Intended Use:
The ENDOGATOR Hybrid Irrigation Tubing (tubing and accessories to accommodate various endoscopes
and irrigation pumps) is intended to provide irrigation via sterile water and to supply air (via an air pump)
or CO 2 (via a CO 2 supply) along with sterile water during GI endoscopic procedures when used in
conjunction with an irrigation pump or cautery unit.
Warnings and Precautions:
•
ALWAYS prime the air/water channel prior to inserting the GI endoscope into the patient.
•
ALWAYS prime the auxiliary water channel prior to inserting the GI endoscope into patient.
•
NEVER attach or reattach the ENDOGATOR Hybrid Irrigation Tubing to a GI endoscope that is/was
inside a patient and has not been reprocessed.
•
ALWAYS close the pinch clip on the air/water tube before disconnecting the air/water tubing from
the GI endoscope.
•
NEVER turn off the air processor/CO 2 supply while the ENDOGATOR Hybrid Irrigation Tubing is
attached to a GI endoscope.
•
DO NOT REMOVE THE BACKFLOW VALVE. The backflow valve is permanently attached to the
irrigation tubing.
•
The backflow valve attached to the ENDOGATOR Hybrid Irrigation Tubing must be in place. If the
backflow valve is missing, then discard the entire ENDOGATOR Hybrid Irrigation Tubing, accessories
and water bottle.
•
DO NOT RESTERILIZE OR REPROCESS.
•
If any of the above prevention guidelines were not followed, or there is any reason to believe that
the ENDOGATOR Hybrid Irrigation Tubing system was contaminated, immediately discard the entire
tubing, accessories and water bottle. Replace with new tubing and unopened sterile water bottle.
•
ALWAYS inspect the GI endoscope's O-rings and gaskets (air/water button, GI endoscope connection,
etc.) for damage. Damaged components can result in less than optimal performance of the ENDOGATOR
Hybrid Irrigation Tubing.
•
Sterility is not guaranteed if package has been opened or damaged. Do not use if packaging or
product is damaged.
•
ENDOGATOR Hybrid Irrigation Tubing is for 24 hour use (discard daily).
•
Contact customer service for assistance.
•
This product contains DEHP (Bis(2-ethylexyl)phthalate) and may be harmful to sensitive populations
(children and pregnant/nursing mothers).
•
Due to the short duration of use and the slow migration rate of DEHP from leachable materials into
aqueous fluid, the residual chemical safety risk is deemed negligible. The risk and benefits of using
this device shall be carefully evaluated by a clinician on a case-by-case basis.
•
Federal (USA) law restricts the sale of this device by or on the order of a physician.
•
PRECAUTION: If sterile water bottle needs replacing during a procedure, refrain from depressing the
air/water valve. There is a potential for backflow to occur if the air/water valve is depressed while no
sterile water bottle is connected to the tubing. If this occurs, replace the tubing immediately.
STERILIZED USING
ETHYLENE OXIDE
#100608 (Includes "S" Series)
ENDOGATOR Hybrid Irrigation Tubing for PENTAX
GI Endoscopes With PENTAX EGP-100P, EGP-100 or
24 HOUR USE
(DISCARD DAILY)
EN
®
ERBE
EIP2 Irrigation Units
®
CONTAINS DEHP
(Bis (2-ethylhexyl) phthalate)