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PSS magLEAD 12gC User Manual

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

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Summary of Contents for PSS magLEAD 12gC

  • Page 1 12gC User Manual Version 1.3 April 2016 Doc. No.: P30001PE0101-03...

  • Page 2: Table Of Contents

    Index 1. Information to the User ................3 2. For Safety Usage ..................4 3. Specifications ..................10 Intended Use ....................10 3.1. Features ......................10 3.2. Performance ..................... 10 3.3. Size, Weight and Power Requirement ............10 3.4. Storage Condition .................... 11 3.5.
  • Page 3 Setting Tip/Tube Rack ..................33 7.6. 8. Basic Operation ..................34 magLEAD 12gC Operation Panel ..............34 8.1. Start Up and Shut Down Procedure ............... 34 8.2. Start Up ....................... 34 8.2.1. Shut Down ......................35 8.2.2. Protocol Run Procedure ................... 35 8.3.

  • Page 4: Information To The User

    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.

  • Page 5: For Safety Usage

    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.
  • Page 6 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...
  • Page 7  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 ...
  • Page 8 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.
  • Page 9 -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 Unplug AC may not be used for extended period of time.
  • Page 10 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.

  • Page 11: Specifications

    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.

  • Page 12: Storage Condition

     Space： Keep distances from walls as shown below for ventilation, maintenance work, etc. Also keep more than 200mm space over the instrument. Environmental Requirement Wall More than 200mm More More Back than than 200mm 200mm Wall Wall magLEAD 12gC Front...

  • Page 13: About Caution Labels Inside Instrument

    Caution  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.

  • Page 14: Caution Label For Pinching Fingers

    3.8.2. Caution label for pinching fingers Place attached：Magtration® Unit Caution  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...
  • Page 15 Caution  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.

  • Page 16: System Components

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

  • Page 17: Side And Rear View

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

  • Page 18: Internal Components

     Elution Tubes：Positions for 1.5ml elution tubes.  Sample Tubes：Positions for 1.5ml sample tubes. Warning The magLEAD 12gC contains a UV lamp. Avoid looking directly UV light. Do not expose your skin to UV light.

  • Page 19: Installation

    Warning  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.
  • Page 20 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. Power Cable Connector for PC RS232C Connector Handheld Barcode Reader Caution ...
  • Page 21 7. Confirm the power switch is turned off. As instructing on Pictures below, open the inlet cover and insert the IC Card. Please make sure that the picture side is ▽ left and the triangle mark faces down when inserting the card. After inserting the card, turn on the power switch on the left side of the unit.

  • Page 22: Configuration And Setting Up The Instrument

    5.2.Configuration and setting up the instrument 5.2.1.Setting the installation date The first time the magLEAD 12gC is switched on, it is necessary to enter the installation date. This date will be recorded in the report file described below. The installation date is also used to let the instrument know when to show the weekly and annual maintenance reminders.

  • Page 23: Installing The Pc Software (Option)

    The data communication between the reader and the instrument is RS232. 5.3.Installing the PC software (Option) The magLEAD 12gC software “magLEAD Communicator” needs to be installed on the PC. The software is needed to receive report files from instrument and to store data on the PC hard disk.
  • Page 24 Mapping the COM port (In case of “Windows7 Professional N”) ■ Click the “Start” button on your PC and select “Control Panel”. ■ Open “Device Manager”. NOTE: The process to open the Device Manager depends on the version of OS. ■...

  • Page 25: Installing The Maglead Communicator Software

    ■ Change the dialog field “COM Port Number” to “COM1”. The USB port is now mapped to COM port 1. Always use COM Port 1 to work with the magLEAD 12gC. 5.3.3.Installing the magLEAD Communicator software ■ Insert the CD labeled “magLEAD Communicator Software” into the PC.
  • Page 26 ■ The magLEAD Communicator software is now ready to receive data from the instrument. ■ In order to check the connectivity between the PC and magLEAD 12gC, use the test described in Section 9.4.3.

  • Page 27: System Components

    6.System Components 6.1. Accessories Power Cable Power Cable for 240VAC Power Cable for 100VAC -. Silicon Grease, Fuses and D-Rings Silicon Grease Fuse (3.15A) D-Rings -. Reagent Cartridge Rack...
  • Page 28 -. Tip/Tube Rack -. Handheld Barcode Reader (Option) Please refer to an attached Barcode Reader use manual for details. -. magLEAD Communicator (PC Software, Optional product) Please refer to “ Installing the PC software (Chapter 5.3)” for details.

  • Page 29: Disposables

    6.2. Disposables Tip(DN-100N Tip) ＆ Tip Holder(Sheath DN100) Elution Tube・Sample Tube Please refer to the package insert of the disposables for details. 6.3. Reagents Prefilled Reagent Cartridges Please refer to the package insert of the reagent for details.
  • Page 30 Caution  Do not reuse any disposables to avoid contamination and/or instrument malfunction.  Do not use disposables/reagents other than specified to avoid instrument malfunction.  Be sure to wear a mask, goggles and gloves for your own safety when loading or discarding reagents, disposables and samples.

  • Page 31: Direction For Use

    7.Direction for Use 7.1. Door operation The door moves up to open and down to close. It is held by magnets at both ends. When opening/closing Door, be careful not to clamp your hand or fingers and be sure that it is held by magnets at either end. Caution ...
  • Page 32 2. Place Reagent Cartridge Rack into the rack setting position on the stage. Be sure that two farthest wells of the cartridge fit into the Heating Block. Caution  Instrument operation without correct placement of Reagent Cartridges or Reagent Cartridge Rack may result instrument malfunction.

  • Page 33: Setting Sample Tubes

    7.3. Setting Sample Tubes Set 1.5ml tubes (w/o caps) containing sample into the Tip/Tube Rack. 7.4. Setting Tip Sets Put tips into the tip holders, and set them in the holes of Tip/Tube Rack. 7.5.Setting Elution Tubes Set 1.5 ml elution tubes into the Tip/Tube Rack. Caution ...

  • Page 34: Setting Tip/Tube Rack

    7.6. Setting Tip/Tube Rack Set tip/tube rack into the instrument. For the setting direction of the rack refer to pictures below. Please make sure that the tip/tube rack Back side of the instrument Front side of the instrument Place the rack, making sure the holes on the right side fit to location pins.

  • Page 35: Basic Operation

    8.Basic Operation 8.1. magLEAD 12gC Operation Panel Operation Panel Description To choose menu 0～9 ７ ８ ９ To previous menu ４ ５ ６ START To run protocol STOP To halt or abort protocol １ ２ ３ (Enter) ENTER: To confirm or enter into next menu ０...

  • Page 36: Shut Down

    After confirming that the run is fully completed, turn the instrument Power Switch off. 8.3. Protocol Run Procedure After you have inserted the protocol IC Card and switched on the magLEAD 12gC, start a protocol as follows. ① Press “START” key to run a protocol, when the MENU screen is displayed.
  • Page 37 Please discard used reagent cartridge and plastic consumables according to your local safety regulations. ⑥ The magLEAD 12gC will automatically generate a report file, and send it to the PC. Note For generating and sending a report, please confirm the serial port setting. Please refer to the section 9.3.3.

  • Page 38: Manual Operation

    9.Manual Operation 9.1. Manual Screen Manual Screen is displayed when “2” key is pressed while MENU Screen is displayed. Press ESC key while Manual Screen is displayed to display MENU Screen again. DD MMM YYYY HH:MM START:Run 1:UV 2:Man 3:Test 4:Setup Key:START,1,2,3,4 Manual Screen MANUAL OPERATION...

  • Page 39: Return Tip Screen

    During operation, following screen appears. MANUAL OPERATION home axis Axis Executing... 9.1.2. Return Tip Screen When “2” key is pressed while Manual Screen is displayed, the following screen appears. MANUAL OPERATION return tip START:Run Key:START,ESC Press “START” to perform the return tip operation or “ESC” to return to the previous screen.

  • Page 40: Resend Screen

    If a report file cannot be sent to the PC, it is temporarily stored on the magLEAD 12gC instrument. Up to 10 report files can be stored. Use the “resend” function to manually transmit the report file(s) to the PC.

  • Page 41: Uv Screen

    UV lamp on as described below. Note UV decontamination helps to reduce possible pathogen contamination of the magLEAD 12gC stage surfaces. The efficiency of inactivation has to be determined for each specific organism and depends, for example, on layer thickness and sample type.

  • Page 42: Switching Off The Uv Lamp

    After entering a valid time, press “START” to switch on the UV lamp. The stage will move slowly back and forth under the UV light. During the UV run, the following screen appears. DECONTAMINATION>Run TotalTime:TT min. LeftTime: LL min. Key:STOP “TT”...

  • Page 43: Setup Screen

    Beginning 50 cycles before the 5000-cycle limit, the instrument will display this screen every time the instrument is switched on. “XXXX” indicates the number of cycles remaining. If this number is “0”, the UV lamp needs to be replaced. Contact Precision System Science for replacement of the UV lamp. 9.3.

  • Page 44: Setting The Serial Port

    Press “SHIFT”-down arrow to move the cursor right, from HH (hours) to MM (minutes). Press “SHIFT”-up arrow to move the cursor left, from MM to HH. Press the up arrow or down arrow to increase or decrease the value of the selected field. After setting the time, store the setting by pressing “ENT”.

  • Page 45: Test Screen

    9.4. Test Screen Test Screen is displayed by pressing “3” key while MENU Screen is displayed. Press “ESC” key while Test Screen is displayed to display MENU Screen again. DD MMM YYYY HH:MM START:Run 1:UV 2:Man 3:Test 4:Setup Key:START,1,2,3,4 TEST 1:Axis 2:Temp 3:Serial 4:Version...

  • Page 46: Serial Port Test Screen

    TEST: TEMPERATURE Temp: ss.s C actual: aa.a C Key:ESC “ss.s” indicates the set temperature, and “aa.a” indicates the current temperature. “r” indicates the result, showing “O” if the temperature is within a given range or “X” if the temperature is outside the given range. 9.4.3.

  • Page 47: Version Screen

    TEST: Key:ESC Use the bar code reader to read a bar code. When a new bar code is read, the previous bar code will be overwritten. A beep sounds after a successful scan of the bar code. The following screen appears, showing up to 55 digits. TEST:BBBBBBBBBBBBBBB BBBBBBBBBBBBBBBBBBBB BBBBBBBBBBBBBBBBBBBB...

  • Page 48: Bar Code Reader (Option)

    10.Bar code reader (Option) The bar code reader is preset to read the following types of bar codes. ■ Code 39 ■ Code 128 ■ QR Code ■ Data Matrix To read a bar code, press the button located on the inner side of the handle of the bar code reader.

  • Page 49: Report File

    For generating and sending a report, please confirm the serial port setting. Please refer to the section 9.3.3. Up to 10 report files can be stored temporarily on the magLEAD 12gC. When additional files are stored, the oldest report files will be deleted.
  • Page 50 12gC Card and copied into report file Trace Additional protocol name (specifies the protocol if there are multiple protocols on the magLEAD 12gC Card) Date of run: Jan 14, 2015 Time stamp for date of run given through internal clock and...

  • Page 51: Maglead Communicator (Option)

    12.magLEAD Communicator (Option) magLEAD Communicator is a software program that runs on a PC. The software receives the report file and stores it in a folder that you define. After the PC has received the report file, you can use and process the file with a LIMS (Laboratory Information Management System) or other programs.
  • Page 52 Select “File” to exit the graphical user interface. Select “Options” to display the following window showing the magLEAD 12gC serial ports. COM1 should already be selected. You can check the serial settings by checking one of the boxes.
  • Page 53 Select “About” in the main window to show the version of the magLEAD Communicator software. Click the “Change path” button in the main window to change the folder where the selected report file is stored. The following window opens. Browse and select the folder.

  • Page 54: Maintenance

    13.Maintenance Maintenance items to be done are listed below. Item Frequency Done By Cleaning of Stage and Racks After every operation User After every operation User Cleaning of Nozzles and Pearcing Unit Greasing D-Rings Once two weeks User Replacement of D-Rings Once half year Field Service Caution...

  • Page 55: D-Ring Maintenance

    Note  Do not use alcohol when cleaning Clear Panel on Door. Use water for those parts.  70% Ethanol is an inflammable. When you use Ethanol 70%, please check close that there is no fire. 13.2. D-Ring Maintenance In order to assure complete connection and for prevention of leakage, it is recommended to implement maintenance of D-Rings once two weeks.
  • Page 56 Wipe off excessive Silicon Grease pasted on the edges of nozzles and Tip Ejector with lint-free paper Caution  Excessive Silicon Grease may cause troubles for instrument operation, such as improper tip off action.

  • Page 57: Troubleshooting

    14.Troubleshooting 14.1. Error Reported During Protocol Run Error during process Code:XXX LineNo.= ##### Key:ESC to return Screen shown above will be displayed, showing error code occurred in xxx. (Refer to Chapter 15 for Error Code List.) ① When an error occurred during a protocol run, screen above is displayed, Alarm Lamp will blink with alarm sounding and the instrument operation is stopped.

  • Page 58: Suspending Or Aborting Protocol Run

    Note  When the same error occurs in running same protocol after executing appropriate action against the error, contact us for technical support. 14.2. Suspending or Aborting Protocol Run While the protocol run is in the phase where data is being read (e.g., sample tube bar code information), you can stop the protocol run by following the instructions below.
  • Page 59 3. After aborting a protocol, press “2” to display “Manual” in the display. Press “2” again to return the tips to the tip rack and to return the modules to their home positions. Caution  Start with steps described above when instrument stopped with Tips on Nozzles. ...

  • Page 60: Frequently Reported Problems

    14.3. Frequently Reported Problems Problem Possible Cause Countermeasures To Be Taken Back light of AC Power Cable Check for connection of AC Power Cable. Be sure to the Display is not connected use Power Cable supplied with instrument. Is not lit properly.

  • Page 61: Error Code List

    15.Error Code List Countermeasure to be taken Code No Description Zero-returning failure due to an operation other than contact us for assistance. a protocol End-limit error due to an operation other than a contact us for assistance. protocol contact us for assistance. Z-axis zero-returning failure during a protocol run contact us for assistance.
  • Page 62 Note  Most of the causes of errors listed above are originated by inadequate setting of disposables/accessories or by opened door. Be sure to check those before restarting protocol run.  When you had error codes other than listed above or the error could not be eliminated by taking countermeasure described, contact us with recording the error codes.
  • Page 63 Manufacturer Precision System Science Co., Ltd. Main Office Address Zip code: 271-0064 88, Kamihongou, Matsudo City, Chiba, Japan Contact TEL： +81-(0)47-303-4800 FAX： +81-(0)47-303-4811 URL： http://www.pss.co.jp E-mail：service@pss.co.jp EC REP Emergo Europe Address Molenstraat 15, 2513 BH The Hague, The Netherlands...

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