WAVE Bioreactor System 200EH - GE Healthcare Life Sciences
Contents
1. WAVE Bioreactor Safety instructions that must be followed for use of System 200EH Safety WAVE Bioreactor System 200EH in 6 languages English Handbook German Spanish French Italian and Swedish WAVE Bioreactor Contains detailed troubleshooting methods System 200EH replacement procedures and spare part lists Maintenance Manual WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 7 1 Introduction 1 2 Associated documentation 8 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 2 Safety precautions The Safety handbook contains our recommendations about precautions and handling procedures for the WAVE Bioreactor System 200EH from GE Healthcare Wave Biotech especially for e Transport and Installation e Setting up the System e Operation e Troubleshooting e Maintenance and Service These safety instructions are meant exclusively for the equipment as delivered They are not valid for other equipment However the level of risk is highly dependent on the application and environment in which the bioreactor is operated In order to secure the safe operation of the equipment a risk assessment must be made This risk assessment in combination with local regulations and policies will result in specific safety instructions for installation operation and maintenance use of proper personal protective equipment or other arrangements that are needed to operate your process safely The warnings required2. might be required to take appropriate measures WARNING All repairs should be done by personnel authorized by GE Healthcare Do not open any covers or replace parts unless specifically stated in instructions CE certification This product complies with the European directives listed below by fulfilling corresponding standards A copy of the Declaration of Conformity is available on request e 2006 95 EC Low Voltage Directive e 2004 108 EC EMC Electromagnetic Compatibility Directive The CE symbol 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 Note The Declaration of conformity is valid only for systems that are marked with the CE logo ce Contents 1 AA 7 1 1 About the Safety instructions nnnnnennn 7 12 Associated documentation cnn 7 2 SOCIO precautions nein 9 2 1 Personal protection ciones 10 2 11 Miscellaneous warningS cine 10 3 Labels indicators and controls occnoccnoncnoncnoncninnnanncnos 13 3 1 System labels ween 3 2 Safety labels 3 3 Emergency stop 3 3 1 Emergency SAUNA ia 34 A A e 3 41 Beacon audible alarm logic 35 IPro
3. Hazardous Substances in Electronic Information Products The number in the symbol is the Environment friendly Use Period EFUP which indicates the period during which the toxic or hazardous substances or elements contained in electronic information products will not leak or mutate under normal operating conditions so that the use of such electronic information products will not result in any severe environmental pollution any bodily injury or damage to any assets The unit of the period is Year OPAQPE WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 15 3 Labels indicators and controls 3 3 Emergency stop 3 3 Emergency stop This section describes the emergency shutdown of the System 200EH 3 3 1 Emergency shutdown In a situation where there is risk of physical injury Step Action 1 Press the EMERGENCY STOP switch Pressing the switch will stop the rocking motion and remove power from the motor and heaters 2 If required switch off the power supply to the system by setting the main circuit breaker to the OFF down position The main circuit breaker is located at the bottom right side of the rear panel 16 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB Labels indicators and controls 3 Alarm settings 3 4 3 4 Alarm settings Alarms when they occur are displayed on the System Touch screen Two types of alarms are available Critical alarms such MOTOR OVERTEMP TEMP PROBE FAI
4. GE Healthcare WAVE Bioreactor System 200EH Safety Handbook A wave Now part of GE Healthcare Important user information All users must read this entire manual to fully understand the safe use of WAVE Bioreactor System 200EH Important WAVE Bioreactor System 200EH is intended for research use only and should not be used in any clinical or in vitro procedures for diagnostic purposes 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 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
5. L and secondary alarms record deviations from the set point 3 4 1 Beacon audible alarm logic The beacon alarm is a large top mounted light on the control panel that changes color depending upon the type of alarm Table 3 2 describes the various alarms Table 3 2 Alarms Beacon Audible buzzer Alarm Contact condition Green No sound OFF No alarms Yellow steady No sound ON Acknowledged alarms present Red Flashing sound ON Unacknowledged alarm Red steady No sound ON Silence pressed but not acknowledged buzzer sound It does not acknowledge the alarm condition The beacon will turn from flashing red to steady red WARNING Pressing the SILENCE AUDIBLE ALARM only stops the CAUTION Press ACKNOWLEDGE ALL ALARMS to acknowledge the new alarms The beacon will turn yellow to indicate that alarms still exist but have been acknowledged If new alarms occur the beacon will flash red and the audible alarm will sound Ifthe acknowledged alarm condition no longer exists then the beacon will go green and the external alarm contact will turn off WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 17 3 Labels indicators and controls 3 5 Product safety 3 5 Product safety 18 International standards and regulatory conformance to CE The WAVE Bioreactor System 200EH complies with the International Standards for product safety according to WTO s TBT agreement IEC UL EN 61010 2001 safety requir
6. and cautions in this Safety Handbook shall in no way in your facility take precedence over more restrictive local regulations and policies WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 9 2 Safety precautions 2 1 Personal protection 2 1 Personal protection 2 1 1 10 For your personal safety it is important that you have a proper knowledge of the entire system that the bioreactor is part of Study any complementary safety instructions and use appropriate personal protection equipment for the specific application and operation environment During the operation and during other work with the bioreactor it is always each individual operator s responsibility to consider e Their own and other s personal safety e The safety of the equipment through correct use in accordance with the descriptions and instructions given in this Safety Handbook and other parts of the System Documentation IMPORTANT Always keep the Safety Handbook on hand when using the bioreactor Miscellaneous warnings WARNING This is a class A product input power gt 1kW intended for Professional use In a domestic environment it may cause radio interference in which case the user might be required to take appropriate measures Note This device complies with FCC part 15 2004 radiofrequency device subpart B Unintentional radiators Class A operation is subject to the following two conditions 1 This device may not cause harmful
7. ductsaletO nase title E Ee Seen 19 4 1 IA 19 4 2 Working place requirements ccoo 21 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 1 Introduction 1 1 About the Safety instructions The Safety instructions are valid for all variants of standard Wave Bioreactor System 200EH The purpose of the Safety Instructions is to describe safety precautions and emergency procedures for the WAVE Bioreactor System 200EH Note that the Safety Instructions only addresses items relating to safety issues and that for most parts is an excerpt from WAVE Bioreactor System 200EH User Manual Please refer to the User Manual for information about the general handling and operation of the system If you have any questions or require further information please contact your local GE Healthcare sales office or service department Contact information is listed on the back cover of this book 1 2 Associated documentation Apart from the Safety Instructions additional associated documentation is provided with the bioreactor The system will be delivered with a full set of System Documentation Table 1 1 describes the complete documentation Table 1 1 Associated documentation Document Contents WAVE Bioreactor How to use the system including concepts System 200EH methodology operation troubleshooting and Operator Manual maintenance This document is also available as online help
8. ements for electrical equipment for measurement control and laboratory use IEC EN 61326 1 1997 Electrical equipment for measurement control and laboratory use EMC requirements The WAVE Bioreactor System 200EH complies with the harmonized standards EN according to the New and Global Approach for conformance with the European product safety directives The above mentioned harmonized standards are conformance to the LVD 2006 95 EC and EMC 2004 108 EC directive For the Machinery Directive 98 37EC following harmonized standards conform compliance EN ISO 12100 1 2003 Safety of machinery Basic concepts general principles for design Part 1 Basic terminology methodologu EN ISO 12100 2 2003 Safety of machinery Basic concepts general principles for design Part 2 Technical principles and specifications EN ISO 14121 1 Safety of machinery Risk assessment Principles The system complies in accordance with ANSI NFPA 70 National Electrical Code NEC and UL 61010 1 Canadian Electrical Code CEC Part CSA C22 1 and CSA C22 2 No 0 FCC Part 15 Electromagnetic compatibility for the US and Canada Complies with the complementary test stated in IEC 61010 1 UL 61010 1 is similar with South Korean requirement The chosen International Standards result in a comprehensive liable framework in line with the Bioreactor business area WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 4 Installation Use the infor
9. er 12 kVA Year 2008 AED CEO HE IMI ee WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 13 3 Labels indicators and controls 3 2 Safety labels 3 2 Safety labels Safety labels are located on the system as illustrated below The labels warn the user of risk of personal injury Fig 3 2 WAVE Bioreactor System 200EH top view Status Beacon 14 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB Labels indicators and controls 3 Safety labels 3 2 In Table 3 1 the safety labels are described Make sure you fully understand the potential hazards indicated by the labels Table 3 1 Safety labels Label Description Danger of pinch injury This sign is located near the rocker Read the user documentation before using the system Do not open any covers or replace parts unless specifically stated in the user documentation The system complies with the requirements for electromagnetic compliance EMC in Australia and New Zealand This system meets all the essential requirements of applicable EU directives and applicable conformity assessment procedures have been applied This symbol indicates a hazardous electrical potential exists and care must be exercised to prevent electrical shock This symbol indicates the product contains hazardous materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain
10. interference 2 This device must accept any interference received including interference that may cause undesired operation WARNING The end user must ensure that all installation maintenance operation and inspection is carried out by qualified personnel who are adequately trained understand and adhere to local regulations and the operating instructions and have a thorough knowledge of the entire system and process WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB Safety precautions 2 Personal protection 2 1 WARNING The bioreactors should not be used for any application other than specified by the manufacturer WARNING Only WAVE approved Cell Culture Bags shall be used on this equipment WARNING The bioreactors are not designed to handle flammable fluids The bioreactor is not approved for work in a potentially explosive atmosphere WARNING Always use protective glasses and other personal protective equipment appropriate with the current application to ensure personal safety during operation WARNING Inspect all connections and tubing before start and replace any defective parts WARNING Ensure that all tubing hoses and cables are placed so that the risk for tripping accidents is minimized WARNING Remove any spillage on the floor immediately to minimize the risk for slipping accidents WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 11 2 Safety precautions 2 1 Personal protectio
11. mation from Appendix A in the WAVE Bioreactor System 200EH Operator manual 4 1 Overall Dimensions For specific measurements see following overall drawings for Base 200 Fig 4 1 Base 200 front dimensions 72 90 185 18 43 28 109 93 176 04 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 19 4 Installation 4 1 Overall Dimensions Fig 4 2 Base 200 side dimensions 43 15 109 60 eA 62 70 159 26 86 28 20 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB Installation 4 Working place requirements 4 2 4 2 Working place requirements e The weight of the WAVE Bioreactor System 200EH must not exceed the maximum load of the installation floor e There should be enough space left for easy access to the whole equipment both for normal operation and maintenance and service operations At least 0 6 m workspace around the base unit e Possible to isolate the working area of the fermentation plant from common areas e The danger zone should be kept clear of obstructions Clean spills immediately to not cause a slip hazard which could lead to injury A Danger zone exists around the WAVE Bioreactor System 200EH 0 6 meter 24 inches from each side of the rocking tray and the area between the cabinet and the rocker WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 21 For contact information for your local office please visit ww
12. n WARNING Make sure no one enters the hazardous area while the system is operating with the rocker in motion WARNING Ensure that no body parts are caught between the base enclosure and the tray while rocking CAUTION Disconnect all tubing hoses and cables before moving the base unit CAUTION Base unit equipped with wheels must be leveled properly with the wheels removed before the system is used CAUTION Only use chemicals that have been proven not to be harmful to the cellbag and the system 12 WAVE Bioreactor System 200EH Safety Handbook 87 4500 60 AB 3 Labels indicators and controls 3 1 System labels This section describes the labels on the WAVE Bioreactor System 200EH Labels for safety product no CE and rating are located on the rear panel A system no label is located on the marking plate The safety label warns the user of risk to personal injury Do not proceed until the instructions are clearly understood and all stated conditions are met System 200EH is labeled with the following information e Product Catalog Number Serial Number e Code no e Line Power Voltage required e Line Current Frequency e Power Consumption e Maximum limited Current Fuse or breaker e Manufacturing Year Fig 3 1 Safety label Tr WAVE SE Healthcare Bioscience BioProcess Corp Wow pert of GE Medicare Catalog ma 28611543 Voltage 200 240 VAC Serial ma 1234567 Frequency 50 60 Hz Code ma 28942519 Pow
13. w gelifesciences com contact GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com bioprocess www gelifesciences com wave imagination at work GE imagination at work and GE monogram are trademarks of General Electric Company a WAVE and WAVE Bioreactor are trademarks of GE Healthcare companies All third party trademarks are the property of their respective owners 2008 General Electric Company All rights reserved First published October 2008 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 Europe 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 87 4500 60 AB 10 2008
Download Pdf Manuals
Related Search