BS-300 Chemistry Analyzer Operation Manual

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2007 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.

For this Operation Manual, the issued Date is 2007-07 (Version: 1.8).

Intellectual Property Statement SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information 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 out of any infringements of patents or other rights of third parties.

Mindray intends to maintain the contents of this manual as confidential information. Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

Release, amendment, reproduction, distribution, rent, adaption and translation of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

, , , , are the registered trademarks or trademarks owned by Mindray in China and other countries. All other trademarks that appear in this manual are used only for editorial purposes without the intention of improperly using them. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to changes without prior notice.

All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance, or use of this manual.

Mindray is responsible for safety, reliability and performance of this product only in the condition that:

all installation operations, expansions, changes, modifications and repairs of this product are conducted by Mindray authorized personnel;

the electrical installation of the relevant room complies with the applicable national and local requirements;

the product is used in accordance with the instructions for use.

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WARNING: It is important for the hospital or organization that employs this equipment to carry out a reasonable service/maintenance plan. Neglect of this may result in machine breakdown or injury of human health.

Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

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 the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than Mindray authorized personnel.

This warranty shall not extend to:

any Mindray product which has been subjected to misuse, negligence or accident;

any Mindray product from which Mindray's original serial number tag or product identification markings have been altered or removed;

any product of any other manufacturer.

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to Mindray, the following procedure should be followed:

1 Obtain return authorization: Contact the Mindray Customer Service Department and obtain a Customer Service Authorization (Mindray) number. The Mindray number must appear on the outside of the shipping container. Returned shipments will not be accepted if the 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 this product is shipped to Mindray for service (this includes customs charges).

3 Return address: Please send the part(s) or equipment to the address offered by Customer Service department.

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Company Contact

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, ShenZhen518057, P.R.China

Tel: +86 755 26582479 26582888

Fax: +86 755 26582934 26582500

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Preface

Who Should Read This Manual

This manual is written for clinical laboratory professionals to:

learn about the BS-300 hardware and software set up and operate the BS-300 maintain and troubleshoot the BS-300

WARNING: The BS-300 Chemistry Analyzer is to be operated only by clinical professionals, doctors or laboratory experimenters trained and authorized by Mindray or Mindray-authorized distributors.

What Can You Find in This Manual

The BS-300 Chemistry Analyzer should be operated and serviced strictly as instructed by this manual.

This manual contains 7 chapters, plus 3 appendixes:

1 System Description

2 Installation

3 Basic Operations

4 Advanced Operations

5 Maintenance

6 Troubleshooting

7 Calculation Methods

Appendix A Specifications

Appendix B Supplies

Appendix C Index

Conventions Used in This Manual

This manual uses certain typographical conventions to clarify meanings in the text.

All capital, italic font indicates a key name, such as ENTER.

Bold font indicates a chapter title, such as 5 Maintenance

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Bold and Italic font indicates:

Screen text displayed by the analyzer, such as Cant save. A menu name, such as Setup. A screen field or value, such as Method.

Safety Symbols

This chart explains the symbols used in this manual.

When you see Then

WARNING:

Read the statement following the symbol. The statement is alerting you to an operating hazard that can cause personal injury.

BIOHAZARD:

Read the statement following the symbol. The statement is alerting you to a potentially biohazardous condition.

CAUTION:

Read the statement following the symbol. The statement is alerting you to a possibility of system damage or unreliable results.

NOTE:

Read the statement following the symbol. The statement is alerting you to information that requires your attention.

Labels Used on the System

The labels attached to some panels use symbols with the text to clarify the meaning of the text. If any of the labels peels off, contact Mindray customer service department or your local distributor for replacement. The table below explains the symbols on the labels.

Serial Number

Manufacturer

Date of Manufacture

Authorized Representative in the European Community

The device is fully in conformance with the Council Directive Concerning In Vitro Diagnostic Medical Devices 98/79/EC.

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The following definition of the WEEE label applies to EU member states only: The use of this symbol indicates that this product should not be treated as household waste. By ensuring that this product is disposed of correctly, you will help prevent bringing potential negative consequences to the environment and human health. For more detailed information with regard to returning and recycling this product, please consult the distributor from whom you purchased the product.

In Vitro Diagnostic equipment

Biohazard Warning: risk of potentially biohazardous infection

Warning: risk of personal injury or equipment damage

Warning: risk of electric shock

Warning: risk of burn

Warning: risk of eye hurt

ON (POWER)

OFF (POWER)

ON (ANALYZING UNIT POWER)

OFF (ANALYZING UNIT POWER)

Alternating current (AC)

Graphics

All graphics, including screens and printout, are for illustration purposes only and must not be used for any other purpose.

EC Representative

Name: Shanghai International Holding Corp. GmbH(Europe)

Address: Eiffestrae 80, 20537 Hamburg Germany

Phone: 0049-40-2513175

Fax: 0049-40-255726

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Safety Precautions

Observe the following safety precautions when using the BS-300 Chemistry Analyzer. Ignoring any of these safety precautions may lead to personal injury or equipment damage.

WARNING: If the system is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired.

Preventing Electric Shocks

WARNING: When the POWER is on, users must not open the rear or side cover.

Spillage of reagent or sample on the analyzer may cause equipment failure and even electric shock. Do not place sample and reagent on the analyzer. In case of liquid ingression, shutspillage, switch off the power suppliesimmediately, remove the spillage and contact Mindray Customer Service Departmentcustomer service department or your local distributor.

Preventing Personal Injury

WARNING: Do not touch such moving parts as sample probe, reagent probe and mixing bar, when the analyzer is in operation.

Do not put your finger or hand into any open part when the analyzer is in operation.

If you want to replace the photometer lamp, first switch off the POWER and then wait at least 15 minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you may get burned.

Eye Protection

WARNING: Light sent by the photometer lamp or the bar code scanner may hurt your eyes. Do not stare into the lamp or the laser beam from the bar code scanner when the analyzer is in operation.

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Preventing Infection

BIOHAZARD: Inappropriately handling samples may lead to biohazardous infection. Do not touch the sample, mixture or waste with your hands. Wear gloves and lab coat and, if necessary, goggles.

In case your skin contacts the sample, follow standard laboratory safety procedure and consult a doctor.

Handling Reagents and Wash Solution

WARNING: Reagents and wash solution are corrosive to human skins. Exercise caution when using the reagents. In case your skin or clothes contact the reagents, wash them off with soap and clean water. In case the reagents spill into your eyes, rinse them with much water and consult an oculist.

Treating Waste Liquids

BIOHAZARD: Dispose of the waste in accordance with your local or national guidelines for biohazard waste disposal and consult the manufacturer or distributor of the reagents for details.

Treating Waste Analyzer

Please observe the following instructions to dispose of the waste analyzer.

WARNING Materials of the analyzer are subject to contamination regulations. Dispose of the waste analyzer in accordance with your local or national guidelines for waste disposal.

Preventing Fire or Explosion

WARNING: Ethanol is flammable substance around the analyzer. Please exercise caution while using the ethanol.

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Precautions on Use

To use the analyzer safely and effectively, pay attention to the following operation notes.

Intended Use

WARNING: The BS-300 Chemistry Analyzer (hereinafter referred to as the BS-300) is a chemistry system that is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine, CSF and other samples. Please consult Mindray first if you want to use the BS-300 for other purposes.

To draw a clinical conclusion, please also refer to the patients clinical symptom and other test results.

Operator

WARNING: The BS-300 is to be operated only by clinical professionals, doctors or laboratory experimenters trained and authorized by Mindray or Mindray-authorized distributors.

Environment

CAUTION: Please install and operate the analyzer in an environment specified by this manual. Installing and operating the analyzer in other environment may lead to unreliable results and even equipment damage.

To relocate the analyzer, please contact Mindray Customer Service Department or your local distributor.

Preventing Interference by Electromagnetic Noise

CAUTION: Electromagnetic noise may interfere with operation of the analyzer. Do not install devices generating excessive electromagnetic noise around the analyzer. Do not use such devices as mobile phones or radio transmitters in the room housing the analyzer. Do not use other CRT displays around the analyzer.

The analyzing unit is designed and tested to EN 61326:2003 Class A. In a domestic environment it may cause radio interference, so you may need to take measures to mitigate the interference. Do not use other medical instruments around the analyzer that may generate electromagnetic noise to interfere with their operations.

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Operating the BS-300

CAUTION: Operate the BS-300 strictly as instructed by this manual. Inappropriate use of the analyzer may lead to unreliable test results or even equipment damage or personal injury.

Before using the system for the first time, run the calibration program and the QC program to make sure it is in a proper state.

Be sure to run the QC program every time you use the system, otherwise the result man be unreliable.

Do not open the sample disk or reagent disk cover when the analyzer is operating.

The RS-232 port on the analyzing unit is to be used for connection with the operation unit only. Do not use it for other purposes. Only use the supplied cable for the connection.

The operation unit is a personal computer with the analyzer control system installed. Installing other software or hardware on this computer may interfere with the system operation. Do not run other software when the system is working.

Do not use this computer for other purposes. Inappropriate use of this computer may introduce computer virus, which may spread through floppy disks, software or network, into the system.

Do not touch the display, mouse or keyboard with wet hands or hands with chemicals on them.

Dont place the POWER to ON again within 10 seconds since placing it to OFF, otherwise the system may enter the protection status. If it does so, place the POWER to OFF and place it to ON again.

Maintaining the BS-300

CAUTION: Maintain the BS-300 strictly as instructed by this manual. Inappropriate maintenance may lead to equipment damage or personal injury.

To wipe off dust from the analyzer surface, use a soft, clean and wet (not too wet) cloth, soaked with soap water if necessary, to clean the surface. Do not use such organic solvents as ethanol for the cleaning. After cleaning, wipe the surface dry with dry cloth.

Switch off all the powers and disconnect the power plug before cleaning. Take necessary measures to prevent water ingression into the system, otherwise it may lead to equipment damage or personal injury.

Replacements of such major parts as the photometer, sample probe, reagent probe, mixing bar and syringe plungers must be followed by a calibration.

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Samples

CAUTION: Use serum samples that are completely separated from blood clots or urine samples that are free from suspended matter. If fibrin exists in the serum samples or suspended matter exist in the urine samples, the sample probe may be blocked.

Medicines, anticoagulants or preservative in the samples may lead to unreliable test results.

Hemolysis, jaundice or chylomicron in the samples may lead to unreliable test results, so sample blanks are recommended

Store the samples properly. Improper storage may change the compositions of the samples and lead to unreliable results.

Sample volatilization may lead to unreliable results. Do not leave the sample open for too long.

Not all the tests the reagents claim capable of analyzing can be analyzed on the analyzer. Consult the reagent suppliers for detailed information.

Certain samples need to be processed before being analyzed by the analyzer. Consult the reagent suppliers for details.

The analyzer has a specific requirement on the minimum sample volume. Refer to this manual for the proper sample volume.

Load the sample to proper tube positions on the sample disk before the analysis begins; otherwise you will not obtain correct results.

Reagents, Calibrators and Controls

CAUTION: Use proper reagents, calibrators and controls in the analyzer.

Select appropriate reagents according to the performance characteristics of the analyzer. Consult the reagent supplier or Mindray-authorized distributor for details when you are not sure about your reagent choice. Store and use the reagents, calibrators and controls strictly as instructed by the suppliers. Otherwise, you may not obtain reliable results or the best performance of the analyzer.

Perform calibration after changing the reagents. Otherwise, you may not obtain reliable results.

Contamination among reagents by carryover may lead to unreliable test results. Consult the reagent supplier for details.

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Setting up BS-300

CAUTION: You need to set up the analyzer strictly as instructed by this manual before using it. To define such parameters as sample volume, reagent volume and wavelength, consult instructions of reagents.

Backing Up Data

NOTE: The analyzer automatically backs up the data to the built-in hard disk. However, data loss is still possible due to mis-deletion or physical damage of the disk. Mindray recommends you regularly back up the data to such medium as CDs.

Computer and Printer

NOTE: Refer to their users manuals for details.

External Equipment

WARNING: External equipment connected to the system, such as PC and printer, shall be consistent with IEC 60950 or EN 60950.

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Contents

Preface.......................................................................................................................................... 1 Who Should Read This Manual ............................................................................................. 1 What Can You Find in This Manual........................................................................................ 1 Conventions Used in This Manual ......................................................................................... 1 Safety Precautions ................................................................................................................. 4 Precautions on Use................................................................................................................ 6

Contents ........................................................................................................................................ i

1 System Description ..........................................................................................................1-1 1.1 Hardware Introduction .........................................................................................1-1

1.1.1 Analyzing Unit ......................................................................................1-2 1.1.2 Operation Unit ....................................................................................1-16 1.1.3 Output Unit .........................................................................................1-16

1.2 Software Introduction.........................................................................................1-17 1.2.1 Software Interface ..............................................................................1-17 1.2.2 Main Interface Components ...............................................................1-18 1.2.3 Mouse Operations ..............................................................................1-21

2 Installation .........................................................................................................................2-1 2.1 Unpacking............................................................................................................2-1 2.2 Installation Requirements ....................................................................................2-1

2.2.1 Installation Environment Requirements................................................2-1 2.2.2 Power Requirements............................................................................2-2 2.2.3 Temperature and Humidity Requirements............................................2-2 2.2.4 Water Supply and Drain Requirements................................................2-3 2.2.5 Space and Accessibility Requirements.................................................2-3

2.3 Connecting the Tanks ..........................................................................................2-4 2.3.1 Connecting the Deionized Water Tank .................................................2-4 2.3.2 Connecting the Waste Tank..................................................................2-4

2.4 ISE Unit (optional) Installation .............................................................................2-5 2.4.1 Installing Electrodes .............................................................................2-6 2.4.2 Installing Reagent Module....................................................................2-8

3 Basic Operations ..............................................................................................................3-1 3.1 Daily Procedure ...................................................................................................3-1 3.2 Preparing for Analysis..........................................................................................3-2

3.2.1 Checking before Startup.......................................................................3-2 3.2.2 Power-on ..............................................................................................3-3 3.2.3 Starting the Operating Software ...........................................................3-3 3.2.4 Setting Up the BS-300..........................................................................3-4 3.2.5 Preparing for Analysis ..........................................................................3-5

3.3 Starting Analysis ..................................................................................................3-5 3.3.1 Calibration ............................................................................................3-5 3.3.2 QC ........................................................................................................3-6 3.3.3 Samples................................................................................................3-6 3.3.4 Editing Results of Sample Runs...........................................................3-7 3.3.5 Printing Results of Sample Runs..........................................................3-7

3.4 Finishing Analysis ................................................................................................3-7 3.4.1 Exiting the Operating Software.............................................................3-7 3.4.2 Shutdown..............................................................................................3-8

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3.4.3 Checking after Shutdown .....................................................................3-8

4 Advanced Operations.......................................................................................................4-1 4.1 Routine ................................................................................................................4-1

4.1.1 Samples................................................................................................4-1 4.1.2 Calibration .......................................................................................... 4-11 4.1.3 QC ......................................................................................................4-13 4.1.4 Status..................................................................................................4-14 4.1.5 Start ....................................................................................................4-34 4.1.6 Probe Stop..........................................................................................4-37 4.1.7 Stop ....................................................................................................4-38 4.1.8 Exit......................................................................................................4-38 4.1.9 Emergency Exit ..................................................................................4-39

4.2 Parameters ........................................................................................................4-39 4.2.1 Assay..................................................................................................4-39 4.2.2 Reagent ..............................................................................................4-61 4.2.3 Calibration ..........................................................................................4-67 4.2.4 QC ......................................................................................................4-87

4.3 Data .................................................................................................................4-108 4.3.1 Export ...............................................................................................4-108 4.3.2 Import ............................................................................................... 4-112 4.3.3 Demographics .................................................................................. 4-114 4.3.4 Result ............................................................................................... 4-116

4.4 System.............................................................................................................4-130 4.4.1 System Status...................................................................................4-130 4.4.2 Setup ................................................................................................4-133 4.4.3 Hospital.............................................................................................4-141 4.4.4 User ..................................................................................................4-146 4.4.5 Log....................................................................................................4-150 4.4.6 Maintenance.....................................................................................4-152 4.4.7 Print ..................................................................................................4-165 4.4.8 Temperature .....................................................................................4-171 4.4.9 Database ..........................................................................................4-173 4.4.10 Bar Code Scanner............................................................................4-175 4.4.11 ISE Unit ............................................................................................4-176

4.5 Help .................................................................................................................4-181 4.5.1 Version..............................................................................................4-181 4.5.2 Guide................................................................................................4-181

5 Maintenance ......................................................................................................................5-1 5.1 Preparation ..........................................................................................................5-1 5.2 Daily Maintenance ...............................................................................................5-2

5.2.1 Checking Sample/Reagent Syringes ...................................................5-2 5.2.2 Checking/Washing Sample Probe........................................................5-3 5.2.3 Checking/Washing Reagent Probe ......................................................5-4 5.2.4 Checking/Washing Mixing Bar .............................................................5-4 5.2.5 Checking Detergents............................................................................5-4 5.2.6 Checking Connection of Deionized Water............................................5-5 5.2.7 Checking Connection of Wastewater ...................................................5-6 5.2.8 Checking Remaining Deionized Water.................................................5-8 5.2.9 Emptying Waste Tank...........................................................................5-8 5.2.10 Emptying Used-Cuvettes Bucket .........................................................5-9 5.2.11 Cleaning ISE Unit (optional) ...............................................................5-10 5.2.12 Pump Calibration (optional)................................................................5-10

5.3 Weekly Maintenance ......................................................................................... 5-11 5.3.1 Washing Sample Probe...................................................................... 5-11 5.3.2 Washing Reagent Probe ....................................................................5-13 5.3.3 Washing Mixing Bar............................................................................5-15 5.3.4 Washing Deionized Water Tank .........................................................5-16

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5.3.5 Washing Waste Tank..........................................................................5-17 5.3.6 Cleaning Sample Disk/Compartment .................................................5-18 5.3.7 Cleaning Reagent Disk/Compartment................................................5-19 5.3.8 Cleaning Panel of Analyzing Unit .......................................................5-20

5.4 Monthly Maintenance ........................................................................................5-21 5.4.1 Cleaning Wash Well of Sample Probe ...............................................5-21 5.4.2 Cleaning Wash Well of Reagent Probe..............................................5-21 5.4.3 Cleaning Wash Well of Mixing Bar .....................................................5-22 5.4.4 Cleaning Sample Probe Rotor............................................................5-23 5.4.5 Cleaning Reagent Probe Rotor ..........................................................5-23 5.4.6 Cleaning Mixing Bar Rotor .................................................................5-24

5.5 Maintenance Every Six Months.........................................................................5-25 5.6 Irregular Maintenance........................................................................................5-25

5.6.1 Unclogging Sample Probe..................................................................5-25 5.6.2 Unclogging Reagent Probe ................................................................5-32 5.6.3 Replacing Sample Probe....................................................................5-38 5.6.4 Replacing Reagent Probe ..................................................................5-38 5.6.5 Replacing Mixing Bar .........................................................................5-39 5.6.6 Replacing Plunger Assembly of Sample/Reagent Syringe ................5-43 5.6.7 Removing Air Bubbles ........................................................................5-45 5.6.8 Replacing Lamp .................................................................................5-46 5.6.9 Replacing Electrode (optional) ...........................................................5-48 5.6.10 Replacing Reagent Module (optional)................................................5-49 5.6.11 ISE Unit Storage (optional).................................................................5-50 5.6.12 ISE Unit Re-activation (optional) ........................................................5-51

5.7 Maintenance Log ...............................................................................................5-51

6 Troubleshooting................................................................................................................6-1 6.1 Classification of Error Messages.........................................................................6-1 6.2 Corrective Measures ...........................................................................................6-4

6.2.1 Corrective Measures for General Errors ..............................................6-4 6.2.2 Corrective Measures for ISE Unit Errors............................................6-48

7 Calculation Methods.........................................................................................................7-1 7.1 Reaction Types....................................................................................................7-1

7.1.1 Endpoint ...............................................................................................7-1 7.1.2 Fixed-Time............................................................................................7-1 7.1.3 Kinetic...................................................................................................7-3

7.2 Calculation Process.............................................................................................7-3 7.2.1 AD Value Absorbance......................................................................7-4 7.2.2 Absorbance Response ....................................................................7-5 7.2.3 Response Calibration Parameter.....................................................7-9 7.2.4 Calibration Parameter Test Result/QC Result ...............................7-13 7.2.5 QC Result QC Conclusion .............................................................7-15

7.3 Calculation Method of ISE Unit (optional) .........................................................7-17

Appendix A Specifications............................................................................................ A-1 A.1 Technical Specifications.......................................................................................A-1 A.2 Power Requirements ...........................................................................................A-2 A.3 Environmental Requirements ..............................................................................A-2 A.4 Dimension and Weight ........................................................................................A-2 A.5 Other Specifications.............................................................................................A-2 A.6 Input/Output Devices ...........................................................................................A-2 A.7 Interface...............................................................................................................A-3 A.8 Built-in Sample Bar Code Scanner (optional)......................................................A-3 A.9 ISE Module (optional) ..........................................................................................A-3

Appendix B Supplies ..................................................................................................... B-1

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Appendix C Index........................................................................................................... C-1

1-1

1 System Description

This chapter includes the following two sections:

Hardware Introduction Software Introduction The BS-300 Chemistry Analyzer is a chemistry system that is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine, CSF and other samples.

NOTE: Not all the parameters the reagents claim capable of testing can be tested on the analyzer. Consult the reagent suppliers for detailed information.

1.1 Hardware Introduction

The BS-300 consists of the analyzing unit, operation unit, output unit, replacing parts and consumables. The analyzing unit and the operation unit are as shown in Figure 1-1.

Figure 1-1 Overview of the analyzing unit and the operation unit

Analyzing Unit Operation Unit

System Description

1-2

1.1.1 Analyzing Unit

The analyzing unit handles all the analyzing operations, which include dispensing samples and reagents, mixing, reaction and measurement, automatically replacing reaction cuvettes, etc.

The analyzing unit consists of the following major parts:

Sample disk assembly Built-in sample bar code scanner (optional) Sample dispenser Reagent disk assembly Reagent dispenser Mixer Reaction cuvette loader Reaction disk assembly Photometric system ISE module (optional)

Figure 1-2 Top view

System Description

1-3

Figure 1-3 Front view

Connect the power cord to the power plug shown in Figure 1-3.

Figure 1-4 Rear view

DEIONIZED WATER: If you choose to feed deionized water from the back of the analyzing unit, pull the deionized water tubing into the unit from here;

D-SENSOR: If you choose to feed deionized water from the back of the analyzing unit, pull the cable of the deionized water level detector into the unit from here;

System Description

1-4

WASTE: If choose to discharge waste from the back of the analyzing unit, pull the waste tubing out of the unit from here;

W-SENSOR: If you choose to discharge the waste from the back of the analyzing unit, pull the cable of the waste level detector out of the unit from here;

COM: It is the serial port for communication with the operation unit; RESET: You can press this button to restart the analyzing unit when it stops

responding.

WARNING: Press the RESET button only when the analyzing unit stops responding. Do not press this button when the unit is working normally. Otherwise, it may lead to system failure, unreliable analysis results or serious unexpected consequences.

1.1.1.1 Sample Disk

The sample disk (as Figure 1-5 shows) holds sample tubes and rotates (counter-clockwise only) the designated tube to the position for the sample probe to aspirate.

Figure 1-5 Sample disk

The sample disk is composed of two circles an inner circle and an outer circle. It provides 60 tube positions, 30 on the inner circle and 30 on the outer circle. Every tube position has an identification number. Positions 1-45 are for samples, E1-E5 for emergency samples, S1-S6 for calibrators, C1-C3 for controls, and W for distilled water. All the other positions except the position W can be used for samples, too.

The sample disk can hold six types of tubes micro sample cup, collection tube, 12mm68.5mm, 12mm 99mm, 12.7mm75mm and 12.7mm100mm. To install the sample disk, keep the handle at the vertical position, align the central hole of the handwheel to the rotor, gently lower the sample disk all the way down (rotate the disk a bit as necessary) and move the handle back to the horizontal position to secure the disk to the rotor. When you have finished installing the disk,

System Description

1-5

grab the handwheel and lightly pull it upward. If the disk remains secured, it means it is well installed.

To remove the sample disk, first shift the handle from the horizontal position to the vertical position. Then grab the handle or handwheel and pull the disk upward to remove it from the rotor.

To load sample tubes, insert the tube into the tube holder until the bottom of the tube contacts the groove on the tube rack.

To remove sample tubes, grab the tube and pull it upward to remove it from the tube holder.

WARNING: Before installing/removing the sample disk, make sure the analyzing unit is turned off and the sample disk has stopped.

Before installing/removing the sample tubes, make sure the analyzing unit is turned off and the sample disk has stopped.

Do not use sample tubes other than the specified.

Before running the analyzing unit, make sure that the sample disk cover is closed and the round red mark on the cover is aligned with its counterpart on the panel. Otherwise the sample probe may be damaged. If samples spill in the sample compartment or on the sample disk, be sure to wipe the spills with cloth soaked with water or disinfector after turning off the analyzing unit.

1.1.1.2 Built-in Sample Bar Code Scanner (optional)

Figure 1-6 Built-in bar code scanner (optional)

Bar Code Scanner Window

The built-in sample bar code scanner (optional) can read the bar code labels on the sample tubes.

The bar code labels can be applied to the following sample tubes.

12mm 99mm 12.7mm75mm 12.7mm100mm

System Description

1-6

The bar code labels applied to the sample tubes must meet the following requirements.

The bottom of the sample tube fully contacts the tube rack of the sample disk. There is no obstruction between the scanner and the bar code labels. Stick the bar code label to the sample tube so that the lower end of the bar code

label is 8-10mm above the bottom of the tube. The length of the bar code label is no more than 55mm with blank areas of 5 mm

are provided at both sides of barcode.

Tube

Bar code label

8-10mm

5mm

5mm

no more than 55m

m

Black print on white background. Stick the bar code label to the sample tube so that the inclination angle is no more

than 5.

Inclination angle

Stick the entire surface of the label to the surface of the sample tube so it will not peel.

When inserting the tube with bar code label into the sample disk, ensure the center of the label is within the 2mm range, as shown in the figures below.

System Description

1-7

+2mm

-2mm

Bar code label

Center of bar code label

NOTE: Mindray recommends printing coding information beside barcode.

Bar code symbol specifications:

The bar code scanner can read the following bar code symbologies: Code 128 (Set A, B, C), Code 39, Codabar, ITF (Interleaved 2 of 5), UPC/EAN, Code93

Feature size: 0.19-0.50mm Length: 3-16 Thin bar: thick bar: 1:2.5-3 Height: 10mm or more Printing: black print on white background; the minimum acceptable symbol grade

is Class C as defined in the ANSI MH10.8M Print Quality Specification.

NOTE: To ensure the stability of reading Codabar, the length of it is no less than 4.

The maximum number of digits will be determined after confirming that the actual printed labels can be read properly.

1.1.1.3 Sample Dispenser

The sample dispenser is composed of a sample probe, probe arm, probe rotor (Figure 1-7), syringe (Figure 1-8) and a fluid system. It aspirates certain amount of

System Description

1-8

sample from the designated sample tube and dispenses the aspirated sample to the designated reaction cuvette. Open the middle door of the analyzing unit and you will see the sample syringe (right) and the reagent syringe (left). The sample syringe can aspirate/dispense 3-45l of sample for clinical chemistry tests or 70l of sample for ISE tests (if the ISE unit is connected) and its minimum scale is 0.5l.

Figure 1-7 Sample dispenser

Figure 1-8 Sample syringe

Sample Syringe

To dispense the sample, the sample probe first moves to the sample tube to aspirate certain amount of the sample, then to the reaction disk to dispense the aspirated sample to a reaction cuvette and finally to the wash well for cleaning.

The sample probe can automatically detect the sample level. When the sample probe contacts obstacles in the vertical direction, its safeguard will automatically protect the probe from damage.

System Description

1-9

WARNING: When the analyzing unit is running, do not place any part of your body or any obstacle in the route the arm moves. Otherwise, it may lead to personnel injury or equipment damage.

1.1.1.4 Reagent Disk Assembly

The reagent disk assembly is composed of a reagent disk and a refrigerator.

The reagent disk (as Figure 1-9 shows) holds the reagent bottles and rotates (counter-clockwise only) the designated bottle to the position for the reagent probe to aspirate.

The refrigerator keeps the reagents in a low temperature environment to keep them stable and minimize volatilization.

Figure 1-9 Reagent disk

The reagent disk has two circles, inner circle and outer circle. There are 25 reagent positions in each circle and the reagent disk has totally 50 reagent positions. The reagent disk can hold the Mindray inner-circle bottles, Mindray outer-circle bottles, Hitachi 7060 bottles, Hitachi 7170 bottles and Hitachi 20ml bottles.

The refrigerator can run 24 hours a day to keep the temperature at 4-10.

NOTE: The refrigerator has a power supply independent of that of the analyzing unit. It will be put into service once the POWER is turned on.

To install the reagent disk, keep the handle at the vertical position, align the central hole of the handwheel to the rotor, gently lower the reagent disk all the way down (rotate the disk a bit as necessary) and move the handle back to the horizontal position to secure the disk to the rotor. When you have finished installing the disk, grab

System Description

1-10

the handwheel and lightly pull it upward. If the disk remains secured, it means it is well installed.

To remove the reagent disk, first shift the handle from the horizontal position to the vertical position. Then grab the handle or handwheel and pull the disk upward to remove it from the rotor.

To load reagent bottles, insert the bottle into the bottle holder until the bottom of the bottle contacts the groove on the bottle rack.

To remove the reagent bottle, grab the bottle and pull it upward to remove it from the bottle holder.

WARNING: Before installing/removing the reagent disk, make sure the analyzing unit is turned off and the sample disk has stopped.

Before installing/removing the reagent bottles, make sure the analyzing unit is turned off and the sample disk has stopped. When installing the bottle, make sure the bottle bottom is in full contact with the bottle rack.

Before running the analyzing unit, make sure that the reagent disk cover is closed and the round red mark on the cover is aligned with its counterpart on the panel. Otherwise the sample probe may be damaged and cooling capacity of the refrigerator will be degraded.

If reagents spill in the reagent compartment or on the reagent disk, be sure to wipe the spills with cloth soaked with water or disinfector after turning off the analyzing unit.

1.1.1.5 Reagent Dispenser

The reagent dispenser is composed of a reagent probe, probe arm, probe rotor (Figure 1-10), syringe (Figure 1-11) and fluid system. It aspirates certain amount of reagent from the designated reagent bottle and dispenses the aspirated reagent to the designated reaction cuvette. The reagent probe arm can preheat the aspirated reagent.

Open the middle door of the analyzing unit and you will see the reagent syringe (right) and reagent syringe (left). The reagent syringe can aspirate/dispense 30-450l of reagent and its minimum scale is 1l.

System Description

1-11

Figure 1-10 Reagent dispenser

Figure 1-11 Reagent syringe

To dispense the reagent, the reagent probe first moves to the reagent bottle to aspirate certain amount of the reagent, then to the reaction disk to dispense the aspirated reagent to a reaction cuvette and finally to the wash well for cleaning.

The reagent probe can automatically detect the reagent level. When the reagent probe contacts obstacles in the vertical direction its safeguard will automatically function to protect the probe from damage.

WARNING: When the analyzing unit is running, do not place any part of your body or any obstacle in the route the arm moves. Otherwise, it may lead to personnel injury or equipment damage.

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1.1.1.6 Mixer

The mixer is composed of a mixing bar, bar arm and rotor, as Figure 1-12 shows. The mixing bar thoroughly stirs the reaction mixture (reagents and sample) in the reaction cuvette.

Figure 1-12 Mixer

For the single-reagent test, the mixer starts to work after the sample is dispensed into the reaction cuvette. For the double-reagent test, the mixer starts to work after the sample or the second reagent is dispensed into the reaction cuvette. The mixing bar moves to a position above the reaction disk, lowers into the cuvette, and rotates to mix the mixture in the cuvette. After that, the bar moves to the wash well for cleaning and de-watering.

1.1.1.7 Reaction Cuvette Loader

The cuvette loader is composed of a cuvette feeder, manipulator and used-cuvette bucket.

This loader loads new cuvettes to the reaction disk and dumps used cuvettes into a bucket. The feeder is located in the cuvette compartment and transfers cuvettes to the manipulator, which grabs the cuvettes and loads them to the reaction disk and then unloads the used cuvettes and dumps them into the used-cuvette bucket. Open the lower door of the analyzing unit and you will see the used-cuvette bucket in the middle.

NOTE: Normally, the used-cuvette bucket can hold 80 segments of reaction cuvettes (10 cuvettes per segment). Be sure to empty the bucket in time so that excessive cuvettes will not overflow and contaminate the cabinet.

Disposable cuvettes are adopted as the reaction cuvettes. Ten cuvettes are bound together as one cuvette segment. The cuvette compartment can house 30 cuvette segments, which are sufficient for 300 continuous tests.

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When all the cuvettes of a cuvette segment have been used, the reaction disk rotates the segment to the unloading position, and then the manipulator dumps the used segment into the used-cuvette bucket and loads the new segment. When a segment is taken from the cuvette compartment, the cuvette feeder pushes the next segment to the loading position.

When there are less than 10 segments in the compartment, the analyzing unit, though keeping working, will give an alarm. Seeing the alarm, you should, if you still have more tests to do, add more segments to the compartment.

When all the segments in the compartment are used, the analyzing unit will stop first loading cuvette segments, and then stop dispensing samples when all the segments on the reaction disk are used. But it will keep working until all the scheduled tests are done.

Present the cuvette segment to the entry of the cuvette feeder as Figure 1-13 shows and gently push it toward inside. Load all the segments one by one until they are all loaded. When you are done, click the Load Cuvette button (refer to 4.1.4.2 Reaction Disk tab for details) to command the cuvette feeder to press the newly added segments forward. Be sure not to load the segments as Figure 1-14 shows.

NOTE: When loading cuvette segments to the entry of the cuvette compartment, be sure to keep them upright. Remove the inclined segments immediately upon seeing them and reload them the right way.

Be sure to load the segments to the cuvette compartment in the right direction (Figure 1-13). Reversely loaded segments (Figure 1-14) may jam the loader and halts the analyzing unit. Do not click the Load Cuvette button before completing adding all the cuvette segments to the compartment. Otherwise, the loading operation may fail.

Figure 1-13 Loading cuvette segments the right way

System Description

1-14

Figure 1-14 Loading cuvette segments the wrong way

Open the middle door to load/remove the used-cuvette bucket.

BIOHAZARD: Be sure to load the used-cuvette bucket to the designated position on the bottom plate. Otherwise, the used-cuvette may not be dumped into the bucket and the spilled reaction mixture may contaminate and corrode the cabinet.

Be sure to wear gloves, goggles and protective clothing when loading or removing the used-cuvette bucket.

Be sure to dispose of the used-cuvette in compliance with the local regulations.

1.1.1.8 Reaction Disk Assembly

The reaction disk assembly is composed of a reaction disk and a temperature-controlled chamber, both of which are inside the analyzing unit. The reaction disk holds the reaction cuvettes, in which the sample reacts with the reagents and colorimetric readings are taken.

The temperature-controlled chamber provides for the reaction an environment of consistent temperature.

The reaction disk can hold 8 cuvette segments (80 cuvettes). The cuvettes adopted are

Disposable; 5mm6mm25mm (5mm optical path); 750l (capable of holding 180-500l of the reaction mixture).

The temperature chamber keeps the temperature at 370.3 with 0.1 fluctuation.

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BIOHAZARD: Be sure to dispose of the used cuvettes in compliance with the local regulations.

CAUTION: The reaction cuvettes should not be re-used. Otherwise, the system performance may be degraded.

During the analyzing process, the reaction disk rotates (counter-clock wise only) to cuvette-loading position, sample-dispensing position, reagent-dispensing position, or mixing position as needed. The colorimetric readings are taken when the specified cuvette passes through the optical axis.

1.1.1.9 Photometric System

The photometric system measures the absorbance of the reacting liquid in the reaction cuvettes. It consists of a measurement optical system and a reference optical system, the former providing 9 monochromatic lights and the latter compensating the former.

Specifications 9 optical paths with fixed interference filters. Wavelengths: 340nm, 405nm, 450nm, 510nm, 546nm, 578nm, 630nm, 670nm, 700nm Half band-width: 12nm Wavelength accuracy: 2nm Measurement range: 0.1-4.0 Abs Lamp: 12V 50VA tungsten-halogen Movement The measurement optical system consists of 9 optical paths. The absorbance is taken when the reaction cuvette rotates to the correspond path. The analyzer can measure the absorbance of 9 cuvettes simultaneously.

1.1.1.10 ISE Unit (optional)

The ISE unit (optional) consists of ISE module, pump module and reagent module, as shown in the figure below.

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Figure 1-15 ISE unit (optional)

Pump module

ISE module

Reagent module to be placed here

The ISE unit (optional) measures the concentration of Li+, Na+, K+ and Cl- in serum, plasma and diluted urine.

The volume of the serum or plasma sample is 70l and that of the diluted urine sample is 140l. The dilution ratio of the urine sample is 1:10 (1 part of urine sample and 9 parts of urine diluent).

There are five electrodes including Li+, Na+, K+, Cl- and reference electrodes in the ISE module. If the Li+ electrode is not selected, a spacer electrode is substituted for it.

Reagent module is integrated with Calibrant A, Calibrant B, waste containers and a chip which indicates the volume of the reagents.

1.1.2 Operation Unit

The operation unit is a computer with the Operating Software of the analyzer installed. It manages test applications, registration, generation of the work list, monitoring of reactions, calculation and data management (entering, storing and searching).

1.1.3 Output Unit

The output unit is a printer that prints out the test results.

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1.2 Software Introduction

1.2.1 Software Interface

The interface of the Operating Software of BS-300 Chemistry Analyzer (hereinafter referred to as the operating software) is shown in Figure 1-16.

Figure 1-16 Interface of the operating software

Header area Displays the names of the operating software and the manufacturer.

Title bar Displays the title of the current display area.

Menu area Displays: [Routine], [Parameters], [Data], [System], [Help]. You can move the mouse to any of the listed menu and click the left button of the mouse (hereinafter referred to as click) to display its pull-down menu.

Pull-down menu You can click the listed item of the pull-down menu to perform certain operation.

Small buttons Click the small button to view the user guide. You can also click Help Guide to view the user guide. Refer to 4.5.2 Guide for details.

Click the small button to exit the operating software. You can also click Routine Exit to exit the software. Refer to 4.1.8 Exit for details.

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Shortcut buttons area

Totally 13 buttons are available, which are: , , , ,

, , , , , , , , . You can click any of the buttons to perform certain operation quickly.

Display area Displays settings, results, graphics and so on.

System status area Displays the system status and reaction temperature.

Warning messages area Displays the warning messages, including malfunction alarm messages and prompt messages for mis-operation. When seeing the warning messages, refer to 6 Troubleshooting for solutions.

Period area Displays how many periods (every period lasts 12 seconds) of test have passed since the beginning of the first test after the latest power-on.

Time area Displays current date and time.

Operator area Displays the current operator who operates the system.

1.2.2 Main Interface Components

Dialog box The dialog box is one of the most common interfaces. See the following example:

Tab See the figure below for examples of the tab. Click the tab and you can access the screen that it indexes.

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Combo box Click and a pull-down list will display, as the figure below shows. Click the desired item to select it.

Combo box

Option button Click the option button to select the option it represents. Note that for a given group of option buttons, you can only select one of them.

Option button

Check box Click the check box to select the option it represents and click it again to de-select it. Note that for a given group of check boxes, you can choose more than one of them at one time.

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Check box

Edit box You can enter characters from the keyboard in the edit box.

Edit box

Button Click a button and you can access the function it indexes.

Scroll bar When the contents to be displayed are too many for one screen, you can use the scroll bar to see the hidden contents. Move the cursor to the scroll bar, press left button of the mouse and hold it, then you can drag the scroll bar upward or downward to see the hidden contents. Or you can press the key such as Page Up, Page Down,oron the keyboard to see the hidden contents.

Scroll bar

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1.2.3 Mouse Operations

Clicking In this manual, clicking refers to moving the pointer of the mouse to the desired item and click the left button of the mouse.

Double-clicking In this manual, double-clicking refers to moving the pointer of the mouse to the desired item and click the left button of the mouse twice swiftly.

Working with the keyboard When you wan to select multiple targets, you need to use the mouse together with the keyboard.

To select discontinuous targets: Press and hold CTRL and click them one by one. Release CTRL when you have selected all the targets.

To select continuous targets: Click the first (or last) of the desired targets, and then press and hold SHIFT and click the last (or the first) of the desired targets. Release SHIFT when you have selected all the targets.

2-1

2 Installation

WARNING: The BS-300 should only be installed by Mindray-authorized personnel only.

To facilitate the installation, you should prepare a place meeting the requirements specified in 2.2 Installation Requirements. If you need to move the analyzer to another site, please contact Mindray Customer Service Department or your local distributor, who are the appropriate people for the moving job.

2.1 Unpacking

When you receive your analyzer, carefully inspect the package. If you see any signs of mishandling or damage, file a claim immediately with Mindray Customer Service Department or your local distributor.

After opening the package, check the delivered goods against the packing list as well as the appearance of the analyzer. If you find anything missing or damaged, alert Mindray Customer Service Department or your local distributor immediately.

2.2 Installation Requirements

CAUTION: Make sure the analyzer is installed in a place meeting the following requirements. Otherwise, it will not perform as promised.

2.2.1 Installation Environment Requirements

The BS-300 is for indoor use only. The bearing platform (or ground) should be level (gradient less than 1/200). The bearing platform (or ground) should be able to bear 500Kg weight. The installation site should be well ventilated.

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2-2

CAUTION: The analyzer radiates heat from its rear side when operating. A well-ventilated environment helps keep the room temperature stable. Use ventilation equipment if necessary. But if so, be sure not to expose the analyzer to the direct draft that may lead to unreliable results.

The site should be free of dusts as much as possible. The site should not be in direct sun. The site should not be near a heat or draft source. The site should be free of corrosive gas and flammable gas. The bearing platform (or ground) should be free of vibration. The site should not be disturbed by large noise or power supply. The analyzer should not be placed near brush-type motors and electrical contacts

that are frequently turned on and off. Do not use such devices as mobile phones or radio transmitters that generate

electromagnetic waves near the analyzer. The above-sea-level height of the site should be lower than 2000 meters.

2.2.2 Power Requirements

Power supply: 100-130V/200-240V~, 50/60Hz, three-wire power cord and properly grounded.

The analyzer should be connected to a properly-grounded power socket, whose maximum power consumption should be 1kVA and neutral-to-ground voltage 6V. If possible, connect the analyzer to a power line specially designed for medical instrumentation.

The distance between the power socket and the analyzer should be less than 5 meters.

WARNING: Make sure the power socket is grounded correctly. Improper grounding may lead to electric shock and/or equipment damage.

Be sure to connect the analyzer to a power socket that meets the above-mentioned requirements and has a proper fuse installed.

2.2.3 Temperature and Humidity Requirements

Ambient temperature: 15-30, with fluctuation less than 2/H. Relative humidity: 35%RH-80%RH, no condensation.

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CAUTION: When used in conditions other than the specified, the analyzer may not provide reliable test results. If the temperature or relative humidity does not meet the above-mentioned requirements, be sure to use air-conditioning equipment.

2.2.4 Water Supply and Drain Requirements

The water must meet requirements of the CAP Type II water. The water temperature should be within 5-32.

BIOHAZARD: Be sure to dispose of the waste according to the local regulations.

CAUTION: The water to be used on the analyzer must meet the requirements of the CAP Type II water. Insufficiently purified water may result in misleading measurement.

2.2.5 Space and Accessibility Requirements

See the figure below for the space and accessibility requirements.

Figure 2-1 Space and accessibility requirements

Analyzing Unit

OperationUnit

Maximum2500

980

710

Minimum500 Minimum500

Min

imum

500

Min

imum

500

Unit: mm

WALL

FRONT

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2.3 Connecting the Tanks

BIOHAZARD: To prevent biohazard contamination, always wear gloves, goggles and protective clothing when doing the below checks.

2.3.1 Connecting the Deionized Water Tank

1 Place the ANALYZING UNIT POWER to OFF.

2 Open the lower door of the analyzing unit.

3 Pull out the extractable plate.

4 Put the pickup tubes and the sensor into the deionized water tank, then close the cap of the deionized water tank clockwise.

5 Put the deionized water tank on the right of the extractable plate.

6 Push the extractable plate back in.

7 Plug the green connector to its counterpart on the analyzing unit and turn the connector clockwise until secure.

BNC ConnectorDeionized Water Connector

(Green)Deionized Water Connector

(Red)

Pickup Tube

8 Plug the red connector to its counterpart on the analyzing unit and turn the connector clockwise until secure.

9 Plug the BNC connector to its counterpart on the analyzing unit and turn the connector clockwise until secure.

10 Close the lower door.

2.3.2 Connecting the Waste Tank

1 Place the ANALYZING UNIT POWER to OFF.

2 Open the lower door of the analyzing unit.

3 Pull out the extractable plate.

4 Put the waste tube and the sensor into the waste tank, then close the cap of the waste tank clockwise.

5 Put the waste tank on the left of the extractable plate.

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2-5

6 Push the extractable plate back in.

7 Keep pressing the pin on the connector and grab the waste tap and insert it to the connector.

BNC Connector Waste Connector

Waste Tube

Waste Tap

Pin

8 Plug the BNC connector to its counterpart on the analyzing unit and turn the connector clockwise until secure.

9 Close the lower door.

2.4 ISE Unit (optional) Installation

BIOHAZARD: To prevent biohazard contamination, always wear gloves, goggles and protective clothing when doing the below checks.

CAUTION: Use the consumables recommended by Mindray. Other consumables may degrade the system performance.

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2.4.1 Installing Electrodes

NOTE: The electrode storage for Li and K is different from the other electrodes. For there is some certain kind of solution in the lumen of the electrode, a tape covering both ends of the lumen can be seen. So whenever unpacking these electrodes, remove the tape first. If some of the solution leaks outside of the electrode, it should be wiped before installation.

Each electrode including the reference electrode has an O-ring on one side of its lumen, so ensure the side with the O-ring towards up when installing the electrodes. If the O-ring is missing, replace with a new one. Extra two O-rings are supplied in the electrode boxes.

Connection Pins

O-ring

1 Place the POWER to OFF.

2 Open the ISE unit (optional) door.

3 Unscrew the screw of the ISE module cover by hand.

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2-7

4 The reference electrode is the first to be installed.

Open the electrode from its protective packaging and remove the insert from the lumen of the reference electrode.

Make sure that the red sphere in the reference electrode floats on the top of the internal fill solution in the reservoir.

Red sphere

Insert

Place the reference electrode inside the housing by pressing down the compression plate and push it straight against the back of the housing. Release the compression plate and ensure the electrode cannot be easily moved.

Sample entry port

Compression plate

Li+ electrode (or Spacer electrode)

Housing

Na+ electrodeK+ electrodeCl- electrodeReference electrode

5 Remove the Chloride electrode from its protective packaging and place it in the ISE module housing in the same way as the reference electrode.

6 Repeat the process for the Potassium electrode.

7 Repeat the process for the Sodium electrode.

8 Repeat the process for the Lithium electrode. If you do not select Lithium electrode, repeat the process for the spacer electrode.

9 Push all the electrodes simultaneously to ensure they are in correct alignment.

All the electrodes for Li (spacer electrode included), Na, K and Cl are the same size and shape. Connection pins at the rear of each electrode are different which ensures that the electrodes are inserted in the correct order. So if one of the electrodes can not be easily push into the housing, check the electrode first then repeat the installation process.

10 Screw the screw of the ISE module cover.

11 Close the ISE unit door.

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2.4.2 Installing Reagent Module

1 Place the POWER to OFF.

2 Open the ISE unit (optional) door.

3 Take off the three red caps from the reagent module. Put the wand on the module, press it down to connect to the module firmly. Then put the module with the wand into the ISE unit.

4 Place the POWER to ON.

5 Restart the operating software, or if it is running, enter the System Maintenance screen and click the Download Settings button at the MotionOthers tab.

6 Enter the ISE screen and click the Replace button.

7 Enter the ISE screen of the operating software.

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8 Enter 20 into the edit box to the right of Time(s) and click the Purge AB button.

9 Close the ISE unit door.

3-1

3 Basic Operations

This chapter provides step-by-step procedures for operating the analyzer for basic tasks.

3.1 Daily Procedure

Basic Operations

3-2

3.2 Preparing for Analysis

3.2.1 Checking before Startup

Do the followings checks before starting the analyzer.

BIOHAZARD: Wear gloves, goggles and protective clothing when performing the

below checks.

Check the power supply and make sure it can supply proper voltage for the analyzer.

Check the connections among the analyzing unit, operation unit and printer. Make sure the connections are right and secure. Check the power cords of the analyzing unit, operation unit and printer and make sure they are well connected to power sockets.

Check and make sure sufficient printing paper is prepared for the printer. Check the sample and reagent syringes for leakage as instructed by 5.2.1

Checking Sample/Reagent Syringes. Check the sample and reagent probes and make sure there is no fluid hanging on

the probe tips. If there is, please contact Mindray Customer Service Department or your local distributor.

Check the connections of the deionized water and wastewater as instructed by 5.2.6 Checking Connection of Deionized Water and 5.2.7 Checking Connection of Wastewater.

Check the sample probe and make sure it is neither dirty nor bent. If it is dirty, wash it as instructed by 5.3.1 Washing Sample Probe; if it is bent, replace it as instructed by 5.6.3 Replacing Sample Probe.

Check the reagent probe and make sure it is neither dirty nor bent. If it is dirty, wash it as instructed by 5.3.2 Washing Reagent Probe; if it is bent, replace it as instructed by 5.6.4 Replacing Reagent Probe.

Check the mixing bar and make sure it is neither dirty nor bent. If it is dirty, wash it as instructed by 5.3.3 Washing Mixing Bar; if it is bent, replace it as instructed by 5.6.5 Replacing Mixing Bar.

Check the cuvette compartment and make sure there are sufficient cuvettes in it. If the cuvettes are not sufficient, add more cuvettes as instructed by 1.1.1.7 Reaction Cuvette Loader.

CAUTION: You must prepare enough cuvettes for the upcoming analysis. If you find the cuvettes are not enough, add more immediately.

Sometimes the new cuvettes are not as smooth as they should be. Check the surface of the cuvettes for bumps and take necessary measures to remove the found bumps before loading them to the compartment. Otherwise, they may jam the analyzing unit.

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Check and make sure there is enough deionized water in the deionized water tank as instructed by 5.2.8 Checking Remaining Deionized Water.

CAUTION: You must prepare enough deionized water. If you find the deionized water is not enough, add more deionized water to the tank.

Check the waste tank and make sure it is empty. If not, empty the tank as instructed by 5.2.9 Emptying Waste Tank.

Check the used-cuvettes bucket and make sure it is empty. If not, empty the bucket as instructed by 5.2.10 Emptying Used-Cuvettes Bucket.

3.2.2 Power-on

Power up the analyzer in the sequence presented below:

Place the POWER to ON. Place the ANALYZING UNIT POWER to ON. Press the power button of the monitor of the operation unit. Press the power button of the computer of the operation unit. Press the power button of the printer.

3.2.3 Starting the Operating Software

NOTE: Ensure the hibernation function of the display is unavailable:

After entering the display properties screen, select Never for Turn off monitor, Turn off hard disks and System standby on the Power Schemes tab and do not select Enable hibernation on the Hibernate tab.

After you have logged on the WINDOWS operating system, you may

Double-click the icon on the desktop to start the operating software; or Click [START] [PROGRAM] or [ALL PROGRAMGS][BS-300 Chemistry

Analyzer Operating Software][BS-300 Chemistry Analyzer Operating Software] to start the operating software.

The operating software will do the initialization procedure in the sequence presented below:

Initializing system environment. Initializing database. Initializing printer. Downloading system settings from the analyzing unit.

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Shaking hands with the analyzing unit.

The system does the startup and warm-up procedures in the sequence presented below and the analyzer will then enter the standby state:

Initializing database, system environment and printer; connecting to the LIS (Laboratory Information System. If the LIS server is configured.); downloading settings; shaking hands with the modules; communicating with the ISE unit (if configured) and the built-in bar code scanner (if configured); running self-tests and resetting the modules. A dialog box will then pop up to ask you to enter your username and password.

NOTE: You need to enter proper username and password to access the control system. Use the initial username and password (username: administrator; password: bs300) if this is the first time the control system being used and then you may edit your own username and password as instructed by 4.4.4 User.

Measuring dark currents; Turning on the lamp of the photometer and loading the first cuvette segment to

measure the backgrounds, which reflects the status of the lamp; Loading new cuvettes, taking their absorbance and marking the dirty ones; Checking the status of the deionized water tank and waste tank and checking the

status of the cuvette compartment; Performing the default washing procedure to wash the exteriors and interiors of

the sample probe, reagent probe and mixing bar with deionized water; Checking the status of the reaction disk repeatedly and displaying its temperature

on the main interface. When the warm-up process is still under way, the status box in the upper right corner displays Incubation and when the expected temperature is reached it displays Idle, indicating the analyzing unit is on standby.

CAUTION: You may start the analysis once the initialization is finished. However, Mindray recommends you wait until the temperature and photometric system is fully stabilized, which is when the status box displays Idle and the analyzer has been turned on for 30 minutes.

3.2.4 Setting Up the BS-300

The analyzer will not function properly unless it is properly set up.

You must complete all the following settings if this is the first time the analyzer being used.

Before requesting the tests, you must finish the following settings:

To set the options regarding the basic parameters of the system, refer to 4.4.2 Setup.

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3-5

To set the options regarding the hospital information, refer to 4.4.3 Hospital. To set the options regarding test parameters and reference, refer to 4.2.1.1

Parameters tab and 4.2.1.2 Reference Range tab. To set the options regarding calibrators and calibration, refer to 4.2.3.1 Calibrator

tab and 4.2.3.2 Rule tab. To set the options regarding controls, QC rule and QC test, refer to 4.2.4.1

Control tab, 4.2.4.2 Rule tab and 4.2.4.3 Setup tab. To set the options regarding the reagent parameters, refer to 4.2.2.1 Reagent

Disk tab. To set the options regarding the carryover information among tests, refer to

4.2.1.5 Carryover tab. To set the options regarding the printing parameters, refer to 4.4.7 Print.

3.2.5 Preparing for Analysis

3.2.5.1 Preparing Reagents

Load reagent bottles to their assigned positions on the reagent disk. Open the bottles.

3.2.5.2 Preparing Distilled Water

Load enough distilled water to position W on the sample disk.

Load enough distilled water to position 49 on the reagent disk.

Load enough urine diluent to position 50 on the reagent disk if ISE tests to be run. Note that the urine diluent recommended by Mindray is used.

3.2.5.3 Checking Remaining Reagents

Check remaining reagents if necessary. Refer to 4.2.2.2 Inventory tab for details.

3.3 Starting Analysis

3.3.1 Calibration

You must calibrate if this is the first time the analyzer being used.

CAUTION:

You need to run the calibration again when you change reagent lots, test parameters, lamp or other conditions.

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3-6

To request calibrations, refer to 4.1.2 Calibration.

After requesting calibrations, you should load corresponding calibrators to their assigned positions on the sample disk.

To run calibrations, refer to 4.1.5 Start.

A calibration run experiences 4 states: Requested, Waiting, Running, Finished. You can check the results of the finished runs in the following ways.

To view the results at the StatusCalib. Test, refer to 4.1.4.4 Calib. Test tab. To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk

tab. To view the results at the CalibrationResult, refer to 4.2.3.3 Result tab. If the ISE unit is connected, refer to 4.4.11.1 Calibration for detailed information about running ISE calibration and check its results.

3.3.2 QC

To request QCs, refer to 4.1.3 QC.

After requesting QCs, you should load corresponding controls to their assigned positions on the sample disk.

NOTE: If the ISE unit (optional) is connected, ISE QC should be performed.

Please use Mindray-recommended controls for ISE QC.

To run QCs, refer to 4.1.5 Start.

A QC run experiences 4 states: Requested, Waiting, Running, Finished. You can check the results of the finished runs in the following ways.

To view the results at the StatusQC Test, refer to 4.1.4.5 QC Test tab. To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk

tab. To view the results at the QCReal-time Result /Daily Result /Day-to-day

Result, refer to 4.2.4.4 Real-time Result tab, 4.2.4.5 Daily Result tab or 4.2.4.6 Day-to-day Result tab.

3.3.3 Samples

To request samples, refer to 4.1.1 Samples.

You can request a STAT sample run in the way similar to an ordinary run, except that you have to tick the check box to the right of STAT, as Figure3-1 shows. The requested STAT run will be inserted into the current work list as Waiting and has higher priority than other tests.

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Figure3-1 Requesting a STAT Sample Run

After requesting, load the samples to their corresponding positions on the sample disk.

To run samples, refer to 4.1.5 Start.

A sample run experiences 4 states: Requested, Waiting, Running, Finished. You can check the results of the finished runs in the following ways.

To view the results at the StatusSample Test, refer to 4.1.4.3 Sample Test tab.

To view the results at the StatusSample Disk, refer to 4.1.4.1 Sample Disk tab.

To view the results at the DataResultResults, refer to 4.3.4.1 Results tab.

3.3.4 Editing Results of Sample Runs

Skip this section if you do not need to edit the sample run results.

CAUTION: Sample run results can only be edited by authorized personnel.

To edit one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1 Results tab for details.

To revise one or more sample run results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1 Results tab for details.

3.3.5 Printing Results of Sample Runs

To print sample results, refer to 4.1.4.3 Sample Test tab or 4.3.4.1 Results tab for details.

3.4 Finishing Analysis

3.4.1 Exiting the Operating Software

To exit the operating software, refer to 4.1.8 Exit for details.

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3.4.2 Shutdown

After exiting the Windows operating system, switch off the following powers in the presented order:

Turn off the printer; Turn off the monitor of the operation unit; Place the ANALYZING UNIT POWER to OFF.

NOTE: The refrigerator still functions after the ANALYZING UNIT POWER is placed to OFF. To shut down the refrigerator, place the POWER to OFF.

3.4.3 Checking after Shutdown

Cap every reagent bottle on the reagent disk. Remove the calibrators, controls, distilled water and samples from the sample

disk. Check the surface of the analyzing unit for stains and wipe them off with clean

soft cloth. Check the waste tank and make sure it is empty. If not, empty the tank as

instructed by 5.2.9 Emptying Waste Tank. Check the used-cuvette bucket and make sure it is empty. If not, empty the

bucket as instructed by 5.2.10 Emptying Used-Cuvettes Bucket.

BIOHAZARD: Exercise with caution. Wear gloves, goggles and protective clothing.

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4 Advanced Operations

The chapter presents an introduction of the BS-300 operating software by menus.

The main interface of the operating software has five major menu groups:

Routine Parameters Data System Help

4.1 Routine

4.1.1 Samples

Click Routine Sample, or press F1 to enter the Request Sample screen, as Figure4-1 shows. You can also enter the Request Sample screen by clicking the

short-cut button .

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Figure4-1 Request Sample screen

The Request Sample screen consists of three zones:

Sample zone displays information regarding the samples; Assays and Profiles zone displays information regarding the assays and

profiles; Operating buttons zone displays such buttons as Browse, Edit, etc.

The Assays zone lists all available tests. You cannot request the assays followed by

a forbidden mark, such as . The double-reagent assays, whose reagent positions have already been set, are yellow-framed; the double-reagent assays, whose reagent positions have not been set yet, are gray-framed. The selected assay is followed by a tick. Only if an assay, whose dilution parameters have been set, is selected after Dilution is selected, the tick is red. Otherwise, the tick is green.

The sample parameters are interpreted as follows.

Parameter What it does How to set Sample Disk

Defines which virtual sample disk the sample is located on.

Click to the right of Sample Disk and select the desired disk from the pull down list.

Sample No. Defines the identification number of the sample or samples. You can enter the desired integers (1-9000) into the edit boxes respectively as the start (left) and end (right) IDs.

If you are entering only one samples ID ensure the two IDs are the same.

Use the system-generated ID(s) or enter the desired ID(s) manually.

Index A system-generated number for fast search.

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Parameter What it does How to set Sample ID Bar code of the sample. Enter the bar code from the

bar code scanner automatically, enter it manually, or leave it blank.

Position Defines the samples position on the selected sample disk. For STAT samples, Mindray recommends they be placed on positions E1-E5.

Use the system-generated number, click to the right of Position to select the desired position, or obtain it by the bar code scanner.

For multiple samples, the selected position represents that of the first sample and the analyzer will generate positions for the rest of the samples.

Tube Defines which type of tube holds the sample.

Click to the right of Tube and select either Large tube or Small tube from the pull down list.

Type Defines the sample type. Click to the right of Type and select one of the following four types: Serum, Plasma, Urine and Others.

Replicates Defines for how many times the analyzer should run this sample. The default value is 1.

Enter the desired integer

(1-10) or click the button to the right of Replicates until the desired integer is reached.

STAT Defines whether the sample is a stat sample. The analyzer will add the stat sample to the current work list.

Tick the check box to the right of STAT.

S. Blank Applies to the tests that use Endpoint method.

Defines whether to replace the reagents with distilled water and take the absorbance of the mixture before formally analyzing the reagents-sample mixture.

This parameter is only available for clinical chemistry tests.

Tick the check box to the right of Blank to enable this function and click it again to disable it.

Dilution Defines whether to dilute the sample before analyzing it.

This parameter is only available for clinical chemistry tests.

Tick the check box to the right of Dilution to enable this function and click it again to disable it.

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To scan bar codes

NOTE: If the built-in bar code scanner (optional) is not connected, the function is unavailable.

1 Click the Scan button and a dialog box pops up.

2 At the Scan Sample ID screen, select sample(s) you want to be scanned.

If you select All Positions, the scanner will scan all the positions in the sample disk; if you select Selected Positions, you need to enter position No. into the edit boxes to the right of Range and the scanner will scan the positions you just entered.

3 Click the Start button and the scanner will begin to work. The scanning results will be displayed at the Result field.

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4 If you want to download information of the scanned samples from the