Device Placement - COOK Medical Enluit Thrive Instrucciones De Uso

DEVICE PLACEMENT

Caution:Prior to device placement, a Gastropexy must have been performed to affix
the stomach wall to the abdominal wall, an incision site must be identified for creation
of stoma tract, then the stoma must be dilated and finally measured, in order to ensure
patient safety and comfort.
Caution:Confirm that the balloon of the Entuit™ Thrive Balloon Retention
Gastrostomy Feeding Tube will not occlude the Pylorus when inflated, specifically,
when device will be inserted into infants or children.
Warning:Do not attempt to affix the stomach to the abdominal wall using the Entuit™
Thrive Balloon Retention Gastrostomy Feeding Tube. Excessive tension, tissue
necrosis and inadvertent tube removal may result in separation of the gastric and
abdominal wall.
1. Select and prepare the appropriately sized Entuit™ Thrive Balloon Retention
Gastrostomy Feeding Tube in accordance with the "DEVICE PREPARATION"
instructions in the section above.
2. Carefully insert device through the established stoma and into the stomach lumen.
Note:Maintain insertion angle perpendicular to the surface of the skin.
3. Verify that device is inside the stomach lumen using fluoroscopic procedures to
determine position of device using the radiopaque mark located on the tip of the
device or by following the instructions provided in the "VERIFICATION OF TUBE
PLACEMENT" section listed below.
4. Inflate the balloon to recommended fill volume (printed on the device) with sterile or
distilled water using a sterile syringe.
Caution:Only use sterile or distilled water for balloon inflation. Do not use air,
saline, feeding formula, medication, or radiopaque contrast for balloon inflation.
5. Gently pull device toward abdomen until balloon is up against the inner stomach
wall.
6. Slide the external bolster down to the skin.
7. Verify that there is no leakage of gastric contents around the stoma site and that
there is not excessive pressure between the balloon and external bolster.
Warning:Inflating balloon with less volume than the recommended volume may
result in leakage of gastric contents and/or device migration. Inflating balloon with
more volume than the recommended volume may decrease balloon performance.
8. Clean any remaining contents around the stoma site with mild soap and water.
VERIFICATION OF TUBE PLACEMENT
Warning:Verify proper tube placement before feeding administration.
1. Draw 10mL of water into a catheter tip syringe and insert into feeding port of the
funnel.
2. Gently pull back on syringe plunger until stomach contents (typically yellow or clear
unless food is in patient's stomach) are aspirated and visible in the feeding lumen.
Note:The presence of gastric contents in the feeding lumen confirms correct
positioning and that feeding tube is inside the stomach lumen.
3. Flush contents with the 10mL of water in the syringe.
4. Remove syringe from device.
FEEDING ADMINISTRATION
Caution:Only begin feeding administration after confirmation of proper feeding tube
placement and patency. Administration of feeding should be performed according to
instructions provided by physician.
Caution:Do not attempt to administer solid nutrients through feeding lumen.
Warning: This device is intended FOR ENTERAL USE ONLY. Do NOT attempt to
connect with the devices mentioned in the main "WARNING" section. Device
funnel is printed "FEED ONLY" and "ENTERAL MEDS ONLY" to further clarify that
this device is intended for enteral applications only.
1. Remove the plug from the feeding port.
2. If feeding with a catheter tip syringe:
2.1 Fill catheter tip syringe with water and connect to the feeding port.
2.2 Prime the feeding lumen with water using the water-filled syringe and inspect
for leakage.
Note:The device may need to be replaced if leakage is present.
2.3 Disconnect syringe. Remove remaining water, if any, and plunger from syringe.
2.4 Reconnect the syringe without the plunger to the feeding port.
2.5 Pour feeding formula into syringe.
2.6 Raise or lower syringe to increase or decrease feeding flow rate.
2.7 Flush the feeding tube with the prescribed amount of water when feeding is
complete.
2.8 Remove syringe.
3. If feeding continuously:
3.1 Attach enteral giving set connector to the feeding port.
3.2 Fill feeding container with feeding formula.
3.3 Allow for filling of feeding lumen. Inspect for leakage.
Note:The device may need to be replaced if leakage is present.
3.4 Connect enteral giving set to pump.
3.5 Set desired flow rate and begin feeding.
3.6 If feeding continuously for long periods of time, flush feeding tube with
prescribed amount of water every 4-6 hours.
3.7 Disconnect enteral giving set from pump and feeding port when feeding is
complete.
3.8 Flush the feeding tube with prescribed amount of water.
4. Reconnect plug to feeding port.
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