avanos MIC Mode D'emploi page 3

AVANOS* MIC
• e n
with ENFit
Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Description
The AVANOS* MIC* Gastric-Jejunal (GJ) Feeding Tube (Fig. 1) provides for
simultaneous gastric decompression/drainage and delivery of enteral nutrition
into the distal duodenum or proximal jejunum.
Indications for Use
The AVANOS* MIC* GJ Feeding Tube is indicated for use in patients who cannot
absorb adequate nutrition through the stomach, who have intestinal motility
problems, gastric outlet obstruction, severe gastroesophageal reflux, are at risk of
aspiration, or in those who have had previous esophagectomy or gastrectomy.
Contraindications
Contraindications for placement of a GJ feeding tube include, but are not limited
to:
• Colonic interposition
• Ascites
• Portal hypertension
• Peritonitis
• Uncorrected coagulopathy
• Uncertainty as to gastrostomy tract direction and length (abdominal wall
thickness)
Warning
Do not reuse, reprocess, or resterilize this medical device. Reuse,
reprocessing, or resterilization may 1) adversely affect the known
biocompatibility characteristics of the device, 2) compromise the
structural integrity of the device, 3) lead to the device not performing as
intended, or 4) create a risk of contamination and cause the transmission
of infectious diseases resulting in patient injury, illness, or death.
Caution
This medical device contains DEHP (dithylhexylphthalate) that is presently
classified in the European Union as a presumed human reproductive toxicant
based on data from animal studies. There is no conclusive scientific evidence
that exposure to DEHP contained in medical devices has caused harmful effects
in humans. A risk assessment, which took into account DEHP exposure of all
indicated patient populations, including those who are potential at increased risk,
was performed for this device and the conclusion is that the device is safe when
used as directed.
Complications
The following complications may be associated with any GJ feeding tube:
• Nausea, vomiting, abdominal bloating or diarrhea
• Aspiration
• Peristomal pain
• Abscess, wound infection and skin breakdown
• Pressure necrosis
• Hypergranulation tissue
• Intraperitoneal leakage
• Buried bumper syndrome
• Peristomal leakage
• Balloon failure or tube dislodgement
• Tube clog
• Gastrointestinal bleeding and/or ulceration
• Gastric outlet obstruction
• Ileus or gastroparesis
• Bowel and gastric volvulus
Diameter
Rx Only
Contains
* Gastric-Jejunal Feeding Tube (GJ-Tube)
Connectors • Surgical Placement
®
Length
Single Use Only
MR Conditional
Other complications such as abdominal organ injury may be associated with the
procedure to place the feeding tube.
Tube Preparation
Warning. Verify package integrity. Do not use if package is damaged
or sterile barrier compromised.
1. Select the appropriate size MIC* GJ Feeding Tube, remove from the package
and inspect for damage.
2. Using the male Luer syringe contained in the kit, inflate the balloon
(Fig. 1-E) with water through the Balloon Inflation Port (Fig 1-A).
Do not use air.
3. Remove the syringe and verify balloon integrity by gently squeezing the
balloon to check for leaks. Visually inspect the balloon to verify symmetry.
Symmetry may be achieved by gently rolling the balloon between the fingers.
Reinsert the syringe and remove all the water from the balloon.
4. Check the external retention bolster (Fig. 1-D). The bolster should slide along
the tube with moderate resistance.
5. Inspect the entire length of the tube for any irregularities.
6. Using an ENFit® syringe, flush both the gastric lumen (Fig. 1-C) and jejunal
lumen (Fig. 1-B) of the tube with water to confirm tube patency.
7. Lubricate the tip of the tube with a water soluble lubricant. Do not use mineral
oil. Do not use petroleum jelly.
8. Generously lubricate the jejunal lumen with water-soluble lubricant. Do not
use mineral oil. Do not use petroleum jelly.
Surgical Procedure
Warning: Discard the sharp trocar with proper care.
1. Through a midline laparotomy, identify the pylorus and the superior epigastric
artery in the abdominal wall.
2. The gastrostomy site should be 10–15 cm from the pylorus to insure that the
gastric ports remain in the stomach. If the gastrostomy is too close to the
pylorus, the gastric suction ports will lie in the duodenum. The gastrostomy
site should also be at least 3 cm away from the costal margin to prevent
damage to the retention balloon by abrasions during movement.
3. Place two concentric purse string sutures around the site. Leave the purse
string needles in place.
4. On the anterior parietal peritoneum, select an exit site that approximates the
gastrostomy. Avoid the superior epigastric artery, drains, or other stomas.
5. Verify the trocar (Fig. 2-B) is inserted through the blue plastic sheath
(Fig. 2-A).
6. Make a stab wound with the trocar/sheath unit from the anterior parietal
peritoneum to the extra abdominal surface (Fig. 3).
7. Remove and discard the trocar leaving the blue plastic sheath in place. Use
caution when handling the razor sharp trocar tip.
8. Insert the MIC* GJ Feeding Tube through the blue plastic sheath toward the
stomach. Insert the tube from the outside to the inside the abdominal cavity.
9. Remove the blue plastic sheath.
10. Using two Babcock clamps on the anterior stomach surface, "tent" the
stomach.
11. Use electrocautery or a scalpel to open the stomach.
12. Dilate the enterotomy with a hemostat.
Transpyloric Jejunal Placement Procedure
1. Generously lubricate the lumen of the white slotted cannula (Fig. 2-C).
2. Slide the cannula into the stomach (Fig. 4).
3. Cannulate the pylorus and the proximal duodenum. Gently shape the cannula
if needed to accommodate the anatomy of the patient.
4. Advance the cannula just beyond the pyloric muscle. Forcing the cannula
blindly against the duodenal wall will obstruct passage of the MIC* GJ
Feeding Tube (Fig. 5).
Sterilized Using
Ethylene Oxide
Caution
Do Not Use If
Package Damaged
Consult instructions for use
Do not
resterilize
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