Avanos MIC Serie Manual Del Usuario página 3

AVANOS* MIC
• e n
with ENFit Connectors
®
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* Gastro-Enteric (GE) 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* GE 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 GE 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 trans-
mission of infectious diseases resulting in patient injury, illness, or death.
Complications
The following complications may be associated with any GE 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.
Tube Preparation
Warning: Verify package integrity. Do not use if package is damaged or sterile
barrier compromised.
1. Select the appropriate size MIC* GE Feeding Tube, remove from the package and inspect for
damage.
2. Using a male Luer syringe, inflate the balloon (Fig. 1-E) with water through the Balloon Infla-
tion Port (Fig. 1-a). Do not use air.
• Inflate the balloon with 3–5 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.
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-B) and jejunal lumen (Fig. 1-C) 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 guidewire with a water soluble lubricant. Do not use mineral oil. Do
not use petroleum jelly.
9. Practice inserting and removing the guidewire through the jejunal lumen of the MIC* GE
Feeding Tube.
Gastro-Enteric Feeding Tube (GE-Tube)
*
Surgical Procedure
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 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. Make a stab wound from the anterior parietal peritoneum to the extra abdominal surface.
6. Insert the MIC* GE Feeding Tube through the stab wound toward the stomach. Insert the tube
from the outside to the inside the abdominal cavity.
7. Using two Babcock clamps on the anterior stomach surface, "tent" the stomach.
8. Use electrocautery or a scalpel to open the stomach.
9. Dilate the enterotomy with a hemostat.
Transpyloric Jejunal Placement Procedure
1. Insert the guidewire through the jejunal lumen of the MIC* GE Feeding Tube.
2. Advance the MIC* GE Feeding Tube until the gastric balloon enters the stomach. Palpate the
tube through the duodenum. When satisfied with the placement, check the position. The tip
should lie 10–15 cm past the Ligament of Treitz.
3. Stabilize the distal tube by holding it with the fingers through the jejunal wall and withdraw
the guidewire.
4. Using a male Luer syringe, inflate the balloon.
• Inflate the LV balloon with 3–5 ml of sterile or distilled water.
• Inflate the standard balloon with 7–10 ml of sterile or distilled water.
Caution: Do not exceed 5 ml total balloon volume inside the LV balloon and 20 ml total
balloon volume inside the Standard balloon. Do not use air. Do not inject contrast into the
balloon.
5. Tie the purse string sutures around the tube.
6. Gently pull the tube up and away from the abdomen until the balloon contacts the inner
stomach wall.
7. Use the purse string sutures to attach the stomach to the peritoneum. Use one or two extra
sutures, if necessary, to ensure a leak-proof seal. Take care to avoid puncture of the balloon.
8. Clean the residual fluid or lubricant from the tube and stoma.
9. Gently slide the external retention bolster to approximately 2–3 mm above the skin. Do not
suture the bolster to the skin.
Verify Tube Position and Patency
1. Verify proper tube placement radiologically to avoid potential complication (e.g. bowel
irritation or perforation) and ensure the tube is not looped within the stomach or small bowel.
Caution: The distal tip of the tube contains tungsten, which is radiopaque and can be
used to radiographically confirm position. Do not inject contrast into the balloon.
2. Flush both the jejunal and gastric lumens with water to verify patency.
3. Check for moisture around the stoma. If there are signs of gastric leakage, check the tube po-
sition and placement of the external retention bolster. Add sterile or distilled water as needed
in 1–2 ml increments. Do not exceed balloon capacity as indicated previously.
4. Check to ensure that the external retention bolster is not placed too tightly against the skin
and rests 2-3 mm above the abdomen for initial placement and 1-2 mm above the abdomen
for a replacement tube.
5. Begin feeding only after confirmation of proper patency, placement and according to physi-
cian instructions.
Replacement Procedure through an Established Gastrostomy Tract
1. Cleanse the skin around the stoma site and allow the area to air dry.
2. Select the appropriate size MIC* GE Feeding Tube and prepare according to the instructions in
the Tube Preparation section above.
3. Perform routine esophagogastroduodenoscopy (EGD). Once the procedure is complete and no
abnormalities are identified that could pose a contraindication to placement of the tube, place
the patient in the supine position and insufflate the stomach with air.
4. Manipulate the endoscope until the indwelling gastrostomy tube is in the visual field.
5. Remove the gastrostomy tube.
6. Insert the guidewire through the jejunal lumen of the MIC* GE Feeding Tube.
7. Advance the MIC* GE Feeding Tube until the gastric balloon enters the stomach.
8. Using endoscopic guidance, grasp the guidewire at the end of the MIC* GE Feeding Tube with
atraumatic forceps.
9. Using the forceps, advance the tube through the pylorus and into the upper duodenum.
When satisfied with the placement, check the position. The tip should lie 10–15 cm past the
Ligament of Treitz.
Note: A suture loop tied to the distal end of the MIC* GE Feeding Tube can assist in placing the
tube through the pylorus into the jejunum.
10. With the jejunal portion of the tube in the visual field, slowly remove the guidewire. If the
jejunal portion of the tube buckles, twists, or kinks, reinsert the guidewire and reposition the
tube using the forceps.
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