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BA-88A Semi-auto Chemistry Analyzer

Operation Manual

2008 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights Reserved.
For this Operators 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,

are the registered trademarks or trademarks owned by Mindray in


BeneHeart,
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.

NOTE:
This equipment
professionals.

must

be

operated

by

skilled/trained

clinical

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.

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

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

ii

Company Contact
Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Address:

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


Nanshan, ShenZhen518057, P.R. China

Tel:

+86 755 26582479 26582888

Fax:

+86 755 26582934 26582500

EC Representative
Name:

Shanghai International Holding Corp. GmbH (Europe)

Address:

Eiffestrae 80, Hamburg 20537, Germany

Phone:

0049-40-2513175

Fax:

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

Then

WARNING

Read the statement following the symbol. The


statement is alerting you to an operating hazard
that can cause personal injury.

BIOHAZARD

Read the statement following the symbol. The


statement is alerting you to a potentially
biohazardous condition.

NOTE

Read the statement following the symbol. The


statement is alerting you to information that
requires your attention.

CAUTION

Read the statement following the symbol. The


statement is alerting you to a possibility of system
damage or unreliable results.

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

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

of

potentially

Protective ground terminal

Warning: Risk of personal injury or equipment


damage
100-240V,50/60Hz

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

10

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

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

11

Contents
Preface ............................................................................................................................... 1

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

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


1.1

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


1.1.1
1.1.2

1.2

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

1.3

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


1.3.1
1.3.2

1.4

2.1

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

2.2

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

2.3

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


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

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

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


3.1

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

3.2

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


3.2.1
3.2.2

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


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

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

2.2.1
2.2.2
2.2.3
2.2.4
2.2.5

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


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

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


1.4.1
1.4.2

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

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


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

3.3

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

3.4

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

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

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

4.2

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

4.2.1
4.2.2
4.2.3
4.2.4
4.3

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

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

4.5

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

4.6

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

4.7

4.8

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

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

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

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

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

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


5.1

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

5.2

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

5.3

Irregular Maintenance...........................................................................................5-2
5.3.1
5.3.2
5.3.3
5.3.4
5.3.5
5.3.6

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

4.4

4.6.1
4.6.2

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

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


Adjusting the Photoelectric Gain .............................................................5-3
Calibrating the Peristaltic Pump...............................................................5-3
Replacing the tubing ................................................................................5-3
Replacing Aspiration Tubing ....................................................................5-7
Replacing Lamp.......................................................................................5-8

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
6.3.2

6.4

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


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

QC Rule ................................................................................................................6-6
6.4.1

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

Appendix A

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

Appendix B

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

II

Appendix C

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

Appendix D

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

III

1
1.1

System Description

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

1.3

Parameters
Light source

Tungsten-halogen lamp (6V, 10W)

Filter

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


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

Absorbance range

03.0A

Readable range

03.5A

Result resolution

0.001A

Reaction container

Flow colorimetric pool (32 ul

Reaction temperature

25, 30, 37 and room temperature.

Result storage capacity

No less than 3000 results.

Test storage capacity

Up to 200 tests information,1000 control results

Weight

7kg

Dimension

420mm350mm158mmlengthwidthheight

Power supply

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


fluctuation)

Input power

140VA

Touchpen and Popup Keypad


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

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

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

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

1-3

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

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

1.3.2 Popup Keypad


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

1.4

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

Select

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

Select

again to switch to the lower case mode.


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

and

to switch between upper case and lower case.

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

Printer

1.4.1 Internal Thermal Recorder


While feeding printing paper, please pay much attention to the following notes.

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

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 50mm20m.

1.4.2 External Printer


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

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.

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

Turn on the system and the printer.

1-5

2
2.1

Installation

Unpacking
When you receive the system, carefully inspect the package. If you see any signs of
mishandling or damage, file a claim immediately with Mindray customer service
department or your local distributor.
After opening the package, check the delivered goods against the packing list as
well as the appearance of the system. If you find anything missing or damaged,
immediately alert Mindray customer service department or your local distributor.

2.2

Installation

2.2.1 System Specifications

Dimension: 420mm 350mm 158mm(LWH)


Weight: 7 kg

2.2.2 Environmental Requirements


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

2-1

Ambient temperature: 15-30


Relative humidity: 35%-85%, without condensation
Above-sea-level height: -400m3,000 m70kPa 1,06kPa
Power supply: 100V-240V~ (10% fluctuation), 50/60Hz (3Hz fluctuation).
The site should be away from the electromagnetic noise and the bearing
platform should be free of vibration.
The site should not be in direct sun
The system should be properly grounded.

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

2.2.3 Space and Accessibility Requirements


Figure 2-1 Space and accessibility requirements

The installation space must be larger than the dimensions (420mm 350mm
158mm, LWH) of the instrument. Please refer to Figure 2-1.
The installation platform should be level with gradient less than 1:200.

2.2.4 Water Requirements


1)
2)

The water must meet requirements of the CAPII water.


The water temperature should be within 15-50

2-2

2.2.5 Waste Bottle


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

NOTE
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

After opening the package, take the system out;

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;

Remove the protection on the optical window;

Connect the waste bottle.

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.

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

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

3
3.1

Basic Operations

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.

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

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

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

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

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

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

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

3.2

Timing Principle

3.2.1 Flow Cell Mode


3.2.1.1 Powering On
1

Place the power switch to On.

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 Basic. Enter the hospital name.

3-2

Click Parameter Routine. 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 Routine 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 Routine 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 Routine 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
1

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.

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

Select the name of the test to be run.

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

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

10

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

12

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.

13

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

14

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.

15

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).

3-4

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.

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

Select the name of the test to be run.

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

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

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

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.

3.2.2 Cuvette Mode


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

3-5

Figure 3-1 Cover the cuvette cap

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

3.3

Edit
During test, the online printing is enabled by default and the test result of each
sample is printed in real time. Patient information and test result can be edited to
print the report.
On the main screen, click Result 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.

3-6

4
4.1

Advanced Operations

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

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.

4-1

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.

4-2

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.

4-3

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.

4-4

Buttons

Function

Add

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

Delete

Delete selected test.

Save

Save the test information.

Cancel

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

Return

Click this button to return to the main screen.

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

The following table explains the parameters on the Restriction Page.


Parameter

Description

Default
reference

Normal range of test result. System will determine whether the


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

Lin. Range

The reportable range of the test result. The default is void.


The linearity range can not be lower than 0 and should be
entered from low concentration to high concentration. The high
and low limit should not be equal.

4-5

Parameter

Description

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

NOTE
The absorbance of reagent blank is entered in the
format of real value10000.
Absorbance
limit

The maximum or minimum absorbance of the test result. For


increase reaction, system will alarm when the reaction
absorbance is higher than the absorbance limit; for decrease
reaction, system ill alarm when the reaction absorbance is lower
than the absorbance limit (for Kinetics and Fixed-time analysis,
the absorbance limit is seen as the substrate depletion limit).

NOTE
The absorbance limit is entered in the format of
real value10000.
Lin. Limit

It is only valid for Kinetics. The range is 0-1. The default is void.
0 means no check.

By Diff.

Set combinations based on sample type and patient gender, and


enter respective reference range for each combination. Those
who are under the age of 12 are taken as children.

The following table introduces the buttons on the page.


Buttons

Function

Save

Save the test information.

Cancel

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

Return

Click this button to return to the main screen.

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

4-6

Figure 4-5 Cal Details

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

Parameter

Description

K factor

For Absorbance analysis, the K factor is fixed at 1 and can not be


edited.
For Kinetics analysis the K factor is selected by default and you
can enter according to the reagent instruction. Decimal is allowed.

Rule

Calibration rule.

Replicate

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

S1-S8

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

The following table introduces the buttons on the screen.


Buttons

Function

Save

Save the test information.

Cancel

After selecting a test and setting or modifying parameters for


it, click this button to cancel the setting or modification.

Return

Click this button to return to the main screen.

4-7

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.

4-8

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

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

Function

Add

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

Delete

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

Save

Save the profile information.

Cancel

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

Return

Click this button to return to the main screen.

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

4-9

Figure 4-8 Calculation

The following table explains the parameters on the Calculation screen.


Parameter

Description

Test

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

Unit

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

Precision

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

Default
reference

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


details.

By Diff.

Set the differential reference range of the calculation. Refer to


4.2.1.2 for details.

4-10

Parameter

Description

Edit
formula

Edit the calculation formula. The screen is shown in the following


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

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


Full name

Full name of the test. It can be void.

The following table introduces the buttons on the screen.


Buttons

Function

Add

Add a new calculation.

Delete

Delete selected calculation.

Save

Save the new calculation or the modified calculation.

Cancel

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

Return

Click this button to return to the main screen.

The default calculation is shown as follows:


1.

GLB globin=TPtotal protein-ALBalbumin

2.

A/G= ALBalbumin/GLBglobin

3.

IBIL indirect bilirubin=TBILtotal bilirubin-DBILdirect bilirubin

4.

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

5.

ApoA1/ApoB

ratio
apolipoprotein A/apolipoprotein B

4-11

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

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


Parameter

Description

Test

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

Unit

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

Precision

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

Default
reference

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


details.

By Diff.

Set the differential reference range of the calculation. Refer to


4.2.1.2 for details.

The following table introduces the buttons on the screen.


Buttons

Function

Add

Add a new off-system test.

Delete

Delete selected off-system test.

Save

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

4-12

4.3

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.

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:
001ALTASTTPALB
002ALTASTGLU
003TPALB
004ALTGLU

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

4-13

Figure 4-10 Request

The following table explains the parameters on the Request screen.


Parameter

Description

Sample ID

Sample ID. Range: 001-999.

Patient

Name of the patient.

Tests

The names of the on-board tests.

Profiles

The names of the defined profiles.

The following table introduces the buttons on the screen.


Buttons

Function

Save

Save the information of newly requested test.

Delete

Delete the requested tests of the selected sample ID.

Cancel

Click this button to cancel requesting, and return to the


status before requesting.

4-14

Buttons

Function

View

Click this button to check the requesting information of all


the samples. Information can be arranged and printed by
test or by sample.

Return

Click this button to return to the main screen.

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

4-15

The following table explains the parameters on the Test screen.


Parameter

Description

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

View parameters of the selected test.


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

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

stabilized,

the

area

shows:

During test, the area shows: Testing


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

4-16

Parameter

Description

Wash

Click Wash. The system will aspirate certain amount of distilled


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

Sample

Run selected tests of the current sample. Click Sample. The


following information will be shown in the window above the
reaction curve.

The area shows the sample ID of the current sample. Use +


and -to change the sample ID. After the completion of a sample
test, the sample ID of the sample blank will increase by 1 (if
requesting is applied, increase the sample ID according to
requesting).
Calibrate

Run selected tests of the calibrator. Click Calibrate. The


following information will be shown in the window above the
reaction curve.

The S1-S8 will be displayed in the drop-down list box according


to parameter setup. you can rearrange the testing order of the
calibrators. Unless all the calibration of the calibrators are
completed, system will disable the sample or control test.
QC

Run selected tests of the control. Click QC. The following


information will be shown in the window above the reaction
curve.

Select control to run QC test. But the control information should


be preset in the parameter setup.
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.

4-17

Parameter

Description

Conc.

Result concentration. While running calibration, this area will


show the set point of the calibrator.

Realtime
ABS

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

Rgt. blk resp

For endpoint analysis, the absorbance of the sample blank is


displayed; for Kinetics and fixed-time analysis, the response of
the reagent blank will be displayed.

The following introduces the buttons on the screen.


Buttons

Function

QC
record

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

Cal
record

Click this button to view the calibration curve and calibration


parameters of the selected test.
Please refer to 4.4 for more details.

Print
curve

Print reaction curve and test result.

Curve
Data

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

Start

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

Return

Click this button to return to the main screen.

The test workflow is shown as follows.

4-18

Figure 4-12 Test workflow

Select test

Water blank

Reagent blank

Calibrator

Sample blank
(Sample)

Yes

Control

Next sample (QC)?


No
End

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

4.4

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

4-19

Figure 4-13 Calibration

The following table explains the parameters on the Calibration Details.

Parameter

Description

Test

Test that has been calibrated.

Date

The date when calibration of the test is run.

Rule

Calibration rule.

4-20

The following explains the Calibrator and Parameter.

Parameter

Description

No.

Calibrator No. The range is S1-S8.

Std. Conc.

Set point of the calibrator.

Response

Response of the calibrator.

Parameter

Parameters in the calibration formula.

Value

Value of the parameters in the calibration formula.

The following introduces the buttons on the screen.


Buttons

Function

Edit

Edit the parameters in the linear calibration equation.


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

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

4-21

Buttons

Function

Print

Print current calibration parameters and curve.

Return

Click this button to return to the main screen.

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

4.5

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

The following table explains the parameters on the screen.


Parameter

Description

Test

All the tests with QC information set will be listed.


Select a test to view the QC result.

Date

The maximum range is one month(31 days).

Control

C1-C3 can be selected.

Lot No.

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

SD

Standard Deviation of the control.

AVG

Concentration of the control.

4-22

Parameter

Description

C1, C2, C3

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


data.

No.

No. of the QC result.

Date

Date when the QC is run.

Concentration

QC result

Remark

Display in control or out of control according the QC result


and QC rule.

Query

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

The following introduces the buttons on the screen.

4.6

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.

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

4-23

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

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

Description

Test

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

Patient

Name of patient.

Sample ID

Sample ID of the patient.

Unit

Unit of the test result.

Test Date

The date when test is run.

Reference

Reference range of the test.

Original

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

Remark

Use simple symbols and abbreviation to comment on the result.


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

All

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


(arranged by sample).

The following table introduces the buttons on the Sample screen.

4-24

Buttons
Query

Function
Click Query to pop up the following page.

Select data range or patient name or/and Sample ID to search for


results that meet the requirement.
Add

Add new patient information.

Edit

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

Delete

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

Upload

Send all the result of the selected sample to LIS.

Print

Print the report of the selected sample.

Return

Click this button to return to the main screen.

4-25

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.

4-26

Buttons
Summary

Function
Click Summary to pop up the following page.

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

Print the report of the selected sample.

Return

Click this button to return to the main screen.

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

4-27

Figure 4-17 Test report

4.6.2.1 Test Result


Figure 4-18 Test result

The following table explains the parameters on the screen.


Parameter

Description

Test

Name of the test.

Conc.

Test result.

Unit

Unit of the test result.

Reference

Reference range of the test.

Response

Response of the test.

Original

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

Remark

Use simple symbols and abbreviation to comment on the result.


Please refer to the Appendix B for more information on symbols.

4-28

The following introduces the buttons on the screen.


Buttons

Function

Add

Click Add to pop up the following screen.

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

flags

can

be

added

or

deleted

in

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

Enter new result in Quantitative area, or select flag result. Click OK


to save the new result and return to the result report screen.
After the test result is edited, the test result displayed in the result
report screen will be updated accordingly. But the original result will
be saved.
Delete

Delete the test result currently selected.

4.6.2.2 Patient Information


Parameter

Description

Name

Name of patient.

4-29

Parameter

Description

Sample ID

Sample ID of the patient. If you enter the screen by selecting a test


result, the sample ID can not be edited. The sample ID should not be
void. Otherwise, the patient information can not be saved.
The entered sample ID can not be the same with the existing sample
ID of the current day.

Type

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

Age

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

Gender

Gender of the patient, including: Male, Female.

MRN

Medical record No. of the patient.

Sender

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

Tester

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

Test Date

The date when sample is tested.

Send Date

The date when sample is sent to be tested.

Reviewed
by

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

Remark

More information about the patient.

The following introduces the buttons on the screen.


Buttons

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

4.7

Save

Save the information on setting.

Cancel

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

Print

Print the report of the selected sample.

Return

Click this button to go back to Sample screen.

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

4-30

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

The following table explains the parameters on the Basic screen.


Parameter

Description

FPGA
Software

The version information of the system.

Hospital

Name of the hospital.

Start button
sound

Start the function of making sound when pressing a button.

Pump
speed

3 pump speeds are available: 1, 2, 3. The default which is


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

Date

Select the date in the date table. Use


year.

and

to select month and

Time

Enter time in the text box.

Standby
interval

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

Colorimetri
c mode

Use cuvette or cell.

4-31

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

The following table introduces the button on the screen.


Buttons

Function

Touchscr. Cal

When the touchscreen is slightly deviated, or when the clicked


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

Save

Save the information on setting.

Return

Click this button to return to the main screen.

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

4-32

Figure 4-20 Dictionary

The following table explains the parameters on the Dictionary screen.


Parameter

Description

Unit

Add, delete test unit.

Type

Add, delete sample type.

Sender

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

Tester

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

Reviewer

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

Qualitative
result

Add, delete qualitative result type.

The following table introduces the buttons on the Dictionary screen.


Buttons

Function

Add

Add new items to the dictionary.

Delete

Delete existing items in the dictionary.

Cancel

Cancel adding information to the dictionary.

Save

Save new items to the dictionary.

Return

Click this button to return to the main screen.

4.7.3 Print Features


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

4-33

Figure 4-21 Print Features

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

Description

Internal
Printer

Select internal thermal recorder to print test result.

External
Printer

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

Start
internal
online PRN

Print the test result in real time.

The following table introduces the button on the screen.


Buttons

Function

Top

Move the selected test to the top of the list.

Up

Move the selected test upward by one line.

Down

Move the selected test downward by one line.

Bottom

Move the selected test to the bottom of the list.

Cancel

Restore the original printing order.

Return

Click this button to return to the main screen.

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

4-34

Figure 4-22 Carryover

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

4.7.5 LIS Setup


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

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

4-35

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

4.8

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

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

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

4-36

Figure 4-24 Database

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

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

4-37

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

4.8.3.1 Pump Calibration


Figure 4-27 Pump calibration

Pump Cal can facilitate the calibration of peristaltic pump. The detailed procedures
are as follows: Prepare 6000l distilled water, select 1st, 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 2nd and 3rd calibration.

NOTE
The error of the volume 6000 l 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

Irregular Maintenance

5.3.1 Cleaning Flow Cell


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

2)

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

3)

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

4)

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

5.3.1.2 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

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

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

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.

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

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

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.

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

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 operators
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.

5.3.5 Replacing Aspiration Tubing


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

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

Pull the
tubing
out

5-7

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

Aspiration
deflection
tube

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

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

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

5.3.6 Replacing Lamp


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

5-8

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

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

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

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.

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 0, 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

R
.
C

This calibration method requires only one calibrator.

Two-point linear calibration


Calibration formula: R = aC + b .
This calibration method adopts two calibration parameters: a and b , where,

a=

R R1
R2 R1
, b = R1 2
C1 .
C 2 C1
C 2 C1

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

Multi-point linear calibration


Calibration formula: R = aC + b .
This calibration method adopts two calibration parameters: a and b .
This calibration method requires n (n3) calibrators. C i is the concentration of
calibrator i . Ri is the response of calibrator i . a and b can be obtained
through the method of least squares.
n

a=

C R
i =1

i =1

C
i =1

( C i )( Ri ) / n
2
i

i =1

( C i ) 2 / n
i =1

6.2 Calculating
Parameters

Nonlinear

Calibration

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

1
1 + exp[(a + b ln C )]

This calibration method adopts four parameters: R0 , K , a and b .


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

6-2

Figure 6-1 Logit-Log 4P calibration curve

C1

C2

C3

C4

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

1
1 + exp[(a + b ln C + cC )]

This calibration method adopts five parameters: R0 , K , a , b and c .


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

Exponential 5P
Calibration formula:

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

This calibration method adopts five parameters:

R0 , K , a , b and c .

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

C1 C2

C3

C4

C5

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

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

6-3

This calibration method adopts five parameters:

R0 , a , b , c and d .

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

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

This calibration method adopts three parameters: a , b and c .


This calibration method requires at least three calibrators. The calibration
parameters can be calculated through the method of polynomial least squares.

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

This calibration method requires 2 to 6 calibrators. The number of calibrators is set


to be n, so the calibration method has 4(n-1) parameters in total: R0i , ai , bi and

ci .

6.3

Calculating Concentration

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=

Rb
a

Where,

a , b - calibration parameters

6-4

Multi-point linear calibration

C=

Rb
a

Where,

a , b - calibration parameters

6.3.2 Calculating Concentration of Nonlinearly Calibrated


Sample/control

Logistic-Log 4P

a ln(
C = EXP(

K
1)
R R0
)
b

Where,

R0 , K , a , b

- calibration parameters

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

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

Polynomial5P
C = exp(a + b(

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

Where,

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

aC 2 + bC + c R = 0

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 Rule

6.4.1 Westgard Multi-rule


Westgard multi-rule is shown below.
Symbol

Explanation

QC
Conclusion

12S

One control value


exceeds 2 standard
deviations.

Warning

13S

One control value


exceeds 3 standard
deviations.

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

22S

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

Out-of-control
(systematic
error)

R4S

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

Out-of-control
(random
error)

41S

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

Out-of-control
(systematic
error)

10X

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

Out-of-control
(systematic
error)

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: 200l9000l

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 power: 140VA

A.3

Environment Requirements

A.3.1

Working Environment

Temperature: 15C30C;

Relative humidity: 35%-85%, no condensation

Atmospheric pressure: 70 kPa-106kPa

Altitude height: -400m3,000 m-1,300feet6,500 feet

A.4

Dimension and Weight

Dimension: 420mm350mm158mmWDH

Weight: 7kg

A-1

A.5

Input/Output Devices

Touchscreen

Popup keyboard

Recorder

A.6

Interface

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

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

A.7

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

Calculation
failed

COV

When calculating nonlinear


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

Recalibrate

Printer can not


print

010

Not enough paper in the printer


or printer damaged

Check whether there is enough


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

Absorbance
exceeds
the
limit

ABS

Absorbance exceeds the limit

Check for impurity in the sample;


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

Reagent blank
out of range

RBK

Reagent goes wrong. Cuvette


is dirty

Rerun after replacing the reagent,


or reset the limit parameters.

No
Interval

NLN

Measuring points in both kinetic


read window and substrate limit
are less than 3

Rerun or rerun after dilution

Out of linear
range
(non-linear)

LIN

Reaction data does not meet


linearity criteria

Rerun or rerun after dilution

Above Linearity
High

>

Calculated
concentration
exceeds high limit of linearity
range

Rerun or rerun after dilution

Above Linearity
Low

<

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


using
default
calibration
parameters

Choose other calibration rule or


parameters
to
calculate.
Recalibrate.

Linear

B-1

Corrective measures provided


by log
Recalibrate

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


system
to
stabilize
after
startup out of
range.

001

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

007

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.

Filter wheel can


not find home
position

008

Photocoupler damaged or dust


on photocoupler or motor
damaged.

Restart the system. If the alarm


continues
contact
Mindray
customer service department or
your local distributor.

Light signal too


weak

009

Photoelectric
collection
is
abnormal

010

Lamp is not turned on, or light


source degenerated, or light
path is obstructed, or lamp falls
off, or gain error occurs

Simulation board error

B-2

Restart the system or refer to the


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

Can not pass


hardware
self-check

011

Light signal too


strong

012

If it happens in two consecutive


times, contact the developer.

Circuit error

Photoelectric
error

gain

B-3

adjusting

Restart the system. If the alarm


continues
contact
Mindray
customer service department or
your local distributor.

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

Part Number

Location

Description

Lamp assembly

BA89-30-86998

Lamp base

Regularly-replace
d part

Flow cell

M90-000168---

Cuvette
installation
hole inside the
optical window

Replace it when
damaged

BA89-30-87035

Internal printer
component

Replace it when
damaged

Pump tubing

M6G-020052---

Peristaltic
pump

Replace it when
damaged

Aspiration

BA89-30-87070

Above
the
Aspirate button

Replace it when
damaged

A30-000001---

Internal printer

Consumable

Internal
assembly

Thermal
paper

printer

printing

D-1

P/N: BA89-20-87038(1.0)