GE Biacore X100 User manual

Biacore™X100
Operating Instructions
Original instructions

Table of Contents
41 Introduction ..........................................................................................................
51.1 About this manual ................................................................................................................................
61.2 Important user information .............................................................................................................
81.3 Regulatory information ......................................................................................................................
91.3.1 EU Directives ....................................................................................................................................
101.3.2 Eurasian Customs Union ............................................................................................................
111.3.3 Regulations for USA and Canada ...........................................................................................
121.3.4 Korean regulatory information ................................................................................................
131.3.5 Other regulations and standards ............................................................................................
151.4 Associated documentation ..............................................................................................................
162 Safety instructions ...............................................................................................
172.1 Safety precautions ...............................................................................................................................
232.2 Labels .........................................................................................................................................................
262.3 Emergency procedures ......................................................................................................................
282.4 Recycling information .........................................................................................................................
292.5 Declaration of Hazardous Substances (DoHS) ........................................................................
313 System description ..............................................................................................
323.1 Biacore X100 instrument ..................................................................................................................
363.2 Indicators and switches ....................................................................................................................
373.3 Sensor chip ..............................................................................................................................................
383.4 Control system .......................................................................................................................................
394 Installation ............................................................................................................
404.1 Site requirements ..................................................................................................................................
434.2 Unpacking, assembly and transport ...........................................................................................
444.3 Connections ............................................................................................................................................
465 Operation ..............................................................................................................
495.1 Overview ...................................................................................................................................................
505.2 Starting the instrument ......................................................................................................................
535.3 Preparing, loading and changing buffers .................................................................................
545.4 Inserting a sensor chip .......................................................................................................................
565.5 Setting the analysis temperature ..................................................................................................
575.6 Preparing and loading samples and reagents .......................................................................
595.7 Starting a run ..........................................................................................................................................
605.8 Post-run procedures ...........................................................................................................................
616 Maintenance .........................................................................................................
636.1 Maintenance preparations ...............................................................................................................
656.2 Maintenance summary ......................................................................................................................
666.3 Cleaning ....................................................................................................................................................
706.4 Component maintenance ................................................................................................................
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Table of Contents

716.5 Replacing the mains fuses ...............................................................................................................
736.6 Calibration ................................................................................................................................................
746.7 Storage ......................................................................................................................................................
777 Troubleshooting ...................................................................................................
787.1 Instrument related problems ..........................................................................................................
827.2 Other problems ......................................................................................................................................
838 Reference information ........................................................................................
848.1 Specifications .........................................................................................................................................
878.2 Chemical resistance ............................................................................................................................
888.3 Health and Safety Declaration Forms .........................................................................................
90Appendix A Software tool texts ............................................................................
91Index .......................................................................................................................
Biacore X100 Operating Instructions 28961142 AD 3
Table of Contents

1 Introduction
About this chapter
This chapter contains important user information, descriptions of safety notices, regula-
tory information, intended use of the Biacore X100 system, and lists of associated docu-
mentation.
In this chapter
See pageSection
51.1 About this manual
61.2 Important user information
81.3 Regulatory information
151.4 Associated documentation
4 Biacore X100 Operating Instructions 28961142 AD
1 Introduction

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.
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 (for example, Power).
Biacore X100 Operating Instructions 28961142 AD 5
1 Introduction
1.1 About this manual

1.2 Important user information
Read this before operating the
product
All users must read the entire Operating Instructions before installing, operating or
maintaining the product.
Always keep the Operating Instructions at hand when operating the product.
Do not operate the product in any other way than described in the user documentation.
If you do, you may be exposed to hazards that can lead to personal injury and you may
cause damage to the equipment.
Intended use 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.
6 Biacore X100 Operating Instructions 28961142 AD
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:
Biacore X100 Operating Instructions 28961142 AD 7
1 Introduction
1.2 Important user information

1.3 Regulatory information
Introduction
This section lists the regulations and standards that apply to the Biacore X100 system.
Manufacturing information
The table below summarizes the required manufacturing information.
InformationRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala, Sweden
In this section
See pageSection
91.3.1 EU Directives
101.3.2 Eurasian Customs Union
111.3.3 Regulations for USA and Canada
121.3.4 Korean regulatory information
131.3.5 Other regulations and standards
8 Biacore X100 Operating Instructions 28961142 AD
1 Introduction
1.3 Regulatory information

1.3.1 EU Directives
Introduction
This section describes the EU Directives that apply to the Biacore X100 instrument.
Conformity with EU Directives
This product fulfills the European Directives listed below. See the EU Declaration of
Conformity for the directives and regulations that apply for the CE marking.
If not included with the product, a copy of the EU Declaration of Conformity is available
on request.
TitleDirective
Machinery Directive (MD)2006/42/EC
Electromagnetic Compatibility (EMC) Directive2014/30/EU
Low Voltage Directive (LVD)2014/35/EU
Restriction of Hazardous Substances (RoHS) Directive2011/65/EU
CE marking
The CE marking and the corresponding EU Declaration of Conformity is valid for the in-
strument when it is:
•used according to the Operating Instructions or user manuals, and
•used in the same state as it was delivered from GE, except for alterations described
in the Operating Instructions or user manuals.
Biacore X100 Operating Instructions 28961142 AD 9
1 Introduction
1.3 Regulatory information
1.3.1 EU Directives

1.3.2 Eurasian Customs Union
Introduction
This section contains additional regulatory information to comply with the Eurasian
Customs Union technical regulations.
Manufacturer and importer
information
The table below summarizes the manufacturer and importer information required by
the Eurasian Customs Union.
InformationRequirement
See Manufacturing informationName and address of manufacturer
Telephone: + 46 771 400 600Telephone number of manufacturer
GE Healthcare LLCImporter and/or company for obtain-
ing information about importer GE Healthcare Life Sciences
Presnenskaya nab., 10C, 12th floor
RU-123 317 Moscow, Russian Federation
Telephone 1: + 7 495 411 9714
Fax nr: + 7 495 739 6932
Email: [email protected]
10 Biacore X100 Operating Instructions 28961142 AD
1 Introduction
1.3 Regulatory information
1.3.2 Eurasian Customs Union

1.3.3 Regulations for USA and Canada
Introduction
This section describes the regulations that apply to the Biacore X100 instrument in the
USA and Canada.
NRTL certification
This symbol indicates that the product has been certified by Intertek, which is a US Oc-
cupational Safety and Health Administration Nationally Recognized Testing Laboratory
(NRTL).
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.
CAN ICES/NMB compliance
This product complies with the Canadian standard ICES-001/NMB-001 concerning
electromagnetic compatibility.
Biacore X100 Operating Instructions 28961142 AD 11
1 Introduction
1.3 Regulatory information
1.3.3 Regulations for USA and Canada

1.3.4 Korean regulatory information
NOTICE
Class A equipment (equipment for business use).
This equipment has been evaluated for its suitability for use in a
business environment.
When used in a residential environment, there is a concern of radio
interference.
주의사항
A급 기기 (업무용 방송통신 기자재)
이 기기는 업무용환경에서 사용할 목적으로 적합성평가를 받은
기기
로서 가정용 환경에서 사용하는 경우 전파간섭의 우려가 있습니
다.
12 Biacore X100 Operating Instructions 28961142 AD
1 Introduction
1.3 Regulatory information
1.3.4 Korean regulatory information

1.3.5 Other regulations and standards
Introduction
This section describes the standards that apply to the Biacore X100 system.
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
Management Methods for the Restriction of the Use of Haz-
ardous Substances in Electrical and Electronic Products.
China RoHS
Standards, applied to this
product
Standard requirements fulfilled by this product are summarized in the table below.
DescriptionStandard
Safety of machinery. General principles for design. Risk
assessment and risk reduction.
EN ISO 12100
Safety requirements for electrical equipment for mea-
surement, control, and laboratory use - Part 1: General
requirements.
IEC/EN 61010-1, UL
61010-1, CAN/CSA-C22.2
No. 61010-1
Particular requirements for automatic and semi-auto-
matic laboratory equipment for analysis and other pur-
poses
IEC/EN 61010-2-081, UL
61010-2-081, CAN/CSA-
C22.2 No. 61010-2-081
Electrical Equipment for Measurement, Control, and
Laboratory Use-EMC requirements-Part 1: General re-
quirements
EN 61326-1
Emission according to CISPR 11, Group 1, class A
Industrial, Scientific and Medical (ISM) Radio Frequency
Generators (Canada)
ICES-001/NMB-001
Biacore X100 Operating Instructions 28961142 AD 13
1 Introduction
1.3 Regulatory information
1.3.5 Other regulations and standards

DescriptionStandard
Technical documentation for the assessment of electrical
and electronic products with respect to the restriction
of hazardous substances
EN 50581
NOTICE
This equipment is not intended for use in residential environments
and may not provide adequate protection to radio reception in
such environments.
Regulatory compliance of
connected equipment
Any equipment connected to Biacore X100 should meet the safety requirements of
IEC/EN/UL/CSA 61010-1, IEC/EN/UL/CSA 60950-1, or other relevant national safety reg-
ulations and standards. The equipment should be installed and used according to the
manufacturer's instructions. Within EU, connected equipment must be CE marked.
14 Biacore X100 Operating Instructions 28961142 AD
1 Introduction
1.3 Regulatory information
1.3.5 Other regulations and standards

1.4 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 GE.
User documentation
Biacore X100 system together with operation of the Control and Evaluation Software is
described in full in the Biacore X100 Handbook.
Sensor surface preparation and general methodology for Biacore applications are de-
scribed in the Biacore Sensor Surface Handbook and the Biacore Assay Handbook respec-
tively. Methodology for concentration measurement using Biacore systems is described
in the Biacore Concentration Analysis Handbook.
Data files, application notes and
user documentation on the web
To order or download data files, application notes or user documentation, see the instruc-
tion below.
ActionStep
Go to www.gelifesciences.com/biacore.1
Click Biacore X100.2
Click RELATED DOCUMENTS.3
Select to download the chosen literature.4
Biacore X100 Operating Instructions 28961142 AD 15
1 Introduction
1.4 Associated documentation

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
See pageSection
172.1 Safety precautions
232.2 Labels
262.3 Emergency procedures
282.4 Recycling information
292.5 Declaration of Hazardous Substances (DoHS)
16 Biacore X100 Operating Instructions 28961142 AD
2 Safety instructions

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
General precautions
WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Do not operate the Biacore X100 system in any other way than
described in the user documentation.
WARNING
Do not use any accessories not supplied or recommended by GE.
Biacore X100 Operating Instructions 28961142 AD 17
2 Safety instructions
2.1 Safety precautions

WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
Use only mains cables supplied or approved by GE.
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 ensure
that hazardous residues are removed.
WARNING
Hazardous waste. Waste liquids and used sensor chips may con-
tain hazardous, flammable or infectious substances. Dispose of all
waste products in accordance with national and local regulations.
CAUTION
Waste tubes and containers must be secured and sealed to prevent
accidental spillage.
18 Biacore X100 Operating Instructions 28961142 AD
2 Safety instructions
2.1 Safety precautions

Flammable liquids and explosive
environment
WARNING
The Biacore X100 system 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 Biacore X100 system. Use re-
quired safety equipment when handling hazardous substances.
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.
Biacore X100 Operating Instructions 28961142 AD 19
2 Safety instructions
2.1 Safety precautions

CAUTION
Biacore X100 systems that are used with toxic or hazardous sub-
stances shall be marked in accordance with local laws and regula-
tions.
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.
20 Biacore X100 Operating Instructions 28961142 AD
2 Safety instructions
2.1 Safety precautions