Fresenius Kabi Agilia Duo Instructions For Use Manual

Fresenius Kabi Agilia Duo Instructions For Use Manual

Two pump accessory
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Agilia Duo
Two Pump Accessory
Instructions For Use

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Summary of Contents for Fresenius Kabi Agilia Duo

  • Page 1 Agilia Duo Two Pump Accessory Instructions For Use...
  • Page 2: Symbol Descriptions

    Symbol descriptions Caution: Federal law restricts this device Refer to the Instructions For Use to sale by or on the order of a physician Warning (Refer to the Instructions For Use) Product reference / part number Batch number Medical Device Unique Device Identifier Output terminal - connector Input terminal - connector...
  • Page 3: Table Of Contents

    2 Compatibility 3 Packaging 4 Agilia Duo installation 4.1 Attaching two pumps together................8 4.2 Attaching the Agilia Duo..................9 5 Cleaning and Low Level Disinfection 5.1 Recommended and Prohibited Agents..............11 5.2 Clean the Device at the Patient bedside.............11 5.3 Instructions for Cleaning and Disinfecting............12 6 Technical characteristics 7 Guidance and manufacturer’s declaration on EMC...
  • Page 4: Introduction

    1 Introduction The Agilia Duo is a two pump accessory designed to centralize the power supply when two Agilia infusion pumps are locked together. This convenient accessory centralizes power of two Agilia pumps and reduces the number of electric power cords.
  • Page 5 ■ Storage and transport pressure: 500 hPa (375 mmHg / 7.25 PSI) to 1060 hPa (795 mmHg / 15.37 PSI). ■ Storage and transport humidity: 10% to 90% maximum, no condensation. To ensure safety and proper operation, read the Instructions For Use accompanying the Agilia infusion pumps before using the Agilia Duo.
  • Page 6: Compatibility

    2 Compatibility The Agilia Duo is compatible with Agilia pumps. For a complete list, refer to the Agilia Connect Infusion System Compatibility Guide that came with your pump. This guide is also available through your Fresenius Kabi representative. WARNING Use ONLY compatible Agilia devices with the Agilia Duo.
  • Page 7: Packaging

    3 Packaging The Agilia Duo packaging contains the following elements: ■ 1 Agilia Duo. ■ 1 Instruction For Use. INFORMATION If the contents in the packaging are not complete or are damaged, please contact your Fresenius Kabi sales representative.
  • Page 8: Agilia Duo Installation

    4. Make sure the two pumps are securely attached together. 5. Before installing two pumps with the Agilia Duo on a pole, fold the two pole clamps down. Then, secure them tightly to the pole.
  • Page 9: Attaching The Agilia Duo

    Unlocked Position 4.2 Attaching the Agilia Duo 1. Insert the two black connectors of the Agilia Duo into the two black power sockets on the back of the connected Agilia pumps. 2. Turn the attachment lock knob clockwise until fully locked and secure.
  • Page 10 2. Install them on a pole. Please refer to the relevant Agilia pump Instructions For Use. 3. Attach the Agilia Duo. 4. Insert the power cord into the black power socket on the side of the Agilia Duo. 5. Insert the other part of the power cord into the wall power outlet.
  • Page 11: Cleaning And Low Level Disinfection

    5 Cleaning and Low Level Disinfection Low level disinfection as per AAMI TIR 12. WARNING To avoid the risks of infection and microbial transmission, make sure to adequately clean and disinfect the equipment in case of dangerous spills such as blood, body fluids or chemotherapy, after each patient use, before any maintenance, on a routine basis when the device is not in use and before storage.
  • Page 12: Instructions For Cleaning And Disinfecting

    ■ Do not place the device in an autoclave or immerse it in liquid. ■ Do not spray liquids directly on connectors. Instead, use a cleaning cloth or disposable wipes. ■ Agilia Duo is not intended to be sterilized. 5.3.1 Cleaning instructions Prerequisites ■...
  • Page 13 1 minute), until all organic matter is dissolved and removed. Do not allow any part of the Agilia Duo to become saturated or submersed in liquid. Do not permit liquids to run, leak, or drip inside of the Agilia Duo housing.
  • Page 14 For cleaning and disinfection of the Agilia infusion pumps, refer to their Instructions For Use.
  • Page 15: Technical Characteristics

    6 Technical characteristics Power supply 100 V - 240 V ~ 50/60 Hz Maximum power input 20 - 30 VA Maximum power output 15 VA per outlet Height/Width/Depth Approx. 6.77 x 1.68 x 2.12 in Weight Approx. 183 g Compliance with standards IEC 60601-1 (Ed.
  • Page 16: Guidance And Manufacturer's Declaration On Emc

    7 Guidance and manufacturer’s declaration on Please refer to the Agilia pump's Instructions For Use, section Guidance and manufacturer’s declaration on EMC.
  • Page 17: Recycling And Disposal

    8 Recycling and Disposal Devices with this label must not be disposed of with the general waste. They must be collected separately and disposed of according to local regulations. INFORMATION For more information on waste processing regulations, contact your Fresenius Kabi representative or local distributor.
  • Page 18: Life Cycle

    9 Life cycle The accessory can be used 10 years in normal conditions.
  • Page 19: Notification Of Serious Incidents

    Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority. Information and contact information: Fresenius Kabi AG Else-Kröner-Str. 1 61352 Bad Homburg - GERMANY Tel: +1 800-933-6925 / +49 (0) 6172 / 686-0...
  • Page 20 This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. Agilia® is a registered trademark in the name of Fresenius Kabi in selected countries. Made in France Revision date: September 2022 Reference: 13482-5_510K_master_ifu_Agilia_Duo_eng-us http://www.fresenius-kabi.com...
  • Page 22 Local contacts for servicing Fresenius Kabi AG Else-Kröner-Str. 1 61352 Bad Homburg - GERMANY Tel.: +1 800-933-6925 / +49 (0) 6172 / 686-0 www.fresenius-kabi.com...

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