GE AKTA avant User manual

GE Healthcare
Getting Started with
ÄKTAavant and UNICORN 6
™ ™

Table of Contents
51 About this guide ...................................................................................................
61.1 Get started ...............................................................................................................................................
101.2 Regulatory information ......................................................................................................................
122 Safety instructions ...............................................................................................
132.1 Safety precautions ...............................................................................................................................
202.2 Labels .........................................................................................................................................................
232.3 Emergency procedures ......................................................................................................................
263 Start up .................................................................................................................
273.1 Start the system and log on to UNICORN ..................................................................................
314 The instrument and the software .....................................................................
324.1 ÄKTAavant instrument overview ...................................................................................................
364.2 UNICORN software overview ..........................................................................................................
394.3 UNICORN software modules ...........................................................................................................
404.3.1 Method Editor module ......................................................................................................................
434.3.2 System Control module ...................................................................................................................
454.3.3 Evaluation module .............................................................................................................................
475 Files and folders in UNICORN .............................................................................
485.1 Navigator overview .............................................................................................................................
515.2 Handling files and folders .................................................................................................................
556 Create a method ..................................................................................................
566.1 Guide to method creation .................................................................................................................
576.1.1 Create and edit methods ................................................................................................................
656.1.2 Predefined methods ..........................................................................................................................
676.1.3 Predefined phases .............................................................................................................................
686.2 Print a method .......................................................................................................................................
707 Prepare the system for a run .............................................................................
717.1 Before you prepare the system ......................................................................................................
727.2 Prepare the flow path .........................................................................................................................
787.3 Prime buffer inlets and purge System pumps .........................................................................
837.4 Connect a column ................................................................................................................................
887.5 Calibrate the pH monitor ..................................................................................................................
907.6 Prepare the Fraction collector ........................................................................................................
958 Run a method ........................................................................................................
968.1 Before you start .....................................................................................................................................
988.2 Applying the sample ............................................................................................................................
1018.3 Start a method run ..............................................................................................................................
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 3
Table of Contents

1068.4 Monitor the run ......................................................................................................................................
1118.5 After run procedures ...........................................................................................................................
1159 Evaluate and print the results ...........................................................................
1169.1 View the results .....................................................................................................................................
1209.2 Peak integration ....................................................................................................................................
1259.3 Print the results ......................................................................................................................................
13010 Maintenance .........................................................................................................
13110.1 Maintenance program .......................................................................................................................
4 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
Table of Contents

1 About this guide
Introduction
This chapter describes the purpose of the guide and provides regulatory information
relevant for ÄKTAavant system.
Contents
This chapter contains the following sections:
See pageSection
61.1 Get started
101.2 Regulatory information
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 5
1 About this guide

1.1 Get started
Introduction
Read this section for an understanding of the purpose and conventions of this guide, as
well as the requirements that you must fulfill before using the ÄKTAavant system.
Purpose of Getting Started
The purpose of this guide is to present a quick and easy guide to the system for a user
with limited or no experience of UNICORN software and ÄKTAavant instrument. The work
flow is presented as practical instructions on how to operate the software and the
instrument. The instructions form a basic framework that you can expand on by reading
selected parts in the other manuals. This Getting Started guide includes the following
topics:
•Basic features of ÄKTAavant and UNICORN
•Create methods
•Prepare the system for runs
•Perform runs
•Make simple evaluations
•Print reports
For best results, follow the guide from page to page in front of the system.
Prerequisites
In order to follow this guide and use the system in the manner it is intended, it is important
that:
•you have a general understanding of how the computer and Windows™ work.
•you understand the concepts of liquid chromatography.
•you have read and understood the Safety instructions chapter in the user
documentation.
•the instrument and software are installed, configured and calibrated according to
ÄKTAavant and UNICORN 6 Installation Guide.
•a user account has been created according to UNICORN 6 Administration and
Technical Manual.
6 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
1 About this guide
1.1 Get started

Pushing the limits beyond
Getting Started
Users who are familiar with the instrument and software and want to learn more about
the system’s advanced features should refer to the list below.
please read..To find out more
about...
ÄKTAavant and UNICORN 6 Installation Guideinstallation
UNICORN 6 Administration and Technical Manualadministration of
databases
ÄKTAavant and UNICORN 6 User Manualinstrument modules and
functions
ÄKTAavant and UNICORN 6 User Manualcalibration
UNICORN 6 Method Manualpredefined methods
UNICORN 6 Method Manualcolumn handling
UNICORN 6 Method Manualmanual method editing
UNICORN 6 Method ManualBufferPro–automatic
buffer preparation
UNICORN 6 Method Manualscouting
UNICORN 6 Method ManualDesign of Experiment
UNICORN 6 Evaluation Manualevaluation
UNICORN 6 Evaluation Manualpeak integration
UNICORN 6 Evaluation Manualcustomized print format
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 7
1 About this guide
1.1 Get started

Intended use
ÄKTAavant is a liquid chromatography system intended for method development. The
system can be used to screen for optimal choice of columns, media and running
parameters to purify selected proteins.
The ÄKTAavant system 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. It is important not to proceed
until all stated conditions are met and clearly understood.
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.
8 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
1 About this guide
1.1 Get started

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).
Text entries that UNICORN generates or that the user must type are represented by a
monotype typeface (e.g., \Program Files\GE
Healthcare\UNICORN\bin\UNICORN Instrument Server.exe.config).
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 9
1 About this guide
1.1 Get started

1.2 Regulatory information
Introduction
This section describes the directives and standards that are fulfilled by the ÄKTAavant
system.
CE conformity
This product complies with the European directives listed in the table below, by fulfilling
the corresponding harmonized standards. A copy of the Declaration of Conformity is
available on request.
TitleDirective
Machinery Directive2006/42/EC
Low Voltage Directive2006/95/EC
ElectroMagnetic Compatibility (EMC) Directive2004/108/EC
Radio Equipment and Telecommunications Terminal
Equipment Directive
1999/5/EC
CE marking
The CE marking and the corresponding declaration of conformity, is valid for the
instrument when it is:
•used as a stand-alone unit, or
•connected to other CE marked GE Healthcare instruments, or
•connected to other products recommended or described in the user documentation,
and
•used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
10 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
1 About this guide
1.2 Regulatory information

International standards
This product fulfills the requirements of the following standards:
NotesDescriptionStandard
Safety requirements for electrical
equipment for measurement,
control, and laboratory use
EN 61010-1, IEC
61010-1, UL 61010-1,
CAN/CSA-C22.2
No.61010-1
Harmonized with
2004/108/EC
EMC emissions and immunity
requirements for electrical
equipment for measurement,
control and laboratory use.
EN 61326-1
CISPR 11 Group 1,
Class B
Harmonized with
2006/42/EC
Safety of machinery — Basic
concepts, general principles for
design
EN-ISO 12100-1,
12100-2
Harmonized with
2006/42/EC
Safety of machinery — Principles of
risk assessment
EN ISO 14121-1,
14121-2
Software declaration of
conformity
UNICORN 6 is technically compatible with all relevant sections of FDA 21 CFR Part 11.
A part 11-system assessment checklist is available on request through the local GEHC
representative.
Regulatory compliance of
connected equipment
Any equipment connected to the ÄKTAavant system should meet the safety requirements
of EN 61010-1/IEC 61010-1, or other relevant harmonized standards. Within EU,
connected equipment must be CE marked.
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 11
1 About this guide
1.2 Regulatory information

2 Safety instructions
Introduction
This chapter contains instructions of how to handle the ÄKTAavant instrument in a safe
way.
Contents
This chapter contains the following sections:
See pageSection
132.1 Safety precautions
202.2 Labels
232.3 Emergency procedures
12 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
2 Safety instructions

2.1 Safety precautions
Introduction
The ÄKTAavant 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 injuries or damage to the equipment.
The safety precautions in this section are grouped into the following categories:
•General precautions
•Personal protection
•Installing and moving the instrument
•System operation
•Maintenance
General precautions
WARNING
Always follow these General precautions to avoid injury when using
the ÄKTAavant instrument.
•Do not operate the ÄKTAavant instrument in any other way than described in the
ÄKTAavant and UNICORN manuals.
•Operation and user maintenance of the ÄKTAavant instrument should be performed
by properly trained personnel only.
•Before connecting a column to the ÄKTAavant 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.
•Do not use any accessories not supplied or recommended by GE Healthcare.
•Do not use the ÄKTAavant instrument 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
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 13
2 Safety instructions
2.1 Safety precautions

NOTICE
Avoid condensation by letting the instrument equilibrate to ambient
temperature.
Using flammable liquids
WARNING
When using flammable liquids with the ÄKTAavant instrument,
follow these precautions to avoid any risk of fire or explosion.
•Fire Hazard. Before starting the system, make sure that there are no unintentional
leakage in the instrument or tubing.
•Explosion hazard. To avoid building up an explosive atmosphere when using
flammable liquids, make sure that the room ventilation meets the requirements
specified in ÄKTAavant and UNICORN 6 Installation Guide.
•Fraction collector. Do not fractionate flammable liquids. When running RPC methods,
or other procedures using solvent based buffers, collect fractions through the outlet
valve.
Personal protection
Warnings
WARNING
To avoid hazardous situations when working with the ÄKTAavant
system, take the following measures for personal protection.
•Always use appropriate personal protective equipment during operation and
maintenance of ÄKTAavant system.
•Hazardous substances. 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 the system.
14 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
2 Safety instructions
2.1 Safety precautions

•Spread of biological agents. The operator has to take 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.
•High pressure. The ÄKTAavant instrument operates under high pressure. Wear
protective glasses at all times.
Cautions
CAUTION
To avoid hazardous situations when working with the ÄKTAavant
system, take the following measures for personal protection.
•Close doors. To minimize the risk of exposure to hazardous chemicals and pressurized
liquids, always close the Foldable door and the Pump cover before starting a run.
•Cut injuries. The tubing cutter is very sharp and must be handled with care to avoid
injuries.
Installing and moving the
instrument
Warnings
WARNING
To avoid personal injury when installing or moving the ÄKTAavant
instrument, follow the instructions below.
•Heavy object. The ÄKTAavant instrument weighs about 100 kg. Use proper lifting
equipment, or use four or more persons when moving the instrument. All lifting and
moving must be performed in accordance with local regulations.
•Moving the instrument horizontally. Three persons are recommended when moving
the instrument horizontally.
•Supply voltage. Make sure that the supply voltage at the wall outlet corresponds to
the marking on the instrument, before connecting the power cord.
•Protective ground. The ÄKTAavant instrument must always be connected to a
grounded power outlet.
•Power cord. Only use power cords delivered or approved by GE Healthcare.
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 15
2 Safety instructions
2.1 Safety precautions

•Access to power switch and power cord. Do not block the rear and side panel of
the instrument. The Power switch must always be easy to access. The power cord
must always be easy to disconnect.
•Installing the computer. The computer should be installed and used according to
the instructions provided by the manufacturer of the computer.
Notices
NOTICE
To avoid damage to ÄKTAavant or other equipment when installing
or moving the instrument, follow the instructions below.
•Vents on the ÄKTAavant instrument. To ensure adequate ventilation, keep papers
and other objects away from the vents of the instrument.
•Disconnect power. To prevent equipment damage, always switch off power to the
ÄKTAavant instrument before an instrument module is removed or installed, or a
cable is connected or disconnected.
•Misuse of UniNet-9 connectors. The UniNet-9 connectors at the rear panel should
not be mistaken for Firewire connectors. Do not connect any external equipment to
the UniNet-9 connectors. Do not disconnect or move the UniNet-9 bus cable.
System operation
Warnings
WARNING
To avoid personal injury when operating the ÄKTAavant system,
follow the instructions below.
•Rotating the instrument. Make sure that there is always at least 20 cm of free space
around the ÄKTAavant instrument to allow rotation on the swivel foot. When rotating
the system, take care not to stretch or squeeze tubing or cables. A disconnected
cable may cause power interruption or network interruption. Stretched tubes may
cause bottles to fall, resulting in liquid spillage and shattered glass. Squeezed tubing
may cause increase in pressure, or block liquid flow. To avoid the risk of turning over
bottles, always place bottles on the buffer tray, and close the doors before rotating
the instrument.
16 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
2 Safety instructions
2.1 Safety precautions

•Fasten sample bottles. Always fasten bottles and cassettes to the rails at the sample
tray. Use appropriate holders for bottles. Shattered glass from falling bottles may
cause injury. Spilled liquid may cause fire hazard and personal injury.
•Electrical shock hazard after spillage. If there is a risk that large volumes of spilled
liquid may penetrate the casing of the ÄKTAavant instrument, immediately switch
off the instrument, disconnect the power cord, and contact an authorized service
engineer.
•Moving parts in Fraction collector. Do not open the Fraction collector drawer when
the Fraction collector is active. If you need to access the Fraction collector, press
Pause, and make sure that the movement has stopped before opening the drawer.
•Using a Superloop. After loading a Superloop, always plug the Syr port on the
Injection valve with a Stop plug. With a Superloop connected to the valve, an
over-pressure may be created during injection.
•Hazardous chemicals during run. When using hazardous chemicals, run System
CIP and Column CIP to flush the entire system tubing with distilled water, before
service and maintenance.
•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.
•RPC runs with 100% acetonitrile. Always replace the green PEEK tubing between
the used system pump and the pressure monitor with orange PEEK tubing, i.d. 0.5
mm, before running RPC with 100% acetonitrile. Set the System pressure alarm to
10 MPa.
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 17
2 Safety instructions
2.1 Safety precautions

Cautions
CAUTION
To avoid hazardous situations when operating the ÄKTAavant
system, follow the instructions below.
•Risk of breaking test vials. Do not use excessive force to press vials with incorrect
dimensions into the Fraction collector cassettes. Glass vials may break and cause
injuries.
•Hazardous chemicals or biological agents in UV flow cell. Make sure that the entire
flow cell has been flushed thoroughly with bacteriostatic solution (e.g., NaOH) and
distilled water, before service and maintenance.
•pH-electrode. Handle the pH-electrode with care. The glass tip may break and cause
injury.
•Max. weight on top tray. Do not place containers with a volume of more than 10
liters on the top tray. The total allowed weight on the top tray is 40 kg.
•Max. size of bottles on front panel. Do not fasten bottles with a volume of more
than 1 liter in the front panel rails.
Notices
NOTICE
To avoid damage to ÄKTAavant or other equipment when operating
the instrument, follow the instructions below.
•Keep UV flow cell clean. Do not allow solutions containing dissolved salts, proteins
or other solid solutes to dry out in the flow cell. Do not allow particles to enter the
flow cell, as damage to the flow cell may occur.
•Waste container height. The maximum level of the waste container content must
be lower than 30 cm above the lab bench, for trouble-free use.
18 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
2 Safety instructions
2.1 Safety precautions

Maintenance
Warnings
WARNING
To avoid personal injury when performing maintenance on the
ÄKTAavant instrument, follow the instructions below.
•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.
•Disconnect power. Always switch off power to the instrument before replacing any
component on the instrument, unless stated otherwise in the user documentation.
•Hazardous chemicals during maintenance. When using hazardous chemicals for
system or column cleaning, wash the system or columns with a neutral solution in
the last phase or step.
NOTICE
Cleaning. Keep the instrument dry and clean. Wipe regularly with
a soft damp tissue and, if necessary, a mild cleaning agent. Let the
instrument dry completely before use.
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB 19
2 Safety instructions
2.1 Safety precautions

2.2 Labels
Introduction
This section describes the safety labels and labels concerning hazardous substances
that are attached to the ÄKTAavant instrument. For information about marking of the
computer equipment, refer to the manufacturer’s instructions.
Labels on the ÄKTAavant
instrument
The illustrations below show the labels that are attached to the ÄKTAavant instrument.
20 Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
2 Safety instructions
2.2 Labels