BK150 User Manual
BK150 User Manual
Urine Analyzer
User Manual
BK150
TEL:+(86)-025-58501357
E-mali:marketing@[Link]
Handheld Urine Analyzer User Manual
Handheld
Urine Analyzer
User Manual
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Handheld Urine Analyzer User Manual Handheld Urine Analyzer User Manual
Contents Contents
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1.1.4 Test cassette 3) Before operating the instrument, please read this user
The test strips and the instrument constitute a complete set. manual carefully and keep it properly for future reference.
4) Do not place this device in liquids or in places where liquids
Attention may fall into it. If the device is wet, unplug the device before
contact it.
· The instrument should be used with test strips produced
by Bioantibody Biotechnology Co., Ltd., otherwise the 5) Do not leave the device unattended while the power cable is
plugged in.
instrument will not be able to perform normal testing or
obtain reliable testing results. 6) Use the device only for the purposes described in the
manual.
· To ensure the correct and safe use of the test strip, please
refer to the label on the packaging and the attached user 7) Do not use test strips that are not provided by our company.
manual. 8) Do not continue to use the device if it is not working proper-
ly or has been damaged.
· Please follow the instructions in the user manual for
proper storage of test strips. Do not use test strips that 9) Do not allow the device to come into contact with surfaces
have expired. that are too hot to touch.
· Each test strip must be checked for damage before use. 10) Do not allow any items to fall into or place them into the
Damage to the shape may affect the detection perfor- opening, pipeline, or joint of the analyzer unless it is specifi-
mance of the test strip. If the box is damaged, check the cally required to do so in the manual.
interior for signs of damage. Do not use the test strip if 11) Do not place any items on top of the device.
damage is found inside. 12) Please operate the instrument in accordance with the
manual. Failure to use the analyzer in the manner
prescribed by our company may impair the protection
provided by the analyzer.
1.1.5 Precautions and warnings 13) Do not use the device in areas where aerosol droplets are
1) The handheld urine analyzer is suitable for urinalysis test present or where oxygen is managed.
strips and urine analyzers for urine analysis based on dry 14) Do not use the device outdoors.
chemical principles, with no other specified use. 15) Wear protective gloves when handling samples, quality
2) Verify that the voltage is set to match the supply voltage. control products, and other materials.
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16) The instrument should not be placed in direct sunlight to 26) Please use fresh urine as a test urine sample, do not add
avoid affecting the testing accuracy. preservatives to the urine sample, and the container
17) Keep the surface of the instrument clean by wiping it with containing urine samples must be clean to prevent residual
absorbent cotton and neutral detergent. detergents and disinfectants from interfering with the
18) Do not use any organic solvents such as solvent oil, grease, determination.
paint thinner, benzene compounds, etc. on any part of the 27) Since the white blood cells in urine with a low specific
instrument, as these reagents will deform the analyzer and gravity, alkaline urine, and urine samples that have been
affect its operation. stored for a long time at high room temperature are easy to
19) The LCD screen can be gently wiped clean with a clean and dissolve, resulting in determination results of the white
soft dry cloth or soft paper. blood cells being higher than those of microscopic
20) The loading stage should be cleaned once a day to avoid examination, so it is necessary to use fresh urine samples for
cross-contamination and residue attachment to the stage, determination. Taking or injecting a large amount of
which will bring difficulties to cleaning. vitamin C will result in low and false-negative test results of
21) Avoid placing the instrument in a tilted or vibrating place, nitrite, bilirubin, urobilogen, glucose and occult blood.
and pay special attention to keeping it at a distance from Please stop taking vitamin C for 10 hours before determina-
machines such as the centrifuge to prevent resonance. tion.
22) The use of this device in a dry environment, especially in the 28) Urine samples for nitrite determination should preferably
presence of artificial materials (artificial fabrics, carpets, be retained in the bladder for more than 4 hours.
etc.), may cause damaging electrostatic discharges, leading 29) The optimal temperature for determination is 15-30 °C. Too
to erroneous conclusions. high or too low temperature will affect the accuracy of
23) It is prohibited to use this device next to a source of strong determination results.
radiation (such as an unshielded RF source), otherwise it 30) If the instrument is damaged during transportation, please
may interfere with the normal operation of the device. contact your local dealer.
24) Do not place the instrument in a position where it is difficult 31) The instrument should avoid high temperatures, humidity,
to disconnect it from operation. and contact with substances such as dust, salt, sulfur, etc.
25) Gloves must be worn before testing operations to prevent 32) The continuous operation time of the instrument should
potential risk of biological contamination. not exceed 24 hours.
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33) If any accessories are damaged, please contact your local other applicable regulations before disposing of the urine
dealer. analyzer. For further information on the proper disposal of
34) Before transportation or treatment due to maintenance or waste, please contact the relevant local government
discontinuation of use, it is necessary to disinfect and clean agencies or regulatory authorities, and do not dispose of it
the instrument with a soft cloth and anhydrous ethanol to at will.
reduce the risk of biological pollution. 41) Please dispose of waste batteries in accordance with local
35) Handling of this instrument and accessories requires environmental regulations.
compliance with national regulations.
36) For in vitro diagnosis only.
1.2 Test principle
37) Contraindications: None.
The handheld urine analyzer BK150 uses monochromatic light to
38) If there is any liquid accidentally flowing into the instrument
scan the reaction zone on the test strip item by item. Since the
or the instrument emits peculiar smell, smoke and other
monochromatic light has different reflectivity in different colors
abnormal conditions during operation, the power supply
and different shades of color, the content of various biochemical
should be immediately cut off, and the after-sales support
components in urine is determined by determining the gradient
department of our company should be contacted (see the
of reflectivity. The instrument scans the test strip item by item
“Contact Information”page in the manual for details).
with two kinds of monochromatic lights. The scanning system
Continue to use the instrument may cause fire, electric
converts the optical signal into an electrical signal, which is
shock, or injury to personnel.
processed by the control system of the instrument, and the
39) Please comply with all national health and safety standards,
reflectivity value of a certain color is calculated. The instrument
including (but not limited to) wearing protective eye wear,
can determine the concentration of a certain biochemical
gloves, and appropriate lab coats when operating and
component in the urine represented by a certain test block based
maintaining this instrument.
on the reflectivity value. After processing by an internal proces-
40) The environmental protection period for the use of the urine
sor, the test results are displayed with clinically significant units
analyzer is 10 years. If it exceeds this period, please remove
and printed.
the battery and dispose of it in accordance with the
“Regulation on the Administration of the Recovery and
Disposal of Waste Electrical and Electronic Products”or
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1 PC BK150 1 set
c a
2 Power adapter / 1 piece
d
2.2 Structure of the instrument
Notes: The appearance of the instrument and accessories shall e
be based on the actual object. Figure 2.2 Figure 2.3
The handheld urine analyzer BK150 is composed of an optical Schematic diagram Schematic diagram
detection system, photoelectric conversion control, micropro- of components (1) of components (2)
cessor (including data analysis and processing software V1), data
communication interface, and LCD display.
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3.2.3 Restrictions for transportation and storage environ- Chpter IV Instrument Installation
ment 4.1 Packaging
Storage temperature range: -20℃-55℃ Carefully unpack the instrument and check its appearance. If
Storage humidity range: 10%-90% there is any handling damage, please report it immediately.
Atmospheric pressure range: 76.0 kPa-106.0 kxPa Inspect the instrument and verify the packing list, take inventory,
and check if the items are complete to ensure complete configu-
3.3 Usage conditions of the instrument ration. If you find incomplete configurations, please contact our
3.3.1 Positioning and placement requirements after-sales support department or your local agent immediately.
The instrument should be placed in an environment that is free
of dust, mechanical vibration, loud noise sources and power 4.2 Installation requirements
interference, and keep away from brush-type motors, flashing Requirements for environment
fluorescent lamps and electrical contact equipment that is 1) The installation environment should be free of dust,
frequently switched on and off. Avoid direct sunlight or being mechanical vibration, loud noise sources and power
placed near heat and wind sources. interference.
2) Keep away from brush-type motors, flashing fluorescent
3.3.2Requirements for power voltage lamps and electrical contact equipment that is frequently
Input voltage: AC100V-AC240V±10%, frequency: switched on and off.
50Hz-60Hz±10%; 3) Avoid direct sunlight or being placed near heat and wind
sources.
3.3.3Normal working conditions
Requirements for space
Ambient temperature range: 0 °C-40 °C
Place the instrument on a stable work surface, and ensure a large
Relative humidity range: 30%-85%
enough space for placing test strips.
Atmospheric pressure range: 76.0 kPa-106.0 kPa
4.3 Instrument installation
Power connection
Correctly use the power adapter configured for this instrument,
plug in the power cord, and connect the power plug to the power
socket.
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Warning
Users are obliged to abide by the relevant regulations on
waste discharge in their region and country.
Figure 5.1
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2) Users can set up the system as needed (in accordance with for the test to be completed.
the requirements in Section 5.6 of the operating manual).
5.2 Stage check
Then press the test button, and the instrument will be in test
1) Before starting a test, the stage should be checked for
state after the loading stage is completely stretched out and
cleanness. If necessary, it is recommended to run the
fixed (Figure 5.2).
“Clean”menu every week, remove the loading stage and
check whether the white calibration sheet on its front end is
clean. If the loading stage is not clean, handle it in
accordance with the relevant contents in Chapter 6“Mainte-
nance” . After installation, restart the instrument for self-test.
Figure 5.2
3) Place the test strip with urine sample on the loading stage,
gently push the test strip to the forefront, make sure there is
no gap between the forefront of the test strip and the
Figure 5.3
loading stage, and press the“Start”button, and then wait
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be automatically incremented by one. The results of each Important: Gloves must be worn prior to test manipulation
test will be retained in the memory of the instrument. One to prevent potential risk of biological contamination.
test generates one record, and each record includes data 5) Place the test strip flat in the test strip slot of the Loading
such as time, test number and test results. The memory of stage and gently push the strip forward until it touches the
the instrument can store 2,000 records. The instrument will top of the Loading stage.
automatically delete the first record and store the latest 6) Wait 60 seconds and press the "Start" button to begin the
record when it is full of 2,000 records. This database is test (Figure 5.4).
automatically managed by the instrument to prevent Important: Do not move the instrument during the test to
duplication or loss of records. avoid abnormal results.
5.3.4 Continuous Testing 7) The test result is displayed on the screen. If a printer is
Note: Continuous test mode is for professional use only, other selected, the test result will be printed (Figure 5.5).
people may cause inaccurate test results. Please dispose of used test strips properly as medical waste.
1) If continuous test mode is used, please turn on the "Contin- 8) Press "Test" to proceed to the next test, put the test strip
uous Test" function of the test mode in the setup menu. which has been soaked for 60 seconds on the Loading stage,
2) In the main interface, press the "Test" button, the interface and press "Start" button to start the test.
prompts "Test Stage" and its related steps, and the Loading If you press "Back", you can go back to the test interface.
stage is extended. The instrument is in the continuous test
mode and the test strip needs to react outside the
instrument for 60 seconds. 5.4 End of the test
3) After the Loading stage is fully extended, if you want to Press the back button on the interface to be tested, and the main
cancel the test, press "Back" to return to the main interface. interface of the instrument will be displayed after the stage is
4) Fully immerse the reagent area of the test strip in the urine completely retracted. To end the use, press and hold the power
(note: all color blocks must be fully immersed in the urine), switch on the surface of the instrument for 3 seconds, and then
keep it fully immersed in the urine for 1-2 seconds, then release it to shut down the instrument. Unplug the power supply
remove it and scrape the side of the test strip along the wall and lay it flat on the worktop.
of the container to remove the excess urine (Figure 5.3). Important:
Start the timer at this point. 1) Do not touch the reagent block part of the test strip with
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2) [Test Mode]: for switching between continuous testing and Chpter VI Maintenance
routine testing. 6.1 Routine maintenance
3) [Clean]: Used to clean the Loading stage. 1) Disassembly of stage
4) [Factory]: for instrument factory function debugging. Enter the menu “Service Settings\Cleaning” , press the
5) [Backlight]: Used to set the brightness of the display. “Loading stage is stretching out”button, and retrieve the
6) [Screen Cal]: Used to calibrate the screen. stage after it exit.
7) [Screen]: Used for switching on/off the screen saver. 2) Cleaning of stage
8) [Update]: Used to update the instrument software program. Wipe the stage with cotton cloth dampened with distilled
9) [Beep]: Used to switch the key sound. water or soft absorbent paper. Use a brush with a cotton tip
10) [About]: Displays the firmware version and serial number of dipped in clean water to scrub the calibration sheet, and let
this instrument. it dry naturally after wiping. Check the surface of the white
calibration sheet for dust, foreign matter, and scratches. If
there are scratches or wear, replace it. (If replacement is
necessary, please contact your local distributor or the
company’ s technical support, do not replace by yourself to
avoid damage)
3) Installment of stage
After cleaning, press the“Loading stage is retracting”button
and gently push in the stage (loaded from the white block
end, cannot be reversed), the stage will automatically enter
the instrument.
4) Regular cleaning
If there is urine alkali on the stage, the following steps
should be followed for cleaning:
①Enter the menu“Service Settings\Cleaning” , press the
“Loading stage is stretching out”button, and retrieve the
stage.
Figure 5.6
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②Dip a cotton swab with acidic cleaning agents (such as ③ Dry the stage with absorbent paper.
dilute hydrochloric acid, acetic acid, etc.) and wipe the 6) Disposal of waste
stage. Please dispose of used test strips properly as medical waste.
③Wipe off the remaining cleaning agent on the stage with a Instrument calibration
damp cloth. 7) Whenever the user has doubts about the instrument,
④Dry the stage with absorbent paper. control materials can be used for calibration. Compared
⑤After cleaning, press the“Loading stage is retracting” with the target value of the quality control, if the above data
button and gently push in the stage, the stage will automati- is the same, it indicates that the instrument is normal,
cally enter the instrument. otherwise the instrument is considered abnormal, please
5) Disinfection contact with the supplier.
The stage often comes into contact with urine. After a period 8) Battery replacement
of time, it should be disinfected regularly according to the The Handheld urine analyzer BK150 uses a lithium battery.
following steps: In the case of a dead battery when the number of samples
①One of the following solutions can be selected for tested is very small, it is necessary to contact the company's
disinfection, and the preparation method is as follows: after-sales service department to replace the internal
a) 2% glutaraldehyde solution: Cidex (with sufficient lithium battery.
concentration) is a convenient and commercially available Attention: Our company is not responsible for any harm or
product. Disinfect the stage refer to the detailed instructions accidents caused by the user opening the instrument without
on the label. permission to replace the internal lithium battery.
b) 0.05% sodium hypochlorite solution: Take 1 mL of 9) Troubleshooting
sodium chlorate (such as Clorox Bleach) and add it to 99 mL This section lists some problems that may be encountered
of water to form a 1:120 dilution. during the use of the Handheld urine analyzer BK150 and
c) Isopropanol (70%~80%), without dilution. Dip a cotton simple solutions. If the problem still cannot be solved using
swab with the prepared disinfectant solution to wipe the the appropriate methods, please contact your seller in a
stage. timely manner to obtain the fastest technical support and
② Wipe off the remaining cleaning agent on the stage with a service.
damp cloth.
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The test strip is stuck in Shut down to clean up the stuck 6.4 Description of electromagnetic compatibility
the stage,and cannot
test strip, and restart for testing. 1) The electromagnetic compatibility indicators of this
enter and exit normally
instrument fully comply with the requirements of IEC
Low battery Charge with a power adapter.
61326-1:2013 Electrical equipment for measurement,
To operate properly, and place the control and laboratory use - EMC requirements - Part 1:
No test strip
processed test strip on the stage. General requirements and IEC 61326-2-6:2013 Electrical
Dry test strip To operate properly. equipment for measurement, control and laboratory use -
EMC requirements - Part 2-6: Particular requirements - In
Note: Before cleaning the instrument, turn off the power vitro diagnostic (IVD) medical equipment. The verification
switch and ensure that the power cord plug is disconnected to method of electromagnetic compatibility indicators is also
avoid short circuit as well as the danger of electric shock! carried out based on the above two standards.
2) Users are responsible for ensuring the electromagnetic
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compatibility of the instrument and using it in an environ- 4) The contents of this manual can be changed without notice.
ment that meets the requirements so that the instrument
can work properly.
Responsibility of Manufacturer
1) We consider ourselves responsible for the safety, reliability
Chpter VII Service, Repair, and Destruction and performance of the instrument only under the follow-
Copyright ing circumstances:
Bioantibody Biotechnology Co., Ltd. Installation, version upgrade, system expansion, instrument
Version No.: V 1.0 recalibration, improvement and repair are all carried out by
Issued/Revised in December, 2022 personnel approved by our company.
Product name: Handheld Urine Analyzer The instrument is used according to the operating instruc-
Model: BK150 tions.
2) Hospitals or institutions using this instrument must
Statement establish a maintenance program for the instrument,
1) Bioantibody Biotechnology Co., Ltd. has the final right to otherwise abnormal instrument failure may occur and
interpret this user manual and has the right to treat it as personal health may be jeopardized.
confidential information. This manual is intended only as a
3) Our company will conditionally provide circuit diagrams
reference for the operation, maintenance and repair of necessary for maintenance when requested by users, and
BK150. Others have no right to disclose the contents of this provide information such as calibration methods to assist
manual to others. users in repairing parts of the instrument proposed by our
2) This manual contains proprietary information protected by company that can be repaired by users with appropriate
copyright laws. All rights are reserved. No part of this technicians.
manual may be copied, reproduced or translated into other
4) The manufacturer assumes no responsibility for failure of
languages without our written consent. the protection provided by the instrument if the customer
3) We do not make any kind of warranty for this information does not use it according to the specified method.
and is not responsible for errors contained in this informa-
tion or for indirect damages resulting from the provision of
this manual.
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Contact Information
Name of registrant/manufacturer: Bioantibody Biotechnology
Co., Ltd.
Registered address: Room 903/905, Building C6, No.9, Weidi
Road, Qixia District, Nanjing.
Tel: +86 025-58501357
Website: [Link]
After-sales service: Bioantibody Biotechnology Co., Ltd.
Tel: +86 025-58501357
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