Table of Contents Table of Contents Introduction ......................4 Important user information ........................5 About this manual ............................6 Associated documentation ........................7 Safety instructions ..................... 8 Safety precautions ............................9 Labels and symbols ............................17 Emergency procedures ..........................20 Danger zone ..............................
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Table of Contents 8.5.5 North America ............................... 71 8.5.6 Regulatory statements ..........................72 8.5.7 Declaration of Hazardous Substances (DoHS) ................73 8.5.8 Other regulations and standards ......................75 Ordering information ........................... 76 Health and Safety Declaration Form ...................... 77 Index ........................... 79 ReadyToProcess STF –...
1 Introduction Introduction About this chapter This chapter contains important user information, intended use of ReadyToProcess™ STF – Dry instrument, and lists of associated documentation. In this chapter Section See page Important user information About this manual Associated documentation ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
1 Introduction 1.1 Important user information Important user information Introduction This section contains important user information about the product and this manual. Read this before operating the product All users must read the entire Operating Instructions before installing, oper- ating, or maintaining the product. Always keep the Operating Instructions at hand when operating the product.
1 Introduction 1.2 About this manual About this manual Introduction This section contains information about the purpose and scope of this manual, notes and tips, and typographical conventions. Purpose of this manual This manual provides information needed to install, operate and maintain the product in a safe way.
1 Introduction 1.3 Associated documentation Associated documentation An installation kit for tube data management is available upon request. The tool helps ReadyToProcess STF – Dry to support different tubing types and manage the factory loaded tubing types. Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Tube Data Management Tool, User Manual, 28999329 is supplied with an installation kit.
2 Safety instructions Safety instructions About this chapter This chapter describes safety precautions, labels and symbols that are attached to the equipment. In addition, the chapter describes emergency and recovery procedures. In this chapter Section See page Safety precautions Labels and symbols Emergency procedures Danger zone Important...
2 Safety instructions 2.1 Safety precautions Safety precautions Introduction ReadyToProcess STF – Dry is powered by mains voltage and handles materials that can be hazardous. Before installing, operating, or maintaining the product, you must be aware of the hazards described in this manual. Definitions This user documentation contains safety notices (WARNING, CAUTION, and NOTICE) concerning the safe use of the product.
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Switch off the instrument, disconnect the power cord and contact Service. 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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2 Safety instructions 2.1 Safety precautions NOTICE Class A product.Class A products 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. Personal protection WARNING Always use appropriate Personal Protective Equipment (PPE) during operation and maintenance of this product.
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2.1 Safety precautions Installing and moving the instruments WARNING Power cord. Only use power cords with approved plugs delivered or approved by Cytiva. WARNING Protective ground. The product must always be connected to a grounded power outlet. WARNING Access to power switch and power cord with plug. Do not block access to the power switch and power cord.
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WARNING The instrument must never be used if any safety functions are out of order. Contact your Cytiva service operator for more informa- tion. WARNING Inspect all connections and tubing before start and replace any defective parts.
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2 Safety instructions 2.1 Safety precautions WARNING Hot surface. Do not touch the blade of the product until it cools down. Always allow the blade to cool down for 30 seconds before accessing the blade. WARNING Hot surface. In case of power failure and instrument reset, the product unlocks the cover lock.
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2 Safety instructions 2.1 Safety precautions CAUTION Depending on the tubes used in the product, hazardous gases may be emitted. Make sure to use the instrument in a room with proper ventilation. CAUTION The cutting blade of the product is a thin piece of stainless steel. It does not have a sharpened edge but can cause cuts if handled improperly.
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Maintenance WARNING Electrical shock hazard. All repairs must be done by service personnel authorized by Cytiva. Do not open any covers or replace parts unless specifically stated in the user documentation. WARNING Disconnect power. Always disconnect power from the instru- ment before performing any maintenance task.
2 Safety instructions 2.2 Labels and symbols Labels and symbols Introduction This section describes the nameplate, labels, and other safety and regulatory informa- tion attached to the product. Nameplate The nameplate provides information about the model, manufacturer, and technical data. Description of symbols and text The following symbols and text may be present on the nameplate: Symbol /...
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2 Safety instructions 2.2 Labels and symbols Description of safety labels The safety labels are described in the table below. Make sure that you fully understand the potential hazards indicated by the labels. Symbol Description Warning! Read the user documentation before using the instrument.
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2 Safety instructions 2.2 Labels and symbols Safety labels on the instrument The safety labels are located on the instrument as illustrated below. The labels warn the user of risk of personal injury. ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
2 Safety instructions 2.3 Emergency procedures Emergency procedures Introduction This section describes how to shut down ReadyToProcess STF – Dry in an emergency situation. The section also describes the result in the event of power failure. Emergency shutdown of ReadyToProcess STF – Dry Switch off the power by pressing the power switch to the "O"...
2 Safety instructions 2.4 Danger zone Danger zone ReadyToProcess STF – Dry The image below shows the danger zone on ReadyToProcess STF – Dry. This danger zone must be kept clear of obstructions during operation. WARNING Hot surface. The cutting blade reaches 400°C during the heating cycle.
3 Instrument description Instrument description About this chapter This chapter describes important parts of the instrument, and gives a brief description of its function. Main parts The illustration below shows the main parts of ReadyToProcess STF – Dry. Part Description Tubing holders (blue and red) Blade holders Touch screen...
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3 Instrument description Rear panel The illustration below shows the rear panel of ReadyToProcess STF – Dry. Part Function Ventilation fan Lifting handle Key lock Data connector Printer connector Power connector Fuse holder Power switch Printer (optional) A separate printer package can be purchased and connected to the printer connector on the rear panel of the instrument.
4 Installation Installation About this chapter This chapter provides required information to enable users and service personnel to unpack, install, and transport the instrument. Safety precautions WARNING The customer must make sure that all installation, maintenance, operation and inspection is carried out by qualified personnel who are adequately trained, understand and adhere to local regulations and the operating instructions, and have a thorough knowledge of the product and the entire process.
4 Installation 4.1 Site requirements Site requirements Introduction This section describes the requirements for space and supplies in the building where ReadyToProcess STF – Dry is to be installed. Conditions Parameter Requirements Allowed location Indoor use only Electrical power 100-120/220-240 V~, 50/60 Hz Transient overvoltages Overvoltage category II Operating temperature...
4 Installation 4.2 Transport Transport This section gives important information that must be considered when transporting the product. WARNING Use lifting handles located on either side of the instrument to lift the product. Use personal protective equipment to avoid any kind of personal injury.
Remove any tape and packaging material from the instrument. Check the equipment for any apparent damage before starting installation. Document any damage carefully and contact your Cytiva representative. ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
4 Installation 4.4 Electrical connections Electrical connections Power connection Connect the power cord to the rear of the instrument (see Rear panel, on page 23) and to a grounded power outlet. See Section 4.1 Site requirements, on page 25 for more information.
4 Installation 4.5 Connecting the printer to ReadyToProcess STF – Dry (optional) Connecting the printer to ReadyToProcess STF – Dry (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 instrument in a safe way. Safety precautions WARNING The customer must make sure that all installation, maintenance, operation and inspection is carried out by qualified personnel who are adequately trained, understand and adhere to local regulations and the operating instructions, and have a thorough knowledge of the product and the entire process.
5 Operation 5.1 Cover lock for ReadyToProcess STF – Dry Cover lock for ReadyToProcess STF – Dry Introduction The cover lock button is located on the lid of ReadyToProcess STF – Dry, see Chapter 3 Instrument description, on page If the cover lock button is... then the lid is...
5 Operation 5.2 Tube fusing process Tube fusing process About this section This section gives an overview of the tube fusing process, describes how to fuse tubes, and how to inspect the welding. In this section Section See page 5.2.1 Operational overview 5.2.2 Fusing tubes...
5 Operation 5.2 Tube fusing process 5.2.1 Operational overview 5.2.1 Operational overview Introduction ReadyToProcess STF – 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.
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5 Operation 5.2 Tube fusing process 5.2.1 Operational overview Stage Description The tubing holders slide the cut tubing into alignment. The hot cutting blade is held against the cut tubing to ensure sterility. The cutting blade returns to the start position and the tubing is simulta- neously pushed together to form the connection.
5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes 5.2.2 Fusing tubes Introduction This section describes how to prepare the instrument for fusing tubes and how to fuse tubes. Safety precautions WARNING Hot surface. The cutting blade reaches 400°C during the heating cycle.
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes Step Action Result: On successful initialization, the display shows the INSERT BLADE screen. The display shows current date and time (1) and instrument ID number (4). Check that the desired tubing dimension (2) and tubing brand (3) are shown. Optional: Follow the steps below to change tubing brand (3): a.
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes Step Action Place the blade in the installation/removal tool as shown below. Use the installation/removal tool to install the blade by pressing the top of the tool with the palm of the hand. During the installation of the blade, secure the blade within the tool by compressing with the thumb as shown in the image below.
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes Insert tubing and start welding Step Action Clean the outside of the tubing area to be connected using a suitable disin- fectant, such as 70% ethanol or isopropanol. Place the tubing firmly in the holders. The tubing ends must protrude out beyond each holder.
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes Step Action Remove the used cutting blade with the installation/removal tool. Secure the blade within the tool by compressing with the thumb as shown in the image below. Note: For optimal operation, do not reuse cutting blades. Open the red tubing holder, then the blue tubing holder.
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes 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).
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5 Operation 5.2 Tube fusing process 5.2.2 Fusing tubes Handling of liquid filled tubing CAUTION Do not attempt to connect liquid-filled tubing using the product, or allow liquid to spill into the instrument. Use a clamp to stop liquid from re-entering. •...
Axial alignment Check that the tubing is axially aligned. If the tubing is offset, the weld will be weaker on one side. Do not use such welds. Contact Cytiva 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.
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 Make sure that the tube type and size matches the type of program selected.
6 Maintenance Maintenance About this chapter This chapter provides information to enable users and service personnel to clean, maintain, replace fuses, and store ReadyToProcess STF – Dry. In this chapter Section See page Cleaning before planned service Cleaning the instrument Regular maintenance of ReadyToProcess STF –...
6 Maintenance 6.1 Cleaning before planned service Cleaning before planned service Cleaning before planned maintenance/service To ensure the protection and safety of service personnel, all equipment and work areas must be clean and free of any hazardous contaminants before a Service Engineer starts maintenance work.
6 Maintenance 6.2 Cleaning the instrument Cleaning the instrument About this section This section describes how to clean the instrument. General cleaning Clean the instrument using a damp cloth with suitable disinfectant that does not affect any markings or signs, or the safety of the instrument. Ethanol (up to 20% as disinfectant) and a lint free cloth can also be used to clean surfaces of the instrument.
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6 Maintenance 6.2 Cleaning the instrument Step Action Clean the spillage area on the instrument surface with a proper cleaning agent and cotton swab. WARNING Do not attempt to touch the instrument in the power ON condition, if large amount of liquid spillage (approx. > 50 mL) is found inside the instrument.
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6 Maintenance 6.2 Cleaning the instrument 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. ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
• Perform safety checks on instrument and surroundings at regular intervals, once in a quarter for safe operating conditions. • Contact Cytiva to schedule the instrument for preventive maintenance by Cytiva service personnel. All other maintenance tasks on ReadyToProcess STF – Dry must be performed by a Cytiva Service representative.
6 Maintenance 6.4 Replacement of fuses Replacement of fuses Safety precautions WARNING Disconnect power. Always disconnect power from the instru- ment before performing any maintenance task. WARNING If a fuse requires repeated replacement, do not continue to use the instrument. Contact an authorized service engineer. WARNING For continued protection from fire hazard, replace only with same type and rating of fuse.
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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. ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
6 Maintenance 6.5 Storage Storage for information about storage conditions. Section 8.1 Specifications, on page 60 CAUTION The product has fragile items. Make sure the product is always in upright position during transport, movement and storage. Also make sure no weight is kept on the instrument or instrument pack- aging.
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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7 Troubleshooting Problem Corrective action The cover does not open. Access door should only open when the cover lock is released by the instrument, or if the program was unable to run to completion. • Turn off the power by pressing the power switch to the "O"...
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7 Troubleshooting Step Instrument checks Tubing insertion Check that the tubing is correctly inserted in the holders. Operation • Check the cutting blade temperature. An infrared sensor measures the cutting blade temperature and modulates power to control temperature. The program stops if the measured temperature differs from the set temperature.
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7 Troubleshooting Error No. Message Possible cause Corrective action ERROR 2 HEATING TOO It took too long for the blade • Try with a new blade. SLOW to reach the sterilization • Check that the blade edges temperature. are clean and unscratched. •...
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7 Troubleshooting Error No. Message Possible cause Corrective action ERROR 8 LIFTOUT The blade liftout operation • Switch off the power to the MOTOR FAIL failed to bring the blade to instrument. the top position in the • Switch on the power to the specified time.
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7 Troubleshooting Error No. Message Possible cause Corrective action ERFE Response error from the PC • Verify that the expected data during communication with is received from the PC (GUI the instrument. application). • Check that the communica- tion cable is connected prop- erly.
8 Reference information Reference information About this chapter This chapter lists the technical specifications of ReadyToProcess STF – Dry, ordering and regulatory information. The chapter also includes ordering information and Health and Safety Declaration forms for service. In this chapter Section See page Specifications...
8 Reference information 8.1 Specifications Specifications This section describes the specifications for the instrument. Parameter Value Supply voltage 100-240 V~ Maximum voltage fluctuation ± 10% from the nominal voltage Frequency 50/60 Hz Maximum current 3.3 A Fuse specification 2 x T4.0 AL 250 V Dimensions (W ×...
8 Reference information 8.2 Compatible tubing for ReadyToProcess STF – Dry Compatible tubing for ReadyToProcess STF – Dry Introduction ReadyToProcess STF – Dry is designed to join thermoplastic tubing. Note: ReadyToProcess STF – Dry cannot be used to join silicone tubing or PTFE. Suitability is based on typical tubing material.
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8 Reference information 8.2 Compatible tubing for ReadyToProcess STF – Dry Change selected tubing type The selected tubing type is shown on the touchscreen display. For instructions on how to change the tubing type, see Start instrument and set tubing brand and dimension, on page Update tubing types To replace the factory loaded tubing types or to add ReadyToProcess tube sizes, refer...
More information about the coating material may be required for cGMP validation. Contact Cytiva Customer Service department and ask for non-disclosure forms. NOTICE Only use PTFE coated cutting blades (BLADES-IR/50) specified for use with the product.
Recycling of hazardous substances The product contains hazardous substances. Detailed information is available from your Cytiva representative. Disposal of electrical components Waste electrical and electronic equipment must not be disposed of as unsorted munic- ipal waste and must be collected separately.
8 Reference information 8.5 Regulatory information Regulatory information Introduction This section lists the regulations and standards that apply to the product. Your system is marked or listed according to the applicable regulatory requirements for your region. Local language translations are provided according to regulatory requirements. In this section Section See page...
Manufacturing information 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 ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
8 Reference information 8.5 Regulatory information 8.5.2 European Union and European Economic Area 8.5.2 European Union and European Economic Area Introduction This section describes regulatory information for the European Union and European Economic Area that applies to the product. Conformity with EU Directives See the EU Declaration of Conformity for the directives and regulations that apply for the CE marking.
8 Reference information 8.5 Regulatory information 8.5.3 Great Britain 8.5.3 Great Britain Introduction This section describes regulatory information for Great Britain that applies to the equipment. Conformity with UK Regulations See the UK Declaration of Conformity for the regulations that apply for the UKCA marking.
Customs Union and (or) the Eurasian Economic Union. Requirement Information Name, address and telephone See Manufacturing information number of manufacturer Importer and/or company for Cytiva RUS LLC obtaining information about 109004, Moscow importer internal city area Tagansky municipal district Stanislavsky str., 21, building 5, premises I,...
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ул. Станиславского, д. 21 стр. 5, помещ. I, ком. 24,25,29 Российская Федерация Телефон: +7 985 192 75 37 Адрес электронной почты: rucis@cytiva.com Description of symbol on the system label Описание обозначения на этикетке системы This Eurasian compliance mark indicates that the product is...
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.
8 Reference information 8.5 Regulatory information 8.5.6 Regulatory statements 8.5.6 Regulatory statements Introduction This section shows regulatory statements that apply to regional requirements. EMC emission, CISPR 11: Group 1, Class A statement NOTICE This equipment is not intended for use in residential environments and may not provide adequate protection to radio reception in such environments.
8 Reference information 8.5 Regulatory information 8.5.7 Declaration of Hazardous Substances (DoHS) 8.5.7 Declaration of Hazardous Substances (DoHS) This section describes the information that applies to the product in China. 根据 SJ/T11364-2014《电子电气产品有害物质限制使用标识要求》特提供如下 有关污染控制方面的信息。 The following product pollution control information is provided according to SJ/ T11364-2014 Marking for Restriction of Hazardous Substances caused by electrical and electronic products.
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8 Reference information 8.5 Regulatory information 8.5.7 Declaration of Hazardous Substances (DoHS) 有害物质的名称及含量 Name and Concentration of Hazardous Substances 产品中有害物质的名称及含量 Table of Hazardous Substances’ Name and Concentration 部件名称 有害物质 Compo- Hazardous substance nent name 铅 汞 镉 六价铬 多溴联苯 多溴二苯醚 (Pb) (Hg) (Cd)
8 Reference information 8.5 Regulatory information 8.5.8 Other regulations and standards 8.5.8 Other regulations and standards Introduction This section describes the additional standards that apply to the product. Additional design considerations For additional design considerations, such as ASME-BPE, GMP and cGMPs information refer to the product-specific specification information provided in the documentation package delivered with each equipment.
8 Reference information 8.6 Ordering information Ordering information For more details on ordering information and for information about spare parts and accessories, visit cytiva.com or contact your local Cytiva representative. ReadyToProcess STF – Dry Operating Instructions 29724820 AA...
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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QR code. cytiva.com Cytiva and the Drop logo are trademarks of Life Sciences IP Holdings Corp. or an affiliate doing business as Cytiva. ReadyToProcess is a trademark of Global Life Sciences Solutions USA LLC or an affiliate doing business as Cytiva.
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