Ambu AuraOnce Product Information
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Ambu AuraOnce Product Information

Single use laryngal mask - sterile, for use by trained clinicians only
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Product Information
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Ambu
AuraOnce
Single Use Laryngal Mask - Sterile
For use by trained clinicians only

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Summary of Contents for Ambu AuraOnce

  • Page 1 Product Information ® ™ Ambu AuraOnce Single Use Laryngal Mask - Sterile For use by trained clinicians only...

  • Page 2: Table Of Contents

    Critical situations and emergencies 8.4.1. Critical situations 8.4.2. Emergencies 8.5. Magnetic resonance imaging (MRI) Illustration 14-15 Symbols Addresses US: Rx only ® Ambu is registered trademark of Ambu A/S, Denmark. Ambu A/S is certifi ed according to ISO 9001, and ISO 13485.

  • Page 3: Warnings/Cautions

    • Adhere strictly to the recommended cuff infl ation volumes as specifi ed in Table 3. Never over-infl ate the cuff after insertion. • Ambu AuraOnce is to be used in patients, who have been clinically evaluated by a clinician familiar with anaesthesia as eligible for a Supraglottic Airway Device.

  • Page 4: Introduction

    2. Introduction 2.1. Intended use The Ambu AuraOnce is intended for use as an alternative to a facemask for achieving and maintaining control of the airway during routine and emergency anaesthetic procedures in fasted patients. The Ambu AuraOnce may also be used where unexpected difficulties arise in connection with airway management.

  • Page 5: Materials

    17,8 cm 20,0 cm 22,0 cm Internal pathway Table 1. Specifi cations for the Ambu AuraOnce 3.1. Materials The Ambu AuraOnce is 100% latex free. The materials used for the product and packaging are: Part Material Airway connector Polypropylene (PP) Tube/Cuff PVC Medical compound infl...

  • Page 6: Principles Of Operation

    CAUTION • Handle the Ambu AuraOnce carefully as it is made of PVC which can be torn or punctured. Avoid contact with sharp or pointed objects. • Always wear gloves during the preparation and insertion of the Ambu AuraOnce to minimize contamination.

  • Page 7: Test 1 - Visual Inspection

    There should not be any bulge nor any sign of leakage in the cuff, pilot tubing or pilot balloon. WARNING Do not use the Ambu AuraOnce if there are any bulges on the cuff or if there are any signs of leakage. Mask size #1½...

  • Page 8: Insertion

    The following points are extremely important: • Check for correct defl ation and lubrication as described above. • The size of the Ambu AuraOnce must fi t the patient. Use the guidelines in Table 3 combined with clinical judgement to select the correct size.

  • Page 9: Placement Technique

    Diffi culty in manoeuvring the angle at the back of the tongue is one of the most common problems encountered when inserting the Ambu AuraOnce. The tip must be pressed against the palate throughout or else the tip may fold on itself or meet an irregularity in the posterior pharynx, e.g.

  • Page 10: Connecting To The Anesthetic System

    • The anaesthetic breathing system must be adequately supported when connected to the Ambu AuraOnce to avoid rotation of the mask. • The patency of the Ambu AuraOnce should be reconfi rmed after any change in the patient’s head or neck position 7.7.

  • Page 11: Usage With Spontaneous Ventilation

    Unexpected regurgitation: Regurgitation may occur even in fasted patients. This may be caused by inadequate level of anaesthesia. One early sign of regurgitation is the appearance of fl uid travelling up the Ambu AuraOnce airway tube. The fi rst signs of regurgitation may be spontaneous breathing, coughing or breath-holding.

  • Page 12: Recovery

    It is recommended to use an exchange catheter for intubation through the Ambu AuraOnce. A fl exible fi berscope can be used through the Ambu AuraOnce to view the airway. It is important to pre-oxygenate the patient and to use standard monitoring procedures. Fiberoptic intubation via the Ambu AuraOnce can be done using an exchange catheter.

  • Page 13: Use Of The Ambu Auraonce For Blind Tracheal Intubation

    (or unconsciousness) is achieved before insertion. The insertion should be successful at the same level of anesthesia that would be suitable for tracheal intubation. If the clinician wishes to intubate the child via the AuraOnce it is recommended that an exchange catheter is used over a fi berscope.

  • Page 16: Symbols

    This product information may be updated without futher notice. Copies of the current version are available from the manufacturer. © Copyright 2008 Ambu A/S, Denmark. All rights reserved. No part of this programme or the programme documentation may be reproduced in any form,...

  • Page 17: Addresses

    +39 039 657811 Fax: +39 039 6898177 Germany www.ambu.it Ambu GmbH In der Hub 5 Spain D-61231 Bad Nauheim Firma Ambu S.L. Tel.: +49 6032 92500 C/ Alcalá 261-265, Edificio 1, 3º Izq Fax: +49 800 ambude 28027 Madrid www.ambu.de Tel:...
  • Page 18 0086 LATEX LATEX FREE Pat. Pending Ambu A/S Baltorpbakken 13 DK-2750 Ballerup Denmark T +45 7225 2000 F +45 7225 2050 www.ambu.com...

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