PSS magLEAD 12gC User manual

magLEAD 12gC User Manual
Version 1.3
April 2016
Doc. No.: P30001PE0101-03

1
Index
1. Information to the User.............................................................................3
2. For Safety Usage.......................................................................................4
3. Specifications..........................................................................................10
3.1. Intended Use ................................................................................................... 10
3.2. Features........................................................................................................... 10
3.3. Performance..................................................................................................... 10
3.4. Size, Weight and Power Requirement............................................................ 10
3.5. Storage Condition............................................................................................ 11
3.6. Transport Condition........................................................................................ 11
3.7. Environmental Requirement .......................................................................... 11
3.8. About Caution Labels Inside Instrument ...................................................... 12
3.8.1. Caution Label for High Temperature ................................................................ 12
3.8.2. Caution label for pinching fingers ..................................................................... 13
3.8.3. Caution Label for Biohazard .............................................................................. 13
4. System Components...............................................................................15
4.1. Front View ....................................................................................................... 15
4.2. Side and Rear View ......................................................................................... 16
4.3. Internal Components ...................................................................................... 17
5. Installation...............................................................................................18
5.1. Setup procedure............................................................................................... 18
5.2. Configuration and setting up the instrument................................................ 21
5.2.1. Setting the installation date............................................................................... 21
5.2.2. Setting the serial port......................................................................................... 21
5.2.3. Setting time and date ......................................................................................... 21
5.2.4. Setting the preventive maintenance reminder ................................................. 21
5.2.5. Installing the bar code reader (Option) ............................................................. 21
5.3. Installing the PC software (Option) ............................................................... 22
5.3.1. System requirements.......................................................................................... 22
5.3.2. Installing the driver of the USB-RS232 converter............................................ 22
5.3.3. Installing the magLEAD Communicator software ........................................... 24
6. System Components...............................................................................26
6.1. Accessories....................................................................................................... 26
6.2. Disposables ...................................................................................................... 28
6.3. Reagents .......................................................................................................... 28
7. Direction for Use .....................................................................................30
7.1. Door operation ................................................................................................. 30
7.2. Setting Reagent Cartridges on Reagent Cartridge Rack .............................. 30
7.3. Setting Sample Tubes ..................................................................................... 32
7.4. Setting Tip Sets ............................................................................................... 32
7.5. Setting Elution Tubes ..................................................................................... 32

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7.6. Setting Tip/Tube Rack .................................................................................... 33
8. Basic Operation.......................................................................................34
8.1. magLEAD 12gC Operation Panel................................................................... 34
8.2. Start Up and Shut Down Procedure............................................................... 34
8.2.1. Start Up ............................................................................................................... 34
8.2.2. Shut Down ........................................................................................................... 35
8.3. Protocol Run Procedure................................................................................... 35
9. Manual Operation....................................................................................37
9.1. Manual Screen................................................................................................. 37
9.1.1. Home Screen........................................................................................................ 37
9.1.2. Return Tip Screen ............................................................................................... 38
9.1.3. Cleaning Screen .................................................................................................. 38
9.1.4. Resend Screen ..................................................................................................... 39
9.2. UV Screen........................................................................................................ 40
9.2.1. Switching on the UV lamp.................................................................................. 40
9.2.2. Switching off the UV lamp ................................................................................. 41
9.2.3. Lifetime reminder of the UV lamp..................................................................... 41
9.3. Setup Screen.................................................................................................... 42
9.3.1. Setting the date................................................................................................... 42
9.3.2. Setting the time................................................................................................... 42
9.3.3. Setting the serial port......................................................................................... 43
9.3.4. Setting the preventive maintenance reminder ................................................. 43
9.4. Test Screen ...................................................................................................... 44
9.4.1. Axis Test Screen.................................................................................................. 44
9.4.2. Temp Test Screen................................................................................................ 44
9.4.3. Serial port test Screen ........................................................................................ 45
9.4.4. Version Screen..................................................................................................... 46
10. Bar code reader (Option).....................................................................47
11. Report file.............................................................................................48
12. magLEAD Communicator (Option) .....................................................50
12.1. User interface .................................................................................................. 50
13. Maintenance.........................................................................................53
13.1. Cleaning Procedure ......................................................................................... 53
13.2. D-Ring Maintenance ....................................................................................... 54
14. Troubleshooting...................................................................................56
14.1. Error Reported During Protocol Run ............................................................. 56
14.2. Suspending or Aborting Protocol Run............................................................ 57
14.3. Frequently Reported Problems....................................................................... 59
15. Error Code List.....................................................................................60

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1.Information to the User
Congratulations on the purchase of magLEAD 12gC, of which PSS’ worldwide patented
principle of MAGTRATION® Technology utilizing magnetic particles.
This book is a guide for the user to use the instrument in safe and effectively.
Please read this book thoroughly to understand the instrument before starting operation.
Also keep this book nearby the instrument for quick reference when you need.
・Do not operate the instrument without understanding instructions described in this book.
・Always keep this book nearby for easy reference at any time.
Please inform us, Precision System Science Co., Ltd., when this book is lost or damaged.
Followings are packed together in this Instrument Package.
Items Qty. Remarks
①magLEAD 12gC Main Body 1
②Power Cable AC100V 1
③Power Cable AC240V 1
④Reagent Cartridge Rack 1
⑤Tip/Tube Rack 1
⑥Silicon Grease 1
⑦D-rings 12
⑧Fuse(3.15A, 250V) 2 For Power Switch
⑨magLEAD 12gC User Manual 1 This book
⑩Package Check List 1
Option
⑪Handheld Barcode Reader 1
⑫magLEAD Communicator (CD) 1 PC software
⑬communication cable 1
⑭USB-RS232 converter 1

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2.For Safety Usage
Most problems are derived from irregular usage of the instrument without following the
safety instructions. Please read this manual thoroughly to understand and to get familiar
with preventive activities to avoid any problems in instrument operation.
If used in a manner not specified by the manufacturer, the protection provided by the
equipment may be impaired.
About Symbols
In this book, symbols are used for easy understanding for those important in instrument
operation. Their meanings are described below.
Symbol Description
This indicates the possibility that one could be killed or
seriously wounded when inadequate operation is done.
This indicates the possibility that one could be wounded or
physical damage could occur when inadequate operation
is done.
Caution Label for High Temperature
Caution label for pinching fingers
Caution Label for Biohazard
Caution
Warning

5
CE mark for Europe
98/79/EC(IVDDirective)
Thisinstrumenthasbeentestedtoandcomplieswithstandards
IEC61010‐1Ed.3(2010),“SafetyRequirementsforElectrical
EquipmentforMeasurement,ControlandLaboratoryUse‐Part1:
GeneralRequirements;”
IEC61010‐2‐101(2015),“Safetyrequirementsforelectrical
equipmentformeasurement,control,andlaboratoryuse‐Part
2‐101:Particularrequirementsforinvitrodiagnostic(IVD)medical
equipment.”
IEC61326‐1(2013),“Electricalequipmentformeasurement,Control
andlaboratoryuseEMCrequirements–Part1:General
requirements.”
IEC61326‐2‐6(2013),“Electricalequipmentformeasurement,
ControlandlaboratoryuseEMCrequirements–Part2‐6:Particular
requirementsinvitrodiagnostic(IVD)medicalequipment.”
UL listing mark for Canada and the USA
ThisinstrumenthasbeentestedtoandcomplieswithstandardsUL
61010‐1Ed.3(2012)andCSA‐C22.2No.61010‐1‐12Ed3.(2012),
“SafetyRequirementsforElectricalEquipmentforMeasurement,
ControlandLaboratoryUse,Part1:GeneralRequirements.”
WEEE mark for Europe
Serial number
Legal Manufacturer
Authorized Representative in the European Community
In Vitro Diagnostic medical devices (98/79/EC)
Describe reference information regarding operating procedure
or specific issues in this manual, or illustrate details of
operation or function. When there exists other information to
be referenced, describe the pages or sections.
Describe information to be emphasized or added for important
points. It means that you need to pay close attention in
operating instrument.
Ref.
Note

6
Do not use other than MagDEA Dx SV kit
The magLEAD 12gC CANNOT be used as an accessory for any of following
diagnostic applications.
1) Determination of;
the blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,
anti-Duffy and anti-Kidd
the irregular anti-erythrocytic antibodies
the human cytomegalovirus, and the human chlamydia
the HLA tissue groups: DR, A, B
the tumoral marker: PSA
2) Detection, confirmation and quantification of;
markers of HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B,
C and D in human specimens
congenital infections: rubella, toxoplasmosis in human samples
3) Diagnosis of the hereditary disease: phenylketonuria
4) Evaluation of the risk of trisomy 21
5) Self-diagnosis, including its related calibrators and control materials:
device for the measurement of blood sugar.
6) Any other applications listed on the latest version of List A, B and Self-test
of Annex II of 98/79/EC.
Do not use in a strong electric field and magnetic field.
Use of instrument in a dry environment may cause may cause erroneous results due to
damage with static discharge.
Caution

7
Examples of Symbols
This Symbol indicates that message of Caution (including Danger and Warning) is
shown. Inside triangle, specific mark is illustrated (the sample on the left shows
electric shock.)
This Symbol indicates what you shall not do. Details are illustrated inside
symbol or nearby the symbol.
This Symbol is used to restrict operations or to illustrate what to do. Details are
illustrated inside the symbol (the sample on the left shows unplugging of AC Plug
from wall outlet.)
Installation
Be sure that no water or liquid would get into the instrument.
It would cause fire or electric shock.
Do not attempt disassembling, modifying or repairing by yourself.
It may cause failure of instrument or electric shock to you.
Ask PSS for repair or maintenance of the instrument.
Actions for Emergency
In an emergency status of instrument, such as extraordinary hot,
smoking, abnormal smell, etc., immediately unplug power cable
from wall outlet to avoid fire or electric shock to you and contact
with us for repair.
The following precautionary instructions are included to ensure the safe operation of
your magLEAD 12gC. Please always keep this book near by the instrument or
operator. Failure to comply with the instructions in this manual may pose dangerous
risk to the user and will void the manufacturer’s warranty.
When troubles occurred with this instrument, immediately turn off the main-power
switch and unplug power cable. Then contact with PSS.
Ban
Ban
Unplug AC
power
Warning

8
When foreign material or water splashed over or got inside
instrument, immediately unplug power cable from wall outlet to
avoid fire or electric shock to you and contact with us.
When power cable is damaged (core wire exposed or broken),
immediately unplug power cable from wall outlet to avoid fire or
electric shock to you and contact with us.
Installation
Avoid places below to install the instrument. Damage to or
malfunctions of the instrument may be caused.
-Place where exposed to direct sunshine
-Place with vibration, high humid or dust.
-Place where strong electric or magnetic fields exist.
-Place where liquid or oil could be splashed on.
-Place where flammable gas, corrosive gas or high heat source
exist.
Setting of the instrument shall be made by field service personnel
authorized by PSS.
Contact us when you transfer the instrument.
Storage
Unplug power cable from wall outlet when the instrument
may not be used for extended period of time.
Unplug AC
power
Unplug AC
power
Ban
Unplug AC
power
Caution
Ban

9
Precautions for Instrument Operation
Possibility of biohazard could not completely be eliminated in
operating the instrument. Use a mask, goggles and gloves
according to the description in this book.
Pay close attention in handling sample with high risk of
biohazard.
When operating the instrument under low temperature
circumstance, keep the instrument power on.
Be sure no foreign materials would get into the instrument from
outside.
Do not scratch or press the operation panel using knives or stuff
with sharp edges.
Pay close attention when working around Piercing Unit not to get
hurt.
Replacement of the fuse shall be made by field service personnel
authorized by PSS. Contact us for fuse replacement.
About Warranty Period
12 months after installation, regardless of its usage.
This warranty excludes the problem derived from inadequate
storage, inadequate usage or operation,
repair/modification/maintenance of the instrument by people who
are not authorized by PSS, though within warranty period.
About Abolishment
Contact PSS when you want to abolish the instrument.

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3.Specifications
3.1.Intended Use
magLEAD 12gC employs PSS’ original technology, Magtration® ,to perform automated
isolation and purification of nucleic acids (DNA and RNA, etc.) using magnetic particles.
It is intended to be used only in combination with MagDEA Dx SV kits indicated for use
with magLEAD 12gC instrument for the applications described in the IFU of the kit. The
system is intended for use by professional users, such as technicians and physicians
trained in molecular biological techniques and the operation of the magLEAD 12gC.
3.2. Features
Full automation of Nucleic Acid extraction/purification by Magtration®
technology
Compact body that occupies minimal space
High speed simultaneous processing of 12 samples by 12 nozzles
Special disposable tips and reaction cartridges for ease of operation
3.3. Performance
Instrument type：Desktop
Throughput：Samples・・・1－12 samples/batch
Processingtime・・・About 30 min/1-12 samples
Temperature control function：Heat Block・・・40 to 95 deg. C
Processing Volume： 25 - 1000ul
Dispensing Accuracy：25 - 50ul・・・・+/-10%
(Aspiration Accuracy) 50 - 1000ul・・・+/-3%
※
Accuracy with distilled water at room temperature 20 – 25 deg.C
Protocol：IC Card
Note
Processing Time depends on protocols.
3.4. Size, Weight and Power Requirement
Size： W500×D535×H574mm
Weight： About 55 kg (121 lbs.)
Power Requirement：AC100－240V±10%, 50/60Hz, 300VA
Do not share power source with other instruments.
Do not place close to instruments giving noises or power fluctuation.
Connect power cable to wall outlet with ground line.
Connect to Protective Earth.
Caution

11
3.5. Storage Condition
Temperature：5 – 40 deg. C
Relative Humidity：15 – 75 % ※Non-Condensing
Barometric Pressure：More than 70kPa(min)
3.6. Transport Condition
Temperature：-25 – + 60 deg. C
Relative Humidity：15 – 75% ※Non-Condensing
Barometric Pressure：More than 70kPa(min)
3.7. Environmental Requirement
Overvoltage Category：Ⅱ
transient overvoltage：2500V
Pollution Degree：2
Installation Site：Indoor Use Only
Temperature：15 – 30 deg. C
Relative Humidity：15 – 75% ※Non-Condensing
Altitude：UP to 2,000m
Space：Keep distances from walls as shown below for ventilation,
maintenance work, etc. Also keep more than 200mm space over the
instrument.
Environmental Requirement
magLEAD 12gC
More than 200mm
Front
Back
Wall Wall
Wall
More
than
200mm
More
than
200mm

12
Please set the instrument on horizontal surface that can
invariably endure instrument weight.
Place the instrument on horizontal surface.
Do not place the instrument where it will get direct sunlight or vibration.
When operating the instrument in a cold chamber or cold room, keep
instrument power on to avoid condensation.
3.8. About Caution Labels Inside Instrument
3.8.1. Caution Label for High Temperature
Place attached ：Heat block and Inner wall of the cover
The part where this label is attached becomes hot. Be sure not to
Touch while working.
Caution
Caution

13
3.8.2. Caution label for pinching fingers
Place attached：Magtration® Unit
The part where this label is attached has possibility of pinching your hand or fingers
by driving mechanism or open/close operation. Take care not to be pinched.
3.8.3. Caution Label for Biohazard
Place attached：Inner wall of the cover
Caution

14
The part where this label is attached (inside cover) has possibility of biohazard
contamination with samples or extracted/purified products. Take care not to be
contaminated.
Note that it is not possible to completely eliminate risk of biohazard from samples or
extracted/purified products in operating this instrument. Wear a mask, goggles and
gloves for your own safety, according to the description in this manual.
Pay close attention when handling highly hazardous samples.
Caution

15
4.System Components
4.1. Front View
*1: Lit when powered on – Green Lamp
*2: Blinks when an error occurred – Red Lamp
*2 Alarm Lamp
Operation Panel
IC Card Inlet
*1 Power Lamp
Door
Display

16
4.2. Side and Rear View
On the left side of the instrument Power Switch is located.
On the back of the instrument, Fuse box and Connectors are located.
Note
Replacement of the fuse shall be made by field service personnel
authorized by PSS. Contact us for fuse replacement.
Connector for Handheld
Barcode Reader
RS232C Connector for PC
Fuse box
Power Cable
Connector
Power Switch

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4.3. Internal Components
Inside the instrument, Magtration® Unit and Stage Unit are located.
1. Magtration®Unit
Syringe Unit：Twelve nozzles to simultaneously process up to 12 samples
with accurate and rapid aspiration and dispensing.
Magnets：Twelve magnets aligned with 12 tips to simultaneously separate
magnetic particles from up to 12 samples.
2. Stage Unit
Reagent Cartridges：Easy placement of special disposable cartridges
(pre-filled with reagents) results in minimizing cross contamination.
The far backside two positions (wells) in the cartridge are used
for heating.
Tip Sets：Positions for tips in the tip holders. One or two tips/tip holders are
used per sample depending on each protocol. Please refer the instruction
indicated in package insert of each reagent kit.
Elution Tubes：Positions for 1.5ml elution tubes.
Sample Tubes：Positions for 1.5ml sample tubes.
The magLEAD 12gC contains a UV lamp. Avoid looking directly UV light. Do not
expose your skin to UV light.
Syringe Unit Magnets
Sample Tubes
Elution Tubes
Tip Sets
(Tips and Tip Holders)
Reagent Cartridges
UV lamp Unit
Warning

18
5.Installation
5.1. Setup procedure
1. Take the instrument out of the crate.
Setting of the instrument shall be made by field service personnel authorized
by PSS. Contact us when you transfer the instrument.
2. Remove protection films attached on the instrument.
3. Open the Door.
4. Push the pipettor head upward.
Warning

19
5. Remove the bubble wrap, Y-axis fixing bracket and silica gel.
6. Connect Power Cable and Handheld Barcode Reader accompanied with
the instrument and then connect Power Cable to wall outlet.
Do not use power cable other than provided to avoid troubles such as temporary
blackout or fire breaking.
Caution
Power Cable
RS232C Connector for PC
Connector for Handheld
Barcode Reader