Biobase BK-AutoHS96 User manual

Automatic Nucleic Acid Extraction System
BK-AutoHS96
User Manual
BIOBASE GROUP
Version 2020.07

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Content
Preface.............................................................................................................................................3
Foreword......................................................................................................................................... 5
I. Product Overview...................................................................................................................... 11
1.1 Basic Product Information............................................................................................... 11
1.2 Product Scope.................................................................................................................. 11
1.3 Product specifications and performance indicators......................................................... 11
1.4 Product Principle..............................................................................................................12
1.5 Definition......................................................................................................................... 12
II. Product installation...................................................................................................................13
2.1 Unpacking inspection...................................................................................................... 13
2.2 Storage and transportation conditions and working environment................................... 13
2.3 Product outline structure.................................................................................................. 15
2.3.1 Product external structure............................................................................................. 15
2.3.2 Internal structure........................................................................................................... 18
2.3.3 Product Consumables................................................................................................... 20
2.4 Instrument installation..................................................................................................... 23
III. Product software description...................................................................................................25
3.1 Software start up.............................................................................................................. 25
3.2 User login.........................................................................................................................25
3.3 Experimental task............................................................................................................ 25
3.4 Data query........................................................................................................................27
3.5 System Management........................................................................................................28
3.6 Equipment control............................................................................................................29
3.7 Helpful information......................................................................................................... 31
3.8 Exit system.......................................................................................................................32
IV. Experiment process.................................................................................................................33
4.1 Experiment process..........................................................................................................33
4.2 Check before starting....................................................................................................... 33
4.3 Boot..................................................................................................................................34
4.4 Experiment preparation....................................................................................................34
4.5 Standard experimental procedure operation.................................................................... 42

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4.6 End of experiment............................................................................................................44
4.7 Shutdown......................................................................................................................... 44
V. Common fault handling............................................................................................................46
5.1 Sample loading module................................................................................................... 46
5.2 Equipment alarm and handling measures........................................................................ 47
5.3 Handling when the instrument is deactivated.................................................................. 47
VI. Product maintenance...............................................................................................................49
6.1 Detergent..........................................................................................................................49
6.2 Daily maintenance........................................................................................................... 49
6.3 Monthly maintenance...................................................................................................... 50
6.4 Annual maintenance........................................................................................................ 50
6.5 Exception maintenance.................................................................................................... 50
6.6 Precaution........................................................................................................................ 50
6.7 Decontamination..............................................................................................................50
Appendix.......................................................................................................................................53

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Preface
Thank you for choosing Automatic Nucleic acid extraction system (BK-AutoHS96). Please read this
operator manual carefully before using the instrument to ensure proper operation.
Please keep this operator manual properly for reference when needed.
Product name：Automatic Nucleic acid extraction system
Model ：BK-AutoHS96
Tel.：[phone]
Fax.：[phone]
Intellectual Property
This operation manual and the intellectual property of the instrument belong to Biobase
Biodustry(Shandong)CO.ltd.
Without the written consent of Biobase Biodustry(Shandong)CO.ltd. any person or entity shall not
copy, revise or translate any part of this manual.
Manufacturer’s Statement
The contents of this operator manual are consistent with the situation of this product. Biobase
Biodustry(Shandong)CO.ltd. reserves the final right to interpret this operation manual.
Biobase Biodustry(Shandong)CO.ltd. shall be responsible for the safety and reliability of the
products when all the following requirements are satisfied:
Assembly, commissioning and maintenance of the instrument are performed by Biobase
Biodustry(Shandong)CO.ltd. after-sales service engineers or other authorized
professionals by Biobase Biodustry(Shandong)CO.ltd.;
All the accessories and consumables used for replacement and maintenance are provided or
accepted by Biobase Biodustry(Shandong)CO.ltd.;
The relevant electrical equipments comply with national standards and the requirements of
this operator manual;
The operation of this instrument is in accordance with this operation manual.
Warranty and maintenance services
The standard warranty period of this product is 1 year. Within this warranty period, the products are
entitled to enjoy free after-sales service; however, the product needs to be repaired due to the
following reasons, which does not fall into the free after-sales range.
You need to pay for maintenance and accessories:
Improper use and man-made damage.
Grid voltage or electromagnetic interference does not conform to the product specified range.
Irresistible natural disasters.
Replace or use parts, accessories, consumables not approved by Biobase
After the warranty period expires, Biobase Biodustry(Shandong)CO.ltd. can continueto
provide maintennance services for fees.
Disassemble the instrument by yourself.
Failures caused by other than the product itself.
After-sale service provider：Biobase Biodustry(Shandong)CO.ltd.
User qualification
This system should only be operated by professionals, doctors, or experimenters trained by Biobase
Biodustry(Shandong)CO.ltd. Or the agents of Biobase Biodustry(Shandong)CO.ltd., and the
operators must be systematically trained in Automatic Nucleic acid extraction system(BK-

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AutoHS96)to meet the corresponding requirements, and have the following qualifications:
You must read and understand the operator manual.
You must have good computer skills,and have a good command of the instrument
and software system operation .
You must be familiar with corresponding laboratory requirements and local laws and
regµLations.
Warning：
Individuals without professional training are forbidden to operate this instrument.
About this operation manual
This manual provides descriptions about main structure, function, performance, installation, use,
operation, maintenance, repair, storage and safety practices to protect the operators and the
instruments related with the Natch CS. Please refer to the corresponding chapter for details. The
users should read the manual carefully for better understanding and command of the operation
knowledge before using the instrument.
Note：
The user manual is intended for the following professionals:
 Daily operation personnels;
 Maintenance and troubleshooting personnels
 People who learn to operate.
The "extractors, instruments, and systems" mentioned in this article all refer to "BK-AutoHS96
Automatic Nucleic acid extraction system".
Software interface
Simplified diagrams of system may be showed in the user manual which may differ from the actual
software interface. Please refer to the actual instrument you purchased.
Appearance of the instrument
Appearance simplified diagrams of instrument, parts, consumables, etc may be showed in the ouser
manual which may be different from the actual ones. Please refer to the actual instrument
youpurchased.
Convention description
This manual describe some basic operations on the system software interface:
 【XX】：Means system software interface buttons.
 Click [XX]: Means to touch and click the corresponding button by mouse.
Signs, labels and symbols

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Foreword
The following signs, labels and symbols may appear to remind operators of the
warnings and potential dangers, please make certain the meaning of the symbols
before use.
Graphic / symbol
Description
Content description
Biohazard:
Remind the user to follow the instructions,otherwise there
is a danger of Biohazard
In vitro diagnostic medical devices
Product serial number
Special attention:Refer to the instruction manual
Telectric shock hazards.
Please refer to the detailed instructions on the Operator
Manual and operate carefully to prevent electric shock
Be careful to pinch and prick.
Please refer to the detailed instructions on the Operator
Manual and handle it carefully.
Do not lean against it.
Pay attention to the UV lamp inside the device.
Please close the door when using and do not stare or
stay in front of the device for a long time after opening,
Do not pour liquid.
Pay attention to the laser light source
Don’t stare at it so as not to cause burns to the eyes.
Watch out for hot burns
Refer to the Operator Manual

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Prompt text description in Operation
Manual Text description
Text
Description
Note
It is used to explain important information in the operation
steps or
other contents that needs to remind the user.
WARNING
Remind the user to follow the instructions, otherwise personal
injury
may be caused.

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Safety Precautions
For safe and effective use of the system, please read the following safety precautions carefully. Any
violation of the following safety precautions may result in damage to the system or personal injury.
If the user does not follow the instructions to use the system, the protection provided by the system
may be invalid.
Electricity safety
In order to use electricity safely and prevent electric shock and damage to the instrument, please
observe the following precautions.
It is a non-household equipment which cannot be directly connected to the
residential low-voltage power supply network.
If there is an external switch or fuse or overcurrent protection device,make sure
them available near the equipment.
Do not place the instrument where it is difficult to operate the disconnection
device. If the plug of the power supply cannot be disconnected immediately in
an emergency, make sure that the wall socket connected to the instrument's
power supply can be touched by hand at all times.
After the installation is completed, customers are not allowed to move the
instrument without authorization. If it tmust be moved, please contact the
installation engineer for on-site service.
This system is grounded via ground wire. The power ground wire must be
grounded to avoid electric shock.
The AC power supply must be stable. It is forbidden to share the power supply
with high-power appliances.
Don’t touch the power connector on the back of the system while running or
maintaining it, otherwise there may be danger of electric shock.
Ac power supply must be stable and share power with high-power electrical
appliances.
When the user is running or maintaining the instrument, do not touch the power
interface at the back of the system, otherwise there may be the risk of electric
shock.
When the main power of the instrument is turned on, non-authorized
maintenance personnel must not disassemble the cover of the instrument.
Spilling the solution into the instrument may cause the instrument to malfunction
and cause electric shock. Don’t place objects on the instrument. In the event of a
spill, immediately turn off the power and contact the customer service
department or the local service representative of Biobase
Biodustry(Shandong)CO.Itd.
Do not plug or unplug the power supply with wet hands.
Disconnect it from all power sources before opening the instrument for any
maintenance or repair which should only be performed by skilled operators.
Make sure that the replaced power supply meets the requirements of this instrument.
If the instrument may be damaged, disconnect it from the power outlet and do
not operate it again.

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Electrical danger
Please observe the following precautions to prevent electrical hazards
WARNING：
 The operator must always observe the electrical safety operation
regulations. Only professional personnel can perform electrical repairs.
Please wear static-free wrist straps or gloves during maintenance to
protect the sensitive components on the instrument from electrostatic
damage.
Mechanical danger
Please observe the following precautions to prevent mechanical hazards
WARNING：
. The instrument compartment door must be closed
during operating it because its moving parts may cause personal
injury during operation It is strictly forbiddentoextend the body parts
into the machine work area Unless the system has stopped working,
you can open the compartment door to place samples, reagents, and
guntips, otherwise it may cause injury to the operator. At the same
time, the instrument maybe damaged. Please note the following
possible mechanical hazards:
 Injury caused by mechanical arm squeeze.

Injury caused by the pipette tip.
Protection against fire and explosion
Please observe the following precautions to prevent fire and explosion,
WARNING：
Alcohol is flammable and should be handled with care.
Electromagnetic interference prevention
Please observe the following precautions to prevent electromagnetic interference,
WARNING：
In order to ensure the normal operation, the user has the responsibility to
ensure that the instrument operates in an environment of electromagnetic
compatibility

The system can’t be installed with strong electromagnetic field
interference which may affect the normal operation.
 Don’t use other medical devices that may generate electromagnetic
interference around the instrument, otherwise it may affect the normal
operation of the instrument.

This instrument complies with EMC requirements which may cause
radio frequency interference in indoor environments. Appropriate

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measures should be taken to reduce interference.
Biohazard prevention
Please observe the following precautions to prevent biohazard effectively,

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Biohazard：
 All liquids and solids in the laboratory are considered to be biological
hazards and the user must take general laboratory precautions.

All clinical samples are considered to be potentially infectious.
Improper use may result in infection. Do not touch the samples directly
with your hands. Always wear gloves and overalls to prevent infection
during operation. Wear protective glasses when necessary.

If the sample accidentally comes into contact with the skin, please
immediately follow the work standards for users to handle it and consult
a doctor.
Waste disposal
To prevent environmental pollution and personal injury caused by waste products, please
observe the following precautions.
Biohazard：Follow the relevant local laws and regulations for the
disposal of used samples, reagents and other wastes.
Other precautions
To use the instrument correctly, please observe the following precautions:
WARNING：
Do not smoke or eat near the instrument.
Avoid direct sunlight when the instrument is in operation..
Please use the software installation package provided by BIOBASE
when installing user software
During user software startup or running, it is prohibited to change the
date and time of the host.
Don’t run other applications while the user software is running

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I. Product Overview
BK-AutoHS96 is a Automatic Nucleic acid extraction system developed by Biobase
Biodustry(Shandong)CO.ltd. with high throughput, high precision, high
efficiencyand pollution prevention.The system adopts a vacuum blood collection tube to
directly load the machine, which integrates a sample carrier, a reagent carrier,a gun carrier,
a sample loading arm, a grasping arm, an oscillation heating modµLe, a refrigeration
modµLe, a magnetic suction module, a barcode scanning module, a protection system, a
transportation system and industrial control system l to a whole with one-button convenient
operation and standardized work flow. It can greatly reduce manual operation
errors ,improve the accuracy of test results and provide solution for highly refined, simple,
automated, and systematic laboratories
1.1 Basic Product Information
Product Name ：Automatic Nucleic acid extraction system，Product model ：BK-AutoHS96
1.2 Product Scope
This product is intend for extract nucleic acid from specimenssuch as serum, plasma, throat
swabs, anal swabs, feces, reproductive tract secretions, exfoliated cells, urine, sputum, etc.
which can be used in clinical gene amplification testing laboratories, CDC Centers for Disease
Control, Research institute laboratories, medical college laboratories, etc.
1.3 Product specifications and performance indicators
Items
Parameter
Sample type
Serum, plasma, throat swab, anal swab, stool,
reproductive tract secretions , exfoliated cells, urine,
sputum, etc.
Supported
reagent types
Pro HBV, HCV, HPV, STDs, EB, HCMV, TB, HFMD and etch
Language
Simplified Chinese / English
Display method
10.4 inch touch screen
Communication
Interface
2 RS232, 4 USB, 2 network ports, 1 HDMI
Power supply
Input: AC 110V-240V, 50/60Hz, 350VA
Dimensions
1320 mm×850 mm×1600 mm (length x width x height)

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Items
Parameter
Net weight
≤350Kg
Barcode scanning
Code39、Code93、Code128、Ean128、EAN/UPC、Codabar
Level detection
Pressure detection / capacitance detection, automatic detection of liquid level
Clot detection
Pressure detection, automatic detection of liquid aspiration and liquid
clogging
Illumination
White cold light source
UV disinfection
Timed opening and closing
Instrument life
8 years. See the label on the production date. The life of this product is
determined based on the life of the key components.
1.4 Product Principle
The instrument include sample carrier, reagent carrier, gun head carrier, sample loading arm,
grasping arm, oscillation heating module, refrigeration modµLe, magnetic module, barcode
scanning module, protection system, transportation system, industrial control system, etc.which
can be used for nucleic acid extraction from specimens accompanied with reagents,
1.5 Definition
LIS system: Laboratory (Inspection Division) information systemHIS system: Hospital
Management Information
SystemPCR: Polymerase Chain Reaction, English name Polymerase Chain Reaction.
CDC: Center for Disease Control and Prevention.System: Refers to the Automatic Nucleic
acid extraction system (BK-AutoHS96).
Software: refers to the software used by the Automatic Nucleic acid extraction system (BK-
AutoHS96).

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2.1 Unpacking
inspection
II. Product installation
Check the packaging and instrument after unpacking the outer box of the Natch CS,
Please contact the transportation company or local distributor immediately if any
damage.
Check out the packing list for the accessories of the instrument main unit after
unpacking the outer box . Please contact the dealer immediately. whether the items are
complete if any inconsistency or missing.
2.2 Storage and transportation conditions and working environment
Storage and transportation conditions
 Ambient temperature: -20 ℃～55 ℃.
 Relative humidity: ≤93%.
Working environment

The installation environment should be as clean as possible without dust,
mechanical vibration, pollution, large noise sources, and electromagnetic
interference.
 For indoor use, avoid direct sunlight or place it in front of heat and wind
sources. Choosea well-ventilated location.
 Ambient temperature: 15 ℃～35 ℃.
 Relative humidity: 15% to 90%.
Power requirements
 Power supply: It must be used in a well-grounded power outlet. Before
installation,,Make sure the input voltage meets the requirements.
Voltage:
AC220V±22
V Frequency:
50Hz Power:
350VA
Space requirements
Leave enough space behind the machine and on both sides of the machine to prevent
poor heat dissipation which may cause the internal temperature of the machine to rise
and malfunction. The space where the instrument is placed must be larger than the
dimensions of the machineto ensure the space required to conduct maintenance, and turn
the power off in emergency.
The space must meet the following conditions, as shown in Figure 2-1:

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1) The reserved space between the right side of the instrument and the wall (or adjacent
object) is
≥50cm;
2) The reserved space between the left side of the instrument and the wall (or adjacent
object) is

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≥10cm;
3) The reserve space between the back of the instrument and the wall (or adjacent objects)
is≥20cm.
4) The front of the instrument is ≥60cm.
2.3 Product outline structure
Figure 2-1 Instrument placement space
Automatic Nucleic acid extraction system (BK-AutoHS96) is consisted of sample carrier, reagent
carrier, tips carrier, sample loading arm, grasping arm, oscillation heating module, cooling module,
magnetic module, barcode scanning module, protection system, transportation system, industrial
control system, etc.
2.3.1 Product external structure
The appearance of the product is shown in Figure 2-2 below.
Appearance of this instrument

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Front view Side view Rear view
Communication interface diagram (enlarged view at A)
Figure 2 Appearance of 2 Automatic Nucleic acid extraction system (BK-AutoHS96)
Table 2 Structure of 1 BK-AutoHS96 Automatic Nucleic acid extraction system
No.
Name
Function
1
Security door
For safety protection
2
Touch screen
To display the operation interface
3
Power switch
For internal power supply of the instrument
4
Lighting switch
Provides interior lighting
5
Left cabinet
For waste tips storage
6
Right cabinet
For item storage
7
Right hanging plate
For circuit board maintenance
8
Left hanging plate
For decoration
9
Top service panel
and
air pipe joint
Robotic arm maintenance and connection of exhaust
pipes.

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10
Rear service panel
For mechanical arm maintenance.

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Table 2 Structure of 1 BK-AutoHS96 Automatic Nucleic acid extraction system
No.
Name
Function
11
Power input socket
Used for power cord connection.
12
Casters and
adjustable
foot cups
Used to adjust the level of the instrument during
transportation and installation.
13
Serial port
Used for communication.
14
USB
Used for communication.
15
Computer forced
switch
Long press for 5 Seconds to force shutdown
computer.
16
Computer power
indicator
To display the computer is powered on or off
17
Computer running
indicator
To display computer operation status
18
HD output interface
To connect external display device.
19
Network port
Used for communication.
20
Computer reset
switch
Used to recover computer programs.
2.3.2 Internal structure
The internal structure of the product is shown in Figure 2-3 below.

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Figure 2 3 Internal Structure of Automatic Nucleic acid extraction system (BK-AutoHS96)