Biossays Series Operating Instructions-20180911 - Копия - Копия

Dear users:
Thanks for choosing our automatic biochemistry analyzer of Biossays™ series!
For safe and better use of this analyzer and to improve your work efficiency,
please read the Instructions thoroughly before start.
After reading the Instructions, keep it handy for quick reference in the future.
If you have any questions regarding your Automatic Biochemistry Analyzer,

please contact your local representative.
Shenzhen New Industries Biomedical

Engineering Co., Ltd.
No.16, Jinhui Road, Pingshan New District,
Shenzhen, 518122, P.R.China
Tel: 0086-755-21536601
Fax: 0086-755-28292740
Lotus Global Co., Ltd.

Tel : 0044-20-75868010
Fax: 0044-20-79006187
Address: 1 Four Seasons Terrace, West
Drayton, Middlesex London, UB7 9GG, United
Kingdom
Specification Catalog Number
BC1200 63000002
Biossays 240 Plus 63000040
Biossays 240 63000043
Intellectual Property Statement
Shenzhen New Industries Biomedical Engineering Co., Ltd. owns the intellectual
properties to these products and copyright of this instructions.
All rights reserved. Any part of this operating instructions cannot be copied, modified,
translated, by anyone or organization without permission.
, , , , and are
the registered trademarks or trademarks owned by Snibe in China and other
countries.
Information about the Product

Product Name: Automatic Biochemistry Analyzer
Model: BC1200, Biossays 240 Plus, Biossays 240
Intended Use: It is used in conjunction with adapter reagents for qualitative and/or
quantitative analysis of the analyte in a human sample.
Information of Operating Instructions

Version: 2.1
Applicable Scope of Software: BC1200 _1.13.3.23 and above
Biossays 240 Plus _1.17.17.1117 and above
Biossays 240_1.17.18.324 and above
Compile Date:06/2018
Issued Date: 09/2018
Table of Contents
Table of Contents
NOTICES ............................................................................................................................................. 1
CHAPTER 1 SYSTEM OVERVIEW ................................................................................................. 1-1
1.1 OVERVIEW................................................................................................................................1-1
1.2 INSTRUMENT SPECIFICATIONS .......................................................................................................1-1
1.3 SYSTEM STRUCTURE....................................................................................................................1-7
1.3.1 Appearance .......................................................................................................................1-7
1.3.1.1 Front view ............................................................................................................................... 1-7
1.3.1.2 Top View ............................................................................................................................... 1-10
1.3.2 System composition ........................................................................................................1-13
1.3.3 Composition of operating unit ........................................................................................1-15
1.4 INSTRUMENT SYMBOLS .............................................................................................................1-15
1.5 OTHER LABELS .........................................................................................................................1-25
CHAPTER 2 INSTRUMENT INSTALLATION ................................................................................... 2-1
2.1 STORAGE AND TRANSPORTATION REQUIREMENTS .............................................................................2-1

2.1.1 Size & weight ....................................................................................................................2-1
2.1.2 Storage requirements .......................................................................................................2-1
2.1.3 Transportation requirements ............................................................................................2-1
2.2 INSTALLATION REQUIREMENTS ......................................................................................................2-1
2.2.1 Space requirements ..........................................................................................................2-1
2.2.2 Environment requirements ...............................................................................................2-2
2.2.3 Power requirements ..........................................................................................................2-2
2.2.4 Water supply and drainage requirements ........................................................................2-3
2.3 POWER ON AND START SYSTEM .....................................................................................................2-3
2.3.1 Start instrument and operating software .........................................................................2-3
CHAPTER 3 WORKING PRINCIPLE............................................................................................... 3-1
3.1 TEST PRINCIPLE ..........................................................................................................................3-1

3.2 ANALYSIS METHODS....................................................................................................................3-2
3.2.1 1-point endpoint method ..................................................................................................3-2
3.2.2 2-point endpoint method ..................................................................................................3-2
3.2.3 2-point rate method..........................................................................................................3-3
3.2.4 Rate A method ..................................................................................................................3-5
3.3 CALIBRATION METHODS ..............................................................................................................3-6
3.3.1 K factor method ................................................................................................................3-6
3.3.2 1-point linear ....................................................................................................................3-7
3.3.3 2-point linear ....................................................................................................................3-7
3.3.4 Multi-point linear ..............................................................................................................3-8
3.3.5 Logistic-Log 4P ..................................................................................................................3-9
3.3.6 Logistic-Log 5P ................................................................................................................3-10
3.3.7 Exponential 5P ................................................................................................................3-10
3.3.8 Polynomial 5P .................................................................................................................3-11
Operating Instructions-EN I
Table of Contents
3.3.9 Parabola..........................................................................................................................3-11
3.3.10 Spline ..........................................................................................................................3-11
3.4 ISE TEST PRINCIPLES .................................................................................................................3-12
3.4.1 Operating principle .........................................................................................................3-12
3.4.2 Production principle of electrode potential ....................................................................3-12
3.4.3 Measurement methods...................................................................................................3-13
CHAPTER 4 ROUTINE OPERATION PROCESS ............................................................................... 4-1
4.1 OPERATION PROCESS ..................................................................................................................4-1

4.2 ANALYSIS PREPARATION ...............................................................................................................4-3
4.2.1 Inspection prior to startup ................................................................................................4-3
4.2.2 Power on and login software ............................................................................................4-4
4.2.3 Confirm instrument status ................................................................................................4-4
4.2.4 Confirm analysis conditions ..............................................................................................4-5
4.2.5 Prepare reagent ................................................................................................................4-6
4.3 TEST ANALYSIS ...........................................................................................................................4-8
4.3.1 Calibration order ...............................................................................................................4-8
4.3.2 QC order ............................................................................................................................4-9
4.3.3 Sample order.....................................................................................................................4-9
4.3.4 Start analysis ..................................................................................................................4-11
4.3.5 Additional sample testing ...............................................................................................4-12
4.3.6 Testing monitoring ..........................................................................................................4-14
4.4 RESULT DISPOSAL .....................................................................................................................4-14
4.4.1 Result confirm .................................................................................................................4-14
4.4.2 Rerun samples.................................................................................................................4-17
4.5 ANALYSIS COMPLETION .............................................................................................................4-18
4.5.1 Shutdown ........................................................................................................................4-18
4.5.2 Operations after shutdown .............................................................................................4-19
CHAPTER 5 SOFTWARE FUNCTION............................................................................................. 5-1
5.1 STATUS DISPLAY LIGHT .................................................................................................................5-1

5.2 SHORTCUT KEY AREA ...................................................................................................................5-2
5.3 [WORK LIST] INTERFACE ..............................................................................................................5-3
5.4 [RESULT] MENU .........................................................................................................................5-4
5.4.1 Recalculate results ............................................................................................................5-5
5.5 [REAGENT INFO] INTERFACE .........................................................................................................5-6
5.6 [CALIBRATION] MENU .................................................................................................................5-6
5.6.1 Calibration types ...............................................................................................................5-7
5.7 [QC] MENU ..............................................................................................................................5-8
5.7.1 Recalculate QC result ........................................................................................................5-8
5.8 [STATUS] MENU .........................................................................................................................5-9
5.9 [SETTING] MENU .....................................................................................................................5-11
5.9.1 Assay basic parameter ....................................................................................................5-13
5.9.2 Calibration parameter ....................................................................................................5-14
5.10 [SYSTEM MAINTENANCE] MENU .................................................................................................5-15
II Operating Instructions-EN
Table of Contents
CHAPTER 6 SYSTEM MAINTENANCE .......................................................................................... 6-1
6.1 PREPARATIONS BEFORE SYSTEM MAINTENANCE ................................................................................6-1

6.1.1 Tools ..................................................................................................................................6-2
6.1.2 Water ................................................................................................................................6-2
6.1.3 Wash liquid .......................................................................................................................6-2
6.2 DAILY MAINTENANCE ITEMS .........................................................................................................6-3
6.2.1 Check water device ...........................................................................................................6-3
6.2.2 Check waste liquid tank ....................................................................................................6-3
6.2.3 Check water connection ....................................................................................................6-4
6.2.4 Check light waste liquid connection ..................................................................................6-4
6.2.5 Check sample / reagent probe ..........................................................................................6-4
6.2.6 Check stirring needle.........................................................................................................6-5
6.2.7 Check washer ....................................................................................................................6-5
6.2.8 Check cuvette ....................................................................................................................6-5
6.3 WEEKLY MAINTENANCE ...............................................................................................................6-6
6.3.1 Clean sample / reagent probe ..........................................................................................6-6
6.3.2 Clean stirring needle .........................................................................................................6-6
6.3.3 Clean sample / reagent disk .............................................................................................6-6
6.3.4 Clean instrument panel .....................................................................................................6-6
6.4 MONTHLY MAINTENANCE ............................................................................................................6-7
6.4.1 Clean cleaning pool of sample / reagent probe ................................................................6-7
6.4.2 Clean cleaning pool of stirring needle...............................................................................6-7
6.4.3 Reaction tank and drainage filter screen ..........................................................................6-7
6.4.4 Water supply filter screen .................................................................................................6-8
6.5 SEMIANNUAL MAINTENANCE ........................................................................................................6-8
6.5.1 Clean cooling fan ..............................................................................................................6-8
6.6 UNSCHEDULED MAINTENANCE......................................................................................................6-8
6.6.1 Maintain sample / reagent probe .....................................................................................6-8
6.6.2 Replace sample / reagent probe .......................................................................................6-9
6.6.3 Replace stirring needle......................................................................................................6-9
6.6.4 Replace light source lamp ...............................................................................................6-10
6.6.5 Replace cuvette ...............................................................................................................6-11
6.6.6 Add alkaline wash liquid .................................................................................................6-12
6.6.7 Clean vacuum tank .........................................................................................................6-12
6.6.8 Water tank ......................................................................................................................6-13
6.7 ISE MODULE MAINTENANCE.......................................................................................................6-14
6.7.1 Components subject to regular cleaning, check and replacement .................................6-14
6.7.2 Daily maintenance ..........................................................................................................6-15
6.7.2.1 Protein removal .................................................................................................................... 6-15
6.7.2.2 Pipe wash .............................................................................................................................. 6-15
6.7.3 ISE check .........................................................................................................................6-15
6.7.4 Replace electrode............................................................................................................6-15
6.7.4.1 Occasion of electrode replacement ...................................................................................... 6-16
6.7.4.2 Methods of electrode replacement ...................................................................................... 6-16
Operating Instructions-EN III

Table of Contents
6.7.5 Replace ISE sampling rigid pipe ......................................................................................6-16

6.7.6 Replace reagent ..............................................................................................................6-17
CHAPTER 7 TROUBLESHOOTING ................................................................................................ 7-1
7.1 DATA EXCEPTION ........................................................................................................................7-1

7.2 INSTRUMENT FAULTS...................................................................................................................7-2
APPENDIX A BC1200 PERFORMANCE INDICATORS...................................................................... A-1
APPENDIX B BIOSSAYS 240 PLUS / BIOSSAYS 240 PERFORMANCE INDICATORS ...........................B-1
IV Operating Instructions-EN
Notices
Notices
This part involves important information and regulations concerning safety and
proper usage of the analyzer.
Please read the Instructions thoroughly before using the analyzer.
Operating Instructions-EN 1
Notices
Purpose
Biossays series automatic biochemistry analyzers and reagents are strictly limited to
use for the purpose of professional in vitro diagnosis. To ensure the reliability of results,
please use reagents and consumables manufactured by Shenzhen New Industries
Biomedical Engineering Co., Ltd. If non-snibe reagents need to be used, please contact
our after-sales staff.
The instructions provide operating instructions for the Biossays series automatic
biochemistry analyzer. The instructions will help you to understand the structure,
operations, routine maintenance, troubleshooting, etc. of the Biossays series automatic
biochemistry analyzer. Please operate in accordance with the Instructions.
Sign introduction
Signal
Sign Description
Word
Warning indicates a situation that, if not avoided, will result
Warning in personal injury, instrument damage, data error or
infection of diseases.
Attention indicates important information that you must
Attention
pay attention to.
Safety precautions
For safe use of this system, read the Instructions carefully before operating the
analyzer. Any operation violating the safety precautions may cause personal injury or
instrument damage.
This system complies with safety requirements on electronic medical instruments. It
shall be installed and operated by qualified personnel in strict accordance with laws and
regulations.
Warning:
1) If you fail to carry out necessary maintenance as per the Instructions,
it may cause instrument failure and health risk.
2) For sake of safety and reliability, the analyzer must be installed and
maintained only by maintenance engineer authorized or approved
by our company. All spare parts used for the analyzer must be
provided or approved by our company or our agent.
2 Operating Instructions-EN
Notices
1. Light and heat

Please comply with the following precautions to avoid personal injury caused by light
and heat of light source.
Warning:
1) During running of the analyzer, do not look directly at the light beam,
which will hurt your eyes.
2) To change light source, disconnect the main power supply of the
analyzer and wait at least for 15min until the light source cools down.
Do not touch the light source when it is still hot.
2. Moving parts
Please comply with the following precautions to prevent personal injury caused by
moving parts during running of the analyzer.
Warning:
1) NEVER touch moving parts, including sample / reagent disk, sample
/ reagent pipetting mechanism, reaction disk, stirring mechanism,
washer, etc. or get your hands or any body part into their motion
path.
2) Do not place any obstacle on the path of moving parts; or it will
cause personal injury or instrument damage.
3) Sample tubes with cap may collide with the pipetting probe, so
please make sure caps are removed from all tubes in the sample
disk.
3. Electrical hazards
In order to prevent electric shock, please comply with the following precautions.
Warning:
1) High voltage inside. Only authorized maintenance personnel can
open the rear and side covers.
2) If liquids like reagent or sample enter into the analyzer, it may cause
failure and electric shock. In such cases, switch off power
immediately and contact our technical service department.
3) To replace parts and components, disconnect power first and then
open rear and side covers.
4) Incorrect earthing may result in electric shock and instrument
damages.
5) Make sure the input voltage meets requirements of the analyzer.
6) Do not touch or carry out electrostatic discharge on parts labelled
with ESD warning sticker.
Notices
4. Fire
Using organic solution may cause fire. Please comply with the following precautions.
Warning:
1) Do not use organic solution in test.
2) The analyzer is not explosion-proof. If you have to use organic
solution nearby, take extreme care to avoid fire or explosion.
5. Preventing the laser burning caused by the barcode reader

Observe the following items to prevent the laser burning caused by the barcode
reader.
Warning:
The laser generated by the barcode reader will shoot the retina directly
and cause the eye injury. Do not stare at the laser beam of the barcode
reader directly.
6. Biochemical hazard
Please comply with the following precautions to prevent biochemical hazards
effectively.
Warning:
1) Improper use of sample may cause infection. Do not contact
samples, mixtures and waste liquids with your hands or other parts
of your body. Please wear gloves, masks and work clothes before
operation to prevent being infected. Wear protective glasses if
necessary.
2) Use reagent and wash liquid with care and avoid contact with them.
In case of skin contact, flush with soap and water promptly. If they
enter eyes by accident, rinse with plenty of water immediately and
visit an ophthalmologist.
3) If a bit of reagent or sample spills on the analyzer, wipe it off with
soft cloth damped with alcohol; if a large amount of reagent or
sample spills on the analyzer, stop using it and contact our
authorized engineer immediately.
4) The analyzer shall be thoroughly disinfected before transportation
for long distance in order to avoid potential spreading of infection.
Notices
7. Waste liquid disposal

In order to prevent environmental pollution and personal injury caused by waste liquid,
please follow the following precautions to dispose waste liquid.
Warning:
1) Some substances contained in reagent, QC liquid, calibration
solution, washing liquid and waste liquid are subject to regulations
on pollutants and their discharge. Please comply with all applicable
state and local regulations, and consult with the manufacturer or
distributor if you have any question.
2) Infectious waste fluid must be disposed properly in infectious waste
treatment facility.
8. Disposal at the end of life

When the analyzer reaches the end of service life, it shall be disposed of as per the
following requirements.
Warning:
As some materials used by the analyzer are subject to regulations on
pollution, the disposal shall comply with relevant laws and regulations.
9. Computer virus protection

Please comply with the following precautions to prevent computer virus.
Warning:
1) Do not do what you are not supposed to do on the computer, such
as clicking unknown popups, to prevent corrupting software system
due to factors like virus invasion or misoperation. Computer virus
may spread via USB disk, Internet, etc.
2) Do not install any software and hardware other than specified by our
company, so as to prevent hampering normal running of computer
software system. During system running, do not run other software.
Notices
■ Precautions for use

Please read the following precautions to use the analyzer correctly and effectively.
1. General precautions
Before using the analyzer, it is a good start to know its applications and general
precautions. Violation of the Instructions may defeat the protection integrated in the
analyzer’s design.
Attention:
1) This product is an in vitro diagnostic medical device, and is used in
conjunction with adapter reagents for qualitative and/or quantitative
analysis of the analyte in a human sample. When making the clinical
decision based on the analysis results, combine with considering the
clinical symptoms or other test results.
2) The Instructions may be revised without prior notice. You can
consult with our customer representative if you have any query.
3) The analyzer is intended for use only by trained professional users.
4) Do not touch computer’s display, mouse or keyboard with hands
stuck with chemicals.
5) Do not fold or press drainage pipes, which may cause blockage in
pipes and overflow of waste liquid from other openings.
6) During its running, the analyzer dissipates heat through its rear part.
Make sure the work environment is well ventilated. Use ventilation
equipment if necessary. but avoid airflow blowing on the analyzer
directly, or it may affect reliability of test results.
7) Before its first use, the analyzer must be calibrated to ensure
accurate performance.
8) No air bubbles can be present in samples, reagents and wash liquid.
Failure to do prevent air bubbles may result in incorrect sample
loading and the reliability of the test results cannot be guaranteed.
Do not move or exchange the reagents before the test is finished.
9) To ensure safe operation and stable test results, do not use expired
wash liquid.
10) Start the analyzer at least 30min before its usage to ensure that the
light source system and the reaction disk temperature is stable.
11) Before testing, check whether consumables (purified water, wash
liquid, etc.) are enough for the tests.
12) Before testing samples, quality control procedures must be
conducted to ensure reliable test results.
Notices
2. Service environment
Attention:
Please install this instrument in environment specified herein. Any
installation and usage beyond specified conditions may result in unreliable
results, or even damage to the instrument.
3. Electromagnetic compatibility
Attention:
1) BC1200,Biossays 240 Plus, Biossays 240 automatic biochemistry
analyzer complies with electromagnetic emission and immunity
requirements in IEC 61326-2-6-2012.
2) Users are responsible for ensuring the electromagnetic compatibility
environment that allows the analyzer to work properly.
3) It is suggested to assess electromagnetic environment before using
the analyzer.
Warning:
1) BC1200,Biossays 240 Plus, Biossays 240 automatic biochemistry
analyzer is designed and tested according to requirements for Class
A analyzer in IEC/CISPR 11:2010. This analyzer may cause radio
interference in household environment, and therefore protective
measures should be taken.
2) It is prohibited to use the analyzer next to a strong radiation source
(e.g. unshielded RF source) because it may interfere with normal
operation of the analyzer.
4. System maintenance
Attention:
1) Please maintain the instrument periodically as specified herein.
Improper maintenance may affect accuracy and precision of test
results, and even damage the instrument or hurt people.
2) Before maintenance, turn off power and pull off the power plug;
otherwise it may damage the instrument or hurt people.
3) Please wear gloves and work clothes before maintenance to prevent
possible infection caused by residue of patient samples on the
instrument.
Notices
4) Dust may gather on surface of the instrument after long-term

storage. To clean the instrument, use a damp soft cloth to wipe the
instrument surface. Prevent water from getting into the instrument.
5) There are no user-serviceable parts inside the instrument. Do not try
to open equipment enclosure or remove the parts. Please contact
our authorized technician if you need help.
6) After changing the light source on the instrument, wavelength
coefficient setting must be done.
5. Sample, reagent, calibration solution and QC liquid
Attention:
1) Medicines, anticoagulants, preservatives and other materials
contained in sample may cause interference to some test results.
2) Store samples properly. Improper storage of sample may lead to
changed sample composition or wrong test results.
3) To prevent evaporation, please do not expose sample to open air for
a long time; otherwise the test results will be inaccurate.
4) The samples with hemolysis, lipemia or jaundice will impact the
results.
5) You must ensure no clot is contained in samples, otherwise the
sample probe will be blocked, which significantly impacts the results.
6) If reagent, calibration solution and quality control liquid are stored
improperly, it may result in inaccurate test results and deteriorated
system performance even within validity period. Usage, storage and
other matters of reagent, calibration solution and quality control
liquid shall be subject to manufacturer’s instructions.
7) Always perform calibration assays after changing reagent; otherwise
the test results will be inaccurate.
8) During testing, reagent cross contamination may influence test
results. Please contact reagent manufacturer for reagent
contamination information.
6. Data backup
Attention:
During testing, this system saves data to hard disk drive automatically. To
prevent data loss due to accidental deletion or hard disk failure, backup
test results and instrument parameters to other media, like CD-ROM, on a
regular basis.
Chapter 1 System Overview
1.1 Overview
Biossays series automatic biochemistry analyzer (the Analyzer) is a discrete,

emergency priority instrument. It is intended to carry out common clinical chemistry tests,
such as liver function, renal function, blood glucose, blood fat, myocardial enzyme, ion
metabolism, etc., and ISE tests such as potassium, sodium, chloride, calcium and PH.
1.2 Instrument Specifications
Table 1.2-1 BC1200 Instrument Specifications
BC1200 Automatic Biochemistry Analyzer
Performance index Standard specifications
600 tests per hour at constant rate; up to 900

Measuring rate
tests per hour with ISE
Basic 88 biochemical assays and 4 ISE assays can be

Test assays
characteristic tested at the same time
s 1-point endpoint method, 2-point endpoint
Analytical method
method, 2-point rate method and rate A method
Quality control Lot quality control, monthly quality control
1 sample tray, 115 positions (50 for routine

Sample tray, sample sample, 20 for emergency treatment sample, 34
position for calibrator, 8 for control and 3 for cleaning
solution)
serum, plasma, urine, cerebrospinal fluid and

Sample category
Sample other body liquids
system
Supporting 5 barcode types (Code128, Code39,
Type of barcode
Code93, Codabar, and 2/5 Interleaved)
Sample volume 2.0~35.0μL
Sample liquid level

Integrated with the sample probe
sensor
Operating Instructions-EN 1-1

R1 and R2 reagent tray with refrigeration

Reagent tray, reagent function; each tray has 45 reagent positions
position (position 45 is for antibiotic phosphate-free
cleaning solution)
Supporting 5 barcode types (Code128, Code39,

Type of barcode
Code93, Codabar, and 2/5 Interleaved)
Reagent
system Reagent volume 20~350μL
Reagent bottle
20mL, 70mL
capacity
Reagent storage The reagent is kept at 5℃~ 15℃ and adopts

temperature semiconductor refrigeration
Reagent level sensor Integrated with the reagent probe
Reaction cell type Divided type
6 groups; 20 for each group, 120 cuvettes in

Cuvette numbers
total
Optical path of cuvette 6mm
Reaction solution
Reaction 150~450μL
volume
system
Reaction time 10 minutes, 22 minutes
Reaction temperature 37℃±0.3℃, fluctuation not greater than ±0.2°C
Stirring mode Solely stirring after reagent charging
Wash cuvette, reagent probe, sample probe and

Rinsing mode
stirring needle automatically
Light source 20W/12V long life tungsten halogen lamp
Wavelength accuracy ±2nm
Absorbance range 0~3.0ABS

Measuring
system Wavelength range Image flattening grating type rear optical splitting
system, simultaneous photometry, acquisition
and process of 16 wavelength. Wavelength: 340,
380, 405, 450, 480, 505, 546, 570, 600, 630、
660, 700, 720, 750, 780 and 800nm
Interface Standard RS-232

Data system
Printer Supporting various main printers
1-2 Operating Instructions-EN

Access to LIS/HIS
Allowed
system
Temperature 10℃~30℃
Relative humidity ≤70%

Operating
environment Atmospheric pressure 86kPa~106kPa
Kept away from strong electromagnetic field

Miscellaneous
interfering source
Temperature -20℃~55℃

Storage
environment Atmospheric pressure 50kPa~106kPa
Well-ventilated room without strong sun

Miscellaneous
exposure or corrosive gas
Safety Overvoltage category Category II

classification
Contamination Class 2
Weight 270kg
Overall size 1220 mm × 800 mm × 1150 mm (L × W × H)
External packing size 1340 mm × 1000 mm × 1430 mm (L × W × H)

Complete
unit Power supply AC 100-240V, 50/60Hz
Power (VA) 1400VA
12L/h (for single reagent only) to 16L/h (for

Water consumption
double reagent only)

Table 1.2-2 Biossays 240 Plus / Biossays 240 Instrument Specifications
Biossays 240 Plus / Biossays 240 Automatic Biochemistry Analyzer
Performance Indicators Standard Specifications
Biossays 240 Plus biochemical module: up to 240

tests/hour;
Throughput Biossays 240 biochemical module: up to 80 tests/20
minutes;
ISE module: up to 200 tests/hour.
Basic
Assay types 88 reagent positions and 5 types of ISE assays
characteristic
1-point endpoint method, 2-point endpoint method,
Analysis methods
2-point rate method and rate A method
Quality control Lot QC, monthly QC
1 sample & reagent disk with refrigeration function,

Sample & reagent consisting of outer, middle and inner rings; the
disk middle ring can be configured as sample or reagent
positions.
Outer ring: 45 positions, which can be used to place

routine samples, STAT samples, calibration solution
and QC liquids, of which W1 and W2 are wash liquid
positions;
Middle ring: 45 positions. When sample tube adapter
is installed, routine samples, STAT samples,
Sample and
calibration solution and QC liquid can be placed;
reagent positions
when sample tube adapter is removed, it can be
Sample & combined with the inner ring for placing 50mL
reagent reagent bottles or 10mL+30mL combined reagent
system bottles.
No. 90 position is fixed for placing hitergent wash
liquid.
Body fluids like serum, plasma, urine, cerebrospinal

Sample types
fluid, etc.
Code128, Code39, Code93, Codabar and 2/5
Barcode type
Interleaved
2.0μL~35.0μL for biochemical assays, and 90.0μL
Sample volume
for ISE assays
Reagent volume 20μL~350μL
Reagent bottle
10mL, 30mL, 50mL
capacity

Reagent storage
2°C~10°C, with semiconductor refrigeration
temperature
Sample & reagent
Liquid level detection, clot detection, anti-collision
probe
Cuvette material Optical plastics
Totally 80 cuvettes divided into 8 groups, 10

Cuvettes loaded
cuvettes/group
Optical path of
5mm
cuvette
Reaction liquid
100μL~380μL
volume
Reaction Reaction time 12min, 32min
system Reaction
37°C±0.2°C, fluctuation not greater than ±0.1°C
temperature
Stirring method Stir separately after adding sample, reagent
Wash cuvette, sample & reagent

Biossays 240
probe and stirring needle
Plus
Washing method automatically
Wash sample & reagent probe and
Biossays 240
stirring needle automatically
20W/12V halogen tungsten lamp, with long service
Light source
life
Wavelength error ±2nm
Absorbance range 0 ABS~3.5ABS

Measurement
system Flat field grating-based spectral system,
simultaneously measuring at 16 wavelengths:
Wavelength range 340nm,380nm,405nm,450nm, 480nm, 505nm,
546nm, 570 nm, 600nm, 630nm, 660nm, 700nm,
720nm, 750nm, 780nm and 800nm
Port Ethernet port

External
Printer Support mainstream printers
interface
LIS system Support LIS system
Temperature 10°C~30°C
Working Relative humidity ≤70%
environment
Atmospheric
86.0kPa~106.0kPa
pressure

Keep far away from interference of strong

Others
electromagnetic field
Temperature -20°C~55°C
Storage Atmospheric
50.0kPa~106.0kPa
environment pressure
Well-ventilated indoor space without strong sunlight
Others
or corrosive gases.
Safety Overvoltage class Class II

classification
Pollution grade Grade 2
Biossays 240
68kg
Weight Plus
Biossays 240 66kg
Overall size
730mm*500mm*620mm
L(L-R)*W(F-B)*H
Out packing size
910mm*615mm*860mm
Complete L(L-R)*W(F-B)*H
instrument Power AC 100-240V,50/60Hz
Power consumption
600VA
(VA)
Biossays 240 2L/h (for single reagent) - 3L/h (for
Plus dual reagent)
Water consumption
1.5L/h (for single reagent) - 2.5L/h
Biossays 240
(for dual reagent)

1.3 System structure
1.3.1 Appearance
1.3.1.1 Front view
 BC1200
(1) (2)
(3) (4) (5) (6) (7)

(1) Roof cover (2) Glass (3) Manufacturer logo
(4) Front left door (5) Front right door (6) Barcode scanning zone
(7) Model mark
Fig. 1.3-1 BC1200 Front View

 Biossays 240 Plus
⑴ ⑵
⑶ ⑷ ⑸
(4) Alarm light (5) Model mark
Fig. 1.3-2 Biossays 240 Plus Front View

 Biossays 240
⑴ ⑵
⑶ ⑷ ⑸
(4) Alarm light (5) Model mark
Fig. 1.3-3 Biossays 240 Front View

1.3.1.2 Top View
 BC1200
(1) (2) (3) (4) (5) (6)
(7) (8) (9)(10) (11) (12)

(1) R1 reagent disk (2) R1 reagent pipetting mechanism
(3) R1 stirring mechanism (4) Reaction disk
(5) Washer (6) Sample pipetting mechanism
(7) Submain switch (8) R2 reagent disk
(9) R2 stirring mechanism (10) R2 reagent pipetting mechanism
(11) Sample disk inner ring refrigeration cover (12) Sample disk
Fig. 1.3-4 BC1200 Top View

⑴ ⑵ ⑶ ⑷ ⑸ ⑹
(1) Stirring mechanism (2) ISE module (optional)

(3) Reaction disk (4) Washer
(5) Sample & reagent pipetting mechanism (6) Sample & reagent disk
Fig. 1.3-5 Biossays 240 Plus Top View

 Biossays 240
⑴ ⑵ ⑶ ⑷ ⑸
(1) Stirring mechanism (2) ISE module (optional)

(3) Reaction disk (4) Sample & reagent pipetting mechanism
(5) Sample & reagent disk
Fig. 1.3-6 Biossays 240 Top View

1.3.2 System composition
 BC1200
Fig. 1.3-7 BC1200 System Composition

Stirring Sample & reagent

ISE Sample &
mechanism pipetting
reagent disk
mechanism
log
conversion
A/D
Interface
conversion
Microcomputer
Reaction Optical
Washer
disk system
Fig. 1.3-8 Biossays 240 Plus System Composition

 Biossays 240
Stirring Sample & reagent

ISE Sample &
mechanism pipetting
reagent disk
mechanism
log
conversion
A/D
Interface
conversion
Microcomputer
Reaction Optical
disk system
Fig. 1.3-9 Biossays 240 System Composition
1.3.3 Composition of operating unit
The operating unit of Biossays series automatic biochemistry analyzer includes a

computer and software installed on the computer. It controls the running, operation and
data processing of the analyzer. The computer includes computer case, monitor, keyboard
and mouse etc.
1.4 Instrument symbols
 BC1200
“Protective Earthing”
This symbol indicates protective earthing label.
It is located on grounding screw holes of the equipment cabinet baseplate, close to the AC
power input port.

"S"
This symbol indicates sample disk.
It is labeled at the bottom center of sample disk.
"R1"
This symbol indicates R1 reagent disk.
It is labeled above the "Make the Plate Cover be Closed When the Analyzer is Working"
label, and align the left side of the label.
"R2"
This symbol indicates R2 reagent disk.
It is labeled at the bottom left of R2 reagent disk, and align with the top of the "Make the
Plate Cover be Closed When the Analyzer is Working" label.
"Indicator of the Rotating Sample Plate"

This symbol indicates the indicator of the rotating sample plate.
It is labeled at the bottom center of the indicator of the rotating sample plate.

"Light Waste Liquid Outlet"

This symbol indicates the light waste liquid outlet.
It is labeled above the light waste liquid outlet.
"Concentrated Waste Liquid Outlet"

This symbol indicates the concentrated waste liquid outlet.
It is labeled to the right of the concentrated waste liquid outlet.
"Sensor Interface of Detecting the Level of Waste Liquid "

This symbol indicates the sensor interface of detecting the level of waste liquid.
It is labeled to the right of the sensor interface of detecting the level of waste liquid.
"Waste Liquid Outlet of Vacuum Tank"

This symbol indicates the waste liquid outlet of vacuum tank.
It is labeled above the waste liquid outlet of vacuum tank.
"Purified Water Inlet"

This symbol indicates the purified water inlet.
It is labeled above the purified water inlet.

"Breaker"
This symbol indicates the type of breaker: ~220V 20A.
It is labeled above the main switch.
"Main Switch"
This symbol indicates the main switch of the instrument.
It is labeled at the bottom center of the main switch.
"Submain Switch"
This symbol indicates the submain switch of the instrument.
It is labeled at the bottom center of the submain switch.
"RS 232"
This symbol indicates the RS 232 port.
It is labeled above the RS 232 port.
"Make the Plate Cover be Closed When the Analyzer is Working"

This symbol and words remind users to make the plate cover of the reagent disk be
closed when the analyzer is working. It is labeled on :
The bottom left of R1 reagent disk.
The bottom right of R2 reagent disk.

"Do not Open the Cover When the Analyzer is Working"

This symbol and words remind users not to open the cover when the analyzer is working.
It is labeled above the handle on the cover.
“Warning Infection!”
This symbol reminds users of biological infection risk.
It is labeled at areas with biological infection risk, including:
Above the "Light Waste Liquid Outlet" label;
Bottom of "Concentrated Waste Liquid Outlet" label;
Bottom right of "Waste Liquid Outlet of Vacuum Tank" label;
Bottom right of sample disk.
"Do not Switch Off the Main Power When the Reagent is Refrigerated"
This symbol and words remind users not to switch off the main power when the reagent is
refrigerated.
It is labeled at the bottom center of the "Main Switch" label.

“Caution”
This symbol indicates cautions on user’s safety.
It is labeled at bottom right of R1 reagent disk.
“Do not Actuate during Operation”

This symbol and signal words indicate warning on moving parts and reminds users not to
touch running parts.
It is located on moving parts of the instrument, including:
The bottom left of R1 reagent arm;
The bottom center of R2 reagent arm;
The bottom left of sample arm;
“Warning on Opening Shell”

This symbol and words warns users not to open the instrument enclosure to prevent
electric shock. For any services, please contact our company or the authorized
professional personnel.
It is labeled on the upper right corner of the rear shell.

 Biossays 240 Plus / Biossays 240
“Protective Earthing”
This symbol indicates protective earthing label.
It is located on the bottom plate between the switching power supply and the filter.
“Interface & Switch”

This symbol indicates submain switch, main switch, network interface and USB interface.
It is located above submain switch, main switch, network interface and USB interface.
“Main Switch Fuse”

This symbol indicates main switch fuse, telling users the model of main switch fuse.
It is located where the fuse of the filter gets replaced.
“Sample & Reagent Disk”

This symbol indicates sample & reagent disk.
It is labeled at the left bottom of sample & reagent disk.
“Lamp”
This symbol indicates light source lamp and that here is the position for installation of light
source lamp.
It is located right above the heat sink of lamp.

“Light Waste Liquid”

This symbol indicates light waste liquid.
It is located on the light waste liquid tank.
“Purified Water”
This symbol indicates purified water.
It is located on the purified water tank.
“Light Wash Liquid”

This symbol indicates light wash liquid.
It is located on the light wash liquid tank.
“Concentrated Waste Liquid”

This symbol indicates concentrated waste liquid.
It is located on the concentrated waste liquid tank.
“Sensor”
This symbol and signal words indicate interfaces of various sensors.
It is located above sensor interfaces on the left of instrument enclosure.

“Liquid”
This symbol and signal words indicate liquid inlets for various liquid circuits.
It is located below liquid interface on the left of instrument enclosure.
"ISE Scanning Area"

This symbol and signal words indicate the RFID scanning area of the ISE module.
It is located on the ISE RFID scanning area on the left side of the instrument.
“Circuit Breaker”
This symbol and signal words indicate circuit breaker and remind users not to switch off
the main power when the reagent is refrigerated.
It is located above the main switch.
“Do not Actuate during Operation”

This symbol and signal words indicate warning on moving parts and reminds users not to
touch running parts.
It is located on moving parts of the instrument, including:
Shell of sample & reagent arm;
Shell of stirring arm.

“Caution”
This symbol indicates cautions on user’s safety.
It is labeled at Middle of cross beam on upper cover.
“Do not Open the Cover when the Analyzer is Working”

This symbol and words remind users not to open the cover when the analyzer is working.
It is labeled in the front of the cover.
“Please Make the Cover be Locked When the Analyzer Working”

This symbol and words remind users to lock the cover when the analyzer is working.
It is labeled to the right of the cover lock.
“Please Make the Plate Cover be Closed when the Analyzer is Working”
This symbol and words remind users to make the plate cover be closed when the analyzer
is working.
It is labeled at the following positions:
Lower right of sample & reagent disk;
Upper left of reaction disk.

“Warning on Opening Shell”

This symbol and words warns users not to open the instrument enclosure to prevent
electric shock. For any services, please contact our company or the authorized
professional personnel.
It is labeled on the upper right corner of the rear shell.
“Warning Infection!”
This symbol reminds users of biological infection risk.
It is labeled at areas with biological infection risk, including:
On the panel near the sample & reagent probe wash trough;
On the panel near the stirring needle wash trough;
Above waste liquid outlets.
1.5 Other labels
Label Description
Manufacturer
Product reference No.
In-vitro diagnostic medical device
Serial No.
Caution: Refer to attached documents

The definition of WEEE symbol below only applies to EU member states. The use of
WEEE symbol on a device indicates the device should not be disposed of as domestic
waste. Ensuring proper scrapping of the device helps avoid potential influence of
hazardous substances on environment and human health. For more information, please
contact your local distributor.
THIS WAY UP
This symbol indicates correct upright position of the transport package.
It is labeled at the upper center of 4 sides of the packing box.
KEEP AWAY FROM RAIN

This symbol indicates the transport package shall be kept away from rain.
FRAGILE
This symbol indicates contents of the transport package are fragile therefore it shall be
handled with care.

DO NOT ROLL
This symbol indicates the transport package shall not be rolled.
DO NOT STACK
This symbol indicates stacking of the transport package is not allowed and no load should
be placed on the transport package.


Chapter 2 Instrument Installation
2.1 Storage and transportation requirements
2.1.1 Size & weight
Table 2.1-1 Size & Weight
Model Weight Overall size (L*W*H) Outer packing size (L*W*H)
BC1200 270Kg 1220 mm*800mm*1150mm 1340mm*1000mm*1430mm

Biossays 240
68kg
Plus
730mm*500mm*620mm 910mm*615mm*860mm
Biossays 240 66kg
2.1.2 Storage requirements
Packaged analyzer shall be stored at a well-ventilated place without direct sunlight

and corrosive gases, and at temperature of -20°C~55°C, relative humidity no more than
93%, atmospheric pressure of 50.0kPa~106.0kPa.
2.1.3 Transportation requirements
Packaged analyzer shall be transported as specified in the purchase order.

 The instrument shall be up right and shall not be tilted or on its side.
 The instrument shall be protected from physical impact, rain and direct sunlight.
2.2 Installation requirements
2.2.1 Space requirements
To ensure necessary space for operation, maintenance and service, installation of

this analyzer shall meet the following requirements:
 Distance from wall to right and left sides of the analyzer shall not be less than 50cm;
 Distance from wall to back of the analyzer shall not be less than 50cm;
 Distance from front of the analyzer to other instruments shall not be less than 100cm;
 Space for installation of waste fluid drainage devices and water supply devices shall
be reserved.

2.2.2 Environment requirements
 Temperature of working environment: 10°C~30°C;

 Relative humidity: ≤70%;
 Atmospheric pressure: 86.0kPa~106.0kPa;
 The environment shall be draughty without dust, mechanical vibration, loud noise and
power interference;
 Keep away from brush-type motor, flickering fluorescent lamp and electrical contact
type equipment that are frequently switched off and on;
 Avoid direct sunlight or direct influence of heat and wind sources;
 During normal working, the loudest noise 1m away from the instrument shall be lower
than 60dB.
 The mounting surface shall be flat and bear weight of at least:
BC1200 270kg
Biossays 240 Plus
100kg
Biossays 240
2.2.3 Power requirements
 Applicable power supply: AC 100-240V,50/60Hz;

 Rated power:
BC1200 1400VA
Biossays 240 Plus
600VA
Biossays 240
 Circuit breaker type:

BC1200 UL certified-250V-20A-slow break type
Biossays 240 Plus
UL certified-250V-6A-slow break type
Biossays 240
 This instrument shall be powered by a well-earthed socket to ensure reliable work.

The socket shall be easily accessible. Do no put the analyzer at such a place where
you cannot unplug the power cable easily.
Warning:
Failure to meet above requirements may affect the instrument’s
performance or damage it, or even cause personal injury.

2.2.4 Water supply and drainage requirements
To ensure normal working of the analyzer, water supply and drainage shall meet the
following requirements:
 Water used by this analyzer shall be provided with professional pure water
manufacturing machine;
 Electrical conductivity of purified water shall be ≤1μs/cm;
 Water supply shall purify water for at least:
BC1200 25L/h
Biossays 240 Plus
5L/h
Biossays 240
 Temperature of supplied water shall be 5°C~32°C;

 Waste liquids produced during instrument running include concentrated/light waste
liquids. The former refer to mixture of sample and reagent, and liquid mixture used to
wash cuvettes, while the latter one refer to all waste liquids other than concentrated
waste liquid.
 Concentrated waste liquid shall be delivered to waste liquid tank through special
pipeline.
Warning:
Waste liquid shall be discharged according to relevant local provisions
on disposal of medical waste.
2.3 Power on and start system
After installation, ensure that power lines and communication lines have been
properly connected to the instrument and computer. Meanwhile, ensure all the pipes such
as pure water inlet pipe, concentrated waste liquid outlet pipe, light waste liquid outlet pipe
as well as wash liquid inlet pipe connecting correctly to the instrument without looseness.
Then power-on and start the system.
2.3.1 Start instrument and operating software
1. Power on the analyzer. Turn on its main and submain power switches.
2. Power on the computer.
3. After logging into the Windows operating system, double click the shortcut icon of the
user software to start it. After start, enter the username and password in the pop-up
login dialog to log into the user software system.

Fig. 2.3-1 Login Interface
Attention:
The system administrator’s username and initial password both are
“snibe”.
4. Upon successful connection between software and instrument, the system will be
initialized automatically, and all parts will finish initialization.
5. When the initialization is completed, and there are no warnings or error messages,
confirm the status of the instrument. For related operations and requirements, see
4.2.3 Confirm instrument status.

Chapter 3 Working Principle
The system is comprised of software and instrument. The former processes data
input and output as well as controls operation of the instrument, while the latter completes
all test actions.
This chapter involves test principle, analysis methods and calibration methods,
detailed as below.
3.1 Test principle
Biochemistry analyzer works on the basis of selective absorption of light by solutions,

i.e. Lambert-Beer Law. For colored matters, the color of its solution is related to its
concentration. The higher the concentration, the deeper the color will be. Concentration of
a solution can be measured by comparing its color depth via optics.
As Lambert-Beer Law suggests: the absorbance of a solution is the product of
absorptivity  , concentration C and optical path length L(cm). When L is constant,
concentration is proportional to absorbance.
Biochemistry analyzer realizes quantitative measurement by using absorption
spectrometry on the basis of this formula:
I 
R  lg 0   CL
 It 
Where: R is the light absorbance rate of a solution when light passes through the
solution; I 0 is the incident intensity; I t is the transmitted intensity;  is the absorptivity.

There are two representing methods: Molar absorptivity and specific absorptivity. Molar
absorptivity means absorbance of 1 mol/L solution when the optical path length is 1cm,
specific absorptivity means absorbance of 1% (w/v) solution when the optical path length
is 1cm. C is concentration of solution; L is thickness (cm) of absorption cell (i.e. optical
path length).
Thickness (L) of absorption cell (i.e. optical path length) and thickness of cuvette are
fixed and known. Absorptivity (  ) is a coefficient related to wavelength, solution
composition and temperature. When solution temperature is stable, absorptivity is a fixed
value (reagent manufacturer will specify value of  directly on reagent box). Thus, in
conditions of stable solution temperature and single wavelength, solution concentration
has a linear relation with its absorbance.
If the sample to be measured is a homogeneous solution, it reacts with incident
monochromatic light only during absorption process without fluorescence, scattering and
photochemical phenomena and various matters it contains have no interaction during
such process; the absorbed light is parallel rays of monochromatic light. Therefore, test
conditions of the instrument completely comply with Lambert-Beer Law.

3.2 Analysis methods
This system is equipped with multiple analysis methods for more reasonable tests on
various biochemical reactions, mainly including 1-point endpoint method, 2-point endpoint
method, rate A method, and 2-point rate method.
3.2.1 1-point endpoint method
1-point endpoint method is to measure absorbance at 1 point after adding sample

and reagent under certain temperature and waiting until reaction equilibrium after a period
of time. The reaction curve is shown as the figure below.
R R2
S+R1
RX
Time (s)
Fig. 3.2-1 1-Point Endpoint Method
Calculation of absorbance: take average absorbance of points L and L-1 as per

equation below:
RL  RL 1
RX 
2
Where, RX is the average absorbance of points L and L-1.
For assays with dual wavelengths, the actual absorbance during every measurement
cycle equals to the difference between absorbance at the primary wavelength and the
secondary wavelength.
3.2.2 2-point endpoint method
Select the first point before reaction, select the second point when reaction ends or
equilibrates, and then calculate sample concentration with difference between
absorbance of the two points. Under certain conditions, this method can reduce sample’s
disturbance to the reaction or the reaction’s color disturbance. The reaction curve is
shown as Fig. 3.2-2.

R2
R
S+R1
(RM+RM-1)/2
(RL+RL-1)/2
Time (s)
Fig. 3.2-2 2-Point Endpoint Method
Calculation of absorbance: Absorbance is calculated by subtracting average

absorbance of points L and L-1 from average absorbance of points M and M-1 as per the
following equation:
RM  RM 1 R  RL 1
RX  k L
2 2
Equation to calculate volume calibration coefficient k:
S  VR1
k
S  VR1  VR 2
Where, RX is the difference obtained by subtracting average absorbance of points L
and L-1 from average absorbance of points M and M-1, i.e. absorbance; k is volume
calibration coefficient; S is sample volume; VR1 is the volume of reagent R1; VR 2 is

the volume of reagent R2.
3.2.3 2-point rate method
2-point rate is also called first-order kinetics or fixed-time method, which means
reaction velocity is proportional to first power of substrate concentration within a certain
period of reaction. As the substrate is consumed gradually, the reaction goes slower and
increase (or reduction) of absorbance becomes smaller and smaller. As it takes a long
time to reach reaction equilibrium, theoretically, measuring can be done at any time.
However, due to the complex components of serum, reaction will become stable only after
some time of complicated and heterogeneous reactions. For any kind of first order
reaction, substrate concentration S at any given time t after reaction starts is:
S  S 0  e  kt

Where, S 0 is the initial concentration of substrate, e is the Napierian base, k is
velocity constant. The correlation between S , the change in substrate concentration,

and S 0 within fixed interval t1 ~ t 2 is:

S  S 0  e kt2  e kt1 
That is, at a given interval, it is common in first order reaction that change in substrate
concentration is proportional to initial concentration of substrate and so is the increase (or
reduction) of absorbance to concentration of measured substance.
2-point rate is stricter than endpoint method. All factors (e.g. pH, temperature,
enzyme concentration, etc.) affecting reaction velocity must be constant and accurate at 2
points and be calibrated with calibration solution at the same time. The reaction curve is
shown as Fig. 3.2-3 below.
R2
R
(RM+RM-1)/2
S+R1
(RL+RL-1)/2
t
Time (s)
Fig. 3.2-3 2-Point Rate Method
Calculation of absorbance: divide the difference of subtracting average absorbance

of points L and L-1 from average absorbance of points of M and M-1 by time, as per the
following equation:
RM  RM 1 RL  RL 1

RX  2 2
t
Where, RX is absorbance calculated by dividing the difference of subtracting

average absorbance of points L and L-1 from average absorbance of points M and M-1 by
time t , which is the time interval between L and M .

3.2.4 Rate A method
Rate A is also called kinetic method or zero-order kinetics, which means reaction
velocity is proportional to zero power of substrate concentration, that is to say reaction
velocity is independent of concentration of the substrate. This is a method for quantitative
analysis based on measured production velocity of reaction product or consumption
velocity of substrate during continuous monitoring of reaction process. In the whole
reaction process, reactant can produce certain product at constant velocity which leads to
uniform reduction or increase in absorbance of the measured solution under a certain
wavelength. The velocity of such reduction or increase ( R ) is proportional to activity

min
or concentration of the measured substance. Rate A method is mainly used for
measurement of enzyme activity. Concentration can be obtained based on changes in
absorbance between specified points.
As concentration of substrate is not high enough, the reaction will be no more at zero
order after substrate is consumed to a certain degree. Thus, zero-order kinetics is only
applicable within certain period of time. Moreover, due to the complex components of
serum, reaction will become stable only after some time of complicated and
heterogeneous reactions. Reaction curve is shown as Fig. 3.2-4 below.
R R2
RM
S+R1
RL
t
Time (s)
Fig. 3.2-4 Rate A Method
Calculation of absorbance: work out rate of change per minute in absorbance

between points L and M with least square method, the equation is:
R X  R
T
Where, RX is the rate of change per minute in absorbance between points L and M
measured with least square method.

3.3 Calibration methods
Calibration is used to transform measured changes of reaction solution’s absorbance

into standard curve of concentration and activity.
In this system, calibration methods fall into two categories: linear calibration and
none-linear calibration. The former contains K factor method, 1-point linear, 2-point linear
and multi-point linear, mainly applicable to assays measured with colorimetry; the latter
contains Logistic-Log 4P, Logistic-Log 5P, Exponential 5P, Polynomial 5P, Parabola and
Spline, mainly applicable to assays measured with turbidimetry.
3.3.1 K factor method
Calibration equation: C  K ( R  R0 )
There are 2 parameters, i.e. K and R0 , where, K is the user-defined K factor,
C1
R0  0 or R0  R1  .
K
It is required to provide 0 or 1 calibration solution, C1 is the concentration of
calibration solution 1, R1 is the absorbance of calibration solution 1. If the number of
calibration solution is 0, R0  0 .
Calibration curve is shown as the figure below.
吸
光
度
RX
R1
C1 CX 浓度
Fig. 3.3-1 K Factor Method

3.3.2 1-point linear
Calibration equation: R  aC
R
There is only one parameter a , a  .
C
It is required to provide 1 calibration solution. C is the concentration of calibration
solution, R is the absorbance of calibration solution.
Calibration curve is shown as Fig. 3.3-2.

Absorbance
RX
C CX Concentration
Fig. 3.3-2 1-Point Linear
3.3.3 2-point linear
Calibration equation: R  aC  b
R2  R1 R2  R1
There are 2 parameters, i.e. a and b , where a  , b  R1   C1 .
C2  C1 C 2  C1
It is required to provide 2 calibration solutions. C1 and C2 are concentrations of
solution 1 and solution 2, R1 and R2 are absorbance of solution 1 and solution 2.
Calibration curve is shown as Fig. 3.3-3.

Absorbance
R2
RX
R1
C1 CX C2 Concentration
Fig. 3.3-3 2-Point Linear
3.3.4 Multi-point linear
Calibration equation: R  aC  b
There are 2 parameters a and b , which can be obtained by linear least square
method in following equation:
n
 n  n 
 C R
i i    i   Ri  n
C
 i 1  i 1 
a  i 1 2
n
 n 

i 1
Ci    Ci  n
2
 i 1 
 n  n  n  
 n 
  Ci R i  

 C i 



 Ri  n n
   C  n
b    Ri  n  

i 1 i 1 i 1
 i 1   n
 n

2 i

 Ci    Ci  n
i 1
 2

 i 1  i 1  
It is required to provide n ( n  3 ) calibration solutions. Ci and Ri are
concentration and absorbance of calibration solution

i , shown as Fig. 3.3-4.

Absorbance
R3
RX
R2
R1
C1 C2 CX C3 Concentration
Fig. 3.3-4 Multi-Point Linear
3.3.5 Logistic-Log 4P
1
Calibration equation: R  R0  K
1  exp[ (a  b ln C )]
There are 4 parameters, i.e. R0 , K , a and b.
It is required to provide at least 4 calibration solutions. Concentration (activity) of the
first calibration solution is zero, the corresponding R shall equal to R0 . This is
applicable to calibration curve where absorbance increment is smaller when concentration

becomes larger, as shown in figure below.
C1 C2 C3 C4 Concentration
Fig. 3.3-5 Logistic-Log 4P

3.3.6 Logistic-Log 5P
1
Calibration equation: R  R0  K
1  exp[ (a  b ln C  cC )]
There are 5 parameters, i.e. R0 , K, a, b and c.

applicable to calibration curve where absorbance increment is smaller when concentration

becomes larger. Compared with Logistic-Log 4P, this curve has higher fitting degree,
shown as the figure below.
C1 C2 C3 C4 C5 Concentration
Fig. 3.3-6 Logistic-Log 5P
3.3.7 Exponential 5P
Calibration equation: R  R0  K exp[ a ln C  b(ln C ) 2  c(ln C ) 3 ]
There are 5 parameters, i.e. R0 , K, a, b and c .

applicable to calibration curve where absorbance increment is larger after concentration

reaches a certain degree, shown as Fig. 3.3-7.

C1 C2 C3 C4 C5 Concentration
Fig. 3.3-7 Exponential 5P
3.3.8 Polynomial 5P
R  R0 R  R0 2 R  R0 3
Calibration equation: ln C  a  b( )  c( )  d( )
100 100 100
There are 5 parameters, i.e. R0 , a , b , c and d .
first calibration solution is zero, the corresponding R shall equal to R0 .
3.3.9 Parabola
Calibration equation: R  aC 2  bC  c
There are 3 parameters, i.e. a , b and c .
It is required to provide at least 3 calibration solutions and solve liner equation in 3
dimensions with least-square calculation method of polynominal.
3.3.10 Spline
R  R0i  ai C  Ci   bi C  Ci   ci C  Ci 
2 3
Calibration equation:
R0i ai bi c
There are 4 parameters, i.e. , , and i .
It is required to provide 2-6 calibration solutions. As it is piecewise fitting, the degree
of fitting is highest among all calibration types.

3.4 ISE test principles
3.4.1 Operating principle
When starting analysis, the instrument puts A Std. into sampling cup with A pump and
moves A Std. to electrode pipes with sample pump to measure relative potentials
comparing with potential of reference electrode. After completion of measurement, take A
Std. away with sample pump and make sampling cup and electrode pipe empty. After
measure potential of calibration solution A, move B Std. into sampling cup with B pump
and pump B Std. again into electrode pipe with sample pump to measure its potential and
compare with potential of reference electrode. Upon completion of measurement, bring
wash liquid for A Std. with A pump and remove the liquid away with sample pump. When
sample probe takes sample and fills it into sampling cup, pump sample into electrode pipe
with sample pump to measure its potential. After measurement, bring wash liquid for A Std.
with A pump, remove the liquid away with sample pump and empty sampling cup and
electrode pipe.
3.4.2 Production principle of electrode potential
Electrode potential is obtained by Nernst equation:
E x  E0  ( RT / nF ) * ln a x (1)
ax  f x cx (2)
Where:
E0 : standard electrode potential
R: gas constant (8.314510 J×mol-1×K-1)

T: absolute temperature (t°C+273.15)(K)
F: Faraday constant (9.6485309×104 C× mol-1)
a x : activity of ion (i)
f x : activity coefficient
c x : concentration
n : charge number of given ion (i) (positive ion is positive, negative ion is negative)

3.4.3 Measurement methods
Standard comparison method is adopted in ISE module. Before measuring samples,

calibrate with two kinds of standard solutions of known concentrations, one for point
calibration and the other for slope calibration. Then, measure samples after completing
calibration.
S
is theoretical slope of electrode and make S  ( RT / nF ) * 2.303 . Concentration
of the first standard solution is C A , the electrode potential measured is E A .
Concentration of the second standard solution is C B , the electrode potential measured is
E B . Concentration of ion which is to be measured in the sample solution is C x , the
electrode potential measured is

E x , then:
E A  E0  S lg f A c A (3)
E B  E0  S lg f B c B (4)
E x  E0  S lg f x c x (5)
f
Where, f A , f B and x are activity coefficients of standard solutions A, B and sample
solution. In practical application, adjust activity coefficient of standard solution to make
f A  f B  f x , and calculate actual slope of electrode with equations (3) and (4) as:
CB
S  ( E B  E A ) / lg( )
CA (6)
Calculate concentration
C x of sample with equations (5) and (3) as:
C x  C A *10 ( Ex  E A ) / S (7)


Chapter 4 Routine Operation Process
According to characteristics of business process of the automatic biochemistry

analyzer, this user software includes sample order handling, calibration order handling,
QC order handling, report handling, alarm handling, status display, statistic workload and
other operation functions, and reagent parameter, QC parameter, calibration parameter
and system parameter settings.
This chapter mainly describes the basic operation process of the system. After users
learn this chapter, they can complete basic daily operations with the system.
4.1 Operation process
Table 4.1-1 Operation process of routine analysis

Steps Window Operations
1. Inspection prior to Before the power switch is turned on, pre-test
startup inspection must be carried out.
2. Power on Power on Biossays series automatic
biochemistry analyzer and computer.
3. Start the user Login Input the operator’s name and password in the
software software login window.
4. Confirm instrument
status
(1) Reaction disk Instrument Confirm whether the temperature of the
temperature confirm status reaction disk is within the following range of the
set value of 37°C:
BC1200 37.0±0.3℃
Biossays 240 Plus
37.0±0.2℃
Biossays 240
(2) Cell blank confirm Photoelectricity Confirm the measured value is within the
maintenance allowed range through cell blank inspection.
5. Confirm analysis
conditions
(1) Assay parameter Assay Confirm parameters of the assays.
confirm parameter Confirm whether such assays are calibrated,
(2) Calibration Curve fitting the calibration is in the valid period, and
parameter confirm calibration methods and parameters are to be
used.
6. Prepare reagent
(1) Position confirm Reagent info Confirm whether reagent register information is

consistent with its position in the reagent disk.

(2)Remaining volume Reagent info Confirm the remaining volume of each assay.
confirm
7. Add calibration Calibration Confirm the assays to be calibrated, and
order whether the position of the calibration solution
for calibration order is consistent with that in
the sample disk.
Add QC order QC Confirm the assays for which QC analysis is
necessary, and whether the position of the QC
solution for QC order is consistent with that in
the sample disk.
8. Add sample order Work List Add single or batch routine sample order;
Add single or batch STAT sample order;
Add single or batch dilution sample order;
Delete and modify sample order information.
9. Start analysis Place sample, calibration solution and QC
solution in their respective position in the
sample disk according to the order list;
Click <Start Test> in the shortcut key area for
analysis.
10. Additional sample Work List Add the additional sample orders during the
testing testing. (If they are STAT samples, carry out
STAT sample order. So does dilution samples);
Click <Start Test> in the shortcut key area for
analysis.
11. Testing Status
monitoring
(1) Status monitoring Monitor status of sample disk, reagent disk /
sample & reagent disk and reaction disk, and
temperature, voltage and liquid status of the
system.
(2) Pause sampling Pause sampling is allowed during the testing.
(3) Stop test When your click <Stop test> during the testing,
the instrument will stop the current operation.
12. Result confirm Result Query, delete and print the results, and view
reaction curves.
13.Rerun samples
(1) Sample rerun Result When the respective sample is selected, click
testing <Rerun> and select the assays you want to
rerun. Then click <Start Test> to rerun the
sample testing.
(2) Result re-confirm Result Confirm and print the rerunning results.
14. Operations at the
end

(1) Exit the operating Click <Exit System> in the shortcut key area to
software confirm exiting the software.
(2) Shutdown Turn off the power of the instrument and the
computer.
15. Operations after Cover each reagent bottle in the reagent disk;
the end Take out calibration solution, QC solution and
samples of the sample disk.
Empty the waste liquid tanks.
4.2 Analysis preparation
Preparations of routine sample analysis should be completed through the following

steps.
4.2.1 Inspection prior to startup
Prior to startup, the following inspection measures should be carried out to ensure the
system can run normally after startup.
Warning:
For the following inspection operations, you must pay attention to
bio-infectious risks, and wear gloves and working clothes to avoid being
infected, and if necessary, protective glasses.
1. Check the power to confirm the power supply is normal.

2. Check the communication and power wires of the instrument, the computers and
the printer to confirm good connection without looseness.
3. Check whether each pipetting probe, the stirring needle and the washer are in
the right position, polluted and bent, and their tips have drops.
4. Check whether there is wash liquid in the sample / reagent disk, and whether it is
sufficient.
5. Check whether there is sufficient wash liquid in the tank.
6. Check whether the waste liquid tank is empty.
7. Check if purified water is sufficient:
Check if the purified water unit is connected with an outside
BC1200 water source. Then power on the unit and open the valve
that connects the instrument to the pure water unit.
Biossays 240 Plus Check water level of the purified water tank, and if not filled,
Biossays 240 supplement water.

4.2.2 Power on and login software
1. Power on Biossays series automatic biochemistry analyzer. Turn on its main and
submain power switches. Its main switch should be normally open to ensure the
running of cooling system if the reagent disk places reagents.
2. Power on the computer and the printer.
3. After you login Windows operating system, double click the shortcut icon of the
user software to start it. After the user software starts, a login dialog (shown as
Fig. 4.2-1) pops up in the screen. Enter the user and password and click <Login>
to enter the user software.
Fig. 4.2-1 Login Interface
Attention:
The system administrator’s name and initial password both are “snibe”.
4. After you login the user software, the instrument will be initialized, and all parts
will finish initialization. When the reaction disk’s temperature is stable, test can
be started.
4.2.3 Confirm instrument status
The instrument should be confirmed normally through the following steps.
1. Confirm the reaction disk’s temperature.

Observe the temperature in the [Instrument Status] window and confirm whether the
reaction disk temperature is within the following range of the set value of 37°C:
BC1200 37℃±0.3℃
Biossays 240 Plus
37℃±0.2°C
Biossays 240
Attention:
After the components of the instrument are initialized, it takes about 20
minutes for the reaction disk temperature to stabilize, and 10 minutes for
the light source to stabilize. Thus, after the reaction disk temperature
becomes stable after startup, sample test can be started.

2. Cell blank confirmation

Click <System Maintenance> in the master key area to open the [System
Maintenance] window. When you enter the window, click <Photoelectricity maintenance>
and select “Cell Blank Test” tab. Click <Start> in the tab, and the instruction will perform
the cell blank test. During the testing, you can click <Stop> to stop the test. The [Cell
Blank Test] window is shown as Fig. 4.2-2.
Fig. 4.2-2 Cell Blank Test
After the testing, the result column will show the results of all cuvettes under 16-way
wave, cuvette No. and times. A judgment will be drawn with test data whether the cuvettes
can be used for sample analysis.
The cell blank test results within ±3,500 meets requirements.
Should cell blank data meet requirements, it can be tested. If abnormal, users are not
recommended to continue sample test, or it may impact the reliability of results.
4.2.4 Confirm analysis conditions
Before the testing, confirm whether assay parameters, calibration methods, normal
range and other settings of such assay are correct, such assay is calibrated and the
calibration is within the valid period. Group/Profile and cross contamination information
should be set up based on demands.
1. Assay parameter confirm

Click <Setting> in the master key area to open the [Setting] window. In the window,
click <Assay Param.> and select the “Basic Parameter” tab to open the [Basic Parameter]
interface. Then, assay parameters will be set up or confirmed one by one according to the
reagent instruction.
2. Calibration parameter confirm

click <Assay Param.> and select the “Calibration Parameter” tab to open the [Calibration
Parameter] interface. Then, calibration parameters will be set up or confirmed one by one

according to the reagent instruction.

Click <Calibration> in the master key area to open the [Calibration] window. In the
window, click <Curve Fitting> to open the [Curve Fitting] interface and confirm whether
such assay is calibrated, and the calibration is within the valid period.
3. Group/Profile settings
click <Group/Profile> to open the [Group/Profile Setting] interface. Then, Group/Profile will
be set up based on the detailed demands.
Profile means putting related assays together, such as liver function tests. Several
assays can be added by clicking the profile name, which is convenient for rapid input
during adding the sample order.
4. Cross contamination settings

click <Cross Contamination> to open the cross contamination setting interface. Then,
cross contamination for reagent, cuvette and sample will be set up based on the detailed
demands.
Cross contamination wash is for reducing or avoiding the contamination between
assays, including among reagent, cuvette and sample.
Attention:
Some assays may impact the results of other assays due to reagent
formula during analysis. The contamination degree varies with reagents.
Operators are recommended to place the reagents subject to cross
contamination separately. If not so, cross wash can be set up to reduce
cross contamination between assays.
4.2.5 Prepare reagent
Place the respective reagent in the reagent position of the reagent disk. Open the
cover of reagent bottle to confirm the remaining volume is sufficient for this sample test.
1. Reagent use and notes

Reagent preparation, use and storage must abide by requirements of the reagent
instruction. No bubble should occur in the reagent. As the reagent contains surfactants,
violent shake will create bubbles. If the reagent probe touches bubbles during the testing,
it will be misjudged that the probe has been access to reagent liquid level, which results in
being unable to pipette the reagent correctly so as to impact the results.
Reagents from different bottles cannot be mixed. If a reagent is added other ones
from different manufacturers or from the same manufacturer but they have different lot No.,
its components will change, bringing inaccurate results.

2. Reagent position confirm

Click <Reagent Info> in the master key area to open the setting interface, and
operate according to the reagent position in the reagent disk.
Reagent register by manual. In the [Reagent Info] interface, input the respective
reagent information, including reagent type, position, assay, bottle size, production date,
bottle No., lot No. Then, click <Modify> to complete reagent register by manual. If reagent
information fails to be scanned due to some reasons, such as barcode being polluted or
falling off, in the reagent bottles, reagent information should be registered by manual.
Automatic barcode scanning register. When the barcode attached in the reagent
bottle is complete and clear, you can click <Scan Barcode> to complete automatic reagent
information register. When you click <Scan Barcode> in the [Reagent Info] window, the
instrument will scan reagent information in the reagent disk automatically. The scanned
information (position, reagent type, assay, remaining volume, remaining times, valid date,
production date, bottle size, bottle No., lot No., barcode) will occur in the reagent
information list. When the remaining volume is less than the reagent bottle alarming
volume, position, remaining volume and remaining times are marked in yellow. When the
remaining times is 0, position, remaining volume and remaining times are marked in red.
When the reagent is expired, its position and valid date are also marked in red.
The [Reagent Info] window shows reagent position in the current reagent disk, and
the reagent information list gives the details. Confirm whether the reagent register
information is consistent with its position in the reagent disk. Confirm whether the
reagents in the current disk meet demands of the sample test to be performed. If there is
no reagent for the assay test in the reagent disk, reagent information should be set up
again. The window is shown as Fig. 4.2-3.
Fig. 4.2-3 Reagent Information
3. Remaining volume confirm

In the [Reagent Info] window, click <Detect Vol> to detect the remaining volume. Then,
the list will update the remaining volume and times. When the reagent probe absorbs
reagent during the testing, such updating should be carried out.
Confirm whether the remaining volume of all reagent bottles in the current reagent
disk meets demands of the sample test to be performed. If the remaining volume of a
reagent bottle in the reagent disk is not enough for the assay test, place another one in
the reagent disk.

Attention:
1、 After registration of reagent information, please detect remaining
volume to confirm remaining volume and times before sample
analysis.
2、 Remaining times are calculated to multiply the section area of the
reagent bottle by reagent lever height measured by the reagent
probe, then divide the reagent volume. Errors of the reagent height
and section area may result in the error of remaining times. Thus,
the remaining times should be regarded as estimates which may not
be in accordance with the actual times of each reagent bottle.
4.3 Test analysis
When preparations prior to analysis are completed, routine sample analysis can be
made.
4.3.1 Calibration order
Click <Calibration> in the master key area to open the [Calibration] window, and
<Calibration Order> to open the [Calibration Order] window, which is shown as Fig. 4.3-1.
When you select the assays for calibration order, the right lower calibration solution
information list will show calibration solution setting information of the selected assay.
After the calibration solution and calibration method are confirmed to be correct. Click
<Add Order> to add calibration order of such assay.
If you want to delete the calibration orders, click <Calibration Result> in the
[Calibration] window to open the [Calibration Result] window. Select order information of
such assay in the calibration information list, and click <Delete> to delete the calibration
order.
Fig. 4.3-1 Calibration Order

4.3.2 QC order
Click <QC> in the master key area to open the [QC] window, and <QC Order> to
open the [QC Order] window, which is shown as Fig. 4.3-2.
Fig. 4.3-2 QC Order
In the [QC Order] window, input QC name, position, QC lot number, target value, SD
and interval, and select the assay for QC order. Click <Add> to complete QC information
input of such assay.
If you want to delete QC information of an assay, select such information in the left
working area of the window (it shows after selected), and click <Delete> to delete
such information.
When you select the assays for which QC order is necessary in the left working area
of the window (it shows after selected), and confirm that the QC information is correct,
and click <Add Order> to add the QC order .
If you want to delete the QC order, click <QC Result> to open the [QC Result] window.
In the upper working area of the window, select such QC order information (it shows
after selected), and click <Delete> to delete them.
4.3.3 Sample order
Click <Work List> in the master key area to open the [Work List] window, which is
shown as Fig. 4.3-3.
Sample No. includes start and end No. They can be added by the system or by
manual. If by manual, input start No. in the first edit box, and end No. in the second. When
the system defaults that these two numbers are the same, it means only one sample;
when end No. is larger than start No., it means batch sample.

Fig. 4.3-3 Work List
1. Single sample order

Input sample No. in “Sample No.” and repeat times in “Repeat Times”, and select the
respective disk No. and position No. in the drop-down list box of “Disk No./Pos”. You can
select the name of the assay to be tested in the assay information list (it gets green after
selected) as well as several assays through Profile. Then, the [Test List] window will show
information about all sample orders.
If you want to add a STAT sample order, select the STAT button (it gets green after
selected). It means the current sample is STAT which will be tested in the first priority.
If you want to dilute a sample, select the Dilution button (it gets green after selected)
to open the [Select Dilution Ratio] dialog window. In the window, select the dilution rate for
the assay to be diluted.
Click <Add Order> to complete adding single sample order. If its sample No. has
been existed, there will be a sign indicating that adding sample order failed.
Obtain the sample’s barcode information and its position No. in the sample disk by
barcode scanning. The barcode scanner in the sample disk will scan all sample positions
of its outer and middle rings to obtain samples’ barcode information.
After starting LIS function to connect LIS server successfully, you can get the
sample’s assays from the LIS sever through LIS application function.
View the test list message, and add/delete assay information in the [Test List] window.
If you want to delete the sample order, click <Delete Sample> in the [Work List]
window to open the [Delete Sample Order Info]dialog window. In the latter window, input
start and end No. of the samples to be deleted, select the assays to be deleted of such
batch, and click <Delete> to delete selected sample order information.
2. Batch sample orders

If many samples go through the same assay test, such as physical examination, the
batch orders can be made.
Input start and end No. of the samples in “Sample No.” and repeat times, and select
their respective disk No. and start position No. of such batch in the drop-down list box of
“Disk No./Pos”. You can select the name of the assays to be tested in the assay
information list (it gets green after selected) as well as several assays through Profile.

Then, the [Test List] window will show information about all sample orders.
If you want to add STAT sample orders, select the STAT button (it gets green after
selected). It means the current batch samples are STAT which will be tested in the first
priority.
If such batch samples need diluting, select the Dilution button (it gets green after
selected) to open the [Select Dilution Ratio] dialog window. In the window, select the
dilution rate for the assays to be diluted.
Click <Add Order> to complete adding batch sample orders. If the sample No. of such
batch has been existed, there will be a sign indicating that adding sample order failed.
Obtain the sample’s barcode information and its position No. in the sample disk by
barcode scanning. The barcode scanner in the sample disk will scan all sample positions
of its outer and middle rings to obtain samples’ barcode information.
After starting LIS function to connect LIS server successfully, you can get the
sample’s assays from the LIS sever through LIS application function.
Warning:
1. The samples with hemolysis, lipemia or jaundice will impact the
results.
2. You must ensure no clot is contained in samples, otherwise the
3. Some substances of the samples, such as drugs, anticoagulants,
preservatives, will disturb the results.
4. Don’t place the samples in the opened container for a long term,
otherwise they may volatilize, which will impact the results.
5. Incorrect parameter settings will impact the results.
6. Shenzhen New Industries Biomedical Engineering Co., Ltd. doesn’t
suggest users themselves to modify and add the results, and shall
not assume any responsibilities for sequences resulting from such
actions.
4.3.4 Start analysis
1. Preparation of wash liquid, calibration solution, QC solution and sample.

Place wash liquids, calibration solutions, QC solutions and samples to be used during
the testing in their respective positions, and confirm whether the positions are consistent
with the order information.
Place wash liquid to be used during the testing in wash liquid position of the sample
disk.
According to the calibration order information, place the respective calibration
solution in the position of the sample disk.
According to the QC order information, place the respective QC solution in the
position of the sample disk.
According to the sample order information, place the respective normal or STAT
samples in the position of the sample disk.

2. Start test
When finishing adding orders, click <Start Test> in the shortcut area to send a test
command, and the instrument will start test.
Attention:
1. Don’t change samples when the sample probe and the sample disk
are running. It can be available when they stop.
2. When the instrument is working, contact with the sample / reagent
probe, the stirring needle and the reaction disk and other running
devices should be avoided.
3. When the instrument is working, don’t change the sample disk or
open the sample / reagent disk’s cover.
4. QC solutions and calibration solutions should be tested with
standard or trace cup.
4.3.5 Additional sample testing
1. Additional assay testing of the added samples

If the added samples require additional assay testing, select such sample No. in the
sample order information list and the assay name in the assay information list. Then, click
<Add Order> to complete the operation. Or, you can click <Add> in [Test List] window to
open [Add Assay] dialog window. In the window, input start and end No. of the samples
which require additional assay testing, and select the assay name in the assay information
list. At last, click <Add> to complete the operation.
After the additional assays are added, click <Start Test> in the shortcut area to test
the assays if there is the reagent of such assay in the reagent disk. If not, you cannot
place the reagent in the reagent disk and test the additional assays.
2. Additional sample testing

If additional samples are required during the testing, sample order should be added
first (refer to 4.3.3Sample order). Input the information about the additional samples in the
sample information column, and select the name of the assays to be tested in the assay
information list. Click <Add Order> to complete the operation.
If STAT samples are to be added, select the STAT button (it gets green after selected).
It means that the current sample is STAT which will be tested as a matter of priority.
If samples are to be diluted, click the dilution button (it gets green after selected) to
open the [Select Dilution Ratio] dialog window. In the window, select the dilution rate of the
assays to be diluted.
After the additional sample orders are added, the additional samples should be
placed in the sample disk. When the instrument is working, users must click <Pause
Sampling> in the shortcut key area to open the [Message Confirm] dialog window.

Fig. 4.3-4 Pause Sampling Confirm Dialog
Click <OK> to pause sampling of new test. Tests which have sample added in the
reaction disk will continue. The sample can be placed in the sample disk only after the
instrument’s sample probe stops running. At this time, it is necessary to confirm whether
the position of such sample in the sample disk is consistent with the sample order
information. After the sample is in place, click <Start Test> in the shortcut key area to
complete continuous loading operations which allow the instrument to start sampling and
continue analysis.
Attention:
1. Please do not keep the system in the Pause Sampling status for a long
time. Otherwise, certain tests may be affected to some extent.
2. In Pause Sampling status, only the sample probe suspends sample, but
the reagent probe does not stop aspirating the reagent. At the time, you
cannot put a new reagent bottle in the reagent disk or uncap the disk.
3. During Pause Sampling status, analysis of sampled assays will not stop.
Attention:
Since the sample probe and the reagent probe of the Biossays 240 Plus /
Biossays 240 analyzer are the same one, that is, the sample & reagent
probe. Please note the following information about the Biossays 240 Plus /
Biossays 240 analyzer:
1. In pause sampling status, the sample & reagent probe stops sampling of
new test while assay analysis for which R1 reagent has been added will
not stop, and the sample & reagent probe will not stop running
immediately.
2. After clicking <Pause Sampling>, if the sample & reagent probe is running,
the <Pause Sampling> button will be shown in red. At this moment, it is
not allowed to place samples and reagents in the sample & reagent disk
or open the sample & reagent disk cover.
3. In pause sampling status, samples and reagents can be placed in the
sample & reagent disk only after the instrument’s sample & reagent
probe stops running and the <Pause Sampling> button turns green.

4.3.6 Testing monitoring
During the testing, monitor status of sample / reagent disk and reaction disk, and the
instrument’s temperature, voltage and liquid status in real time. In case of additional
sample fault, instrument fault and other conditions, pause sampling. If major faults occur, it
is necessary to stop test.
Click <Status> in the master key area to open the [Status] window which shows the
current status of sample / reagent disk and reaction disk, and the instrument’s current
temperature, voltage and liquid status.
4.4 Result disposal
After the testing, the result can be observed in the [Result] window.
Result disposal includes confirmation of results and testing of rerunning samples.
4.4.1 Result confirm
Click <Result> in the master key area to open the [Result] window, which is shown as
Fig. 4.4-1. As the window shows test results of all assays, users can view, delete, rerun
and print test results, and view reaction curves, etc. They can also input sample details in
the patient information list of the [Report] window for previewing and printing reports.
In the [Result] window, click [Expt. Result] to enter the [Expt. Result] window. The left
sample list will show information about all samples. When you click the sample you want
to view, the right result list will show all assays and result information of such sample.
Fig. 4.4-1 Expt. Result
Click <Search Sample> to input the respective date. You can query historical result
information as well as result information of a certain sample No.
Click <Send Sample> to open [Send Sample - Sample List] dialog window. When you
select sending conditions in the window, it will send result information that matches the

conditions. After you click <OK>, the window will disappear. Thus, sending the result is
finished.
Click <Print Sample> to open [Print Sample - Sample List] dialog window. When you
select printing conditions in the window, it will print result information that matches the
conditions. After you click <OK>, the window will disappear. Thus, printing the result is
finished.
Click <Export Sample> to select export conditions. It will output result information that
matches the conditions. After you click <OK>, the [Export Sample - Sample List] dialog
window will disappear. Thus, the result is exported via Excel document.
Warning:
1. The samples with hemolysis, lipemia or jaundice will impact the
results.
2. You must ensure no clot is contained in samples, otherwise the
3. Some substances of the samples, such as drugs, anticoagulants,
preservatives, will disturb the results.
4. Don’t place the samples in the opened container for a long term,
otherwise they may volatilize, which will impact the results.
5. Incorrect parameter settings will impact the results.
6. Shenzhen New Industries Biomedical Engineering Co., Ltd. doesn’t
suggest users themselves to modify and add the results, and shall
not assume any responsibilities for sequences resulting from such
actions.
1. Reaction curve
If you want to view the reaction curve of a certain result, click result information of
such test and <Reaction Curve> to open the [Reaction Curve] dialog window. The window
shows the reaction curve of the result, which is shown as Fig. 4.4-2.
Fig. 4.4-2 Reaction Curve

The result information list in the below window shows assay, sample No., barcode,
cuvette No., primary wave, secondary wave, test date, result time, etc. The right Abs list
shows Abs value of all points’ primary wave and secondary wave. The reaction curve can
be expressed in three ways: primary wave-secondary wave, primary wave, secondary
wave
Click <Print> to output the reaction curve of the result, including result information,
reaction curve and Abs value of all points.
Click <Cancel> to exit the [Reaction Curve] dialog window.
2. Report preview and print

In the [Result] window, click <Report> to enter the [Report] window, which is shown
as Fig. 4.4-3.
Fig. 4.4-3 [Report] Window
Select the test date of the reports to be printed in the drop-down list box of “Test
Date:”.
When you select sample No. to be viewed in the sample information list, the left
patient information list will show details of the selected samples, and the middle result
information list will show the result information of all assays of the selected samples.
Details of the sample in the left patient information list need editing by users in order
to print a complete report. Such details include sample No., patient type, patient No.,
name, sex, age, department, sample type, character, sender, send time, operator, verifier,
diagnosis and remark. Click <Save> to finish the edition of sample patient information.
Click <Preview> to preview reports to be printed, which is shown as Fig. 4.4-4 .
In the [Preview] dialog window, click <Cancel> to exit the window. If you want to print
the report, click <Print> to output it.

Fig. 4.4-4 Preview Dialog Figure
If you want to print the batch test reports, click <Print> in the [Report] window (Fig.
4.4-3) to open the [Sample No. Range] dialog window, which is shown as the figure below.
Enter start and end No. of the samples to be printed to output the test reports of the
selected samples. After you click <OK>, the window will disappear. Thus, printing the
reports by batch is finished.
Fig. 4.4-5 Sample No. Range Dialog
4.4.2 Rerun samples
1. Sample rerun testing

If some assays of the sample require rerun (for example, the assay’s result exceeds
normal range) after the sample is tested, tick (it shows after selected) such sample in
the [Expt. Result] window (Fig. 4.4-1), and click <Rerun> to open the [Rerun-Sample
Select] dialog window, which is shown as Fig. 4.4-6 below. After you select the conditions
for rerun and click <OK>, the window will disappear. Thus, the rerunning result, whose
status is waiting for test, is added in the result list on the right of the [Result] window.
Click <Start Test> in the shortcut key area to send test commands that allows the
instrument to start test.

Fig. 4.4-6 Rerun-Sample Select Dialog
Attention:
1. Only the current day’s test results can be rerun.
2. Sample rerun testing must be made by clicking <Start Test> in the
shortcut area to send a rerun command.
2. Re-confirmation of rerunning results

After the sample rerun testing is over, click the rerunning sample in the sample
information list in the left of the [Expt. Result] window, and the right result list will display
the rerunning results. Confirm the rerunning sample result with reference to 4.4.1, and
print the test report.
4.5 Analysis completion
After all tests are completed, test results are confirmed and test reports are printed,
you can exit the operating software and Windows operating system, and then turn off the
power supply of each part.
4.5.1 Shutdown
When the current day’s tests come to an end that all operations and tests are finished,
you can exit the user software and Windows operating system, and turn off the power
supply of each part in the following order:
1. Turn off the printer’s power;
2. Turn off the computer’s power;
3. Turn off the submain switch power of the instrument.
4. If there is pure water unit, turn off the pure water unit’s power.
Attention:
When its auxiliary switch power is off, the cooling system is still working.
In order to close the system, please turn off the master power switch.

4.5.2 Operations after shutdown
In order for the next work preparations, the following should be checked:
1. Check whether each pipetting probe, the stirring needle and the washer are in
the right position, polluted and bent, and their tips have drops.
2. Cover each reagent bottle in the reagent disk.
3. Take out calibration solutions, QC solutions and samples in the sample disk.
4. Empty the waster liquid tank.
5. Check whether there are stains in the instrument’s plane part. If any, wipe out
them with clean soft cloth.


Chapter 5 Software Function
5.1 Status display light
status display light shows the connected status of

the user software and the instrument and of the user software and LIS sever and the used
status of ISE module.
shows the connected status of user software and the instrument as follows:
Red It represents the user software could not open the port connecting
Red the instrument, and the connection between the user software and
the instrument failed.
Green It represents the user software could open the port connecting the
Red instrument, but the connection between the user software and the
instrument failed.
Green It represents the user software could open the port connecting the
Green instrument, and the connection between user software and the
instrument succeeded.
shows the connected status of user software and LIS server as follows:
Red It represents the user software could not open the port connecting
Red LIS server, and the connection between the user software and LIS
server failed.
Green It represents the user software could open the port connecting LIS
Red server, but the connection between user software and LIS server
failed.
Green It represents the user software could open the port connecting LIS
Green server, and the connection between user software and LIS server
succeeded.
shows the used status of ISE module as follows:

Red It represents ISE module is not selected.
Red
Green It represents ISE module is selected but is wrong.
Red
Green It represents ISE module is selected and operates normally.
Green

5.2 Shortcut key area
The shortcut key area is in the lower user software interface, which displays
commonly used function buttons, convenient for users’ operation.
Relevant function description is given below.

Button Function
<Start Test>button. When you click this button, the user software
sends a start test command to the instrument, and the latter starts
test.
<Pause Sampling> button. When you click this button, the

instrument stops sampling of new test, and the testing will continue
if sampling is made. After the sample probe stops running, users
can add sample in the sample disk or handle other emergencies.
After placing the additional sample and clicking <Start Test>, the
instrument continuously loads.
<Stop Test>button. Click this button to stop the instrument’s current

testing.
If it is necessary to stop the instrument suddenly due to faults or
other special reasons, the user software will send a stop test
command to the instrument after you click this button. The
instrument will stop running immediately.
<Instrument Status>button. Click this button to open the

[Instrument Status] window and monitor its
current status.
<User Logout>button. Click this button to return the login interface

and switch the user.
When the operator takes a break, please lock the operating
software to avoid that non-users destroy or modify data.
<Exit System>button. Click this button to open [Message Confirm]

dialog. After double check, exit the User software.

Attention:
1、 Before you click <Start Test> button, please confirm samples,
calibration solutions, QC solutions, reagents and others are in the
right position.
2、 Unless specifically specified, for example, instrument faults, it’s not
recommended to use such function. After the testing stops, all the
tests which have not finished running should void. Click <Start
Test>button to re-start all unfinished tests.
3、 When the operator takes a break, please lock the operating software
to avoid that non-users destroy or modify data.
5.3 [Work List] interface
Click <Work List> in the master key area to open the [Work List] window as shown in
the figure below. You can add sample order, view and delete sample order information,
and view test list etc.
Fig. 5.3-1 [Work List] interface
Button Function
Add Order Click this button to complete adding single or batch sample orders.
Scan Barcode When you click this button, the barcode scanner in the sample disk
will scan all sample positions of its outer and middle rings to obtain
samples’ barcode information.
LIS Apply When you start LIS function to connect LIS server successfully,
click this button to obtain samples’ assay information from the LIS
server.
Test List Click this button to open the [Test List] window showing test list
information of sample order that matches the screening criteria,
you can delete, print, export test list information and add assay.
Delete Sample Click this button to delete the sample order information that
matches the screening criteria.

Button Function
STAT It means the current sample is STAT after selected.
Dilution The [Select Dilution Ratio] dialog window will pop up after selected.
Select the sample’s assays to be diluted and dilution rate.
During the testing, the instrument will prepare dilution sample with
dilution solution and sample which are mixed in a clean cuvette,
and pipette sample from the cuvette for loading and testing during
the sampling.
Warning:
Sample deletion will result in void tests of the sample. As data cannot be
recovered, please be careful.
5.4 [Result] menu
Click <Result> in master key area to open [Result] window. The Button function of its
sidebar menu is described as follows:
Fig. 5.4-1 [Result] menu
Button Function
Expt. Result Display result and carry out search, rerun, print, send, delete on it
and check reaction curve etc.
If result is abnormal, it gets yellow. If you select the result, result
flag will be displayed in Result Flag Info window which is movable
and in the lower right corner. If result is normal, the Result Flag Info
window will be hidden.
Report You can edit patient information, preview and print report in this
window.
Statistics/Calc. This window is used to conduct statistics on results of an assay
within specified period
or recalculate results based on new calibration curve.

Attention:
1. After adding sample rerun orders, click <Start Test> button in
shortcut key area to retest the assays that are required for rerun.
2. For assay tested in other systems, it is possible to add its result and
print report with other assays in this system.
Warning:
1、 Results once deleted, are unrecoverable, please delete with care.
2、 It is not advised to modify/add results, and Shenzhen New
Industries Biomedical Engineering Co., Ltd. will assume no
responsibility for any consequences resulted therefrom.
5.4.1 Recalculate results
Click <Statistic/Calc.> button in [Result] window to open [Statistics/Calc.] window as

shown in the figure below.
Fig. 5.4-2 [Statistics/Calc.] window
If concentration in a certain assay is calculated based on expired calibration curve, it

is required to recalculate the concentration according to the latest calibration curve, and
you can click <Recalculate> button to recalculate. Result information list in the right will
update concentration and statistics list in the left will update statistics.
Attention:
Concentration, once recalculated based on the latest calibration curve, is
unrecoverable, please recalculate with care.

5.5 [Reagent Info] interface
Click <Reagent Info> button in master key area to open [Reagent Info] window, where
you can set up reagent information, scan reagent barcode information, detect remaining
reagent volume etc.
Fig. 5.5-1 [Reagent Info] interface
Attention:
Do not open the reagent disk cover during sample analysis to avoid
dangers or damages to the analyzer.
5.6 [Calibration] menu
Click <Calibration> button in master key area to open [Calibration] window. The
Button function of its sidebar menu is described as follows:
Fig. 5.6-1 [Calibration] menu

Button Function
Calibration Order This window is used for adding calibration orders of assay.
Calibration Result This window is used to view, search, delete calibration result
and check reaction curve of the result etc.
If calibration result is abnormal, it will turn yellow and a result
flag will show in Result Flag Info window. If calibration result is
normal, the Result Flag Info Window will be hidden.
Curve Fitting This window is used to display and print relevant information of
calibration curve, such as calibration method, fitting formula,
fitting parameter and calibration curve, etc.
ISE Calibration This window is used to view ISE calibration result and carry
out point calibration, slope calibration, removing protein and
pipe washing etc.
Attention:
1. In case of changes in analysis conditions due to modification of lot
No., test parameters, light source lamp and other reasons,
recalibration is necessary.
2. Calibration results once deleted, are unrecoverable, please delete
with care.
5.6.1 Calibration types
Difference of three calibration types:

Type Volume Update Applicable calibration
method
Blank Cal. 1 calibration solution of Update blank All calibration methods
reagent blank value of reagent
Span Cal. Calibration solution Update value of a 2-point linear and
except reagent blank multi-point linear
calibration methods
Full Cal. Multiple calibration Update calibration All calibration methods
solutions registered curve with all
points
Attention:
It is advisable to conduct reagent blank test everyday as reagent blank
test is vital for obtaining correct results and blank value is useful to check
validity of reagent, deduct reaction background and to deduct
absorbance changes resulted from reagent in rate A and 2-point rate
methods.

5.7 [QC] menu
Click <QC> button in master key area to open [QC] window. The Button function of its
Fig. 5.7-1 [QC] menu
Button Function
QC Order This window is used for adding QC order of assay.
If you set up QC interval of assay, during routine sample
analysis after selecting assay, the analyzer will automatically
insert QC assay for test in accordance with number of interval
samples.
QC Result This window is used to view, search, recalculate, delete QC
result and check reaction curve of the result etc.
If QC result is abnormal, it will turn yellow and a result flag will
show in movable Result Flag Info window.
Lot QC This window is used to check the QC Lot Graph, QC data and
QC analysis results of the QC liquid with the same lot No.
Conduct QC analysis based on Westgard Multirules.
Monthly QC This window is used to check the QC Month Graph, QC data
and QC analysis results of the QC liquid of different lot No. or
of different QC liquids.
Conduct QC analysis based on Westgard Multirules.
Warning:
QC Results once deleted, are unrecoverable, please delete with care.
5.7.1 Recalculate QC result
If concentration in a certain assay is calculated based on expired calibration curve, it

is required to recalculate the concentration according to the latest calibration curve, and
you can select the QC result in the upper workspace in [QC Result] window ( shows

after selected), and click <Recalculate> button to open [Message Confirm] dialog window,
which is shown as the figure below.
Fig. 5.7-2 Message Confirm Dialog
Click <OK>to recalculate concentration based on the latest calibration curve of the
assay. Concentration will be updated in the upper workspace in [QC Result] window.
Click <Cancel> to cancel recalculation.
Attention:
Concentration, once recalculated based on the latest calibration curve, is
unrecoverable, please recalculate with care.
5.8 [Status] menu
Click <Status> in master key area to open [Status] window. The Button function of its
Fig. 5.8-1 BC1200 [Status] menu Fig. 5.8-2 Biossays 240 Plus /
Biossays 240 [Status] menu

Button Function
Sample Disk This window is used to display the sample disk graph and its
current status. The current status of samples in the sample
disk are distinguished by color.
R1 Disk This window is used to display the reagent1 disk graph and its
current status. The current status of each reagent position is
differentiated by color.
R2 Disk This window is used to display the reagent2 disk graph and its
current status. The current status of each reagent position is
Sample&Reagent Disk This window is used to display the sample & reagent disk
graph and its current status.
The type and status of each sample position in the disk are
differentiated by color combination of the inner and outer rings.
The outer color represents type, the inner color represents
current status.
The current status of each reagent position is differentiated by
color.
Reaction Disk This window is used to display the reaction disk graph and its
current status. The current status of each cuvette is
ISE This window is used to display ISE module’s running status, A
Std. reagent kit status, B Std. reagent kit status, information
related to electrode status and provide respective functions of
replacing A Std., B Std. and Electrode, etc.
Instrument Status This window is used to display the analyzer’s current
temperature, voltage and liquid status. If respective
temperature and voltage exceeds the limited range, it is
displayed in red. The liquid status gets green in the normal
status and red in other status.

5.9 [Setting] menu
Click <Setting> in master key area to open the [Setting] window. The Button function
of its sidebar menu is described as follows:
Fig. 5.9-1 [Setting] menu
Button Function
Assay Param. This window is used to set up base parameter, normal range,
calibration parameter, QC rule, dilution parameter and auto
dilution of assays.
Group/Profile This window is used to set up profile information. All selectable
profiles are displayed in the profile bar of the [Work List]
window.
Relevant assays are put together to create assay profile with
obvious clinical significance, for example, liver function, and
renal function, for quick addition of assays during adding
sample orders.
Calculate Assay This window is used to set up calculate assay and its normal
range.
Calculate assay means using results of two or more assays to
create a new assay with certain clinical significance by certain
calculations, for example, A/G.
Cross Contamination This window is used to set up cross contamination of reagent,
cuvette and sample.

Button Function
Cross contamination wash is a function that reduces or avoids
the contamination between assays. Due to reagents, serious
cross contamination may occur between some assays. In
order to eliminate such contamination, users are required to
isolate assays which produce cross contamination with those
which don’t produce when they preset assays. If not so, auto
wash should be added by setting contamination information
before testing contaminated assays.
ISE Assay This window is used to set up ISE assay information, normal
range and whether using ISE module.
Manual Assay This window is used to set up manual assay and its normal
range.
Manual assay refers to all assays which are not tested in the
analyzer. Users can input patient’s manual assay results which
will be printed with reports.
System Setting This window is used to set up user, hospital information, report
information, LIS, print, experiment parameter, language and
other settings.
Workload This window is used to view and print workload within the
selected period. With statistic workload, you can count
workload of send departments, senders, operators and assays
in the selected period.
Attention:
1. When sex and sample type are the same within normal range, no
inclusion or overlap is allowed for age.
2. After respective dilution rate for an assay has setted up in the
[Dilution Parameter] window, you can select it in [Calibration
Parameter], [Auto Dilution] and [Work List] windows.
3. If a test assay has selected “Use Auto Dilution”. When the assay
result exceeds set threshold, dilution test will be made automatically
at set dilution rate (testing is subject to quantity of auto dilution
rates).
4. “snibe” is the default administrator’s name. The name and authority
cannot be changed. “snibe” user’s initial password is “snibe”. Please
change it immediately.
5. After setting the department, doctor, patient type, clinical diagnosis,
remark, sample type and sample character in the [Hospital Setting]
and [Report Setting] windows, you can select the appropriate
information when editing patient information in the [Report] window.
6. After setting the unit name in the [Report Setting] windows, you can
select results’ unit information when you edit assay parameter,
calculate assay, manual assay and ISE assay.

5.9.1 Assay basic parameter
Click “Basic Parameter” in the [Assay Param.] window to open the [Basic Parameter]
window, where you can set up base assay parameter, shown as the figure below.
Fig. 5.9-2 Basic Parameter
Parameter Meaning
Effective Input appropriate point range according to the reagent
Photometry Points instructions. 0 means no points.
The analyzer records Abs data once per
BC1200
12s.
Biossays 240
The analyzer records Abs data once per
Plus
15s.
Biossays 240
Serum Index Test If selected (it shows after selected), all the samples which
containing the assay test will have serum index test.
Abs Limits Set up Abs check range in the input box.
If such check is not carried out, input 0 (negative reaction) or
3.3 (positive reaction).
Prozone Check Input range of prozone check.
If such check is not carried out, input -3.3 (lower) or 3.3
(upper).Select upper and lower and input respective value in
the drop-down list box.
Calculation Factor It is for relationship calibration to verify consistency of results
(Y = aX + b) from the analyzer and other instruments.
Attention:
Set up relevant parameters correctly in accordance with the reagent
instructions. Incorrect settings cannot ensure correct results.

5.9.2 Calibration parameter
Click “Calibration Parameter” in the [Assay Param.] window to open the [Calibration
Parameter] window where you can set up calibration parameter of an assay, shown as the
figure below.
Fig. 5.9-3 Calibration Parameter
Parameter Meaning
Cal. Interval (Day) Expired period of calibration curve.
Please set up calibration interval of the calibration curve in
order to judge whether it is within expired period.
Sensitivity Check Difference between the maximum and minimum calibration
solution contraction. If it is lower than this set value, alarm will
sound for exceeding sensitivity.
If such check is not carried out, input 0.
Discrete Check During the calibration, each calibration solution should be
tested twice and taken an average. If Abs difference of two
tests is larger than the set value of discrete check, alarm will
sound for exceeding discrete check range.
If such check is not carried out, input 3.3.
Drift Rate Check Difference between concentration absorbance calculated by
approximate expression and test absorbance in non-linear or
multi-point linear calibration curves. If it exceeds set value of
drift rate check, alarm will sound.
If such check is not carried out, please input 3.3.
Blank Level Check During the calibration, average Abs value of calibration
solution 1 in the two tests exceeds the blank level check range,
alarm will sound.
Lower in the first edit box, and upper in the second.
If such check is not carried out, please input -3.3-3.3.

Attention:
1. Set up relevant parameters correctly in accordance with the reagent
instructions. Incorrect settings cannot ensure correct results.
2. Calibration method must be followed to determine quantity of
calibration solutions. Save failed if insufficient.
5.10 [System Maintenance] menu
Click <System Maintenance> in master key area to open [System Maintenance]

window. The Button function of its sidebar menu is described as follows:
Fig. 5.10-1 [System Maintenance] menu
Button Function
System Info This window is used to view system version information.
Initialize Click this button to send an initialization command to the
analyzer, and the latter will perform the command.
Reset Click this button to send a reset command to the analyzer, and
the latter will perform the command.
Component Maintenance Click this button to open the [Component Debugging] dialog
window. Then you can select the components for which
initialization is required in the window ( shows after selected)
and click <Send>, the software will send an initialization
command of the components to the analyzer, and the latter will
perform the command.

Button Function
Photoelectricity This window is used to conduct cell blank test, stability test,
maintenance light intensity check.
Under normal circumstances, users are recommended to do
cell blank test once a week. They should do so after replacing
cuvette. Should cell blank data meet requirements, it can
conduct sample tests.
Under normal circumstances, users are recommended to do
light intensity check once a month. They should do so after
replacing light source. Should data meet requirements, it can
conduct sample tests.
Low Level Command This window is used to send a low level command by which a
component of the analyzer is controlled to complete a certain
operation.
The analyzer must complete initialization before a low level
command is sent.
System Log This window is used to check and delete alarm and error
information. Users can take respective measures according to
alarm and error information.

Chapter 6 System Maintenance
6.1 Preparations before system maintenance
In order to guarantee the system’s reliability, good running status and service life, you
are required to operate and regularly maintain the system in strict accordance with the
instructions.
If you have any problems about use and maintenance unmentioned in this Chapter,
please contact technical service department or your local dealer of Shenzhen New
Industries Biomedical Engineering Co., Ltd.
Table 6.1-1 Accessory Information

Remark
No. Name Position Period (replacement
method)
Sample / reagent Non-scheduled 6.6.2 Replace
Sample / reagent
1 pipetting replacement. Replace it sample /
probe
mechanism when damaged or bent reagent probe
Non-scheduled
Stirring 6.6.3 Replace
2 Stirring needle replacement. Replace it
mechanism stirring needle
when damaged or bent
BC1200、Biossays 240
Plus: Non-scheduled
replacement. Replace it
(consumable) when the
cell blank test value of
6.6.5 Replace
3 Cuvette Reaction disk cuvette is found abnormal
cuvette
several times;
Biossays 240:
Disposable consumables
are used, which should be
replaced after each use.
Non-scheduled 6.6.4Replace
replacement. Replace the light source
Light source Light source
4 light source lamp lamp
lamp component
(consumable material)
when it ages
Alkaline wash Sample disk,
5 Replenish when used up
liquid wash liquid tank
6 Acid wash liquid Sample disk Replenish when used up

Hitergent wash
7 Reagent disk Replenish when used up
liquid
8 ISE cleaner Sample disk Replenish when used up
ISE-Reagent
9 —— Replenish when used up
pack
6.1.1 Tools
1. Accessories (supplied with the instrument)

Cross head screwdriver disassemble and install cover plate
Allen wrench for Biossays 240 Plus / Biossays 240 analyzer, to
disassemble and install component
Acupuncture needle clean sample / reagent probe
Probe cleaner clean probe in case of blockage
Fixed block for BC1200 analyzer, to adjust the stirring needle height
2. Objects to be prepared by users

Clean gauze clean all parts of the analyzer
Swabs clean sample / reagent probe
Dust collector clean cooling fan
Water bucket (2 pieces) for BC1200 analyzer waste solution discharge; not required if
the waste solution is directed to the sewage
Measure cylinder or for filling water to the refrigeration system water tank of
beaker BC1200 analyzer
6.1.2 Water
The instrument should use purified water with conductivity ≤ 1 μs/cm during the
routine operation and system maintenance. When you use water supply device,
remember to conduct maintenance and check on a regular basis. See water device
manual for details or contact the manufacturer or retailer.
6.1.3 Wash liquid
Wash liquid is used to clean parts of the analyzer. All kinds of wash liquid are
available from Shenzhen New Industries Biomedical Engineering Co., Ltd. In case of any
other alternatives, cuvette, sample / reagent probe, stirring needle and piping may fail to
be cleaned up, affecting results accuracy and precision. The company shall not assume
responsibilities for inaccuracy caused by such actions.

There are 4 kinds of wash liquid:

1. Hitergent wash liquid: It is placed in the wash liquid position of each reagent disk.
After all reagent are added, the reagent probe will pipette hitergent wash liquid in the
wash liquid bottle to wash itself; it pipettes wash liquid three times, at least 100μL
each time.
If you want to wipe all parts of the analyzer or soak cuvette, 2% hitergent wash liquid
should be used.
BC1200 analyzer exchanges the water in the reaction tank once and fill 6ml antibiotic
phosphate-free cleaning solution. If the latter is not filled, the cuvette will present
captive bubbles and the bacteria will propagate in the reaction tank.
2. Alkaline wash liquid: It is placed in the wash liquid tank for cleaning cuvette and in the
wash liquid position of sample disk for cleaning sample probe.
3. Acid wash liquid: It is placed in the wash liquid position of sample disk for cleaning
sample probe when sample cross contamination should be avoided.
4. ISE cleaner: It is used for cleaning protein in the ISE piping, and placed in the the
following position:
BC1200 position E70 of sample disk.
Biossays 240 Plus
user-selected position on the sample & reagent disk.
Biossays 240
6.2 Daily maintenance items
6.2.1 Check water device
Start water purifier and check the conductivity which should be ≤1μs/cm; otherwise
the water purifier manual should be followed to make maintenance.
6.2.2 Check waste liquid tank
1. Confirm the analyzer is turned off.

2. Screw off the waste liquid tank’s cover in a counterclockwise direction, and take
down the cover, waste liquid pipe and waste liquid sensor.
3. Pour away waste liquid.
4. Put the cover, the pipe and the sensor back, tighten the tank lid clockwise.

Warning:
1. Pay attention to the danger of biology infections when you are
operating. Please wear gloves and working clothes to prevent
infection, and if necessary, protective glasses. As for disposal of
waste liquid tanks, you should obey local emission standard, and
consult relevant reagent manufacturers or distributors.
2. Tank top cannot be higher than the waste liquid outlet.
3. The pipe should be inserted into the tank, without bending or
twisting; otherwise concentrated waste liquid will be leaked out.
6.2.3 Check water connection
1. Confirm the analyzed part is powered off.

2. Check there is a leakage in the water connector of the analyzer. If so, remove
leaked water with clean gauze, and check whether the connector is loose. If loose,
tighten it.
6.2.4 Check light waste liquid connection
1. Confirm the analyzer is powered off.

2. Check if there is a leakage in the connector of light waste liquid of the analyzer. If
so, remove leaked water with clean gauze, and check whether the connector is
loose. If loose, tighten it.
3. Check whether the light waste liquid pipe is connected well with drainage system.
Warning:
1. Pay attention to the danger of biology infections when you are
operating. Please wear gloves and working clothes to prevent
infection, and if necessary, protective glasses. As for disposal of
light waste liquid tanks, you should obey local emission standard,
and consult relevant reagent manufacturers or distributors.
2. Waste gauze should be disposed of according to relevant provisions.
Don’t discard carelessly.
6.2.5 Check sample / reagent probe
1. Observe whether sample / reagent probe is bent or dirty.

2. If bent, it is necessary to replace it. See “6.6.2 Replace sample / reagent probe” for
detailed operations.
3. In case of dirty appearance, it is necessary to clean it. See “6.3.1 Clean sample /

reagent probe” for detailed operations.

4. Observe whether there are liquid drops on sample / reagent probe. If any, please
contact our company’s technical service department or local dealer.
5. When you are cleaning sample / reagent probe, observe whether water flows from
the inside wall of sample / reagent probe are consecutive, the flow direction is
appropriate,and the outside wall wash water flow is normal.
6. If the outside wall wash water flow is abnormal, please contact our company’s
technical service department or local dealer.
7. If water flows from the inside wall are abnormal, clean sample / reagent probe.
See “6.6.1 Maintain sample / reagent probe” for detailed operations. If
abnormalities continue after cleaning, please contact our company’s technical
service department or local dealer.
6.2.6 Check stirring needle
1. Observe stirring needle is bent or has dirty appearance.

2. If bent, it is necessary to replace it. See “6.6.3Replace stirring needle” for detailed
operations.
3. In case of dirty appearance, it is necessary to clean it. See “6.3.2Clean stirring
needle” for detailed operations.
4. When washing stirring needle, observe whether stirring needle rotation and water
yield are normal. If abnormal, please contact our company’s technical service
department or local dealer.
6.2.7 Check washer
Observe whether the washer’s needle is bent. If bent, please contact our company’s
technical service department or local dealer.
6.2.8 Check cuvette
1. Observe whether the cuvette is installed correctly and completely. If damaged, a

new one should be used.
2. Check whether the cuvette is loose. If loose, tighten the thumb screws on the
cuvette.

6.3 Weekly maintenance
6.3.1 Clean sample / reagent probe
1. The analysis unit is powered off.

2. Take down the cover of the sample / reagent disk.
3. Gently pull up the rocker arm of the sample / reagent probe to the top, and move it
to make the sample / reagent probe stay in a position convenient for operation.
4. Grip gauze soaked in intensive wash liquid with tweezers and gently wipe surface
of the sample / reagent probe (especially tips) until probe surface is clean.
5. Grip gauze soaked in pure water with tweezers and gently wipe the sample /
reagent probe.
6. After the cleaning, turn the sample/reagent probe above the cleaning pool.
6.3.2 Clean stirring needle
1. Confirm the analysis unit is powered off.

2. Gently pull up the rocker arm of the stirring needle to the top, and move it to make
the stirring needle stay in a position convenient for operation.
3. Grip gauze soaked in intensive wash liquid with tweezers and gently wipe surface
of the stirring needle until surface is clean without dirt.
4. Grip gauze soaked in water with tweezers and gently wipe the stirring needle.
the stirring needle stay in a position above the cleaning pool.
6.3.3 Clean sample / reagent disk

2. Take down the cover of the sample / reagent disk.
3. Take out all containers to hold liquid.
4. Get down the sample / reagent tray.
5. Rinse sample / reagent tray with water, and wipe it.
6. Wipe the inside sample / reagent bin with clean gauze, and when necessary, plus
a little water or disinfectant.
7. After the cleaning, fit sample / reagent disk and tighten the cover.
6.3.4 Clean instrument panel

2. Wipe the analysis unit panel with clean gauze, and when necessary, plus a little
water or disinfectant.

6.4 Monthly maintenance
6.4.1 Clean cleaning pool of sample / reagent probe

to make the sample / reagent probe away from the cleaning pool.
3. Clean the cleaning pool’s interior and surroundings of the sample / reagent probe
with clean swabs.
4. After the cleaning, turn the sample / reagent probe above the cleaning pool.
6.4.2 Clean cleaning pool of stirring needle
1. Confirm the analysis unit is powered off.

the stirring needle stay distance from the cleaning pool.
3. Clean the cleaning pool’s interior and surroundings of the stirring needle with
clean swabs.
the stirring needle stay in a position above the cleaning pool.
6.4.3 Reaction tank and drainage filter screen
This section applies to the instrument model: BC1200.

The contaminated reaction tank or blocked drainage filter screen will cause the test
result inaccurate. Therefore, it is necessary to clean the tank and filter screen every
month.
1. Unscrew the fixing screws of the washer to remove it.
2. Remove the 6 groups of cuvettes and place them in the purified water;
alternatively, unscrew the reaction disk fixing screws to remove the entire disk and
keep it in a dry and clean place.
3. Wipe the light measuring window of reaction tank with the clean and wet gauze
gently (do not scuff the window).
4. Remove the reaction tank drainage filter screen, rinse it with water and then install
it back.
5. After cleaning the reaction tank, install the reaction disk and cuvettes.
6. Install the washer back and fix it.
7. Carry out the cell blank test in the [Photoelectricity maintenance] window. The
acceptable inter-cell difference is between ±3500. The cell blank value should
comply with the requirement before testing.

6.4.4 Water supply filter screen

The water supply filter is to prevent the ion exchange resin or rubber particles
entering the instrument inside pipes. The filter clogging will cause the water supply
insufficient. Therefore, the monthly cleaning is necessary.
1. Close the pure water unit water outlet valve.
2. Switch off the analyzer.
3. Cover the filter cap with the gauze to unscrew the cap and accept the water flows
from the outlet with the water bucket.
4. Take out the water supply filter, rinse it with water and then install it back.
6.5 Semiannual maintenance
6.5.1 Clean cooling fan
As there is dust in cooling fan surface after long-term use of the analyzer, it should be
cleaned once per 6 months.
Cooling fan cleaning:
1. Turn off the analyzer’s main power.
2. A dust collector is used to remove dust in the fan.
As there is dust in dust boot surface of cooling fan after long-term use of the BC1200
analyzer, it should be cleaned once per 6 months.
Cleaning of dust boot:
1. Hold the handle of dust boot at both sides of the fan and unplug the two dust boots
directly.
2. Remove the dust on the boot with the dirt collector.
3. Rinse the boots with the clean water.
4. After wiping with the cloth, install the dust boots back.
6.6 Unscheduled maintenance
6.6.1 Maintain sample / reagent probe
When water flows are found abnormal during the sample / reagent probe cleaning, it
may be caused due to probe block and should be cleaned. The sample / reagent probe
should follow disassembly, cleaning and installation orders.


to make the sample / reagent probe stay in a position of the sample / reagent bin
convenient for operation.
3. Hold the rocker arm’s shell with fingers, pull up and take it down.
4. Screw off the pipe connector.
5. Disassemble the sample /reagent probe.
6. Connect the connector on one end of the probe cleaner with the connector of the
probe. Take a clean standard cup, inject sodium hypochlorite wash liquid and put
the probe’s tip into it. When you pull up the piston to pipette wash liquid, it will be
drained after 5 minutes in the injector. If still blocked, you should pull up and down
the injector’s piston repeatedly when the probe is soaked in hot water for 5
minutes
7. If the probe’s tip has no water out after step 6, it indicates serious blockage. At this
time, the tip should go through acupuncture needle for second cleaning. After the
cleaning, you should repeat step 6 with probe cleaner.
6.6.2 Replace sample / reagent probe
If the sample / reagent probe is damaged or has bent tip, you should replace it in strict
accordance with the following steps.
to make the sample / reagent probe stay in a position of the sample / reagent bin
convenient for operation.
4. Screw off the pipe connector and connection lines.
5. Disassemble the sample /reagent probe.
6. Put a new one into the shell, tighten the pipe connector and plug connection lines.
7. Install the shell in the respective position.
6.6.3 Replace stirring needle
If the stirring needle is damaged or has bent tip, you should replace it in strict
accordance with the following steps.
the stirring needle stay in a position of the sample/reagent bin convenient for
operation.
4. Screw off two screws of the stirring needle with a small cross head screwdriver,
and take it down.

5. Put these two screws in a new stirring needle, align the motor shaft and tighten the
screws.
6. Install the shell in the respective position.
6.6.4 Replace light source lamp
When a light source lamp is burn in, its light quantity will damp, reducing the
analyzer’s accuracy. You should do light intensity check. If it exceeds the range, replace it
immediately.
1. Light intensity check

Click <Photoelectricity maintenance> in the [System Maintenance] window and select
“Light Intensity Check”. When you click <Start> in the [Light Intensity Check] window, the
analyzer will perform light intensity check automatically. If data is lower than 28,000 as
results occur in the mode of AD value, it indicates this light source lamp is burn in, and you
should replace it.
2. Replace light source lamp

a. Prepare a new tungsten halogen lamp.
b. About 30 minutes after the analyzer is powered off (lamp house becomes cool), you
can operate in order to avoid burning.
c. If there is a washer, first remove the fixing screw of the washer to dismantle the
washer. Then loosen counter-clockwise the thumb screw in the center of reaction
disk until the screw comes off the screw hole, and take down the whole reaction
disk.
d. Screw off two fixed terminals of the lamp’s leading wire, and take down the wire.
e. Screw off two fixed screws of the halogen tungsten lamp, and take down the lamp.
f. Change a new lamp in steps opposite to the above. It is necessary to tighten the
screws. The leading wire should not be loose or folded.
g. Install the reaction disk and the washer in their original positions, and turn on the
analyzer.
h. Enter the Service software; after initializing the analyzer, click <Wavelength Factor>
in [Optical System] window to open the [Wavelength Factor Setting] window; then
execute “Calculate Wavelength Factor”, and save the parameter.
i. Enter the user software. When the analyzer is standby, carry out “Light Intensity
Check”. The light quantity value should not be less than 28,000. When it meets the
requirement, you can have a test.

6.6.5 Replace cuvette
1. Semi-permanent cuvette:
If cell blank value is disqualified after the cuvette is cleaned, you should replace a
new cuvette.
Attention:
A new cuvette should be soaked in 2% hitergent wash liquid for 8 hours
before use. Take it out, and install in the reaction disk after a complete
clean. After installed, blank level check should be done. When light
quantity meets requirements, you can have a test.
a) Turn off the analyzer’s power switch.

b) Screw off the washer’s fixed screws with protective gloves, and disassemble the
washer.
c) Remove the thumb screws fixing the cuvettes.
d) Take down the cuvettes.
e) Install the new cuvettes in its position of the reaction disk, and lock it with thumb
screws.
f) Turn off the analyzer’s power switch.
g) Select “Cell Blank Test” in the [Photoelectricity maintenance] window of the
[System Maintenance] window. The differences among cuvettes of test result
should be within ±3,500. When the result of cell blank test meets the requirement,
you can have a test.
2. Disposable cuvette:
Disposable cuvettes need to be replaced after each use.
a) Wait for the analyzer to stop and be in the "Standby" status.
b) In the "Replace Cuvettes" column on the right side of the [Reaction Disk Status]
window, select the cuvette group No. to be replaced and click the <Replace>
button.
c) Wear protective gloves, open the cover of the reaction disk, and remove the
thumbscrews fixing the cuvettes of the corresponding group No.
d) Take down the group of cuvettes.
e) Install the new cuvettes in the same positions on the reaction disk and tighten
screw by hand.
f) After confirming that the replacement of the group of cuvettes has been completed
in the pop-up dialog, the status of the group of cuvettes will be updated in the
[Reaction Disk Status] window.
g) After replacing all cuvettes, cover the reaction disk. Click the <Scan Cuvettes>
button in the [Reaction Disk Status] window to scan all the cuvettes. The
difference between the cell blank data of cuvettes and reference cell blank value
should be within ±3,500. Cuvette that meet requirements can be used for testing.

Warning:
1. Beware of the risk of biological infection and wear gloves and work
clothes during operation to prevent infection, and wear protective
glasses when necessary.
2. For the disposal of waste liquids and waste cuvettes, please comply
with local emission standards, relevant laws and regulations and
consult with related manufacturers or distributors.
6.6.6 Add alkaline wash liquid
 BC1200:
1. Push the instrument rear panel gate open.
2. Pull out the alkaline wash liquid tank bracket.
3. Unscrew the alkaline wash liquid tank cover counterclockwise.
4. Fill the alkaline wash liquid.
5. Tighten the alkaline wash liquid tank cover.
6. Push the alkaline wash liquid tank bracket inside the instrument.
7. Close the instrument rear panel gate.
 Biossays 240 Plus:

1. First dilute the provided alkaline wash liquid with purified water with a ratio of 1:7.
2. Screw off the wash liquid tank’s cover in a counterclockwise direction.
3. Add alkaline wash liquid.
4. Tighten the cover.
6.6.7 Clean vacuum tank

Where the waste solution spills in the vacuum tank, the waste solution in the tank
must be discharged. Otherwise, it will cause the other parts abnormal (in the case of
instrument abnormity, contact the after service person of Snibe in time),
1. Power off the instrument.
2. Remove the analyzer back panel and take out the hose connecting the vacuum
tank bottom.
3. Unplug the hose plug and accept the waste solution flowing out of the tank with
the container such as water bucket.
4. After discharging the waste solution in the vacuum tank, fit the rubber hose plug
back and place the hose in the instrument.
5. Install the back panel.

6.6.8 Water tank

The refrigeration system water tank is in the right front of the instrument while the
constant temperature water tank is at the right side near the lower.
1. Fill pure water to the water tank

The water in the refrigeration system water tank will become dirty after long time and
cause the water cycle failure. In addition, the evaporation will reduce the water level and
consequently impair the normal working of refrigeration system. Therefore, the water
should be replaced once every year.
a) Turn off the general power of the instrument.
b) Open the instrument front right door.
c) Unplug the two rubber hose rubber plugs of the refrigeration system water tank,
place a container under the hose and discharge the pure water in the tank.
d) After discharging the water, fill pure water to the low level hose until the water
flows out of the high level hose.
e) Power on the instrument, wait for a few minutes and fill pure water to the low
level hose until the water flows out of the high level hose. This requires 3L water
approximately.
f) Fit the rubber plug back.
g) Close the instrument door.
2. Discharging the pure water in the constant temperature water tank

The pure water in the tank must be discharged in the case of instrument handling.
a) Turn off the general power of the instrument.
b) Remove the right side cover plate of the instrument.
c) Remove the hose rubber plug.
d) After discharging the water completely, fit the rubber plug back and install the
right side cover plate.

6.7 ISE module maintenance
6.7.1 Components subject to regular cleaning, check and replacement
See Table 6.7-1 for parts to be cleaned regularly and components to be replaced
(based on 8-hour service of the analyzer):
Table 6.7-1Parts to be Cleaned Regularly and Components to be Replaced
(○: regular cleaning, check ●: regular component replacement)

Cycle
Refer
SN Item Dail Timel Wee Monthl Per 2 Per 3 Semia
ence
y y kly y months months nnual
A Std.
1 peristaltic ○
pump pipe
B Std.
2 peristaltic ○
pump pipe
Sample
3 peristaltic ○
pump pipe
4 K+ electrode ●
+
5 Na electrode ●
-
6 Cl electrode ●
2+
7 iCa electrode ●
8 pH electrode ●
Reference
9 ●
electrode
Sampling rigid
10 ○
pipe
Protein
11 ○
removal

6.7.2 Daily maintenance
6.7.2.1 Protein removal
After the ISE test, electrodes may be polluted by protein, fat or bacteria. When it is
over, electrodes should be cleaned up for use in the next day.
When the current day’s testing is finished, place more than 250μL of ISE cleaner in
the sample disk; then click <Calibration> in the [Remove Protein] window of the
[Calibration] window to execute “Remove Protein”.
6.7.2.2 Pipe wash
During the electrode use, the analyzer will do sample test, automatic electrode
maintenance and automatic timing calibration. If it’s turned off in these operations, it may
result in liquid residue in ISE pipe, even electrode soaking in liquid, which will affect the
analyzer’s normal use in the next time. There, it’s recommended to wash ISE pipe with
water before power-off.
1. Select “Pipe Wash” in the [ISE Calibration] window of the [Calibration] window.
2. After the wash, turn off the analyzer.
6.7.3 ISE check
After the long-term use of electrodes, they will be polluted so as to result in inaccurate
results. Thus, the method below should be followed to have a check.
Select “Point Cal.” 10 times in the [ISE Calibration] window of the [Calibration]
window to obtain check results.
Attention:
The difference between two check values of the same electrode should
be less than 0.2.
6.7.4 Replace electrode
Attention:
1. Generally, don’t open the ISE cover, or it may cause poor control
over temperature to result in incorrect results.
2. Electrode replacement and device check should be finished in 1
hour.
After the long-term use of ion-selective electrode, its potential will become small to
lead to poor response, and you should replace with a new electrode.

6.7.4.1 Occasion of electrode replacement
If slope of ISE calibration is abnormal, an alarm will sound. See Table 6.7-2.
Table 6.7-2 Slope Range of ISE Calibration

Slope
+ +
Alarm
K Na Cl- iCa2+ pH
<40mV <40mV <20mV <30mV Abnormal
≤35mV
or >70mV or >70mV or >40mV or >65mV ISE slope
40mV～ 40mV～ 20mV～ 30mV～
>35mV Normal
70mV 70mV 40mV 65mV
When slope of Na+, K+, Cl-, iCa2+ or pH is abnormal up to alarm level, replace with a
new ion-selective electrode.
When slope of Na+, K+, Cl-, iCa2+ or pH electrodes is lower or unstable, replace with
new reference electrodes.
If alarm still sounds or QC test cannot to satisfy requirements with normal slope, it
demonstrates poor electrode response. In such case, it may be caused by pipe pollution
and can be resolved by cleaning.
If ISE calibration value is normal in the previous day, but sharp change of the current
day’s slope, it may result from other reasons except for electrode. Check whether there is
liquid leakage, and blockage and bubbles in the pipe.
6.7.4.2 Methods of electrode replacement
1. Click <Replace Electrode> in the [ISE Status] window of the [Status] window, and
operate in accordance with the dialog.
2. After the electrode is replaced, the system will go through initialization and
electrode calibration because of change of electrode status.
6.7.5 Replace ISE sampling rigid pipe
 BC1200:
1. Open the instrument analysis unit ISE cover plate.
2. Unplug the old rigid pipe and install the new one.
3. If drops occur, wipe them with gauze with water.
4. Install ISE cover plate back.

 Biossays 240 Plus / Biossays 240:

1. Use a tool to remove the panel on the left of reaction disk.
2. Rotate the rigid pipe joint counter-clockwise to remove the old rigid pipe and
replace it with a new one.
3. If drops occur, wipe them with gauze with water.
4. Install ISE cover.
6.7.6 Replace reagent
1. Click <Replace A Std.> or <Replace B Std.> in the [ISE Status] window of the
[Status] window, and operate in accordance with the dialog.
2. After the reagent is replaced, the system will go through pipe perfusion and
electrode calibration because of change of reagent status.


Chapter 7 Troubleshooting
7.1 Data exception
When such data exception is found, it can be confirmed by QC liquid measurement,

repeated measurement and checking analyzer status. Data exceptions and relevant
solutions are listed in the table below.
Table 7.1-1 Data Exception and Solutions
Type Causes Solutions

1. Failure of maintaining the 1. Maintain the analyzer as per the
analyzer regularly. Operating Instructions.
2. Poor quality of water. 2. Water conductivity shall be ≤
1μs/cm.
3. Insufficient wash liquid and 3. Add wash liquid.
poor washing of cuvette.
4. Reagent goes bad or is mixed 4. Replace reagent, store and use it
Poor
with impurity. correctly.
repeatability
5. Crystallization of reagent. 5. Replace reagent.
6. Cross-contamination of 6. Do not put reagents that may cause
analysis assays. cross-contamination at continuous
positions, or adopt
cross-contamination procedures to
avoid.
7. Disqualified samples (e.g. 7. Centrifuge disqualified samples
poor centrifugation). again.
1. Calibration solution is 1. Use calibration solution quickly
concentrated or loses after putting it into standard cup
Poor efficiency. and store it properly.
accuracy 2. Bad reagent formula. 2. Replace reagent.
3. Poor setting of analysis 3. Set up parameters accurately.
conditions.
1. Stray light absorbance does 1. Check if cuvette is clean, and if any
not meet the requirement . dirt adheres to cuvette wall.
2. When absorbance linearity is 2. Check if light quantity meets the
Poor within ±5%, maximum requirement.
absorbance absorbance does not meet 3. Check if cuvette transmittance
the requirement. meets the requirement.
3. Absorbance accuracy is not 4. Replace cuvette.
within the allowable error. 5. Check if pipetting volume accuracy

4. Change of absorbance meets the standard.

stability is greater than 0.01. 6. Please contact our after-sales
5. Coefficient of variation of service personnel if the problem
absorbance repeatability is cannot be solved.
greater than 1.5%.
1. Accuracy of reaction disk 1. Check if reaction disk heating driver
temperature is not within the circuit works normally.
Adverse
required range of set value, 2. Please contact our after-sales
temperature
and fluctuation does not meet service personnel if the problem
the requirement. cannot be solved.
1. Pipetting error exceeds ±5%, 1. Check if gas leak exists in pipeline.
and coefficient of variation 2. Set parameters correctly.
Inaccurate
exceeds 2%. 3. Please contact our after-sales
pump volume
service personnel if the problem
cannot be solved.
1. Sample carryover rate does 1. Use wash liquid provided by our
not meet the requirement. Company.
Poor 2. Coefficient of variation of 2. Please contact our after-sales
performance within-run precision of clinical service personnel if the problem
assays does not meet the cannot be solved.
requirement.
7.2 Instrument faults
Instrument faults and relevant solutions are listed in the table below:
Table 7.2-1 Instrument Faults
Type Causes Solutions

1. Dirty on probe tip. 1. Wipe and clean pipetting probe
Water drop on with alcohol swabs.
probe tip 2. Air leakage in pipe or 2. Check air tightness of pipe and
plunger pump. plunger pump.
1. Wash liquid is in 1. Add wash liquid.
shortage.
2. Air leakage in washer 2. Check pipe joint of washer.
Water drop on
pipe.
washer needle
3. Nozzle or piping 3. Maintain washer and contact our
blockage. after-sales service staff if it is
necessary to replace pipeline.
1. Nozzle or piping 1. Maintain washer and contact our
No liquid flowing
out of washer

2. Purified water 2. Supplementary purified water.

shortage.
1. Nozzle or piping 1. Maintain probe and contact our
No water during
probe washing
2. Purified water 2. Supplementary purified water.
shortage.
Washer nozzle or piping Maintain washer and contact our
Water flowing out of
cuvette
Leakage of inject Poor installation of joint. Re-stall after confirmation of leakage.
pump
1. Poor installation of 1. Re-stall after confirmation of
joint. leakage.
Bubbles in inject 2. Poor exhaust 2. Exhaust air. You can tap on the
pump performance. inject pump lightly to eliminate tiny
bubbles through vibration during
washing.
1. The pure water unit is 1. Switch on the power of pure water
BC1200:
not powered on. unit.
Constant
2. The reaction tank 2. Clean the filter screen.
temperature water
drainage filter screen
does not flow out of
is blocked.
reaction tank when
3. There is air in the 3. Bleed the air.
the tank is clean.
water supply pipe.
BC1200: 1. Water outlet, inlet or 1. Clean the water outlet, inlet or
No water in pipeline clogs. pipeline.
reaction tank or the 2. Reaction tank liquid 2. Contact the after-service
water level is too level detecting sensor maintenance staff for inspection.
high fails.
1. The reaction tank 1. Clean the reaction tank.
water level is low or
BC1200: the tank is dirty.
In reaction tank 2. The reaction tank is 2. Clean the reaction tank after
Air bubbles present cleaned without the powering on the pure water unit.
pure water unit
powered on.


Performance Indicators
Appendix A BC1200 Performance Indicators
Biochemical module
A.2.1 Stray light

Absorbance should not be less than 3.2.
A.2.2 Absorbance linearity range

When relative bias is within ±5%, maximum absorbance should not be less than 2.8.
A.2.3 Absorbance accuracy

It should conform to Table 1.
Table 1 Requirements on Absorbance Accuracy
Absorbance Allowable error
0.5 ±0.025
1.0 ±0.07
A.2.4 Absorbance stability

Variation of absorbance should not be greater than 0.01.
A.2.5 Absorbance repeatability

Expressed with coefficient of variation, it should not be greater than 1.5%
A.2.6 Temperature accuracy and fluctuation

Temperature value should be within ±0.3℃ of set value and fluctuation not greater
than ±0.2℃.
A.2.7 Sample carryover rate

Sample carryover rate should not be greater than 0.5%.
A.2.8 Adding accuracy and repeatability

Test the nominal minimum and maximum sample adding volume and an adding
volume around 5μL. Adding error should not exceed ±5% and coefficient of variation not
exceed ±2%;
Test the nominal minimum and maximum reagent adding volume. Adding error
should not exceed ±5% and coefficient of variation not exceed ±2%.
A.2.9 Within-run precision of clinical assays

Coefficient of variation (CV) of within-run precision should conform to Table 2.
Operating Instructions-EN A-1

Table 2 Requirements on Within-run Precision
Assay Concentration range Coefficient of variation
(CV)
ALT (alanine aminotransferase) 30U/L-50U/L ≤5%
UREA (urea) 9.0mmol/L-11.0mmol/L ≤2.5%
TP (total protein) 50.0g/L-70.0g/L ≤2.5%
ISE module
A.2.10 Accuracy
Accuracy should conform to Table 3.
A.2.11 Precision
Precision should conform to Table 3.
A.2.12 Linearity
Linearity deviation of instrument should conform to Table 3.
A.2.13 Stability
Stability of instrument should conform to Table 3.
A.2.14 Carryover rate

Carryover rate should conform to Table 3.
Table 3 Requirements on Performance of ISE Module

Parameter Accuracy Precision (CV) Linearity (D) Stability Carryover rate
(B) (S) (C)
K+ ≤3.0% ≤1.5% ≤3.0% ≤2.0% ≤1.5%
Na+ ≤3.0% ≤1.5% ≤3.0% ≤2.0% ≤1.5%
Cl－ ≤3.0% ≤1.5% ≤3.0% ≤2.0% ≤1.5%
A.2.15 Appearance and structure

A.2.15.1 Graphic symbols and text on the panel should be accurate, clear, uniform and no
scratches;
A.2.15.2 Fasteners should be connected securely and reliably without looseness;
A.2.15.3 Moving parts should be steady without problems like getting stuck, jump and
significant backlash; the key group should rebound flexibly;
A.2.15.4 Appearance should be neat without crack or scratch;
A.2.15.5 Painted surfaces should have uniform color without obvious color difference;
A.2.15.6 Surfaces of metal parts should be free from obvious pits and burrs;
A-2 Operating Instructions-EN

Appendix B Biossays 240 Plus / Biossays 240 Performance Indicators
B.2.1 Appearance
The following appearance requirements should be satisfied:
a) Appearance should be neat without crack or scratch; text and logo should be clear;
b) Painted surfaces should have uniform color without obvious color difference;
c) Moving parts of the analytical system should be steady without problems like getting
stuck, jump and significant backlash; the key group should rebound flexibly;
d) Surfaces of metal parts should be free from obvious pits and burrs;
e) Fasteners should be connected securely and reliably without looseness;
B.2.2 Stray light

Absorbance should not be less than 3.5.
B.2.3 Absorbance linearity range

When relative bias is within ±5%, maximum absorbance should not be less than 3.2.
B.2.4 Absorbance accuracy

It should conform to Table 1.
Table 1 Requirements on Absorbance Accuracy
Absorbance Allowable error
0.5 ±0.025
1.0 ±0.07
B.2.5 Absorbance stability

Variation of absorbance should not be greater than 0.01.
B.2.6 Absorbance repeatability

Expressed with coefficient of variation, it should not be greater than 1.5%
B.2.7 Temperature accuracy and fluctuation

Temperature value should be within ±0.2℃ of set value and fluctuation not greater
than ±0.1℃.
B.2.8 Sample carryover rate

Sample carryover rate should not be greater than 0.05%.
B.2.9 Adding accuracy and repeatability

Test the nominal minimum sample adding volume 2.0μL and maximum sample
adding volume 35.0μL and an adding volume around 5.0μL. Adding error should not
exceed ±5% and coefficient of variation not exceed 2%;
Operating Instructions-EN B-1

Test the nominal minimum reagent adding volume 20μL and maximum reagent
adding volume 350μL. Adding error should not exceed ±5% and coefficient of variation not
exceed 2%.
B.2.10 Within-run precision of clinical assays

Coefficient of variation (CV) of within-run precision should conform to Table 2.
Table 2 Requirements on Within-run Precision of Clinical Assays
Assay Concentration range Coefficient of variation
(CV)
ALT (alanine aminotransferase) 30U/L-50U/L ≤5%
UREA (urea) 7.0mmol/L-11.0mmol/L ≤2.5%
TP (total protein) 50.0g/L-70.0g/L ≤2.5%
B.2.11 ISE Accuracy

Accuracy of instrument should conform to Table 3.
B.2.12 ISE Precision

Precision of instrument should conform to Table 3.
B.2.13 ISE Linearity

Linearity of instrument should conform to Table 3.
B.2.14 ISE Stability

Stability of instrument should conform to Table 3.
B.2.15 ISE Carryover rate

Carryover rate of instrument should conform to Table 3.
Table 3 Requirements on Performance of ISE
Linearity(D)
Accuracy Precision Correlation Stability Carryover

Parameter Range/
(B) (CV) Deviation coefficient (R) rate (C)
(mmol/L)
(r)
+
K not exceed ≤1.5% 1.5~7.5 ≤3.0% ≤2.0% ≤1.5%
±3.0%
≥0.995
+
Na not exceed ≤1.5% 100.0~180.0 ≤3.0% ≤2.0% ≤1.5%
±3.0%
B-2 Operating Instructions-EN

-
Cl not exceed ≤1.5% 80.0~160.0 ≤3.0% ≤2.0% ≤1.5%
±3.0%
not exceed
≤5.0%or
±5.0%or
2+
iCa ≤1.5% 0.50~2.50 ≤0.05 ≤3.0% ≤2.0%
±0.05
mmol/L
mmol/L
pH not exceed ≤1.5% 6.80~7.60 ≤3.0% ≤2.0% ≤3.5%
±3.0%
Operating Instructions-EN B-3

Biossays Series Operating Instructions-20180911 - Копия - Копия

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Biossays Series Operating Instructions-20180911 - Копия - Копия

Uploaded by

Copyright:

Available Formats

Dear users:

Thanks for choosing our automatic biochemistry analyzer of Biossays™ series!

If you have any questions regarding your Automatic Biochemistry Analyzer,

Shenzhen New Industries Biomedical

Lotus Global Co., Ltd.

Specification Catalog Number

Information about the Product

Information of Operating Instructions

CHAPTER 1 SYSTEM OVERVIEW ................................................................................................. 1-1

CHAPTER 2 INSTRUMENT INSTALLATION ................................................................................... 2-1

2.1 STORAGE AND TRANSPORTATION REQUIREMENTS .............................................................................2-1

CHAPTER 3 WORKING PRINCIPLE............................................................................................... 3-1

3.1 TEST PRINCIPLE ..........................................................................................................................3-1

CHAPTER 4 ROUTINE OPERATION PROCESS ............................................................................... 4-1

4.1 OPERATION PROCESS ..................................................................................................................4-1

CHAPTER 5 SOFTWARE FUNCTION............................................................................................. 5-1

5.1 STATUS DISPLAY LIGHT .................................................................................................................5-1

CHAPTER 6 SYSTEM MAINTENANCE .......................................................................................... 6-1

6.1 PREPARATIONS BEFORE SYSTEM MAINTENANCE ................................................................................6-1

Operating Instructions-EN III

6.7.5 Replace ISE sampling rigid pipe ......................................................................................6-16

CHAPTER 7 TROUBLESHOOTING ................................................................................................ 7-1

7.1 DATA EXCEPTION ........................................................................................................................7-1

APPENDIX A BC1200 PERFORMANCE INDICATORS...................................................................... A-1

APPENDIX B BIOSSAYS 240 PLUS / BIOSSAYS 240 PERFORMANCE INDICATORS ...........................B-1

Please read the Instructions thoroughly before using the analyzer.

1. Light and heat

5. Preventing the laser burning caused by the barcode reader

7. Waste liquid disposal

8. Disposal at the end of life

9. Computer virus protection

■ Precautions for use

4) Dust may gather on surface of the instrument after long-term

5. Sample, reagent, calibration solution and QC liquid

Chapter 1 System Overview

Biossays series automatic biochemistry analyzer (the Analyzer) is a discrete,

1.2 Instrument Specifications

Table 1.2-1 BC1200 Instrument Specifications

BC1200 Automatic Biochemistry Analyzer

Performance index Standard specifications

600 tests per hour at constant rate; up to 900

Basic 88 biochemical assays and 4 ISE assays can be

Quality control Lot quality control, monthly quality control

1 sample tray, 115 positions (50 for routine

serum, plasma, urine, cerebrospinal fluid and

Sample volume 2.0~35.0μL

Sample liquid level

Operating Instructions-EN 1-1

R1 and R2 reagent tray with refrigeration

Supporting 5 barcode types (Code128, Code39,

Reagent storage The reagent is kept at 5℃~ 15℃ and adopts

Reagent level sensor Integrated with the reagent probe

Reaction cell type Divided type

6 groups; 20 for each group, 120 cuvettes in

Optical path of cuvette 6mm

Reaction temperature 37℃±0.3℃, fluctuation not greater than ±0.2°C

Stirring mode Solely stirring after reagent charging

Wash cuvette, reagent probe, sample probe and

Light source 20W/12V long life tungsten halogen lamp

Wavelength accuracy ±2nm

Absorbance range 0~3.0ABS

Interface Standard RS-232

1-2 Operating Instructions-EN