cytiva Biacore 8K User manual

Biacore 8K/8K+
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 About this manual ......................................................................................................................................... 5
1.2 Important user information ....................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 8
1.4 Glossary ............................................................................................................................................................. 9
2 Safety instructions ............................................................................................. 12
2.1 Safety precautions ........................................................................................................................................ 13
2.2 Labels ................................................................................................................................................................. 20
2.3 Emergency procedures ............................................................................................................................... 22
3 System description ............................................................................................ 27
3.1 Instrument components ............................................................................................................................. 28
3.2 Flow system ..................................................................................................................................................... 33
3.3 Temperature control .................................................................................................................................... 38
3.4 Sample handling ............................................................................................................................................. 39
3.5 Signal detection and processing .............................................................................................................. 41
3.6 System software ............................................................................................................................................. 42
4 Installation .......................................................................................................... 43
4.1 Site requirements .......................................................................................................................................... 45
4.2 Unpacking, assembly and transport ....................................................................................................... 50
4.3 Reinstalling the software ............................................................................................................................ 52
4.4 Connections ..................................................................................................................................................... 53
5 Operation ............................................................................................................ 55
5.1 Starting the system ....................................................................................................................................... 58
5.2 Preparing for a run ......................................................................................................................................... 61
5.3 Preparing and loading samples ................................................................................................................ 64
5.4 Performing the run ........................................................................................................................................ 65
5.5 Closing down the software ......................................................................................................................... 68
6 Maintenance ....................................................................................................... 69
6.1 User maintenance operations .................................................................................................................. 71
6.2 Storage .............................................................................................................................................................. 75
7 Troubleshooting ................................................................................................. 76
7.1 Troubleshooting tools .................................................................................................................................. 77
7.2 Instrument problems ................................................................................................................................... 79
8 Reference information ....................................................................................... 84
8.1 System specifications .................................................................................................................................. 85
8.2 Ordering information ................................................................................................................................... 87
8.3 Chemical resistance of wetted parts ..................................................................................................... 88
8.4 Recycling information .................................................................................................................................. 90
8.5 Regulatory information ............................................................................................................................... 91
8.5.1 Contact information .................................................................................................................................... 92
8.5.2 European Union and European Economic Area .............................................................................. 93
Table of Contents
2 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

8.5.3 Eurasian Economic Union
Евразийский экономический союз .................................................................................................. 94
8.5.4 Regulations for North America ............................................................................................................... 96
8.5.5 Regulatory statements .............................................................................................................................. 97
8.5.6 Other regulations and standards .......................................................................................................... 98
8.6 Declaration of Hazardous Substances (DoHS) ................................................................................... 99
8.7 Health and Safety Declaration Form ...................................................................................................... 101
Index ........................................................................................................................... 103
Table of Contents
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices,
intended use of the Biacore™ 8K/8K⁺ system, and information concerning associated
documentation.
In this chapter
Section See page
1.1 About this manual 5
1.2 Important user information 6
1.3 Associated documentation 8
1.4 Glossary 9
1 Introduction
4 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

1.1 About this manual
Purpose of this manual
The Operating Instructions provide you with the information needed to install, operate,
and maintain the product in a safe way.
Scope of this manual
These Operating Instructions apply to Biacore 8K systems with Product No. 29327020
and to Biacore 8K⁺ systems. The systems differ in sample capacity (see Sample hotel
and sample compartment, on page 29) but are otherwise closely similar. The two
systems together are referred to as the Biacore 8K/8K⁺ system. For Biacore 8K
systems with Product No. 29146489, refer to the Operating Instructions provided with
the system.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
In electronic format, references in italics are clickable hyperlinks.
1 Introduction
1.1 About this manual
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 5

1.2 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, oper-
ating 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 documenta-
tion. 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 of the product
The Biacore 8K/8K⁺ system provides real-time label-free analysis of molecular interac-
tions in laboratory research. The Biacore 8K/8K⁺ system is intended for research use
only and shall not be used for diagnostic purposes in any clinical or in vitro procedures.
Prerequisites
In order to operate the Biacore 8K/8K⁺ system safely and according to the intended
purpose the following prerequisites must be met:
•You must read and understand the Safety Instructions chapter of these Operating
Instructions.
•The system should be installed according to the instructions in the Installation
chapter of these Operating Instructions.
•You should have a general understanding of the use of a personal computer running
Microsoft® Windows® in the version provided with your product.
•You should be acquainted with the use of general laboratory equipment and with
handling of biological materials.
A system administrator familiar with management of Microsoft SQL Server® databases
is required. Familiarity with database management is not required for operation of the
Biacore 8K/8K⁺ system.
1 Introduction
1.2 Important user information
6 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

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
proceed 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
Note: A note is used to indicate information that is important for trouble-free and
optimal use of the product.
Tip: A tip contains useful information that can improve or optimize your proce-
dures.
1 Introduction
1.2 Important user information
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 7

1.3 Associated documentation
Introduction
This section describes the user documentation that is delivered with the product, and
how to find related literature that can be downloaded or ordered from Cytiva.
User documentation
The main components of the documentation for the Biacore 8K/8K⁺ system are listed
in the table below.
Translations of the Biacore 8K/8K
⁺ Operating Instructions are provided in PDF format
on the documentation CD inside the back cover of the printed Operating Instructions.
Other documentation is available for download from cytiva.com/Biacore8K-system.
Documentation Main contents
Biacore 8K/8K⁺ Operating
Instructions
Instructions needed to install, operate and maintain
the Biacore 8K/8K⁺ system in a safe way.
Biacore 8K⁺ User Manual Detailed system description and instructions for
preparing and running experiments.
Biacore Insight Evaluation
Software User Manual
Detailed instructions for using the Biacore Insight
Evaluation Software to evaluate the results of
experiments with the Biacore 8K/8K⁺ instrument.
Software help On-screen assistance for using the Biacore 8K/8K⁺
and Biacore Insight software.
Biacore 8K/8K⁺ Site
Preparation Guide
Requirements for space, power and other supplies,
and environmental conditions for installing and
running the Biacore 8K/8K⁺ system.1
eLicensing Guide for
Biacore Systems
Instructions for handling electronic software
licenses.1
Biacore Insight Database
Installation and
Management Guide
Instructions for installing and maintaining the data-
base used to store data from the Biacore 8K/8K⁺
system.1
1These instructions are not required for normal use of the Biacore 8K/8K⁺ system.
User documentation on the web
Links to laboratory guidelines, application notes, documentation and other online
resources may be found on cytiva.com/bcappsupport. You will need to register on the
web site to access some of these links.
1 Introduction
1.3 Associated documentation
8 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

1.4 Glossary
Biacore terminology
Terms used in work with Biacore systems are explained in the following table.
Term Meaning
Active surface The sensor surface in the flow cell used for analysis of the inter-
action. This is normally flow cell 2.
Adjustment for
controls
Adjustment of the sample response for changes in the surface
activity during the course of an experiment, by normalizing with
reference to control sample responses measured at intervals.
Analysis cycle A sequence of injections of liquid over the sensor surface,
repeated as many times as required during the course of an
experiment. In the Biacore 8K/8K⁺ system, one cycle can include
analysis of up to 8 interactions, one in each channel.
Analyte The analyte is the interaction partner in solution, that is injected
over and interacts with the ligand on the sensor surface.
Note:
The analyte is not necessarily the object of the experimental
investigation. For example, an antibody screening experiment
may be set up where different antibodies are attached to the
sensor surface as ligands, and challenged with antigen injected
in solution as analyte. In this case, the object of the investigation
is the ligand.
Association
phase
The phase of an analysis cycle where analyte is injected over the
sensor surface and (potentially) binds to the ligand.
Baseline The response level from which sample responses are measured.
A baseline is automatically set before each injection in an anal-
ysis cycle: baselines may be set at other points in a sensorgram if
required.
Blank
subtraction
Subtraction of the response from a blank sample (usually buffer)
from that from a test sample, to eliminate components of the
response that are common to both samples.
Capture The term capture is used to refer to attachment of ligand to the
sensor surface by high affinity binding to an immobilized
capturing molecule. Attachment by capture is normally rever-
sible.
Capturing
molecule
A molecule that is permanently attached to the sensor surface
with the purpose of capturing ligand by high affinity binding.
1 Introduction
1.4 Glossary
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 9

Term Meaning
Channel A single path for liquid flow over the sensor surface. The
Biacore 8K/8K⁺ system has 8 parallel channels, each consisting
of two flow cells. For a given injection, the same flow settings
apply to all 8 channels.
Detection spot The area on the sensor surface where detection occurs. In the
Biacore 8K/8K⁺ system, there is one detection spot in each flow
cell.
Dissociation
phase
The phase of an analysis cycle immediately following the associ-
ation phase, when buffer flows over the sensor surface and any
bound analyte may dissociate spontaneously.
Enhancement
molecule
A secondary analyte injected after the main analyte, intended to
enhance the response and/or specificity of the first analyte
binding.
Flow cell The region of a channel where detection occurs. In the
Biacore 8K/8K⁺ system, each channel consists of two flow cells
arranged in series. When both flow cells are addressed, liquid
flows first over flow cell 1 (Fc1) and then over flow cell 2 (Fc2).
Flow channel See Channel.
Immobilization The term immobilization is used to refer to permanent attach-
ment of ligand or capturing molecule to the sensor surface,
normally by covalent coupling.
Ligand The ligand is the interaction partner attached to the surface.
Attachment may be through covalent coupling (immobiliza-
tion) or high affinity binding to an immobilized capturing mole-
cule (capture).
Note:
Use of the term ligand in Biacore contexts does not imply that
the molecule is a ligand for a cellular receptor.
Parallel flow A flow pattern where liquid flows through all channels in the
same way and at the same time. In the Biacore 8K/8K⁺ system,
the eight channels are arranged in parallel.
Reference
subtraction
Subtraction of the response from the reference surface from
that from the active surface, to eliminate components of the
response that are common to both surfaces.
Reference
surface
The sensor surface in the flow cell used as a reference. This is
normally Fc1.
Regeneration The act of removing all non-covalently attached material from
the sensor surface (usually by injection of a regeneration solu-
tion) in preparation for the next analysis cycle.
1 Introduction
1.4 Glossary
10 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

Term Meaning
Relative
response
The magnitude of the SPR signal relative to a chosen reference
point (usually the baseline before sample injection).
Resonance
unit (RU)
The unit of measurement for the SPR response. A response of
1 RU is roughly equivalent to a change in protein concentration
of 1 pg/mm2 on the surface of Sensor Chip CM5. This correlation
may differ for different molecules and on different sensor chip
surfaces.
Report point Median response over a short window (typically 5 s).
Running buffer Buffer used for continuous flow during an experiment.
Sensor chip A gold-covered glass slide to which one of the interactants (the
ligand) is attached.
Sensor surface The surface of the sensor chip on which the interaction being
studied takes place.
Sensorgram A plot of response against time during one analysis cycle.
Normally, sensorgram refers to a single plot from one channel,
either a single flow cell (reference or active) or the difference
between flow cells (reference-subtracted).
Serial flow A flow pattern where the same liquid flows through two or more
flow cells, one after another. In the Biacore 8K/8K⁺ system, the
two flow cells in each channel can be addressed in series or sepa-
rately.
SPR Surface plasmon resonance (Surface plasmon resonance), the
detection principle used in Biacore instruments.
1 Introduction
1.4 Glossary
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 11

2 Safety instructions
About this chapter
This chapter describes safety precautions, labels and symbols that are attached to the
equipment. In addition, the chapter describes emergency and recovery procedures,
and provides recycling information.
Important
WARNING
Before installing, operating or maintaining the product, all
users must read and understand the entire contents of this
chapter to become aware of the hazards involved.
In this chapter
Section See page
2.1 Safety precautions 13
2.2 Labels 20
2.3 Emergency procedures 22
2 Safety instructions
12 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

2.1 Safety precautions
Introduction
The safety precautions in this section are grouped in the following categories:
•General precautions
•Flammable liquids and explosive environment
•Personal protection
•Installing and moving
•Power supply
•Operation
•Maintenance
•Decommissioning
General precautions
WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Do not operate the product in any other way than described in the
user documentation.
WARNING
Do not use any accessories not supplied or recommended by
Cytiva.
WARNING
Waste liquids may contain hazardous or flammable substances.
Take appropriate precautions to avoid spillage of hazardous waste.
2 Safety instructions
2.1 Safety precautions
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 13

WARNING
Hazardous waste. Waste liquids and used sensor chips may
contain hazardous, flammable or infectious substances. Dispose of
all waste products in accordance with national and local regula-
tions.
CAUTION
Do not block the air inlet and outlet vents on the rear and left side of
the instrument.
Flammable liquids and explosive
environment
WARNING
The product is not intended for use in locations with explosion risks
or fire hazards.
WARNING
Liquids marked as flammable must not be used as running buffer or
pumped reagents. Any buffer or reagent containing flammable
substances must be placed in properly covered positions in micro-
plates.
WARNING
Explosion hazard. To avoid building up an explosive atmosphere
when using flammable liquids, make sure that the room ventilation
meets the local requirements.
Personal protection
WARNING
Always wear appropriate protective clothing and equipment during
operation and maintenance of the product. Use required safety
equipment when handling hazardous substances.
2 Safety instructions
2.1 Safety precautions
14 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

WARNING
Liquids in the buffer bottles or tubing may be toxic or flammable or
may cause chemical burns or irritation to skin and eyes. Take
appropriate precautions in the event of bottle breakage, accidental
spillage and insecure fitting of tubings to bottles.
WARNING
Concentrated disinfectant solutions are corrosive. Use appropriate
personal protective equipment when handling such solutions.
CAUTION
The products that are used with toxic or hazardous substances
shall be marked in accordance with local laws and regulations.
CAUTION
Pinch risk. Take care that fingers are not trapped by moving parts
on the instrument.
CAUTION
Accidental breakage of glass bottles may leave sharp fragments
and splinters that can cause cuts and abrasions.
Installing and moving
WARNING
Heavy package. The delivered instrument package is heavy. Use
suitable lifting and moving equipment to handle the package.
WARNING
Heavy object. Use four or more properly trained persons or suit-
able lifting equipment when moving the instrument. Lifting equip-
ment must not press on the instrument covers. All lifting and
moving must be performed in accordance with local regulations.
2 Safety instructions
2.1 Safety precautions
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 15

WARNING
Use only the lifting rods provided with the system to lift the instru-
ment.
WARNING
Heavy object. The trolley or bench on which the product is
installed must have a load capacity of at least 200 kg.
CAUTION
Wear protective shoes with steel toecaps when moving the instru-
ment to protect against falling objects.
CAUTION
Make sure that hands or fingers are not trapped under the instru-
ment when the instrument is lifted or moved.
CAUTION
Lock the wheels on the trolley before using the instrument.
Power supply
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
Power cord. Use only the power cord delivered with the system.
Do not replace the connectors on the power cord.
2 Safety instructions
2.1 Safety precautions
16 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

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.
Operation
WARNING
A fume hood or similar ventilation system shall be installed when
flammable or noxious substances are used.
WARNING
Heavy objects. Bottles and waste containers with capacity 5 L or
more may be heavy. Take appropriate precautions when lifting.
CAUTION
Do not overload the pull-out shelf on the trolley. The maximum load
capacity is marked on the shelf.
CAUTION
Do not touch the pumps while they are moving.
CAUTION
If buffer and water bottles are placed on a separate bench, make
sure that the instrument and bottles are not moved apart during
operation.
CAUTION
Ensure that all fluidic tubes are secured and properly connected or
sealed at both ends before, during and after operation.
2 Safety instructions
2.1 Safety precautions
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 17

CAUTION
Waste tubes and containers must be secured and sealed to
prevent accidental spillage.
CAUTION
Make sure that the waste container has sufficient space for
maximum waste volume when the equipment is left unattended.
CAUTION
Frequent use of a computer keyboard and/or mouse may cause
repetitive strain injury or disorder. Observe applicable regulations
and recommendations for computer workplace ergonomics.
Maintenance
WARNING
All service and repairs, with the exception of operations explicitly
described in the user documentation, must be carried out by
personnel authorized by Cytiva. Do not open any covers or replace
any parts unless specifically stated in the user documentation.
WARNING
The product contains mains voltage of up to 240 V AC. Disconnect
mains cord before replacing fuses. Do not remove instrument
covers.
WARNING
For continued protection from fire hazard, replace only with same
type and rating of fuse.
WARNING
If the instrument may be contaminated with biohazards, decon-
taminate the instrument before performing maintenance on any
instrument parts. Contact your local service representative for
further information about decontamination procedures.
2 Safety instructions
2.1 Safety precautions
18 Biacore 8K/8K⁺ Operating Instructions 29286967 AC

WARNING
Do not use more than 250 mL 20% ethanol on any single occasion
for maintenance procedures.
WARNING
Explosion risk. Do not run Shutdown or any other maintenance
procedures that use 20% ethanol at sample compartment temper-
atures above 25°C.
Decommissioning
WARNING
Decontaminate the equipment before decommissioning to ensure
that hazardous residues are removed.
2 Safety instructions
2.1 Safety precautions
Biacore 8K/8K⁺ Operating Instructions 29286967 AC 19

2.2 Labels
Introduction
This section describes the various labels found on the product and associated equip-
ment, and explains their meaning.
System label
The system label is located on the back of the equipment. The system label identifies
the equipment and shows electrical data, regulatory compliance, and warning
symbols.
The system label information is explained in the following table.
Symbol Meaning
Warning! Read the Operating Instructions before using the
system. Do not open any covers or replace parts unless specifi-
cally stated in the user documentation.
This symbol indicates that electrical and electronic equipment
must not be disposed of as unsorted municipal waste and must
be collected separately. Please contact an authorized represen-
tative of the manufacturer for information concerning the
decommissioning of equipment.
This symbol indicates that the product contains hazardous mate-
rials in excess of the limits established by the Chinese standard
GB/T 26572 Requirements of concentration limits for certain
hazardous substances in electrical and electronic products.
This symbol indicates that the system complies with applicable
European directives.
This symbol indicates that the system complies with applicable
requirements for Australia and New Zealand.
This symbol indicates RRA registration of compatibility in Korea.
The registration number of the product will appear beside the
symbol.
Eurasian Conformity mark: the single conformity mark indicates
that the product is approved for circulation on the markets of the
member states of the Eurasian Customs Union.
2 Safety instructions
2.2 Labels
20 Biacore 8K/8K⁺ Operating Instructions 29286967 AC