BKP2000 User Manual

Fluorescence Immunoassay Analyzer
BKP2000
Instruction Manual
BIOBASE POCT CO.,LTD

BIOBASE POCT CO.,LTD Fluorescence Immunoassay Analyzer BKP2000
目录
Product Instruction ..................................................................................................................................................1
Intellectual property rights ..............................................................................................................................2
Statement .........................................................................................................................................................3
Use Objects ..................................................................................................................................................... 4
Safety Symbols ............................................................................................................................................... 5
Safety Notes .................................................................................................................................................... 6
Operation precautions ..................................................................................................................................... 9
Warranty and Maintenance Services ............................................................................................................ 14
After-sales service and contact details ..........................................................................................................16
Foreword ............................................................................................................................................................... 17
1. Product Overview ............................................................................................................................................. 18
1.1. Instrument introduction ......................................................................................................................... 18
1.2. Main structural composition .................................................................................................................. 18
1.3. Scope of application ...............................................................................................................................21
1.3.1. Intended Uses ..............................................................................................................................21
1.3.2. Applicable Items ......................................................................................................................... 21
1.3.3. Intended use environment ...........................................................................................................21
1.4. Basic principle ....................................................................................................................................... 21
1.5. Software ................................................................................................................................................. 23
1.6. Network Security ................................................................................................................................... 23
1.7. Contraindications ................................................................................................................................... 24
2. The basic parameters and the conditions of use ............................................................................................... 25
2.1. The basic parameters ..............................................................................................................................25
2.2. Function ................................................................................................................................................. 26
2.3. Transport and storage conditions of the instrument .............................................................................. 26
3. Instrument installation ...................................................................................................................................... 27
3.1. Package .................................................................................................................................................. 27
3.2. Unpack ................................................................................................................................................... 27
3.3. Packing List： ....................................................................................................................................... 27
3.4. Installation requirements ....................................................................................................................... 28
3.4.1. Installation Environment ............................................................................................................ 28
3.4.2. Supply Voltage Requirements .....................................................................................................28
3.4.3. Accessories connection ...............................................................................................................29
3.4.4. Connect the power cable .............................................................................................................29
3.4.5. Thermal printing paper installation rules ................................................................................... 29
3.4.6. Start-up Procedure ...................................................................................................................... 30
3.4.7. Shutdown Procedure ...................................................................................................................30
3.4.8. LIS connection operation procedures .........................................................................................31
4. Operation interface instructions ........................................................................................................................32
4.1. Item interface function description ........................................................................................................32
4.2. Test interface function description .........................................................................................................33
4.2.1. Temperature control range setting operation procedure .............................................................34
4.2.2. Sample type setup procedure ......................................................................................................34
I
4.2.3. Patient information, doctor information setting operating procedures ...................................... 35
4.2.4. Quick Test Operating Procedure .................................................................................................36
4.3. Record interface function description ....................................................................................................36
4.3.1. Test Record View Details ........................................................................................................... 37
4.3.2. Manual printing procedure for test records ................................................................................ 37
4.4. QC interface function description ..........................................................................................................38
4.5. User interface function description ........................................................................................................39
4.6. System interface function description ................................................................................................... 40
4.6.1. About ...........................................................................................................................................40
4.6.2. Test Set ........................................................................................................................................40
4.6.3. Lis/His .........................................................................................................................................41
4.6.4. Print Set .......................................................................................................................................41
4.6.5. System Set ...................................................................................................................................42
4.6.6. User ............................................................................................................................................. 43
4.7. Pwr ......................................................................................................................................................... 43
5. Item Test Operation Procedures ....................................................................................................................... 44
5.1. Power On ............................................................................................................................................... 44
5.2. Sample Test Information Settings ..........................................................................................................44
5.3. Read item ID information ......................................................................................................................45
5.4. Sampling ................................................................................................................................................ 45
5.5. Add sample .............................................................................................................................................46
5.6. Detect ..................................................................................................................................................... 46
5.7. Result Output ......................................................................................................................................... 47
6. Cleaning and Disinfection ................................................................................................................................ 48
7. Instrument Care and Maintenance .................................................................................................................... 50
7.1. Maintenance Daily .................................................................................................................................50
7.1.1. Check the loading card position ................................................................................................. 50
7.1.2. Check the discard bin ..................................................................................................................50
7.1.3. Check the printing paper .............................................................................................................50
7.2. Maintenance Weekly ..............................................................................................................................51
7.2.1. Clean the printer ......................................................................................................................... 51
7.2.2. Clean the discard bin .................................................................................................................. 51
7.2.3. Clean the loading card position .................................................................................................. 51
7.2.4. Clean the outside of the instrument ............................................................................................ 51
7.3. Keep air circulation ................................................................................................................................52
7.4. Keep the power supply stable ................................................................................................................ 52
7.5. Overheating protection .......................................................................................................................... 52
7.6. Other maintenance ................................................................................................................................. 53
7.7. The key to maintenance of System Hardware ....................................................................................... 53
8. Quality Control and Calibration ....................................................................................................................... 54
8.1. Quality Control ...................................................................................................................................... 54
8.2. Calibration ..............................................................................................................................................54
9. Troubleshooting Guidelines ..............................................................................................................................55
9.1. Analysis and treatment of the reasons why the whole machine does not work .................................... 55
9.2. The instrument is turned on,but the display is black .............................................................................55
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9.3. The instrument failed to obtain ID information .................................................................................... 56
9.4. Instrument cannot print test results ........................................................................................................56
9.5. Individual test results show that no sample has been added ................................................................. 56
10. Accessories list ................................................................................................................................................60
11. After Sales Service, Repair and Destruction ...................................................................................................61
III
BIOBASE POCT CO.,LTD Fluorescence Immunoassay AnalyzerBKP2000
Product Instruction
Thank you for choosing Fluorescence Immunoassay Analyzer (Hereinafter
referred to as the instrument) of BIOBASE POCT CO.,LTD. This instrument is an
immunofluorescence automatic detection system based on the principle of
photoelectric detection, which needs to be used with special fluorescent
immunoreagents. It is widely used in many fields such as disease detection, medical
care, epidemic monitoring, food inspection and quarantine. To reduce the risk of fire,
electric shock and personal injury, please read and understand all instructions, follow
the warnings and instructions indicated on the instrument itself, and always follow
basic safety precautions. The protection provided by the equipment may be impaired
if the equipment is used in a manner not specified by the manufacturer. In all cases
marked with a warning sign, the instruction manual should be consulted to clarify the
nature of the potential hazard and any countermeasures that must be taken.
This instruction manual is applicable to the model BKP2000, and the actual
interface operation shall prevail.
Date of preparation/revision of the manual:June 20, 2022
Manual version number: V1.0
This manual gives the following two safety warning signs to guide the
instrument operator to avoid injury or damage to the instrument and to obtain wrong
test results. In order to remind the operator to avoid potentially dangerous and
hazardous conditions, we have given different prompt signs depending on the degree
of hazard of the operation.
WARNING: Failure to follow the operating procedures may result in

greater harm to the operator, the environment, or both.
NOTE: Emphasizes the operation method that must be followed to avoid

possible danger or damage to the instrument and possible erroneous test results.
NOTE: Emphasize important information.

All personnel who may use, maintain, move and maintain the instrument should
read this manual carefully. If any unexpected failure occurs during the operation and
use of the instrument, please refer to the contact information in this manual and call
the company for technical support.
1
Intellectual property rights
The intellectual property rights of this instruction manual and its corresponding
products belong to BIOBASE POCT CO.,LTD.
BIOBASE POCT CO.,LTD. All rights reserved
Without the prior written consent of the company, no individual or organization
may copy (including any means of photography, reprint, transcription, etc.), copy,
modify or translate any part of this instruction manual.
If the contents of this manual are changed, the user will not be notified separately.
2
BIOBASE POCT CO.,LTD Fluorescence Immunoassay AnalyzerBKP2000
Statement
BIOBASE POCT CO.,LTD has the final right to interpret this instruction
manual.
The company believes that it is responsible for the safety, reliability and
performance of the product only when all the following requirements are met,
namely:
 Assembly operation, expansion, readjustment, improvement, maintenance and
replacement of parts are all carried out by professionals recognized by the
company;
 All repairs involve the replacement of parts and the accessories and consumables
used for them are the original equipment (original) of the company or approved
by the company;
 The relevant electrical equipment conforms to the national standards and the
requirements of this instruction manual;
 The operation of the product is carried out in accordance with this instruction
manual.
3
Use Objects
The audience of this instruction manual is the following:

Personnel who carry out the daily operation of the system;
Personnel who perform system maintenance and troubleshooting;
Personnel who learn system operation.
Before using the product, please read the contents of this instruction manual
carefully and use the product correctly. Please keep this instruction manual in a safe
place for reference at any time. Warranty is voided if the precautions described in this
instruction manual are not followed during use.
In order to keep the protection provided by the equipment effective, the

experimenter or operator should consult and operate according to the requirements of
this instruction manual.
WARNING:
This instrument is limited to the operation and use of inspection
professionals, doctors or laboratory personnel trained by the company
or its agents.
4
Safety Symbols
Various safety symbols are used in this manual and the analyzer to remind you of
matters needing attention during operation. As shown in the table below:
NO. Symbol Signs Explain
Documentation must be consulted in all cases marked with

this symbol in order to ascertain the nature of the potential
hazard and any countermeasures that must be taken. If you
1. WARNING
do not use the instrument in accordance with the
instructions in this manual, the protective measures
provided by this instrument may become invalid.
Used in the nameplate position; indicates that the medical
2. IVD
device is an in vitro diagnostic medical device.
Risk of Used in the card carrier to indicate a biological
3. biological contamination hazard, which may be present if instructions
infection are not followed.
It indicates that the correct position of the transport package
4. Up
is vertical upward.
It indicates that the transport package contains fragile items,

5. Fragile
so it should be handled with care.
It indicates that the transport package should be protected

6. Fear of rain
from rain.
7. No rolling It indicates that the transport package cannot be rolled over.
Stacking Indicates that the maximum number of layers that can be

8.
Layer Limit stacked for the same shipping package is 3.
The user uses this product voluntarily, and the operation, maintenance, repair and
transportation of this product must strictly follow the safety precautions listed below.
The design of this product fully considers biological pollution protection, electrical
safety protection and mechanical movement protection. Any operation that does not
comply with the safety precautions or other prompts in this manual may cause
protection failure, or may Can undermine the safety standards of design and
manufacture and the intended range of use of the instrument.
5
Safety Notes
BIOBASE POCT CO.,LTD does not assume any responsibility for any loss caused
by the user not reading this manual or operating in accordance with the contents of this
manual! To use this instrument safely, please read the following safety precautions
carefully. Any operation that violates the following safety precautions may cause
personal injury or damage to the instrument.
WARNING：
In all cases marked with this warning sign, the instruction manual should be
consulted in order to clarify the nature of the potential hazard and any
countermeasures that must be taken. If you do not use the instrument in
accordance with the instructions in this manual, the protective measures provided
by this instrument may become invalid.
Biological Protection
For effective protection against biological hazards, please observe the following
precautions.
Risk of biological infection

 Improper use of samples can lead to infection. Do not touch reagent cards,
samples, quality controls, and waste cards with bare hands. Be sure to wear
gloves, work clothes to prevent infection, and protective glasses if necessary.
 If the sample accidentally comes into contact with the skin, please handle it
according to the user's work standards immediately and consult a doctor.
6
Protection against chemical hazards
In order to prevent personal injury caused by dangerous chemicals, please observe the
following precautions.
WARNING：
Some reagents may damage the skin. Please use reagents carefully to prevent
direct contact between hands and clothes. In case of contact with hands or
clothes, wash immediately with soap and water. In case of eye contact, rinse
immediately with plenty of water and consult an ophthalmologist.
Waste liquid treatment
To prevent the waste liquid from causing environmental pollution and personal
injury, please observe the following precautions when disposing of the waste liquid.
Risk of biological infection：
 Some substances in the reagent are regulated by pollution regulations and
discharge standards. Please comply with local emission standards and consult
the relevant reagent manufacturer or distributor. Please dispose of used reagent
cards in accordance with the "Medical Waste Management Regulations" to
avoid biological hazards.
 When handling waste liquid, be sure to wear gloves, work clothes to prevent
infection, and protective glasses if necessary.
Prevent Fire And Explosion
To prevent fire and explosion, please observe the following precautions.

WARNING：
Alcohol is flammable and must be handled with great care.
7
Disposal of waste immunoassay analyzer
Please dispose of the discarded immunoassay analyzer according to the following requirements.
WARNING：
Some of the substances in the discarded immunoassay analyzer are subject to
pollution regulations. Please comply with the local waste disposal standard to
dispose of the abandoned immunoassay analyzer.
Instrument out of use
To reduce or eliminate the risks involved in taking the equipment out of service,
such as during service, transportation, or disposal, observe the following precautions.
WARNING：
During equipment maintenance, transportation, or processing, please clean and
disinfect the surface of the instrument and other components with biological
risks, and remind relevant personnel of the risks of the instrument to avoid
biological risks or other hazards during transportation or maintenance.
8
Operation precautions
In order to use the immunoassay analyzer correctly and effectively, please read the
following notes carefully.
Instrument use
WARNING：
 The instrument is used in conjunction with fluorescent immunochromatography
reagents labeled with fluorescent microspheres, and is used for in vitro
quantitative detection of analytes in human samples.
 When making clinical judgments based on analytical results, please also consider
clinical symptoms or other test results.
Instrument installation
WARNING：
 Please place the instrument firmly in a stable and safe place to prevent the
instrument from falling.
 Please operate the instrument in an environment where the ambient temperature
is within the range of 10℃~30℃, the humidity is within the range of ≤70%RH,
and the atmospheric pressure is within the range of 86kPa~106kPa.
 Do not place anything on the power cord, and place the instrument in a place
where the power cord will not be stepped on or tripped over.
 Do not place the device in a location where it is difficult to access the
disconnect device.
Please keep the instrument away from the source of fire, otherwise the instrument
may be deformed and there is a risk of fire.
9
Use environment
Be careful：
 Please install the instrument correctly according to the installation environment
specified in the instruction manual. Installation and use of this instrument outside
the specified conditions may give unreliable results and may result in damage to
the instrument.
 At least 10cm of space should be left around the instrument to ensure air
circulation and facilitate the heat dissipation of the instrument.
 Please keep the environment where the instrument is used clean and avoid dust,
otherwise there will be a danger of destroying the instrument.
 Electromagnetic environment should be assessed before operating equipment.
 If you need to change the system status, please contact the company customer
service center or the distributor in your area.
Protection against electromagnetic waves and noise
Be careful：
 Do not place equipment that emits abnormal noise near the instrument. Keep
the instrument away from other electrical equipment, such as stereos; speakers in
stereos may generate strong magnetic fields, and open magnetic fields may cause
damage to data or displays.
 Do not use other medical equipment near this instrument. Electromagnetic waves
emitted by this instrument may cause malfunctions of other medical instruments
in its vicinity.
10
Electromagnetic Compatibility Related Precautions
Be careful：
 This instrument is designed and tested according to Group 1 Class A equipment
in GB 4824. In a domestic environment, this equipment may cause radio
interference, requiring precautions.
 Do not use this device near strong radiation sources (such as unshielded radio
frequency sources), otherwise it may interfere with the normal operation of the
device.
 Users are responsible for ensuring the electromagnetic compatibility
environment of the equipment so that the equipment can work normally.
 It is recommended to evaluate the electromagnetic environment before using
the equipment.
 This instrument complies with the immunity and emission requirements specified
in this part of GB/T 18268.26.
Instrument use
Be careful：
 Please use the instrument according to the relevant instructions in the
instruction manual. Improper use may result in inaccurate test results and may
even cause instrument damage or personal injury.
 Please unplug the power cord on the instrument during thunderstorms,
otherwise there is a danger of electric shock or fire.
 If your instrument falls, please unplug the power cord and seek help from the
company's customer service center, otherwise there will be a risk of electric shock
or fire.
 Please do not put lit cigarettes or candles on the instrument, otherwise there will
be a risk of fire or damage to the instrument.
 Please do not block foreign objects in the fan exhaust port of the instrument,
otherwise it will cause the risk of fire or damage to the instrument.
 Please do not scratch the display with sharp objects, otherwise the display may
be damaged.
 This instrument is designed and tested according to the Class A equipment in
GB 4824. In a domestic environment, this equipment may cause radio
interference, requiring precautions.
 Non-professional medical laboratory personnel of medical institutions should not
operate it. This product must be operated by inspection professionals, doctors or

laboratory professionals who have studied this manual and have been trained by
Shandong Brocade Rapid Testing Technology Co., Ltd. or Shandong Brocade
Rapid Testing Technology Co., Ltd. agents.
11
Instrument maintenance
Be careful：
 Please maintain the instrument according to the relevant instructions in the

instruction manual. Improper maintenance measures may result in incorrect
analytical results and may even result in instrument damage or personal injury.
 If the instrument is placed for a long time, dust may accumulate on the surface.
When cleaning, please use a clean soft cloth soaked in water and wring it out, gently
wipe the surface, and dip a small amount of 75% ethanol if necessary. After
cleaning, dry the surface with a dry cloth. Please use mild instrument-specific
products to clean the instrument, and do not use the instrument until the instrument
is completely dry, otherwise there will be a risk of electric shock or fire. If in doubt
about the compatibility of disinfectants or cleaning agents with equipment parts or
materials contained within the equipment, the manufacturer should be consulted.
 Before cleaning, please turn off all power of the instrument and unplug the power
cord; during the cleaning process, please take necessary measures to prevent water
droplets from entering the instrument, otherwise it may cause damage to the
instrument or personal injury.
 If the instrument needs to be repaired due to failure, please contact the company's
customer service center. When repairing or suspending use, please confirm that
there is no reagent card left in the instrument; before the instrument is repaired,
please carry out routine sterilization and disinfection.
 During the maintenance period, the instrument may need to be stopped or
transported. Please operate with care to avoid the risk of biological infection,
electric shock, and moving parts due to maintenance.
 After completing any inspection or repair, ask a technical service engineer to
perform a safety test. Neglecting the safety test may result in electric shock or fire.
Sample
Be careful：
 Please use the correct sample storage measures. Improper sample storage
practices may alter the composition of the sample and lead to incorrect analytical
results.
 To prevent the sample from volatilizing, do not leave the sample open for a
long time. If the sample volatilizes, it may lead to incorrect analytical results.
 Some samples may not be analyzed based on test parameters and reagents used.
For these samples, please consult the relevant reagent manufacturer or distributor.
12
Other Notes
a. Please do not use loose or damaged power sockets, otherwise there will be danger
of electric shock and fire.
b. Use the correct grounding. If the socket is not properly grounded, there is a danger
of electric shock and damage to the instrument.
c. Do not touch the power socket when your hands are wet, otherwise there will be a
risk of electric shock
d. Please use your instrument under the appropriate voltage/current standard. Working
under the unsuitable voltage/current will result in the danger of electric shock, fire
or damage to the instrument.
e. If you hear noise from the power cord and power interface, please unplug the power
cord immediately and seek help from your company's customer service center,
otherwise there will be a risk of fire or electric shock.
f. Please keep the power socket and power interface in close contact, loose contact
may cause fire hazard.
g. Do not bend the power cord or place heavy objects on the power cord to avoid
damage to the power cord by persons and animals. Damaged power cords may
cause electric shock or fire.
h. Please keep the power cord and plug clean, otherwise there will be a risk of fire.
i. If foreign objects or liquids enter the instrument, please remove the power cord and
any other cables from the instrument, and seek help from the company's customer
service center, otherwise there will be danger of electric shock, fire and damage to
the instrument.
j. Limit requirements for toxic and hazardous substances
k. This instrument complies with the limit requirements of toxic and hazardous
substances stipulated in SJ/T11363-2006.
NOTE:
In all cases marked with a warning sign , the instruction manual should be consulted
to clarify the nature of the potential hazard and any countermeasures that must be taken.
13
Warranty and Maintenance Services
The warranty period of the purchased instrument is subject to the sales contract.
Consumables: Refers to disposable consumable materials that need to be replaced after
each use or fragile materials that need to be replaced regularly. Consumables have no
warranty service.
The warranty period starts from the "purchase date" filled in the "Warranty Card"
attached to the instrument. The "Warranty Card" is the only proof for calculating the
warranty period. In order to protect your rights, please fill in the warranty card after the
instrument is installed, and hand over the second copy ("B") of the warranty card to the
installer or mail it back to the company's customer service center.
Please note that the following situations will not be covered under warranty:
 The customer fails to fill in and return the equipment warranty card within 30 days
after the completion of the installation and acceptance;
 The factory number of the instrument provided by the customer is incorrect (our
company confirms whether the warranty is guaranteed by the factory number of the
instrument);
 The company is not responsible for the failure and damage of the instrument in the
following circumstances, or for direct or indirect damage during use:
 Failure and damage caused by violation of the method of use, precautions and
purpose of use described in this instruction manual;
 Failure and damage caused by the operation of inspection professionals, doctors or
laboratory personnel not trained by the company or the agent designated by the
company;
 Failure and damage caused by maintenance or modification by companies other
than those designated by the company;
 Failure and damage caused by the use of instruments other than those designated by
the company;
 Failure and damage caused by the inconsistent operating environment and the
operating environment (power conditions, installation environment, etc.) specified
14
by the company;
 Failure and damage caused by irresistible natural disasters;
 Failure and damage caused by the company's unknowing movement or transfer
(transportation) after the instrument is installed;
 Instrument failure caused by the use of reagents and other consumables not
approved by the company does not belong to the scope of maintenance services
provided by the company;
 Other faults not caused by the instrument itself.
During the warranty period, if the fault is caused by the design and manufacturing
defects of our company, it will be repaired free of charge, and our company will take
corresponding countermeasures according to the fault content.
After the expiration of the warranty period, the company can continue to provide
fee based maintenance services.
15
After-sales service and contact details
After-sales service
Please contact our after-sales service department.
Repair
 Confirm failure and repair method ： First, contact the company's after-sales
service department to confirm the fault situation and confirm whether the repair
method is on-site repair or return to the factory for repair.
 Repair fees：Negotiate with the company according to the specific situation.
 Freight：If the immunoassay analyzer is shipped to the company for repair, the
user shall bear the freight (including customs fees).
Return
 Get permission to return goods. Contact after-sales service department of the

company and inform product serial number (see the nameplate of immunoassay
analyzer for details), explain the reason for return. If the product serial number
cannot be clearly identified, the company will not return the goods.
 On the premise of obtaining the right to return goods, please go through the
relevant procedures according to the requirements of the company.
Contact Details
Company Name： BIOBASE POCT CO.,LTD

Company Address：401 room,A area,4th Floor , 2# building,No.9 Gangxing Road,
High-tech Zone, Jinan City, Shandong Province, China
Name of the manufacturer:BIOBASE POCT CO.,LTD
Production Address:Tech Town Accelerator Building 1, Qilu High-tech
Development Zone, Qihe County, Dezhou city, Shandong Province, China
After-sales service unit:BIOBASE POCT CO.,LTD Customer Service Center
After-Sales Service Tel：0531-68629723
Postcode:250000
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Foreword
Welcome to the Fluorescence Immunoassay Analyzer Instructions, this instruction
manual details the product overview, instrument installation, software operation
interface description, Item test operation process, maintenance, quality control,
troubleshooting, precautions and other aspects. Optimum performance of the instrument
can only be guaranteed if the manufacturer's published instructions for use are fully
followed, and must therefore be operated and maintained in accordance with the
contents of these instructions. If you have any questions, please contact our company.
Before using this instrument, please read and understand the contents of this
instruction manual carefully to ensure that this instrument can be used correctly.
The pictures in this instruction manual are for illustration or example only, not for
other purposes. The actual picture please refer to the instrument.
17
1. Product Overview
1.1. Instrument introduction
(1) Instrument Name：Fluorescence Immunoassay Analyzer

(2) Model：BKP2000
(3) Specification: 1 unit/box
(4) Software Name：Fluorescence Immunoassay Analyzer Software
(5) Software release version: V1
(6) Software full version: V1.0.0
(7) Production date: See the nameplate
(8) Service life: The service life of the immune analyzer is 5 years from the date of
installation of the instrument (NOTE: excluding man-made damage). The expected
service life of the instrument is determined according to the high temperature and
high humidity accelerated life test. The instrument should be maintained, serviced
and repaired in accordance with the instructions. Instruments that have been
confirmed to maintain their basic safety and effectiveness after maintenance,
upkeep and repair can be used normally.
1.2. Main structural composition
Fluorescence Immunoassay Analyzer consists of host (including optical detection

module (fluorescence), scanning module, data processing module, liquid crystal display
module, incubation module, information acquisition module, printer, housing) and
embedded software (software release version V1), power cord .
The main component of the optical detection module is an optical path box, which
is mainly composed of a light source, an optical path platform, and a detection
component.
The scanning module is mainly composed of a code scanner, a scanning head
connecting plate, a scanning head mounting seat and its fixing parts.
The data processing module is mainly composed of the measurement circuit board
18
and its fixing parts.

The LCD module is mainly composed of LCD screen and control board.
The incubation module includes structures such as a stepping motor, a pulley, a
dial-card turntable, a disc, a spindle module, a clip-card module, and a turntable
detection switch assembly.It can carry 12 reagent cards at one time.
The information collection module mainly refers to the ID card reader.
(1) Appearance diagram
PC power switch
10.1-inch
display screen
Loading card
ID card slot position
Printer
Discard bin
19
Cooling vent
Power
interface
Accessory
interface
Picture 1-1 Appearance diagram
(2) Internal structure layout
Scanning module
Optical detection module
(fluorescence)
Card Carrier
Power supply
Incubation module
Discard card box
Picture 1-2 Internal structure layout
Note: The appearance of the instrument is subject to the actual product.
20
1.3. Scope of application
1.3.1. Intended Uses
Fluorescence Immunoassay Analyzer is used in conjunction with fluorescent

immunochromatography reagents labeled with fluorescent microspheres for in vitro
quantitative detection of analytes in human samples.
1.3.2. Applicable Items
Including pathogenic pathogen antigens/antibodies, proteins, carbohydrate,

vitamins, kidney disease, myocardial disease, immune function and other items.
1.3.3. Intended use environment
It can be applied to central laboratories, outpatient/emergency laboratories, clinical

departments and other medical service points (such as community medical points),
physical examination centers, etc. in medical institutions, as well as scientific research
laboratories. For laboratory medicine professionals to perform in vitro diagnostic
experiments only.
1.4. Basic principle
(1) Principles of Immune Response：

1 Competition method：
The detection area (T line) on the NC membrane of the detection card is coated
with antigen, and the quality control area (C line) is coated with goat anti-mouse
IgG.After the sample is added to the sample well, the liquid is chromatographed upward
under the capillary effect.The analyte (antigen) in the sample competes with the antigen
in the detection area (T line) on the NC membrane to bind the antibody labeled with
fluorescent microspheres during the chromatography process, and then continues to be
chromatographed upward,at the C line, a solid-phase goat anti-mouse IgG-fluorescent
microsphere-labeled antibody complex is formedFluorescent microspheres emit visible
21
light signals under excitation light. The more analytes in the sample, the less complexes
accumulate on the T line. The signal intensity of the fluorescently labeled antibody on
the T line is inversely proportional to the content of the analyte in the sample.
2 Sandwich method：
The detection area (T line) on the NC membrane of the detection card is coated
with coating antibody, and the quality control area (C line) is coated with goat
anti-mouse IgG.After the sample is added to the sample well, the liquid is
chromatographed upward under the capillary effect. During the chromatography process,
the analyte in the sample is first combined with the labeled antibody labeled with
fluorescent microspheres to form the analyte-fluorescent microsphere labeled labeled
antibody complex, and then continue to be chromatographed upwards.Then the complex
will be bound by the coated antibody coated on the T line, and a solid-phase coated
antibody-antigen to be tested-fluorescent microsphere-labeled labeled antibody complex
will be formed at the position of the T line.At the position of the C line, a solid-phase
anti-mouse IgG-fluorescent microsphere-labeled labeled antibody complex was
formed.The fluorescent microspheres emit fluorescent signals under excitation light.
The more analytes in the sample, the more complexes accumulate on the T line. The
signal intensity of the fluorescently labeled antibody reflects the amount of the analytes
captured.
(2) Working principle：
Drop the sample containing the antigen (antibody) to be tested in the sample
application area. If you use the fast mode, you need to wait for the antigen and antibody
to react completely before putting it into the instrument, and the instrument will directly
read the data;If you choose the normal mode, you need to directly put the reagent card
that has just added the sample on the loading card position. When the instrument detects
that a card is inserted, it will start the countdown. After the predetermined time is over,
the instrument will read the data.The read procedure is as follows:The instrument
automatically turns on the LED light source and scans the reaction area of the reagent
card horizontally.The LED will gradually irradiate the detection area, and then irradiate
to the quality control area, and the fluorescent immune complexes solidified on the
22
reagent card will be excited under the specific wavelength of the LED.The excited light
is collected by the silicon photocell and converted into an electrical signal. The strength
of the electrical signal is strictly related to the number of fluorescent molecules.试 The
fluorescence signal of the reagent card will be converted to the corresponding voltage
signal, and the software calculates the signal value of the reagent card by the highest
peak area method.Substitute this value into the calibration curve to calculate the
concentration, and the reading process ends. Finally, discard the reagent card after the
test is completed.
1.5. Software
Software interface: wizard-style interface, intuitive layout and program settings, easier
to operate and edit.
Language support: Chinese or English.
Data storage: The instrument can store experimental data files.
Data transmission: The experimental data can be printed out through the printer, or the
experimental data can be exported to the U disk through USB.
1.6. Network Security
Software operating environment requirements:

Embedded software, its operating environment requirements are as follows:
Android platform: PowerVR SGX544MPI, 8G (EMMC), android6.0 or above.
Motherboard hardware configuration:
Control board main control chip: GDF205VCT6
Memory: AT24C64
Network type: none
Security software: none
Data interface: LIS port, LAN port, USB port.
LIS port and LAN port are used to connect LIS.
The USB port is used for keyboard and mouse access, data export and system upgrade.
23
The LIS port transmission protocol is the RS232 communication protocol. The LAN
port transmission protocol is TCP/IP or UDP/IP protocol, and the USB interface
protocol is USB protocol.
Data type: export data through USB data interface, the storage medium is U disk, and
the exported test data is in .xls format.
Access Control: Deny any unauthorized external access. The software can log in to the
software after the user enters the user name and password for verification.
It is divided into two levels: administrator and ordinary user. Ordinary user authority:
can only access the test data of this user; administrator authority: can access the test data
of all users.
1.7. Contraindications
No
24
2. The basic parameters and the conditions of use
2.1. The basic parameters
Host size and weight 336mm×410mm×400mm（L*W*H）；17KG；

Sample type Whole Blood, Serum, Plasma, Urine
Detection speed Single detection time <10s
Detection method Supports multiple items in one card
Printer Built-in thermal printer，57mm
10.1-inch 24-bit true color LCD screen (screen can be
Display screen
customized)
Interface Language Chinese and English, other languages can be expanded
Data storage Unlimited
Excitation light source LED
Working wavelength Excitation spectrum Center wavelengthλ0=365nm；
range Receive spectrum Center wavelengthλ1=615nm；
Detection channel 1
Reaction channel (Card 12
Carrier)
Power-on warm-up time After powering on, set the required temperature, and the
temperature can be tested when the temperature meets the
requirements.
Power consumption 108VA
Power Specifications power supply：AC220 V ～50HZ；
Indoor use;
The altitude is below 2000m;
Ambient temperature: 10℃～30℃;
Relative humidity: ≤70%;
Normal working Atmospheric pressure: 86.0kPa～106.0kPa
conditions The power supply voltage fluctuation should not exceed ±10%
of the nominal voltage;
Transient overvoltage is category II of facility category
(overvoltage category);
The rated pollution degree is 2.
Storage and transportation The ambient temperature is -40℃ ～ 55℃, and the relative
environment humidity is not more than 70%
Repeatability: CV≤5%.
Stability: σ≤±8%.
Performance indicators
Linear correlation: (r) ≥ 0.98.
Accuracy: Δn≤±8%.
25
2.2. Function
(1) The analyzer should have ID card information reading function.

(2) The analyzer has a data display function: after testing with the analyzer, the test results
can be inquired.
(3) The analyzer has touch operation function.
(4) The analyzer has the function of automatic printing. After the test is over, it can
automatically print the test results.
(5) The analyzer has a self-checking function.
(6) The analyzer has a fault prompt: the analyzer has corresponding prompts for operation
errors.
(7) The analyzer monitors the temperature of the reaction zone in real time. The set
temperature range should be between 10°C and 40°C. The analyzer will prompt when the
temperature is not within the set range. (applicable to BKP2000)
(8) The analyzer has the function of prompting when the discarded card bin is full.
(applicable to BKP2000)
(9) The analyzer has a LIS data interface.
(10) The analyzer has user access control: it is divided into two levels: administrator and
common user. Common user authority: can only access the test data of this user;
administrator authority: can access the test data of all users.
2.3. Transport and storage conditions of the instrument
Transport
The instrument under the packaging condition is suitable for road, railway, air and
water transportation. During loading, unloading and transportation, it should prevent severe
vibration and shock, and should not be affected by moisture, and should not be mixed with
flammable and corrosive substances. Requirements according to the order contract.
Storage
When storing the instrument, it should be placed in the original packaging box, placed
in a well-ventilated room, the packaging box should be padded, the ambient temperature
should be -40°C ~ 55°C, and the relative humidity should not be greater than 70%.Harmful
gases, flammable, explosive substances and corrosive gases are not allowed.
26
3. Instrument installation
Please use this instrument under conditions that meet the environmental requirements
of the instrument.
3.1. Package
If the package is damaged after receiving the instrument, or the instrument is obviously
damaged, please contact the carrier immediately and file a claim according to the degree of
damage. At the same time, please contact your supplier to confirm that the instrument is
well packaged, and then follow the steps below to remove the packaging materials and
install the instrument.
3.2. Unpack
Carefully remove the instrument and accessories from the box, saving the packing
material for future shipping or storage.
(1) Count the random accessories item by item according to the packing list.
(2) Check the instrument and accessories for mechanical damage.
(3) When handling the instrument, it should be handled with care, and it is strictly
forbidden to force the front case directly to avoid damage to the instrument.
(4) Place the instrument main body on a stable flat operating table.
If there are any problems please restore the packaging and contact your supplier
immediately.
3.3. Packing List：
No. Name Quantity Unit Remark

1. Host (including packing 1 piece Standard accessories
box, pearl cotton pad)
2. User's manual 1 piece Standard accessories
3. Certificate 1 piece Standard accessories
27
4. Warranty Card 1 piece Standard accessories

5. Power cable 1 piece Standard accessories
6. Network cable 1 piece Standard accessories
7. Fuse 2 piece Standard accessories
8. Mouse and keyboard set 1 set Optional accessories
9. Barcode Gun 1 piece Optional accessories
10. Printer paper 1 piece Optional accessories
3.4. Installation requirements
3.4.1. Installation Environment
1) The instrument should be placed in a stable and level room with no serious dust, no
direct sunlight and no corrosive gas, and the work surface can carry a weight of more than
20kg;
2) There is no strong vibration source and strong electromagnetic field around;
3) Do not place the instrument in a position where it is difficult to operate the disconnect
device, where the distance between the back of the instrument and the wall is at least
10cm;
4) Nothing should be covered on the instrument to prevent the ventilation openings from
being blocked;
5) Please try not to use parallel sockets to avoid fire caused by overload;
6) A 220V filter and an effectively grounded socket must be used;
7) The instrument should be tested in an environment of 10℃-30℃, and operate in strict
accordance with the operation precautions in this manual.
3.4.2. Supply Voltage Requirements
Power supply: AC 220V, 50Hz. Rated input power: 108VA.

During use, be careful to avoid short circuit and risk of electric shock!
NOTE: Documentation must be consulted in all cases marked with a symbol .
28
3.4.3. Accessories connection
Install the randomly configured related accessories on the corresponding interface of

the instrument (such as: AC power cord, mouse, keyboard, etc.), according to needs, you
can also directly touch the screen without using the mouse and keyboard.
3.4.4. Connect the power cable
Make sure that the power switch on the rear panel of the analyzer is in the off (O) state,
insert the female end of the power cord plug into the power socket of the instrument, and
insert the other end of the power cord into the power socket.
3.4.5. Thermal printing paper installation rules
Press the "SPRT" button in the upper right corner of the instrument with your finger to
open the printer door, then place the thermal printer paper configured with the printer into
the printer compartment and close the door.
Figure 3-1 Thermal Printer Diagram

1、Thermal printing paper 2. Door button 3. Online status indicator 4. Power indicator
Notes
Thermal printing paper size (width is 57±0.5mm, outer diameter is 30±0.5mm).
The paper is installed with the thermally coated side facing up.
Before closing the door, please extend the printing paper 2-5cm outwards.
29
3.4.6. Start-up Procedure
Power on the instrument, then turn on the AC power switch and the PC power switch in
sequence. After the instrument is turned on, enter the user name and password, enter the
software experiment operation interface and enter the equipment self-check program（The
position of the switch is shown in Figure 3-2 and Figure 3-3 below.）
PC power
switch
AC power
switch
Figure 3-2 AC power switch location diagram Figure 3-3 PC power switch location diagram
3.4.7. Shutdown Procedure
In the experimental operation and test interface of the instrument, click the "Pwr"
button on the left, and then press the power button on the front to shut down, as shown in
Figure 3-4 below:
（Figure 3-4）
30
Notes
a. During the normal testing process, it is strictly forbidden to turn off the instrument or
force the power off.
b. When the instrument is normally shut down, it is strictly forbidden to force power off
the instrument directly.
c. When the instrument does not work for a long time, the external power supply should
be completely cut off.
3.4.8. LIS connection operation procedures
a. Connect the instrument to the PC through the serial cable, and connect in the following
way, as shown in Figure 3-5.
Serial
Serial port
cable
（Figure 3-5）
b. Enter the "Test Set" page in the system settings page of the main system menu, and
configure the "Auto upload Lis after test" option to configure whether to automatically
upload Lis after the test is completed.
（Figure 3-6）
31
4. Operation interface instructions
Start the instrument, initialize the instrument and perform self-test. After the self-test is
completed, the display interface is shown in Figure 4-1. Software system functions include
[Test], [Rec], [QC], [User], [Item], [Sys], [Pwr]
Main Menu
Area
Information
Setting Area
Test Status
（Figure 4-1）
4.1. Item interface function description
Before testing, you need to read the Item card information. Insert the ID card, click to
read the Item card, after the reading is successful, you can set the default Item card. And set
the reference range etc. as needed.
（Figure 4-2）
32
4.2. Test interface function description
After entering the Item information, you need to enter the sample information before
the sample test.
Select the sample type, enter the sample number, the number of samples, select the
processing situation, and enter the sample information. Enter patient information and doctor
information, click Generate, it will be displayed in the test list, insert the reagent card, start
the test, and you can view the test progress in the test list. In the running status bar, it
displays the status of the reagent card storage tray,
incubation/progress/completed/discarded/abnormal.
（Figure 4-3）
33
4.2.1. Temperature control range setting operation procedure
Click the temperature display area in the upper right corner of the interface, and then
set the desired temperature range in the dialog box.
（Figure 4-4）
4.2.2. Sample type setup procedure
Click the "Drop-Down" button in the red area in the figure below, and select the sample
type according to the experimental requirements.
（Figure 4-5）
34
4.2.3. Patient information, doctor information setting operating procedures
You can fill in the relevant information of the patient and doctor according to the test
needs.
（Figure 4-6）
（Figure 4-7）
35
4.2.4. Quick Test Operating Procedure
Select the number of the required quick test in the sample number to be tested, and then
click the "Up" button.
（Figure 4-8）
4.3. Record interface function description
Click the [Rec] button, the interface is displayed as shown in Figure 4-9.
The historical test records of the completed tests are displayed on the record page. The
test results can be filtered according to the sample type and time. Select the test results to
view the details, delete, export, Lis, and print.
（Figure 4-9）
36
4.3.1. Test Record View Details
在记录界面中选中对象，点击界面中“详情”按键，可查看详细信息。
Select the object in the record interface and click the "Details" button in the interface to
view the detailed information.
（Figure 4-10）
4.3.2. Manual printing procedure for test records
Select the print object in the record interface, and click the "Print" button in the
interface.
（Figure 4-11）
37
4.4. QC interface function description
Click the [QC] button, the interface is displayed as shown in Figure 4-12.
Displays a list of all current QCs, and can view and filter the QC summary data.
（Figure 4-12）
The quality control chart interface displays the result curve of the quality control
product tested in the specified month.
（Figure 4-13）
38
Add, modify or delete the parameter information of the quality control

product.Information includes QC number, QC Mater, Result,Batch,Tar Val,Min Val,Max Val,
SD Val, CV Val, etc.
（Figure 4-14）
4.5. User interface function description
Display the user list, add or delete users.
（Figure 4-15）
39
4.6. System interface function description
4.6.1. About
Click the [About] button, the user can view the software version information
4.6.2. Test Set
Click the [Test Set] button, the interface is displayed as shown in Figure 4-16.
Test Before: Entry Method, Entry Count Down, Task Test.
Testing: Pre-Read, Scan Barcode.
Test After: Print, Measure Pattern, Send Lis.
（Figure 4-16）
40
4.6.3. Lis/His
Click the [Lis/His] button, the interface is displayed as shown in Figure 4-17.
Lis/His Set: Lis Connection, Code, Remote IP, Remote Port ,
Lis/His Test: Sample Number, Result, Test Time, Item Name.
（Figure 4-17）
4.6.4. Print Set
Click the [Print Set] button, the interface is displayed as shown in Figure 4-18.
Set up the printer, define the company name and prompt information.
（Figure 4-18）
41
4.6.5. System Set
Click the [System Set] button, the interface is displayed as shown in Figure 4-19.
Clock Set: Set the clock pattern and time.
IP Set: Set IP acquisition method, automatic acquisition/manual setting, input IP and
mask.
System Set: Input Method Pattern (virtual/physical),Language Pattern
(Chinese/English).
（Figure 4-19）
42
4.6.6. User
Click the [User] button, the interface is displayed as shown in Figure 4-20.
Display the current user, view the account number and user name. Change the
password and log out.
（Figure 4-20）
4.7. Pwr
Click the [Pwr] button, a window for confirming shutdown will pop up, and the
software will execute the shutdown procedure, prompting to turn off the power.
（Figure 4-21）
43
5. Item Test Operation Procedures
5.1. Power On
Turn on the external power of the instrument and turn on the power switch of the PC.
After the instrument is fully turned on, it will enter the Item test interface (the waiting time
for booting is about 30 seconds)
5.2. Sample Test Information Settings
In the test interface, edit the sample number, sample type, patient information, doctor
information, etc., and select the processing situation (Normal Test, Quick Test).
（Figure 5-1）
44
5.3. Read item ID information
Insert the Item ID chip into the ID card slot, and click the "Read ID" button on the test
interface to obtain Item information.
（Figure 5-2）
Note: The same sample ID information does not need to be read twice!
5.4. Sampling
Aspirate the blood sample, add it to the buffer, and mix well.
（Figure 5-3）
45
5.5. Add sample
Using a pipetting gun, add the mixed sample to the reagent card.
（Figure 5-4）
5.6. Detect
Insert the reagent card into the "Loading card position" (be careful not to use too much
force when inserting or pulling out the reagent card), the instrument will automatically test
the sample after detecting the reagent card.
Loading card position
（Figure 5-5）
46
5.7. Result Output
After the Item test is completed, the instrument will automatically save the test results,
and the operator can output the results through the built-in printer, external printer or Lis
system.
（Figure 5-6）
47
6. Cleaning and Disinfection
"Fluorescence Immunoassay Analyzer" is an inspection instrument, which is a

non-sterile medical device and does not require sterilization. It only needs to be maintained
and maintained according to ordinary medical equipment, and the outside can be kept clean.
Recommended cleaning and disinfection methods: The analyzer casing or frequently
touched places are very easy to become dirty. In order to keep the working environment
clean and reduce biological risks, the exposed parts of the analyzer should be cleaned in a
timely manner.
External cleaning and maintenance method: Use lint-free gauze and 75% ethanol to
clean the outer surface of the instrument. After cleaning, please dry the surface with a dry
cloth. Be careful not to clean any internal parts or interior surfaces with cleaning agents.
The basis for the determination of the disinfection process: due to the common dust on
the surface of the equipment shell, use a cloth dipped in water to wipe the dust directly to
complete the removal of dust.Ethanol is used for product disinfection because ethanol is a
medium-effective disinfectant, which is medium-effective, quick-acting, non-toxic, irritating
to skin and mucous membranes, and non-corrosive to metals. This method is formulated
according to WS/T 367-2012 "Technical Specifications for Disinfection in Medical
Institutions" and GB/T 27949-2011 "Technical Requirements for Disinfectants for Medical
Devices".
Prohibited: Do not clean or maintain the instrument while it is powered on or in
operation.
Prohibited: Never pour water or other solutions into any of the instrument parts. When
the instrument is energized, inflow of liquid may cause electric shock!
NOTE: Ethanol is a flammable and volatile liquid.
NOTE: Ethanol is a flammable and volatile liquid.Exposure can irritate eyes, skin and
respiratory tract and may cause central nervous system hypofunction and liver damage.Wear
suitable protective eyewear, clothing, and gloves when cleaning with ethanol.
48
High surface temperature: During instrument operation, the incubation module may be
exposed to high temperatures. Before cleaning or maintaining the instrument, pay attention
to the temperature to avoid burns.
Biohazard: Please treat and handle all samples as potentially biohazardous.If a liquid
sample is spilled or splashed, immediately sterilize with an appropriate disinfectant to avoid
spreading contaminants that contaminate instruments or cause injury to laboratory
personnel.
Biohazard: Do not handle or manipulate any potentially biohazardous samples without
taking any safety precautions.
49
7. Instrument Care and Maintenance
The instrument does not require extensive maintenance under normal use. If the
instrument is used for a long time, regular cleaning and a small amount of maintenance are
required to ensure the normal operation of the instrument. Before cleaning the instrument,
please read this chapter carefully. Correct maintenance and cleaning of the instrument will
help prolong the service life of the instrument.
We should pay attention to the following issues in the maintenance process:
1) Arrange someone to be responsible for maintaining the machine;
2) The specific maintainer of the machine should emphasize the importance of
maintenance to all users of the machine in their daily work;
3) During the maintenance work, be sure to wear gloves, work clothes to prevent
infection, and protective glasses if necessary. Do not throw away the gauze used for wiping,
please dispose of it properly in accordance with relevant regulations.
7.1. Maintenance Daily
When the instrument is turned on every day, it can automatically complete an

initialization, perform self-check, and clean up the reagent card storage tray.
7.1.1. Check the loading card position
Check whether there is any foreign object at the loading card position, whether the
operation is smooth, and whether there is a stuck phenomenon.
7.1.2. Check the discard bin
Check whether there are multiple or full cards in the discarded card bin, and clean it up
in time. If the discarded card bin is full or there are too many cards, the software will
prompt that the discarded card bin is full, affecting the experiment process.
7.1.3. Check the printing paper
Check whether there is printing paper in the printer, and replenish it in time, so as not
to affect the printing of the experimental results.
50
7.2. Maintenance Weekly
7.2.1. Clean the printer
Check the printer to see if the print roller is glued.

When cleaning, turn off the printer, slide the upper cover limit block, and open the
upper cover assembly position of the printer; turn the printing roller, and at the same time
use a 75% ethanol cotton swab (should be wrung out) to wipe off the dust and stains on the
surface of the printing roller.Wait 5-10 minutes and close the lid when it evaporates
completely.
7.2.2. Clean the discard bin
The discarded card bin is mainly used to store discarded reagent cards. After a long
time, there will be the risk of biological infection hazards. It should be cleaned and
disinfected in time.When cleaning, please wear gloves, use a piece of lint-free gauze and
75% ethanol to clean only its surface, after cleaning, please dry it with a dry cloth.
7.2.3. Clean the loading card position
When the reagent card enters from loading card position, there is a risk of biological
infection hazards. It should be cleaned and disinfected in time.When cleaning, please wear
gloves, use a lint-free gauze, cotton swab and 75% ethanol to clean only the surface, after
cleaning, please dry with a dry cloth.
7.2.4. Clean the outside of the instrument
The analyzer casing or frequently touched places are very easy to become dirty. In
order to keep the working environment clean and reduce biological risks, the exposed parts
of the analyzer should be cleaned in a timely manner.When cleaning, turn off the switch of
the immunoassay analyzer, wear gloves, and use a piece of lint-free gauze and 75% ethanol
to clean only its outer surface. After cleaning, please dry it with a dry cloth.
51
NOTE：
WARNING：
Do not spill liquids on the analyzer to avoid liquid immersion and damage to the
immunoanalyzer.
Risk Of Biological Infection：
During Maintenance Work, Be Sure To Wear Gloves, Work Clothes To Prevent
Infection, And Protective Glasses If Necessary.
Do Not Throw Away The Gauze Used For Wiping, Please Dispose Of It Properly In
Accordance With Relevant Regulations.
7.3. Keep air circulation
This instrument requires air circulation, so periodically check the area where the
instrument is placed to ensure that there is adequate ventilation and that no other objects are
interfering with the air flow around the instrument.
7.4. Keep the power supply stable
The normal operation of this instrument requires a stable power supply, so please check
the power supply of this instrument regularly to ensure that the power supply voltage is
consistent with the voltage required by the instrument (±10% deviation is allowed). And
ensure that the rated load of the power socket is not less than the requirements of the
instrument.
7.5. Overheating protection
The heating system of the instrument is equipped with an overheat protection device.
When the heating system fails and the temperature value exceeds the upper limit of the
allowable range, the protection device will automatically disconnect and cannot be restored;
at this time, the heating system cannot continue to rise and fall normally. After the above
failure occurs in the heating system, the user should stop using the instrument and contact
the manufacturer for maintenance in time.
52
NOTE：
Heating maintenance: Since the heating source is inside the instrument, it cannot be
sensed by touch. Therefore, you can actually set the temperature through the software and
observe the displayed temperature to judge whether the heating of the instrument is normal.
If the heating source fails, the software will also have a temperature reminder. It is
recommended to perform temperature calibration once a year, which can be calibrated by
our company or by the Metrology Institute.
7.6. Other maintenance
 Please use the parts provided by our company.
 For daily cleaning and maintenance of the immunoassay analyzer, please clean the surface
of the immunoassay analyzer with lint-free gauze after the power is turned off, and use 75%
ethanol to clean the parts of the immunoassay analyzer.
 Users can contact the customer service center of the company if they have any questions.
 After use in a clinical setting, if the instrument does need to be repaired or replaced, it should
be decontaminated before repackaging and shipping. Thoroughly scrub the outer surfaces of
the instrument with an inorganic laboratory disinfectant (containing less than 0.1% bleach)
and lint-free gauze. Do not spray the instrument with disinfectant or clean any internal parts
and surfaces.
WARNING：
Hazardous radiation exposure may result if the control or adjustment device is
not used in accordance with this specification.
7.7. The key to maintenance of System Hardware
WARNING:
Do not switch the immune analyzer on and off frequently, and the interval
between switching on and off should be more than 1 minute.
Regularly clean the discarded card compartment.
Do not place items on top of the immunoassay analyzer.
When moving the immunoassay analyzer, avoid vigorous shaking.
The equipment contains no operator serviceable components and regular
maintenance must be performed by an authorized service technician to avoid
electric shock.
53
8. Quality Control and Calibration
8.1. Quality Control
The instrument has been quality controlled before leaving the factory. After the
instrument is debugged and installed, it can be directly tested with reagents.If you need to
perform quality control on the instrument again, you can perform quality control by testing
the quality control card.The implementation of quality control is the same as when testing
ordinary samples, that is, directly testing the concentration of the quality control card with
the Fluorescence Immunoassay Analyzer.
If the reading value of the instrument is compared with the target value of the quality
control product, if the reading value meets the target value range requirements of the quality
control product, the instrument can be tested; if it does not meet the target value range
requirements, it is forbidden to use! And contact the company's customer service center in
time to return to the factory for calibration or maintenance.
8.2. Calibration
After 1 year of normal use, the user needs to use the standard for calibration. The
calibration method is the same as when testing ordinary samples, that is, directly use the
Fluorescence Immunoassay Analyzer to test the concentration of the reagent card with the
standard added.If the reading value meets the target value range of the standard, it can
continue to be used.If the reading value is deviated, do not use it! And contact the
company's customer service center in time for processing.
54
9. Troubleshooting Guidelines
9.1. Analysis and treatment of the reasons why the whole machine does not work
 Cause Analysis：
（1）No power at the power outlet
（2）The main switch of the instrument is not turned on
（3）Fuse open circuit
（4）No voltage output of switching power supply
 Treatment Method
（1）Check whether the indicator light of the power socket is displayed normally or use a
multimeter to measure the output voltage of the power socket.
（2）Turn on the main switch of the instrument.
（3）Replace the fuse（Specifications and models：F3AL250V）
（4）Change the switching power supply
9.2. The instrument is turned on,but the display is black
（1）PC PCB failure
（2）Data line failure
（3）Display failure
（1）Externally connect the display function of the instrument to eliminate the fault of the
PC PCB (if the external display function of the instrument cannot be displayed, it is judged
as a fault of the PC PCB)
（2）Replace the display line.
（3）Replace the display.
55
9.3. The instrument failed to obtain ID information
（1）ID card is invalid
（2）ID card slot failure
（1）Replace the ID card and obtain it again.
（2）Replacing the ID card slot.
9.4. Instrument cannot print test results
 Cause Analysis（Built in）：

（1）No paper or paper turned over.
（2）Printer failure.
（1）Install the paper and confirm the paper installation orientation.
（2）Replace the printer.
 Cause Analysis（External）：
（1）Driver installation is abnormal.
（2）USB line connection is abnormal.
（3）External printer not turned on
（1）Check whether the printer connection cable is abnormal or replace the data cable.
（2）Install the paper and confirm the paper installation orientation.
（3）Replace the printer.
9.5. Individual test results show that no sample has been added
（1） The reagent card is not loaded with the test sample or the sample volume is
insufficient.
（2） The sample is not immersed in the reagent card test area within the predetermined
56
time.
（3） The reagent card is leaking.
（1）Select the unsampled item and click "Throw" on the test interface to retest the sample
by adding sample.
（2）Wait for the instrument to test the sample for a second time.（If the second test still
shows that no sample has been added, click "Throw" to re-add the sample for testing.）
（3）Replace the reagent card and reload the test（Liquid leakage judgment method: take out
the reagent card and dissect it, and check whether there are obvious traces of sample liquid
leakage at the lower part of the sample hole）
Instrument daily failure analysis and processing summary table：
Fault phenomenon Cause Analysis Exclusion method
The corresponding power switch

View the instruction manual
is not turned on
The instrument does The power fuse is blown Please replace the fuse
not respond when The power cord is not connected

Reseat the power cord
turned on properly
Other hardware of the Please contact the company
instrument is faulty customer service center
One of the built-in printing and
Internal printing and external external printing is turned off. If

Test results cannot be
enabled at the same time or it cannot be ruled out, please
printed
other hardware failure contact the company customer
service center
Individual reagent Reagent card barcode is fuzzy or Manually select "Modify
57
card barcodes cannot other faults Barcode" or contact the company
be read customer service center
The built-in printout Change the paper installation

paper turned over
has no content orientation
The instrument Replace the ID chip or contact
cannot read the ID ID chip is abnormal the company customer service
card information center
The results of
Select the item and click
individual test items
Sample test area signal is low "Continue Test" or click
indicate "no sample
“Throw” to re-test the item
added"
Note: The above daily failure analysis and Treatment Method are for reference only, if
necessary, please contact the company's customer service center. When the instrument fails,
but the displayed error code is not in the above table, stop the operation immediately and
contact the company customer service center.
58
 Fuse replacement
Fuse burnt will cause the instrument to fail to power on
Maintenance supplies:
A flat-blade screwdriver
Instrument status:
Make sure the instrument is turned off when performing this maintenance operation.
Note:
WARNING：
It cannot be replaced with a fuse of a different specification.
Steps:
1. Confirm that the instrument is turned off and unplug the power cord;
2. Prepare a new fuse (F3AL250V);
3. Use a flat-blade screwdriver to lift out the fuse socket at the power male head of the
rear panel of the instrument, and take out the fuse;
4. Observe whether the fuse is blown, burnt black and other abnormal phenomena;
5. If the fuse is blown or burnt black, replace the new fuse to the current position;
6. Install and tighten in the reverse order of removal.
59
10. Accessories list
To ensure personal safety and ensure the performance of the immunoassay analyzer,
please use accessories manufactured or recommended by BIOBASE POCT CO.,LTD. If
necessary, please contact BIOBASE POCT CO.,LTD or your regional distributor. Please
order all kinds of consumables and accessories from our company one month in advance.
Do not use consumables from any other company. Some of the chemical components in
them will speed up the damage of your instrument and cause greater losses. If the
accessories are damaged, please contact our company or the local distributor in time for
replacement.
Name Replacement Period and Method

Power Cable In case of aging or damage, please contact the manufacturer or agent
Network Cable In case of aging or damage, please contact the manufacturer or agent
Fuse In case of damage, please contact the manufacturer or agent
Mouse And If necessary, please contact the manufacturer or agent
Keyboard Set
Barcode Gun If necessary, please contact the manufacturer or agent
Printer Paper If necessary, please contact the manufacturer or agent
60
11. After Sales Service, Repair and Destruction
When the Fluorescence Immunoassay Analyzer fails, please call BIOBASE POCT
CO.,LTD for consultation first, and we will provide telephone technical support to help
guide customers to troubleshoot.
If the instrument needs to be recalled for repair, please send the instrument back for
repair as required. The general repair cycle does not exceed seven working days.
If the instrument really needs to be scrapped, the company will provide a new
instrument during the warranty period.
If for some reason the user needs to destroy the Fluorescence Immunoassay Analyzer,
it is recommended that the user do so in accordance with the Class B Electronic Instrument
Regulations.
The company declares that the above service guarantee can only be obtained if the
manufacturer's instruction manual is fully complied with, and the company will not be
responsible for any damage caused by this.
61
Medical Device Registration Certificate No.：
Product Technical Requirements No.：
Medical Device Manufacturing License No.：
BIOBASE POCT CO.,LTD

Registrant Name：BIOBASE POCT CO.,LTD
Registration address ： 401 room,A area,4th Floor , 2# building,No.9 Gangxing Road,

High-tech Zone, Jinan City, Shandong Province, China
Manufacturer's name：BIOBASE POCT CO.,LTD
Production address：Tech Town Accelerator Building 1, Qilu High-tech Development Zone,

Qihe County, Dezhou city, Shandong Province, China
After-sale Service Unit：BIOBASE POCT CO.,LTD Customer Care Center
Contact Number：0531-68629723
Postal code：250000

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Fluorescence Immunoassay Analyzer

BIOBASE POCT CO.,LTD

WARNING: Failure to follow the operating procedures may result in

NOTE: Emphasizes the operation method that must be followed to avoid

NOTE: Emphasize important information.

Intellectual property rights

The audience of this instruction manual is the following:

In order to keep the protection provided by the equipment effective, the

NO. Symbol Signs Explain

Documentation must be consulted in all cases marked with

It indicates that the transport package contains fragile items,

It indicates that the transport package should be protected

7. No rolling It indicates that the transport package cannot be rolled over.

Stacking Indicates that the maximum number of layers that can be

Risk of biological infection

Protection against chemical hazards

Waste liquid treatment

Prevent Fire And Explosion

To prevent fire and explosion, please observe the following precautions.

Disposal of waste immunoassay analyzer

Instrument out of use

 The instrument is used in conjunction with fluorescent immunochromatography

reagents labeled with fluorescent microspheres, and is used for in vitro

quantitative detection of analytes in human samples.

clinical symptoms or other test results.

instrument from falling.

 Please operate the instrument in an environment where the ambient temperature

and the atmospheric pressure is within the range of 86kPa~106kPa.

where the power cord will not be stepped on or tripped over.

 Do not place the device in a location where it is difficult to access the

may be deformed and there is a risk of fire.

 Please install the instrument correctly according to the installation environment

circulation and facilitate the heat dissipation of the instrument.

otherwise there will be a danger of destroying the instrument.

 Electromagnetic environment should be assessed before operating equipment.

service center or the distributor in your area.

Protection against electromagnetic waves and noise

damage to data or displays.

emitted by this instrument may cause malfunctions of other medical instruments

Electromagnetic Compatibility Related Precautions

in this part of GB/T 18268.26.

operate it. This product must be operated by inspection professionals, doctors or

 Please maintain the instrument according to the relevant instructions in the

Warranty and Maintenance Services

After-sales service and contact details

 Repair fees：Negotiate with the company according to the specific situation.

 Get permission to return goods. Contact after-sales service department of the

Company Name： BIOBASE POCT CO.,LTD

1.1. Instrument introduction

(1) Instrument Name：Fluorescence Immunoassay Analyzer

1.2. Main structural composition

Fluorescence Immunoassay Analyzer consists of host (including optical detection

and its fixing parts.

(1) Appearance diagram

Picture 1-1 Appearance diagram

(2) Internal structure layout

Picture 1-2 Internal structure layout

Note: The appearance of the instrument is subject to the actual product.

1.3. Scope of application

Host size and weight 336mm×410mm×400mm（LWH）；17KG；