This product is not made with natural rubber latex
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U
:
NTENDED
SE
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.
The AquaShield
system (#00711540) is compatible with commercially available water bottles such as Baxter, Hospira and BBraun.
®
The AquaShield
system (#00711542) is compatible with commercially available water bottles such as Versylene
®
Deutschland GmbH, Aqua B. Braun and Versol.
W
P
ARNINGS AND
RECAUTIONS
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.
Never attach or reattach the AquaShield
•
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.
Endoscopic procedures should only be performed by persons having adequate training and familiarity with endoscopic techniques.
•
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
•
bottles and between patient uses.
Do not attempt to reuse, reprocess, refurbish, remanufacture, or resterilize this device. STERIS Endoscopy did not design this
•
device nor is it intended to be reused, reprocessed, refurbished, remanufactured, or resterilized. Performing such activities on this
disposable medical device presents a safety risk to patients (i.e. compromised device integrity, cross-contamination, infection).
C
:
ONTRAINDICATIONS
Contraindications include those specific to any endoscopic procedure.
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NSTRUCTIONS FOR
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1.
Prior to clinical use familiarize yourself with the device.
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
the Water Bottle 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
water from 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.
:
®
system to an endoscope that is/was inside the patient and has not been reprocessed.
®
system. Ensure that the Pinch Clamp is in the open position. Avoid contact with
Pinch
Cl
Endoscope
Connector
®
system during device setup, replacement of water
®
system from the endoscope.
Lid
C
Water
Bottle
®
system from the endoscope. This will prevent
®
Fresenius, Baxter