ÄKTAready - GE Healthcare Life Sciences
Contents
1. Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com imagination at work GE imagination at work and GE monogram are trademarks of General Electric Company AKTA DropDesign AKTAready ReadyToProcess and UNICORN are trademarks of GE Healthcare companies UNICORN Any use of this software is subject to GE Healthcare Standard Software End User License Agreement for Life Sciences Software Products The use of AKTAready High Flow Kit and Low flow Kit may require a license under the following patents and equivalent patents in other countries US Pat No 6 712 963 and 7 052 603 assignee SciLog Inc A free non transferable limited license to use these products under above mentioned patents accompanies the purchase of the product from any GE Healthcare company and its licensed distributors All third party trademarks are the property of their respective owners 2007 2008 General Electric Company All rights reserved First published Dec 2007 All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them A copy of these terms and conditions is available on request Contact your local GE Healthcare representative for the most current information GE Healthcare UK Ltd Amersham Place Little Chalfont Buckinghamshire HP7 9NA UK GE Healthcare Bio Sciences Corp 800 Centennial Avenue P O Box 1327 Piscataway NJ 08855 1327 USA GE Healthcare E2. for user interaction such as physical buttons signs and indicators on the system cabinet are written with bold typeface e g AIR VENT button Emphasized words as well as named references to other sections or documents are written with italic typeface Warning symbols WARNING The WARNING symbol and notice highlight instructions that must be followed to avoid personal injury Do not proceed until all stated conditions are clearly understood and met Caution notices CAUTION The CAUTION notice highlights instructions that must be followed to avoid damage to the product or other equipment Do not proceed until all stated conditions are met and clearly understood Notes Note A Note is used to indicate information that is important for trouble free and optimal use of the product Associated documentation AKTAready User Manual describes the operation of AKTAready The user manual provides instructions for preparing the system and performing a run using UNICORN control system The manual furthermore contains technical information and instructions for troubleshooting and user maintenance AKTAready Installation Guide describes installation of the AKTAready system The installation guide is primarily intended for service personnel authorized by GE Healthcare AKTAready Safety Instructions 28 9192 48 AB 9 1 Safety instructions 1 1 Introduction UNICORN control system is described in three manuals e Getting Starte
3. or disconnected See AkTAready Installation Guide for more information about installation of AKTAready 12 AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 General safety precautions 1 2 Electricity WARNING No serviceable parts inside Electrical shock hazard All repairs should be done by service personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in the user documentation WARNING Disconnect power To prevent equipment damage always disconnect power from the AKTAready system before an instrument module is removed or installed or a cable is connected or disconnected Refer to AKTAready Installation Guide for instructions concerning configuration of mains power The live and neutral cable conductors are distinguished by numbers and protective ground by color Live Black wire marked 1 Neutral Black wire marked 2 Protective ground Green Yellow wire Connector marked with symbol for earth connection D Ground Fault Circuit Interruptors intended for protection of the operator are not available as an installation option from GE Healthcare However if ground fault protection for the system is desired a Ground Fault Circuit Interruptor with a sens ing threshold of gt 10 mA may be installed WARNING Protective ground AKTAready must always be connected to a grounded power outlet WARNING Supply voltage Before connec
4. see next section This immediately stops the pump 22 KTAready Safety Instructions 28 9192 48 AB Controls and indicators The AKTAready system is equipped with the following indicators switches and push buttons Safety instructions 1 Labels and indicators 1 4 A short description of each button and lamp is given in the following table Text in bold typeface corresponds to the labels on the system cabinet See KTAready User Manual for detailed information about the function of buttons and indicator lamps No 1 Component PAUSE CONTINUE button and alarm indicator lamp Description Press button to pause an ongoing process Press again to continue Lamp shows steady yellow light during pause Flashing yellow light indicates UNICORN alarm RUN indicator lamp Shows green light when system is running No light when system is idle between runs or during pause POWER indicator lamp Shows flashing green light during initial communication connection when power is switched on Steady green light when power is on and communication with UNICORN software is established Mains power switch System power switch located on the left side of the unit Emergency stop button Stops the pump and closes all inlet and outlet valves AKTAready Safety Instructions 28 9192 48 AB 23 1 Safety instructions 1 4 Labels and indicators 24 No Component Descriptio
5. GE Healthcare AKTAready Safety Instructions ReadyToProcess Important user information All users must read this entire manual to fully understand the safe use of AKTAready Safety notices This manual contains warnings and cautions concerning the safe use of the product See definitions below WARNING The WARNING symbol and notice highlight instructions that must be followed to avoid personal injury Do not proceed until all stated conditions are clearly understood and met CAUTION The CAUTION notice highlights instructions that must be followed to avoid damage to the product or other equipment Do not proceed until all stated conditions are met and clearly understood Notes Note A Note is used to indicate information that is important for trouble free and optimal use of the product Recycling This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment WARNING This is a Class A product In a domestic environment it might cause radio interference in which case the user might be required to take appropriate measures WARNING All repairs should be done by A personnel authorized by GE Healthcare Do not open any covers or replace parts unless specif
6. are best transported and positioned using the column trolleys designed for the system ordering information in appendix in AKTAready User Manual Compressed air It is important for both personal safety and safe operation of the system that correct pressure and quality of compressed air is used The basic requirements are e Oil and particle free 14 AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 General safety precautions 1 2 e 30 C dew point e Working pressure 5 5 7 bar e 50 NI m normal liter per minute WARNING Check that the Pressure Control Regulator for the system air supply is set to the pressure stated in the specifications see AKTAready User Manual WARNING Ensure that correct air pressure is always maintained Too high or too low air pressure may be hazardous and may cause erroneous results and leakage AkTAready Safety Instructions 28 9192 48 AB 15 1 Safety instructions 1 3 Safety precautions during operation 1 3 Safety precautions during operation General This section covers possible hazards to operators of AKTAready systems in day to day work Precautions when operating the equipment are primarily associated with high pressure chemicals and mechanical components It is strongly recommended that the installation wizards provided with the system are used when installing new flow kits and columns See AKTAready User Manual for instructions on how to open the wizards and f
7. ble European directives A copy of the corresponding Declaration of Conformity is available upon request Note The Declaration of conformity is valid only for systems that are marked with the CE logo CE certification CE AKTAready Safety Instructions 28 9192 48 Edition AB Contents 1 Safety instructions Led IRTOdUCtIONM mens nbannin tentant 8 12 General safety precautions cesssessssscccssssssssuseessessecsssssssessseenees 11 13 Safety precautions during operation csessssssssessesscssecssssessseeees 16 14 Labels and indicators 15 Emergency procedures ue 25 LE CIRO CV CIN suron ar EERE E nR 26 KTAready Safety Instructions 28 9192 48 Edition AB AKTAready Safety Instructions 28 9192 48 Edition AB 1 Safety instructions Safety instructions 1 This chapter contains the English version of the safety instructions for AKTAready Contents Section See page 1 1 Introduction 8 1 2 General safety precautions 11 1 3 Safety precautions during operation 16 1 4 Labels and indicators 21 1 5 Emergency procedures 25 1 6 Recycling 26 AKTAready Safety Instructions 28 9192 48 AB 1 Safety instructions 1 1 Introduction 1 1 Introduction About this handbook The purpose of this handbook is to describe safety precautions and emergency and disposal procedures for AKTAready as well as provide instructions for recycling A presentation of safety labels is also included Note All users must r
8. d e User Reference Manual 2 vol e Administration and Technical Manual WARNING Read these safety instructions and all relevant user documentation before installing or using AKTAready WARNING Do not operate AKTAready in any other way than described in the AKTAready and UNICORN manuals 10 A list of associated documentation is found in an appendix in AKTAready User Manual AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 General safety precautions 1 2 1 2 General safety precautions General e Read the user manuals before using AKTAready e Any equipment connected to the system should meet the requirements of the IEC 61010 and local adaptations EN UL Within EU connected equipment must be CE labelled e Do not operate AKTAready hardware or UNICORN control system in any other way than described in AKTAready and UNICORN user manuals WARNING Operation and user maintenance of AKTAready should be performed by properly trained personnel only Personal safety To ensure personal safety during operation always use protective glasses and personal protective equipment appropriate for the current application Personal protective equipment and protective clothing should be used according to local regulations and recommendations WARNING High pressure The AKTAready system operates under high pressure Wear protective glasses at all times WARNING Heavy object The system weighs 230 kg Use suitabl
9. e lifting equipment and protective equipment when lifting the system Protective footwear is required All lifting and moving must be performed in accordance with local regulations Installation requirements The system and the software should be installed and prepared by personnel authorized by GE Healthcare The AKTAready system is designed for indoor use only In order to minimize any safety risks and to obtain optimal function from the system it is important to pay AkTAready Safety Instructions 28 9192 48 AB 11 1 Safety instructions 1 2 General safety precautions close attention to the environment in which the system is installed The following conditions should be fulfilled e Minimal dust e Placement on a level floor e Avoid corrosive gas e Avoid direct sunlight e Avoid strong magnetic or electric fields e Avoid vibration e Ambient temperature between 2 C and 30 C e Relative humidity 20 95 non condensing WARNING Service installation and maintenance of components inside the system cabinet should be performed only by personnel authorized by GE Healthcare WARNING AKTAready is not designed for use in an environment where explosion proof equipment is required The system does not fulfill the requirements of the ATEX Directive WARNING Disconnect power To prevent equipment damage always disconnect power from the AKTAready system before an instrument module is removed or installed or a cable is connected
10. ead the instructions in this chapter to fully understand the safe use of AKTAready Note AKTAready and the UNICORN software should be installed and prepared by personnel authorized by GE Healthcare Note To avoid risk of injury operation and user maintenance should be performed by properly trained personnel only and in accordance with the instructions in the documentation supplied This handbook does not contain user information safety instructions or specifications pertaining to the PC If you have any questions or require further information please contact your local GE Healthcare office or service department Contact information is listed on the back cover of this handbook The AKTAready system AKTAready is an isocratic low pressure automated liquid chromatography system using ready to use AKTAready flow paths and ReadyToProcess columns AKTAready is designed for process development process scale up and small scale production AKTAready is controlled by UNICORN software version 5 11 or higher 8 AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 Introduction 1 1 Symbols and typography Menu commands the names of dialogue boxes windows and option buttons are written in a bold italic typeface Menu commands are written with the menu name and the command separated by a colon For example File Open refers to the Open command in the File menu Names of hardware components relevant
11. eed the specified column maximum pressure Excessive pressure may also damage the flow kit If excessive pressure is detected and the air trap is in line press the AIR VENT button on the system cabinet to reduce the pressure If excessive pressure is detected when the air trap is bypassed take the following steps 1 In UNICORN set Manual Flow to 0 and set the airtrap in line 2 Press CONTINUE in UNICORN or on the system cabinet 3 Press the AIR VENT button on the system cabinet The flow path is depressurized through the air trap tubing CAUTION The end of the air trap tubing should be directed away from the operator preferably it should be connected to a waste hose AkTAready Safety Instructions 28 9192 48 AB 17 1 Safety instructions 1 3 Safety precautions during operation Chemicals WARNING Hazardous chemicals When using hazardous chemicals all suitable protective measures such as wearing protective glasses must be taken Work with hazardous chemicals should furthermore be done in accordance with local regulations and recommendations For a list of recommended chemicals see appendix in AKTAready User Manual WARNING Hazardous chemicals When using hazardous chemicals ensure that the entire flow path has been flushed thoroughly with distilled water before service and maintenance and before dismounting of flow kits WARNING Corrosive chemicals NaOH is corrosive and therefore dangerous to health Avo
12. ically stated in instructions AKTAready Safety Instructions 28 9192 48 Edition AB CE certification This product complies with the European directives listed below by fulfilling corresponding harmonized standards A copy of the Declaration of Conformity is available on request AKTAready complies with MD 98 37 EC Machinery Directive EMC 2004 108 EC Electro Magnetic Compatibility LVD 2006 95 EC Low Voltage Directive Conformity Applied harmonized standards ISO 12100 1 Safety of machinery Basic oncepts general principles for design Part 1 asic terminology methodology ISO 12100 2 Safety of machinery Basic ncepts general principles for design Part 2 echnical principles 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements EN 61326 Electrical equipment for measurement control and laboratory use EMC requirements for equipment intended for use in industrial location H79omwam O 1 m The CE logo and corresponding declaration of conformity is valid for the instrument when it is used as a stand alone unit or connected to other CE marked GE Healthcare instruments or connected to other products recommended or described in this manual and used in the same state as it was delivered from GE Healthcare except for alterations described in this manual This product meets the requirements of applica
13. id spillage Wear protective glasses and required protective clothing WARNING Never leave a flow kit containing aggressive liquids mounted on the system for longer time periods Either dispose of the flow path or rinse it with water or suitable solution WARNING AkKTAready is not designed for use with flammable liquids or in potentially explosive environments AKTAready does not fulfill the requirements of the ATEX Directive For a list of recommended liquids see appendix in AKTAready User Manual Mechanical components Pinch valves AKTAready system cabinet is equipped with pinch valves with tubing locks that are manually opened and closed when a new flow kit is mounted When in operation the pinch valves exert high mechanical force lt 18 KTAready Safety Instructions 28 9192 48 AB Safety instructions 1 Safety precautions during operation 1 3 Although the valves are equipped with a lock with a protective plate there is still a risk of pinch injury when changing flow kit or in case of air pressure failure Warning labels indicate potential risk of pinch injury WARNING Never put fingers or any objects other than the intended tubing in the pinch valve opening WARNING Ensure that clothing or other equipment does not get caught in the pinch valves Pump The peristaltic pump will only function with its lid securely fastened see AKTAready User Manual However with the lid properly mounted the
14. ls and indicators 1 4 1 4 Labels and indicators System label The system label is located on the right side of the leg support of the system cabinet arrow in figure The Code number in the system label identifies the system as being an AKTAready eD AKTArea dy system while the Serial number identifies the Code Number 28906380 unique system installation system Number Manufacturing Year Supply Voltage 100 120 200 208 The Supply voltage field gives the voltage alternatives for AKTAready The voltage that Configured For the system is currently configured for is 220 230 240 V Frequency 50 60 Hz shown in the Configured for field The Max Power Consumption LKVA 7 H A Pneumatic Supply 5 5 7bor configured voltage is assigned during Protection Class P45 installation Frequency is the AC frequency of the power supply and Max Power A Consumption shows the maximum effect GE Healthcare Bio Sciences AB Bj rkgatan 30 ne peas wi The Pneumatic Supply field shows the pressure range required for the compressed air supply The Protection class is the electrical appliances protection classification according to international standard IEC 60529 The symbols in the system label are Label Description This symbol indicates that the waste of electrical and electronic X equipment must not be disp
15. n 6 AIR VENT Air trap Button controlling air trap ventilation through ventilation button valve HV301 Used for releasing excess air from air trap 7 Installation switch Used for releasing and engaging valves during flow kit and column installation Three different positions FLOW KIT INSTALL Opens all valves User can manually open close valve locks RUN Engages all valves User cannot open valve locks valves are controlled by UNICORN COLUMN INSTALL Releases valves between column and air trap Allows for removal of air in tubing between column and air trap The installation switch only works when the system is in its end state not during run If the switch is turned during a run a warning will be issued The switch will then have to be reset to RUN position in order to work AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 Emergency procedures 1 5 1 5 Emergency procedures Emergency shutdown In a situation where there is a risk of injury switch off the ongoing run by pressing the emergency button on the front of the system cabinet If required also switch off the mains power supply The emergency switch immediately stops the pump motor and puts the system in pause mode WARNING Pressing the emergency stop button does not automatically depressurize the flow path Restarting To restart from pause mode simply press the PAUSE ALARM button The system will continue the ru
16. n with all settings intact Power failure routine If electrical power to the system is lost the AKTAready system pump stops and the valves revert to default positions WARNING Power failure does not automatically depressurize the flow path If only the system is affected by the power failure and not the computer UNICORN will display text saying that communication has been broken and that no data are recovered When power returns to normal the system will be in End position i e it will not resume the run A UPS uninterrupted power supply protects against temporary power failures by enabling the system to continue to operate for a limited time A UPS is not included with the system Contact your local GE Healthcare representative for more information about the options for your specific system AkTAready Safety Instructions 28 9192 48 AB 25 1 Safety instructions 1 6 Recycling 1 6 Recycling About recycling When an AKTAready system is taken out of service the different materials must be separated and recycled according to national and local environmental regulations Contact your local GE representative for information about how to proceed Flow kits are disposed of according to local regulations regarding potentially dangerous waste 26 AKTAready Safety Instructions 28 9192 48 AB For contact information for your local office please visit www gelifesciences com contact GE Healthcare Bio Sciences AB
17. or a detailed description of the different steps included High pressure During operation the liquid in the system is under high pressure The part of the flow path between pump and column may reach a maximum pressure of 5 bar Always use AKTAready flow kits and ReadyToProcess columns or other columns designed to withstand the pressure Before starting a run make sure that e all inlets and outlets are properly assigned e all connections are tightened e there are no kinks or blockages anywhere in the flow path WARNING Use only AKTAready flow kits supplied by GE Healthcare ordering information in appendix in AKTAready User Manual WARNING Over pressure Use columns that withstand expected pressures If not the columns might rupture resulting in injury Preferably use ReadyToProcess columns from GE Healthcare WARNING Over pressure Before connecting the column check that it is not damaged or otherwise defective Damaged or defective columns might leak or burst 16 AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 Safety precautions during operation 1 3 WARNING Over pressure Never block an assigned outlet tubing with for instance stop plugs since this will create over pressure and might result in injury WARNING Over pressure The flow rate may under no circumstances exceed the specified column maximum flow rate Excessive flow may affect the packed medium causing the pressure to exc
18. osed as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of equipment AkTAready Safety Instructions 28 9192 48 AB 21 1 Safety instructions 1 4 Labels and indicators WARNING Read the user documentation before using the system Do A not open any covers or replace parts unless specifically stated in the user documentation This system complies with the requirements for electromagnetic compliance EMC in Australia and New Zealand CE This system meets all the essential requirements of applicable EU direc tives Safety labels Safety labels are located on the front of the system cabinet as illustrated below The labels warn the user of risk for personal injury A In the table below the safety labels are described Make sure you fully understand the potential hazards indicated by the labels Description WARNING Pinch hazard This sign is located next to pinch valves and close to the pump Never put your fingers or any objects other than the intended tubing in the pinch valve openings Ensure that clothing or other equipment does not get caught in the pinch valves A G WARNING Rotating rollers cogwheels This sign is located on the pump Never touch the pump or pump lid while the pump is run ning In case of emergency press the emergency stop button
19. re is a small opening next to the pump tubing where items could get stuck between the lid and the pump rollers The exterior surfaces of the pump may get hot during operation After operation allow time for the pump to cool down before touching it WARNING Never touch the pump or pump lid while the pump is running Other precautions WARNING Only products recommended by GE Healthcare should be used with AKTAready Use of non authorized products may be hazardous cause damage to the system and or have negative effects on performance WARNING It is recommended that personnel working near AKTAready on a daily basis wear ear protection High flow rates combined with high pressure can cause noise up to 75 dB A AkTAready Safety Instructions 28 9192 48 AB 19 1 Safety instructions 1 3 Safety precautions during operation CAUTION Always make sure that the chromatography media columns and system components are compatible with sodium hydroxide at the concentration time and temperatures used CAUTION Do not allow solutions containing dissolved salts proteins or other solid solutes to dry out in the UV cell Do not allow particles to enter the cell as damage to the cell might occur CAUTION Excessive temperatures may damage the equipment Do not run the system at higher temperatures than the specified maximum operation temperature 30 C 20 AKTAready Safety Instructions 28 9192 48 AB Safety instructions 1 Labe
20. ting the power cord make sure that the supply voltage at the wall outlet corresponds to the marking on the instrument WARNING High voltage The mains cable should be connected by authorized service personnel Faulty connection might result in live system parts that can give lethal electric shocks AkTAready Safety Instructions 28 9192 48 AB 13 1 Safety instructions 1 2 General safety precautions Lifting and moving The AKTAready system is equipped with wheels and should normally not be lifted See AkTAready Installation Guide for detailed information about lifting points lifting equipment etc Moving the system requires that the wheels are unlocked see AKTAready Installation Guide WARNING Heavy object The system weighs 230 kg Use suitable lifting equipment and protective equipment when lifting the system Protective footwear is required WARNING The wheels of the system should be locked during normal use The wheels should be unlocked only when moving the unit WARNING Moving the system on a sloping surface requires at least two persons WARNING Risk of squeeze injury Do not get caught between the moving system cabinet and other objects WARNING Do not attempt to lift the system by the handle on the left side of the system cabinet The handle is for manoeuvring the cabinet on the floor not for lifting Avoid lifting heavy containers and columns Use suitable lifting equipment and trolleys Heavy columns
21. urope GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare Bio Sciences KK Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan 28 9192 48 AB 04 2008
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