HA-86 (89) Auto Hematology Analyzer User s Manual

Transcription

1 HA-86 (89) Auto Hematology Analyzer User s Manual 3, Hagavish st. Israel Tel: , Fax: mrc@mrclab.com MRC.7.17

2 HA-86 (89) User's Manual How to use this Manual Thank you for using HA-86 (89). Before operating the analyzer, be sure to read the Manual carefully. To get the best results, you must be aware of our analyzer and its performance before clinical diagnosis and testing. This is the User s Manual for MRC HA-86 (89). It describes the installation, daily use and maintenance, etc. of the analyzer. After reading the Manual, please keep it properly for future reference. The functions may vary depending on the version or configuration of the analyzer. Please keep all packing materials for future storage, transport or return to the manufacturer for repair. If you have any questions, contact your dealer. Meaning of Symbols Warning: Indicates when the user ignores this symbol and misuses the analyzer, casualties, serious injury or serious property loss may be caused to the user. Caution: Indicates when the user ignores this symbol and misuses the analyzer, personal injury, wrong output results or property loss may be caused to the user. Precautions for Diagnosis Caution: The product is a clinical examination analyzer for inspection. Clinical diagnosis based on testing results should be performed by doctors according to the clinical symptoms of the patients by combining other inspection results. Representation MRC reserves the right for the final explanation of the User s Manual. The illustrations in the Manual give typical examples only and may not be completely consistent with the actual displaying on the product. Take practicality as standard. Never use the illustrations for other purposes. Without written consent of MRC, no individual or organization may duplicate, modify or translate the contents of the Manual. MRC will be responsible for the safety, reliability and performance of the product only when all the following requirements are met: Assembly, re-debugging, expansion, improvement and repair should be performed by persons recognized by MRC; 1

3 HA-86 (89) User's Manual The product is operated according to the Manual; The related electrical equipment complies with the national standards. Caution The analyzer must be used by medical examination professionals or trained doctors, nurses or laboratory technicians. Warning If no satisfied maintenance/repair plan is achieved, the analyzer may fail abnormally and may endanger personal health. Ensure to use the analyzer in the conditions specified in the Manual. Otherwise, it may cause the analyzer s failure to function normally and unreliable measurement results, damage the components of the analyzer, and endanger personal safety. 2

4 HA-86 (89) User's Manual Graphics and Symbols Temperature Limit The temperature limit of the transport package. Refer to the User s Manual. In vitro diagnostic equipment. Fragile Objects The transport package contains fragile objects. Be careful in handling. Upward The correct position of the transport package is straight up. Prevent Rain Protect the transport package against rain. Layers Limit The maximum number of layers stacked for the same kind of package. n indicates the layers limit. Prevent Sunshine Avoid direct sunshine. Do Not Roll Do not roll the transport package. Caution. The general caution icon appears adjacent to an explanation of conditions that could interfere with the proper functioning of the instrument. Biological and chemical hazards Laser Warning High Voltage Warning 3

5 HA-86 (89) User's Manual The general warning icon alerts users to other potential health or safety hazards. Protective grounding Pierce Warning Lifting Position Indication 4

6 HA-86 (89) User's Manual Warning and Precautions This analyzer is only provided for in vitro diagnosis, please carefully read the following warnings before use. They are required to be strictly followed. Warning: Read the following precautions carefully before using the analyzer. In case of peculiar smell, smog or noise during use, immediately turn off the power and remove the plug from the socket, and immediately apply for inspection with the dealer or our agent. If you continue to use the analyzer in that case, fire, electric shock or casualties may be caused. Prevent blood, reagent or metal pieces, such as staple, etc., from entering the analyzer. Otherwise short circuit or fire may be caused. In case of abnormality, immediately turn off the power and unplug the plug from the socket, and immediately apply for inspection with the dealer or our agent. Do not open the shell of the live analyzer for operation. Do not touch the electronic circuit in the analyzer. Particularly, touch with wet hand may cause electric shock. Wear rubber gloves and use the specified tools, parts and components when maintaining and inspecting the analyzer. Prevent scalding caused by out-of-control heating of the DIFF bath or failure of the motor. When the operation is ended, wash hands with disinfectant. Otherwise the skin in contact with blood may be infected. Be very careful when treating samples. Be sure to wear rubber gloves, otherwise infection may be caused. In case the sample enters the eye or wound, immediately rinse with plenty of clear water and receive examination by a doctor. Do not touch the internal devices when the analyzer is operating, especially the moving parts, otherwise personal injury may be caused. The analyzer uses a laser for measurement. Follow the specifications when operating the laser to prevent the laser from shining in eyes and causing damage. Use and Disposal of Reagent Prevent the reagent from being in contact with skin and clothing during operation. In case it is in contact with skin or clothing, rinse with plenty of clear water to prevent injury. In case the reagent enters the eye, immediately rinse with plenty of clear water and receive examination by a doctor. If you swallow the reagent, immediately consult a doctor and drink water generously to spit the reagent. Used test tubes and other consumables for the analyzer should be 5

7 HA-86 (89) User's Manual disposed properly as medical waste or infectious waste. If contaminated by blood, etc., they may be infected by pathogen. Voltage, Connection and Grounding of Power Supply Ensure the power supply and grounding environment of the analyzer are good and steady. Never insert the power plug into a socket other than 220V AC socket. Otherwise fire or electric shock may be caused. Be sure to use the three-core electric cable supplied with the analyzer in installation, ensure good grounding, and put the analyzer in a place for easy power off operation. Otherwise fire or electric shock may be caused. Never damage the insulating covering of the electric cable. Do not jerk the electric cable or hang heavy objects with the electric cable. Otherwise short circuit or open circuit may be caused, thus causes electric shock or fire. Be sure to turn off the power before connecting peripheral equipment. Otherwise electric shock or failure may be caused. In accordance with the Pharmaceutical Affairs Law, modification of medical instruments is prohibited. 6

8 Table of Contents HOW TO USE THIS MANUAL... 1 GRAPHICS AND SYMBOLS... 3 WARNING AND PRECAUTIONS... 5 TABLE OF CONTENTS... 7 CHAPTER 1 INTRODUCTION Introduction Product Name Auto Hematology Analyzer Model HA-86 (89) Features Parameters Composition and Structure Performance Intended Use Technical Parameters PC Configuration Model of Vacuum Blood Collection Tube Barcode Specification CHAPTER 2 OPERATION PRINCIPLE Overview Sample Aspiration Diluted Sample White Blood Cell (WBC) Measurement Hemoglobin Concentration (HGB) Measurement Red Blood Cell (RBC)/Platelet (PLT) Measurement Parameters CHAPTER 3 INSTALLATION Unpacking Steps of Unpacking Handling Method Installation and Use Environment Requirements of Power Supply Installation

9 CHAPTER 4 START-UP Precautions before Power-on Logging on System CHAPTER 5 SYSTEM SETUP Normal Limits Units Print Time and Language Optional Functions Shortcut Input User Management Maintenance Abnormal Prompt Communication Optional Item Other CHAPTER 6 DAILY OPERATIONS Daily Quality Control Sample Preparation Venous Blood Collection Peripheral Blood Collection Blood Sample Blending Sample Analysis Work List Sample Analysis in Closed Sampling Mode Sample Analysis in Automatic Sampling Mode Processing of Analysis Results CHAPTER 7 DETAILS CHAPTER 8 ARCHIVES CHAPTER 9 QUALITY CONTROL L-J Quality Control Setup Analysis Graphs List X-B Quality Control Setup Graphs

10 9.2.3 List X-R Quality Control Setup Analysis Graphs List Calculation CHAPTER 10 CALIBRATION Preparation before Calibration Manual Calibration Auto Calibration Calibration with Calibrator Calibration with Fresh Blood Inspection of Calibration Coefficient CHAPTER 11 EXIT CHAPTER 12 SERVICE Daily Maintenance Replacement of Reagent Clean Upkeep Fluidics Maintenance Sleep Automatic Sleep Exit Sleep Data Maintenance Logs System Status Version Information Statistical Information Mechanical Check Prompt of Sampling Probe Replacement Fuse Replacement CHAPTER 13 TROUBLESHOOTING APPENDIX I: NAMES AND CONTENTS OF TOXIC/HAZARDOUS SUBSTANCES OR ELEMENTS

11 Chapter 1 Introduction 1.1 Introduction Product Name Auto Hematology Analyzer Model HA-86 (89) Features This analyzer has two sampling modes, i.e. Automatic and Closed. The Automatic sampling mode provides the whole blood test mode and supports one-time start and reciprocating sampling quantity can be up to 25 tube racks. The autoloader of HA-86 carries up to 5 tube racks, each of which holds up to 10 samples. The autoloader of HA-89 carries up to 10 tube racks, each of which holds up to 10 samples. The Closed sampling mode provides the Whole Blood and Pre-diluted analysis modes. After sampling, the analyzer performs the analysis automatically and provides WBC 5-part differentiation results and scattergram, parameter results and histograms of RBC and PLT Parameters The analyzer has two test modes, i.e. CBC and CBC+DIFF. The CBC mode provides 14 blood parameters and 3 histograms. The CBC+DIFF mode provides 24 blood parameters, 4 study parameters, 2 scattergrams, and 2 histograms. Table 1-1 Parameter Table Mode CBC CBC+DIFF WBC WBC RBC RBC HGB HGB HCT HCT MCV MCV MCH MCH MCHC MCHC RDW-SD RDW-SD RDW-CV RDW-CV PLT PLT MPV MPV Parameter PCT PCT PDW PDW P-LCR P-LCR - NEU% - LYM% - MON% - EOS% - BAS% - NEU# - LYM# - MON# - EOS# - BAS# - ALY% Study - ALY# Parameter - IG% 10

12 Graph - IG# WBC histogram - RBC histogram RBC histogram PLT histogram PLT histogram - Main scattergram - Side scattergram Caution: (1) - indicates that the current test mode does not provide it. (2) Study parameters are used for study only and can t be used as basis for clinical diagnosis. 1.2 Composition and Structure The analyzer mainly includes shell assy, frame assy, optical system, power supply, sampling assy, pump valve, bath assy, etc. Its structure is shown in the figure below. Front View of Analyzer 1- Shell 2 - Sample Compartment 3 - Autoloader 4 - Tube Rack 5 Aspirate Key 6 - Open Compartment Door Key 7 - Status Indicator Board (Power Supply, Running, Alarm, Laser) 11

13 Back View of Analyzer 1 - Network Port 2 - Earthing Rod 3 - Waste Liquid Sensor 4 - Waste Liquid Tube Connector 5 - Cleanser 6 - Diluent 7-86H Lyse 8-86D Lyse 9 - Power Supply Connector (including 2 fuses) Left Side View of Analyzer 1 - Power Supply Switch 2 - Power Supply 3 - Liquid Detection Sensor 4 - Liquid Valve 5 - Syringe 6 Sample Compartment 7 - Liquid Pressure Sensor 12

14 Right Side View of Analyzer 1 - Sampling Assy 2 - DIFF Bath 3 - RBC/HGB Bath 4 - Pump Assy 5 - Circuit Board 6- Cooling Fan 1.3 Performance For performance indicators not specified in this section, they are applicable to both the Whole Blood and Pre-diluted modes. 1. Blank Table 1-2 Blank Requirements Parameter WBC RBC HGB PLT HCT 0.2 x 0.02 x 10 x Limits 1g/L 9 10 /L /L 9 10 /L 0.5% 2. Carry-over Table 1-3 Carry-over Parameter Carry-over, % WBC 0.5 RBC 0.5 HGB 0.5 PLT 1 13

15 3. Repeatability Table 1-4 Repeatability Parameter Whole Blood Mode CV(%) or Absolute Reference Range Deviation WBC 2 9 (4~15) x 10 /L RBC (3.5~6) x 10 /L HGB 1.5 (110~180)g/L HCT/MCV 1 35%~50% /(70~120)fL PLT 4 9 (100~500) x 10 /L MPV 4 / NEU% ±4 (Absolute Deviation) LYM% MON% EOS% BAS% ±3 (Absolute Deviation) ±2 (Absolute Deviation) ±1.5 (Absolute Deviation) ±0.8 (Absolute Deviation) (50%~60%) and WBC 4 x 9 10 /L (25%~35%) and WBC 4 x 9 10 /L (5%~10%) and WBC 4 x 9 10 /L (2%~5%) and WBC 4 x 9 10 /L (0.5%~1.5%) and WBC 4 x 9 10 /L 4. Linearity Table 1-5 Linearity Parameter Whole Blood Mode (%) Measurement Range 9 9 Within ±0.3 x 10 /L (1.0~6.0) x 10 /L WBC 9 Within ±5% (6.1~99.9) x 10 /L RBC HGB PLT Within ±0.05 x Within ±5% Within ±2g/L Within ±2% /L (0.30~1.00) x (1.01~7.00) x (20~70)g/L (71~240)g/L /L /L 9 9 Within ±10 x 10 /L (20~125) x 10 /L 9 Within ±8% (126~999) x 10 /L HCT ±3% or ±2HCT% 0-67% 5. Comparability 14

16 Table 1-6 Comparability Parameter Deviation Requirements, % WBC Within ±3 RBC Within ±2 HGB Within ±2 PLT Within ±5 HCT/MCV Within ±2 6. Display Range Table 1-7 Display Range Parameter Value WBC x 10 /L RBC x 10 /L HGB g/l HCT % PLT x 10 /L 1.4 Intended Use The analyzer is mainly used to test human blood samples, make qualitative and quantitative analysis of the visible components of blood, and provide the related information. It is suitable for testing white blood cell quantity (WBC), red blood cell quantity (RBC), platelet quantity (PLT), hematocrit (HCT), hemoglobin (HGB), and WBC 5-part differentiation. It is used in experiments made by medical units, inspection units, disease control centers, scientific research institutions, etc. 1.5 Technical Parameters Testing Principle: Measuring Speed: Min. Blood Volume: Display: Connector: Work Environment: Storage Environment: Transport Environment: Mains Input: WBC/RBC/PLT: Electrical impedance; HGB: Colorimetry; WBC 5-part differentiation: Laser scattering method Automatic Whole Blood mode: 60 tests/hour Sampling Closed Whole Blood mode: 70s/test Sampling Pre-diluted mode: 70s/test 1ml External PC Ethernet port 15 C~30 C; RH 30%~85%; Air Pressure 70kpa-106kpa 0 C~40 C; RH 85%; Air Pressure 50kpa-106kpa Temperature -20 ~55 ; RH 93%; Atmospheric Pressure 50kPa~106kPa a.c.100v-240v, 50Hz/60Hz 15

17 Input Power: Analyzer Noise: 600VA Standby 60dB; Running 66.5dB 1.6 PC Configuration The operational software of this analyzer is installed on the PC. The recommended PC configuration is as follows: CPU: 1.6GHz or above Memory: 512MB or above; HDD Capacity: 160GB or above; Display: Best Display Resolution 1366*768 OS: Microsoft Windows XP Windows Vista Windows 7 or above; Hardware Configuration: At least one network port is used to connect to the analyzer. If the analyzer needs to be communicated with the lab information system, dual NIC is required. Two USB ports. Before using the analyzer, set the IP address of the PC to the fixed address and the subnet mask to For the specific operations, refer to the Help file of Windows. 1.7 Model of Vacuum Blood Collection Tube In the Closed Sampling mode, the test tubes of the following specifications can be used: Ф13 x 75(mm) (excluding cap size) Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф10.25 x 64(mm) (excluding cap size) BD Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф11.5 x 66(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф11 x 40(mm) (1.5ml centrifuge tube), applicable to the Pre-diluted mode; Ф8.5 x 40(mm) (excluding cap size) 0.5ml MiniCollect Blood Collection Tube, applicable to the Pre-diluted mode. Each type of blood collection tube can be used normally when it is used with the corresponding type of adapter. The figure below shows three types of adapter: 16

18 Adapter 1 Adapter 2 Adapter 3 Put the corresponding adapter into the sample compartment. The corresponding relation between each type of blood collection tube and the adapters is shown in the table below. indicates the type of blood collection tube uses that type of adapter. Table 1-8 Corresponding Relation Table of Blood Collection Tubes and Adapters for Closed Sampling Adapter Specification Adapter 1 Adapter 2 Adapter 3 Ф13 x 75(mm) Ф10.25 x 64(mm) Ф11.5 x 66(mm) Ф11 x 40(mm) Ф8.5 x 40(mm) The sample compartment is shown in the figure below: 17

19 In the Automatic Sampling mode, the following test tubes can be used: Ф13 x 75(mm) (excluding cap size) Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф10.25 x 64(mm) (excluding cap size) BD Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф11.5 x 66(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф13 x 65(mm) (excluding cap size) SARSTEDT Vacuum Blood Collection Tube, applicable to the Whole Blood mode; Ф15 x 75(mm) (excluding cap size) Vacuum Blood Collection Tube, applicable to the Whole Blood mode. For automatic sampling, each type of blood collection tube can be used normally when it is used with the corresponding type of adapter or when the adapter is removed. The test tube rack uses the following two types of adapter: Adapter 1 Adapter 2 Put the corresponding adapter into the test tube rack. The corresponding relation between each type of blood collection tube and the adapters is shown in the table below. indicates the type of blood collection tube uses that type of adapter. 18

20 Table 1-9 Corresponding Relation Table of Blood Collection Tubes and Adapters for Automatic Sampling Adapter Specification Adapter 1 Adapter 2 Ф13 x 75(mm) Ф10.25 x 64(mm) Ф11.5 x 66(mm) Ф13 x 65(mm) Ф15 x 75(mm) If the φ15 x 75(mm) Vacuum Blood Collection Tube is used, the test tubes can be put into the test tube rack only after the adapter on the test tube rack has been removed, as shown in the figure below: Note: The height of the vacuum blood collection tube including the cap size does not exceed 83mm. 1.8 Barcode Specification The sample barcode symbology and barcode digits supported by the built-in barcode scanner are show in the table below. Barcode Type Number of Digits of Barcode Code 39 1~20 Code 128 1~20 ITF25 Even number between 1~20 Codabar 1~20 UPC/EAN Controlled by built-in barcode scanner CODE 93 1~20 Barcode Height: A 10mm Barcode Label Width: B 45mm Clear Zone on Both Sides of Barcode: C 5mm 19

21 Width to Narrow Ratio of Barcode: 2.5:1 to 3.0:1 Barcode Precision: Above 0.127mm Barcode Quality: According to the ANSI MH10.8M standard, Level C For correct reading of barcode, the barcode should be affixed within the range of 50mm shown in the figure below. 20

22 Chapter 2 Operation Principle 2.1 Overview This analyzer adopts the Coulter Principle to test the quantity and volume distribution of WBC, RBC and PLT, adopts the colorimetry to measure hemoglobin concentration, and adopts the semiconductor laser flow cell analysis technique to obtain WBC 5-part differentiation. Based on this, the analyzer calculates the results of other parameters. 2.2 Sample Aspiration In the Whole Blood work mode, the analyzer aspirates 20μL (CBC+DIFF mode) or 10μL (CBC mode) whole blood sample. In the Pre-diluted work mode, you should first blend the 20μL peripheral blood sample and 180μL diluent outside the analyzer to form a 1:10 diluted sample, and send the diluted sample to the analyzer for sampling. Here, the analyzer aspirates 80μL (CBC+DIFF mode) or 40μL (CBC mode) diluted sample. 2.3 Diluted Sample The sample to be analyzed, after aspirated to the analyzer, is divided into two parts, which, through the different reagent effects during dilution, form the test samples used for WBC test /HGB measurement, RBC/PLT measurement, and WBC differentiation measurement respectively. According to the different needs, the analyzer provides two analysis modes, i.e. Whole Blood and Pre-diluted analysis modes. 1) Dilution Ratio of Each Channel in Whole Blood Mode WBC test /HGB measurement channel: 1:370 RBC/PLT measurement channel: 1:18000 WBC differentiation channel: 1:100 2) Dilution Ratio of Each Channel in Pre-diluted Mode WBC quantity /HGB measurement channel: 1:760 RBC/PLT measurement channel: 1:24420 WBC differentiation channel: 1: White Blood Cell (WBC) Measurement The basic principle for WBC testing is the electrical impedance method (Coulter Principle) and laser scattering method. The testing principle for the electrical impedance method (Coulter Principle) is shown in the figure below. 21

23 During the test with the electrical impedance method, the sample being tested, after diluted, enters the WBC test unit which has a small opening called Detection Aperture. The aperture has a pair of positive and negative electrodes on both sides that are connected to the constant current power supply. As blood cells have the features of bad conductor, when the blood cells in the diluted sample pass through the test aperture under the constant negative pressure, the resistance between electrodes will change, thus forms a pulse signal with the size in proportion to the volume of the cell on both ends of the electrode. When the cells pass through the aperture continuously, a series of electrical pulses will be produced on both ends of the electrode. The quantity of these electrical pulses reflects the number of blood cells. Compare the amplified electrical pulses collected with the channel voltage threshold corresponding to the normal WBC range, and calculate the number of electrical pulses in the WBC channel of the electrical pulse amplitude. Thus, all electrical pulses collected are classified according to the different channel voltage thresholds, and the number of electrical pulses in the WBC channel is the number of WBCs. The number of cells in each channel range divided based on the pulse voltage amplitude decides the volume distribution of cells. The two-dimensional diagram with the x-coordinate representing cell volume and the y-coordinate representing relative cell quantity is the histogram reflecting the cell population distribution. In the laser scattering method, when a certain amount of diluted blood sample is injected into the flow cell, wrapped by the sheath fluid formed by the diluent, the cells lining up one by one pass through the center of the flow cell. When the blood cells suspending in the sheath fluid pass through the laser detection area, the blood cells are irradiated by the laser beam, and the nature of the scattered light produced is relating to the cell size, cytomembrane, and refractive index of the internal structure of cell. The schematic diagram of laser scattering method is as follows: 22

24 The small-angle, large-angle and side-angle scattered lights in the direction of laser beam are measured, which reflect the size of blood cell, complexity of cell nucleus, and granularity respectively. The DIFF channel scattergram is obtained based on these scattered lights, as shown in the figure below. From the scattergram, the respective proportion of lymphocyte, monocyte, eosinophil, neutrophil and basophil in the total number of WBCs can be obtained. NEUT Size MON BASO EOS Size MON LYM BASO LYM Granularity Complexity 2.5 Hemoglobin Concentration (HGB) Measurement In the colorimetric pool, after lyse is added to the diluted sample, the RBCs are dissolved, and hemoglobins are released. The hemoglobins are combined with the lyse to form 23

25 hemoglobin compound. At one end of the colorimetric pool, let the LED light tube emit monochromatic light with the wavelength of 550nm to irradiate the hemoglobin compound. At the other end, the phototube receives transmission light; the optical intensity signal is amplified and converted to voltage signal which is compared with the voltage produced by the blank transmission light measured before the sample is added to the colorimetric pool (that is, there is only diluent in the colorimetric pool) to obtain the HGB of the sample. 2.6 Red Blood Cell (RBC)/Platelet (PLT) Measurement The analyzer uses the principle of impedance method to test the number of RBCs/PLTs in the RBC analysis unit. The test unit has a small opening called Detection Aperture. The aperture has a pair of positive and negative electrodes on both sides that are connected to the constant current power supply. As blood cells have the features of bad conductor, when the blood cells in the diluted sample pass through the test aperture under the constant negative pressure, the resistance between electrodes will change, thus forms a pulse signal with the size in proportion to the volume of the cell on both ends of the electrode. When the cells pass through the aperture continuously, a series of electrical pulses will be produced on both ends of the electrode. The quantity of these electrical pulses reflects the number of blood cells. Compare the amplified electrical pulses collected with the channel voltage threshold corresponding to the normal RBC/PLT volume range, and calculate the number of electrical pulses in the RBC/PLT channel of the electrical pulse amplitude. Thus, all electrical pulses collected are classified according to the different channel voltage thresholds, and the number of electrical pulses in the RBC/PLT channel is the number of RBCs/PLTs. The number of cells in each channel range divided based on the pulse voltage amplitude decides the volume distribution of cells. The two-dimensional diagram with the x-coordinate representing cell volume and the y-coordinate representing relative cell quantity is the histogram reflecting the cell population distribution. 2.7 Parameters The parameters are calculated as follows: White Blood Cell Quantity (WBC) The analyzer obtains the WBC quantity by directly measuring the number of electrical pulses corresponding to WBC. Neutrophil Percentage (NEUT%) Particle quantity in neutrophilarea in DIFFchannel NEU % 100% Particle quantity in WBC area in DIFFchannel Lymphocyte Percentage (LYM%) Particle quantity in lymphocytearea in DIFFchannel LYM % 100% Particle quantity in WBC area in DIFFchannel Monocyte Percentage (MON%) Particle quantity in monocytearea in DIFFchannel MON % 100% Particle quantity in WBC area in DIFFchannel 24

26 Eosinophil Percentage (EOS%) Particle quantity in eosinophil area in DIFFchannel EOS % 100% Particle quantity in WBC area in DIFFchannel Basophil Percentage (BAS%) Particle quantity inbasophilarea indiff channel BAS % 100% Particle quantity in WBC area indiff channel Neutrophil Quantity (NEUT#) NEU # WBC NEUT% Lymphocyte Quantity (LYM#) LYM # WBC LYM% Monocyte Quantity (MON#) MON# WBC MON% Eosinophil Quantity (EOS#) EOS # WBC EOS% Basophil Quantity (BAS#) BAS # WBC BAS % Hemoglobin Concentration (HGB) Backgroundlight intensity HGB Constant LN Sample light intensity Red Blood Cell Quantity (RBC) The analyzer obtains the RBC quantity by directly measuring the number of electrical pulses corresponding to RBC. Mean Corpuscular Volume (MCV) MCV is obtained from the RBC histogram. Hematocrit (HCT) MCV RBC HCT 10 Mean Corpuscular Hemoglobin (MCH) HGB MCH RBC Mean Corpuscular Hemoglobin Concentration (MCHC) HGB MCHC 100 HCT Red Cell Distribution Width - Coefficient of Variation (RDW-CV) RDW-CV is obtained from the RBC histogram, with the unit of %. Red Cell Distribution Width - Standard Deviation (RDW-SD) RDW-SD is obtained from the RBC histogram, with the unit of fl. Platelet Quantity (PLT) The analyzer obtains the PLT quantity by directly measuring the number of electrical pulses corresponding to PLT. Mean Platelet Volume (MPV) MPV is obtained from the PLT histogram. 25

27 Platelet Distribution Width (PDW) PDW is obtained from the PLT histogram and is a heterogeneity parameter reflecting the platelet volume, with the unit of fl. Platelet Hematocrit (PCT) MPV PLT PCT Platelet Large Cell Ratio (P-LCR) Particle quantity inplt large cellarea P LCR 100%, with the unit of %. PLT particle quantity 26

28 Chapter 3 Installation 3.1 Unpacking Steps of Unpacking Unpack the analyzer and remove the materials for transport. Keep the packing case and packing materials properly for future repacking. 1) Put the packing case upright and ensure the arrow on the packing case points upward. 2) Open the side plates of the packing case with tools, take out the accessories and check the objects against the accessories list. If any object is missing, immediately inform MRC s Customer Service Department or the retailer. Check the contents in the packing case and check that the following are included: HA-86(89) Analyzer User s Manual Packing List&QC Certificate HA-86(89) System Software CD HA-86(89) Brief Operating Instruction Power Cable Network Cable Protective Grounding Wire Fuse 250V 10A LASER Key Bottleneck Holder Waste Bottle Lid Assembly Diluent Bottle Lid Assembly Cleanser Bottle Lid Assembly 86H Lyse Bottle Lid Assembly 86D Lyse Bottle Lid Assembly 3) Take out the upper buffer. At least four persons carefully take the analyzer from the packing case by grasping the carrying handles at the bottom on both sides of the analyzer and put it on the operation desk. 4) Unbind the movable mechanism, such as sampling assy, etc. Caution: The accessories packed should be consistent with the packing list. If any component is missing or damaged or any accessory is inconsistent with the packing list, please contact the retailer Handling Method Ensure to securely bind the movable mechanism, such as sampling assy, etc., particularly the sampling probe should be put on the top, before handling. For short-distance transport in the smooth and steady condition, a trolley, etc. can be used. During handling and transport, take care to protect the front panel, sampling probe, and liquid path connector on the rear side against external force or contact with other 27

29 objects or damage. During handling and transport, the product must be kept upright and must not be inclined or put on its side. Try to avoid vibration during handling. After handling, check and debug the machine before use. Caution: (1) Keep the packing case for packing before long-distance transport. The analyzer must be put on a level operation desk, rather than angular surface. (2) The analyzer is heavy. Prevent it from falling and injuring people. 3.2 Installation and Use Environment This analyzer must be installed by professionals. In order to ensure the analyzer works normally, put it in a workplace meeting the following requirements: No direct sunshine; No large amounts of dust; No strong electromagnetic radiation; Easy power off operation; A level, solid desk that is big enough; With good ventilation; Avoid moist and high temperature; Avoid violent vibration and impact. Caution: (1) The normal working environment for the analyzer is temperature 15~30 and HR 30%~85%. (2) After installation, try to avoid frequent movement. To move the analyzer, use a steady cart. The angle of inclination should not be greater than 15 when it is moved. (3) It must be installed and moved by authorized professionals 3.3 Requirements of Power Supply a.c.100v-240v 50Hz/60Hz 600VA 28

30 Warning: (1) The AC power supply must be well grounded. (2) Check that the input voltage meets the requirements of the analyzer. The AC power supply must be stable. Sharing a power supply with high power electrical appliances is prohibited. It is better to be equipped with a regulated power supply. (3) Before connecting the electric cable, check that the switch of the analyzer is off. (4) In case of smog, peculiar smell or abnormal noise, immediately turn off the power and contact the retailer. (5) To unplug the electric cable, grasp the plug, rather than the wire. 3.4 Installation a) Space Requirements: The distance between the right door of the analyzer and the wall shall be 100cm, and the distance between the rear side of the analyzer and the wall shall be 50cm. Make sure there is adequate space on the operation desk and under the analyzer for the diluent, cleanser and waste liquid containers. (Ensure the space for repair and maintenance; consider the heat dissipation of the analyzer and protect the liquid path tube on the back of the analyzer against extrusion which may impact the normal flow of reagents); b) Use a network cable to connect the analyzer and the external PC, and use an electric cable to connect the analyzer to the circuit; c) The cleanser, diluent, lyse and waste liquid containers are connected to the connectors on the analyzer respectively according to the silk-screen mark. 29

31 Chapter 4 Start-Up 4.1 Precautions before Power-on Before you power on the analyzer each time, pay attention to the following to ensure the system is ready: Reagents You should use the reagents designated by the Company and store and use them strictly according to the instructions of the reagents. Before using the analyzer, check that the reagents are connected correctly. Before use, ensure the reagent bottles or containers have adequate reagents. Waste Liquid Container Check whether the waste liquid container is full. It is suggested to empty the waste liquid container before powering on the machine. Liquid Tube Check whether the reagent and waste liquid tubes are bent and whether the connection is reliable. Power Supply Check whether the power plug of the analyzer has been fully inserted into the power socket. Keyboard, Mouse, and External PC Check whether the network cable of the external PC has been connected to the analyzer. Check whether the power cables of the keyboard and mouse have been connected to the external PC. Check whether the IP address of the external PC has been set to and whether the date/time is consistent with the fact. Printer (optional) Check whether the paper for the printer is adequate and whether it is installed in place. Check whether the power plug of the printer has been inserted into the power socket and whether its electric cable has been connected to the external PC. 4.2 Logging on System To start the analyzer 1. Turn on the power of the analyzer. 2. Check that the indicator on the analyzer is lit up. To start the external PC and run the software 1. Turn on the external PC. 2. Turn on the display. 3. After the PC is started and enters the OS, run the software kit installed. 4. After the software is started, the login dialogue box will be popped up, as shown in the figure below: 30

32 The initial administrator username and password are admin. Caution: Password is shell-sensitive. 5. Input the correct username and password and click the Login button, and the analyzer will execute the startup initialization operation, as shown in the figure below: NOTE: (1) Before running the software, check that the electric cable of the external PC has been connected to the analyzer. If the analyzer is not connected to the PC, wait till the two are connected. The analyzer will begin to execute the initialization operation. If they are not connected within 1 minute, the system will enter the analysis software automatically. (2) In case of error during startup, you can make troubleshooting by referring to Troubleshooting in this Manual. If the error can t be resolved, contact our Customer Service Department or the agent. (3) When the analyzer is being powered on, the sequence of starting the analyzer and running the system software is not restricted. 31

33 6. During the initialization, the cleaning and blank test will be performed. When the blank test is ended, the system will enter the sample analysis interface and display the result of the blank test, as shown in the figure below: For the blank test, only the test values of WBC, RBC, HGB, HCT, and PLT are displayed. The acceptable range is as follows: Table 3-1 Acceptable Limits of Blank Parameter Limits WBC 0.2 x 10 9 / L RBC 0.02 x / L HGB 1g / L HCT 0.5% PLT 10 x 10 9 / L NOTE: (1) The blank test refers to the measurement of the background noise by the analyzer. (2) If the result of the first blank test during start-up is out of the range, the analyzer will automatically run a blank test again. (3) The serial number of the result of blank test is 0. (4) If the test is performed when the result of blank test is out of the range, an unreliable test result will be obtained. 7. After the initialization is finished, if you have selected to execute analysis according to the worklist, when any entry is detected to be not screened in the list, the following prompt box will be popped up on the interface: Click Yes and take the first entry not shielded in the worklist as the next sample to be analyzed. Click No to shield all entries in the worklist. 32

34 Chapter 5 System Setup The analyzer has been initialized before leaving factory. You can set some parameters to meet the different needs, In order to ensure the safety of setup and data, the analyzer divides the operators into administrators and common users and open different setup functions for different user authorities. Administrators have higher authority than common users and can set more items. The setup functions for an operator logging as an administrator are described below. 5.1 Normal Limits The range of normal values is the range of reference values based on different normal groups. If the analysis result is out of the range of normal values, this will be deemed clinical abnormality. On the interface and the printed report, indicates the analysis result is higher than the upper limit of the range of normal values; indicates lower than the lower limit. The analyzer has universal, adult male, adult female, child, infant, newborn, and 10 user-defined reference ranges. The default setting is General. You should select appropriate reference groups according to the actual situation of the samples and set appropriate range of reference values. From the Population Classification dropdown box, select the class to be set, and the software will automatically read the corresponding setting. The default upper and lower limits of user-defined reference ranges are 0. In the edit box, input the corresponding values and click the Save button to save the current settings. On the System Setup interface, select the Normal Limits item to enter the Range of Normal Limits Setup interface, as shown in the figure below: To check the information on the range of reference values or modify the name, age range 33

35 and sex of a user-defined reference group, click the Set Reference Group button to open the Reference Group Setup dialogue box, as shown in the figure below: The reference group name and other information of the 6 fixed reference groups in the list of reference groups can t be modified. You can modify the name, age range, and sex of the 10 user-defined reference groups as needed. Caution: (1) The reference group name must not be empty. (2) The name of a user-defined reference group must not be the same as that of any fixed reference group, and the names of the user-defined reference groups must be different from each other. If Automatically match user-defined reference groups according to the sex and age is not selected, when the sample information is input, the system will automatically select one of the fixed reference groups according to the sex and age. Otherwise, the system will select a matching group from the fixed reference groups and user-defined reference groups, and you need not to input the information manually. 5.2 Units This analyzer provides 6 fixed units and 1 user-defined unit. You can directly select fixed units or define the units of the parameters according to the actual needs. The units of all modules of the system are set here. 34

36 For other options other than User-defined, the units of the parameters can be viewed only and can t be modified. If User-defined is selected, the units of the parameters can be modified.click the Save button to save the user-defined unit settings. 5.3 Print Default Printer The default printer will be used for the printing for all modules. If you have modified the default printer in the Windows OS, the printer name in this combo box will change. At the same time, if the printer is modified here, the default printer in the Windows OS will also change. Format of Report For report printing, A4, A5, and B5 are supported. The formats include 1. A5 all parameters with graphs; 2. A5 all parameters without graphs; 3. A4 all parameters 35

37 with graphs; 4. A4 all parameters without graphs; 5. B5 all parameters with graphs; 6. B5 all parameters without graphs. All parameters means all parameters measured by the analyzer are printed. The parameters to be printed can be modified with the User-defined function. With graphs means histograms and scattergrams are printed. Reporting Title The name of the unit printed on the report heading. Remarks of Report Printed in the bottom left corner of the report to explain the report. Auto Printing If Auto Printing is selected, when the sample analysis is ended, the test result will be printed automatically. Auto Printing after Verification If this option is selected, the test result will be printed automatically after the sample has been verified on the List Review and Details Review interfaces. Printing Alarm Flag If this option is selected, the alarm messages of the parameters and graphs will be printed on the sample result report. User-defined Click the User-defined button to open the following dialogue box: On the Sample Information tab, the fields and sequence of printing of the report can 36

38 be set. The items added to the right list are the printing items, and the printing sequence is from top to bottom. On the Result tab, the number and sequence of printing parameters can be set. There are CBC and CBC+DIFF templates for setup. The number of parameters of each template and their sequence on the report are adjustable. Font Size Title Font Size is used to set the font size of the heading of the report to be printed; Fields Font Size is used to set the font size of the sample information fields and inspection information fields; Results Font Size is used to set the font size of the test parameters and results. 5.4 Time and Language It is used to set the date and time and their formats as well as the language used by the software. 37

39 5.5 Optional Functions Sample No. The start sample number of each day can be set, with the default of 1. The sample number for the day is the last sample number plus 1. To use a date prefix, tick the Use Prefix option. An example of the sample number format is By default, this option is not ticked. Automatically delete finished entries in the worklist If Analysis according to Worklist is selected, when the sample analysis is ended, the corresponding sample entry in the worklist will be deleted automatically. Prompt for Pre-diluted Mode In the sample analysis, if the blood sample mode is Pre-diluted, when the analysis is going to begin, the system will prompt whether to analyse in the Pre-diluted mode. If you select Yes, the analysis in the Pre-diluted mode will begin; if you select No, no operation will be executed. Analysis according to Worklist If this option is selected, the test and analysis will be performed according to the sample information input in the worklist. Each sample newly analyzed matches the entry To be Run in the worklist. After verification, automatically skip to the next sample to be verified If this option is selected, after the sample is verified on the Details Review interface, the system will automatically display the next sample not verified. Display research use parameters If this option is selected, when the sample analysis is ended, you can click the RUP button to open the Research Use Parameters interface to view the result of the research use parameters. Verifier When you enter the interface for the first time after installing the software, if you have the verification authority, the field will display your username by default; 38

40 otherwise, it will display the username of the first operator with verification authority in the User Management list by default. The dropdown list displays all usernames with verification authority set on the User Management interface. After the settings are saved, if you have the verification authority, when the verification operation is executed successfully, the Verifier field will display your name set here; otherwise, the username in the login dialogue box popped up will be displayed. Use Barcode Scan If the autoloader is equipped with a barcode scanner, select this option to enable the Barcode Scan function. Scan Tube Rack No. Automatically After selecting the Use Barcode Scan function, you can select Scan Tube Rack No. Automatically. The tube rack number will be obtained from the barcode affixed to the test tube rack. Scan Sample No. Automatically After selecting the Use Barcode Scan function, you can select Scan Sample No. Automatically. The sample number will be obtained from the barcode affixed to the test tube. Display Statistical Information Automatically After selecting the Display statistical information automatically when auto sampling ended option, after the automatic sampling analysis, the analyzer will pop up the following dialogue box automatically which displays the statistical result of this automatic sampling. Obtaining of blood sample/analysis mode failed and adopt mode for previous sample to continue analysis If this option is selected, in the automatic sampling, when Analysis according to Worklist is selected and no entries in the worklist are matched, or in the System Setup -> Communication Setup module, the communication mode is set to Two-way and no sample information is obtained from the LIS/HIS server, the sample will be analyzed in the mode for the previous sample, otherwise, this sample will be skipped. Alarm Buzzer After the Alarm Buzzer is started, the buzzer in the analyzer will give alarm sound in case of alarm; if the Alarm Buzzer is turned off, the buzzer will not give alarm sound. 39

41 5.6 Shortcut Input When Shortcut Input is set, you can input the item information of a sample with the shortcut code, without inputting the full name. The items that can be set include department, deliverer, patient type, sex, and charge type. Add Input the field name, shortcut code, and remarks in the fields of Edit Information. If Default item of sample profile is selected, before the sample information is input, the default set will be displayed in the corresponding field. It is suggested to use numbers and letters or their combination to form a shortcut code. The remarks information can be empty Modify When an item is selected, the information on this item can be modified. Delete When an item is selected, this item can be deleted, and the sample information fields input for this item will also be deleted. 40

42 5.7 User Management Add The Add function is used to add users. Click the Add button to open the following Add User dialogue box: Input the contents in the edit box, click the Authority combo box, and set the authority of the new user to Common User and Administrator. If it is set to Common User, you can select whether to open the verification authority; if it is set to Administrator, the verification authority is opened by default, which can t be changed. Click OK to save the settings or Cancel to directly exit. Edit In the user list, click the user cell to be modified. Click the Edit button to pop up the following dialogue box: 41

43 You can modify your username and authority as needed. Click the OK button to save the user information modified. Caution: (1) The username must not be empty or repeated. (2) If the administrator who has logged in changes his authority to that for Common User, the settings will be valid only after he logs out and logs in again. Delete In the user list, select a user line and click the Delete button to pop up the confirmation dialogue box. After you click OK, the current user will be deleted. Caution: (1) The current user may not be deleted. (2) The user admin may not be deleted. Change Password Change Password is used to change the password of the current user. Input the old password of the user correctly, input the new password, click OK, and the system will prompt The password has been changed. Click OK to exit the Change Password dialogue box. 42

44 5.8 Maintenance Auto-sleep Waiting Time When there is no action of the fluidics, the analyzer will enter the sleep mode according to this set time, with the range of 10 to 60 minutes and the default of 30 minutes. Time of Cleanser Soak It is used to set the time of soak in cleanser, with the range of 10 to 30 minutes and the default of 10 minutes. Frequency of Automatic Cleanser Soak Used for setting how many tests can be performed before Soaking in Cleanser operation start automatically, with the range of 30 to 150 pcs and the default of 100 pcs. If the analyzer kept power on without Soak in Cleanser performed for 24 hours, the Soak in Cleanser operation will also be started automatically. Frequency of Automatic Concentrated Cleanser Soak Used for setting how many tests can be performed or how long time keep working before the Soak with Concentrated Cleanser operation start automatically, with the range of 200 to 800 samples and the default of 400 samples or the range of 1 to 7 days and the default of 7 days. 43

45 5.9 Abnormal Prompt You can set some alarm prompts of the analyzer on this interface. If the result of analysis exceeds the alarm limit set, the analyzer will give the corresponding text prompt. For Immature Gran, Left Shift, Atypical/Abn Lympho, etc., the analyzer will display information according to the internal judgment standard, and you need not to set it Communication It is used to set the parameters of data communication between the analysis software of the analyzer and the external information system (such as LIS). When the operational software is opened, the system will automatically connect to the workstation according to the communication address set. After the system is connected to the workstation, the connection icon of the LIS will display the Connected status; otherwise it will display the Disconnected status. 44

46 Interface Setup Including IP address and port. Fill in the IP address and port number of the main machine of the external information system connected to this system. Communication Mode Including one-way and two-way modes. One-way: Sending test results and other information to the external information system only and not obtaining sample/patient information from the LIS/HIS. Two-way: Sending test results and other information to the external information system and obtaining sample/patient information from the LIS/HIS. Send result instantly If this option is selected, each time a analysis result comes out, the system will send the result to the external information system automatically. When the communication mode is set to Two-way, this check box will be selected automatically and be greyed out, that is, it can t be set to Off. Wait for Communication Response If this option is selected, whenever the operational software sends a sample result or Quality Control result message, it will wait for ACK. When the ACK is received or in the event of timeout, it will send the next message. If this option is not selected, after the operational software sends a sample result or Quality Control result message, it will immediately send the next one and ignore the ACK message sent by the LIS. Mode of Histogram Transmission (1) Not Transmit: The histogram is not transmitted during communication for sample entries; (2) Transmit with bitmap: The histogram is directly transmitted to the LIS/HIS of the client in the form of graph during communication for sample entries; (3) Transmit with binary data: The histogram is transmitted to the LIS/HIS of the client in the form of raw binary data respectively during communication for sample entries. The default is Not Transmit. 45

47 Mode of Scattergram Transmission (1) Not Transmit: The scattergram is not transmitted during communication for sample entries; (2) Transmit with bitmap: The scattergram is directly transmitted to the LIS/HIS of the client in the form of graph during communication for sample entries; (3) Transmit with binary data: The scattergram is transmitted to the LIS/HIS of the client in the form of raw binary data respectively during communication for sample entries. The default is Not Transmit Optional Item Through the setup of this module, blood type input can be added. Select Input Blood Type and click the Save button to save the settings, and ABO blood type and Rh blood type input and selection box will be added to the Worklist and Details Review interfaces, where you can input blood type and print it on the report Other Enter this interface to view the serial number of the analyzer. 46

48 47

49 Chapter 6 Daily Operations 6.1 Daily Quality Control Quality Control analysis of the analyzer should be performed before sample analysis. For the specific operations, see Chapter 9 Quality Control. 6.2 Sample Preparation Blood sample collection is divided into venous blood collection and peripheral blood collection. Warning: Do not directly touch the blood sample, QC or calibrator. The disposal of such items must follow the relevant SOP Venous Blood Collection Venous blood can be collected with a vacuum negative pressure tube or with the common collection method under ordinary pressure. Anticoagulant must be dropped to all venous blood collection containers beforehand. At present, EDTA.K 2.2H 2 O is the commonly-used anticoagulant, with the content of mg/mL. In the Closed Sampling and Automatic Sampling modes, the volume of whole blood sample must not be less than 1mL Peripheral Blood Collection Blood Collection Site: For adults, the appropriate collection site is the inner side of the fingertip of the middle finger or ring finger of the left hand; for children above half a year old, the middle finger; for infants under half a year old, the typical appropriate collection site is the thumb or the outer side of the bottom of the foot. Blood Collection Method: The peripheral blood collection specification of the health department should be followed. In general, the local puncture method is adopted for peripheral blood collection. The typical collection method is collection through puncture in the fingertip. The blood collection tubes are 20μL constant volume blood collection tubes or bullet shaped blood collection tubes. For convenient review, it is suggested to use blood not less than 30μL. In blood collection, in the event of poor blood flow, slightly apply pressure on the far end of the wound. Never apply force around the puncture to prevent the interstitial fluid from entering the blood, which may impact the accuracy of the result of test and analysis Blood Sample Blending When running a test in the Closed Sampling mode, blend the sample manually. The suggested method is: shake the test tube up and down and rotate it for 3-5 minutes. Do not shake it too vigorously. 48

50 Caution: (1) The sample for WBC differentiation or PLT test should be stored in the room temperature and analyzed within 8 hours after collection. (2) If the result of PLT, MCV or WBC differentiation is not needed, the sample can be stored in a 2-8 refrigerator for 24 hours. The refrigerated sample can be analyzed only after it is put in the room temperature for at least 30 minutes. (3) The sample placed still for a period of time can be analyzed only after it is blended. If the sample has been placed still for too long or is not fully blended, the accuracy of the test result may be impacted. 6.3 Sample Analysis All articles (sample, control, calibrator, reagent, waste liquid, etc.) and areas in contact with such articles have the potential hazard of biological infectivity. When touching the related articles and areas in the laboratory, you should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) Warning: (1) The sampling probe is pointed and may carry blood sample, QC and calibrator with the potential hazard of biological infectivity, so avoid touching the sampling probe. (2) The test object of the analyzer is blood sample. If other substances are sucked, the analyzer may not work normally. Caution: (1) Do not used disposable goods repeatedly. (2) If the vacuum blood collection tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a blood collection tube no more than three times Work List Before sample analysis, sample information can be input through the worklist. During sample analysis, the settings in the worklist will be read automatically; when the sample analysis is finished, the sample information will be saved to the database. Click the Worklist menu item under the menu or the Worklist button on the toolbar to enter the Worklist interface, as shown in the figure below: 49

51 The Worklist functions include Data Reading and Display, Add, Insert, Save, Delete, Search, Screen, Copy, and Print. Add: Adds an entry to the end of the worklist. The analysis status of the added entry is To be Run. Insert: Inserts an entry before the selected entry, and the serial numbers will be resorted. If there is not any entry in the list, Insert equals to Add. Save: Saves the entry information edited. Delete: Deletes the selected entry. If the status of this entry is Running, it can t be deleted. Search: Searches related entries according to the designated search criteria. Search criteria include sample number, medical record number, and name. You can select Fuzzy Search or Exact Search. The entries searched are highlighted in the current list. Shield: Shields the selected sample to be analyzed. This entry will be skipped in analysis, and the next sample to be analyzed not shielded will be selected. Entries being analyzed and analyzed can t be shielded. Shielded entries can be edited and deleted. If any shielded entry is selected, the button will become Cancel, and the shielding of the selected entry will be cancelled and the selected entry will be greyed out. Copy: Copies the selected entry. Print: Prints the selected entry in the worklist. For a sample being analyzed, the sample number, sampling mode, and test mode cant be modified. The information on a sample analyzed can t be edited or modified. If edit or modification is required, this should be performed in the history data. If the sample information is set in the worklist, you can select whether to delete the entry automatically when the analysis is ended. If you select Not Delete, when you check the entry in the worklist, you can see the analysis status of the sample is Finished. 50

52 The input fields are described below: Sample No.: The ID number identifying a sample. It can be directly input or read with a barcode scanner. 20 characters and numbers are permited. In sample analysis, if the last one or several digits of the Sample No. is or are numbers, the Sample No. will be accumulated automatically; otherwise, the Sample No. is generated with the default rule. Sampling Mode: Automatic-Whole Blood, Closed-Whole Blood, and Closed-Pre-diluted can be selected. The default is Automatic-Whole Blood. Test Mode: The CBC+DIFF or CBC mode can be selected. The default is CBC+DIFF. Tube Rack No., Test Tube No.: If the blood sample mode is Automatic-Whole Blood, then Rack No. and Tube No. are activated, and the position of the sample on the test tube rack can be input. Name: Up to 50 letters. Sex: Male or Female can be selected. If none is selected, the default is empty. Date of Birth: The date of birth of the patient. After the date of birth is input, the Age field will be automatically calculated according to the difference between Current System Date and Date of Birth, and the age value newly calculated and the unit will be displayed in the Age Value edit box and the Unit combo box. If the date of birth input is after the current date, the date of birth will be deemed invalid. Age: The age value is input in the edit box, and the unit of age is selected. The unit of age can be year(s) old, month(s), day(s), and hour(s). The range of values is If 0 is input, the age value will not be displayed in the report printed. Reference Group: Universal, Adult Male, Adult Female, Child, Infant, Newborn, and 10 user-defined reference groups can be selected, with the default of Universal. The name, age range, and sex of user-defined reference groups can be set in System Setup. The system will automatically match reference groups according to the sex and age. If Automatically match user-defined reference groups according to the sex and age when the sample information is input is selected in the reference value setup, the user-defined reference groups will be included in the range of automatic selection. When the age range of a user-defined reference group is the same as that of a fixed reference group, the user-defined reference group will be selected. If Automatically match user-defined reference groups according to the sex and age when the sample information is input is not selected, then only the six fixed reference groups will be matched. If the reference group matched is inconsistent with the previous selection, the reference group automatically matched will be adopted. Charge: The type of fee payment for test of the patient. Medical No.: The number of the medical record of the patient. Bed No.: The number of the bed where the patient is located Department: The name of the department can be directly input or selected from the dropdown box. Deliverer: The name of the deliverer can be directly input or selected from the dropdown box. Delivery Time: The time the sample is submitted can be directly input or adjusted 51

53 with the increase/decrease button on the right side. Patient Type: Can be directly input or selected from the dropdown box. The system has set 4 patient types, i.e. Outpatient Service, Hospitalization, Emergency Treatment, and Physical Examination. Clinical Diagnosis: Information on suspected and diagnosed cases can be input here. Remarks: Information to be declared is input in the Remarks box. NOTE: (1) Before sample analysis, the appropriate normal range should be set, otherwise, incorrect alarm prompt will be obtained when the sample analysis is finished. (2) If analysis is performed according to the worklist, other samples To be Run can be added, edited, deleted, etc. during the analysis. For entries Running, the Sample No., Mode, Rack No. and Tube No. (in the Automatic Sampling mode) in the information input area can be edited, but other information can t. (3) If analysis is not performed according to the worklist, the sample analysis has no impact on the sample information input in the worklist. (4) If Two-way LIS/HIS Communication is selected in Setup, after the sample number is input with the keyboard or barcode scanner and saved, the related information will be read from the LIS/HIS and the analysis will be performed according to such information. When the analysis is finished, the result data, graph, sample/patient information will be immediately uploaded to the LIS/HIS Sample Analysis in Closed Sampling Mode For the analysis in the Closed Sampling mode, the sample should be blended manually. If a standard test tube is used, the test tube needs not to be opened; if a centrifuge tube is used, the test tube cap should be opened manually. If the sample to be analyzed is a pre-diluted sample, it should be pre-diluted outside the analyzer. The specific steps are: 1. Click the Diluent button on the toolbar, and the analyzer will automatically prepare for diluent spitting and display the following dialogue box: 2. Put the test tube into the sample compartment door and close the compartment door. Press the Aspirate Key, and the analyzer will aspirate 180uL diluent through the sampling probe and prompt Dispensing diluent on the interface. If you do not exit the interface, the diluent can be spit continuously. 3. Collect 20uL peripheral blood, rapidly inject it into the centrifuge tube containing diluent, cover the tube, and blend the contents. 4. Click the Exit button, and the analyzer will carry out cleaning. After the cleaning, the 52

54 prompt dialogue box will close automatically. Caution: (1) You can also dispense 180uL diluent with the pipette. (2) After the peripheral blood and the diluent fully react, the solution should be placed still for 3 minutes and reblended before analysis. (3) The analysis should be finished within 30 minutes after the sample is diluted, otherwise the analysis result may not be reliable. (4) To analyze the pre-diluted sample in the sample compartment, the adapter supplied with the product should be used. The sample anlsysis in the Closed Sampling mode can be performed on the Analysis interface or Details interface. The specific operation steps are: 1. On the Analysis interface, click the Next Sample button to open the Setup dialogue box, as shown below: Select the corresponding sample type and test mode and click the OK button. The sample compartment door will be opened automatically. Put the prepared sample into the sample compartment and close the compartment door manually. 2. Click the Start button on the Analysis interface or the Aspirate Key on the front shell of the analyzer, and the analyzer will begin to aspirate the blood sample for analysis. The status bar of the software will prompt the sample analysis status, and the green status indicator on the front shell of the analyzer will also flash, which indicates the test is being performed. When the test is finished, the result and graph of the parameter will be displayed, as shown in the figure below (take the Whole Blood mode and CBC+DIFF mode as an example): 53

55 After aspirating the blood sample, the analyzer will open the sample compartment door automatically. Take the test tube away. 3. Sample information can be input or modified before and after sample analysis: a) Before analysis, sample information can be input in the worklist beforehand; b) After analysis, sample information can be input on the Details interface. 4. To cancel the Closed sampling, click the Next Sample button to select the Automatic Sampling mode. NOTE: (1) When the system enters the Sample Analysis interface for the first time, the next sample is the current sample. (2) In the Closed Sampling mode, the Aspirate Key has the equivalent function to the Start button on the interface. (3) The Sample No. is generated automatically and can be changed according to the actual situation. If the last digit of the Sample No. is a number, the Sample No. can be accumulated automatically; otherwise, the next Sample No. will be generated automatically by the system. (4) If analysis is performed according to the worklist, the first entry that is not shielded and is to be analyzed (or that is error) in the corresponding worklist is the next sample to be analyzed in the Closed Sampling mode till the worklist becomes empty or has no entries that are not shielded Sample Analysis in Automatic Sampling Mode The sample analysis in the Automatic Sampling mode is performed with the autoloader. After the autoloader is started, the analyzer will automatically complete tube rack pushing, test tube blending, pierce, sampling and analysis, and result processing and display without manual intervention. Sample analysis mainly includes the following cases: 1. Neither automatically scan Sample No. or Tube Rack No. nor run analysis according to the worklist In System Setup, the Analysis according to Worklist, Automatically Scan Sample 54

56 No., and Automatically Scan Rack No. options are not selected. Sample No. is generated automatically or set by the user; Tube Rack No. is accumulated from 1. The sample entries in the worklist are not impacted. 2. Not automatically scan Sample No. or Tube Rack No., but run analysis according to the worklist In System Setup, the Analysis according to Worklist option is selected, but the Automatically Scan Sample No. and Automatically Scan Rack No. options are not. Before starting analysis, compare the information on the sample entries in the worklist, indicate Sample No. on the prepared sample test tube label and put the test tube into the corresponding test tube position. NOTE: (1) The analyzer automatically runs analysis of the samples in the worklist that are not shielded and are to be analyzed in the Automatic Sampling mode (or that is error) in the sequence of the sample positions. (2) The information on the next sample is obtained from the related information on the entry at the foremost in the worklist that is not shielded and is to be analyzed in the Automatic Sampling mode (or that is error). (3) For analysis according to the worklist, if the current position has a test tube and the worklist does not have the information on this test tube, and Obtaining of blood sample/analysis mode failed and adopt mode for previous sample to continue analysis is set in System Setup, then Sample No. is automatically generated by the system and the analysis is performed in the analysis mode for the previous sample, otherwise this test tube will not be grabbed and will be skipped. (4) If Automatically delete finished entries in the worklist is selected in Setup, the samples analyzed will be automatically deleted from the worklist. 3. Automatically scan Sample No. and/or Tube Rack No., but not run analysis according to the worklist In System Setup, the Analysis according to Worklist option is not selected, but the Automatically Scan Sample No. and (or) Automatically Scan Rack No. option is selected. The sample analysis has no impact on the sample information input in the worklist. If the Automatically Scan Sample No. option is selected, affix the barcode label with the method described in the Barcode Label section of this chapter. If the Automatically Scan Rack No. option is selected, when the tube rack number scan is invalid during the test, the test tubes on this tube rack will not be tested, and the samples on the subsequent tube racks will be analyzed. Caution: If the Sample No. displayed is NOREAD, this indicates the scan is invalid. You can re-input the sample number when reviewing the sample result. 4. Automatically scan Sample No. and/or Tube Rack No. and run analysis according to the worklist In System Setup, the Analysis according to Worklist option and the Automatically Scan Sample No. and (or) Automatically Scan Rack No. option(s) are selected. After the analysis is started, the analyzer will begin to scan Sample No. and/or Tube Rack No. and run analysis of the samples matching the work order in sequence. If the Automatically Scan Sample No. option is selected, affix the barcode label with the method described 55

57 in the Barcode Label section of this chapter. If the Automatically Scan Rack No. option is selected, when the tube rack number scan is invalid during the test, the test tubes on this tube rack will not be tested, and the samples on the subsequent tube racks will be analyzed. NOTE: (1) If the Automatically Scan Rack No. option is not selected, the system will look for the entries matching the sample number scanned in the worklist and assign the Tube Rack No. and Test Tube No. of the sample to the entry (to override the existing information input), and the analysis status of the entry will also be changed from To be Run to Running. (2) If the number scanned does not match the entry in the worklist or the number scanned is wrong, and if Obtaining of blood sample/analysis mode failed and adopt mode for previous sample to continue analysis is set in System Setup, then the sample will be analyzed in the mode for the previous sample, otherwise, this sample will be skipped. (3) If the Sample No. displayed is NOREAD, this indicates the scan is invalid. You can re-input the sample number when reviewing the sample result. (4) If Automatically delete finished entries in the worklist is selected in Setup, the samples analyzed will be automatically deleted from the worklist. The specific operation process is as follows: 1. Put the test tube into the test tube rack and place the test tube rack on loading platform on the right side horizontally in sequence, with the slot of the test tube rack on the right side. The default analysis mode is CBC+DIFF. To change the mode, click the Next Sample button to open the Setup dialogue box, as shown below: Select the corresponding analysis mode, set the start sample number, tube rack number and test tube number, and click the OK button. NOTE: (1) Start the analysis in Automatic Sampling mode, and the Next Sample button will be greyed out, which can t be changed. (2) The tube rack number and test tube number in the Next Sample setup are the start positions, and the test tubes before these positions will not be analyzed. If the tube rack number set is 1 and the test tube number is 3, then Samples 1-1 and 1-2 on the test tube rack will be skipped, and Sample 1-3 will be analyzed. 56

58 2. Click the Start button on the Sample Analysis interface or the Aspirate Key on the front shell of the analyzer, and the analyzer will begin to push the test tube rack and run blood sample analysis in sequence. If Analysis according to Worklist is selected, the sample information will be automatically matched and saved. If the test tube rack-test tube position where the sample is located is inconsistent with the setting, and if Obtaining of blood sample/analysis mode failed and adopt mode for previous sample to continue analysis is set, the next sample will be analyzed. During blood sample analysis, the status bar of the software displays the status of the current and next samples, and the green status indicator on the front shell of the analyzer also flashes, which indicates the test is being performed. When the test is ended, the test tube rack will be automatically pushed to the unloading tray on the left side of the autoloader, and the result and graph of the parameter will be displayed on a real time basis during the analysis. The figure below shows the result when the running of the autoloader is ended (take the CBC+DIFF mode as an example): Click Start, and the button prompt will become Stop. Click this button, and the autoloader will end the sample analysis and push the test tube rack in the feeding area to the unloading tray, and will not continue to load other test tube racks to the feeding area. 3. Sample information can be input or edited in the worklist before sample analysis, or input or modified on the detailed review interface after the sample analysis is finished. 4. To insert an STAT sample during the analysis in Automatic Sampling mode, click the STAT button, and the autoloader will suspend operation. When the current sample analysis is finished, the STAT Sample Information Setup dialogue box will be popped up, and the sample compartment door will be opened automatically. You can complete the subsequent operations according to the steps of sample analysis in the Closed Sampling mode. After the STAT is inserted, the STAT button prompt will become Cancel STAT. Click the Cancel STAT button to continue the analysis 57

59 in the Automatic Sampling mode. 5. When the analysis in the Automatic Sampling mode is ended, a Statistical Result dialogue box will be popped up on the interface. NOTE: (1) In System Setup, Display statistical info. automatically when automatic sampling ended can be set. (2) If the statistical value of the corresponding statistical item in the Statistical Info. dialogue box is not 0, you can click the Details button to view the sample number, test time, and sample position of the corresponding sample. 6. When the automatic sampling is ended, all test tube racks have been automatically moved to the left slot of the autoloader, and you can take the sample away safely. 7. You can enter the List review interface or Details interface to verify and print the sample result. Before printing, the printing can be set through System Setup. NOTE: (1) When the system enters the Sample Analysis interface for the first time, the next sample is the current sample. (2) In the Automatic Sampling mode, the Aspirate Key has the equivalent function to the Start button on the interface. (3) If analysis is performed according to the worklist, the next sample is the sample entry that has the same tube rack number and test tube number, that is not shielded and is to be analyzed in the Automatic Sampling mode (or that is error) in the corresponding worklist. If the test tube barcode scan is selected, the test tube barcode scanned will be corresponded to the sample number of the entry in the Automatic Sampling mode in the worklist. If the same sample number is found, the tube rack number and test tube number in the worklist will be updated with the actual position of the test tube. (4) If multiple test tube racks of sample are required for the analysis of a batch of samples, the additional test tube racks should be put into the right side slot of the autoloader during the sample analysis, and those in the left side slot should be taken out timely Processing of Analysis Results The analyzer can automatically save analysis results. When the number of samples tested reaches the upper limit of storage, the earliest entry will be overridden. The upper limit of sample result storage is 100,000 entries. When the result analysis is finished, the analyzer will give alarms of parameters. The specific alarm messages include: and on the right side of the parameter result indicate the test result is out of the set range of reference values of the parameter, but is still in the display range. The parameter result ::::: indicates aperture blockage or channel blockage. 58

60 The parameter result indicates that the parameter is invalid or can t be calculated. * displayed together with the parameter result indicates the parameter result is suspected. The parameter result indicates the parameter is out of the display range, with its calculation parameters and relevant parameters replaced with and its affected parameters added with *. + displayed together with the parameter result indicates the parameter is out of the measurement range, with its calculation parameters and relevant parameters added with *. The suspicion sign * of parameters indicates the confidence level of the parameter result is not high. The possible causes corresponding to the parameters are shown in the table below: Parameter Possible Causes WBC Poor hemolysis Nucleated red blood cells, large PLT / PLT Clumps interference Electrical noise and bubble interference Aperture blockage NEU%, LYM%, MON%, EOS%, Poor DIFF channel hemolysis BAS% Low-level white blood cell Nucleated red blood cells, large PLT / PLT Clumps interference White blood cell fragment Electrical noise and bubble interference Dirty or blocked flow cell HGB The analyzer has not been calibrated. High white blood cell interference, high lipid blood sample Abnormal hemoglobin voltage RBC Large PLT / PLT Clumps interference Small red blood cell interfered by platelet Abnormal red blood cell distribution Electrical noise and bubble interference Aperture blockage PLT Large PLT / PLT Clumps Small red blood cell interference PLT Abn Distribution Electrical noise and bubble interference Aperture blockage Alarm messages explain results with alarm. The specific contents are shown in the table below: Type Alarm Message Description WBC Flag WBC Abn Scattergram WBC Abn Histogram Possible causes: The sample is abnormal. The flow cell is dirty or blocked. Possible causes: The hemolysis is poor. There is nucleated red blood cells, large PLT / PLT Clumps interference. 59

61 RBC Flag PLT Flag Leukocytosis Leukocytopenia Neutrophilia Neutropenia Lymphocytosis Lymphopenia Monocytosis Eosinophilia Basophilia Blasts? Immature Gran? Left Shift? Atypical/Abn Lympho? RBC Lyse resistance? RBC Abn Distribution Dimorphic Population Erythrocytosis Anisocytosis Anemia Macrocytosis Microcytosis Hypochromia RBC Agglutination? HGB Interference? Iron Deficiency? PLT Abn Distribution Thrombocytosis Thrombocytopenia PLT Clumps? There is electrical noise and bubble interference. The aperture is blocked. WBC is greater than the set value (default: 18 x 10 9 /L). WBC is less than the set value (default: 2.5 x 10 9 /L). NEU# is greater than the set value (default: 1 x 10 9 /L). NEU# is less than the set value (default: 1.0 x 10 9 /L). LYM# is greater than the set value (default: 4.0 x 10 9 /L). LYM# is less than the set value (default: 1.0 x 10 9 /L). MON# is greater than the set value (default: 1.0 x 10 9 /L). EOS# is greater than the set value (default: 0.7 x 10 9 /L). BASO is greater than the set value (default: 0.2 x 10 9 /L). In the DIFF scattergram, the number of particles in the Blasts area is big. In the DIFF scattergram, the number of particles in the Immature Gran area is big. In the DIFF scattergram, the number of particles in the Left Shift area is big. In the DIFF scattergram, the number of particles in the Atypical/Abn Lympho area is big. In the DIFF scattergram, the number of undissolved RBCs is big. Possible causes: There is large PLT / PLT Clumps interference. Small RBC is interfered by platelet. There is electrical noise and bubble interference. The aperture is blocked. The sample is abnormal, for example, the patient is under treatment of iron deficiency or under blood transfusion, etc. RBC is greater than the set value (default: 6.5 x /L). RDW-CV is greater than the set value (default: 20%) or RDW-SD is greater than the set value (default: 60fL). HGB is less than the set value (default: 100g/L). MCV is greater than the set value (default: 110fL) MCV is less than the set value (default: 70fL). MCHC is less than the set value (default: 290g/L). RBC channel parameters are abnormal. RBC channel parameters are abnormal. RBC channel parameters are abnormal. Possible causes: There is large PLT / PLT Clumps. There is small RBC interference. There is electrical noise and bubble interference. The aperture is blocked. PLT is greater than the set value (default: 600 x 10 9 /L). PLT is less than the set value (default: 60 x 10 9 /L). The PLT histogram is abnormal. 60

62 Chapter 7 Details On the Details interface, the data and graph information of a single sample in the database are browsed in the form of scattergram + histogram. This interface displays the updated information and test results by default, as shown in the figure below: Browse Data Click the Last and Next buttons to browse the last and next samples. The samples can also be browsed with the Page Up and Page Down keys on the keyboard. Edit Information To change or input sample information, input information in the edit box or select information from dropdown box on the top of the interface. When the focus leaves the edit box, the information will be saved automatically. If the input is invalid, a prompt message will appear on the right of the edit box, and the information will not be saved. Press the Enter key to switch the input. Quick input is supported for Department, Sender, Patient Type, Sex, and Charging Type. Shortcut codes can be set in System Setup. When a shortcut code is input, the corresponding information will be called out. Print Click the Print button and print the information, result data, histogram, and scattergram of the current sample according to the set report template. Verify After the sample information and analysis results are verified, click the Verify button to verify the sample. If you are a common user without verification authority, click the Verify button to pop up the Authority Authentication dialogue box, input the username with 61

63 verification authority and the password. When the correct username and password are input, the Verifier field will display the username input. If you are an administrator or above or a common user with verification authority opened, click this button, and the Authority Authentication dialogue box will not be popped up. You can verify the sample directly. The Verifier field for the current sample will display the name of the verifier set in the Setup module. When the verification is successful, no information on the sample can be modified, the sample/patient information will be greyed out, and the Verify button will become a Cancel button. If After verification, automatically skip to the next sample to be verified is set in System Setup, then, after the verification, the system will automatically skip to the next sample to be verified. If After verification, automatically print report is set, then, when the Verify button is clicked and the verification is finished, the report for this entry will be printed automatically. Lock Click the button to lock the current entry. You can switch to other interfaces. When the updated test result comes out, the interface will not be refreshed automatically and will still display the information, result data and graph of the current entry, with the values of position and total refreshed only. If you have not locked the current interface, when the updated result comes out, the updated result will be refreshed. Edit Result 1. Click the Edit button, the edit box will appear at the result of the measurement parameters and percentage of WBC differentiation parameter. You can directly modify the result in the edit box. 2. After the result is modified, click the Save button to save the modification. If the focus is in the edit box, you can press the Enter key to save the modification. When the modification is saved, the edit box will disappear automatically. NOTE: (1) Only users at the administrator level have the authority of editing results. Common users can t edit results before inputting the username and password of the administrator. (2) If the result of a measurement parameter is modified, the result of its relevant parameters will also change, and the alarm of high/low/suspected will be given again according to the modified result. (3) Only the results of the measurement parameters (WBC, RBC, HGB, HCT, and PLT) and the percentage of WBC differentiation parameter can be modified. (4) After the result of WBC differentiation percentage is edited, the absolute values corresponding to the WBC differentiation parameter will be recalculated. (5) If, after the result of WBC differentiation percentage is edited, the sum of the percentages of the parameters does not equal to 100%, the prompt Invalid result. The sum of differentiation percentages is not equal to 100%! will appear when the data are being saved. 62

64 (6) After the result is edited, the E tag will appear before the parameter result directly modified manually. The e tag will appear before the result data of its relevant parameters modified as the parameter result is directly modified manually. (7) The results of the background sample and the verified entries can t be edited. Restore Result Restore can restore the results of the parameters to the original measurement values of the analyzer and remove the tag ( E or e ) produced after Edit Result is executed. NOTE: (1) Only users at the administrator level have the authority of restoring results. Delete Common users can t restore results before inputting the username and password of the administrator. (2) The results of the background sample and the verified entries can t be edited. Click the button to pop up the prompt Are you sure to delete the record? Click OK to delete the sample entry displayed on the current Details interface and close the dialogue box. Samples deleted are divided into two cases: (1) If the sample deleted is the updated sample, after it is deleted, a new sample before it will appear on the interface; (2) If the sample deleted is not the updated sample, after it is deleted, the sample immediately after it will appear on the interface. If you click Cancel, the sample will not be deleted, and the confirmation dialogue box will be closed. The system will return to the Details interface and still display the current sample. NOTE: (1) The S tag appears on the left top corner of the Sample No. edit box for STAT samples. (2) After the sample information is set on the Sample Analysis interface, the sample analysis, including analysis in the Automatic Sampling mode and the Closed Sampling mode, can be started with the Aspirate Key on the Details interface. 63

65 Chapter 8 Archives Whenever a sample is tested, the system will save the test data automatically. The analyzer can save the measurement values of parameters, Flag messages, histograms, and scattergrams of up to 100,000 samples. You can view the result information of the samples through the List or Graph Review, print, delete, modify and search the sample data meeting the designated criteria. Click the Archives button on the toolbar to open the History Data List window, as shown in the figure below: From the history list, you can view the sample results for the current day or a week that meet the search criteria. The entries for the current day are displayed by default. The entries in the list are sorted from left to right according to the test time (from new to old) of the samples. The first entry in the list is the entry newly analyzed. If new test result comes out, the list interface will be refreshed automatically to display the updated sample information. The red parameters displayed in the list indicate the test result is lower or higher than the range of normal values of the parameter. Each page of the list displays up to 500 entries. The function buttons are described below: <<- Switch the displayed page to the previous page. ->> Switch the displayed page to the next page. CV Value Click a single column of the list with the mouse and select a historic datum. With the Ctrl or Shift key on the keyboard, select multiple columns and click the CV Value button, and the CV Value statistics dialogue box will be popped up. You can view the SD (Standard Deviation) and CV (Coefficient of Variation) of WBC, NEU%, LYM%, MON%, EOS%, BAS%, RBC, HGB, 64

66 MCV, and PLT. Verify You can verify one or more entries selected. If the selected sample has been verified, the button will become Cancel ; if the selected entries include entries verified and those not verified, the verification status of the last selected entry will decide the status of the Verify button. The processing tag V is added to verified samples. Search You can look for entries meeting the designated criteria in the range of all samples. Click the Search button to open the combined search dialogue box. The default interval between the start date and the end date is the recent year. You can use one or more criteria for search. Input the information and click OK. If there is any entry meeting the criteria, it will be displayed in the history list; otherwise, the system will pop up the following prompt: Delete The Delete function can be used to delete the selected data and all history data. Click a single column of the list with the mouse and select a historic datum. With the Ctrl or Shift key on the keyboard, you can select multiple columns to delete. If no data are selected, the system will prompt that all sample data will be deleted. Details The Details function is used to view the detailed information of a sample. Select an entry from the history list, double-click or click the Details button to enter the sample graph review window. For the operation, refer to Chapter 7 Details. Export You can export test results to an Excel sheet for data analysis. The operation steps are as follows: 1. Click the Export button to open the Data Export dialogue box. 65

67 2. The default export folder of the software is C:\HA-86_History. To change the folder, you can directly input a valid folder name in the edit box or click the... button to open the Browse Folders dialogue box and designate a folder. 3. Select the desired export mode and click the OK button to pop up the Export Prompt Message box, which indicates the export is successful. You can open the Excel file for View, Edit, and Statistics. 4. Click the OK button to return to the history list interface. You can repeat the above steps for multiple exports. Print Click a single column of the list with the mouse and select a historic datum. With the Ctrl or Shift key on the keyboard, you can select multiple columns. Click the Print button, and the analyzer will print the history data of the selected samples in the printing mode set in System Setup. The processing tag P is added to printed samples. Communicate With the Communicate function, the sample data can be transmitted to the external information system. If network connection between the operational software and the external information system has been established, the Communicate button will be activated, and the LIS/HIS icon in the status bar will display the online status. Click the Comm. button to open the Communication dialogue box, as shown in the figure below: 66

68 Select the data to be transmitted and click the Start button to begin to transmit the data to the external information system. The dialogue box will be closed, and the communication status icon in the status bar will flash. To stop the transmission, click the Comm. button again to open the Communication dialogue box. During data transmission, the Start button will become a Stop button. Click the Stop button to stop data transmission. The processing tag C is added to samples communicated. NOTE: (1) The HL7 protocol is used for the communication between the system and the LIS/HIS and data management software. The protocol specification is not attached to this Manual. If you need it, please contact our Customer Service Department. (2) The number of an STAT sample is yellow. 67

69 Chapter 9 Quality Control Quality control reflects the accuracy and repeatability of the system. The quality control procedure provided by the analyzer provides a reliable and effective method for detecting and preventing the possible system errors. If any system error exists, the results of sample analysis may be unreliable. In order to always keep accurate analysis results and find and timely clear the system errors of measurement of the analyzer, it is suggested to perform quality control of the analyzer regularly. This analyzer provides three quality control methods, i.e. L-J quality control, X-B quality control, and X-R quality control. Caution: You should use the QC and reagents designated by the Company and store and use them strictly according to their instructions. 9.1 L-J Quality Control L-J Quality Control is a frequently used quality control method in inspection and quality management and a common indoor quality control method for laboratories. It is very important for ensuring reliable test results and improving the test quality. L-J Quality Control has the Whole Blood and Pre-diluted modes. You can perform quality control of all or some parameters Setup Click L-J QC under the QC menu and select Setup or directly click L-J QC on the toolbar to enter the Quality Control Setup interface. No.: The Quality Control setting of each lot no. corresponds to a file. The selection range of file numbers is

70 Lot No.: Lot no. of the QC. It can t be empty. Expiry Date: Expiry date of the QC. QC Name: The name of the QC set by the operator. Level: High, medium, and low. The default is medium-level Quality Control. Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood. The default is Closed-Whole Blood. Operator: The username currently logged in. After the Quality Control settings are saved, the system will record automatically. Modification Date: After the Quality Control settings are saved, the system will automatically record the current date as the creation date. Target Value, Limits Value: According to the target value table corresponding to the lot no., input its reference value and tolerance in the edit box after the parameter for Quality Control respectively. If no reference value and (or) tolerance are (is) input, the parameter will not participate in quality control. Save: Used to save the Quality Control setting of the current Quality Control file. If this Quality Control file has data, the data will be updated. Caution: The lot no. and Quality Control mode of a Quality Control file must not be repeated at the same time. Delete: The Quality Control data, including setup data and test data, of the selected Quality Control file are deleted Analysis After the Quality Control parameters of the selected Quality Control file are set, the Quality Control analysis of the Quality Control file can be performed. Click L-J QC under the QC menu and select Analysis or directly click L-J QC on the toolbar to enter the Quality Control Analysis interface. All articles (sample, control, calibrator, reagent, waste liquid, etc.) and areas in contact with such articles have the potential hazard of biological infectivity. When touching the related articles and areas in the laboratory, you should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) Warning: (1) The sampling probe is pointed and may carry blood sample, control and calibrator with the potential hazard of biological infectivity, so avoid touching the sampling probe. (2) The sample may spill out of the blood collection tube not covered and cause biological pollution. Be careful when operating a blood collection tube with the cap opened. (3) The reagents may irritate eyes, skin, and mucosa. When touching the reagents related articles in the laboratory, you 69

71 should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) (4) Once any reagent is in contact with the skin, immediately rinse with plenty of water and, when necessary, receive treatment by a doctor. Once any reagent is in contact with the eye, immediately rinse with plenty of water and receive treatment by a doctor. 1. Check that the information in the Quality Control file is consistent with the QC to be tested, and the QC is not expired. 2. Prepare the QC according to the QC instructions. a) If the mode is Closed Sampling, press the Open Compartment Door Key on the front shell to open the compartment door. Put the QC into the sample compartment door and close the compartment door. Press the Aspirate Key on the front shell or the Start button to begin the test. If the mode is Pre-diluted, click the Diluent button on the toolbar and prepare a pre-diluted sample beforehand. The specific steps are described in the Daily Operations chapter. Start analysis. b) If the mode is Automatic Sampling, put the tube rack on loading platform on the right side of the autoloader, and press the Aspirate Key on the front shell or the Start button to begin the analysis in the Automatic Sampling mode. 3. When the analysis is finished, the Quality Control result will be displayed on the current interface and will be automatically saved in the current Quality Control file. 4. Each Quality Control file can store up to 500 Quality Control results. Caution: If the test tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a test tube no more than three times. 70

72 9.1.3 Graphs Click L-J QC under the QC menu and select Graphs or directly click L-J QC on the toolbar to enter the Quality Control Graphs interface. Quality Control Graphs display the Quality Control data distribution graphically for easy understanding of the deviation trend of the analyzer. The information displayed on the interface and the functions of buttons are as follows: Lot No.: Lot no. of the QC corresponding to the Quality Control file. Expiry Date: Expiry Date of the QC. Mode: Closed-Whole Blood, Closed-Pre-diluted, or Automatic-Whole Blood. Time: Test time of data corresponding to the Quality Control point. S/N: Serial number of the Quality Control point among all Quality Control data points. Each screen displays the Quality Control graphs of the 5 parameters and the Mean (Mean Value), SD (Standard Deviation), and CV% (Coefficient of Variation) of each parameter. The 3 values on the left of the Quality Control graph, from top to bottom, are: target value + limits value of QC, target value of QC, and target value - limits value of QC. The vertical scroll bar is used to switch between parameters to be displayed. The horizontal scroll bar, when used with the and keys, is used to display the Quality Control data of different serial numbers. Print Used to print the Quality Control graph of the current group of parameters. Order Order can be used to adjust the display sequence of parameters according to the actual needs. Click the Order button to open the following dialogue box: 71

73 The sequence of parameters can be adjusted with Top, Up, Down, and Bottom. Order is applicable to the display of Quality Control list. Delete Can be used to delete the data of the selected Quality Control point and all Quality Control data. Click the Delete button to open the following dialogue box: Selected Data refers to the Quality Control point corresponding to the current position of the blue browse line in the Quality Control graph List Click L-J QC under the QC menu and select List or directly click L-J QC on the toolbar to enter the Quality Control List interface: 72

74 Print All data or the data for the designated date can be printed. Click the Print button to pop up the Printing Mode Selection box, as shown in the figure below. Click the OK button to print data: Delete Click the Delete button to delete the Quality Control data selected in the list. If no data are selected, all data will be deleted. Export Quality Control data can be exported to a.csv or.txt file. Communicate Quality Control data can be transmitted to the external information system. If network connection between the operational software and the external information system has been established, the Comm. button will be activated, and the LIS/HIS icon in the status bar will display the online status. Click the Communicate button to open the Communication dialogue box, as shown in the figure below: 73

75 Select the data to be transmitted and click the Start button to begin to transmit the data to the external information system. The dialogue box will be closed, and the communication status icon in the status bar will flash. To stop the transmission, click the Communicate button again to open the Communication dialogue box. During data transmission, the Start button will become a Stop button. Click the Stop button to stop data transmission. NOTE: The HL7 protocol is used for the communication between the system and the LIS/HIS and data management software. The protocol specification is not attached to this Manual. If you need it, please contact our Customer Service Department. 9.2 X-B Quality Control X-B Quality Control does not use QC and runs statistical analysis according to the samples actually tested. As the physiological change in MCV, MCH, and MCHC of RBC is very small, the X-B mean can manage the accuracy of the system. The analyzer conducts X-B Quality Control of 3 parameters, i.e. MCV, MCH, and MCHC. X-B Quality Control data come from random samples and are not classified by disease. Whole blood or pre-diluted samples can be used as sample sources. A reference range is composed of the given value and the upper and lower limits. The change trend in the reference range of each batch of X-B values is observed. The analyzer stores up to 100 X-B Quality Control data. When the number of Quality Control results stored exceeds the maximum, the new Quality Control result will override the earliest result Setup Click X-B QC under the QC menu and select Setup to enter the Quality Control Setup interface: 74

76 In the Samples/Batch edit box, input the number of sample results selected whenever an X-B Quality Control point is calculated, with the range of , the default of 20, and the maximum number of groups of 100 groups. If X-B Analysis is set to On, the valid results of the tested sample will be also taken as data of X-B Quality Control analysis. If the sample meets either of the following criteria, it will be deemed invalid and will not be included in the Quality Control calculation: 1. Samples with the RBC result out of the linear range of the analyzer and other parameters out of the following ranges: 50 MCV 150fL, 20pg MCH 40pg, 240g/L MCHC 440g/L; 2. Blank result; 3. Other Quality Control data analysed; 4. Error of the analyzer that impacts the sample measurement during the analysis. The sample data are divided into groups, with each group including n samples. The mean of each group of data is calculated. The general mean, general standard deviation (SD), and general coefficient of variation (CV) are calculated based on the means of the batches of data. The initial value can be set according to the empirical value. The tolerance is set to ±3%. When the number of statistical samples reaches 400, the general mean of X-B can be set as a target value. The default initial values of the reference values of the parameters are: MCV: 89.5fL MCH: 30.5pg MCHC: 340g/L 75

77 The default initial values of the deviation values of the parameters are: MCV: 2.7fL MCH: 0.9pg MCHC: 10g/L Caution: The target value and limits value should not be empty Graphs Click X-B QC under the QC menu and select Graphs to enter the Quality Control Graph interface: Current/Total: Displays the position and total of X-B Quality Control analysis of the current Quality Control data point. The 3 values on the left of the Quality Control graph, from top to bottom, are: target value + limits value, target value, and target value - limits value. Mean: Displays the mean of all Quality Control data points. SD: Standard Deviation CV%: Coefficient of Variation The horizontal scroll bar, when used with the and keys, is used to display the Quality Control data of different serial numbers Print Click the Print button to print the Quality Control graphs of the 3 parameters. Delete Can be used to delete the data of the selected Quality Control point and all Quality Control data. Click the Delete button to open the following dialogue box: 76

78 Selected Data refers to the Quality Control point corresponding to the current position of the blue browse line in the Quality Control graph List Click X-B QC under the QC menu and select List to enter the Quality Control List interface. The data of the X-B Quality Control point are displayed in the list on the top of the window. The specific calculation process is described below. Assume the number of samples of each group is N. The calculation formula of mean is: X Bi X F 2 Bi 1 SGN F) / ( N In which F N 1 SGN( X ij X Bi 1) X ij X Bi 1 X Bi : Mean of the current batch; X Bi 1 SGN: Sign function. : Mean of the previous batch 77

79 SGN(number) If number is SGN returns > 0 1 = 0 0 < 0-1 X ij : Sample data of the current batch. Each X Bi calculated is drawn as the point in the Quality Control graph. If the number of data in the last batch does not reach N, X Bi will not be calculated. For the first group of data, where there is no X B for the previous batch, the target value set will be used. Data List: Click Data List to open the Detailed Data List dialogue box, where the detailed sample data of each Quality Control point can be viewed. Print: Prints the Quality Control list. Export: The Quality Control data can be exported to a.csv or.txt file. Delete: Can be used to delete the selected or all X-B Quality Control data. Communicate:Transmit QC data to the external information system. If network connection between the operational software and the external information system has been established, the Comm. button will be activated, and the LIS/HIS icon in the status bar will display the online status. 9.3 X-R Quality Control X-R Quality Control, i.e. Mean-Difference Quality Control, is a common quality control method in the industry and an effective method for adjusting and forecasting whether there is any abnormal fluctuation. This Quality Control and the L-J Quality Control are complementary. X -R Quality Control reflects the degree of stability of Quality Control data mainly through the control graph, and its Quality Control graph is a composite graph Setup Before X-R Quality Control, necessary setup of Quality Control parameters is required. Click X-R QC under the QC menu and select Setup to enter the Quality Control Setup interface: 78

80 No.: The QC setting of each lot no. corresponds to a file. The selection range of file numbers is Lot No.: Lot no. of the QC. It can t be empty. Expiry Date: Expiry Date of the QC. QC Name: The name of the QC set by the operator. Level: High, medium, and low. The default is medium-level Quality Control. Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood. The default is Closed-Whole Blood. Operator: The username currently logged in. After the Quality Control settings are saved, the system will record automatically. Modification Date: After the Quality Control settings are saved, the system will automatically record the current date as the creation date. Save: Used to save the Quality Control setting of the current Quality Control file. If this Quality Control file has data, the data will be updated Analysis After the Quality Control parameters of the selected Quality Control file are set, the Quality Control analysis of the Quality Control file can be performed. Click X-R QC under the QC menu and select Analysis to enter the Quality Control Analysis interface: All articles (sample, control, calibrator, reagent, waste liquid, etc.) and areas in contact with such articles have the potential hazard of biological infectivity. When touching the related articles and areas in the laboratory, you should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) 79

81 Warning: (1) The sampling probe is pointed and may carry blood sample, QC and calibrator with the potential hazard of biological infectivity, so avoid touching the sampling probe. (2) The sample may spill out of the blood collection tube not covered and cause biological pollution. Be careful when operating a blood collection tube with the cap opened. (3) The reagents may irritate eyes, skin, and mucosa. When touching the reagents related items in the laboratory, you should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) (4) Once any reagent is in contact with the skin, immediately rinse with large amount of water and, when necessary, receive treatment by a doctor. Once any reagent is in contact with the eye, immediately rinse with large amount of water and receive treatment by a doctor. 1. Check that the information in the Quality Control file is consistent with the QC to be tested, and the QC is not expired. 2. Prepare the QC according to the QC instructions. a) If the mode is Closed Sampling, press the Open Compartment Door Key on the front shell to open the compartment door. Put the QC into the sample compartment door and close the compartment door. Press the Aspirate Key on the front shell or the Start button to begin the test. If the mode is Pre-diluted, click the Diluent button on the toolbar and prepare a pre-diluted sample beforehand. The specific steps are described in the Daily Operations chapter. Start analysis. b) If the mode is Automatic Sampling, put the test tube rack on loading platform on the right side of the autoloader, and press the Aspirate Key on the front shell or 80

82 the Start button to begin the analysis in the Automatic Sampling mode. 3. When the analysis is finished, the interface will display the result of the first analysis. 4. Prepare the QC and execute the second Quality Control analysis. 5. When the analysis is ended, the Quality Control results (2 Quality Control test values and, X (Mean) and R (Difference)) will be displayed on the current interface and automatically saved in the current Quality Control file. The analyzer can display the Quality Control results of all parameters in the Quality Control list. If Quality Control is not performed for some parameters, the corresponding cells will be empty. 6. Click the Cancel button to delete the data for the first analysis and begin the analysis again. Caution: (1) If the Quality Control quantity is measured once only, the result will not be saved. (2) After the results of the second Quality Control analysis are obtained, the histogram and scattergram displayed on the interface will refresh the graphs corresponding to the results of the second Quality Control analysis. (3) Each Quality Control file can store up to 500 Quality Control results (X (Mean) and R (Difference)). (4) If the test tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a test tube no more than three times Graphs X-R Quality Control Graph can visually reflect the degree of stability of the analyzer. When the analyzer is in the control status, the points in the graph will be randomly distributed near both sides of the center line. For the points away from the center line, the nearer to the upper and lower control limits, the fewer points there are. Click the Graphs button to view the Quality Control graph. 81

83 Quality Control graphs display the Quality Control data distribution graphically for easy understanding of the deviation trend of the analyzer. The information displayed on the interface and the functions of buttons are described below: Lot No.: Lot no. of the QC corresponding to the Quality Control file. Expiry Date: Expiry Date of the QC. Mode: Closed-Whole Blood, Closed-Pre-diluted, and Automatic-Whole Blood. Time: Test time of data corresponding to the Quality Control point. S/N: Serial number of the Quality Control point among all Quality Control data points. Each screen displays the X and R graphs of the 2 parameters and the Mean (Mean Value), SD (Standard Deviation), and CV% (Coefficient of Variation) of each parameter. The 3 values on the left of the Quality Control graph, from top to bottom, are: upper limit, mean, and lower limit. The vertical scroll bar is used to switch between parameters to be displayed. The horizontal scroll bar, when used with the and keys, is used to display the Quality Control data of different serial numbers. Print Used to print the Quality Control graph of the current group of parameters. Order Order can be used to adjust the display sequence of parameters according to the actual needs. Click the Order button to open the following dialogue box: The sequence of parameters can be adjusted with Top, Up, Down, and Bottom. Order is applicable to the display of Quality Control list. Delete Can be used to delete the data of the selected Quality Control point and all Quality Control data. Click the Delete button to open the following dialogue box: 82

84 Selected Data refers to the Quality Control point corresponding to the current position of the blue browse line in the Quality Control graph List Click the List button to view the list of Quality Control results, as shown in the figure below: Print All data or the data for the designated date can be printed. Click the Print button to pop up the Printing Mode Selection box, as shown in the figure below. Click the OK button to print data: Delete Click the Delete button to delete the Quality Control data selected in the list. If no 83

85 data are selected, all data will be deleted. Export Quality Control data can be exported to a.csv or.txt file Calculation The calculation formulas of X and R are as follows: X X n R R n X : Mean of 2 tests R: Difference between 2 tests (absolute value) X : General mean R: Mean of ranges n: Number of groups (each group is tested twice) The calculation formulas of the upper and lower limits of X and R are as follows: Upper limit of X (UCL) = X + 3 Lower limit of X (LCL) = X - 3 R kd 2 R kd 2 d 3 R Upper limit of R (UCL) = R + 3 d 2 X R QC reflects the degree of stability of QC data mainly through the control graph, and its QC graph is a composite graph. Each parameter has X (Mean) graph and R (Range) graph. The X (Mean) graph is shown below: The 1st line is the upper limit of X (UCL); the 2nd line is X ; the 3rd line is the lower limit of X (LCL). The maximum value is X + 6 R R ; the minimum value is X - 6. kd 2 kd 2 The maximum value line and the minimum value line are not drawn. 84

86 The R (Difference) graph is shown below: The 1st line is the upper limit of R (UCL); the 2nd line is R ; the 3rd line is the zero point. In the formula, d and 2 d are the coefficients decided by the number of Quality Controls 3 each day, which can be looked up from the table below: Table 7-1 X-R Quality Control Graph Coefficient Table Coefficient k d 2 1 d 2 d This analyzer uses k=2 for calculation. 85

87 Chapter 10 Calibration The analyzer has been strictly tested and calibrated before leaving factory and does not need frequent calibration. However, the measurement results may drift due to many causes during transport and use. The purpose of analyzer calibration is to ensure accurate test results. In order to ensure the accuracy of measurement of the analyzer and obtain stable and reliable test results, the analyzer must be calibrated in the following cases. 1. When the analyzer is used for the first time or reinstalled in a different place. 2. The analyzer is repaired. 3. The Quality Control results are deviated. This analyzer supports 3 calibration modes, i.e. manual calibration, calibration with calibrator, and calibration with fresh blood. Six parameters, i.e. WBC, RBC, HGB, MCV, PLT and MPV, can be calibrated in the Whole Blood mode or Pre-diluted mode. Caution: The measurement data can be used as valid data only after the analyzer has been calibrated Preparation before Calibration This analyzer can be calibrated with fresh blood and calibrator. This analyzer has 2 sets of calibration coefficient for the Whole Blood mode and the Pre-diluted mode respectively. Before calibration, inspect the analyzer by following the steps described below and check that the machine works normally. If any problem is found, stop the calibration. 1) Inspect the analyzer and the reagents to ensure the analyzer is in the normal status, the reagents are adequate, and the materials required are complete. 2) Perform the blank check and check that the blank measurement value meets the requirements. 3) Perform repeated measurements with the medium-level blood sample on the Analysis interface and check that the machine works within the accuracy range. 4) Test the carry-over. The carry-over should be within the range specified for the analyzer. Caution: (1) The calibrator should be the commercial calibrator designated by the Company and should be stored and used according to the requirements. Before checking that all calibrations are completed correctly, do not use the measurement results for medical or clinical diagnosis. (2) During calibration with fresh blood, perform collection, blending, etc. strictly according to the Laboratory SOP Manual Calibration Click Manual Calibration under the Calibration menu to enter the Manual Calibration 86

88 interface, as shown in the figure below: Caution: If you are a common user, you can view the calibration coefficient on the interface only and can t run calibration. To run calibration, you should log out first and log in again as an administrator. The steps of manual calibration are as follows: 1. In the Sample Analysis window, use the calibrator to perform multiple measurements (at least thrice). 2. Record the measurement data of the item. 3. Calculate a new calibration coefficient. Calculate a new calibration coefficient with the following formula: New calibration coefficient= Current calibration coefficient x Reference value of calibrator Mean of measurements 4. In the Manual Calibration interface, select the blood sample mode and input the new calibration coefficient in the calibration value input box. 5. Click the Save button to save the current calibration result. In which, the calibration date will be automatically updated to the current date, and the operator is updated to the username currently logged in. 6. Click the Print button to print the saved calibration coefficient. Caution: The calibration coefficient input should be within 75%-125%, with up to two decimal places. If the calibration coefficient calculated is out of this range, check whether the sample has not been fully blended or whether the operation is wrong, etc. Calibration can t be operated before the cause is determined Auto Calibration When Auto Calibration is selected, the analyzer can automatically calculate a new 87

89 calibration coefficient after the calibrator is tested. The analyzer performs calibration in the Closed Sampling mode. The coefficient calibrated will be automatically delivered to the Automatic Sampling mode. Click Auto Calibration under the Calibration menu to enter the Automatic Calibration interface. For calibration with calibrator or fresh blood, whenever the calibration test is finished, the analyzer will automatically make the following processing: 1. If the test value of a parameter in the current test results is out of the linear range of the parameter, but within its display range, the calibration data will be displayed. At the same time, a dialogue box will be popped up to prompt that the data of this calibration are invalid. Click OK to close the dialogue box, and the data of this calibration in the list will be deleted automatically. 2. If the test value of a parameter in the current test results is out of the display range of the parameter, --- will appear in the list. At the same time, a dialogue box will be popped up to prompt that the data of this calibration are invalid. Click OK to close the dialogue box, and the data of this calibration in the list will be deleted automatically. If part of the data have been tested and the calibrator coefficient has not been calculated or the calibration coefficient has been calculated but is not saved, when you exit the Automatic Calibration interface, the software will give prompt to ask whether you are sure to exit Calibration with Calibrator The steps of calibration with calibrator are as follows: 88

90 1. Set calibrator. Click the Setup button to open the Auto Calibration Settings interface and set the parameters of the calibrator. Lot No.: Lot number of the calibrator. After the Lot No. is input and saved, when you log in next time, you can select it from the dropdown list and view or change the data of this Lot No. Expiry Date: Expiry date of the calibrator. If the expiry date is less than the current system date, when you click OK to return, the analyzer will give warning. You must use other types of calibrator for calibration. Sample Type: Mode in which the calibration will be performed. Targets: Reference value of each parameter of the calibrator. If the calibration of a parameter is not required, its Targets input box will be left empty. Click the OK button to save the settings and exit. 2. Press the Open Compartment Door Key on the front shell of the analyzer to open the compartment door, put the calibrator into the compartment door, and close the compartment door. 3. Press the Aspirate Key to begin the analysis. The interface will prompt that the analysis is in progress. When the analysis is ended, the result will be displayed on the current interface. After 3 tests, the system will automatically calculate a new calibration coefficient. 4. Repeat the test process. When the number of valid data in the list reaches 11, a prompt box will be popped up to prompt that the calibration has been finished and no test is allowed any more. 5. After the calibration coefficient is obtained, the system will judge whether the calibration coefficient is valid. If the calibration coefficient meets the following two criteria, it is invalid and can t be saved. a) Either calibration coefficient is outside the deviation range of 75%-125%. 89

91 b) The CV value of either calibration parameter exceeds the repeatability index of the analyzer. 6. If the new calibration coefficient is valid, click the Save button, and the system will save the new calibration coefficient. The coefficient on the Manual Calibration interface will also be updated Calibration with Fresh Blood The steps of calibration with fresh blood are as follows: 1. Prepare 3-5 normal fresh blood samples. 2. Use the prepared 3-5 normal fresh blood samples to perform at least 3 measurements on the reference analyzer, calculate the mean, and take this mean as a reference value; or perform measurements and calculation according to the reference method and take the data obtained as a reference value. 3. Click the Setup button to open the Automatic Calibration Setup interface and set the parameters of the fresh blood sample. Sample Type: Mode in which the calibration will be performed. Targets: Reference value of each parameter of the fresh blood. If the calibration of a parameter is not required, its Targets input box will be left empty. Click the OK button to save the settings and exit. 4. Return to the Automatic Calibration Test interface, which displays the number of the current calibration blood sample. 5. Prepare whole or pre-diluted fresh blood sample. Press the Open Compartment Door Key on the front shell of the analyzer to open the compartment door, put the vacuum tube or centrifuge tube into the compartment door, and close the compartment door. 6. Press the Aspirate Key to begin the analysis. The interface will prompt that the analysis is in progress. When the test is ended, the result will be displayed on the current interface. After 3 tests, the system will automatically calculate a new 90

92 calibration coefficient. 7. Repeat the test process. When the number of valid data in the list reaches 11, a prompt box will be popped up to prompt that the calibration has been finished and no test is allowed any more. 8. After the calibration coefficient is obtained, the analyzer will judge whether the calibration coefficient is valid. If the calibration coefficient meets the following two criteria, it is invalid. a) Either calibration coefficient is outside the deviation range of 75%-125%. b) The CV value of either calibration parameter exceeds the repeatability index of the analyzer. 9. Repeat Steps 3~8 to finish the testing of other calibration blood samples. If the calibration coefficient of a blood sample calculated is invalid, the reference value, all existing calibration data and various calculated values, including calibration coefficient, of the current blood sample will be cleared before the blood sample is switched. If the calibration coefficient of the current blood sample has not been calculated, the blood sample will be directly switched to another one after the reference value and all existing calibration data are cleared. When the test is finished, the calibration coefficients of the various blood samples will be displayed on the calibration coefficient line at the bottom of the Automatic Calibration interface. If the blood sample test reaches 3 groups, the mean calibration coefficient will be calculated automatically. 10. If you are sure to use the new mean calibration coefficient, click the Save button, and the system will save the new calibration coefficient. The coefficient on the Manual Calibration interface will also be updated Inspection of Calibration Coefficient After the calibration is finished, the calibration coefficient should be inspected. The suggested steps are: 1. Analyze the calibrator at least 3 times and check whether the analysis result is within the permissible range. 2. Analyze the high-, medium- and low-level QC. Measure each concentration at least 3 times and check whether the analysis result is within the permissible range. 3. Analyze at least 3 normal fresh blood samples with the reference value known, measure each sample at least 6 times, and check whether the analysis result is within the permissible range. Caution: If the vacuum blood collection tube is pierced repeatedly, the rubber tube cap may be damaged, and the debris produced may cause inaccurate analysis result. It is suggested to pierce a blood collection tube no more than three times. 91

93 Chapter 11 Exit Exit includes Minimize, Logout, Shut Down, and Exit System. Minimize Used to minimize the analysis software to the status bar.with the shortcut keys ALT+W, the software can be directly minimized. To restore, use ALT+Q. Logout Click the Logout button to pop up the following dialogue box: You can log on to the system only after inputting the correct username and password. Shut Down It is suggested to execute the power-off operation after the analyzer has been working for 24 hours continuously. To turn off the analyzer, the analysis software should be connected with the analyzer. When the power-off operation is finished, the power-off prompt will be popped up, as shown in the figure below: After the analyzer is turned off, click the OK button or wait till the prompt box closes automatically. Here, you have not exited the analysis software, and you can still execute other operations not relating to the analyzer. To exit the software, select Exit System. Exit System To turn off the analyzer and exit the analysis software, select Exit System. Click OK, and the analyzer will begin to execute the same operation as Shut Down. When the operation is finished, the power-off prompt will be popped up to ask whether you are sure to exit the software. Click OK, and the whole analysis software will be turned off. 92

94 Caution: (1) The analyzer can t be turned off if the analyzer is not connected to the external PC. (2) Do not force a power-off of the analyzer during a test or other sequences. (3) You can t exit the system software before turning off the analyzer. 93

95 Chapter 12 Service 12.1 Daily Maintenance This analyzer is a clinical precision analyzer. In order to keep the analyzer in the good condition, get reliable measurement results, and reduce the frequency of faults of the analyzer, daily upkeep and maintenance should be performed. This section describes the relevant maintenance operations. Warning: Maintenance operations should be performed according to the User s Manual and the Service Manual, otherwise, damage of the analyzer may be caused. All articles (sample, control, calibrator, reagent, waste liquid, etc.) and areas in contact with such articles have the potential hazard of biological infectivity. When touching the related articles and areas in the laboratory, you should follow the Laboratory Safety SOP and wear the personal protective equipment (such as laboratory protective clothing, gloves, etc.) Caution: (1) If cleaning is not done according to the recommended procedure every day, the stability of the analyzer and the accuracy of analysis results may be impacted. (2) During maintenance, prevent touching the tip of the sampling probe. (3) The components and parts provided by the Company must be used for analyzer maintenance. If you have any question, please contact our Customer Service Department or the agent Replacement of Reagent Warning: (1) The reagents may irritate eyes, skin, and mucosa. When touching the reagents, you should wear the personal protective equipment. (2) Once any reagent is in contact with the skin, immediately rinse with plenty of water and, when necessary, receive treatment by a doctor. 94

96 Caution: (1) Before use, let the reagent sit for a period of time, so that it becomes stable. (2) After replacing the reagent, you should run a blank test to ensure the value of the blank test is within the required range. You need to replace the reagent in the following cases: The reagent is replaced with the whole container/whole bottle of new reagent. The reagent in the tube is contaminated. There is bubble in the tube. Click the Service button on the main menu and select Daily Maintenance on the menu popped up or directly click the Daily Maintenance button on the toolbar to enter the Daily Maintenance interface. Select the Replace Reagent tab to enter the following interface. You can replace the following reagents: Diluent Cleanser 86H lyse 86D lyse The steps of reagent replacement are as follows: 1. Click the button for the reagent to be replaced and input the lot no., shelf life and total amount of the replacement reagent on the dialogue box popped up. 95

97 2. The Set button is used to set reagent information, where the analyzer will not execute the replacement operation or change the internal record of remaining reagent. Click the Replace button to save the lot no. and shelf life input. Set the remaining reagent to the total amount of reagent currently set. The Replace Reagent prompt box will be popped up, as shown below. 3. After the reagent is replaced, the following dialogue box will be popped up to prompt that the reagent has been replaced. 4. Click the OK button to close the dialogue box. 5. Replace other reagents according to the above steps Clean You should clean the corresponding components when the following are observed: The WBC or HGB blank result is out of the blank range. The WBC bath cleaning can be executed. The RBC and (or) PLT result is out of the blank range. The RBC bath cleaning can be executed. There are many particles in the scattergram of the blank result. The DIFF bath cleaning can be executed. There are many particles in the scattergram of the blank result or the differentiation effect of the WBC scattergram is not good. The flow cell cleaning can be executed. The sampling probe is dirty. The sampling probe cleaning can be executed. If the blank parameter results of the parameters are out of the blank range, the fluidics cleaning can be executed to clean all tubes once. Click the Service button on the main menu interface and select Daily Maintenance on the 96

98 menu popped up or directly click the Daily Maintenance button on the toolbar to enter the Daily Maintenance interface. Select the Clean tab to enter the following interface. You can clean the following components: WBC bath RBC bath DIFF bath Pipeline Sampling probe Flow cell (DIFF optical measurement channel) The steps of cleaning are as follows: 1. Click the button for the component to be cleaned to begin to clean the component and pop up the prompt of the corresponding function. 2. When the cleaning is finished, the following dialogue box will be popped up to prompt that the cleaning has been finished. 3. Click the OK button to close the dialogue box. 4. Clean other components according to the above steps Upkeep You should keep the analyzer in good repair in the following cases: The aperture of the counting bath is blocked. Unclog, Zap Apertures, and Back Flush can be executed. 97

99 After running large amount of samples, the blank test values of the analyzer are out of the blank range, the differentiation effect of WBC scattergram is not good or the aperture is blocked. After other cleaning operations, the situation has not been improved. The Soaking in Cleanser operation can be executed. The analyzer in use should be soaked in concentrated cleanser every week. Click the Service button on the main menu and select Daily Maintenance on the menu popped up or directly click the Daily Maintenance button on the toolbar to enter the Daily Maintenance interface. Select the Maintain tab to enter the following interface. You can execute the following maintenance operations: Blockage removal of aperture Burning of aperture Back-flushing of aperture Fluidics Soak in Cleanser DIFF Bath Soak in Concentrated Cleanser WBC/RBC Bath Soak in Concentrated Cleanser Fluidics Soak in Concentrated Cleanser DIFF Bath Soak in Concentrated Cleanser If abnormal measurement values are caused in the DIFF channel, which is not improved after other maintenance operations, the DIFF Bath Soak in Concentrated Cleanser maintenance function can be performed. The steps of DIFF Bath Soak in Concentrated Cleanser are as follows: 1. Click the DIFF Bath Soak in Concentrated Cleanser button to pop up the dialogue box for prompting you to confirm soaking. 98

100 2. Click the OK button. The sample compartment door will open automatically, and the dialogue box for prompting you to put the test tube containing concentrated cleanser into the sample compartment will be popped up. 3. Close the compartment door manually and press the Aspirate Key on the front shell of the analyzer to pop up the following prompt box and begin soak preparation. 4. When the preparation is finished, a countdown dialog box shown below will be popped up, and the soaking process will begin. 5. The soaking time is 5 minutes, during which, the soaking can t be terminated. 6. When the soaking is ended, cleaning will be performed. 7. When the cleaning is finished, the following dialogue box will be popped up. 8. Click the OK button to close the dialogue box. 9. When necessary, repeat the DIFF Bath Soak in Concentrated Cleanser operation by following the above steps. 99

101 WBC and RBC Bath Soak in Concentrated Cleanser If abnormal measurement values are caused by the blockage of the aperture, which is not improved after other maintenance operations, the WBC and RBC Bath Soak in Concentrated Cleanser maintenance function can be performed. The steps of WBC/RBC Bath Soak in Concentrated Cleanser are as follows: 1. Click the WBC/RBC Bath Soak button to pop up the dialogue box for prompting you to confirm soak. 2. Click the OK button. The sample compartment door will open automatically, and the dialogue box for prompting you to put the test tube containing concentrated cleanser into the sample compartment will be popped up. 3. Close the compartment door manually and press the Aspirate Key on the front shell of the analyzer to pop up the following prompt box and begin soak preparation. 4. When the preparation is finished, a countdown dialog box shown below will be popped up, and the soaking process will begin. 5. The soaking time is 5 minutes, during which, the soaking can t be terminated. 6. When the soaking is ended, cleaning will be performed. 100

102 7. When the cleaning is finished, the following dialogue box will be popped up. 8. Click the OK button to close the dialogue box. 9. When necessary, repeat the WBC/RBC Bath Soak operation by following the above steps Fluidics Soak in Cleanser The steps of Soaking in Cleanser are as follows: 1. Click the Cleanser Soak button to pop up the dialogue box for prompting you to confirm soaking. 2. Click the OK button to begin to clean pipeline and baths. 3. The preparation for soaking in cleanser will begin. 4. When the preparation is finished, a countdown dialog box shown below will be popped up, and the soaking process will begin. 5. The soaking time is 10 minutes. You can end the soaking early by clicking the Terminate button. When the soaking is ended, cleaning will be performed. 101

103 6. When the cleaning is finished, the following dialogue box will be popped up 7. Click the OK button to close the dialogue box. 8. When necessary, repeat the Cleanser Soak operation by following the above steps Fluidics Soak in Concentrated Cleanser The steps of Fluidics Soak in Concentrated Cleanser are as follows: 1. Click the Fluidics Conc. Cleanser Soak button to pop up the dialogue box for prompting you to confirm soaking. 2. Click the OK button. The sample compartment door will open automatically, and the dialogue box for prompting you to put the test tube containing concentrated cleanser into the sample compartment will be popped up. 3. Close the compartment door manually and press the Aspirate Key on the front shell of the analyzer to pop up the following prompt box and begin the preparation for the first soaking. 4. When the preparation is finished, the prompt box prompting you to aspirate concentrated cleanser will be popped up again, and the liquid aspiration will be performed again. 102

104 5. Press the Aspirate Key on the analyzer to pop up the following prompt box and begin the preparation for the second soaking. 6. When the preparation is finished, a countdown dialog box shown below will be popped up, and the soaking process will begin. 7. The soaking time is 5 minutes, during which, the soaking can t be terminated. 8. When the soaking is ended, assy reset will be performed. 9. When the initialization is finished, cleaning will be performed. 10. When the cleaning is finished, the Finish dialogue box will be popped up. 11. Click the OK button to close the dialogue box. 12. When necessary, repeat the Fluidics Soak in Concentrated Cleanser by following the above steps Fluidics Maintenance Click the Service button on the main menu interface and select Daily Maintenance on the menu popped up or directly click the Daily Maintenance button on the toolbar to enter the 103

105 Daily Maintenance interface. Select the Fluidics Maintenance tab to enter the following interface. You can execute the following functions: Empty WBC bath Empty RBC bath Empty DIFF bath Empty Fluidics Empty Flowcell Analyzer Initialization Pack (before containerization and transport) Prime Empty WBC bath To replace the components corresponding to the WBC bath, execute the Empty WBC bath function first Empty RBC bath To replace the components corresponding to the RBC bath, execute the Empty RBC bath function first Empty DIFF bath To replace the components corresponding to the DIFF bath, execute the Empty DIFF bath function first. 104

106 Empty Fluidics Before short-distance transport of the analyzer (transport time < 2 hours), the Empty Fluidics operation should be executed Empty Flowcell To replace the components corresponding to the flow cell, execute the Empty Flowcell function first Pack The analyzer needs packing upon drain before it is let sit out of service for a period of time (more than 1 week) or before long-distance transport (transport time > 2 hours). The steps of packing are as follows: 1. Click the Pack button to pop up the following prompt dialogue box. 2. Loosen the bottleneck joint of the reagent bottle according to the prompt. Click the OK button to begin the Drain function, and the following prompt will be popped up. 3. When the drain is finished, the following prompt dialogue box will be popped up. 4. Put the tube into the distilled water container according to the prompt. Click the OK button to begin the distilled water perfusion, and the following dialogue box will be 105

107 popped up. 5. When the distilled water perfusion is finished, the following prompt dialogue box will be popped up. 6. When cleaning is finished, the following prompt dialogue box will be popped up. 7. Take the tube out of the distilled water container according to the prompt. Click the OK button to execute the Drain function again, and the following promptwill be popped up. 8. When the drain is finished, the following dialogue box will be popped up to prompt that the packing has been finished. 106

108 9. Click the OK button to turn off the analysis software. Power off the analyzer Initialize You should execute analyzer initialization in the following cases: Any main component is replaced, or the fluidics system of the analyzer is repaired. Any error occurs. There is a prompt of device run-time error Prime To replace all reagents at a time, the Prime function can be executed Sleep Automatic Sleep If the analyzer is let sit without fluidics operation for 30 minutes (default), it will enter the sleep mode automatically. During the sleep, sample analysis is impossible. You can set the time before the analyzer enters the sleep mode automatically. On the System Setup interface, select Maintenance. Fill in the time (range: minutes) in the Automatic Sleep Latency filed. Caution: (1) When there is any fluidics action, the analyzer can t enter the sleep mode automatically. (2) When any operation relating to the analyzer is required, exit the sleep mode first. During the sleep, actions unrelated to the analyzer, such as communication, printing, etc., are not impacted. During the sleep, click a button for a fluidics function, and the following prompt box will be popped up Exit Sleep Depending on the duration of sleep of the analyzer, different degrees of tube cleaning (for different lengths of maintenance time) will be executed automatically when you exit the sleep mode. You can exit the sleep mode by pressing the Aspirate key on the front panel of the analyzer: 107

109 After you have exited the sleep mode, the above prompt box will close automatically, and the analyzer will exit the sleep mode Data Maintenance The Data Maintenance module provides data export, data recovery, data clear, etc. The interface is shown in the figure below: System Data: Backup and recovery of database and graph data of samples. Config Parameters: Parameters relating to performance and the analyzer, such as gain, calibration coefficient, mechanical parameter setup, etc. Data Clear: Historic data of samples, Quality Control results, and log data can be cleared here. Conventional Sample Data Import: Results of sample analysis can be imported to the current database from another one Logs Select the Logs menu to enter the following interface. You can view calibration records, parameter modification, error information, daily maintenance, and other log information relating to the operations of the analyzer. 108

110 Print: Prints the current log record. Export: Exports the log record to a.txt file for viewing System Status System Status displays the environment temperature of the analyzer and the heating temperature of the DIFF bath. Reagent can be used to view the current remaining reagent and the estimated remaining number of times of analysis Version Information Select the Version Information menu to enter the following interface, where you can view the version of the configuration. 109

111 12.7 Statistical Information Select the Statistical Information menu to enter the following interface. You can view the number of sample tests, number of Quality Controls, and number of calibrations. Click the Detail... button after Sample count times, and the interface will display the detailed statistical result of the number of sample tests. 110

112 Click the Detail... button after QC Times, and the interface will display the detailed statistical result of the number of Quality Controls. Click the Detail... button after Calibration Times, and the interface will display the detailed statistical result of the number of calibrations. Probe piercing times records the number of tests of sample analysis, Quality Control and calibration in the Whole Blood mode and records how the sampling probe is used Mechanical Check Click the Service button on the main menu interface and select Mechanical Check from the menu pooped up to open the following dialogue box. 111

113 1. You can test various parts and components. Click the button corresponding to the item to begin self-tests and observes whether the corresponding parts and components move. 2. Valve Self-test. Select the number of the valve to be tested, such as valve 1. Click the Check button to test the condition of valve 1. Judge whether the valve works normally according to whether the valve has opening/closing sounds. 3. If All is selected, when you click the Check button, all valves will be tested in the ascending order of valve numbers Prompt of Sampling Probe Replacement When the number of piercing of a sampling probe reaches or exceeds 40000, the system will prompt replacement of sampling probe. Operate according to the prompt and click the OK button to close the prompt dialogue box. Caution: (1) When the criteria of automatic prompt of sampling probe replacement are met, if the analyzer is in the running status, the prompt won t be given before the current operation is finished. (2) When the prompt of sampling probe replacement is popped up, if the sampling probe is not replaced, the system will give prompt again whenever 100 sample tests have been executed. 112

114 12.10 Fuse Replacement If there is no power supplied to the analyzer and the analyzer can t be powered on, fuse burn-out may be one of the causes. Check whether the fuse is in good condition. To replace the fuse, refer to the following figure and screw off the fuse holder indicated by the arrow with a straight screwdriver to replace the fuse. 113

115 Chapter 13 Troubleshooting In case of error of the analyzer, the status bar of the analysis software will give text prompt, and the background color of the status bar will change. The background color for general errors is yellow; for severe errors, red. If the buzzer is not set to Off in System Setup, the buzzer will also give out alarm sound. Click the red exclamation mark icon appearing on the text status bar or status bar to open the following dialogue box, where you can view and clear the error. The table below lists the common errors of the analyzer and their solutions. If the error can t be cleared according to the tips in this chapter or more detailed information is required, please contact our Customer Service Department. Error 1)The analyzer can t be started. 2) The analyzer is powered off automatically. Solution 1. Check whether the analyzer is powered on. 2. Check whether the power plug has got loose. 3. Check the voltage. 4. If the error still exists,please contact our customer service department. 1. Check whether the power supply of the analyzer is powered on. 2. Check whether the electric cable has got loose. 3. Power off the fuse in the analyzer, turn off the power supply, and restart the analyzer. 4. If the error still exists,please contact our customer service department. 3) Pressure abnormal. 1. Click the "Remove error" button to execute assy initialization. 2. If the error still exists,please contact our customer service department. 4)Diluent syringe action 1. Click the Remove error button to execute assy initialization. abnormal. 2. If the error still exists,please contact our customer service department. 5)Sample syringe action 1. Click the Remove error button to execute assy initialization. 114