PSS magLEAD 5bl User Manual
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PSS magLEAD 5bl User Manual

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Fully Automated Nucleic Acid Purification System
User's Manual
Ver. 1.07

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Summary of Contents for PSS magLEAD 5bl

  • Page 1 Fully Automated Nucleic Acid Purification System User’s Manual Ver. 1.07...
  • Page 2 Index Introductions ............3 For Safety Usage ............4 Specifications ............9 System Components ............16 Installation ............21 Accessories and Disposables ..........23 Direction for Use ............26 Basic Operations ............31 Maintenance ............37 Troubleshooting ............39 List of Error Codes ............ 42...
  • Page 3 Please inform us, Precision System Science Co., Ltd., when this book is lost or damaged. Followings are packed together in this Instrument Package. Description Qty. Remarks magLEAD 5bL Main Body Combo (Tube) Rack Reagent Cartridge Rack SD Card Fuse AC240V power cable AC110V power cable User’s Manual...
  • Page 4 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 5 Details are illustrated inside the symbol (the sample on the left shows unplugging of AC Plug from wall outlet.) The following precautionary instructions are included to ensure the safety magLEAD 5bL operation of your . Please always keep this book near by the instrument or operator.
  • Page 6 Warning Installation ・ Be sure that no water or liquid would get into the instrument or that the instrument will not get wet. It would cause fire or electric shock. ・ Do not attempt disassembling, modifying or repairing by yourself. It may cause malfunction of instrument or electric shock to you.
  • Page 7 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 8 ・ This warranty excludes the problems derived from inadequate storage, usage or operation, repair/modification/maintenance of the instrument by anyone who are not authorized by PSS, though within warranty period. About Abolishment Contact us when you want to abolish the instrument.

  • Page 9: Specifications

    (DNA, RNA etc.). It is intended to be used only in combination with MagDEA Dx LV kits and magLEAD Tip LV sets indicated for use with magLEAD 5bL instrument for the applications described in the IFU of the kit. The system...

  • Page 10: Temperature Control

    ➢ Throughput: Samples 1－5 samples/batch Processing time About 90 min/1-5 samples ➢ Temperature Control： Heat Blocks Room Temperature-85 deg. C ➢ Handling Volume： 1000 - 20000µl ➢ Dispensing Accuracy： 1000µl less than CV 10% 20000µl less than CV 10% ※Accuracy with distilled water at room temperature 20 - 25 deg.C Note Processing Time depends on protocols.

  • Page 11: Environmental Requirement

    Storage Condition ➢ Temperature： 5 - 40℃ ➢ Relative Humidity： 15 – 75 % *Non-Condensing ➢ Barometric Pressure： More than 70kPa(min) Transport Condition ➢ Temperature： -25 – + 60 deg. C ➢ Relative Humidity： 15 – 75% ※Non-Condensing ➢ Barometric Pressure： More than 70kPa(min) Environmental Requirement ➢...
  • Page 12 Environmental Requirement ➢ Wall More than 200mm Back More than More than 200mm 200mm Wall Wall magLEAD Front Caution ・ Please set the instrument on horizontal surface that can invariably endure instrument weight. ・ Place the instrument on horizontal surface. ・...
  • Page 13 Caution ・ The part where this label is attached becomes hot. Be sure not to touch while working. 3.8.2 Caution Label for Biohazard Place attached： Front of instrument Caution ・ The part where this label is attached (inside cover) has possibility of biohazard contamination with samples or extracted/purified products.
  • Page 14 About Labels in Rating plate Explanations of labels in rating plate are described in following table. 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 ‐...
  • Page 15 In Vitro Diagnostic medical devices (98/79/EC) magLEAD 5bL is not considered as a medical device (IVD) in the United States of America, and it is not registered with the FDA.
  • Page 16 System Components Front View Front Door LCD Panel Power Lamp ＊1 Operation Panel SD card slot Light when powered on – green light Blinks when an error occurred – red light Working - orange light...

  • Page 17: Right Side View

    4.1.1 Operation Panel Upper key Right key Lower key Left key Enter key Upper key：Operation of this key will move a cursor upwards. Left key：Operation of this key will go back to the previous screen. Right key：Operation of this key will move a cursor right. Lower key: Operation of this key will move a cursor downward Enter key: Operation of this key will start the protocol or be settled action items.

  • Page 18: Back View

    Back View Power inlet, USB port, RS-232C port and Temperature Indicator are located on the back side of instrument. 4.3.1 Back View 4.3.2 Back bottom view Temperature Indicator RS-232C Connector Fuse Unit Power Inlet Connector Power Cable USB Port (For maintenance) Caution ・...

  • Page 19: Internal Components

    Connecting non-authorized devices could cause malfunctions. Note ・ Replacement of the fuse shall be made by field service personnel authorized by PSS. Contact us for fuse replacement. Internal Components Inside the instrument, Magtration® Unit and Stage Unit are located. Bellows...
  • Page 20 ➢ Magnet Five magnets are aligned with 5 tips to simultaneously separate magnetic particles for up to 5 samples. 4.4.2 Stage ➢ Reagent Cartridge Rack Cartridge Ruck and Reagents Cartridge can be loaded. ➢ Heat Block(highlighted with red line ➢ Combo (Tube) Rack Sample and Elution Tubes can be loaded.

  • Page 21: Installation

    *Refer to the unpacking procedures attached to take out. Warning ・ Setting of the instrument shall be made by field service personnel authorized by PSS. Contact us when you transfer the instrument. Remove protection films attached on the instrument ②...
  • Page 22 Warning ・ Setting of the instrument shall be made by field service personnel authorized by PSS. Contact us when you transfer the instrument.

  • Page 23: Accessories And Disposables

    Accessories and Disposables Accessories Name of Accessories Quantity Reagent Cartridge Rack Combo (Tube) Rack SD Card Fuse AC240V power cable AC110V power cable 6.1.1 Reagent Cartridge Rack It holds up to five Lx Cartridges. 6.1.2 Combo (Tube) Rack It holds up to five Tubes of 50.0ml and 2.0ml. 6.1.3 SD Card It is used for update of firmware and protocols or storage of barcode...
  • Page 24 Handheld Barcode Reader is an Option item. It can read the information of Reagents and Tips. Disposables 6.2.1 Disposables Produced by PSS List of Disposables Produced by PSS Code Product Description Place to be Used F7230 magLEAD Tip LV set...
  • Page 25 6.2.2 Recommended Disposables Produced by Other Companies List of the recommended disposables from other companies Manufacturer Code Product Description Place to be Used 2.0ml Tube with Screwed SARSTEDT 72.693 Combo (Tube) Rack 3181-345- Labcon SuperClear 50 mL Labcon Combo (Tube) Rack Conical Tubes *Disposables needed vary by application and also disposables other than listed above may be recommended in some applications.

  • Page 26: Direction For Use

    Direction for Use Opening and closing of the Front Door Front Door opens up and closes down. If the door is opened to its uppermost position, it is held there. If Front Door is opened or closed while the instrument is running, the operation is interrupted and it is not possible to resume from where it stopped.
  • Page 27 Putting On and Taking Out Reagent Cartridge Rack Reagent Cartridge Rack can be taken out for cleanup. Take Reagent Cartridge Rack out of the stage to clean it up and put it back. Caution ・ Handle Reagent Cartridge Rack gently without giving excessive force to avoid damaging it.
  • Page 28 7.3.2 Setting Sample Tubes Set 2.0ml tubes without caps in row. Caution ・ Number of Tube Sets needed depends on protocols. Please refer to the package insert of the reagent for the details. Be sure to put Tubes before setting them in Combo Rack. 7.3.3 Setting Combo (Tube) Rack Set combo (tube) rack into the instrument.
  • Page 29 7.3.4 Set of Bellows tips ① Slide Bellows Lock to right to unlock. ② Set Bellows Tips on the bellows tip holder so that the flange (highlighted by red arrow) is placed under the bellows. Bellows Bellows Tips Bellows Lock Set all the tips and slide Bellows Lock to left to lock.
  • Page 30 Disposal procedure for reagents and consumables After a protocol is completed and operation stops completely, a door is opened, and a reagent and consumables are removed. Caution ・ Do not reuse any consumables /reagents to avoid contamination or instrument malfunction. ・...

  • Page 31: Basic Operations

    Basic Operations Start Up and Shut Down Procedure 8.1.1 Start Up ① Close Front Door. (Refer to sections “7.1 Front Door Operation.”) ② Turn on Power Switch located on the Left side of the instrument. ③ The instrument is started up and LCD screen is activated. 8.1.2 Shut Down ①...
  • Page 32 Caution ・ Protocols will vary depending on the reagent. Please refer to the Instruction manual to select the respective reagents. ・ Malfunction will occur when using the wrong protocol, which could result in failure and negative effect on the extracts. Determining the protocol and perform the operation according to ③...
  • Page 33 ORG position ･ORG ALL ･ORG Z ･ORG P ･ORG Y ･ORG M ② Select axis to return Home with key and press key to execute. ※Pressing ORG ALL will home all axes in these sequence M→Z→Y→P ③ Push key, returns to "Menu" screen. 8.3.2 Manual movement Allows each axis to perform movement manually.

  • Page 34: System Menu

    *Press and hold the key will cause the movement to go faster in that direction, press and release will result in jog movement. ⑤ Push key, returns to "Menu" screen. 8.3.3 UV Lamp This screen menu is for the purpose of turning on the UV Lamp ①...
  • Page 35 8.4.1 Error history Record the latest 3 errors and error status of the processed protocol <Display Contents> Occurrence date (6 digits), Page executed protocol (P&2 digits), Error code (E&2 digits), Error Line (L&4 digits) 8.4.2 Diagnostics ・ Axis Stroke Carry out normalization check on home position of each axis, stroke and limit sensor.
  • Page 36 key to select the set item, key to execute. ② Date Time Cur: CMM/CD/CYYY Cur: CH:CM:CS Set: SMM/SD/SYYY Set: SH:SM:SS key to select the set item, key to execute and key to ③ return to previous menu. ・ Protocol Add/Delete To add and delete the Protocol.

  • Page 37: Maintenance

    Maintenance Items of maintenance activity are listed below. Items Frequency Operator Cleaning Stage and Racks After every run User Cleaning Magtration Unit After every run User Maintenance Once a year Field Service Caution ・ Possibility of biohazard from samples or extracted/purified products could not completely be eliminated in operating the instrument.
  • Page 38 Beside above, all accessories and inside instruments. Cleaning Method: Choose liquid depending on the pollution status and wipe the polluted place using paper, such as Kim Wipe®, moistened with the liquid. Use a mask, goggles and gloves when cleaning the instrument for your safety.

  • Page 39: Troubleshooting

    10 Troubleshooting Error Reported During Protocol Run 10.1 Error during process Page:XX Code:YYYY Line No.=ZZZZ Press [LEFT] key Error code reported is shown in place of “YYYY” in the above screen. (Refer to section “11. List of Error Codes” for error codes.) ①...
  • Page 40 will return to Top Menu with each axis staying where it is and if “Start”, the rest of the protocol run will be executed from where it stopped. *If a protocol is aborted by “Break”, a new set of Tip Sheath needs to be taken up.
  • Page 41 10.3 Frequently Reported Problems Presumable Problem Countermeasures Cause Power is not AC Power Cable Check for connection of AC Power Cable. Be sure to supplied to is not connected use Power Cable supplied with instrument. ※Do not use power cable other than supplied one. instrument properly.

  • Page 42: List Of Error Codes

    While in run, Y axis end limit error occurs. While in run, Z axis timeout error Take note of displayed error code occurs. and contact PSS for further technical support. While in run, P axis timeout error occurs. While in run, M axis timeout error occurs.
  • Page 43 PSS for further technical support. Not pass SelfDiagnostics Take note of displayed error code Initialization error of temperature and contact PSS for further controller technical support. While in Pause, Break is selected Nothing Take note of displayed error code...
  • Page 44 Incorrect command name system software or protocols. | N/A Take note of the error code and No data for one row contact PSS for further technical No data at the assigned cut out support. position No data although there is assigned...
  • Page 45 Incorrect " " system software or protocols. | N/A Take note of the error code and Duplicated labels contact PSS for further technical Incorrect label name to be registered support. | N/A No VP table number assigned Duplicated VP table numbers...
  • Page 46 These errors are related to protocol system software or protocols. Take note of the error code and Failure of jump address search in a contact PSS for further technical protocol support. Incorrect wait time set in a protocol Layer of function call exceeds limit Failure of InputStr in a protocol.
  • Page 47 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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