GE HEALTHCARE AKTAprime plus Operating Instructions Manual
ÄKTAprime plus
Operating Instructions
Original instructions
Table of Contents
41 Introduction ..........................................................................................................
51.1 Important user information .............................................................................................................
61.2 Regulatory 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
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