BA-88 Operation Manual v1.1 PDF
BA-88 Operation Manual v1.1 PDF
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called Mindray) owns all rights to this unpublished work and intends to maintain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unpublished copyright.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.
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.
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.
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.
Mindray is not responsible for the effects on safety, reliability and performance of
the BA-88 Semi-Auto Chemistry Analyzer-Operator’ Manual if:
Return Policy
Return Procedure
In the event that it becomes necessary to return a unit to Mindray, the following
procedure should be followed:
Company Contact
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.
Safety Symbols
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.
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
BIOHAZARD:
Inappropriately handling samples may lead to biohazardous
infection. Do not touch the sample, mixture or waste with your hands.
Wear gloves and lab coat and, if necessary, goggles.
In case your skin contacts the sample, follow standard laboratory
safety procedure and consult a doctor.
Certain reagents are strongly acid or alkaline. Exercise caution when
using the reagents. In case your skin or clothes contact the reagents,
wash them off with soap and clean water. In case the reagents spill
into your eyes, rinse them with much water and consult an oculist.
Treating Waste
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.
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
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.
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.
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.
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.
CAUTION:
To define such parameters as sample volume, reagent volume and
wavelength, follow the instructions in this manual and the instructions
of reagents.
CAUTION:
1 A statement that the IVD equipment complies with the emission
and immunity requirement description in this part of the IEC 61326
series.
Contents
Preface ............................................................................................................1
Conventions Used in This Manual .................................................................................. 1
Safety Precautions.......................................................................................................... 3
Precautions on Use ........................................................................................................ 4
1 General................................................................................................1-1
2 Specifications.....................................................................................2-1
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
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
1 General
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:
Reagent open.
2 Specifications
Light source
Wavelength range
Photometric Range
Flowcell
Analysis method
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
Input
Touch screen
Display
Printer
Opreating environment
Temperature: 15 – 30 °C
Humidity: 20 – 80 %
Atmospheric pressure:86-105kPa
Power requirement
AC 230V+/-10%, 50/60Hz
Power Consumptions
100VA
Dimension
Weight
7.5 kg
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.
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.
Note:
Verify that the input voltage is compatible with the instrument and the
proper type of fuse is installed.
4 System Structure
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
Setup Program
5.1 Measure
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.
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:
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.
C=△A/min×Factor
TV: total reaction volume, SV: sample volume, d: optical path,ε: Moore constant.
5.2.1 QC graphics
established from QC data automatically.
5.2.2 Settings
set mean value and SD value.
5.2.4 Print
Touch Print to print out detailed QC information.
5.3 Setup
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 .
5.3.6 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.
5.4 Program
Program
Edit Test
New Test
Delete Test
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
1 ABC 2DEF
3 GHI 4JKL
5MNO 6PQR
7STU 8VWX
9YZ 0
. NEXT
YES CLR
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.
5.4.2.1 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
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 .
Note:
The interval reading time for fixed time and kinetic method is 10
seconds.
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.
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 .
“$”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 .
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.
6 Operation
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.
6.6 Measure
The measuring procedure is explained as follows (take the glucose as the example):
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.
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.
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.
Caution:
Make sure the sample has the same ID for different tests.
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.
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.
BIOHAZARD:
All the analyzer components and surfaces are potentially infectious,
take proper protective measures for operation or 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.
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.
8 Trouble-shooting
(2)broken fuse.
Solution:
Solution:
(2)eliminate blockage;
So lu tion : Shut down and re-start the instrument. Enter the Setup \ Volume Cal
menu to re-calibrate the aspiration volume.
(4)damaged filter.
Solution:
(2)tube blocked;
(4)aged lamp;
(6)polluted reagent.
Solution:
(1)wash flow cell with proper detergent and keep bubbles away;
(2)poor standard;
(3)wrong factor;
(4)polluted reagent;
Solution:
9 Abbreviation
07 TP Total Protein
08 ALB Albumin
09 GLU Glucose
10 CHOL Cholesterin
13 APOA1 Apolipoprotein A1
14 APOB Apolipoprotein B
16 HBDH α-hydroxybutyrate
17 CK Creatine kinase
18 CK-MB MB isoenzyme of CK
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
10 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
Bandwidth................................................. 2-1
S
calculation................................................. 1-1
T
chemistry analyzer.............................. 1-1,5-1
Touch screen ...................................... 1-1,2-2
environment............................2-2,3-1,6-1,8-2
W
Humidity.................................................... 2-2
instrument.......................................................
1-1,3-1,5-1, 5-3, 5-4,6-1, 6-2,7-1,8-1, 8-2
Measurement...................................... 1-1,5-1
printer ...........................................1-2,2-2,5-3