Mindray BA-88A Operation Manual

Mindray BA-88A is an advanced semi-automated chemistry analyzer designed to provide accurate and reliable test results. With its user-friendly interface, automated processes, and comprehensive testing capabilities, the BA-88A streamlines laboratory operations, allowing you to focus on delivering exceptional patient care.

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BA-88A Semi-auto Chemistry Analyzer

Operation Manual

For this Operator’s Manual, the issued Date is 2008-09 (Version: 1.0).

Intellectual Property Statement

SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter called

Mindray) owns the intellectual property rights to this Mindray product and this manual. This manual may refer to information protected by copyrights or patents and does not convey any license under the patent rights of Mindray, nor the rights of others. Mindray does not assume any liability arising out of any infringements of patents or other rights of third parties.

Mindray intends to maintain the contents of this manual as confidential information.

Disclosure of the information in this manual in any manner whatsoever without the written permission of Mindray is strictly forbidden.

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

, , , , , BeneView, WATO,

BeneHeart, are the registered trademarks or trademarks owned by Mindray in

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

Responsibility on the Manufacturer Party

Contents of this manual are subject to changes without prior notice.

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

Mindray is responsible for 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;

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

NOTE:

This equipment must be operated by skilled/trained clinical professionals.

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.

Warranty

THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES,

EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY

OR FITNESS FOR ANY PARTICULAR PURPOSE.

Exemptions

Mindray's obligation or liability under this warranty does not include any transportation or other charges or liability for direct, indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Mindray or repairs by people other than

Mindray authorized personnel.

This warranty shall not extend to:

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

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

any product of any other manufacturer.

Return Policy

Return Procedure

In the event that it becomes necessary to return this product or part of this product to

Mindray, the following procedure should be followed:

1 Return authorization: Contact the Customer Service Department and obtain a Customer Service Authorization number. This number must appear on the outside of the shipping container. Returned shipments will not be accepted if the number is not clearly visible. Please provide the model number, serial number, and a brief description of the reason for return.

2 Freight policy: The customer is responsible for freight charges when this product is shipped to Mindray for service (this includes customs charges).

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

Company Contact

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

Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,

Nanshan, ShenZhen518057, P.R. China

Tel:

Fax:

+86 755 26582479 26582888

+86 755 26582934 26582500

EC Representative

Name:

Address:

Phone:

Fax:

Shanghai International Holding Corp. GmbH (Europe)

Eiffestra β e 80, Hamburg 20537, Germany

0049-40-2513175

0049-40-255726 iii

Preface

Before using the system, please read this operation manual thoroughly for relevant operation instructions.

Please keep this manual properly for convenient use.

Intended Reader

This manual is geared for clinical professionals to:

Operate the system;

Maintain and troubleshoot the system;

Learn about the system operation.

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…

WARNING

BIOHAZARD

NOTE

CAUTION

Then…

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

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

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

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

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 of potentially biohazardous infection

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

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.

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.

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.

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.

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.

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;

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.

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.

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.

Preface ............................................................................................................................... 1

Contents ............................................................................................................. I

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

1.1

Introduction ........................................................................................................... 1-1

1.1.1

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

1.1.2

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

1.2

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

1.3

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

1.3.1

Touchpen ................................................................................................. 1-3

1.3.2

Popup Keypad ......................................................................................... 1-4

1.4

Printer ................................................................................................................... 1-4

1.4.1

Internal Thermal Recorder....................................................................... 1-4

1.4.2

External Printer ........................................................................................ 1-5

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

2.1

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

2.2

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

2.2.1

System Specifications.............................................................................. 2-1

2.2.2

Environmental Requirements .................................................................. 2-1

2.2.3

Space and Accessibility Requirements.................................................... 2-2

2.2.4

Water Requirements................................................................................ 2-2

2.2.5

Waste Bottle............................................................................................. 2-2

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

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

3.1

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

3.2

Timing Principle .................................................................................................... 3-2

3.2.1

Flow Cell Mode ........................................................................................ 3-2

3.2.2

Cuvette Mode .......................................................................................... 3-5

3.3

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

3.4

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

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

4.1

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

4.2

Parameter ............................................................................................................. 4-2

4.2.1

Routine.....................................................................................................4-2

4.2.2

Profile.......................................................................................................4-9

4.2.3

Calculation ...............................................................................................4-9

4.2.4

Off-system..............................................................................................4-12

4.3

Test .....................................................................................................................4-13

4.3.1

Request..................................................................................................4-13

4.3.2

Test ........................................................................................................4-15

4.4

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

4.5

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

4.6

Result..................................................................................................................4-23

4.6.1

Result.....................................................................................................4-24

4.6.2

Edit.........................................................................................................4-27

4.7

Setup...................................................................................................................4-30

4.7.1

Basic ......................................................................................................4-31

4.7.2

Dictionary ...............................................................................................4-32

4.7.3

Print Features ........................................................................................4-33

4.7.4

Carryover ...............................................................................................4-34

4.7.5

LIS Setup ...............................................................................................4-35

4.8

Maintenance .......................................................................................................4-36

4.8.1

Database................................................................................................4-36

4.8.2

Log .........................................................................................................4-37

4.8.3

Maintenance ..........................................................................................4-38

4.8.4

Shutdown ...............................................................................................4-39

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

5.1

Daily Maintenance ................................................................................................5-1

5.2

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

5.3

Irregular Maintenance...........................................................................................5-2

5.3.1

Cleaning Flow Cell...................................................................................5-2

5.3.2

Adjusting the Photoelectric Gain .............................................................5-3

5.3.3

Calibrating the Peristaltic Pump...............................................................5-3

5.3.4

Replacing the tubing ................................................................................5-3

5.3.5

Replacing Aspiration Tubing ....................................................................5-7

5.3.6

Replacing Lamp.......................................................................................5-8

6 Calculating Calibration Parameters and QC Rule ............................. 6-1

6.1

Calculating Linear Calibration Parameters ...........................................................6-1

6.2

Calculating Nonlinear Calibration Parameters......................................................6-2

6.3

Calculating Concentration.....................................................................................6-4

6.3.1

Calculating Concentration of Linearly Calibrated Sample/control ...........6-4

6.3.2

Calculating Concentration of Nonlinearly Calibrated Sample/control......6-5

6.4

QC Rule ................................................................................................................6-6

6.4.1

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

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

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

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

Appendix D Supplies................................................................................. D-1

III

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

Filter

Tungsten-halogen lamp (6V, 10W)

Interferential filter.6 wavelengths (available): 340nm,

405nm, 510nm, 546nm, 578nm and 630nm.2 wavelengths (optional): 450nm and 670nm.

Absorbance range

Readable range

Result resolution

Reaction container

Reaction temperature

0 ～ 3.0A

0 ～ 3.5A

0.001A

Flow colorimetric pool (32 ul ）

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.

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

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

Select and to switch between upper case and lower case.

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

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

again to switch to the lower case mode.

To exit the popup keypad, click any place other than the popup keypad.

1.4 Printer

Thermal

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.

1-4

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.

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.

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

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

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

Weight: 7 kg

2.2.2 Environmental

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.

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.

1) The water must meet requirements of the CAPII water.

2) The water temperature should be within 15-5 0℃

2-2

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-ventilated ٛ

ٛ ٛ ٛ

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

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.

3.2.1.1 Powering On

Place the power switch to On.

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

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 Routine Æ 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 Routine Æ 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 Routine Æ 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.

3-3

Endpoint

Prepare the samples and 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).

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.

Dispense sample or calibrator or control into the tube.

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

Take the tube out to prepare it for analysis.

7 Select the name of the test to be run.

8 Click , put the inlet tube into the distilled water, and click

Aspirate .

9 Click , put the inlet tube into the reagent blank, and click

Aspirate .

10 Select 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. 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.

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

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 .

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).

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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.

Test on the main screen to enter the test screen.

4 Select the name of the test to be run.

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

6 Click , put the inlet tube into the reagent blank, and click

Aspirate .

7 Select 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 .

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.

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.

The operation for cuvette mode is almost the same with that of the flow cell. The differences are: 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.

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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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Advanced Operations

Power on the analyzer and the system will go through initialization procedure as shown in the following figure.

Figure 4-1 Initialization Screen

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.

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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.

4.2.1.1 Basic

Click Add to enter the screen shown in figure 4-3. The Routine includes: Basic ,

Restriction , Cal details and QC Information .

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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.

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

Lin. Range

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.

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

Absorbance range of the reagent blank. Once this range is 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.

Absorbance limit

Lin. Limit

By Diff.

NOTE

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

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.

It is only valid for Kinetics. The range is 0-1. The default is void.

0 means no check.

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.

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Figure 4-5 Cal Details

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

Parameter

K factor

Description

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.

Replicate

S1-S8

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.

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

Save

Cancel

Return

Function

Save the test information.

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

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

Save

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

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.

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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

Precision Precision of the result. Select from the drop-down list 1, 0.1, 0.01,

0.001. The default is 1.

Default reference

By Diff.

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.

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

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.

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:

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

2. A/G= （ albumin ） /GLB （ globin ）

3. IBIL indirect bilirubin ） =TBIL （ total bilirubin ） -DBIL （ direct bilirubin ） ratio

4. AST/ALT glutamic-oxal(o) acetic transaminase/glutamate-pyruvate transaminase

5. ApoA1/ApoB 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.

Unit

The length of the test name should not exceed 10 characters.

Otherwise, warning messages will appear.

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

By Diff.

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

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

Save

Delete selected off-system test.

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

Sample ID

Patient

Tests

Profiles

Description

Sample ID. Range: 001-999.

Name of the patient.

The names of the on-board tests.

The names of the defined profiles.

The following table introduces the buttons on the screen.

Buttons

Save

Delete

Cancel

Function

Save the information of newly requested test.

Delete the requested tests of the selected sample ID.

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

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Buttons

View

Function

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

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The following table explains the parameters on the Test screen.

Parameter

Tests

Description

Parameter

A list of all the on-board tests. The requested test is marked with

“*”.

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 stabilized, the area shows:

Temperature stabilizing…

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.

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Parameter Description

Wash Click water to wash the tubing.

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.

Sample

For endpoint analysis, you can choose whether to run sample blank or not based on the status of the sample.

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

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.

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.

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.

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Parameter

Conc.

Description

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.

Print curve

Please refer to 4.4 for more details.

Print reaction curve and test result.

Curve

Data

Start

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

Return

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

Click this button to return to the main screen.

The test workflow is shown as follows.

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Figure 4-12 Test workflow

Select test

Water blank

Reagent blank

Calibrator

Sample blank

(Sample)

Control

Yes

Next sample (QC)?

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.

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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 R

0 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

Test

Date

Control

Lot No.

AVG

Description

All the tests with QC information set will be listed.

Select a test to view the QC result.

The maximum range is one month(31 days).

C1-C3 can be selected.

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

Standard Deviation of the control.

Concentration of the control.

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Parameter

C1, C2, C3

No.

Date

Description

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

No. of the QC result.

Date when the QC is run.

Remark

Query

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

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

Test

Patient

Sample ID

Unit

Test Date

Reference

Original

Remark

All

Description

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.

Name of patient.

Sample ID of the patient.

Unit of the test result.

The date when test is run.

Reference range of the test.

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

Use simple symbols and abbreviation to comment on the result.

Refer to the appendix of this manual for more details on the symbols.

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 Function

Query Click to pop up the following page.

Add

Edit

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

Add new patient information.

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 Function

Summary Click to pop up the following page.

Return

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 the report of the selected sample.

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.

Unit

Test result.

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

Edit

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 flags can be added or deleted in

Setup Dictionary .

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

Delete

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 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.

Type

The entered sample ID can not be the same with the existing sample

ID of the current day.

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

Age

Gender

MRN

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

Gender of the patient, including: Male, Female.

Medical record No. of the patient.

Sender

Tester

Name of the doctor who sent the sample to the clinical laboratory.

You can add or delete the names in Setup Dictionary .

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

Remark

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

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.

Save

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

Save the information on setting.

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

Return

Print the report of the selected sample.

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

Start button sound

Name of the hospital.

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

Time

Standby interval

Colorimetri c mode

Select the date in the date table. Use and to select month and year.

Enter time in the text box.

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

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

Return

Save the information on setting.

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

Tester

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

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

Add

Delete

Cancel

Save

Return

Function

Add new items to the dictionary.

Delete existing items in the dictionary.

Cancel adding information to the dictionary.

Save new items to the dictionary.

Click this button to return to the main screen.

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

Top

Function

Move the selected test to the top of the list.

Down

Bottom

Cancel

Return

Move the selected test upward by one line.

Move the selected test downward by one line.

Move the selected test to the bottom of the list.

Restore the original printing order.

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.

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.

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 1 st

, and then click Start . The

4-38

system will start to aspirate distilled water. When all the water has been aspirated, click Stop . Follow the procedure above to finish the 2 nd

and 3 rd

calibration.

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

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 Daily Maintenance

1 、 Use neutral wash solution and wet cloth to remove the spillage on the instrument.

2 、 Wash the tubing with distilled water or DI water before shutting down the analyzer (for instrument installed with flow cell).

5-1

3 、 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).

5.2 Weekly Maintenance

1 、 Wash the waste bottle interior with clean water. Soak the bottle with disinfector if necessary.

2 、 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.

5.3.1.1 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 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.

5.3.1.2 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).

5.3.1.3 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.

5-2

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.

5.3.2 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.

5.3.3 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.

5.3.4 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.

5-3

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.

5-4

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.

5-5

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.

5-6

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.

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

5-7

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

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:

5-8

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

5-9

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.

5-10

Calculating Calibration

Parameters and QC Rule

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

, a , b , c - calibration parameters

6.1 Calculating Linear Calibration Parameters

One-point linear calibration

Calibration formula: R = aC

This calibration method adopts only one calibration parameter a , a =

6-1

This calibration method requires only one calibrator.

Two-point linear calibration

Calibration formula: R = aC + b .

This calibration method adopts two calibration parameters: a =

−

, b = R

−

） C

. a and b , where,

This calibration method requires two calibrators. concentrations of calibrator 1 and calibrator 2. responses of calibrator 1 and calibrator 2.

and

are respectively the

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 . R i

is the response of calibrator i . a and b can be obtained through the method of least squares.

a = n

∑ i = 1

C i

R i i n

∑

= 1

C i

− ( i n

∑

= 1

−

C i

( n

∑ i = 1

)( i n

∑

= 1

C i

) 2

R i

) / n

/ n

Parameters

Logistic-Log 4P

Calibration formula: R = R

+ K

1 +

1 exp[ − ( a + b ln C )]

This calibration method adopts four parameters: R

, 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 smaller and smaller with the concentration increase. See Figure 6-1.

.This calibration method is applied to the calibration curve that the response becomes

6-2

Figure 6-1 Logit-Log 4P calibration curve

C1 C2 C3 C4

Logistic-Log 5P

Calibration formula: R = R

+ K

1 + exp[ − ( a

+ b ln C + cC )]

This calibration method adopts five parameters: R

, 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

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 = R

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

This calibration method adopts five parameters: R

, 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 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

C1 C2 C3 C4 C5

Polynomial 5P

Calibration formula: ln C = a + b (

R − R

100

) + c (

R − R

100

) 2 + d (

R − R

100

0 ) 3

6-3

This calibration method adopts five parameters: R

, 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 R

Parabola

Calibration formula: R = aC 2 + bC + c

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 = R

0 i

+ a i

( C − C i

) + b i

( C − C i

) 2 + c i

( C − C i

) 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: R

0 i

, a i

, b i

and c i

6.3 Calculating

6.3.1 Calculating Concentration of Linearly Calibrated

Sample/control

One-point linear calibration

C =

R a

Where, a - calibration parameter

Two-point linear calibration

C =

R − b a

Where, a , b - calibration parameters

6-4

Multi-point linear calibration

C =

R − b a

Where, a , b - calibration parameters

6.3.2 Calculating Concentration of Nonlinearly Calibrated

Sample/control

Logistic-Log 4P

C = EXP (

− a − ln(

− R

0 b

− 1 )

)

Where,

, 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 − R

100

) + c (

R − R

100

) 2 + d (

R − R

100

0 ) 3 )

Where,

, 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

6-5

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.

6.4 QC

6.4.1 Westgard

Westgard multi-rule is shown below.

Symbol Explanation QC

Conclusion

Warning 1

One control value exceeds ±2 standard deviations.

One control value exceeds ±3 standard deviations.

Out-of-control

(random error, systematic error)

Two control values for one

Out-of-control

(systematic level exceed ±2 standard deviations.

error)

4S difference between two consecutive control error) values exceeds 4 standard deviations.

Out-of-control

(random

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

(systematic error)

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

Out-of-control

(systematic error)

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

6-6

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.

6-7

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: 200 μ l ～ 9000 μ l

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

Input 140VA

A.3 Environment Requirements

A.3.1 Working Environment

Temperature: ～ 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: × 350mm × 158mm （ W × D × H ）

Weight:

A-1

A.5 Input/Output Devices

Touchscreen

Popup

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 Safety Classification

Electric shock protection I type equipment powered by external equipment.

Overvoltage type: II

Pollution level: 2

Device type: fixed device

Work type: Continuous

Protection degree against poisonous liquid: common device

Sterilization method recommended by the manufacturer: not applicable

Safety degree (classified according to the use in environment where combustible, anesthetic gases mixed with air or oxygen mixed with nitrogen-monoxide, nitrogen-dioxide): not applicable to places with combustible, anesthetic gases

A-2

Appendix B Error Messages

Error message Code Causes

Calibration monotone checking error

MON Nonlinear calibration curve is not monotone

Corrective measures provided by log

Recalibrate

Calculation failed

COV When calculating nonlinear calibration result, if no qualified

Recalibrate result is obtained after 1000 iterations, calibration is failed

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 limit

ABS exceeds the

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 RBK Reagent goes wrong. Cuvette out of range is dirty

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

No Linear

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

< Calculated concentration exceeds low limit of linearity range

Rerun or rerun after dilution

Calculation error for calculation test

CIE Cannot calculate final result by using current formula and participated Test Result

Check the formula and rerun those tests involved in calculation.

Concentration calculate error

CCE Cannot calculate final result by Choose other calibration rule or using default calibration parameters parameters to calculate.

Recalibrate.

B-1

Light signal too weak

ADL Lamp is not turned on, or light source degenerated, or light path is obstructed, or lamp falls off, or gain error occurs

Restart the system or refer to the

5.3.2. If the alarm continues contact Mindray customer service department or your local distributor.

Dark current is too high

DRH AD collection error or circuit noise too strong.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Time to for the 001 system to stabilize after startup out of range.

Temp. data collection error; refrigeration plate error; main board error; refrigeration plate invalid.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Cuvette temperature too high

002 Temp. data collection error; refrigeration plate error; main board error; refrigeration plate invalid.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Cuvette temperature too low

003 Temp. data collection error; refrigeration plate error; main board error; refrigeration plate invalid.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Cuvette temperature fluctuation out of range

004 Temp. data collection error; refrigeration plate error; main board error; refrigeration plate invalid.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Fan blocked during running

005

Fan blocked or damaged

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Temperature switching exceeds time limit

006 Temp. data collection error; refrigeration plate error; main board error; refrigeration plate invalid.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Sensor abnormal

Filter wheel can not find home position

007

008

Main board error or temp. sensor abnormal or temp. out of measurable range.

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

Photocoupler damaged or dust

Restart the system. If the alarm continues contact Mindray on photocoupler or motor damaged. customer service department or your local distributor.

Light signal too weak

009 Lamp is not turned on, or light source degenerated, or light path is obstructed, or lamp falls off, or gain error occurs

Restart the system or refer to the

5.3.2. If the alarm continues contact Mindray customer service department or your local distributor.

Photoelectric 010 collection is abnormal

Simulation board error

Restart the system. If the alarm continues contact Mindray customer service department or your local distributor.

B-2

Can not pass hardware self-check

011

Circuit error

If it happens in two consecutive times, contact the developer.

Light signal too strong

012 Photoelectric gain adjusting Restart the system. If the alarm error continues contact Mindray customer service department or your local distributor.

B-3

Appendix C External Printer

The system is compatible with (not limited to) the following printers:

HP DeskJet 5652

HP DeskJet 3820

HP DeskJet 5438

HP DeskJet 3668

HP DeskJet D2368

HP Photosmart D5168

HP Business InkJet 1000

C-1

Appendix D Supplies

To ensure personal safety and system performance, use only supplies manufactured or recommended by our company. Contact our customer service department or your local distributor for details.

Part Name

Lamp assembly

Part Number

BA89-30-86998

Location

Lamp base

Description

Regularly-replace d part

Flow cell M90-000168--- Cuvette installation hole inside the optical window

Replace it when damaged

Internal printer assembly component

Replace it when damaged