Ambu aScope 4 RhinoLaryngo Intervention Instructions For Use Manual

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INSTRUCTIONS
FOR USE
Ambu
aScope
4
®
RhinoLaryngo Intervention
Abridged - version - ENG

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Summary of Contents for Ambu aScope 4 RhinoLaryngo Intervention

  • Page 1 INSTRUCTIONS FOR USE Ambu aScope ® ™ RhinoLaryngo Intervention Abridged - version - ENG...
  • Page 3 CONTENTS PAGE English (Instructions for use) ..........................4-11...
  • Page 4: Intended Use

    They describe only the basic operation and precautions related to the operations of aScope 4 RhinoLaryngo Intervention. Before initial use of the aScope 4 RhinoLaryngo Intervention it is essential for operators to have received sufficient training in clinical endoscopic techniques and to be familiar with the intended use, warnings and cautions mentioned in these instructions.
  • Page 5: Adverse Events

    Ambu aView displaying unit. This caution does not apply when the endoscope is used with the Ambu aView 2 advance. 5. Operating the aScope 4 RhinoLaryngo Intervention with reverse grip of the handle will cause an image on the display that is upside down.
  • Page 6 2.3. Endoscope parts Part Function Handle Suitable for left and right hand. Control lever Moves the distal tip up or down in a single plane. Working Allows for instillation of fluids and insertion of channel port endoscopic accessories. Can be used for instillation of fluids, suction and Working channel insertion of endoscopic accessories.
  • Page 7: Explanation Of Symbols Used

    Atmospheric pressure limitation. Relative humidity limitation. Temperature limitation. UK Conformity Assessed. UK Responsible Person. Importer (For products imported into Great Britain only). INMETRO Certificate Medical Electrical Equipment. A full list of symbol explanations can be found on https://www.ambu.com/symbol-explanation.
  • Page 8 4. Use of the endoscope Optimize patient position and consider applying relevant anesthetics to minimize patient discomfort. Numbers in gray circles below refer to illustrations on page 2. 4.1. Preuse check of the endoscope 1. Check that the pouch seal is intact before opening. 1a 2.
  • Page 9: After Use

    In case of corrective actions needed based on the inspection act according to local hospital procedures. Disconnect 10 Disconnect the endoscope from the Ambu displaying unit. Disposal 11 Dispose of the endoscope, which is a single-use device. The endoscope is considered contaminated after use and must be disposed of in accordance with local guidelines for collection of infected medical devices with electronic components.
  • Page 10: Troubleshooting

    Storage aScope 4 RhinoLaryngo Intervention Storage temperature [°C, (°F)] 10 – 25 (50 – 77) Relative humidity [%] 10 – 85 Atmospheric pressure [kPa] 50 – 106 Transportation aScope 4 RhinoLaryngo Intervention Temperature [°C, (°F)] -10 – 55 (14 – 131) Relative humidity [%] 10 –...
  • Page 11 Problem Possible cause Recommended action Low picture quality. Blood, saliva etc. on the If the object cannot be seen clearly, lens (distal tip). clean the distal tip. Absent or reduced Working channel blocked. Withdraw the endoscope and suction capability clean the working channel using a or difficulty in cleaning brush or flush the working inserting endoscopic...
  • Page 12 Ambu A/S Ambu Ltd Baltorpbakken 13 First Floor, Incubator 2 2750 Ballerup Alconbury Weald Enterprise Campus Denmark Alconbury Weald T +45 72 25 20 00 Huntingdon PE28 4XA ambu.com United Kingdom www.ambu.co.uk Ambu and other trademarks are trademarks of Ambu A/S...

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