GE AKTApure User manual

ÄKTA™pure
Operating Instructions
Original instructions

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Table of Contents
51 Introduction ..........................................................................................................
61.1 About this manual ................................................................................................................................
71.2 Important user information .............................................................................................................
91.3 Regulatory information ......................................................................................................................
122 Safety instructions ...............................................................................................
132.1 Safety precautions ...............................................................................................................................
232.2 Labels .........................................................................................................................................................
262.3 Emergency procedures ......................................................................................................................
292.4 Recycling information .........................................................................................................................
302.5 Declaration of Hazardous Substances (DoHS) ........................................................................
323 The instrument and software ............................................................................
333.1 ÄKTA pure instrument overview ....................................................................................................
443.2 UNICORN software ...............................................................................................................................
453.2.1 UNICORN software overview ....................................................................................................
463.2.2 System Control module ...............................................................................................................
494 Installation ............................................................................................................
504.1 Site preparation .....................................................................................................................................
514.1.1 Delivery and storage ....................................................................................................................
534.1.2 Room requirements ......................................................................................................................
564.1.3 Site environment ............................................................................................................................
584.1.4 Power requirements .....................................................................................................................
604.2 Hardware installation .........................................................................................................................
614.2.1 Unpack the instrument ................................................................................................................
674.2.2 Install the computer equipment ..............................................................................................
684.2.3 Connect system units ...................................................................................................................
714.2.4 Prepare waste tubing ...................................................................................................................
744.2.5 Prepare the pump rinsing system ...........................................................................................
774.2.6 Start the instrument and the computer ...............................................................................
784.3 Software installation ...........................................................................................................................
794.4 Start UNICORN and connect to system ......................................................................................
824.5 Prime inlets and purge pump heads ...........................................................................................
904.6 Performance test ..................................................................................................................................
914.7 Activate Power-save ...........................................................................................................................
925 Prepare the system for a run .............................................................................
945.1 Before you prepare the system ......................................................................................................
955.2 Prepare the flow path .........................................................................................................................
995.3 Prime inlets and purge pump heads ...........................................................................................
1005.4 Connect a column ................................................................................................................................
1055.5 Pressure alarms .....................................................................................................................................
1085.6 Prepare for a run at cold room temperature ...........................................................................
ÄKTA pure Operating Instructions 29-0229-97 AE 3
Table of Contents

1096 Run a method ........................................................................................................
1106.1 Before you start .....................................................................................................................................
1136.2 Applying the sample ............................................................................................................................
1166.3 Start a method run ..............................................................................................................................
1186.4 Monitor the run ......................................................................................................................................
1196.5 After run procedures ...........................................................................................................................
1237 Maintenance .........................................................................................................
1268 Reference information ........................................................................................
1278.1 System specifications .........................................................................................................................
1308.2 Chemical resistance guide ...............................................................................................................
1358.3 Check/Change the Node ID of a module ...................................................................................
138Index .......................................................................................................................
4 ÄKTA pure Operating Instructions 29-0229-97 AE
Table of Contents

1 Introduction
About this chapter
This chapter contains important user information, description of safety notices, regula-
tory information and a general description of the intended use of ÄKTA pure.
In this chapter
This chapter contains the following sections:
See pageSection
61.1 About this manual
71.2 Important user information
91.3 Regulatory information
ÄKTA pure Operating Instructions 29-0229-97 AE 5
1 Introduction

1.1 About this manual
Purpose of the Operating
Instructions
The Operating Instructions provide you with the instructions needed to install, operate
and maintain ÄKTA pure in a safe way.
Typographical conventions
Software items are identified in the text by bold italic text. A colon separates items in a
group, thus Flowpath:Injection valve refers to the Injection valve item in the Flowpath
group.
Hardware items are identified in the text by bold text (for example, the Power button).
6 ÄKTA pure Operating Instructions 29-0229-97 AE
1 Introduction
1.1 About this manual

1.2 Important user information
Read this before operating ÄKTA
pure
All users must read the entire ÄKTA pure Operating Instructions before installing,
operating, or maintaining the instrument. Always keep the ÄKTA pure Operating
Instructions at hand when operating ÄKTA pure.
Do not operate ÄKTA pure in any other way than described in the Operating Instructions.
Otherwise, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use
ÄKTA pure is intended for the purification of bio-molecules, in particular proteins, for re-
search purposes. It is intended to be used by trained laboratory staff members in research
laboratories at departments within academia and industry.
ÄKTA pure shall not be used in any clinical procedures, or for diagnostic purposes.
Prerequisites
In order to follow this manual and use the system in the manner it is intended, it is im-
portant that:
•you have a general understanding of how the computer and Microsoft®Windows®
work.
•you understand the concepts of liquid chromatography.
•you have read and understood the Safety instructions chapter of these Operating
Instructions.
•a user account has been created according to UNICORN Administration and Technical
Manual.
ÄKTA pure Operating Instructions 29-0229-97 AE 7
1 Introduction
1.2 Important user information

Safety notices
This user documentation contains safety notices (WARNING, CAUTION, and NOTICE)
concerning the safe use of the product. See definitions below.
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.
CAUTION
CAUTION indicates a hazardous situation which, if not avoided,
could result in minor or moderate injury. It is important not to pro-
ceed until all stated conditions are met and clearly understood.
NOTICE
NOTICE indicates 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:
8 ÄKTA pure Operating Instructions 29-0229-97 AE
1 Introduction
1.2 Important user information

1.3 Regulatory information
Introduction
This section lists the directives and standards that are fulfilled by ÄKTA pure.
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, 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
Radio Equipment and Telecommunications Terminal
Equipment (R&TTE) Directive.
1999/5/EC
International standards
This product fulfills the requirements of the following standards:
NotesDescriptionStandard
EN ISO standard is har-
monized with EU direc-
tive 2006/42/EC
Safety of machinery. General princi-
ples for design. Risk assessment and
risk reduction.
EN ISO 12100
ÄKTA pure Operating Instructions 29-0229-97 AE 9
1 Introduction
1.3 Regulatory information

NotesDescriptionStandard
EN standard is harmo-
nized 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 is harmo-
nized with EU directive
2004/108/EC
Electrical equipment for measure-
ment, control and laboratory use -
EMC requirements
EN/IEC 61326-1
(Emission accord-
ing to CISPR 11,
Group 1, class A)
EN standard is harmo-
nized with EU directives
1999/5/EC
Electromagnetic compatibility and
Radio spectrum Matters (ERM); Elec-
troMagnetic Compatibility (EMC)
standard for radio equipment and
services.
ETSI EN 301 489-3
EN standard is harmo-
nized with EU directive
1999/5/EC
Electromagnetic compatibility and
Radio spectrum Matters (ERM); Short
Range Devices (SRD); Radio equip-
ment in the frequency range 9 kHz
to 25 MHz and inductive loop sys-
tems in the frequency range 9 kHz
to 30 MHz.
ETSI EN 300 330-2
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, including interference that may cause undesired
operation.
The user is cautioned that any changes or modifications not expressly approved
by GE could void the user’s authority to operate the equipment.
Note:
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide rea-
sonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio frequen-
cy 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 re-
quired to correct the interference at his own expense.
10 ÄKTA pure Operating Instructions 29-0229-97 AE
1 Introduction
1.3 Regulatory information

Environmental conformity
This product complies with the following environmental regulations.
TitleRequirement
Restriction of Hazardous Substances (RoHS) Directive2011/65/EU
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
Registration, Evaluation, Authorization and restriction of
CHemicals (REACH)
Regulation (EC) No
1907/2006
Administration on the Control of Pollution Caused by Elec-
tronic Information Products, China Restriction of Hazardous
Substances (RoHS).
ACPEIP
CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•used as a stand-alone unit, or
•connected to other products recommended or described in the user documentation,
and
•used in the same state as it was delivered from GE, except for alterations described
in the user documentation.
Regulatory compliance of
connected equipment
Any equipment connected to ÄKTA pure should meet the safety requirements of EN/IEC
61010-1, or relevant harmonized standards. Within EU, connected equipment must be
CE marked.
ÄKTA pure Operating Instructions 29-0229-97 AE 11
1 Introduction
1.3 Regulatory information

2 Safety instructions
About this chapter
This chapter describes safety precautions, safety labels and emergency shutdown pro-
cedures for ÄKTA pure. Decommissioning information is also described.
In this chapter
This chapter contains the following sections:
See pageSection
132.1 Safety precautions
232.2 Labels
262.3 Emergency procedures
292.4 Recycling information
302.5 Declaration of Hazardous Substances (DoHS)
12 ÄKTA pure Operating Instructions 29-0229-97 AE
2 Safety instructions

2.1 Safety precautions
Introduction
The ÄKTA pure 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
•Flammable liquids
•Personal protection
•Installing and moving the instrument
•System operation
•Maintenance
Some of the safety precautions in this chapter concern modules or situations that are
described in other manuals.
General precautions
WARNING
Do not operate ÄKTA pure in any other way than described in the
Operating Instructions.
WARNING
Operation and user maintenance of ÄKTA pure should be performed
by properly trained personnel only.
WARNING
Before connecting a column to ÄKTA pure, 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.
ÄKTA pure Operating Instructions 29-0229-97 AE 13
2 Safety instructions
2.1 Safety precautions

WARNING
Do not use any accessories not supplied or recommended by GE.
WARNING
Do not use ÄKTA pure if it is not working properly, nor if it has suf-
fered 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
NOTICE
Avoid condensation by letting the instrument equilibrate to ambient
temperature.
Flammable liquids
CAUTION
Fire Hazard. Before the system is turned on, make sure that there
is no unintentional leakage of flammable liquids, or other buffers,
in ÄKTA pure or tubing.
CAUTION
Explosion hazard. To avoid building up an explosive atmosphere
when using flammable liquids, make sure that the room ventilation
meets the local requirements.
14 ÄKTA pure Operating Instructions 29-0229-97 AE
2 Safety instructions
2.1 Safety precautions

CAUTION
Reversed Phase Chromatography (RPC) runs with 100% acetoni-
trile in ÄKTA pure. Always replace the PEEK tubing between the
used system pump and the pump pressure monitor with orange
PEEK tubing, i.d. 0.5 mm, before running RPC with 100% acetonitrile.
The tubing to be replaced is green for 25 ml/min systems and beige
for 150 ml/min systems. Set the System pressure alarm to 10 MPa
for 25 ml/min systems.
CAUTION
Moving tubes with flammable liquids. Move tubes filled with
flammable liquids carefully, to prevent spillages that may come in
contact with an ignition source.
Personal protection
CAUTION
Always use appropriate personal protective equipment during op-
eration and maintenance of ÄKTA pure.
CAUTION
Hazardous substances. When using hazardous chemical and bio-
logical 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,
maintenance and decommissioning of the equipment.
CAUTION
High pressure. ÄKTA pure operates under high pressure. Wear
protective glasses at all times.
ÄKTA pure Operating Instructions 29-0229-97 AE 15
2 Safety instructions
2.1 Safety precautions

CAUTION
Cut injuries. The tubing cutter is very sharp and must be handled
with care to avoid injuries.
Installing and moving the
instrument
Warnings
WARNING
Protective ground. The ÄKTA pure instrument must always be
connected to a grounded power outlet.
WARNING
Only use grounded power cords delivered or approved by GE.
WARNING
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.
Cautions
CAUTION
Heavy object. Use proper lifting equipment, or use two or more
persons when moving the instrument. All lifting and moving must
be performed in accordance with local regulations.
16 ÄKTA pure Operating Instructions 29-0229-97 AE
2 Safety instructions
2.1 Safety precautions

CAUTION
Supply voltage. Make sure that the supply voltage at the wall
outlet corresponds to the marking on the instrument, before con-
necting the power cord.
Notices
NOTICE
Vents on ÄKTA pure. To ensure adequate ventilation, keep papers
and other objects away from the vents of ÄKTA pure.
NOTICE
Disconnect power. To prevent equipment damage, always switch
off power to the ÄKTA pure instrument before an instrument
module is removed or installed, or a cable is connected or discon-
nected.
NOTICE
Misuse of UniNet-9 connectors. The UniNet-9 connectors at the
rear panel should not be confused with Firewire connectors. Only
connect GE marked products to the UniNet-9 connectors. Do not
disconnect or move the UniNet-9 bus cable.
NOTICE
Any computer used with the equipment shall comply with IEC 60950
and be installed and used according to the manufacturer's instruc-
tions.
ÄKTA pure Operating Instructions 29-0229-97 AE 17
2 Safety instructions
2.1 Safety precautions

System operation
Warnings
WARNING
Electrical shock hazard after spillage. If there is a risk that large
volumes of spilled liquid may penetrate the casing of ÄKTA pure,
immediately switch off ÄKTA pure, disconnect the power cord, and
contact an authorized service engineer.
Cautions
CAUTION
Fasten bottles and cassettes. Always fasten bottles and cassettes
to the rails at the front and side panel. Use appropriate holders for
bottles. Shattered glass from falling bottles may cause injury. Spilled
liquid may cause fire hazard and personal injury.
CAUTION
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.
CAUTION
pH-electrode. Handle the pH-electrode with care. The glass tip
may break and cause injury.
18 ÄKTA pure Operating Instructions 29-0229-97 AE
2 Safety instructions
2.1 Safety precautions

CAUTION
Max. weight on Buffer tray. Do not place containers with a volume
of more than 5 liters each on the Buffer tray. The total allowed
weight on the Buffer tray is 20 kg.
CAUTION
Disconnect power. Always switch off power to ÄKTA pure before
cleaning any of its components, unless stated otherwise in the user
documentation.
CAUTION
Avoid spillage and overflow. Make sure that the system is prepared
according to the settings in the method to be run. For example
make sure that the waste tubing is inserted in an appropriate waste
container and secured in place.
CAUTION
Avoid spillage and overflow. Make sure that the waste tubing is
inserted in an appropriate waste container and secured in place.
CAUTION
Risk of explosion. Do not use Mixer chamber 15 ml in the low flow
system. The maximum pressure for Mixer chamber 15 ml is 5 MPa.
CAUTION
Fasten the waste tubing. During operation at high pressure the
ÄKTA pure instrument may release bursts of liquid in the waste
tubing. Securely fasten all waste tubing to the ÄKTA pure instrument
and to the waste vessel.
ÄKTA pure Operating Instructions 29-0229-97 AE 19
2 Safety instructions
2.1 Safety precautions

Notices
NOTICE
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.
NOTICE
Avoid condensation. If ÄKTA pure is kept in a cold room, cold
cabinet or similar, keep ÄKTA pure switched on in order to avoid
condensation.
NOTICE
Avoid overheating. If ÄKTA pure is kept in a cold cabinet and the
cold cabinet is switched off, make sure to switch off ÄKTA pure and
keep the cold cabinet open to avoid overheating.
NOTICE
Place the computer in room temperature. If the ÄKTA pure instru-
ment is placed in a cold room, use a cold room compatible comput-
er or place the computer outside the cold room and use the Ether-
net cable delivered with the instrument to connect to the computer.
Maintenance
Warnings
WARNING
Electrical shock hazard. All repairs should be done by service
personnel authorized by GE. Do not open any covers or replace
parts unless specifically stated in the user documentation.
20 ÄKTA pure Operating Instructions 29-0229-97 AE
2 Safety instructions
2.1 Safety precautions