Intended Use - US endoscopy AquaShield Gebrauchsanweisung

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NTENDED SE
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The AquaShield system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during
endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles. This device is intended to be used for not more than 24 hours.
For use with Olympus endoscopes series 140, 160, 180, 190, 240, 260 and 290, specifically those endoscopes that have a distal air/water nozzle.
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The AquaShield system (#00711540) is compatible with commercially available water bottles such as Baxter, Hospira and BBraun.
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The AquaShield system (#00711542) is compatible with commercially available water bottles such as Versylene
Aqua B. Braun and Versol.
W P
ARNINGS AND RECAUTIONS
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This disposable medical device is intended to be used for no more than 24 hours after package has been opened. This device should be
discarded within this time period regardless of number of uses.
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Never attach or reattach the AquaShield
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US Endoscopy did not design this device to be reprocessed or used for more than the 24 hour period after the package has been opened, and
therefore cannot verify that reprocessing can clean and/or sterilize or maintain the structural integrity of the device to ensure patient and/or user
safety.
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Monitor the water level in the water bottle during the procedure. Water feeding will stop once the water level drops below the water bottle tubing.
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Any institution, practitioner, or third party who reprocesses, refurbishes, remanufactures, resterilizes, and/or reuses this disposable medical device
must bear full responsibility for their safety and effectiveness.
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Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques.
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Consult the medical literature relative to complications, hazards, and techniques prior to the performance of any endoscopic procedure.

Use proper aseptic techniques to avoid contamination of the AquaShield
patient uses.
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ONTRAINDICATIONS
Contraindications include those specific to any endoscopic procedure.
I U :
NSTRUCTIONS FOR SE
This product is manufactured not to contain latex.
1. Prior to clinical use familiarize yourself with the device.
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Read the "Warnings and Precautions" and the "Instructions for Use." Review the diagram.
2. Open a bottle of sterile water (250cc, 500cc, or 1000cc).
3. Open the sterile pouch and remove the AquaShield
Tubing to reduce the risk of contamination.
4. Insert the Water Bottle Tubing into the sterile water bottle and firmly tighten the threaded Lid Cap to ensure a seal.
5. Connect the Endoscope Connector to the air/water port connection on the endoscope.
6. Turn on the light source of the processor.
7. Prime the air/water channel prior to insertion of the endoscope into a patient. If water pressure is low, check to see that the Lid Cap is
tightly closed and the Endoscope Connector is firmly attached to the air/water port connection.
8. If water bottle needs to be replaced, use proper aseptic technique.
9. When procedure is completed, close the Pinch Clamp and disconnect the AquaShield
leaking from the Endoscope Connector.
10. Turn off air processor after disconnecting the AquaShield
11. Ensure that the device is discarded within 24 hours after the package has been opened. A label is provided with the device.
Product Disposal:
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws
and regulations.
Issued Date: June 2014
Warning:
An issued or revision date for these instructions is included for the user's
information. In the event that two years have elapsed between this date and
product use, the user should contact US Endoscopy to determine if additional
information is available.
Listening...and delivering solutions
solutions design, and all marks denoted with ® or ™ are registered with the U.S. Patent
and Trademark Office, or trademarks owned by US Endoscopy.
US Endoscopy, a wholly owned subsidiary of STERIS Corporation
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Olympus is a registered trademark of Olympus Optical Co., Ltd.
Made in the U.S.A.
00731591 Rev. F
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system to an endoscope that is/was inside the patient and has not been reprocessed.
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system. Ensure that the Pinch Clamp is in the open position. Avoid contact with the Water Bottle
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, the US Endoscopy listening...and delivering
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system during device setup, replacement of water bottles and between
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system from the endoscope.
Pinch Clamp
Endoscope
Connector
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Fresenius, Baxter Deutschland GmbH,
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system from the endoscope. This will prevent water from
Lid Cap
Water Bottle
Tubing