RSS magLEAD 12gC User manual

Doc. No.：P30001PE0101-07
magLEAD 12gC Instruction for Use
Version 2
May 2022

1Doc. No.：P30001PE0101-07
Index
1. Information for the User.......................................................................... 3
2. Information for Safe Usage..................................................................... 5
3. Specifications........................................................................................ 11
3.1. Intended Use..........................................................................................................11
3.2. Features .................................................................................................................11
3.3. Performance...........................................................................................................11
3.4. Size, Weight, and Power Requirements...............................................................11
3.5. Storage Conditions ................................................................................................12
3.6. Transport Conditions ............................................................................................12
3.7. Environmental Requirements and Instrument life............................................12
3.8. About the Caution Labels Inside the Instrument...............................................13
3.8.1. Caution label for hot surface .............................................................................. 13
3.8.2. Caution label for crushing of hands................................................................... 14
3.8.3. Caution label for biological hazard .................................................................... 14
3.8.4. Caution label for UV Lamp ................................................................................ 15
4. System Components............................................................................. 16
4.1. Front View .............................................................................................................16
4.2. Side and Rear View ...............................................................................................17
4.3. Internal Components ............................................................................................18
5. Installation............................................................................................. 19
5.1. Setup procedure.....................................................................................................19
5.2. Configuration and setting up the instrument.....................................................22
5.2.1. Setting the installation date............................................................................... 22
5.2.2. Setting the serial port ......................................................................................... 22
5.2.3. Setting time and date ......................................................................................... 22
5.2.4. Setting the preventive maintenance reminder ................................................. 22
5.2.5. Installing the barcode reader (optional) ............................................................ 22
5.3. Installing the PC software (optional)...................................................................23
5.3.1. System requirements .......................................................................................... 23
5.3.2. Installing the driver of the USB-RS232 converter............................................ 23
5.3.3. Mapping the COM port (For users of “Windows 10 Professional”).................. 24
5.3.4. Installing the magLEAD Communicator .......................................................... 25
6. System Components............................................................................. 27
6.1. Accessories .............................................................................................................27
6.2. Disposables ............................................................................................................29
6.3. Reagents.................................................................................................................29
7. Directions for Use ................................................................................. 31
7.1. Door operation .......................................................................................................31
7.2. Inserting Reagent Cartridges into the Reagent Cartridge Rack.......................31
7.3. Inserting Sample Tubes........................................................................................33
7.4. Inserting magLEAD Tip and Sheath sets ...........................................................33
7.5. Inserting Elution Tubes........................................................................................33
7.6. Inserting the Tip/Tube Rack.................................................................................34

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8. Basic Operation..................................................................................... 35
8.1. magLEAD 12gC Operation Panel ........................................................................35
8.2. Startup and Shutdown Procedure........................................................................35
8.2.1. Startup................................................................................................................. 35
8.2.2. Shutdown............................................................................................................. 36
8.3. Protocol Run Procedure ........................................................................................36
9. Manual Operation.................................................................................. 38
9.1. Manual Screen.......................................................................................................38
9.1.1. Home Screen........................................................................................................ 38
9.1.2. Return Tip Screen ............................................................................................... 39
9.1.3. Cleaning Screen .................................................................................................. 39
9.1.4. Resend Screen ..................................................................................................... 40
9.2. UV Screen ..............................................................................................................41
9.2.1. Switching on the UV lamp.................................................................................. 41
9.2.2. Switching off the UV lamp ................................................................................. 42
9.2.3. Lifetime reminder of the UV lamp..................................................................... 42
9.3. Setup Screen ..........................................................................................................43
9.3.1. Setting the date................................................................................................... 43
9.3.2. Setting the time................................................................................................... 43
9.3.3. Setting the serial port ......................................................................................... 44
9.3.4. Setting the preventive maintenance reminder ................................................. 44
9.4. Test Screen.............................................................................................................45
9.4.1. Axis Test Screen.................................................................................................. 45
9.4.2. Temp Test Screen................................................................................................ 45
9.4.3. Serial port test Screen ........................................................................................ 46
9.4.4. Version Screen..................................................................................................... 47
10. Barcode reader (optional).................................................................. 48
11. Report file........................................................................................... 48
12. magLEAD Communicator (optional).................................................. 51
12.1. User interface.....................................................................................................51
13. Maintenance....................................................................................... 54
13.1. Cleaning Procedure ...........................................................................................54
13.2. D-Ring Maintenance..........................................................................................55
14. Troubleshooting................................................................................. 57
14.1. Error Reported During Protocol Run ...............................................................57
14.2. Suspending or Aborting a Protocol Run...........................................................58
14.3. Frequently Reported Problems.........................................................................60
15. Error Code List................................................................................... 62
16. Revision history................................................................................. 63

3Doc. No.：P30001PE0101-07
1.Information for the User
Congratulations on purchasing the magLEAD 12gC instrument, which features Precision
System Science’s worldwide patented Magtration® technology utilizing magnetic particles.
This Instructions for Use provides information necessary for the safe and effective use of the
instrument. Please read this manual thoroughly to familiarize yourself with the device and its
settings before you use it.
・Do not operate the instrument without understanding the instructions described in this
manual.
・Always keep this manual near the instrument in case you need a quick reference.
Please inform us, Precision System Science Co., Ltd., if this manual is lost or damaged.
The following items are included in the instrument package.
Items
Qty.
Remarks
1. magLEAD 12gC main body
1
2. Power cable AC100V
1
3. Power cable AC240V
1
4. Reagent cartridge rack
1
5. Tip/tube rack
1
6. Silicon grease
1
7. D-rings
12
8. Fuse (3.15A, 250V)
2
For power switch
9. Package insert
1
10. Package checklist
1
Optional items (Not included)
11. Handheld barcode reader
1
12. magLEAD Communicator (CD)
1
PC software
13. Communication cable
1
14. USB-RS232 converter
1
Disposables (Not included)
F4430_magLEAD Consumable kit
1. magLEAD Tip and Sheath set
52
DN 100N, Sheath DN 100N
2. Micro tube
100
3. Screw cap
100

4Doc. No.：P30001PE0101-07
Reagents (Not included)
Code
Name
E1300
MagDEA Dx SV
IC card (Not included)
Code
Name
I7712
MagDEA Dx SV 200 12gC
I7812
MagDEA Dx SV 400 12gC
For other RUO products, please see the PSS homepage.
Please notice to the manufacturer and the competent authority of the Member State in which
the user and/or the patient is established, in case where any serious incident has occurred
in relation to the device.

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2.Information for Safe Usage
Most problems arise from incorrect usage of the instrument and from not following the safety
instructions. Please read this manual thoroughly so you can understand and familiarize
yourself with measures for preventing problems in instrument operation.
If the instrument is used in a manner not specified by the manufacturer, the protective
features of the equipment may be impaired.
About the Symbols
This manual uses various symbols to help you easily understand important information
regarding safe operation of the instrument. Their meanings are described below.
Symbol
Description
Indicates the need for the userto consult the instructions for use.
When the instructions for use and patient information are
located within the same electronic instructions for use, a
manufacture may choose to use this symbol to indicate both.
To indicate that caution is necessary when operating the device
or control close to where the symbol is placed, or to indicate that
the current situation needs operator awareness or operator
action in order to avoid undesirable consequences.
Caution label for hot surface
To warn of a hot surface.
Caution label for crushing of hands
To warn of a closing motion of mechanical parts of equipment.
Caution label for biological hazard
To warn of a biological hazard.
Caution label (e.g. of UV Lamp)
To signify a general warning
Manufacturer
Indicates the medical device manufacturer.
Authorized representative in the European community /
European Union
Indicate the authorized representative in the European
community / European Union.
In vitro diagnostic medical devices
Indicates a medical device that is intended to be used as an in
vitro diagnostic medical device.
magLEAD 12gC is not considered as a medical device (IVD) in
the United States of America, and it is not registered with the
FDA.
Warning
Caution

6Doc. No.：P30001PE0101-07
CE mark for Europe
Regulation (EU) 2017/746 (IVD Directive)
This instrument has been tested and complies with the
following standards:
IEC61010-1 Amd.1 Ed3: 2016, “Safety requirements for
electrical equipment for measurement, control and
Laboratory use ‐Part 1: General requirements”
IEC61010-2-101: 2018, “Safety requirements for electrical
equipment for measurement, control, and laboratory use ‐
Part 2‐101: Particular requirements for in vitro diagnostic
(IVD) medical equipment”
EN61326-1: 2013, “Electrical equipment for measurement,
control and laboratory use EMC requirements –Part1:
General requirements”
EN 61326-2-6: 2013, “Electrical equipment for measurement,
control and laboratory use EMC requirements –Part2-6:
Particular requirements in vitro diagnostic (IVD) medical
equipment.”
About the symbol of label
The symbols on the labels for devices other than those listed above are described below.
Serial number
Indicate the manufacturer’s serial number so that a specific
medical device can be identified.
YYYYMMDD
Country of manufacture “Japan”
To identify the country of manufacture of products.
The date of manufacture.
Unique device identifier
Indicates a carrier that contains unique device identifier
information.
UL listing mark for Canada and the USA
This instrument has been tested 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.”
This product complies with the WEEE Directive (2002/96/EC)
marking requirement. This marking indicates that you must
not discard this electrical/electronic product in domestic
household waste.

7Doc. No.：P30001PE0101-07
Other’s symbol
This symbol indicates a caution message (including danger
and warning). The mark inside the triangle specifies the type
of caution (the example on the left illustrates electric shock).
This symbol indicates actions that you should not perform.
Details are illustrated inside the symbol or near the symbol.
This symbol is used to restrict operations or to illustrate what
action should be performed. Details are illustrated inside the
symbol (the example on the left shows unplugging of an AC
plug from the wall outlet).
⚫Do not use kits other than the MagDEA Dx reagent kits.
⚫The magLEAD 12gC CANNOT be used as an accessory for any of following
diagnostic applications:
1) Determination of:
◆blood groups: ABO system, rhesus (C, c, D, E, e), anti-Kell, anti-Duffy or
anti-Kidd
◆irregular, anti-erythrocytic antibodies
◆human cytomegalovirus and human chlamydia
◆HLA tissue groups DR, A, or B
◆PSA tumor marker
2) Detection, confirmation, or 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 or toxoplasmosis in human samples
3) Diagnosis of the hereditary disease phenylketonuria
4) Evaluation of the risk for trisomy 21
5) Self-diagnosis from blood sugar measurements, including related
calibrations or controls.
6) Any other applications listed on the latest version of Class A(Sterile), B , C
and D of Annex VIII of Regulation (EU)2017/746.
⚫Do not use this instrument in a strong electric field or magnetic field.
⚫Use of this instrument in a dry environment may cause erroneous results due to damage
from static discharge.
Caution

8Doc. No.：P30001PE0101-07
The following precautionary instructions are included to ensure safe operation of
the magLEAD 12gC instrument. Please always keep this manual near 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.
If problems occur with the instrument, immediately turn off the main power
switch and unplug the power cable. Then contact PSS.
Installation
•Be sure that no water or liquid gets inside the instrument.
This could cause fire or electric shock.
•Do not attempt to disassemble, modify, or repair the instrument
yourself. This may cause instrument failure or electric shock to you.
Contact PSS for instrument repair or maintenance.
Emergency Situations
•In case of an instrument emergency, such as extraordinary heat,
smoking, abnormal smell, etc., immediately unplug the power
cable from the wall outlet to avoid fire or electric shock. Contact
PSS for repair.
•If foreign material or water splashes onto the instrument or gets
inside the instrument, immediately unplug the power cable from the
wall outlet to avoid fire or electric shock. Contact PSS.
•If the power cable is damaged (e.g., the core wire is exposed or
broken), immediately unplug the power cable from the wall outlet
to avoid fire or electric shock. Contact PSS.
Warning
Prohibited
acts
Prohibited
acts
Unplug AC
power
Unplug AC
power
Unplug AC
power

9Doc. No.：P30001PE0101-07
Installation
•Avoid installing the instrument in the locations indicated below.
This may cause instrument damage or malfunction.
-Locations exposed to direct sunshine
-Locations with high vibrations, humidity, or dust
-Locations with strong electric or magnetic fields
-Locations where liquid or oil could splash onto the instrument
-Locations with flammable gas, corrosive gas, or high heat sources.
•The instrument will be installed by field service personnel
authorized by PSS.
Contact us if you need to move the instrument.
Storage
•Unplug the power cable from the wall outlet if the instrument
will not be used for an extended period of time.
Precautions for Instrument Operation
•There is a possibility of biohazard exposure while operating the instrument. Wear
appropriate personal protective equipment such as a mask, goggles, and gloves.
•Pay close attention when handling biohazardous samples.
•When operating the instrument under low temperature conditions, keep the instrument
power on.
•Make sure that no foreign materials get into the instrument from outside.
•Do not scratch or press the operation panel with knives or other sharp items.
•Pay close attention when working around the piercing unit to prevent injury to yourself.
•Barcode scanner uses LEDs. Do not look directly at the LED.
•The fuse should only bereplaced by field service personnel authorized by PSS. Contact
us for fuse replacement.
Caution
Prohibited
acts
Prohibited
acts
Unplug AC
power

10 Doc. No.：P30001PE0101-07
About the Warranty Period
•12 months after installation, regardless of the instrument usage.
•This warranty excludes problems that occur due to inadequate storage, inadequate
usage or operation, or repair, modification, or maintenance of the instrument by people
who are not authorized by PSS, even within the warranty period.
About Disposal
•Contact PSS if you need to dispose of the instrument.

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3.Specifications
3.1.Intended Use
magLEAD 12gC employs PSS’s original Magtration®technology to perform automated
isolation and purification of nucleic acids (DNA, RNA) using magnetic particles.
The instrument is intended to be used only in combination with the MagDEA Dx reagent
kits for magLEAD 12gC instrument only for the applications described in the product’s
instructions for use. 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 up to 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
Processing time・・・About 30 min/1 - 12 samples
➢Temperature control function：Heat Block・・・40 to 90 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 the protocol in use.
3.4. Size, Weight, and Power Requirements
➢Size：W500×D535×H574mm
➢Weight：About 55 kg (121 lbs.)
➢Power requirement：AC100 - 240V +/- 10%, 50/60Hz, 300VA
•Do not share a power source with other instruments.
•Do not place next to other instruments that cause noises or power fluctuation.
•Connect the power cable to the wall outlet with a grounded line.
•Connect to protective earth.
Caution

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3.5. Storage Conditions
➢Temperature：+5 ~ +40 deg. C
➢Relative humidity：15 ~ 75 % ※Non-condensing
➢Barometric pressure：More than 70kPa (min)
3.6. Transport Conditions
➢Temperature：- 25 ~ + 60 deg. C
➢Relative humidity：15 ~ 75% ※Non-condensing
➢Barometric pressure：More than 70kPa (min)
3.7. Environmental Requirements and Instrument life
➢Overvoltage category：Ⅱ
Transient overvoltage：2500 V
➢Pollution degree：2
➢Installation site：Indoor use only
➢Temperature：+15 ~ +30 deg. C
➢Relative humidity：15 - 75% ※Non-condensing
➢Altitude：Up to 2,000 m above the sea level
➢Space：Maintain sufficient distances from the walls as indicated below for
ventilation, maintenance work, etc. Also maintain more than 200 mm free space
above the instrument.
➢Designed to last 5 years or more (4 runs/day, 250 day/year) with proper
maintenance.
Environmental Requirements
magLEAD 12gC
More than 200 mm
Front
Back
Wall
Wall
Wall
More
than 200
mm
More
than 200
mm

13 Doc. No.：P30001PE0101-07
•Place the instrument on a horizontal surface that can
support the instrument weight.
•Place the instrument on a horizontal surface.
•Do not place the instrument in locations exposed to direct sunlight or
vibrations.
•When operating the instrument in a cold chamber or cold room, keep the
instrument power on to avoid condensation.
3.8. About the Caution Labels Inside the Instrument
3.8.1. Caution label for hot surface
Place attached ：Heat block and inner wall of the cover
•The area where this label is attached becomes hot during operation. Be sure not to
touch this area.
Caution
Caution

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3.8.2. Caution label for crushing of hands
Place attached：Magtration® Unit
•The area where this label is attached can potentially pinch your hand or fingers in the
driving mechanism of the open/close operation. Take care not to be pinched.
3.8.3. Caution label for biological hazard
Place attached：Inner wall of the instrument cover
Caution

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•The area where this label is attached (inside cover) has the potential of biohazard
contamination from samples or extracted/purified products. Take care not to expose
yourself to potential contamination.
•Note that it is not possible to completely eliminate biohazard risk from samples or
extracted/purified products while operating this instrument. Wear a mask, goggles,
and gloves for your own safety as described in this manual.
•Pay close attention when handling highly hazardous samples.
3.8.4.Caution label for UV Lamp
Place attached：Top of the instrument cover
CAUTION UV emitted from this product.
IEC62471 Risk Group 2
•The magLEAD 12gC contains a UV lamp. Avoid looking directly at the UV light. Do
not expose your skin to UV light.
Caution
Caution

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4.System Components
4.1. Front View
*1: Green LED: Lit when powered on
*2: Red LED: Blinks if an error occurred
*2 Alarm Status
LED (red)
Operation Panel
IC Card Inlet
*1 Power Status
LED (green)
Door
Display

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4.2. Side and Rear View
The power switch is located on the left side of the instrument.
The fuse box and connectors are located on the back of the instrument.
Note
•Replacement of the fuse shall only 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
The Magtration®unit and stage unit are located inside the instrument.
1. Magtration®Unit
➢Syringe Unit：Twelve nozzles for simultaneous processing of up to 12 samples
with accurate and rapid aspiration and dispensing.
➢Magnets：Twelve magnets aligned with 12 tips for simultaneous separation of
magnetic particles from up to 12 samples.
2. Stage Unit
➢Reagent Cartridges：Simple placement of special disposable cartridges
pre-filled with reagents minimizes cross-contamination.
The back two positions (wells) in the cartridge are used for heating.
➢Tip Sets：Positions for tips (DN100N tips) in the tip sheath. One or two tips or
tip sheath (Sheath DN100) are used per sample depending on the protocol.
Refer the instructions provided in the package insert for the reagent kit.
➢Elution Tubes：Positions for Micro tube.
➢Sample Tubes：Positions for Micro tube.
Syringe Unit
Magnets
Sample Tubes
Elution Tubes
Tip Sets
(magLEAD Tip and Sheath
set)
Reagent Cartridges
UV lamp Unit

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5.Installation
5.1. Setup procedure
1. Remove the instrument from the shipping crate.
•The instrument will be installed by field service personnel authorized
by PSS. Contact us if you need to move the instrument.
2. Remove the protective films attached to the instrument.
3. Open the instrument door.
4. Push the pipettor head upward.
Warning