Terumo T-SEAL III Operator's Manual
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Terumo T-SEAL III Operator's Manual

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T-SEAL
III
®
Terumo Tube Sealing Device
Version 1.0
Operator's Manual

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Summary of Contents for Terumo T-SEAL III

  • Page 1 T-SEAL ® Terumo Tube Sealing Device Version 1.0 Operator’s Manual...
  • Page 2 T-SEAL III Terumo Tube Sealing Device Operator’s Manual UNLOCKING POTENTIAL TERUMOBCT.COM Page 1 of 15 Version 1.0 Rev 02/2021 ©2021 Terumo BCT, Inc.

  • Page 3: Table Of Contents

    5.2 How to Seal Tubes 6. Cleaning 6.1 Sealing Head 7. Troubleshooting 7.1 Sealer 8. Warranty and Service 8.1 Warranty 8.2 Service 8.3 Product Disposal UNLOCKING POTENTIAL TERUMOBCT.COM Page 2 of 15 Version 1.0 Rev 02/2021 ©2021 Terumo BCT, Inc.

  • Page 4: Warnings And Cautions

    Warning! If any of the components of T-SEAL III are exposed to blood, they must be cleaned with an appropriate disinfectant solution. Warning! The device must always be connected to a grounded outlet and with an appropriate alternating current mains source, 100 or 240 V ~.

  • Page 5: Scope

    Up to eight devices can be linked (cascaded) together for simultaneous sealing of segments. T-SEAL III includes a built-in sealing head and is ready to operate. The front cover can be easily removed for cleaning.
  • Page 6 EN 60601-1-2: 2015, Collateral standards for Electromagnetic Compatibility Electrical safety: Class I Waterproof IPX0. Not waterproof T-SEAL III is used in the same environment as medical equipment (hospitals and blood banks). It must be used by highly qualified personnel. Manufacturer Conroy Medical AB According to MDR:...
  • Page 7 Table 1: Guidance and Manufacturer’s Declaration – Electromagnetic Emission T-SEAL III is intended for use in the electromagnetic environment specified below. The customer or the user of T-SEAL III should assure that it is used in such an environment. Emission Test Compliance Electromagnetic Environment —...
  • Page 8 If the measured field strength in the location in which T-SEAL III is used exceeds the applicable RF compliance level above, it should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating T-SEAL III.
  • Page 9 Recommended Separation Distance Between Portable and Mobile RF Communications Equipment and the T.3828 T-SEAL III T-SEAL III is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of T-SEAL III can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and T-SEAL III.

  • Page 10: Symbols/Markings Description

    Product separately. Use collection and return systems available to you. Product brought to EU market after August 13, 2005. Symbol for “MINIMUM AND MAXIMUM ATMOSPHERIC AIR PRESSURE” UNLOCKING POTENTIAL TERUMOBCT.COM Page 9 of 15 Version 1.0 Rev 02/2021 ©2021 Terumo BCT, Inc.

  • Page 11: Installation

    1. Unfold the positioning wing. 2. Fix the tube segment length by positioning the T-SEAL III devices in the correct slot of the positioning wing. The segment length can be modified in increments of 1 cm. Minimum segment length is 7 cm (first slot position);...

  • Page 12: Functional Description

    4. Connect the T-SEAL III devices to the power supply by connecting the AC power cord to the AC power inlet and then to an earthed AC socket. 5. Make sure that the power switches are OFF. 6. Insert a communication termination plug into the COM IN of the leader.

  • Page 13: Preparation Before Use

    Good sealing pattern Bad sealing pattern 6. Cleaning This section gives information on the cleaning procedure and frequency for T-SEAL III, which requires minimal maintenance for efficient operation. Follow the cleaning procedure below. Warning! For your own safety, always turn off the power switch and disconnect the power cord.

  • Page 14: Sealing Head

    Caution! Do not disinfect or sterilize any part of T-SEAL III using an autoclave or with ethylene oxide gas. Doing so will make the device unusable and invalidate the warranty. Do not use chemical or abrasive cleaners such as acetone or ammonia.

  • Page 15: Warranty And Service

    Terumo BCT guarantees that the equipment is fit for the purposes and indications described in the labelling when used in accordance with the instruction for use. Unless the equipment is used in accordance with such instructions, this warranty is void and of no effect.

  • Page 16: Product Disposal

    Terumo BCT will not be responsible for unauthorized returns or for units damaged in shipment due to improper packing. 8.3 Product Disposal For disposal of T-SEAL III (and accessories) at the end of the calculated life cycle of 10 years, please ensure the following: Do not dispose of T-SEAL III as unsorted municipal waste.
  • Page 17 Version 1.0 Operator’s Manual Document number: D0000011338 Terumo BCT, Inc. Terumo BCT Europe N.V. Terumo BCT Asia Pte. Ltd. Terumo BCT Latin America S.A. Terumo BCT Japan, Inc. 10811 West Collins Ave. Europe, Middle East and Africa 89 Science Park Drive La Pampa 1517–12...

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