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GE AKTAprime plus, Operating Instructions Manual

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List of hazardous substances

Hazardous substance

有毒有害物质或元素

Component
name

部件名称

PBDE

多溴二苯醚

PBB

多溴联苯

Cr6+

六价铬

Cd

镉

Hg

汞

Pb

铅

0

0

0

0

X

X

ÄKTAprime plus

1

1

The product has not been tested as per the Chinese standard SJ/T11363-2006 Requirements
for Concentration Limits for Certain Hazardous Substances in Electronic Information Product.

30

ÄKTAprime plus Operating Instructions 28-9597-89 AB

2 Safety instructions

2.5 Declaration of Hazardous Substances (DoHS)

Summary of Contents for AKTAprime plus

Page 1: ...GE Healthcare Life Sciences ÄKTAprime plus Operating Instructions Original instructions ...

Page 2: ......

Page 3: ... 3 4 Connections 32 3 5 Spare parts and accessories 33 4 Operation 33 4 1 Operation overview 33 4 2 Starting the instrument 34 4 3 Preparations before start 39 4 4 Performing a run 41 4 5 Procedures after a run 43 5 Maintenance 43 5 1 General 44 5 2 User maintenance schedule 46 5 3 Cleaning 47 5 4 Component maintenance 47 5 5 Disassembly and assembly of components and consumables 48 5 6 Calibratio...

Page 4: ...57 7 2 Chemical resistance 61 7 3 System recommendations 62 7 4 Health and Safety Declaration Form 64 7 5 Ordering information 65 A Connection diagram Liquid flow path 66 B Tubing 4 ÄKTAprime plus Operating Instructions 28 9597 89 AB Table of Contents ...

Page 5: ...stem works if a computer is used The user must understand the concepts of liquid chromatography The user must read and understand the Safety Instructions in this manual ÄKTAprime plus and software should be installed configured and calibratedaccording to these Operating Instructions About this chapter This chapter contains important user information a description of the intended use of ÄKTAprime p...

Page 6: ...e plus is a compact liquid chromatography system designed for one step pu rification of proteins at laboratory scale ÄKTAprime plus is intended for research use only and shall not be used in any clinical procedures or for diagnostic purposes Safety notices This user documentation contains WARNINGS CAUTIONS and NOTICES concerning the safe use of the product See definitions below Warnings WARNING WA...

Page 7: ...ble free and optimal use of the product Note A tip contains useful information that can improve or optimize your procedures Tip Typographical conventions Software items are identified in the text by bold italic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text by bold text e g Power switch 1 2 Regulatory informat...

Page 8: ...ormity is available on request Title Directive Machinery Directive MD 2006 42 EC Low Voltage Directive LVD 2006 95 EC Electromagnetic Compatibility EMC Directive 2004 108 EC CE marking The CE marking and the corresponding Declaration of Conformity is valid for the instru ment when it is used as a stand alone unit or connected to other CE marked instruments or connected to other products recommende...

Page 9: ...s ment and risk reduction EN ISO 12100 Regulatory compliance of connected equipment Any equipment connected to ÄKTAprime plus should meet the safety requirements of EN 61010 1 IEC 61010 1 or relevant harmonized standards Within the EU connected equipment must be CE marked Environmental conformity Title Requirement Restriction of Hazardous Substances RoHS Directive 2011 65 EU Waste Electrical and E...

Page 10: ...ain parts of the instrument Function Part Function Part Switch valve 10 Fraction collector 1 Conductivity cell 11 Monitor and controller 2 Flow restrictor 12 LCD display 3 UV flow cell 13 Push buttons 4 Column 14 Pump 5 Sample loop 15 Pressure sensor 6 Flow diversion valve 16 Mixer 7 Column holder 17 Injection valve 8 Buffer valve 9 10 ÄKTAprime plus Operating Instructions 28 9597 89 AB 1 Introduc...

Page 11: ...100 120 Powermax 90VA autorange Frequency 50 60Hz SYSTEM NO CODE NO 1 2 3 4 5 6 7 8 9 10 11 Connection No Connection No pH electrode 7 RS 232 to computer 1 Conductivity flow cell 8 Flow diversion valve 2 Optical unit 9 Fraction collector 3 Power switch 10 Measurement data to recorder 4 Mains power inlet 11 On off signals to recorder 5 UV lamp 6 ÄKTAprime plus Operating Instructions 28 9597 89 AB 1...

Page 12: ...mpleted end Stop manual operation Hold method time or volume and the gradient at the cur rent concentration Pump and fraction collector continue uninterrupted hold cont Continue the normal method operation Pause all operation without ending the method All func tions including pump and fraction collector are stopped pause cont Continue the normal method operation Advance the fraction collector one ...

Page 13: ...d manually using a syringe V2 4 From the injection valve the flow is directed to the column and then to the UV Conductivity and optional pH monitor UV C pH 5 From the monitors the flow is directed to the Fraction collector F or the Waste W F W 6 1 4 Monitoring and evaluation PrimeView software PrimeViewis a software that allows real time monitoring evaluationand report generation on an external co...

Page 14: ...ption installation and maintenance ÄKTAprime plus Operating Instructions Detailedsystem description Comprehen sive user instructions method creation operation advanced maintenance and troubleshooting ÄKTAprime plus User Manual Short step by stepinstructions for select ed applications using the prepro grammed method templates System preparation and value table for the method templates ÄKTAprime plu...

Page 15: ...urpose Contents Document A completecontrol software packagefor supervision of ÄKTAprime plus automated liquid chromatogra phy systems PrimeView User Manual Component documentation Documentation for components produced both by GE Healthcare and by a third party are if existent also included in the document package ÄKTAprime plus Operating Instructions 28 9597 89 AB 15 1 Introduction 1 5 User docume...

Page 16: ...d personal injury or damage to the equipment The safety precautions in this section are grouped into the following categories General precautions Using flammable liquids Personal protection Installing and moving the instrument System operation Maintenance General precautions Always follow these General precautions to avoid injury when using the ÄKTAprime plus instrument WARNING Do not operate ÄKTA...

Page 17: ... accessories not supplied or recommended by GE Healthcare WARNING Do not use ÄKTAprime plus if it is not working properly or if it has suffered any damage for example damage to the power cord or its plug damage caused by dropping the equipment damage caused by splashing liquid onto it CAUTION Waste tubes and containers must be secured and sealed to prevent accidental spillage CAUTION Make sure tha...

Page 18: ... be installed when flammable or noxious substances are used Personal protection WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of ÄKTAprime plus system WARNING When using hazardous chemical and biological agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or ...

Page 19: ...r required Personal Protective Equipment PPE at all times Installing and moving the instrument WARNING Supply voltage Make sure that the supply voltage at the wall outlet corresponds to the marking on the instrument before con necting the power cord WARNING Protective ground ÄKTAprime plus must always be connected to a grounded power outlet WARNING Power cord Only use power cords with approved plu...

Page 20: ...tshall comply with IEC 60950 and be installed and used according to the manufacturer s instruc tions NOTICE Disconnect power To prevent equipment damage always discon nect power from the ÄKTAprime plus instrument before an instru ment module is removed or installed or a cable is connected or disconnected System operation WARNING Hazardous chemicals during run When using hazardous chemi cals run Sy...

Page 21: ... CAUTION Hazardous chemicals in UV flow cell Make sure that the entire flow cell has been flushed thoroughly with bacteriostatic solution for example NaOH and distilled water before service and mainte nance NOTICE If the ÄKTAprime plus is kept in a cold room cold cabinet or similar keep the system switched on in order to minimize the risk of con densation The UV lamp can be turned off to save lamp...

Page 22: ...m or column cleaning wash the system or columns with a neutral solution in the last phase or step WARNING Do not perform any type of maintenance work while the system is powered electrically or when the piping system is pressurized Note that the piping system can be pressurized even when the system is closed down WARNING Only spare parts and accessories that are approved or supplied by GE Healthca...

Page 23: ...NING Before disassembly check that there is no pressure in the piping system WARNING Disconnect power Always disconnect power from the instrument before replacing fuses WARNING Decontaminate the equipment before decommissioning to ensure that hazardous residues are removed CAUTION Fire hazard Follow instructions in ÄKTAprime plus Operating Instructions for correct installation of a new UV lamp If ...

Page 24: ...th a soft damp tissue and if necessary a mild cleaning agent Let the instrument dry completely before use 2 2 Labels In this section This section describes the instrument labels and labels concerning hazardous substances that are attached to the ÄKTAprime plus instrument For information about marking of the computer equipment refer to the manufacturer s instructions Labels on the instrument The il...

Page 25: ...d ministration OSHA as meeting the legal requirements of Title 29 of the Code of Federal Regulations 29 CFR Part 1910 7 Labels concerning hazardous substances Meaning Label This symbol indicates that the waste of electrical and electronic equip ment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for ...

Page 26: ... power to the instrument by pressing the Main power switch to the 0 position The run is interrupted immediately 2 Power failure The result of a power failure depends on which unit that is affected will result in Power failure to The run is interrupted immediately in an undefined state The data collected up to the time of the power failure is available in PrimeView ÄKTAprime plus The PrimeView comp...

Page 27: ...mental regulations Recycling of hazardous substances ÄKTAprime plus contains hazardous substances Detailed information is available from your GE Healthcare representative Disposal of electrical components Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for ...

Page 28: ... mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year In order to maintain the declared EFUP the product shall be operated normally according to the instructions and environmental conditions as defined in the product manual and p...

Page 29: ...it Meaning Value Indicates that this toxic or hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in SJ T11363 2006 O 表示该有毒有害物质在该部件所有均质材料中的含量均在SJ T11363 2006 标准规定的限量要 求以下 Indicates that this toxic or hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in SJ T11363 200...

Page 30: ...0 0 X X ÄKTAprime plus 1 1 The product has not been tested as per the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Product 30 ÄKTAprime plus Operating Instructions 28 9597 89 AB 2 Safety instructions 2 5 Declaration of Hazardous Substances DoHS ...

Page 31: ...re Stable laboratory bench e g 120 80 cm Placement 20 to 95 non condensing Humidity 3 2 Transport The equipment can be transported on a trolley capable of supporting at least 20 kg NOTICE Lift the instrument in the upright position Do not use the fraction ation arm as a lifting handle Before moving the system disconnect all cables and tubing connected to peripheral components and liquid containers...

Page 32: ...tallation 3 4 Connections Communication Connect the system according to the electrical drawings in Electrical and communication connections on page 11 Flow path All parts and tubing are mounted on the system at delivery Connect a waste tube buffer and sample bottles and optional accessories Electrical power Connect the power cord to a grounded power outlet specified in Section3 1 Site require ment...

Page 33: ...es after a run 4 See PrimeView user documentation Evaluate the results 5 Liquid flow path See Appendix A Connection diagram Liquid flow path on page 65 for an illustration of the liquid flow path in ÄKTAprime plus 4 2 Starting the instrument If the system is not already turned on 1 Turn on the system using the Power switch at the rear panel The system now per forms a self test 2 First the system n...

Page 34: ... a 0 45 µm filter Purification setup Removing storage solution from the flow path At delivery and during storage the flow path is filled with 20 ethanol This should be removed before continuing the setup Do not use buffer with high salt concentration to flush out the ethanol It might cause too high backpressure Note To flush out the ethanol using deionized water 1 Put the inlet tubing A1 A8 that i...

Page 35: ...e removed by flushing 100 ethanol through the pump These two procedures are described in the following two sections Purging the flow path using the Purge kit 1 Remove the stop plug from the pump 2 Connect the Purge kit to the pump 1 2 3 4 5 6 7 8 9 1 0 m l 3 Put the used inlet tubing in the appropriate buffers 4 Run the pump at 0 1 ml min Filling inlet tubing A1 A8 1 Go to Set Buffer Valve using t...

Page 36: ...the pump for at least 30 s and press pause cont 7 Move inlet tubing A1 to deionized water 8 Press pause cont and run the pump for 1 min 9 Finish by pressing end and then OK Preparing the tubing and column 1 Put inlet tubing A1 in the binding buffer 2 Put inlet tubing B in the elution buffer 3 Put the three waste capillaries brown color from port 4 and 5 on the injection valve and port NO on the fr...

Page 37: ...eight of the delivery arm using the lock knob 1 so that the bottom of the tube sensor 2 is about 5 mm below the top of the tubes The tubes should always be below the horizontal mark on the tube sensor 5 mm 1 2 3 If necessary adjust the length of the tubing exposed according to the sequence shown below the hole in the delivery arm used in step 3 and 4 is only used for ad justing the tubing length 5...

Page 38: ... synchronization is turned on Drop synchronization can NOT be used at flowrates above 3 ml min Note Preparing the monitors 1 Check the UV lamp filter position and the lamp position 2 Calibrate the pH electrode optional See ÄKTAprime plus User Manual for more information Filling the buffer inlet tubing When running an application templates the buffer inlet tubing will automatically be filled with b...

Page 39: ...refully inject the sample into the sample loop Do NOT remove the syringe after the injection because the loop might otherwise be emptied due to self drainage or air may be introduced in the flow path 4 4 Performing a run Selecting template and starting the run 1 Select Templates in the main menu and press OK 2 Select Application Template and press OK 3 Select the appropriate template for example H...

Page 40: ...nstructions and unexpected conditions e g warnings and alarms The log is saved in the result file Selecting curves to be displayed 1 In PrimeView module select View Properties 2 In the Properties dialog click the Curves tab 3 In the Display curves list select the curves you want to display 4 Click OK For more information on customizing the view panes see PrimeView User Manual 40 ÄKTAprime plus Ope...

Page 41: ...uate the results PrimeView Evaluation module provides facilities for the presentation and evaluation of separation results To start PrimeView Evaluation module click PrimeView Evaluation icon on the Windows desktop See ÄKTAprime plus User Manual and PrimeView User Manual for how to evaluate the results 4 5 Procedures after a run Cleaning after a run NOTICE Do not allow solutions which contain diss...

Page 42: ...ample loop volume of deionized water 2 Rinse the sample loop by injecting the water through the fill port on the injection valve 3 Put all used inlet tubings in water 4 In the Templates menu select ApplicationTemplate and then System Wash Method 5 Select the used inlet ports Inlets A1 and B will always be washed 6 Press OK to start the method The system flow path is now automatically flushed For i...

Page 43: ...al and follow the instructions WARNING Electrical shock hazard All repairs should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the user documenta tion WARNING Disconnect power Always disconnect power from the instrument before replacing any component on the instrument unless stated otherwise in the user documentation...

Page 44: ...ctions in ÄKTAprime plus Operating Instructions for correct installation of a new UV lamp If the lamp is not installed properly it may be overheated and cause a fire hazard NOTICE Cleaning Keep the instrument dry and clean Wipe regularly with a soft damp tissue and if necessary a mild cleaning agent Let the instrument dry completely before use 5 2 User maintenance schedule Table 5 1 provides a gui...

Page 45: ...0 05 MPa Check the back pressure as follows 1 Disconnect the flow restrictor 2 Connect a tubing approx 1 m i d 1 mm to the waste port port 5 on the injection valve Set the injection valve manually to Waste position Put the open end in a waste container 3 Run the pump manually at 10 ml min with water Note the back pressure Bp1 on the pump display or in the Run Data window 4 Set the system to Pause ...

Page 46: ...opy the form you need from Section7 4 Health and Safety Declaration Form on page62 or print it from the PDF file available on the User Documentation CD Cleaning In Place All components in the system are designed for ease of CIP After repeated separation cycles contaminating material might progressively build up in the system and on the column This material may not have been removed by the cleaning...

Page 47: ...ce Maintenanceandpreventive replacementof parts of themajorcomponentsare described in the respective manuals included in the system documentation The system documentation also includes a spare part list to be used to find common spare parts and their code numbers for ordering This list can also be found online at www gelifesciences com AKTA 5 5 Disassembly and assembly of components and con sumabl...

Page 48: ...s for descriptions of how to perform these calibrations The calibrations are performed from PrimeView by selecting System Calibrate in System Control How often Component Every day pH monitor if applicable When required Pump if applicable When required Pressure reading Only necessary if specific conductivity with high accuracy is measured Cond_Calib Cell constant Conductivity flow cell Must be done...

Page 49: ... according to their respective instructions Storage conditions The following conditions shall be maintained while the system is in storage Temperature 2 C to 30 C preferably room temperature Relative humidity 0 to 95 non condensing preferably low humidity After storage clean the system calibrate all monitors and perform a leakage test before using the system ÄKTAprime plus Operating Instructions 2...

Page 50: ...bar on top of the mixer housing The stirrer bar should ro tate when the system is in Run mode The mixer function can also be checked by running the installa tion test Incorrect mixer func tion Clean the UV cell by flushing Decon 90 Deconex 11 or equivalent Dirty UV cell Noisy UV signal sig nal drift or instability Check if the signal is still noisy with water Impure buffer Purge the pump according...

Page 51: ...ine drift or noisy signal Tighten the clamps If necessary replace the clamps Leaking tube connec tions Check the mixer function by plac ing a stirrer bar on top of the mixer housing The stirrer bar should ro tate when the system is in Run mode The mixer function can also be checked by running the installa tion test Incorrect mixer func tion Clean the conductivity cell by flushing 1 M NaOH or 20 et...

Page 52: ...n the mixer and start it by starting the pump at a low flow rate You should both hear and feel the mixer motor and stirrer when they are spinning Incorrect motor func tion Check for loose tubing connec tions Use the flow restrictor Air in the flow cell Ghost peaks appear in the gradient profile Wash the tubing and check pump is operating properly Dirty tubing Unlinear gradients or slow response to...

Page 53: ...irrer bar on top of the mixer housing The stirrer bar should rotate when the system is in Run mode The mixer function can also be checked by running the installation test Incorrect mixer func tion 6 3 pH curve problems Corrective action Possible cause Error symptom Check that the electrode cable is connected properly Faulty electrode con nection No response to pH changes The electrode glass membra...

Page 54: ... instruc tions in Monitor pH C 900 User Manual Contaminated elec trode glass mem brane Slow pH response or Calibrationimpossible If the membrane has dried out the electrode may be restored by soaking it in buffer overnight Membrane has dried out 54 ÄKTAprime plus Operating Instructions 28 9597 89 AB 6 Troubleshooting 6 3 pH curve problems ...

Page 55: ...asurements are not possible since dehydration of the membrane will occur It is recom mended that the pH electrode is not used in applications using or ganic solvents Mount the dummy electrode instead Check that the pump and valves operate correctly Incorrect pump or valve operation If air in the flow cell is suspected tap the flow cell carefully or tilt it to remove the air Alternatively flush the...

Page 56: ...tions in ÄKTAprime plus User Manual Clean the valves according to Pump P 920 User Manual Inlet or outlet check valves not functioning correctly Clean the valves according to ÄKTAprime plus User Manual Replace the piston seal according to the instructions in ÄKTAprime plus User Manual Piston seal leaking Flush through to clear blockage Blockage or part blockage of flow path If necessary replace tub...

Page 57: ...cation 530 400 450 mm Dimensions H W D 13 kg Weight 4 C to 40 C Ambient temperature 10 to 95 Relative humidity tolerance non condensing 84 to 106 kPa 840 to 1060 mbar Atmospheric pressure 7 2 Chemical resistance Comments EEC no CAS no Exposure up to 2 months Exposure 1 day Chemical OK OK Acetaldehyde OK OK Acetic acid 5 200 580 7 64 19 7 OK OK Acetic acid 70 FFKM PP and PE swell 200 835 2 75 05 8 ...

Page 58: ...ol 249 576 7 29340 81 6 OK OK Citric acid Kalrez CTFE PP and PE are affected by long term use Avoid OK Chloroform OK OK Cyclohexane OK OK Detergents PVDF is affected by long term use 200 664 3 67 68 5 Avoid Avoid Dimethyl sulphox ide ETFE PP PE and PVDF are affected by long term use Avoid Avoid 1 4 Dioxane 200 837 3 75 08 1 OK OK Ethanol 100 Silicone not resis tant Pressure limit for PEEK decrease...

Page 59: ...m use Avoid OK Hydrochloric acid 0 1 M 200 661 7 67 63 0 OK OK Isopropanol 100 200 659 6 74 93 1 OK OK Methanol 100 Silicone not resis tant Avoid OK Nitric acid diluted Elgiloy is affected by long term use Avoid Avoid Nitric acid 30 Titanium alumini um oxide and glass are affected by long term use 231 633 2 7664 38 2 Avoid OK Phosphoric acid 10 209 529 3 584 08 7 OK OK Potassium carbon ate 231 211...

Page 60: ...d by long term use Avoid OK Sulphuricacid dilut ed Avoid Avoid Sulphuric acid mediumconcentra tion Silicone PP and PE are not resistant Avoid Avoid Tetrachloroethy lene ETFE CTFE PP and PE are not resistant Avoid Avoid Tetrahydrofuran Pressure limit for PEEK decreases Avoid OK Toluene 200 927 2 76 03 9 OK OK Trichloroacetic acid 1 200 929 3 176 05 1 OK OK Trifluoroacetic acid 1 200 315 5 57 13 6 O...

Page 61: ...s Refer to ÄKTAprime plus User Manual or contact your local GE Healthcare representative for the most current information ÄKTAprime plus Operating Instructions 28 9597 89 AB 61 7 Reference information 7 3 System recommendations ...

Page 62: ...her suitable survey Adequate space and clearance is provided to allow safe access for instrument service repair or installation In some cases this may require customer to move equipment from normal operating location prior to GE arrival Consumables such as columns or gels have been removed or isolated from the instrument and from any area that may impede access to the instrument All buffer waste v...

Page 63: ...pital letters Company or institution Position or job title Date Year month date 200000 00000 00000 GE imagination at work and GE monogram are trademarks of General Electric Company GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA 2010 12 General Electric Company All rights reserved First published April 2010 28 9800 27 AB 05 2012 Return authorization ...

Page 64: ...7 5 Ordering information For ordering information visit www gelifesciences com AKTA 64 ÄKTAprime plus Operating Instructions 28 9597 89 AB 7 Reference information 7 5 Ordering information ...

Page 65: ... UV pH 1100 G1 87 G2 98 1 2 3 4 5 6 7 8 10 9 11 12 13 14 Description No Description No Loop 500 μl 8 Buffers 1 Waste 9 Buffer valve 2 Column 10 Gradient switch valve 3 Male Male 11 System pump 4 Flow restrictor 0 2 MPa 12 Pressure monitor 5 Flow diversion valve 13 Stop plug 6 Fraction collector 14 Mixer 7 ÄKTAprime plus Operating Instructions 28 9597 89 AB 65 A Connection diagram Liquid flow path ...

Page 66: ... 2 9 170 FEP A Inlet A1 8 2 103 2 9 1250 FEP B Inlet A2 1 0 103 1 6 510 FEP AB Switch valve Pump A3 66 0 75 150 PEEK G1 Pump Pressure monitor 53 0 75 120 PEEK G2 Pressure monitor Mixer 133 0 75 300 PEEK G3 Mixer Valve 287 0 75 650 PEEK G4 Valve UV Column 110 0 75 250 PEEK G5 UV Cond 7 0 50 38 PEEK Union 1 16 male 1 16 male Cond Flow restrictor 243 0 75 550 PEEK G6 Flow restrictor Frac coll 181 0 7...

Page 67: ......

Page 68: ...13 General Electric Company All rights reserved First published Aug 2009 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare repre sentative for the most current information GE Healthcare Europe GmbH Munzinger Strasse 5 D 7911...

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