Intended Use; Warnings And Precautions - Medivators ENDO SMARTCAP Instrucciones De Uso

Intended Use:

ENDO SMARTCAP® disposable tubing is intended to be used with CO 2 source and / or pump along with a sterile water source to supply CO 2 and sterile water to an
gastrointestinal 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 SMARTCAP tubing to an GI endoscope that is / was inside the patient and has not been reprocessed.
• ALWAYS close the pinch clip before disconnecting ENDO SMARTCAP tubing from the GI endoscope.
• NEVER turn off the CO 2 while ENDO SMARTCAP tubing is attached to an GI endoscope.
• ALWAYS remove the colonoscope from the light source before removing the adapter from the colonoscope. (#100141)
• ALWAYS Dispose of the adapter after each procedure. (#100141)
• NEVER Remove the backflow valve. Backflow valves are permanently attached to the device.
• NEVER Use a product with a missing backflow valve. If the backflow valve is missing, then discard the entire tubing, adapter, and water bottle.
• DO NOT RE-STERILIZE OR REPROCESS
• Do not close stopcock to shut off CO 2 flow on regulator or insufflator operating over 16 PSI.
• If any of the above prevention guidelines were not followed, or there is any reason to believe that ENDO SMARTCAP system was contaminated, immediately
discard the entire tubing and water bottle. Replace with a new tubing and an unopened sterile water bottle.
• ALWAYS inspect the GI endoscopes o-rings and gaskets (air / water button, endoscope connection, etc) for damage. Damaged components can result in less
than optimal performance of ENDO SMARTCAP tubing.
• Sterility is not guaranteed if package has been opened or damaged. Do not use if packaging or product is damaged.
• ENDO SMARTCAP tubing 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 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.
• PRECAUTION: If sterile water bottle 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 sterile water bottle is connected to the tubing. If this occurs, replace the tubing 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):
100145CO2EXT/ 100145CO2EXTU
ENDO SMARTCAP tubing for OLYMPUS®140/240, 160/260, 180/280, 190/290 series GI Endoscopes with extended CO 2 input
1.
Open the sterile peel pack and remove ENDO SMARTCAP tubing. Open a bottle of sterile water (250cc, 500cc, or 1000cc). Drop the weighted tube into the
sterile water bottle and firmly tighten the bottle cap to ensure a secure seal. Remove the label from the pouch and apply it to the bottle of sterile water. Write
the date and time on the label.
2.
Connect the backflow valve of ENDO SMARTCAP tube to the CO 2 insufflator or CO 2 source tubing . Follow instructions from the CO 2 manufacturer.
3.
Place ENDO SMARTCAP tubing, connected to the bottle of sterile water, in the water bottle holder provided.
4.
Connect the distal tip of ENDO SMARTCAP tubing to the GI endoscope with a firm pushing motion.
5.
Turn on the CO 2 insufflator.
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 replaced, use proper aseptic technique.
9.
When the procedure is finished, close the pinch clip and disconnect ENDO SMARTCAP tubing from GI endoscope. Turn off CO 2 at the conclusion of the
procedure.
10.
Discard the ENDO SMARTCAP tubing daily.
100150CO2EXT/ 100150CO2EXTU
ENDO SMARTCAP tubing for OLYMPUS 100/200, 130/230 series and PENTAX® GI Endoscopes with extended CO 2 input
1.
Open the sterile peel pack and remove ENDO SMARTCAP tubing. Open a bottle of sterile water (250cc, 500cc, or 1000cc). Drop the weighted tube into the
sterile water bottle and firmly tighten the bottle cap to ensure a secure seal. Remove the label from the pouch and apply it to the bottle of sterile water. Write
the date and time on the label.
2.
Connect the backflow valve of ENDO SMARTCAP tube to the CO 2 insufflator or CO 2 source tubing . Follow instructions from the CO 2 manufacturer.
3.
Place ENDO SMARTCAP tubing, connected to the bottle of sterile water, in the water bottle holder provided.
4.
Connect the distal tip of ENDO SMARTCAP tubing to the GI endoscope with a firm pushing motion.
5.
Turn on the CO 2 insufflator.
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 replaced, use proper aseptic technique.
9.
When the procedure is finished, close the pinch clip and disconnect ENDO SMARTCAP tubing from GI endoscope. Turn off CO 2 at the conclusion of the
procedure.
10.
Discard the ENDO SMARTCAP tubing daily.
4 IFU-70 / REV D
STERILIZED USING
24 HOUR USE
STERILE EO !
ETHYLENE OXIDE
(DISCARD DAILY)
STERILIZED USING
24 HOUR USE
STERILE EO !
ETHYLENE OXIDE
(DISCARD DAILY)
CONTAINS DEHP
PHT DEHP
(Bis(2-ethylhexyl)phthalate)
CONTAINS DEHP
PHT DEHP
(Bis(2-ethylhexyl)phthalate)