637.2Faults and actions ................................................................................................................................
This chaptercontains important userinformation,descriptions of safetynotices,regulatory information, intended use of the Monitor UV-900 system, and lists of associated
documentation.
In this chapter
See pageSection
41.1 About this manual
51.2 Important user information
61.3 Regulatory information
1.1About this manual
Purpose of the Operating
Instructions
The Operating Instructions provides you with the instructions needed to handle Monitor
UV-900 in a safe way.
Typographical conventions
Software items areidentifiedin the textby bold italic text. A colonseparatesmenu 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).
101.4 User documentation
4Monitor UV-900 Operating Instructions 28962214 AD
1.2Important 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
Monitor UV-900 is a UV-absorbtion monitor for use in liquid chromatograhy.
Monitor UV-900 is intended for research use only, and shall not be used in any clinical
procedures, or for diagnostic purposes.
1 Introduction
1.2 Important user information
Prerequisites
In order to operate Monitor UV-900 in the way it is intended:
•
The user must have a general understanding of bioprocessing equipment and with
the handling of biological materials.
•
The user should understand the concepts of liquid chromatography.
•
The usermust read andunderstand the SafetyInstructions chapter inthe Operating
Instructions.
•
Monitor UV-900 must be installed in accordance with the site requirements and instructions in the Operating Instructions.
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 resultin death orserious injury. Itis important notto 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:
Tip:
A note is used to indicate information that is important for trouble-free and
optimal use of the product.
A tip contains useful informationthat can improve or optimize your procedures.
1.3Regulatory information
Introduction
This section lists the regulations and standards that apply to the Monitor UV-900.
6Monitor UV-900 Operating Instructions 28962214 AD
Manufacturing information
The table below summarizes the required manufacturing information.
In this section
1 Introduction
1.3 Regulatory information
1.3.1 EU Directives
InformationRequirement
GE Healthcare Bio-Sciences AB,Name and address of manufacturer
Björkgatan 30, SE 751 84 Uppsala, Sweden
See pageSection
71.3.1 EU Directives
81.3.2 Eurasian Customs Union
91.3.3 Regulations for USA and Canada
91.3.4 Other regulations and standards
1.3.1EU Directives
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.
The CE marking and the corresponding EU Declaration of Conformity is valid for the instrument 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.
1.3.2Eurasian 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.
ing information about importer
InformationRequirement
See Manufacturing informationName and address of manufacturer
Telephone: + 46 771 400 600Telephone number of manufacturer
GE Healthcare LLCImporter and/orcompany for obtain-
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: LSrus@ge.com
8Monitor UV-900 Operating Instructions 28962214 AD
1.3.3Regulations for USA and Canada
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 acceptanyinterferencereceived,includinginterferencethatmaycauseundesired
operation.
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 reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipmentgenerates,uses,and can radiateradiofrequency energy and, if notinstalled 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 required to correct the interference at his own expense.
The user is cautioned that anychanges or modifications not expressly approved
by GE could void the user’s authority to operate the equipment.
1 Introduction
1.3 Regulatory information
1.3.3 Regulations for USA and Canada
CAN ICES/NMB compliance
This product complies with the Canadian standard ICES-001/NMB-001 concerning
electromagnetic compatibility.
1.3.4Other regulations and standards
Introduction
This section describes the standards that apply to the Monitor UV-900 system.
Environmental conformity
This product conforms to the following environmental requirements.
TitleRequirement
Waste Electrical and Electronic Equipment (WEEE) Directive2012/19/EU
China RoHS
Management Methods for the Restriction of the Use of Hazardous Substances in Electrical and Electronic Products.
Standard requirements fulfilled by this product are summarized in the table below.
DescriptionStandard
EN ISO 12100
EN 61010-1, IEC 61010-1,
UL 61010-1, CAN/CSAC22.2 No. 61010-1
EN 61326-1
ICES-001/NMB-001
Safety of machinery. General principles for design. Risk
assessment and risk reduction.
Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General
requirements.
Electrical Equipment for Measurement, Control, and
Laboratory Use-EMC requirements-Part 1: General requirements
(Emission according to CISPR 11, Group 1, class A)
NOTICE
This equipmentis not intended for
use in residential environments
and may not provide adequate
protection to radio reception in
such environments.
Industrial, Scientific and Medical (ISM) Radio Frequency
Generators (Canada)
1.4User documentation
In addition to these Operating Instructions, the documentation package supplied with
Monitor UV-900 also includes product documentation binders containing detailed
specifications and traceability documents.
The mostimportantdocuments in thedocumentpackagewithregardtotechnicalaspects
of Monitor UV-900 are listed below.
10Monitor UV-900 Operating Instructions 28962214 AD
System-specific documentation
1 Introduction
1.4 User documentation
ContentUser documentation
Monitor UV-900 Operating
Instructions
Monitor UV-900 User Manual
EU DeclarationofConformity for
Monitor UV-900
System description. User instructions, method
creation, operation, maintenance and troubleshooting.
Detailed system description. Comprehensive user
instructions, method creation, operation, advanced maintenance and troubleshooting.
Document whereby the manufacturer ensures
that theproductsatisfies and isin conformity with
the essentialrequirementsofthe applicable directives.
This chapter describes safety compliance, safety labels, general safety precautions,
emergency procedures, power failure and recycling of Monitor UV-900.
In this chapter
This chapter contains the following sections:
See pageSection
122.1 Safety precautions
172.2 Labels
192.3 Emergency procedures
2.1Safety precautions
Introduction
The Monitor UV-900 is powered by mains voltage and handles pressurized liquids that
may be hazardous. Before installing,operating or maintaining the monitor, you mustbe
aware of the hazards described inthis manual. Followthe instructionsprovidedto avoid
personal injury or damage to the equipment. The safety precautions in this section are
grouped into the following categories:
•
General precautions
•
Using flammable liquids
•
Personal protection
•
Installing and moving the instrument
•
System operation
202.4 Procedures for decommissioning
212.5 Declaration of Hazardous Substances (DoHS)
12Monitor UV-900 Operating Instructions 28962214 AD
•
Maintenance
General precautions
Always follow these Generalprecautions to avoid injury when using theMonitor UV-900
instrument.
2 Safety instructions
2.1 Safety precautions
WARNING
Do not operate Monitor UV-900 in any other way than described
in the Monitor UV-900 manual.
WARNING
Only properly trained personnel may operate and maintain the
product.
WARNING
Do not use any accessories not supplied or recommended by GE.
WARNING
Do not use Monitor UV-900 if it is not working properly, or if it has
suffered any damage, for example:
When using flammable liquids with the Monitor UV-900, follow these precautions to
avoid any risk of fire or explosion.
Personal protection
WARNING
Fire Hazard. Before starting the system, make sure that there is
no leakage.
WARNING
A fume hood or similar ventilation system shall be installed when
flammable or noxious substances are used.
WARNING
Always useappropriatePersonalProtectiveEquipment(PPE) during
operation and maintenance of this product.
WARNING
Hazardous substances and biological agents. When using haz-
ardous chemicaland biologicalagents, take all suitableprotective
measures, such aswearingprotectiveclothing,glasses and gloves
resistant to the substances used. Follow local and/or national
regulations for safeoperationand maintenance ofMonitorUV-900.
WARNING
Spread of biological agents. The operatormust take all necessary
actions toavoid spreading hazardous biological agents.Thefacility
must comply with the national code of practice for biosafety.
14Monitor UV-900 Operating Instructions 28962214 AD
Installing and moving the
instrument
2 Safety instructions
2.1 Safety precautions
WARNING
Supply voltage. Before connectingthepowercord,makesurethat
the supply voltage at the wall outlet corresponds to the marking
on the instrument.
WARNING
Protective ground. The product must always be connected to a
grounded power outlet.
WARNING
Power cord. Only use power cords with approved plugs delivered
or approved by GE.
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.
WARNING
High intensity UV light.This product useshighintensity ultra-violet
light. Do not disconnect the optical fibers while the lamp is on.
CAUTION
Make sure that the system is placed on a stable, level bench with
adequate space for ventilation.
If liquid is spilled on the equipment, the electrical power supply
must be disconnected immediately. The equipmentmust be completely dry on the inside and the outside before reconnecting the
power supply.
WARNING
Hazardous biological agents during run. When using hazardous
biological agents, run System CIP and Column CIP to flush the
entire pump with bacteriostatic solution (e.g. 1M NaOH) followed
by a neutral buffer and finally distilled water, before service and
maintenance.
WARNING
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.
Maintenance
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.
WARNING
Use only approved parts. Only spare parts and accessories that
are approved or supplied by GE may be used for maintaining or
servicing the product.
16Monitor UV-900 Operating Instructions 28962214 AD
2 Safety instructions
2.1 Safety precautions
WARNING
Corrosive substance. NaOH is corrosive and therefore dangerous
to health. When using hazardous chemicals, avoid spillage and
wear protective glasses and other suitable Personal Protective
Equipment (PPE).
WARNING
When using hazardous chemicals, make sure that the entire flow
cell has been flushed thoroughly with bacteriostatic solution, for
example NaOH, and distilled water, before service and maintenance.
WARNING
When usinghazardouschemicals,makesurethat the entire system
has beenflushedthoroughlywith bacteriostatic solution,e.g.NaOH,
and distilled water before service and maintenance.
WARNING
Disconnect power. Always disconnectpower from theinstrument
before replacing any component on the instrument, unless stated
otherwise in the user documentation.
2.2Labels
Introduction
This section describes the system label on Monitor UV-900 and its meaning.
The system label information is explained in the table.
The specific data shown on the system label below is only an example. Actual
data is specific for each individual system and may varyfrom system tosystem.
DescriptionLabel text
Code number.Code no:
Serial number.Serial no:
Year (YYYY) and month (MM) of manufacture.Mfg Year:
Voltage.Voltage:
Supply voltage frequency.Frequency:
Max power.Max power:
Warning! Read the user documentation before using
the system. Do not open any covers or replace parts
unless specifically stated in the user documentation.
This symbolindicates that waste electricaland electronic equipmentmust not bedisposed as unsorted municipal waste and must be collected separately. Please
contact an authorized representative of the manufacturer for information concerning the decommissioning
of equipment.
18Monitor UV-900 Operating Instructions 28962214 AD
2 Safety instructions
2.2 Labels
DescriptionLabel text
This symbol indicates that the product contains hazardous materials 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.
The system complies with applicable European directives.
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.
The system complies with the requirements for
electromagnetic compliance (EMC) inAustralia and New
Zealand.
CAN ICES-1/NMB-1
CAN ICES-1/NMB-1indicates that this product complies
with the Canadian standard ICES-001 concerning
technical requirements relative to radiated noise emissions from Industrial, Scientific and Medical radio frequency generators.
This symbol indicates that Monitor UV-900 has been
certified bya Nationally Recognized Testing Laboratory
(NRTL). NRTL meansan organization,which is recognized
by the US Occupational Safety and Health Administration (OSHA) as meeting the legal requirements of Title
29 of the Code of Federal Regulations (29 CFR), Part
1910.7.
2.3Emergency procedures
Introduction
This section describes how to perform an emergency shutdown of Monitor UV-900. The
section also describes the result in the event of power failure.
In an emergency situation, do as follows to stop the run:
Switch off power to the instrument by switching the On/off switch on the rear panel to
the (O) position. If required, disconnect the mains power cord. The run is interrupted
immediately.
Power failure
In the event of power failure the run is interrupted immediately.
2.4Procedures for decommissioning
Introduction
This section contains information about the decommissioning of Monitor UV-900.
Decontamination
The product must be decontaminated before decommissioning. All local regulations
must be followed with regard to scrapping of the equipment.
Disposal of the product
When taking the product out of service, the different materials must be separated and
recycled according to national and local environmental regulations.
Recycling of hazardous
substances
Monitor UV-900 contains hazardous substances. Detailed information is available from
your GE representative.
20Monitor UV-900 Operating Instructions 28962214 AD
2 Safety instructions
2.4 Procedures for decommissioning
Disposal of electrical
components
Waste ofelectrical and electronic equipment mustnot be disposed as unsortedmunicipal
waste and must be collected separately. Please contact an authorized representative
of the manufacturer for information concerning the decommissioning of equipment.
The following product pollution control information is provided according to SJ/T11364-2014 Marking
for Restriction of Hazardous Substances caused by electrical and electronic products.
This symbolindicates the product containshazardous materials in excess ofthe limits
established by the Chinese standard GB/T 26572 Requirements of concentration
limits for certain restricted substances in electrical and electronic products. The
number in the symbol is the Environment-friendly Use Period (EFUP), which indicates
the period during which the hazardous substances contained in electrical and electronic products will not leak or mutateunder normal operatingconditions so that the
use ofsuch electrical andelectronic productswill not result inany severe environmental pollution,any bodily injuryor damage toany assets. Theunit of theperiod is “Year”.
In order to maintain the declared EFUP, the product shall be operated normally according to the instructions and environmental conditions as defined in the product
manual, and periodic maintenance schedules specified in Product Maintenance Procedures shall be followed strictly.
Consumables or certain parts may have their own labelwith an EFUP value less than
the product. Periodic replacement of those consumables or parts to maintain the
declared EFUP shallbe done in accordance withthe ProductMaintenance Procedures.
This product must not be disposed of as unsorted municipal waste, and must be
collected separately and handled properly after decommissioning.
22Monitor UV-900 Operating Instructions 28962214 AD
2.5 Declaration of Hazardous Substances (DoHS)
有害物质的名称及含量
Name and Concentration of Hazardous Substances
产品中有害物质的名称及含量
Table of Hazardous Substances’ Name and Concentration
2 Safety instructions
部件名称
Component
name
本表格依据SJ/T 11364的规定编制。
This table is prepared according to SJ/T 11364.
0:
X:
•
0:
X:
表示该有害物质在该部件所有均质材料中的含量均在 GB/T 26572规定的限量
要求以下。
表示该有害物质至少在该部件的某一均质材料中的含量超出 GB/T 26572规定
的限量要求。
此表所列数据为发布时所能获得的最佳信息.
Indicates that this hazardous substance contained in all of the homogeneous
materials for this part is below the limit requirement in GB/T 26572.
Indicates that this hazardous substance contained in at least one of the homogeneous materialsused for this part is above thelimit requirementin GB/T 26572