MagCore Plus II User manual

MagCore® Plus II
Operation Manual
CONTENTS
Safety Precautions . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . 2
IVD Symbols Reference . . . . . . . . . . . . . . . . . 4
Specification. . . . . . . . . . . . . . . . . . . . . . . . . . 5
━ Operating Parameters                       5
━ Operating Environment                      5
━ Applications                              5
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
━ Before Installation                          6
━ System Overview                          7
━ Install Reagent Cartridge                      8
━ Install Tube, Tip                            8
━ Installation                               9
━ Installation Settings And Test                    9
━ Installation                              10
Touch Panel and User Interface . . . . . . . . . . .
12
Operation Before Starting the Instrument            13
━ Emergency Stop                          14
━ Start Programs                           15
━ Saved Settings                           16
━ Access to Saved Settings                     16
━ Set and Select Users                        17
━ Set User                               17
━ Select User Name                         17
━ Scan Sample / Elution Tube                   18
━ Scan Kit Lot                             18
━ Pause and Abort                          19
━ Set Up the System Time                     19
━ Set the Instrument Nickname                  20
━ Network Connection Settings                  20
━ LIMS Data Collection                       21
1 Get Data from USB Flash Drive                 21
2 Access to information by Network Connection       22
━ Remote monitoring APP                     23
1 Download the APP                        23
2 Registration                           23
3 Log in the APP and Pair the Instrument          23
4 APP interfaces                         24
Easy Maintenance . . . . . . . . . . . . . . . . . . . 27
━ Replace O-Ring                        27
━ Piston Test                            27
━ Clean Piercing Needles                    30
━ Eject Tip                             30
━ Heater Test                           31
━ UV Sterilization                      31
━ Alarm History                          32
━ System Status                          32
━ Program Update                       33
━ Clean the Waste Box                     33
━ Replace Fuse                          34
Document Revision History . . . . . . . . . . . . 36
15F, No.15,Qiaohe Rd,ZhongheDist, NewTaipeiCity 235029, Taiwan
September 2022
EN-MagCore® Plus II
Operation Manual-1.0.0

1www.rbcbioscience.com
Safety Precautions
Before Use
WARNINGS and CAUTIONS stated below are intended to protect the individual from injuries
and avoid damage to machines.
CAUTIONS
Risk Of Electric Shock
Do Not Open
CAUTION:
To reduce the risk of electric shock, do not remove the cover. Refer to qualified
service technician for inner part servicing.
CAUTION:
1. Handle The Power Supply Cord Carefully
Do not damage or twist the power supply cord. Damaged or twisted cord may
cause electric shock or error when used. When you remove it from the outlet, be
sure to remove by holding the plug and not by pulling the cord.
2. Do Not Place Anything Inside
Do not place metal objects inside the MagCore®System and wipe away all spilled
liquid to minimize the risk of system error and electric shock.
1. Read Instructions – All the safety and operating instructions should be read before
operating the instrument.
2. Keep the Instructions – Please keep the safety and operating instruction manual for
future reference.
General Warning. Please follow the instruction for
operation, be aware of electrical hazard caused by
inappropriate operation.
1. Power Supply
2. Barcode Scanner
Warning: Biological Hazard
Warning: High Temperature
Please read the instruction carefully and keep for future
reference.
This product is confirmed with European Union
conformity assessment regulations regarding health
and safety or environmental protection.
Waning: Electricity
Handle the power cord carefully.
Hold the plug when unplugging the cord.
Keep the set free from moisture,
liquid, and dust.
Unplug the power cord if the system
will not be used again in a long time.
Do not obstruct the ventilation space.
Do not let foreign objects in the set.
Do not let insecticides, benzene, and
thinner come in contact with the set.
Do not ever disassemble or modify
the set in any way.
Avoid high temperatures.
Leave space for sufficient heat dissipation during installation.
NOTE ON USE:
SAFETY INSTRUCTIONS
3. Cautions and Warnings – All warning signs should be attached on the product and
shown in the user's manual.
4. Follow Instructions – All operating and use instructions should be followed.
5. Cleaning – Unplug the product before cleaning. Use only 75% of EtOH to clean the
surface of instrument.
6. Attachments – Do not attach anything on the instrument.
7. Liquid and Moisture – Do not use this product near water and avoid moist areas -
bath tub, wash bowl, kitchen sink, laundry, swimming pool or in a moist basement.
8. Proper Installation – Do not place this product on an unstable cart, stand, tripod,
bracket, or table. The product may fall and caues serious injury to a child or adult, and
serious damage to the product. Use only with a cart, stand, tripod, bracket, or table
recommended by the manufacturer, or sold with the product. Any mounting of the
product should follow the manufacturer’s instructions, and should use a mounting
tool recommended by the manufacturer.
9. Ventilation – Slots and openings in the cabinet are designed for ventilation, which
is required for safe operation and minimizing the chance of overheating. The product
should be placed on a hard surface to ensure proper ventilation. This product should
not be placed in a built-in installation such as a bookcase or rack unless proper
ventilation is ensured or instructed by the manufacturer.
10. Power Sources – This product should be operated only from the type of power
source indicated on the label. If you are not sure of the type of power supply at your
lab, consult the seller or local power company. For products intended to operate from
battery or other sources, refer to the operating instructions.
11. Grounding or Polarization – This product may be equipped with a polarized
alternating-current plug. This plug will fit into the power outlet in one way only. This is
a safety feature. If you are unable to insert the plug fully into the outlet, try reversing the
plug. If the plug should still fail to fit, contact your electrician to replace your obsolete
outlet. Do not defeat the safety purpose of the polarized plug.
12. Power-Cord Protection – Power-supply cords should be routed so that they are
not likely to be walked on or pinched by items placed near or against them. Pay extra
attention to the plugs, convenience receptacles, and the connecting point where the
cord extends out of the product.
13. Lightning – Unplug the product if it will not be used again for a long period or in the
case of a heavy storm. This will prevent damage to the product due to lightning and
power surges.
14. Overloading – Do not overload wall outlets, extension cords, or integral convenience
receptacles as this can result in a risk of fire or electric shock.
15. Object and Liquid Entry – Never push objects of any kind into this product as they
may touch dangerous voltage points or short-out parts that could result in a fire or
electric shock. Never spill liquid of any kind on the product.
16. Servicing – Do not attempt to repair this product by yourself. Refer all servicing to
qualified service technician.
17. Damage Requiring Service – Unplug this product from the wall outlet and refer
servicing to qualified service technician under the following conditions:
a) When the power-supply cord or plug is damaged,
b) If liquid has been spilled, or objects have fallen into the product,
c) If the product has been exposed to rain or water,
d) If the product does not operate normally following the operating instructions.
Adjust only controls covered by the operating instructions as an improper adjustment
of other controls may result in damage and will often require extensive work by a
qualified technician to restore the product to its normal operation,
e) If the product has been dropped or damaged in any way, and
f)When the product exhibits a distinct change in performance
– this indicates a need for service.
18. Replacement Parts – When replacement is required, be sure the service technician
uses replacement parts specified by the manufacturer or those with similar features
as the original part. Unauthorized substitutes may result in fire, electric shock, or other
hazards.
19. Safety Check – Upon completion of any shipment, storage, installation or
maintenance service to this product, ask the service technician perform safety checks
to confirm that the products is in proper operating condition.
20. Heat – The product should be placed away from heat sources such as radiators, heat
registers, stoves, or other products that produce heat.
21. Moving Product - The machine requires two people lifting from both sides at the
bottom edge. Do not attempt to lift by bending forward. Bend your hips and knees to
squat down, keep the machine close to your body, and straighten your legs to lift.
22. Ultraviolet(UV) radiation production - The front door panel is made of UV resistant
material. During UV Sterilization, if the front door be opened, the interlock will turn off
UV lamps automatically.

2
MagCore® Plus II
Intended use
The MagCore® Nucleic Acid Extraction System is an automated nucleic acid purification system
consistingoftheMagCore®instrument, software,Kit (consumables and reagents).
The MagCore® Nucleic Acid Extraction System is intended to be used by professional users for the
purificationofnucleicacidsfrombiologicalsamplesforinvitrodiagnosticpurposes.
The MagCore® Nucleic Acid Extraction Kits are intended to be used with MagCore® Nucleic Acid
Extraction System.
GENERAL CONSIDERATIONS
BeforeUsing
• Do notoperateMagCore®withoutqualifiedoperationtraining.
• Readuser’smanualcarefullybeforeoperation.
HandlingRequirements
• Do notuseakitafteritsexpirationdate.
• Do not touch the reagents with bare hands. Keep away from your skin, eyes, or mucous membranes. If
contactdoesoccur, washtheaffectedareaimmediately withlargeamounts of water.Ifyouspill thereagents,
dilutethespill with waterbeforewipingit up.
• Do not allow reagents to mix with sodium hypochlorite solution or strong acids. This mixture can produce a
highlytoxicgas.
Precautions
The following procedure is designed to process maximum 16 samples at the same time. The MagCore®
instrument can handle all numbers of samples between 1 and 16. For a detailed description of instrument setup
andhandling,refertotheMagCore® instrumentOperator’sManual.
• Store the Reagent Cartridge to +15 to +25°C before use. If you use the reagents at temperatures outside the
recommendedrange,thekitmaynotwork well.
• Document the lot number of the kit in case of complaints or questions for RBC Bioscience Technical Service
regardingany componentofthekit(reagentcartridgesordisposables).
• Make sure you have followed the instructions regarding type and amount of sample material. Wrong
type and amount of sample material may cause clumping of MGPs which cannot be detected by the Clot
Detection functionoftheinstrument.Clumping ofbeadsmayleadto lowyieldandpurityofnucleicacids,cross-
contamination,andinhibition of downstreamassays(e.g.,PCR).
• After the run has finished, carefully inspect the instrument for any signs of spillage. If spillage occured, clean the
instrumentasdescribedin the Operator’sManual.
• Somebufferscontainguanidinium saltswhicharehazardous irritants.Donotallowthese tocomeinto contact
with skin, eyes, or mucous membranes. If contact does occur, wash the affected area immediately with large
amounts of water. If necessary, immediately contact your laboratory supervisor and seek medical assistance
Whenspillingthesereagents,dilutethespill with largeamountsofwaterbeforeattemptingtocleanupthespill.
• Do not allow reagents containing guanidine thiocyanate (lysis and wash buffer well ) to contact sodium
hypochlorite(bleach)solution or acids.Thesemixturesproducea highlytoxicgas.
• Please notice that you may be required to report serious incidents that have occurred in relation to the device to
themanufacturerand thecompetentauthorityinwhich the userand/orthepatientis established.

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Preventionof Cross-Contamination
To minimize the risk of cross-contamination and to prevent contact with potentially infectious materials,
always complete the processes involving sample preparation such pipetting of blood samples in a designated
partofthebenchtoporsafetyhoodbeforestarting PCR setup.
To further minimize the risk of contamination, always carry out sample preparation, PCR setup, and the PCR
runitselfinseparate rooms specially designatedforeachphaseintheworkflow.
SafetyInformationLaboratory Procedures
Handle all samples as potentially infectious, using safe laboratory procedures. As the sensitivity and titer of
potential pathogens in the sample material varies, the operator must optimize pathogen inactivation by the
Lysis/BindingBufferortakeappropriate measures,according tolocalsafetyregulations.
RBC Bioscience does not warrant that samples treated with Lysis Buffer are completely inactivated and
noninfectious.Aftersampleprocessing is completed,removeandautoclavealldisposableplastics.
• Do not eat,drinkorsmokein the laboratory work area.
• Wear protective disposable gloves, laboratory coats, and eye protection when handling samples and kit
reagents.
• Do not contaminate the reagents with bacteria, viruses, or nucleases. Use disposable pipettes and nuclease-
free pipette tips only to remove aliquots from reagent bottles. Use the general precautions described in the
literature.
• Washhandsthoroughlyafterhandlingsamplesandreagents.
• Complete each phase of the PCR/RT-PCR workflow before proceeding to the next phase. For example, you
should finish PCR/RT-PCR sample preparation before starting PCR/RT-PCR setup. Sample preparation, PCR/
RT-PCR setup andthePCR/RT-PCR run itselfshouldalsobeperformed in separatelocations.
WasteHandling
• Discardunusedreagents and wasteinaccordancewithcountry,federal, state,andlocal regulations.
• Safety DataSheets(SDS)areavailable upon requestfromthelocaldistributor.

4
MagCore® Plus II
Reference Symbol
Referencesymbol Descriptionof Symbol
CEmark
InVitroDiagnostic Device
Authorizedrepresentative intheEuropean Community
Manufacturer
Contentsucientfor <n>tests
Warning: electricity
Instruction manualmust beread beforeoperating
Consultinstructionsfor use
Alternatecurrentinput
Use-by Date
Nouseperiod
Temperaturestorageconditions 15ºC /30ºC
Cataloguenumber (product code)
Lotnumber
Model
Numberofaliquots
Includedinthe product
Cartridge codenumber
Sterile
Sterilizedusing irradiation
Serial Number
Fuse
After mixingstore at0ºC /8ºC
After openingstore at0ºC /8ºC
IVD Symbols Reference

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Model Plus II
System Method Cellulose Coated Magnetic Beads
System Components 1. Pipetting Unit: Dispensing, transferring, X -Y two axis movements.
2. Electric Control: PLC module and Arm-based main board embedded in.
3. UV Light: Power 8W, life duration 11,000 hrs .
4. Heating Block: RT-90° C .
5. Display Screen: 7 inches colored touch panel .
6. Accessories: T - Rack, Cartridge Rack s, barcode scanner
Power Supply Voltage: AC 100V~240V; Frequency: 50/60Hz ; Max. 4.5AMax, 450W
Dimension W523 x D602 x H605 (mm) / W20.59x D23.7 x H23.81 (inches)
Net Weight 70kg / 154.35lbs
Specification
━ Operating Parameters
━ Operating Environment
━ Applications
Applications: Whole Blood DNA (200μl/400μl/1,200μl), Viral Nucleic Acid (DNA/RNA 200μl/400μl/1,200μl), FFPE Genomic DNA,
FFPE Total RNA, Forensic DNA, Plasma and Circulating Cell-Free DNA (1,200μl/4,000μl), Tissue Genomic DNA, Plant Genomic
DNA, Bacterial DNA, Whole Blood Total RNA, Cultured Cells Total RNA, Tissue Total RNA, Plant Total RNA.
Processing Capacity 1-16 samples per batch
Processing Time 30-90 minutes (depends on sample type and method)
Sample Volume 200 μl /400 μl /1,200 μl / 4ml
Elution Volume 30μl /40μl /60μl /100μl /150μl /200 μl
Yield Average 6μg Genomic DNA from
200μl human whole blood
Purity DNA : O.D A260/280 ratio 1.8 ± 0.1
RNA : O.D A260/280 ratio 2.0 ± 0.2
Pipetting Accuracy 500μl ≤ 4%
Humidity Allowed During Operation: 30%-75%
Pressure Allowed During Operation: 700hPa-1060hPa
Temperatures Allowed During Transportation / Storage Packaging 10°C- 40°C
Temperatures Allowed During Operation 15°C-35°C
Pollution Degree Level 2

6
MagCore® Plus II
Accessories
Installation
1. T-Rack X 1
2. Cartridge Rack X 1
3. Power Cable X 2 (Europe standard and U.S.A standard)
4. Grease X 1
5. 3mm O-Rings X 16
6. 5mm O-Rings X 16
7. Empty Cartridge X 10
8. Sample Tube /ElutionTube X 20
9. PipetteTip X 20
10. Waste Box X 1
11. Barcode Scanner X 1
Please refer to the machine size shown in the above figure to prepare an appropriate position for the machine and
reserve space for thermal dissipation.
1234 5
7
6
8 9
10 11
━ Before Installation
605 mm
Left Side (Keep space clear)
Height (Keep space clear)
602mm
523mm
Depth
Width

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━ System Overview
Touch Panel
Logo Indicator
Front Door
Back Service Lid
Operation Area
Waste Box
Scanner Port
USB Port
Main Power Switch
Ethernet Port
Power Outlet

8
MagCore® Plus II
━ Install Tube, Tip
Warning :
Please do not use the Tips and Tubes which are not provided by the original manufacturer.
The test result may be not correct and the machine may be damaged due to different Tips
and Tubes usage.
━ Install Reagent Cartridge
1. Put consumables and tips into the
corresponding wells according to the left figure
2. Put T-Rack on cartridge rack, then install and
push cartridge rack to the innermost gently
Please install the Tip and Tube according to
the instructions of extraction kit user manual.
Pull cartridge rack outward (toward user), take it out and
place consumables accordingly, please insert cartridges
beforeT-rack, then install and push the cartridge rack to the
innermost gently
Please insert the front end of the cartridge into the
space below the fixing plate of the Cartridge Rack.
W5 Elution Tube
W1
W2
W3
W4
W5
W4 200μl SP Tip
W3 Pipette Tip
W2 DNase / Tip Holder set
W1 Sample Tube - FS Tip

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━ Installation ━ Installation Settings And Test
Step 1.
Please Set Up the Local Time.
Please refer to System Status chapter for the information
about the operation.
Step 2.
Set the Instrument Nickname
Go to Page 17
Step 3.
Network Connection Settings
Go to Page 17
Step 4.
Test Piston
Please refer to Piston Test chapter for information
about the operation.
Step 5.
Test Heater
Please refer to Heater Test chapter for information
about the operation.
Step 1.
1. Open the Front Door
2. Turn on the machine
Step 2.
This step requires to keep the front door open.
Press Maintenance
Press Advanced
Accessory Box
Cushioning Material

10
MagCore® Plus II
━ Installation Settings And Test
Open the Front Door
For Restricted Personnel Use
Installation
AB
C D
Accessory Box
Cushioning Material
Remove cushioning material
and take out accessory box.
Remove the brackets and cable ties then
pull out the touch panel.
Remove the two brackets
191106
1
1Close the front door. 1
Switchon the power, the machine will initialize automatically.
2
Move the rack module outward manually,
then cut off and remove the two cable ties
2
2
Accessory Box
Romove cushioning material
Take out accessory box
Pull out the touch panel and tighten screw
after touch panel is erected.
3
━ Installation

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Open the Front Door
For Restricted Personnel Use
Installation
AB
C D
Accessory Box
Cushioning Material
Remove cushioning material
and take out accessory box.
Remove the brackets and cable ties then
pull out the touch panel.
Remove the two brackets
191106
1
1Close the front door. 1
Switch onthe power,the machine will initialize automatically.
2
Move the rack module outward manually,
then cut off and remove the two cable ties
2
2
Accessory Box
Romove cushioning material
Take out accessory box
Pull out the touch panel and tighten screw
after touch panel is erected.
3

12
MagCore® Plus II
Touch Panel and User Interface
MagCore® Plus II provides 7-inches full-color touch panel and easy-to-use user interface.
Operator only needs to pay attention to the panel to know the current status, ending time and
test report of the machine. The figure below shows the function list of the operation screen and
the description of the status icons.
Start
Report
Setup
Saved Protocols
Maintenance
Eject Tip
Execute Extraction Execute quick run with
selection of pre-saved
protocols
System Maintenance
Functions
Overview of the latest
runs with barcodes
System Settings
Status Column Icons Panel Board Lighting
Front Door is Open
Front Door is Closed
Machine Connected to Network
Machine is not Connected to
Network
USB Flash Drive Plugged In
* Format USB Flash Drive to FAT32
The Panel will light up the following lights when the
instrument is in operation:
Blue Light: The Instrument is on Stand-by
Green Light: The Instrument is in Operation
Red Light: The Instrument Gives a Warning Alert

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Operation Before Starting the Instrument
Close the door after the setting is completed and
press START to run the extraction.
Please Follow the Instructions Below to Operate the Instrument:
After loading the reagents, cartridges and tips, see page 5 and set the required parameters without
opening the door.
After closing the door, press START to start operation.
Plunged Upward from
the Lower Edge of the
Front Door
The Front Door Will
Rise Automatically For the sake of safety, the front door will not open to the top.
Please push the front door up to
raise it to the top when needed.
Precautions When Opening the Front Door
A.
B.
BA

14
MagCore® Plus II
━ Emergency Stop
Please read the security information to correctly stop the machine
when an accident takes place.
When an emergency situation occurs and the machine is
operating, please press the stop button or open the front
door to stop the machine immediately.
Program Code
201
Pause
Current Status
Time Remaining Estimated finish time
00 : 0
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Select DNase Treatment. (Only for RNA kit.)
Select Sample Volume.
Select Elution Buffer. (Only for tissue kit.)
Close the door and press Start.
Please pretreat the sample according to the
instructions of the user manual of the MagCore®
Kit and put consumables into the machine.
Press Start to go to the next step.
To Select User and Scan Barcodes: See Page 12
Press Next to choose the code number.
Please confirm the reagent set code number to be
used in the extraction.
Select the number of the cartridge.
Select User
Select
Scan Sample Scan Elution T
ube
Scan Kit LOT
Back Next
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━ Start Programs
!The number
can be found in the
sticker on the cartridge.
If you need to save this setting, please
refer to page 11 to know how to save
customized settings.

16
MagCore® Plus II
If you need to save a customized setting, you can
save it here and use the predetermined parameters
for later uses.
After selecting the parameters, the confirmation
of your settings will be displayed. Press SAVE AS to
open the Saved Protocols page.
Select the parameters that you want to save shown
in the blue area. Saved Protocol option saves up to
six records.
Press Save Protocol to save the customized
parameters.
Press Back to confirm your settings.
After loading the Tips and Cartridges:
Press Saved Protocols on the start page
Select the parameters that you want to execute
shown in the blue area.
Press Start Protocol
Press Start after confirmation of your selected
parameters.
━ Saved Settings ━ Access to Saved Settings

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Instrument can help you record the User Name as
well as the Sample, Elution Tubes and Kit Lot No.
used in the extraction for LIMS integration data.
Select this icon if you want to add or edit an user´s
information. Instrument provides up to six records.
Edit name on the name block as shown in the
figure.
Press Enter when finish editing.
Press the name block you want to select
After displaying of the selected name, press Done
to finish.
━ Set and Select Users
━ Set User ━ Select User Name
Select User
Select
Scan Sample Scan Elution Tube
Scan Kit LOT
Back Next
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Select User
Select
Scan Sample Scan Elution Tube
Scan Kit LOT
Back Next
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Input
A S D F G H J K L
Z X C V B N M
Q W E R T Y U I O P
Enter BackspaceEsc
!@# $ % ^ & * ( ) .
,
JAMES

18
MagCore® Plus II
Select Scan Kit LOT
The system will ask you if you want to delete all
the barcode data stored before. Press Execute to
delete it
Deletion Completed
You can start scanning, and the system will
automatically jump to the next item after scanning.
If you need to rescan an item, please press the
digital block to rescan.
━ Scan Sample / Elution Tube ━ Scan Kit Lot
Select User
Select
Scan Sample Scan Elution Tube
Scan Kit LOT
Back Next
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Select User
Select
Scan Sample Scan Elution Tube
Scan Kit LOT
Back Next
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Select Scan Sample or Scan Elution Tube
The system will ask you if you want to delete all
the barcode data stored before. Press Execute to
delete it.
Deletion Completed
You can start scanning, and the system will
automatically jump to the next item after scanning.
If you need to rescan an item, please press the
digital block to rescan.
There is a kit LOT barcode
on the Cartridge Box label
of the KIT you purchased.
You can scan this barcode
for LIMS data storage
purposes.

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Select System Time Setup to set up the system
time of the machine.
Please input the local date and time and then press
the Update button to save the system time. You
can see the time that you changed in “Current
Time” after the change is finished.
━ Pause and Abort
You can pause or abort the current extraction
while the program is in progress. Press the Pause
button to pause at any time, and the machine will
immediately suspend operation. This button is
used as an emergency stop button.
After the Pause screen appears, you can press
Continue to continue with the extraction or press
Abort to cancel all.
Aborting Operation in Progress
Abortion Completed
━ Set Up the System Time
Setup
Back
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System Time Network InfoUnit nickname System Status