Fresenius Kabi Agilia Holder Ambulance Mounting Instructions
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Fresenius Kabi Agilia Holder Ambulance Mounting Instructions

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Agilia Holder
Ambulance
Mounting Instructions
&
Instructions For Use

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Summary of Contents for Fresenius Kabi Agilia Holder Ambulance

  • Page 1 Agilia Holder Ambulance Mounting Instructions & Instructions For Use...
  • Page 2 Device identification label Symbols Descriptions Product serial number Product reference / part number Not applicable Not for use in residential areas Refer to the accompanying documents Name and address of the manufacturer / Date of manufacture CE mark according to European Directive 93/42/CE Packaging symbols Symbols Descriptions...
  • Page 3 Local contacts for servicing Complete this box with your contacts: 7190-6_Master_IFU_Ambulance_Holder_Agilia_eng...

  • Page 4: Table Of Contents

    ..............11 OMPATIBLE DISPOSABLE 2.5 A ....12 GILIA PUMP PERFORMANCES IN VIBRATING ENVIRONMENT MOUNTING INSTRUCTIONS TO FIX AGILIA HOLDER AMBULANCE IN ROAD AMBULANCE INSTALLATION, MANAGEMENT AND REMOVAL OF AGILIA IV PUMP 15 4.1 I NSTALLATION OF AN GILIA PUMP INTO THE...
  • Page 5 ORDERING INFORMATION 9.1 R .............. 26 ECOMMENDED ACCESSORIES 9.2 AC ................. 26 POWER CORD 9.3 M ....... 26 OUNTING INSTRUCTIONS NSTRUCTIONS WARRANTY 10.1 G ........... 27 ENERAL CONDITIONS OF WARRANTY 10.2 L ................27 IMITED WARRANTY 11 RECYCLING AND DISPOSAL 12 GLOSSARY OF TERMS 7190-6_Master_IFU_Ambulance_Holder_Agilia_eng...

  • Page 6: Introduction

    Introduction The Agilia Holder Ambulance allows the use of Agilia IV pumps in road ambulances. This document is intended for:  Biomedical departments in order to install the Agilia Holder Ambulance properly.  End users of Agilia Holder Ambulance. 1.1 Scope This document is applicable to the Agilia Holder Ambulance.

  • Page 7: Intended Use

    Agilia Holder Ambulance is a medical device intended to be used in road ambulances equipped with AC power source and a horizontal rail in order to fix one Agilia IV pump. Agilia Holder Ambulance is designed to be used only on ISO 19054:2005 rails. Danger: ...

  • Page 8: Contraindications

    NOT to fix or remove an Agilia IV pump into the Agilia Holder Ambulance while Agilia IV pump is operating.  Do not fix the Agilia Holder Ambulance on vertical poles and/or on round rails.  In road ambulance environment, the following accessories...

  • Page 9: Use Environment

    1.5 Use environment Warning:  Agilia Holder Ambulance should be used under the specified operational and storage conditions listed below to ensure its proper performance.  Due to use environment (into road ambulances), Agilia Holder Ambulance can be hot.  It is recommended to check and charge the Agilia IV pump battery to avoid that the infusion stops in case of short or long interruptions of mains power.

  • Page 10: Description

    CE mark according to the 93/42/CEE Medical directive with standards • EN 1789: 2010 Medical vehicles and their equipment - Road ambulances 2.1 Detailed description of Agilia Holder Ambulance Clamp Shaped base Hinged fixing arm Two securing clamps with screws...

  • Page 11: Packaging Content

    2.2 Packaging content The Agilia Holder Ambulance packaging contains the following elements:  one Agilia Holder Ambulance with its two keys for one Agilia IV pump.  one ‘Mounting instructions and Instructions for Use’.  one number 13 wrench.  one hexagonal 6 pans wrench.

  • Page 12: Agilia

    2.5 Agilia IV pump performances in vibrating environment Pump essential performances are maintained. If the Agilia IV pumps are used outside the road ambulance environment, please refer to their In- structions For Use.

  • Page 13: Mounting Instructions To Fix Agilia Holder Ambulance In Road Ambulance

    The Agilia Holder Ambulance should be positioned into the road ambulance at a minimum height so that the line remains loose be- tween the pump and the IV access. Fix the Agilia Holder Ambulance in the road ambulance prior to install an Agilia IV pump.
  • Page 14 6 pans wrench (1). 2. Tighten the 2 lock nuts clockwise with a no 13 flat wrench (2). 3. Push and pull the Agilia Holder Ambulance to check it is not loose but securely fixed to the horizontal rail.

  • Page 15: Installation, Management And Removal Of Agilia Iv Pump

    Holder Ambulance 1. Check visually the Agilia IV pump before installing. 2. Using one of the two keys, delivered with Agilia Holder Ambulance, unlock the clamp as shown below: 3. Lift the clamp to release the hinged fixing arm of the Agilia Holder Ambulance : 4.
  • Page 16 7. Position the Agilia IV pump on the shaped base of the Agilia Holder Ambulance. Front bumpers of the Agilia IV pump should be in contact with the holes designed in the Agilia Holder Ambulance shaped base ( A markings in the hereinafter drawing): 8.
  • Page 17 10. Lock the clamp with one of the two keys: 11. Remove the two keys from the Agilia Holder Ambulance . 12. Keep the 2 keys in two different safe places. 13. Connect the AC power cord of the Agilia IV pump, without any electric extension lead, to the road ambulance power source.

  • Page 18: Management Of The Bulance

    Instructions For Use for further information about the use of Agilia IV pumps.  Fresenius Kabi recommends a specific pump to be allocated for the use in road ambulance in combination with Agilia Holder Ambulance .

  • Page 19: Removal Of Ana

    2. Switch the Agilia IV pump off. 3. De-install the disposable. 4. Unlock the clamp of the Agilia Holder Ambulance with one of the two keys: 5. Lift the clamp to release the hinged fixing arm: 6. Lift the hinged fixing arm:...
  • Page 20 7. Remove the Agilia IV pump from the Agilia Holder Ambulance shaped base: 8. Disconnect the AC power cord from the road ambulance power source. Pull down the hinged fixing arm: 10. Close the clamp.

  • Page 21: Alarms And Safety Features Of Agilia Iv Pumps Mounted Into The Agilia Holder Ambulance

    Audible alarm signals should be adjusted in ‘Options’ menu of the Agilia IV pumps. For further information, please refer to Agilia IV pumps Instructions For Use. Fresenius Kabi recommends the adjustment of the audible Agilia IV pumps alarm signals at their maximum levels. Recommendations for cleaning 6.1 Prohibited cleaning agents...

  • Page 22: Precautions For Cleaning

    6.4 Cleaning guidelines and protocol Agilia Holder Ambulance is part of the patient’s immediate environment. It is advisable to clean the Agilia Holder Ambulance regularly and especially before connecting a new patient and after removal of the Agilia IV pump as well as before any maintenance op- eration in order to protect the patient and the operator.

  • Page 23: Storage Of Agilia Holder Ambulance

    1. Prepare the detergent-disinfectant solution. 2. Remove the Agilia IV pump from the Agilia Holder Ambulance . 3. Moisten by vaporization of detergent-disinfectant solution the Agilia Holder Ambulance , including the mobile parts.

  • Page 24: Servicing

    Clean and disinfect, then pack it in the provided packaging and ship to Fresenius Kabi. Fresenius Kabi is not liable for loss or damage to the Agilia Holder Ambulance during transport. For maintenance of Agilia IV pumps, please refer to the Instructions For Use.

  • Page 25: Quality Control

    8.4 Regular check To ensure that the Agilia Holder Ambulance is functional, regularly check: 1. External aspect of the Agilia Holder Ambulance : absence of crack or visible damage. 2. Check that the white shock absorbers are still in place.

  • Page 26: Ordering Information

    Please contact your Fresenius Kabi sales representative for ordering. 9.1 Recommended accessories No accessory is necessary with the Agilia Holder Ambulance . 9.2 AC power cord Several AC power cords are available for Agilia pumps according to the country specifications.

  • Page 27: Warranty

    Warranty 10.1 General conditions of warranty Fresenius Kabi guarantees that this product is free from defects in material and workmanship during the period defined by the accepted sales conditions. 10.2 Limited warranty To benefit from the materials and workmanship guarantee from our...

  • Page 28: Recycling And Disposal

    Recycling and disposal Warning: Before disposal of the Agilia Holder Ambulance, remove installed Agilia IV pump. Agilia Holder Ambulance must be disposed of according to local regulations. Information: For further information pertaining to waste processing regulations, contact your local Fresenius Kabi representative or local distributor.

  • Page 29: Glossary Of Terms

    Glossary of terms Term Description Alternating Current Agilia, Range of infusion pumps manufactured by Fresenius Kabi Agilia IV pumps Agilia Holder Ambulance CE mark European Conformity Mark Centimeters Hecto Pascal H/W/D Height / Width / Depth ID/N° Identification Number International Electrotechnical Commission...
  • Page 30 This document may not be reproduced in whole or in part without the written consent of Fresenius Kabi. ® Agilia is a registered trademark by Fresenius Kabi in selected countries. Revision date: January 2016 Fresenius Kabi AG 61346 Bad Homburg...

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