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STERILE TUBE FUSER - DRY - GE Healthcare Life Sciences

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1. 400 C during the heating cycle Do not try to open the protective cover during the welding WARNING Pinch Hazard of STERILE TUBE FUSER DRY There are movable parts under the protective cover Do not try to open the protective cover during the welding To lock the cover press and hold the COVER LOCK button until you hear a CLICK for a few seconds Make sure that the COVER LOCK button is down during the welding and aligning operation STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 25 3 Operation 3 2 Operating procedure Fig 3 2 COVER LOCK button down lid is locked Fig 3 3 COVER LOCK button up lid is unlocked 26 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Installing and removing blades 3 3 3 3 Installing and removing blades WARNING The cutting blade of STERILE TUBE FUSER DRY is a thin piece of alloy material It does not have a sharpened edge but can cause cuts if handled improperly Be sure to read and understand the procedure of how to install and remove the blade 1 Place STERILE TUBE FUSER DRY blade in Installation Removal Tool as shown below Fig 3 4 Blade with the Installation Removal tool 2 Use Installation Removal tool to install the blade by pressing the top of the tool with the palm of the hand During blade installation secure the blade within the tool by compressing with thumb as shown Fig 3 5 Side view STERILE TUB
2. Installation Removal tool Display indicates BLADE INSTALLED CLOSE COVER 5 Close the cover Press the COVER The blade moves down The COVER LOCK button LOCK is released Display indicates INSTALL TUBING 6 Place the tubing firmly in the Display indicates READY TO CUT tubing is not full of liquid by clamping upstream and then the RED holder holders The tubing ends must protrude out beyond each holder CAUTION Make sure that the Close the BLUE left holder first CLOSE COVER STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK STEP User Action 7 Close the cover Press the COVER LOCK button Operation 3 Operating procedure 3 2 Response The blade will heat to the depyrogenation temperature The display will show the temperature and hold time Then the blade will be allowed to cool to the cutting temperature After reaching the set cut temperature it will move upwards cutting through the tubing Next the tubing holder will move sideways to align the cut tubing and the tubing will be pushed together while the blade retracts The blade will cool down The the display will show a WELD XXXX COMPLETE message REMOVE BLADE AND TUBES is indicated in the display 8 Remove the blade and the tubes The display indicates TO RESET CLOSE COVER 3 2 2 Safety precautions during operation WARNING Hot Surfaces of STERILE TUBE FUSER DRY The cutting blade reaches
3. 8 BIOPRENETM C FLEX 082 C FLEX 374 x x x 4x PHARMED BPT SANIPURE 60 SANIPURE BDF TYGON PVC Note The Tubing Brand names on the instrument screen may not look exactly the same STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 43 A Compatible tubing as in the table above The Tubing Brand names displayed on the instrument screen are abbreviations with the purpose to identify the tube material Change selected tubing types The selected tubing type is shown on the touchscreen display For instructions on how to change the tubing type refer to Change the tubing type on page 33 Update tubing types To replace the factory loaded tubing types or to add the ReadyToProcess tube sizes order STF DRY TUBE DATA MANAGEMENT TOOL GUI For ordering information refer to Appendix C 44 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Appendix B Blade contact materials The cutting blade is made of a special Nicrome alloy NiCrA that has the required electrical characteristics for resistance heating The tubing contacts a black polytetrafluoroethylene PTFE coating only This coating is baked on at high temperature and is suitable for food contact applications The coating ensures minimal adhesion to the tubing during the welding and cutting
4. Hz 3 3 A Tubing holders Available in size range from 1 4 to 7 8 tubing OD See Appendix C 2 x T4 0 AL 250 V 5 x 20 mm See Appendix A See Appendix A Single use Packaged in 50 Qty 2 to 3 minutes Indoor use only Degree 2 FCC Part 15 Subpart B Class A and EN61326 1 IEC EN UL61010 1 and CAN CSA C22 2 No 61010 1 20 to 80 non condensing STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 41 5 Specifications 5 2 Tubing Storage 20 C to 60 C temperature Operating 0 C to 30 C temperature 5 2 Tubing Most thermoplastic tubing can be joined in the STERILE TUBE FUSER DRY For compatible tube types refer to Appendix A 42 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Appendix A Compatible tubing Introduction The STERILE TUBE FUSER DRY is designed to join thermoplastic tubing Note STERILE TUBE FUSER DRY cannot be used to join silicone tubing or PTFE Suitability is based on typical tubing material The user must determine suitability of autoclaved irradiated or otherwise treated tubing Tested tubing brands The tested tubing brands are listed in the table below The ReadyToProcess tube sizes are marked with an x in the table Denotes the factory loaded tubing types Tubing dimension 1 D x O D in inches Data ver 4 03 Date 09 11 1 8 3 16 3 16 Ye 18 5 16 1 4 3 8 7 16 3 8 x x x x x x x x x x 1 4 5 16 3 8 3 8 7 16 7 16 1 2 1 2 9 16 5
5. cycle This improves the quality of the weld and results in minimal smearing The inert nature of the coating also eliminates any potential contamination The black reflection free coating also improves the infra red emissivity of the blade making it possible to accurately estimate blade temperature with non contact infrared sensors More information about the coating material may be required for cGMP validation Please contact our Customer Service department and ask for non disclosure forms STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 45 B Blade contact materials 46 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Appendix C Ordering Information SI No Catalog Number Description 1 28954327 BLADE REMOVAL TOOL STFIR 2 WV001984 KEY REPLACE 6 TUMBLER 3 29002652 STF DRY TUBE DATA MANAGEMENT TOOL GUI 4 28411701 STFIRC BLADES 50 5 29002629 STF DRY PINCH HOLDER 1 4in 6 28411685 STFIRC HOLDER 5 16in 7 28411686 STFIRC HOLDER 3 8in 8 28411683 STFIRC HOLDER 7 16in 9 28411687 STFIRC HOLDER 1 2in 10 28412899 STFIRC HOLDER 9 16in 11 28411681 STFIRC HOLDER 5 8in 12 28411682 STFIRC HOLDER 3 4in 13 28411688 STFIRC HOLDER 7 8in For more details on ordering information visit www gelifesciences com bioprocess STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 47 Appendix C Ordering Information 48 STERILE TUBE FUSER DRY Operator Manual 87
6. maintained and serviced as per the recommended schedule to ensure warranty coverage It is the responsibility of the end user to verify and validate the suitability of this instrument for a specific application Connections should be carefully inspected before use STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 15 1 Introduction 1 6 Disclaimer 16 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 2 Principle of operation Introduction STERILE TUBE FUSER DRY is used to connect two pieces of thermoplastic tubing together and produce a sterile joint Each piece of tubing is connected on one end to a container bag or process equipment The other end is sealed by a clamp plug or other closure Making a sterile joint To make a sterile joint a new cutting blade is inserted in to the instrument each time The blade is heated to 400 C For 10 seconds before tube cutting and welding This ensures that the blade is sterile and depyroginated Fusing procedure Stage Description 1 A new cutting Blade is inserted into the blade holder and it retracts into the unit Next the tubing is placed in the Left and Right tubing holders The COVER LOCK push button initiates the steps in the cutting and welding program The cutting blade is heated to 400 C and held there for 10 seconds This ensures that the blade is sterile and depyrogenated The blade is allowed to cool to a preset temperature depending on the type of
7. may occur during operation This will include the error number a brief description of the error and a time stamp STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 37 3 Operation 3 12 Using the printer 38 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 4 Troubleshooting 4 1 Error checking The STERILE TUBE FUSER DRY is designed to monitor all aspects of its operation If a step does not perform properly the unit will not proceed to the next step of the operation Step 1 Setup The machine checks that the holders are correctly installed and no tubing is present The unit goes through internal electronic diagnostics to check that all systems are functional Finally the holders are moved into alignment and checked STERILE TUBE FUSER DRY uses position sensing switches and probes to provide feedback on correct positioning This ensures long trouble free operation and minimal realignment requirements Step 2 Blade Installed The unit checks that a blade is installed Then the blade is retracted into the machine Step 3 Tubing installed The unit checks that the tubes are correctly installed in each holder and that everything is in the correct position If all checks are satisfactory the unit starts heating the blade to about 400 C for sterilization and depyrogenation An infrared sensor measures the blade temperature and modulates power to control temperature The program will fail if the measured temperature is
8. reset the unit Check that the holders are correctly installed and do not move in their mounts Make sure that the left and right holders are for same diameter tube Make sure the holders are locked in correctly with the locking tabs pulled out towards the front of the machine Check that the tubing is the correct size Check that the machine is set to the correct tubing type Try using a new cutting blade If the machine does not perform properly please contact your local GE Healthcare representative 4 3 General troubleshooting and error messages For information about general troubleshooting and error messages refer to the STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 40 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 5 Specifications 5 1 Specifications Catalog Number Performance Dimensions Weight Power Options Fuse Max Tubing OD Min Tubing OD Cutting Blades BLADES IR 50 Typical fusing cycle Enclosure Pollution EMC LVD Relative humidity 28 9996 02 Tubing diameters from 1 4 to 7 8 using interchangeable tubing holders Typical welding cycle 2 to 3 minutes Non contact infrared blade temperature sensor Uses single use PTFE coated cutting blades Serial communication port Can be used to weld most thermoplastic tubing See Appendix A W x D x H 395 mm x 355 mm x 265 mm 15 5 x 14 x 10 4 16 kg 35 lb 100 to 240 V auto switching 50 or 60
9. tubing to be connected This temperature is set between 190 C and 270 C depending on the tubing type and diameter The heated blade is then moved so that it melts through the two tubing pieces simultaneously During this operation the blade temperature is controlled and the tubing is forced against both sides of the blade to maintain a sterile operation Once the tubing has been cut the instrument slides the cut tubing pieces into alignment The blade is then extracted while the tubing is pushed together The tubing pieces remain at all times in contact with the hot 190 C to 270 C blade ensuring sterile operation Once the blade is fully extracted the weld is allowed to cool STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 17 2 Principle of operation Stage Description 8 The lid interlock is released when the weld is complete and the machine can be opened The connected tubing can then be removed and the STERILE TUBE FUSER DRY is ready for immediate reuse 10 The used blade and cut tubing ends are discarded Reproducible procedure The STERILE TUBE FUSER DRY is a fully automated instrument and will only indicate the successful completion of the welding cycle if all operations have functioned properly The procedure is completely reproducible and independent of operator skill Therefore it can be readily validated to assure a sterile joint Use of a new dispo
10. 4500 21 AK For local office contact information visit GE imagination at work and GE monogram are trademarks of General s z Electric Company www gelifesciences com contact HOT LIPS TUBE SEALER and ReadyToProcess are trademarks of GE Healthcare companies GE Healthcare Bio Sciences AB C FLEX PHARMED SANIPURE and TYGON are trademarks of Saint Gobain Bj rkgata n30 Performance Plastics Corporation 75184U ppsala BIOPRENE is a trademark of Watson Marlow Limited 2008 2011 General Electric Company All rights reserved weqen First published October 2008 All goods and services are sold subject to the terms and conditions of sale www gel ifesciences com bioprocess 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 Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany 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 Japan Corporation Sanken Bldg 3 25 1 Hyakunincho Shinjuku ku Tokyo 169 0073 Japan imagination at work 87 4500 21 AK 10 2011
11. BE FUSER DRY There are movable parts under the protective cover Do not try to open the protective cover during the welding WARNING Access to power switch and power cord The power switch must always be easy to access The power cord must always be easy to disconnect WARNING The cutting blade of STERILE TUBE FUSER DRY is a thin piece of alloy material It does not have a sharpened edge but can cause cuts if handled improperly Be sure to read and understand the procedure of how to install and remove the blade WARNING Do not touch the blade of STERILE TUBE FUSER DRY until it cools down Always allow the blade to cool down for 30 seconds before accessing the blade WARNING Depending of which tubes that are used in STERILE TUBE FUSER DRY hazardous gases may emit Make sure to use the instrument in a room with proper ventilation CAUTION Only use tubing that is compatible with the instruments Refer to Appendix A for a list of tubing types that have been tested CAUTION Do not attempt to connect liquid filled tubing using STERILE TUBE FUSER DRY or allow liquid to spill into the instrument STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Introduction 1 STERILE TUBE FUSER DRY 1 4 CAUTION Depending on which tubes that are used in STERILE TUBE FUSER DRY hazardous gases may emit Make sure to use the instrument in a room with proper ventilation NOTICE Leave space around the unit for proper ventilati
12. E FUSER DRY Operator Manual 87 4500 21 AK 27 3 Operation 3 3 Installing and removing blades 3 Press Installation Removal Tool with palm of hand until blade is fully inserted into mounted position Remove Installation Removal Tool and close STERILE TUBE FUSER DRY lid 4 Removal of blade is accomplished by reversing the steps described above WARNING Do not touch the blade of STERILE TUBE FUSER DRY until it cools down Always allow the blade to cool down for 30 seconds before accessing the blade 28 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Load the tubing 3 4 3 4 Load the tubing 1 Clean the outside of the tubing area to be connected using a suitable disinfectant 2 Place the tubing firmly in the holders The tubing ends must protrude out beyond each holder 3 Close the BLUE left holder first and slide it towards the RED right holder Clamp it down securely 4 Close the RED holder and tighten the clamp 5 Close the cover 6 Press and hold the COVER LOCK button until you hear a CLICK for a few seconds to sequence the program Tubing to container 2 Tubing to container 1 Il Left tubing holder Right tubing holder Close this first then slide to right and clamp Close this next and clamp down STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 29 3 Operation 3 5 Remove the tubing 3 5 Remove the tubing 1 First remove the used blade and discard 2 Open
13. ERILE TUBE FUSER DRY Part Description 1 Ventilation fan 2 Key lock 3 Power switch 4 Data jack 5 Fuse holder 6 Power connector STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 13 1 Introduction 1 5 Features Interchangeable tube holders The image below shows the tube holders of STERILE TUBE FUSER DRY PTFE coated cutting blades The image below shows the PTFE coated cutting blades of STERILE TUBE FUSER DRY 1 5 Features e Fully automated operation with touchpanel e True thermal weld provides exceptional strength e Aseptic connection without a laminar flow hood e New compact design portable e Can weld different tube diameters e Advanced infrared non contact sensor e Requires only 90 to 264 VAC 50 to 60 Hz 4 AMP Universal voltage 14 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Introduction 1 Disclaimer 1 6 1 6 Disclaimer The STERILE TUBE FUSER DRY has been tested to produce welds of sufficient quality and strength to permit sterile transfers It is believed to be adequate for the intended application Under no circumstances can data in this manual be submitted to any regulatory agency in support of a clinical product without specific written permission from the manufacturer The manufacturer guarantees the mechanical operation of the equipment only and is not liable for any loss incurred due to the use of this equipment Equipment must be
14. GE Healthcare Life Sciences STERILE TUBE FUSER DRY Operator Manual Contents L NUMER DUNO its 5 1 1 Important user information canon 5 1 2 Regulatory information incio acilan 7 1 3 Safety Precautions mision ti i 9 14 STERILE TUBE FUSER DRY 11 1 5 FEGE S id 14 T6 Disc viii EAA 15 2 Principle of Oper rs 17 Z1 Operating SCHEMATIC ccoo 19 3 Operation 21 A A A RAE 22 3 2 Operating procedure 24 3 2 1 Main operating StePS cccccccccam 24 3 2 2 Safety precautions during operation 2d 3 3 Installing and removing blades eel 3 4 Load the tubing 3 5 Remove the tubing 30 36 Change The tUBDING holders avion 31 37 Change ANE LU DING Pacos 33 3 8 Inspecting weld quality AN 3 9 How to handle liquid filled tubing 35 3 10 Using different types Of tubing coco 35 3 11 Welding different diameters 3 12 Using the printer cnn A o AA A A 4 1 Error checking 4 2 Possible issues a 4 3 General troubleshooting and error MESSAGES w ocmoo 40 Me 811 6 1 pee ad 41 SE SPECIFIC NS cri nin i 41 S2 E ovens S0sasbbcxesenensteobus Sabaater er 42 Appendix A Compatible tubing coooooomommmmmmmmmmmmm 43 Appendix B Blade contact materialS o ooomomomooomooo 45 Appendix C Ordering Information ccooooomomommmommmmm 47 STERILE TUBE FUSER DRY Operato
15. IPS TUBE SEALER Tube Data Management Tool User Manual available with GUI tool STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 35 3 Operation 3 11 Welding different diameters 3 11 Welding different diameters 36 The STERILE TUBE FUSER DRY is capable of joining tubing of various outer diameters Different sets of tubing holders specific to each tubing outer diameter must be purchased Each holder set consists of a BLUE left holder and a RED right holder Both holders must be changed as a set The machine reads the coded holders and runs the appropriate stored program STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Using the printer 3 12 3 12 Using the printer A separate printer package can be purchased and connected to the STERILE TUBE FUSER DRY printer port on the rear panel of the machine To use the printer attach the printer AC adaptor to a 100 to 240 V 50 or 60 Hz power supply and to the printer Attach the supplied communication cable to the printer DB 25 connector and the STERILE TUBE FUSER DRY connector The printer will print reports displaying the Unit ID Program Version Tube data Version the tube type and OD of the tubing being used and the current weld number along with other relevant parameters related to the welding conditions of the particular weld being performed In addition to displaying the machine setup information the printer will also print any errors that
16. RY The cutting blade reaches 400 C during the heating cycle Do not try to open the protective cover during the welding WARNING 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 Access to power switch and power cord The power switch must always be easy to access The power cord must always be easy to disconnect CAUTION Only use tubing that is compatible with the instruments Refer to Appendix A for a list of tubing types that have been tested CAUTION Do not attempt to connect liquid filled tubing using STERILE TUBE FUSER DRY or allow liquid to spill into the instrument STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 21 3 Operation 3 1 Controls CAUTION Depending on which tubes that are used in STERILE TUBE FUSER DRY hazardous gases may emit Make sure to use the instrument in a room with proper ventilation NOTICE Leave space around the unit for proper ventilation NOTICE Only use PTFE coated cutting blades BLADES IR 50 specified for use with STERILE TUBE FUSER DRY For optimal use do not reuse blades 3 1 Controls Normal operation is performed using the COVER LOCK button This button ensures that the cover is locked while the mechanism is moving and also sequences the program steps The COVER LOCK button pops out to indicate that the cover
17. ade e Ensure holders are closed and properly latched Flange Pa even all the way around 34 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 How to handle liquid filled tubing 3 9 3 Good tensile strength Pull GENTLY at the weld It should not come apart or start to crack PULL AND TWIST TO TEST 3 9 How to handle liquid filled tubing It is not possible to weld together tubing that is filled with liquid Before sealing pump out the excess fluid Stop re enter of liquid by clamping the tubing All clamps must be placed outside the Lid CAUTION AN Do not attempt to connect liquid filled tubing using STERILE TUBE FUSER DRY or allow liquid to spill into the instrument 3 10 Using different types of tubing Most thermoplastic tubing can be joined in the STERILE TUBE FUSER DRY It is not possible to weld together non thermoplastic formulations such as Teflon silicone or natural rubber A list of compatible tubing is provided in Appendix A WARNING Depending of which tubes that are used in STERILE TUBE FUSER DRY hazardous gases may emit Make sure to use the instrument in a room with proper ventilation Your machine was set with the default tube types as shown in Appendix A The additional tube types in that table may be programmed into the unit but only four tube types are allowed at one time To replace the factory loaded tube types refer to the STERILE TUBE FUSER DRY and HOT L
18. atform 3 Pull the locking tabs towards the front of the unit to lock the tubing holders Fig 3 7 Holders correctly installed Pull the locking tab all the way towards the front of the unit to lock the tubing holder Tubing Holders are coded so that the machine automatically reads the holder type and selects the appropriate program Insert only a mated set of holders Note Before installing ensure that right amp left tube holders are of same size Fig 3 8 Holders incorrectly installed Locking tab not pulled forward to lock 32 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Change the tubing type 3 7 3 7 Change the tubing type Introduction STERILE TUBE FUSER DRY is pre programmed to accept up to four tubing types The instrument comes with factory loaded setting of 4 tube types Only approved tubing types are displayed for each holder Custom tubing materials and sizes can be programmed Please contact your local GE Healthcare representative for custom programming To replace the factory loaded tube types refer to the STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Tube Data Management Tool User Manual available with GUI tool Instructions At the INSERT BLADE screen press the CHANGE button Select and press the desired tubing type on the display If no tubing types appear on the first screen check the second screen Press the NEXT button to view the second screen and select the tubi
19. different from the controlled temperature After a user set time 5 to 10 seconds the blade is allowed to cool to a preset temperature 190 C to 270 C depending on the tubing type and diameter The cutting process then begins The blade temperature is controlled at all times and the program will fail if the temperature is not maintained Once the tubing has been cut the holders are moved into alignment Position sensors verify that correct positioning has occurred An error will result if the holders do not move correctly After alignment the holders are moved towards each other to form the weld as the blade moves upwards The amount of movement and timing is programmed and monitored by position sensors STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 39 4 Troubleshooting 4 2 Possible issues Step 4 Cool down The unit is then allowed to cool to a preset temperature typically 50 C and then held for additional few seconds This ensures that the blade is safe to touch and the weld is properly annealed The cover interlock is then released to signal the completion of a successful weld After the tubing and blade are removed press the COVER LOCK button to reset the unit for the next weld 4 2 Possible issues In the event that the machine malfunctions during the welding process the cycle will not complete Turn the power to the machine OFF Allow the blade to cool down for 30 seconds before switching ON again This should
20. is released and can be opened The Touchpanel display provides the operator interface for prompts and data entry Fig 3 1 22 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Controls 3 1 Fig 3 1 INSERT BLADE screen Date and time Unit ID number Tubing size Tubing type Press CHANGE to select available tubing types The main power switch is located at the rear of the unit A Key lock on the rear is used for diagnostics and program downloads A Programming lock key is normally supplied with the unit but it is also included with a PC interface program and data cable kit from GE Healthcare STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 23 3 Operation 3 2 Operating procedure 3 2 Operating procedure 5 2 1 24 Main operating steps STEP User Action Response 1 Switch power ON The display will show the version number and data revision CLOSE COVER instruction is displayed on the screen 2 Press the COVER LOCK button to The unit will initialize and test all the close the cover motors INSTALL HOLDER instruction is displayed on the screen 3 Open the cover and install the holder Display indicates the current tube settings The tube size is based on the holder To change the tube material press CHANGE Select the appropriate material and press BACK to return to the main screen The display also indicates INSERT BLADE 4 Insert the blade using the blade
21. ng type Fig 3 9 If you have already inserted the blade and wish to change the tubing type simply remove the blade to get this selection screen If the tubing has been installed you must remove the tubing cycle power to the machine and then remove the blade to get this screen Available tubing types The tubing diameter is set by the holder type and is read automatically by the machine when the holder is inserted See Appendix A for a list of available tubing sizes STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 33 3 Operation 3 8 Inspecting weld quality 3 8 Inspecting weld quality The STERILE TUBE FUSER DRY is designed to make reproducible and reliable connections however it is still critical to inspect the weld prior to use Note Allow the weld to cool for 2 to 3 minutes before inspection to achieve optimal strength 1 Axial alignment Check that the tubing is axially aligned If the tubing is offset then the weld will be weaker on one side Do not use such welds Contact the Service department to realign the unit 2 Uniform weld Check that you see a flange all around the weld This indicates that the weld is uniform in the radial direction If you do not see a flange all the way around then discard the weld Perform the checks described and weld again e Ensure correct tubings are used e Ensure correct holders are used e Ensure approved tubing size and formulation are used e Insert a new bl
22. o laboratory use 61010 1 EN 61326 1 EMC emissions and Harmonized with immunity requirements for 2004 108 EC measurement control and laboratory use EN ISO 12100 2010 Safety of machinery General Harmonized with principles for design Risk 2006 42 EC assessment and risk reduction STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 7 1 Introduction 1 2 Regulatory information CE conformity Directive Title 2006 42 EC Machinery Directive MD 2006 95 EC Low Voltage Directive LVD 2004 108 EC ElectroMagnetic Compatibility EMC Directive CE marking CE The CE marking and the corresponding Declaration of Conformity is valid for the instrument when it is e used asa stand alone unit or e connected to other CE marked instruments or e connected to other products recommended or described in the user documentation and e used in the same state as it was delivered from GE Healthcare except for alterations described in the user documentation or explicitly authorized by GE Healthcare Regulatory compliance of connected equipment Any equipment connected to STERILE TUBE FUSER DRY should meet the safety requirements of EN 61010 1 1 EC61010 1 or relevant harmonized standards Within the European Union connected equipment must be CE marked 8 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Introduction 1 Safety precautions 1 3 Recycling This symbol indicates
23. on NOTICE Only use PTFE coated cutting blades BLADES IR 50 specified for use with STERILE TUBE FUSER DRY For optimal use do not reuse blades NOTICE This is a class A product input power gt 1 kW 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 1 4 STERILE TUBE FUSER DRY Introduction STERILE TUBE FUSER DRY is an automated instrument designed to produce sterile joints of thermoplastic tubings without the need for a laminar flow cabinet or similar environmental control unit The machine is useful for connecting tubing between process containers and equipment The unit is designed to connect large diameter tubing enabling high flow rates and large transfer volumes Major uses are in bioprocessing and in aseptic applications Note The STERILE TUBE FUSER DRY is not to be used for medical applications STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 11 1 Introduction 1 4 STERILE TUBE FUSER DRY Main parts The illustration below shows the main parts of STERILE TUBE FUSER DRY 1 Part Description 1 Tubing holders blue and red 2 Blade holders 3 Touch screen 4 COVER LOCK button 5 Cover Lid 12 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Rear panel Introduction 1 STERILE TUBE FUSER DRY 1 4 The illustration below shows the rear panel of ST
24. r Manual 87 4500 21 AK STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 1 Introduction 1 1 Important user information Read this before using STERILE TUBE FUSER DRY All users must read the entire STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions before installing using or maintaining the instrument Always keep the Operating Instructions at hand when using STERILE TUBE FUSER DRY Do not operate STERILE TUBE FUSER DRY 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 STERILE TUBE FUSER DRY is an automated instrument designed to produce sterile joints of thermoplastic tubings STERILE TUBE FUSER DRY shall not be used in any clinical procedures or for diagnostic purposes Safety notices This user documentation contains WARNINGS CAUTIONS and NOTICES concerning the safe use of the product See definitions below STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 5 1 Introduction 1 1 Important user information Warnings WARNING A WARNING indicates a hazardous situation which if not avoided could result in death or serious injury It is important not to proceed until all stated conditions are met and clearly understood Cautions CAUTION CAUTION indicates a hazardous situation which if not avoided could result in minor or mode
25. rate injury It is important not to proceed until all stated conditions are met and clearly understood Notices NOTICE gt NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips Note A Note is used to indicate information that is important for trouble free and optimal use of the product Tip A tip contains useful information that can improve or optimize your procedures Typographical conventions Software items are identified in the text by bold italic text A colon separates menu levels thus File Open refers to the Open command in the File menu Hardware items are identified in the text by bold text e g Power switch 6 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Introduction 1 Regulatory information 1 2 1 2 Regulatory information This section lists the directives and standards that are fulfilled by STERILE TUBE FUSER DRY Manufacturing information The table below summarizes the required manufacturing information For further information see the EC Declaration of Conformity document Requirement Content Name and address of GE Healthcare Bio Sciences AB manufacturer Bjorkgatan 30 SE 751 84 Uppsala Sweden International standards Standard Description Notes EN 61010 1 Safety requirements for EN harmonized with IEC 61010 1 electrical equipment for 2006 95 EC UL 61010 1 measurement control and CAN CSA C22 2 n
26. sable blade for each cycle eliminates any potential cross contamination concerns 18 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Principle of operation 2 Operating schematic 2 1 2 1 Operating schematic 1 Blade is installed and it retracts into the unit Next the tubing is placed in the holders Tubing end to be Left tubing holder Right tubing holder 3 Tubing 2 to discarded y be connected STERILE TUBE FUSER DRY Tubing end to Cutting blade be discarded Tubing 1 to be connected 2 Blade heats up and then cuts through both tubing pieces 3 Tubing holders slide the cut tubing into alignment Hot blade is held against the cut tubing to ensure sterility 4 The blade returns to the start position and the tubing is simultaneously pushed together to form the connection 5 Discard the used blade and cut tubing ends Remove the connected tubing c STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 19 2 Principle of operation 2 1 Operating schematic 20 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 3 Operation Precautions 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 WARNING Hot Surfaces of STERILE TUBE FUSER D
27. 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 1 3 Safety precautions All users must read this section and the Safety instructions chapter in STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions before using STERILE TUBE FUSER DRY and observe the safety information at all times during use 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 WARNING Do not operate STERILE TUBE FUSER DRY in any other way than described in the user documentation WARNING 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 Hot Surfaces of STERILE TUBE FUSER DRY The cutting blade reaches 400 C during the heating cycle Do not try to open the protective cover during the welding STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 9 1 Introduction 1 3 Safety precautions 10 WARNING Pinch Hazard of STERILE TU
28. the RED holder 3 Next open the BLUE holder and slide it to the left to open 4 Remove the tubing and discard the cut ends 5 Close the cover 6 Press and hold the COVER LOCK button until you hear a CLICK for a few seconds to reset the machine Tubing to container 2 Tubing to container 1 lt I Left tubing holder Right tubing holder Open after the right tubing holder has been Open this first when unloading unloaded 30 STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK Operation 3 Change the tubing holders 3 6 3 6 Change the tubing holders Introduction The tubing holders can be quickly changed to connect different diameter tubing The holders must be changed as a set Left and Right holders Removing the tubing holders 1 Open the cover 2 Locate the locking tab on the holder Push the locking tab towards the rear of the unit to unlock the tubing holder 3 Lift the holder out 4 Repeat the procedure on the second holder Fig 3 6 Removing the tubing holders Lift the tubing holder out Push the Locking Tab towards the rear of the unit to unlock the tubing holder STERILE TUBE FUSER DRY Operator Manual 87 4500 21 AK 31 3 Operation 3 6 Change the tubing holders Installing the tubing holders 1 Open the cover 2 Ensure to use the correct tubing holder and set each tubing holder on its platform Ensure that the alignment pins under the tubing holder mate into holes in the pl

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