TM
ENDOGATOR
Hybrid Irrigation Tubing
Intended Use:
The ENDOGATOR™ Hybrid Irrigation Tubing (tubing and accessories to accommodate various GI 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 a 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
™
ENDOGATOR™ Hybrid Irrigation Tubing for OLYMPUS
Series GI Endoscopes with ENDO STRATUS™ Pump, OLYMPUS OFP
or BOSTON SCIENTIFIC
ENDOGATOR Hybrid Irrigation Tubing for OLYMPUS 140/160/180
Series GI Endoscopes with OLYMPUS AFU-100, OLYMPUS OFP,
24 HOUR USE
(DISCARD DAILY)
EN
#100609 (includes "S" series)
140/160/180
®
®
ENDOSTAT™ II Pump Irrigation Units
#100610 (includes "S" series)
ERBE
EIP2 or EGP-100 Irrigation Units
®
CONTAINS DEHP
(Bis (2-ethylhexyl) phthalate)