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1.3

Regulatory information

Introduction

This section lists the regulations and standards that apply to the ÄKTA pure instrument.

Manufacturing information

The table below summarizes the required manufacturing information.

Information

Requirement

GE Healthcare Bio-Sciences AB,

Name and address of manufacturer

Björkgatan 30, SE 751 84 Uppsala, Sweden

In this section

See page

Section

9

1.3.1 EU Directives

10

1.3.2 Eurasian Customs Union

11

1.3.3 Regulations for USA and Canada

12

1.3.4 Other regulations and standards

8

ÄKTA pure Operating Instructions 29022997 AF

1 Introduction

1.3 Regulatory information

Summary of Contents for AKTApure

Page 1: ...KTA pure Operating Instructions Original instructions...

Page 2: ...UNICORN software overview 53 3 2 2 The System Control module 55 4 Installation 56 4 1 Site preparation 57 4 1 1 Delivery and storage 59 4 1 2 Room requirements 62 4 1 3 Site environment 64 4 1 4 Powe...

Page 3: ...t 122 6 2 Applying the sample 125 6 3 Start a method run 127 6 4 Monitor the run 128 6 5 After run procedures 132 7 Maintenance 135 8 Reference information 136 8 1 System specifications 139 8 2 Chemic...

Page 4: ...on intended use of the KTA pure system and lists of associated documen tation In this chapter This chapter contains the following sections See page Section 5 1 1 About this manual 6 1 2 Important user...

Page 5: ...ments using previously created methods in UNICORN software 6 3 2 and later Typographical conventions Software items are identified in the text by bold italic text A colon separates items in a group fo...

Page 6: ...s for re search purposes It is intended to be used by trained laboratory staff members in research laboratories at departments within academia and industry KTA pure shall not be used in any clinical p...

Page 7: ...zardous situation which if not avoided could result in minor or moderate injury It is important not to pro ceed until all stated conditions are met and clearly understood NOTICE NOTICE indicates instr...

Page 8: ...turing information Information Requirement GE Healthcare Bio Sciences AB Name and address of manufacturer Bj rkgatan 30 SE 751 84 Uppsala Sweden In this section See page Section 9 1 3 1 EU Directives...

Page 9: ...ty EMC Directive 2014 30 EU Low Voltage Directive LVD 2014 35 EU Restriction of Hazardous Substances RoHS Directive 2011 65 EU Radio Equipment Directive RED 2014 53 EU CE marking The CE marking and th...

Page 10: ...formation Requirement See Manufacturing information Name and address of manufacturer Telephone 46 771 400 600 Telephone number of manufacturer GE Healthcare LLC Importer and or company for obtain ing...

Page 11: ...pressly 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...

Page 12: ...se EMC requirements Part 1 General re quirements EN 61326 1 Emission according to CISPR 11 Group 1 class A Industrial Scientific and Medical ISM Radio Frequency Generators Canada ICES 001 NMB 001 Elec...

Page 13: ...r use in residential environments and may not provide adequate protection to radio reception in such environments KTA pure Operating Instructions 29022997 AF 13 1 Introduction 1 3 Regulatory informati...

Page 14: ...he system including Fraction collectors Descriptions of compo nents Information about how to run and maintain the system KTA pure User Manual 29119969 System specification and declaration of mate rial...

Page 15: ...Evaluation Classic module in UNICORN Description of the evaluation algorithms used in UNICORN UNICORN Evaluation Manual1 Overview and detailed description of the system control features in UNICORN In...

Page 16: ...actical tips on chromatography refer to KTA Laboratory scale Chromatography Systems Instrument Management Handbook product code 29010831 16 KTA pure Operating Instructions 29022997 AF 1 Introduction 1...

Page 17: ...ibes emergency and recovery procedures and provides recycling information In this chapter This chapter contains the following sections See page Section 18 2 1 Safety precautions 28 2 2 Labels 31 2 3 E...

Page 18: ...neral precautions Personal protection Flammable liquids and explosive environment Installing and moving the system System operation Maintenance General precautions WARNING Do not operate the product i...

Page 19: ...r similar keep it switched on in order to avoid condensa tion Personal protection WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of this product WARN...

Page 20: ...biological agents The facility must comply with the national code of practice for biosafety WARNING High pressure The product operates under high pressure Wear protective glasses and other required Pe...

Page 21: ...for 25 ml min systems and beige for 150 ml min systems Set the System pressure alarm to 10 MPa for 25 ml min systems Installing and moving the instrument WARNING Protective ground The product must alw...

Page 22: ...and other objects away from the vents of the in strument NOTICE Disconnect power To prevent equipment damage always discon nect the power from the product before an instrument module is removed or ins...

Page 23: ...en bottles and cassettes Always fasten bottles and cassettes to the rails at the front and side panel Use appropriate holders for bottles Shattered glass from falling bottles may cause injury Spilled...

Page 24: ...t the waste tubing is inserted in an appropriate waste container and secured in place CAUTION Avoid spillage and overflow Make sure that the waste tubing is inserted in an appropriate waste container...

Page 25: ...nd keep the cold cabinet open to avoid overheating NOTICE Place the computer in room temperature If the KTA pure instru ment is placed in a cold room use a cold room compatible comput er or place the...

Page 26: ...n to make sure that any hazardous solvents and biological agents have been flushed out from the system CAUTION The system uses high intensity ultra violet light that is harmful to the eyes Before chan...

Page 27: ...e using a cleaning agent so that no hazardous solvents or biological agents remain on the surface Perform a system CIP using a neutral solution Make sure that any hazardous solvents or biological agen...

Page 28: ...trument is printed on the instrument labels located on the back of the instrument and below the pump tray on the front of the instrument Rating label The rating label is located on the back of the ins...

Page 29: ...at the supply voltage at the wall outlet corresponds to the marking on the instrument This symbol indicates that electrical and electronic equipment must not be disposed of as unsorted municipal waste...

Page 30: ...that this product complies with the Canadian standard ICES 001 concerning technical require ments relative to radiated noise emissions from Industrial Sci entific and Medical radio frequency generato...

Page 31: ...cy situation stop the run by either pausing the run or switching off the instrument as described below then If you want to press the Pause button on the Instrument control panel Note The buttons on th...

Page 32: ...f switching off the power switch off the instrument Power failure The result of a power failure depends on which unit is affected will result in Power failure to The run is interrupted immediately The...

Page 33: ...emporary overload of the processor and display an error message This may appear as a computer failure The run continues and you can restart the UNICORN client to regain control No data will be lost Co...

Page 34: ...tem on page 88 Uninterruptible power supply UPS A UPS can prevent data loss during a power failure and allow time for a controlled shut down of KTA pure For UPS power requirements see the system speci...

Page 35: ...ated and recycled according to national and local environmental regulations CAUTION Always use appropriate personal protective equipment when de commissioning the equipment Disposal of electrical comp...

Page 36: ...ditions so that the use of such electrical and electronic products will not result in any severe environmen tal pollution any bodily injury or damage to any assets The unit of the period is Year In or...

Page 37: ...46697 0 GB T26572 X GB T 26572 0 Indicates that this hazardous substance contained in all of the homogeneous materials for this part is below the limit requirement in GB T 26572 X Indicates that this...

Page 38: ...In this chapter This chapter contains the following sections See page Section 39 3 1 KTA pure instrument overview 50 3 2 UNICORN software Illustration of the system The illustration below shows the KT...

Page 39: ...f the instrument and the computer on the right side of the instru ment Core module configurations KTA pure is available with two core module configurations one for flow rates up to 25 ml min and one f...

Page 40: ...the location of the main parts of the instrument 1 2 4 3 5 6 Function Part Wet sides 1 Buffer tray 2 Holder rails 3 Instrument control panel 4 Power switch 5 Ventilation panel 6 40 KTA pure Operating...

Page 41: ...s of the modules and parts shown in the illustration below 1 2 4 3 5 6 7 8 9 10 11 Function Part Inlet valve 1 Pump rinsing liquid tube 2 System pump B 3 Pressure monitor 4 System pump A 5 Mixer 6 Out...

Page 42: ...alve type should be used The narrow channels in the valves for KTA pure 25 will give too high back pressure if used above 50 ml min The larger volumes in the H valves for KTA pure 150 may decrease res...

Page 43: ...F9 R E9 E9 I O box S9H S9 Sample pump Core modules Core modules need to be installed for the system to run Description Core module A high precision pump which delivers buffer or sample in purification...

Page 44: ...dules The following modules may be added to the flow path Description Module Option Inlet valve with seven inlets Inlet valve V9 IA or V9H IA Inlet valve Inlet valve with seven inlets Inlet valve V9 I...

Page 45: ...at the fixed wavelength 280 nm UV monitor U9 L UV monitor Measures the UV Vis absorbance at three wavelengths in the range of 190 700 nm UV monitor U9 M Measures the conductivity of buffers and eluted...

Page 46: ...1 2 3 4 Function Part Power Communication indicator white 1 Continue button with a green light indicator 2 Pause button with an orange light indicator 3 Alarm and error indicator red 4 Status indicat...

Page 47: ...The Power Communication in dicator flashes slowly Power on The system is starting up Connecting The Power Communication in dicator flashes quickly Connecting The instrument is ready to use Ready The...

Page 48: ...onization is ongoing Wash The Power Communication in dicator displays a constant light and the Continuebuttonflashes slowly A run has been put on hold Hold A run has been paused Pause Both the Power C...

Page 49: ...ant light and the Alarm and error indica tor flashes The system is in power saving mode Power save The Power Communication in dicatordisplaysa pulsatinglight A module is being re pro grammed to be com...

Page 50: ...learn more about System Control and the other three modules Administration Method Editor and Evaluation see the UNICORN documentation package In this section See page Section 51 3 2 1 UNICORN softwar...

Page 51: ...one or a combination of Method Editor Predefined methods with built in application support Drag and drop functionto buildmethodswithrelevant steps Line by line text editing The interface provides easy...

Page 52: ...d Evaluation Classic it is possible to access descriptions of the active window by pressing the F1 key This can be especially helpful when editing methods 52 KTA pure Operating Instructions 29022997 A...

Page 53: ...rent data in numerical values The Chromatogram pane 2 illustrates data as curves during the entire run The current flow path is illustrated in the Process Picture 3 which allows manual inter actions w...

Page 54: ...the method run while current flow rate and valve positions are sustained End Permanently ends the method run Continue Resumes for ex ample a held or paused method run ConnecttoSystems Opens the Connec...

Page 55: ...re Read the entire Installation chapter before starting to install KTA pure In this chapter This chapter contains the following sections See page Section 56 4 1 Site preparation 68 4 2 Hardware instal...

Page 56: ...the installation The performance specifications of the system can be met only if the laboratory environ ment fulfills the requirements stated in this chapter In this section See page Section 57 4 1 1...

Page 57: ...receive the delivery Record on the receiving documents if there is any apparent damage on the delivery box Inform your GE representative of such damage Move the delivery box to a protected location in...

Page 58: ...umidity at 40 C for 48 hrs Relative humidity Equipment for transportation The following equipment is recommended for handling the delivery boxes Specifications Equipment Suitable for a lightweight pal...

Page 59: ...ch and power cord The power switch must always be easy to access The power cord with plug must always be easy to disconnect CAUTION Explosion hazard To avoid building up an explosive atmosphere when u...

Page 60: ...32 cm 60 cm The illustration below shows the space recommended for KTA pure with Fraction col lector F9 C 39 cm 60 cm 63 cm 54 cm Min 10 cm 80 cm There must be at least 10 cm free space on all sides...

Page 61: ...KTA pure see table below Equipment dimensions 630 mm 470 mm 535 mm Equipment weight Weight Item up to 53 kg KTA pure instrument approximately 9 kg Computer approximately 3 kg Monitor KTA pure Operati...

Page 62: ...pecifications Environmental requirements Requirement Parameter Indoor use only Allowed location 4 C to 35 C Ambient temperature operation 25 C to 60 C Ambient temperature storage 20 to 95 noncondensin...

Page 63: ...W Computer incl monitor and printer Refer to manufacturer s instructions for more information Typically 600 W Total Maximum 900 W KTA pure Operating Instructions 29022997 AF 63 4 Installation 4 1 Site...

Page 64: ...tate Ready 25 VA in state Power save 1100 VA Max power consump tion 1 socket per instrument up to 3 sockets for computer equipment Number of sockets EU or US plugs Grounded mains sockets fused or prot...

Page 65: ...Intel Dual Core or faster Intel Dual Core or faster Intel Dual Core or faster Architecture Note UNICORN is tested using the English U S Code 1033 operating system language version Using other language...

Page 66: ...interface to be scaled The interface scale must remain at 100 to avoid issues with clipping and misaligning of parts of the UNICORN user interface Normally the scale is set at 100 by default 66 KTA p...

Page 67: ...Fraction collector test and system test 1 liter Distilled water System test 0 5 liter 1 acetone and 1 M NaCl in distilled water Priming of the pump piston rinsing system 200 ml 20 ethanol Laboratory e...

Page 68: ...and power cord with plug Do not block access to the power switch and power cord The power switch must always be easy to access The power cord with plug must always be easy to disconnect In this sectio...

Page 69: ...See page Section 86 4 2 6 Start the instrument and the computer KTA pure Operating Instructions 29022997 AF 69 4 Installation 4 2 Hardware installation...

Page 70: ...rsons when moving the instrument All lifting and moving must be performed in accordance with local regulations Lift the instrument onto the bench by hand Follow the instruction below to remove the tra...

Page 71: ...contents in the Buffer tray and lift off the packages from the tray 3 Lift off the cardboard hood and remove the protecting material from the instrument 4 KTA pure Operating Instructions 29022997 AF...

Page 72: ...ft off the tray on the wet side on the front of the instrument to access the instrument handles 5 72 KTA pure Operating Instructions 29022997 AF 4 Installation 4 2 Hardware installation 4 2 1 Unpack t...

Page 73: ...o or more persons and grip the instrument from the front from the back or from either side only one side is shown below 6 KTA pure Operating Instructions 29022997 AF 73 4 Installation 4 2 Hardware ins...

Page 74: ...ordance with local regulations 8 The instrument flow path is filled with 50 ethanol at delivery Note Accessories packages The illustrationbelow shows the accessoriespackagesplaced in the Buffer tray a...

Page 75: ...KTA pure Operating Instructions 2 DVD packages with Instrument Configuration software and manuals 3 KTA pure Operating Instructions 29022997 AF 75 4 Installation 4 2 Hardware installation 4 2 1 Unpac...

Page 76: ...lling Unpack and install the computer according to the manufacturer s instructions NOTICE Any computer used with the equipment must comply with IEC 60950 and be installed and used according to the man...

Page 77: ...computer and the KTA pure instrument WARNING Power cord Only use power cords with approved plugs delivered or approved by GE WARNING Supply voltage Before connecting the power cord make sure that the...

Page 78: ...e KTA pure instrument Action Step Select the correct power cord to be used Each instrument is delivered with 2 alternative power cords 1 Power cord with US plug 2 m Power cord with EU plug 2 m Discard...

Page 79: ...uter network card 1 The illustration below shows the symbol of the network connector If the computer is to be connected to an external network connect a network cable between the main network card of...

Page 80: ...er tray Buffer tray Rescue drainage Prepare waste tubing Follow the instructions below to prepare the waste tubing CAUTION Fasten the waste tubing During operation at high pressure the KTA pure instru...

Page 81: ...fastened to the KTA pure instrument 2 Fasten waste tubing from the valves with the clips on the front of the system Fasten waste tubing from the Buffer tray with the clips on the rear of the system K...

Page 82: ...liquid during the run 3 Note If the tubing is too short replace it with new tubing Do not lengthen the tubing as this might cause obstruction of the tubing Fasten all waste tubing securely to the was...

Page 83: ...mechanism of the pump The illustration below shows the parts and tubing of the pump piston rinsing system 1 2 3 4 5 Description Part Pump rinsing liquid tube holder top 1 Pump rinsing liquid tube 2 Pu...

Page 84: ...l 2 Place the pump rinsing liquid tube back in the holder 3 Insert the inlet tubing to the system pump piston rinsing system into the fluid in the rinsing solution tube Note Make sure that the inlet t...

Page 85: ...the outlet tubing into the fluid in the rinsing solution tube 7 Fill the rinsing solution tube so that the tube contains 50 ml of 20 ethanol 8 KTA pure Operating Instructions 29022997 AF 85 4 Installa...

Page 86: ...ter Action Step Switch on the instrument by pressing the power switch to the I position 1 Result The instrument starts and the Instrument control panel displays a white slowly flashing light Turn on t...

Page 87: ...in the Administration and Technical Manual Software installations You can install UNICORN in one of the following configurations as a complete UNICORN installation on a stand alone workstation full in...

Page 88: ...ation and Technical Manual Start UNICORN and log on Follow the instructions to start UNICORN and log on to the program A valid e license must be available for the workstation See Administration and Te...

Page 89: ...nd enter a network ID in the User Name field click OK Result The selected UNICORN modules open Connect to system Follow the instructions to connect the instrument to UNICORN The system must have been...

Page 90: ...box 2 Select a system check box Click Control for that system Click OK Result The selected instrument can now be controlled by the software Tip If UNICORN is unable to connect to the selected instrum...

Page 91: ...pump B 2 Validate purge of System pump B 3 Purge System pump A 4 Validate purge of System pump A 5 End the run 6 The procedures for purging the pump heads and priming the inlets using the Process Pic...

Page 92: ...the selected port Connect a 25 to 30 ml syringe to the purge valve of one of the pump heads of the pump that is being prepared Make sure that the syringe fits tightly into the purge connector 4 Open t...

Page 93: ...hat the piece of waste tubing connected to the Injection valve port W1 is placed in a waste vessel 1 In the Process Picture 2 Click on the Injection valve and select System pump waste Result The Injec...

Page 94: ...ump B is active In the Process Picture 4 Click on the buffer inlets Select the position of one of the inlets that will be used at the beginning of the run Result The inlet valve switches to the select...

Page 95: ...of System pump B Make sure that the syringe fits tightly into the purge con nector 6 Open the purge valve by turning it counter clockwise about three quarters of a turn Draw a small volume of liquid s...

Page 96: ...of pump B Follow the instructions below to check that there is no air left in the pump after performing a purge Action Step In the Process Picture 1 Click on the Injection valve and select Manual load...

Page 97: ...pump heads of System pump A by following the same procedure as in Purge System pump B on page 93 but replace step 3 with the following actions In the Process Picture Click on the pumps Set Conc B to...

Page 98: ...End the run Click the End button in the System Control toolbar to end the run 98 KTA pure Operating Instructions 29022997 AF 4 Installation 4 5 Prime inlets and purge pump heads...

Page 99: ...A pure instrument into use run a performance test to check the function of the equipment See the purifcation instrument User manual for further instruc tions KTA pure Operating Instructions 29022997 A...

Page 100: ...connected and in state Ready Follow the instructions below to activate Power save Action Step In the System Control module on the System menu click Settings 1 Result The System Settings dialog opens...

Page 101: ...damage caused by dropping the equipment damage caused by splashing liquid onto it WARNING Always use appropriate Personal Protective Equipment PPE during operation and maintenance of this product WARN...

Page 102: ...entilation meets the local requirements In this chapter This chapter contains the following sections See page Section 103 5 1 Before you prepare the system 104 5 2 Prepare the flow path 108 5 3 Prime...

Page 103: ...to use which column position to use which buffers and samples to prepare which sample application technique to use that the pH electrode is connected and calibrated CAUTION Reversed Phase Chromatogra...

Page 104: ...and personal injury CAUTION Max weight on Buffer tray Do not place containers with a volume of more than 5 liters each on the Buffer tray The total allowed weight on the Buffer tray is 20 kg CAUTION...

Page 105: ...rument modules are presented in the table below The configuration of the system is defined by the user 4 5 6 7 8 9 10 11 12 13 14 15 16 17 W1 W2 W 3 2 1 Description Part Pressure monitor 1 Sample pump...

Page 106: ...Conductivity monitor 14 Flow restrictor 15 Outlet valve 16 Fraction collector 17 Waste W W1 W2 Waste ports The table below shows the waste ports of the Injection valve and outlet valves Illustrations...

Page 107: ...outlet tubing Connect tubing to the outlet ports of the outlet valve that are to be used during the run If no fraction collector is used immerse the outlet tubing in suitable tubes or flasks If a frac...

Page 108: ...ads Note that the procedures described in this section may have to be adapted if your system configuration differs from the one described in this manual Note For instructions on how to prime the inlet...

Page 109: ...ssure alarm based on the specifications of the chosen column type However when running manual runs you have to set the pressure limits yourself Also to protect the column media special settings are ne...

Page 110: ...n directly to the flow path tubing Use appropriate tubing and connectors The instructions below show a system configured with Column valve V9 Cs Action Step Attach an appropriate column holder to the...

Page 111: ...t The Column valve switches to position 1 In the Process Picture 6 Click on the Pumps Enter a low System flow e g 0 2 ml min Click Set flow rate Result A system flow of 0 2 ml min starts KTA pure Oper...

Page 112: ...ode and the top part of the column is filled with buffer connect the tubing to the top of the column 7 Connect a piece of tubing to the bottom of the column 8 112 KTA pure Operating Instructions 29022...

Page 113: ...Use the port opposite to the one already connected to the column in this example port 1B If no column valve is used connect the tubing to the next module in the flow path 9 Click the End icon in the S...

Page 114: ...stem pressure and tubing dimensions See the instructions below to set the pressure alarm for the column to be used in the run and if applicable to set the parameters for the tubing dimensions Settubin...

Page 115: ...alculates the Pre column pressure 5 Pre column pressure alarms It is important that the pre column pressure alarm is set during all runs where a column is used The pressure alarm can be set in the met...

Page 116: ...lled the delta column pressure will be measured but the alarm must be set manually if needed Set pressure alarms Pressure alarm limits may be set manually in System Control The example below de scribe...

Page 117: ...Place the computer in room temperature If the KTA pure instru ment is placed in a cold room use a cold room compatible comput er or place the computer outside the cold room and use the Ether net cabl...

Page 118: ...etailed information about how to run the system see UNICORN System Control Manual In this chapter This chapter contains the following sections See page Section 119 6 1 Before you start 122 6 2 Applyin...

Page 119: ...25 ml min systems CAUTION Always use appropriate personal protective equipment during op eration and maintenance of KTA pure CAUTION Hazardous substances When using hazardous chemical and bio logical...

Page 120: ...un At the end of a method the run stops automatically All pumps stop and an acoustic end signal sounds and End is displayed in the Run Log To interrupt a method during a run you may use the Hold Pause...

Page 121: ...l result Note Warnings concerning use of hazardous substances CAUTION Hazardous chemicals during run When using hazardous chemi cals run System CIP and Column CIP to flush the entire system tubing wit...

Page 122: ...ion regarding the different sample applications techniques see KTA pure User Manual Description Stage The sample loop is filled with sample Load The sample is injected onto the column Inject How to fi...

Page 123: ...al load position Load sample into the sample loop To avoid sample loss due to siphoning leave the syringe in the port until the sample has been injected onto the column during the run Tip It is recomm...

Page 124: ...d washed out using buffer from the system pumps The total buffer volume to be used for emptying and washing the sample loop is set in the Method Editor in the Phase Properties tab of the Sample Applic...

Page 125: ...n a method and start a run Action Step Open the System Control module and click the Open Method Navigator button 1 Result The Method Navigator pane opens Select the method to run and click the Run but...

Page 126: ...tion the Select Columns dialog opens For further information on column handling please refer to UNICORN Method Manual and UNICORN System Control Manual If column logging was not chosen during installa...

Page 127: ...un the layout of the module and the procedure to customize the view of the different panes Process picture The Process picture pane displays the current flow path during the run and can be used to con...

Page 128: ...instrument with a neutral solution to make sure that any hazardous solvents and biological agents have been flushed out from the system System cleaning After a method run is completed perform the foll...

Page 129: ...d make sure to keep the pressure in the system after the column below the pressure limits for the modules in the flow path Note If applicable prepare the pH electrode for storage as described in KTA p...

Page 130: ...UNICORN Follow the instructions to log off or exit UNICORN This can be performed from any of the UNICORN modules then If you want to on the File menu click Log off log off UNICORN Result All open UNIC...

Page 131: ...Shut down the instrument Switch off the instrument by pressing the power switch to the O position KTA pure Operating Instructions 29022997 AF 131 6 Run a method 6 5 After run procedures...

Page 132: ...ed on KTA pure is outlined below See KTA pure User Manual for detailed information about the maintenance procedures Maintenance is divided into Weekly maintenance Monthly maintenance Bi annual mainten...

Page 133: ...an the instrument externally Perform System CIP Perform Column CIP Replace tubing and connectors Clean the Conductivity flow cell Calibrate the Conductivity monitor Calibrate the UV monitor Replace Mi...

Page 134: ...ork Please complete the checklist in the On Site Service Health and Safety Declaration Form or the Health and Safety Declaration Form for Product Return or Servicing depending on whether the instrumen...

Page 135: ...oduct Documentation for detailed technical specifications In this chapter This chapter contains the following sections See page Section 136 8 1 System specifications 139 8 2 Chemical resistance guide...

Page 136: ...al Power consumption 25 VA power save IP 21 Enclosure protective class KTA pure 25 Tubing and connectors Inlet FEP tubing i d 1 6 mm Tubing connector 5 16 Ferrule yellow 1 8 Pump to Injection valve PE...

Page 137: ...NF connections Waste ETFE tubing i d 1 0 mm Fin gertight connector 1 16 Optional tubing kits i d 0 5 mm i d 1 0 mm Environmental ranges Data Parameter 25 C to 60 C Storageandtransporttemperaturerange...

Page 138: ...Equipment noise level Acoustic noise level Equipment 60 dB A KTA pure instrument 138 KTA pure Operating Instructions 29022997 AF 8 Reference information 8 1 System specifications...

Page 139: ...nformation about chemical resistance of the KTA pure instrument In this section See page Section 140 8 2 1 General information about biocompatibility and chemical resis tance 142 8 2 2 Chemical resist...

Page 140: ...and make sure that the column is not mounted on the Column Valve V9 C The Column Valve V9 C contains a pressure sensor which can be damaged by 1 M hydrochloric acid If sodium hypochlorite is used as s...

Page 141: ...dependent Unless otherwise stated all concentrations are 100 Note KTA pure Operating Instructions 29022997 AF 141 8 Reference information 8 2 Chemical resistance guide 8 2 1 General information about...

Page 142: ...that you have the MSDS available from your chemical distributor and or databases on the internet Note Aqueous buffers The specified aqueous buffers are suitable for continuous use CAS no EC no Concen...

Page 143: ...0 Solubilization and denaturing agents The following chemicals are suitable for continuous use as additives in separation and purification methods CAS no EC no Concentra tion Chemical 50 01 1 200 002...

Page 144: ...al for more information 2 Mobile phase system It is recommended to replace the mixer sealing ring with the highly resistant O ring product code 29 0113 26 if the system is to be exposed to organic sol...

Page 145: ...d EDTA 37482 11 4 253 523 3 20 mM Mercaptoethanol 7447 40 7 231 211 8 4 M Potassium chloride Other substances The following chemicals are suitable for continuous use CAS no EC no Concentra tion Chemic...

Page 146: ...1 1 6 mm Note For Mixer chamber 0 6 1 4 and 5 ml 29011326 O ring 13 1 1 6 mm highly resistant can be used as an alternative to 28953545 28981857 O ring 22 1 1 6 mm Note For Mixer chamber 15 ml 1810271...

Page 147: ...kit standard 29011332 Tubing kit for inlet valve V9 IA 7 ports 29051197 Tubing kit for inlet valve V9H IA 7 ports 29011333 Tubing kit for inlet valve V9 IB 7 ports 29051189 Tubing kit for inlet valve...

Page 148: ...older spool 11000407 Inlet filter holder kit 11000410 Screw lid GL45 kit UV monitor Code no Item 29011360 UV monitor U9 L Fixed wavelength 28979386 UV flow cell U9 0 5 0 5 mm for U9 M 28979380 UV flow...

Page 149: ...77015102 Deep well plate 24 x 10 ml 28956402 Cassette for 50 ml tubes 2 pack 28956427 Cassette for 3 ml tubes 2 pack 29133422 Cassette for 5 ml tubes 2 pack 28956425 Cassette for 8 ml tubes 2 pack 28...

Page 150: ...e rack upgrade kit 95 x 18 mm 18112468 Tube rack upgrade kit 40 x 30 mm 19606702 Drive sleeve Valves Code no Item 29011367 Column valve kit V9 C 29050951 Column valve kit V9H C 29011355 Column valve V...

Page 151: ...ve kit V9 O 29050949 Outlet valve kit V9H O 29011356 Outlet valve kit V9 Os 1 outlet 29090694 Outlet valve kit V9H Os 1 outlet 29011359 pH valve kit V9 pH 29051684 pH valve kit V9H pH 29011353 Versati...

Page 152: ...kit 28985812 Connector 1 16 male and Luer female External air sensors Code no Item 28956502 Air sensor L9 1 2 mm 28956500 Air sensor L9 1 5 mm pH monitor Code no Item 28954215 pH electrode 28956497 O...

Page 153: ...5 Jumper D SUB D type 29012474 External module cable short F type 29011366 External module cable long F type 29032425 Cable 2 5 m UniNet 9 D type SystemPumpsandSamplepump S9H Code no Item 28952642 P9...

Page 154: ...m UniNet 9 D type UNICORN There are different UNICORN products and licenses available for different purposes for example licenses for use with a workstation or for working remotely Contact your local...

Page 155: ...e testorothersuitablesurvey Adequate space andclearance is providedto allowsafe access forinstrumentservice repairor installation Insome cases this mayrequirecustomerto move equipmentfrom normaloperat...

Page 156: ...ous orhazardous biological substances pleasespecify OtherHazardous Chemicals please specify Equipment must be decontaminatedpriortoservice return Pleaseprovide atelephone number whereGE cancontact you...

Page 157: ...onment precau tions 20 F FCC compliance 11 Flammable liquids precau tions 20 Flow path illustration 105 prepare 104 G General precautions 18 H Holders ordering information 148 I Important user informa...

Page 158: ...purge system pumps 91 108 Purpose of this manual 5 R Recycling information decontamination 35 Reference information 135 chemical resistance guide 139 Regulatory information 8 Room requirements introd...

Page 159: ...System Control module 53 Unpack the instrument 70 W Waste ports 106 Waste tubing 80 prepare 80 107 Weight instrument 61 KTA pure Operating Instructions 29022997 AF 159 Index...

Page 160: ...nditions 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 curr...

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