Biobase BK-PR48 User manual

Automated Sample Processing System
BK-PR48
User Manual
Biobase Biodustry (Shandong) Co., Ltd

I
Foreword
Thank you for purchasing Automated Sample Processing System（BK-PR48）
Before using the product, please read the user manual carefully for correct using.
Please keep this user manual for reference.
Product Name:
Automated Sample Processing System
Model:
BK-PR48
Company:
BIOBASE Biodustry (SHANDONG) Co.,LTD
Address:
No.9 Gangxing Road, High-Tech Zone ,Jinan City,
Shandong Province, China
Date of production:
See the nameplate for detail
Service life:
5Year
Tel:
[phone]/03
Fax:
[phone]
Intellectual property
The intellectual property of this user manual and its corresponding products
belongs to Biobase Biodustry (Shandong) Co., Ltd. (hereinafter referred to as
“our company” or “us”).
No individual or organization may reproduce (including photographing,
reprinting, transcription, etc.), copy, modify or translate any part of this manual
without the prior written consent of our company.
is a registered trademark or trademark of Biobase Biodustry
(Shandong) Co., Ltd.
Declaration of Conformity
This medical device has been assigned to class A according to Annex II + Annex III +
Article 17 of IVDR (EU) 2017/746. It bears the mark
whose single Authorized EU-Representative:
Name:Luxus Lebenswelt GmbH
Address:Kochstr.1, 47877, Willich, Germany
Email: [e-mail]

II
Manufacturer's Statement
Biobase Biodustry (Shandong) Co., Ltd (hereinafter referred to as “our
company” or “us”) has the final interpretation right of this user manual.
Our company is responsible for the safety, reliability and performance of the
product when all of the following requirements are met:
Assembly operations, expansion, re-adjustment, improvement, repair and
replacement of parts are performed by professionals recognized by our
company.
All repairs involving replacement parts and supporting accessories and
consumables are original (original) or approved by our company.
The relevant electrical equipment complies with national standards and the
requirements of this user manual.
Product operation is carried out in accordance with this user manual.

III
Warranty and Repair services
The standard warranty period of this product is 1 year. During the warranty
period, the products will have free after-sales service.However, if the product
needs to be repaired due to the following reasons, it does not fall into the scope
of free after-sales service. You need to pay the maintenance fee and accessories
fee:
improper use, man-made damage.
Power grid voltage or electromagnetic interference does not conform to the
scope of product regulations.
Irresistible natural disasters.
Replace or use parts, accessories, consumables that are not original (original)
or not approved by the Company or are repaired by personnel not authorized
by the Company.
Disassemble and install the instrument by yourself.
After the expiry of the warranty period, the company can continue to provide
charging maintenance services.
Other faults not caused by the product itself.

i
Catalogue
Foreword.............................................................................................................................................. I
Warranty and Repair services............................................................................................................III
Security Information........................................................................................................................... 1
1 Product Description..........................................................................................................................5
1.1 Basic Information..................................................................................................................5
1.2 Application Scope................................................................................................................. 5
1.3 Parameters............................................................................................................................. 5
1.4 Product Principle...................................................................................................................6
1.5 Packing List...........................................................................................................................6
1.6 Consumables......................................................................................................................... 6
2 Product Installation Requirements................................................................................................... 8
2.1 Environmental Requirements........................................................................................................8
2.2 Power Supply Requirements.........................................................................................................8
2.3 Space Requirements...................................................................................................................... 8
3 Instrument Unpacking and Installation..........................................................................................10
3.1 Check Before Unpacking.................................................................................................... 10
3.2 Installation...........................................................................................................................10
4 Product Structure............................................................................................................................12
4.1 External Structure................................................................................................................12
4.2 Internal Structure.................................................................................................................12
5 Software Description......................................................................................................................21
5.1 Software Startup..................................................................................................................21
5.2 Program Operation.............................................................................................................. 21
5.3 Program Management......................................................................................................... 22
5.4 Instrument Management..................................................................................................... 24
5.5 About................................................................................................................................... 25
6 Operating Instruction......................................................................................................................27
6.1 Experimental Process..........................................................................................................27
6.2 Check Before Power-on...................................................................................................... 27
6.3 Power-on............................................................................................................................. 27
6.4 Preparation Before Experiment...........................................................................................27
6.5 Standard Experimental Procedure.......................................................................................28
6.6 Shut Down...........................................................................................................................29
6.7 Program Management Input Information........................................................................... 29
7 Software Update.............................................................................................................................34
7.1 Single Step Movement........................................................................................................ 34
7.2 Cap Screwing Debugging................................................................................................... 35
7.3 Sampling Arm Debugging.................................................................................................. 37
7.4 Software and Hardware Version Query.............................................................................. 38
7.5 Manual/Operation Log Query.............................................................................................39
8. Faults Handing.............................................................................................................................. 40
8.1 Mechanical Arm Module.................................................................................................... 40
8.2 Alarm and Troubleshooting.................................................................................................41

ii
8.3 Maintenance Before Out of Service....................................................................................41
9 Product Maintenance......................................................................................................................42
9.1 Cleaning Agent....................................................................................................................42
9.2 Daily Maintenance.............................................................................................................. 42
9.3 Monthly Maintenance......................................................................................................... 43
9.4 Yearly Maintenance.............................................................................................................43
9.5 Abnormal Maintenance....................................................................................................... 43
9.6 Prophylactic Measures........................................................................................................ 43
9.7 Pollution Exclusion............................................................................................................. 44

1
Security Information
Logos, labels and symbols
Various safety symbols and tests are used in this user manual and the analyzer to
remind you of the things you need to be aware of during operation. As shown in the
following table:
Symbol
Description
Biohazard:
In all cases marked with this warning mark it is necessary to
consult the user manual in order to ascertain the nature of the
potential hazard and any action that must be taken.If you do not
follow the instructions in the user manual to use the device, the
protective measures provided by the device may fail.
Caution, hot surface:
Used for halogen lamp position. Indicates a burn hazard and may
be burnt if contacted or not followed.
Mechanical hazard:
Used for the position of moving parts such as sample arm, stirring
arm, cleaning mechanism, etc.. Indicating potential danger,
forbidden to touch the moving parts during operation to avoid
getting involved in, if not in accordance with the instructions, may
cause personal injury.
Caution:
In all cases marked with this warning mark it is necessary to
consult the user manual in order to ascertain the nature of the
potential hazard and any action that must be taken.If you do not
follow the instructions in the user manual to use the device, the
protective measures provided by the device may fail.
F3AL250V
Fusible tube type label.
CE mark：
This medical device has been assigned to class I according to
Annex VIII of the Regulation (EU) 2017/745. It bears this mark.
European Authorized Representative:
Represents the authorized representative of the European Union.
Company LOGO.
Instructions of the word promts in the user manual.
Promts
Description
Notice
It is used to describe the important information in the operation procedure or
other contents that need to be reminded of.
Caution
Remind users to follow the instructions; otherwise, personal injury may occur.

2
Safety precautions
To use this system safely and effectively, please read the following safety
precautions carefully. Any operation that violates the following safety precautions
may cause system damage or personal injury. If users do not follow instructions to use
the system, the protective measures provided by the system may be invalid.
Electric safety
To use electricity safely and prevent electric shock and equipment damage,
please observe the following precautions.
Caution：
This instrument is only suitable for non-domestic use and cannot be directly
connected to the residential low-voltage power supply network.
If there is an external switch or fuse or overcurrent protection device, it
should be installed near the instrument.
Do not place the instrument in a place where it is difficult to cut off the
power. If the power plug cannot be disconnected immediately in an
emergency, please make sure that the wall socket connected to the
instrument power can be reached by hand at all times.
The installed instrument is not allowed to be moved by the customer. If it
must be moved, please contact the installation engineer for on-site service.
This instrument is grounded through the ground wire of the power cord. To
avoid electric shock, the ground wire of the power supply must be grounded.
The AC power supply must be stable and it is forbidden to share the power
supply with high-power electrical appliances.
During the operation or maintenance of the instrument, please do not touch
the power interface at the back of the instrument to prevent electric shock.
When the main power of the instrument is turned on, unauthorized
maintenance personnel are not allowed to disassemble the shell of the
instrument.
Spilling liquid in the instrument may cause the instrument to malfunction
and cause electric shock. Please do not place objects on the instrument. In
case of liquid spillage, please turn off the power immediately and contact
our service center.
Do not plug or unplug the power supply with wet hands.
Before disassembling the instrument for any maintenance or repair,
disconnect all power sources connected to it. If these maintenance operations
must be carried out, they can only be carried out by professionals who
understand the dangers and are skilled in the operation.
Make sure that the replaced power supply meets the requirements of this
instrument.
If the instrument may be damaged, disconnect the power socket and do not
operate it again.

3
Mechanical hazard
To prevent mechanical hazards, please observe the following precautions.
Mechanical hazard:
When the instrument is working, there is a potential danger. The
operator must be professionally trained and must follow the
instructions to ensure operation in a safe area.
Do not touch the moving parts of the instrument while the
instrument is in operation. Moving parts include sampling arm,
screw capping arm, etc.
Do not put your fingers or hands into open parts while the
instrument is working.
Fire and explosion hazard
To prevent fire and explosion, please observe the following precautions.
Electromagnetic interference protection
To prevent electromagnetic interference, please observe the following
precautions.
Biohazard protection
In order to effectively protect against the risk of biological infection, please
observe the following precautions.
Caution:
Alcohol is flammable, please use it with care.
Caution:
In order to ensure the normal operation of the instrument, the user is
responsible for ensuring the electromagnetic compatibility environment of
the equipment.
Electromagnetic interference may affect the normal operation of the device.
It is prohibited to install the device in an environment with strong
electromagnetic field interference.
It is forbidden to use other medical equipment that may cause
electromagnetic interference around the instrument, otherwise it may affect
the normal operation of the equipment.
The instrument complies with EMC requirements. The instrument may cause
radio frequency interference in the indoor environment. Appropriate
measures should be taken to reduce the interference.

4
Waste disposal
To prevent environmental pollution and personal injury caused by waste, please
observe the following precautions.
Others
In order to use the instrument correctly, please observe the following
precautions.
Storage and transportation conditions
Ambient temperature: -15℃～45℃.
Relative humidity: ≤85%.
Altitude: ≤2000m.
Notice: If the instrument has been unpacked and needs to be moved for
transportation, please repack the instrument before it can be transported.
Biohazard:
All liquids and solids in the laboratory are considered to be biohazardous,
and users must take general precautions in the laboratory.
All clinical samples are considered to be potentially infectious. Improper use
may lead to infection. Please do not touch the samples directly with your
hands. Please be sure to wear gloves and overalls during operation to prevent
infection, and wear protective glasses when necessary.
If the sample or other liquid accidentally touches the skin, please handle it
immediately in accordance with the user's working standards and consult a
doctor.
Biological risk：
The disposal of samples, reagents and other wastes after use shall comply
with relevant local laws and regulations.
Caution:
It is forbidden to smoke or eat near the instrument.
During operation, avoid direct exposure to strong light.
When installing the software, please use the software installation package
provided by our company.
During the startup or running of the software, it is prohibited to change the
date and time of the host.
When the user software is running, other applications are prohibited from
running.

5
1 Product Description
Automated Sample Processing System（BK-PR48）is a set of high throughput,
high precision, high efficiency, pollution prevention automated sampling transfer
processing system developed by our company.This instrument can directly load
vacuum blood collection tubes or virus collection tubes. The system integrates sample
carrier, sample retention carrier, reagent carrier, pipette tip carrier, sample application
arm, protection system, transportation system, and industrial control system. This
instrument has one-button convenient operation and standardized workflow, which
can greatly reduce manual operation errors and improve the accuracy of detection
results. It provides a systematic way to build a highly refined, simple, automated, and
systematic laboratory solution.
1.1 Basic Information
Product name:Automated Sample Processing System
Product model ：BK-PR48
1.2 Application Scope
This product is suitable for the liquid transfer and processing of serum, plasma,
throat swab, anal swab, feces, genital tract secretions, exclined cells, urine, sputum,
etc. (depending on the extraction reagent). It can be used in clinical gene
amplification testing laboratory, CDC Center for Disease Control and Prevention,
scientific research institute laboratory, medical university laboratory, etc.
1.3 Parameters
Table 1-1
No.
Functions
Technical parameters
1
Model
BK-PR48S
2
Sample flux
1-48，multiple lofting can achieve full plate 96 well operation
3
Sample type
Plasma, serum, whole blood, swab, etc.
4
Sampling channel
1
5
Sample carrier
1, 6*8 with locking device (compatible with a variety of
sampling tubes)
6
Mechanical arm
2（sampling arm, screw capping arm）,independent movements
do not interfere with each other
7
Detection solution
scheme
Air pressure type liquid level detection scheme, plug needle
intelligent detection
8
Pipetting volume
5-1000ul（1000 and 50ul 2 tip types, or 1000 and 200ul）
9
Pipetting property
20ul, CV≤2%, accuracy≤5.0%, tip type 50ul
1000ul, CV≤0.5%, accuracy≤1.0%, tip type1000ul
10
Deep well plate site
2, （Compatible H plate and square plate）
11
Tip site
3, （One for discarding the tip with the box put in, others are
main structure positioning）
12
PCR site
1

6
13
Reagent carrier
1, (2mL centrifuge tube+2mL Preserve tube+5mL Preserve
tube)4+4+4（2mL and 5mL Located separately）
14
Pollution prevention
and control
External droplet capture tray design
Air-tight and anti-drip design
15
Product function
Nucleic acid extraction samples in tubes
Nucleic acid extraction reagent loading (develop and retain PCR
system construction function)
16
Suitable for nucleic acid
extraction system
HS32 and HS96 nucleic acid extraction system
17
OSD (on screen display)
10.1 inch touch screen
18
USB communication
Standard equipped（Upgrade）
19
IAP function
Standard equipped
1.4 Product Principle
The system integrates sample carrier, sample retention carrier, reagent carrier, pipette tip
carrier, sample application arm, protection system, transportation system, and industrial control
system, transfer of samples.
1.5 Packing List
No.
Name
Unit
Quantity
Note
1
Host
PCS
1
2
Instrument bottom ark
PCS
1
3
Sample carrier
PCS
2
4
Reagent carrier
PCS
1
5
Deep well plate carrier
PCS
1
6
Tips carrier
PCS
1
7
Capacitive stylus
PCS
1
8
Inner Hexagonal Wrench
set
1
M2～M6
9
Cross screwdriver
PCS
1
5*100mm
10
Ball-end hexagon wrench
PCS
1
6mm
11
RVV power cord
root
1
12
Fuse（250V/3A，Φ5*20mm, quick
disconnect type, glass tube package）
PCS
2
13
Qualification Certificate
PCS
1
14
User Manual
copy
1
15
Inspection report
copy
1
1.6 Consumables
No.
Name
Schematic diagram
Function
Cycle
1
5mL preserve tube
Store reagents
Throwaway

7
2
PCR tubes
Store the extraction
products, the reaction
liquid, etc..
3
1000μL tip
Liquid distribution
4
200 μL tip
Liquid distribution
5
50 μL tip
Liquid distribution
6
1.5mL Centrifuge
tube
Sample storage

8
2 Product Installation Requirements
2.1 Environmental Requirements
The installation environment should be free of dust, mechanical vibration,
pollution, large noise sources and electromagnetic interference as much as
possible.
For indoor use, avoid direct sunlight or in front of heat and wind sources, and
choose a well-ventilated location.
Ambient temperature: 10℃～40℃.
Relative humidity: ≤80%.
The altitude does not exceed 2000m.
Power supply: AC 220V 50HZ.
Atmospheric pressure: 76kPa～106.0kPa.
2.2 Power Supply Requirements
Power supply: It must be used under the condition of good grounding of the
power socket. Please confirm whether the input voltage meets the requirements before
installation.
(For specific power requirements, please refer to the above section 1.3
Parameters)
2.3 Space Requirements
Please reserve enough space around the instrument before installation to avoid
affecting the heat dissipation and causing the internal temperature of the instrument to
become too high and cause malfunctions. The installation space must meet the
following conditions to ensure normal maintenance and emergency shutdown of the
power supply:
1) The distance between the right side of the instrument and the wall (or
neighbors) ≥20cm.
2) The distance between the left side of the instrument and the wall (or
neighbors) ≥20cm.
3) The distance between the back of the instrument and the wall (or neighbors)
≥20cm.
4) The operating distance directly in front of the instrument is ≥70cm.
The overall external dimensions of the instrument are as follows:

9
Figure 2-1

10
3 Instrument Unpacking and Installation
3.1 Check Before Unpacking
After receiving the packing box, please check the outer packaging of the
instrument carefully to see if there is any damage, and check if the anti-touch and
anti-tilt shipment labels turn red. As shown in the figure below, if there is damage or
the label turns red, please contact our company or local agent.
Figure 3-1 Monitored anti-tilting shipment label
Figure 3-2 Monitored anti-touching shipment label
3.2 Installation
After confirming that the packing box is not damaged, please follow the steps
below for unpacking inspection and installation. Check the appearance of the
instrument and check whether the accessories are complete according to the packing
list. If you find any damage or missing accessories, please contact our company or
local agent immediately. Notice:The instrument must be installed by a professional
technician.
Red position
Red position

11
1. Unpack the outer package.
2. Check the appearance of the instrument, take out the pearl cotton inside the
instrument.
3. Take out the accessory box, check the packing list, and find the tool wrench from
the accessory box.
4. Move the instrument to the reserved installation space.
5. Use a clean cloth to gently wipe off the dirt and dust on the moving rails, and add
lubricating oil regularly according to the maintenance requirements.
6. Connect the power cord and power on , enter the software, and the instrument
self-checks.
Figure 3-1 Instrument packaging

12
4 Product Structure
4.1 External Structure
The product appearance is shown in the figure below.
Table 4-1 Automated sample processing system structure
No.
Name
Function
Notes
1
LCD screen
Show operation software interface.
2
Power switch
Power supply for control instrument.
3
Sampling arm
Used for pipetting.
4
Cap screwing arm
Used to open the cap.
5
Sample carrier
For the placement of sample.
6
96 well PCR tubes
carrier
For the placement of PCR tubes.
7
Tips carrier
For the placement tips.
8
Deep well plate
carrier
For the placement of deep well plate .
9
Reagent carrier
For the placement of reagent tube
placement.
10
Power port
Power supply for instrument.
Fuse
Used for safe circuit operation.
Φ5*20mm, quick disconnect
type, glass tube package
（250V/3A）
11
USB
For communication.
4.2 Internal Structure
The product internal structure is shown in the figure below.

13
Figure 4-2
Table 4-2 The product internal structure
No.
Name
Function
Notes
1
Sampling arm
Used for pipetting.
2
Tips carrier
For the placement of tips.
3
Waste tips carrier
For the placement of waste tips.
4
Reagent carrier
For the placement of reagent tube.
5
Deep well plate carrier
For the placement of deep well plate.
6
Sample/PCR tubes
carrier
For the placement of sample or PCR
tubes.
One carrier can be
optional each time.
7
Cap screwing arm
Used to open the cap of the sample or
reagent.

14
4.2.1 The function of the tips carrier
Figure 4-2-1 Tips carrier
Table 4-2-2 Structure tips carrier
No.
Name
Function
Notes
1
Tips carrier
For the placement of tips.
2
Waste tips carrier
For the placement of waste tips.
positioning bolt
Guiding groove shrapnel
Figure 4-2-2
Tips carrier function:
As shown in the figure 4-2-2, the tip head carrier is positioned by two guiding grooves
marked in the red box and a positioning bolt, and is fixed by the shrapnel.When the
tips carrier placing, it is necessary to ensure that the gap of the carrier is occluding
with the positioning bolt, and the shrapnel is stuck on both sides of the carrier to
prevent the carrier from falling off. After placing the carrier, the edge of the carrier is
parallel to the instrument operating platform.