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Miltenyi Biotec MACS TubeSealer User Manual

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MACS® TubeSealer
User Manual

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Summary of Contents for Miltenyi Biotec MACS TubeSealer

  • Page 1 MACS® TubeSealer User Manual...
  • Page 2 Prodigy Tubing Sets, and CliniMACS PBS/EDTA Buffer. Only those products which are included in the ARTG may be used in Australia. CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research use only and not for therapeutic or diagnostic use.
  • Page 3 MACS® TubeSealer User Manual Issued: 2020-05 38004/04 Miltenyi Biotec B.V. & Co. KG Friedrich-Ebert-Straße 68 51429 Bergisch Gladbach Germany Miltenyi Biotec Technical Support: +49 2204 8306-8484 +49 2204 8306-80 (hotline) +49 2204 8306-89 macstec@miltenyibiotec.de www.miltenyibiotec.com...
  • Page 5 Before putting the system into operation, care­ fully read and understand the safety information, warnings, precautions, and instructions for proper operation of the MACS TubeSealer provided in the instructions for use of the CliniMACS Prodigy System components (including, without limitation, the safety information in this user manual, chapter 3 “Important safety information”) and in any safety­related...

  • Page 7: Table Of Contents

    Table of contents Introduction General information Technical support Glossary Graphical depiction Glossary of symbols and terms Important safety information MACS® TubeSealer Regulatory information Technical data Components of the MACS® TubeSealer Unpacking and installation 4.4.1 Unpacking and inspection of spare part Operating instructions 4.5.1 Description of sealing...
  • Page 8 Table of contents (continued) Troubleshooting Legal notes Limited warranty Trademarks Appendix Guidance and manufacturer’s declaration on electromagnetic compatibility...

  • Page 9: Introduction

    Introduction 1.1 General information The MACS TubeSealer is a fully automatic accessory for sealing PVC and EVA tubing. The hand unit is connected to the CliniMACS Prodigy by a cable. The sealing takes place in the hand unit when the trigger is pressed. All CliniMACS Prodigy Tubing Sets as well as different types and sizes of tubing can be used and the necessary sealing time is self-adaptive to fit the tubing used.

  • Page 11: Glossary

    Glossary 2.1 Graphical depiction The following chart depicts the panels used in this user manual to inform the user about potential risks if the outlined warnings and precautions are not followed. The hazard level classifies the hazard, as described below. The level, type, and source of the hazard, as well as potential consequences, prohibitions, and measures are indicated as follows.

  • Page 12: Glossary Of Symbols And Terms

    2.2 Glossary of symbols and terms An overview of symbols and terms used for the MACS TubeSealer is provided in the CliniMACS Prodigy User Manual (Instrument). The glossary of symbols depicts the symbols used for labeling of the CliniMACS Products.

  • Page 13: Important Safety Information

    Before putting the system into operation, care­ fully read and understand the safety information, warnings, precautions, and instructions for proper operation of the MACS TubeSealer provided in the instructions for use of the CliniMACS Prodigy System components (including, without limitation, the safety information in this user manual, chapter 3 “Important safety information”) and in any safety­related...
  • Page 14 • Never use the heat sealer with consumables, accessories, transducers, and/or cables other than those approved by Miltenyi Biotec to ensure safe and proper operation of the heat sealer. Note: The use of consumables, accessories, transducers, and/or cables not expressly approved by Miltenyi Biotec could void the warranty and/or invalidate the authority to operate this heat sealer under applicable regulations.
  • Page 15 Failure to comply with the safety information, warnings, precautions, and instructions in the user manual (and in other safety related publications issued by Miltenyi Biotec for use with the heat sealer) could lead to improper or incorrect use, handling or care of the product and cause a...
  • Page 16 Table 4.1) and operational procedures listed in this manual. The heat sealer must be used by trained operators only. Operator training will be provided by a Miltenyi Biotec Sales representative. Follow the operating instructions while operating the heat sealer. The heat sealer is used in the same environment as laboratory equipment.
  • Page 17 In case of sealer malfunction (for example, intermittent operation, poor quality seals, sealing time seems too long or too short), use a different heat sealer and/or call Miltenyi Biotec Technical Support for assistance. Periodically check the pattern of the sealing visually (see section 4.5...

  • Page 19: Macs® Tubesealer

    Any serious incident that has occurred in relation to this product should be reported to Miltenyi Biotec B.V. & Co. KG – using the contact information provided – and the competent authority of the member state in which the user of this product is established.

  • Page 20: Technical Data

    The user might need to take mitigation measures, such as relocating or reorienting the heat sealer. Changes or modifications of the heat sealer, unless expressly approved by Miltenyi Biotec, may void the authority to operate the heat sealer pursuant to FCC 47 CFR.

  • Page 21: Components Of The Macs® Tubesealer

    Read chapter 3 “Important safety information” before installation and use of the heat sealer. Seal indicator LED Tubing slot Electrode release lock Trigger Electrode remove grip Connector Cable Figure 4.1: The MACS TubeSealer hand unit with cable and connector...

  • Page 22: Unpacking And Installation

    4.4 Unpacking and installation RIsk of damage to the MACS TubeSealer. Risk of damage to the heat sealer if it is unpacked or installed by unauthorized persons. Unpacking and initial installation of the MACS TubeSealer must only be performed by an authorized local Miltenyi Biotec Service Provider.

  • Page 23: Description Of Sealing

    4.5.1 Description of sealing The MACS TubeSealer has several safety functions that identify whether it is possible to seal the tubing before sealing is attempted. If the heat sealer does not start, see chapter 5 “Troubleshooting” for further information. The sealing process is based on radio frequency technology.

  • Page 24: Environmental Requirements

    1 cm (½ inch) apart. 4.5.2 Environmental requirements Safety and performance of the MACS TubeSealer may be compromised. Safety and performance of the heat sealer may be compromised if it is used outside its specifications.

  • Page 25: Cleaning And Disinfection

    4.6 Cleaning and disinfection The MACS TubeSealer requires minimal maintenance for efficient operation. Follow the cleaning and disinfection procedure described below. Risk of electric shock or damage to the heat sealer. For safety reasons, always disconnect the hand unit from the CliniMACS Prodigy.
  • Page 26 For cleaning the electrodes, remove the mobile electrode. Pull the gray trigger till “click” to release the front electrode. Then push electrode release lock forward (see Figure 4.2). Electrode release lock Figure 4.2: Pull the gray trigger. First push the electrode inward and then pull out the electrode (see Figure 4.3).

  • Page 27: Disposal

    Note: It is recommended to perform some sealing tests before resuming use. 4.7 Disposal The MACS TubeSealer must be separately collected according to the European directive of waste of electrical and electronic equipment (WEEE). For final disposal, the heat sealer must be returned to the manufacturer. Clean the heat sealer according to the instructions given in section 4.6.

  • Page 29: Troubleshooting

    Troubleshooting This section is intended to cover common problems and offers recommended solutions for the MACS TubeSealer. For information not covered in Table 5.1, contact Miltenyi Biotec Technical Support or the authorized local Miltenyi Biotec Service Provider. Symptom Probable cause...
  • Page 30 (see section 4.6). Wet electrodes Dry the electrodes and try again (see section 4.6). Dirty electrodes Clean the electrodes (see section 4.6). Mobile electrode out Contact Miltenyi Biotec Technical of position Support. Other cause Contact Miltenyi Biotec Technical Support. Intermittent Cable broken...

  • Page 31: Legal Notes

    6.1 Limited warranty Except as stated in a specific warranty statement, which may accompany this Miltenyi Biotec product, or unless otherwise agreed in writing by a duly authorized Miltenyi Biotec representative, Miltenyi Biotec’s warranty for products purchased directly from Miltenyi Biotec shall be subject to the terms and conditions of sale under which it was provided to you by the respective Miltenyi Biotec sales organization.

  • Page 32: Trademarks

    6.2 Trademarks CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. All other company, product and service names, logos, and brands used herein are property of their respective owners and are...

  • Page 33: Appendix

    RF instrument or the operation in separate circuits may be required. Guidance and manufacturer’s declaration – Electromagnetic emissions The MACS TubeSealer is intended for use in the electromagnetic environment specified below. The customer or the user of the heat sealer should assure that it is used in such an environment.
  • Page 34 Guidance and manufacturer’s declaration – Electromagnetic immunity The MACS TubeSealer is intended for use in the electromagnetic environment specified below. The customer or the user of the heat sealer should assure that it is used in such an environment. IEC 60601...
  • Page 35 Guidance and manufacturer’s declaration – Electromagnetic immunity The MACS TubeSealer is intended for use in the electromagnetic environment specified below. The customer or the user of the heat sealer should assure that it is used in such an environment. IEC 60601...
  • Page 36 Recommended separation distances between portable and mobile RF communications equipment and the MACS TubeSealer The MACS TubeSealer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the heat sealer can...
  • Page 37 Guidance and manufacturer’s declaration – Electromagnetic emissions The MACS TubeSealer is intended for use in the electromagnetic environment specified below. The customer or the user of the heat sealer should assure that it is used in such an environment.
  • Page 38 Guidance and manufacturer’s declaration – Electromagnetic immunity The MACS TubeSealer is intended for use in the electromagnetic environment specified below. The customer or the user of the heat sealer should assure that it is used in such an environment. Immunity test...
  • Page 39 Guidance and manufacturer’s declaration – Electromagnetic immunity to RF wireless communication equipment Test Immunity Band Maximum Distance Compliance Frequency Service Modulation Test Level (MHz) Power (W) Level (V/m) (MHz) (V/m) TETRA 400 Pulse – Modulation 18Hz GMRS460, – FRS460 ±5kHz deviation 1kHz sine LTE Band 13, 17 Pulse...
  • Page 40 Miltenyi Biotec provides products and services worldwide. Visit www.miltenyibiotec.com/local to find your nearest Miltenyi Biotec contact. CliniMACS, CliniMACS Prodigy, MACS, and the Miltenyi Biotec logo are registered trademarks or trademarks of Miltenyi Biotec B.V. & Co. KG and/or its affiliates in various countries worldwide. Copyright © 2020 Miltenyi Biotec and/or its affiliates. All rights reserved.

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