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Prologue

How to Use this Manual

Important:

Before operating the MagNA Pure Compact Instrument, be sure to read and

understand the warnings, cautions and safety requirements in this manual. Failure to
follow the instructions contained in this manual may have hazardous consequences.

䉴

contents of the MagNA Pure Compact system package

䉴

design of the instrument

䉴

accessories and disposable plastics required for instrument operation

䉴

isolation method of the MagNA Pure Compact Instrument

䉴

use the MagNA Pure Compact Software

䉴

prepare the instrument for a purification run

䉴

perform a purification run

䉴

User Maintenance

䉴

Service Maintenance by the Roche service

䉴

Cleaning of the instrument

䉴

Troubleshooting

Chapter A

General Overview describes

Chapter B

How To Operate the MagNA Pure Compact Instrument describes how to

Chapter C

Presents additional information on maintenance
of the instrument and troubleshooting

Intended Use of the Instrument

How to Use this Manual

MagNA Pure Compact Manual.book Seite 7 Dienstag, 28. Februar 2006 4:16 16

Содержание MagNA Pure Compact Instrument

Страница 1: ...MagNA Pure Compact Instrument Addendum 5 to Operator s Manual Version 1 3 Software Version 1 1 July 2016 For general laboratory use...

Страница 2: ......

Страница 3: ...ing to electromagnetic compatibility EMC Directive 2014 35 EU of the European Parliament and Council of 26 February 2014 relating to electrical equipment designed for use within certain voltage limits...

Страница 4: ...nstrument please contact your Roche Diagnostics representative Published by Roche Diagnostics GmbH Sandhofer Stra e 116 68305 Mannheim Germany 2013 Roche Diagnostics 0805521100110716 For general labor...

Страница 5: ...MagNA Pure Compact Instrument Addendum 4 to Operator s Manual Version 1 3 Software Version 1 1 November 2013 For general laboratory use...

Страница 6: ......

Страница 7: ...ct Instruments has been removed for serial numbers starting with MPCC1550 If you have any questions regarding the MagNA Pure Compact System please contact your Roche Diagnostics representative To call...

Страница 8: ...n to the MagNA Pure Compact Operator s Manual The floppy disk drive on the MagNA Pure Compact Instruments starting with serial number MPCC1550 has been removed Old Version New Version without Floppy D...

Страница 9: ...not included with the MagNA Pure Compact Instrument 9 USB Ports There are two USB ports USB 1 and USB 2 ports can be used for any accessories that are not included with the MagNA Pure Compact Instrum...

Страница 10: ...Instrument must be shut down 2 Insert update disk 3 Switch on instrument 4 Software is automatically updated 5 After Main Screen is displayed remove update disk 6 Update complete 7 The instrument is...

Страница 11: ......

Страница 12: ...ished by Published by Roche Diagnostics GmbH Sandhofer Stra e 116 68305 Mannheim Germany 2013 Roche Diagnostics 1 1113 For general laboratory use MAGNA PURE LIGHTCYCLER AND TAQMAN are trademarks of Ro...

Страница 13: ...For general laboratory use MagNA Pure Compact Instrument Addendum 3 to Operator s Manual Version 1 3 Software Version 1 1 August 2012...

Страница 14: ...arding this matter please do not hesitate to contact your Roche Diagnostics representative To call write fax or email us visit the Roche Applied Science home page http www roche applied science com an...

Страница 15: ...Simple Information regarding the MagNA Pure Compact Instrument Operator s Manual Version 1 3 27270610 MagNA Pure Compact OP 1 3 2nd Addendum 4S indd 1 27270610 MagNA Pure Compact OP 1 3 2nd Addendum 4...

Страница 16: ...liance prevents potential negative consequences for the environment and human health The Instrument must be treated as biologically contaminated hazardous waste Decontamination i e a combination of pr...

Страница 17: ...Instrument is designed in accordance with Protection Class I IEC The chassis housing of the Instru ment is connected to protection earth PE by means of a cable For protection against electrical shock...

Страница 18: ...Robotic Arm is only possible after the Instrument Door is closed and locked Description of the Instrument page 29 Current Version Additional Information Socket for power cable This is the plug in for...

Страница 19: ...t Software Update 1 1 2 Versatile Nucleic Acid Purification Smart Small Simple 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum 2 indd 1 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum 2 indd...

Страница 20: ...the instrument including the Plausibility Check improves tip handling includes updated and improved protocols a list of installed protocols has also been implemented in the Maintenance Menu improves...

Страница 21: ...act Instrument Operator s Manual Versatile Nucleic Acid Purification Smart Small Simple 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum 2 indd 3 22051208 MagNA Pure Compact SW Update 1 1 2 Addend...

Страница 22: ...ment for measurement control and laboratory use EMC requirements CAN CSA C22 2 No 1010 1 92 CAN CSA C22 2 CSA C22 2 61010 1 CE Testing Information The instrument conforms to following directives as is...

Страница 23: ...trument requires very little setup Choose for the MagNA Pure Compact Instrument a clean dry level stable surface within 3 m of a compatible electrical outlet To ensure proper ventilation leave 10 cm o...

Страница 24: ...ain Menu Screen Table 4 Overview of menu and submenu structure page 41 Current Version Changes Maintenance Detailed Actions Maintaining Leakage Test Counter and Reminder Error Log O ring Exchange Liqu...

Страница 25: ...housekeeping genes incl G6PDH HPRT ALAS and _2 microglobulin The level of expression of an appropriate endogenous IC should not vary with the experimental conditions or treatments to be compared The...

Страница 26: ...1 Leakage Test page 72 Current Version Changes New Screenshot 1 1 Leakage Test page 73 Current Version Changes New Screenshot New Screenshot Chapter C 22051208 MagNA Pure Compact SW Update 1 1 2 Adde...

Страница 27: ...e 77 Current Version Changes New Screenshot 1 2 2 O Ring Exchange page 78 Current Version Changes New Pictures New Pictures New Pictures Chapter C 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum...

Страница 28: ...ument Operator s Manual Current Version Changes New Pictures New Pictures New Pictures Chapter C 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum 2 indd 10 22051208 MagNA Pure Compact SW Update 1...

Страница 29: ...2 O Ring Exchange page 79 Current Version Changes New Pictures New Pictures New Pictures New Pictures New Pictures Chapter C 22051208 MagNA Pure Compact SW Update 1 1 2 Addendum 2 indd 11 22051208 Mag...

Страница 30: ...tracts Service Maintenance may only be per formed by a Roche Diagnostics service engineer Contact your local Roche representative for maintenance assis tance and for more details on country specific s...

Страница 31: ...oche representant have these informations ready or make sure the remote service option is enabled In the event that you want to trouble shoot an error together with a local Roche representative have t...

Страница 32: ...your local Roche Diagnostics representant and you will receive a new one Your local Roche Diagnostics representative will define an administrator authorization during installation of the Instrument T...

Страница 33: ...representantative For installation with the MagNA Pure Compact Instrument please contact your local Roche representative 7 3 MagNA Pure Compact Accessories page 100 Current Version Changes Waste Tank...

Страница 34: ...e Problem Report button and select OK in the pop up window 2 The Problem Report is created and stored on the attached USB Memory Stick A pop up window will open when the Problem Report has been saved...

Страница 35: ...www roche applied science com MagNA Pure Compact Operator s Manual Instrument Version 1 0 Software Version 1 1...

Страница 36: ......

Страница 37: ...1 Operating Reagents 14 2 3 2 Maintenance Items 15 2 4 Set up 16 2 4 1 Selecting a Location 16 2 4 2 Easy Teaching Procedure 16 2 4 3 Software Setup 17 3 Description of the Instrument 21 3 1 General D...

Страница 38: ...ification Protocols 67 1 User Maintenance 71 1 1 Leakage Test 71 1 2 O ring Maintenance 75 1 2 1 Greasing the O rings 75 1 2 2 O ring Exchange 76 2 Service Maintenance 81 2 1 Counter and Reminder 82 2...

Страница 39: ...Prologue MagNA Pure Compact Manual book Seite 3 Dienstag 28 Februar 2006 4 16 16...

Страница 40: ...MagNA Pure Compact Operator s Manual Version 1 3 4 MagNA Pure Compact Manual book Seite 4 Dienstag 28 Februar 2006 4 16 16...

Страница 41: ...ns The instrument is intended for nucleic acid preparation in general laboratory use by trained professionals Contact Addresses Revision History Copyright 2006 Roche Diagnostics GmbH All rights reserv...

Страница 42: ...must fulfill the standards set by IEC 950 Information security in technical equipment including electronic business machines Acronym Test Symbol Testing Information CE The instrument conforms to follo...

Страница 43: ...nt operation isolation method of the MagNA Pure Compact Instrument use the MagNA Pure Compact Software prepare the instrument for a purification run perform a purification run User Maintenance Service...

Страница 44: ...l is used to label potentially hot instrument surfaces BIOHAZARD This symbol is used to indicate that certain precautions must be taken when working with potentially infectious material IMPORTANT NOTE...

Страница 45: ...General Overview MagNA Pure Compact Manual book Seite 9 Dienstag 28 Februar 2006 4 16 16...

Страница 46: ...MagNA Pure Compact Operator s Manual Version 1 3 10 A A MagNA Pure Compact Manual book Seite 10 Dienstag 28 Februar 2006 4 16 16...

Страница 47: ...610 mm H 570 mm Weight approx 60 kg Power supply 100 240 V AC 10 Frequency 50 60 Hz 5 Power consumption Max 400 VA Fuses 4 0 AT 2 pieces Heat emission 1440 kJ h max 860 kJ h average value during opera...

Страница 48: ...ndoor use Maximum relative humidity 80 for operating temperatures up to 31 C decreases linearly to 50 for operating temperatures up to 40 C Altitude up to 2000 m Processing capability 1 to 8 samples p...

Страница 49: ...re Compact Instrument is a standalone instrument which needs no additional computer The computer is already included in the instrument housing and and may be operated via a touch screen Standard Compo...

Страница 50: ...es needed for a standard purification run If you need additional tubes e g for an internal control or maintenance activities leakage test you must order them from Sarstedt See the Appendix for detaile...

Страница 51: ...hanging pro cess Please contact your local Roche Diagnostics representative if you need O rings changed or want one of these tools Elution Tubes 35 tubes per package 2 0 ml each with stand with barcod...

Страница 52: ...umidity or extremes of temperature Do not use the instrument where there is a risk of explosion 2 4 2 Easy Teaching Procedure The software has been preinstalled by the manufacturer The installer servi...

Страница 53: ...used for documentation pur poses only and does not influence the purification protocol Action Software Screen Turn on the MagNA Pure Compact Instrument by pressing the Power On button on the front of...

Страница 54: ...inute 59 to minute 0 or vice versa without causing the hour setting to change Touch the Up and Down buttons to the right of each number to change the values for year month and day see figure The Up bu...

Страница 55: ...cation run has ended End of the run If you don t want one of these alarms just select for that particular alarm For each alarm you want choose whether the alarm sound should be given at low medium or...

Страница 56: ...ample material type a new name into the entry field below the material list Select the Add button to add the new name to the Material List The MagNA Pure Compact Instrument is now ready for use Action...

Страница 57: ...ipette head can process 1 8 samples per run In addition this pipette head has a specialized sensor unit which can detect clots in sample material and loss of reaction tips 3 2 Function Principle When...

Страница 58: ...olled by the software This prevents anyone from reaching inside the instrument during the purification which might lead to injuries The door permits a good view of the interior of the instrument Durin...

Страница 59: ...rack with elution tube rack the heating units and the waste tank It moves back and forth horizontally along the y axis thereby moving the cartridge rack with the prefilled reagent cartridges into pos...

Страница 60: ...generated as well as transfer it easily to other instruments or computers e g for sample tracking documentation or trouble shooting In addition new MagNA Pure Compact Purification protocols can be upl...

Страница 61: ...ve forward and backward from the rear of the chamber For separation of magnetic beads from the buffers the magnetic plate moves closer to the reaction tips thereby immobilizing the magnetic beads on t...

Страница 62: ...l before purifi cation starts After it uses them the instrument places the tips back into their original positions on the tip tray for easy disposal 5 Front Door The front door can be opened for maint...

Страница 63: ...PA glass fiber filter Note This HEPA filter retains some aerosols However the MagNA Pure Compact Instrument is not guaranteed to be fully air tight Although the total air flow from the platform goes t...

Страница 64: ...c compartment 3 Main Switch Use the Main Switch to turn the instrument on and off e g in case of an emergency or if the instrument is not in use for longer time periods In routine daily use the instru...

Страница 65: ...l Port The parallel port is intended to be used for the connection with a local printer 8 Serial Port RS232 The serial port might be used for additional external devices for LIMS 9 USB Ports There are...

Страница 66: ...ditional sample tubes capacity 2 0 or 1 5 ml from Sarstedt and place them in row 2 the Internal Control Tube Rack For details see the Related Products section in Chapter C In row 3 primary sample tube...

Страница 67: ...ividual barcode These tubes are provided with the reagent kits The rack has numbered positions 1 8 and can stand upright on e g a bench 4 Drip Tray The Drip Tray keeps any accidentally spilled liquid...

Страница 68: ...ter C for details on emptying the liquid waste tank 6 Drop catcher The drop catcher is carried by the upper side of the magnet unit and is placed directly below the nozzle head each time it moves anyw...

Страница 69: ...e Delta IBM Code 11 CODABLOCK and Code 16K PDF 417 Enhanced Features Puzzle SolverTM data editing and data concatenation Weight approx 200 g Case Material ABS and Polycarbonate Cable Length 2 m 6 1 ft...

Страница 70: ...of 100 C Do not touch the block during and directly after purification If you touch the block it may burn you 2 Housing Biological hazardous material is processed inside the instrument 3 Warning Read...

Страница 71: ...How to Operate the MagNA Pure Compact Instrument MagNA Pure Compact Manual book Seite 35 Dienstag 28 Februar 2006 4 16 16...

Страница 72: ...MagNA Pure Compact Operator s Manual Version 1 3 36 B B MagNA Pure Compact Manual book Seite 36 Dienstag 28 Februar 2006 4 16 16...

Страница 73: ...orma tion button to see a more complete description of the function 1 1 Starting the MagNA Pure Compact Instrument To start the MagNA Pure Compact Instrument push the Power On button on the front of t...

Страница 74: ...automatically perform a self test after a certain period of instrument inactivity You must confirm execution of this self test on a message window Function Test Instrument communication Check for cor...

Страница 75: ...activated at this time 3 Display field for error codes information A short error code is displayed here if an error occurs For an overview about instrument errors please see chapter 4 2 Instrument Err...

Страница 76: ...Information Errors warnings and additional informations are displayed in the display for error codes information To obtain more detailed information about the current software function or about the e...

Страница 77: ...Chapter B Perform the sequence of steps on the Sample Ordering Screens Operator Authorization Sample Ordering 1 Sample Ordering 2 Sample Ordering 3 Sample Ordering 4 available with IC Sample Ordering...

Страница 78: ...elution tubes for downstream application Insert tip trays Insert elution tubes Run the purification protocol Remove disposables Liquid waste handling Instrument ready for next isolation Workflow Inse...

Страница 79: ...ells Avoid touching the two single open wells and do not use them as handles Mix the content of the cartridge wells by turning the whole cartridge upside down several times Avoid any foam formation Le...

Страница 80: ...t Negative Control by using a sample material negative for your target Internal Control by adding a defined amount of a control template e g plasmid DNA to all samples to be purified or by analyzing a...

Страница 81: ...t of any RNA degradation The advantage of using an endogenous IC is that both internal control mRNA and target mRNA is extracted from cells or tissue and reverse transcribed together Commonly used end...

Страница 82: ...e the field b Enter the password c Cancel leeds back to the Main Menu d Confirm your choices by touching the Next button which will be active only if the Operator and Password fields are filled in and...

Страница 83: ...de scanner to scan the barcode of the first prefilled Reagent Cartridge Note In case you experience difficulties in scan ning the barcode try to scan holding the barcode scanner in different angles wi...

Страница 84: ...usly added positions will be dark blue b The name of the appropriate purification kit will also be displayed c Note It is not possible to enter barcodes of the same type catalogue number Barcodes from...

Страница 85: ...s may leed to suboptimal results e g processing performance yield etc optional If you are using an internal control select a control volume from the pull down menu adjacent to the Internal Control Vol...

Страница 86: ...he virtual keyboard Repeat the above sample placement and identification steps for each sample to be purified e g for Sample position 2 3 8 Result As you fill in the Sample ID field for each sample th...

Страница 87: ...e to dark blue installed in instrument Insert the Tube Rack with sample and internal controls into the MagNA Pure Compact Instrument Touch the IC Tubes inserted confirmation button The Next button wil...

Страница 88: ...n will be active Start the purification by touching this button The HEATING Screen will appear displaying the time needed for heating of the heating units When heating is completed the PROCESS Screen...

Страница 89: ...he result by touching the appropriate function buttons icons at the bottom of the RESULT Screen Note If you touch the Save button a pop up window will open to allow you to specify the export format pl...

Страница 90: ...utton Result The Waste Discard Confirmation screen appears Before performing the test do the following in the instrument First remove the Sample and Elution Tube Racks Make sure the Tip Trays are stil...

Страница 91: ...f the Waste Tank is too full overflowing liquid will pour into the Drip Tray However if the overflow is too great liquid waste will flow into into the instrument housing and even onto the lab bench Th...

Страница 92: ...C to prevent corrosion of the instrument stage Always use gloves when you touch the instrument or reagents and observe the instructions on the Material Safety Data Sheet that accompanies the reagents...

Страница 93: ...are created they may be added to the MagNA Pure Compact Instrument via external data carrier disks e g software update disk during program start up Additional protocols will be available for download...

Страница 94: ...MagNA Pure Compact Operator s Manual Version 1 3 68 B B MagNA Pure Compact Manual book Seite 68 Dienstag 28 Februar 2006 4 16 16...

Страница 95: ...Maintenance and Trouble Shooting MagNA Pure Compact Manual book Seite 69 Dienstag 28 Februar 2006 4 16 16...

Страница 96: ...MagNA Pure Compact Operator s Manual Version 1 3 70 C C MagNA Pure Compact Manual book Seite 70 Dienstag 28 Februar 2006 4 16 16...

Страница 97: ...er please contact your local Roche representative As well it is advisable to document there or in the MagNA Pure Software documentation all operators and used reagent kit lot no s in order to be able...

Страница 98: ...eaking and need to be changed change the O rings as described in Section C 1 2 2 perform the Leakage Test again to make sure the new O rings are working correctly are O K do nothing now but repeat the...

Страница 99: ...s in sample position confirmation button Empty tubes in elution position confirmation button Tip trays inserted confirmation button As you touch each confirmation button the symbol on the button chang...

Страница 100: ...Head Watch the water level within the Reaction Tips If the water level remains the same in all tips none of the tips is leaking If you observe different water levels in diffe rent tips or drops of li...

Страница 101: ...e for correctly lubricating the O ring Note We advise checking O ring lubrication periodically and adding small amounts of vacuum grease as needed Never use bleach or ethanol to clean the Nozzle Head...

Страница 102: ...ve or a Leakage Test see above indicates that the O rings are damaged or worn out use the O ring exchange tool to replace them with new ones Description of the O ring Exchange Tool User Maintenance O...

Страница 103: ...screen access the MAIN MENU Screen Touch the Maintenance button Result The MAINTENANCE Screen appears Touch the O Ring Exchange button Result The O RING EXCHANGE Screen appears User Maintenance O ring...

Страница 104: ...usher toward the pin until it is inserted into the groove in the nozzle Move the O ring pusher closer to the pin until it displaces the O ring from the groove Use your thumb to pull down the part of t...

Страница 105: ...way from the nozzle The O ring is now removed from the nozzle Place a new greased O ring on the shaft of the O Ring Exchange Tool Make sure the O ring is well below the pin Insert the pin of the O Rin...

Страница 106: ...to the MAINTENANCE Screen Perform the Leakage Test as described in Section C 1 3 below If Then you have successfully changed the O rings touch the OK button to confirm the O ring exchange the O ring...

Страница 107: ...act your local Roche representant for maintenance assistance and for more details on country specific service contracts During Service Maintenance the Roche service engineer will do the following 1 Ch...

Страница 108: ...layed on the screen To view the current counter and set reminder values you can access the Counter and Reminder Screen via the respective button on the Maintenance Menu Screen Reminder values can chan...

Страница 109: ...moistened with deonized water If a spill of reagents occurs the instrument should be cleaned with a 70 ethanol solu tion or any acceptable PCR laboratory cleaner Turn the instrument power Off and dis...

Страница 110: ...ld be cleaned with a 10 v v bleach solution 0 5 sodium hypochlorite followed by thorough cleaning with 70 ethanol Commercial liquid household bleach typically contains sodium hypochlorite at a concen...

Страница 111: ...ination procedure is finished either return to the MAIN MENU Screen to perform a purification run e g when the decontamination has been run overnight or shut the instrument down For safety reasons it...

Страница 112: ...ou want to trouble shoot an error together with a local Roche representant have these informations ready or make sure the remote service option is enabled The Error Log shows the following information...

Страница 113: ...eat entering of the barcode ID or type in barcode manually If problem persists contact Technical Service The entered kit name coded in the cartridge ID barcode is invalid Repeat entering of the barcod...

Страница 114: ...ists contact Technical Service 3516 Magnet home position sen sor failed Magnet home position sensor malfunction Magnet home position sensor is not working properly Restart system If problem persists c...

Страница 115: ...tube in referenced channel number Check and add sample volume in respective channel if needed Smaller volume than selec ted was detected in the sample tube in referenced channel number Check and add...

Страница 116: ...and was created The save folder did not exist and was created 3561 No Cartridge Ch_X Ordered cartridge was not found A cartridge that was orde red during sample ordering was not found Check stage set...

Страница 117: ...ervice 3583 Temperature timeout error Process aborted due to time out error of heating unit temperatures Process aborted due to timeout error of heating unit temperatures Restart system If problem per...

Страница 118: ...ple ordering 3607 Small Tip missing No small Tip was detected in referenced channel number Check if tip tray has been inserted and contains small tip No small Tip was detected in referenced channel nu...

Страница 119: ...lf test Press OK for retry If that fails restart system If problem persists contact Technical Service 5606 Magnetic sensor failed 5606 Retry _ Internal error regarding magnetic sensor Sensor failed du...

Страница 120: ...s prior to use Degraded nucleic acid Inappropriate storage of samples Use fresh or frozen samples avoid using samples that were stored at room temperature for extended periods of time Incorrect storag...

Страница 121: ...much sample material refer to the respective pack insert of the reagent kit Storage of samples was not optimal Use fresh or frozen samples avoid using samples that were stored at room temperature for...

Страница 122: ...ertain parameters of a purification run You can search for Run ID Sample ID Elution ID Date Lot No or you can call up the data from the previous run by using the Last Run button The runs which are mat...

Страница 123: ...f this run select it on the touch screen and touch the Select but ton The result screen of the respective run will be displayed and can be printed or saved to a disk or LIMS Documentation MagNA Pure C...

Страница 124: ...rights are secured with a password and enable to define additional operators During the administrator authorization the pass word will be displayed hidden to guarantee confidentiality In case you sho...

Страница 125: ...rtion of the respective action performed by the instrument e g purification run Recommended Printer for the Use with MagNA Pure Compact Instrument Hewlett Packard Laserjet 1015 For installation with t...

Страница 126: ...ucleic Acid Isolation Kit I 1 Kit 32 reactions 03 730 964 001 MagNA Pure Compact Nucleic Acid Isolation Kit I Large Volume 1 Kit 32 reactions 03 730 972 001 MagNA Pure Compact RNA Isolation Kit 1 Kit...

Страница 127: ...ube Rack 31 56 Elution Tubes 15 31 56 56 Elution Volume 12 52 Error Codes 40 86 86 Error Log 86 Front Door 22 22 48 Fuse 29 Genomic DNA 14 Global Action Buttons 39 Heating Block 26 26 HEPA filter 27 I...

Страница 128: ...ion Run 41 42 42 60 Reaction Tip 23 25 Reagent Cartridges 14 23 43 48 Result 60 Sample Material 20 54 Sample Ordering 48 48 48 48 66 Sample Tube 14 30 54 Sample Tube Rack 66 Sample Volume 12 52 Screen...

Страница 129: ......

Страница 130: ...www roche applied science com 04555791001 0306 Roche Diagnostics GmbH Roche Applied Science 68298 Mannheim Germany...

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