GE HEALTHCARE Monitor UV-900 Operating Instructions Manual

Monitor UV-900
Operating Instructions
Original instructions

Table of Contents

Table of Contents
41 Introduction ..........................................................................................................
41.1 About this manual ................................................................................................................................
51.2 Important user information .............................................................................................................
61.3 Regulatory information ......................................................................................................................
81.3.2 Eurasian Customs Union ............................................................................................................
91.3.3 Regulations for USA and Canada ...........................................................................................
91.3.4 Other regulations and standards ............................................................................................
101.4 User documentation ...........................................................................................................................
122 Safety instructions ...............................................................................................
122.1 Safety precautions ...............................................................................................................................
172.2 Labels .........................................................................................................................................................
192.3 Emergency procedures ......................................................................................................................
202.4 Procedures for decommissioning .................................................................................................
212.5 Declaration of Hazardous Substances (DoHS) ........................................................................
243 System description ..............................................................................................
243.1 Illustrations ..............................................................................................................................................
253.2 Flow cell .....................................................................................................................................................
273.3 Monitor principle ...................................................................................................................................
304 Installation ............................................................................................................
314.1 Unpacking ................................................................................................................................................
314.2 Site requirements ..................................................................................................................................
314.3 Transport ..................................................................................................................................................
314.4 Assembly ..................................................................................................................................................
374.5 Connecting electrical cables ...........................................................................................................
415 Operation ..............................................................................................................
425.1 Starting the instrument ......................................................................................................................
425.2 Reading absorbance values ............................................................................................................
435.3 Menu selection and settings ...........................................................................................................
505.4 Changing flow cell ................................................................................................................................
515.5 UV cell calibration .................................................................................................................................
545.6 Restart after power failure ...............................................................................................................
556 Maintenance .........................................................................................................
566.1 Cleaning before planned service ...................................................................................................
576.2 Cleaning the instrument housing ..................................................................................................
576.3 User maintenance schedule ...........................................................................................................
576.4 Cleaning-in-place .................................................................................................................................
586.5 Checking the instrument ...................................................................................................................
596.6 Cleaning the flow cell and optical connectors ........................................................................
2 Monitor UV-900 Operating Instructions 28962214 AD
Table of Contents
606.7 Storage ......................................................................................................................................................
627 Troubleshooting ...................................................................................................
637.1 General ......................................................................................................................................................
637.2 Faults and actions ................................................................................................................................
647.3 Error messages ......................................................................................................................................
668 Reference information ........................................................................................
668.1 Technical specifications .....................................................................................................................
698.2 Health and Safety Declaration Form ...........................................................................................
708.3 Menu overview .......................................................................................................................................
718.4 Accessories and spare parts ...........................................................................................................
738.5 Ordering information ..........................................................................................................................
Monitor UV-900 Operating Instructions 28962214 AD 3

1 Introduction

1 Introduction
About this chapter
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
1.1 About 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
4 Monitor UV-900 Operating Instructions 28962214 AD
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
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.
Monitor UV-900 Operating Instructions 28962214 AD 5
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 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.

1.3 Regulatory information

Introduction
This section lists the regulations and standards that apply to the Monitor UV-900.
6 Monitor 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
1.3.1 EU 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.
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
Monitor UV-900 Operating Instructions 28962214 AD 7
1 Introduction
1.3 Regulatory information
1.3.1 EU Directives
CE marking
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.

1.3.2 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.
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
8 Monitor UV-900 Operating Instructions 28962214 AD
1.3.3 Regulations 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.

1.3.4 Other 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.
Monitor UV-900 Operating Instructions 28962214 AD 9
1 Introduction
1.3 Regulatory information
1.3.4 Other regulations and standards
Standards, machinery and electrical equipment
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)

1.4 User 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.
10 Monitor 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.
Monitor UV-900 Operating Instructions 28962214 AD 11

2 Safety instructions

2 Safety instructions
About this chapter
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
2.1 Safety 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)
12 Monitor 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:
damage to the power cord or its plug
damage caused by dropping the equipment
damage caused by splashing liquid onto it
Monitor UV-900 Operating Instructions 28962214 AD 13
2 Safety instructions
2.1 Safety precautions
Using flammable liquids
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.
14 Monitor 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.
Monitor UV-900 Operating Instructions 28962214 AD 15
2 Safety instructions
2.1 Safety precautions
System operation
WARNING
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.
16 Monitor 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.

2.2 Labels

Introduction
This section describes the system label on Monitor UV-900 and its meaning.
Monitor UV-900 Operating Instructions 28962214 AD 17
2 Safety instructions
2.2 Labels
System label
The illustration below shows the system label.
Note:
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.
18 Monitor 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.

2.3 Emergency 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.
Monitor UV-900 Operating Instructions 28962214 AD 19
2 Safety instructions
2.3 Emergency procedures
Emergency shutdown
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.

2.4 Procedures 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.
20 Monitor 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.

2.5 Declaration of Hazardous Substances (DoHS)

根据SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下有关污染控制方面的 信息。
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.
电子信息产品污染控制标志说明
Explanation of Pollution Control Label
该标志表明本产品含有超过中国标准GB/T 26572 《电子电气产品中限用物质的限 量要求 》中限量的有害物质。标志中的数字为本产品的环保使用期,表明本产品 在正常使用的条件下,有毒有害物质不会发生外泄或突变,用户使用本产品不会 对环境造成严重污染或对其人身、财产造成严重损害的期限。单位为年。
为保证所申明的环保使用期限,应按产品手册中所规定的环境条件和方法进行正 常使用,并严格遵守产品维修手册中规定的定期维修和保养要求。
产品中的消耗件和某些零部件可能有其单独的环保使用期限标志,并且其环保使 用期限有可能比整个产品本身的环保使用期限短。应到期按产品维修程序更换那 些消耗件和零部件,以保证所申明的整个产品的环保使用期限。
本产品在使用寿命结束时不可作为普通生活垃圾处理,应被单独收集妥善处理。
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”.
Monitor UV-900 Operating Instructions 28962214 AD 21
2 Safety instructions
2.5 Declaration of Hazardous Substances (DoHS)
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.
22 Monitor 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
有害物质
Hazardous substance
Cd
Hg
Pb
六价铬
(Cr(VI))
多溴联苯
PBB
多溴二苯醚
PBDE
00000X18110835
00000X28923194
Monitor UV-900 Operating Instructions 28962214 AD 23
Data listed in the table represents best information available at the time of publication.
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