Mindray BC-2800 Operation Manual

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Brand: Mindray
Category: Measuring Instruments
Model: BC-2800
File Type: PDF
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Pages: 91

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BC-2800 BC-2800  A  Auutto o Hem Hemat atoollooggy A y Annal alyyzer zer Operation Manual Operation Manual

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,

Y BIO-MEDICAL ELECTRONICS CO., LT LTD. (hereinafter D. (hereinafter called Mindray) called Mindray) owns all rights to this unpublished work and intends to maintain this work as confidential. owns all rights to this unpublished work and intends to maintain this work as confidential. Mindray may also seek to maintain this work as an unpublished copyright. This publication is Mindray may also seek to maintain this work as an unpublished copyright. This publication is to be used solely for the purposes of reference, operation, maintenance, or repair of Mindray to be used solely for the purposes of reference, operation, maintenance, or repair of Mindray equipment. No part of this can be disseminated for other purposes. equipment. No part of this can be disseminated for other purposes. In the event of inadvertent or deliberate publication, Mindray intends to enforce its rights to In the event of inadvertent or deliberate publication, Mindray intends to enforce its rights to this work under copyright laws as a published work. Those having access to this work may this work under copyright laws as a published work. Those having access to this work may not copy, use, or disclose the information in this work unless expressly authorized by Mindray not copy, use, or disclose the information in this work unless expressly authorized by Mindray to do so. to do so.  All  All information information contained contained in in this this publication publication is is believed believed to to be be correct. correct. Mindray Mindray shall shall not not be be liable for errors contained herein nor for incidental or consequential damages in connection liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this material. This publication may refer to with the furnishing, performance, or use of this material. This publication may refer to information and protected by copyrights or patents and does not convey any license under the information and protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties. out of any infringements of patents or other rights of third parties. Content of this manual is subject to changes without prior notice. Content of this manual is subject to changes without prior notice. PROPERTY OF SHENZHEN MINDR PROPERTY OF SHENZHEN MINDRAY BIO-MEDICAL AY BIO-MEDICAL ELECTRONICS CO., LTD. ELECTRONICS CO., LTD.  AL  ALL RIGHTS RESERVE L RIGHTS RESERVEDD Re Respons sponsibilit ibility on the manufacturer pa y on the manufacturer party rty Mindray is responsible for safety, reliability and performance of this equipment only in the Mindray is responsible for safety, reliability and performance of this equipment only in the condition that: condition that: • all installation, expansion, change, modification and repair of this equipment are conducted all installation, expansion, change, modification and repair of this equipment are conducted by Mindray qualified personnel; by Mindray qualified personnel; • applied electrical appliance is in compliance with relevant National Standards; applied electrical appliance is in compliance with relevant National Standards;

This equipment is not intended for family usage.

This equipment is not intended for family usage. This equipment must be operated by skilled/trained clinical personnel. This equipment must be operated by skilled/trained clinical personnel. Warning Warning It is important for the hospital or organization that employs this equipment to carry out a It is important for the hospital or organization that employs this equipment to carry out a reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury reasonable maintenance schedule. Neglect of this may result in machine breakdown or injury of human health. of human health. Warranty Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANT ABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE. FITNESS FOR ANY PARTICULAR PURPOSE. Exemptions Exemptions Mindray's obligation or liability under this warranty does not include any transportation or Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or the improper use or application of the product or the substitution upon it of parts or accessories not approved by Mindray or repaired by anyone other than a Mindray authorized accessories not approved by Mindray or repaired by anyone other than a Mindray authorized representative. representative. This warranty shall not extend to any instrument which has been subjected to misuse, This warranty shall not extend to any instrument which has been subjected to misuse, negligence or accident; any instrument from which Mindray's original serial number tag or negligence or accident; any instrument from which Mindray's original serial number tag or product identification markings have been altered or removed, or any product of any other product identification markings have been altered or removed, or any product of any other manufacturer. manufacturer. RReetur turn n PPoli olicy cy Re Return turn Procedure Procedure In the event that it becomes necessary to return a unit to Mindray, the following procedure In the event that it becomes necessary to return a unit to Mindray, the following procedure should be followed: should be followed: 1. 1. Obtain return Obtain return authorization. Contact authorization. Contact the Mindray the Mindray Service Department Service Department and obtain and obtain aa Customer Service Authorization (Mindray) number. The Mindray number must appear on Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Return shipments will not be accepted if the the outside of the shipping container. Return shipments will not be accepted if the Mindray number is not clearly visible. Please provide the model number, serial number, Mindray number is not clearly visible. Please provide the model number, serial number,

and a brief description of the reason for return.

2. Freight policy. The customer is responsible for freight charges when equipment is shipped to Mindray for service (this includes customs charges). Company Contact  Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R.China Free hot line:+86 800 830 3312 Phone: +86 755 26582888 Fax: +86 755 26582680

Biohazard:  Consider all materials

(specimens, controls, calibrators, or components that contain or have contacted human blood) as being potentially infectious. Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. Probe Hazard: The probe is sharp and may contain biohazardous materials, including controls and calibrators. Avoid any unnecessary contact with the probe and  probe area. NOTE: Indicate to the operator information of importance in the  procedure to be performed. This heading is also used to indicate specific sample handling techniques that are helpful in operating the instrument. CAUTION: Indicate to the operator information of importance that could result in damage to the instrument or affect the test due to improper operation if these instructions are not followed. WARNING: Indicate to the operator information regarding potential hazards that may cause personal harm to the operator if these instructions are not followed.

1.3 System Introduction

1.3.1 Name and Intended Use The full name of this analyzer is BC-2800 Auto Hematology Analyzer. It is a quantitative, automated hematology analyzer and leukocyte differential counter for In Vitro Diagnostic Use in clinical laboratories. It determines the following 19 hematological parameters and presents 3 histograms of blood specimens. Table 1-2 Parameters and histograms Group Parameter Abbreviation White Blood Cell or leukocyte WBC Lymphocyte Lymph# Mid-sized cell Mid# Granulocyte Gran# Lymphocyte percentage Lymph% Mid-sized cell percentage Mid% Granulocyte percentage Gran% WBC Group WBC histogram HGB Group Hemoglobin Concentration HGB Hemoglobin Concentration RBC Hematocrit HCT Mean Corpuscular (erythrocyte) Volume MCV Mean Cell (erythrocyte) Hemoglobin MCH Mean Cell (erythrocyte) Hemoglobin Concentration MCHC RBC Group Red Blood Cell (erythrocyte) Distribution Width Coefficient of Variation RDW-CV Note The purpose of this analyzer is to identify the normal patient, with all normal system-generated parameters, and to flag or identify patient results that require additional studies.

Mean Platelet Volume

MPV Platelet Distribution Width PDW Plateletcrit PCT PLT Group PLT histogram 1.3.2 Classifications CE: General In vitro diagnostic medical devices 1.3.3 Supplementary Data Mindray aperiodically issues and delivers supplementary documents pertaining to operation or maintenance of this instrument. Be sure to read and observe these documents carefully and precisely as well as insert them into this manual for convenient reference 1.3.4 Service Assistance If this analyzer does not operate properly, follow the directions in Chapter 9, Troubleshooting. If the error cannot be corrected by the recommended methods, contact the Mindray Customer Service Department or the distributor 1.3.5 Reagents, Calibrators and Controls The reagents, controls, calibrators, and analyzer are components of a whole system and must be used as one. Be sure that any products to be used have been tested and certified by the manufacturer. Mindray recommends the reagents described in Chapter 1.5.10 Reagents. Do not use the reagents or controls from different suppliers, or else the analyzer may not perform as promised and even be damaged. Each reagent should be examined prior to its application. Product integrity may be compromised in damaged containers. If a package appears damaged, inspect the inside for signs of leakage or moisture and find them, do not use the reagent. Read the user’s instructions of the reagents and operate as instructed when using the reagents. Unless otherwise specified, reagents must be stored and used at room temperature.

Besides diluting the blood sample, the diluent provides an environment similar to blood plasma

to keep the sizes of blood cells unchanged within a certain period of time and serves as a conductive media for blood cells analysis. 2. Lyse The lyse can rapidly break down the red blood cell membranes and reduce cellular debris to a size small enough so that it does not interfere with white blood cell analysis. White cells can then be segregated into three sub-populations for differential analysis.The absorbency of the lyse-hemoglobin mixture is determined by the hemoglobin. 3. Rinse The rinse is a detergent used to wash the tubing and wet the volumetric tube. 4. E-Z Cleanser The Enzymatic Cleanser is an enzyme based, isotonic cleaning solution and wetting agent used to rinse the tubing and bath. This cleanser will not damage the plastic parts of the analyzer. 5. Probe Cleanser The probe cleanser is used to maintain the analyzer. 1.3.5.2 Calibrators and Controls Calibrators and controls are whole blood products manufactured to calibrate and verify the operation of instruments. The “calibrators” and “controls” that appear in the rest of this manual refer to the calibrators and controls to be used on this analyze only. You shall order them only from Mindray customer service department or the distributor. Note To properly and safely use the reagents, be sure to read the tags on the package and the supplied data sheet.

1.4 Principles of

Principles of Ope Operation ration 1.4.1 1.4.1 Me Measuring Prin asuring Principl ciplee This analyzer adopts the Coulter Principle to count WBC, RBC and PLT cells and to draw their This analyzer adopts the Coulter Principle to count WBC, RBC and PLT cells and to draw their corresponding histograms. The Hemoglobin concentration (HGB) is obtained by the corresponding histograms. The Hemoglobin concentration (HGB) is obtained by the colorimetric method. The result of the rest parameters are derived from those (see colorimetric method. The result of the rest parameters are derived from those (see Chapter Chapter 1.4 1.4.4, De .4, Derivati rivation on of of Para Parameters meters).). 1.4.2 1.4.2 Dilution Dilution Usually in blood specimens, the cells Usually in blood specimens, the cells are too close to are too close to each other to be identified or measured. each other to be identified or measured. For this reason, the diluent is For this reason, the diluent is used to separate the cells so used to separate the cells so that they are drawn through the that they are drawn through the aperture one at a time as aperture one at a time as well as to well as to create a conductive environment for blood analysis. This create a conductive environment for blood analysis. This analyzer can processes two types of analyzer can processes two types of blood samples – whole blood samples (see blood samples – whole blood samples (see Chapter Chapter 2.5 2.5.1 Prep .1 Preparing aring Whole Bl Whole Blood ood Samples Samples) and prediluted blood samples (see ) and prediluted blood samples (see Chapt Chapter 2.5.2 er 2.5.2 Prepa Preparing ring Prediluted Samples Prediluted Samples ). When analyzing a whole blood sample, this ). When analyzing a whole blood sample, this analyzer analyzer aspirates 13 aspirates 13 L of the sample and follow the procedure presented in Figure 1-1 to dilute it L of the sample and follow the procedure presented in Figure 1-1 to dilute it before proceeding to the actual analysis. before proceeding to the actual analysis. Figure 1-1 How a whole blood sample is Figure 1-1 How a whole blood sample is diluted diluted

When analyzing a prediluted sample, the operator should first collect 20

When analyzing a prediluted sample, the operator should first collect 20  L capillary specimen L capillary specimen and dispense 1.6mL diluent from this analyzer to predilute the specimen. Then the operator and dispense 1.6mL diluent from this analyzer to predilute the specimen. Then the operator should present the prediluted sample to the analyzer, which will aspirate 0.7ml of the sample should present the prediluted sample to the analyzer, which will aspirate 0.7ml of the sample for further dilution, as Figure 1-2 shows. for further dilution, as Figure 1-2 shows. Figure 1-2 How a prediluted sample is diluted Figure 1-2 How a prediluted sample is diluted  After  After reacting with reacting with the the diluent diluent and and lyse, lyse, the the cells cells mainly mainly fall fall into into the the following following three three volume volume ranges: ranges: WBC: 30 WBC: 30 350 fL 350 fL RBC: 25 RBC: 25 250 fL 250 fL PLT: 2 PLT: 2 30 fL 30 fL 1.4.3 1.4.3 Contro Control of Sample V l of Sample Volum olumee This analyzer employs an This analyzer employs an optical volumetric metering system to optical volumetric metering system to determine the sample volume determine the sample volume aspirated through the apertur aspirated through the aperture. Each count cycle, e. Each count cycle, as shown in Figure 1-3, s as shown in Figure 1-3, starts when the tarts when the liquid surface passes the upper sensor of the volumetric t liquid surface passes the upper sensor of the volumetric tube and ends till the ube and ends till the lower sensor is lower sensor is reached. If bubbles or an abnormal flow rate is detected, the system will alarm the operator for reached. If bubbles or an abnormal flow rate is detected, the system will alarm the operator for errors. When this happens, see Chapter 9 errors. When this happens, see Chapter 9 Troubleshooting Troubleshooting for the solutions. for the solutions.

e ffaalll l ddoowwn

n tthhrroouuggh h tthhee volumeritc tube volumeritc tube 3 3 Counting start Counting start when the when the liquid surface pass the upper liquid surface pass the upper sensor. sensor. 4 4 Counting end when Counting end when the liquid the liquid surface pass the lower sensor surface pass the lower sensor Lower sensor Lower sensor Upper sensor Upper sensor Lower sensor Lower sensor Upper sensor Upper sensor Lower sensor Lower sensor Upper sensor Upper sensor Figure 1-3 Figure 1-3 How sample volume is controlled How sample volume is controlled 1.4.4 Derivation of Parameters 1.4.4 Derivation of Parameters 1.4.4.1 1.4.4.1 WBC WBC WBC WBC(10 (1099/ L) is the number of leukocytes measured directly by counting the white blood cells / L) is the number of leukocytes measured directly by counting the white blood cells passing through the aperture. Note that when you observe in the microscope NRBCs passing through the aperture. Note that when you observe in the microscope NRBCs (nucleated red blood cells), which do not react with the lyse and can be mistaken by the (nucleated red blood cells), which do not react with the lyse and can be mistaken by the analyzer for white cells, be sure to correct the system-generated result by the following analyzer for white cells, be sure to correct the system-generated result by the following formula, formula, where WBC represents the system-generated white cell number, NRBC the number of NRBCs where WBC represents the system-generated white cell number, NRBC the number of NRBCs counted in 100 white cells and counted in 100 white cells and WBC WBC′ ′  the corrected white cell number.  the corrected white cell number. 1.4.4.2 1.4.4.2 WBC WBC differential differential With the help of the diluent and lyse, this analyze can size the white cells into three With the help of the diluent and lyse, this analyze can size the white cells into three sub-popul sub-populations - lymphocytes, ations - lymphocytes, mid-sized cells, and granulocytes. mid-sized cells, and granulocytes. Lymphocytes are the largest white cells whose sizes are 30fL Lymphocytes are the largest white cells whose sizes are 30fL 85fL. Granulocytes are the 85fL. Granulocytes are the smallest white cells whose sizes are above 125fL. Between them are the mid-sized cells smallest white cells whose sizes are above 125fL. Between them are the mid-sized cells whose sizes are 85fL whose sizes are 85fL 125fL. 125fL.  NRBC  NRBC WBC WBC WBC WBC     100 100 100 100 '' ××

Based on the WBC histogram, this analyzer calculates Lymph

Based on the WBC histogram, this analyzer calculates Lymph , Mid , Mid   and Gran   and Gran  as as follows, follows, where PL where PL  particles in the particles in the lymphocyte region lymphocyte region 10 // L 10 99 )) PM PM  particles in the mid size particles in the mid size region region 10 // L 10 99 )) PG PG  particles in the particles in the granulocyte region granulocyte region 10 // L 10 99 ).). Having achieved the three parameters above, this analyzer proceeds to calculate the Lymph# , Having achieved the three parameters above, this analyzer proceeds to calculate the Lymph# , Mid# and Gran# as follows. Mid# and Gran# as follows. 1.4.4.3 1.4.4.3 HGB HGB Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as Using the colorimetric method, this analyzer calculates hemoglobin concentration (g/L) as follows. follows. HGB(g/L)=Constant× HGB(g/L)=Constant×Log Log 10 10 (Blank (Blank Photocurre Photocurrent/Sample nt/Sample Photocurren Photocurrent)t) 1.4.4.4 1.4.4.4 RBC RBC RBC (10 RBC (1012 12/L)is the number of erythrocytes measured directly by counting the erythrocytes /L)is the number of erythrocytes measured directly by counting the erythrocytes passing through the aperture. passing through the aperture. 1.4.4.5 1.4.4.5 MCV MCV Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and Based on the RBC histogram, this analyzer calculates the mean cell volume (MCV) and expresses the result in fL . expresses the result in fL . ( ( )) 100 100 (%) % (%) % ×× ++ ++ == PG PG PM PM PL PL PL PL  Lymph  Lymph ( ( )) 100 100 (%) % (%) % ×× ++ ++ == PG PG PM PM PL PL PM PM  Mid  Mid ( ( )) 100 100 (%) % (%) % ×× ++ ++ == PG PG PM PM PL PL PG PG Gran Gran 100 100 )) 10 // ((10 %(%) %(%) )) 10 // ((10 ## 99 99 L WBC WBC  Lymph  Lymph  L  L  Lymph  Lymph ×× == 100 100 )) 10 // ((10 %(%) %(%) )) 10 // ((10 ## 99 99 L WBC WBC  Mid  Mid  L  L  Mid  Mid ×× == 100 100 )) 10 // ((10 %(%) %(%) )) 10 // ((10 ## 99 99 L WBC WBC Gran Gran  L  L Gran Gran ×× ==

HCT, MCH and MCHC

This analyzer calculates the HCT (%), MCH(pg) and MCHC(g/L) as follows: 1.4.4.7 RDW-CV Based the WBC histogram, this analyzer calculates the CV (Coefficient of Variation) of the erythrocyte distribution width. 1.4.4.8 RDW-SD RDW-SD (RBC Distribution Width – Standard Deviation, fL) is set on the 20% frequency level with the peak taken as 100%, as Figure 1-4 shows. Figure 1-4 RBC Distribution Width – Standard Deviation 1.4.4.9 PLT PLT (109/L) is measured directly by counting the platelets passing through the aperture. 1.4.4.10 MPV Based on the PLT histogram, this analyzer calculates the mean platelet volume (MPV, fL). 1.4.4.11 PDW Based on the PLT histogram, this analyzer calculates the platelet distribution width (PDW). 1.4.4.12 PCT This analyzer calculates the PCT as follows. 10 ) ( ) / (10 (%) 12  MCV   fL  L  RBC  HCT × = 10000 ) ( ) (10 / (%) 9  MPV   fL  L PLT PCT × = ) / 10 ( ) / ( ) ( 12  L  RBC  HGB g  L  MCH   pg = 100 (%) HCT HGB(g / L) MCHC(g/ L) × =

Table 1-3 Directly measured parameters and histograms

Parameter Abbreviation Default Unit White Blood Cell or leukocyte WBC 109/L Hemoglobin Concentration HGB g/L Red Blood Cell or erythrocyte RBC 1012/L Platelet PLT 109/L WBC histogram RBC histogram PLT histogram Table 1-4 Parameters derived from histograms Parameter Abbreviation Default Unit Lymphocyte percentage Lymph% % Mid-sized cell percentage Mid% % Granulocyte percentage Gran% % Mean Corpuscular (erythrocyte) Volume MCV fL Red Blood Cell (erythrocyte) Distribution Width Coefficient of Variation RDW-CV % Red Blood Cell (erythrocyte) Distribution Width Standard Deviation RDW-SD fL Mean Platelet Volume MPV fL Platelet Distribution Width PDW Table 1-5 Calculated parameters Parameter Abbreviation Default Unit Lymphocyte Lymph# 109/L Mid-sized cell Mid# 109/L Granulocyte Gran# 109/L Hematocrit HCT %

e and Hum

Humiidi dity ty  Ambient  Ambient TTemperatu emperature:15 re:15  30 30 (When overheated, the system will give an alarm without (When overheated, the system will give an alarm without stopping running) stopping running) Relative humidity: 30% Relative humidity: 30% 85% 85%  Atmospheric p  Atmospheric pressure: 60.0kP ressure: 60.0kPaa 106.0kPa. 106.0kPa. 1.5.13 Transportation and storage environment 1.5.13 Transportation and storage environment  Ambient temp  Ambient temperature: erature: -10 -10  40 40  Relative Relative humidity: humidity: 10% 10% 93% 93%   Atmospheric p  Atmospheric pressure: ressure: 50.0kPa 50.0kPa 106.0kPa. 106.0kPa. 1.5.14 1.5.14 Dimension Dimension Width Width Height Height Thickness Thickness 32.2cm 43.7cm 39.7cm 32.2cm 43.7cm 39.7cm 1.5.15 1.5.15 Weight Weight Net Weight Net Weight  17.9KG 17.9KG Gross Weight Gross Weight  25.2 25.2 KG KG

1.6 System O

System Operation peration 1.6.1 1.6.1 Ma Main in Unit Unit Figure 1-5 Front view Figure 1-5 Front view 1 ---- LCD 1 ---- LCD 2 ---- Keypad 2 ---- Keypad 3 ---- Recorder 3 ---- Recorder 4 ---- Power Indicator 4 ---- Power Indicator 5 ---- [START] key 5 ---- [START] key 6 ---- Sample Probe 6 ---- Sample Probe

1 --- Power switch

1 --- Power switch 2 --- 2 --- Equipotentiality Equipotentiality 3 --- Waste Outlet (Red) 3 --- Waste Outlet (Red) 4 --- Lyse Inlet (Orange) 4 --- Lyse Inlet (Orange) 5 --- Rinse Inlet 5 --- Rinse Inlet (Blue) (Blue) 6 --- Diluent Inlet 6 --- Diluent Inlet (Green) (Green)

Figure 1-7 Left view

Figure 1-7 Left view 1 --- RS232 Port1 (for 1 --- RS232 Port1 (for the scanner) the scanner) 2 --- Parallel (also for the 2 --- Parallel (also for the floppy disk drive) floppy disk drive) 3 --- RS232 Port 2(for 3 --- RS232 Port 2(for the computer) the computer) 4 --- Power Interface of Floppy Disk Drive 4 --- Power Interface of Floppy Disk Drive 5 --- Keyboard Interface 5 --- Keyboard Interface

Figure 1-8 Display areas

Title area Displays the screen title, such as Count or Review. Count Mode areaDisplays current count mode. Six count modes are available. Whole Blood - All Parameter Prediluted - All Parameter Whole Blood - WBC/HGB Prediluted - WBC/HGB Whole Blood - RBC/PLT Prediluted - RBC/PLT System Status areaDisplays whether the system is ready for sample analysis. Three modes are available, Ready, Running and Waiting. System Time areaDisplays system. Window area Displays all types of operation information. Error Messages AreaDisplays error messages. Reagent StatusDisplays status of the remaining reagents. See chapters 3 and 7 for details. On-Line HelpDisplays help information.)

The input devices includes a [START] key, 18-key keypad and PS/2 keyboard(optional).

The [START] key is located behind the sample probe. The keypad consists of 18 keys, as Figure 1-9 shows. Figure 1-9 Keypad  A PS/2 keyboard can be connected to the PS/2 interface of this analyzer and it is useful when you have to edit complicated information. See   for the major functions of the keys.   Key functions Keypad Keyboard [START] key Functions [MENU] [Esc] Enters/exits the system menu. [PRINT] [P] or [p] Prints by the recorder or printer. [HELP] [H] or [h] Displays help information. [DEL] [Del] or [Delete] Deletes data or task. [DILUENT] Enters the Add diluent screen. [MODE] [Ctrl + A] Switches to another analysis mode (works only in the Count screen). [ENTER] [Enter] Confirms a certain operation. [PgUp] and [PgDn] [PgUp] or [PgDn] Switches to another screen; enters digits. [↑] [↓] [↑] [↓] Moves the cursor to a certain Note If your analyzer is not equipped with a PS/2 keyboard, you will not be able to use the functions controlled by the keyboard only.

[F1] [F2] [F3] [F4]

[F5] [F1] [F2] [F3] [F4] [F5] Function keys. Other keys Other functions. [START] Starts aspiration. 1.6.4 Screen Saver To extend the service life of the LCD, this analyzer will enter the screen saver if no any operation was done in the past 10 minutes. When it happens, the LCD will be dark and the power indicator will be flickering. You can press any key to resume the display.

1.6.5 System Menu

See Figure 1-10 for the structure of the system menu.                          Figure 1-10 System menu

1.7 Operation Summary

The BC-2800 can analyze two types of blood specimens – whole blood samples and prediluted blood samples. See Table 1-7. Table 1-7 Operation summary Do preliminary checks (reagent and waste containers, tubing connections, power connections and the like) Turn on the analyzer power The system begins self-test and does the startup procedure and then enters the Count screen(if every thing is normal). Select appropriate count mode and prepare the samples to be analyzed. Present the sample to the sample probe and press the [START] key for aspiration. The system will automatically analyzes the sample and displays the results. Edit patient information(optional) Print out analysis result Do the shutdown procedure. Turn off the power.

Chapter 2 Installation

2.1 Unpacking When you receive this analyzer, carefully unpack and check it. File a claim immediately with the shipping carrier if you find any physical damage. Compare the delivered goods against the packing list to ensure that the shipment is complete. If the shipment appears incomplete, notify Mindray Customer Service Department or your distributor immediately.

2.2 Installation Requirements

2.2.1 Installation Environment The environment should be as free as possible from dust, mechanical vibrations, loud noises and electrical interference. Avoid proximity to brush-type motors, flickering fluorescent lights and electrical contacts that regularly turn on and off. Avoid placing this analyzer in direct sun or in front of a source of heat or draft. Operating this analyzer in ways other than those specified by this manual may damage it and leads to wrong analysis result. 2.2.2 Space Requirement Be sure to place this analyzer on a table with enough space for the reagent containers. 2.2.3 Power Requirements This analyzer requires a properly grounded socket supplying AC 220V  15%(or 110V 15%). The power frequency should be 50/60 1Hz, the maximum power consumption 180VA, fuse 250V 2A or 125V 4A. If possible, connect this analyzer to a dedicated ground line. Note that it is imperative that this analyzer be grounded. Be sure to connect the Equipotentiality at the back of the analyzer to a dedicated ground line. Note Be sure to keep the reagent at the same height as the analyzer. Note Make sure the input power meets the requirements and an appropriate fuse is installed on it.

Connecting the diluent container

Take out the diluent inlet tubing with a green connector from the accessory kit. Take out the diluent container, in which there should be enough diluent. Insert the tubing end that has no connector into the diluent container, as Figure 2-1 shows and turn the container cover clockwise until secure. Connect the tubing connector to the DILUENT inlet (green) on the back of BC-2800 and turn it clockwise until secure. Figure 2-1 Diluent container Do the following steps when the installation is done. 1. Enter the diluent volume as instructed by section 7.2.1.1 Setting remaining volumes for reagents. 2. Enter the expiration date as instructed by section 7.2.1.3 Setting expiration dates of reagents. 3. Prime the diluent tubing with diluent as instructed by section 8.1.1 Diluent Prime Biohazard Consider all materials (specimens, reagents, controls, calibrators, or components that contain or have contacted human blood) as being potentially infectious. Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory.

Connecting the rinse container

Take out the rinse inlet tubing with a blue connector from the accessory kit. Take out the rinse container, in which there should be enough rinse. Insert the tubing end that has no connector into the rinse container, as Figure 2-2 shows and turn the container cover clockwise until secure. Connect the tubing connector to the RINSE inlet (blue) on the back of BC-2800 and turn it clockwise until secure. Figure 2-2 Rinse connector Do the following steps when the installation is done. 1. Enter the rinse volume as instructed by section 7.2.1.1 Setting remaining volumes for reagents. 2. Enter the expiration date as instructed by section 7.2.1.3 Setting expiration dates of reagents. 3. Prime the rinse tubing with rinse as instructed by section 8.1.2 Rinse Prime. 2.3.1.3 Connecting the lyse Take out the lyse inlet tubing with an orange connector from the accessory kit Take out the lyse container, in which there should be enough lyse. Insert the tubing end that has no connector into the lyse container, as Figure 2-3 shows, and turn the container cover clockwise until secure. Connect the tubing connector to the LYSE inlet (orange) on the back of BC-2800 and turn it clockwise until secure.

Figure 2-3 Lyse container

Do the following steps when the installation is done. Enter the lyse volume as instructed by section 7.2.1.1 Setting remaining volumes for reagents. Enter the expiration date as instructed by section 7.2.1.3 Setting expiration dates of reagents. Prime the lyse tubing with as instructed by section 8.1.3 Lyse Prime. 2.3.1.4 Connecting the waste container Take out the waste inlet tubing with a red connector from the accessory kit. Connect the tubing connector to the WASTE inlet (red) on the back of the analyzer and turn it clockwise until secure. Place the waste container on a table as high as or lower than the analyzer. Insert the other end of the tubing into the waste container. Enter the volume of the waste container as instructed by section 7.2.1.2 Setting volume of dischargeable waste. 2.3.2 Waste Disposal Biohazard Consider all materials (specimens, reagents, controls, calibrators, or components that contain or have contacted human blood) as being potentially infectious. Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. WARNING Handle and dispose of the waste according to acceptable laboratory, local state and national standards.

2.4 Loading Recording Paper

Follow the steps given below to install the recording paper. 1. Follow the arrow in the figure below to open the door of the recorder, as Figure 2-4 shows. Figure 2-4 Open the recorder door 2. Lift the press bar, as Figure 2-5 shows. Figure 2-5 Lift the press bar 3. Insert recording paper into the paper entry, as Figure 2-6 shows.

4. Push the press bar back and close the recorder door, as Figure 2-7 shows.

Figure 2-7 Close recorder door

3.4 Entering Sample Information

You may enter sample information in any of the three modes, ID only, All info and Batch edit, depending on the configuration of your analyzer. Note that the  All info mode cannot co-exist with the other two modes. 3.4.1 ID Only Mode If your analyzer is configured as ID only, it means you can only enter the sample IDs into this analyzer. Follow either of the ways given below to do so. 1. If you have a barcode scanner connected to your analyzer, you may enter the bar-coded sample ID at the Count screen or the Next sample screen simply by presenting the bar code to the scanner (see the user’s manual of the scanner for more details). The scanner buzzes when the scanning is done. 2. If the bar-code scanner is not available, you may follow the steps given below to enter the sample ID from the keypad or external keyboard.   At the Count  screen, press [F1] to enter the Next sample  screen, as Figure 3-3 shows. Figure 3-3 Entering ID of the next sample  Press [←] or [→] to move the cursor within the edit box right of ID. Press [PgUp] or [PgDn] (or the numeric keys on a keyboard) to enter a digit at the position where the cursor is located.  When you are done entering the sample ID, press [ENTER] to save the changes and the entered number will be displayed in the ID field of the Next sample area of the Count  screen. If you want to ignore the entered number, for any reason, you may

press [MENU] and a dialog box will pop up, as Figure3-4 shows. To ignore the entered

number, move the cursor to No and press [ENTER]; otherwise, move the cursor to Yes and press [ENTER]. Figure3-4 Dialog box 3.4.2  All Info Mode If you analyzer is configured as  All info, it means you can enter all pieces of information regarding the sample (patient name, chart number and the like) into this analyzer. To enter them, press [F1] at the Count  screen to enter the Enter sample information screen, as Figure 3-5 shows. Follow the instructions given below to fill out the listed fields one by one. Note When the ID of the next sample is 0 and you have pushed the [START] key, the system will perform the background check.

Entering sample information

1. To enter the sample ID, you may  A. Press [] or [] to move the cursor to the edit box right of ID, as Figure 3-5 shows. B. Press [] or [] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. To modify an entered digit, you can move the cursor to the corresponding location and re-enter the desired digit. If a bar-code scanner is available, you present the bar code to the scanner and the scanner buzzes when the scanning is done. C. When you are done entering the sample ID, press [] or [] to move the cursor to the next field to be edited. 2. To enter the gender of the patient, you may  A. Press [] or [] to move the cursor to the edit box right of Gender , as Figure3-6 shows. B. Press [ENTER] to display the pull-down menu, as Figure3-6 shows. C. Press [] or [] to select Male for the male patient, or Female for the female patient, or blank for the patient whose sex you are unaware of. D. Press [ENTER] to confirm the selection. E. Press [] or [] to move the cursor to the next field to be edited.

3. To enter the patient name, you may

 A. Press [] or [] to move the cursor the edit box right of Name B. Use a keyboard to enter the patient name. Press [DEL] if you want to delete the character after the cursor. Press [Backspace] (on the external keyboard), if you want to delete the character before the cursor. C. When you are done entering the patient name, press [] or [] to move the cursor to the next field to be edited. 4. To enter the patient age Before entering the patient’s age, you should know that this analyzer provides three ways for you to do so - entering the age in years, in months and in days. The first way is designed for the adult patients or pediatric patients no younger than one-year old; the second is designed for the infant patients older than one month old (including one month) and younger than one year old; the third is designed for the neonatal patients no more than one month old. You can choose only one of the three ways to enter the patient age.  A. To enter the patient age in years, you may a. Press [] or [] to move the cursor to the edit box left of Year . b. Press [←] or [→] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. To modify an entered digit, you can move the cursor to the corresponding location and re-enter the desired digit. Note that you can only enter a positive integer no greater than 255 in this edit box. c. When you are done entering the patient age, press [↑] or [↓] to move the cursor to the next field to be edited.

B. To enter the patient in months, you may

a. Press [↑] or [↓] to move the cursor to the edit box left of Month. b. Press [←] or [→] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. To modify an entered digit, you can move the cursor to the corresponding location and re-enter the desired digit. Note that you can only enter a positive integer no greater than 12 in this edit box. c. When you are done entering the patient age, press [↑] or [↓] to move the cursor to the next field to be edited. C. To enter the patient age in days, you may a. Press [↑] or [↓] to move the cursor to the edit box left of Day. b. Press [←] or [→] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. To modify an entered digit, you can move the cursor to the corresponding location and re-enter the desired digit. Note that you can only enter a positive integer that is no greater than 31 in this edit box. c. When you are done entering the patient age, press [↑] or [↓] to move the cursor to the next field to be edited. 5. To enter the chart number of the patient, you may  A. Press [↑] or [↓] to move the cursor to the edit box right of Chart No.. B. Press [←] or [→] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. If you want to modify an entered digit, just move the cursor to that position and enter the desired digit. C. When you are done entering the chart number, press [↑] or [↓] to move the cursor to the next field to be edited. 6. To enter the bed number of the patient, you may  A. Press [↑] or [↓] to move the cursor to the edit box right of Bed No.. B. Press [←] or [→] to move the cursor within the edit box. Press [PgUp] or [PgDn] (or the numeric keys of a keyboard) to enter a digit at the position where the cursor is located. If you want to modify an entered digit, just move the cursor to that position and enter the desired digit. C. When you are done entering the bed number, press [↑] or [↓] to move the cursor to the

next field to be edited.

7. To enter the name of the department from which the sample came, you may  A. Press [] or [] to move the cursor to the edit box right of Dept. B. Use a keyboard to enter the name of the department (similar to the way you enter patient names). This edit box automatically saves the entered item to its pull-down menu (Figure3-7), which can be accessed by pressing [ENTER]. Totally 30 items can be saved in the pull-down menu, and you may press [↑] or [↓] to move the cursor to the interested item and press [ENTER] to select it. C. When you are done entering the department name, press [↑] or [↓] to move the cursor to the next filed to be edited. Figure3-7 Select department name 8. To enter the name of the person who sent the sample for analysis, you may  A. Press [] or [] to move the cursor the edit box right of Sender. B. Use a keyboard to enter the name of the person who sent this sample. This edit box automatically saves the entered item to its pull-down menu, which can be accessed by pressing [ENTER]. Totally 30 items can be saved in the pull-down menu, and you may press [↑] or [↓] to move the cursor to the interested item and press [ENTER] to select it. C. When you are done entering the name, press [] or [] to move the cursor to the next field to be edited. 9. To enter the name of the person who is to analyze the sample, you may  A. Press [] or [] to move the cursor the edit box right of Tester.

box automatically saves the entered item to its pull-down menu, which can be

accessed by pressing [ENTER]. Totally 30 items can be saved in the pull-down menu, and you may press [↑] or [↓] to move the cursor to the interested item and press [ENTER] to select it. C. When you are done entering the name, press [] or [] to move the cursor to the next field to be edited. 10. To enter the name of the person who is to review the analysis result, you may  A. Press [] or [] to move the cursor the edit box right of Checker . B. Use a keyboard to enter the name of the person who is to review this sample. This edit box automatically saves the entered item to its pull-down menu, which can be accessed by pressing [ENTER]. Totally 30 items can be saved in the pull-down menu, and you may press [↑] or [↓] to move the cursor to the interested item and press [ENTER] to select it. C. When you are done entering the name, press [] or [] to move the cursor to the next field to be edited. 11. When you are done entering the patient information, you may  A. Move the cursor to Yes and press [ENTER] to save the changes and exit to the Count screen, or B. Move the cursor to No and press [ENTER] to exit to the Count screen without saving the changes.

Batch Edit Mode

If your analyzer is configured as Batch edit, you can continuously enter information of a batch of samples. Follow the steps given below to do so. 1. At the Count screen, press [F4] to enter the Batch edit screen, as Figure 3-8 shows. Figure 3-8 Batch edit screen 2. Follow the instructions given in section 3.4.2 All Info Mode to enter the information of the first sample. 3. Press the appropriate arrow keys to move the cursor to Save and press [ENTER] to save the changes. 4. Repeat the last two steps until you are done with the batch. 5. If you want to review the entered information of a specific sample, press the appropriate arrow keys to move the cursor to Prev. or Next and press [ENTER] to review the information of the previous or next sample until the desired sample is reached.  If you want to delete the currently displayed sample information, press the appropriate arrow keys to move the cursor to Delete and press [ENTER] to complete the deletion.  When you are done with the batch, press the appropriate arrow keys to move the cursor to Exit  and press [ENTER] to exit to the Count  screen. After a sample is analyzed, its corresponding sample information will be automatically displayed in the Current sample area.

3.5 Preparing Samples

BC-2800 is capable of analyzing two types of samples - whole blood samples and prediluted samples. 3.5.1 Preparing Whole Blood Samples Mindray recommends BC-2800 be used to analyze the whole blood samples that use K 2EDTA as the anticoagulant. The demanded dose of the anticoagulant is 1.5 ~ 2.2mg/ml blood. 3.5.2 Preparing Prediluted Samples 1. Press [MODE] to select the prediluted mode (any mode preceded by PB). 2. Press [DILUENT] to enter the Add Diluent screen, as Figure 3-9 shows. Figure 3-9  Add Diluent screen Biohazard Consider all materials (specimens, reagents, controls, calibrators, or components that contain or have contacted human blood) as being potentially infectious. Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. Cautions  Avoid direct contact with blood specimens.

3. Present a clean sample cup to the sample probe and press [START] to add 1.6ml diluent

(controlled by the analyzer itself) to the cup. Be sure to incline the cup at the angle shown in Figure 3-10, to force the diluent to flow into the cup against the cup wall so that no bubbles will be produced during the process. Figure 3-10  Adding diluent 4. Remove the sample cup when the sample probe has risen up and press [ENTER] to exit the Add Diluent screen. 5. Collect 20µL capillary blood specimen and immediately add it to the sample cup and shake to mix them. 6. Pay particular attention to the following notes.  A. When you are done mixing the prediluted sample (capillary blood-diluent mixture), be sure to wait for 3 minutes before analyze it. B. When you are done mixing the prediluted sample, be sure to analyze it within 40 minutes if you want to acquire reliable WBC differential results. C. If you are not interested in the differential result, you can analyze the prediluted sample within two hours after it is ready. D. Be sure to prevent dusts from falling into the prepared diluent. Otherwise, you may acquire misleading result. E. The precision of the analysis results of the prediluted samples vary depending on the operators. Mindray recommends every laboratory evaluate the stability of the results based on its sample quantity and collection method.

3.6 Sample Analysis

To keep this analyzer precise, be sure to run the QC program every day before beginning sample analysis. See chapter 4, Quality Control, for details. 3.6.1  Analyzing Samples 3.6.1.1 Selecting Analysis Mode  At the Count screen, press [MODE] to select one of the six analysis modes. The selected mode will be displayed in the Count Mode area. 1. WB-All It stands for the Whole Blood - All Parameter mode, meaning the sample to be analyzed is a whole blood sample and all the 19 parameters are to be analyzed. 2. WB- WBC/HGB It stands for the Whole Blood - WBC/HGB Group mode, meaning the sample to be analyzed is a whole blood sample and only the following parameters are analyzed: WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran% and HGB, plus the WBC histogram. 3. WB-RBC/PLG It stands for the Whole Blood – RBC/PLC Group mode, meaning the sample to be analyzed is a whole blood sample and only the following parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, PDW and PCT, plus the RBC and PLT histograms. 4. PB-All It stands for the Prediluted Blood - All Parameter mode, meaning the sample to be analyzed is a prediluted blood sample and all the 19 parameters are to be analyzed, plus 3 histograms. 5. PB- WBC/HGB It stands for the Prediluted Blood - WBC/HGB Group  mode, meaning the sample to be analyzed is a whole blood sample and only the following parameters are analyzed: WBC, Lymph#, Mid#, Gran#, Lymph%, Mid%, Gran% and HGB, plus the WBC histogram. 6. PB-RBC/PLG It stands for the Prediluted Blood – RBC/PLC Group mode, meaning the sample to be analyzed is a prediluted blood sample and only the following parameters are analyzed: RBC, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, PDW and PCT, plus the RBC and PLT histograms.

Analyzing Whole Blood Samples

Follow the steps given below to analyze a whole blood sample. 1. Press [MODE] to select the appropriate analysis mode. 2. Present the whole blood sample to the sample probe. Press [START] and the probe will automatically aspirate 13l sample. 3. Remove the sample when aspiration is done (when the analyzer buzzes) and the sample probe has risen up. 4. Wait for the analyzer to finish the analyzing process, during which the center of the screen displays the analyzing progress and the System Status Area displays Running. When the analysis is done, the result is displayed in the Analysis Result Area, and the ID in the Next sample area automatically increases by one. 3.6.1.3 Analyzing Prediluted Blood Samples Follow the steps given below to analyze a prediluted blood sample. 1. Press [MODE] to select the appropriate analysis mode. 2. Present the prediluted blood sample to the sample probe. Press [START] and the probe will automatically aspirate 0.7ml sample. 3. Remove the sample when aspiration is done (when the analyzer buzzes) and the sample probe has risen up. 4. Wait for the analyzer to finish the analyzing process, during which the center of the screen displays the analyzing progress and the System Status area displays Running. When the Biohazard Consider all materials (specimens, reagents, controls, calibrators, or components that contain or have contacted human blood) as being potentially infectious. Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. Warning The probe is sharp and may contain biohazard materials, including controls and calibrators. Avoid any unnecessary contact with the probe and probe area. Note To have an accurate aspiration, be sure to keep certain distance between the probe and the bottle bottom during the aspirating process.

Figure 7-28 Selecting parameter unit

 Press [] or [] to move the cursor to the desired unit and press [ENTER] to confirm the selection.  When you are done selecting units, press[] or [] to move the cursor to other settings you want to change. 7.2.5.2 Setting count time If the WBC or RBC count time is inappropriately set, the system may give false alarms for clogs or bubbles. When this happens, follow the steps given below to change the WBC or RBC count time. Refer to the actual count time (see Chapter 8.3.1 for details) when editing the settings here.  Obtain the administrator authority as instructed in Chapter7.1.1.   At the Setup screen, press [F1] to select the Count group.  Press [] or [] to move the cursor to the edit box right of WBC or RBC in the Count time field.  Press []PgUp] or [PgDn] to enter the desired time.  When you are done entering the count time, press[] or [] to move the cursor to other settings you want to change. 7.2.5.3 Exiting setting parameter units and count time  When you are done changing all the printing and transmission settings you want to change, you may  press [F1] to select other setting group you want to change, or  press [MENU] and a dialog box will pop up to remind you to save the changes, as Figure 7-29 shows. Press [] or [] to move the cursor to Yes and press [ENTER] to save the changes and exit to the system menu or move the cursor to No and press [ENTER] to exit to the system menu without saving the changes.

Figure 7-29 Saving changes

7.2.6 Reference Range You can set a reference range for every parameter. The system will flag any analysis result that exceeds this range with either an H or L. This analyzer divides the patients into 5 patient groups, which are all listed in Table 7-4. Table 7-4 Patient groups                                           The upper and lower limits of the reference ranges are visible to all users but changeable only to administrators, as Figure 7-30 shows. Follow the instructions below to set the limits.

Figure 7-30 Setting reference range

7.2.6.1 Selecting patient group Follow the steps given below to select the patient group you want.   At the Setup screen, press [F1] to select the Ref. range group.  Press [] or [] to move the cursor to the combo box right of Group. Press [ENTER] to display the pull-down menu, as Figure 7-31 shows. Figure 7-31 Selecting patient group

Press [] or [] to move the cursor to General, Male adults, Female adults, Pediatric

patients or  Neonates and press [ENTER] to confirm the selection.  When you are done selecting the patient group, press [] or [] to move the cursor to the parameter whose reference range you want to view or change. 7.2.6.2 Setting reference ranges(administrators only) For the General, Male adults, Female adults and Pediatric patients groups, the manufacturer-recommended references are available for all the 19 parameters. As for the Neonates, the manufacturer-recommended references are only available for the following 5 parameters, WBC, Lymph#, RBC, HGB and PLT. You may enter or change the references to your own need. Follow the steps given below to do so.  Obtain the administrator authority as instructed in Chapter7.1.1.   At the Setup screen, press [F1] to select the Ref. range group.  Press [↑] or [↓] to move the cursor to General, Male adults, Female adults, Pediatric patients or Neonates and press [ENTER] to confirm the selection.  Press [↑] or [↓] to move the cursor to the upper or lower limit of the parameter (for instancet WBC) whose reference range you want to change. See Figure 7-32 Figure 7-32 Setting upper limit for WBC  Press [] or [] to move the cursor within edit box. Press [PgUp] or [PgDn] (or the numeric keys on an external keyboard) to enter a digit at the position where the cursor is located.  Press [↑] or [↓] to move the cursor to the lower limit of the parameter (for instancet WBC) whose reference range you want to change. See Figure 7-33.

Figure 7-33 Setting lower limit for WBC

 Press [] or [] to move the cursor within edit box. Press [PgUp] or [PgDn] (or the numeric keys on an external keyboard) to enter a digit at the position where the cursor is located.  When you are done setting the ranges, press [F2] to save the changes, as Figure 7-34 shows. Press [ENTER] to confirm. Figure 7-34 Changes saved  If you want resume the default settings by the manufacturer, press [F4]. 7.2.6.3 Exiting editing reference ranges When you are done changing all the printing and transmission settings you want to change, you may

press [MENU] and a dialog box will pop up to remind you to save the changes. Press [ ]

or [] to move the cursor to Yes and press [ENTER] to save the changes and exit to the system menu or move the cursor to No and press [ENTER] to exit to the system menu without saving the changes. Figure 7-35 Saving changes 7.2.7 Other Settings There are also other settings you can view or change. Follow the instructions given below to do so. 7.2.7.1 Muting beeper This analyzer beeps when errors occur. You can mute the beeper by pressing any key or leave the beeper beeping unit the errors are removed. Follow the steps given below to do so.   At the Setup screen, press [F1] to select the Other group.  Press [] or [] to move the cursor to the edit box right of Pressing any key to mute the beeper. Press [ENTER] to display the pull-down menu, as Figure 7-36 shows.  Press [] or [] to move the cursor to other settings you want to edit.

Figure 7-36 Selecting how to mute the beeper

7.2.7.2 Setting LCD contrast Follow the steps given below to adjust the LCD contrast.   At the Setup screen, press [F1] to select the Other group.  Press [] or [] to move the cursor to LCD contrast, as Figure 7-37 shows. Figure 7-37 Setting LCD contrast  Press [PgUp] or [PgDn] to adjust the contrast.  When you are done adjusting the contrast, press [] or [] to move the cursor to other settings you want edit. 7.2.7.3 Setting alarm time Follow the steps given below to set how long the error messages should be displayed on the screen (2s 120s).

 At the Setup screen, press [F1] to select the Other group.

 Press [] or [] to move the cursor to Alarm time, as Figure 7-38 shows. Figure 7-12 Setting alarm time  Press [PgUp] or [PgDn] to adjust the time.  When you are done adjusting the time press [] or [] to move the cursor to other settings you want edit. 7.2.7.4 Setting PBM color(administrator authority needed  Follow the steps below to set the background color of the Count screen when it is in the prediluted mode  Obtain the administrator authority as instructed in Chapter7.1.1.   At the Setup screen, press [F1] to select the Other group.  Press [] or [] to move the cursor to PBM color , as Figure 7-39 shows.

Press [] or [] to select Black or Blue and press [ENTER] to confirm the selection.

 Press [] or [] to move the cursor to other settings you want to change. 7.2.7.5 Exiting editing other settings When you are done changing all the printing and transmission settings you want to change, you may  press [F1] to select other setting group you want to change, or  press [MENU] and a dialog box will pop up to remind you to save the changes, as Figure 40 shows. Press [] or [] to move the cursor to Yes and press [ENTER] to save the changes and exit to the system menu or move the cursor to No and press [ENTER] to exit to the system menu without saving the changes. Figure 7-40 Saving changes

Chapter 8 Maintenance

Regular cleaning and maintenance are demanded to guarantee this analyzer operating properly. This chapter introduces how to take care of this analyzer and check the system status. Liquid overflow or leak during the operation of this analyzer will degrade the accuracy of the analysis results. Once it occurs, immediately wipe off the spills. If it occurs inside this analyzer, be sure to shut down the power immediately and call Mindray Customer Services Department or the distributor. Otherwise, the service life of this analyzer may be shortened. 8.1 Regular Maintenance To keep this analyzer in a good shape, regular maintenance is demanded. 8.1.1 Special Notes The parts in contact with blood are potentially infectious. Be sure to wear standard laboratory attire (including rubber gloves) when maintaining or operating this analyzer and wash your hands with detergent when you are done.  Be sure to keep you hair, clothes, cuff or hands away from the moving parts of this analyzer.  Be sure to use specified tools or parts to maintain this analyzer and be sure to clean the used tools as instructed by their instruction manual when you are done.  Be sure to use soft and clean cloth, or neutral detergent-soaked cloth (twisted dry), or soft cloth washed by ethanol to clean the surface of this analyzer.  Be sure to pay attention to the marks or symbols on this analyzer. Be sure not to touch the power plug at the back of this analyzer with wet hands or wet rags.  Be sure not use organic solvent or acid/alkaline detergent to wash the surface of this analyzer. Otherwise, the surface may fade or become corrupted.  Be sure to avoid direct contact with the reagents that will hurt your eyes, skin and diaphragm. In case you spill the reagents on you skin, be sure to wash them off with much water. In case you spill the reagents into your eyes, be sure to immediately wash your eyes with much water and go see a doctor for further treatment.

Recommended Regular Maintenance

Maintenance Period Content of Maintenance If you are to use this analyzer 24 hours a day, be sure to perform the E-Z cleanser cleaning procedure everyday. Everyday Run the QC program everyday. See Chapter 4 Quality Control  for details. Every three days If you are to use this analyzer 24 hours a day, be sure to perform the Probe cleanser cleaning procedure every three days. Every Week If you shut down your analyzer every day and follow the specified shutdown procedure to do that, you need to perform the Probe cleanser cleaning procedure every week. Every Month You should use the supplied sample probe localizer to calibrate the position of the sample probe to that of the wipe block. The analysis result is sensitive to their alignment. When you think the bath might be dirty, perform the Clean the bath procedure. When the analyzed samples add up to 300, the system will remind the user to perform the Probe cleanser cleaning procedure. When the analyzed samples add up to 4,000, the system will remind the user to perform the Clean wipe block procedure. When this analyzer is not to be used for two weeks, be sure to perform the Prepare to ship procedure to empty and wash the flow system. To obtain reliable analysis results, this analyzer needs to work in a normal status. Be sure to run the Self-test items regularly to check the status of this analyzer. When this analyzer gives alarms for clogging, you can perform the Flush aperture or Zap aperture procedure, or press [F2] at the Count screen to unclog the system.  As needed If you see other error messages, see Chapter 9 Troubleshooting, for solutions.

8.3 System Status

The items displayed in the Status screen reflect how the system is functioning and contribute significantly to diagnosing system errors. You may follow the instructions given below to check those items. Press [MENU] to enter the system menu and press the appropriate arrow keys to move the cursor to Service  Status, as Figure 8-17 shows. Figure 8-17 Entering status screen Press [ENTER] to enter the Status screen, as Figure 8-18 shows. Figure 8-18 Status screen

Note that you can only view the displayed status items without changing them. If any of the

displayed item exceeds the given range, see Chapter 9 Troubleshooting for solutions.

8.4 System Self-Test

The system self-test is a major way to locate system errors. Follow the instructions given below to view and check the available self-tests items. Press [MENU] to enter the system menu and press the appropriate arrow keys([][][][])to move the cursor to Service   Self-test, as Figure 8-19 shows. Figure 8-19 Entering self-test screen Press [ENTER] to enter the Self-test screen, as Figure 8-20 shows. If you want acquire help information, press [HELP]. Figure 8-20 Self-test screen

Circuit, as shown on the left of the screen. You can switch between the groups by pressing [F1]

and once a group is selected, the test items, including their test results (if available), belonging to that group will be displayed on the right of the screen. You may press [PRINT] to print out the displayed results. Follow the instructions given below to conduct every test and if you want to acquire help information, press [HELP]. 8.3.1 Testing Tubing  At the self-test screen, press [F1] to select the Tubing  group, as Figure 8-20 shows. The following test items will be displayed on the right of the screen: 1. Count Time WBCS It measures the duration of a WBC count, namely how many seconds it takes for the aspirated fluid flows from the first sensor to the second. 2. Count Time RBCS It measures the duration of a RBC count, namely how many seconds it takes for the aspirated fluid flows from the first sensor to the second. 3. Aperture(v) It measures the voltage (v) over the aperture. 4. Vacuum It checks whether the vacuum system functions normally. 5. Pressure It checks whether the system flushes the aperture at a normal pressure. 6. Filter It checks whether the filter functions normally. 8.3.2 Testing Motors and Recorder/Printer  At the Self-test screen, press [F1] to select the Machine group, as Figure 8-21 shows. The following test items will be displayed on the right of the screen. Press [ ] or [] to select the desired item and press [ENTER] to conduct the test.

Figure 8-21 Testing mechanic parts

1. Syringe motor The syringe motor controls the aspiration volume. This test checks whether the motor functions normally. 2. Rotation motor The rotation motor rotates the sample probe inside the analyzer. This test checks whether the motor functions normally. 3. Elevator motor The elevator motor controls elevation of the sample probe. This test checks whether the motor functions normally. 4. Print This test checks whether the recorder or printer functions normally. If normal, when you can press [ENTER], the recorder or printer will print out Printer(recorder) test; if abnormal, the screen will display the corresponding error message and you can see Chapter 9 Troubleshooting for solutions. 8.3.3 Testing Valves Malfunctioning valves will lead to malfunctions of the tubing. Therefore, testing the valves is a major way to remove fluidics errors.  At the Self-test  screen, press [F1] to select the Valve group, as Figure 8-22 shows. The following test items will be displayed on the right of the screen. Press the appropriate arrow keys ([][][][])to select the valve you want to check and press [ENTER] to test it. If the valve goes through the Off-On-Off sequence without making abnormal sound, it passes the

test. Otherwise, something may be wrong with the valve.

Figure 8-22Testing valves 8.3.4 Testing Circuits  At the Self-test screen, press [F1] to select the Circuit group, as Figure 8-23 shows. You can test the A/D interrupt at this screen by pressing [ENTER] to see whether the WBC, RBC and PLT signals can be properly converted into digital signals. Figure 8-23 Testing A/D converter

The log records all the major events taking place during the running of this analyzer. It helps

the service engineers diagnose system errors. Press [MENU] to enter the system menu and press the appropriate arrow keys ([][][][]) to move the cursor to ServiceLog, as Figure 8-24 shows. Figure 8-24 Entering log Press [ENTER] to enter the Log screen, as Figure 8-25 shows. Figure 8-25 Log screen The recorded events are divided into four groups,  All, Para set, Error and Other  (including setting discriminators, system self-test and updating system software), which are all listed on

the left of the screen. All the recorded are listed on the right of the screen by default. You can

press [F1] to select the interested group and the right of the screen will display the events of the selected group only. Every screen displays 10 events. You can press [ ] or [] to check the events one by one or press [PgUp] or [PgDn] to check the events on the previous or next screen. If you want to print out the displayed events, press [PRINT]. If you want to acquire help information, press [HELP]. For every recorded event, the NO. column displays the sequences of the recorded events; the Time column displays the time when this event occurred; the Type column displays the event type (the error events are also marked the corresponding error codes that are explained in Chapter 10.1); the Times column displays how many times (1 255) this event occurred and if it occurred more than 255 times, the excessive events will be recorded from 1 to another log file; the Information column displays extra information regarding the event. This analyzer can save maximum 100 log files and once the maximum number has been reached, the newest log will automatically cover the oldest one.

8.6 System Configuration

To view the system configuration, press [MENU] to enter the system menu, and then press the appropriate arrow keys to move the cursor to Service Press [ENTER] to enter the Config screen, as Figure 8-26 shows, where you can only view the system configuration without changing it. Figure 8-26 Configuration Every screen displays 13 items and you can press [] or [] to select the item you want to see, or press[PgUp] or [PgDn] to go to the previous or next screen. If you want to print out the configuration, press [PRINT]. If you want to acquire help, press [HELP]. 

8.7 Printing Management

Press the [MENU] to enter the system menu and press the appropriate arrow keys ([][][][])to move the cursor to ServicePrint, as Figure 8-27 shows. Figure 8-27 Entering print screen Press [ENTER] to enter the Print screen, as Figure 8-28 shows. The printing tasks are queued in this screen, where you can view the all tasks and delete those waiting to be processed. Once something goes wrong with the printing device, the task being processed will be deleted and the queued tasks will keep waiting. Once the system finds the error has been removed, it will resume printing and process the tasks from the first one. Note that you cannot change the sequence of the queued tasks. Figure 8-28 Print screen

You can perform the following operations at the Print screen:

 Press [↑] or [↓] to select the desired task.  Press [DEL] to delete the selected task.  Press [HELP] to display the help information.  Press [MENU] to return to the system menu.

8.8  Adjusting Sample Probe and Probe Wipe Block

The relative position between the sample probe and probe wipe block has influence on the analysis results. In the accessory box, there is a sample probe localizer, as Figure 8-30 shows. You need to use the localizer to adjust the position of the sample probe if you have replaced wipe block, or observed motor error, or wrong analysis result. Also, as required by regular maintenance, you should use the localizer to adjust the position of the sample probe monthly. Figure 8-29 Probe localizer 8.8.1  Adjusting Sample Probe Position Follow the steps given below to adjust the sample probe position: 1. Refer to Chapter 8.1.8 and follow the steps 1 and 2 to remove the right plate of this analyzer. 2. Access the Setup Password screen and enter the administrator password to obtain the administrator authority (see Chapter 7.1.1). Access the Service Self-test screen. 3. Press [F1] to select the Machine  group and press [] or [] to move the cursor to Elevator motor, as Figure 8-30 shows. Biohazard Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. Warning The probe is sharp and may contain biohazard materials, including controls and calibrators. Avoid any unnecessary contact with the probe and probe area.

Figure 8-32 Sample probe above the bath

6. Loose the retaining screw by a screwdriver, as Figure 8-33 shows. Figure 8-33 Removing screws 7. Remove the probe from the wipe block and insert the localizer into the wipe block from the bottom, as Figure 8-34 shows.

Figure 8-34 Using localizer

8. Insert the probe into the wipe block until it reaches the localizer, as Figure 8-35 shows. Figure 8-35 Inserting sample probe into wipe block 9. Retighten the screw to fix the probe and remove the localizer to wrap up the adjustment. 8.8.2 Replacing Probe Wipe Block Follow he steps given below to replace the probe wipe block 1. Refer to Chapter 8.7.1 and do the steps 1~6. Biohazard Wear standard laboratory attire, glove and follow safe laboratory procedures when handling any material in the laboratory. Warning The probe is sharp and may contain biohazard materials, including controls and calibrators. Avoid any unnecessary contact with the probe and probe area.

2. Pull the loosen sample probe upward to remove the wipe block and disconnect the tubes

from the wipe block (pay attention to the correspondence between the tubes and the connectors ), as Figure 8-36 shows. 3. Refer to Chapter 8.7.1 and do the steps 7~9 of fix the sample probe. Figure 8-36 Installing wipe block

Chapter 9 Troubleshooting

The chapter deals with the codes, possible causes and solutions of the errors. If the error remains after you have tried the recommended method, call Mindray Customer Service Department or the distributor. This chapter consists of two parts, the first part dealing with the errors and assigned error codes and the second possible causes and recommended solutions.

9.1 Error Codes

The errors recorded in the log are presented in the error codes. See Table 9-1 for the correspondence between the errors and error codes. Table 9-1 Errors and codes Code Error Code Error Code Error 0401 Envir. Temp.  Abnormal 0402 Background abnormal 0403 HGB error 0404 HGB adjust 0405 WBC clog 0406 WBC bubbles 0407 RBC clog 0408 RBC bubbles 0801 Communication error 0802 Scanner error 0803 Scanner communication error 1001 Printer out of paper 1002 Printer connection error 1003 Recorder communication error 1004 Recorder out of paper 1005 Recorder too hot 1006 Press bar up 2001 Lyse out 2002 Diluent expired 2003 Rinse expired 2004 Lyse expired 2005 Filer error 2006 Real-time clock error 4002 Syringe motor error 4003 Rotation motor error 4004 Elevator motor error 4005 A/Derror 4008 Vacuum error 4009 Press error 400B Diluent out 400C Rinse out 400D Waste full 8001 File error 8002 Dynamic memory error

This chapter presents measures to be taken when the errors occur.

9.2.1 A/D Error Something is wrong with the A/D converter on the CPU board. Solution  Access Service → Self-test → Circuit. Test the A/D interrupt as instructed by Chapter 8.4.4. The error will be cleared if the test result is normal. Otherwise, call Mindray Customer Service Department or the distributor. 9.2.2 Dynamic Memory Error Something is wrong with the system memory. Turn off the analyzer and call Mindray Customer Service Department or the distributor. 9.2.3 HGB Error HGB gain is not correct and HGB blank voltage is within 0V 3.2V or 4.9V 5V. Solution  Access Setup  Password to gain the administrator authority as instructed by Chapter 7.1.1.  Access Setup  Settings  Gain to adjust the HGB blank voltage to 3.4 4.8V (4.5V recommended) as instructed by Chapter 7.2.4.3. If the error still remains, turn off this analyzer and call Mindray Customer Service Department or the distributor. 9.2.4 HGB Adjustment HGB gain is not correct and HGB blank voltage is within 3.2 --- 3.4V or 4.8 --- 4.9V. Solution  Access Setup  Password to gain the administrator authority as instructed by Chapter 7.1.1.  Access Setup   Settings   Gain to adjust the HGB blank voltage to 3.4  4.8V (4.5V recommended) as instructed by Chapter 7.2.4.3.  If the error still remains, turn off this analyzer and call Mindray Customer Service Department or the distributor. 9.2.5 RBC Clog This error message occurs when the actual RBC count time is greater than the preset RBC count time by 2 seconds.

clogged aperture; inappropriate RBC count time settings or solenoid valve

error. Solution 1. Access Service  Maintenance  and do the Zap aperture and  Flush aperture procedures as instructed by Chapters 8.2.4 and 8.2.5. 2. After unclogging, access Setup  Settings  Count  to note down the preset RBC count time. Access Service  Self-test Tubing and test the actual RBC count time as instructed by Chapter 8.4.1. If the tested time differs from the preset time by less than 2 seconds, it means the unclogging is successful and you can return to the Count screen to continue the analysis. Other wise,  Access Service Maintenance  to soak the bath and tubing with probe cleanser as instruction by Chapter 8.2.6. When the soaking is done, access Setup Settings Count  to note down the preset RBC count time. Access Service Self-test Tubing and test the actual RBC count time as instructed by Chapter 8.4.1. If the tested time differs from the preset time by less than 2 seconds, it means the unclogging is successful and you can return to the Count screen to continue the analysis. If the difference is still greater than 2 seconds and stabilized around a certain value, access Setup Settings Count  to change the RBC count time accordingly. After the adjustment, test the actual count time again and make sure the difference is within 2 seconds. 3. If the error still remains, call Mindray Customer Service Department or the distributor. 9.2.6 RBC Bubbles This error message occurs when the actual RBC count time is less than the preset RBC count time by 2 seconds. Possible causes 1. Insufficient diluent or rinse. 2. Loose tubing connection 3. Inappropriate RBC count time setting. Solution 1. Check if the diluent or rinse is sufficient. If not, change a new container of diluent of rinse as instructed by Chapter 2.3. 2. Check the tubing connections. If necessary, reconnect the tubing as instructed by Chapter

3. If the error still remains, Access Setup  Password to gain the administrator authority

as instructed by Chapter 7.1.1 and then access Setup  Settings  Count and adjust the RBC count time as instructed by Chapter 7.2.5.2. 4. If the error still remains, turn off this analyzer and call Mindray Customer Service Department or the distributor. 9.2.7 WBC Clog This error message occurs when the actual WBC count time is greater than the preset WBC count time by 2 seconds. Possible causes clogged aperture; inappropriate WBC count time settings or solenoid valve error. Solution 1. Access Service Maintenance  and do the Zap aperture and Flush aperture procedures as instructed by Chapters 8.2.4 and 8.2.5. 2. After unclogging, access Setup Settings Count to note down the preset WBC count time. Access Service Self-test Tubing and test the actual WBC count time as instructed by Chapter 8.4.1. If the tested time differs from the preset time by less than 2 seconds, it means the unclogging is successful and you can return to the Count screen to continue the analysis. Otherwise,  Access Service Maintenance  to soak the bath and tubing with probe cleanser as instruction by Chapter 8.2.6. When the soaking is done, access Setup Settings Count to note down the preset WBC count time. Access Service Self-test Tubing and test the actual WBC count time as instructed by Chapter 8.4.1. If the tested time differs from the preset time by less than 2 seconds, it means the unclogging is successful and you can return to the Count screen to continue the analysis. If the difference is still greater than 2 seconds and stabilized around a certain value, access Setup Settings Count  to change the WBC count time accordingly. After the adjustment, test the actual count time again and make sure the difference is within 2 seconds. 3. If the error still remains, call Mindray Customer Service Department or the distributor.

9.2.8 WBC Bubbles

This error message occurs when the actual WBC count time is less than the preset WBC count time by 2 seconds. Possible causes 1. Insufficient diluent or rinse. 2. Loose tubing connection 3. Inappropriate WBC count time setting. Solution 1. Check if the diluent or rinse is sufficient. If not, change a new container of diluent of rinse as instructed by Chapter 2.3. 2. Check the tubing connections. If necessary, reconnect the tubing as instruction by Chapter 2.3. 3. If the error still remains, access Setup Password to gain the administrator authority as instructed by Chapter 7.1.1 and then access Setup Settings Count  and adjust the WBC count time as instructed by Chapter 7.2.5.2. 4. If the error still remains, turn off this analyzer and call Mindray Customer Service Department or the distributor. 9.2.9 Background Abnormal  At least one parameter failed the background check. Solution  At the Count screen, press [F3] to do the startup procedure. If the error still remains, access Service Maintenance and do the Probe cleanser cleaning procedure as instructed. When the cleaning is done, return to the Count screen and check the background again to seen whether the error is cleared. If not, call Mindray Customer Service Department or the distributor. 9.2.10 Rinse Expired Possible causes rinse has expired or its expiration date is not correctly set. Solution Check the rinse. If it is expired, change a new container of rinse as instructed by Chapter 2.3; if not, access Setup Settings Reagents and adjust the expiration date as instructed by Chapter 7.2.1.3.

9.2.11 Printer Out of Paper

Possible cause The printing paper ran out or is not correctly installed. Check the whether the printer is out of paper. If so, load paper to the printer; otherwise, re-install the existing paper. 9.2.12 Printer Connection Error Check whether the printer is well connected to the analyzer. 9.2.13 Waste full The waste container is full. Empty the container as instructed by Chapter 2.3, or change a new container to receive the waste and re-set the waste container volume as instructed by  Chapter 7.2.1.2. 9.2.14 Filter error Something is wrong with the filter of the vacuum chamber. Solution  Access Service Self-test Tubing and test the filter as instructed by Chapter 8.4. The error is cleared if the result is normal. If not, call Mindray Customer Service Department or the distributor. 9.2.15 Environmental Temperature Abnormal Possible causes Solution  Access Service Status and check the environmental temperature. If the temperature exceeds the specified range by 15-35, you need to adjust the work environment of this analyzer so that the analyzer works in the requested environment. If the temperature is within the requested range and the error remains, call Mindray Customer Service Department or the distributor. 9.2.16 Recorder Out of Paper Possible causes recording paper has run out or is not correctly installed. abnormal environmental temperature or malfunctioning temperature sensor.

Check whether the recording paper has run out. If so, load new paper; if not, re-install the

existing paper as instructed by Chapter 2.3.3. If the error still remains, call Mindray Customer Service Department or the distributor. 9.2.17 Recorder Communication Error Call Mindray Customer Service Department or the distributor. 9.2.18 Recorder Too Hot Possible causes the recording head overheats. Stop using the recorder. If the error repeats, call Mindray Customer Service Department or the distributor. 9.2.19 Press Bar Up The press bar of the recorder is up. Push it back as instructed by Chapter2.3.3 If the error still remains, call Mindray Customer Service Department or the distributor. 9.2.20 Rotation Motor Error Something is wrong with the motor that rotates the sample probe.  Access Service Self-test Machine and test the motor as instructed by Chapter 8.4.2. The error will be cleared if the result is normal. Otherwise, call Mindray Customer Service Department or the distributor. 9.2.21 Lyse Expired The lyse has expired. Check whether the lyse has expired. If so, change a new container of lyse as instructed by Chapter 2.3; if not, access Setup Settings Reagents and adjust the expiration date as instructed by Chapter 7.2.1.3.

Elevator Motor Error

vator Motor Error Something is wrong with the motor that Something is wrong with the motor that controls elevation of the sample probe. controls elevation of the sample probe.  Access  Access Service Self-test Machine Service Self-test Machine and test the  and test the motor as instructed by motor as instructed by Chapter Chapter 8.4. 8.4.22.. The error will be cleared if the result is normal. Otherwise, call Mindray Customer Service The error will be cleared if the result is normal. Otherwise, call Mindray Customer Service Department or the distributor. Department or the distributor. 9.2.23 9.2.23 Real-Time Clock Error Real-Time Clock Error Something is wrong with the clock. Something is wrong with the clock.  Access  Access Setup Setup Se Setti ttings ngs Date Date & & Time Time  and set the time and date as instructed by   and set the time and date as instructed by Chapter Chapter 7.2. 7.2.33 and restart the analyzer to  and restart the analyzer to enable the new settings. If enable the new settings. If the error still remains, call the error still remains, call Mindray Customer Service Department or the distributor. Mindray Customer Service Department or the distributor. 9.2.24 9.2.24 Sca Scanner Error nner Error Too long or invalid bar code. Too long or invalid bar code. Check and make sure the bar code is Check and make sure the bar code is correct. If the error still correct. If the error still remains, call Mindray Customer remains, call Mindray Customer Service Department or the distributor. Service Department or the distributor. 9.2.25 9.2.25 Scanner Communication Error Scanner Communication Error Something is wrong with the communication between the scanner and the analyzer. Something is wrong with the communication between the scanner and the analyzer. Check the connection between the two devices. Check the connection between the two devices. 9.2.26 9.2.26 Communica Communication tion EError rror The received communication settings are different with the The received communication settings are different with the BC-2800. BC-2800.  Access  Access Se Setup tup Se Settings ttings Print Print & & comm. comm.  and change the communication settings   and change the communication settings accordingly as instructed by accordingly as instructed by Chapt Chapter 7.2.2.2. er 7.2.2.2. 9.2.27 9.2.27 File E File Erro rrorr Something is wrong with file saving. Something is wrong with file saving.

Turn off the analyzer and call Mindray Customer Service Department or the distributor.

Turn off the analyzer and call Mindray Customer Service Department or the distributor. 9.2.28 9.2.28 Rinse Out Rinse Out Possible causes Possible causes insufficient rinse or wrong rinse insufficient rinse or wrong rinse volume setting. volume setting. Solution Solution Check if there is sufficient rinse left. If so, access Check if there is sufficient rinse left. If so, access Setup Settings Reagents Setup Settings Reagents  and   and adjust the remaining rinse volume as instructed by adjust the remaining rinse volume as instructed by Chapter 7.2.1.1 Chapter 7.2.1.1; if not, change a new ; if not, change a new container of rinse as instructed by container of rinse as instructed by Chapter 2.3 Chapter 2.3.. 9.2.29 9.2.29 Lyse Out Lyse Out Possible causes Possible causes insufficient lyse or wrong lyse volume setting. insufficient lyse or wrong lyse volume setting. Solution Solution Check if there is sufficient lyse left. If so, access Check if there is sufficient lyse left. If so, access Setup Setup Settings Reagents Settings Reagents and adjust  and adjust the remaining lyse volume as instructed by the remaining lyse volume as instructed by Chapter Chapter 7.2. 7.2.1.1 1.1; if not, ; if not, change a new containe change a new container of r of lyse as instructed by lyse as instructed by Chapter 2.3. Chapter 2.3. 9.2.30 9.2.30 Diluent Out Diluent Out Possible causes Possible causes insufficient diluent or wrong diluent volume setting. insufficient diluent or wrong diluent volume setting. Solution Solution Check if there is sufficient diluent left. If so, access Check if there is sufficient diluent left. If so, access Setup Settings Reagents Setup Settings Reagents  and   and adjust the remaining diluent volume as instructed by adjust the remaining diluent volume as instructed by Chapter 7.2.1.1 Chapter 7.2.1.1; if not, change a new ; if not, change a new container of diluent as instructed by container of diluent as instructed by Chapter 2.3. Chapter 2.3. 9.2.31 9.2.31 Diluent Expired Diluent Expired The diluent has expired. The diluent has expired. Check whether the diluent has expired. If so, change a new container of diluent as instructed Check whether the diluent has expired. If so, change a new container of diluent as instructed by by Chapter 2.3 Chapter 2.3; if not, access ; if not, access Setup Settings Reagents Setup Settings Reagents and adjust the expiration and adjust the expiration date as instructed by date as instructed by Chapter Chapter 7.2.1 7.2.1.3. .3. 9.2.32 9.2.32 Pressure Error Pressure Error The vacuum chamber does not reach the expected pressure within the given time. The vacuum chamber does not reach the expected pressure within the given time.

Tubing and test the pressure as instructed by

and test the pressure as instructed by Chapter Chapter 8.4.1 8.4.1. The error will be cleared if the result is normal; otherwise, call Mindray Customer Service . The error will be cleared if the result is normal; otherwise, call Mindray Customer Service Department or the distributor. Department or the distributor. 9.2.33 9.2.33 VVacuum acuum Error Error The system does not reach the The system does not reach the expected vacuum within the given time. expected vacuum within the given time. Solution Solution  Access  Access Service Self-test Tubing Service Self-test Tubing and test the  and test the vacuum as instructed by vacuum as instructed by Chapter Chapter 8.4. 8.4.11.. The error will be cleared if the result is normal; otherwise, call Mindray Customer Service The error will be cleared if the result is normal; otherwise, call Mindray Customer Service Department or the distributor. Department or the distributor. 9.2.34 9.2.34 Syringe Motor Error Syringe Motor Error Something is wrong with the motor controls the syringe that aspirates/dispenses samples and Something is wrong with the motor controls the syringe that aspirates/dispenses samples and reagents. reagents. Solution Solution  Access  Access Service Self-test Machine Service Self-test Machine and test the motor as instructed by and test the motor as instructed by Chapter 8.4.2 Chapter 8.4.2.. The error will be cleared if the result is normal; otherwise, call Mindray Customer Service The error will be cleared if the result is normal; otherwise, call Mindray Customer Service Department or the distributor. Department or the distributor.

 A.3.1 Transmission at Count Screen

Transmission at Count Screen If the auto transmission function is on, once the analysis is done, the BC-2800 will If the auto transmission function is on, once the analysis is done, the BC-2800 will automatically transmit the results to the automatically transmit the results to the external computer external computer. If . If the auto transmission function is the auto transmission function is off, off, you can o you can only transmit nly transmit the result the results manually s manually at the at the Review Review screen.  screen.  A.3.2  A.3.2 Transmission at Review Screen Transmission at Review Screen Select the results you want to transmit and transmit them to the external computer as Select the results you want to transmit and transmit them to the external computer as instructed by Chapter 6.2.4. instructed by Chapter 6.2.4.  A.3.3  A.3.3 Transmission at QC T Transmission at QC Table Screen able Screen Tran Transmit the smit the results as instructed by results as instructed by Chapter 4.1.5. Chapter 4.1.5.  A.4  A.4 Transmission Date Format Transmission Date Format  A.4.1  A.4.1 Description Description  A.4.1.1  A.4.1.1 Symbols Symbols Table A-1 Symbols Table A-1 Symbols [ENQ] 0x05 [ENQ] 0x05 [STX] 0x02 [STX] 0x02 [EOT] 0x04 [EOT] 0x04 [EOF] 0x1A [EOF] 0x1A [ETX] 0x03 [ETX] 0x03 [ACK] 0x06 [ACK] 0x06 [NACK] 0x15 [NACK] 0x15 "A" 0x41 "A" 0x41 "B" 0x42 "B" 0x42 "C" 0x43 "C" 0x43 "#" 0x30-0x39 "#" 0x30-0x39 "*" 0x2A "*" 0x2A  A.4.1.2  A.4.1.2 Programming Programming If the Handshake is off, BC-2800 will transmit the body of the text without acknowledging the If the Handshake is off, BC-2800 will transmit the body of the text without acknowledging the presence of an external computer. presence of an external computer. If the Handshake is on, BC-2800 will communicate with the external computer in following If the Handshake is on, BC-2800 will communicate with the external computer in following

BC-2800 sends an

sends an ENQ (05 He ENQ (05 Hex), then wait x), then waits up to 4 s up to 4 seconds for seconds for the externa the externall computer to respond. If the external computer does not respond, then one more ENQ computer to respond. If the external computer does not respond, then one more ENQ (05 Hex) is tried before giving up. (05 Hex) is tried before giving up. 2. 2. The external The external computer must respond computer must respond by sending by sending an an ACK (06 ACK (06 Hex). If any Hex). If any other other response is received, another ENQ (05 Hex) will be sent by the analyzer (a maximum response is received, another ENQ (05 Hex) will be sent by the analyzer (a maximum of only two ENQ [05 Hex] will be of only two ENQ [05 Hex] will be sent). sent). 3. 3. The The analyzer analyzer then then sends sends  Body of text Body of text EOT (04 Hex) EOT (04 Hex) ETX (03 Hex) ETX (03 Hex) 4. Disconnection 4. Disconnection  A.  A. BC-2800 BC-2800 sends a sends an ETX n ETX 03 Hex), 03 Hex), then wai then waits 4 ts 4 seconds seconds for the for the external co external computer mputer to to respond. If no response is received, one more ETX (03 Hex) is sent, BC-2800 respond. If no response is received, one more ETX (03 Hex) is sent, BC-2800 waits 4 seconds before giving up and gives alarm of communication error. waits 4 seconds before giving up and gives alarm of communication error. B. B. The The external computer external computer must respond must respond by by sending an sending an ACK (06 ACK (06 Hex). If Hex). If the external the external computer responds by sending a NACK (15 Hex), then BC-2800 will execute Step computer responds by sending a NACK (15 Hex), then BC-2800 will execute Step 3 once again. If anything else is received, BC-2800 will send ETX (03 Hex) once 3 once again. If anything else is received, BC-2800 will send ETX (03 Hex) once more. more.  A.4.2  A.4.2 Sample Date Format Sample Date Format Sample Data Format as shown in Table A-2 Sample Data Format as shown in Table A-2   Table A-2 Sample Data Format Table A-2 Sample Data Format If If handshake handshake is is selected selected [ENQ] [ENQ] If ha If handsh ndshake ake is n is not s ot selec elected ted [STX] [STX] Body of the text start Body of the text start TText ext Distinc Distinction tion Code Code “A” “A” ID ######## ID ######## Sample Sample Mode Mode ## Month ## Month ## Day ## Day ## Year #### Year #### Hour ## Hour ## Minutes ## Minutes ## Seconds ## Seconds ## WBC[10 WBC[1099/L] ###.# /L] ###.# Lymph#[10 Lymph#[1099/L] ###.# /L] ###.#

Communication Communication Mid#[10 Mid#[1099/L] ###.# /L] ###.# Gran#[10 Gran#[1099/L] ###.# /L] ###.# Lymph%[%] ##.# Lymph%[%] ##.# Mid%[%] ##.# Mid%[%] ##.# Gran%[%] ##.# Gran%[%] ##.# RBC[10 RBC[1012 12/L] ##.# /L] ##.# HGB[g/L] ### HGB[g/L] ### MCHC[g/L] #### MCHC[g/L] #### MCV[fL] ###.# MCV[fL] ###.# MCH MCH [pg] [pg] ###.# ###.# RDW-CV[%] ##.# RDW-CV[%] ##.# HCT[%] ##.# HCT[%] ##.# PLT[10 PLT[1099/L] #### /L] #### MPV[fL] ##.# MPV[fL] ##.# PDW ##.# PDW ##.# PCT[%] .### PCT[%] .### RDW-SD[fL] ###.# RDW-SD[fL] ###.# Reserved ############ Reserved ############ Rm # Rm # R1 # R1 # R2 # R2 # R3 # R3 # R4 # R4 # Pm # Pm # Ps # Ps # Pl # Pl # L1 L1 Region Region ### ### L2 L2 Region Region ### ### L3 L3 Region Region ### ### L4 L4 Region Region ### ### L5 L5 Region Region ### ### L6 L6 Region Region ### ### L7 L7 Region Region ### ### L8 L8 Region Region ### ### Reserved ################ Reserved ################ WBC WBC Histo Histo (256 (256 channels) channels) ### ### RBC RBC Histo Histo (256 (256 channels) channels) ### ###

Body of the text end

Body of the text end If If handshake handshake is is selected selected [EOT] [EOT] If ha If handsh ndshake ake is n is not s ot selec elected ted [EOF] [EOF] For all the data formats, if the data are mark “*” in BC-2800, then “*” (2A Hex) will be For all the data formats, if the data are mark “*” in BC-2800, then “*” (2A Hex) will be transmitted to the external computer. transmitted to the external computer. L1 Region - L8 Region are LI L1 Region - L8 Region are LI - L8 of - L8 of eight histogram discriminators as shown in Figure A-2. eight histogram discriminators as shown in Figure A-2. Figure A-2 L1- L8 Figure A-2 L1- L8 demonstratio demonstrationn  A.4.3  A.4.3 St Standard QC Data Format andard QC Data Format Standard QC Data Format as shown in Table A-3 Standard QC Data Format as shown in Table A-3  Table A-3 Standard QC Data Format Table A-3 Standard QC Data Format If If handshake handshake is is selected selected [ENQ] [ENQ] If ha If handsh ndshake ake is n is not s ot selec elected ted [STX] [STX] Body of the text start Body of the text start TText ext Distinc Distinction tion Code Code “B” “B” File File No. No. ## Lot Lot No. No. ###### ###### Month ## Month ## Day ## Day ## Year #### Year #### WBC[10 WBC[1099/L] ###.# /L] ###.# RBC[10 RBC[1012 12/L] #.## /L] #.## HGB[g/L] ### HGB[g/L] ###

Body of the text end

If handshake is selected [EOT] If handshake is not selected [EOF] If handshake is selected [ETX] If the Lot No., Month, Day, Year are empty in QC Edit menu, the “*” (2A Hex) will be transmitted to the external computer.  A.4.4 Run QC Data Format Standard QC Data Format as shown in Table A-4 Table A-4 Run QC Data Format If handshake is selected [ENQ] If handshake is not selected [STX] Body of the text start Text Distinction Code ‘C’ Month ## Day ##

Body of the text end

If handshake is selected [EOT] If handshake is not selected [EOF] If handshake is selected [ETX]

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