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Table of Contents
Related Manuals for Terumo BCT T5460
Summary of Contents for Terumo BCT T5460
- Page 1 LCT-7010en 12/2015...
- Page 2 INTRODUCTION Every effort has been made to ensure that the information in this document is correct, but we make no guarantee to this effect and would appreciate any observations regarding the contents of this document. We may make improvements and alterations to the instrument and these changes will be incorporated in new issues of this publication when practicable.
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Page 3: Table Of Contents
INTRODUCTION CONTENTS INTRODUCTION ................... 4 SYMBOLS/MARKINGS DESCRIPTION ............5 WARNINGS AND CAUTIONS ................ 6 SPECIFICATIONS, PARTS AND ACCESSORIES ..........7 Specifications..........................7 Parts ............................. 8 Accessories ..........................9 User Interchangeable Parts ..................... 9 INSTALLATION .................... 10 Unpacking and Inspection ..................... 10 Environmental Requirements .................... -
Page 4: Introduction
Hand unit to create a series of seals. T-SEAL MOBILE is comprised of a Hand unit and Battery unit which is connected to the Hand unit with the integrated cable. It is complete with inbuilt sealing head and ready to operate. -
Page 5: Symbols/Markings Description
SYMBOLS/MARKINGS DESCRIPTION SYMBOLS/MARKINGS DESCRIPTION On instrument and labels: This marking reflects compliance with the Council Directive 93/42/EEC on Medical Devices. This marking reflects compliance with EN 60601-1 and national standards for USA (ANSI/AAMI ES60601-1:2005) and Canada (CSA C22.2 No. 60601-1) Markets Class II Battery charger: double insulation during charging. -
Page 6: Warnings And Cautions
If any of the components of T-SEAL MOBILE are exposed to blood, they must be cleaned with an appropriate disinfectant solution. -
Page 7: Specifications, Parts And Accessories
0.4 up to 3 sec. depending on tubing Intended Use ......The T-SEAL MOBILE is an automatic system for sealing PVC and EVA tubes connected to blood bags included either in Blood Packs or in Apheresis Disposable Sets. The sealing can be performed when the donor is still connected to the Blood Pack or the Apheresis Disposable Set. -
Page 8: Parts
SPECIFICATIONS, PARTS AND ACCESSORIES Electrical safety ....During charging Class II. During use: Internal power supply. The T-SEAL MOBILE is used in the same environment as medical equipment (hospitals and blood banks). It must be used by highly qualified personnel. Manufacturer according to Conroy Medical AB: MDD ........ -
Page 9: Accessories
SPECIFICATIONS, PARTS AND ACCESSORIES Accessories Description Holster Extension cord 1.2 m 5-pol 8METSM004 8METSM005 4.4 User Interchangeable Parts Description Hand unit Battery unit Battery charger Kit Primary without plug Adaptors 8METSM001 8METSM002 8METSM003 8METSM037... -
Page 10: Installation
INSTALLATION INSTALLATION This chapter involves unpacking, temperature requirements and installation of the instrument. 5.1 Unpacking and Inspection Visually inspect the cardboard box for damage. Report any damage immediately. 2. Lift the instrument out of the cardboard box and place it on a flat surface. The instrument is shipped in one cardboard box that includes: I. -
Page 11: Installation Procedure
INSTALLATION 5.3 Installation Procedure Preparing the sealer for use Fit correct mains input plug to the Battery charger. 2. The changeable mains connector is available for European continent (standard), UK, USA/Canada and Australia/New Zealand and as IEC standard 320 C8. 3. -
Page 12: Functional Description
FUNCTIONAL DESCRIPTION FUNCTIONAL DESCRIPTION This chapter describes how T-SEAL MOBILE works, where the connectors and the indications are placed on the unit and their functions. Front view of Battery unit Charge level Recharge Battery test Hand unit/Battery indicator indicator button... -
Page 13: Description Of Sealing
See section 7.4 for a description of the different LED indications on the Hand unit in case of problems. 6.2 Description of Equipment T-SEAL MOBILE consists of a Battery unit and a Hand unit. Below is a short description of each component. The Hand unit consists of an RF-generator with intelligent sense control, ergonomic handgrip with trigger, the moving electrode (which can be removed for cleaning) and the cable with connector. -
Page 14: Checking The Battery Unit
FUNCTIONAL DESCRIPTION 6.3 Checking the Battery unit To check the battery, just press the “TEST” button ❸ and the battery charge level indicator ❶ lights up. The capacity indication is in steps of twenty percent. The battery can be recharged at any time or at least when zero (red) remains. The zero level is also indicated on the handle with the red light and when seal is attempted, the seal function will be blocked. -
Page 15: Operating Instructions
3. Connect the Hand unit cable into the combined Hand unit/Battery charger cable connector. NOTE Do not try to connect other sealers to the T-SEAL MOBILE Battery unit than the Terumo BCT T-SEAL MOBILE Hand unit. 7.2 How to Seal Tubes 1 Put the tube to be sealed down to the bottom of the slot in the Hand unit. -
Page 16: If The Sealer Doesn´t Start
CAUTIONS the sealing time seems too long or too short) contact your local Terumo BCT representative for assistance. Periodically check whether the shape of the seal is symmetrical and there is a clear line in the middle of the seal (see picture below). -
Page 17: Troubleshooting
Charge level LEDs doesn’t Battery too low voltage. Charge battery for 3 hours. light. Fuse blown. Contact your local Terumo BCT representative. Other cause. Contact your local Terumo BCT representative. Charge Level LEDs do not No voltage Charge battery for 48 hours light up during charge Fuse blown. -
Page 18: Hand Unit
Hand unit defective. Battery not charged/low Charge battery for 3 hours. charge. Cable broken. Contact your local Terumo BCT representative. Other cause. Bad sealing. Low battery charge. Check the Battery unit charge level. Charge battery if needed. Moving electrode doesn’t Clean and oil electrode shaft, move smoothly in handle. -
Page 19: Cleaning
CLEANING CLEANING This chapter gives information on the cleaning (procedure, frequency) of the Battery and Hand units. The Sealer requires minimal maintenance for efficient operation. Follow the cleaning procedure below. For you own safety always disconnect the Hand unit or charger from WARNINGS the Battery unit. -
Page 20: Hand Unit
CLEANING 9.2 Hand Unit Clean once per week or more frequently, as required, if spillage of blood occurs. For cleaning the electrodes remove the moving electrode. Removal of moving electrode: Pull the blue trigger to “click” to release the moving electrode. Push spring lock forward. -
Page 21: Warranty And Service
Terumo BCT´s sole obligation shall be limited to repair or replacement, at Terumo BCT´s option and expense, of the defective part or unit for a period of two (2) years following the date of initial delivery to the original purchaser. -
Page 22: Product Disposal
10.3 Product Disposal Product Disposal For disposal of T-SEAL MOBILE, or parts thereof, (including accessories) at the end of the calculated life cycle of 7 years, please ensure the following: • Do not dispose T-SEAL MOBILE as unsorted municipal waste. -
Page 23: Emc Tables
Guidance and Manufacturer’s Declaration – Electromagnetic Emission The T5460 T-SEAL MOBILE Portable Tube Sealer is intended for use in the electromagnetic environment specified below. The customer or the user of the T5460 T-SEAL MOBILE should assure that it is used in such an environment. Emission Test... - Page 24 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The T5460 T-SEAL MOBILE is intended for use in the electromagnetic environment specified below. The customer or the user of the T5460 T-SEAL MOBILE should assure that it is used in such an environment.
- Page 25 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the T5460 T-SEAL MOBILE 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 the T5460 T- SEAL MOBILE.
- Page 26 RF communications equipment and the T5460 T-SEAL MOBILE The T5460 T-SEAL MOBILE is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the T5460 T-SEAL MOBILE can help prevent electro-magnetic...
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Page 27: Declaration Of Conformity
DECLARATION OF CONFORMITY DECLARATION OF CONFORMITY... - Page 28 DECLARATION OF CONFORMITY PSPEC233 version 4 Terumo BCT, Inc. 10811 W. Collins Ave., Lakewood, CO 80215, USA ®: Registered trademark ©: Copyright 2015 Terumo BCT, Inc. – All rights reserved...
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