BA-88A - Operation Manual - V4.0 - EN [PDF]

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BA-88A Semi-auto Chemistry Analyzer

Operator’s Manual

© 2008-2012 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Reserved.

All rights

For this Operator’s Manual, the issue date is 2012-10.

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 copyright or patents and does not convey any license under the patent rights or copyright of Mindray, or of others. 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, rental, adaptation, translation or any other derivative work of this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

,

,

,

,

BeneView,

WATO, BeneHeart, are the trademarks, registered or otherwise, of Mindray in China and other countries. All other trademarks that appear in this manual are used only for informational or editorial purposes. They are the property of their respective owners.

Responsibility on the Manufacturer Party Contents of this manual are subject to change without prior notice. All information contained in this manual is believed to be correct. Mindray shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this manual. Mindray is responsible for the effects on safety, reliability and performance of this product, only if: „

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; and

„

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

i

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 personal injury. NOTE: This equipment professionals.

must

be

operated

by

skilled/trained

clinical

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: „

Malfunction or damage caused by improper use or man-made failure.

„

Malfunction or damage caused by unstable or out-of-range power input.

„

Malfunction or damage caused by force majeure such as fire and earthquake.

„

Malfunction or damage caused by improper operation or repair by unqualified or unauthorized service people.

„

Malfunction of the instrument or part whose serial number is not legible enough.

„

Others not caused by instrument or part itself.

ii

Customer Service Department Manufacturer: Address:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Website:

www.mindray.com

E-mail Address:

[email protected]

Tel:

+86 755 81888998

Fax:

+86 755 26582680

Mindray Building,Keji 12th Road South,High-tech industrial park,Nanshan,Shenzhen 518057,P.R.China

EC Representative EC-Representative: Address:

Shanghai International Holding Corp. GmbH (Europe)

Tel:

0049-40-2513175

Fax:

0049-40-255726

Eiffestraβe 80, 20537 Hamburg, Germany

iii

iv

Preface Before using the system, please read this operation manual thoroughly for relevant operation instructions. Please keep this manual properly for convenient use.

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

Conventions Safety Symbols Safety symbols alert you to potentially dangerous conditions and information that requires your attention. These safety symbols, together with related text, apply to specific procedures and appear as needed throughout 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.

NOTE

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

CAUTION

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

1

Labels The labels attached to the surface of the instrument use symbols to clarify the meaning of the text. If any of the labels peels off, contact our company customer service department or your local distributor for replacement. The chart below explains the symbols on the labels. Serial number Manufacture date

Manufacturer Authorized Representative in the European Community 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 biohazardous infection

of

potentially

Protective ground terminal

Warning: Risk of personal injury or equipment damage 100-240V～,50/60Hz

AC 100-240V, 50/60Hz Power ON Power OFF Serial port to connect the equipment to PC

2

USB port, which complies with the USB 2.0 protocol.

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

3

Safety Precautions Observe theses safety precautions when using the system. Ignoring any of the precautions may lead to personal injury or equipment damage.

WARNING If the instrument is used in a manner not specified by our company, the protection provided by the system may be impaired.

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

WARNING When the instrument is turned on, users must not open the 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 spillage, switch off the power immediately, remove the spillage and contact our company customer service department or your local distributor. This instrument is supplied with a slow-blow fuse (250V, 3.15A), which must not be replaced by the user. Power supply: 100-240V~, 50/60Hz. The instrument is supplied with a three-wire power cord and should be properly grounded during application.

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

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

4

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 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.

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 procedures and consult a doctor.

Handling Reagents and Wash Solution WARNING Reagents and enhanced wash solution may hurt human skins. Exercise caution when using the reagents and enhanced wash solution. In case your skin or clothes contact them, wash them off with clean water. In case the reagents or wash solution spill into your eyes, rinse them with much water and consult an oculist.

5

Treating Waste Liquids Please observe the following instructions to prevent environmental pollution and personal injury caused by waste.

BIOHAZARD Some substances in reagent, control, enhanced wash solution and waste are subject to regulations of contamination and disposal. Dispose of them in accordance with your local or national guidelines for biohazard waste disposal and consult the manufacturer or distributor of the reagents for details. Wear gloves and lab coat and, if necessary, goggles.

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 Please observe the following instructions to prevent fire and explosion.

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

6

Precautions on Use To use the system safely and efficiently, please pay much attention to the following operation notes.

Intended Use WARNING The system is an analyzer designed for in vitro quantitative determination of clinical chemistries in serum, plasma, urine and 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 system is to be operated only by clinical professionals, doctors or laboratory experimenters trained by our company or our 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 our customer 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. The electromagnetic environment should be evaluated prior to operation of the device. 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. The electromagnetic noise might lead to system failures. Do not use other medical instruments around the system that may generate electromagnetic noise to interfere with their operations.

7

NOTE It is the manufacturer's responsibility to provide equipment electromagnetic compatibility information to the customer or user.

NOTE It is the user's responsibility to ensure that a compatible electromagnetic environment for the equipment can be maintained in order that the device will perform as intended.

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 system is in normal status. Be sure to run the QC program every time you use the system, otherwise the result may be unreliable. Do not touch the screen with wet hands or hands contaminated by chemicals. Do not place the Power to ON again within 10 seconds since placing it to OFF;

8

Maintaining the System CAUTION Maintain the system strictly as instructed by this manual. Inappropriate maintenance may lead to unreliable results, or even equipment damage and personal injury. To wipe off dust from the system surface, use a soft, clean and wet (not too wet) cloth, soaked with mild soap solution if necessary, to clean the surface. Do not use such organic solvents as ethanol for cleaning. After cleaning, wipe the surface with dry cloth. Switch off all the powers and unplug the power cord 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 lamp assembly must be followed by a calibration. Check the pump tubing for leakage as needed and replace the tubing in time. Otherwise, the normal aspiration of the system might be affected. It is recommended that the inner system tubing should be replaced every 24 months to avoid possible blockage or invalidation brought about by aging.

Setting up the System CAUTION To define such parameters as calculation method and wavelength, follow the instructions in this manual and the package insert of the reagents.

9

Samples CAUTION Use samples that are completely free of insoluble substances like fibrin, or suspended matter; otherwise the probe may be blocked. Medicines, anticoagulants or preservative in the samples may lead to unreliable results. Hemolysis, icterus or lipemia in the samples may lead to unreliable test results, so a sample blank is 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. Some samples may not be analyzed on the system based on parameters the reagents claim capable of testing. Consult the reagent manufacturer or distributor for details. Certain samples need to be processed before being analyzed by the system. Consult the reagent manufacturer or distributor for details.

Reagents, Calibrators and Controls CAUTION Use appropriate reagents, calibrators and controls on the system. Select appropriate reagents according to performance characteristic of the system. Consult the reagent suppliers, our company or our authorized distributor for details, if you are not sure about your reagent choice. Store and use reagents, calibrators and controls strictly as instructed by the suppliers. Otherwise, you may not obtain reliable results or best performance of the system. Improper storage of reagents, calibrators and controls may lead to unreliable results and bad performance of the system even in validity period. Perform a calibration after changing reagents. Otherwise, you may not obtain reliable results. Contamination caused by carryover among reagents may lead to unreliable test results. Consult the reagent manufacturer or distributor for details.

10

External Equipment WARNING External equipment connected to the analogue and digital interfaces must be complied with the relevant Safety and EMC standards (e.g., IEC 60950 Safety of Information Technology Equipment Standard and CISPR 22 EMC of Information Technology Equipment Standard (CLASS B)). Any person, who connects additional equipment to the signal input or output ports and configures an IVD system, is responsible for ensuring that the system work normally and complies with the safety and EMC requirements. If you have any problem, consult the technical services department of your local representative.

Communication interface CAUTION The system is equipped with two USB ports which can be used in connecting the keyboard, mouse, printer and other external equipments or in system upgrading. RS232 is used in connecting the PC with the analyzer to transfer data. These three ports should not be used to operate the system for usage other than those mentioned above. Otherwise, system might be damaged.

11

12

Contents Intellectual Property Statement ........................................................................................... i Responsibility on the Manufacturer Party............................................................................ i Warranty ..............................................................................................................................ii Exemptions..........................................................................................................................ii Customer Service Department ...........................................................................................iii EC Representative .............................................................................................................iii

Preface............................................................................................................... 1 What Can You Find in This Manual .................................................................................... 1 Conventions........................................................................................................................ 1 Safety Precautions ............................................................................................................. 4 Precautions on Use ............................................................................................................ 7

Contents ............................................................................................................. I 1

System Description ..............................................................................1-1 1.1

Introduction ........................................................................................................... 1-1 1.1.1 1.1.2

1.2

Parameters ........................................................................................................... 1-3

1.3

Touchpen and Popup Keypad .............................................................................. 1-3 1.3.1 1.3.2

1.4

Touchpen ................................................................................................. 1-3 Popup Keypad ......................................................................................... 1-4

Printer ................................................................................................................... 1-4 1.4.1 1.4.2

2

Overview.................................................................................................. 1-1 Outlook .................................................................................................... 1-1

Internal Thermal Recorder....................................................................... 1-4 External Printer ........................................................................................ 1-4

Installation.............................................................................................2-1 2.1

Unpacking............................................................................................................. 2-1

2.2

Installation............................................................................................................. 2-1 2.2.1 2.2.2 2.2.3 2.2.4 2.2.5

2.3

System Specifications.............................................................................. 2-1 Environmental Requirements .................................................................. 2-1 Space and Accessibility Requirements.................................................... 2-2 Water Requirements ................................................................................ 2-2 Waste Bottle............................................................................................. 2-3

Installation............................................................................................................. 2-3 2.3.1

Connecting Power Cord .......................................................................... 2-3

2.4

Storage for a Short Period .................................................................................... 2-4

2.5

Storage for Long Period........................................................................................ 2-4

I

3

Basic Operations.................................................................................. 3-1 3.1

Preparation for Powering On ................................................................................3-1

3.2

Timing Principle ....................................................................................................3-2 3.2.1 3.2.2

4

3.3

Edit........................................................................................................................3-6

3.4

Shutdown ..............................................................................................................3-6

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

Powering On .........................................................................................................4-1

4.2

Parameter .............................................................................................................4-2 4.2.1 4.2.2 4.2.3 4.2.4

4.3

Routine.....................................................................................................4-2 Profile.......................................................................................................4-9 Calculation ...............................................................................................4-9 Off-system..............................................................................................4-12

Test .....................................................................................................................4-13 4.3.1 4.3.2

Request..................................................................................................4-13 Test ........................................................................................................4-15

4.4

Calibration...........................................................................................................4-19

4.5

QC.......................................................................................................................4-22

4.6

Result..................................................................................................................4-23 4.6.1 4.6.2

4.7

4.8

Result.....................................................................................................4-24 Edit.........................................................................................................4-27

Setup...................................................................................................................4-30 4.7.1 4.7.2 4.7.3 4.7.4 4.7.5

Basic ......................................................................................................4-31 Dictionary ...............................................................................................4-32 Print Features ........................................................................................4-33 Carryover ...............................................................................................4-34 LIS Setup ...............................................................................................4-35

Maintenance .......................................................................................................4-36 4.8.1 4.8.2 4.8.3 4.8.4

5

Flow Cell Mode ........................................................................................3-2 Cuvette Mode ..........................................................................................3-5

Database................................................................................................4-36 Log .........................................................................................................4-37 Maintenance ..........................................................................................4-38 Shutdown ...............................................................................................4-39

Maintenance ......................................................................................... 5-1 5.1

Parts and Consumables .......................................................................................5-1

5.2

Tools Required for Maintenance...........................................................................5-2

5.3

Daily Maintenance ................................................................................................5-2

5.4

Weekly Maintenance ............................................................................................5-2

5.5

Irregular Maintenance...........................................................................................5-3 5.5.1 5.5.2 5.5.3 5.5.4 5.5.5

Cleaning Flow Cell...................................................................................5-3 Adjusting the Photoelectric Gain .............................................................5-4 Calibrating the Peristaltic Pump...............................................................5-4 Replacing the tubing ................................................................................5-4 Replacing Aspiration Tubing ....................................................................5-8

II

5.5.6

6

Replacing Lamp....................................................................................... 5-9

Operation Theories...............................................................................6-1 6.1

Principles of analysis ............................................................................................ 6-1

6.2

Principles of Measurement ................................................................................... 6-2 6.2.1 6.2.2 6.2.3

Endpoint Measurements.......................................................................... 6-2 Fixed-time Measurements ....................................................................... 6-2 Kinetic Measurements ............................................................................. 6-3

6.3

Calculating Linear Calibration Parameters........................................................... 6-3

6.4

Calculating Nonlinear Calibration Parameters ..................................................... 6-4

6.5

Calculating Concentration .................................................................................... 6-6 6.5.1 6.5.2

6.6

Calculating Concentration of Linearly Calibrated Sample/control ........... 6-6 Calculating Concentration of Nonlinearly Calibrated Sample/control...... 6-7

QC Rule ................................................................................................................ 6-7 6.6.1

Westgard Multi-rule.................................................................................. 6-8

Appendix A

Specifications........................................................................ A-1

Appendix B

Error Messages ..................................................................... B-1

Appendix C

External Printer ..................................................................... C-1

III

IV

1

System Description

1.1 Introduction 1.1.1 Overview The system consists of the analyzer, built-in microprocessor, popup keyboard, internal printer and LCD screen.

1.1.2 Outlook The front view of the semi-auto chemistry analyzer is shown in figure 1-1.

1-1

Figure 1-1 Front View of the Semi-Auto Chemistry Analyzer

The rear view of the semi-auto chemistry analyzer is shown in figure 1-2. Figure 1-2 Rear View of the Semi-Auto Chemistry Analyzer

1-2

USB port is to connect the printer and other external equipments; serial port is to transmit the data after connected to PC.

1.2 Parameters Light source

Tungsten-halogen lamp (6V, 10W)

Filter

Interferential filter.6 wavelengths (available): 340nm, 405nm, 510nm, 546nm, 578nm and 630nm.2 wavelengths (optional): 450nm and 670nm.

Absorbance range

0～3.0A

Readable range

0～3.5A

Result resolution

0.001A

Reaction container

Flow colorimetric pool (32 ul）

Reaction temperature

25℃, 30℃, 37℃ and room temperature.

Result storage capacity

No less than 3000 results.

Test storage capacity

Up to 200 tests information,1000 control results

Weight

7kg

Dimension

420mm×350mm×158mm（length×width×height）

Power supply

100V-240V~ (±10% fluctuation) ， 50/60Hz (±3Hz fluctuation)

Input power

140VA

1.3 Touchpen and Popup Keypad The system is provided with a touchpen, which is used in combination with touchscreen and popup keypad to operate the system.

CAUTION Be sure to use the supplied pen to operate the touchscreen. Do not touch the screen with sharp-edged tools. Otherwise the screen may be damaged.

1.3.1 Touchpen The system is provided with a touchscreen and pen, which are used as input tools and can be operated as follows:

Click ’Click’ means the act of moving the pen to the desired item and then touching the screen gently.

1-3

The ‘click’ operation is used to operate all buttons, options, edit boxes and popup keypad.

Drag ‘Drag’ means the act of keeping touching the screen with pen and moving to desired place. The ‘drag’ operation is used to move the scroll bars.

1.3.2 Popup Keypad The popup keypad is used to input numbers, letters and characters.

„

Continuously click Ctrl for two times to switch between English and Chinese.

„

Select

„

Select and click a letter. The letter is input in upper case, but the following letters will be input in lower case.

„

Select

„

again to switch to the lower case mode. To exit the popup keypad, click any place other than the popup keypad.

and

to switch between upper case and lower case.

. All letters you then enter are input in upper case. Select

1.4 Printer 1.4.1 Internal Thermal Recorder While feeding printing paper, please pay much attention to the following notes.

„ „

Before feeding printing paper, please ensure the instrument has been powered off. After feeding printing paper, be sure to cover the record.

CAUTION Do not use any tools like sandpaper that may damage the thermal components. Do not squeeze the thermal print head.

NOTE The paper used for the thermal recorder should be 50mm×20m.

1.4.2 External Printer The external printer is supported by the system. If you want to purchase a printer, please contact our company customer service department or your local distributor. The printer is shown in the figure below, connecting to the power supply and USB port.

1-4

WARNING The printer must be connected to properly-grounded power socket.

NOTE You are recommended to use printers that are compatible with the system and listed in (not limited to) Appendix. If you have any questions about the printers, please contact our company customer service department or your local distributor.

Figure 1-3 Connection of External Printer

Perform the following steps to install the printer: 1

Plug the data cable to the USB port on the back of the instrument.

2

Plug the power cord to a properly-grounded power socket.

3

Turn on the system and the printer.

1-5

1-6

2

Installation

2.1 Unpacking When you receive the system, 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 system. If you find anything missing or damaged, immediately alert Mindray customer service department or your local distributor.

2.2 Installation 2.2.1 System Specifications „ „

Dimension: 420mm ×350mm ×158mm(L×W×H) Weight: 7 kg

2.2.2 Environmental Requirements CAUTION: Make sure the system is installed in a place meeting the requirements. Otherwise, it will not perform as promised.

2-1

„ „ „ „ „ „ „

Ambient temperature: 15℃-30℃ Relative humidity: 35%-85%, without condensation Above-sea-level height: -400m～3,000 m（70kPa ～ 1,06kPa） Power supply: 100V-240V~ (±10% fluctuation), 50/60Hz (±3Hz fluctuation). The site should be away from the electromagnetic noise and the bearing platform should be free of vibration. The site should not be in direct sun The system should be properly grounded.

WARNING Please make sure that the power is properly grounded. Improper grounding may lead to electric shock and/or equipment damage. Be sure to connect the system to a power socket that meets the above-mentioned requirements and has a proper fuse installed.

2.2.3 Space and Accessibility Requirements Figure 2-1 Space and accessibility requirements

„ „

The installation space must be larger than the dimensions (420mm × 350mm × 158mm, L×W×H) of the instrument. Please refer to Figure 2-1. The installation platform should be level with gradient less than 1:200 and should be able to bear at least bear the weight of 10kg.

2.2.4 Water Requirements 1) 2)

The water must meet requirements of the CAPII water. The water temperature should be within 15-50℃

2-2

2.2.5 Waste Bottle A waste bottle should be provided by the user to treat waste liquid, and other suitable ways to dispose the waste liquid are also applicable.

NOTE 不 The waste bottle should not be sealed, otherwise the peristaltic pump can not function to aspirate.

2.3 Installation Installation procedure: 1

After the system is delivered to your place, check the delivered goods against the packing list

2

After opening the package, take the system out;

3

Place the system on the operating platform and ensure at least 200mm distance between the system and the wall. Remove the package of the system;

4

Remove the protection on the optical window;

5

Connect the waste bottle.

6

Connect the power cable, turn on the analyzer and the system is started. The system will enter the main screen after self-check and tubing washing. （If cuvette mode is selected, tubing wash is not needed）.

7

After system is stabilized, request 1-2 tests and run. Evaluate the test results.

8

After confirming that the system works normally, shutdown the system following the instruction indicated in this manual.

2.3.1 Connecting Power Cord Connect one end of the power cord to the socket on the back of the analyzer, the other end to power supply. Turn on the power to start the system. The analyzer will start initialization check-up which will take about 3 minutes. After that, the operating screen will be displayed.

WARNING The system is equipped with three-wire power cord. Make sure the power socket is grounded correctly. Improper grounding may lead to electric shock and/or equipment damage. Be sure to connect the system to a power socket that meets the system requirements and has a proper fuse installed.

2-3

CAUTION Before connecting the power supply, make sure the system is shutdown.

2.4 Storage for a Short Period When storing the analyzer for a short period, please ensure that the flow cell is filled with clean distilled water or DI water (for instrument with flow cell installed).

2.5 Storage for Long Period When storing the analyzer for a long period, please ensure that analyzer and accessory in the package be stored: „ Temperature: -20-55℃ „ Relative humidity: not more than 85% „ Free from erosive gas „ Well-ventilatedٛ ٛٛٛ

NOTE When storing the analyzer for long period, please ensure that no liquid in the flow cell and the tubing (for instrument with flow cell installed).

2-4

3

Basic Operations

3.1 Preparation for Powering On You should perform the following operations before powering on the analyzer.

BIOHAZARD Wear gloves and lab coat and, if necessary, goggles when performing the following operations.

1

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

2

Check if the power cord of the system is properly connected.

3

Check and make sure sufficient printing paper is prepared for the printer. If not, feed more printing paper.

4

If external printer is applied, check if the data cable has been connected to the system. Check if the power cord of the printer is properly connected.

3-1

5

Check if the waster tube at the back of the system is connected to the waste bottle or other disposal channels. Check if the waste bottle is full. If yes, empty the waste bottle.

NOTE Twisted tubing will make the system incapable of aspiration (for system installed with flow cell). Please check before use, ensuring Ensure the tubing is not blocked, bent, or twisted.

CAUTION It will take 15 minutes or more for the lamp and temperature control system to be stable, after the system is started.

3.2 Timing Principle 3.2.1 Flow Cell Mode 3.2.1.1 Powering On 1

Place the power switch to On.

2

Press the power button of the printer (if internal thermal recorder is applied, skip this procedure).

3

Place the power switch to On. The system starts initialization which takes about 2 minutes. During this process, aspirate DI water as directed by the message on the screen. After initialization and self-check, the main screen is displayed

3.2.1.2 Setting up the Analyzer The analyzer will not function properly unless it is properly set up. If this is the first time the analyzer being used you must complete all the following settings. In daily use, you should perform the following configuration as needed. You must enter the hospital information if this is the first time the analyzer being used. Before requesting test, you must finish the following settings: Basic information, calibration information and reference range; QC information is recommended. „ Click Setup Æ Basic. Enter the hospital name.

3-2

„ Click Parameter Æ Routine.Æ Basic. Follow the reagent instruction to enter the test parameters concerning reaction type, primary wavelength, secondary wavelength, delay, measuring time, result unit, result precision and reaction temperature, whether to run reagent blank, etc. Refer to 4.2.1.1 Basic for more information. „ Click Parameter Æ RoutineÆ Cal Details. For Kinetics, you can enter the K factor according to the reagent instruction, or select proper calibration rule. For Endpoint and Fixed-time analysis, select proper calibration rule and enter the set points of the calibrators. Refer to 4.2.1.3Calibration for more information. „ Click Parameter Æ RoutineÆ Restriction. Enter the reference range. You can determine whether it is necessary to enter linearity range, reagent blank absorbance, absorbance limit and linearity limit, etc. Refer to 4.2.1.2 Restriction for more information. „ Click Parameter Æ RoutineÆ QC Information. Enter control lot No. mean concentration and SD and select proper QC rule. Refer to 4.2.1.4 QC Information for more information.

NOTE The displayed absorbance is the result of the real absorbance multiplied with 10000, so the absorbance you enter should also be multiplied with 10000, but this does not affect the calculation of the final result.

3.2.1.3 Test For Endpoint analysis, the test workflow is slightly different from that of the Fixed-time and Kinetics analysis. The following introduces them separately.

NOTE The displayed absorbance is the result of the real absorbance multiplied with 10000, but this does not affect the calculation of the final result.

Endpoint 1

Prepare the samples and calibrators and controls.

3-3

2

Prepare proper amount of reagent according the number of the samples. If it is double-reagent analysis, it is recommended that R1 and R2 are mixed and then dispensed into respective tubes (or other reaction containers).

NOTE Check the reagent instruction, or consult the reagent manufacturer or distributor to see if mixing of R1 and R2 are allowed prior to testing. 3

Dispense sample or calibrator or control into the tube.

4

Incubate the tube in a water bath tank or external incubator for a while.

5

Take the tube out to prepare it for analysis.

6

Click Test on the main screen to enter the test screen.

7

Select the name of the test to be run.

8

Click Water Blank, put the inlet tube into the distilled water, and click Aspirate.

9

Click Reagent Blank, put the inlet tube into the reagent blank, and click Aspirate.

10

Select Calibrate and select calibrator in the drop down list box of S1-S8. Put the inlet tube into the calibrator to be tested and click Aspirate. If it is multiple-point calibration, you can proceed to the next step only when the calibration tests of all the calibrators are completed.

11

Put the inlet tube into the sample blank, and click Aspirate.

NOTE You can determine whether it is necessary to run sample blank. Hemolysis, icterus or lipemia in the samples may lead to unreliable test results, so a sample blank is recommended. 12

Select Sample ID and click Sample. Put the inlet tube into the sample and click Aspirate. Repeat this to test other samples.

13

After calibration is finished. Click QC and select controls from the drop-down list box C1-C3. Put the inlet tube into the control to be tested and click Aspirate.

14

After all the tests are completed, put the inlet tube into the distilled and click Wash.

Fixed-time and Kinetics 1

Prepare the samples, calibrators and controls. Prepare proper amount of reagent according the number of the samples. If it is double-reagent analysis, it is recommended that R1 and R2 are mixed and then dispensed into respective tubes (or other reaction containers).

2

NOTE Check the reagent instruction, or consult the reagent manufacturer or distributor to see if mixing of R1 and R2 are allowed prior to testing.

3-4

3

Click Test on the main screen to enter the test screen.

4

Select the name of the test to be run.

5

Click Water Blank, put the inlet tube into the distilled water, and click Aspirate.

6

Click Reagent Blank, put the inlet tube into the reagent blank, and click Aspirate.

7

Select Calibrate and select calibrator in the drop down list box of S1-S8. Dispense calibrator into the tube with reagent in it. Put the inlet tube into the calibrator to be tested and click Aspirate. If it is multiple-point calibration, you can proceed to the next step only when the calibration tests of all the calibrators are completed. (If K factor is manually entered, skip it) Put the inlet tube into the sample blank, and click Aspirate.

8

Select Sample ID and click Sample. Put the inlet tube into the container where sample is mixed well with the reagent and click Aspirate. Repeat this to test other samples.

9

After calibration is finished. Click QC and select controls from the drop-down list box C1-C3. Put the inlet tube into the container where control is mixed well with the reagent and click Aspirate.

10

After all the tests are completed, put the inlet tube into the distilled and click Wash.

CAUTION For flow cell, if the system switches to other tests or after test of high concentration sample is run, wash the flow cell (for cuvette, washing should be done after every test). Otherwise, the result might be unreliable.

3.2.2 Cuvette Mode The operation for cuvette mode is almost the same with that of the flow cell. The differences are: a) During startup initialization, you do not have to wash the tubing b) During test, you should open the optical window and remove the cuvette ; c) During test the reactant is dispensed into the cuvette manually. A cuvette cap specific for cuvette should be used to cover the cuvette (see figure 3-1). Press Aspirate button or Start to start the test. d) After the test is completed, the cuvette should be washed manually. e) The tubing need not to be washed during shutdown.

3-5

Figure 3-1 Cover the cuvette cap

NOTE： Make sure the cuvette cover and the optical window is closed, during test, otherwise the test result might not be reliable.

3.3 Edit During test, the online printing is enabled by default and the test result of each sample is printed in real time. Patient information and test result can be edited to print the report. On the main screen, click Result Æ Sample. Select the sample to be edited and click Edit to enter the patient information including name, gender, age, etc. Click Print to print the patient report.

3.4 Shutdown Click Shutdown on the main screen. Please follow the instructions displayed on the screen to wash the tubes with distilled water and then wait for 20 seconds. Shutdown the printer (external printer) and the analyzer. During this process, test information, system setup, patient information and test result will be saved.

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4

Advanced Operations

4.1 Powering On Power on the analyzer and the system will go through initialization procedure as shown in the following figure. Figure 4-1 Initialization Screen

4-1

After passing the self-checking, the system will prompt message to aspirate distilled water. Press Aspirate button on the instrument. After aspiration, the main screen will be displayed. If the system failed to pass self-checking, the initialization will be terminated and the main screen will be displayed. Please contact Mindray customer service department or your local distributor for troubleshooting.

NOTE If the system failed to pass self-checking, most of the operation including running test will be disabled, except for same inquiry. Please refer to 4.3 Test for more information.

After initialization, the main screen will appear as shown in figure 4-2. Figure 4-2 Main Screen

4.2 Parameter Click Parameter to enter the parameter screen as shown in figure 4-3.The tests include routine, profile, calculation and off-system. The left list indicates the name of the saved tests; the right list indicates the information of the selected test. Click Add, Delete, Save and Cancel to add, modify and delete test information.

4.2.1 Routine The test information includes the basic information (such as calculation methods, wavelengths, etc.), restriction information ( such as reference range) and information about calibration and QC.

4-2

4.2.1.1 Basic Click Add to enter the screen shown in figure 4-3. The Routine includes: Basic, Restriction, Cal details and QC Information. Figure 4-3 Basic

The following table explains the parameters on the Basic screen.

Parameter

Description

Test

The test name should be set and same test names are not allowed. The length of the test name should not exceed 10 characters. Otherwise, warning messages will appear.

Reac. Type

Analyzing method, including Endpoint, Fixed-time, Kinetics and Absorbance. The default is Endpoint.

Direction

It refers to the changing direction of the absorbance during the reaction process, including Inc and Dec. If the absorbance increases, select Inc; otherwise, select Dec.

Pri.

Primary wavelength to be used on the test.

Sec.

Secondary wavelength to be used on the test. The default is void, indicating no secondary wavelength applied to the test. The primary and the secondary wavelength can not be the same.

Delay

A period between the end of the aspiration and the start of the test. Acceptance range is 6-999 sec. The minimum increment or decrement is 1 sec.

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Parameter

Description

NOTE The delay is mainly to balance the reaction temperature and eliminate the effect of small bubbles. For Endpoint and Absorbance analysis, the delay is usually set as 6-10 sec. For Fixed-time and Kinetics analysis, it is mainly used to eliminate the effect of unwanted reactions, usually set as 30-60s. Refer to the reagent instruction for more details.

Measuring time

A period for reading the absorbance to be used to calculate the result. The acceptance range is 1-9999sec (3-9999sec for Kinetics analysis). The minimum increment or decrement is 1 sec.

NOTE The measuring time for endpoint analysis is usually around 5sec; for Fixed-time and Kinetics, please refer to the reagent instruction and it is usually more than 30sec.The reading interval is 1 sec for single wavelength and 2sec for double wavelengths.

Unit

Unit of the result. Select from the drop-down list. The options include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The default is void. The units can be added and deleted in Setup.

Precision

Precision of the result. Select from the drop-down list 1, 0.1, 0.01, 0.001.The default is 1.

Asp. Vol.

If refers to the sample volume (200-9000ul) to be dispensed for the reaction. The default is 500ul.

Rgt. Blank

Whether to run reagent blank.

NOTE Reagent blank must be run for endpoint analysis. For Kinetics, Fixed-time and Absorbance analysis, refer to the reagent instruction to decide whether to run.

Temp.

The temperature of the cuvette or flow cell. The options include room temperature, 25℃, 30℃ and 37℃.The default is 37℃.

Full name

Full name of the test. It can be void.

The following table introduces the buttons on the screen.

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Buttons

Function

Add

Add new tests. Do not enter a test name already exists.

Delete

Delete selected test.

Save

Save the test information.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

4.2.1.2 Restriction Enter the test reference range, linearity range, absorbance limit and so on in Restriction page to evaluate the result and to note the operator. Figure 4-4 Restriction information

The following table explains the parameters on the Restriction Page. Parameter

Description

Default reference

Normal range of test result. System will determine whether the test result is normal based on the reference range. The default is void. The reference range can not be lower than 0 and should be entered from low to high. The high and low limit should not be equal.

Lin. Range

The reportable range of the test result. The default is void. The linearity range can not be lower than 0 and should be entered from low concentration to high concentration. The high and low limit should not be equal.

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Parameter

Description

Reagent blank Absorbance range of the reagent blank. Once this range is absorbance exceeded, error message will appear. The reagent blank absorbance should be entered from low to high. The high and low limit should not be equal. The default is void.

NOTE The absorbance of reagent blank is entered in the format of real value×10000. Absorbance limit

The maximum or minimum absorbance of the test result. For increase reaction, system will alarm when the reaction absorbance is higher than the absorbance limit; for decrease reaction, system ill alarm when the reaction absorbance is lower than the absorbance limit (for Kinetics and Fixed-time analysis, the absorbance limit is seen as the substrate depletion limit).

NOTE The absorbance limit is entered in the format of real value×10000. Lin. Limit(%)

It is only valid for Kinetics. The range is 0-100. The default is void. 0 means no check.

By Diff.

Set combinations based on sample type and patient gender, and enter respective reference range for each combination. Those who are under the age of 12 are taken as children.

The following table introduces the buttons on the page. Buttons

Function

Save

Save the test information.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

4.2.1.3 Calibration The Cal Details screen is where you can set the test calibration information including calibration rule, calibrator concentration and replicates.

4-6

Figure 4-5 Cal Details

The following table explains the parameters on the Cal Details screen.

Parameter

Description

K factor

For Absorbance analysis, the K factor is fixed at 1 and can not be edited. For Kinetics analysis the K factor is selected by default and you can enter according to the reagent instruction. Decimal is allowed.

Rule

Calibration rule.

Replicate

It refers to the times of each calibration test. It ranges from 1-3. The default is 1. Set the number of calibrators and the calibrator set point. The set point of the calibrator is arranged from lowest to highest. The void means 0 concentration. If set points are not set according to the above rules, error message will appear.

S1-S8

NOTE After the information about the number of the calibrators and the set points are modified, the existing information about calibration parameters and calibration curve will be deleted, so recalibration is required.

The following table introduces the buttons on the screen. Buttons

Function

Save

Save the test information.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

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4.2.1.4 QC Information The QC Information screen is where you can set the test QC rule and control information. Figure 4-6 QC information

The following table explains the parameters on the QC Information screen. Parameter

Description

Rule

Set QC rule for the selected test. One or more rules can be selected, or none is selected.

Control

You can set 3 controls of different concentrations and one QC rule for each test. For any level of control, once any one of the parameters (control lot, concentration or SD) is entered, you should enter the rest of the parameters to complete the setting. Otherwise, the control information can not be saved, and error message will appear.

The following table introduces the buttons on the page. Buttons

Function

Save

Save the test QC information.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

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4.2.2 Profile Tests grouped together for certain clinical purposes (for instance liver function) constitute a profile. Figure 4-7 Profile

Profile name list is on the left side of the screen, all the on-board test names are listed on the right side of the screen. Select a profile name on the left side and the tests it includes will shown are the list on the left side. The following table explains the parameters on the Profile screen. The following table introduces the buttons on the page. Buttons

Function

Add

Add a new profile. Enter the profile name in the Profile name text box, select tests in the list below the box, and then click save.

Delete

Delete the selected profile. The tests listed on the right side of the screen can not be deleted.

Save

Save the profile information.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

4.2.3 Calculation Calculating certain tests can derive certain new tests of clinical purpose. Calculation name list is on the left side of the screen, detailed information of the selected calculation is shown on the right side.

4-9

Figure 4-8 Calculation

The following table explains the parameters on the Calculation screen. Parameter

Description

Test

The test name should be set and same test names are not allowed.. The length of the test name should not exceed 10 characters. Otherwise, warning messages will appear.

Unit

Unit of the result. Select from the drop-down list. The options include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The default is void. The units can be added and deleted in Setup.

Precision

Precision of the result. Select from the drop-down list 1, 0.1, 0.01, 0.001. The default is 1.

Default reference

Enter the normal range of the calculation. Refer to 4.2.1.2 for details.

By Diff.

Set the differential reference range of the calculation. Refer to 4.2.1.2 for details.

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Parameter

Description

Edit formula

Edit the calculation formula. The screen is shown in the following figure. How to use the function of the screen to edit formula: the Routine list the tests to be used in the formula. Click Ins to insert these tests into the formula. Click Clear to clear all the information entered in the Formula text box.

Click OK to save; click Cancel to return to the Profile. Full name

Full name of the test. It can be void.

The following table introduces the buttons on the screen. Buttons

Function

Add

Add a new calculation.

Delete

Delete selected calculation.

Save

Save the new calculation or the modified calculation.

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

The default calculation is shown as follows: z

GLB （globin）=TP（total protein）-ALB（albumin）

z

A/G= ALB（albumin）/GLB（globin）

z

IBIL （indirect bilirubin）=TBIL（total bilirubin）-DBIL（direct bilirubin）

z

AST/ALT glutamic-oxal(o) transaminase ratio

z

ApoA1/ApoB

acetic

transaminase/glutamate-pyruvate

apolipoprotein A/apolipoprotein B

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4.2.4 Off-system All the tests that are not run by the analyzer are referred to as the off-system tests. You can manually enter the off-system test results in to the system to print out them in the patient report. For newly added off-system test, it is printed after the routine tests. You can readjust the printing order in Setup. Figure 4-9 Off-system

The following table explains the parameters on the off-system screen. Parameter

Description

Test

The test name should be set and same test names are not allowed. The length of the test name should not exceed 10 characters. Otherwise, warning messages will appear.

Unit

Unit of the result. Select from the drop-down list. The options include g/L, mmol/L, umol/L, U/L, mg/dL, IU/L, mg/L and void. The default is void. The units can be added and deleted in Setup.

Precision

Precision of the result. Select from the drop-down list 1, 0.1, 0.01, 0.001.The default is 1.

Default reference

Enter the normal range of the calculation. Refer to 4.2.1.2 for details.

By Diff.

Set the differential reference range of the calculation. Refer to 4.2.1.2 for details.

The following table introduces the buttons on the screen. Buttons

Function

Add

Add a new off-system test.

Delete

Delete selected off-system test.

Save

Save the new off-system or the modified off-system.

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Buttons

Function

Cancel

After selecting a test and setting or modifying parameters for it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

4.3 Test Click Test on the main screen to enter the test screen. The Test screen is divided into three parts: Request, Test and Result. You can run test directly, or run after requesting. The sample ID will automatically increase according to the testing order, if requesting is used.

4.3.1 Request Before testing, you can enter all the samples and the tests into the system. After entering the Test screen. The tests will be marked with “*”. The sample ID will automatically increase according to the testing order. The following shows an example: 001：ALT，AST，TP，ALB 002：ALT，AST，GLU 003：TP，ALB 004：ALT，GLU

The test list shows tests which have been requested but not yet run. These tests are marked with “*”. If you select ALT, during test, the first sample ID is 001, the second 002 and the third sample ID will increase automatically to 004. The requesting status of samples is shown in the list on the left side of the screen; tests are shown in the list in the middle of the screen; profiles are shown in the list on the right side of the screen. In Request screen: After selecting or entering a sample ID, select the tests in the test list. If you are to select a profile, select it in the profile list. Click Save. The requested sample will be shown in the list on the left side of the screen. Select a sample ID in the left list to view the tests requested on this sample.

4-13

Figure 4-10 Request

The following table explains the parameters on the Request screen. Parameter

Description

Sample ID

Sample ID. Range: 001-999.

Patient

Name of the patient.

Tests

The names of the on-board tests.

Profiles

The names of the defined profiles.

The following table introduces the buttons on the screen. Buttons

Function

Save

Save the information of newly requested test.

Delete

Delete the requested tests of the selected sample ID.

Cancel

Click this button to cancel requesting, and return to the status before requesting.

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Buttons

Function

View

Click this button to check the requesting information of all the samples. Information can be arranged and printed by test or by sample.

Return

Click this button to return to the main screen.

4.3.2 Test Click Test on the main screen to enter the test screen. Figure 4-11 Test

4-15

The following table explains the parameters on the Test screen. Parameter

Description

Tests A list of all the on-board tests. The requested test is marked with “*”. Parameter

View parameters of the selected test. Parameters include: test name, reaction type, wavelength, temperature, delay, measuring time, aspiration volume, blank mode, calibration equation (K factor). Click Return to return to Test

System status area Instrument status and information during test is shown in this area. When system is normal, the area shows Standby When sample or other solution to be tested is selected, the area shows: Please aspirate. When system fails, the area shows: error! When temperature is not Temperature stabilizing…

stabilized,

the

area

shows:

During test, the area shows: Testing… When light intensity is too weak, the area shows: light source too weak. When saving the result, the area shows: Result saved. Sample information The area shows the sample ID of the current sample. Use “+” and “-“to change the sample ID. After the completion of a sample test, the sample ID of the sample blank will increase by 1 (if requesting is applied, increase the sample ID according to requesting). Click this button to wash the tubes after system aspirating distilled water.

4-16

Parameter

Description

Wash

Click Wash. The system will aspirate certain amount of distilled wa NOTE The Wash button can not respond during test or when temperature is stabilizing.

Stop

Stop testing or washing. The sample ID will not increase automatically.

Water Blank

Run DI water zero.

Rgt. Blank

Run reagent blank for the selected test.

Sample Blank

Run Sample Blank for the selected sample. The test result of the next sample will have sample blank deducted. For endpoint analysis, you can choose whether to run sample blank or not based on the status of the sample.

Sample

Run selected tests of the current sample. Click Sample. The following information will be shown in the window above the reaction curve.

The area shows the sample ID of the current sample. Use “+” and “-“to change the sample ID. After the completion of a sample test, the sample ID of the sample blank will increase by 1 (if requesting is applied, increase the sample ID according to requesting). Calibrate

Run selected tests of the calibrator. Click Calibrate. The following information will be shown in the window above the reaction curve.

The S1-S8 will be displayed in the drop-down list box according to parameter setup. you can rearrange the testing order of the calibrators. Unless all the calibration of the calibrators are completed, system will disable the sample or control test. QC

Run selected tests of the control. Click QC. The following information will be shown in the window above the reaction curve.

Select control to run QC test. But the control information should be preset in the parameter setup.

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Parameter

Description

Water blank

When the system running distilled water zero, the ABS of water blank is displayed When the system running reagent blank, the ABS of reagent blank is displayed.

Conc.

Result concentration. While running calibration, this area will show the set point of the calibrator.

Realtime ABS

During test, this area shows the real-time ABS. When test is completed, this area shows the response of the current sample.

Rgt. blk resp

For endpoint analysis, the absorbance of the sample blank is displayed; for Kinetics and fixed-time analysis, the response of the reagent blank will be displayed.

The following introduces the buttons on the screen. Buttons

Function

QC record

Click this button to view the QC result of the selected test. Please refer to 4.5 for more details.

Cal record

Click this button to view the calibration curve and calibration parameters of the selected test. Please refer to 4.4 for more details.

Print curve

Print reaction curve and test result.

Curve Data

Click this button to view the reaction curve points of all the periods.

Start

Click this button to aspirate and run test. The button can be used as a substitute for Aspirate button.

Return

Click this button to return to the main screen.

The test workflow is shown as follows.

4-18

Figure 4-12 Test workflow

Select test

Water blank

Reagent blank

Calibrator

Sample blank (Sample)

Yes

Control

Next sample (QC)? No End

NOTE During test, if the cuvettes are contaminated, the test result might not be reliable. We recommend you to wash the cuvette using ethanol solution (the volume ratio of ethanol and water is 4:1) or wash solutions specific for cuvette. For more details, please refer to 5.3.1.1 Low Background Soaking the cuvettes in ethanol or other wash solutions is forbidden.

4.4 Calibration You can view calibration curve, calibration parameters and edit the linear calibration parameters in the Calibration screen.

4-19

Figure 4-13 Calibration

The following table explains the parameters on the Calibration Details.

Parameter

Description

Test

Test that has been calibrated.

Date

The date when calibration of the test is run.

Rule

Calibration rule.

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The following explains the Calibrator and Parameter.

Parameter

Description

No.

Calibrator No. The range is S1-S8.

Std. Conc.

Set point of the calibrator.

Response

Response of the calibrator.

Parameter

Parameters in the calibration formula.

Value

Value of the parameters in the calibration formula.

The following introduces the buttons on the screen. Buttons

Function

Edit

Edit the parameters in the linear calibration equation. Enter new values in the K and R0 text box; click OK to save and enter the Calibration screen. The calibration curve and information will be refreshed in the meantime. Click Cancel to cancel the setting.

NOTE The formula can only be edited when the calibration rule is linear calibration (single-point, two-point and multi-point).

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Buttons

Function

Print

Print current calibration parameters and curve.

Return

Click this button to return to the main screen.

CAUTION The replacement of certain components should be followed with calibration. Otherwise, you may get unreliable result.

4.5 QC You can view the QC result and QC reaction curve, and check whether the test is out of control and print QC reaction curve in the QC screen. Figure 4-14 QC

The following table explains the parameters on the screen. Parameter

Description

Test

All the tests with QC information set will be listed. Select a test to view the QC result.

Date

The maximum range is one month(31 days).

Control

C1-C3 can be selected.

Lot No.

The latest 5 lot No. will be displayed. The default is the most recent lot No..

SD

Standard Deviation of the control.

AVG

Concentration of the control.

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Parameter

Description

C1, C2, C3

A tab used to switch between C1, C2 and C3 to view the QC data.

No.

No. of the QC result.

Date

Date when the QC is run.

Concentration

QC result

Remark

Display “in control” or “out of control” according the QC result and QC rule.

Query

Inquire the QC curve and the result of the selected test and control within the specified time range.

The following introduces the buttons on the screen. Buttons

Function

Delete

Delete all the QC result of selected condition.

Print

Print current calibration parameters and curve.

Upload

Click this button to send the control result of the selected test to LIS.

Return

Click this button to return to the main screen.

4.6 Result You can inquire, edit, modify and printer the patient report.

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4.6.1 Result 4.6.1.1 View Results by Sample Figure 4-15 View Results by Sample

Select Sample to display the result by sample; select Test to display the result by test. The result of the current day will be displayed by default. It there is no test result for the current day. No data will be displayed. The following table explains the parameters on the screen. Parameter

Description

Test

Name of the test. Select a test to view all the test result of the current day in the list on the right side of the screen.

Patient

Name of patient.

Sample ID

Sample ID of the patient.

Unit

Unit of the test result.

Test Date

The date when test is run.

Reference

Reference range of the test.

Original

Original result of the test. If the result is edited, the original result is kept for checking up.

Remark

Use simple symbols and abbreviation to comment on the result. Refer to the appendix of this manual for more details on the symbols.

All

Select all the test names (arranged by test) or sample IDs (arranged by sample).

The following table introduces the buttons on the Sample screen.

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Buttons Query

Function Click Query to pop up the following page.

Select data range or patient name or/and Sample ID to search for results that meet the requirement. Add

Add new patient information.

Edit

Select one sample to a sample result to enter the Edit page or enter the page directly. The editing function will be elaborated separately in the following.

Delete

Delete all the result of the selected test, when it is displayed by test. Delete all the result of the selected sample, when it is displayed by sample.

Upload

Send all the result of the selected sample to LIS.

Print

Print the report of the selected sample.

Return

Click this button to return to the main screen.

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4.6.1.2 View Results by Test Figure 4-16 View Results by Test

Refer to the above for parameter on Test screen. The following table introduces the buttons on the Test screen. Buttons Query

Function Click Query to pop up the following page.

Select data range or patient name or/and Sample ID to search for results that meet the requirement.

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Buttons Summary

Function Click Summary to pop up the following page.

Select Test (including all the on-board tests and defined off-system tests) and time range to search for results that meet the requirement. Print

Print the report of the selected sample.

Return

Click this button to return to the main screen.

4.6.2 Edit Click Edit or Add in Result window to enter the screen to edit the result report. When you enter the screen by clicking Edit, the sample ID can not be edited; when you enter the screen by clicking Add, the sample ID can be edited. The screen is divided into two parts: one part is for information of the test report, including patient information and doctor information; the other part is for test result information, where you can add, delete or edit the test results.

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Figure 4-17 Test report

4.6.2.1 Test Result Figure 4-18 Test result

The following table explains the parameters on the screen. Parameter

Description

Test

Name of the test.

Conc.

Test result.

Unit

Unit of the test result.

Reference

Reference range of the test.

Response

Response of the test.

Original

Original result of the test. If the result is edited, the original result is kept for checking up.

Remark

Use simple symbols and abbreviation to comment on the result. Please refer to the Appendix B for more information on symbols.

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The following introduces the buttons on the screen. Buttons

Function

Add

Click Add to pop up the following screen.

Select the test name (including routine test and calculation test in the Routine drop-down list box. Enter the Quantitative and/or flag result in the Result area. Select test name for off-system test, enter the test result in Result area. Off-system tests and Setup-Dictionary. Edit

flags

can

be

added

or

deleted

in

After selecting a test result, click Edit to pop up the following screen.

Enter new result in Quantitative area, or select flag result. Click OK to save the new result and return to the result report screen. After the test result is edited, the test result displayed in the result report screen will be updated accordingly. But the original result will be saved. Delete

Delete the test result currently selected.

4.6.2.2 Patient Information Parameter

Description

Name

Name of patient.

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Parameter

Description

Sample ID

Sample ID of the patient. If you enter the screen by selecting a test result, the sample ID can not be edited. The sample ID should not be void. Otherwise, the patient information can not be saved. The entered sample ID can not be the same with the existing sample ID of the current day.

Type

The options are serum, plasma and urea, etc. You can add or delete the types in Setup-Dictionary.

Age

Age of the patients. The units are Year, Month, Day.

Gender

Gender of the patient, including: Male, Female.

MRN

Medical record No. of the patient.

Sender

Name of the doctor who sent the sample to the clinical laboratory. You can add or delete the names in Setup-Dictionary.

Tester

Name of the doctor who tested the sample. You can add or delete the names in Setup-Dictionary.

Test Date

The date when sample is tested.

Send Date

The date when sample is sent to be tested.

Reviewed by

Name of the doctor who reviewed the test report. You can add or delete the names in Setup-Dictionary.

Remark

More information about the patient.

The following introduces the buttons on the screen. Buttons

Function Click this button to view or edit the information of last sample. Click this button to view or edit the information of the next sample.

Save

Save the information on setting.

Cancel

Cancel all the editing and return to the status before editing.

Print

Print the report of the selected sample.

Return

Click this button to go back to Sample screen.

4.7 Setup You can set hospital name, system date and time, data dictionary, touchscreen calibration and delete history data in Setup.

4-30

4.7.1 Basic Figure 4-19 Basic setup of the system information

The following table explains the parameters on the Basic screen. Parameter

Description

FPGA Software

The version information of the system.

Hospital

Name of the hospital.

Start button sound

Start the function of making sound when pressing a button.

Pump speed

3 pump speeds are available: 1, 2, 3. The default which is recommended to the user is 1.When there are some impurities in the flow cell or tubing that can not be cleared, select pump speed 2 or 3 to clear them. After washing, it is recommended that pump speed 1 should be restored.

Date

Select the date in the date table. Use year.

and

to select month and

Time

Enter time in the text box.

Standby interval

Set the time interval for the system to enter Standby status.

Colorimetri c mode

Use cuvette or cell.

4-31

NOTE Sound alarming is available on the system. If the sound of pressing a button is shut off, the sound alarming function will be disabled, then you should observe the prompt information for any alarming.

The following table introduces the button on the screen. Buttons

Function

Touchscr. Cal

When the touchscreen is slightly deviated, or when the clicked position and the position of the cursor are not the same, the input might be affected. It is necessary to calibrate the touchscreen. Follow the instructions on the screen to complete the touchscreen calibration as shown in the following figure.

Save

Save the information on setting.

Return

Click this button to return to the main screen.

4.7.2 Dictionary The Dictionary screen contains three parts: the list on the left side of the screen shows the dictionary items; the list on the top right side shows the detailed information of the selected item; the text box and the buttons below the detailed information list are used to add, delete and save new information for the selected dictionary item.

4-32

Figure 4-20 Dictionary

The following table explains the parameters on the Dictionary screen. Parameter

Description

Unit

Add, delete test unit.

Type

Add, delete sample type.

Sender

Add, delete the name of the doctor who sends the sample.

Tester

Add, delete the name of the doctor who tests the sample.

Reviewer

Add, delete the name of the doctor who reviews the sample result.

Qualitative result

Add, delete qualitative result type.

The following table introduces the buttons on the Dictionary screen. Buttons

Function

Add

Add new items to the dictionary.

Delete

Delete existing items in the dictionary.

Cancel

Cancel adding information to the dictionary.

Save

Save new items to the dictionary.

Return

Click this button to return to the main screen.

4.7.3 Print Features You can select the printer, adjust the printing order of the tests in Print Features.

4-33

Figure 4-21 Print Features

The following table explains the parameters on the Print Features screen. Parameter

Description

Internal Printer

Select internal thermal recorder to print test result.

External Printer

Select external printer to print test result. The Appendix lists the printers the system supports.

Start internal online PRN

Print the test result in real time.

The following table introduces the button on the screen. Buttons

Function

Top

Move the selected test to the top of the list.

Up

Move the selected test upward by one line.

Down

Move the selected test downward by one line.

Bottom

Move the selected test to the bottom of the list.

Cancel

Restore the original printing order.

Return

Click this button to return to the main screen.

4.7.4 Carryover In Carryover screen, you can set some tests between which carryover may exists to notify operators to rinse the tubes, thus the effect brought about by carryover can be minimized.

4-34

Figure 4-22 Carryover

Select contaminating test in the Contaminating test list; select contaminated test in the Contaminated test list. Select Save to save the setting.

4.7.5 LIS Setup You can send the test result to LIS, after some parameters have been set is LIS setup. Figure 4-23 LIS setup

Enter specified information in LIS manufacture and LIS. Set the Index of Test config., Result Setup, Unit and Type, according to the index No. provided by LIS. The operation is as follows: Select Test config. and the list on the left side of the screen shows all the test names on the system. Select one test and enter the index on the LIS into the Index beside the test name. After setting is completed, click Save to return to the main screen.

4-35

Enter the right information in LIS manufacturer and LIS text box. Set the Index for test, quantitative result, qualitative result, unit, sample type in consistent with those provided by LIS. The index number will be the unique symbol recognized by LIS, facilitating the communication between the analyzer and the LIS. If the wrong index number is set, the result can not be correctly uploaded. The detailed operation is as follows: select Test config., the list on the right of the screen will list the names of all the routine and calculation tests. Select one test, enter its index number in Index column. Click save to complete the setting. When the system is connected with data management software, In Instrument reg.—Channel No. setup, the channel No. of fields like test information, sample type should be consistent with System—LIS setup in BA-88A, otherwise, the information can not be uploaded correctly. After all the settings are complete, click Save to return to the main screen.

4.8

Maintenance You can do maintenance on the database or the instrument; manage the system log on Maintenance screen.

NOTE While doing maintenance, only use the component provided by Mindray customer service department or your local distributor.

4.8.1 Database On Database screen, you can check the maximum capacity for storing the test results and the remaining capacity. Deleting history data to release space can also be done on this screen. If maximum capacity is reached, new test result will replace the history result automatically. Select DB backup to transfer the test information and test result on the analyzer to USB disk.

4-36

Figure 4-24 Database

4.8.2 Log You can view failure records on this screen. Figure 4-25 Log

Error list is on the left side of the Log screen. On the right side of the screen, detailed information about the selected item is shown, including Error Info., Causes and Corrective, which can be used as reference while troubleshooting the failures.

4-37

4.8.3 Maintenance In this screen, you can conduct maintenance by selecting Pump cal and Gain adjust. The Password function is only available to service personnel and authorized distributors. Figure 4-26 Maintenance

4.8.3.1 Pump Calibration Figure 4-27 Pump calibration

Pump Cal can facilitate the calibration of peristaltic pump. The detailed procedures are as follows: Prepare 6000µl distilled water, select 1st, and then click Start. The system will start to aspirate distilled water. When all the water has been aspirated, click Stop. Follow the procedure above to finish the 2nd and 3rd calibration.

4-38

NOTE The error of the volume 6000 µl should be as small as possible. As soon as all the distilled water is aspirated, the Stop should be clicked, otherwise the calibration might not be precise.

4.8.3.2 Gain Adjustment Figure 4-28 Gain adjustment

After replacing the lamp, cuvette, filter or when alarm messages like “Light signal too weak”, “Light signal too strong” appears, the Gain adjust can be used to adjust the light intensity to proper degree. The detailed operation is as follows: prepare distilled water, click Start-Aspirate. Save the new gain coefficient after adjustment.

4.8.4 Shutdown Click Shutdown on the main screen. Please follow the instructions displayed on the screen to wash the tubes with distilled water and then shutdown the power.

CAUTION After powering off, do not power on immediately. Wait at least 10 seconds, if powering on is required.

4-39

4-40

5

Maintenance

To ensure good performance of the system, regular maintenance is required.

WARNING Do not perform any maintenance procedures that are not described in this chapter. Otherwise, it may lead to personnel injury or equipment damage. Do not touch the parts other than specified. Performing unauthorized maintenance procedures may damage your system, void any applicable warranty or service contract and even cause personal injury. Do not spill water or reagent on mechanical or electrical components of the system.

BIOHARZARD Wear gloves and lab coat and, if necessary, goggles during maintaining process. Before maintenance or packaging for transportation, the used instrument should be disinfected to ensure personal safety.

5.1

Parts and Consumables Please use the parts and consumables manufactured or recommended by our company in order to achieve the promised system performance. If needed, contact our customer service department or your local distributor.

5-1

Part Name

Part Number

Location

Description

Lamp assembly

BA89-30-86998

Lamp base

Regularly-replace d part

Flow cell

M90-000168---

Cuvette installation hole inside the optical window

Replace it when damaged

BA89-30-87035

Internal printer component

Replace it when damaged

Pump tubing

M6G-020052---

Peristaltic pump

Replace it when damaged

Aspiration

BA89-30-87070

Above the Aspirate button

Replace it when damaged

A30-000001---

Internal printer

Consumable

Internal assembly

Thermal paper

printer

printing

5.2 Tools Required for Maintenance The following tools will be used for maintenance of the system. „

Hex wrenches (M1.5, M3 and M4)

„

Cross-headed screwdrivers (large, medium and small)

„

Needle tube

„

Tweezers

„

Clean gauze

„

scissors

5.3 Daily Maintenance Use neutral wash solution and wet cloth to remove the spillage on the instrument. Wash the tubing with distilled water or DI water before shutting down the analyzer (for instrument installed with flow cell). When the system is not in use, make sure that the tubing and the flow cell is filled with clean distilled water (or DI water).

5.4 Weekly Maintenance Wash the waste bottle interior with clean water. Soak the bottle with disinfector if necessary. If the instrument will not be in use for a long time. Detach the pump head from the pump to elongate the service life of the pump tubing.

5-2

5.5 Irregular Maintenance 5.5.1 Cleaning Flow Cell 5.5.1.1 Low Background Contamination of the flow cell or bubble in the flow cell might cause low background. You can use the ethanol solution to clean the flow cell ( also applies for bubble in the flow cell). The procedure is as follows: 1)

Click Wash on the software to wash the tubing. After 5 seconds, click Stop.

2)

Prepare about 5 ml ethanol solution in the tube. Put the aspiration tubing into the tube and click Wash. After 5 seconds, click Stop. Wait for 10 seconds.

3)

Wash with ethanol solution for 5 seconds again, and then wait for 10 seconds. Wash the tubing with DI water for 10-20 seconds. The cleaning is completed.

4)

Other recommended wash solutions include: 0.1N NaOH (KOH) solution (with some surfactant); or, enzyme solution capable of decomposing the protein; or, reagent used in chemistry analysis, capable of removing the protein, total protein reagent (biuret) and etc.

5.5.1.2 Before switching to other tests Before switching to other tests, it is recommended the flow cell be washed with distilled water (or DI water). This is very necessary for tests which carryover might take place, or samples whose concentration differs a lot. The cleaning should last for no less than 5 seconds. The amount of distilled water (or DI water) should be around 1.5 ml. You can also use the wash solution specifically for chemistry analyzer to wash first, then with the distilled water (or DI water).

5.5.1.3 Cleaning Exterior of the Flow Cell If the optical surface of the flow cell is contaminated, use cloth soaked with certain amount of absolute alcohol to clean it.

5-3

WARNING Some reagents are corrosive. Exercise caution when handling the reagents. In case the reagents or wash solution spill into your eyes, rinse them with much water and consult an oculist.

5.5.2 Adjusting the Photoelectric Gain When the alarm message “Light signal too weak” or “Light signal too strong” appears, please check whether there is air in cuvette or whether the cuvette is placed right. If not, please adjust the photoelectric gain. After entering the Maintenance screen, click Gain adjust to pop up the Gain adjust page. Click Start and do as the system prompts. The system will complete the photoelectric adjustment and parameter configuration automatically. If the adjustment failed, possible reasons are: bubble in the flow cell or dirty optical elements or low intensity of the lamp, or damaged boards. After photoelectric gain is completed, wait for 10 min before testing. Otherwise, test result might be affected because of unstable light source.

NOTE The lamp must be replaced when its light intensity attenuates to the specified threshold. When the range of background preset by the system can not be restored by adjusting the photoelectric gain, it might be possible that the light intensity attenuates to the specified threshold and the lamp should be replaced timely.

5.5.3 Calibrating the Peristaltic Pump The flow volume of the peristaltic pump might change after being used for a certain period, so it is necessary to calibrate the flow volume of the pump, if obviously incorrect aspiration volume of the pump is observed.

5.5.4 Replacing the tubing When the instrument is in use, if you notice that the instrument can not aspirate or aspiration volume decreases obviously, check for leakage in the peristaltic pump. If yes, the pump tubing might be broken and it should be replaced. A pump tubing is in the accessory package (outer diameter 3.2mm, length 150-160mm, yellow).The procedure for replacing is shown as follows: 1

Shutdown the instrument and disconnect the power cable between the instrument and the power supply.

5-4

2

Locate the position where the peristaltic pump is installed. Pull out the tubing that goes through the backboard of the analyzer for 40-50mm until the adapter is exposed. Pinch the two buckles on the left and right side of the pump shell and detach the pump head carefully. Pull the tubing out slightly

Pinch the buckles to detach the pump head

3

After detaching the pump head, unplug the tubing (yellow) whose adapters are closer to the pump head.

Unplug the tubing (yellow) whose adapters are closer to the pump head.

5-5

4

After unplugging the adapters, pinch the buckles on the pump head and detach the pump shell.

Pinch the buckles on the pump head and detach the pump shell.

5

After detaching the pump shell, press the roller inside the pump to take the used pump tubing out. Remove the red ring on the used tubing and install them on the new tubing. Install the new pump tubing on the pump and carefully pull it to make the tubing fit well with the inside of the pump without any twisting. Make sure the lengths exposed at both ends are roughly the same. If necessary, pull both ends of the tubing slightly.

5-6

6

After mounting the pump shell, install the pump head on the pump. Install the pump head on the pump, with the motor shaft into the installation hole

Pinch the buckles to lock the pump head

7

After installing the pump head, connect the tubing with the tubing that goes through the backboard and the waste tubing. The pump tubing on the left should be connected to the tubing that goes through the backboard, the pump tubing on the right to the waste tubing. The pump tubing on the left should be connected to the tubing that goes through the backboard.

the pump tubing on the right to the waste tubing.

8

After connecting the tubing, slip the tubing that goes through the backboard into the analyzer until the adapters does not expose to the outside.

9

Check the installation for any errors. Connect the analyzer to the power supply and calibrate the pump. Please refer to the relevant part of the operator’s manual for calibration method.

BIOHARZARD When replacing the pump tubing, wear gloves and lab coat and, if necessary, goggles. In case your skin contacts the waste, follow standard laboratory safety procedure and consult a doctor.

5-7

NOTE The service life of the pump tubing is 18 month. Tubing should be checked irregularly and replaced in time. Do not use excessive force while pulling, slipping the tubing or doing any operation that might pulling the tubing. Otherwise, the tubing might be damaged or the inner connection might be cut off. While connecting the tubing, insert the tubing into the adapter until the tubing reaches the bottom of the adapter so as to ensure the reliability of the connection. While installing the pump tubing into the pump, avoid twisting. If necessary, pull the tubing back and forth slightly. Calibrate the pump after replacing the pump tubing. Otherwise, the aspiration volume might not be correct and the test may be affected.

5.5.5 Replacing Aspiration Tubing During operation, if the aspiration tubing is blocked and can not be unblocked, replace it with the tubing (OD: 1.6mm; length: 200-220mm, transparent material), with one end connected with silicone tube-OD: 4mm; length: about 30mm) in the accessory. The replacement procedure is as follows: 1

Open the optical window cover and press the bottom of the flow cell ( if flow cell fastening screw is installed, you do not have to press), then carefully pull the metal inlet tubing which is connected with the flow cell ( the slimmer one which is closer to the front of the instrument)

Pull the tubing out

5-8

2

Connect the thicker end of the new tube to the inlet metal tube and then guide the tube through the deflection tube. The thicker end is connected with the metal tube

Aspiration deflection tube

BIOHAZARD When replacing the pump tubing, wear gloves and lab coat and, if necessary, goggles. In case your skin contacts the waste, follow standard laboratory safety procedure and consult a doctor.

NOTE After replacement is completed, please make sure that the flow cell is pressed to the bottom of the installation hole (the top of the flow cell should be on the same level with the installation surface). Otherwise the test result might not be reliable.

NOTE When connecting the tube, the tube should reach the root of the metal tube to ensure reliability. After the aspiration tubing is installed, the bending part should be transitioned smoothly, no sharp angle, corrugation is allowed

5.5.6 Replacing Lamp When the system warns that the background is too weak (no bubble in the flow cell) and the warning can not be dealt with by cleaning the flow cell, the optical element and adjusting the photoelectric gain. The detailed operation is as follows:

5-9

1

Open the optical window cover, use cross screw driver to unscrew the screws on the lamp replacement window cover. Remove the cover.

Unscrew the two screws and remove the replacement window cover

2

Unscrew the fastening screw of the lamp base (if it is difficult to dismount, some tools like the clipper might be used). Put the screws in a proper place outside the instrument. Pinch the lamp base directing line and then carefully take the lamp assembly out).

Lamp base fastening screw

Lamp base directing line

5-10

3

Pull the wire out and you can see the wire joint connecting the lamp assembly, with one end connecting to the lamp and the other end connecting to the inside of the instrument. Pinch both ends of the joint and press the buckle to disconnect the joint. The dismounting is completed.

Wire joint

4

Connect the new lamp with the wire joint of the lamp assembly and wire joint in the instrument. Install the lamp into the installing hole in the lamp base. Fasten the retaining screw on the lamp base.

5、

After installation, power on the instrument. Adjust the gain. Check the background after the instrument is stabilized to check whether the replacement is successful.

WARNING If you want to replace the 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.

NOTE When replacing the lamp assembly, do not touch the surface of the bulb. When dismounting the restraining screw of the lamp base, please take extra care to avoid element falling into the inside of the instrument. If it is difficult to dismount, some tools like the clipper might be used. The photoelectric gain should be adjusted after the lamp is replaced. For more details, please refer to 5.3.2 Adjusting the Photoelectric Gain.

5-11

5-12

6

Operation Theories

6.1 Principles of analysis The system adopts the analysis principle of colorimetry and turbidity,.

6-1

6.2 Principles of Measurement The system performs measurement with the following principles: „

Endpoint

„

Fixed-time

„

Kinetic

6.2.1 Endpoint Measurements In endpoint measurements, the reaction reaches equilibrium after a period of time. Since the equilibrium constant is quite high, it can be considered that all substrates (analytes) have changed into products, and the absorbance of the reactant will not change any more. The absorbance change is directly proportional to the analytes’ concentration. The endpoint method, also called equilibrium method, is most ideal for measurements. The endpoint reaction is insensitive to minor changes in such conditions as the enzyme volume, pH value and temperature, provided the changes are not significant enough to affect the reaction time.

6.2.2 Fixed-time Measurements In fixed-time measurements, namely, rate measurements, the reaction velocity (v) is directly proportional to the substrate concentration [S] within a specific period, that is, v=k[S]. As the substrate is consumed continuously, the reaction velocity is decreasing gradually, and so is the absorbance change rate. It takes a long time for the reaction to reach equilibrium. Theoretically, the absorbance reading can be taken at any time. The reaction can, however, become steady only after a lag because it is complicated at the beginning and there are miscellaneous reactions due to complex serum compositions. For any rate measurements, the substrate concentration [S] at a given point t since the reaction begins is obtained through the following formula:

[S ] = [S 0 ]× e − kt Where,

S0: the initial substrate concentration e: base of the natural log k: velocity constant The change of substrate concentration Δ[S] over a fixed time interval, t1 to t 2 , is related to [S0] by the following equation: [ S 0] =

− Δ[ S ]

e

− kt1

−e

− kt 2

That is, the change in substrate concentration is directly proportional to its initial concentration within a fixed time interval. This is the common feature of rate

6-2

measurements. Within this interval, the absorbance change is directly proportional to the analytes concentration. The fixed-time reaction is also called, rate reaction, first-order Kinetic reaction and two-point Kinetic reaction.

6.2.3 Kinetic Measurements In Kinetic measurements, namely, zero-order Kinetic measurements or continuous-monitoring measurements, the reaction velocity is not related to substrate concentration and remains constant during the reaction process. As a result, the analytes absorbance changes evenly at a given wavelength, and the change rate (ΔA/min) is directly proportional to the activity or concentration of the analytes. The Kinetic method is usually used to measure enzyme activity. In fact, it is impossible for the substrate concentration to be absolutely high, and the reaction will be no longer a zero-order reaction when the substrate is consumed to certain degree. Therefore, the reaction type only stands within certain reaction period. In addition, the reaction can become steady only after a period of time, because the reaction is complicated at the beginning and there are miscellaneous reactions due to complex serum compositions. In Kinetic reaction, the concentration or activity is obtained according to the absorbance change among specified measuring points.

6.3 Calculating Linear Calibration Parameters The system provides two calibration methods: linear calibration and nonlinear calibration. Linear calibration includes one-point linear calibration, two-point linear calibration and multi-point linear calibration. They are mainly used for tests determined by colorimetry. Nonlinear calibration includes Logit-Log 4P, Logit-Log 5P, Exponential 5P, Polynomial 5P, Parabola and Spline. They are mainly used for tests determined by turbidity. In this section,

R - calibrator response C - calibrator concentration (activity) K , R 0, a , b , c - calibration parameters

One-point linear calibration Calibration formula: R = aC This calibration method adopts only one calibration parameter a , a = This calibration method requires only one calibrator.

Two-point linear calibration Calibration formula: R = aC + b .

6-3

R . C

This calibration method adopts two calibration parameters: a and b , where,

a=

R − R1 R2 − R1 ）C1 . , b = R1 −（ 2 C 2 − C1 C 2 − C1

This calibration method requires two calibrators. C 1 and C 2 are respectively the concentrations of calibrator 1 and calibrator 2. R 1 and R 2 are respectively the responses of calibrator 1 and calibrator 2.

Multi-point linear calibration Calibration formula: R = aC + b . This calibration method adopts two calibration parameters: a and b . This calibration method requires n (n≥3) calibrators. C i is the concentration of calibrator i . Ri is the response of calibrator i . a and b can be obtained through the method of least squares. n

a=

n

n

∑ Ci Ri − (∑ Ci )(∑ Ri ) / n i =1

i =1

n

∑C i =1

2 i

i =1

n

− (∑ C i ) 2 / n i =1

6.4 Calculating Nonlinear Calibration Parameters

Logistic-Log 4P Calibration formula: R = R0 + K

1 1 + exp[−(a + b ln C )]

This calibration method adopts four parameters: R0 ,

K , a and b .

This calibration method requires at least four calibrators. The concentration (or activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.This calibration method is applied to the calibration curve that the response becomes smaller and smaller with the concentration increase. See Figure 6-1. Figure 6-1 Logit-Log 4P calibration curve

R

C1

C2

C3

C4

C

6-4

Logistic-Log 5P Calibration formula: R = R0 + K

1 1 + exp[−(a + b ln C + cC )]

This calibration method adopts five parameters: R0 , K , a , b and c . This calibration method requires at least five calibrators. The concentration (or activity) of calibrator 1 is 0, and the corresponding R is equal to R 0.The applications of the calibration method are the same with that of Logit-Log 4P, but this method has a higher fitting.

Exponential 5P Calibration formula:

R = R0 + K exp[a ln C + b(ln C ) 2 + c(ln C ) 3 ]

This calibration method adopts five parameters:

R0 , K , a , b and c .

This calibration method requires at least five calibrators. The concentration (or activity) of calibrator 1 is 0, and the corresponding R is equal to R0 0.This calibration method is applied to the calibration curve that the response increases sharply when the concentration reaches a specific value. See Figure 6-2. Figure 6-2 Exponential 5p calibration curve

R

C1 C2

C3

C4

C5

C

Polynomial 5P Calibration formula: ln C = a + b(

R − R0 R − R0 2 R − R0 3 ) + c( ) + d( ) 100 100 100

This calibration method adopts five parameters:

R0 , a , b , c and d .

This calibration method requires at least five calibrators. The concentration (or activity) of calibrator 1 is 0, and the corresponding R is equal to R0 .

Parabola Calibration formula: R = aC + bC + c 2

6-5

This calibration method adopts three parameters: a , b and c . This calibration method requires at least three calibrators. The calibration parameters can be calculated through the method of polynomial least squares.

Spline Calibration formula: R = R0i + ai (C − C i ) + bi (C − C i ) + ci (C − C i ) 2

3

This calibration method requires 2 to 6 calibrators. The number of calibrators is set to be n, so the calibration method has 4(n-1) parameters in total: R0i , ai , bi and

ci .

6.5 Calculating Concentration

6.5.1 Calculating Sample/control

Concentration

One-point linear calibration

C=

R a

Where,

a - calibration parameter

Two-point linear calibration

C=

R−b a

Where,

a , b - calibration parameters

Multi-point linear calibration

C=

R−b a

Where,

a , b - calibration parameters

6-6

of

Linearly

Calibrated

6.5.2 Calculating Concentration of Nonlinearly Calibrated Sample/control

Logistic-Log 4P

− a − ln( C = EXP(

K − 1) R − R0 ) b

Where,

R0 , K , a , b

- calibration parameters

Logistic-Log 5P The positive real root is obtained with the dichotomy method.

Exponential5P The positive real root is obtained with the dichotomy method.

Polynomial5P C = exp(a + b(

R − R0 R − R0 2 R − R0 3 ) + c( ) + d( ) ) 100 100 100

Where,

R0 , a , b , c , d - calibration parameters Parabola The positive real root of the following linear quadratic equation is obtained:

aC 2 + bC + c − R = 0 Spline Spline defines several calculation sections based on the responses of calibration concentrations. Each section differs in specific parameters. Therefore, the section to which the current response belongs should be confirmed before Spline calculation. The parameters of relevant section shall be used to obtain a positive real root with the dichotomy method.

6.6 QC Rule

6-7

6.6.1 Westgard Multi-rule Westgard multi-rule is shown below. Symbol

Explanation

QC Conclusion

12S

One control value exceeds ±2 standard deviations.

Warning

13S

One control value exceeds ±3 standard deviations.

Out-of-control (random error, systematic error)

22S

Two consecutive control values for one level exceed ±2 standard deviations.

Out-of-control (systematic error)

R4S

The difference between two consecutive control values exceeds 4 standard deviations.

Out-of-control error)

41S

Four consecutive control values for one level exceed ±1 standard deviation.

Out-of-control (systematic error)

10X

Ten consecutive control values for one level lie on one side of the mean.

Out-of-control (systematic error)

(random

Westgard multi-rule QC conclusion flow for single control is shown in Figure 6-3. Figure 6-3 Westgard Multi-rule QC Conclusion Flow

For several controls, the conclusion logic is similar to the above condition, except for multiple continuous QC data, which should be combined simultaneously.

6-8

Appendix A Specifications

A.1

Technical Specifications „

Test principle: Colorimetry, Turbidity

„

Analytical methods: Endpoint, Fixed-time, Kinetic and Absorbance. All of the four methods support double wavelength

„

Sample volume: 200μl～9000μl

„

Light source: tungsten-halogen lamp 6V, 10W.

„

Wavelength: 340nm, 405nm, 510nm, 546nm, 578nm, 630nm. Optional: 450nm, 670nm.

A.2

Power Requirements „

Power supply: 100-240V～, 50/60Hz

„

Voltage fluctuation: ±10%

„

Input power: 140VA

A.3

Environment Requirements

A.3.1

Working Environment „

Temperature: 15ºC～30ºC;

„

Relative humidity: 35%-85%, no condensation

„

Atmospheric pressure: 70 kPa-106kPa

„

Altitude height: -400m～3,000 m（-1,300feet～6,500 feet）

A.4

Dimension and Weight „

Dimension: 420mm×350mm×158mm（W×D×H）

A-1

„

A.5

Weight: 7kg

Input/Output Devices „

Touchscreen

„

Popup keyboard

„

Recorder

A.6

Interface „

RS-232: interface between the analyzer and the PC.

„

USB port: interface between the analyzer and the mouse, keyboard or portable storage device.

A.7

EMC Requirements This equipment complies with the emission and immunity requirements described in EN 61326-1:2006 and EN 61326-2-6:2006.

A.8

Safety Classification „

Overvoltage type: II

„

Pollution level: 2

„

Work type: Continuous

„

IP(Ingress Protection):IPX0, (0 means not waterproof)

A-2

Appendix B Error Messages Error message

Code

Causes

Calibration monotone checking error

MON

Nonlinear calibration curve is not monotone

Calculation failed

COV

When calculating nonlinear calibration result, if no qualified result is obtained after 1000 iterations, calibration is failed

Recalibrate

Printer can not print

010

Not enough paper in the printer or printer damaged

Check whether there is enough paper. Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Absorbance exceeds the limit

ABS

Absorbance exceeds the limit

Check for impurity in the sample; check the quality of the reagent; check whether the cuvette is clean; check the optical system. If the alarm continues contact Mindray customer service department or your local distributor.

Reagent blank out of range

RBK

Reagent goes wrong. Cuvette is dirty

Rerun after replacing the reagent, or reset the limit parameters.

No Interval

NLN

Measuring points in both kinetic read window and substrate limit are less than 3

Rerun or rerun after dilution

Out of linear range (non-linear)

LIN

Reaction data does not meet linearity criteria

Rerun or rerun after dilution

Above Linearity High

>

Calculated concentration exceeds high limit of linearity range

Rerun or rerun after dilution

Above Linearity Low