Intended Use; Warnings And Precautions - Steris AquaShield 00711541 Instrucciones De Uso

This product is not made with natural rubber latex.
I U :
NTENDED SE
®
The AquaShield system CO
endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
For use with Olympus endoscopes series 140, 160, 180, 190, 240, 260 specifically those endoscopes that have a distal air/water nozzle.
The AquaShield ® system CO
The AquaShield system CO
Deutschland GmbH, Aqua B. Braun and Versol.
AquaShield ®
BX00711541 and BX00711543
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
multiple endoscopes are used during a procedure and possible contamination is expected on the connections, discard the device after the
procedure and before the next patient.
 When using the AquaShield
prevent overpressurization of the water bottle.
 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
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.
I U :
NSTRUCTIONS FOR SE
For Use with Air
1. Prior to clinical use, inspect and familiarize yourself with the device and review the diagram below. If there is evidence of damage,
do not use this product and contact your local Product Specialist.
2. The Pinch Clamp should be in the open position when removed from the package.
3. Open a bottle of sterile water and remove cap. (250cc, 500cc, or 1000cc).
4. Remove 1/3 of the sterile water from the full sterile water bottle. This will allow for improved water pressure for better insufflation
and water flow.
5. Open the sterile pouch and remove the AquaShield
contamination.
6. Insert the Water Bottle Tubing into the sterile water bottle and firmly tighten the threaded Lid Cap to ensure a seal.
7. Attach the Endoscope Connector to the endoscope.
8. Leave the Pinch Clamp on the Endoscope Tubing in the open position.
9. Turn on the light source of the processor and press the Air/Pump button to the ON position.
10. 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. Check that the Endoscope Connector is firmly attached to the endoscope.
11. Perform air insufflation and water flow for lens cleaning as described in the Olympus instruction manuals for air/water valve and
endoscope being used together with a sterile water bottle.
12. If the water bottle needs to be replaced, use proper aseptic technique.
After Procedure is completed
 Follow the Olympus manufacturer's guidelines for purging the air/water channel system when the procedure is completed.
 Close the Pinch Clamp on the Endoscope Tubing and disconnect the Endoscope Connector from the endoscope. This will
prevent water from leaking from the Endoscope Connector.
 Follow the manufacturer's guidelines for turning off the light source and the Air/Pump of the processor.
 Ensure that the device is discarded within 24 hours after the package has been opened. A label is provided with the device.
For Use with CO (Turn OFF the Air/Pump on the Light Source of the Processor)
2
1. Prior to clinical use, inspect and familiarize yourself with the device and review the diagram below. If there is evidence of damage,
do not use this product and contact your local Product Specialist.
2. The Pinch Clamp should be in the open position when removed from the package.
3. Open a bottle of sterile water and remove cap. (250cc, 500cc, or 1000cc).
00731827 Rev.J
is intended to be used with an air or carbon dioxide (CO
2
(#00711541) is compatible with commercially available water bottles such as Baxter, Hospira and BBraun.
2
(#00711543) is compatible with commercially available water bottles such as Versylene
2
system CO Water Bottle tubing length
2
25cm
:
®
system CO
® system CO it is recommended that an insufflator or supply tubing with a flow control device be used to
2
) source with the purpose of supplying sterile water to the
2
CO tubing length
2
10cm
to an endoscope that is/was inside the patient and has not been reprocessed. If
2
®
system CO
® system CO . Avoid contact with the Water Bottle Tubing to reduce the risk of
2
during device setup, replacement of water bottles
2
® Fresenius, Baxter