BS-200 Chemistry Analyzer Operation Manual

© 2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved. For this Operation Manual, the issued Date is 2006-03 (Version: 1.2).

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.

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.

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NOTE: This equipment is to be operated only by medical professionals trained and authorized by Mindray or Mindray-authorized distributors.

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 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

Company Contact Manufacture:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, P.R.China, 518057

Phone:

+86 755 26582479 26582888

Fax:

+86 755 26582500 26582501

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Preface Before using the BS-200 Chemistry Analyzer, please read this operation manual thoroughly for relevant operation instructions.

Who Should Read This Manual This manual is written for clinical laboratory professionals to perform daily operating tasks; perform system maintenance and troubleshooting; learn about the BS-200 hardware and software.

WARNING: The BS-200 Chemistry Analyzer is to be operated only by medical professionals trained and authorized by Mindray or Mindray-authorized distributors.

What Can You Find in This Manual This operation manual covers principles, operations, daily maintenance and troubleshooting of the system. Please operate and service the system strictly as instructed by this manual.

Conventions Used in This Manual This manual uses certain typographical conventions to clarify meanings in the text. Bold font indicates a chapter title, such as 4 Maintenance Bold and Italic font indicates text displayed on the screen, such as Sample Request.

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.

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Preface When you see …

CAUTION:

NOTE:

Then … Read the statement following the symbol. The statement is alerting you to a possibility of system damage or unreliable results. 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 the panels of the system use symbols with the text to clarify the meaning of the text. The chart below explains the symbols on the labels. Serial Number Date of Manufacture Manufacturer The device is fully in conformance with the Council Directive Concerning In Vitro Diagnostic Medical Devices 98/79/EC. 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 ～

Alternating current (AC) ON (MAIN POWER) OFF (MAIN POWER)

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Preface ON (Power) OFF (Power)

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

EC Representative Name:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestrasse 80 D-20537 Hamburg Germany

Phone:

+49 40 2513174

Fax:

+49 40 255726

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Preface

Safety Precautions Observe the following safety precautions when using the BS-200 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 Mindray, the protection provided by the system may be impaired.

Preventing Electric Shock Please observe the following instructions to prevent electric shock.

WARNING: When the MAIN POWER is on, users must not open the rear cover or side cover. Liquid ingression may lead to electric shock or equipment damage. In case of liquid ingression, shut off the power supply and contact Mindray Service Department or your local distributor.

Preventing Personal Injury Caused by Moving Parts Please observe the following instructions to prevent personal injury caused by moving parts.

WARNING: Do not touch such moving parts as probe and mixing bar, when the system is in operation. Do not put your finger or hand into any open part when the system is in operation.

Preventing Personal Injury Caused by Photometer Lamp Please observe the following instructions to prevent personal injury caused by photometer lamp.

WARNING: Light sent by the photometer lamp may hurt your eyes. Do not stare into the lamp when the system is in operation. If you want to replace the photometer lamp, first switch off the MAIN POWER and then wait at least 30 minutes for the lamp to cool down before touching it. Do not touch the lamp before it cools down, or you may get burned.

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Preface

Preventing Infection Please observe the following instructions to protect against the biohazardous 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. Certain reagents are strongly acid or alkaline. 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 Please observe the following instructions to prevent environmental pollution and personal injury caused by waste.

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.

Preventing Fire or Explosion Please observe the following instructions to prevent fire and explosion.

WARNING: Do not use flammable substance around the system.

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Preface

Precautions on Use To use the BS-200 Chemistry Analyzer safely and efficiently, please pay attention to the following operation notes.

Intended Use WARNING: The BS-200 Chemistry Analyzer is a chemistry system that is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or CSF samples. Please consult Mindray first if you want to use the system for other purposes. To draw a clinical conclusion, please also refer to the patient’s clinical symptoms and other test results.

Operator WARNING: The BS-200 Chemistry Analyzer is to be operated only by medical professionals trained and authorized by Mindray or Mindray-authorized distributors.

Environment CAUTION: Please install and operate the system in an environment specified by this manual. Installing and operating the system in other environment may lead to unreliable results and even equipment damage. To relocate the system, please contact Mindray Service Department or your local distributor.

Preventing Interference by Electromagnetic Noise CAUTION: Electromagnetic noise may interfere with operations of the system. Do not install devices generating excessive electromagnetic noise around the system. Do not use such devices as mobile phones or radio transmitters in the room housing the system. Do not use other CRT displays around the system. Do not use other medical instruments around the system that may generate electromagnetic noise to interfere with their operations.

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Preface

Operating the System CAUTION: Operate the system strictly as instructed by this manual. Inappropriate use of the system may lead to unreliable test results or even equipment damage or personal injury. Before using the system for the first time, run the calibration program and QC program to make sure the analyzer is in proper state. Be sure to run the QC program every time you use the system, otherwise the result may be unreliable. Do not open the cover of the sample/reagent disk when the system is in operation. 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 connections. Only use the supplied cable for the connection. The operation unit is a personal computer with the control software 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 it will probably introduce computer virus, which may spread into the system through floppy disks, software or network. Do not touch the display, mouse or keyboard with wet hands or hands with chemicals. Don’t place the MAIN 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 MAIN POWER to OFF and place it to ON again.

Maintaining the System CAUTION: Maintain the system strictly as instructed by this manual. Inappropriate maintenance may lead to unreliable results or equipment damage or personal injury. To wipe off dust from the system 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 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. Replacement of such major parts as photometer, probe, mixing bar and syringe plunger assembly must be followed by a calibration.

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Preface

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 exists in the urine samples, the probe may be blocked. Medicines, anticoagulants or preservative in the samples may lead to unreliable 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 a long period. Not all the tests the reagents claim capable of analyzing can be analyzed on the system. Consult the reagent suppliers for details. Certain samples need to be processed before being analyzed by the system. Consult the reagent suppliers for details. The system has a specific requirement on the sample volume. Refer to this manual for proper sample volume. Load the sample to proper tube position 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 system. Select appropriate reagents according to performance characteristics of the system. Consult the reagent suppliers, Mindray or Mindray-authorized distributor for details, if 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 best performance of the system. Perform calibration after changing the reagents. Otherwise, you may not obtain reliable results. Contamination caused by carryover among reagents may lead to unreliable test results. Consult the reagent suppliers for details.

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Preface

Setting up the System CAUTION: To define such parameters as sample volume, reagent volume and wavelength, follow the instructions in this manual and the instructions of reagents.

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

Computer and Printer NOTE: Refer to their operation 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 1

System Description ... 1-1 1.1

1.2

2

Installation ... 2-1 2.1 2.2

2.3 2.4 2.5 2.6 2.7 2.8 3

Hardware Introduction ... 1-1 1.1.1 Analyzing Unit ... 1-1 1.1.2 Operation Unit ... 1-6 1.1.3 Output Unit ... 1-6 Software Introduction... 1-6 1.2.1 Software Interface ... 1-6 1.2.2 Main Interface Components ... 1-8

Unpacking... 2-1 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 Connecting Deionized Water Tank ... 2-4 Connecting Waste Tank... 2-5 Installing/Removing Sample/Reagent Disk ... 2-5 Installing/Removing Sample Tubes ... 2-6 Installing/Removing Reagent Bottles... 2-7 Installing/Removing Cuvettes ... 2-7

Basic Operations ... 3-1 3.1 3.2

3.3

3.4 3.5

Daily Procedure ... 3-1 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 Control Software ... 3-3 3.2.4 Setting Up the Analyzer... 3-4 3.2.5 Preparing Reagents... 3-5 Starting Analysis ... 3-5 3.3.1 Reagent Blank... 3-5 3.3.2 Calibration ... 3-5 3.3.3 QC ... 3-6 3.3.4 Samples... 3-6 Processing Results ... 3-7 3.4.1 Editing Results of Samples ... 3-7 3.4.2 Printing Results of Samples ... 3-7 Finishing Analysis ... 3-7 3.5.1 Exiting the Control Software... 3-7 3.5.2 Shutdown... 3-7 3.5.3 Operations after Shutdown... 3-8

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Contents 4

Advanced Operations... 4-1 4.1

4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10

4.11 4.12

4.13

4.14

4.15

4.16

4.17

5

Sample Request ... 4-1 4.1.1 Sample Information ... 4-3 4.1.2 Delete a Sample... 4-5 4.1.3 Change Position ... 4-6 4.1.4 Requesting Samples or Modifying Information ... 4-7 QC Request ... 4-7 Start ... 4-10 Probe Stop ... 4-11 Stop...4-12 Current Results... 4-13 Replace... 4-15 Re-log ... 4-17 Exit... 4-17 History... 4-18 4.10.1 Conditions... 4-20 4.10.2 Add Off-system Test Results ... 4-22 4.10.3 Compensate Results ... 4-23 4.10.4 Edit Results ... 4-25 4.10.5 Reaction Curve... 4-27 4.10.6 Delete Results ... 4-28 4.10.7 Print Results ... 4-29 4.10.8 Result Trend Curve ... 4-30 Reagent ... 4-32 Calibration... 4-33 4.12.1 Calibration Request... 4-33 4.12.2 Results... 4-37 4.12.3 Calibrator ... 4-45 QC ...4-47 4.13.1 Real-time QC... 4-48 4.13.2 Daily QC ... 4-49 4.13.3 Day to Day QC ... 4-52 4.13.4 Control ... 4-55 Status... 4-57 4.14.1 Sample Disk ... 4-58 4.14.2 Reagent Disk ... 4-61 4.14.3 Reaction Disk ... 4-65 Statistics... 4-65 4.15.1 Worklist... 4-66 4.15.2 Results... 4-67 4.15.3 Workload ... 4-70 4.15.4 Charges ... 4-72 Setup ... 4-74 4.16.1 Test ... 4-75 4.16.2 Profile ... 4-85 4.16.3 Calculation... 4-87 4.16.4 Off-system Test... 4-89 4.16.5 Carryover... 4-90 4.16.6 System... 4-91 4.16.7 Hospital... 4-96 4.16.8 User ... 4-98 4.16.9 Print ... 4-101 Maintenance ... 4-105 4.17.1 Daily Maintenance... 4-105 4.17.2 Log... 4-107 4.17.3 Import/Export... 4-109 4.17.4 Commission... 4-111

Maintenance ... 5-1

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Contents 5.1 5.2

5.3

5.4 5.5 5.6

5.7

Preparation ... 5-1 Daily Maintenance ... 5-2 5.2.1 Checking Remaining Deionized Water... 5-2 5.2.2 Emptying Waste Tank... 5-3 5.2.3 Checking Connection of Deionized Water... 5-3 5.2.4 Checking Connection of Wastewater ... 5-4 5.2.5 Checking Syringe ... 5-5 5.2.6 Checking Probe... 5-6 5.2.7 Checking Mixing Bar ... 5-7 Weekly Maintenance ... 5-7 5.3.1 Cleaning Probe... 5-7 5.3.2 Cleaning Mixing Bar ... 5-8 5.3.3 Washing Deionized Water Tank ... 5-9 5.3.4 Washing Waste Tank ... 5-10 5.3.5 Cleaning Sample/Reagent Compartment ... 5-11 5.3.6 Cleaning Panel of Analyzing Unit ... 5-11 Monthly Maintenance ... 5-12 5.4.1 Cleaning Wash Well of Probe... 5-12 5.4.2 Cleaning Wash Well of Mixing Bar ... 5-12 Maintenance Every Six Months ...5-12 Irregular Maintenance... 5-13 5.6.1 Unclogging Probe... 5-13 5.6.2 Replacing Probe... 5-16 5.6.3 Replacing Mixing Bar ... 5-17 5.6.4 Replacing Plunger Assembly of Syringe ... 5-18 5.6.5 Replacing Lamp ... 5-20 Maintenance Log ...5-22

6

Troubleshooting... 6-1

7

Calculation Methods... 7-1 7.1

7.2

Appendix A A.1 A.2 A.3 A.4 A.5 A.6 A.7

Analytical Methods ... 7-1 7.1.1 Endpoint ... 7-1 7.1.2 Fixed-Time... 7-2 7.1.3 Kinetic... 7-3 Calculation Process... 7-5 7.2.1 Absorbance ... 7-5 7.2.2 Response ... 7-6 7.2.3 Calibration Parameters... 7-9 7.2.4 Concentration ... 7-12 7.2.5 QC rules ... 7-14 Specifications... A-1 Technical Specifications...A-1 Power Requirements ...A-1 Environmental Requirements ...A-2 A.3.1 Storage Requirements...A-2 A.3.2 Operation Requirements ...A-2 Dimension and Weight ...A-2 Other Specifications...A-2 Input/Output Devices ...A-2 Interface...A-3

Appendix B

Supplies ... B-1

Appendix C

Index... C-1

III

1

System Description This chapter includes the following two sections: Hardware Introduction Software Introduction The BS-200 Chemistry Analyzer is a chemistry system that is designed for the in vitro quantitative determination of clinical chemistries in serum, plasma, urine or CSF samples.

NOTE: Not all the tests the reagents claim capable of analyzing can be analyzed on the system. Consult the reagent suppliers for details.

1.1

Hardware Introduction The system consists of the following three units – the analyzing unit, operation unit and output unit.

1.1.1 Analyzing Unit The analyzing unit consists of the following major parts: Sample/Reagent Disk Dispenser Mixer Reaction Disk Photometric System

1-1

System Description Figure 1-1 Analyzing unit

Cover

Syringe Dispenser Mixer Reaction Disk

MAIN POWER

Sample/Reagent Disk

Power

Upper Cabinet

Lower Cabinet (optional)

1.1.1.1 Sample/Reagent Disk The sample/reagent disk holds sample tubes and reagent bottles.

Figure 1-2 Sample/Reagent disk

Sample/reagent Disk

The disk is composed of two circles – sample disk on the outer circle and reagent disk on the inner circle.

1-2

System Description The sample disk provides 40 sample tube positions and the reagent disk provides 40 reagent bottle positions. On the reagent disk, No. 39 is for detergent and No. 40 is for distilled water.

NOTE： Mindray recommends you to use the following detergents: Acid: 0.1mol/l hydrochloric acid; Alkaline: 0.5% (V/V) javel water。

The sample disk can hold the following sample tubes: Micro sample cup and centrifugal tube Collection tube: Ф12×68.5, Ф12×99, Ф12.7×75 and Ф12.7×100 Plastic tube The reagent disk can only hold Mindray bottles, which are available in two types, 40ml and 20ml. The sample/reagent disk is located in the sample/reagent compartment, which has a refrigerator to keep the temperature at 4-15 ˚C.

WARNING: Make sure the disk cover is closed; otherwise it may degrade the refrigeration and damage the probe. Before running the analyzing unit, make sure that the disk cover is closed and the round red mark on the cover is aligned with its counterpart on the panel. Otherwise the probe may be damaged.

NOTE： The refrigerator will be put into service once the MAIN POWER is turned on. Do not use sample tubes and reagent bottles other than the specified ones.

1.1.1.2 Dispenser The dispenser is composed of a probe, arm and rotor.

1-3

System Description Figure 1-3 Dispenser

Arm

Rotor

Probe

Wash Well

The probe aspirates certain amount of sample from the designated sample tube, or reagent from the designated reagent bottle, and then dispenses them into the designated cuvette on the reaction disk. After dispensing the sample or the reagent, the probe moves to the wash well for cleaning. Sample volume: 3µl-45µl; precision: 0.5µl. Reagent volume: 30µl -450µl; precision: 1µl. The dispenser is capable of preheating the reagent, detecting the sample/reagent level, capable of tracking level and protecting against collision in the vertical direction.

WARNING: When the analyzing unit is in operation, 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.

1.1.1.3 Mixer The mixer is composed of a mixing bar, arm and rotor.

1-4

System Description Figure 1-4 Mixer

Arm

Mixing Bar

Rotor

Wash Well

The mixing bar thoroughly stirs the reaction mixture (reagent and sample) in the cuvette. After stirring, it moves to the wash well for cleaning. For the single-reagent test, the mixer starts to work after the sample is dispensed into the cuvette. For the double-reagent test, the mixer starts to work after the sample or the second reagent is dispensed into the cuvette.

1.1.1.4 Reaction Disk The reaction disk holds the cuvettes, in which the sample reacts with the reagent(s) and colorimetric readings are taken.

Figure 1-5 Reaction disk

Dispensing Position Mixing Position

Reaction Disk

The reaction disk can hold 8 cuvette segments (80 cuvettes). During the analyzing process, the reaction disk rotates to dispensing position or mixing position as needed. The colorimetric readings are taken when the specified cuvette passes through the optical axis. The cuvettes adopted are

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