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Manufacturing information

The table below summarizes the required manufacturing information. For further infor-
mation, see the EU Declaration of Conformity (DoC) document.

Content

Requirement

GE Healthcare Bio-Sciences AB,

Name and address of manufacturer

Björkgatan 30, SE 751 84 Uppsala, Sweden

Conformity with EU Directives

This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.

Title

Directive

Machinery Directive (MD)

2006/42/EC

Electromagnetic Compatibility (EMC) Directive

2004/108/EC

Low Voltage Directive (LVD)

2006/95/EC

CE marking

The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:

•

used as a stand-alone unit, or

•

connected to other products recommended or described in the user documentation,
and

•

used in the same state as it was delivered from GE, except for alterations described
in the user documentation.

ÄKTAprime plus Operating Instructions 28-9597-89 AC

1 Introduction

1.2 Regulatory information

Содержание AKTAprime plus

Страница 1: ...ÄKTAprime plus Operating Instructions Original instructions ...

Страница 2: ...3 4 Connections 31 3 5 Spare parts and accessories 32 4 Operation 32 4 1 Operation overview 32 4 2 Starting the instrument 33 4 3 Preparations before start 38 4 4 Performing a run 40 4 5 Procedures after a run 42 5 Maintenance 42 5 1 General 43 5 2 User maintenance schedule 45 5 3 Cleaning 46 5 4 Component maintenance 46 5 5 Disassembly and assembly of components and consumables 47 5 6 Calibration...

Страница 3: ...emical resistance 60 7 3 System recommendations 61 7 4 Health and Safety Declaration Form 63 7 5 Ordering information 64 Appendix A Connection diagram Liquid flow path 65 Appendix B Tubing ÄKTAprime plus Operating Instructions 28 9597 89 AC 3 Table of Contents ...

Страница 4: ...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...

Страница 5: ... 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 WARNING ...

Страница 6: ...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...

Страница 7: ...rresponding harmonized standards Title Directive Machinery Directive MD 2006 42 EC Electromagnetic Compatibility EMC Directive 2004 108 EC Low Voltage Directive LVD 2006 95 EC CE marking The CE marking and the corresponding EU Declaration of Conformity is valid for the in strument when it is used as a stand alone unit or connected to other products recommended or described in the user documentatio...

Страница 8: ...utioned that any changes or modifications not expressly approved by GE could void the user s authority to operate the equipment Note This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to part 15 of the FCC Rules These limits are designed to provide rea sonable protection against harmful interference when the equipment is operated in a commercia...

Страница 9: ...ation Products China Restriction of Hazardous Sub stances RoHS ACPEIP Registration Evaluation Authorization and restriction of CHemicals REACH Regulation EC No 1907 2006 1 3 Instrument Product description ÄKTAprime plus is a compact liquid chromatography system designed for one step pu rification of proteins at laboratory scale 1 2 3 4 5 6 7 8 9 10 17 16 15 14 13 12 11 Figure 1 1 The main parts of...

Страница 10: ...Power switch is located at the rear of the system Electrical and communication connections l 0 l 0 Drop Sensor Frac Valve RS 232 Recorder Rec On off pH Ground pH Probe Conductivity Flow Cell UV UV lamp Mains Voltage 220 240V 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 c...

Страница 11: ...pecific menu option or Enter a menu OK Return one menu level Esc Interrupt method operation before the run is completed 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 fr...

Страница 12: ...to pull liquid from buffer container B SW B 2 The mixer M mixes the buffers M 3 Sample is applied from the sample loop connected to injection valve V2 that has been previously filled 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 collec...

Страница 13: ... containing detailed specifications and traceability documents Themostimportantdocumentsinthedocumentpackagewithregardtotechnicalaspects of ÄKTAprime plus are System specific documentation Content User documentation All instructions needed to operate the in strument in a safe way including brief system description installation and maintenance ÄKTAprime plus Operating Instructions Detailedsystem de...

Страница 14: ...on Together with each system the following software documentation is supplied providing additional information that applies to ÄKTAprime plus independent of the specific configuration Purpose Contents Document A completecontrol software packagefor supervision of ÄKTAprime plus automated liquid chromatogra phy systems PrimeView User Manual Component documentation Documentation for components produc...

Страница 15: ...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...

Страница 16: ...e any accessories not supplied or recommended by GE 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 that the ...

Страница 17: ... 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 ...

Страница 18: ... and other 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 ÄKTAprime plus must always be connected to a grounded power outlet WARNING Power cord Only use power cords with approved plugs delive...

Страница 19: ...Any computerused with the equipmentshall 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...

Страница 20: ... 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...

Страница 21: ...system 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 may...

Страница 22: ...missioning 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 the lamp is not installed properly it may be overheated and cause a fire hazard CAUTION The system uses high intensity ultra violet light Do not remove the UV lamp while the system is running Before replacing a UV lam...

Страница 23: ...rument 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 illustration below shows an example of the identification label that is attached to ÄKTAprime plus ÄKTAprime plus Operating Instructions 28 9597 89 AC 23 2 Safety ins...

Страница 24: ...ed Testing Laboratory NRTL NRTL means an organization which is recognized by the US Occupational Safety and Health Administration 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 mu...

Страница 25: ...Step To pause the run without ending the method press the Pause button located at the instrument front 1 If required switch off 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 und...

Страница 26: ...nvironmental regulations Recycling of hazardous substances ÄKTAprime plus contains hazardous substances Detailed information is available from your GE 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 infor...

Страница 27: ...eriod EFUP which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating con ditions 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 main...

Страница 28: ...所列数据为发布时所能获得的最佳信息 0 Indicates that this toxic or hazardous substance contained in all of the homogeneous ma terials for this part is below the limit requirement in SJ T11363 2006 X Indicates that this toxic or hazardous substance contained in at least one of the homoge neous materials used for this part is above the limit requirement in SJ T11363 2006 Data listed in the table represents best infor...

Страница 29: ...ts Requirement Parameter Indoor use Operation site Maximum 2000 m Altitude Stable laboratory bench e g 120 80 cm Placement 100 120 220 240 V AC 10 50 60 Hz Electrical power Overvoltage category II Transient overvoltages 4 C to 40 C Ambient temperature 20 to 95 non condensing Humidity 84 to 106 kPa 840 to 1060 mbar Atmospheric pressure 2 Pollution degree WARNING Do not block the ventilation inlets ...

Страница 30: ...king Check for damage Check the equipment for damage before starting assembly and installation There are no loose parts in the transport box All parts are either mounted on the system or located in the accessory kit box If any damage is found document the damage and contact your local GE representative Unpack the system Remove straps and packing material Then set the equipment upright before start...

Страница 31: ...s Electrical power Connect the power cord to a grounded power outlet specified in Section 3 1 Site require ments on page 29 3 5 Spare parts and accessories For correct up to date information on spare parts and accessories visit www gelifesciences com AKTA ÄKTAprime plus Operating Instructions 28 9597 89 AC 31 3 Installation 3 4 Connections ...

Страница 32: ...dures 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 64 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 syste...

Страница 33: ... 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...

Страница 34: ...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...

Страница 35: ...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...

Страница 36: ...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...

Страница 37: ... 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...

Страница 38: ...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...

Страница 39: ...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 ÄKTAprime plus Operat...

Страница 40: ...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...

Страница 41: ...mple 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 in...

Страница 42: ...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...

Страница 43: ...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...

Страница 44: ...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 ...

Страница 45: ...y Copy the form you need from Section 7 4 Health and Safety Declaration Form on page61 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 clea...

Страница 46: ...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...

Страница 47: ...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...

Страница 48: ... 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 48 ÄKTAprime plus Operating Instruction...

Страница 49: ...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...

Страница 50: ...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...

Страница 51: ...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...

Страница 52: ...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...

Страница 53: ... 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 ÄKTAprime plus Operating Instructions 28 9597 89 AC 53 6 Troubleshooting 6 3 pH curve problems ...

Страница 54: ...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...

Страница 55: ...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...

Страница 56: ...A Power consumption T 1 0 AH 250 V AC approved type not replaceable by the user Fuse specification 530 400 450 mm Dimensions H W D 13 kg Weight Maximum 2000 m Altitude 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 80 dB A Noise level 1 The instrument switches automatically to the input voltage supplied within...

Страница 57: ...125 02 9 OK OK Ammonium chlo ride OK OK Ammonium bicar bonate OK OK Ammonium nitrate 231 984 1 7783 20 2 OK OK Ammonium sul phate OK OK 1 Butanol OK OK 2 Butanol 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...

Страница 58: ... Hexane Silicone not resis tant 231 595 7 7647 01 0 OK OK Hydrochloric acid 0 1 M Silicone not resis tant Titanium is af fected by long term 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 an...

Страница 59: ...1310 73 2 Avoid OK Sodium hydroxide 2 M 231 820 9 7757 82 6 OK OK Sodium sulphate PEEK and titanium are affected 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...

Страница 60: ...and PE are af fected by long term use Avoid OK o Xylene and p Xy lene 7 3 System recommendations Refer to ÄKTAprime plus User Manual or contact your local GE representative for the most current information 60 ÄKTAprime plus Operating Instructions 28 9597 89 AC 7 Reference information 7 2 Chemical resistance ...

Страница 61: ...ed en removed fr above has bee onnel and our c ce Engineer st e Service Engi may lead to de swer Yes or ers in box belo ous substance scanner surfac ument is clean ed to allow saf re customer to have been rem e instrument from the area Seria en cleaned to Comp Date GE and GE GE Healthc NJ 08855 1 2010 14 On Site Safety customers all arts a repair T neer upon arr lays in servicin No ow es ces or ot...

Страница 62: ...ease specify service retu e system equ Wate Ethan None Argo Liqui lease d above has b ervice numbe er service Healt for Pr and or Service Ticket nel our custom aminants befo with your retu cing or return return to GE m d additional cl n in contact wi ces please sp y rn Please pro uipment er nol e empty n Helium Nit d Nitrogen Seria been cleaned t Comp instit Date er GE and GE GE Healthc NJ 08855 1...

Страница 63: ...7 5 Ordering information For ordering information visit www gelifesciences com AKTA ÄKTAprime plus Operating Instructions 28 9597 89 AC 63 7 Reference information 7 5 Ordering information ...

Страница 64: ... 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 64 ÄKTAprime plus Operating Instructions 28 9597 89 AC A Connection diagram Liquid flow path ...

Страница 65: ...3 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 ...

Страница 66: ...e on request PrimeView 2011 2015 General Electric Company 2009 2015 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...

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