Fresenius Kabi Agilia Link 4 Instructions For Use Manual
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Fresenius Kabi Agilia Link 4 Instructions For Use Manual

Fresenius Kabi Agilia Link 4 Instructions For Use Manual

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Agilia Link
Rack System
Instructions For Use

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Summary of Contents for Fresenius Kabi Agilia Link 4

  • Page 1 Agilia Link Rack System Instructions For Use...

  • Page 2: Symbol Descriptions

    Symbol Descriptions Symbols used in this document Danger: Warning of an imminent hazard that could result in serious personal injury and/or product damage if the written instructions are not followed. Warning: warning of a potential hazard that could result in serious personal injury and/or product damage if the written instructions are not followed.
  • Page 3 General symbol for recyclable material Atmospheric pressure limitation FSC : Forest Stewardship Council Eco packaging symbol Paper from responsible sources Indicates the authorised representative in Switzerland...

  • Page 4: Table Of Contents

    Table of contents 1 Introduction 1.1 Scope........................6 1.2 Intended purpose....................6 1.3 Intended use......................6 1.4 Clinical benefits.....................7 1.5 Side-effects......................7 1.6 Risks for patients....................7 2 Description 2.1 System Definition of Agilia Link................9 2.2 Compatible Pumps....................9 2.3 Front View......................9 2.4 Side View with Power Plug..................10 2.5 Side View with Functional Earth Terminal............10 2.6 Back View (Device Identification Label)..............11 2.7 Packaging......................11...
  • Page 5 9 Servicing and Warranty 9.1 Servicing......................27 9.2 Warranty......................28 10 Ordering Information 10.1 Agilia Link Packaging..................29 10.2 Accessories and Options...................29 11 Technical Specifications 11.1 Technical Data....................30 11.2 Compliance with Standards................31 12 Guidance and Manufacturer’s Declaration on EMC 12.1 Electromagnetic Compatibility................32 12.2 Electrostatic Discharge (ESD)................32 12.3 Electromagnetic Compatibility and Interference Guidance.......33 12.4 EMC and essential performances..............34 13 Glossary of Terms...

  • Page 6: Introduction

    1.3.3 Intended Users Agilia Link must only be used by qualified and trained healthcare professionals. The estimated duration for training is 15 minutes. Users are recommended to attend a refresher training session every year. For training, contact your Fresenius Kabi sales representative.

  • Page 7: Clinical Benefits

    ■ Hyperbaric chambers INFORMATION For more information on using Agilia Link in specific conditions, contact your Fresenius Kabi sales representative. 1.4 Clinical benefits Agilia Link is an accessory that has no clinical benefits, but directly assists the medical functionality of Agilia infusion pumps in terms of their intended purpose.
  • Page 8 ■ Under-delivery ■ Delay of Therapy ■ Biological or Chemical Contamination ■ Traumatic Injuries ■ Electrisation...

  • Page 9: Description

    Agilia Link has 4, 6 or 8 outlets to power Agilia pumps. These outlets are connected to a functional earth with Link Functional Earth Cable. Agilia Link is ONLY compatible with Agilia pumps from Fresenius Kabi sold in your country. 2.3 Front View...

  • Page 10: Side View With Power Plug

    Symbol Location Symbol description Do not remove the rack from pole or rails if pumps are connected. The rack is heavy when installed with pumps. On right and left sides Remove pumps first, before removing the rack from poles or rails. Unscrew lower pole clamp first.

  • Page 11: Back View (Device Identification Label)

    2.6 Back View (Device Identification Label) Legend Upper pole clamp Lower pole clamp Device Identification Label Symbol Symbol description Clamps must be mounted outside this area The Unique Device Identification label (UDI) is represented in AIDC (Automatic Identification and Data Capture) and readable text: ■...
  • Page 12 If the packaging contents are incomplete or damaged, contact your Fresenius Kabi sales representative. Packaging description: ■ Packaging weight: – Agilia Link 4: approximately 1.4 kg. – Agilia Link 6: approximately 1.8 kg. – Agilia Link 8: approximately 2.2 kg ■ Packaging consists of: recycled cardboard, cardboard wedges.

  • Page 13: Infusion System: Installation And Removal

    3 Infusion System: Installation and Removal WARNING If Agilia devices or accessories appear damaged, stop using them and send them for maintenance instead. 3.1 Agilia Link Preparation Pole clamp installation and adjustments. 1. Slide clamps on the back of Agilia Link. 2.
  • Page 14 WARNING ■ Fasten rack clamps firmly on the pole or rails to avoid any movement of the rack and to avoid patient or user injuries. ■ Always use the 2 rack clamps to ensure the stability of the device when mounted on a pole or on a rail.
  • Page 15 Instructions for Use. We recommend the user to verify that the fixing mechanism Link/pole is tightened enough at every modification of infusion system configuration. Compatibility between Agilia rack and Fresenius Rolling stands Fresenius Kabi Rolling Stand part number Z073100 Z073150 Z073110...

  • Page 16: Pump Installation And Removal

    ■ It is recommended to use the pump and its accessories with the power cord or accessory from the Agilia range supplied by Fresenius Kabi. If such power cord is not available, be sure to use a cable with the same specifications.
  • Page 17 3.3.1 Installing a Pump When used with pumps, follow instructions as per the pump Instructions for Use (prefer the lowest positions for large volume pumps). ■ During installation, be sure that sets are not kinked, not pinched or damaged when pump is mounted on the rack. ■...

  • Page 18: Remove Agilia Link From Fixed Pole, Fixed Rails Or Rolling Stand

    4. When the rack is powered by AC power, check pump display to confirm power display light is ON and listen to the audio pump signal. 3.3.2 Removing a Pump When Infusion has Ended In order to remove a pump, proceed as follows: ■...
  • Page 19 3. Unscrew the lower clamp first. 4. Next unscrew the upper clamp and remove the rack from the pole or rails. 5. Store the rack in a suitable place. Refer to Device Storage on page 23 for additional information.

  • Page 20: Cleaning And Disinfection

    4 Cleaning and Disinfection Equipment must be thoroughly cleaned after each use. Equipment may be disinfected when appropriate. Disinfecting the equipment without prior cleaning is not effective. Patients, operators, and maintenance staff are exposed to the risk of infection and microbial transmission when the equipment is not adequately cleaned and disinfected.

  • Page 21: Cleaning Instructions

    ■ This cleaning procedure shall be started immediately after contamination either by blood or body fluids. ■ The cleaning procedure shall be done prior to the disinfection procedure. The disinfection procedure shall be done directly after the cleaning procedure. The contact time shall be in accordance with the recommendations of the disinfectant agent's manufacturer (respect the indicated contact time for the required antimicrobial activity).
  • Page 22 1. For cleaning, with a fresh ready-to-use wipe, wipe down accessories. Allow the accessories to completely dry. 2. For disinfection, repeat the step 1.

  • Page 23: Device Storage

    5 Device Storage 5.1 Precautions for Storage Handle the device with care during storage. Store the device in a cool, dry place. The storage area must be clean and organized. Clean and disinfect the device prior to storage. Refer to Cleaning and Disinfection on page 5.2 Storage and Transport Conditions...

  • Page 24: Agilia Link Quick Check Protocol

    It is recommended that this protocol be performed after installation and before use of the device on a new patient. Note: if one or more tests fail, contact the appropriate service department or Fresenius Kabi sales representative. Agilia Link serial number or inventory number...

  • Page 25: Troubleshooting

    Remove power cable with an abnormally hot part ■ Do not use this device ■ Contact your biomedical department or Fresenius Kabi sales representative immediately Power status indicator is not lit ■ Check power cable connection to the rack ■...

  • Page 26: Recycling

    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 and dismantling, please contact your Fresenius Kabi sales representative or local distributor.

  • Page 27: Servicing And Warranty

    3. Pack the device in the provided packaging. 4. Ship the device to Fresenius Kabi. Fresenius Kabi is not liable for loss or damage to the device during transport. For more information on servicing, contact your Fresenius Kabi sales representative.

  • Page 28: Warranty

    ■ the device must not have been altered or repaired by unqualified personnel; ■ the serial number (SN) must not have been altered, changed or erased. If one or more of these conditions have been violated, Fresenius Kabi will prepare a repair estimate covering all required parts and labor.

  • Page 29: Ordering Information

    10 Ordering Information Additional power cords and 'Instructions for Use' documents must be ordered separately. Contact your Fresenius Kabi sales representative for ordering. INFORMATION For a list of compatible accessories, disposables and software, and for ordering information, refer to the System Components booklet.

  • Page 30: Technical Specifications

    Standard appliance inlet IEC type C14 - male - 3 poles Power supply 100 V to 240 V AC / 50/60 Hz Maximum power Agilia Link 4: 60 VA (with pumps) Agilia Link 6: 90 VA Agilia Link 8: 120 VA...

  • Page 31: Compliance With Standards

    11.2 Compliance with Standards Complies with the Medical Device Regulation (EU) 2017/745. IP22 protection against dust and splashing liquid Electro-medical Complies with EN/IEC Type B applied part equipment safety 60601-1 Class I with protective earth (Electromagnetic Complies with EN/IEC 60601-1-2 compatibilty) NOTE: ■...

  • Page 32: Guidance And Manufacturer's Declaration On Emc

    12 Guidance and Manufacturer’s Declaration on 12.1 Electromagnetic Compatibility DANGER Do not use the device in Magnetic Resonance Imaging (MRI) environments. WARNING ■ Agilia Link and its accessories are intended to be used in the electromagnetic environments specified below. ■ The customer or the user of the Agilia Link should ensure that it is used in such environments.

  • Page 33: Electromagnetic Compatibility And Interference Guidance

    ■ Use of anti-static equipment ■ Preliminary user discharge (explained below) ■ Anti-static clothing The best precaution is preliminary user discharge on a grounded metal object such as a rail, a pole or a metal part located at the rear of the Agilia Link. For maintenance operation performed on Agilia Link, place the device on a conductive working surface, and wear a special ESD conductive wristband.

  • Page 34: Emc And Essential Performances

    If Agilia Link is placed near devices such as HF surgical equipment, X-Ray equipment, NMR, cell phones, DECT phones or wireless access points, portable RFID reader, large scale RFID reader and RFID tags, it is essential to observe a minimum distance between Agilia Link and this equipment.
  • Page 35 Emission Test Compliance Obtained by the Electromagnetic Environment Device - Guidance RF emissions CISPR 11 Class A The Agilia Link is suitable for use in all establishments other than Harmonic emissions Class A domestic and those directly IEC61000-3-2 connected to the public low-voltage power supply Voltage fluctuations Flicker Compliant...
  • Page 36 Immunity Compliance Electromagnetic Environment - Guidance Test 60601-1-2 Level Obtained by - - - - - - - - - the Device 60601-2-24 Test Level Voltage dips, < 5% Ut < 5% Ut AC power quality should be that of a typical commercial short (>...
  • Page 37 Immunity Compliance Electromagnetic Environment - Guidance Test 60601-1-2 Level Obtained by - - - - - - - - - the Device 60601-2-24 Test Level Portable and mobile RF communication equipment should be used no closer to any part of Agilia Link (including cables), than the recommended separation distance calculated from the transmitter frequency equation.
  • Page 38 12.4.4 Table 6 - Recommended Separation Distances Between Portable and Mobile RF Communication Equipment and Agilia Link INFORMATION ■ Agilia Link and its accessories are intended for use in electromagnetic environments in which radiated RF disturbances are controlled. ■ Users of Agilia Link may prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and Agilia Link as recommended below, and according to the maximum output power of the communication equipment...
  • Page 39 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Discharge ± 8 kV contact ± 8 kV contact Wooden, tiled or (ESD) IEC ± 15 kV air ± 15 kV air concrete flooring, with 61000-4-2 a relative humidity...
  • Page 40 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Near field 385 MHz, PM 18Hz, 27 V/m 385 MHz, PM 18Hz, 27 V/m For minimal distance radiated RF 450 Mhz, 1 KHz, 28 V/m 450 Mhz, 1 KHz, 28 V/m approach 30 cm 710 MHz, PM 217 Hz, 9 V/m...
  • Page 41 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Power 30 A / m 400 A / m If necessary, the frequency power magnetic field (50 / 60 Hz) should be measured magnetic in the intended field IEC...
  • Page 42 Immunity IEC 60601-1-2 Compliance level obtained Electromagnetic test IEC 60601-2-24 by the device environment – Test level guidance Voltage 0 % Ut (100% dip in Ut) for 0,5 0 % Ut (100% dip in Ut) for 0,5 Electricity power dips, short cycle at 0°, 45°, 90°, 135°,180°, cycle at 0°, 45°, 90°, 135°,180°, quality should be that...

  • Page 43: Glossary Of Terms

    13 Glossary of Terms Term Description Ampere Alternating Current Agilia Range of infusion pumps manufactured by Fresenius Kabi Ampere hour CISPR International Special Committee on Radio Interference CT Scan Computed Tomography DECT Digital Enhanced Cordless Telecommunications Electrocardiogram Electroencephalogram Electromagnetic compatibility...
  • Page 44 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...
  • Page 46 Local contacts for servicing Fresenius Kabi AG Fresenius Vial S.A.S. Else-Kröner-Str. 1 Le Grand Chemin 61352 Bad Homburg - GERMANY 38590 Brézins - FRANCE Tel.: +49 (0) 6172 / 686-0...

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