Intended Use; Warnings And Precautions - Medivators ENDOGATOR Instrucciones De Uso

Intended Use:

The ENDOGATOR™ System (tubing and accessories to accommodate various GI endoscopes and irrigation pumps) is intended to provide irrigation via sterile
water during GI endoscopic procedures when used in conjunction with an irrigation pump (or cautery unit).

Warnings and Precautions:

•
Guidelines for Preventing Cross Contamination:
•
ALWAYS prime the auxiliary water channel prior to inserting the GI endoscope into patient.
•
NEVER attach the ENDOGATOR™ Irrigation Tubing directly to the biopsy channel without also using a secondary backflow valve.
(applicable if using PENTAX
•
DO NOT REMOVE THE BACKFLOW VALVE. Backflow valves are permanently attached to the ENDOGATOR Irrigation Tubing.
•
The backflow valve attached to the ENDOGATOR Irrigation Tubing must be in place. If the backflow valve is missing, then discard the entire
ENDOGATOR Irrigation Tubing, accessories and water bottle.
•
DO NOT RE-STERILIZE OR REPROCESS
• Ensure that tubing and irrigation flow is functioning properly.
•
If any of the above prevention guidelines were not followed, or there is any reason to believe that the ENDOGATOR System was contaminated,
immediately discard the entire ENDOGATOR Irrigation Tubing, accessories and water bottle. Replace with new ENDOGATOR Irrigation Tubing, accessories,
and unopened sterile water bottle.
•
Sterility is not guaranteed if package has been opened or damaged. Do not use if packaging or product is damaged.
•
ENDOGATOR Irrigation 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.
•
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):
100130 / 100130U
ENDOGATOR™ Tubing for BOSTON SCIENTIFIC
or ENDO STRATUS™ Pumps
100130F / 100130FU
ENDOGATOR Tubing for BOSTON SCIENTIFIC ENDOSTAT II, OLYMPUS OFP,
or ENDO STRATUS™ Pumps with FUJIFILM™ Connector
1.
Open the sterile peel pack and remove the ENDOGATOR Irrigation Tubing. Open a bottle of sterile water (250cc, 500cc, or 1000cc). Drop the 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. Open the pump head. Place the printed section of the irrigation tubing, where the text "Place in Pump Head" is printed, in the pump head and close.
(Note: Ensure that the text "Place in Pump Head" is centered, aligned and carefully pulled taut before closing the pump head.) Take care to prevent the
connector from touching the ground.
3.
Connect the backflow valve (distal tip of the ENDOGATOR Tubing) to the intended ENDOGATOR™ Auxiliary Water Connector or Biopsy Irrigation
Accessory. When connecting to a FUJIFILM™ GI Endoscope, use item 100130F or item 100130FU with the elbow connection.
4.
Prime the tubing prior to use by activating the foot pedal; flush water through the entire GI endoscope.
5.
WARNING: To prevent cross-contamination, always prime the auxiliary water channel prior to inserting the GI endoscope into patient.
6.
If the water bottle needs to be replaced, use proper aseptic technique.
7.
When the procedure is finished, turn off the pump unit before disconnecting the ENDOGATOR Irrigation Tubing.
8.
Discard the ENDOGATOR Tubing daily.
200230 / 200230U
ENDOGATOR Tubing for ENDOGATOR™ EGP-100 Irrigation Pump,
OLYMPUS OFP and AFU-100 and ERBE
200230F / 200230FU
ENDOGATOR Tubing for ENDOGATOR EGP-100 Irrigation Pump
with FUJIFILM Connector
1.
Open the sterile peel pack and remove the ENDOGATOR Irrigation Tubing. Open a bottle of sterile water (250cc, 500cc, or 1000cc). Drop the 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.
Open pump head, insert ENDOGATOR Tubing and close pump head. (Note: Ensure that tubing is placed in between tube markers.)
3.
Connect the backflow valve (distal tip of the ENDOGATOR Tubing) to the intended ENDOGATOR Auxiliary Water Connector or Biopsy Irrigation Accessory.
When connecting to a FUJIFILM GI Endoscope, use item 200230F or item 200230FU with the elbow connection.
4.
Prime the tubing prior to use by activating the foot pedal; flush water through the entire GI endoscope.
5.
WARNING: To prevent cross-contamination, always prime the auxiliary water channel prior to inserting the GI endoscope into patient.
6.
If the water bottle needs to be replaced, use proper aseptic technique.
7.
When the procedure is finished, turn off the pump unit before disconnecting the ENDOGATOR Irrigation Tubing.
8.
Discard the ENDOGATOR Tubing daily.
100105
ENDOGATOR™ Extension Tubing
1.
Open the sterile peel pack and remove the ENDOGATOR Extension Tubing.
2.
Luer lock the extension tubing to the backflow valve on the ENDOGATOR™ Irrigation Tube Set.
3.
Attach any of the ENDOGATOR™ Irrigation Accessories to the leur lock of the backflow valve on the ENDOGATOR Extension Tubing.
4.
Prior to each procedure, activate the footswitch to prime the tube set and GI endoscope with sterile water.
5.
When procedure is finished, turn off the pump unit before disconnecting the ENDOGATOR Tubing.
Biopsy Channel)
®
ENDOSTAT™ II, OLYMPUS
®
EIP2 Pumps
®
STERILIZED USING
ETHYLENE OXIDE
OFP,
®
STERILIZED USING
ETHYLENE OXIDE
STERILIZED USING
ETHYLENE OXIDE
STERILIZED USING
ETHYLENE OXIDE
STERILIZED USING
ETHYLENE OXIDE
EN - 7
24 HOUR USE CONTAINS DEHP
(DISCARD DAILY)
(Bis(2-ethylhexyl)phthalate)
24 HOUR USE CONTAINS DEHP
(DISCARD DAILY)
(Bis(2-ethylhexyl)phthalate)
24 HOUR USE
CONTAINS DEHP
(DISCARD DAILY) (Bis(2-ethylhexyl)phthalate)
24 HOUR USE CONTAINS DEHP
(DISCARD DAILY)
(Bis(2-ethylhexyl)phthalate)
24 HOUR USE CONTAINS DEHP
(DISCARD DAILY)
(Bis(2-ethylhexyl)phthalate)