 7.9.2 Reticulocyte Sample Preparation ......................................................................80 7.9.3 Reticulocyte Test ................................................................................................80 7.10 Statistic ................................................................................................................82 7.11 Shutoff .................................................................................................................83

Chapter 8 Quality Control ..................................................................................................84 8.1 Overview ...............................................................................................................84 8.2 Quality Control Options ........................................................................................85 8.3 QC Operation ........................................................................................................86 8.4 L-J QC ...................................................................................................................87 8.4.1 L-J QC Edit ........................................................................................................87 8.4.2 L-J QC Run ........................................................................................................88 8.4.3 L-J QC Graph Analysis ......................................................................................89 8.4.4 L-J QC Data Query ............................................................................................89 8.5 X-B QC ..................................................................................................................90 8.5.1 X-B QC Edit .......................................................................................................91 8.5.2 X-B QC Run .......................................................................................................91 8.5.3 X-B QC Graph Analysis .....................................................................................92 8.5.4 X-B QC Data Query ...........................................................................................93 8.6 X-R QC .................................................................................................................94 8.6.1 X-R QC Edit .......................................................................................................94 8.6.2 X-R QC Run .......................................................................................................95 8.6.3 X-R QC Graph Analysis .....................................................................................95 8.6.4 X-R QC Data Query ...........................................................................................97 8.7 X QC .....................................................................................................................98 8.7.1 X QC Edit ...........................................................................................................98 8.7.2 X QC Run ..........................................................................................................99 8.7.3 X QC Graph Analysis ...................................................................................... 100 8.7.4 X QC Data Query ............................................................................................ 101

Chapter 9 Calibration ...................................................................................................... 103 9.1 Overview ............................................................................................................ 103 9.2 Calculate Frequency .......................................................................................... 104 9.3 Preparation for Calibration ................................................................................. 105 9.4 Calibration Mode ................................................................................................ 106 9.4.1 Calibrated Calibration ..................................................................................... 106 9.4.2 Whole Blood Calibration ................................................................................. 108

IV

9.4.3 Manual Calibration ........................................................................................... 110 Chapter 10 Maintenance .................................................................................................. 114

10.1 Overview ........................................................................................................... 114 10.2 Routine Maintenance ........................................................................................ 114 10.2.1 Daily Maintenance ......................................................................................... 114 10.2.2 Weekly Maintenance ..................................................................................... 115 10.2.3 Monthly Maintenance .................................................................................... 116 10.3 Maintenance procedure .................................................................................... 117 10.3.1 Prime All ......................................................................................................... 118 10.3.2 Prime Lyse ..................................................................................................... 119 10.3.3 Prime Diluent ................................................................................................ 120 10.3.4 Prime Detergent............................................................................................ 120 10.3.5 Prime Sheath ................................................................................................ 120 10.3.6 Cauterize Aperture ........................................................................................ 121 10.3.7 Flush Aperture .............................................................................................. 121 10.3.8 Clean Transducers ....................................................................................... 122 10.3.9 Prepare Shipping .......................................................................................... 122 10.3.10 Other Maintenances ................................................................................... 123

Chapter11 Troubleshooting ............................................................................................. 125 11.1 Overview .......................................................................................................... 125 11.2 Troubleshooting Guidance ............................................................................... 125 11.3 Obtaining Technical Assistance ....................................................................... 126 11.4 Troubleshooting ............................................................................................... 126 11.4.1 Faults Related to Reagents .......................................................................... 127 11.4.2 Faults Related to Test Value ......................................................................... 128 11.4.3 Fault Related to Hard Ware .......................................................................... 129

Appendix A Specifications ............................................................................................... 130 A.1 Technical Specifications .................................................................................... 130 A.1.1 Parameters ..................................................................................................... 130 A.1.2 Test Speed ...................................................................................................... 131 A.1.3 QC Mode ........................................................................................................ 131 A.1.4 Reagents of Product....................................................................................... 131 A.1.5 Calibration Mode ............................................................................................ 131 A.1.6 Parameters Measurement and Calculation ................................................... 131 A.1.7 Input/Output Devices ...................................................................................... 131 A.2 Physical Specifications ...................................................................................... 132 A.2.1 Power Requirement ....................................................................................... 132 A.2.2 Environment Requirement ............................................................................. 132 A.2.3 Storage Environment ...................................................................................... 132 A.2.4 Size and Weight ............................................................................................. 132 A.2.5 Waste Disposal............................................................................................... 132 A.2.6 Minimum Sample Volume .............................................................................. 133 A.2.7 Dilution Ratio .................................................................................................. 133 A.2.8 Counting Aperture .......................................................................................... 133

V

A.2.9 HGB measurement ........................................................................................ 133 A.3 Performance Index ............................................................................................ 133 A.3.1 Precision ......................................................................................................... 133 A.3.2 Linearity .......................................................................................................... 134 A.3.3 Accuracy of WBC five part differential ............................................................ 134 A.3.4 Carryover ........................................................................................................ 134 A.3.5 Background Counting ..................................................................................... 134 A.3.6 Accuracy ......................................................................................................... 135 A.3.7 Display Range of Main Parameter ................................................................. 135 A.4 Reagent Specifications ...................................................................................... 135 A.5 Reagent Consumption ...................................................................................... 136 A.6 Parameters Alert Messages .............................................................................. 136

Appendix B Toxic and Hazardous Substances or Elements .......................................... 137 Appendix C Daily Operation Procedure .......................................................................... 138

VI

Copyright and Declaration

Declaration: All contents in this manual were strictly compiled according to related laws and regulations in China, as well as the specific condition of 5500 Auto hematology Analyzer, covering all the updated information before printing. Chinacare Medical CO., LTD. is fully responsible for the revision and explanation of the manual, and reserves the right to renovate the relevant contents without separate notification. Some of the demonstration pictures are for reference and subject to real object if any differences.

All the information included is protected by copyright. No part of this document may be reproduced, stored or transmitted in any form or by any means unless written authorization by Chinacare Medical Electronic CO., LTD.

All instructions must be followed strictly in operation. In no event should Chinacare Medical Electronic CO., LTD be responsible for failures, errors and other liabilities resulting from user's noncompliance with the procedures and precautions outlined herein.

Limited Responsibility for Quality Warranty:

The manual for 5500 Auto Hematology Analyzer, defines the rights and obligations between the Chinacare and the customers about the responsibility for quality warranty and after-sale service, also the related agreements on commencement and termination.

Chinacare warrants the 5500 sold by the Chinacare and its authorized agents to be free from defects in workmanship and materials during normal use by the original purchaser. This warranty shall continue for a period of one year since the date of installation. The analyzer life is ten years.

Chinacare assumes no liability in the following situations even during the period of warranty:

a) Failure due to abuse the analyzer or neglect the maintenance.

b) Use reagents and accessories other than manufactured

or recommended by Chinacare.

c) Failure due to operation not under the instructions described in the manual.

d) Replace accessories not specified by Chinacare, or after maintenance or repair by a service agent not approved or authorized by Chinacare.

CAUTION:

VII

THE ANALYZER IS FOR PROFESSIONAL AND PRESCRIPTION USE ONLY.

Technical service and troubleshooting are provided by CHINACARE Customer Support Center. Professional technician and sale representative will be sent to offer you timely service when necessary.

Version : 01/2011

1

Chapter 1 Introduction

1.1 Overview

5500 Five-Part-Diff Auto Hematology Analyzer is an in vitro diagnostic medical device. It can analyze and output 30 parameters of the a specimen (including 6 graphics). The Optical detection section uses He-Ne laser to analyze the five part differential of white blood cells, Coulter theory for the amount of red blood cells and platelet, and colorimetry for hemoglobin concentration.

NOTE

Ø Read this instruction carefully before operating, especially the safety information. Please keep this manual properly for future reference.

Ø If the user does not operate the instrument according to operation manual, misemployment will lead to inaccurate measurement and cause misdiagnosing, delaying patient’s treatment or doing harm to the operator himself, even damaging the instrument.

Ø Any attempt to brief, optimize, improve or elide expected activities which listed in operation manual will be likely to cause some negative impact on the precision of instrument.

Ø User must follow the instruction strictly when they he operating the medical instrument.

1.2 Hazard Sign

General information for the operation of the analyzer is contained in this manual, which covers the best guidance for a new operator to master the characteristics of the analyzer and operation methods, as well as for daily inquiry. Do peruse before first operation. This manual uses the following warning conventions:

WARNING Denotes the operator should follow the instruction under this symbol, or it may have a personal injury.

Introduction

2

CAUTION Denotes potential hazards that could result in a minor injury, also used for conditions or activities which could interfere with proper function of the analyzer.

WARNING

Denotes potential bio-hazard.

WARNING Denotes a laser hazard which, if non-compliance with procedures or engineering controls, may result laser damage to eyes. NOTE Denotes special operator/service information or standard practices. Do read through this manual before operation, maintenance, displacement to the analyzer.

Introduction

3

1.3 Guidance

This manual contains general information, which is the best guidance for new operators. Please read this manual thoroughly at the first use. You can use contents to quickly find the required information in daily use. All related personnel should read this manual.

This manual includes 11 chapters and 3 appendices. Operator can find the information needed according to the table.

Information Reference

Parameters Chapter 1 Introduction

Notices for Operation Chapter 2 Safety Information for Operation

Structure and Use Chapter 3 System and Function

Installation Chapter 4 Installation

Measurement Principle and Procedure Chapter 5 Principles of Operation

System Parameter Setting Chapter 6 Settings

Daily Operations Chapter 7 Daily Operation

Requirement and Method of QC Chapter 8 Quality Control

Requirement and Method of Calibration Chapter 9 Calibration

Maintenance Chapter 10 Maintenance

Troubleshooting Chapter 11 Troubleshooting

Detailed Specification Appendix A Specifications

Daily Operations Procedure Appendix B Manufacturing Measuring Apparatus License

Introduction

4

1.4 Parameters

Item Content Explanation Test Parameter 34 parameters(wi th graphics) Scatter diagram, histogram,

three-dimensional plot Operation Closed sampling. Special intelligent

recognition test tube rack allows sampling continuously. A batch of 120 samples can be handled at a time, and the emergency sample can be inserted at any time.

Avoid directly contact with samples and ensure safety.

Language Engl ish Software supports onl ine and U disk upgrade.

Display Sett ing Equipped wi th brand computers and LCD monitors.

Data management and networking are convenient.

Data Storage ≥ 200 000 test results (with graphics) Speed Single (emergency) sampl ing 100 / h

Continuous (batch) sampl ing 110 / h Output Mode External printer, Choose to

pr in t the h i s tog ram. D i f feren t warning s igns prompt probableabnormal i t ies of specimen.

Reference range can be printed out in a Engl ish report format.

Blood Volume Whole blood (batch) automated sampling mode 160 µL±put5％

Anticoagulation wi th EDTA-K2/EDTA-K3.

Whole blood single (emergency)

sampling mode 160 µL±5％

Reagent Di luent, detergent, lyse (non-toxic environment-friendly reagents), sheath

Sample Aspiration Probe Rinsing

Use the automatic washing device to f lush the inside and outside wal l of sample aspiration probe.

Avoid samples cross contamination and operators contacting the samples.

Blood Separation

Rotate shear valve High precision, wear-resistant. Take the middle blood and exhaust the interference from bubbles and carryover.

Unit Selection With two units selection for WBC, RBC, HGB, PLT and other items.。

Meet the parameters unit requests for di fferent countries and places.

Introduction

5

HGB Test Cyanide-free quaternary ammonium salt hemoglobin. LED l ight source, 540nm wavelength colorimetry.

Environmental regents can avoid the effects of operators' health, and be good for environmental protect ion. If use the toxic reagents, you need to purchase special ist processing equipment, which wi l l increase costs.

Control and Cal ibration

With calibrator, fresh blood and manual calibration; With LJ, X, XR, XB control mode etc.

C oe f f i c i en t o f Variation

WBC ≤1.5% Lineari ty WBC： 0.0×109 /L -99.9×109 /L RBC ≤1.0% RBC： 0.1×1012 /L -7.00×1012 /L HGB ≤1.5% HGB： 0 g/L-300g/L MCV ≤1.0% PLT： 0×109 /L -999×109 /L HCT ≤2.0% PLT ≤4.0%

Structure

Adopt separately removable syringe structure.

Enhance accuracy and maintain easi ly

Maintenance

With automatic moni tor ing funct ion to prompt the operator t o pe r f o rm au tom a t i c main tenance or t roubleshooting procedures.

Improve the l i fet ime of equipment, and maintain the best working condit ions

Reference Range

With 9 different groups normal range parameter setting function.

Can be adjusted according to different geographical groups; and the instrument will automatically identify and match the best reference.

Flush High-voltage cautery. Removable ruby aperture plate is easy to clean. Positive and negative pressure recoil and intelligent automatic cleaning.

Securi ty Have a good electrical security with the flow electricity isolation system. Host Size 760MM×684MM×676.5MM(length × width × height) Power ≤600VA Fuse 250V/2.5A weight About 91.5kg

6

Chapter 2 Safety Information for Operation

2.1 Overview

In addition to the safety use information, the general matters of operators in terms of security are also shown in this chapter. Please read this chapter carefully before operation.

2.2 Special Requirements

u 5500 five-Part-Diff Automated Hematology Analyzer is for blood cell count, WBC five part differential and hemoglobin concentration measurement in clinical laboratory.

u Only allow to use the reagents and detergents mentioned in this manual. Operating requirements also include regular cleaning and maintenance.

2.3 General Requirements

u Read the operation manual before using. Understand all the important signs. Please keep manual for future reference.

u Following the manual instructions to start the analyzer, otherwise the functions of the analyzer will lose due to accidental mechanical damage and undesirable environment.

u The instrument must be operated in accordance with the methods mentioned in this manual strictly.

u Keep long hair, fingers and clothes away from rotating parts with a certain distance.

u Turn off the power switch and unplug the power cord immediately if the instrument gives off odor or smoke, otherwise it will cause fire, electric shock or injury. If this happens, please contact the after-sale service department.

u Do not spill the samples or reagent and do not let other things fall into the instrument, otherwise it will cause short circuit. If this happens, turn off the power switch and unplug the power cord immediately, then contact the after-sale service department.

u Do not touch the circuit, especially a wet hand, which will cause electric

Safety Information for Operation

7

shock.

electric shock.

u The analyzer must be connected to a receptacle with correct voltage, and grounding at the same time.

u Avoid damaging the power cord. Do not put any device upon the power cord. Do not pull the power cord.

u Turn off the power before connecting other devices (host computer, printer).

u The instrument is connected with AC power. There is a hazardous voltage symbol in the interface. using power adapters of other brands may cause wrong test results due to the substandard technique data.

2.4 Electromagnetism Security

u The motor is inside the instrument, it will produce alternative electric field and magnetic field.

u The instrument may not function properly due to the strong electromagnetic interference.

u It may cause data conversion errors and incorrect results due to strong electromagnetic interference and poor grounding.

2.5 Installation

u The analyzer must be installed in dry and dust-free place. Avoid placing in the place where is wet and with poor ventilation or in the dirty air with salt and sulfur. Since the shell material is ABS + PC, it will be corrupted if being placed in a high pH environment.

u Avoid splashing water on the analyzer.

u Do not expose the instrument to the place with large temperature difference and direct sunlight.

u Avoid vibration. The instrument should be put into the box with foam to prevent damage during storage and transport. Improper package may lead to abnormal operation of the instrument.

u Installation site must be well ventilated.

u This instrument does not produce ionizing radiation, but we should take other equipments that generate strong ionizing radiation into consideration, such as X-ray, γ-ray which may cause test results errors.


8

u The equipment should not be installed in the place where stores chemicals and generates gas.

u The frequency and voltage required should be consistent with those in the instruction and have the ability to allow current. The instrument should be equipped with precision power supply or UPS.

u The equipment is about 90kg, falling may cause injury during carrying.

u Wrong reagent or incorrect operation may cause wrong results.

2.6 Antipollution

u All the components and surface of the instrument have the potential infectivity. The sample probe should keep an appropriate distance from the surrounding objects in order to facilitate running.

u Wear protective clothing and rubber gloves during operation, maintenance, service or repair. Wash hands with disinfectant after work.

u Do not contact the waste and its components with free hands.

u Instrument uses blood as samples. Blood may contains microbial pathogens which can cause infection easily. Therefore, operation must be done carefully, if necessary, wear protective gloves to prevent the operator himself and people around being infected by pathogenic microorganisms. Even the control and calibrator can be infectious, we should wear protective clothing and rubber gloves during calibration.

2.7 Reagent

u Check marks on the package.

u Avoid direct contacting with reagents, since the reagents may irritate eyes, skin and mucous membranes.

u If skin contacts with the reagent, rinse it with plenty of water immediately.

u If eye contacts with the reagent, rinse it with plenty of water and seek medical advice immediately.

u Establish a set of emergency measures in laboratory is very necessary.

u Protect the reagents from being polluted by dust, dirt and germs.

u Reagents must be used within the validity period.

u Handle the reagents properly to prevent bubble. Do not shake! The reagent can not be used immediately after transport.


9

u Do not let the reagents spilt. If it happens, wipe away with a cloth.

u If you swallow reagents accidentally, please seek the medical attention immediately.

u Diluent is a kind of good conductor, if being spilt next to the wire or device, it may cause electric shock. Please turn off the power, unplug the plug and clean the diluent.

u The probe cleaning solution or detergent is strongly alkaline cleaner. Do not let it contact the skin or clothes. If that happens, rinse the skin and clothes with plenty of water immediately.

u Probe cleaning solution contains sodium hypochlorite. If it contacts the instrument surface, wipe up with a cloth immediately, otherwise it will corrode the surface.

u Ensure that the reagents keep the same level with the instrument or lower. Do not put reagents on the top of the instrument.

2.8 Maintenance

u As a precision electro-optical instrument, maintenance is necessary for normal operation. The test data may have small deviations without regular cleaning. In rare cases, operator might being infected due to poor cleaning.

u To prevent infection, electric shock and burn, operator must wear rubber gloves in maintenance work. Wash hands with disinfectant after work.

u Use special tools for maintenance.

u All the cleaning and maintenance procedures must be in accordance with the manual operation.

u Do the daily, weekly, monthly maintenance in accordance with the manual operation.

u If the instrument is not used for a long time, empty the rinsing flow according to the procedure before disuse. Ensure the instrument is in a good working condition before reuse.

u reinstallation can only be done when replacing standby parts.

2.9 Laser

CAUTION: The instrument uses He-Ne laser, the laser is protected by a shield.

If remove the shield, the laser may burn eyes and cause harmful radiation.


10

Only the service technician assigned by CHINACAREcan open the lid.

2.10 Consumables

The disposal of residual reagents, cleaning agent and all waste must comply

with local laws and regulations. Used samples and reagents should be

separated from ordinary waste, or they may cause environmental pollution.

Pollutants may also make the equipment unable to work.

2.11 Security Sign

Be ware of electric shock

Protect from heat and radioactive

sources

Equipotentiality

Alternating current

In vitro diagnostic medical device

Lot number

Serial number

Use by

Metering License


11

Production Date

Manufacturer

2.12 Operators

u This medical instrument must be operated by well-trained personnel

exclusively. If being operated incorrectly by non-skilled staff,

misemployment will lead to inaccurate measurement and cause

misdiagnosing, delaying patient’s treatment or doing harm to the operator

himself, even damaging the instrument.

u Falling to operate in accordance with instruction will lead to incorrect

operation, such as test parameter setting error. It may damage the

instrument and result in wrong diagnosis results.

u Maintenance should be carried out by professional technicians. It will

cause test errors result from unauthorized technicians and nonstandard

maintenance.

u Invalid hardware / software will affect the accuracy of test results. The

operator needs to contact the after-sale service personnel as soon as

possible.


12

2.13 Computer Virus

CAUTION Although our software has been checked to make sure there is no computer virus, some measures must be considered in the daily operation. Here are some checking procedures, but not completed. Depending on your working conditions to choose appropriate measures:

1. Use a virus checker program for regularly checking.

2. Do not install other application program except virus checker program.

3. Do not open unknown email attachments.

4. Do not download any file which has nothing to do with the software program.

5. Check files in the folder for anti-virus.

6. Do not use U disk or other storage media on the computer to prevent

bringing virus to the computer.

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Chapter 3 System and Function

3.1 Overview

5500 Five-Part-Diff Auto Hematology Analyzer is an vitro diagnostic medical

device. It is used for blood cell count, WBC five part differential and

hemoglobin concentration measurement in clinical tests. This instrument can

provide the accurate test data of human venous blood, which provide the

necessary reference for clinical diagnosis.

The instrument provides a fast count, all operations (including sampling,

measurement and results output) are fully automated. You only need to put the

whole blood samples on the test tube rack. The instrument will automatically

start counting when detecting the samples. About 30 seconds,

three-dimensional graphics data and results can be displayed in the LCD

screen. The results can be printed or transmitted to the LIS system.

The biggest feature of the instrument is that it can automatically sampling and

rinse the residual blood on the sample aspiration probe, which can avoid

operators contacting the samples directly to ensure the security.

3.2 Parameter

NOTE Ø The instrument is suitable for screening instrument clinically, the operator

should integrate medical cases to review results to do the clinical

judgments, if necessary, microscopy for specimens should be done.

Ø The physicians need the subsidiary information of patients which includes

age, sex, genetic factors for further examination.

The instrument can analyze and arrange the samples data automatically and

shows the blood cell and white blood cell 5 part differential count respectively.

System and Function

14

Also, it will give the three-dimensional plot and scatter diagram of white blood

cells and histogram of red blood cells and platelet.

The 5500 generates the following 34 test parameters in table 3-1(including two

histograms, two three-dimensional plots and two scatter diagrams).

Figure3-1 Parameters Abbreviation Full Name Unit

WBC White Blood Cell Count 109cells/L LYM% Lymphocyte Percent % MON% Monocyte Percent % NEU% Neutrophile Percent % EOS% Eosinophile Percent % BAS% Basophil Percent % LYM# Lymphocyte Count 109cells/L MON# Monocyte Count 109cells/L NEU# Neutrophile Granulocyte Count 109cells/L EOS# Eosinophile Granulocyte Count 109cells/L BAS# Basophil Granulocyte Count 109cells/L RBC Red Blood Cell Count 1012cells/L HGB Hemoglobin g/L HCT Hematocrit (relative volume of erythrocytes) % MCV Mean Corpuscular Volume fL MCH Mean Corpuscular Hemoglobin pg MCHC Mean Corpuscular Hemoglobin Concentration g/L RDW_CV Red Blood Cell Distribution Width repeat

precision %

RDW_SD Red Blood Cell Distribution Width STDEV fL PLT Platelet Count 109cells/L MPV Mean Platelet Volume fL PDW Platelet Distribution Width fL PCT Plateletcrit % P_LCC Large Platelet Count 109cells/L P_LCR Large Platelet Percent % RETIC Reticulocyte % RETIC_ABS Reticulocyte absolute number 109/ul IIRF Immature Reticulocyte Fraction %

Remark: PCT and PDW are the inferred parameters. They are provided for

laboratory use only.

System and Function

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3.3 Structure

CAUTION

Ø The instrument needs several people work together to move since it is relatively large. Please use proper tools and follow relevant safety code when moving.

Ø Take out the instrument and then check whether the appearance is intact. Ensure there is no damage during transport.

The analyzer is consisted of host, computer and an external printer (optional).

Figure 3-1A Front View

1---Standby Status Indicator 2---Working Status Indicator

3---Fault Status Indicator

1

2

3

16

Figure 3-1B Front View (Remove the front cover)

1---WBC/HGB Counting Chamber 2----LMS Counting Board

3----RBC Counting Chamber 4---- Peristaltic Pump

5--- Sample Aspiration Probe

1

2

3

4

5

17

Figure 3-2 A Left Side View

1--- Left Side Door Holder 2--- Detergent Reservoir

3--- Diluent Container 4--- Sheath Container

5--- Sheath Flow Connector 6---- Diluent Flow Connector

7--- Waste Flow Connector 8---Lyse Flow Connector

9---Detergent Flow Connector 10---- Waste Sensor Connector

1

2

3

4

5

6

7

8 9

10

18

Figure 3-2 B Left Side view (Remove the left side door)

19

Figure 3-3 A Right Side view

1--- Right Side Door Holder 2--- Power Switch

1

2

20

Figure 3-3 B Right Side View (Remove the right side door)

21

Figure 3-4 Rear View

1--- Grounding Terminal 2---- COM Port

3--- Power Receptacle 4--- Power Input Stopwatch

5--- Cooling Fan 6---- USB Port

1

5

6 4

2 3

22

Figure 3-5 Vertical View（Optical Bench）

Ø The He-Ne laser is above the instrument. Do not open the upper cover for

your safety, only the personnel authorized by UNIT can open it.

System and Function

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3.4 Counting Operation Screen

After startup, the instrument will enter into the count screen automatically.

Figure 3-6 Counting Interface

This interface can be divided into the following areas by functions:

1. Main Menu Area

By clicking the button, operator can enter into corresponding interface to achieve the functions. Please refer to the following table to select the appropriate button.

System and Function

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Table 3-2 Main Menu Button Button Function Data Query the test results QC Run quality control operation Setup Set system parameters Maintenance Replacement of reagents, maintenance of equipment Service Maintain and test the equipment Limitation Limitation setting Help Operation help Exit Turn off the equipment

2. Data Edit Area

Display name, age, sex, blood type and other details of samples. The operator can switch input methods to input sample information by pressing "Ctrl + Shift".

3. Shortcut Key Area

Table 3-2 Shortcut Key Button Shortcut Key Function Run Do the background test Clean Pour the diluent, detergent, sheath and lyse into

relevant tubes Flush Special flush procedure Transfer Transmit the test data to other computer systems

manually, such as the LIS system Print Print the test result 3D View the three-dimensional map of WBC differential. Today Display today’s data Input Sampling automatically and input the data Reticulocyte Reticulocyte test interface

4. System Time

Display current date and time.

5. Counting Results Display Area

Display test results, parameter units, reference range, alarms, scatter plot, 3D map and other results information.

3.5 Reagent, Control and Calibrator

The reagent is configured specifically for the 5500 flow systems in order to provide optimal system performance.Each 5500 is checked at the factory using the specified reagents and all performance claims were generated using these reagents. Thus non-CHINACAREreagents will lead to defects in the

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25

performance of the analyzer and serious mistakes, even accidents. NOTE

Ø Reagents must be stored at room temperature to ensure optimal performance. All reagents should be protected from direct sunlight, undercooling and overheating during storage.

Ø The background test should be done after the replacement of diluent, lyse, sheath and detergent to ensure it is within the normal range.

Ø The reagent inlet tubes have a cap attached that minimizes evaporation and contamination during use. The pipe can only insert reagent through the cap. Please close the cap tightly.

Ø Ensure all reagents to be used in validity period.

3.5.1Diluent

Diluent is a kind of reliable isotonic diluent to meet the requirements as follows:

(1) Dilute WBC, RBC, PLT, HGB.

(2) Keep the shape of cells during test process.

(3) Clean WBC and RBC micro-aperture and tubes.

(4) Provide a conductive environment for counting

Storage and service life after opening: Keep the diluent under 5-35 ℃, after opened, it can be used to the validity period on the label. Once opened (connected to the instrument), the product shelf life is only 60 days.

3.5.2 Sheath

Sheath is used to keep the original ecology of blood cells and bleach RBC to eliminate the scattering of laser. WBC maintains the closest cell structure to its original state. Basophil structure occurs minor changes for the water-soluble property of basophilic granule. RBC osmotic pressure is higher than sheath, so RBC is changed by sheath. The hemoglobin of RBC diffuses from the cells, and moisture content of sheath diffuses into cells. Although the cell membrane remains good, but the RBC and sheath have the same refractive index, and it showed under the laser virtually.

Storage and service life after opening: Keep the sheath under 5-35 ℃, after opened, it can be used to the validity period on the label. Once opened (connected to the instrument), the product shelf life is only 60 days.

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3.5.3 Lyse

Lyse is a new reagent without azide and cyanide and meets the requirements as follows:

(1) Dissolve RBC instantly with minimum ground substance complex.

(2) Transform the membrane of the WBC to diffuse the cytoplasm. At the same time, the membrane will shrink centre on nucleus. As a result, WBC is present in granular shape.

(3) Transform the hemoglobin to the hemo-compound which is suitable for the measurement in the condition of 540nm wavelength.

(4) Avoid the serious pollution to human body and environment that caused by cyanide.

Storage and service life after opening: Keep the lyse under 5-35 ℃, after opened, it can be used to the validity period on the label. Once opened (connected to the instrument), the product shelf life is only 60 days.

3.5.4 Detergent

Detergent contains the active enzyme to clean the agglomerated protein in the WBC, RBC probes and measurement circuit.

Storage and service life after opening: Please store it in a cool dry place under 5-35℃. Away from direct sunlight, or ingredients of detergent will be invalid as the exposure time goes on. Once opened (connected to the instrument), the product shelf life is only 60 days.

3.5.5 Probe Detergent

Probe detergent contains effective oxide to clean the stubbornly-blocked apertures on the WBC, RBC probes.

CAUTION

Ø Detergent and probe detergent is alkali cleaning agent

(1) Prevent skin and eyes from contacting the reagent.

(2) Once contact with skin, rinse with water.

(3) Once contact with eyes, rinse with water and seek medical treatment immediately.

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(4) If ingested, induce vomiting and seek medical treatment immediately.

3.5.6 Control and Calibrator

Control and calibrator are for quality testing and calibration.

Control is an industrial production of whole blood. It is a hematology reference control used in monitoring determinations of blood cell values on hematology analyzers. It is with low, normal and high value. Three controls must be run every day to ensure the reliability of the results. Calibrator is also an industrial production of whole blood. It is used for calibration. Please refer to the instruction of control and calibrator for use and storage methods.

The "control" and "calibrator" mentioned in this manual refer to the special control and calibrator assigned by URIT. Users can purchase from CHINACAREor agents designated by URIT.

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Chapter 4 Installation

4.1 Overview

CAUTION

Ø Environment Requirements: Temperature: 15 ℃ ~ 35 ℃ ; Relative humidity: ≤ 85%;

Ø Place the instrument on a smooth and big enough platform which is easy to operate. Away from direct sunlight.

Ø Try to use a separate AC receptacle, and install stabilized voltage supply or UPS. Do not share an AC receptacle with centrifuges, room temperature shower (thermostat), refrigerators, air conditioners or ultrasonic cleaning equipment or other equipment which will interfere the instrument

CAUTION

Installation of the analyzer by an unauthorized or untrained person could result in personal injury which is exclusive of the warranty. Never attempt to install and operate the analyzer without a CHINACAREauthorized representative. This instrument has been tested strictly before delivery. It should be carefully packed before transport in order to avoid being hit. Check the package carefully to see whether there is a physical damage when arrive. If damaged, please immediately contact the after-sale service department of CHINACAREor local agent.

4.2 Unpacking and Inspection

Take out the analyzer and accessories from shipping carton carefully, keep the packing material for further transport or storage. Check as the following: (1) Quantity of accessories according to the packing list. (2) Leakage or soakage. (3) Mechanical damage. (4) Bare lead, inserts and accessories. Do contact CHINACARECustomer Support Center if any problem occurs.

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4.3 Space Requirements

In order to ensure the proper space for operation, maintenance and replacement of reagents, the host installation needs to meet the following requirements: (1) Choose a place near the power supply. (2) Eight inches of space behind the analyzer must be left for air flow. (3) There should be 100 cm of space above to either side of the analyzer for service access. (4) Sufficient space is required beneath for reagents, waste containers.

4.4 Power Supply Requirements

Be sure that the system is located at the desired site before attempting any connections. See Table 4-1 for details.

Table 4-1 Power Supply Requirement Optimal Voltage Voltage Range Frequency

AC220V AC220V±22V 50/60 Hz

WARNING: Ø Analyzer should be used in the condition of well ground connection for

ensuring accuracy of instrument and safety of operator. Ø A fluctuated voltage would impair performance and reliability of the

analyzer. Proper action such as the installation of E.C manostat (not provided by URIT) should be taken before operation.

Ø Frequent power failure will seriously decrease the performance and reliability of the analyzer. Proper action such as the installation of UPS (not provided by URIT) should be taken before operation.

4.5 Environment Requirements

(1) Temperature: 15～35℃(Optimum temperature is 25 ℃) (2) Relative humidity: ≤ 85% (3) Recommend to install heating and cooling air conditioning (4) Avoid using the instrument at extremely high or low temperature. (5) Away from direct sunlight. (6) Choose a well-ventilated place. (7) Away from communication equipment which may interfere the instrument by producing altofrequency electric wave.

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WARNING: The instrument takes full account of the electromagnetic compatibility problems. The electromagnetic interference generated by instrument will not disturb itself and devices nearby. If the test result has a large deviation, please check whether the instrument is being placed near a electromagnetic field or a short wave radioactive source (radar, X ray, centrifuge, scanner, cell phone etc.).

4.6 Waste Requirements

WARNING: To prevent environmental pollution, the waste is prohibited to pour into the sewer directly. The waste must be processed by biological or chemical methods before pouring into the sewer. Hospitals and laboratories have the obligation to comply with the relevant provisions of environmental protection department of local government. For every 20L waste, it is recommended to add the following chemicals into waste containers: (1) 50ml of sodium hydroxide solution (200g / L) to prevent gas forming. (2) 250ml of sodium hypochlorite solution (12% chlorine) to handle the waste

biological risk.

4.7 System Installation

4.7.1 Computer Installation

CAUTION Please ensure that the computer equipped is only for controlling the operation. If install other software, use removable storage devices such as U disk, or play games, surf the Internet on the computer, etc., it will easily being infected by virus and cause system damage or other errors.

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4.7.2 Tubing Installation

There are five tube-connectors on the left panel: LYSE, DILUENT, DETERGENT, SHEATH and WASTE, each of which is wrapped with a cap to avoid contamination by the CHINACAREbefore shipment. Uncover and set the caps aside carefully for further use on initial installation. NOTE Ø After installation, all tubes should be in a nature relaxed state and without

distortion. Ø Using tools for tubing installation is prohibitive. Only installing by hand is

allowed. Ø The reagent bottle can not be used if there is damage, leakage, expiration

and other anomalies. Please contact with local suppliers or after-sale service department of CHINACAREdirectly.

Ø To ensure safety and take optimal system performance into account, manufacturers recommend that all reagents should be placed on the same base or lower position.

1. LYSE Tubing Installation Remove the lyse tube with red faucet from reagent kit and attach it to LYSE connector on the left panel, place the other end into the lyse container. Twist the cap until secure. 2. DILUENT Tubing Installation Remove the diluent tube with blue faucet from reagent kit and attach it to DILUENT connector on the left panel. Place the other end into the diluent container. Twist the cap until secure. 3. DETERGENT Tubing Installation Remove the detergent tube with yellow faucet from reagent kit and attach it to DETERGENT connector on the left panel. Place the other end into the detergent container. Twist the cap until secure. 4. SHEATH Tubing Installation Remove the sheath tube with black faucet from reagent kit and attach it to SHEATH connector on the left panel. Place the other end into the sheath container. Twist the cap until secure. 5. WASTE Tubing Installation Remove the waste tube with black faucet from reagent kit and attach it to WASTE connector on the left panel, connect BNC plug with the socket marked “SENSOR” on the rear panel. Twist the tube’s cap clockwise onto the waste

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container until secure. Place the container on the level at least 50cm lower than the analyzer.

4.7.3 Printer Installation

Following these steps to install the printer: 1. Place the printer in an appropriate location adjacent to the instrument so as to operate easily; 2. Take out the printer from transport package. 3. Check the printer, if being damaged, please contact supplier; 4. Check the printer power; 5. Assembly the printer according to printer manual; 6.Connect the power cord to the printer, and then insert the wire into the grounding plug; 7. Confirm that the printer and computer are properly connected; 8. Install the ink cartridges and paper according to the instructions; ensure the printer is adjusted to the correct receiver size; 9. Connect the power cord to a grounded outlet and turn the power on.

4.8Transport and Storage Requirement

When the instrument is without using for a long time or before transportation, please run the "Prepare Shipping" procedure. please refer to Chapter 11 "Maintenance" for details. Proceed as follows: 1. Select "Non-use Packing" on the "Maintenance" interface; 2. Follow the prompts to unplug the relevant tubing connectors and keep the waste interface; 3. Instrument starts emptying operation, and the progress bar is on the bottom of the screen. 4. After emptying, back to maintenance interface. NOTE Ø Storage temperature: -20 ℃ ~ 55 ℃;. Ø Relative Humidity: ≤ 95%;. Ø Atmospheric pressure: 50kPa-106kPa Ø Before delivery, external disinfection is needed.

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Chapter 5 Principles of Operation

5.1 Overview

5500 uses electrical impedance method (also known as Coulter principle) to detect the amount and volume distribution of white blood cells, red blood cells and platelets. The colorimetric method is for determining the content of hemoglobin. The 4-angle laser scattered method is for the five part differential of white blood cells. Three separated channels are used for getting the blood cells counting results respectively.

(1) WBC and five part differential data are detected with laser in WOC flow cell. (2) WBC and HGB are detected by electrical impedance and colorimetric methods in WBC counting chamber. (3) The data of RBC and PLT are detected by electrical impedance methods in RBC counting chamber.

In each counting process, the instrument will aspirate, dilute and mix the samples and then test each parameter.

5.2 Sample Aspiration

5500 supports two modes of cell blood counting analysis, these two models are closed sampling. (1) Whole blood automated (batch) sampling mode; (2) Whole blood single (emergency) sampling mode. The aspiration volumes are: Whole blood automated (batch) sampling mode 160 µL±5％ Whole blood single (emergency) sampling mode 160 µL±5％ The whole blood sample is aspirated into the analyzer by the aspiration peristaltic pump and distributed into different test channels by shear valve.

5.3 Sample Dilution

The sample is divided into trisection after being aspirated. These triplet samples will inflood into the WBC counting chamber, RBC counting chamber and sheath pre-mixing cup respectively and then react with different reagents to get the results of white blood cell counting / hemoglobin measurement, red blood cell / platelet counting and WBC five differential. According to the different needs of the operators, the instrument provides two

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operating modes: whole blood automated (batch) sampling mode and whole blood single (emergency) sampling mode.

5.3.1 Whole Blood Automated (Batch) Sampling Mode

1. WBC / HGB Dilution Process

2. RBC / PLT Dilution Process

Whole Blood Sample 20ul

Add 8ml Diluent

Add 1ml Lyse

Dilution ratio is 1:400

Whole Blood Sample 0.64ul

Add 8ml Diluent



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3. WBC Differential Dilution Process

5.3.2 Whole Blood Single (Emergency) Sampling Mode.

The counting process is the same as whole blood automated sampling mode. It mainly used for inserting emergency test during the batch test process

Whole Blood Sample 28ul

Add 1.5ml Sheath



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5.4 WBC Test Principle

5.4.1Four-Angle Laser Light Scatter Technology

Figure 5-1 WOC Flow Cell

The whole blood samples are diluted with an appropriate proportion with sheath; white blood cell remains its original state approximately. Using flow cytometry to make the cells in a single arrangement. The scattering density can be tested through the laser beam detection zone.

(1) 00: Forward angle light scatter (10～30), which can be used to measure cell size;

(2) 100: Narrow-Angle Light Scatter (700～1100), which can be used to measure cell complexity and structure.

(3) 900D: Ninety-degree depolarized light scatter (7000～11000), which can be used to isolate the eosinophil from neutrophile.

(4) 900: Vertical light scattering (700～1100), which is mainly used to measure the inside particles and components of the cells.


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Figure 5-2 Multi-Angle Laser Scatter Optical Bench Light source is a vertical direction He-Ne laser with wavelength of 632.8nm and frequency of 5nw. Laser beam goes through a cylindrical lens which can change the shape of beam spot from circle to oval. Then the beam goes through a 125um cutting slice which can prevent low light passing and forming a homogeneous diffraction fringe. Finally, it is shaped into a spot with a diameter of 80um through an imaging lens and focus on the cell in the quartz sheath flow pool.

The laser beam is small in the horizontal direction, so the cells do not scatter laser much. If the remaining horizontal light reaches the 0° detector, light diaphragm can block it to prevent electronics saturation. The horizontal forward angle light directly scatter to the punch hole through the convergent lens. The light of 0 degree pass through the hole to the silicon photodiode detective unit of 0 degree.10 degrees scattering light reaches to the 10 degrees silicon photodiode detection unit by reflector. Vertical scattered light is collected by the condenser lens group, and then go through a 700um cutting opening (filter stray light and improve accuracy). After the scattered light which contains cell information passing through the condenser lens group, the vertical scattered light will be divided into two parts by a beam splitter mirror. A part of light directly scatters to the 90 degrees photomultiplier tube. The remaining scattered light will go through the line polarizer, and only the depolarizing scattered light can reach 90 degrees depolarizing photomultiplier tube.


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Figure 5-2 Optical Detection System

1— System Work Platform 2— Laser Bracket 3— Laser Plate 4— HE-NE Laser 5— Reflector Plate 6— Support Copper Cylinder 7— Cylindrical Mirror Bracket 8— 125 Microns Slit and Bracket 9— Imaging Lens Group and Bracket

10—WOC Flow Cell Fine-tuning Mechanism 11—WOC Flow Cell 12—Side Condenser Group and Fine-tuning Mechanism 13—Forward Condenser Group and Bracket 14—700 Microns Slit and Bracket 15—Spectroscope and polarizer Bracket 16—PMT Shield 17—PMT 18—PMT Position Adjusting Mechanism


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Figure 5-3 Scatter Plot Principle The gray area on left scatter plot is the ghost cells. It reflects that RBC dissolve into pieces on the scatter plot; green is for lymphocyte group; pink is for monocyte group; blue is for neutrophil; white is for basophil group; red is for eosinophil group.

Figure 5-4 Three-dimensional Plot

Figure 5-4 is a three-dimensional plot of WBC (3D). It can be magnified to view WBC differential and change S0, S10, S90 relative positions according to clinical experience.

5.4.2 White Blood Cell Differential

5500 does the four-angle scatter analysis for the cells which go through the WOC flow cell. White blood cells are being divided into 5 parts: basophil, eosinophil, monocyte, neutrophil and lymphocyte. The default unit of cells number is 109/L. l White Blood Cell Number Get the value of WOC and WIC simultaneously by laser and electrical impedance methods and finally get the total number of white blood cells through the system.


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l Lymphocyte Number (Lym#)

l Lymphocyte Percent

Lym% = Lym#/WBC

l Monocyte Number (Mon#)

l Monocyte Percent

Mon% = Mon# /WBC

l Neutrophil Number (Neu#)

l Neutrophil Percent

Neu%=Neu#/WBC

l Eosinophil Number (Eos#)

l Eosinophil Percent

Eos%=Eos#/WBC

l Basophil Number( Bas#)

l Basophil Percent

Bas%=Bas#/WBC

5.5 Hemoglobin Concentration Test Principle

5.5.1 Colorimetry Principle

Add lyse into the diluted sample in WBC counting chamber. Red blood cells will dissolve and release hemoglobin. Then the hemoglobin combines with lyse to form hemoglobin mixture. Use LED light-emitting diode to illuminate the hemoglobin mixture by the monochromatic light of 540nm wavelength at one end of the WBC counting chamber. At the other end, using optical tube to receive the transmitted light and then amplify the light intensity signal to voltage signal. Compare it with the voltage generated by the transmission light intensity before adding the sample into the colorimetry chamber (only with diluent) to get the value of hemoglobin concentration. Hemoglobin concentration is proportional to the absorbance of samples of 540nm wavelength. The process of measurement and calculation is done automatically by the analyzer, and the results will be displayed in the analysis results area.


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5.5.2 HGB Parameter

Hemoglobin concentration (HGB) is calculated by the following formula:

×=

S

B

EEKHGB ；

K is a constant. EB is the luminous intensity of light pass through the background. ES is the luminous intensity of light pass through the samples.

5.6 Red Blood Cell /Platelet Test Principle

5.6.1 Electrical Impedance Principle

The analyzer uses the traditional electrical impedance for the blood cells testing and counting. See Figure 5-5, conductive liquid (mainly diluent) provides constant current source for electrode to help the circuit form a stable impedance loop. When the cell pass through the pores, the conductive liquid is substituted by cells, and the resistance of loop changes to produce electrical pulses. When different volumes of cells pass through the pore, there will have different electrical pulses amplitude. So that we can determine the number and size of cells according to the number and amplitude of electrical pulses.

Figure 5-5 Electrical Impedance


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As the number of pulses corresponds to the number of cells pass through the pores, the pulse amplitude corresponds to the volume of the cells, so the analyzer can count and classify the cells according to size of the cells. The analyzer automatically divides the cells into red blood cells, white blood cells, platelets and other groups in accordance with pre-set volume classification procedure.

5.6.2 Volumetric Metering

Figure 5-6 Volumetric Metering The analyzer controls the quantity of samples that pass through the pore during counting by volumetric metering unit to obtain the exact counting results of blood cells in quantitative samples. The volumetric metering unit includes volumetric metering tube and two photodetectors. As shown in Figure 5-6, empty the volumetric metering tube before counting. When the sample flows through the pore, the liquid level of volumetric metering tube will decline slowly. When the liquid level passes through the start detector, it will produce an electrical signal and then the analyzer starts counting; when the liquid level reaches the stop detector, it also will generate an electrical signal and then finish counting. If there are bubbles or other abnormal flowage in the flow system during the process, "bubble" or "clog" alarm will be shown. Please refer to chapter 11 Troubleshooting for handling.


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5.6.3 Red Blood Cell Parameters

l RBC Number The instrument gets the number of red blood cell count (RBC) by measuring the corresponding electrical pulse numbers of RBC directly. The unit is 1012/L.

RBC = n ×1012 / L l MCV The mean corpuscular volume (MCV) is the average volume of individual red blood cells. The MCV is derived from the RBC size distribution data. The unit is fL. l HCT The hematocrit (HCT) is the ratio of red blood cells to plasma. It is expressed as a percentage of the whole blood volume. The HCT is calculated from the RBC count and the MCV as follows:

l MCH The mean corpuscular hemoglobin (MCH) is the average amount of hemoglobin in the red blood cell and being expressed in picograms. The MCH is calculated from the RBC and the HGB as follows:

l MCHC

The mean corpuscular hemoglobin concentration (MCHC) is the ratio of the weight of hemoglobin to the volume of the average red blood cell. It is expressed in percent and calculated from the HGB and the HCT as follows:

l RDW-CV The RDW-CV is derived from the RBC histogram and being expressed in percent. l RDW-SD The RDW-SD is the width of 20% peak value of red blood cell distribution


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histogram .The unit is fL.

l RDW The RDW is derived from the RBC histogram. It is the volume distribution geometric standard deviation of RBC.

5.6.4 Platelet Parameters

l PLT Number The instrument gets the number of platelet (PLT) by measuring the corresponding electrical pulses of RBC directly. The unit is 109/L.

PLT = n ×109 / L l MPV The mean platelet volume (MPV) is derived from the PLT histogram after the PLT count has been determined. The unit is fL. l PDW The platelet distribution width (PDW) is a measure of the heterogeneity of the PLT population. It is expressed as the geometric standard deviation(10 GSD). l PCT The PLT is calculated as follows:

Remark: The unit of PLT is 109/L. The unit of MPV is fL

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Chapter 6 Settings

6.1 Overview

Initialization setting of 5500 has been done before delivery. Setting of the interface at the first boot is default. To meet the different needs, some parameters can be re-set.

6.2 Time Setting

There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and DD-MM-YYYY. Y indicates Year, M indicates Month, D indicates Day. If time setting is changed, the time on screen and printed output will also change. 1. Entering into Setting Click "Time" button on the "Setup" interface , and then enter into the interface as Figure 6-1.

Figure 6-1 Time Setting

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2. Select Format There are three formats of date: YYYY-MM-DD, MM-DD-YYYY, and DD-MM-YYYY. Click the button to select the format needed. 3. Modification Determine the correct date and time, then direct input "year / month / day, hour / minute / second". 4. Save and Exit Modify the date and time, then click the "OK" bottom in the right corner of the interface shown in Figure 6-2. Click “Yes" to save the results; click "No" to exit.

6.3 System Maintenance

Cleaning time, sleep status and counting time can be set in the interface shown in Figure 6-3.

Figure 6-3 System Setting

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1. Auto Clean Setting Enter into the "Setup" interface, and then click "System Maintenance", select "Times" in "Auto Clean”. It is recommended that the flow system should be cleaned once for each one hundred counting. See Figure 6-4.

Figure 6-4 Auto Clean Setting

2. Auto Sleep Setting Enter into the "Setup" interface, and then click "System Maintenance", select "Times" in "Auto Sleep”. It is recommended to set the time according to the frequency in order to save energy. See Figure 6-5:

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Figure 6-5 Auto Sleep Setting 3. Auto Blank Setting Enter into the "Setup" interface and then click "System Maintenance". It is recommended to select "on" in "Auto Blank” so that after each boot, the instrument can automatically enter into counting interface and run background tests to check whether the instrument is normal.

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Figure 6-6 Auto Blank Setting 4. Counting Time Setting Enter into the "Setup" interface and then click "System Maintenance”. Set the upper and lower limits of WBC and RBC counting time warning as shown in Figure 6-7.The upper limit of WBC is 14 seconds. If the counting time is more than this value, "Clog" will be alarmed. The lower limit of WBC is 9 seconds. If the counting time is more than this value, "Bubble" will be alarmed. The upper and lower limits of RBC are similar to those of WBC. Note: The upper and lower limits are set before delivery. Generally, they should not be modified so as to avoid false alarm.

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Figure 6-7 Counting Time Setting

6.4 Dictionary Maintenance

If the name of the same department or doctor needs to be inputted repeatedly in the "Counting" and "Query" interface, the operator can set up a simple code. When editing patient’s information, the operator only needs to input the code and press "Enter" button, then the corresponding department or doctor’s name will be displayed. 1. Entering into Dictionary Maintenance Enter into "Setup" interface and click "Dictionary Maintenance", then the default interface will be displayed as Figure 6-8. 2. Department Code Setting

Click "Add", input the name of department in name box, such as "internal medicine" and then input “1" in code column. If the operator wants to input "internal medicine" next time, he only needs to input "1" then press "Enter".

Click "Del" button to delete the code item established.

Click "Mod" button to modify the code item established.

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Figure6-8 Department Setting

3. Doctor Code Setting

Click "Doctor" menu. Operator can establish a relationship between the code and doctors' name to save input time.

Click "Add", input doctor's name in name box, such as "LiQiang" and “002" in code column. Once the operator wants to input "LiQiang" next time, he only needs to input "002" then press "Enter". See Figure 6-9.

Click "Del" button to delete the code item established.

Click "Mod" button to modify the code item established.

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Figure 6-9 Doctor Setting

6.5 Barcode Information

The user can select the encoded mode of built-in barcode scanner supported by the analyzer in "Bar Code Info" interface. See Figure 6-10.

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Figure 6-10 Bar Code Information Setting

6.6 Sampler

Function of auto sampling can be set in "Sampler" interface. The analyzer can stop sample counting by selecting "Auto Sampler Pause Condition" if there is something wrong with the instrument. The sample numbering rule in the mode of auto sampling can be set in the interface “Vacant test tube rack, next sample NO.”. If choose "Keep", even the analyzer find a vacancy in the test tube rack, the sample number of the next one will not change; If choose "Auto-increment", the next sample number will be added "1". In "Scan Mode of Auto-sampler" interface, if select "Auto Scan", the test tubes number will be scanned by the built-in scanner; if select "No Scan", the test tubes number will not be scanned. In "Batch Input Data" interface, if you choose "Read by ID", the data can only be read when the test tube number scanned is in accordance with input number; if you select "Read by order", the system will match the patients' information before batch test according to the data results detected. If you do not want to input patients' information, please select "Unread". See Figure 6-11.

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Figure 6-11 Sampler Setting

6.7 Display Setting

Select the languages of parameters according to the unit of some parameters which need to be modified. 1. Entering into Display Setting Click "Display" after entering into "Setting" interface as shown in Figure 6-12.

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Figure 6-12 Display Modification Interface

2. Display Modification Setting The operator can select different parameters units, Chinese and English parameter language and reference value order etc. Click the "triangle" button to select the desired display settings, the results on screen and those printed out will also change. 3. Save and Exit Click SAVE, the save dialog box will display (see figure 6-13). Select YES to save the modification of display settings and back to the corresponding interface, and NO is contrary.

Figure 6-13 Save Dialog Dox

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6.8Print Setting

1. Entering into Print Setting Click “Print” in the Setup interface and enter the Print Setting interface.(see figure 6-14)

Figure 6-14 Print Setting

2. Setting Print Options In Print Setting, operator can select printer type, print format, auto print and input hospital name in “print title”. 3. Save and Exit Click SAVE, the save dialog box will display (see figure 6-15). Select YES to save the print settings and back to the corresponding interface, and NO is contrary.

6.9 Transfer Setting

In Transfer Setting, operator can set the port number, baud rate, data bit, stop bit and parity bit of the external communication port. 1. Entering into Transfer Setting Select Transfer in the Setup interface, then enter the Transfer Setting interface (see figure 6-16)

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Figure 6-16 Transfer Setting Interface

2. Modify Transport protocols Operator can modify the port number, baud rate, data bit, stop bit and parity bit of the communication port. If the auto-trans is ON, the test results will transmit from the communication port automatically. CAUTION Ø Transfer setting is already set before delivery. As a rule, there is no need to

reset, or the data transmission will be affected. Necessary modification should be done under the guidance of CHINACAREengineer.

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3. Save and Exit Click SAVE, the save dialog box will display (see figure 6-17). Select YES to save the modification of transfer settings and back to the corresponding interface, and NO is contrary.

Figure 6-17 Save Setting

NOTE

Ø Click SAVE and select YES to save the settings after modification, otherwise it will lose.

6.10 Group Parameters

To monitor abnormal test parameters of blood samples, it is essential for the operator to set normal ranges of the parameters according to laboratorial or clinical requirement. Information or indication will be given if the test values exceed the range. The analyzer provides the limit of 24 parameters, any results exceeding the range will be marked H (High) or L (Low). H means the results are higher than the upper limits, while L means the results are lower than the lower limits. CAUTION Ø The shift in parameter limit may cause changes in abnormal indication of

hematology index. Please confirm the necessity for changing.

6.10.1 Limit Review

At Limit setting interface, operator can input proper parameter limits or use the default limits. Default limits are different depending on the patient group. Figure 6-18 depicts the General group limits, and figure 6-19 depicts the User1 group limits.

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Figure 6-18 Limit Setting

Figure 6-19 Limit Setting

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6.10.2 Limit Modification

Operate as follows to modify the parameter limit: 1. Click the triangle on the right side of Group to select the group that needs

to be modified. 2. Select the lower or upper limit of parameters need modification. Move the

cursor into edit box, press “Backspace” on the keyboard to delete raw data and input the new lower or upper limit.

3. Click SAVE, the save dialog box will display (see figure 6-20). Select NO to cancel and go back to browsing status of parameters Select YES to save the modification and back to the corresponding interface.


6.11 User Management

Operator should login the system with identity to operate the routine check. Only the administrator can modify user setting, so message erection of the operator is necessary. 1. Entering User Management Setting Click User in the Setup interface, then enter user management interface(see figure 6-21)

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Figure 6-21 User Management

2. Add User Input the user’s name, select Permission, set password (default password is null) and click Add to add the new user.(see figure 6-22)

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Figure 6-22 Add User

3. Modify User Double click the user to modify the User name, group and password. 4. Delete User Select and click Del. to delete the user. Then select YES or NO to confirm whether to delete the user or not.(see figure 6-23)

Figure 6-23 Delete user

6.12 Permission

In order to guarantee the proper use, it is necessary for the administrator to only give partial permission to operators, such as only allow operators to query and count data, but can not delete. Select one permission in the left box, click Add, it will display in the right box

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after clicking Add. Click Del. to delete the selected permission in the right box.(see figure 6-24)

Figure 6-24 Permission Setting

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Chapter7 Daily Operation

7.1 Overview

This chapter describes the whole procedures of daily operation from startup to shutoff, and explains the process of different modes of sample analysis in detail. Daily Operation Flow Chart as follows: CAUTION Ø The analyzer must be operated by medical inspection professionals or

trained doctors, technicians.

7.2 Preparations

Check the analyzer as the following steps before startup to ensure the system

Preparations

Startup

Quality Control

Specimen Preparation

Sample Count

Shutoff

Data Input

Result Query And Output

Statistic

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is ready. 1. Check the Waste Container The waste should be processed properly and cleaned up before startup every day. 2. Check the Reagents, Tubes and Powers Ensure diluent, lyse, detergent and sheath meet the test. Ensure the tubes of reagents and waste connected well and without bending. Ensure the power plugs of instrument, computer and outlet connection is reliable. 3. Check the Printer Ensure printing paper is sufficient and the installation is proper. Ensure the power is on and the cable has been connected with the analyzer and the computer properly. 4. Check the Mouse and the Keyboard Ensure the mouse and the keyboard has been connected with the computer.

CAUTION

All clinical specimens, controls, calibrators and waste with potentially infectious hazard. The operator should comply with the safe operation provisions in laboratory and wear personal protective equipment (lab coats, gloves etc.) when handling these materials.

7.3. Startup

Turn on the power switch on the right panel, then the status indicator on the front panel will be orange. The analyzer will automatically detect the operation of the components when self-checking and initialization after loading, and then rinse the flow system. It takes about 3 minutes before entering the Blood Cell Count interface (See Figure 7-1) after initialization.

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Figure 7-1 Blood Cell Count

After startup, background counting should be performed before blood sample test. Analyzer can be set to run background counting automatically after startup. Consult Chapter 6 for the instrument settings.

The range of background is listed in Table 7-1.

Table 7-1 Range of background

Parameter Acceptable range WBC ≤0.20x109/L RBC ≤0.02x1012/L HGB ≤1g/L PLT ≤10.0x109/L

If the background result is out of this range, repeat the above procedures until it is in this range. If the results are still out of this range after repeat five times, please refer to please refer to 11.4.2 for Troubleshooting for help.

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7.4 Quality Control

Quality Control should be performed before daily test to ensure accuracy of the results. Please refer to Chapter 8 Quality Control.

7.5 Collection of Blood Samples

CAUTION

Ø Considering all the clinical specimens, controls and calibrators etc that contain human blood or serum as being potentially infectious, wear lab coats, gloves and safety glasses and follow required laboratory or clinical procedures when handling these materials.

Ø Do not directly contact blood samples, controls and calibrators, and follow required procedures when disposing.

CAUTION Ø Blood collection and disposal should be performed according to the local

and national environmental regulations or laboratory’s requirements. Ø Ensure the whole procedure of blood collection is clean and

contamination-free. All specimens must be properly collected in tubes containing the EDTA (EDTA-K2·2H2O) anticoagulant.

Ø Do not shake the sample tube violently. Ø Venous blood can only be stored for 4 hours at room temperature.

CHINACARErecommends the blood sample be kept at the temperature between 2-8℃ for longer storage.

7.5.1 Whole blood collection

Collect whole blood sample through vein-puncture and store it in a clean sample tube with EDTA-K2·2H2O, which can keep the configuration of WBC, RBC and avoid platelets aggregation. Gently shake the tube 5~10 times and ensure mix well. The following anticoagulants are commonly used in whole blood collection: 1. Heparin:

Lead to cell aggregation and change the cytoplasm’s color of Romanowsky staining. The concentration of high heparin > 7.5UL/ capillary will lead to increased in HCT and MCV.

2. Sodium citrate: Since sodium citrate is liquid, it may be diluted to 10/11 of the original in

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the tube filled with whole blood. This anticoagulant is used for agglutination when a suspect EDTA causes spurious thrombocytopenia.

3. ACD and CPDA: Most widely used in cell Concentration (especially platelet concentrates), usually not used for cell counts.

4. EDTA: In the salt of EDTA, use EDTA K2（United States and Japan）and EDTA K3（United States and Europe）,sometimes NA2EDTA. And EDTA K2, EDTA K3 which recommend by ISCH in1993 are most widely used in the blood test of the world. But other EDTA salts can also be used. EDTA could lead to Pseudo-thrombocytopenia through Platelet aggregation. (Incidence is about 1/800)

5. Fluoride: Use before EDTA. Without side effects according to the survey

7.5.2 Sample stability

Better to use fresh whole blood. ICSH (International Committee for Standardization of Hematology) defined fresh blood as: samples processed within 4 hours after collecting. When whole blood samples are thoroughly mixed, placed in EDTA-tubes, and tested within 8 hours after collecting, the accuracy of each parameter will be highest. Test samples within 5 to 20minutes or over 8 hours, the WBC volume distribution will offset.

7.6 Information Input

Click Data in the interface to input the detail information about the sample, and Chinacarerecommends operator to input the detail information before sample analysis. (see figure 7-2)

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Figure7-2 Data Input

Click “Ctrl+Shift” on the keyboard to select Input Method. Name: Input letters or numbers. Sex: Select male or female. If not selected, default as blank. Age: Select Year, Month and Day. Blood Type: Select A, B, O, AB, A Rh+, A Rh-, B Rh+, B Rh-, AB Rh+, AB Rh-. O Rh+, O Rh-. If not selected, default as blank. Group: Select Auto, Man, Woman, Child, New-born, General, Custom 1, Custom 2, Custom3. If Auto is selected, the reference values are listed as Table 7-2.

Table 7-2 Reference Value Reference Value Age(Year) Sex

General NO input Blank, M,F General ≥16 Blank

Man ≥16 M Woman ≥16 F

Child >1 and ＜16 Blank, M,F Baby <1 Blank, M,F

ID: The ID number is in range from 00000000 to 99999999. If no ID input, the

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ID of current sample will be automatically added follow the last one. Case ID: Input the sample number. Bed No.: Input bed No. of patient. Department: Input department name or code of operator. Checker: Input checker’s name or code. Sender: Input sender’s name or code. Assessor: Input assessor’s name or code. NOTE: The ID number is set to 0 only under Background Count. The blood sample ID CAN NOT be 0. CAUTION: Each sample has a corresponding identification number. Do not confuse.

7.7 Sample Counting

7.7.1 Mode

Click on the main interface, the dialog box as figure 7-3 will be displayed. Select the mode, then press Yes, that the mode will switch to corresponding

mode. At the same time, the icon on the screen will change. means single

sampling whole blood mode , means single sampling pre-dilution mode,

means multiple sampling whole blood mode.

Figure 7-3 Mode Switch

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NOTE: Ø User can choose CBC if he wants whole blood and pre-dilution modes.

CBC mode is only available for counting and without differentials. The counting result includes 18 parameters and the diagrams of RBC and PLT.

Ø “CBC+5Diff+RRBC"--- For counting after dissolving the indissolvable red blood cells. It is suggested that when RRBC? alarm, switch counting mode to CBC+5Diff+RRBC, and then run counting again so as to eliminate the interference of white blood cell coning from the indissolvable red blood cells. If WBC total number is far less than that of the first counting, it shows that this specimen contains indissolvable red blood cells

7.7.2 Counting and Analysis

WARNING The sharp sample needle contains residues of clinical specimens, controls or calibrators probably have potential infectivity. Do not directly contact the sample probe. NOTE Ø Do not reuse disposables. Ø Ensure the inputted ID number correspond with the sample. CAUTION Do not open the front panel after start counting.

7.8 Data Query and Output

After each counting, the results are automatically saved in a database that could store at least 200,000 results include 34 parameters (2 scatter diagrams, 2 histograms, 2 Three-dimensional plots).Operator could review all of the results, scatter diagrams and histograms that store in the database through query and statistic.

7.8.1 Data Query

Click “Data”-“Query” at the main interface, and then enter the query interface. (See f igure 7-4)

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Figure 7-4 Data Query

The operator can quickly query the results of specimens according to the query condition such as date, ID, name, sex, age, blood type etc. (Combined Query is available).Take ID as an example, to query the results between ID 45 and ID 50, click the box in the left of ID and input 45 to 50, click Query, the needed results will be displayed. (See Figure 7-5)

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Figure 7-5 Number Query

7.8.2 Data Selection

Click the result needed, the row of result will be highlighted to identify being selected. Figure 7-6 is the sample record of number 44.

Figure 7-6 Select Single Result

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Select single data (such as No.44), click “Data” (or double-click directly), then the detail information of the datum will be displayed.

Figure 7-7 Query Detail Information

Click All, all data in the Query Interface will be displayed in red to identify being selected. (See figure 7-8)

Figure 7-8 Select All

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7.8.3 Data Deletion

After processing plenty of samples, it is necessary to clean up or delete the mass data stored in the analyzer according to the requirement of the operator. There are two methods to delete data—D_All and Del. . NOTE Be aware that once the data are deleted, they can NOT be recovered. Please operate with caution.

7.8.4 Precision

Check the precision of each parameter of selected sample result, including Mean, SD, CV%. The calculation formulas are as follows:

N is the number of samples selected, Xi is the results of i times for the specified parameters. Selected the results that need to be calculated CV, click Prec. into the interface as figure 7-9, and check the precision.

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Figure7-9 Precision NOTE Ø Calculate the precisions of 3~30 samples results . Ø “***”means invalid. If some parameters of selected sample are invalid, the

precision is invalid too. Click Exit and back to the Query interface.

7.8.5 Trend Graph

Operator could see trend graphs of 6 parameters (WBC、RBC、PLT、HGB、MCV、RDW-CV)of selected sample. Choose the sample result, and click Trend Graph into Trend Graph interface. (see figure 7-10)

Figure 7-10 Trend Graph

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NOTE Ø Check trend graphs of 3~500 sample results. Ø “***”means invalid. If some parameters of selected sample are invalid, the

Mean, SD, CV% are invalid too. The lower, target value and upper of left trend graph are set to the range of reference of the general automatically. Please refer to Chapter 6 Trend graph setting.

The trend graph instruction as follows: u Every dot corresponds with a single sample result. u Abscissa indicates the quantity of the selected samples, ordinate indicates

the parameters results. u The 3 data on the left side of trend graph correspond with 3 lines, means

lower, target value and upper from bottom to top. Upper: Mean＋Limit(Average×10%); Target value: Mean; Lower: Mean－Limit(Average×10%); u The 3 data on the right side of trend graph mean: Mean--Average; SD--Standard Deviation; CV%--Coefficient of Variation;

N is the number of samples selected, Xi is the results of i times for the specified parameters.

7.9 Reticulocyte Analysis

The reticulocyte package software enables the operator of the 5500 system to analyze a whole blood specimen for reticulocytes. The reticulocyte specimen is prepared by using reticulocyte reagent to produce a diluted, stained sample. Press Retc to start reticulocyte analysis. The analysis screen is shown below.

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Figure 7-11 Reticulocyte Analysis The prepared specimen run with the reticulocyte package on the 5500 system will measure results as a reticulocyte percentage. The reticulocyte absolute number is automatically calculated when the RBC value is made available from the Standard Hematology Data Log or entered by the operator. The Immature Reticulocyte Fraction (IRF) is calculated from the Reticulocyte % and displayed below the Reticulocyte absolute number.

7.9.1 Principles of Operation

Reticulocytes are defined by the National Committee for Clinical Laboratory Standards (NCCLS) as transitional red cells, between nucleated red cells and the so-called mature erythrocytes. In contrast to mature RBCs, reticulocytes contain ribosomal RNA. This RNA can be seen with certain supravital, cationic dyes that simultaneously stain and precipitate the polyanion to form a network or reticulum. The 5500 system reticulocyte method uses the thiazine dye New Methylene Blue N. The reticulocyte assay is performed in the WOC channel of the instrument. Sample preparation is performed manually by diluting 20 μl of blood into a tube of CHINACAREReticulocyte Reagent. At room temperature, staining of reticulum is complete within approximately 15 minutes. The stained

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sample is aspirated in the Open Mode. After the stained sample is aspirated, it is diluted approximately 50-fold with Sheath Reagent. Once diluted with Sheath, the RBCs sphere due to the influence of the nonionic detergent incorporated into the staining solution. Sphering is necessary to eliminate optical orientational noise that would otherwise be introduced into the scatter measurements. The usual lytic action of the Sheath is prevented by electrolytes contained in the staining solution and the lack of the usual incubation period used in this channel during WBC analysis. In addition, the high New Methylene Blue concentration in the staining reagent exerts a stabilizing effect on RBCs. During data acquisition, 10 degree and 90 degree scatter are collected for up to 30,000 events. The 0 degree threshold is set high enough to exclude most platelets. Histogram data are used to differentiate reticulocytes, mature RBCs, platelet clumps, and nucleated cells. Reticulocytes have 10 degree scatter that are similar to the scatter for mature RBCs, but differ from them by exhibiting greater 90 degree scatter. Reticulocytes are reported in percent. The instrument will automatically calculate the reticulocyte Absolute value if an RBC count is entered. The RBC value may be obtained from the Standard Hematology Data Log, or it may be entered by the operator directly on screen. Immature reticulocytes contain more RNA and absorb more stain than mature reticulocytes; therefore, they exhibit greater 90 degree scatter. On the URIT5500, immature reticulocytes are classified as the population of reticulocytes that exceed a predetermined scatter threshold. Consequently, it is possible to determine the Immature Reticulocyte Fraction (IRF) from the scatter measurements. The IRF was initially designated as the Reticulocyte Maturation Index (RMI), and defined by NCCLS H44-A1 as a quantitative expression of the relative maturation of the reticulocytes in the observed reticulum in New Methylene blue-stained preparations. However, these quantitative visual measurements of reticulocyte maturation have been little used due to the subjectivity and imprecision of the manual analysis. Since automated reticulocyte methods allow the enumeration of immature reticulocytes as a subfraction of the total reticulocyte population, the preferred nomenclature is Immature Reticulocyte Fraction (IRF). The immature reticulocytes are then reported as a fraction (or percent) of the reticulocytes. The clinical utility2of the IRF is widely recognized as follows: l Monitor hemopoietic regeneration after bone marrow transplant,

hemopoietic stem cell transplantation, or intesive chemotherapy l Monitor bone marrow toxic insults from drugs (for example, AZT) l Monitor erythropoietin therapy in renal failure, AIDS, infants,

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myelodysplastic syndromes, and blood donations l Classify anemia l Monitor efficacy of anemia therapy (Fe, B12, Folate)

7.9.2 Reticulocyte Sample Preparation

NOTICE

1. Add 20uL blood samples to be tested to reticulocyte dye test tube (3.7mL),

and place it at about 30 ° C ~ 35 ° C for 15 to 30 minutes after mixing.

2. The accuracy of the results will be affected more than 2 hours.

NOTE

Avoid contacting with skin and clothing when using the reticulocyte reagent,

since it contains new methylene blue which will contaminate skin, clothing and

many other surfaces.

7.9.3 Reticulocyte Test

Place the prepared reticulocyte samples into the single sampler, then the

dialog shown in Figure 7-12 will pop up. Operator inputs the serial number and

RBC value, then click Run, that the reticulocyte test begins, as shown in Figure

7-13

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Figure7-12 Reticulocyte Test Screen

Figure 7-13 Process of Reticulocyte Test

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7.10 Statistic

On Blood Cell Count Interface, click “Data”→ “Stat.” to enter statistics interface (See Figure 7-14). Operation procedure is as follows:

Figure 7-14 Statistics

1. In the box of statistic date, click to select Start Date and End Date, then

click OK.(see figure 7-15)

Figure 7-15 Data

2. Select types such as Department and Sender in the Statistics Type box,

and then all items selected will be displayed in the middle list box. 3. Select statistic item (or multi-select), click “Cal”, then the desired data will

be displayed in the right list.

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4. Click Back to return Blood Cell Count Interface. 5. Click Print to print the statistics.

7.11 Shutoff

Shutoff procedure should be performed after finishing all the tests and before turning off the power. Clean the counting chambers and related tubes. If continuously use the analyzer or finishing today’s test, shutoff procedure should be performed at least once every 24 hours. The procedure of Shutoff as follows: 1. Click “Exit” on the main interface; 2. Pop-up close confirmation dialog; 3. Check whether the procedure of shutoff is finished, the close dialog box is shown or not. 4. Turn off the power of the instrument and the computer. CAUTION May lead to data loss and abnormal boot If the shutoff procedure is not performed.

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Chapter 8 Quality Control

8.1 Overview

It’ probably leads to unreliable results for a long time use. In order to maintain

the analyzer precision and eliminate system errors, it’s necessary to perform

quality control.

It’s better to use low, normal and high controls to perform quality control

everyday or using normal control at least. When using control of new lot,

please combine it with the existing controls for 5 days, twice per day, and the

results should be within the range of parameters of the control instruction.

In the following conditions, perform quality control with controls recommended

by URIT:

l After daily start-up procedures completed

l The reagent lot number changed

l After calibration

l After maintenance, or component replacement

l In accordance with the laboratory or clinical QC protocol

l In suspicion of abnormal parameter value

CAUTION

Ø Considering all the clinical specimens, controls and calibrators etc. that

contain human blood or serum as being potentially infectious, wear lab

coats, gloves and safety glasses and follow required laboratorial or clinical

procedures when handling these materials.

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NOTE

Ø Ensure to perform the following procedure before using the control

removed from the refrigerator:

1. Leave it for 15 minutes to reach room temperature (18-35°C).

2. Rub the vial for 10 to 15 times;

3. And gently invert the vial 1for 0 to 15 times;

4. Ensure that the contents of vial are completely suspended by

inverting the vial and viewing the bottom. Repeat step 2 and 3 for 8

times, or for 2 minutes, until completely suspended.

8.2 Quality Control Options

(1) L-J QC

L-J QC (Levey-Jennings graph) is a simple and visual QC method with which

operator can draw QC value directly on graph after get the Mean, SD and CV.

Mean, SD and CV are derived from following formulas:

(2) X-R QC

In X-R QC method, X indicates mean value, R indicates range of value. X

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graph is mainly used to judge that if the mean value falls in required level. R

graph is mainly used to judge that if the range of value falls in required level.

(3) X QC

X QC is the variation of X-R QC; they have the same basic principle. The

difference is that the control dot in X graph indicates the mean value of two

values other than one value. On this foundation, it calculates the Mean, SD

and CV.

(4) X-B QC

X-B QC is a moving average method which is first promoted in 1970s’. It’s

based on the principle that, RBC count is varied due to the concentration of

dilution, human blood pathology and technical factor, but the hemoglobin

content in specific unit is hardly interfered by those preceding factors.

According to this characteristic, quality control of the samples is being done by

surveying the value of MCV, MCH, and MCHC.

8.3 QC Operation

Click QC in main interface, pop up interface as figure 8-1:

Figure 8-1 QC Mode Select

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System offers four quality control options: L-J QC, X-B QC, X-R QC and X QC.

Select the mode and click to enter corresponding interface.

8.4 L-J QC

In L-J QC, the operator could perform QC with 20 test parameters at most.

Considering the different needs, selecting partial parameters for QC is

available. 3 QC documents of high, normal and low are provided for saving.

8.4.1 L-J QC Edit

In different interfaces, click QC Edit enter corresponding edit interface. In L-J

QC interface, click L-J QC to enter edit interface. Input control lot NO., expiry

data and level, then input desired assay and limit according to the control

instruction.(see figure 8-2)

Figure 8-2 L-J QC Edit

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NOTE

The limit should not be more than 40% of assay, or the limit cannot be saved in

database.

Click OK after editing, the dialog box about whether to save the edit result will

display.(see figure 8-3)


8.4.2 L-J QC Run

In L-J QC interface click QC Run, enter the interface as figure 8-4.

Figure 8-4 L-J QC Run

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8.4.3 L-J QC Graph Analysis

In L-J QC interface click QC Analysis, enter graph analysis interface as figure

8-5:

Figure 8-5 L-J QC Graph Analysis

8.4.4 L-J QC Data Query

In the L-J QC interface, click QC Query, enter data query interface as figure

8-6:

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Figure 8-6 L-J QC Query

8.5 X-B QC

X-B QC is different to others, with which the systems can only edit three

parameters: MCV, MCH, and MCHC. It is a QC without controls and a means

of monitoring instrument like controls, but they can’t substitute each other.

NOTE

Ø Recommend using X-B QC, when the quantity of samples is more than

100.

Ø X-B QC is for the use of random sample, not for classification samples.

Ø Observed the trend of QC result in reference range which made up by

reference, low and high limit.

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8.5.1 X-B QC Edit

Before QC analysis, operator should finish the QC edit as follow:

1. In the main interface, click QC, and then click X-B to enter X-B QC

interface.(see figure 8-7)

Figure 8-7 X-B QC

2. Input the assay and limit of parameters that require for quality control.

3. Input the number of required samples when calculate a dot of X-B QC. The

range of selection is 20 to 200, CHINACARErecommend the number is 20.

4. In the X-B QC interface, click On in the X-B Edit to open the X-B mode.

8.5.2 X-B QC Run

When finish QC edit, click Count to operate quality control. The system will

automatically operate a QC calculation after analyzing, and get a dot that

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correspond with each reference of X-B QC and save it in X-B QC graph and

X-B QC list.

8.5.3 X-B QC Graph Analysis

Operator can review QC results of three parameters through graphs. After the

count of group samples completed, the results of MCV, MCH, MCHC will depict

a dot on the graph. For example, the “X-B QC ” is ON and “Bacth No.” is 20,

then after the subsequent 20 counts, the system will calculate a X-B QC value

and a corresponding control dot which will display on the graph.

There are three graphs of MCV, MCH and MCHC. The graphs will update at

once after each QC counting. QC results are arranged in graphs according to

storage time. The latest is on the left side and its serial number is 1.

QC Graph instruction:

1、 Graph abscissa indicates QC run times, ordinate indicates QC result.

2、 Every parameter graph can display at most 31 dots.

3、 Every parameter graph’s upper transverse line means assay plus limit.

4、 Every parameter graph’s lower transverse line means assay subtract

limit.

5、 The 3 values on the left side of parameter graph mean:

l upper limit —— assay limit;

l middle line —— assay;

l lower limit —— assay － limit.

If the control dot falls in the area between upper and lower lines of the

corresponding graph, it means the dot is under control range; If not, the dot is

not under control range.(see figure 8-8)

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Figure 8-8 X-B QC Graph

8.5.4 X-B QC Data Query

Operator can review QC results of three parameters through QC Query as the

figure 8-9 show.

Figure 8-9 X-B QC Data

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8.6 X-R QC

X-R QC needs controls. If run a background QC, the system will alarm QC

result is invalid.

8.6.1 X-R QC Edit

Before QC analysis, operator should finish QC Edit as follows:

1. At main interface, click QC, then click X-R QC, enter X-R QC Edit/Run

interface.(See figure 8-10).

Figure 8-10 QC edit/run

2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.

3. Input lot NO., and select expiry date according to control instruction.

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8.6.2 X-R QC Run

When finish QC Edit, place the prepared control in Emerge place, the analyzer

will automatically aspirate the controls to start analysis.

In QC interface, system displays two control results, and calculates the mean

and range automatically after finishing the second QC count.

8.6.3 X-R QC Graph Analysis

X-R QC is similar to X QC; operator can review QC results of 24 parameters

through QC graphs. At X-R QC interface, click QC Analysis, enter graph

analysis interface.(see figure 8-11)

Figure 8-11 X-R QC Graph

X-R QC is different from X QC is, the dot on X-R QC Graph indicates mean

value or range of two QC results. The system cannot display low, normal and

high control graphs simultaneously in one interface, please select Level to

change.

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In X-R QC interface, there are X graph and R graph. X graph displays the

mean value dot while the R graph displays the range dot.

If operator selects group 1 of low level to perform QC twice, the dot correspond

with mean will be within X graph which correspond with low value 1. It also fits

for the dots of other groups— the dot correspond with range is within

corresponding R graph.

QC results are arranged in QC graph according to storage time, the latest is on

the left side and its serial number is 1.

X graph instruction:



3、 Every parameter graph’s middle transverse line indicates X(mean

value of QC results).

4、 Every parameter graph’s upper transverse line means X upper limit＝X

＋A×R.

5、 Every parameter graph’s lower transverse line means X lower limit＝X

－A×R.


l upper limit —— X upper limit＝X＋A×R

l middle line —— X

l lower limit —— X lower limit＝X－A×R

R graph instruction:



3、 Every parameter graph’s middle transverse line indicates R(mean

value of QC result range).

4、 Every parameter graph’s upper transverse line means R upper limit＝B

×R.

5、 Every parameter graph’s lower transverse line means R lower limit＝C

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×R.


l upper limit —— R upper limit＝B×R

l middle line —— R

l lower limit —— R lower limit＝C×R



not under control range.

8.6.4 X-R QC Data Query

When finish QC count, operator can review QC result of 24 parameters

through QC Query. Click QC Query to enter the interface as figure 8-12:

Figure 8-12 X-R QC Query

Click Pgprv or Pgnex to review the data. Operator could review 31 items data

at most. Click D_All to delete all data.

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The difference to X and L-J QC Query is: each page in the X-R QC Query

interface display three QC results that include mean value and range. But the

first page of the first two columns is total mean and average range in the X-R

QC Query.

The QC data would update after running two new controls.

8.7 X QC

In X QC, analyzer should aspirate control to operate QC. The operator could

perform QC with 20 test parameters. Considering the different needs, selecting

partial parameters for QC is available. 3 QC documents of high, normal and

low are provided for saving.

8.7.1 X QC Edit

Before QC analysis, operator should finish QC Edit as the follows:

1. In the main interface, click QC, then click X QC, enter X QC Edit

interface.(see figure 8-13)

Figure 8-13 X QC Edit

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2. Select corresponding level: low 1, low 2, low 3; normal 1, normal 2, normal

3; High 1, High 2, High 3.

3. Input lot NO., and select expiry date according to control instruction.

4. Input assay and limit value according to control instruction.

After QC Edit, click Save, the dialog box that whether to save the result or not

will display.(see figure 8-14).

Figure 8-14 Save Settings

8.7.2 X QC Run

In X QC interface, click QC Run, enter the interface as figure 8-15:

Figure 8-15 X QC Run

Select the level, lot No. and expiry date that X QC Edit selected.

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In QC interface, system displays two control results, and calculates the mean

value automatically after finishing the second QC count. The column of mean

value show the mean value, the column of reference range show reference

range that user input in the QC Edit.

In the QC Run interface, place the prepared control in Emerge place; the

analyzer will automatically aspirate the controls to start analysis. If the

reference value of current group is empty, the system will alarm and can not

run the QC count. Back to QC edit interface, then input QC reference value

and limit of deviation for running QC count. If run a background QC, the system

will alarm QC result is invalid.

8.7.3 X QC Graph Analysis

After QC Run, operator can review QC results of 20 parameters through QC

Graph. In X QC interface, click QC Analysis, then enter the interface as figure

8-16:

Figure 8-16 X QC Analysis

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101

The dot on the X QC Graph indicates mean value of two QC results. there are

low, normal and high graphs. If select group 1 and low level to run a control

sample, the control dot will present in low 1 graph. Other selections will present

in corresponding graph.

QC results are arranged in graphs according to storage time. The latest is on

the left side and its serial number is 1.

QC graph instruction:



3、 Every parameter graph’s upper transverse line means assay plus limit.

4、 Every parameter graph’s lower transverse line means assay subtract

limit.


l upper limit —— assay plus limit

l middle line —— assay

l lower limit —— assay subtract limit



not under control range.

8.7.4 X QC Data Query

In X QC interface, click QC Query, enter QC Data Query interface, operator

can review the QC results of 20 parameters.(see figure 8-17)

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Figure 8-17 X QC Query

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Chapter 9 Calibration

9.1 Overview

Analyzer is detected and calibrated at the factory just prior to shipment. For

some reasons the result may be a little out of the range. Calibration is to insure

the accuracy of results. Calibration is a process to standardize the analyzer by

its deviation of value and parameter, calibration factor.

The instrument provides three calibration modes: Calibrator Calibration, Whole

Blood Calibration, and Manual Calibration.

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CAUTION Ø Only calibrators recommended by CHINACAREcan be used to accomplish

the calibration.

Ø Follow the use instruction to store and use calibrator.

Ø Check if the container is broken or cracked before using the calibrator.

Ø Make sure the calibrators are brought to room temperature and well mixed

slowly before use.

Ø Make sure the calibrators are within the expiry date.

Ø Make sure the analyzer without problem and precision meet the

requirement before calibration.

Ø Never apply to the laboratory or clinic use unless all the parameters are

accurately calibrated.

CAUTION Ø Slowly remove a vial of blood calibrator from refrigerator, and warm to

room temperature by rubbing.

Ø Ensure the contents of a veil are completely suspended by inverting the

veil 30 times at least.

9.2 Calculate Frequency

To ensure analyzer’s precision and obtain reliable test results, the

parameters(WBC，RBC，PLT，HGB and MCV) should be calibrated in the following

situations:

(1) Working environment changes greatly;

(2) One or multiple parameters’ test results are moving;

(3) Any major component that affect the measurement is replaced;

(4) For long time no use;

(5) Requirement of the laboratory or the clinic;

(6) The reagent has been replaced;

(7) The analyzer presents deviation when running quality control.

MCV and HCT are relative parameters to each other, thus one can be obtained

from given value of the other. Only MCV can be calibrated by the analyzer.

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Usually the manufacturer will give the value for MCV, HCT at the same time.

CAUTION Considering all the clinic specimens, controls and calibrators ect that contain

human blood or serum as being potentially infectious, wear lab coats, gloves

and safety glasses, and follow require laboratory or clinic procedures when

handling these materials.

9.3 Preparation for Calibration

Before calibration, inspect the analyzer as the following requirements:

(1)Ensure the adequate reagents are in the shelf life and uncontaminated.

(2)Run a background test and make sure the results are accordance with table

9-1 background range; Table 9-1 background range

Parameter Range WBC ≤0.20x109/L RBC ≤0.02x1012/L HGB ≤1g/L PLT ≤10.0x109/L

(3)The analyzer no errors;

(4)Verify the precision of the analyzer. At Hematology Analyzer, run a normal

control for 11 times, query the results from second to eleventh result precision

in Query. Make sure the CVs are accordance with table 9-2 precision;

Table 9-2 Precision

Parameter Precision（CV/%） Range WBC ≤1.5% 4.0×109/L ~ 15.0×109/L RBC ≤1.0% 3.00×1012/L ~ 6.00×1012/L HGB ≤1.5% 100 g/L ~ 180g/L HCT ≤2.0% 35% ~ 50% MCV ≤1.0% 70fL ~ 120fL PLT ≤4.0% 100×109/L ~ 500×109/L

(5)Carryover is determined by running high and low controls of WBC, RBC, HGB, PLT. The high control is run in triplicate follow by three low control running cycles. The carryover is calculated by the following formula and result is confirmed to table 9-3:

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Table 9-3 Carryover Parameter Result

WBC ≤0.5% RBC ≤0.5% HGB ≤0.5% PLT ≤0.5%

9.4 Calibration Mode

9.4.1 Calibrated Calibration

In main interface, click Cal, then click Sta Cal into the interface as figure 9-1.

And calibrate as follows：

1. Input lot NO. and expiry date according to the calibrator instruction;

2. Select the parameter needed. Default select all;

3. Input the reference value according to the calibrator instruction and the

reference value of parameters do not need to be calibrated is blank.

4. Place the prepared calibrators in Emerge place; the analyzer will

automatically aspirate the calibrators to start analysis. The analyzer could

automatically calculate the mean value of 11 tests at most.

CHINACARErecommend testing 3 to 5 times at least.

5. The new calibration coefficient is calculated according to the reference

value of calibrators and mean. Click Save to save the new calibration

coefficient that calculated by system automatically.

6. Click Print to print the new calibration coefficient; and click Back to exit

system calibration.

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Figure 9-1 Calibration Mode

Note Ø WBC Impedance Count (WIC) is the result of WBC that obtains through

electrical impedance method. And WBC Optical Count (WOC) is the result

of WBC that obtains through optical method.

Ø The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，

HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.

Ø Click Save to save the data before exiting system or the data will be lost.

7. Validation of Calibrated coefficient

After calibration, Chinacarerecommend to follow the steps below to validate

the calibrated coefficients:

(1) Test the calibrators three times at least, and check whether the results are

within the allowed range.

(2) Analyze high, normal and low controls, and each control should be tested

for three times at least and check whether the results are within the

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allowed range.

(3) Analyze three normal fresh blood samples, three times for each at least.

And check whether the results are within the allowed range.

The principles of new calibration value:

l Mean value=(value1+value2+value3+value4)/4

l New calibration value=(reference/mean value)×former calibration

value

l If the new calibration value<70%, consider it equals to 70%; if the new

calibration value>130%, consider it equals to 130%

For example: the reference value of PLT of the calibrator is 220, current

calibration value is 103% and mean value is 230, thus the new calibration

value is;

New calibration value =103%×220/230

=98.52%

NOTE Ø The calibration coefficient is allowed in the range of 70%~130%, if the

test values exceed the limit; the critical value in the limit range should

be selected as the new coefficient for calibration. And in that case,

operator should find out reasons and calibrate again.

9.4.2 Whole Blood Calibration

In main interface, click Cal, then select Blo Cal, enter the interface as the

figure 9-2.

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Figure 9-2 Whole Blood Calibration

Calibrate the analyzer as follows: (1) Select the desired parameters and sample No..

(2) Prepare 3 to 5 normal whole blood samples according to the collection

of blood sample in Chapter 7.

(3) Use 3~5 prepared samples and test each of them for three times at least to

get the mean. Consider the mean or the data that obtained through the

reference method as reference value.

(4) Place the prepared calibrators in Emerge place, the analyzer will

automatically aspirate the calibrators to start analysis, the analyzer could

automatically calculate the mean value of 11 tests at most.

CHINACARErecommend testing 3 to 5 times at least)

(5)Repeat steps 4 until obtain more than three calibration coefficients. The

system will automatically calculate the mean value of each calibration

coefficient.

(6) Click Save to save the new calibration coefficient.

(7)Click Print to print the new calibration coefficient; Click Back to exit the

system calibration.

Note: WBC Impedance Count (WIC) is the result of WBC that obtain through

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110

electrical impedance method. And WBC Optical Count (WOC) is the result of

WBC that obtains through optical method.







for three times at least and check whether the results are within the

allowed range.



9.4.3 Manual Calibration

Following the steps below to operate manual calibration:

1. Operator chooses whole blood single sampling mode in the main interface,

and uses calibrator to test more than three times to obtain mean.

2. Click Cal in the main interface ,enter calibration interface, and click Man

Cal into the interface as figure 9-3 show:

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Figure 9-3 Manual Calibration

Note Ø WBC Impedance Count (WIC) is the result of WBC that obtain through

electrical impedance method. And WBC Optical Count (WOC) is the result

of WBC that obtains through optics method.

Ø The analyzer can calibrate a certain or all parameters of WIC，WOC，RBC，

HGB，MCV，MPV, RDW_CV, RDW_SD, PLT，PDW.

Ø Click Save to save the data before exit system calibration or the data will

be loss.

3. Input the assay and values of desired parameters of calibrator, and click Cal,

the system will automatically calculate the new calibration coefficient.(See

figure 9-4)

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Figure 9-4 Calculate Coefficient

4. Click Save to save the new setting.







for three times at least and check whether the results are within the allowed

range.

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Chapter 10 Maintenance

10.1 Overview

Routine care and regular maintenance are essential to keep the best status, precision of the analyzer and minimize system problems, prolong the life span. Procedures and instruction for preventive maintenance are discussed in this chapter. More information is available at CHINACARECustomer Support Centre. Preventive maintenance should be performed daily, weekly and monthly. Pertinent maintenance is also included in this Chapter according to actual requirement.

CAUTION Ø Considering all components’ surface may be potentially infectious, safety

protective measures should be taken to avoid infection, electric shock or burn. Wear gloves when some cleaning do or maintenance works. Clean hands with disinfectant after work.

10.2 Routine Maintenance

10.2.1 Daily Maintenance

1. Time Set The analyzer is designed with auto-maintenance program. Instrument should be set to automatically perform cleaning after continuously working on more than 100 specimens. And background test should be set to perform automatically after startup.

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Figure 10-1 Setup

2. Shutoff To get correct results, it’s necessary to clean counting chambers and rinse the flow system to prevent measurement errors caused by residues. Shutoff program should be performed when the analyzer tests more than 500 specimens or finish today’s work. If continuously use the instrument, shutdown program should be performed once at least every 24 hours. For detail instructions, please refer to chapter 7 Daily Operation of Shutoff.

10.2.2 Weekly Maintenance

1. Surface Maintenance Clear the smudge on the surface, especially the blood on the aspiration probe and its surrounding, to remove the protein aggregation or debris to reduce the possibility of the blockage.Wipe the outside of the probe and surrounding with gauze soaked by litmusless detergent before cleaning other parts. CAUTION Ø Never use corrosive acids, alkali or volatile organic solvent (such as

acetone, aether and chloroforms) to wipe the outside of the analyzer, but only litmusless detergent.

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2. Clean Shave Valve

Figure 10-2 Maintain In the main interface select Maint, enter the interface as figure 10-2, and select Clean Shear Valve to clean shear valve. Regular cleaning of the shear valve ensures the accuracy and precision of performance, prevent leak caused by reagent and blood residue. The shear valve will be dirty after a long time use, so remove it and clean the rotary valve with distilled water are necessary. Shear valve must be cleaned with detergent firstly and then with distilled water again. For detailed instruction of removal, please refer to Maintenance Manual or contact with CHINACARECustomer Support Centre.

10.2.3 Monthly Maintenance

1. Check and Clean Reagent Syringes The Reagent Syringes need to be cleaned on a regular basis to prevent reagent residue buildup, which may cause leakage or improper functioning. Syringes should be cleaned one at a time to ensure that each syringe is being placed in the correct position. Replace each syringe after it is cleaned and then remove the next one to be cleaned. Materials Required: 1. A large container filled with approximately 500 mL of deionized water;

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2. Clean and soft cloth; 3. Deionized water; 4. Small container of appropriate reagent to refill the clean syringes; 5. Appropriate personal protective equipment. Clean Procedure: 1. Empty the flow system; 2. Remove the front covers to gain access to the Syringe Assembly. 3. Lift the syringe out of the snap-in bracket. 4. Aspirate the deionized water into the syringe until it is full. Continue to pull

on the plunger until it is removed from the barrel. 5. Rinse the plunger and barrel thoroughly with deinoized water. If the seal

ring has been worn to be replaced with new. 6. Carefully reinsert the plunger into the wet barrel. 7. When the syringe has been reinstalled, run several background counts

and observe the action of each syringe during the cycle. The plunger should move smoothly up and down and the syringe should not leak.

CAUTION Ø Do not push or pull on the plunger when the syringe is dry, as it may

damage the plunger. Avoid touching the plunger because oil from the fingers may cause it to move erratically.

2. Maintenance of mechanical parts It mainly aims at mechanism maintenance, including lubricate electricity axis, X, Y leader of sampling organ etc. 3. Check and Replace Sample Aspiration peristaltic Pump Tube The tube on the peristaltic pump needs to be replaced on a regular basis to ensure proper fluid movement through the instrument. However, the frequency of replacement depends on instrument use in each laboratory. Chinacarerecommends checking the soakage of peristaltic pump whether sufficiency at least once monthly.

10.3 Maintenance procedure

In main interface, click Maint into the interface as figure 10-3:

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Figure 10-3 Maintenance

The analyzer offers the following three maintenance operations on flow system: u Prime: Aspirate all or depart of reagents to the corresponding tube to

replace the reagent. u Clean: Clean count chamber, aspiration probe, shear valve ect. u Empty: Empty count chamber, waste chamber, vacuum accumulator or all

tube.

10.3.1 Prime All

In the following conditions, perform this operation: u Use the analyzer first time; u Replace all reagents; u Make sure the analyzer has problem. Operate as the following steps: 1. Select Prime All in the Maintain interface; 2. The analyzer starts to replace diluent, detergent, sheath and lyse, and

display the progress bar at the bottom of screen. 3. The operation is completed and back to the Maintain interface.(see figure

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119

10-4)

CAUTION Ø Considering all the specimens, controls, calibrators and waste etc. that

contain human blood or serum as being potentially infectious, wear lab coats, gloves and safety glasses and follow required laboratory or clinical procedures when handling these materials.

NOTE Ø Keep the reagent still for a certain time to ensure it stable. Ø After replace the diluent, detergent, sheath or lyse, perform background

count to ensure the background values are in the acceptable range.

Figure 10-4 Prime All

10.3.2 Prime Lyse

In the following three conditions, perform this operation: u There are bubbles in the lyse tubing; u The lyse in tubing is contaminated; u Replace a new lyse.

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The procedures as follows: 1. Select Prime Lyse in MAINT interface; 2. The analyzer start to perform the function and display the process bar at

the bottom of screen; 3. The operation is completed and back to the MAINT interface.

10.3.3 Prime Diluent

In the following three conditions, perform this operation: u There are bubbles in the diluent tubing; u The diluent in tubing is contaminated; u Replace a new diluent. The procedures as follows: 1. Select Prime Diluent in MAINT interface; 2. The analyzer start to perform the function and display the process bar at


10.3.4 Prime Detergent

In the following three conditions, perform this operation: u There are bubbles in the detergent tubing; u The detergent in tubing is contaminated; u Replace a new detergent. The procedures as follows: 1. Select Prime Detergent in MAINT interface; 2. The analyzer start to perform the function and display the process bar at


10.3.5 Prime Sheath

In the following three conditions, perform this operation: u Three are bubbles in the WOC Flow Cell; u The sheath in tubing is contaminated; u Replace a new sheath.

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The procedures as follows: 1. Select Prime Sheath in MAINT interface; 2. The analyzer start to perform the function and display the process bar at


10.3.6 Cauterize Aperture

Cauterize both sides of the ruby aperture with a high voltage to clear protein, dust etc that adhere or block on the aperture, to prevent and eliminate blockage associating. The procedures as follows: 1. Select Cauterize Aperture in the MAINT interface; 2. The analyzer start to perform the function and display the process bar at

the bottom of the screen; 3. The operation is completed and back to the MAINT interface.(see figure

10-5)

Figure 10-5 Cauterize Aperture

10.3.7 Flush Aperture

Flush aperture may rinse the ruby aperture and prevent and eliminate blockage associating with Cauterize Aperture. The procedures as the follows:

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122

1. Select Flush Aperture in the MAINT interface; 2. The analyzer start to perform the function and display the process bar at

the bottom of the screen; 3. The operation is completed and back to the MAINT interface.

10.3.8 Clean Transducers

CAUTION Ø Considering all the specimens, controls, calibrators and waste etc. that

contain human blood or serum as being potentially infectious, wear lab coats, gloves and safety glasses and follow required laboratory or clinical procedures when handling these materials.

Clean Transducers function is to rinse transducers with diluent and scour it with play bubbles. The procedures as the follows: 1. Select Clean Transducers in the MAINT interface; 2. The analyzer start to perform the function and display the process bar at

the bottom of the screen; 3. The operation is completed and back to the MAINT interface. If blockage is severe, select Empty WBC Cup or Empty RBC Cup, the analyzer will automatically empty the liquid in both sides of the aperture. And remove the ruby aperture, brush it with probe detergent or enzyme, then wash it with distilled water. If the ruby aperture has been reinstalled, run several times of background counts to check whether it is blockage. CAUTION Ø Consider the probe detergent is corrosive; operator should wear lab coats,

gloves, and follow required laboratory or clinical procedures.

10.3.9 Prepare Shipping

Perform this function before shipping or leave unused for a long time, the procedures as the follows: (1) Take out the diluent inlet tube connecting with the diluent port on the rear

panel from container, discharge the diluent remained in tube; (2) Take out the lyse inlet tube connecting with the lyse port on the rear panel

from container, discharge the diluent remained in tube;

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123

(3) Take out the detergent inlet tube connecting with the detergent port on the rear panel from the container, discharge the detergent remained in tube;

(4) Take out the sheath inlet tube connecting with the sheath port on the rear panel from container, discharge the sheath remained in tube;

(5) Keep the remaining reagents in their containers and store them according to instructions. Operator should establish and confirm to the effective storage measures to prevent reagent from deteriorated, misusage or misdrinking. The reagent should be away from temperature extremes.

(6) Select Prepare Shipping in the MAINT interface; (7) The analyzer start to perform the function and display the process bar at

the bottom of the screen; (8) The operation is completed and back to the MAINT interface. (see the

figure 10-7)

Figure 10-7 Prepare Shipping

10.3.10 Other Maintenances

Clean Aspiration Probe--------scour the inside of aspiration probe with diluent. Clean Shear Valve--------rinse the shear vale with diluent.

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124

Clean sheath channel--------clean Pre-mixing chamber and WOC Flow Cell. Clean Impedance Channels-------clean WBC/RBC counting chamber and volumetric metering tube. Open Press Control Module------provide pressure for press chamber and negative press for negative press chamber. Close Press Control Module--------close the pressure on the press chamber and negative press chamber. Empty Waste Chamber 1/2----------discharge the waste remained in waste chamber 1 or chamber 2 to the outside of analyzer. Empty WBC/RBC Cup---------------empty the diluent remained in the WBC/RBC cup. Empty Shear Valve---------empty the liquid stored in the shear valve.

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Chapter11 Troubleshooting

11.1 Overview

This chapter gives instructions for identifying, troubleshooting and correction of analyzer problems. If the malfunction is not solved according to the guidance or more detail information is needed, please contact CHINACARECustomer Support Centre. NOTE: This manual is not a maintenance manual, but provides the measurements when the analyzer malfunction alarm only.

Considering the analyzer handling the materials that contain human blood or serum as being potentially infectious, please follow the established bio-safety procedure when maintain or troubleshoot the analyzer.

11.2 Troubleshooting Guidance

Troubleshooting Guidance is designed to assist operator in identifying and resolving analyzer problems. Instruction is also given for obtaining technical assistance immediately from CHINACARECustomer Support Centre. The first step in the process is to understand normal analyzer operation and preventive maintenance. Good experience of the analyzer is essential for identifying and resolving operational problems. Logical troubleshooting may be divided into three steps: (1) Problem Identification (2) Problem Isolation (3) Corrective Action Step1: Problem Identification means not only identifying what is wrong, but also what is right. The investigation should identify the problem area and eliminate areas that are right. Once done, the troubleshooting process moves quickly to next step. Step2: Problem Isolation means further classifying the problem. Analyzer problems are generally divided into three categories: (1) Hardware component related; (2) Software computer programs related;

Troubleshooting

126

(3) Measurement related to sample analysis. Hardware and software problems can only be corrected by a CHINACAREauthorized engineer. The operator can correct sample measurement problems with assistance from CHINACAREengineers. Step3: Corrective Action Corrective Action means operator taking appropriate action to correct the problem. If operator can correct the problem, with or without technical assistance from the manufacture, normal operation can quickly resume.

11.3 Obtaining Technical Assistance

Technical assistance is obtained by calling the CHINACARECustomer Support Centre. When assistance is needed, please be prepared to provide the following information for Customer Support Specialists: (1) The analyzer model; (2) Serial number and version number; (3) Description of the problem and surroundings, including status and operation; (4) The lot number of the reagents (lyse, diluent, detergent etc. ) (5) Related data and report of the problem. Familiar problems and disposals are given in this Chapter. The operator can identify the cause according to the warning information and operate according to Troubleshooting Guidance.

11.4 Troubleshooting

Familiar problems and corrective actions are listed as follows. If the problems can not be corrected, or technical assistance is needed, please contact with CHINACARECustomer Support Centre.

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127

11.4.1 Faults Related to Reagents

Fault Probable Cause Corrective Action

Lyse empty Lyse is run out or lyse inlet tube is blocked.

1.Check that if the lyse is run out. 2.Perform Maint→Prime Lyse. 3.If fault still occurs, please contact with URIT.

Diluent empty Diluent is run out。

1.Check that if diulent is run out. 2.Perform Maint→Prime Diluent. 3.If fault still occurs, please contact with URIT.

Detergent empty

Detergent is run out.

1.Check that if the detergent is run out. 2.Perform Maint→Prime Detergent. 3.If the fault still occurs, please contact with

URIT. Sheath empty Sheath is run

out 1.Check that if the sheath is run out. 2.Perform Maint→Prime Sheath. 3.If the fault still occurs, please contact with

URIT. Waste full Waste

container is full or waste sensor is in fault.

1.Check that if the waste container is full. 2.Check that if the sensor is wet or short circuit. 3.If the fault still occurs, please contact with

URIT.

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11.4.2 Faults Related to Test Value

Fault Probable Cause Correction Action

High background value

Reagents are contaminated or overdue; Reagent tube contaminated

1.Check that if the reagents are contaminated or overdue.

2.Perform Maint→Prime All to rinse the flow system.

3.If the fault still occurs, perform Maint→Clean 。 Transducers. Run a background test again to

check if the fault disappeared. 4.If the fault still occurs, please contact with URIT.

HGB inaccuracy

HGB background voltage hopping

1.Select Service to enter the system test interface, and check the HGB_AMP_SET.

2.If the HGB_AMP_SET is out of range, contact with the CHINACAREto modify the value.

WBC clog or RBC clog

ruby aperture clogged; WBC counting time incorrect; solenoid valve problem

1.Perform Cauterize Aperture or Flush Aperture in the MAINT interface. Then run a background counting to check the count time.

2.If fault still occurs, inject probe detergent with the syring into WBC/RBC cup to soak the ruby aperture.

3.If fault still occurs, please contact with URIT.

WBC bubble or RBC bubble

Diluent or detergent run out or deficient Reagent tubing loose leads to leakage

1.Check that the diluent or detergent if run out. 2.Check the reagent tubing connection, prevent

leakage. 3.Perform Tubing Clean in MAINT interface. 4.If the fault still occurs, please contact with URIT.

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11.4.3 Fault Related to Hard Ware

Fault Probable Cause Correction Action

No response when startup

1.The power wire is not connection well with the power socket.

2.The fuse may be burnout.

1.Check the power wire connection. 2.Check whether the fuse has burned out. 3.If the fault still occurs, turn off the power, and contact

with URIT.

Moto sounds abnormally

1.Moto connecting wire loose.

2.Travel Optocoupler problem.

3.Moto problem; 4.Moto drive circuit

problem.

1.Turn off the power, and contact with URIT.

Counting time is so long or no counting time

1.Ruby aperture clogged.

2.Valve no movement.

1.Perform Empty WBC/RBC Cup to empty the liquid both sides of the ruby aperture. And move the ruby aperture and brush it with probe detergent or enzyme, then wash it with distilled water. When the ruby aperture has been reinstalled, run several background counts to check whether it is block aging.

2.If the fault still occurs, please contact with URIT.

Printer no response

1.Connecting wire problem.

2.Printer problem

1.Check the power wire and connecting wire of the printer. If the printer still doesn’t work, please re-plug wires and restart the computer and printer.

2.If the fault still occurs, connect the printer to another normal computer separately and install the driver to test the printer if it is normal.

3.If the fault still occurs, please contact with URIT.

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Appendix A Specifications

A.1 Technical Specifications

A.1.1 Parameters

Abbreviation Full Name Unit

WBC White Blood Cell Count 109cells/L LYM% Lymphocyte Percent % MON% Monocyte Percent % NEU% Neutrophile Percent % EOS% Eosinophile Percent % BAS% Basophil Percent % LYM# Lymphocyte Count 109cells/L MON# Monocyte Count 109cells/L NEU# Neutrophile Granulocyte Count 109cells/L EOS# Eosinophile Granulocyte Count 109cells/L BAS# Basophil Granulocyte Count 109cells/L RBC Red Blood Cell Count 1012cells/L HGB Hemoglobin g/L HCT Hematocrit (relative volume of erythrocytes) % MCV Mean Corpuscular Volume fL MCH Mean Corpuscular Hemoglobin pg MCHC Mean Corpuscular Hemoglobin Concentration g/L RDW_CV Red Blood Cell Distribution Width repeat

precision %

RDW_SD Red Blood Cell Distribution Width STDEV fL PLT Platelet Count 109cells/L MPV Mean Platelet Volume fL PDW Platelet Distribution Width fL PCT Plateletcrit % P_LCC Large Platelet Count 109cells/L P_LCR Large Platelet Percent % RETIC Reticulocyte % RETIC_ABS Reticulocyte absolute number 109/ul IIRF Immature Reticulocyte Fraction %

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A.1.2 Test Speed

The test speed of Whole Blood Automated Sampling Mode is no less than 100 samples per hour, and the Whole Blood Single Sampling Mode too.

A.1.3 QC Mode

There are four QC modes, L-J QC, X-B QC, X-R QC and X QC.

A.1.4 Reagents of Product

The reagents used in analyzer: diluent, lyse, detergent and sheath. The detail information about them is in A.4 Reagent Specification.

A.1.5 Calibration Mode

The modes of calibration are Calibrator Calibration, Whole Blood Calibration,

and Manual Calibration.

A.1.6 Parameters Measurement and Calculation

(1) The laser light method for determining the quantity and Five-Part-Diff of WBC.

(2) Electrical impedance method for determining the quantity of RBC and PLT. (3) The colorimetric method for determining the content of HGB. (4) MCV，HCT，RDW，MPV，PDW，MCH，MCHC，PCT are obtained directly

by calculating the stored data.

A.1.7 Input/Output Devices

(1) Outer computer; (2) Outer printer (optional);

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CAUTION Ø Computer, printer and other external devices must be passed CCC(C&E)

Compulsory Certification. It may cause the system work improper system work and personal injury by using substandard external devices.

A.2 Physical Specifications

A.2.1 Power Requirement

Optimum work Voltage Work Voltage range Frequency AC220V AC220V±22V 50/60 Hz

A.2.2 Environment Requirement

(1) Temperature: 15°C~35°C; (2) Relative Humidity: ≤85％; (3) Barometric Pressure: 60kPa~106kPa;

A.2.3 Storage Environment

(1) Temperature: -20°C~55°C; (2) Relative Humidity: ≤95%; (3) Barometric Pressure: 50kPa~106kPa;

A.2.4 Size and Weight

(1) Height: about 676.5mm（26.6 inch）; (2) Length: about 760mm（29.9 inch） ; (3) Width: about 684mm（26.9 inch）; (4) Weight: about 91.5Kg;

A.2.5 Waste Disposal

According to the standard of local or nation dispose the waste.

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A.2.6 Minimum Sample Volume

(1) Minimum required blood sample: 1ml; (2) Analyzer aspirate required sample: 160μl;

A.2.7 Dilution Ratio

(1) WBC: about 1:400 (2) RBC/PLT about 1:12500

A.2.8 Counting Aperture

(1) WBC: 100μm; (2) RBC/PLT: 68μm;

A.2.9 HGB measurement

(1) Measure HGB in WBC/HGB cup; (2) The illuminant is led, and the wavelength is 540nm.

A.3 Performance Index

A.3.1 Precision

Parameter Precision Range Acceptable Limits

（CV%） WBC 4.0 x109 /L ~15.0x109 /L ≤1.5% RBC 3.00 x1012 /L ~6.00x1012

/L ≤1.0%

HGB 100 g/L ~180 g/L ≤1.5% PLT 100 x109 /L ~500x109 /L ≤4.0%

HCT / MCV

35%~50% 70 fL ~120 fL

≤2.0% ≤1.0%

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A.3.2 Linearity

Parameter Linearity Range Acceptable Limits

WBC 0 x109 /L ~10.0x109 /L ≦±0.3 x109 /L 10.1 x109 /L ~99.9x109 /L

≦±5%

RBC

0.10 x1012 /L ~1.00x1012 /L

≦±0.05 x1012 /L

1.01 x1012 /L ~7.00x1012 /L

≦±5%

HGB 0 g/L ~70 g/L ≦±2 g/L 71 g/L ~300 g/L ≦±2%

PLT 0x109 /L ~100x109 /L ≦±10 x109 /L 101 x109 /L ~999x109 /L ≦±10%

A.3.3 Accuracy of WBC five part differential

The measurement values of NEU, LYM, MON, EOS and BAS are in the acceptable range. (99% of the confidence interval)

A.3.4 Carryover

Parameter Measurement Result WBC ≤0.5% RBC ≤0.5% HGB ≤0.5% PLT ≤0.5%

A.3.5 Background Counting

Parameter Measured Value Range

WBC ≤0.20x109 /L RBC ≤0.02x1012 /L HGB ≤1g /L PLT ≤10.0x109 /L

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A.3.6 Accuracy

Parameter Acceptable Range (%) WBC ≦±4.0% RBC ≦±2.0% HGB ≦±2.0% HCT / MCV ≦±2.5% PLT ≦±7.0%

A.3.7 Display Range of Main Parameter

Parameter Display Range WBC 0～99.00 x 109/L RBC 0～99.00 x 1012/L HGB 0～300g/L HCT 0%～99% PLT 0～2000 x 109/L

A.4 Reagent Specifications

Name Model Specification Diluent 5500 20L

Detergent 5500 5L/10L Sheath 5500 20L Lyse 5500 500mL/1L

CAUTION: Do not pour the remaining reagent in it when replace a new reagent, or it will lead to cross contamination of the reagents.

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A.5 Reagent Consumption

Operation Diluent Detergent Sheath Lyse Probe

Detergent Startup 35ml 44ml 32ml 3ml 0ml Counting 40ml 20ml 12ml 0.7ml 0ml Prime (Clean)

35ml 40ml 30ml 3ml 0ml

Shutoff 30ml 30ml 28ml 0ml 0ml

A.6 Parameters Alert Messages

Parameter Data Alerts

Suspect Parameter Flags

Suspect Population Flags

Interpretive Messages

WBC If the result below lower limit, it displays in blue and marked L; If the result above upper limit, it displays in red and marked H;

WBC NWBC FWBC NRBC RRBC

Leukopenia Leukocytosis When RRBC? alarm,switch to RRBC mode for counting again.

Differential NEU LYM MON EOS BAS

Same as WBC DFLT (NLMEB)

BAND IG BLAST VARLYM

Neutropenia Neutrophilia Lymphopenia Lymphocytosis Monocytosis Eosinophilia Basophilia

PLT MPV

Same as WBC LRI URI LURI PLTR

MPV Suppressed (not displayed or printed )

Thrombocytopenia Thrombocytosis Microcytic PLT Macrocytic PLT

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Appendix B Toxic and Hazardous

Substances or Elements

Parts

Toxic and Hazardous Substances or Elements

Plumbum（Pb）

Mercury（Hg）

Cadmium（Cd）

Chromium VI（Cr(VI)）

Polybromi-nated Biphanyls(PBB)

Polybrominate-d Diphenyl Ethers（PBDE）

Host

Shell ○ ○ ○ ○ ○ ○

Printed circuit board Assembly

× ○ ○ ○ ○ ○

Sheet metal Parts

○ ○ ○ × ○ ○

Plastic Parts

○ ○ ○ ○ ○ ○

Machining parts

○ ○ ○ ○ ○ ○

Hardware ○ ○ ○ ○ ○ ○

Flow System Parts

○ ○ ○ ○ ○ ○

Cable ○ ○ ○ ○ ○ ○

Accessories ○ ○ ○ ○ ○ ○ Packaging Materials

○ ○ ○ ○ ○ ○

○：The content of toxic or hazardous substance in the homogeneous materials of the parts above is in the acceptable range of SJ/T11363-2006. ×：The content of toxic or hazardous substance is exceed the acceptable range of SJ/T11363-2006 in at least one kind of homogeneous material of the parts above. (The circuit board used lead solder in machining process and sonme parts of the board contain plumb；And some sheetmetal parts use chromium VI for surface ） Memo：Printed circuit board Assembly is consist of printed circuit board, capacitance, connector and other parts. Lithium cell is detachable and recyclable part.

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Appendix C Daily Operation Procedure

1. Startup and Run (1) Make sure the power wire is properly connected; None reagent tubes is

bending or detached; Check if the waste container is full. (2) Turn on the power of computer and analyzer; (3) The analyzer starts to performing initialized self-checking program

automatically and rinse the flow system, then goes to main Interface. It’s takes about 5 to 8 minutes.

(4) Perform a background count and QC control to ensure the analyzer operates normally.

(5) Whole Blood Automated Sampling mode for analyzing a group of specimens and Whole Blood Single Sampling mode for an emergency specimen.

(6) Query, output and print the data. (7) Necessary maintenance should be operated according to the situation. 2. Shutoff Procedures (1) Click Exit in the main interface to shutoff; (2) The analyzer automatically rinse the flow system; (3) Turn off the power switches off the analyzer and computer when display

“Thank you for using, please turn off the power” display on the screen. 3. Daily Maintenance (perform it before shutoff) (1) The analyzer will automatically perform daily maintenance with the time set

according to the quantity of the test samples. (2) If ruby aperture is clogged, perform “Cauterize Aperture”, “Flush Aperture”

and “Clean Transducers” procedures in the MAINT interface. (3) When continuously use the analyzer, shutoff procedure should be

performed at least once every 24 hours. 4. Weekly Maintenance (1) The surface maintenance of the analyzer. (2) Remove and disassemble the shear valve, brush them with enzyme, and

clean it with distilled water before install. (3) Clean the slot of the auto-sample loader and tube racks. 5. Monthly Maintenance (1) Check and clean the reagent syringes. (2) Mechanical parts maintenance. (3) Check or replace the sample aspiration peristaltic pump tubing.

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6. Other Maintenances If the ruby aperture is block aging severely, select Empty WBC Cup or Empty RBC Cup, the analyzer will automatically empty the liquid in both sides of the aperture. And remove the ruby aperture, brush it with probe detergent or enzyme, then wash it with distilled water. When the ruby aperture has been reinstalled, run several times of background counts to check whether it is blockage.

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Appendix D HL7 One-way Communication Protocol A. Communication Protocol Information is transferred by the following methods. <SB>information<EB><CR> <SB> is Start Block Character needs 1byte corresponds to ASCII <VT> hexadecimal 0x0B <EB> is End Block Character needs 1byte corresponds to ASCII <FS> Hexadecimal 0x1C <CR> is Carriage Return needs 1byte corresponds to ASCII <CR> hexadecimal 0x0D Information is the data that we want to transfer. Please refer to the following for details. B. Information Grammar 1. Delimiter | --- Fields Delimiter ^ --- Component Delimiter & --- Subcomponent Delimiter ~ --- Repeat Delimiter \ --- Escape Character 2. Data Type CX extended composite id whith check digit CE code element CM composite CQ composite quantity with units DR datetime range DT data DLN driver’s license number EI entity identifier HD hierarchic designator FN family name FT formatter text IS coded value for user-defined tables ID coded values for HL7 tables JCC job code NM numeric PT processing type PL person location ST string SI sequence ID TS time stamp

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TQ timing quantity TX text data XAD extended address XCN extended composite ID number and name XON extended composite name and ID number for organizations XPN extended person name XTN extended telecommunications number VID version identifier 3. Field Meaning 3.1. There is a message header at the beginning of each message. It is MSH field. The meaning of MSH is shown as below

No. Field Data Type Length Explanation 1 Field mark ST 1 Separatora 2 Encoding chars ST 4 Separator listing 3 Sending Application EI 180 Sending end applications 4 Sending Facility EI 180 Sending end facility 5 Receiving Application EI 180 Receiving end applications 6 Receiving Facility EI 180 Receiving end facility 7 DateTime Message TS 26 Current message event,

system time 8 Security ST 40 Security 9 MessageType CM 7 Message Type 10 Message Control ID ST 20 Message control ID is used to

distinguish different messages. See the table below.

11 Processing ID PT 3 Dispose of ID P Product 12 VersinID VID 60 HL7 version is 2.3.1 13 Application

Acknowledgment Type

IS 1 Set null

14 Retain 15 Retain 16 Retain 17 Retain 18 Encoder ST Encoding is UNICODE MSH-10 Description 0001 Instrument transmits results automatically. 1001 Lis responses, instrument transmits results automatically.

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Example: MSH|^~\&|URIT|UT-5200|LIS|PC|20100930100436||ORU^R01|0001|P|2.3.1|1|||||UNICODE 3.2. PID--- Definition of patients' data field

No. Field Data Type Length Explanation 1 Set ID PID SI 4 Identify different fields, fill

with 1 generally. 2 Patient ID EI 20 Patient ID., hospital No.,

set null 3 Patient Identifier List CX 20 Indicate batch number

when QC 4 Alternate Patient ID CX 20 Bed No. 5 PatientName XPN 48 Name 6 Mother’s Maiden Name XPN 48 Mother’s Maiden Name,

set null 7 Date/Time of Birth TS 26 Birthday；

Indicate validity when QC 8 Sex IS 1 Male or female 9 Patient Alias XPN 48 Retain patient alias 10 Race CE 80 Retain race 11 Patient Address XAD 106 Retain patient address 12 County Code IS 4 Retain county code 13 Phone Number XTN 40 Retain phone No. 13 Phone Number Bus XTN 40 Retain office phone No. 14 Primary Language CE 60 Retain mother tongue 15 Marital Status CE 80 Retain Marital Status 16 Religion CE 80 Retain religion … The rest part is not

needed to be filled.

Example: PID|1|1010051|A1123145|15|Mary||19811011|M 3.3. PV1---Definition of patient visiting record field

No. Field Data Type Length Explanation 1 Set ID PV1 SI 4 Identify different fields, fill

with 1 generally. 2 Patient Class IS 1 Patient category 3 Assigned Patient

Location PL 80 Be used to indicate

patient department

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Example: PV1|1Clinic| Surgery | 3.4. OBR--- Definition of Doctor's Advice

No Field Data Type

Length Explanation

1 Set ID OBR SI 4 Identify different fields, fill with 1 generally.

2 Placer Order Number EI 22 Serial number 3 Assigned Patient

Location EI 22 Sample number

4 Universal Service ID CE 200 Universal service ID 5 Priority ID 2 Priority set null 6 Requested DateTime TS 26 Application time 7 ObservationDatetime TS 26 Inspection starting time, set

null 8 Observation DateTime

end TS 26 Inspection end time

9 Collection Volume CQ 20 Specimen collection capacity, set null

10 Collector Identifier XCN 60 Sender name 11 SPE ActionCode ID 1 Sample handling code, set

null 12 Danger Code CE 60 Danger code alarm 13 Relecant Clinical Info ST 200 "Diagnosis" ^ "Remark",

each length should not be more than 100 bytes

14 SPE Received DateTime TS 26 Sample receiving time 15 SPE Source CM 300 Sample classification, blood,

urine etc. 16 Ordering Provider XCN 120 Inspector name 17 OrderCallback Phone

Number XTN 40 Callback phone, set null

18 Placer Field1 ST 60 Sender field 1, Inspection department

19 Placer Field2 ST 60 Set null 20 Filler Field1 ST 60 Operator field 1, set null … The rest part is not

needed to be filled. Set null

28 Result Copies to XCN 60 Verifier Example： OBR|1|1010051|000001|URIT^UT-5200||20101010093000||20101010093500||sender||| diagnosis^remark||BLD|Inspector||||||||||||verifier|

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3.5. OBX

No Field Data Type

Length Explanation

1 Set ID OBX SI 4 Identify different fields, fill with 1 generally.

2 Value Type ID 3 NM means figure type, ST means value type

3 Observation Identifier CE 590 Observe identifier name 4 Observation SubID ST 20 Observe sub-id project name 5 Observation value ST 65535 Check result 6 Units CE 90 Unit 7 References Range ST 90 Reference range is from small

to big; QC means reference value and deviation.

8 Abnormal Flags ID 5 H,L and N indicate high, low and normal value respectively.

9 Probability ID 5 Probability, set null 10 Nature of Abnormal Test ID 2 C indicates WBC and RBC

clog; B indicates bubble, when normal, set null

11 Observe Status ID 1 Observe results, take F for final result.

12 Date Last Observe TS 26 The time for observing normal value, set null

13 User Defined Access Checks

ST 20 Original results

Example: OBX|1|NM|WBC||8.21|10^9/L|4.00-10.00|L|||F|| 3.6. MSA

No Field Data Type Length Explanation 1 Acknowledgment Code ID 2 Confirmation code: AA is

for receiving, AE for error and AR for refusing.

2 Message Control ID

ST 20

3 Text Message ST 80 Message 4 Expected Sequence

Number NM 15

5 Delayed Acknowledgment Type

ID 1

6 Error Condition CE 100 Error condition

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MMSA-6 is used to indicate different errors, see the table below.

MSA-1 MSA-6 MSA-3 False Description AA 0 Message accepted Receive successfully AE 101 Segment sequence error The fields order in message is

not correct, or the necessary fields are lost.

102 Required field missing Necessary fields of a paragraph are lost.

103 Data type error Data type of fields is false. For example, digital is changed into character.

104 Key not found Key identifier is not found

105 Resend Resend data

AR 201 Unsupported message type

Unsupported message type

202 Unsupported event code Unsupported event code 203 Unsupported processing

id Unsupported processing ID

204 Unsupported version id Unsupported version ID 205 Unknown key identifier Unknown key identifier，For

example, transmit an inexistent patient information.

206 Duplicate key identifier Duplicate key identifier 207 Application record locked Affairs in application storage

level can't be carried out. For example, database is locked

208 Application internal error Other errors in unknown application.

209 Application unready Application is not ready 3.7. ERR

No Field Data Type Length Explanation 1 Error Code and Location CM 80 Code and position error ERR-1 Assembly 1 Assembly 2 Assembly 3 Explanation 001 Record already

exist Test tube No. The test tube record has already

existed. 002 Lis Recieved

Faild Test tube No. Lis receiving error, resending data

is required. 003 Read REQ error Test tube No. Fail to read request form. 004 Read BarCode Test tube rack No. Instrument fails to read test tube

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Errer number. 3.8. QRD

No Field Data Type

Length Explanation

1 Query Date/Time TS 26 Query time 2 Query Format Code ID 1 D （display format） 3 Query Priority ID 1 I（Immediate） 4 Query ID ST 10 Distinguish different

queries ,accumulate with query times. The initial value is 1.

5 Deferred Response Type ID 1 Set null 6 Deferred Response

Date/Time TS 26 Set null

7 Quantity Limited Request

CQ 10 RD（Records）

8 Who Subject Filter XCN 60 Take as a test tube code \ sample number.

9 What Subject Filter CE 60 OTH 10 What Department Data

Code CE 60 Set null

11 What Data Code Value Qual.

CM 20 Set null

12 Query Results Level ID 1 3.9. QRF

No Field Data Type Length Explanation 1 Where Subject Filter ST 20 Take UT-5200 2 When Data Start

Date/Time TS 26 Application time

3 When Data End Date/Time

TS 26 Deadline

4 What User Qualifier ST 60 Set null 5 Other QRY Subject Filter ST 60 Set null 6 Which Date/Time

Qualifier ID 12 RCT(Specimen receipt

date/time, receipt of specimen in filling ancillary (Lab))

7 Which Date/Time Status Qualifier

ID 12 ANY(Any status)

8 Date/Time Selection Qualifier

ID 12 ALL(All values within the range)

9 When Quantity/Timing TQ 60 Set null

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Qualifier 3.10. QSP

No Field Data Type Length Explanation 1 Set ID - DSP 4 SI 2 Display Level SI 4 3 Data Line TX 300 Content queried 4 Logical Break Point ST 4 5 Result ID TX 20 Use QSP-1 to distinguish different queried information in QSP fields.

Set ID – DSP Message 1 Test Tube Number 2 Serial Number 3 Name 4 Sex 5 Birthday 6 Blood Type 7 Group 8 Patient Number 9 Bed Number 10 Patient Type 11 Department 12 Sender 13 Inspector 14 Verifier 15 BLDV is for venous blood, BLDC is for peripheral blood. 16 Clinical diagnosis 17 Remark 18 Sampling time, sending time 19 inspection time Example DSP|1||Mary||<CR>

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4. Communication process 4.1. Instrument transmits test results to lis server

<SB> MSH PID PV1 OBR OBX OBX …… <EB><CR> OBX fields can be repeated. Transmitted test results include patient information, 24 parameters, 2 histograms and 2 scatter plots. The 2 histograms and 2 scatter plots are BMP format and transmitted with base64 code; For example： Instrument transmits test results to lis server <SB> MSH|^~\&|URIT|UT-5200|LIS|PC|20110627144458||ORU^R01|0001|P|2.3.1||||||UNICODE<CR> PID|1||||||||<CR> PV1|1|||<CR> OBR|1||BAR101010101|URIT^UT-5200||||01110621143134|||||^||||||||||||||||<CR> OBX|1|NM|WBC||110.0|10^9/L|40.0-100.0|H|||F|||||||<CR> OBX|2|NM|LYM||35.57|%|20.00-40.00||||F|||||||<CR> OBX|3|NM|MON||5.84|%|3.00-8.00||||F|||||||<CR> OBX|4|NM|NEU||57.37|%|50.00-70.00||||F|||||||<CR> OBX|5|NM|EOS||1.14|%|0.50-5.00||||F|||||||<CR> OBX|6|NM|BASO||0.08|%|0.00-1.00||||F|||||||<CR> OBX|7|NM|LYM#||284.5|10^9/L|80.0-400.0||||F|||||||<CR> OBX|8|NM|MON#||46.7|10^9/L|10.0-80.0||||F|||||||<CR> OBX|9|NM|NEU#||458.9|10^9/L|200.0-700.0||||F|||||||<CR> OBX|10|NM|EOS#||9.1|10^9/L|0.0-50.0||||F|||||||<CR> OBX|11|NM|BASO#||0.6|10^9/L|0.0-10.0||||F|||||||<CR>

UT-5200 Lis server ORU^R01

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OBX|12|NM|RBC||4.49|10^12/L|3.50-5.50||||F|||||||<CR> OBX|13|NM|HGB||0|g/L|0-1079738368|L|||F|||||||<CR> OBX|14|NM|HCT||26.4|%|37.0-50.0|L|||F|||||||<CR> OBX|15|NM|MCV||59.0|fL|80.0-100.0|L|||F|||||||<CR> OBX|16|NM|MCH||24.0|pg|27.0-31.0|L|||F|||||||<CR> OBX|17|NM|MCHC||0|g/L|0-1081344000|H|||F|||||||<CR> OBX|18|NM|RDW_CV||16.1|%|11.5-14.5|H|||F||||||<CR> OBX|19|NM|RDW_SD||45.0|fL|35.0-56.0||||F||||||<CR> OBX|20|NM|PLT||0|10^9/L|0-1079574528|H|||F|||||||<CR> OBX|21|NM|MPV||12.3|fL|7.0-11.0|H|||F|||||||<CR> OBX|22|NM|PDW||14.7|fL|15.0-17.0|L|||F|||||||<CR> OBX|23|NM|PCT||0.41|%|0.10-0.28|H|||F|||||||<CR> OBX|24|NM|P_LCR||1.37|%|0.50-1.80||||F|||||||<CR> OBX|25NM|RBCHistogram^LeftLine||1||||||F||||||<CR> OBX|26|NM|RBCHistogram^RightLine||118||||||F||||||<CR> OBX|27|ED|RBCHistogram||UT5200^Histogram^512Byte^HEX^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||||||F||||||<CR> OBX|28|NM|PLTHistogram^LeftLine||8||||||F||||||<CR> OBX|29|NM|PLTHistogram^RightLine||127||||||F||||||<CR> OBX|30|ED|PLTHistogram||UT5200^Histogram^256Byte^HEX^0000000005050601010203040505060708090a0b0b0b0b0b0b0a0a0a0b0b0b0b0c0c0b0b0a0a090807060605050505060606060605050504040303030302020202020202020202020202020202020202020101010101010102020202020303030302020202010101010101020202020202020202020202020203030303030303||||||F||||||<CR> OBX|31|ED|S0_S10DIFFScattergram||UT5200^Image^BMP^Base64^Qk32lgMAAA……<CR> OBX|32|ED|S90_S90DDIFFScattergram||UT5200^Image^BMP^Base64^Qk32lgMAAA……<CR> <EB><CR>

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