Site requirements ............................31 Transport ................................32 Unpacking ................................. 33 Electrical connections ..........................34 Connecting the printer to Sterile Tube Fuser - Wet (optional) ............. 35 Operation ......................36 Overview ................................39 Cover lock ................................. 42 Fusing tubes ..............................43 Changing tubing holder ..........................
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Regulations for North America ....................... 80 8.6.5 Regulatory statements ..........................81 8.6.6 Declaration of Hazardous Substances (DoHS) ................82 8.6.7 Other regulations and standards ......................84 Health and Safety Declaration Form ...................... 85 Index ........................... 87 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
1 Introduction Introduction About this chapter This chapter contains important user information about the Sterile Tube Fuser - Wet instrument, and lists of associated documentation. In this chapter Section See page About this manual Important user information Associated documentation Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
In electronic format, references in italics are clickable hyperlinks. Illustrations The images and annotations in this document are for illustrative purposes only. The configuration of individual products may vary, and therefore illustrations may not reflect the actual system delivered. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Intended use of Sterile Tube Fuser - Sterile Tube Fuser - Wet is an automated instrument designed to produce sterile joints of thermoplastic tubings. Sterile Tube Fuser - Wet shall not be used in any clinical procedures, or for diagnostic purposes. Prerequisites In order to operate Sterile Tube Fuser - Wet in the way it is intended: •...
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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 proce- dures. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Associated documentation Introduction This section describes the documentation delivered with Sterile Tube Fuser - Wet. Supplied documentation In addition to the Operating Instructions, the Sterile Tube Fuser - Wet instrument is supplied with an Operator Manual: Document Contents Sterile Tube Fuser - Wet Operator...
Emergency procedures Danger zone Important WARNING Before installing, operating or maintaining the product, all users must read and understand the entire contents of this chapter to become aware of the hazards involved. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
2.1 Safety precautions Safety precautions Introduction Sterile Tube Fuser - Wet is powered by mains voltage and handles materials that can be hazardous. Before installing, operating or maintaining the system, you must be aware of the hazards described in this manual.
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WARNING Use only approved parts. Only spare parts and accessories that are approved or supplied by Cytiva may be used for maintaining or servicing the product. WARNING Use appropriate personal protective equipment to prevent inhala- tion of toxic fumes when heating and treating thermoplastics.
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NOTICE Only use PTFE coated cutting blades (BLADES-IR/50) specified for use with Sterile Tube Fuser - Wet. For optimal use, do not reuse blades. Personal protection WARNING Always use appropriate personal protective equipment during installation, operation, inspection, maintenance and cleaning of Sterile Tube Fuser - Wet.
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WARNING Sterile Tube Fuser - Wet is not designed to handle flammable liquids. WARNING Sterile Tube Fuser - Wet is not approved for work in a potentially explosive atmosphere. Installing and moving the instrument WARNING Power cord. Only use power cords with approved plugs delivered or approved by Cytiva.
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Disconnect all tubing, hoses and external cables before moving the unit. CAUTION Sterile Tube Fuser - Wet has fragile items. Make sure Sterile Tube Fuser - Wet is always in upright position during transport, move- ment and storage. Also make sure no weight is kept on the instru- ment or instrument packaging.
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Remove external clamps only after confirming a good weld joint. WARNING In setup mode of Sterile Tube Fuser - Wet, with the Programming lock key horizontal, the instrument can be run with cover open. The blade poses a burn hazard and movable parts poses a pinch hazard if the weld process is started in this mode.
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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 - Wet until it cools down. Always allow the blade to cool down for 30 seconds before accessing the blade.
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Use only tubing that is compatible with the instruments. CAUTION The cutting blade of Sterile Tube Fuser - Wet is a thin piece of stain- less steel. It does not have a sharpened edge but can cause cuts if handled improperly. Be sure to read and understand the procedure for installing and removing the blade.
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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 Sterile Tube Fuser - Wet, refer to Section 8.2 Compatible tubing for, on page 71...
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For continued protection from fire hazard, replace only with same type and rating of fuse. Refer to Section 8.1 Specifications, on page 70 for fuse specification. CAUTION Change the blade after every cut to avoid sterility issues. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Please contact an authorized representative of the manufacturer for infor- mation concerning the decommissioning of equipment. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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2 Safety instructions 2.2 Symbols and abbreviations Safety labels on Sterile Tube Fuser - The safety labels are located on Sterile Tube Fuser - Wet as illustrated below. The labels warn the user of risk of personal injury. Sample XX-XXXX-XX...
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Indicates a hot surface and that care must be exercised to prevent injury. Indicates a pinch hazard and that care must be exercised to prevent injury. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
2 Safety instructions 2.3 Emergency procedures Emergency procedures Introduction This section describes how to do an emergency shut down of Sterile Tube Fuser - Wet instrument. The section also describes the result in the event of power failure. Precautions WARNING Access to power switch and power cord with plug.
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Conforms to ANSI/UL Std. 61010-1. Cert. to CAN/CSA Std. C22.2 No. 61010-1. Power failure If the power to Sterile Tube Fuser - Wet fails during the welding operation, the tubes may not be completely welded. Re-initiate the welding process by following the instructions displayed on the Touch Screen.
2.4 Danger zone Danger zone Sterile Tube Fuser - Wet The following diagram shows the danger zone on Sterile Tube Fuser - Wet. This danger zone should be kept clear of obstructions during operation. WARNING Hot surfaces of Sterile Tube Fuser - Wet. The cutting blade reaches 400°C during the heating cycle.
3 Instrument description Instrument description About this chapter This chapter gives an overview of the Sterile Tube Fuser - Wet instrument, and a brief function description. Introduction Sterile Tube Fuser - Wet is an automated instrument designed to produce sterile joints of thermoplastic tubings without the need for a laminar flow cabinet or similar environ- mental control unit.
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Blade holders Lifting handle Touch screen Cover lock button Cover or Lid Tubing holders The illustration below shows the holders used in Sterile Tube Fuser - Wet instrument. Part Function Top handle Knob Upper holder body Place for inserting external clamps...
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The illustration below shows the clamp used with the holders on Sterile Tube Fuser - Wet. PTFE coated cutting blades The illustration below shows the blade used in Sterile Tube Fuser - Wet instrument. Rear panel The illustration below shows the rear panel of Sterile Tube Fuser - Wet.
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In addition to displaying the instrument setup information, the printer also prints any errors that may occur during operation. This includes the error number, a brief description of the error, and a time stamp. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
4 Installation Installation About this chapter This chapter provides required information to enable users and service personnel to unpack, install, and transport the Sterile Tube Fuser - Wet. In this chapter Section See page Site requirements Transport Unpacking Electrical connections...
4.1 Site requirements Site requirements Introduction This section describes the requirements for space and supplies in the building where the Sterile Tube Fuser - Wet instrument will be installed. Environmental and electrical power requirements The following general requirements must be fulfilled:...
Also make sure no weight is kept on the instru- ment or instrument packaging. Sterile Tube Fuser - Wet is designed to be portable and can be moved to different loca- tions. Moving should only be performed by qualified personnel.
4.3 Unpacking Unpacking WARNING Use lifting handles located on either side of the instrument to lift Sterile Tube Fuser - Wet. Use personal protective equipment to avoid any kind of personal injury. Follow the steps below to unpack the instrument. Step...
Protective ground. The product must always be connected to a grounded power outlet. Tube holder installation The Tubing holders can be quickly installed to connect different diameter tubing. Refer Section 5.4 Changing tubing holder, on page 51 for more details. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
4 Installation 4.5 Connecting the printer to Sterile Tube Fuser - Wet (optional) Connecting the printer to Sterile Tube Fuser - Wet (optional) Follow the steps below to connect the printer. Step Action Connect the printer AC adapter to a 100 to 240 V~, 50 or 60 Hz power supply and to the printer.
5 Operation Operation About this chapter This chapter gives instructions on how to operate the Sterile Tube Fuser - Wet instrument in a safe way. In this chapter Section See page Overview Cover lock Fusing tubes Changing tubing holder Inspecting weld quality...
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Follow local and/or national regulations for safe operation, maintenance and decommissioning of the system. WARNING Hot surfaces of Sterile Tube Fuser - Wet. The cutting blade reaches 400°C during the heating cycle. Do not try to open the protective cover during the welding.
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NOTICE Only use PTFE coated cutting blades (BLADES-IR/50) specified for use with Sterile Tube Fuser - Wet. For optimal use, do not reuse blades. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Overview Introduction Sterile Tube Fuser - Wet 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.
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(E) indicates the part of the tube to be discarded. The blade moves up and the tubing ends are fused together to form a welded connection. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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5 Operation 5.1 Overview Stage Description The connected tubing is removed and the used cutting blade and cut tubing ends are discarded. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
5 Operation 5.2 Cover lock Cover lock Introduction The Cover lock button is located on the lid of Sterile Tube Fuser - Wet, see Chapter 3 Instrument description, on page If the Cover lock button is... then the lid is...
Follow the instructions below to start the instrument and install the tubing holders. Step Action Switch on the power to Sterile Tube Fuser - Wet by pressing the power switch to the "I" position. Before powering on, check that • The tubes are not inserted in the holders.
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Holders are coded so that the instrument automatically reads the holder type and selects the appropriate program. Result: The instrument detects the holder and the display message indicates the holder size. The display also shows the INSERT BLADE screen. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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Follow the instructions below to insert a cutting blade. CAUTION The cutting blade of Sterile Tube Fuser - Wet is a thin piece of stain- less steel. It does not have a sharpened edge but can cause cuts if handled improperly. Be sure to read and understand the procedure for installing and removing the blade.
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Press the Installation/Removal Tool with the palm of your hand until the blade is fully inserted into mounted position. Remove the Installation/ Removal Tool. Close the Sterile Tube Fuser - Wet lid and press the cover lock button, for location see Chapter 3 Instrument description, on page Once you press the cover lock button, the blade automatically retracts into the instrument.
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Refer to Schematic operation, on page 39 for more information. Turn the upper holder body 90 degrees. Close the upper holder body of both right and left tube holders. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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Unscrew the knob of the left and right tube holders and move the knob shaft away from holders. Open the top handles and leave them at fully open posi- tion. Refer to the image in Step 3 of Insert tubing and start welding, on page Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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If you want to weld different tubing size, change the tubing holder. Refer to for more information. Changing tubing holders, on page 51 Switch off the power to Sterile Tube Fuser - Wet by pressing the power switch to the "O" position. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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Close the cover and press the cover lock button to continue with the next tube welding cycle. Result: The display shows INSERT BLADE on the screen. Start at step 1 of Insert a cutting blade, on page Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Repeat step 2 on the second holder. To install the new holder, set each new holder on its platform. Align the new holders to the correct position using locating pins. Tighten the captive screws. Close the holder. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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 Cytiva Service to realign the instrument. Uniform weld The illustration below shows an example of a correct welding with a uniform flange:...
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Make sure that the tubes are properly clamped on both sides of the weld in order not to compromize the sterility of the tube if any ruptures emerge. Pull gently at the weld and make a gentle twist. The tubing should not come apart or start to crack. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
The Tubing Database consists of various parameters specific to each tube type and size. These include temperature, positioning data and sequence timing. Contact Cytiva if you need to update the Tubing Database. NOTICE Improper use of tube data may cause damage to the unit and is not covered under the warranty.
6 Maintenance Maintenance About this chapter This chapter provides information to enable users and service personnel to clean, maintain, replace fuses and store the Sterile Tube Fuser - Wet instrument. In this chapter Section See page Cleaning before planned service...
Health and safety declaration forms Health and safety declaration forms are available for copying or printing in the Refer- ence information chapter of this manual, or on digital media supplied with the user documentation. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Do not remove external clamps clamped on fused tubes before ensuring a good weld. Refer to Inspecting weld quality, on page Dismantle the tube holders from the instrument for cleaning using proper cleaning agent along with lint free cloth. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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20% ethanol. Infrared sensor window Clean the infrared sensor window (indicated by an arrow below) every 2 months. Use a lint free cloth or cotton swab with 100% isopropanol or 70% ethanol. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
• Contact Service to schedule the instrument for preventive maintenance by Cytiva service personnel. All other maintenance tasks on Sterile Tube Fuser - Wet must be performed by a Cytiva Service representative. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Disconnect the power cord from the instrument. Lift out the fuse cover located below the power switch (see arrow). Lift out the broken fuses. Insert new fuses. Replace the fuse cover on the instrument. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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6 Maintenance 6.4 Replacement of fuses Step Action Connect the power cord. Switch on the power to the instrument by pressing the power switch to the "I" position. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
CAUTION Sterile Tube Fuser - Wet has fragile items. Make sure Sterile Tube Fuser - Wet is always in upright position during transport, move- ment and storage. Also make sure no weight is kept on the instru- ment or instrument packaging.
If the suggested actions in this guide do not solve the problem, or if the problem is not covered by this guide, contact your Cytiva representative for advice. General troubleshooting Problem Corrective action The display is not lit.
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Service. Automatic error checking The Sterile Tube Fuser - Wet 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.
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Error messages In the event an error occurs during the cycle, one of the following messages may be displayed on the LCD. Contact Cytiva Service and provide the error message(s) to assist in troubleshooting the problem. NOTICE Errors 1 through 12 cannot be confirmed without causing damage to the equipment.
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• If the motor fails to move, contact Service. TEMPERATURE ERROR 9 The infrared temperature Contact Service to replace and SENSOR FAIL sensor has failed. recalibrate the infrared tempera- ture sensor. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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• Verify if the expected data is during communication with received from PC (GUI appli- the instrument. cation). • Check if the communication cable is connected properly. • Restart the PC application (GUI). Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
8 Reference information Reference information About this chapter This chapter lists the technical specifications of Sterile Tube Fuser - Wet. In this chapter Section See page Specifications Compatible tubing for Blade contact materials Further information Recycling information Regulatory information Health and Safety Declaration Form...
395 × 370 × 265 mm Weight 16 kg Acoustic noise level < 70 dB A Operating temperature 2°C to 35°C Storage temperature 2°C to 35°C Relative humidity tolerance 20% to 80%, non-condensing Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Sterile Tube Fuser - Wet is designed to join thermoplastic tubing. Note: Sterile Tube Fuser - Wet 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.
Please contact our Customer Service department and ask for non-disclosure forms. NOTICE Only use PTFE coated cutting blades (BLADES-IR/50) specified for use with Sterile Tube Fuser - Wet. For optimal use, do not reuse blades. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
8 Reference information 8.4 Further information Further information For more details on ordering information and for information about spare parts and accessories, visit cytiva.com/bioprocess or contact your local Cytiva representative. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Disposal of the product When taking Sterile Tube Fuser - Wet out of service, the different materials must be separated and recycled according to national and local environmental regulations. Recycling of hazardous substances Sterile Tube Fuser - Wet contains hazardous substances.
European Union and European Economic Area 8.6.3 Eurasian Economic Union Евразийский экономический союз 8.6.4 Regulations for North America 8.6.5 Regulatory statements 8.6.6 Declaration of Hazardous Substances (DoHS) 8.6.7 Other regulations and standards Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
The table below summarizes the required manufacturing information. Requirement Information Name and address of manufacturer Cytiva Sweden AB Björkgatan 30 SE 751 84 Uppsala Sweden Telephone number of manufacturer + 46 771 400 600 Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
• used according to the Operating Instructions or user manuals, and • used in the same state as it was delivered, except for alterations described in the Operating Instructions or user manuals. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
В следующей таблице приводится сводная информация о производителе и импортере, согласно требованиям Технических регламентов Таможенного союза и (или) Евразийского экономического союза. Требование Информация Информацию об изготовлении Наименование, адрес и номер См. телефона производителя Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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Member States of the Customs Union of the Eurasian Economic Union Данный знак о Евразийском соответствии указывает, что изделие одобрено для использования на рынках государств-членов Таможенного союза Евразийского экономического союза Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Note: The user is cautioned that any changes or modifications not expressly approved by Cytiva could void the user’s authority to operate the equip- ment. 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.
When used in a residential environment, there is a concern of radio interference. 주의사항 A급 기기 (업무용 방송통신 기자재) 이 기기는 업무용환경에서 사용할 목적으로 적합성평가를 받 은 기기 로서 가정용 환경에서 사용하는 경우 전파간섭의 우려가 있습 니다. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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 sepa- rately and handled properly after decommissioning. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
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Indicates that this hazardous substance contained in at least one of the homogeneous materials used for this part is above the limit requirement in GB/T 26572 • Data listed in the table represents best information available at the time of publication. Sterile Tube Fuser - Wet Operating Instructions 29024010 AD...
Regulatory compliance of connected equipment Any equipment connected to Sterile Tube Fuser - Wet must meet the safety require- ments of IEC/EN 61010-1 or relevant harmonized standards. Within the European Union, connected equipment must be CE-marked.
Service Ticket #: To make the mutual protection and safety of Cytiva service personnel and our customers, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts a repair. To avoid delays in the servicing of your equipment, complete this checklist and present it to the Service Engineer upon arrival.
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To make sure the mutual protection and safety of Cytiva personnel, our customers, transportation personnel and our environment, all equipment must be clean and free of any hazardous contaminants before shipping to Cytiva. To avoid delays in the processing of your equipment, complete this checklist and include it with your return.
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