Contraindications - COOK Medical ENTUIT START Gebrauchsanweisung

ENTUIT® START INITIAL PLACEMENT
GASTROSTOMY SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of
a physician (or a properly licensed practitioner).
DESCRIPTION
The Entuit Start Initial Placement Gastrostomy Sets consist of multiple dilators,
one or more Peel-Away sheath introducer(s) with dilator(s), and an 0.038",
100 cm long wire guide.
INTENDED USE
The Entuit Start Initial Placement Gastrostomy Set is intended to assist the
physician with the initial placement of feeding tubes while performing a
gastrostomy in adult patients only.

CONTRAINDICATIONS

Contraindications include, but are not limited to:
• Ascites
• Colonic interposition
• Portal hypertension
• Gastric varices
• Peritonitis
• Morbid obesity
WARNINGS
Aspiration pneumonia may result from feeding tube placement.
PRECAUTIONS
• Imaging guidance is recommended during use of this product.
• This product is intended for use by physicians trained and experienced
in percutaneous diagnostic and interventional techniques. Standard
techniques should be employed.
• Prior to use, ensure that the gastrostomy device to be inserted will fit
through the lumen of the Peel-Away sheath in the set.
PRODUCT RECOMMENDATIONS
IPSG Size
S
M
M
L
L
INSTRUCTIONS FOR USE
NOTE: Prior to using the components of this set, it is necessary to place
gastropexy securement devices and gain percutaneous access to the stomach
through the abdominal wall.
1. Under fluoroscopic or endoscopic visualization, insert and advance
the 0.038" 100 cm wire guide through the percutaneous access needle
cannula. Advance the wire guide far enough to ensure the flexible portion
of the wire guide is within the stomach, well past the insertion tract.
2. While maintaining wire guide position, withdraw and remove the needle
cannula.
3. Use a scalpel to create a dermatotomy alongside the wire guide at the
insertion site, extending through the subcutaneous tissue and fascia.
4. Activate the hydrophilic coating on the dilators by wiping them with a
gauze sponge soaked with saline or sterile water. Keep wet during use.
5. While maintaining wire guide position, advance the smallest diameter
dilator over the wire and across the tract. Advance the dilator until the full
diameter of the dilator has passed through the tract.
NOTE: Do not advance the tip of the dilator past the distal end of the
wire guide.
6. While maintaining wire guide position, remove the dilator.
7. Repeat step 5 with the remaining dilators, progressing from the smallest
diameter to the largest. NOTE: When using the IPSG-L set, the 24 French
dilator is optional when placing the 22 French sheath.
8. Once the final dilator is removed, insert the appropriately sized Peel-Away
introducer over the wire guide, while maintaining wire guide position.
NOTE: See Product Recommendations section for recommended
gastrostomy tube to be used.
9. Confirm endoscopically or fluoroscopically that the distal end of the Peel-
Away sheath is through the percutaneous tract and positioned within
the stomach.
10. While maintaining position of the Peel-Away sheath, remove the dilator
and wire guide.
Peel-Away Introducer
PLVW-16.0-38
PLVW-18.0-38
PLVW-20.0-38
PLVW-22.0-38
PLVW-26.0-38
Recommended Gastrostomy Tube
12 Fr, 14 Fr
22 Fr, 24 Fr
3
ENGLISH
16 Fr
18 Fr
20 Fr