Professional Documents
Culture Documents
00 | 1
Revision History
1. Description......................................................................................... 13
1.1. SPECIFICATIONS .............................................................................................................................. 13
1.2. FRONT VIEW ................................................................................................................................... 14
1.3. REAR VIEW ...................................................................................................................................... 14
1.4. INSTALLATION ................................................................................................................................. 15
1.4.1. OPERATING ENVIRONMENT............................................................................................................... 15
1.4.2. POWER REQUIREMENTS .................................................................................................................... 15
3. Operation .......................................................................................... 25
3.1. CHECK BEFORE POWER-ON ............................................................................................................ 25
3.2. POWER-ON ..................................................................................................................................... 25
3.3. CALIBRATING THE ASPIRATION VOLUME........................................................................................ 25
3.4. CHECKING FILTER ............................................................................................................................ 25
3.5. SETTING TEST PARAMETERS ........................................................................................................... 25
3.6. MEASURE ........................................................................................................................................ 25
3.7. EXIT TEST......................................................................................................................................... 26
3.8. WASH FLOW CELL ........................................................................................................................... 26
3.9. SELECT OTHER TESTS ...................................................................................................................... 26
3.10. PRINT TEST RESULTS ....................................................................................................................... 26
4. Maintenance ..................................................................................... 27
Appendices-TSB ......................................................................................... 31
APPENDIX 1: SAFETY SYMBOLS................................................................................................................ 31
APPENDIX 2: REAGENT AND CONSUMMABLES LIST ............................................................................... 33
APPENDIX 3: ABREVIATIONS .................................................................................................................... 35
SFRI Sarl owns all rights to this unpublished work and intends to maintain this work as confidential.
SFRI Sarl 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 SFRI Sarl equipment.
No part of this can be disseminated for other purposes.
In the event of inadvertent or deliberate publication, SFRI Sarl 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 SFRI Sarl to do so.
All information contained in this publication is believed to be correct. SFRI Sarl 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 SFRI
Sarl, nor the rights of others. SFRI Sarl does not assume any liability arising out of any infringements
of patents or other rights of third parties.
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 SFRI Sarl.
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, SFRI Sarl may provide, with compensation, necessary circuit diagrams, calibration
illustration list and other information to help qualified technician to maintain and repair some parts,
which SFRI Sarl may define as user serviceable.
Exemptions
SFRI Sarl'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
SFRI Sarl or repaired by anyone other than a SFRI Sarl authorized representative.
This warranty shall not extend to any instrument which has been subjected to misuse, negligence or
accident; any instrument from which SFRI Sarl's original serial number tag or product identification
markings have been altered or removed, or any product of any other manufacturer.
Warning
The BSA 3000 is an In Vitro Diagnostic instrument. It may indirectly bring risks to patients and
present a direct risk to operators and the environment during manipulation. To avoid these risks, be
sure to read the following instructions carefully.
This device uses AC 220V alternating courant. Do not open the rear cover before
switching off the power supply. If you need to open the rear cover of the device for
maintenance reasons, please contact our service personnel or professionals.
Patient samples are potentially contaminating agents. Manipulate with care using
appropriate protection equipment (glasses, gloves and laboratory coat) and be sure to
dispose of the waste in accordance with relevant regulations of your hospital.
Do not operate the device unless you have read this Operation Manual carefully
The BSA-3000 is a semi-automatic high precision and high reliability chemistry analyzer with an open
reagent system. The analyzer uses 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 pipe ting, 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.
1.1. Specifications
Measuring Method
End point, Kinetic, two point Kinetic, Fixed time, Calibration
Absorbance, Turbidimetry. Linear
Regent blank, Sample blank Non linear up to 6 points
Monochromatic and bichromatic method Factor
Reaction curve displayed
Memory Storage
Light Source 3000 results per day available in memory at any
Quartz halogen lamp 12 V/ 20 W time and transferable via LIS
Stray light: <1.0% at 340 nm
Lamp saving feature largely prolongs lamp life Thermostatic Control
By means of Peltier elements
Optics 25°, 30°, 37°C,
Filter wheel can hold up to 8 filters Precision: ± 0.1°C
7 standard filters: 340 nm, 405 nm, 492 nm, 510
nm, 546 nm, 578 nm, and 630 nm Input/Output
1 free position for extra filter RS232 port for mono-directional LIS
Bandwidth <8 nm
Anti-vibration and anti-disturbance optical Printout
system ensures highly accurate and reliable Built-in thermal printer, 57.5 mm wide paper,
results recording width 48 mm
Touch screen
Start
key
Sample probe
Power
Power Grounding
Peristaltic Fan Switch
RS232 Plug Pole
Pump
Note: Verify that the input voltage is compatible with the instrument and the proper type of fuse is
installed.
The main menu of the BSA-3000 includes eight sub-menus, as the figure below shows.
2.1. Analysis
2.1.1. SELECT TEST
The semi-automatic chemistry analyzer can conduct only one type of test at a time. The operation is:
touch ANALYSIS and then select the test to be conducted.
2.1.2. ANALYSIS
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:
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 (△ ) within the
measuring time.
Calculation of the kinetic method is based on ABS variation rate (△ min),
min × Factor
VT x 1000
Factor
VE x d x ε
TV: total reaction volume, SV: sample volume, d: optical path, ε: Moore constant.
2.2.2. PRINTERS
Select PRINTER to switch on or switch off the printer
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 and then the following menu will be displayed.
Test Name
1 ABC 2DEF
3 GHI 4JKL
5 MNO 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.
Warning
Changing the test name is prohibited if the result of this test is still present.
2.2.3.1.3. WAVELENGTH
Seven wavelengths (340nm, 405nm, 492nm, 510nm, 546nm, 578nm, 630nm) can be selected. For
glucose, the wavelength is 492nm.
The operation is: touch WAVELENGTH and select 492NM. Reselect WAVELENGTH 2 times a “2”
appears on the right of wavelength then:
If you want to work in Monochromatic mode select 492NM again
If you want to work in Bichromatic mode select the 2nd wavelength
2.2.3.1.4. 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.
2.2.3.1.10. 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.
2.2.3.1.11. 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.
2.2.3.1.13. 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 .
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
2.3.1. QC GRAPHICS
Established from QC data automatically.
2.3.2. SETTINGS
Set mean value and SD value.
2.3.4. PRINT
Touch PRINT to print out detailed QC information.
2.7. Transfer
Select TRANSFER to transmit the sample result data and QC data to PC. When the transmission is
done, the system will return to the previous menu.
2.8. Service
Select SERVICE the following screen is displaying:
3.2. Power-On
Turn on the power. After initialization, the system will enter the main menu automatically.
Warning
Proceed to the following operations only after 10~15 minutes warm-up.
3.6. Measure
The measuring procedure is explained as follows (take the glucose as the example):
From the main menu select ANALYSIS
Select the test. Click for example on 09GLU
Before measuring, check the parameters that are displayed on the top of the screen, and make sure
they are correct.
Then:
• Select 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.
Note: If the test parameter for “Reagent Blank” is “No”, RB will not be displayed.
• Select 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.
• Select 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.
• Select 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.
• If you want to change the sample ID press NEXT ID or ID XXX to change the sample ID.
Warning
Make sure the sample has the same ID for different tests.
• 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 2 ml. Select RINSE, press the Start key, and rinse the
flow cell with distilled water – detergent – distilled water.
Warning
Before shutdown, make sure to wash the flow cell thoroughly and fill it with distilled water.
2. 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.
5. Check the aspiration volume regularly. If necessary, replace the aged tube.
7. Handle and dispose of the waste according to acceptable laboratory, local state and national
standards.
Abnormal Display of A-C Improper value for standard 1. Wash flow cell with proper
Curve point and concentration. detergent.
2. Adjust the optical components to
correct position.
3. Replace the lamp.
4. Replace the filter.
Absorbance of the Filter 1. Bubbles in flow cell. 1. Wash flow cell with proper
Is too High 2. Deviated optical parts. detergent and keep bubbles away.
3. Aged lamp. 2. Replace the tube.
4. Damaged filter. 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.
Poor Repeatability of 1. Dirty flow cell subject to 1. Add standard of correct volume.
Test Results remaining bubbles. 2. Use qualified standard.
2. Tube blocked. 3. Correct the factor.
3. High carryover due to 4. Use qualified reagent.
inaccurate aspiration volume. 5. Correct the temperature setting.
4. Aged lamp. 6. Prepare sample and reagent as
5. Poor internal ventilation or instructed.
ambient temperature too high.
6. Polluted reagent.
Results are too High or 1. Inaccurate standard volume. 1. Replace peristaltic pump tube.
too Low 2. Poor standard.wrong factor. 2. Eliminate blockage.
3. Polluted reagent. 3. Check the tubing system, if
4. Wrong temperature setting necessary, change the aged tube.
for kinetic method. 4. Replace peristaltic pump motor.
5. Wrong sample-to-reagent 5. Contact the manufacturer.
ratio.