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BK-280
User Manual
Foreword
Description -I
Description
Revision statement
This document applies to the latest and higher version of the software listed.
File Name: Automatic chemistry analyzer User Manual
Version: V3.0
Last update: Oct., 2021
Contents: This manual describes in detail the use of the product, function and use of
methods to ensure that the clinical laboratory technician to carry out the smooth
detection of the daily work, recorded the relevant daily maintenance content. The
pictures in this manual are only for illustrative and illustration and not intended for
any other purpose. The actual picture is subject to the product. In this manual, the
mouse operation as an example, explain the various methods of operation.
Description -II
Description
Intellectual property
The intellectual property of this user manual and its corresponding products belongs to
Biobase Biodustry (Shandong) Co., Ltd. (hereinafter referred to as “our company” or
“us”).
No individual or organization may reproduce (including photographing, reprinting,
transcription, etc.), copy, modify or translate any part of this manual without the prior
written consent of our company.
If the contents of this user manual are changed, the user will not be notified
Description -III
Description
Statement
Description -IV
Description
User
The readers of this user manual are the following laboratory specialists.
Personnel who perform daily operations of the system.
Personnel performing system maintenance and troubleshooting.
Personnel who learns system operation.
Please read the contents of this user manual carefully before using the product and use
the product correctly. Please keep this user manual in a safe place so that you can
check it out at any time. If the precautions stated in this user manual are not followed
during use, no warranty will be given.
Description -V
Description
Transportation
When the instrument is in the packaging status, take care to prevent rain and sun
exposure during transportation to prevent severe impact, heavy pressure and dumping.
Note:
If the instrument has been unpacked and needs to be moved, repack the
instrument before shipping.
Storage
The packaged instrument should be stored at -10℃~40℃, relative humidity is not
more than 85%, no corrosive gas and well ventilated environment.
Description -VI
Description
The warranty period of the purchased product is subject to the sales contract. Supplies
are not warranted for consumable.
The following conditions will not be covered by the warranty.
The customer has not filled in and returned the equipment warranty card within
30 days after the installation acceptance is completed.
The serial number of the equipment provided by the customer is incorrect.
Malfunctions and damages caused by violation of the usage, precautions and
intended use described in this user manual.
Failure and damage caused by operations such as inspection professionals,
doctors or laboratory personnel trained by our company or the agent designated
by our company.
Failure and damage caused by repair or modification of the other company.
Failure and damage caused by use with instruments other than those specified
by our company.
Failure and damage caused by the inconsistency between the operating
environment and the operating environment (power supply conditions,
installation environment, etc.) specified by our company.
Failure and damage caused by irresistible natural disasters.
Failure and damage caused by our company's unintentional movement or
transfer (transport) after the equipment is installed.
If the instrument fails due to the use of consumables such as reagents not
approved by our company, it is not within the scope of our company providing
maintenance services.
Other failures caused by non-products themselves.
During the warranty period, if there is a failure caused by defects in the design
and manufacture of our company, the repair will be carried out without
compensation. Our company will take corresponding countermeasures
according to the fault content.
After the warranty period expires, our company can continue to provide
fee-based repair services.
Description -
Description
After-sales service
Description -
Preface
This user manual describes in detail the use, function and usage of the product, and
introduces the product according to the most complete configuration to ensure that the
clinical laboratory technicians engaged in the test successfully carry out the daily
inspection work and record the relevant daily maintenance contents. Content may not
apply to the product you purchased. If you have any questions, please contact us.
Before using this product, please read and understand the contents of this user manual
to ensure that the product can be used correctly.
The pictures in this user manual are for illustrative purposes only and are for no other
purpose. The actual picture is subject to the product.
This user manual includes the following sections:
Description page
Preface
Security Information
Chapter 1 System Overview
Chapter 2 Basic Operation
Chapter 3 System Setting
Chapter 4 Calculation Method
Chapter 5 Reagent Application
Chapter 6 Calibration Test
Chapter 7 QC Test
Chapter 8 Sample Test
Chapter 9 Data Processing
Chapter 10 Item Parameters
Chapter 11 System Function
Chapter 12 LIS Transmission Operation Method
Chapter 13 Maintenance
Chapter 14 Alarm and Fault Handling
Appendix
Catalogue
Catalogue
Foreword ......................................................................................................................................................... I
Security Information ....................................................................................................................................... I
1 System Overview ........................................................................................................................................ 1
1.1 Installation Requirements and Steps ................................................................................................ 2
1.1.1 Installation Requirements ...................................................................................................... 2
1.1.2 Instrument Installation........................................................................................................... 7
1.2 System Connection........................................................................................................................... 9
1.2.1 Overall Structure ................................................................................................................. 11
1.2.2 Reagent&sample Processing System .................................................................................. 14
1.2.3 Reaction System .................................................................................................................. 20
1.2.4 Cleaning System.................................................................................................................. 22
1.2.5 Mixing System .................................................................................................................... 23
1.2.6 Photoelectric Colorimetric System...................................................................................... 24
1.2.7 Operation System ................................................................................................................ 25
1.2.8 Peripheral Equipment .......................................................................................................... 25
1.2.9 Accessories and Consumables ............................................................................................ 25
1.2.10 Laboratory Water Purifier ................................................................................................. 25
1.3 Optional Modules ........................................................................................................................... 25
1.4 Software Introduction and Operation ............................................................................................. 26
1.4.1 Software Interface ............................................................................................................26
1.4.2 Mouse Usage ....................................................................................................................... 30
1.5 System Parameter ........................................................................................................................... 30
2 Basic Operation ........................................................................................................................................... 1
2.1 Operate Chart ................................................................................................................................... 2
2.2 Check Before Power on ................................................................................................................... 2
2.2.1 Check the Water Supply ........................................................................................................ 2
2.2.2 Check the Power Supply ....................................................................................................... 2
2.2.3 Check Printer Paper............................................................................................................... 2
2.2.4 Check Waste Liquid Connection........................................................................................... 3
2.2.5 Inspection of Probes .............................................................................................................. 3
2.3 Turn on Analyzer ............................................................................................................................. 3
2.3.1 Turn on the Power ................................................................................................................. 3
2.3.2 Software ................................................................................................................................ 4
2.4 Instrument Status Confirmation ....................................................................................................... 6
2.5 Preparation for Reagent.................................................................................................................... 6
2.5.1 Preparation for Reagent ......................................................................................................... 7
2.5.2 Loading Reagent Manually ................................................................................................... 7
2.6 Calibration Test .............................................................................................................................. 10
2.6.1 Calibration Testing .............................................................................................................. 10
2.6.2 Prepare Calibration Products ............................................................................................... 11
2.6.3 Start Calibration Test .......................................................................................................... 12
2.7 QC .................................................................................................................................................. 12
2.7.1 QC Test ............................................................................................................................... 12
2.7.2 Prepare QC Product............................................................................................................. 13
2.7.3 Start QC Testing .................................................................................................................. 13
2.8 Sample Testing ............................................................................................................................... 14
2.8.1 Regular Sample Testing ...................................................................................................... 14
2.8.2 Preparing Regular Samples ................................................................................................. 16
2.8.3 Test Start ............................................................................................................................. 17
2.9 Emergency Sample Test (STAT) ................................................................................................... 17
2.9.1 Emergency Sample Input .................................................................................................... 17
2.9.2 Preparing Emergency Sample ............................................................................................. 18
Catalogue -1
Catalogue
13 Maintenance .............................................................................................................................................. 1
13.1 Overview ........................................................................................................................................ 2
13.1.1 Introduction ......................................................................................................................... 2
13.1.2 Accessories Information ...................................................................................................... 2
13.1.3 Maintenance Supplies and Tools......................................................................................... 3
13.2 Regular Maintenance ..................................................................................................................... 4
13.2.1 Introduction ......................................................................................................................... 4
13.2.2 Maintenance Period Definition ........................................................................................... 4
13.2.3 Maintenance Contents ......................................................................................................... 5
13.3 Daily Maintenance ......................................................................................................................... 6
13.3.1 Check Probe / Stirrer / Cleaning Needles / Cleaning Tank ................................................. 6
13.3.2 Check Pure Water Connection ............................................................................................ 8
13.3.3 Check Waste Connection .................................................................................................... 8
13.3.4 Cuvette Detection ................................................................................................................ 9
13.3.5 Water Pipe Maintenance ................................................................................................... 10
13.4 Weekly Maintenance .................................................................................................................... 10
13.4.1 Cleaning the Out Walls of Probes ..................................................................................... 10
13.4.2 Cleaning Condensed Water ............................................................................................... 12
13.5 Monthly Maintenance .................................................................................................................. 12
13.5.1 Cleaning Tanks.................................................................................................................. 12
13.6 Maintenance Every Three Months ............................................................................................... 13
13.6.1 Replacing the Cuvettes ...................................................................................................... 13
13.6.2 Cleaning the Reaction Tank .............................................................................................. 15
Operation steps............................................................................................................................................. 15
13.7 Maintenance Every Six Months ................................................................................................... 15
13.7.1 Replacing the Light Source ............................................................................................... 15
Operation steps............................................................................................................................................. 17
13.8 Unscheduled Maintenance ........................................................................................................... 19
13.8.1 Cleaning the Panels ........................................................................................................... 19
Operation steps............................................................................................................................................. 20
13.8.2 Cleaning Reagent & Sample Tray ..................................................................................... 20
13.8.3 Cleaning the Inner Wall of Probes .................................................................................... 21
13.8.4 Cleaning the Inner Wall of Cleaning Needles ................................................................... 26
13.8.5 Replacing the Sampling Probe .......................................................................................... 29
13.8.6 Replacing the Stirrer.......................................................................................................... 30
13.8.7 One key auto gain calibration............................................................................................ 33
13.8.8 Replacing the Cuvette ....................................................................................................... 35
13.8.9 Add Coolant ...................................................................................................................... 36
13.8.10 Add Cleaning Solution C ................................................................................................ 37
14 Alarm and Fault Handling ......................................................................................................................... 1
14.1 Troubleshooting Methods .............................................................................................................. 2
14.1.1 Introduction ......................................................................................................................... 2
14.1.2 Observing Instrument Failure Prompt ................................................................................. 2
14.2 Instrument Faults and Handling ..................................................................................................... 3
Appendix A: Electrical Schematic Diagram ................................................................................................... I
Appendix B: Water System Diagram ............................................................................................................. II
Appendix C: Reagents Parameter Sheet....................................................................................................... III
Appendix D: Cross Contamination Reference Sheet .....................................................................................V
Catalogue -5
Security Information
This chapter introduces the safety symbols used in the user manual and their
meanings. It summarizes the safety hazards and precautions when using the
instrument, as well as the labels and specific meanings attached to the instrument,
and lists the components included in the instrument. It also lists whether the
content of toxic and harmful substances or elements contained in each component
meets the relevant standards.
Security Information
Safety symbol
Various safety symbols are used in this user manual and the analyzer to remind
you of the things you need to be aware of during operation. As shown in the
following table:
Symbol Sign language Description
In all cases marked with this warning mark it is
necessary to consult the user manual in order to ascertain
the nature of the potential hazard and any action that
Caution
must be taken.If you do not follow the instructions in the
user manual to use the device, the protective measures
provided by the device may fail.
Used for reagent&sample probes and waste drains.
Biological
Indicates a risk of biological infection, and if not
infection risk
followed, there may be a risk of biological infection.
Caution, hot Used for halogen lamp position. Indicates a burn hazard
surface and may be burnt if contacted or not followed.
Used to indicate a static-sensitive device or to indicate a
Electrostatic
device or connector that has not been tested for
sensitive device
antistatic.
Used for the position of moving parts such as sample
arm, stirring arm, cleaning mechanism, etc.. Indicating
Be careful to get potential danger, forbidden to touch the moving parts
involved in during operation to avoid getting involved in, if not in
accordance with the instructions, may cause personal
injury.
Protective For internal and external grounding. Please ensure that
conductor terminal the instrument is well grounded.
At the nameplate position. Indicates manufacturer
Manufacturer
information.
Refer to the At the nameplate position. For other information, see the
instructions user manual.
In vitro diagnostic At the nameplate position. Indicates that the medical
instrument instrument is an in vitro diagnostic medical instrument.
European
At the nameplate position. Represents the authorized
Authorized
representative of the European Union.
Representative
At the nameplate position. Represents the authorized
CE mark
representative of the European Union.
Indicates correct upright position of the transport
This way up
package.
Contents of the transport package are fragile therefore it
Fragile
shall be handled with care.
Safety precautions
Introduction
For use of this instrument safely, please read the following safety precautions
carefully. Any operation that violates the following safety precautions may result
in personal injury or damage to the instrument.
Caution:
In all cases marked with this warning sign, the user manual is
required to clarify the nature of the potential hazard and any
countermeasures that must be taken. If you do not follow the
instructions in this user manual, the protective measures provided
by this instrument may be invalid.
Waste treatment
Waste treatment:
Some substances in reagents, controls, calibrators, cleaning
solutions, and waste liquids are subject to pollution regulations
and emission standards. Please comply with local emission
standards and consult the relevant reagent manufacturer or
distributor.
When handling waste, be sure to wear gloves, wear overalls to
prevent infection, and wear protective glasses if necessary.
System Information -
Security Information
System Information -V
Security Information
Operational precautions
Introduction
In order to use the instrument correctly and effectively, please read the following
precautions carefully.
Instrument use
Caution:
This instrument is used to quantitatively analyze the clinical
chemistry of serum, plasma, urine, cerebrospinal fluid and other
samples.
When considering clinical results based on the results of the
analysis, please consider clinical symptoms or other test results.
Use environment
Be careful:
The electromagnetic environment should be evaluated before
operating the equipment.
Please install the instrument correctly according to the
installation environment specified in the user manual. Do not
place the device in a location where it is difficult to operate the
disconnect device. Installation and use of this instrument outside
of the specified conditions may result in unreliable results and
may result in damage to the instrument.
If you need to change the system status, please contact our
company's customer service center or distributor in your area.
System installation
Caution:
This product is a permanently connected device that uses
switches and circuit breakers as disconnect devices. In order
not to affect the normal operation of the instrument, before
installation, ensure that the building in the installation location
is equipped with a switch or circuit breaker that meets the
requirements of IEC 61010-2: 2001 as the disconnect device.
The switch or circuit breaker in the building should clearly
indicate that the switch or circuit breaker is the disconnect
device of the instrument.
System Information -
Security Information
Instrument use
Be careful:
Please follow the instructions in the user manual to use the
instrument. Improper use may result in inaccurate
measurements and may even result in damage to the instrument
or personal injury.
Before using the instrument for the first time, please set the
calibration and then carry out QC to confirm that the instrument
is working properly.
When using the instrument, QC procedures must be performed,
otherwise the reliability of the results cannot be guaranteed.
Do not open the sample/reagent cover during the analysis
The network port of the analyzer is set to be connected to the
network port of the computer. Do not connect to cables other
than any other device. Please use the dedicated cable provided
by our company to connect the analyzer to the computer.
The computer is a platform for operating the instrument-specific
operating software. Installing any software or hardware other
than our company's designated content on this computer may
prevent the instrument from functioning properly. Do not run
other software while the instrument is in operation.
Computer viruses can destroy software and data. Please do not
use your computer for other purposes or to connect to the
Internet.
Do not touch your computer's monitor, mouse, or keyboard with
wet or chemically-friendly hands.
Do not turn the power switch back on within 10 seconds of
turning off the analyzer's total power, otherwise the instrument
may enter protection. If the instrument enters the protection
status, please turn it off and then turn it on again.
System Information -
Security Information
Parameter settings
Be careful:
The instrument needs to set parameters such as sample size,
reagent amount, and measurement wavelength. When setting
these parameters, please follow the instructions in the user
manual and refer to the instructions provided with the reagents.
Instrument maintenance:
Be careful:
Follow the instructions in the user manual to maintain the
instrument. Improper maintenance may result in incorrect
analysis and may even result in damage to the instrument or
personal injury.
The instrument may be placed for a long time and may have
dust on the surface. When cleaning, use a clean soft cloth
soaked in water, wring it out gently, and if necessary, dip a
small amount of soap. Do not use organic solvents such as
alcohol. After cleaning, dry the surface with a dry cloth.
Before cleaning, please turn off all power to the instrument and
unplug the power cord. During the cleaning process, take
necessary measures to prevent water droplets from entering the
instrument, otherwise the instrument may be damaged or
personal injury.
Check the main components, such as replacement of halogen
lamps, reagent&sample probes, stirrer, and injection
components, and calibration analysis must be performed.
If the instrument needs to be repaired due to malfunction, please
contact our company customer service center. During
maintenance, the instrument may need to be taken out of service
or transported. Please be careful to avoid biological hazards,
electric shock hazards, and moving parts hazards due to
maintenance.
When replacing the light source lamp, it is necessary to wait for
more than 20 minutes after the power is turned off to perform
the lamp replacement operation. Otherwise, the high
temperature light source lamp and the light source box may
cause burns.
System Information -
Security Information
Sample
Be careful:
Use a complete serum sample and a urine sample that does not
contain suspended solids. If the serum sample contains fibrin,
or if the urine sample contains insoluble impurities such as
suspended solids, it may block the reagent&sample probe and
affect the analysis results.
Drugs, anticoagulants, preservatives, etc. present in the sample
may interfere with certain analytical results
Hemolysis, jaundice, chylomicron, etc. in the sample may affect
the analysis results. It is recommended to do a sample blank
test.
Please use the correct sample storage measures. Improper
sample storage measures may alter the composition of the
sample and result in incorrect analysis results.
To prevent the sample from evaporating, do not leave the
sample open for a long time. If the sample evaporates, it may
result in incorrect analysis results.
Some samples may not be analyzed based on test parameters
and reagents used. For these samples, please consult the reagent
manufacturer or distributor and the distributor of our company.
The sampling quantity is required for the analysis of this
instrument. When sampling, determine the appropriate sample
size according to the instructions in this user manual.
Before analyzing, please confirm that the sample is placed in
the correct sample position, otherwise you may not get the
correct result.
Data backup
Note:
The instrument has the function of automatically storing data
on the computer's hard disk, but the computer hard disk data is
deleted or the hard disk is damaged due to other reasons, which
may result in data being unrecoverable. Please periodically
back up the analysis data and measurement parameters to other
mobile storage devices.
System Information -
Security Information
System Information -
1 System Overview
Optional module
System specification
System Overview
Pure water
bucket is
connected with Power Supply
the water inlet Socket
by the TPU
pipe ,and level
detection of
float switch. The power socket analyzer using
Monitor:17inches or more,
needs good grounding (at least
resolution is not less than
three 5A socket can be used.)
1366*768.
System Overview -2
System Overview
outlet port 1 and 2 is connected to the waste liquid tank or the waste liquid discharge outlet
through the corresponding outlet pipe.
1.1.1.1 Installation space requirements
In order to facilitate the operation, maintenance and repair of the instrument, the analyzer
must meet the following conditions during installation:
The distance between the left and right sides of the instrument and the wall should
be no less than 500mm.
The distance between the rear panel and the wall of the instrument should be no less
than 500mm.
The distance between the front of the instrument and other instruments should be no
less than 1000mm.
Guarantee the space for the waste liquid device and the pure water supply device
during installation.
System Overview -3
System Overview
Caution:
Protective grounding must be good to prevent electric shock and instrument
failure.
System Overview -4
System Overview
frequency: 15kHz~80MHz
Radio frequency
IEC 61000-4-6 Level: 3V A
conduction
modulation: 80%AM@1kHz
System Overview -5
System Overview
Caution:
The accuracy of normal operation and test data cannot be guaranteed for the
instrument in environments other than those described above. If the
temperature and humidity do not meet the above requirements, please use
air conditioning equipment and humidification equipment.
The instrument generates heat during operation and is discharged through
the rear of the instrument. The working environment should be well
ventilated and ventilation equipment should be used if necessary. However,
airflow should be avoided to blow directly to the instrument, otherwise it
may affect the accuracy of the instrument test.
Caution:
The water quality must meet the water supply requirements. Otherwise,
insufficient water purity may affect the test results.
Ensure that the water supply hole and pipeline installation of the instrument should be kept
unobstructed. In addition, the inlet of the L-frame of the instrument should be higher than
the pure water bucket, and the height difference from the liquid level of the feed water
should be less than 50cm.
Ensure that the drainage hole and pipeline installation of the instrument should be kept
unobstructed, and the outlet of the instrument L frame should be higher than the waste
System Overview -6
System Overview
liquid barrel mouth (or special discharge port for waste liquid), and the length of the waste
pipe should not exceed 2m.
Biological infection risk:
Dispose of the waste liquid from the instrument in accordance with local
discharge standards. When installing the drain line, be sure to wear gloves,
wear overalls to prevent infection, and wear protective glasses if necessary.
System Overview -7
System Overview
System Overview -8
System Overview
Communication line
1
1
5 7
6 8
16
10
17
15
9
18
11 13
12
15
14
1 19
No Name Note
1 Top cover Protect the sampling system, stirring system and reaction system.
Here you can observe the working conditions of the internal
2 Observation window
systems, such as sampling system ,stirring system, etc.
3 Front panel Strike when maintenance the machine.
Bottom cabinet
4 Table and lockers.
(Optional)
5 Alarm indicator lamp Liquid level alarm and temperature alarm.
6 Right panel Strike when adding coolant and maintenance water system.
7 Power switch Operation switch and cooling switch.
8 Left panel Power switch is located on the left side panel.
Connect grounding cable, water alarm float switch and water tube
9 L-type support
connection.
10 Power panel Open or close power supply and power cable connection.
11 Earth stud Used to connect grounding cable.
12 Aviation joint Connect water alarm float switch to alarm purifier and waste water.
13 Vent Used for the gas out of the pure water tank.
14 Outfall Connect armored tube, empty waste water.
15 Inlet Connect silicone tube, provide purifier water.
Communication
16 Used to connect analyzer and PC.
interface
17 Fuse Protect the safe operation of the circuit.
18 Main switch Used to control the main power of the analyzer.
19 Power cable Connect power supply.
3
4 6
5
2
1
2
11 12 13 14 15 16 17 18 19
1-Circuit board, 2-Water L frame, 3-R&S arm, 4-Stirring arm, 5-cleaning tank,
6-Pinboard of AD, 7-Halogen lamp, 8-Terminal block, 9-Optical component, 10-Cleaning arm,
11-Baseplate, 12-R&S tray, 13-Pinboard, 14-Sample pump, 15-cleaning tank, 16-Coolant tank,
17-Reaction tray, 18-Pure water tank, 19-Pump and valve component, 20-Circulating pump
Figure 1-17 Instrument structure
Sample tube
Cooling
assembly
Reagent bottle
Stepping
motor
1
3
2
5
2
3
2
7
3
8
4
9
10
11
12
5
Nut
Up fixed screw
Spring
Adapter sleeve
Anti-collision base
can calculate the remaining amount of reagent by the distance the sampling needle
descends, and display the remaining reagent in the [Reagent Information] interface. As
shown in Figure 1-23.
Click " ", initialization process is the same as the power on process.
During the sampling process, the sampling needle first detects the liquid level and then
continues to descend a certain distance to suck the sample or reagent.
When check movement, click "instrument check" button, as Figure 1-24 shown, R&S tray
and rotating to a certain number. Click the buttons in the figure to check the position of the
sampling needle in the cleaning position, reagent &sample tray and reaction cup.
Gas outlet
Coolant inlet
Incubator
Peltier
Fixed film