GE HEALTHCARE AKTAprime plus Operating Instructions Manual

ÄKTAprime plus
Operating Instructions
Original instructions
Table of Contents
41 Introduction ..........................................................................................................
51.1 Important user information .............................................................................................................
91.3 Instrument ...............................................................................................................................................
131.4 Monitoring and evaluation ...............................................................................................................
131.5 User documentation ...........................................................................................................................
152 Safety instructions ...............................................................................................
152.1 Safety precautions ...............................................................................................................................
232.2 Labels .........................................................................................................................................................
252.3 Emergency procedures ......................................................................................................................
262.4 Recycling information .........................................................................................................................
272.5 Declaration of Hazardous Substances (DoHS) ........................................................................
293 Installation ............................................................................................................
293.1 Site requirements ..................................................................................................................................
293.2 Transport ..................................................................................................................................................
303.3 Unpacking ................................................................................................................................................
303.4 Connections ............................................................................................................................................
313.5 Spare parts and accessories ...........................................................................................................
324 Operation ..............................................................................................................
324.1 Operation overview .............................................................................................................................
324.2 Starting the instrument ......................................................................................................................
334.3 Preparations before start ..................................................................................................................
384.4 Performing a run ...................................................................................................................................
404.5 Procedures after a run .......................................................................................................................
425 Maintenance .........................................................................................................
425.1 General ......................................................................................................................................................
435.2 User maintenance schedule ...........................................................................................................
455.3 Cleaning ....................................................................................................................................................
465.4 Component maintenance ................................................................................................................
465.5 Disassembly and assembly of components and consumables .....................................
475.6 Calibration ................................................................................................................................................
485.7 Storage ......................................................................................................................................................
496 Troubleshooting ...................................................................................................
496.1 UV curve problems ...............................................................................................................................
506.2 Conductivity curve problems ..........................................................................................................
526.3 pH curve problems ...............................................................................................................................
556.4 Pressure curve problems ..................................................................................................................
2 ÄKTAprime plus Operating Instructions 28-9597-89 AC
Table of Contents
567 Reference information ........................................................................................
567.1 Specifications .........................................................................................................................................
577.2 Chemical resistance ............................................................................................................................
607.3 System recommendations ...............................................................................................................
617.4 Health and Safety Declaration Form ...........................................................................................
637.5 Ordering information ..........................................................................................................................
64Appendix A Connection diagram - Liquid flow path .........................................
65Appendix B Tubing ..................................................................................................
ÄKTAprime plus Operating Instructions 28-9597-89 AC 3
Table of Contents
1 Introduction
Purpose of the Operating Instructions
The OperatingInstructions provide you with the instructions needed to handle ÄKTAprime plus in a safe way.
Prerequisites
In order to operate ÄKTAprime plus as is intended, the following pre-requisites must be fulfilled:
The user should have a general understanding of how a PC and the Microsoft
®
Windows®operating system 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 softwareshould be installed, configured andcalibrated according to these Operating Instructions.
About this chapter
This chapter contains important user information, a description of the intended use of ÄKTAprime plus, regulatory information, list of associated documentation, definitions of safety notices and so on.
4 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.1 Important user information
Read this before operating the product
All users must read the entire Operating Instructions before installing, operating or maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documentation. If you do, you may be exposed to hazards that can lead to personal injury and you may cause damage to the equipment.
Intended use
ÄKTAprime plus is a compact liquid chromatography system designed for one-step pu­rification 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 indicates a hazardous situation which, if not avoided,
could result in death or serious injury. Itis important not to proceed until all stated conditions are met and clearly understood.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 5
1 Introduction
1.1 Important user information
Cautions
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to proceed until all stated conditions are met and clearly understood.
Notices
NOTICE
NOTICE indicates instructions that must be followed to avoid
damage to the product or other equipment.
Notes and tips
A note is used to indicate information that is important for trouble-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 information
In this section
This section describes the directives and standards that are fulfilled by ÄKTAprime plus.
6 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.1 Important user information
Manufacturing information
The table below summarizes the required manufacturing information. For further infor­mation, see the EU Declaration of Conformity (DoC) document.
ContentRequirement
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.
TitleDirective
Machinery Directive (MD)2006/42/EC
Electromagnetic Compatibility (EMC) Directive2004/108/EC
Low Voltage Directive (LVD)2006/95/EC
CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in­strument when it is:
used as a stand-alone unit, or
connected to otherproducts recommended ordescribed in theuser 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 7
1 Introduction
1.2 Regulatory information
International standards
This product fulfills the requirements of the following standards:
NotesDescriptionStandard
EN standard isharmonized with EU directive 2006/95/EC
Safety requirements for electrical equipment for measurement, control, and laboratory use
EN/IEC 61010-1, UL 61010-1, CAN/CSA-C22.2 No. 61010-1
EN standard isharmonized with EU directive 2004/108/EC
Electrical equipment for measure­ment, control and laboratory use
- EMC requirements
EN 61326-1
EN ISO standard is harmo­nized with EU directive 2006/42/EC
Safety of machinery. General principles for design. Risk assess­ment and risk reduction.
EN ISO 12100
FCC compliance
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, includinginterference that maycause undesired operation.
The user is cautioned that any changes or modifications notexpressly 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 rea­sonable protection against harmful interference when the equipment is operated in a commercial environment. This equipmentgenerates, uses,and canradiate radiofrequen­cy energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be re­quired to correct the interference at his own expense.
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.
8 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.2 Regulatory information
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
Restriction of Hazardous Substances (RoHS) Directive2011/65/EU
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
Administration on the Control of Pollution Caused by Electronic Information Products, China Restriction of Hazardous Sub­stances (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 pu­rification 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 the instrument.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 9
1 Introduction
1.2 Regulatory information
FunctionPartFunctionPart
Switch valve10Fraction collector1
Conductivity cell11Monitor and controller2
Flow restrictor12LCD display3
UV flow cell13Push buttons4
Column14Pump5
Sample loop15Pressure sensor6
Flow diversion valve16Mixer7
Column holder17Injection valve8
Buffer valve9
The 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
220-240 V
100-120 /
Power max
90 VA
autorange
~
Frequency
50-60 Hz
(SYSTEM NO.)
(CODE NO.)
1
2
3
4
5
6
7
8
9
10
11
ConnectionNo.ConnectionNo.
pH electrode7RS-232 to computer1
Conductivity flow cell8Flow diversion valve2
10 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.3 Instrument
ConnectionNo.ConnectionNo.
Optical unit9Fraction collector3
Power switch10Measurement data to recorder4
Mains power inlet11On/off signals to recorder5
UV lamp6
Navigation menu
The system is operated from the push buttons and LCD display at the front panel.
end
OK
Esc
pause
/cont
hold
/cont
feed tube
Figure 1.2: Push buttons.
DescriptionButton
Find a specific 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 cur­rent concentration. Pump and fraction collector continue uninterrupted.
hold /cont
Continue the normal method operation.
Pause all operation without ending the method. All func­tions, including pump and fraction collector, are stopped.
pause /cont
Continue the normal method operation.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 11
1 Introduction
1.3 Instrument
DescriptionButton
Advance the fraction collector one position.feed tube
Basic flow path
IN
IN
P
M
UV
C
pH
F
W
V2
V1
B
SW
Figure 1.3: Basic flow path.
DescriptionPartStage
Pump P pumps buffer from a buffer container connected to the buffer valve V1.
P, V11
To form a gradient the switch valve (SW) can be used topull liquid from buffer container (B).
SW, B2
The mixer (M) mixes the buffers.M3
Sample is applied from the sample loop connected to injection valve (V2) that has been previously filled manually using a syringe.
V24
From the injection valve, the flow is directed to the column, and then to the UV, Conductivity, and optional pH monitor.
UV, C, pH5
From the monitors, the flow is directed to the Fraction collector F or the Waste W.
F, W6
12 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.3 Instrument
1.4 Monitoring and evaluation
PrimeView™software
PrimeView isa software thatallows realtime monitoring,evaluation and report generation on an external computer.
For more information about PrimeViewevaluation systemand instructionsfor installation, see the PrimeView User Manual supplied.
Paper chart recorder
It is possible to connect a chart recorder to ÄKTAprime plus to get real time monitoring. For more information see the ÄKTAprime plus User Manual.
1.5 User documentation
In addition to these Operating Instructions, the documentation package supplied with ÄKTAprime plus also includes product documentation binders containing detailed specifications and traceability documents.
The mostimportant documentsin the document package withregard to technical aspects of ÄKTAprime plus are:
System-specific documentation
ContentUser documentation
All instructionsneeded to operate the in­strument in a safe way, including brief system description, installation, and maintenance.
ÄKTAprime plus Operating Instructions
Detailed systemdescription. Comprehen­sive user instructions, method creation, operation, advanced maintenance and troubleshooting.
ÄKTAprime plus User Manual
Short step-by-stepinstructions forselect­ed applications using the prepro­grammed method templates. System preparation and value table for the method templates.
ÄKTAprime plus Cue Cards
ÄKTAprime plus Operating Instructions 28-9597-89 AC 13
1 Introduction
1.4 Monitoring and evaluation
ContentUser documentation
Covers the system introduction, step by step installation, setting-up the run and evaluation of results.
ÄKTAprime plus training video
Document whereby the manufacturer ensures that the product satisfies and is in conformity with the essential require­ments of the applicable directives.
EU Declaration of Conformity for ÄKTAprime plus
Software documentation
Together with each system, the following software documentation is supplied providing additional information that applies to ÄKTAprime plus, independent of the specific configuration:
Purpose/ContentsDocument
A completecontrol software packagefor supervision of ÄKTAprime plus automated liquid chromatogra­phy systems.
PrimeView User Manual
Component documentation
Documentation forcomponents produced both by GE and by a third-party are, ifexistent, also included in the document package.
14 ÄKTAprime plus Operating Instructions 28-9597-89 AC
1 Introduction
1.5 User documentation
2 Safety instructions
About this chapter
This chapter describes safety compliance, safety labels, general safety precautions, emergency procedures, power failure and recycling of ÄKTAprime plus.
2.1 Safety precautions
Introduction
The ÄKTAprime plus instrument is powered by mains voltage and handles pressurized liquids that may be hazardous. Before installing, operating or maintaining the system, you must be aware of the hazards described in this manual. Follow the instructions
provided to avoid 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 ÄKTAprime plus in any other way than described in the ÄKTAprime plus and PrimeView manuals. If the equipment is used in a manner not specified by the manufacturer, the protec­tion provided by the equipment may be impaired.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 15
2 Safety instructions
WARNING
Operation anduser maintenance of the ÄKTAprime plusinstrument should be performed by properly trained personnel only.
WARNING
Before connecting a column to the ÄKTAprime plus instrument, read the instructions for use of the column. To avoid exposing the column to excessive pressure, make sure that the pressure limit is set to the specified maximum pressure of the column.
WARNING
Do not use 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 tubesand containersmust be secured and sealed to prevent accidental spillage.
CAUTION
Make sure that the waste container is dimensioned for maximum possible volume when the instrument is left unattended.
16 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.1 Safety precautions
NOTICE
Avoid condensation by letting the unit equilibrate to ambient tem­perature.
Using flammable liquids
When using flammableliquids withthe ÄKTAprimeplus instrument, followthese precau­tions to avoid any risk of fire or explosion.
WARNING
Fire Hazard. Before starting the system, make sure that there is
no leakage.
WARNING
A fume hood or similar ventilation system shall be installed when flammable or noxious substances are used.
Personal protection
WARNING
Always use appropriate Personal ProtectiveEquipment (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 national regulations for safe operation and maintenance of ÄKTAprime plus.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 17
2 Safety instructions
2.1 Safety precautions
WARNING
Spread of biological agents. The operatorhas totake all necessary
actions to avoid spreading hazardous biological agents in the vicinity of the instrument. The facility should comply with the na­tional code of practice for biosafety.
WARNING
High pressure. ÄKTAprime plus operates under high pressure.
Wear protective glasses 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 con­necting 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 delivered
or approved by GE Healthcare.
18 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.1 Safety precautions
WARNING
Access to power switch 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.
WARNING
Do not block the ventilation inlets or outlets on the system.
WARNING
Installing the computer. The computer should be installed and
used according to the instructions provided by the manufacturer of the computer.
NOTICE
Any computerused with the equipment shall comply withIEC 60950 and beinstalled andused according to the manufacturer's instruc­tions.
NOTICE
Disconnect power. To preventequipment damage,always discon-
nect power from the ÄKTAprime plus instrument before an instru­ment 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 System CIP and Column CIP to flush the entire system tubing with distilled water, before service and maintenance.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 19
2 Safety instructions
2.1 Safety precautions
WARNING
Hazardous biological agents during run. When using hazardous
biological agents, run System CIP and Column CIP to flush the entire system tubing with bacteriostatic solution (e.g. NaOH) fol­lowed by a neutral buffer and finally distilled water, before service and maintenance.
WARNING
There must always be a sample loop connected to ports 2 and 6 of the injection valve. This is to prevent liquid spraying out of the ports when switching the valve. This is especially dangerous if hazardous chemicals are used.
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 mainte­nance.
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 con­densation. (The UV lamp can be turned off to save lamp life time when the system is not in use.)
NOTICE
When switchingoff thecold cabinet, makesure that you also switch off the ÄKTAprime plus system and leave the door to the cold cabinet open to avoid overheating.
20 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.1 Safety precautions
Maintenance
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 documenta­tion.
WARNING
Disconnect power. Always disconnect power from the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
WARNING
Hazardous chemicals duringmaintenance. When using hazardous
chemicals for 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 be used for maintaining or servicing ÄKTAprime plus.
WARNING
Make sure thatthe piping system is completelyleakage free before performing any CIP on the system.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 21
2 Safety instructions
2.1 Safety precautions
WARNING
NaOH is corrosive and therefore dangerous to health. When using hazardous chemicals, avoid spillage and wear protective glasses and other suitable Personal Protective Equipment (PPE).
WARNING
After assembly, the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets, burst pipes or explosive atmosphere.
WARNING
Before disassembly, check that there is no pressure in the piping system.
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 the lamp is not installed properly it may be overheated and cause a fire hazard.
CAUTION
The systemuses high intensity ultra-violet light. Do not removethe UV lamp while the system is running. Before replacing a UV lamp, ensure that the lamp is disconnected to prevent injury to eyes.
If the mercury lamp is broken, make sure that all mercury is re­moved anddisposed according tonational andlocal environmental regulations.
22 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.1 Safety precautions
NOTICE
Cleaning. Keep the instrument dry and clean. Wipe regularly with
a softdamp tissue and, if necessary, a mildcleaning agent. Let the instrument dry completely before use.
2.2 Labels
In this section
This sectiondescribes theinstrument 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 instructions
2.1 Safety precautions
Symbols used in instrument labels
MeaningLabel
Warning! Read the user documentation before usingthe equipment.
Do not open any covers or replace parts unless specifically stated in the user documentation.
The equipment complies with the requirements for electromagnetic compliance (EMC) in Australia and New Zealand.
The equipment complies with applicable European directives.
This symbol indicates that ÄKTAprime plus has been certified by a Nationally Recognized Testing Laboratory (NRTL). NRTL means an organization, which isrecognized by theUS Occupational Safetyand 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
MeaningLabel
This symbol indicates that the waste of electrical and electronic equip­ment must not be disposed as unsorted municipal waste and must be collected separately. Please contact anauthorized representative of the manufacturer for information concerning the decommissioning of equipment.
24 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.2 Labels
MeaningLabel
This symbol indicates that the product contains hazardous materials in excess ofthe limitsestablished by the Chinesestandard SJ/T11363-2006 Requirements for ConcentrationLimits forCertain HazardousSubstances in Electronics.
2.3 Emergency procedures
In this section
This section describeshow to do an emergency shutdownof the ÄKTAprime plus system. The section also describes the result in the event of power failure.
Emergency shutdown
In an emergency situation, do as follows to stop the run:
ActionStep
To pause the run without ending the method, pressthe Pausebutton 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 undefined state
The data collected up to the time of the power failure is available in PrimeView
ÄKTAprime plus
The PrimeViewcomputer shuts down in an undefined state
The run continues, but data cannot be saved in PrimeView.
Computer
ÄKTAprime plus Operating Instructions 28-9597-89 AC 25
2 Safety instructions
2.2 Labels
2.4 Recycling information
Decontamination
ÄKTAprime plus shall be decontaminated before decommissioning and all local regula­tions shall be followed with regard to scrapping of the equipment.
Disposal, general instructions
When taking ÄKTAprime plus out of service, the different materials must be separated and recycled according to national and local environmental regulations.
Recycling of hazardous substances
ÄKTAprime plus contains hazardous substances. Detailed information is available from your GE representative.
Disposal of electrical components
Waste ofelectrical andelectronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment.
26 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.4 Recycling information
2.5 Declaration of Hazardous Substances (DoHS)
根据SJ/T11364-2006《电子信息产品污染控制标识要求》特提供如下有关污染 控制方面的信息。
The following product pollution control information is provided according to SJ/T11364-2006 Marking for Control of Pollution caused by Electronic Information Products.
电子信息产品污染控制标志说明
Explanation of Pollution Control Label
该标志表明本产品含有超过SJ/T11363-2006《电子信息产品中有毒有害物质的限 量要求》中限量的有毒有害物质。标志中的数字为本产品的环保使用期,表明本 产品在正常使用的条件下,有毒有害物质不会发生外泄或突变,用户使用本产品 不会对环境造成严重污染或对其人身、财产造成严重损害的期限。单位为年。
为保证所申明的环保使用期限,应按产品手册中所规定的环境条件和方法进行正 常使用,并严格遵守产品维修手册中规定的期维修和保养要求。
产品中的消耗件和某些零部件可能有其单独的环保使用期限标志,并且其环保使 用期限有可能比整个产品本身的环保使用期限短。应到期按产品维修程序更换那 些消耗件和零部件,以保证所申明的整个产品的环保使用期限。
本产品在使用寿命结束时不可作为普通生活垃圾处理,应被单独收集妥善处理。
This symbolindicates theproduct contains hazardous materials in excess of the limits established bythe Chinese standard SJ/T11363-2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products. The number in the symbol is the Environment-friendly Use Period (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 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 periodic maintenance schedules specified in Product Maintenance Pro­cedures shall be followed strictly.
Consumables or certain parts may have their own labelwith an EFUPvalue less than the product. Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordancewith theProduct Maintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be collected separately and handled properly after decommissioning.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 27
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
有毒有害物质或元素的名称及含量
Name and Concentration of Hazardous Substances
产品中有毒有害物质或元素的名称及含量
Table of Hazardous Substances’ Name and Concentration
有毒有害物质或元素
Hazardous substance
部件名称
Component name
多溴二苯醚
PBDE
多溴联苯
PBB
六价铬
Cr6+
Cd
Hg
Pb
00000X11-0013-13
0:
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
X:
表示该有毒有害物质至少在该部件的某一均质材料中的含量超出SJ/T11363-2006 标准规 定的限量要求
此表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 ma­terials 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 homoge­neous materials used for this part is above the limit requirement in SJ/T11363-2006.
Data listed in the table represents best information available at the time of publication.
28 ÄKTAprime plus Operating Instructions 28-9597-89 AC
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
3 Installation
ÄKTAprime plus is delivered in protective packing material and shall be unpacked with great care.
Any equipment connected to ÄKTAprime plus must fulfill applicable standards and local regulations.
A video describing the installationprocess, is supplied with each ÄKTAprimeplus system.
For detailed information on Installation, see ÄKTAprime plus User Manual.
3.1 Site requirements
RequirementParameter
Indoor useOperation site
Maximum 2000 mAltitude
Stable laboratory bench e.g. 120 × 80 cmPlacement
100-120/220-240 V AC ±10%, 50-60 HzElectrical power
Overvoltage category IITransient overvoltages
4°C to 40°CAmbient temperature
20% to 95%, non-condensingHumidity
84 to 106 kPa (840 to 1060 mbar)Atmospheric pressure
2Pollution degree
WARNING
Do not block the ventilation inlets or outlets on the system.
3.2 Transport
The equipment can be transported on a trolley capable of supporting at least 20 kg.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 29
3 Installation
NOTICE
Lift the instrument in the upright position. Do not use the fraction­ation arm as a lifting handle.
Before moving the system:
disconnect all cables and tubing connected to peripheral components and liquid containers.
remove any loose items from the top of the instrument.
grasp the instrument firmly by placing the fingers under the base of the main unit and lift.
For more information on transport, see ÄKTAprime plus User Manual.
3.3 Unpacking
Check for damage
Check the equipment for damage before starting assembly and installation. There are no loose parts in the transport box.All partsare either mountedon thesystem 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 starting installation.
3.4 Connections
Communication
Connect thesystem according to the electrical drawings in Electrical and communication
connections, on page 10.
30 ÄKTAprime plus Operating Instructions 28-9597-89 AC
3 Installation
3.2 Transport
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 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
4 Operation
About this chapter
This chapter provides instructions for the use of ÄKTAprime plus.
4.1 Operation overview
Workflow
The typical workflow in ÄKTAprime plus, after turning on the system, can be divided into a number of steps.
SectionActionStep
Section 4.3 Preparations before start, on page 33Prepare the system for a run1
Section 4.4 Performing a run, on page 38Start a run using a method2
Viewing the run, on page 39During a run - view and change parame-
ters
3
Section 4.5 Procedures after a run, on page 40Procedures after a run4
See PrimeView user documentation.Evaluate the results5
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 per­forms a self-test.
2
First thesystem nameand software versionnumber are displayed. Several messages are then shown during the self-test. If an error is detected during the self-test, an error message is shown.
3
All parameters are automatically set to factory default values during the self-test.
32 ÄKTAprime plus Operating Instructions 28-9597-89 AC
4 Operation
4
The self-test takes about 30–40 seconds. When the test is completed, the display shows the Templates menu.
The system can be used for most applications after 15 min of lamp warm-up but the full specifications are not obtained until after 1 hour.
Note:
4.3 Preparations before start
Buffer preparation
Prepare buffers according to ÄKTAprime plus cue cards.
Sample preparation
1
Adjust the sample composition to the binding buffer by:
diluting the sample in binding buffer, or
buffer exchange using HiTrap™ Desalting or HiPrep™ 26/10 Desalting column.
2
Filter the sample through 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 A1A8 that is used and B in deionized water.
At delivery, only A1 and B are installed.
Note:
2
Put all waste capillaries, W1W3, in waste.
3
Select Templates in the main menu using the and buttons and press OK.
4
Select Application Template and press OK.
5
Select System Wash Method and press OK.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 33
4 Operation
4.2 Starting the instrument
6
Choose to wash the A2A8 inlet tubing that is used by pressing OK at those cursor positions. A1 and B will always be washed.
At delivery, only A1 and B are installed.
Note:
7
Scroll to OK and press the OK button.
8
Press OK to start the method.
9
When the method is finished, replace the first collection tube. It will contain a small amount of water after the system wash.
Purging the pump and inlet tubing
If there are large amounts of air in the tubing or if you suspect air in the pump, use the Purge kit to purge the flow path. Air bubbles that still are trapped in the pump (causing increased pulsation) can be removedby flushing100% ethanolthrough thepump. 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
10
ml
3
Put the used inlet tubing in the appropriate buffers.
4
Run the pump at 0.1 ml/min.
Filling inlet tubing A1A8:
1
Go to Set Buffer Valve using the arrow buttons.
2
Set the chosen A inlet and press OK. The valve switches to the selected port .
3
Draw buffer with the purge syringe until liquid enters the syringe.
4
Repeat step 1–3 until all chosen A inlet tubing is filled.
Filling inlet tubing B:
1
Go to Set Concentration %B and set the concentration to 100%.
34 ÄKTAprime plus Operating Instructions 28-9597-89 AC
4 Operation
4.3 Preparations before start
2
Press OK. The switch valve turns to the inlet B port.
3
Draw buffer with the purge syringe until liquid enters the syringe.
4
Replace the purge tubing with the stop plug.
5
Stop the pump by pressing end and then OK.
Flushing the pump with 100% ethanol:
1
Put inlet tubing A1 in deionized water.
2
Run the pump at 40 ml/min for 1 min and press pause/cont.
3
Move inlet tubing A1 to 100% ethanol
4
Press pause/cont, run the pump for 10–20 s and press pause/cont.
5
Set the flow rate to 5 ml/min using the arrow buttons.
6
Press pause/cont, run 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 fraction collector valve in waste.
4
Connect a column, for example a HisTrap™ HP 1 ml column, between port 1 on the injection valve and the upper port of the UV flow cell. Use a suitable length of PEEK tubing and 1/16" male connectors.
1
2
3
4
ÄKTAprime plus Operating Instructions 28-9597-89 AC 35
4 Operation
4.3 Preparations before start
DescriptionNo.DescriptionNo.
HisTrap column3Tubing from injection valve1
UV cell41/16" male connector2
Other unions and connectors might be required for other columns.
Note:
Preparing the fraction collector
1
Fill the fraction collector rack with, for example, 18 mm tubes (minimum 40 pcs.).
2
Adjust the height of the delivery arm using the lock knob (1) so that the bottom of the tubesensor (2)is about5 mmbelow 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 ad­justing the tubing length).
5.
3.
4.
1.
2.
36 ÄKTAprime plus Operating Instructions 28-9597-89 AC
4 Operation
4.3 Preparations before start
4
Check that the tube sensor (1) is in the correct position for the tube size. The eluent tubing should be over the center of the collection tube. Use the red sensor control knob (2) to position the tube holder (3).
2
1
3
5
Rotate the rack by hand until the rear half of the tube sensor rests against the first tube.
6
Press feed tube on the front panel (see Figure1.2). The bowl moves to the correct position to collect the first fraction in the first tube.
7
Make sure that drop 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 buffer.
For other applications, fill the inlet tubing manually with buffer as described in the ÄKTAprime plus User Manual.
Filling the sample loop
Using an injection fill port
ÄKTAprime plus Operating Instructions 28-9597-89 AC 37
4 Operation
4.3 Preparations before start
1
Connect a sample loop between port 2 and 6 on the injection valve. Make sure that the sample loop is large enough for your sample.
2
Connect a luer female/1/16" male union to port 3.
3
Fill a syringe with five loop volumes of deionized water or binding buffer.
4
Fit the syringe in the Luer union (1) and carefully inject the buffer.
3
1
5
Remove the syringe and fill it with at least two loop volumes of the sample.
6
Carefully 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 theappropriate template, for example His Tag PurificationHisTrap, and press OK.
4
Set the sample volume and press OK.
5
Press OK to start the purification run.
38 ÄKTAprime plus Operating Instructions 28-9597-89 AC
4 Operation
4.3 Preparations before start
Viewing the run
When the pump starts running, the progress of the run can be viewed in the two panes in PrimeView.
The Curves pane displays monitor signal values graphically.
The Logbook pane displays all actions (e.g. method start and end, base instructions and method instructions)and unexpectedconditions (e.g. warningsand 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 Operating Instructions 28-9597-89 AC 39
4 Operation
4.4 Performing a run
Ending the run
Press OK at the Method Complete prompt. This will cause all valves to return to their default positions.
To stop the run on a system before it is finished:
1
Press the end button.
2
Select yes and press OK.
Error indication
When a warning or an alarm is issued from a system, an error code is displayed. See ÄKTAprime plus User Manual for guidance.
Evaluate the results
PrimeView Evaluation module provides facilities for the presentation and evaluation of separation results.
To start PrimeView Evaluation module, click PrimeView Evaluation iconon theWindows 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 dissolved salts, proteins or other solid solutes to dry out in the UV flow cell.
40 ÄKTAprime plus Operating Instructions 28-9597-89 AC
4 Operation
4.4 Performing a run
NOTICE
Do not allow particles to enter the UV flow cell as damage to the flow cell might occur.
Buffers notcontaining anysalt can be left in the system for ashort time after a run, even overnight (not in the pH electrode, see instructions below).
NOTICE
If a buffer containing salt has been used, the flow path must be flushed with deionized water.
To flush the flow path:
1
Fill a syringe with five times the sample 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 theTemplates menu, selectApplication Template 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 informationon cleaningand long-termstorage, seeSection 5.3 Cleaning, on page 45 and Section 5.7 Storage, on page 48.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 41
4 Operation
4.5 Procedures after a run
5 Maintenance
About this chapter
This chapter provides instructions for routine component maintenance and a mainte­nance schedule.
5.1 General
Regular maintenanceis important for safeand trouble-free operationof yourinstrument. The usershould perform daily andmonthly maintenance. Preventivemaintenance should be performed on a yearly basis by qualified service personnel.
For maintenance of a specific component, carefully read the component manual 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 documenta­tion.
WARNING
Disconnect power. Always disconnect power from the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
WARNING
Hazardous chemicals duringmaintenance. When using hazardous
chemicals for system or column cleaning, wash the system or columns with a neutral solution in the last phase or step.
42 ÄKTAprime plus Operating Instructions 28-9597-89 AC
5 Maintenance
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
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 national regulations for safe operation and maintenance of ÄKTAprime plus.
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.
NOTICE
Cleaning. Keep the instrument dry and clean. Wipe regularly with
a softdamp tissue and, if necessary, a mildcleaning agent. Let the instrument dry completely before use.
5.2 User maintenance schedule
Table 5.1 provides a guide to maintenance operations and intervals at which these op-
erations should be performed by the user. The user is however responsible for deciding the type of operations and length of intervals necessary to maintain system function and safety.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 43
5 Maintenance
5.1 General
Table 5.1: User maintenance schedule
Instructions/referenceActionInterval
Visually inspect the system for leaks.Leak inspectionDaily
1
For cleaning the flow path,see Cleaning-In-
Place, on page 45.
2
For leaving the system for a few days, see
Section 5.7 Storage, on page 48.
Wash thesystem flow path
Calibrate thepH electrode (if applicable) accord­ing to Monitor pH/C-900 User Manual.
Calibrate pHelectrode (optional)
Check theinlet filters visually and replace them if necessary.
Check inlet filtersWeekly
Replace the on-line filter.Replace on-line filter
(if applicable)
Check thatflow restrictor generates the follow­ing back-pressure:
Flow restrictorMonthly
FR-904: 0.4 ±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 theopen endin awaste 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 and connect the flow restrictor tothe openend of thetubing (observe theIN marking).Put theflow restric­tor in the waste container.
5
Press Continue so that the pump run at 10 ml/min with water. Note the back-pressure (Bp2) on the pump display, or in the Run Data window.
6
Calculate the back-pressure generated by the flow restrictor (Bp2-Bp1). Replace it if it is not within limit.
44 ÄKTAprime plus Operating Instructions 28-9597-89 AC
5 Maintenance
5.2 User maintenance schedule
Instructions/referenceActionInterval
Check for external or internal leakage. Replace channel plate and distribution plate yearly or when required. Refer to the relevant valve in­struction sheet.
Valve inspectionYearly
5.3 Cleaning
Cleaning before planned maintenance/service
To ensure the protection and safety of service personnel, all equipment and work areas must beclean and free of any hazardous contaminants before a Service Engineerstarts maintenance work.
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 theinstrument isgoing tobe serviced on site or returned for service, respectively.
Copy theform 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 cleaning step described above. The nature and degree of contamination depends on the sampleand thechromatographic conditions employed. These should be considered when designing a cleaning protocol.
Routine cleaning should be performed at intervals aimed at prevention rather than cleaning the system from growth or contamination.
WARNING
Make sure thatthe piping system is completelyleakage free before performing any CIP on the system.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 45
5 Maintenance
5.2 User maintenance schedule
Make sure that the process control method for cleaning flushes all possible flow paths in the system. After cleaning, rinse the entire system with water or suitable liquid until the piping/tubing system is completelyfree from theCIP solution(monitors in the system can be used as detectors). Do not leave NaOH or other cleaning agents in the system for long periods.
WARNING
Hazardous chemicals duringmaintenance. When using hazardous
chemicals for system or column cleaning, wash the system or columns with a neutral solution in the last phase or step.
WARNING
NaOH is corrosive and therefore dangerous to health. When using hazardous chemicals, avoid spillage and wear protective glasses and other suitable Personal Protective Equipment (PPE).
See also Section 5.7 Storage, on page 48.
5.4 Component maintenance
Maintenance and preventivereplacement of parts ofthe major components are 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 con­sumables
The operator must carefully read and understand the instructions supplied for each component before disassembly and assembly of the component. When replacing con­sumables, suchas tubingand tubingconnectors, allneccessary safetyprecautions must be taken. Contact your local GE Healthcare representative if further information or help is needed.
WARNING
Disconnect power. Always disconnect power from the instrument
before replacing any component on the instrument, unless stated otherwise in the user documentation.
46 ÄKTAprime plus Operating Instructions 28-9597-89 AC
5 Maintenance
5.3 Cleaning
WARNING
Before disassembly, check that there is no pressure in the piping system.
WARNING
After assembly, the piping system must be tested for leakage at maximum pressure for continued protection against injury risks due to fluid jets, burst pipes or explosive atmosphere.
5.6 Calibration
The table below lists the type and frequency of calibrations that can be done on the in­strument. Refer toPrimeView userdocumentation andto theindividual componentUser Manuals and Instructions for descriptions of how to perform these calibrations. The calibrations are performed from PrimeView by selecting System:Calibrate in System Control.
How oftenComponent
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 constantConductivity
flow cell
Must be done when changing the conductivity flow cell (Temp).
Temperature
Must be done when changing the conductivity flow cell (Cond_Cell).
Entering a new cell con­stant
ÄKTAprime plus Operating Instructions 28-9597-89 AC 47
5 Maintenance
5.5 Disassembly and assembly of components and consumables
5.7 Storage
General recommendation
For storage, the system must first be cleaned as described in Cleaning-In-Place, on
page 45. After cleaning, the system must be filled with 0.01 M NaOH or 20% ethanol
solution.
Columns and media shall be stored 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 thesystem, calibrateall monitors, and perform a leakage test before using the system.
48 ÄKTAprime plus Operating Instructions 28-9597-89 AC
5 Maintenance
5.7 Storage
6 Troubleshooting
6.1 UV curve problems
Corrective actionPossible causeError symptom
Clean the system. Make sure air is removed.
Dirt or residues in the flow path from previ­ous runs. Air in the eluents.
Ghost peak
Clean the column according to the column instructions.
Residue in the column from previous runs
Check the mixer function by plac­ing a stirrer bar on top ofthe mixer housing. The stirrer bar should ro­tate when the system is in Run mode. Themixer function can also be checked by running the installa­tion test.
Incorrect mixer func­tion
Clean the UV cell by flushing Decon™ 90, Deconex™ 11 or equivalent.
Dirty UV cellNoisy UV-signal, sig-
nal drift or instability
Check if the signal is still noisywith water.
Impure buffer
Purge the pump according to Pump User Manual. Run a system wash with buffer.
Air in the pump or in the UV cell
ÄKTAprime plus Operating Instructions 28-9597-89 AC 49
6 Troubleshooting
Corrective actionPossible causeError symptom
Check thelamp run time according to and replace if necessary. Refer to ÄKTAprime plus User Manual.
Aging UV lampLow sensitivity
Check that the lamp position and the filter position are both set to the wavelength tobe used,280 nm or 254nm. Referto ÄKTAprime plus User Manual.
UV lamp in wrong po­sition
Calculate thetheoretical extinction coefficient of the protein. If it is ze­ro or very low at 280 nm, the pro­tein cannot be detected.
The theoretical extinc­tion coefficient too low
6.2 Conductivity curve problems
Corrective actionPossible causeError symptom
Check the flow restrictor after the flow cell.
Air in the pump or the flow cell
Baseline drift or noisy signal
Tighten the clamps. If necessary, replace the clamps.
Leaking tubeconnec­tions
Check the mixer function by plac­ing a stirrer bar on top ofthe mixer housing. The stirrer bar should ro­tate when the system is in Run mode. Themixer function can also be checked by running the installa­tion test.
Incorrect mixer func­tion
Clean the conductivity cell by flushing 1M NaOH or 20% ethanol.
Dirty conductivity cell
Equilibrate the column. If neces­sary, clean the column using a method plan for column cleaning.
Column notequilibrat­ed
Clean the flow cell according to procedure in MonitorUser Manual.
Dirty flow cellConductivity measure­ment with the same buffer appears to de­crease over time
Use a temperature compensation factor. See Monitor User Manual.
Decrease in ambient
temperature
50 ÄKTAprime plus Operating Instructions 28-9597-89 AC
6 Troubleshooting
6.1 UV curve problems
Corrective actionPossible causeError symptom
Check that the pump is operating and is programmed correctly.
Incorrect pump func­tion
Waves on the gradi­ent
Check that the mixing chamber is free from dirt or particles.
Dirty mixing chamber
Change to a larger mixing cham­ber volume if necessary.
Insufficient mixing chamber volume
Check the motor operation. Place a hand on the mixer and start it by starting the pump at a low flow rate. You shouldboth hearand feel the mixer motor and stirrer when they are spinning.
Incorrect motor func­tion
Check for loose tubing connec­tions. Use the flow restrictor.
Air in the flow cellGhost peaks appear
in the gradient profile
Wash the tubing and check pump is operating properly.
Dirty tubingUnlinear gradients or slow response to %B changes
Change to smaller mixer volume.Incorrect mixer vol-
ume
ÄKTAprime plus Operating Instructions 28-9597-89 AC 51
6 Troubleshooting
6.2 Conductivity curve problems
Corrective actionPossible causeError symptom
Check that the conductivity flow cell cable is connected properly.
Loose connection of conductivity flow ca­ble
Incorrect or unstable reading
Check that the pump and valves operate correctly.
Incorrect pump and valves function
If temperature compensation is being used,check that the temper­ature sensor is calibrated,and that the correct temperature compen­sation factor is in use.
Incorrect temperature compensation factor
Check thatthe columnis equilibrat­ed. If necessary clean the column.
Dirty or incorrectly equilibrated column
Check the operation of the mixer. The mixer function is checked by placing a stirrer 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 func­tion
6.3 pH curve problems
Corrective actionPossible causeError symptom
Check that the electrode cable is connected properly.
Faulty electrode con­nection
No response to pH changes
The electrode glass membrane may becracked. Replacethe elec­trode.
Damaged electrode
Check that the pH monitor is cor­rectly connected according to the ÄKTAprime plus User Manual.
Incorrectly connected pH monitor
Clean thepH electrode as detailed in Monitor pH/C-900 User Manual.
Dirty pH electrodeSmall response to pH
changes
If theproblem remains, replacethe pH electrode.
52 ÄKTAprime plus Operating Instructions 28-9597-89 AC
6 Troubleshooting
6.2 Conductivity curve problems
Corrective actionPossible causeError symptom
Check the electrode glass mem­brane. If it is contaminated, clean the electrode following the instruc­tions in Monitor pH/C-900 User Manual.
Contaminated elec-
trode glass mem-
brane
Slow pH response or Calibration impossible
If themembrane hasdried 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
Corrective actionPossible causeError symptom
Check that the electrode cable is connected properly.
Problem with elec­trode
Incorrect or unstable pH reading
Check thatthe electrode is correct­ly inserted in the flow cell and, if necessary, hand-tighten the nut.
Check that the pH electrode is not broken.
Calibrate the pH electrode.
Clean the pH electrode if required, see MonitorpH/C-900 User Manual.
Compare the response of the pH electrode with that of another pH electrode. If the response differ greatly, the electrode may require cleaning or replacement.
In organic solvents such as ethanol, methanoland acetonitrile, stable pH measurements are not possible since dehydration of the membrane will occur. It is recom­mended that the pH electrode is not used in applications using or­ganic 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 cell with buffer at 20 ml/min (E100 system)or 10 ml/min (E 10 system) for 1/2 min. Use the flow restrictor FR-902 after the pH electrode.
Air in the flow cell
There may be interference from static fields. Connect the pH flow cell and the rear panel of the monitor usinga standard laborato­ry 4 mm “banana plug” cable.
Static interference
54 ÄKTAprime plus Operating Instructions 28-9597-89 AC
6 Troubleshooting
6.3 pH curve problems
Corrective actionPossible causeError symptom
Replace the pH electrode.Problem with the
electrode
pH values vary with varied back pressure
6.4 Pressure curve problems
Corrective actionPossible causeError symptom
Check all connections for leaks.Air bubbles passing through or trapped in the pump
Erratic flow, noisy baseline signal,irregu­lar pressure trace
Check thatthere is sufficient eluent
present in the reservoirs.
Use degassed solutions.
Purge the pump.
Follow the instructions 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 tubing.
Check inlet tubing filter. It can be-
come clogged if unfiltered buffers
or samplesare applied. See instruc-
tions for flushing through at the
end of the run in ÄKTAprime plus
User Manual.
ÄKTAprime plus Operating Instructions 28-9597-89 AC 55
6 Troubleshooting
6.3 pH curve problems
7 Reference information
About this chapter
This chapter contains technical data, regulatory and other information.
7.1 Specifications
ValueParameter
Housing: IP20Ingression protection
Flow cells: IP44
100-120/220-240 V AC ±10% autorange1, 50 to 60 Hz
Supply voltage
Overvoltage category IITransient overvoltages
90 VAPower consumption
T 1.0 AH 250 V AC, approved type (not replaceable by the user)
Fuse specification
530 × 400 × 450 mmDimensions (H × W × D)
13 kgWeight
Maximum 2000 mAltitude
4°C to 40°CAmbient temperature
10% to 95%Relative humidity tolerance(non-condensing)
84 to 106 kPa (840 to 1060 mbar)Atmospheric pressure
< 80 dB ANoise level
1
The instrument switches automaticallyto the input voltagesupplied, withinthe limitsspecified in the table.
56 ÄKTAprime plus Operating Instructions 28-9597-89 AC
7 Reference information
7.2 Chemical resistance
CommentsEEC no.CAS no.Exposure
up to 2 months
Exposure
< 1 day
Chemical
OKOKAcetaldehyde
OKOKAcetic acid, < 5%
200-580-764-19-7OKOKAcetic acid, 70%
PP and PE swell.200-835-275-05-8OKOKAcetonitrile
PVDF is affected by long term use.
AvoidOKAcetone, 10%
Silicone is affected by long-term use.
231-635-37664-41-7OKOKAmmonia, 30%
235-186-412125-02-9OKOKAmmonium chlo-
ride
OKOKAmmonium bicar-
bonate
OKOKAmmonium nitrate
231-984-17783-20-2OKOKAmmonium sul-
phate
OKOK1-Butanol
OKOK2-Butanol
249-576-729340-81-6OKOKCitric acid
Kalrez™, CTFE, PP and PE areaffected by long term use.
AvoidOKChloroform
OKOKCyclohexane
OKOKDetergents
PVDF is affected by long term use.
200-664-367-68-5AvoidAvoidDimethyl sulphox-
ide
ETFE, PP, PE and PVDF are affected by long term use.
AvoidAvoid1, 4-Dioxane
ÄKTAprime plus Operating Instructions 28-9597-89 AC 57
7 Reference information
7.2 Chemical resistance
CommentsEEC no.CAS no.Exposure
up to 2 months
Exposure
< 1 day
Chemical
200-837-375-08-1OKOKEthanol, 100%
Silicone not resis­tant. Pressure limit for PEEKdecreases.
AvoidOKEthyl acetate
203-473-3107-21-1OKOKEthylene glycol,
100%
Silicone not resis­tant.
200-579-164-18-6OKOKFormic acid, 100%
200-289-556-81-5OKOKGlycerol, 100%
OKOKGuanidinium hy-
drochloride
Silicone not resis­tant. Pressure limit for PEEKdecreases.
AvoidOKHexane
Silicone not resis­tant.
231-595-77647-01-0OKOKHydrochloric acid,
0.1 M
Silicone not resis­tant.Titanium isaf­fected by long term use.
AvoidOKHydrochloric acid,
> 0.1 M
200-661-767-63-0OKOKIsopropanol, 100%
200-659-674-93-1OKOKMethanol, 100%
Silicone not resis­tant.
AvoidOKNitric acid, diluted
Elgiloy™ is affected by long term use.
AvoidAvoidNitric acid, 30%
Titanium, alumini­um oxide and glass are affected by long term use.
231-633-27664-38-2AvoidOKPhosphoric acid,
10%
209-529-3584-08-7OKOKPotassium carbon-
ate
58 ÄKTAprime plus Operating Instructions 28-9597-89 AC
7 Reference information
7.2 Chemical resistance
CommentsEEC no.CAS no.Exposure
up to 2 months
Exposure
< 1 day
Chemical
231-211-87447-40-7OKOKPotassium chloride
ETFE, PP and PE not resistant.
AvoidAvoidPyridine
OKOKSodium acetate
OKOKSodium bicarbon-
ate
OKOKSodium bisulphate
OKOKSodium borate
OKOKSodium carbonate
231-598-37647-14-5OKOKSodium chloride
PVDF and borosili­cate glass are af­fected by long term use.
215-185-51310-73-2AvoidOKSodium hydroxide,
2 M
231-820-97757-82-6OKOKSodium sulphate
PEEK and titanium are affected by long term use.
AvoidOKSulphuric acid, dilut-
ed
AvoidAvoidSulphuric acid, medium concentra­tion
Silicone, PP and PE are not resistant.
AvoidAvoidTetrachloroethy­lene
ETFE, CTFE, PP and PE are not resistant.
AvoidAvoidTetrahydrofuran
Pressure limit for PEEK decreases.
AvoidOKToluene
200-927-276-03-9OKOKTrichloroacetic
acid, 1%
200-929-3176-05-1OKOKTrifluoroacetic acid,
1%
ÄKTAprime plus Operating Instructions 28-9597-89 AC 59
7 Reference information
7.2 Chemical resistance
CommentsEEC no.CAS no.Exposure
up to 2 months
Exposure
< 1 day
Chemical
200-315-557-13-6OKOKUrea, 8M
PP and PE are af­fected by long term use.
AvoidOKo-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
7.4 Health and Safety Declaration Form
On site service
Ser
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ment type /
by confirm t
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rom the area
Seria
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Com
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Date
GE and GE GE Healthc NJ 08855-
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© 2010-14
On Sit
e
Safet
y
ustomers, all
arts a repair.
T
neer upon arr
ays in servici
n
“No”.
w.
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(YYYY/MM/D
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onogram are trad
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oval of any
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lectric Company. venue, P.O. Box 132
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OC1149542/28-98
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lth &
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must be ng of your
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0-26 AC 05/2014
ÄKTAprime plus Operating Instructions 28-9597-89 AC 61
7 Reference information
7.4 Health and Safety Declaration Form
Product return or servicing
Retu num
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To ma all eq
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your e
1.
2.
3.
Yes
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ke sure the m
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uipment, ple
Please not
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No
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hone No:
d and/or gas
ment type /
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by confirm t
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has been ma
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ion or job titl
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eive a return
call local te
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ion
tual protecti
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be clean and
f
ase complete
that items wi which is not s bject to additi amination wil
lease specif
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p
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this checklist
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ubstances a
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erved. First publish
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Form ing
vironment,
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nt and
l be applied
contact
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62 ÄKTAprime plus Operating Instructions 28-9597-89 AC
7 Reference information
7.4 Health and Safety Declaration Form
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
Appendix A Connection diagram - Liquid flow path
Flow path and components
Cond
1
2
3
4
5
6
7
W1
W2
W3
G5
410
W3
1000
W2
1000
W1
G6
550
F1
G3
300
250
A1
1250
B
1250
1
2
3
4
5
6
7
8
A
170
AB
510
G4
650
UV
pH
1100
G1 87
G2
98
1
2
3
4
5
6
7
8
10
9
11
12
13
14
DescriptionNo.DescriptionNo.
Loop (500 μl)8Buffers1
Waste9Buffer valve2
Column10Gradient switch valve3
Male/Male11System pump4
Flow restrictor (0.2 MPa)12Pressure monitor5
Flow diversion valve13Stop plug6
Fraction collector14Mixer7
64 ÄKTAprime plus Operating Instructions 28-9597-89 AC
A Connection diagram - Liquid flow path
Appendix B Tubing
Names in the Label column in TableB.1 refer to tubing labels in the liquid flow path connection diagram, see Appendix A Connection diagram - Liquid flow path, on page64.
Table B.1: Tubing specifications for ÄKTAprime plus
Volume (μl)
I.D. (mm)
Length (mm)
MaterialLabelUse
8.2 × 10
3
2.91250FEPA1Inlet A11
1.1 × 10
3
2.9170FEPAInlet A1
8.2 × 10
3
2.91250FEPBInlet A2
1.0 × 10
3
1.6510FEPABSwitch valve - Pump A3
660.75150PEEKG1Pump - Pressure monitor
530.75120PEEKG2Pressure monitor - Mixer
1330.75300PEEKG3Mixer - Valve
2870.75650PEEKG4Valve - UV (Column)
1100.75250PEEKG5UV - Cond
70.5038PEEKUnion, 1/16" male / 1/16" male
Cond - Flow restrictor
2430.75550PEEKG6Flow restrictor – Frac. coll.
1810.75410PEEKF1Frac. tubing
7851.01000PEEKW1, W2, W3Waste
ÄKTAprime plus Operating Instructions 28-9597-89 AC 65
B Tubing
GE and GE monogram are trademarks of General Electric Company.
ÄKTA,HiPrep,HisTrap, HiTrap andPrimeViewaretrademarks of GeneralElectric Company or one of its subsidiaries.
Decon is a trademark of Decon Laboratories Ltd.
Deconex is a trademark of Borer Chemie AG.
Elgiloy isatrademarkofCombinedMetalsofChicago,L.L.C., ElginNationalWatch Company.
Kalrez is a trademark of DuPont Performance Elastomers L.L.C.
Microsoft and Windows are registered trademarks of Microsoft Corporation.
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Any use of PrimeView is subject to GE Healthcare Standard Software End-User License Agreement forLife SciencesSoftwareProducts.A copyof thisStandard Software End-User License Agreement is available 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 whichsupplies them. A copyof these terms and conditions is available on request. Contact your local GEHealthcare repre­sentative for the most current information.
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www.gelifesciences.com/AKTA
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