Intended Use; Warnings And Precautions - Medivators ENDOGATOR HF130 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 disconnect the auxiliary water connector or tubing prior to the completion of the procedure.
•
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
•
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 high flow irrigation tubing, accessories and water bottle. Replace with new ENDOGATOR high flow irrigation tubing, acces-
sories, 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 high flow irrigation tubing is for single use only. Reuse poses a risk of cross contamination of bodily fluids.
•
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):
HF130 / HF130U
ENDOGATOR High Flow Irrigation Tubing for OLYMPUS® OFP, OFP II, or
ENDO STRATUS® Irrigation Pumps and OLYMPUS and FUJINON®
GI Endoscopes
HF230 / HF230U
ENDOGATOR High Flow Irrigation Tubing for OLYMPUS OFP, AFU-100 and
ENDOGATOR™ EGP-100 Irrigation Pumps and OLYMPUS and FUJINON
GI Endoscopes
1.
Open the sterile peel pack and remove the ENDOGATOR high flow 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 high flow irrigation tubing and close pump head. (Note: Ensure that tubing is placed in between tube markers.)
3.
Connect the scope connector clip to the biopsy port of your OLYMPUS or FUJINON GI endoscope
4.
Prime the tubing prior to use by activating the foot pedal; flush water through the entire GI endoscope.
5.
If the water bottle needs to be replaced, use proper aseptic technique.
6.
When the procedure is finished, turn off the pump unit before disconnecting the ENDOGATOR high flow irrigation tubing.
7.
Discard the ENDOGATOR high flow irrigation after each procedure, in accordance with state, local and federal regulation.
HFP130 / HFP130U
ENDOGATOR High Flow Irrigation Tubing for OLYMPUS OFP, OFP II and
ENDO STRATUS Irrigation Pumps and PENTAX® GI Endoscopes
HFP230 / HFP230U
ENDOGATOR High Flow Irrigation Tubing for OLYMPUS OFP, AFU-100 and
ENDOGATOR EGP-100 Irrigation Pumps and PENTAX GI Endoscopes
1.
Open the sterile peel pack and remove the ENDOGATOR high flow 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 Luer connector of the tube set to the biopsy port of your PENTAX GI endoscope
4.
Prime the tubing prior to use by activating the foot pedal; flush water through the entire GI endoscope.
5.
If the water bottle needs to be replaced, use proper aseptic technique.
6.
When the procedure is finished, turn off the pump unit before disconnecting the ENDOGATOR high flow irrigation tubing.
7.
Discard the ENDOGATOR high flow irrigation after each procedure, in accordance with state, local and federal regulation.
ONLY
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
STERILIZED USING
STERILE EO
ETHYLENE OXIDE
EN
2
CONTAINS DEHP
DEHP
PHT
SINGLE USE ONLY
(Bis(2-ethylhexyl)phthalate)
2
CONTAINS DEHP
DEHP
PHT
SINGLE USE ONLY
(Bis(2-ethylhexyl)phthalate)
2
CONTAINS DEHP
PHT DEHP
SINGLE USE ONLY
(Bis(2-ethylhexyl)phthalate)
2
CONTAINS DEHP
PHT DEHP
SINGLE USE ONLY (Bis(2-ethylhexyl)phthalate)
IFU-76 / REV B 3