cytiva Biacore X100 User manual

Biacore™ X100
Operating Instructions
Original instructions
cytiva.com

Table of Contents
1Introduction ........................................................................................................ 4
1.1 Important user information ....................................................................................................................... 5
1.2 About this manual ......................................................................................................................................... 6
1.3 Associated documentation ....................................................................................................................... 7
2 Safety instructions ............................................................................................. 8
2.1 Safety precautions ........................................................................................................................................ 9
2.2 Labels ................................................................................................................................................................. 15
2.3 Emergency procedures ............................................................................................................................... 16
3 System description ............................................................................................ 18
3.1 Biacore X100 instrument ............................................................................................................................ 19
3.2 Indicators and switches ............................................................................................................................... 23
3.3 Sensor chip ....................................................................................................................................................... 24
3.4 Control system ............................................................................................................................................... 25
4 Installation .......................................................................................................... 26
4.1 Site requirements .......................................................................................................................................... 27
4.2 Unpacking, assembly and transport ....................................................................................................... 30
4.3 Connections ..................................................................................................................................................... 31
5 Operation ............................................................................................................ 33
5.1 Overview ............................................................................................................................................................ 35
5.2 Starting the instrument ............................................................................................................................... 36
5.3 Preparing, loading and changing buffers .............................................................................................. 39
5.4 Inserting a sensor chip ................................................................................................................................. 40
5.5 Setting the analysis temperature ............................................................................................................ 42
5.6 Preparing and loading samples and reagents .................................................................................... 43
5.7 Starting a run ................................................................................................................................................... 45
5.8 Post-run procedures ..................................................................................................................................... 46
6 Maintenance ....................................................................................................... 47
6.1 Maintenance preparations ........................................................................................................................ 49
6.2 Maintenance summary ............................................................................................................................... 50
6.3 Cleaning ............................................................................................................................................................ 51
6.4 Component maintenance .......................................................................................................................... 55
6.5 Replacing the mains fuses .......................................................................................................................... 56
6.6 Calibration ........................................................................................................................................................ 58
6.7 Storage .............................................................................................................................................................. 59
7 Troubleshooting ................................................................................................. 61
7.1 Instrument related problems .................................................................................................................... 62
7.2 Other problems .............................................................................................................................................. 66
8 Reference information ....................................................................................... 67
8.1 Specifications .................................................................................................................................................. 68
Table of Contents
Biacore X100 Operating Instructions 28961142 AF 2

8.2 Chemical resistance ..................................................................................................................................... 70
8.3 Recycling information .................................................................................................................................. 71
8.4 Regulatory information ............................................................................................................................... 72
8.4.1 Contact information .................................................................................................................................... 73
8.4.2 European Union and European Economic Area .............................................................................. 74
8.4.3 Great Britain ................................................................................................................................................... 75
8.4.4 Eurasian Economic Union (Евразийский экономический союз) .......................................... 76
8.4.5 North America ............................................................................................................................................... 78
8.4.6 China .................................................................................................................................................................. 79
8.4.7 General regulatory statements .............................................................................................................. 82
8.4.8 Other regulations and standards .......................................................................................................... 83
8.5 Ordering information ................................................................................................................................... 84
8.6 Health and Safety Declaration Form ...................................................................................................... 85
Index ........................................................................................................................... 87
Table of Contents
Biacore X100 Operating Instructions 28961142 AF 3

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regu-
latory information, intended use of the Biacore™ X100, and lists of associated docu-
mentation.
In this chapter
Section See page
1.1 Important user information 5
1.2 About this manual 6
1.3 Associated documentation 7
1 Introduction
Biacore X100 Operating Instructions 28961142 AF 4

1.1 Important user information
Introduction
This section contains important user information about the product and this manual.
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 install, operate, or perform maintenance on the product in any other way than
described in the user documentation. If you do, you may be exposed or expose others
to hazards that can lead to personal injury and you may cause damage to the equip-
ment.
Intended use of the product
Biacore X100 is a system for real-time label-free analysis of molecular interactions in
laboratory research. Biacore X100 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 Biacore X100 in the way it is intended:
•The user must read and understand the Safety instructions chapter in the Operating
Instructions.
•The system must be installed according to the instructions in the Installation
chapter of the Operating Instructions.
•The user must have a general understanding of the use of a personal computer
running Microsoft Windows in the version provided with your product.
•The user must 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 data-
bases is recommended. Familiarity with database management is not required for
operation of Biacore X100.
1 Introduction
1.1 Important user information
Biacore X100 Operating Instructions 28961142 AF 5

1.2 About this manual
Introduction
This section contains information about the purpose and scope of this manual, notes
and tips, and typographical conventions.
Purpose of this manual
This manual provides information needed to install, operate and maintain the product
in a safe way.
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.
Typographical conventions
Software items are identified in the text by bold italic text.
Hardware items are identified in the text by bold text.
Tip: The text can include clickable hyperlinks to reference information.
1 Introduction
1.2 About this manual
Biacore X100 Operating Instructions 28961142 AF 6

1.3 Associated documentation
Introduction
This section describes the user documentation 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 Biacore X100 are listed in the table
below. Translations of the Biacore X100 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/biacore.
You need to register on the website to access some of these documents.
Documentation Main contents
Biacore X100 Operating Instructions
(this manual)
Instructions needed to install, operate,
and maintain Biacore X100 in a safe
way.
Biacore X100 Handbook, BR100801 Detailed system description and
instructions for preparing, running, and
evaluating experiments.
Biacore X100 Site Preparation Guide,
29145041
Requirements for space, power, and
environmental conditions for installing
and running Biacore X100.1
Biacore X100 Installation Instructions,
29288193
Instructions for installing or upgrading
the software and database.¹
Biacore Application Guides General methodology for Biacore X100,
such as principles of kinetics and affinity
analysis, sensor surface preparation,
and concentration measurements.
Support Navigator On-screen assistance for using
Biacore X100 control and evaluation
software.
1These instructions are not required for normal use of Biacore X100.
1 Introduction
1.3 Associated documentation
Biacore X100 Operating Instructions 28961142 AF 7

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.
In this chapter
Section See page
2.1 Safety precautions 9
2.2 Labels 15
2.3 Emergency procedures 16
Important
WARNING
All users must read and understand the entire contents of
this general safety chapter, and the specific safety precau-
tions information in each subsequent chapter of this manual
to become aware of the hazards involved.
2 Safety instructions
Biacore X100 Operating Instructions 28961142 AF 8

2.1 Safety precautions
Introduction
Biacore X100 is powered by mains voltage and handles materials that can be
hazardous. Before installing, operating or maintaining the system, you must be aware
of the hazards described in this manual.
Follow the instructions to avoid injury to the operator or other personnel,
damage to samples or other substances handled by the equipment, to the
product, or to other equipment in the area.
The safety precautions in this section are grouped in the following categories:
•General precautions
•Flammable liquids and explosive environment
•Personal protection
•Installing and moving the product
•Operation
•Maintenance
Definitions
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.
2 Safety instructions
2.1 Safety precautions
Biacore X100 Operating Instructions 28961142 AF 9

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
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
Use only mains cables supplied or approved by Cytiva.
WARNING
Do not block the rear or side panels of the instrument. The power
switch must always be easy to access. The power cord must always
be easy to disconnect.
WARNING
Decontaminate the equipment before decommissioning to make
sure that hazardous residues are removed.
2 Safety instructions
2.1 Safety precautions
Biacore X100 Operating Instructions 28961142 AF 10

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
Waste tubes and containers must be secured and sealed to
prevent accidental spillage.
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 capped vials in the sample
rack.
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
Biacore X100 Operating Instructions 28961142 AF 11

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.
CAUTION
The products that are used with toxic or hazardous substances
must 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 the product
CAUTION
Wear protective shoes with steel toecaps when moving the instru-
ment to protect against falling objects.
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.
CAUTION
Make sure that hands or fingers are not trapped under the instru-
ment when the instrument is lifted or moved.
2 Safety instructions
2.1 Safety precautions
Biacore X100 Operating Instructions 28961142 AF 12

Operation
WARNING
Handle bottles carefully. Accidental breakage of buffer or water
bottles may cause flooding of the bottle tray, and liquid may come
into contact with electrical circuits, causing electric shock and/or
fire hazards.
WARNING
A fume hood or similar ventilation system shall be installed when
flammable or noxious substances are used.
CAUTION
Accidental breakage of buffer or water bottles may cause flooding
of the bottle tray, and liquid may enter the instrument enclosure. If
this happens, disconnect the instrument from the mains power and
call your local service representative.
CAUTION
Do not touch the pumps while they are moving.
CAUTION
Make sure that the waste container has sufficient space for
maximum waste volume when the equipment is left unattended.
CAUTION
Make sure 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 X100 Operating Instructions 28961142 AF 13

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
The injection needle is sharp. Take care when working in the
sample compartment.
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
Biacore X100 Operating Instructions 28961142 AF 14

2.2 Labels
Introduction
This section describes the system label and other safety or regulatory labels that are
attached to the product.
Nameplate
The nameplate provides information about the model, manufacturer, and technical
data.
Description of symbols on the system
label
The following symbols may be present on the system label.
Symbol/text Meaning
Warning! Read the user documentation before using the system.
Do not open any covers or replace parts unless specifically stated
in the user documentation.
Product no Instrument catalog number
Code no Instrument assembly number
Serial no Instrument serial number
Mfg. Date Year (YYYY) and month (MM) of manufacture
Voltage Electrical rating: Mains voltage (VAC )
Frequency Electrical rating: Frequency (Hz)
Max Power Electrical rating: Maximum power (VA)
Fuse rating Fuse rating: number of fuses, type T (slow acting), trip current (A),
breaking capacity H (high), or maximum voltage (V)
2 Safety instructions
2.2 Labels
Biacore X100 Operating Instructions 28961142 AF 15

2.3 Emergency procedures
Introduction
This section describes how to shut down the Biacore X100 system in an emergency
situation, and the procedure for restarting the Biacore X100 system.
The section also describes the result in the event of power failure.
NOTICE
Do not use the acute emergency stop procedure unless there is a
risk of injury, damage or loss of valuable material. All operations
including buffer flow and data collection are stopped immediately.
To stop a run under controlled conditions before it is complete, choose Run →Stop
Run Sensorgram from the menu bar in Biacore X100 Control Software . This will stop
both the run and the data collection at the end of the current cycle. A dialog is
displayed while the current cycle is finished.
Emergency shutdown
In an emergency situation, follow the steps below to stop the run.
Step Action
1Press Ctrl-Break (Ctrl-Pause) on the keyboard to stop the run and the data
collection immediately.
2In the dialog box that appears, click Yes if you want to wash the system with
running buffer. You should do this if possible. The wash operation takes
about 3 minutes.
NOTICE
Do not leave the system in an emergency stop condition. Always
follow the restart procedure if possible, to restore the instrument
to normal condition.
2 Safety instructions
2.3 Emergency procedures
Biacore X100 Operating Instructions 28961142 AF 16

Power failure
The following table describes the consequences of a power failure.
Power failure
to...
will result in...
Biacore X100
instrument
•The run is interrupted immediately.
•Data collected up to and including the last cycle completed
before the power failure is saved in the result file.
Computer •The computer shuts down immediately.
•Instrument operation continues for a short time (until the
internal data buffer is full) and then stops.
•Data collected up to and including the last cycle completed
before the power failure is saved in the result file, but there
is a risk that the result file may be corrupt and cannot be
read.
Restart procedure
Follow the steps below to restart the system after an emergency shutdown.
Step Action
1Turn on mains power if it is switched off and check that the instrument starts
normally.
2If you need to clean the liquid handling system, eject the sensor chip and
insert a maintenance chip. See Section 6.3 Cleaning, on page 51 for further
instructions.
2 Safety instructions
2.3 Emergency procedures
Biacore X100 Operating Instructions 28961142 AF 17

3 System description
About this chapter
This chapter gives an overview of the Biacore X100 system, and a brief description of its
function.
In this chapter
Section See page
3.1 Biacore X100 instrument 19
3.2 Indicators and switches 23
3.3 Sensor chip 24
3.4 Control system 25
3 System description
Biacore X100 Operating Instructions 28961142 AF 18

3.1 Biacore X100 instrument
Main parts of the instrument
The main parts of the instrument are identified below.
1
3
2
4
5
6
7
8
9
10
Part Function
1 Status indicators
2 Lower front door with pump compartment and optional degasser
(included in Biacore X100 Plus Package) behind
3 Buffer tubes
4 Buffer bottle
5 Buffer tray
6 Upper front door with sensor chip port behind
7 Sample compartment with sample rack
8 Waste tubing
9 Waste bottle
10 Waste tray
3 System description
3.1 Biacore X100 instrument
Biacore X100 Operating Instructions 28961142 AF 19

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
Waste liquids may contain hazardous or flammable substances.
Take appropriate precautions to avoid spillage of hazardous waste.
CAUTION
Accidental breakage of buffer or water bottles may cause flooding
of the bottle tray, and liquid may enter the instrument enclosure. If
this happens, disconnect the instrument from the mains power and
call your local service representative.
CAUTION
Waste tubes and containers shall be secured and sealed to prevent
accidental spillage.
Sample compartment
1
2
3
4
5
6
3 System description
3.1 Biacore X100 instrument
Biacore X100 Operating Instructions 28961142 AF 20