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Ambu aScope Duodeno 2 Instructions For Use Manual

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INSTRUCTIONS
FOR USE
Ambu
aScope
®
For use by specialized healthcare professionals and
experienced gastrointestinal endoscopists trained
on ERCP procedures.
For use in professional healthcare facilities.
For use with Ambu
Duodeno 2
™
aBox
2.
®
™

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Summary of Contents for Ambu aScope Duodeno 2

  • Page 1 INSTRUCTIONS FOR USE Ambu aScope Duodeno 2 ® ™ For use by specialized healthcare professionals and experienced gastrointestinal endoscopists trained on ERCP procedures. For use in professional healthcare facilities. aBox For use with Ambu ® ™...
  • Page 2 aBox 2 pMax CO 80 kPa / 12 psi pMax VAC: -76 kPa / -11 psi...

  • Page 3: Table Of Contents

    CONTENTS PAGE 1. Important information – Read before use ................4 1.1. Intended use/Indication for use ........................4 1.1.1. Intended patient population ........................4 1.1.2. Intended use environment.........................4 1.2. Intended user ................................4 1.3. Contraindications ..............................4 1.4. Clinical benefits................................4 1.5. Warnings and cautions ............................5 1.6.

  • Page 4: Important Information - Read Before Use

    1. Important information – Read before use Read these instructions for use (IFU) carefully before using the aScope™ Duodeno 2. These instructions describe the function, setup and precautions related to operating the aScope™ Duodeno 2. Please be aware that these instructions do not explain or discuss clinical procedures. Before initial use of the aScope™...

  • Page 5: Warnings And Cautions

    1.5. Warnings and cautions WARNINGS 1. For single use only. Do not reuse, reprocess or resterilize, as these processes may leave harmful residues or cause endoscope malfunction. Reuse of the endoscope may cause cross-contamination potentially leading to infections. 2. Confirm that the opening of the insufflation/rinsing valve is not blocked or covered and that the insufflation pressure does not exceed the given limit.

  • Page 6: Potential Adverse Events

    2. Device description The endoscope is to be connected to an Ambu displaying unit. For information about Ambu displaying units, please refer to the Ambu displaying units' instructions for use. 2.1. Device parts aScope™...

  • Page 7: Ascope™ Duodeno 2 Parts

    • Irrespective of the chosen fluid management system, the suction container assembly used must feature overflow protection in order to prevent fluids from entering the system; this feature is commonly referred to as “self-sealing”, “shut-off-filter” or similar. • Endoscopic accessories specified to be compatible with a working channel size (ID) of 4.2 mm / 12.6 Fr or less.
  • Page 8 Part Function Control section The user holds the endoscope at the control section with the left hand. The control wheels and buttons may be manipulated with the left and/or right hand. Elevator control lever Turning this lever in the “U” direction raises the elevator shovel.
  • Page 9 Part Function Working channel port The working channel port provides access to the working channel, which functions as: – Suction channel. – Channel for the insertion or connection of endoscopic accessories. – Fluid feed channel (from a syringe via the biopsy valve).

  • Page 10: Use Of Ascope™ Duodeno 2

    Should any irregularity be observed after inspection, follow the instructions as described in section 5, “Troubleshooting”. If the endoscope malfunctions, do not use it. Contact your Ambu sales representative for further assistance. 3.1. Preparation and inspection of aScope™ Duodeno 2 Inspection of the device Check that the pouch seal is intact, and that the device’s expiration date has not yet been...

  • Page 11: Operating The Ascope™ Duodeno 2

    Check that the water level in the water bottle and remaining volume in the suction container are sufficient for the impending procedure. Confirm that the fluid container’s connection adapter fits properly and it cannot be rotated. Connecting suction As the endoscope is equipped with a standard suction connector, standard suction tubing can be used/is compatible.
  • Page 12 Insufflation/rinsing Cover the opening of the insufflation/rinsing valve to feed gas from the insufflation/rinsing nozzle at the distal tip. Press the insufflation/rinsing valve fully down to feed sterile water onto the objective lens. Injection of fluids Fluids can be injected through the working channel by inserting a syringe into the working channel port of the endoscope.

  • Page 13: After Use

    To prevent infection, it is strictly forbidden to ship contaminated medical devices. As a medical device, the endoscope must be decontaminated on site prior to shipment to Ambu. Ambu reserves the right to return contaminated medical devices to the sender.

  • Page 14: Troubleshooting

    The following tables show the possible causes of and countermeasures against challenges that may occur due to equipment setting errors or damage to the device. Please contact your local Ambu representative if more detailed information is needed. Prior to use, please do the pre-check as described in section 3.
  • Page 15 Possible problem Possible cause Recommended action Elevator shovel cannot Endoscope is defective. Withdraw the endoscope be manipulated, or its and connect a new one. movement is restricted. Endoscopic accessory Elevator shovel raised. Lower elevator shovel. protrudes from the distal tip and cannot be withdrawn. Rinsing/insufflation Possible problem Possible cause...
  • Page 16 Suction Possible problem Possible cause Recommended action Diminished or Vacuum source/suction Connect vacuum source/suction pump no suction. pump is not connected and switch ON. or not switched ON. Suction container is full Change the suction container if it is full. or not connected.
  • Page 17 Endoscope is defective. Withdraw the endoscope and connect a new one. Displaying unit is Contact your Ambu representative. defective. Image suddenly Camera or illumination Switch ON LED as described in darkens.

  • Page 18: Explanation Of Symbols Used

    Possible problem Possible cause Recommended action Picture is frozen. Endoscope is defective. Withdraw the endoscope and connect a new one. Displaying unit is Contact your Ambu representative. defective. Unusual image ARC mode See displaying unit IFU. contrast levels. unintentionally ON/OFF. Improper image/ See displaying unit IFU.
  • Page 19 Caution: Federal law restricts this Single sterile device to sale by or Rx only barrier system on the order of a licensed health care practitioner A full list of symbol explanations can also be found on ambu.com/symbol-explanation.
  • Page 20 Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark T +45 72 25 20 00 ambu.com Ambu and other trademarks are trademarks of Ambu A/S.

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