00732020 Rev. E
This product is not made with natural rubber latex.
I
NTENDED
U
SE
:
The AquaShield
®
system – Pentax is intended to be used with an air or carbon dioxide (CO
2
) 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 Pentax endoscopes, specifically those endoscopes that have a distal air/water nozzle.
The AquaShield
®
system - Pentax (#00711550) is compatible with commercially available water bottles such as Baxter, UK Baxter, Hospira and BBraun.
W
ARNINGS AND
P
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
®
system - Pentax to an endoscope that is/was inside the patient and has not been reprocessed. If 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.
Monitor the water level in the water bottle during the procedure. Water flow for lens cleaning will stop once the water level drops below the water
bottle tubing.
When using the AquaShield
®
system – Pentax with CO
2
it is recommended an insufflator should be used or a supply tubing with a flow control device
to prevent overpressurization of the water bottle.
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
®
system – Pentax during device setup, replacement of water 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.
I
NSTRUCTIONS FOR
U
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.
Open a bottle of sterile water and remove cap. (250cc, 500cc, or 1000cc)
3.
Open the sterile pouch and remove the AquaShield
®
system - Pentax.
4.
Ensure that the
Pinch Clamp
is in the open position.
5.
Avoid contact with the
Water Bottle Tubing
to reduce the risk of contamination.
6.
Insert the
Water Bottle Tubing
into the sterile water bottle and firmly tighten the threaded
Lid Cap
onto the water bottle. Ensure the cap seats on the
bottle without being cocked or cross-threaded. If the lid is coced or corss-threaded, this can lead to leakage and/or reduced sterile water flow or
decreased insufflation.
7.
Attach the
Endoscope Connector
to the endoscope.
8.
Attach the
Air Source Connector
to the light source of the processor.
9.
Turn on the light source of the processor.
10.
Prime the air/water channel prior to insertion of the endoscope into a patient.
If water pressure or insufflation is low, assess the following:
Check to see that the
Lid Cap
is tightly attached to the water bottle (not cocked or cross threaded).
Check that the
Endoscope Connector
is firmly attached to the endoscope.
Check that the
Air Source Connector
is firmly attached to the light source of the processor.
Remove 1/3 of the sterile water from a full sterile water bottle, this will allow for improved water pressure for better insufflation and water flow.
11. Perform air insufflation and water flow for lens cleaning as described in the Pentax 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 Pentax manufacturer’s guidelines for purging the air/water channel system when the procedure is completed.
Close the Pinch Clamp 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 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
2
(Turn
OFF the Pump/Air on the Light Source of the Processor)
For use with Pentax OF-G11 Gas adapter
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.
Open a bottle of sterile water and remove cap. (250cc, 500cc, or 1000cc)
3.
Open the sterile pouch and remove the AquaShield
®
system - Pentax.
4.
Ensure that the
Pinch Clamp
is in the open position.
5.
Avoid contact with the
Water Bottle Tubing
to reduce the risk of contamination.
6.
Insert the
Water Bottle Tubing
into the sterile water bottle and firmly tighten the threaded
Lid Cap
onto the water bottle. Ensure the cap seats on the
bottle without being cocked or cross-threaded. If the lid is cocked or cross-threaded, this can lead to leakage and/or reduced sterile water flow or
decreased insufflation.
