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STERILE TUBE FUSER - DRY and HOT LIPS TUBE SEALER

1. BIOPRENE C Flex 082 C Flex 374 x X x x x PHARMED BPT SANIPURE P 60 SANIPURE 4 BDF TYGON PVC Note The tubing brand names on the instrument screen may not look exactly the same as in the table above The tubing brand names displayed on the instru ment screen are abbreviations with the purpose to identify the tube material 96 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 7 Reference information 7 3 Compatible tubing for HOT LIPS TUBE SEALER Change selected tubing type For instructions on how to change the tubing type refer to Sealing tubes on page 56 Update tubing types To add the ReadyToProcess tube sizes refer to the STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Tube Data Management Tool User Manual that is supplied with an in stallation kit available upon request STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 97 7 Reference information 7 4 Blade contact materials for STERILE TUBE FUSER DRY 74 98 Blade contact materials for STERILE TUBE FUSER DRY The cutting blade is made of a special Nichrome alloy NiCrA that has the required electrical characteristics for resistance heating The tubing is in contact with a black polytetrafluoroethylene PTFE coating only This coating is applied at high tempera
2. BBE E ABBAS WRARTE Component name Hazardous substance KR i BRERA ZR AR Pb Hg Cd 28 9996 02 X 0 0 0 0 0 28 4117 04 X 0 0 0 0 0 0 RRBZABSAS WREZRBEM ARMA HS BY ESJ 711363 2006 tr EME BY BR BE RAE x RRBZRBRSWRSY ERI AR HA EHH SBM SI 711363 2006 HEM EMRBER ERFIR A A 4 tP BERS REA 0 Indicates that this toxic or hazardous substance contained in all of the homogeneous ma terials for this part is below the limit requirement in SJ T11363 2006 x Indicates that this toxic or hazardous substance contained in at least one of the homoge neous materials used for this part is above the limit requirement in SJ T11363 2006 Data listed in the table represents best information available at the time of publication 38 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 3 Installation 3 Installation Precaution WARNING The end user must ensure that all installation maintenance oper ation 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 In this chapter Section See page 3 1 Site requirements 40 3 2 Unpacking 42 3 3 Transport 43 3 4 Connections 44 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 39 3 Installation 3 1 Site requirements 3 1
3. Functional validation Follow the instruction below to perform a functional validation using the Functional verification gauge Step Action il Start the instrument STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 73 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Step Action 2 Wait until the READY light glows then press the Enter button Result The LCD display shows PRESS UP T CAL DOWN GAUGE CAL Eee 3 Press the Cursor down button to perform the Functional verification gauge validation test 4 When INSERT GAUGE AND PRESS ENTER is shown on the LCD display insert the Functional verification gauge and press the Enter button 74 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Step 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Action 5 If then only the PASS end of press the Cursor up button the Functional Result The display shows CAL PASSED AND RE verification gauge CYCLE POWER Recycle the power and start the passes through the instrument jaws without any difficulty any part of the FAIL press the Cursor down button end of the Result The display shows CALIBRATION FAIL Functional Calibrate to make sure that jaws are within the verification gauge specified tolerance passes throu
4. 96 20 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 1 Safety precautions STERILE TUBE FUSER DRY WARNING In setup mode of STERILE TUBE FUSER DRY with the Programming lock key horizontal the instrument can be run without the cover in place The blade poses a burn hazard if the weld process is started in this mode Use caution when in setup mode and keep clear of the blade and blade assembly WARNING Pinch hazard when using STERILE TUBE FUSER DRY There are movable parts under the protective cover Do not try to open the protective cover during the welding 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 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 In case of power failure and instrument reset STERILE TUBE FUSER DRY unlocks the COVER LOCK Do not touch the blade for approximately one minute till it cools down WARNING The blade must be properly pushed down into its blade holders to enable the temperature sensor to measure the correct blade temperature gt PPP Pe gt STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2
5. Disconnect all tubing hoses and cables before moving the unit System operation STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER gt WARNING Do not drop objects into the unit If an object has been dropped into the unit disconnect the power supply before lifting the object out of the unit gt WARNING The instrument must never be used if any safety functions are out of order Contact your GE service operator for more information STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 19 2 Safety instructions 2 1 Safety precautions WARNING Inspect all connections and tubing before start and replace any defective parts CAUTION Ensure that all tubing hoses and cables are placed so that the risk for tripping accidents is minimized CAUTION Only use tubing that is compatible with the instruments CAUTION Remove any spillage on the floor immediately to minimize the risk for slipping accidents CAUTION Leave space around the unit for proper ventilation Note Improper use of tube data may cause damage to the unit and is not covered under the warranty For a list of tubing types that have been tested for e STERILE TUBE FUSER DRY refer to Section 7 2 Compatible tubing for STERILE TUBE FUSER DRY on page 94 e HOT LIPS TUBE SEALER refer to Section 7 3 Compatible tubing for HOT LIPS TUBE SEALER on page
6. LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 7 Reference information 7 2 Compatible tubing for STERILE TUBE FUSER DRY Change selected tubing type The selected tubing type is shown on the touchscreen display For instructions on how to change the tubing type refer to Start instrument and set tubing brand and dimension on page 48 Update tubing types To replace the factory loaded tubing types or to add the ReadyToProcess tube sizes refer to the STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Tube Data Management Tool User Manual that is supplied with an installation kit available upon request STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 95 7 Reference information 7 3 Compatible tubing for HOT LIPS TUBE SEALER 7 3 Compatible tubing for HOT LIPS TUBE SEALER Introduction The HOT LIPS TUBE SEALER is designed to seal thermoplastic tubing Note HOT LIPS TUBE SEALER cannot be used to seal 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 Tubing dimension I D x O D in inches Data ver 0809 Date 09 11 3 16 1 4 1 4 516 1 4 3 8 3 8 x x x x x x x 3 8 3 8 76 76 1 2 1 2 5 8
7. TUBE FUSER DRY The following diagram shows the danger zone on STERILE TUBE FUSER DRY This danger zone should be kept clear of obstructions during operation 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 and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 2 Danger zone HOT LIPS TUBE SEALER The following diagram shows the danger zone on HOT LIPS TUBE SEALER This danger zone should be kept clear of obstructions during operation WARNING Hot surfaces of HOT LIPS TUBE SEALER The jaws reach over 200 C during the heating cycle Do not touch the jaws during operation STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 27 2 Safety instructions 2 3 COVER LOCK for STERILE TUBE FUSER DRY 2 3 COVER LOCK for STERILE TUBE FUSER DRY Introduction The COVER LOCK button is located on the lid of STERILE TUBE FUSER DRY see Section 1 3 STERILE TUBE FUSER DRY on page 10 If the COVER LOCK button is then the lid is down locked up unlocked To lock the cover press and hold the COVER LOCK button for a few seconds until you hear a CLICK sound NOTICE Make sure that the COVER LOCK button is down during the entire welding and aligning operat
8. and Metric Hex keys to loosen or fasten them STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 1 Tube Restrictor replacement Remove the Tube Restrictors Follow the instruction below to remove the Tube Restrictors Step Action 1 Switch on the power to the HOT LIPS TUBE SEALER by pressing the power switch to the I position and wait for the initialization to be completed Press the Enter button on the keypad Result The rear jaw will move away from the operator Switch off the power to HOT LIPS TUBE SEALER by pressing the power switch to the O position and disconnect the power plug from the rear of the unit Remove Hex pan head screw 1 using a T8 Torx wrench Move and hold the Red flag indicator in a position where it does not block the top Tube Restrictor and pull out the top Tube Restrictor Slightly loosen Hex pan head screw 2 using a T10 Torx wrench STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 71 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 1 Tube Restrictor replacement Step Action 6 Remove the bottom Tube Restrictor from the unit by pulling it up and away from the front jaw assembly using needle nose pliers Insert new Tube Restrictors Follow the instruction below to insert the new Tube Restrictors Step Action 7 In
9. disinfectant Z 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 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 1 STERILE TUBE FUSER DRY Step Action 6 Press and hold the COVER LOCK button for a few seconds to sequence the program Remove connected tubing and turn off the instrument CAUTION The cutting blade of STERILE TUBE FUSER DRY is a thin piece of stainless steel 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 Step Action 1 On successful completion of the cycle the display shows a WELD COMPLETE message and the cover interlock releases 2 Open the cover 3 Remove the used cutting blade with Installation Removal Tool Secure the blade within the tool by compressing with thumb as shown in the image below Note For optimal operation do not reuse cutting blades 4 Open the red Tubing holder then the blue Tubing holder STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 51 4 Operation 4 1 STERILE TUBE FUSER DRY Step Action 5 Remove the connected tubing and di
10. the jaws will open auto matically STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 91 7 Reference information 7 Reference information In this chapter Section See page 7 1 Specifications 93 7 2 Compatible tubing for STERILE TUBE FUSER DRY 94 7 3 Compatible tubing for HOT LIPS TUBE SEALER 96 7 4 Blade contact materials for STERILE TUBE FUSER DRY 98 7 5 Further information 99 92 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 7 1 Specifications STERILE TUBE FUSER DRY 7 Reference information 7 1 Specifications Parameter Value Supply voltage 100 120 V AC 10 or 220 240 V AC 10 50 60 Hz Maximum current 3 3 A Fuse specification 2 x T4 0 AL 250 V Dimensions W x D x H 395 x 355 x 265mm Weight 16 kg Acoustic noise level lt 70 dB A Ambient temperature 0 C to 30 C Storage temperature 20 C to 60 C Relative humidity tolerance 20 to 80 non condensing HOT LIPS TUBE SEALER Parameter Value Supply voltage 100 120 V AC 10 or 220 240 V AC 10 50 60 Hz Maximum power 350 VA Fuse specification 2 x T3 15AL 250 V Dimensions W x D x H 165 x 356 x 203 mm Weight 8kg Acoustic noise level lt 55 dB A Ambient temperature 2 C to 32 C Storage temperature 25 C to 50 C Relative humidity tolerance 2 to 80 non cond
11. user documentation 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 Olt gt This symbol indicates that the product contains hazardous materials in excess of the limits established by the Chinese standard SJ T11363 2006 Requirements for Concentration Limits for Certain Hazardous Substances in Electronics fN fN The system complies with applicable European directives Refer to Section 1 2 Regulatory information on page 7 D The system complies with the requirements for electromagnetic compliance EMC in Australia and New Zealand Safety label description 30 The safety labels are described in the table below Make sure that you fully understand the potential hazards indicated by the labels Description Indicates a hot surface and that care must be exercised to prevent injury STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 4 Labels Description Indicates a pinch hazard and that care must be exercised to prevent injury Safety labels on STERILE TUBE FUSER DRY The safety labels are located on STERILE TUBE FUSER DRY as illustrated below The labels warn the user of risk of
12. x iseieccccc inn ciahanapetiooan 63 5 1 2 Cleaning of HOT LIPS TUBE SEALER a 66 5 2 Maintenance of STERILE TUBE FUSER DRY wiccecccccsssssssssssesssssccsssssssssussessssseccesssssssusseessesseesees 67 5 3 Maintenance of HOT LIPS TUBE SEALER 68 5 31 Tube Restrictor replacement n z 69 5 3 2 Functional validation and calibration weseeccccssssssssssssssssssssssssssssssssssssssssssssscesccssccseceeceecececeeees 73 5S4 Replacementof USES nenssemiiinkasanranummnn n N A eis 80 5 5 SLOG GO gura R AE E E E E ER 82 TrOuDIES OOt gress snr Tansee Center esr rer Se ett st serern errs 83 6 1 STERILE TUBE FUSER DRY cstesssasssssdeiccicsedecccseistitedscslesciesseariaasned tedesgusafeearissbitacsedsleossselecuwecivaneels 84 6 2 HOT LPS TUBE SEALER isss anaa naait a Meeda i ies 90 Reference information 92 TL SpECMCtON Sannn N E ANE AENA EAG 93 7 2 Compatible tubing for STERILE TUBE FUSER DRY nn sssssssssssssisssrsssssssssrssssrssrssessrrsnesnrssnrsne 94 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Table of Contents 7 3 Compatible tubing for HOT LIPS TUBE SEALER n cssssssssesssssscsssssssssssssesessssescesssnsssssseseesees 96 74 Blade contact materials for STERILE TUBE FUSER DRY As 98 7 5 F rther mformat Oieee EAEAN ANAR i 99 nE LE AE EE E EEA E LESE E L E tenes A AEE EE EE 100 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 3 1 Introduct
13. 1 2 Safety instructions 2 1 Safety precautions CAUTION The cutting blade of STERILE TUBE FUSER DRY is a thin piece of stainless steel 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 CAUTION Do not attempt to connect liquid filled tubing using STERILE TUBE FUSER DRY or allow liquid to spill into the instrument CAUTION Holders must not be mounted on the STERILE TUBE FUSER DRY during initial alignment of the system NOTICE Make sure that the COVER LOCK button is down during the entire welding and aligning operation NOTICE Cover must be closed for the instrument to operate The cover in terlock will only allow it to be opened when it is safe The COVER LOCK button pops out to indicate that the cover is released and can be opened OOP Ee D HOT LIPS TUBE SEALER WARNING Hot surfaces of HOT LIPS TUBE SEALER The jaws reach over 200 C during the heating cycle Do not touch the jaws during operation 22 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 1 Safety precautions WARNING Pinch hazard when using HOT LIPS TUBE SEALER The jaws are moving during clamping and calibration Keep away from the jaws when clamping tubes and during the calibration procedure WARNING Before star
14. 4 The Tubing holders slide the cut tubing into alignment The hot cutting blade is held against the cut tubing to ensure sterility 5 The cutting blade returns to the start position and the tubing is simultane ously pushed together to form the connection an 6 The connected tubing is removed and the used cutting blade and cut tubing ends are discarded Prior to use Prior to use the instrument should be tested by making a few trial welds which should be examined If the sample welds are not acceptable contact Service Fusing tubes 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 and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 47 4 Operation 4 1 STERILE TUBE FUSER DRY 48 WARNING Pinch hazard when using STERILE TUBE FUSER DRY There are movable parts under the protective cover Do not try to open the protective cover during the welding WARNING In case of power failure and instrument reset STERILE TUBE FUSER DRY unlocks the COVER LOCK Do not touch the blade for approximately one minute till it cools down NOTICE gt Cover must be closed for the instrument to operate The cover in terlock will only allow it to be opened when it is safe The COVER LOCK button pops out to indicate th
15. E FUSER DRY 26 E Emergency procedures 34 Emergency shutdown HOT LIPS TUBE SEALER 35 STERILE TUBE FUSER DRY 34 Power failure 35 F FCC compliance 8 Fuses replacement 80 Fusing tubes 49 G General Precautions 16 H HOT LIPS TUBE SEALER Cleaning 66 Control panel 55 Danger zone 27 Illustration 12 Maintenance 69 Sealing tubes 59 Troubleshooting 91 Illustrations HOT LIPS TUBE SEALER 12 STERILE TUBE FUSER DRY 10 Installing and moving the instru ment precautions 19 International Standard 8 M Maintenance HOT LIPS TUBE SEALER 69 Precautions 24 61 STERILE TUBE FUSER DRY 67 Manufacturing information 7 P Personal protection 18 Power cord connection 44 Power failure 35 R Recycling procedures 36 Reference information 93 Regulatory compliance of con nected equipment 9 S Safety precautions 16 General precautions 16 Installing and moving the instrument 19 Maintenance 24 61 Personal protection 18 System operation 19 Using flammable liquids 18 Sealing tubes 59 Site requirements 40 STERILE TUBE FUSER DRY Blade contact materials 98 Cleaning 63 COVER LOCK 28 Danger zone 26 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Fusing tubes 49 Illustration 10 Maintenance 67 Schematic operation 47 Troubleshooting 85 Storage 82 System operation precau tions 19 T Transport 43 Troublesh
16. K Limited 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 28 9641 39 AD 02 2015 a49
17. Operating Instructions 28 9641 39 AD 81 5 Maintenance 5 5 Storage 5 5 Storage Refer to Section 7 1 Specifications on page 93 for information CAUTION The instrument has fragile items Ensure that the instrument is al ways in upright position during transport movement and storage Also ensure no weight is kept on instrument or on the instrument packaging 82 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 6 Troubleshooting 6 Troubleshooting In this chapter Section See page 6 1 STERILE TUBE FUSER DRY 84 6 2 HOT LIPS TUBE SEALER 90 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 83 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY G1 STERILE TUBE FUSER DRY General troubleshooting Problem Corrective action The display is not lit e Check that the instrument is plugged in e Check that the power switch is in the I posi tion e Afuse has blown Refer to Section 5 4 Replace ment of fuses on page 80 for instructions on how to replace fuses e If problem persists contact Service The instrument does not recog e Make sure that the holder tabs are locked nize that the holders are in pulled out towards the front of the instru stalled ment e Check that tubing is the correct size and firmly clamped in the holder e Check that the holders are in the correct posi tion and firmly seated in the ins
18. RILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 1 Cleaning 5 1 1 Cleaning Infrared sensor window Clean the infrared sensor window indicated by an arrow below every 2 months Use a lens cleaning kit to clean the sensor window STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 65 5 Maintenance 5 1 Cleaning 5 1 2 Cleaning of HOT LIPS TUBE SEALER 5 1 2 Cleaning of HOT LIPS TUBE SEALER General cleaning Clean the system using a damp cloth with suitable disinfectant that does not affect any markings or signs or the safety of the system Ethanol up to 20 as disinfectant and a lint free cloth can also be used to clean surfaces of the instrument PTFE jaw covers Wipe the black PTFE jaw covers see arrow with alcohol if there is any tubing residue or discoloration LIFTUPTO LOAD TUBE 66 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 2 Maintenance of STERILE TUBE FUSER DRY 5 2 Maintenance of STERILE TUBE FUSER DRY All maintenance tasks on STERILE TUBE FUSER DRY other than specified below needs to be done by a GE service representative Contact Service Replace the fuse in case of fuse failure See Section 5 4 Replacement of fuses on page 80 for more information Handle and store the tube holders in a safe designated place Dropping the holders o
19. STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions Original instructions Table of Contents Table of Contents 1 MU a eee 4 1 1 Important user information 5 1 2 Regulatory information 7 1 3 STERILE TUBE FUSER DRY a 10 1 4 HOT LIPS TUBE SEALER iicesmunnniimanininanian nnna 12 15 Associated GO CUPISMECEIOMN sinin ananin ARN ANN 14 Safety INStrUCtTIONS cicera e Ei 15 2 1 Safety preC UtON S inienn N NT NAROA ANNE 16 2 2 Danger ZONE m mease aa E ATAN NT RE 26 25 COVER LOCK for STERILE TUBE FUSER DRY oicceeccccssssssssssssesssssscssssssssssssessessesescssssssssusessesees 28 BAF NGS Sats cosasssszsssscsstatenctesetasslaashcstusnasivnasseesteantesttesesins 29 2 5 Emergency procedures a 34 2 6 Recycling procedures oe eessssssssssessssssesssssessssssssssnsesies i 36 2 7 Declaration of Hazardous Substances DOHS woececccccssssssssssssessesssssccsssssssssussessssecsssssssssuseesees 37 Lif 2 12 9 AE E E en Se eee so E E E ARA 39 3 1 Site requirements 40 3 2 Unpacking s s E 42 e Ae O E Ee A E A epesuusaece avant fedetennsanebaeanotyuvazeces 43 BA ConnecUONnS prenens aenn E R RE EER 44 Operatoria an aaa aa aaia R 45 4 1 STERILE TUBE FUSER DRY sinire e N a A PE AAEE EEE EIET EEE AEEA 46 4 2 HOT LIPS TUBE SEALER sicccscsassstsssttsasneccscesevtasssstintseashestsaest E iets 55 Maintendnce csore cieaiete acces daaees becastaceaaas 61 51L CEINE n AAE E N 62 5 1 1 Cleaning
20. Site requirements STERILE TUBE FUSER DRY Parameter Requirements Electrical power 100 120 220 240 V AC 10 50 to 60 Hz Transient overvoltages Overvoltage category Il Operating temperature 0 C to 30 C Humidity 20 to 80 non condensing Pollution degree 2 Altitude Maximum 2000 m HOT LIPS TUBE SEALER Parameter Requirements Electrical power 100 120 220 240 V AC 10 50 to 60 Hz Transient overvoltages Overvoltage category ll Operating temperature 2 C to 32 C Humidity 2 to 80 non condensing Pollution degree 2 Altitude Maximum 2000 m Requirements on instrument placement The following requirements apply to both STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER e There should be at least 0 6 m of space around the instrument for easy access to the whole equipment both for normal operation and for maintenance and service operations 40 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 3 Installation 3 1 Site requirements e The danger zone see Section 2 2 Danger zone on page 26 should be kept clear of obstructions e The instrument is designed for normal laboratory environments and must be protect ed from splashes or dusty operations e The instruments are equipped with ventilation fans Make sure that the air flow is not blocked STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instruc
21. ails Contact Service to repair COVER LOCK ERROR 11 PUSH MOTOR The X axis motor compress Switch off the power to the in FAIL es the tubes together during strument the weld This error indicates f thatthie motor failed t e Switch on the power to the in move correctly strument and follow the dis play messages e Ifthe motor fails to move contact Service ERROR 12 RESET FAIL The instrument failed to reset Check that all tubes are removed to the start configurations and that nothing is obstructing the movement of the motors ERROR 13 REMOVE TUBES The instrument was powered Remove all tubes and cycle power up with tubes stillinsertedin off on to restart the instrument the holders N A ERFF e Time out error e Check if the cable is connect ed properly e The communication ca oe ble may be disconnect e Switch off the power to the in ed or the communica strument tion error has occurred e Wait for 2 to 3 minutes due to noise and so on e Switch on the power to the in strument 88 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Error No N A Message ERFE Possible cause Response error from the PC during communication with the instrument 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY Corrective action e Verify if the expected data is received from PC GUI applica tion e Check if the communication cable is conne
22. aluation Authorization and restriction of 1907 2006 CHemicals REACH ACPEIP Administration on the Control of Pollution Caused by Elec tronic Information Products China Restriction of Hazardous Substances RoHS STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 9 1 Introduction 1 3 STERILE TUBE FUSER DRY 1 5 STERILE TUBE FUSER URRY The illustration below shows the main parts of STERILE TUBE FUSER DRY 1 Part Description Tubing holders blue and red Blade holders Touch screen COVER LOCK button Cover or Lid Main parts 1 2 3 4 5 10 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Rear panel 1 Introduction 1 3 STERILE TUBE FUSER DRY The illustration below shows the rear panel of STERILE TUBE FUSER DRY Part Function 1 Ventilation fan 2 Key lock 3 Power switch 4 Data jack 5 Fuse holder 6 Power connector STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 11 1 Introduction 1 4 HOT LIPS TUBE SEALER 1 4 HOT LIPS TUBE SEALER Introduction HOT LIPS TUBE SEALER is an instrument used for heat sealing of thermoplastic tubing It is useful for sealing feed harvest and sample tubing connected to bags or other con tainers for storage and transportation HOT LIPS TUBE SEALER is designed to seal a wi
23. and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 55 4 Operation 4 2 HOT LIPS TUBE SEALER Sealing tubes WARNING Pinch hazard when using HOT LIPS TUBE SEALER The jaws are moving during clamping and calibration Keep away from the jaws when clamping tubes and during the calibration procedure WARNING Before starting HOT LIPS TUBE SEALER please make sure that no objects tubes are kept in between the heating jaws or moving path WARNING Hot surfaces of HOT LIPS TUBE SEALER The jaws reach over 200 C during the heating cycle Do not touch the jaws during operation Step Action 1 Switch on the power to HOT LIPS TUBE SEALER by pressing the power switch to the I position Result The LCD display shows INITIALIZING and sealing jaws moves to the load position INITIALIZING PLEASE WAIT When initialization is complete the The LCD display shows INSERT TUBING the tubing type and the tubing dimension i d x o d in inches The READY light also turns on INSERT TUBING CFLEX 3 8 x 5 8 56 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 2 HOT LIPS TUBE SEALER Step Action 2 To change tubing type and tubing dimension e Press the MENU button SELECT TUBING CFLEX 3 8 x 5 8 e Press the up or down cursor buttons until the desired tubing type and diameter are displayed e Press enter button The para
24. area is free of liquid or bubbles Note No clamps plugs or seals should be inside the danger zone of the instrument see Section 2 2 Danger zone on page 26 Inspecting seal quality The HOT LIPS TUBE SEALER is designed to make reproducible and reliable seals however it is still critical to inspect the seal prior to use A common cause for a poor seal is that the wrong tubing type and or dimension have been set during tubing sealing Note Allow the seal to cool for 2 to 3 minutes before inspection to achieve optimal strength Check seal Check that e the seal has smooth and uniform edges STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 59 4 Operation 4 2 HOT LIPS TUBE SEALER e the seal has uniform width e the seal has no splitting or cracking e there are no bubbles arrow in figure indicates a trapped bubble e the plastic has melted through and that the seal is homogeneous Note If the seal is wider on top then it was not centered properly in the sealer jaws Cutting sealed tubing HOT LIPS TUBE SEALER produces a seal that is wide enough to be easily cut Simply use scissors to cut through the middle of the seal This procedure is useful for sealing and detaching tubing from bags 60 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 Maintenance Precautions WARNING The end user must ensure t
25. asses through the jaws Please refer to Section 5 3 1 Tube Restrictor replacement on page 69 for more information on next steps STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 79 5 Maintenance 5 4 Replacement of fuses 5 4 Replacement of fuses Precautions WARNING Disconnect power Always disconnect power from the instrument before performing any maintenance task WARNING If a fuse requires repeated replacement do not continue to use the instrument Contact an authorized service engineer Refer to Section 7 1 Specifications on page 93 for information about the fuse types and rating WARNING For continued protection from fire hazard replace only with same type and rating of fuse Refer to Section 7 1 Specifications on page 93 for fuse specification Instructions Step Action 1 Disconnect the power cord from the instrument 2 Lift out the fuse cover located below the power switch see arrow 3 Lift out the broken fuses 80 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 4 Replacement of fuses Step Action 4 Insert new fuses 5 Replace the fuse cover on the instrument 6 Connect the power cord 7 Switch on the power to the instrument by pressing the power switch to the I position STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER
26. at the cover is released and can be opened Start instrument and set tubing brand and dimension Step Action 1 Switch on the power to STERILE TUBE FUSER DRY by pressing the power switch to the I position Result Close the lid and lock by pressing COVER LOCK button in order to proceed further On successful initialization the display shows the INSERT BLADE screen 1 as 297 2007 aa 50 0189l 174 IDx 7716 OD l 3 7 PHARMED a 7 5 The display shows current date and time 1 and instrument ID number 4 2 Check that desired tubing dimension 2 and tubing brand 3 are shown STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 1 STERILE TUBE FUSER DRY Step Action 3 Optional change tubing brand 3 e Press the CHANGE button 5 e Press the desired tubing type on the new display If no tubing types ap pear on the first screen press the NEXT button to open the second screen Note If you have already inserted the blade and wish to change the tubing type simply remove the blade to get the INSERT BLADE screen Note If the tubing has been inserted you must remove the tubing cycle power to the instrument and then remove the blade to get the INSERT BLADE screen 4 Optional change tubing dimension Use a Tubing holder with the desired dimension The tubing dimension is then automatically entered in the instrument To change a Tubin
27. cted properly e Restart the PC applica tion GU STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 89 6 Troubleshooting 6 2 HOT LIPS TUBE SEALER 62 HOTLIPS TUBE SEALER General troubleshooting Problem The LCD display is not lit Possible cause e The instrumentis not plugged in e The power switch is in the O position e Instrument fuse has blown Corrective action e Check that the instrument is plugged in e Check that the power switch is in the I position e If any instrument fuses has blown refer to Section 5 4 Replacement of fuses on page 80 for instructions on how to replace fuses e If problem persists contact Service The seal is not satisfac tory e The tubing program is not set correctly e Incorrect tubing is used e The tubing is not centered in the jaws e The motor need adjustment e Check that the tubing program is set correctly by clicking on the MENU button and co relating the tube inserted to the selected tubing e Check that you are using the correct tubing e Check that tubing is centered in the jaws e Perform mechanical assembly cali bration according to the instruc tions in Calibration on page 75 LCD error message Mechanism was obstructed from complete movement Remove tubing and any other object from the jaws and cycle power off on HEATER FAILURE MOTOR OVERLOAD to re
28. de range of tubing diameters Major uses are in bioprocessing and in aseptic applications HOT LIPS TUBE SEALER is equipped with an embedded software for control and supervi sion Main parts The illustration below shows the main parts of HOT LIPS TUBE SEALER Part Description 1 Moving jaw 2 LCD display 3 GO button 4 LIFT UP TO LOAD TUBE handle 12 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Rear panel 1 Introduction 1 4 HOT LIPS TUBE SEALER The illustration below shows the rear panel of HOT LIPS TUBE SEALER Part Description 1 Power switch 2 Fuse holder 3 Power connector 4 Key lock 5 Data jack STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 13 1 Introduction 1 5 Associated documentation 1 5 Associated documentation Introduction This section describes the documentation associated with STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Supplied documentation In addition to the Operating Instructions the STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER instruments are supplied with the respective Operator Manual Document Contents STERILE TUBE FUSER DRY Operator How to use the system including con Manual supplied with STERILE TUBE cepts methodology operation and trou FUSER DRY bleshooting HOT LIPS TUBE SEALER Operator Manual The
29. e 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 and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 1 Introduction 1 2 Regulatory information 1 2 Regulatory information Introduction This section lists the directives and standards that are fulfilled by STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Manufacturing information The table below summarizes the required manufacturing information For further infor mation see the EU Declaration of Conformity DoC document Requirement Name and address of manufacturer GE Healthcare Bio Sciences AB Bjorkgatan 30 SE 751 84 Uppsala Sweden Conformity with EU Directives This product complies with the European directives listed in the table by fulfilling the corresponding harmonized standards Directive Title 2006 42 EC Machinery Directive MD 2004 108 EC Electromagnetic Compatibility EMC Directive 2006 95 EC Low Voltage Directive LVD STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instr
30. e the error message s to assist in troubleshooting the problem NOTICE Errors 1 through 12 can not be confirmed without causing damage to the equipment Error 13 can be user confirmed if necessary Error No Message Possible cause Corrective action ERROR 1 INITIALIZATION The instrument was notable e Check if anything is obstruct heating system within the holders specified time out period i e Switch off the power to the in strument e Check if COVER LOCK button iS up e Wait 2 to 3 minutes e Switch on the power to the in strument e Retry initialization 86 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY Error No Message Possible cause Corrective action ERROR 2 HEATING TOO It took too long for the blade e Try with a new blade SLOW to reach the sterilization temperature e Check that the blade edges are clean and unscratched e Contact service for further as sistance ERROR 3 STERILIZATION The temperature when steril e Repeat the operation with a FAIL izing the blade dropped be new blade low the set point oa e Call Service if the problem persists ERROR 5 RETRACT MOTOR The blade retract operation e Check for obstructions FAIL failed to retract the blade in the specified time e Switch off the power to the in strument e Switch on the power to the in stru
31. ed for work in a potentially explosive atmosphere Personal protection STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER WARNING Always use appropriate personal protective equipment during op eration and maintenance of STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER WARNING Hazardous substances When using hazardous chemical and bio logical agents take all suitable protective measures such as wearing protective glasses and gloves resistant to the substances used Follow local and or national regulations for safe operation and maintenance of the system WARNING Spread of biological agents The operator has to take all necessary actions to avoid spreading hazardous biological agents in the vicinity of the instrument The facility should comply with the na tional code of practice for biosafety 18 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Installing and moving the instrument 2 Safety instructions 2 1 Safety precautions STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER WARNING Power cord Only use power cords delivered or approved by GE WARNING Protective ground The instruments must always be connected to a grounded power outlet 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 A A A A CAUTION
32. enance of HOT LIPS TUBE SEALER 5 3 1 Tube Restrictor replacement 5 3 1 Tube Restrictor replacement Introduction The Tube Restrictors are wearable components that require periodic replacement to ensure good quality sealing of thermoplastic tubing Depending on tube size and tubing formulation approximately 40 to 60 seals can be created before the Tube Restrictors need to be replaced It is recommended to replace the Tube Restrictors as a part of the routine maintenance of HOT LIPS TUBE SEALER For more information about inspecting the quality of the seal see Inspecting seal quality on page 59 Tools required e Torx wrenches T8 and T10 e Needle nosed pliers STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 69 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 1 Tube Restrictor replacement Tube Restrictor assembly illustration Part Description 1 Red flag indicator 2 Metal steering peg 3 Hex pan head screw 1 Hex pan head screwl2 Top restrictor Bottom restrictor Note Note 70 Screws may vary depending on the production year of the unit The picture above is of an older unit where hex pan head screws were not used and is solely for illustration purposes Older installations may be held in place with two button head screws in position 3 and 4 shown in the picture above Use a Precision Phillips screwdriver
33. ensing STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 93 7 Reference information 7 2 Compatible tubing for STERILE TUBE FUSER DRY 7 2 Compatible tubing for STERILE TUBE FUSER DRY Introduction 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 I D x O D in inches Data ver 4 03 Date 09 11 1 8 3 16 3 16 1 4 1 4 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 8 BIOPRENE C Flex 082 C Flex 374 x X X X PHARMED BPT SANIPURE 60 SANIPURE F BDF TYGON PVC Note The tubing brand names on the instrument screen may not look exactly the same as in the table above The tubing brand names displayed on the instru ment screen are abbreviations with the purpose to identify the tube material 94 STERILE TUBE FUSER DRY and HOT
34. essly approved by GE could void the user s authority to operate the equipment 8 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 1 Introduction 1 2 Regulatory information 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 rea sonable protection against harmful interference when the equipment is operated in a commercial environment This equipment generates uses and can radiate radio frequen cy energy and if not installed 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 re quired to correct the interference at his own expense Regulatory compliance of connected equipment Any equipment connected to STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER should meet the safety requirements of EN 61010 1 IEC 61010 1 or relevant harmonized standards Within the European Union connected equipment must be CE marked Environmental conformity This product complies with the following environmental regulations Requirement Title 2011 65 EU Restriction of Hazardous Substances RoHS Directive 2012 19 EU Waste Electrical and Electronic Equipment WEEE Directive Regulation EC No Registration Ev
35. g holder see Changing Tubing holder on page 52 Insert a cutting blade CAUTION The cutting blade of STERILE TUBE FUSER DRY is a thin piece of stainless steel 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 Step Action 1 Place the STERILE TUBE FUSER DRY blade in Installation Removal Tool as shown below STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 49 4 Operation 4 1 STERILE TUBE FUSER DRY 50 Step Action Use Installation Removal Tool to install the blade by pressing the top of the tool with the palm of the hand During the blade installation secure the blade within the tool by compressing with thumb as shown in the image below Press Installation Removal Tool with palm of your hand until the blade is fully inserted into mounted position Remove Installation Removal Tool Close the STERILE TUBE FUSER DRY lid and press the COVER LOCK button for location see Section 1 3 STERILE TUBE FUSER DRY on page 10 Once you press the COVER LOCK button the blade automatically retracts into the instrument Wait for the cover interlock to release Insert tubing and start welding Step Action 1 Clean the outside of the tubing area to be connected using a suitable disin fectant 70 ethanol or isopropanol can be used as a suitable
36. gh the jaws Calibration Follow the instruction below to calibrate HOT LIPS TUBE SEALER Step Action 1 2 Switch the power switch to the O position Remove the Tube Restrictors according to the procedure Remove the Tube Restrictors on page 71 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD T5 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Step Action Make sure that there is nothing between the jaws which obstructs the jaws from closing completely against each other as shown in the illustration be low 4 Release the GO button when the LCD display shows READY TO CAL 76 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Step Action 5 Verify that the tube restrictors have been removed and that nothing obstructs the jaws Press GO to continue calibration Result The display shows CALIBRATING and the jaws start closing Make sure no objects restrict the jaws from closing completely Note If GO button is pressed during calibration calibration stops and LCD displays CALIBRATION ABORTED Operator has to recycle power and perform the steps from beginning in order to calibrate again The jaws will close to approximately 5 mm apart and then start m
37. hat all installation maintenance oper ation 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 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 Disconnect power Always disconnect power from the instrument before performing any maintenance task In this chapter Section See page 5 1 Cleaning 62 5 2 Maintenance of STERILE TUBE FUSER DRY 67 5 3 Maintenance of HOT LIPS TUBE SEALER 68 5 4 Replacement of fuses 80 5 5 Storage 82 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 61 5 Maintenance 5 1 Cleaning 5 1 Cleaning In this section Section See page 5 1 1 Cleaning 63 5 1 2 Cleaning of HOT LIPS TUBE SEALER 66 62 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 1 Cleaning 5 1 1 Cleaning 5 1 1 Cleaning General cleaning Clean the system using a damp cloth with suitable disinfectant that does not affect any markings or signs or the safety of the system Ethanol up to 20 as disinfectant and a lint free cloth can also be used to clean surfaces of the instrument Liqu
38. he instrument before performing any maintenance task WARNING If a fuse requires repeated replacement do not continue to use the instrument Contact an authorized service engineer gt Pe gt Refer to Section 7 1 Specifications on page 93 for information about the fuse types and rating WARNING For continued protection from fire hazard replace only with same type and rating of fuse CAUTION Change the blade after every cut to avoid sterility issues gt gt HOT LIPS TUBE SEALER WARNING Pinch hazard when using HOT LIPS TUBE SEALER The jaws are moving during clamping and calibration Keep away from the jaws when clamping tubes and during the calibration procedure gt STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 1 Safety precautions Troubleshooting STERILE TUBE FUSER DRY NOTICE Errors 1 through 12 can not be confirmed without causing damage to the equipment Error 13 can be user confirmed if necessary Reference information STERILE TUBE FUSER DRY 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 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 25 2 Safety instructions 2 2 Danger zone 2 2 Danger zone STERILE
39. he release position and the sealing jaws are cool enough to touch tf When the READY light turns on remove the tubing REMOVE TUBING CFLEX 3 8 x 5 8 8 If another tube sealing is desired press the GO button and the instrument resets Follow the instructions Sealing tubes from step 3 and onwards Note Each seal cycle takes about 2 to 3 minutes depending on the tubing type and dimension 9 Inspect the seal carefully before use see Inspecting seal quality on page 59 58 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 2 HOT LIPS TUBE SEALER Step Action 10 When no more tube sealing is desired switch off the power to HOT LIPS TUBE SEALER by pressing the power switch to the O position Handling of filled tubing NOTICE gt Do not spill liquid into HOT LIPS TUBE SEALER This can cause serious damage and will void the warranty NOTICE gt High pressures can be generated if the liquid in the seal area has no place to go when it is clamped down by the sealing jaws Make sure that the liquid can be displaced up or downstream of the seal and that the temporary clamps or plugs are secure The HOT LIPS TUBE SEALER can handle liquid filled tubing Typically a clamp or plug is used to prevent the liquid from leaking while the tubing is sealed The liquid is displaced by the specially contoured jaws and the seal
40. id spillage cleaning In case of spillage mild cleaning agents should be used to clean the instrument holders and clamps depending on the hazard level of the process chemicals biological being used Step Action 1 Switch off the instrument and disconnect power cable before initiating the cleaning process 2 Unlock the tube holders open the holders and rotate 90 degree to facilitate tube removal Note Do not remove external clamps clamped on fused tubes before ensuring a good weld Refer to Inspecting weld quality on page 54 3 Dismantle the tube holders from the instrument for cleaning using proper cleaning agent along with lint free cloth STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 63 5 Maintenance 5 1 Cleaning 5 1 1 Cleaning Step Action 4 Clean the spillage area on the instrument surface with a proper cleaning agent and cotton swab WARNING In case of large amount more than about 50 ml of liquid spillage inside the instrument switch off the instrument and contact Service Do not touch the instrument in power ON condition Lid Clean the polycarbonate lid with 40 ethanol or 40 isopropanol Danger zone The danger zone under the cover see Section 2 2 Danger zone on page 26 may be cleaned periodically using a small handheld vacuum cleaner Any spillage may be cleaned with a lint free cloth moistened with water or up to 20 ethanol 64 STE
41. ing procedures 36 2 7 Declaration of Hazardous Substances DoHS 37 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 15 2 Safety instructions 2 1 Safety precautions 2 1 Safety precautions Introduction Before installing operating maintaining and inspecting the instrument you must be aware of the hazards described in the user documentation Follow the instructions pro vided to 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 Maintenance General precautions STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER WARNING Perform a risk assessment for any risks due to the process or pro cess environment Evaluate the effect the system and the processes where it is used have to the classification of the hazardous area The process might cause the area to increase or the zone classifi cation to change Implement the risk reduction measures needed including use of personal protection equipment WARNING The end user must ensure that all installation maintenance oper ation 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 ent
42. ion COVER LOCK button illustration COVER LOCK button down locked lid COVER LOCK button up unlocked lid 28 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 4 Labels 24 Labels Introduction This section describes the system label and the safety labels on STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER System label illustration The illustration below shows an example of a system label XXXXXXXX XXXXXXXXXXXXXX Code no xxxxxxxx Voltage Serial no xxxxxxxx Frequency Mfg Year 2014 Max Power Fuse A CE O ATA WN Made in Sweden GE Healthcare Bio Sciences AB z 751 84 Uppsala Sweden System label description Label Description Code no e STERILE TUBE FUSER DRY 28999602 e HOT LIPS TUBE SEALER 28411704 Serial no Instrument serial number Mfg Year Manufacturing year Voltage 100 120 220 240 V AC Frequency 50 60 Hz Max Power e STERILE TUBE FUSER DRY 350 VA e HOT LIPS TUBE SEALER 3 3 A STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 29 2 Safety instructions 2 4 Labels re om o Description e STERILE TUBE FUSER DRY 2 x T4 0 AL 250V e HOT LIPS TUBE SEALER 2 x T3 15 AL 250V Warning Read the user documentation before using the sys tem Do not open any covers or replace parts unless specifically stated in the
43. ion 1 Introduction Purpose of the Operating Instructions The Operating Instructions provide you with the instructions needed to handle STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER in a safe way Prerequisites In order to operate STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER safely and according to the intended purpose the following prerequisites must be met e You should be acquainted with the use of general laboratory equipment and with handling of biological materials e You must read Chapter 2 Safety instructions on page 15 e Thesystem should be installed according to the instructions in Chapter 3 Installation on page 39 e You must read STERILE TUBE FUSER DRY Operator Manual 87 4500 21 and HOT LIPS TUBE SEALER Operator Manual 87 4500 07 In this chapter Section See page 1 1 Important user information 5 1 2 Regulatory information 7 1 3 STERILE TUBE FUSER DRY 10 1 4 HOT LIPS TUBE SEALER 12 1 5 Associated documentation 14 4 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 1 Introduction 1 1 Important user information 1 1 Important user information Read this before using STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER All users must read the entire Operating Instructions before installing using or maintaining the instrument Always keep the Operating Instructions at hand when using STERILE TUBE FUSER DRY or HOT LIPS TUBE SEALER Do not ope
44. ire system and process 16 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 1 Safety precautions WARNING Do not operate STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER in any other way than described in the user documentation WARNING Operation and user maintenance of STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER should be performed by properly trained personnel only WARNING Only use spare parts and accessories that are approved or supplied by GE for maintaining or servicing the system NOTICE STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER are class A products 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 Oo gt gt gt STERILE TUBE FUSER DRY CAUTION Do not attempt to connect liquid filled tubing used STERILE TUBE FUSER DRY This will void the warranty STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 17 2 Safety instructions 2 1 Safety precautions Using flammable liquids STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER WARNING STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER are not de signed to fuse and seal tubing containing flammable fluids STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER are not approv
45. ment and follow the dis play messages e Ifthe motor fails to move contact Service ERROR 6 CUT MOTOR FAIL The cut operation failed to e Switch off the power to the in reach the cut position in the strument specified time f e Switch on the power to the in strument and follow the dis play messages e Ifthe motor fails to move contact Service ERROR 7 ALIGN MOTOR The align operation failed to e Switch off the power to the in FAIL align the cut tubes in the strument specified time f e Switch on the power to the in strument and follow the dis play messages e Ifthe motor fails to move contact Service STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 87 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY LANA Message Possible cause Corrective action ERROR 8 LIFTOUT MOTOR The blade liftout operation e Switch off the power to the in FAIL failed to bring the blade to strument the top position in the speci Fedtime e Switch on the power to the in strument and follow the dis play messages e Ifthe motor fails to move contact Service ERROR 9 TEMPERATURE The infrared temperature Contact Service to replace and SENSOR FAIL sensor has failed recalibrate the infrared tempera ture sensor ERROR 10 COVER OPEN Cover opened during opera Asafety interlock stops the weld tion cycle if the cover is forced open or COVER LOCK f
46. meters for the selected tubing are loaded A beep confirms that loading is complete e Press the MENU button to abort the selection and retain the original setting 3 Lift the LIFT UP TO LOAD TUBE handle upwards 1 Result The red Safety flag turns from position 3 to position 2 to allow in sertion of the tubing The illustrations below show the instrument from the top left and from the right hand side right 17 w i 3 4 Place the tubing between the jaws resting on the stainless steel platform 5 Press the LIFT UP TO LOAD TUBE handle 1 and verify that the red Safety flag is on top of the tubing 3 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 57 4 Operation 4 2 HOT LIPS TUBE SEALER Step Action 6 e Press and hold the GO button e Release the GO button when a beep is heard If the GO button is released before the jaws have closed to the preset sealing position the jaws open again The jaws close to squeeze the tubing The READY light goes out Once the jaws are closed the sealing begins The LCD display shows the progress of the cycle and the time in seconds for each step Step LCD display Step LCD display 1 HEATING 4 SEALING TEMP xxx C a5 asi 2 SOAKING 3 WAITING TIME TO GO S RELEASE IN XX s 3 COOLING 6 ie TEMP XXX C S SEAL COMPLETE When the seal cycle is complete the instrument opens to t
47. n the pin side could cause damage to holder and result in poor fit Check whether the code plate underneath the left tube holder is intact before use Tighten the captive screw if the installed tube holders are found to be slack Clean the instrument surface welding region amp tube holders for any liquid spillage after tube welding operation Perform safety checks on instrument and surroundings at regular intervals once in a quarter for safe operating conditions Schedule the instrument for preventive maintenance by GE service personnel Contact Service STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 67 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 Maintenance of HOT LIPS TUBE SEALER About this section All maintenance tasks on HOT LIPS TUBE SEALER other than specified in this section needs to be done by a GE service representative Contact Service e User can replace the fuse in case of fuse failure See Section 5 4 Replacement of fuses on page 80 for more information e Itis recommended to service the instrument every six months including cleaning Functional validation or Calibration retest and safety check Contact Service In this section Section See page 5 3 1 Tube Restrictor replacement 69 5 3 2 Functional validation and calibration 73 68 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 3 Maint
48. nformation 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 con ditions 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 In order to maintain the declared EFUP the product shall be operated normally ac cording to the instructions and environmental conditions as defined in the product manual and periodic maintenance schedules specified in Product Maintenance Pro cedures shall be followed strictly Consumables or certain parts may have their own label with an EFUP value less than the product Periodic replacement of those consumables or parts to maintain the declared EFUP shall be done in accordance with the Product Maintenance Procedures This product must not be disposed of as unsorted municipal waste and must be collected separately and handled properly after decommissioning STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 37 2 Safety instructions 2 7 Declaration of Hazardous Substances DoHS ABASURARTANAMRES Name and Concentration of Hazardous Substances FmPAsaASWArrRNamReak Table of Hazardous Substances Name and Concentration
49. of liquid filled tubing 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 and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 53 4 Operation 4 1 STERILE TUBE FUSER DRY It is not possible to weld together tubing that is filled with liquid Pump out the excess fluid before welding tubing Stop liquid from re entering by clamping the tubing All clamps must be placed outside the lid Inspecting weld quality 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 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 Service to realign the instrument 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 Check for the following 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 blade e Ensure holders are closed and properly latched If you are unable to ge
50. ooting HOT LIPS TUBE SEALER 91 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD Index STERILE TUBE FUSER DRY 85 Tube restrictor replacement 69 Tubing compatible HOT LIPS TUBE SEALER 96 Tubing holders 10 46 50 51 Changing 52 U Unpacking 42 Using flammable liquids pre cautions 18 101 For local office contact information visit www gelifesciences com contact GE Healthcare Bio Sciences AB Bj rkgatan 30 751 84 Uppsala Sweden www gelifesciences com bioprocess GE and GE monogram are trademarks of General Electric Company HOT LIPS TUBE SEALER and ReadyToProcess are trademarks of General Electric Company or one of its subsidiaries C Flex PHARMED SANIPURE and TYGON are trademarks of Saint Gobain Perfor mance Plastics Corporation BIOPRENE is a trademark of Watson Marlow Limited Torx is a trademark of Acument Intellectual Properties LLC All other trademarks are the property of their respective owners 2009 2015 General Electric Company All rights reserved First published Dec 2009 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 repre sentative for the most current information GE Healthcare Europe GmbH Munzinger Strasse 5 D 79111 Freiburg Germany GE Healthcare U
51. oving to gether slowly The LCD display shows the incremented position count infor mation When the jaws touch the zero calibration is complete and the jaws will automatically retract to do a repeatability check If then the repeatability test the operation proceeds to CAL GAUGE TEST completes success fully the repeatability test the operation is terminated and the LCD display fails shows CALIBRATION FAIL Contact Service STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 77 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Step Action 6 When INSERT GAUGE AND PRESS ENTER is shown on the LCD display insert the Functional verification gauge as shown and press the Enter button 78 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration Step Action 7 If then only the PASS end of press the Cursor up button the Functional Result The display shows CAL PASSED AND RE verification gauge CYCLE POWER Recycle the power and start the passes through the instrument jaws without any difficulty any part of the FAIL press the Cursor down button end of the Result The display shows CALIBRATION FAIL Functional Contact Service verification gauge p
52. personal injury STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 31 2 Safety instructions 2 4 Labels Safety labels on HOT LIPS TUBE SEALER The safety labels are located on HOT LIPS TUBE SEALER as illustrated below The labels warn the user of risk of personal injury 32 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 4 Labels Serial no Mig Veor 2018 Max Power Az OC EBD aw oma at Mode in Sweden GE Healthcare Bio Sciences AB 751 84 Uppsala Sweden STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 33 2 Safety instructions 2 5 Emergency procedures 2 5 Emergency procedures Introduction This section describes how to do an emergency shutdown of STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER The section also describes the result in the event of power failure Emergency shutdown of STERILE TUBE FUSER DRY Switch off the power by pressing the power switch to the O position The power switch is located at the rear of the instrument see the illustration below 34 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 5 Emergency procedures Emergency shutdown of HOT LIPS TUBE SEALER Switch off the power by pressing the power switch to the O position The power switch i
53. r local GE representative Disposal of electrical components Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately Please contact an authorized GE representative for information concerning the decommissioning of your equipment 36 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 7 Declaration of Hazardous Substances DoHS 2 7 Declaration of Hazardous Substances DoHS ARHESJ T11364 2006 BFS MSR AMMAR PHM PAAR RASNE The following product pollution control information is provided according to J T11364 2006 Marking for Control of Pollution caused by Electronic Information Products BFS SP m5 Ee olin H Explanation of Pollution Control Label BwrRERAAT DSAMWSI 11363 2006 HFRS RPABASYAMR AD BER FREWER A RYA MERAWRFAAP mAIRE AH RAR AY FPRELREAWRET ABASWRAFRASRERRS APERE m FEM MAEM SSRRNBAR UTEP SRSHRR SUAF FA RAGE Pt FR AY 2 GR 5 FA BBR ER m EAR PE SR A HE TIE FEA HPT RAs PME MASCARA ER Pan FAY aE A SE SE a EB R A REARS HB RMA FARBIR A RELL hE MASHER MEARS mS BIR ERAS ao OGRE PT RAR AY SSN on AR EA PRR ANF Ge CEE FA on 2G RAN AR AD AE SS EEA I RS SA 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 Hazardous Substances in Electronic I
54. rate STERILE TUBE FUSER DRY or HOT LIPS TUBE SEALER 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 HOT LIPS TUBE SEALER is an automated instrument designed to seal thermoplastic tubing STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER 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 Warnings WARNING 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 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 1 Introduction 1 1 Important user information Cautions CAUTION CAUTION indicates a hazardous situation which if not avoided could result in minor or moderate injury It is important not to pro ceed until all stated conditions are met and clearly understood Notices NOTICE NOTICE indicates instructions that must be followed to avoid damage to the product or other equipment Notes and tips Not
55. s located at the rear of the instrument see the illustration below If an emergency situation occurs when clamping tubing the clamping operation is im mediately interrupted if the GO button is released Power failure If the power to the then the tubes may not be completely STERILE TUBE welded FUSER DRY fails during action Re initiate the welding process by following the the welding operation instructions displayed on the Touch Screen HOT LIPS TUBE SEALER sealed fails during the sealing Action Re initiate the sealing process operation STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 35 2 Safety instructions 2 6 Recycling procedures 2 6 Recycling procedures Introduction This section contains information about the decommissioning of STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Decontamination The equipment shall be decontaminated before decommissioning and all local regulations shall be followed with regard to scrapping of the equipment Disposal general instructions When taking STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER out of service the different materials must be separated and recycled according to national and local en vironmental regulations Recycling of hazardous substances STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER may contain hazardous sub stances Detailed information is available from you
56. scard the cut ends Note Inspect the weld carefully before use see Inspecting weld quality on page 54 6 Close the cover and press the COVER LOCK button to reset the instrument 7 Optional Start at step 3 in Start instrument and set tubing brand and dimension on page 48 to make additional tubing welds Each weld cycle takes about 2 minutes 8 Switch off the power to STERILE TUBE FUSER DRY by pressing the power switch to the O position Changing Tubing holder The Tubing holders can be quickly changed to connect different diameter tubing The Tubing holders must be changed as a pair left and right Tubing holders must be the same size The Tubing holders are coded so that the instrument automatically reads the Tubing holder type and selects the appropriate program Step Action 1 Open the cover 52 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 1 STERILE TUBE FUSER DRY Step Action 2 For each Tubing holder e Push the Locking tab towards the rear of the instrument to unlock the Tubing holder arrows e Lift out the Tubing holder 3 Select desired Tubing holder pair the pair must match 4 Place each Tubing holder on its platform Note Ensure that the alignment pins under the Tubing holder are placed into holes in the platform 5 Pull the locking tabs towards the front of the instrument to lock the Tubing holders Handling
57. se documents are also available as supplied with HOT LIPS TUBE SEALER ONline help Related documentation STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Tube Data Management Tool User Manual is supplied with an installation kit available upon request The installation kit enables the user to e extend the STERILE TUBE FUSER DRY or HOT LIPS TUBE SEALER instrument to support different tubing types e manage the factory loaded tubing types For more information see Section 7 2 Compatible tubing for STERILE TUBE FUSER DRY on page 94 and Section 7 3 Compatible tubing for HOT LIPS TUBE SEALER on page 96 For ordering information see Section 7 5 Further information on page 99 14 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 2 Safety instructions 2 Safety instructions About this chapter This chapter contains safety information and describes symbols and labels that are at tached to STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER In addition the chapter describes emergency procedures and provides recycling information All users must read this chapter before using STERILE TUBE FUSER DRY or HOT LIPS TUBE SEALER and observe the safety information at all times during use In this chapter Section See page 2 1 Safety precautions 16 2 2 Danger zone 26 2 3 COVER LOCK for STERILE TUBE FUSER DRY 28 2 4 Labels 29 2 5 Emergency procedures 34 2 6 Recycl
58. sert the new bottom Tube Restrictor using needle nose pliers 8 Move and hold the Red flag indicator in a position where it does not block the new top Tube Restrictor and insert the new top Tube Restrictor 9 Fasten Hex pan head screw 1 using a T8 Torx wrench Tighten Hex pan head screw 2 using a T10 Torx wrench 10 Switch on the power to the unit by pressing the power switch to the I po sition and wait for the initialization to be completed 11 Perform some test welds to verify functionality of the unit 72 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 5 Maintenance 5 3 Maintenance of HOT LIPS TUBE SEALER 5 3 2 Functional validation and calibration 5 3 2 Functional validation and calibration Introduction This section describes how to perform a functional validation and a calibration of HOT LIPS TUBE SEALER A functional validation should be performed every six months to check that the jaw mechanism in HOT LIPS TUBE SEALER is within the specified tolerance The functional validation is done using the Functional verification gauge illustrated below If functional validation fails the operator or service engineer manually triggers the cali bration routine Precaution WARNING Pinch hazard when using HOT LIPS TUBE SEALER The jaws are moving during clamping and calibration Keep away from the jaws when clamping tubes and during the calibration procedure
59. set the instrument LCD error message The heater temperature was too Contact Service HEATER OVERTEMP high due to internal malfunction LCD error message The temperature sensor has failed Contact Service SENSOR FAILURE or is giving invalid readings LCD error message The heater did not reach set tem Contact Service perature within time out period 90 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 6 Troubleshooting 6 2 HOT LIPS TUBE SEALER Possible cause Corrective action LCD error message Motor caused jaw to retract be Try to reset by cycling power off on SAFETY SWITCH TRIP Yond a sofe position The motion Contact Service if problem persists is stopped and the program halt ed Automatic error checking The HOT LIPS TUBE SEALER is designed to monitor all aspects of its operation If a step does not perform properly the instrument will not proceed to the next step of the oper ation Step Instrument checks Initialization Check that components have the correct position ing Clamp tubing Check that the GO button is pressed until the jaws reach the final position Heat tubing Check that the jaws have the correct position Seal tubing Check that the sealing temperature is reached Then the fans are turned on to start cooling the tubing Cool down Check the temperature At the completion of the cool down period the instrument will beep and
60. t a uniform flange contact Service for help SS Good tensile strength Pull gently at the weld and make a gentle twist Make sure that the tubes are properly clamped in both sides of the weld in order not to compromize the sterility of the tube if any ruptures emerges The tubing should not come apart or start to crack C aja 54 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 2 HOT LIPS TUBE SEALER 4 2 HOT LIPS TUBE SEALER Operation overview HOT LIPS TUBE SEALER is used to seal tubing permanently This is done by clamping the tubing to be sealed in a precise position between two heated jaws The molten tubing is pressed together and cooled under high pressure resulting in a permanent leak proof butt seal e Refer to Section 7 3 Compatible tubing for HOT LIPS TUBE SEALER on page 96 HOT LIPS TUBE SEALER for all approved tubing types It is not possible to seal non thermo plastic materials such as PTFE or silicone e HOT LIPS TUBE SEALER can handle various size tubing diameters specified in Sec tion 7 3 Compatible tubing for HOT LIPS TUBE SEALER on page 96 HOT LIPS TUBE SEALER Control panel The operating controls are located on the front panel of the instrument Part Description 1 LCD display 2 MENU button 3 Cursor up button 4 Cursor down button 5 Enter button 6 READY indicator 7 GO button STERILE TUBE FUSER DRY
61. ting HOT LIPS TUBE SEALER please make sure that no objects tubes are kept in between the heating jaws or moving path CAUTION If there is liquid in the tubing when using HOT LIPS TUBE SEALER it will evaporate as it comes into contact with the heater pads If the tube is full of liquid the liquid can be released during the weld and can cause a spill in or around the equipment CAUTION Depending on which tubes that are used in HOT LIPS TUBE SEALER hazardous gases may be emitted Make sure to use the instrument in a room with proper ventilation NOTICE Do not spill liquid into HOT LIPS TUBE SEALER This can cause serious damage and will void the warranty NOTICE High pressures can be generated if the liquid in the seal area has no place to go when it is clamped down by the sealing jaws Make sure that the liquid can be displaced up or downstream of the seal and that the temporary clamps or plugs are secure Oo 0 amp FP PR gt STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 23 2 Safety instructions 2 1 Safety precautions Maintenance 24 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER 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 Disconnect power Always disconnect power from t
62. tions 28 9641 39 AD 41 3 Installation 3 2 Unpacking 3 2 Unpacking Follow the instruction below to unpack the instrument Step Action 1 Remove the instrument from the shipping container 2 Remove any tape and packaging material from the instrument 3 Check the equipment for any apparent damage before starting installation Document any damage carefully and contact your GE representative 42 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 3 Installation 3 3 Transport 3 53 Transport STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER are designed to be portable and can be moved to different locations Moving should only be performed by qualified per sonnel STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 43 3 Installation 3 4 Connections 3 4 Connections Connect the supplied power cord into the rear of the instrument and to a grounded power outlet specified in Section 3 1 Site requirements on page 40 WARNING Protective ground The instruments must always be connected to a grounded power outlet 44 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 Operation Precaution WARNING The end user must ensure that all installation maintenance oper ation and inspection is carried out by qualified personnel who are adequately trained understand and adhere
63. to local regulations and the operating instructions and have a thorough knowledge of the entire system and process In this chapter Section See page 4 1 STERILE TUBE FUSER DRY 46 4 2 HOT LIPS TUBE SEALER 55 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 45 4 Operation 4 1 STERILE TUBE FUSER DRY 41 STERILE TUBE FUSER DRY Operation overview The STERILE TUBE FUSER DRY is used to weld together thermoplastic tubing in a sterile manner 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 e See Section 7 2 Compatible tubing for STERILE TUBE FUSER DRY on page 94 for all approved tubing types It is not possible to seal non thermoplastic materials such as PTFE or silicone e The STERILE TUBE FUSER DRY can handle various tubing diameters specified in Section 7 2 Compatible tubing for STERILE TUBE FUSER DRY on page 94 Schematic operation Stage Description 1 The cutting blade A is installed It retracts into the instrument 2 The tubing B is placed in the holders C Arrows B indicate the part of tubing to be connected 3 The cutting blade heats up and when heated it cuts through both tubing pieces 46 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 4 Operation 4 1 STERILE TUBE FUSER DRY Stage Description
64. trument e Check the holder code plate attached to the bottom of the left blue holder The instrument does not recog e Make sure you are using the correct tubing nize that the tubing is inserted O D for the holder and that it is firmly clamped e Make sure that there is tubing over the tube detector in each holder It may be necessary to adjust the tube detector microswitches lo cated on the posts under the holders The cover does not open Access door should only open when the COVER LOCK is released by the instrument or if the pro gram was unable to run to completion e Turn off the power by pressing the power switch to the O position in order to release the cover Wait for the blade to cool before attempting to repair the instrument 84 STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY Problem Corrective action The instrument malfunctions during the welding process causing the instrument to stop Reset the instrument by turning the power to the instrument off and wait 10 seconds or so before turning the power on again 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 instrument Check that the
65. tubing is of the correct size Check that the instrument is set to the correct tubing type Try using a new cutting blade If the instrument still does not perform proper ly contact Service Automatic error checking The STERILE TUBE FUSER DRY is designed to monitor all aspects of its operation If a step does not perform properly the instrument does not proceed to the next step of the operation Step Instrument checks Setup Check that the holders are correctly installed Check that no tubing is present Check that all systems are functional Check that the holders are moved into align ment and checked Cutting blade insertion Check that a cutting blade is inserted Tubing insertion Check that the tubing is correctly inserted in the holders STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 85 6 Troubleshooting 6 1 STERILE TUBE FUSER DRY Step Instrument checks Operation e Check the cutting blade temperature An infrared sensor measures the cutting blade temperature and modulates power to control temperature The program stops if the mea sured temperature differs from the set temper ature e Check that the tubing has the correct position after alignment and before welding Error messages In the event an error occurs during the cycle one of the following messages may be displayed on the LCD Contact Service and giv
66. ture and is suitable for food contact applications The coating ensures minimal adhesion to the tubing during the welding and cutting 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 NOTICE gt Only use PTFE coated cutting blades BLADES IR 50 specified for use with STERILE TUBE FUSER DRY For optimal use do not reuse blades STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 7 Reference information 7 5 Further information 7 5 Further information For more details on ordering information and for information about spare parts and accessories visit www gelifesciences com bioprocess or contact your local GE represen tative STERILE TUBE FUSER DRY and HOT LIPS TUBE SEALER Operating Instructions 28 9641 39 AD 99 Index Index 100 C CE conformity 7 CE marking 8 Cleaning HOT LIPS TUBE SEALER 66 STERILE TUBE FUSER DRY 63 COVER LOCK 28 Cutting blade 46 49 51 D Danger zone HOT LIPS TUBE SEALER 27 STERILE TUB
67. uctions 28 9641 39 AD 1 Introduction 1 2 Regulatory information CE marking The CE marking and the corresponding EU Declaration of Conformity is valid for the in strument when it is e used as a stand alone unit 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 except for alterations described in the user documentation International standards Standard Description Notes EN IEC 61010 1 Safety requirements for electri EN standard is harmo UL 61010 1 cal equipment for measure nized with EU directive ment control and laboratory 2006 95 EC CAN CSA C22 2 ee No 61010 1 EN IEC 61326 1 Electrical equipment for mea EN standard is harmo Emission according surement control and laborato nized with EU directive to CISPR 11 Group 1 Y use EMC requirements 2004 108 EC class A EN ISO 12100 Safety of machinery General EN ISO standard is harmo principles for design Risk as nized with EU directive sessment and risk reduction 2006 42 EC 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 accept any interference received including interference that may cause undesired operation Note The user is cautioned that any changes or modifications not expr

STERILE TUBE FUSER - DRY and HOT LIPS TUBE SEALER

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