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BA-88 Operation Manual v1.1 PDF

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0% found this document useful (1 vote)
2K views

BA-88 Operation Manual v1.1 PDF

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 49

BA-88

Semi-Auto Chemistry Analyzer

Operator’s Manual
Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
called Mindray) owns all rights to this unpublished work and intends to maintain
this work as confidential. Mindray may also seek to maintain this work as an
unpublished copyright. This publication is to be used solely for the purposes of
reference, operation, maintenance, or repair of Mindray equipment. No part of this
can be disseminated for other purposes.

In the event of inadvertent or deliberate publication, Mindray intends to enforce its


rights to this work under copyright laws as a published work. Those having access
to this work may not copy, use, or disclose the information in this work unless
expressly authorized by Mindray to do so.

All information contained in this publication 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 material.
This publication may refer to information and 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.

Content of this manual is subject to changes without prior notice.

© 2005-2006 Shenzhen Mindray Bio-medical Electronics Co., Ltd. All rights


Reserved.

Responsibility on the manufacturer party


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

„ all installation, expansion, change, modification and repair of this equipment


are conducted by Mindray qualified personnel;
„ applied electrical appliance is in compliance with relevant National Standards;
„ the Analyzer is operated under strict observance of this manual.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) i


WARNING:
For continued safe use of this equipment, it is necessary that the
listed instructions are followed. However, instructions listed in this
manual in no way supersede established medical practices
concerning patient care.
„ This equipment is intended for use only by medical
professionals in health care institutions.

„ To avoid electrical shock, you shall not open any cover by


yourself. Service must be carried out by qualified personnel.

„ It is dangerous to expose electrical contact or applicant coupler


to normal saline, other liquid or conductive adhesive. Electrical
contact and coupler such as cable connector, power supply
must be kept clean and dry. Once being polluted by liquid, they
must be thoroughly dried. If to further remove the pollution,
please contact your biomedical department or Mindray.

„ The equipment is an IVD medical equipment, but not a self-test


IVD medical equipment, it is suitable for used in hospital or other
special medical institution, and haven’t the reagent provided
with the equipment.

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

Upon request, Mindray may provide, with compensation, necessary circuit


diagrams, calibration illustration list and other information to help qualified
technician to maintain and repair some parts, which Mindray may define as user
serviceable.

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

Workmanship & Materials

Mindray guarantees new equipment other than accessories to be free from defects
in workmanship and materials for a period of one year from date of shipment
under normal use and service. Mindray's obligation under this warranty is limited
to repairing, at Mindray’s option, any part which upon Mindray's examination
proves defective.

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 substitution upon it of parts or accessories not approved by Mindray or
repaired by anyone other than a Mindray authorized representative.
ii Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)
This warranty shall not extend to any instrument which has been subjected to
misuse, negligence or accident; any instrument from which Mindray's original
serial number tag or product identification markings have been altered or removed,
or any product of any other manufacturer.

Safety, Reliability and Performance

Mindray is not responsible for the effects on safety, reliability and performance of
the BA-88 Semi-Auto Chemistry Analyzer-Operator’ Manual if:

„ Assembly operations, extensions, re-adjusts, modifications or repairs are


carried out by persons other than those authorized by Mindray.
„ Personel unauthorized by Mindray repairs or modifies the instrument.

Return Policy
Return Procedure

In the event that it becomes necessary to return a unit to Mindray, the following
procedure should be followed:

1 Obtain return authorization: Contact the Mindray Service Department


and obtain a Customer Service Authorization (Mindray) number. The
Mindray number must appear on the outside of the shipping container.
Returned shipments will not be accepted if the Mindray number is not
clearly visible. Please provide the model number, serial number, and a
brief description of the reason for return.
2 Freight policy: The customer is responsible for freight charges when this
product is shipped to Mindray for service (this includes customs
charges).
3 Return address: Please send the part(s) or equipment to the address
offered by the Customer Service Department

Company Contact

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


Address: Mindray Building, Keji 12th Road South, Hi-tech Industrial
Park, Nanshan, Shenzhen 518057 P. R. China
Phone: +86 755 26582479 26582888
Fax: +86 755 26582934 26582500

EC-Representative: Shanghai International Holding Corp.


GmbH(Europe)
Address: Eiffestraβe 80, Hamburg 20537, Germany
Tel: 0049-40-2513175
Fax: 0049-40-255726

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) iii


Preface

Preface
This manual gives detailed description to BA-88 Semi-Auto Chemistry Analyzer
Operator’s Manual concerning its performance, operation, and other safety
information. Reading through this manual is the first step to get familiar with the
equipment and make the best out of it.

This manual is intended for persons who are trained in the use of this field and
have adequate experience in operation of analyzing equipment.

Conventions Used in This Manual

Safety Symbols

Symbol Warning Condition Action

Biohazard: Consider all Wear standard laboratory


materials (specimens, reagents, attire, glove and follow safe
controls, calibrators, or laboratory procedures when
components that contain or have handling any material in the
contacted human blood) as being laboratory.
potentially infectious.

Electrical Shock Hazard: Before continuing, unplug the


The electrical warning icon alerts BA-88 analyzer from the
users to the possibility of electrical electrical outlet.
shock in the described activity or
at the posted location.

Probe Hazard: The probe is Avoid any unnecessary


sharp and may contain biohazard contact with the probe and
materials, including controls and probe area.
calibrators.

NOTE: Indicate to the operator


information of importance in the
procedure to be performed. This
heading is also used to indicate
specific sample handling
techniques that are helpful in
operating the instrument.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 1


Preface

CAUTION: Indicate to the


operator information of importance
that could result in damage to the
instrument or affect the test due to
improper operation if these
instructions are not followed.

WARNING: Indicate to the


operator information regarding
potential hazards that may cause
personal harm to the operator if
these instructions are not followed.

2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Preface

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

WARNING:
If the system is used in a manner not specified by 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 MAIN POWER is on, users must not open the rear cover
or side cover.
Liquid ingression may lead to electric shock or equipment damage.
In case of liquid ingression, shut off the power supply and contact our
company or your local distributor.

Preventing Infection

Please observe the following instructions to protect against the biohazardous


infection.

BIOHAZARD:
Inappropriately handling samples may lead to biohazardous
infection. Do not touch the sample, mixture or waste with your hands.
Wear gloves and lab coat and, if necessary, goggles.
In case your skin contacts the sample, follow standard laboratory
safety procedure and consult a doctor.
Certain reagents are strongly acid or alkaline. Exercise caution when
using the reagents. In case your skin or clothes contact the reagents,
wash them off with soap and clean water. In case the reagents spill
into your eyes, rinse them with much water and consult an oculist.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 3


Preface

Treating Waste

Please observe the following instructions to prevent environmental pollution and


personal injury caused by waste.

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

Preventing Fire or Explosion

Please observe the following instructions to prevent fire and explosion.

WARNING:
Do not use flammable substance around the system.

Precautions on Use
To use the BA88 analyzer safely and efficiently, please pay attention to the
following operation notes.

Intended Use

WARNING:
The BA88 analyzer is a chemistry system that is designed for the in
vitro quantitative determination of clinical chemistries in serum,
plasma, urine or CSF samples. Please consult our company first if
you want to use the system for other purposes.
To draw a clinical conclusion, please also refer to the patient’s clinical
symptoms and other test results.

Operator

WARNING:
The analyzer is to be operated only by medical professionals trained
and authorized by our company or distributors authorized by our
company

4 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Preface

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 company or your local
distributor.

Preventing Interference by Electromagnetic Noise

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

Operating the System

CAUTION:
Operate the system strictly as instructed by this manual.
Inappropriate use of the system may lead to unreliable test results or
even equipment damage or personal injury.
Before using the system for the first time, run the calibration program
and QC program to make sure the analyzer is in proper state.
Be sure to run the QC program every time you use the system,
otherwise the result may be unreliable.
Do not open the cover of the sample/reagent disk when the system is
in operation.
The RS-232 port on the analyzing unit is to be used for connection
with the operation unit only. Do not use it for other connections. Only
use the supplied cable for the connection.
Don’t place the MAIN POWER to ON again within 10 seconds since
placing it to OFF; otherwise the system may enter the protection
status. If it does so, place the MAIN POWER to OFF and place it to
ON again.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5


Preface

Maintaining the System

CAUTION:
Maintain the system strictly as instructed by this manual.
Inappropriate maintenance may lead to unreliable results or
equipment damage or personal injury.
To wipe off dust from the system surface, use a soft, clean and wet
(not too wet) cloth, soaked with soap water if necessary, to clean the
surface. Do not use such organic solvents as ethanol for cleaning.
After cleaning, wipe the surface dry with dry cloth.
Switch off all the powers and disconnect the power plug before
cleaning. Take necessary measures to prevent water ingression into
the system, otherwise it may lead to equipment damage or personal
injury.
Replacement of such major parts as photometer, probe, mixing bar
and syringe plunger assembly must be followed by a calibration.

Setting up the System

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

Electromagnetic emission and immunity.

CAUTION:
1 A statement that the IVD equipment complies with the emission
and immunity requirement description in this part of the IEC 61326
series.

2 If emission compliance is Class A,state the warning: this


equipment has been designed and tested to CISPR 11 Class A, in a
domestic environment it may cause radio interference,in which
case,you may need to take measures to mitigate the interference.

3 an advisory that the electromagnetic environment should be


evaluated prior to operation of the device

4 Do not use this device in close proximity to sources of strong


electromagnetic radiation (e.g. unshielded intentional RF sources),as
these may interfere with the proper operation.

6 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Contents

Contents
Preface ............................................................................................................1
Conventions Used in This Manual .................................................................................. 1
Safety Precautions.......................................................................................................... 3
Precautions on Use ........................................................................................................ 4

1 General................................................................................................1-1

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

3 Installation Requirements .................................................................3-1


3.1 Unpacking ......................................................................................................... 3-1
3.2 Operating Environment ..................................................................................... 3-1
3.3 Power Requirements ........................................................................................ 3-2

4 System Structure ...............................................................................4-1


4.1 Front View ......................................................................................................... 4-1
4.2 Rear View.......................................................................................................... 4-2

5 System Menu......................................................................................5-1
5.1 Measure ............................................................................................................ 5-1
5.1.1 Select test ............................................................................................ 5-1
5.1.2 Measure ............................................................................................... 5-1
5.2 Quality Control .................................................................................................. 5-2
5.2.1 QC graphics ......................................................................................... 5-2
5.2.2 Settings ................................................................................................ 5-2
5.2.3 delete data ........................................................................................... 5-2
5.2.4 Print...................................................................................................... 5-3
5.3 Setup................................................................................................................. 5-3
5.3.1 Date and Time...................................................................................... 5-3
5.3.2 Volume Cal........................................................................................... 5-3
5.3.3 Feed paper........................................................................................... 5-3
5.3.4 Send Data ............................................................................................ 5-3
5.3.5 Light source.......................................................................................... 5-4
5.3.6 Rinse .................................................................................................... 5-4
5.3.7 Result review........................................................................................ 5-4
5.3.8 Zero drift check .................................................................................... 5-4
5.3.9 Filter check........................................................................................... 5-4
5.4 Program ............................................................................................................ 5-5
5.4.1 New Test .............................................................................................. 5-5
5.4.2 Edit Test ............................................................................................... 5-6

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) i


Contents

5.5 Print report ........................................................................................................ 5-9


5.6 Work list ............................................................................................................ 5-9

6 Operation ............................................................................................6-1
6.1 Check before Power-On ................................................................................... 6-1
6.2 Power-On .......................................................................................................... 6-1
6.3 Calibrating the Aspiration Volume..................................................................... 6-1
6.4 Checking Filter .................................................................................................. 6-2
6.5 Setting Test Parameters.................................................................................... 6-2
6.6 Measure ............................................................................................................ 6-2
6.6.1 Main menu ........................................................................................... 6-2
6.6.2 Select test ............................................................................................ 6-2
6.6.3 Measure ............................................................................................... 6-2
6.7 Exit Test............................................................................................................. 6-4
6.8 Wash Flow Cell ................................................................................................. 6-4
6.9 Select Other Tests............................................................................................. 6-4
6.10 Print Test Results........................................................................................... 6-4

7 Maintenance .......................................................................................7-1

8 Trouble-shooting................................................................................8-1
8.1 Black Screen after Power-On ........................................................................... 8-1
8.2 Abnormal Aspiration or No Aspiration ............................................................... 8-1
8.3 No Aspiration When Start key is Pressed ......................................................... 8-2
8.4 Abnormal Display of A-C curve......................................................................... 8-2
8.5 Absorbance of the Filter is Too High................................................................. 8-2
8.6 Poor Repeatability of Test Results .................................................................... 8-3
8.7 Results Too High or Too Low ............................................................................ 8-3

9 Abbreviation .......................................................................................9-1

10 Index..................................................................................................10-1

ii Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


General

1 General

The chemistry analyzer is an instrument utilizing optical, mechanical and computer


technologies. It is an important laboratory instrument running most routine clinical
chemistry tests. Chemistry analyzers can be divided into two categories – the fully
automatic analyzer and the semi automatic analyzer. The fully automatic analyzer
completes most of the routine operations automatically, such as sample & reagent
pipetting, mixing, heating, analyzing, calculating, printing and rinsing. It meets the
demand of hospitals with large sample volume and diverse test items.

The semi automatic analyzer automates certain operations (such as heating,


analyzing, calculating and printing), while reaction solution has to be prepared
manually. This type of instrument is more suitable to small laboratories and hospitals
with smaller sample volume.

The BA-88 is a semi-auto chemistry analyzer with high precision and high reliability.
It is intended to examine of specimens of blood serum derived from the human body.
The examine items include the incorporated liver, the incorporated nephridium,
blood fat, blood sugar, cardiac muscle enzyme, abio-ion etc.

It features:

„ Analysis methods: end point, kinetic, fixed time and absorbance


„ Linear and non-linear calibration
„ Touch screen, large LCD display
„ Anti-vibration and anti-disturbance optical system ensures highly accurate and
reliable results
„ Measurement precision of 0.0001ABS and calculation precision of 0.00001ABS
„ Reaction curve displayed
„ Lamp saving feature largely prolongs lamp life

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 1-1


General

„ Comprehensive quality control program, Levey-Jenning graphics included


„ Audible / visual alarm available
„ Built-in high-speed thermal printer

„ Reagent open.

1-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Specifications

2 Specifications

Light source

„ Quartz-halogen lamp 12V/20W

Wavelength range

„ Automatic by 8 positions filter-wheel


„ 7 standard filters: 340, 405, 492, 510, 546, 578, 630nm
„ 1 position free for optional filter
„ Half Bandwidth < 8nm
„ Stray light: < 1.0 % @ 340 nm

Photometric Range

„ 0.0000 to 3.0000 ABS


„ Resolution: 0.0001 ABS
„ Drift: 0.002 A/hour

Flowcell

„ Stainless steel body with quartz window


„ Measuring volume 32 uL
„ Aspiration volume programmable: 200 – 2000 uL
„ Optical path 10mm

Analysis method

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 2-1


Specifications

„ End point, with or without reagent blank


„ End point, with sample blank and with or without reagent blank
„ Kinetic, with or without linearity check
„ Fixed time, with or without reagent blank
„ Absorbance
„ Turbidimetry
„ Linear and non-linear standardization

Parameter Settings

„ Method
„ Wavelength
„ Temperature
„ Reagent blank y/n
„ Sample blank y/n
„ Delay time
„ Measuring time
„ Reaction type
„ Absorbance limit
„ Aspiration volume
„ Standards
„ Linearity check
„ Unit for results

Memory

„ 3000 results

Temperature control

„ By means of Peltier elements


„ 25, 30, 37 °C optional
„ Precision: +/- 0.1°C

Input

„ Touch screen

Display

„ Large LCD display

Printer

„ Built-in thermal printer

2-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Specifications
Interface

„ RS-232 serial port

Opreating environment

„ Temperature: 15 – 30 °C
„ Humidity: 20 – 80 %
„ Atmospheric pressure:86-105kPa

Power requirement

„ AC 230V+/-10%, 50/60Hz

Power Consumptions

„ 100VA

Dimension

„ 42cm x 38cm x 17cm

Weight

„ 7.5 kg

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 2-3


Installation Requirements

3 Installation Requirements

WARNING:
The system should be installed only by personnel authorized by our
company.

The system should be installed by personnel authorized by our company, and you
should prepare a proper site for installation.

If you need to move the system to another site, please contact our company or your
local distributor, who are the appropriate people for the moving job.

3.1 Unpacking
When you receive the system, carefully inspect the package. If you see any signs of
mishandling or damage, file a claim immediately with our company 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, alert
our company or your local distributor immediately.

3.2 Operating Environment


„ The instrument should be installed on a stable and solid platform that is free of
mechanical vibration and away from vibration source.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 3-1


Installation Requirements

„ The environment should be as free as possible from dust, corrosive gas, loud
noises and electrical interference.
„ Avoid placing the instrument in direct sun or in front of a source of heat or draft.
„ Ambient temperature: 15~30 ℃ , humidity: 20~80%, Atmospheric
pressure:86-105kPa.
„ The equipment shall be placed with the rear side 20 cm far away from the wall,
ensure the well ventilation and easy to disconnect the supply cord.
„ Replace the paper of printer: open the printer cover, and then loose the printer,
turn the roll to make the paper outside the printer cover opening, then closed the
cover.

3.3 Power Requirements


„ The input voltage should be 220/110 VAC +/- 10%, 50/60Hz.
„ Power supply and grounding should be correctly connected.

Note:
Verify that the input voltage is compatible with the instrument and the
proper type of fuse is installed.

3-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


System Structure

4 System Structure

4.1 Front View

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 4-1


System Structure

4.2 Rear View

4-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


System Menu

5 System Menu

The main menu of the BA-88 includes six sub-menus: Measure, Quality Control,
Setup, Program, Print Report and Work list, as the figure below shows.

Main Menu

Measure Quality Control

Setup Program

Print Report Work list

5.1 Measure

5.1.1 Select test


the semi-automatic chemistry analyzer can conduct only one type of test at a time.
The operation is: touch Measure, then select the test to be conducted.

5.1.2 Measure
For the end point, results should be taken when the reaction is over. Add the sample
or the standard to the reaction tube, and then add the reagent to the tube. After
incubation, take the colorimetric results on the instrument.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5-1


System Menu

For the kinetic or fixed time, the results should be taken within the steady rate range
of the reaction. Add sample to the tubes, then add reagents and take results
immediately.

For the end point, there are two ways to obtain the result. One is to check the A-C
curve, and the other is to calculate with the following equation:

C = (Sample ABS-Reagent Blank ABS-Sample Blank ABS)×Factor

Standard concentration
Factor =
(Standard ABS—Reagent blank ABS)

The equation of the fixed time is almost same as that of the end point. The difference
is the sample ABS, reagent blank ABS, calibrator ABS should be changed to the
ABS variation (△A) within the measuring time.

Calculation of the kinetic method is based on ABS variation rate (△A/min),

C=△A/min×Factor

TV: total reaction volume, SV: sample volume, d: optical path,ε: Moore constant.

5.2 Quality Control


QC graphics, settings, deleting data and printing data are included.

5.2.1 QC graphics
established from QC data automatically.

5.2.2 Settings
set mean value and SD value.

5.2.3 delete data


Select “Delete Last Month” and only the QC data of the last month will be deleted.
Select “Delete All Data” and all QC data of the past 31 days will be deleted.

5-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


System Menu

5.2.4 Print
Touch Print to print out detailed QC information.

5.3 Setup

5.3.1 Date and Time


system date and time.

The date format is: Year-Month-Day.

The time format is: Hour:Minute:Second.

For example, the time is 18:35 on December 23, 2002, then the operation is: touch
Date and Time , touch 2 , 0 , 0 , 2 , YES ;touch 1 , 2 , YES ;touch
2 , 3 , YES ;touch 1 , 8 , YES ; touch 3 , 5 , YES .

5.3.2 Volume Cal


To calibrate aspiration volume. After a certain period, the aspirating force of the
pump tube may change, which will cause the discrepancy between the set aspiration
volume and the actual aspiration volume. Therefore, aspiration volume should be
calibrated regularly, usually once per week. The operation is: to uch Volume Cal.
and then present 1 ml distilled water to the sample probe. Press the Start key to
active the aspiration. When the water is all aspirated into the instrument, release the
Start key to stop the aspiration, then the new calibration value is displayed. Usually
this step is to be repeated several times until the difference between the new
calibration value and current value is less than 10%.

5.3.3 Feed paper


The operation is: touch Feed paper and the printer will run a while to load the
paper.

5.3.4 Send Data


To transmit the sample result data and QC data to PC. The operation is: touch Send
Data . When the transmission is done, the system will return to the previous menu.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5-3


System Menu

5.3.5 Light source


Touch Light Source,select Turn on or Turn off , and the corresponding image will
be displayed.

5.3.6 Rinse
The flow cell should be rinsed after each type of test. First rinse with distilled water,
then rinse with the recommended detergent, and finally rinse with distilled water
again. The rinsing volume should be no less than 2ml. The operation is: touch
Rinse , press the Start key, and rinse the flow cell with distilled water—detergent —
distilled water.

5.3.7 Result review


Two ways to review the results, by the test or by the sample. The operation is: touch
Review by Test , select the test name, then all the results for this test will be printed
out. Or, touch Review by ID , enter the sample’s ID number, then all the results for
this sample will be printed out.

5.3.8 Zero drift check


Fill the flow cell with distilled water, continuously read the absorbance at 340nm
wavelength for 10 minutes. The difference between the maximum and minimum
absorbance value should be no greater than 0.006 ABS. The operation is: touch
Zero Drift , present the distilled water to sample probe, then press the Start key. The
zero drift check will start after the aspiration. The maximum, minimum and current
absorbance values (ABS) are all displayed on the screen. After 10 minutes, the
system will display the message “Zero drift check passed” or “Zero drift check failed”.

5.3.9 Filter check


Check the position and absorbance of each filter. For the new instrument, all the
filters’ absorbance should be less than 0.200, except for the free position (F8). The
operation is: touch Filter Check,present the distilled water to the sample probe, and
press the Start key. After the aspiration is done, the filters will be checked and the
results will be displayed on the screen.

5-4 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


System Menu

5.4 Program

5.4.1 New Test


26 tests are pre-programmed and stored in the instrument. The parameters of these
tests can be changed by the user, while the test number and test name are fixed and
cannot be changed or deleted. Besides the pre-programmed tests, the user can
define new tests as necessary. Up to 6 characters can be entered for the test name.
The operation is: touch Program , and the following menu will be displayed:

Program

Edit Test

New Test

Delete Test

Touch New Test , and the following menu will be displayed:

New Test
15 LDH 16 HBDH
17 CK 18 CK-MB
19 CO2 20 BUN
21 Cr 22 Ca
23 p 24 MG
25 UA 26 AMS
27 28

Select a new number, then the following menu will be displayed.

Test Name ____

1 ABC 2DEF
3 GHI 4JKL

5MNO 6PQR
7STU 8VWX

9YZ 0

. NEXT

YES CLR

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5-5


System Menu

For example, assuming ABS is to be entered, the operation is: touch 1ABC twice,
then “A” is displayed. Touch NEXT, touch 1ABC three times, then “AB” is
displayed. Touch NEXT, touch 7STU twice, then “ABS” is displayed. Touch
YES and return to the previous menu.

Caution
Changing the test name is prohibited if the result of this test is still
present.

5.4.2 Edit Test


Different tests require different parameters. Test parameters include: method, wave
length, temperature, aspiration volume, reagent blank, delay time, measuring time,
reaction type, ABS limit, decimal, standard, factor, linear check, unit, measure range
and normal range. The following description takes glucose as the example.

5.4.2.1 Method
The following methods can be selected: Absorbance, End Point, Fixed time, and
Kinetic. Select End Point for the glucose. The operation is: touch 09GLU , Method
and select End Point .

5.4.2.2 Wavelength

Seven wave lengths(340nm, 405nm, 492nm, 510nm, 546nm, 578nm, 630nm)can


be selected. For the glucose the wavelength is 492nm. The operation is: touch
Wavelength and select 492nm .

5.4.2.3 Temperature

4 options available -- room temperature, 25℃, 30℃ and 37℃. Room temperature is
selected for GLU. The operation is: touch Temperature and select Room
Temp .

5.4.2.4 5.4.2.4 Reagent blank


„ Yes --with reagent blank
„ No -- without reagent blank.
No reagent blank for the glucose. The operation is: touch Reagent Blank and
select No .

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System Menu

5.4.2.5 Delay time


For the Absorbance and End Point, the delay time is usually 1 second. For the fixed
time and kinetic, the delay time should be set according to the reagent instruction
sheet. The operation is: touch Delay time then enter the required time.

5.4.2.6 Measuring time


For the absorbency and end point, the measuring time is usually 1 second. For the
fixed time and kinetic, the time should be set according to the reagent instruction
sheet. The operation is: touch Measuring time then enter the required time.

Note:
The interval reading time for fixed time and kinetic method is 10
seconds.

5.4.2.7 Reaction type


„ Increase: the absorbance value increases during the reaction.
„ Decrease: the absorbance value decreases during the reaction.
This parameter does not apply to the glucose. Skip this item.

5.4.2.8 ABS limit


The range is 0.0000-3.0000A. For the increase reaction, the absorbance of the last
reading point should not be greater than the limit. Otherwise, the result is followed by
a “*” . For the decrease reaction, the absorbance of the last reading point should
not be lower than the limit. Otherwise, the result is followed by a “*” . This
parameter does not apply to the Absorbance and End Point.

5.4.2.9 Decimal
0 for integer results, 1 for one decimal place, 2 for two decimal places, 3 for three
decimal places. Select 2 for GLU. The operation is : touch Decimal and select
2.

5.4.2.10 Factor
For the kinetic, the factor is entered according to the reagent instruction sheet. For
the end point and fixed time, the factor is calculated by measuring the standard. For
the absorbance, the factor is 1. For the glucose, the factor is calculated by
measuring the standard.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5-7


System Menu

5.4.2.11 Linear check


If the measuring result is non-linear, NL will be displayed. There is no linear check for
the end point or the absorbance

5.4.2.12 Unit
Seven result units can be selected: U/L, mmol/L, umol/L, mg/L, G/L, mg/dl and ABS.
For the glucose the unit is mmol/L. The operation is: touch Unit and select
mmol/L .

5.4.2.13 Aspiration volume


To set the volume of the reaction mixture to be aspirated into the flow cell. Too small
aspiration volume may cause high carryover. The recommended volume is
500ul~1000ul. For example, assuming 1000ul is to be entered, the operation is:
touch Aspiration Vol , enter 1 0 0 0 , then touch YES .

5.4.2.14 Measure range

“$”is displayed in case the result exceeds the range. For the glucose, the range is
0.00-2.22. The operation is: touch Measure Range H ,enter 2 . 2 2
YES , then touch Measure range L , enter 0 . 0 0 YES .

5.4.2.15 Normal range


Reference range for normal results. “H” or “L” is automatically printed when the test
result exceeds the range. The operation is similar as previous section.

5.4.2.16 Standard point


Four calibration modes are available: 0, 1, multi-point linear and multi-point
non-linear. “0” means no standard and applies to the absorbance and the Kinetic.
“1” means only one standard and applies to the end point and the fixed time. Up
to 6 standards can be defined with the multi-point linear method or multi-point
non-linear method. This applies to the end point only. Select 1 for the glucose. The
operation is: touch STD Point and select 1 .

5.4.2.17 Standard value


Enter the standard concentration accordingly. No standard value entered for 0
standard point. Enter one standard value for 1 standard point. Enter 2~6 standard
values for multi-point settings.

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System Menu

Note:
If less than 6 standards to be defined, then after entering all the
standard values, set the value of the next point to 0. For example, if 4
standards to be defined totally, then set the value of the 5th point to 0.
In this way the system can decide the number of standards. If the
standard value of the glucose is 5.55, the operation is: touch STD 1 ,
enter 5 . 5 5 YES.

5.5 Print report


Touch Print Report then all the test results of current date will be printed out by the
sample ID.

5.6 Work list


1 Touch Worklist to input the work list at the main menu. Select the sample
ID, then select the tests to be conducted. The selected items will be
displayed in reverse video. Touch Exit after entering all the tests for this
sample. Repeat this operation for all the samples.
2 Check and confirm the work list. Touch Print by ID then all the selected
test items will be printed out by the sample ID. Check and correct the errors,
then proceed to next step.
3 Print a list by the test. Touch Print by Test then a list will be printed out
by test items. This helps the user to prepare the samples and reagents
properly.
4 Sample measurement: At the main menu, touch Measure and all the
tests will be displayed. Each test to be conducted is preceded by a “ ”.
Select the test to enter the menu of the next level. After running zero,
standardization and quality control, touch Sample to measure the
samples. (when “ ” is displayed inside ID: XXX , the sample ID will
change automatically according to the work list, thus it can not be changed
by the user) Measure the samples in turn. The measuring results will be
saved to the system automatically. When all the samples for the current test
item are finished, “ ” will blink and disappear, then the user can
change the sample ID freely and measure the suspicious samples again.
After that, rinse the flow cell with distilled water and return to the main menu.
Repeat this step for the other tests. Proceed to next step when all the tests
are finished.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 5-9


Operation

6 Operation

6.1 Check before Power-On


The operating environment should be as free as possible from dust, corrosive gas,
mechanical vibrations, loud noises and electrical interference. Avoid placing the
instrument in direct sun or in front of a source of heat or draft. Power supply and
grounding are properly connected. The input voltage should be compatible with the
instrument. Ambient temperature and humidity is within the related requirements.

6.2 Power-On
Turn on the power. After initialization, the system will enter the main menu
automatically.

Caution:
Proceed to the following operations only after 10~15 minutes warm-up.

6.3 Calibrating the Aspiration Volume


Usually the aspiration volume is calibrated once a week. See Section 5.3.2 “Volume
Cal” .

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 6-1


Operation

6.4 Checking Filter


See Section 5.3.9 “Filter check”.

6.5 Setting Test Parameters


Different tests require different parameters. Set the parameters as instructed by
Section 5.4.2 “Edit Test ”. The parameters are saved automatically.

6.6 Measure
The measuring procedure is explained as follows (take the glucose as the example):

6.6.1 Main menu


touch Measure

6.6.2 Select test


touch 09GLU

6.6.3 Measure
Before measuring, check the parameters that are displayed on the top of the screen,
and make sure they are correct.

6.6.3.1 Zero

Touch zero and present the distilled water to the sample probe. Press the Start key
to aspirate the distilled water. After zeroing, “ A: 0.000 ” will be displayed on the
screen.

Note:
If the test parameter for “Reagent Blank” is “No”, the user should
execute this step with reagent instead of distilled water.

6-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Operation

6.6.3.2 Reagent blank

Touch RB and present the reagent to the sample probe. Press the Start key to
aspirate the reagent. After reading the absorbance of the reagent, the value will be
displayed on the screen.

Note:
If the test parameter for “Reagent Blank” is “No”, RB will not be
displayed.

6.6.3.3 Standard

Touch Standard and present the standard-reagent mixture to the sample probe.
Press the Start key to aspirate the mixture. The absorbance reading of the mixture
and the factor are displayed. The factor is calculated and saved into the instrument
automatically.

6.6.3.4 Quality control

Touch QC and present the control to the sample probe. Press the Start key to
aspirate the control. The absorbance reading and measuring result of the control are
displayed. The measuring result is saved into the QC file.

6.6.3.5 Sample

Touch Sample and present the sample to the sample probe. Press the Start key
to aspirate the sample. The absorbance reading and measuring result of the sample
are displayed. The result is also printed out automatically. Repeat this step to
measure the samples in turn.

6.6.3.6 Change sample ID

Press Next ID or ID XXX to change the sample ID.

Caution:
Make sure the sample has the same ID for different tests.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 6-3


Operation

6.7 Exit Test


Touch Exit to exit the menu.

6.8 Wash Flow Cell


See Section 5.3.6 “Rinse”.

6.9 Select Other Tests


Repeat step 6.6~6.8.

6.10 Print Test Results


When all the tests are done, select “Print Report ” to print all the results by sample
ID.

The BA88 can also transmit the sample data to an external computer (a host)
through its RS232 port.

Caution:
Before shutdown, make sure to wash the flow cell thoroughly and fill it
with distilled water.

6-4 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Maintenance

7 Maintenance

Preventive and corrective maintenance procedures are required to keep the BA88 in
a good operating condition. This chapter introduces how to maintain your analyzer.

Caution:
„ Do not perform any maintenance procedures that are not
described in this chapter. Performing unauthorized maintenance
procedures can damage your analyzer.

„ In case of problems not specified in this manual, contact Mindray


customer service department or your local distributor for assistance.

„ Only Mindray-supplied parts can be used for maintenance. For


any questions, contact Mindray customer service department or your
local distributor.

BIOHAZARD:
All the analyzer components and surfaces are potentially infectious,
take proper protective measures for operation or maintenance.

„ The instrument must be operated under the environmental requirements.


„ After turning on the power or the lamp, wait 15~20 minutes before starting the
test. After turning off the lamp, wait about 10 minutes for the lamp to cool down
before turning it on again.
„ Make sure the measurement is free of bubbles.
„ Wash the flow cell after finishing each kind of test.
„ Check the aspiration volume regularly. If necessary, replace the aged tube.
„ Before replacement the aged tube, please clean the tube at least three times
with distilled water or special scour, then remove the aged tube and disconnect

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 7-1


Maintenance

the aged tube on the connection position, connect the new tube and install on
the frame, do not throw away the aged tube conveniently, dispose it according
to the regulation of the hospital.
„ Fill the flow cell with distilled water before shutdown.
„ Touch the specimens will cause biohazard, do not touch the specimens,
admixture or waste liquid directly, please operate the equipment with germproof
gloves, if you touch the specimens please see the doctor.
„ If the current fuses of the AC inlet were broken, replace it with an VDE approved
fuse with rated value of 250V、2A.
„ If the lamp of the equipment is damaged, do not replace it by yourself, please
return the equipment to manufacturer or replace it under the supervision of our
manufacturer’s technical person.
„ Handle and dispose of the waste according to acceptable laboratory, local state
and national standards.

Caution:
„ Since the specimens may have fatal pathogen or virus, the
disposition of tubes, colorimetry, waste liquid and bottle shall be
according to the relevant regulation of the hospital, throw them away
conveniently will cause a biohazard.

„ The waste liquid bottle shall be placed on a horizontal plane, and


the capsule shall be fixed well to prevent the bottle from turning over, if
the bottle turn over, please slip off the liquid with dry rag (with glove on
your hand), then sterilize the relevant position.

„ If you want to move or transit the equipment, please clean the tube three times
and make the tube have no specimen, acutely vibration and collision shall be
prevented, make the equipment at horizontal position, never turn over the
equipment.

7-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Trouble-shooting

8 Trouble-shooting

8.1 Black Screen after Power-On


Cause:

(1)poor connection of the power cable;

(2)broken fuse.

Solution:

(1)connect the power cable properly;

(2)replace the fuse.

8.2 Abnormal Aspiration or No Aspiration


Cause:

(1)aged peristaltic pump tube;

(2)tubing system blocked;

(3)tubing system leaking or loose;

(4)defective peristaltic pump motor.

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 8-1


Trouble-shooting

Solution:

(1)replace peristaltic pump tube;

(2)eliminate blockage;

(3)check the tubing system, if necessary, change the aged tube.

(4)replace peristaltic pump motor

(5) contact the manufacturer.

8.3 No Aspiration When Start key is Pressed


Cause: calibrated value for aspiration volume is lost.

So lu tion : Shut down and re-start the instrument. Enter the Setup \ Volume Cal
menu to re-calibrate the aspiration volume.

8.4 Abnormal Display of A-C curve


Cause: Improper value for standard point and concentration

Solution: set the correct parameters and re-create the curve.

8.5 Absorbance of the Filter is Too High


Cause:

(1)bubbles in flow cell;

(2)deviated optical parts;

(3) aged lamp;

(4)damaged filter.

Solution:

(1)wash flow cell with proper detergent;

(2)adjust the optical components to correct position;

(3) replace the lamp;

(4)replace the filter.

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Trouble-shooting

8.6 Poor Repeatability of Test Results


Cause:

(1)dirty flow cell subject to remaining bubbles;

(2)tube blocked;

(3)high carryover due to inaccurate aspiration volume;

(4)aged lamp;

(5)poor internal ventilation or ambient temperature too high;

(6)polluted reagent.

Solution:

(1)wash flow cell with proper detergent and keep bubbles away;

(2)replace the tube;

(3)re-calibrate aspiration volume or replace the peristaltic pump tube;

(4)replace the lamp;

(5)operate the instrument under proper environment;

(6)use qualified reagent.

8.7 Results Too High or Too Low


Cause:

(1) inaccurate standard volume;

(2)poor standard;

(3)wrong factor;

(4)polluted reagent;

(5)wrong temperature setting for kinetic method;

(6)wrong sample-to-reagent ratio.

Solution:

(1)add standard of correct volume;

(2)use qualified standard;

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 8-3


Trouble-shooting

(3)correct the factor;

(4)use qualified reagent;

(5)correct the temperature setting;

(6) prepare sample and reagent as instructed.

8-4 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Abbreviation

9 Abbreviation

No. Abbreviation Full Name

01 ALT Alanine aminotransferase

02 AST Aspartate aminotransferase

03 ALP Alkaline phosphatase

04 GGT Gamma Glutamyl transferease

05 T.BILI Total bilirubin

06 D.BILI Direct bilirubin

07 TP Total Protein

08 ALB Albumin

09 GLU Glucose

10 CHOL Cholesterin

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 9-1


11 TRIG Triglyceride

12 HDL-CH High density lipoprotein-cholesterol

13 APOA1 Apolipoprotein A1

14 APOB Apolipoprotein B

15 LDH Lactic dehydrogenase

16 HBDH α-hydroxybutyrate

17 CK Creatine kinase

18 CK-MB MB isoenzyme of CK

19 CO2 Carbon dioxide

20 BUN Blood urine nitrogen

21 Cr Creatinine

22 Ca2+ Calcium

23 P Phosphorus

24 Mg2+ Magnesium

25 UA Urine acid

26 AMS Amylase

27 K Kalium

28 Na Natrium

29 Cl Chlorine

9-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


Index

10 Index

Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1) 10-1


Index

A Q

absorbance.....................................................
Quality Control................................... 5-1, 5-2
............ 1-1,2-1,5-3, 5-4, 5-5, 5-6, 5-7,6-2,8-1

ANALYSIS METHOD.......................... 1-1,2-1 R

B reagent .........1-1,2-1,5-1, 5-2, 5-5, 5-6,-2,8-2

Bandwidth................................................. 2-1

C Setup ........................................... 5-1, 5-2,8-1

calculation................................................. 1-1

chemistry analyzer.............................. 1-1,5-1
Touch screen ...................................... 1-1,2-2

E Temperature ................................ 2-1, 2-2,5-5

environment............................2-2,3-1,6-1,8-2

H Work list............................................. 5-1, 5-8

Humidity.................................................... 2-2

instrument.......................................................
1-1,3-1,5-1, 5-3, 5-4,6-1, 6-2,7-1,8-1, 8-2

input voltage ....................................... 3-1,6-1

Measurement...................................... 1-1,5-1

printer ...........................................1-2,2-2,5-3

Program............................................. 5-1, 5-4

10-2 Semi-Auto Chemistry Analyzer Operator’s Manual (V1.1)


P/N: BA88-20-29826(V1.1)

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