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Intended Use:
ENDO SMART BOTTLE™ rinse and insufflation system is intended to be used with an air or CO 2 source and / or pump along with a sterile
water source to supply air or CO 2 and sterile water to an endoscope during endoscopic procedures.
Warnings and Precautions:
•
Guidelines for Preventing Cross Contamination:
•
ALWAYS prime the air / water channel prior to inserting the GI endoscope into the patient.
•
NEVER attach or reattach ENDO SMART BOTTLE system to a GI endoscope that is / was inside the patient and has not been
reprocessed.
•
NEVER turn off the air processor / CO 2 while ENDO SMART BOTTLE system is attached to a GI endoscope.
•
ALWAYS remove the colonoscope from the light source before removing the adapter from the colonoscope.
DO NOT RE-STERILIZE OR REPROCESS
•
•
If any of the above prevention guidelines were not followed, or if there is any reason to believe that ENDO SMART BOTTLE system
was contaminated, immediately discard the entire ENDO SMART BOTTLE system. Replace with a new ENDO SMART BOTTLE
system.
•
ALWAYS inspect the GI endoscope's o-rings and gaskets (air / water button, endoscope connection, etc) for damage. Damaged
components can result in less than optimal performance of ENDO SMART BOTTLE system.
•
Sterility is not guaranteed if package has been opened or damaged. Do not use if packaging or product is damaged.
•
ENDO SMART BOTTLE system is for 24 hour use (discard daily).
•
This product contains DEHP (Bis(2-ethylhexyl)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 chemi-
cal 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.
•
PRECAUTION: If ENDO SMART BOTTLE system needs replacing during a procedure, refrain from depressing the air/water valve. A
potential for backflow may occur if the air/water valve is depressed while no ENDO SMART BOTTLE system is connected to the GI
endoscope. If this occurs, replace the ENDO SMART BOTTLE system immediately.
•
Contact customer service for assistance.
•
Federal (USA) law restricts the sale of this device by or on the order of a physician.
Instructions for Use (by product number):
ESB-145
ENDO SMART BOTTLE Rinse and Insufflation System for OLYMPUS® 140/240, 160/260, 180/280, 190/290
Series GI Endoscopes
1.
Open the sterile peel pack and remove ENDO SMART BOTTLE system. Open a bottle of sterile water. Pour the sterile water into the
ENDO SMART BOTTLE system using aseptic techniques and firmly tighten the cap to ensure a secure seal. The volume of sterile wa-
ter within the ENDO SMART BOTTLE system should not exceed the fill line on the device. Write the date and time on the bottle.
2.
NOTE: If CO 2 source is used, connect the ENDO SMARTCAP™ CO 2 source tubing (100551) to the ENDO SMART BOTTLE system.
Follow instructions for use of the CO 2 insufflator per manufacturer's instruction.
3.
NOTE: If air is used in place of CO 2, ensure the cap is on the CO 2 luer connection.
4.
Connect the ENDO SMART BOTTLE system to the air/water port of the GI endoscope with a firm pushing motion.
5.
Turn on the air processor or CO 2.
6.
Prime the channel and test for air and water prior to insertion of GI endoscope. If the water pressure is low, ensure that the water
bottle is tightly closed.
7.
WARNING: To prevent cross-contamination, always prime the air / water channel prior to inserting the GI endoscope into the patient.
8.
If water bottle needs to be refilled, use proper aseptic technique.
9.
When the procedure is finished, disconnect ENDO SMART BOTTLE system from GI endoscope. Turn off air processor/CO 2 at the
conclusion of the procedure.
10. Discard the ENDO SMART BOTTLE system daily, in accordance with local, state and federal regulations and laws.
WARNING:
After use, these products may be potential biohazards. Handle and dispose of in accordance with accepted medical
practice and applicable local, state, and federal laws and regulations.
2
50098-471 REV C
STERILIZED USING
STERILE EO
DO NOT RESTERILIZE
ETHYLENE OXIDE
ONLY
CONTAINS DEHP
24 HOUR USE
PHT
DEHP
!
(Bis(2-ethylhexyl)phthalate)
(DISCARD DAILY)
DATE
© 2014 MEDIVATORS Inc. 50098-471/C
TIME
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