avanos MIC Mode D'emploi page 3

AVANOS* MIC
• e n
with ENFit ®
Connector
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* Jejunal (J) Feeding Tube (Fig. 1) allows for delivery of enteral nutrition and
medication directly into the distal duodenum or proximal jejunum.
Indications for Use
The AVANOS* MIC* J 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 J 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)
• Lack of adherence of the stomach to the abdominal wall (replacement only)
• Lack of established gastrostomy tract (replacement only)
• Evidence of infection around stoma site (replacement only)
• Presence of multiple stoma fistulous tracts (replacement only)
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.
Complications
The following complications may be associated with any J 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
Other complications such as abdominal organ injury may be associated with the procedure to
place the feeding tube.
Placement
This AVANOS* J Feeding Tube may be placed in the following ways:
Surgically
Percutaneously under fluoroscopic (radiologic) guidance
Percutaneously under endoscopic guidance
A replacement to an existing device using an established stoma tract
Warning: A gastropexy must be performed to affix the stomach to the anterior
abdominal wall, the feeding tube insertion site identified and stoma tract dilated
prior to initial tube insertion to ensure patient safety and comfort.
Warning: Do not use the retention balloon of the feeding tube as a gastropexy
device. The balloon may burst and fail to attach the stomach to the anterior
abdominal wall.
Tube Preparation
Warning: Verify package integrity. Do not use if package is damaged or sterile
barrier compromised.
1. Select the appropriate size MIC* J Feeding Tube, remove from the package and inspect for
damage.
2. Adjust the length of the tube by trimming the distal end with a razor blade or scalpel. Ensure
that the cut is smooth and blunt and the length sufficient to be placed 10–15 cm beyond the
Ligament of Treitz.
3. Using a male Luer syringe, inflate the balloon (Fig. 1-D) with water through the Balloon
Inflation Port (Fig 1-A). Do not use air.
• Inflate the balloon with 2–3 ml of water for low volume tubes identified by LV following
the REF code number.
• Inflate the balloon with 7–10 ml of water for standard tubes.
Jejunal Feeding Tube (J-Tube)
*
4. 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.
5. Check the external retention bolster (Fig. 1-C). The bolster should slide along the tube with
moderate resistance.
6. Inspect the entire length of the tube for any irregularities.
7. Using an ENFit® syringe, flush the jejunal lumen (Fig. 1-B) of the tube with water to confirm
tube patency.
8. Lubricate the tip of the tube with a water soluble lubricant. Do not use mineral oil. Do not use
petroleum jelly.
9. Generously lubricate the jejunal lumen with water-soluble lubricant. Do not use mineral oil.
Do not use petroleum jelly.
Suggested Surgical Procedure (Stamm Gastrostomy)
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 on the greater curvature of the
stomach. 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. Make a stab wound from the anterior parietal peritoneum to the extra abdominal surface.
Insert the tube from the outside to the inside the abdominal cavity.
Note: The use of a right angle clamp may be used to facilitate placement.
Caution: Never use a clamp with sharp teeth or tenaculum to pull the tube into position.
This will damage the tube.
6. Using two Babcock clamps on the anterior stomach surface, "tent" the stomach.
7. Use electrocautery or a scalpel to open the stomach.
8. Dilate the enterotomy with a hemostat.
Suggested Site Preparation
1. Use standard Radiologic or Endoscopic techniques to visualize and prepare for gastrostomy
tube placement.
2. Verify that no abnormalities are present that could pose a contraindication to placement of
the tube and place the patient in the supine position.
3. Select a gastrostomy site that is free of major vessels, viscera, and scar tissue. The site is
usually one third the distance from the umbilicus to the left costal margin at the midclavicular
line.
4. Prep and drape the selected insertion site per facility protocol.
Gastropexy Placement
Warning: It is recommended to perform a three point gastropexy in a triangle
configuration to ensure attachment of the gastric wall to the anterior abdominal wall.
1. Place a skin mark at the tube insertion site. Define the gastropexy pattern by placing three
skin marks equidistant from the tube insertion site and in a triangle configuration.
Caution: Allow adequate distance between thse insertion site and gastropexy
placement to prevent interference of the T-Fastener and inflated balloon.
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and
peritoneum.
3. Place the first T-Fastener and confirm intragastric position. Repeat the procedure until all
three T-Fasteners are inserted at the corners of the triangle.
4. Secure the stomach to the anterior abdominal wall and complete the procedure.
Create the Stoma Tract under Fluoroscopic (Radiologic)
Visualization
Create the stoma tract with the stomach still insufflated and in apposition to the abdominal
wall. Identify the puncture site at the center of the gastropexy pattern. With fluoroscopic
guidance, confirm that the site overlies the distal body of the stomach below the costal
margin and above the transverse colon.
Warning: Avoid the epigastric artery that courses at the junction of the medial
two-thirds and lateral one-third of the rectus muscle.
Warning: Take care not to advance the puncture needle too deeply in order to
avoid puncturing the posterior gastric wall, pancreas, left kidney, aorta or spleen.
5. Anesthetize the puncture site with local injection of 1% lidocaine down to the peritoneal
surface.
6. Insert a .038" compatible introducer needle at the center of the gastropexy pattern into the
gastric lumen directed toward the pylorus.
Note: For J tube placement, the best angle of insertion is a 45 degree angle to the surface of
the skin.
7. Use fluoroscopic visualization to verify correct needle placement. Additionally, to aid in
verification, a water filled syringe may be attached to the needle hub and air aspirated from
the gastric lumen.
Note: Contrast may be injected upon return of air to visualize gastric folds and confirm position.
8. Advance a guidewire, up to .038", through the needle and coil in the fundus of the stomach.
Confirm position.
9. Remove the introducer needle, leaving the guidewire in place, and dispose of according to
facility protocol.
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