Halyard MIC, Инструкция по эксплуатации

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Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Description
The HALYARD* MIC* Gastrostomy (Fig 1) / Bolus Feeding Tube (Fig 2) allow for
delivery of enteral nutrition and medication directly into the stomach and/or
gastric decompression.
Indications for Use
The HALYARD* MIC* Gastrostomy / Bolus Feeding Tube are indicated for use in
patients who require long term feeding, are unable to tolerate oral feeding, who
are at low risk for aspiration, require gastric decompression and / or medication
delivery directly into the stomach.
Contraindications
Contraindications for placement of a gastrostomy feeding tube include, but are
not limited to ascites, colonic interposition, portal hypertension, peritonitis and
morbid obesity.
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 low-profile gastrostomy
feeding tube:
• Skin Breakdown
• Infection
• Hypergranulation Tissue
• Stomach or Duodenal Ulcers
• Intraperitoneal Leakage
• Pressure Necrosis
Note:
Verify package integrity. Do not use if package is damaged or sterile barrier
compromised.
Placement
The HALYARD* MIC* Gastrostomy / Bolus feeding tubes may be placed surgically,
percutaneously under fluoroscopic or endoscopic guidance or as a replacement
to an existing device using an established stoma tract.
Caution:
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.
Caution:
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.
Warning: The insertion site for infants and children should be high
on the greater curvature to prevent occlusion of the pylorus when the
balloon is inflated.
Tube Preparation
1. Select the appropriate gastrostomy feeding tube, remove from the package
and inspect for damage.
2. Using a Luer slip syringe, inflate the balloon with sterile or distilled water
through the balloon port
(Fig 1C & 2C)
.
• Inflate the balloon with 3-5 ml of sterile or distilled water for low volume
tubes identified by LV following the REF code number.
• Inflate the balloon with 7-10 ml sterile or distilled 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. Lubricate the tip of the tube with a water soluble lubricant. Do not use
mineral oil. Do not use petroleum jelly.
Suggested Radiologic Placement Procedure
1. Place the patient in the supine position.
2. Prep and sedate the patient according to clinical protocol.
3. Insure that the left lobe of the liver is not over the fundus or the body of the
stomach.
4. Identify the medial edge of the liver by CT scan or ultrasound.
5. Glucagon 0.5 to 1.0 mg IV may be administered to diminish gastric
peristalsis.
Caution: Consult Glucagon instructions for use for rate of IV injection
and recommendations for use with insulin dependent patients.
6. Insufflate the stomach with air using a nasogastric catheter, usually 500
to 1,000 ml or until adequate distention is achieved. It is often necessary
to continue air insufflation during the procedure, especially at the time of
needle puncture and tract dilation, to keep the stomach distended so as to
appose the gastric wall against the anterior abdominal wall.
7. Choose a catheter insertion site in the left sub-costal region, preferably
over the lateral aspect or lateral to the rectus abdominis muscle (N.B. the
superior epigastric artery courses along the medial aspect of the rectus) and
directly over the body of the stomach toward the greater curvature. Using
fluoroscopy, choose a location that allows as direct a vertical needle path as
possible. Obtain a cross table lateral view prior to placement of gastrostomy
when interposed colon or small bowel anterior to the stomach is suspected.
Note: PO/NG contrast may be administered the night prior or an enema
administered prior to placement to opacify the transverse colon .
8. Prep and drape according to facility protocol.
Gastropexy Placement
Caution: 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.
Warning: Allow adequate distance between the 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
1. 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.
Caution:
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.
2. Anesthetize the puncture site with local injection of 1% lidocaine down to
the peritoneal surface.
3. Insert a .038” compatible introducer needle at the center of the gastropexy
pattern into the gastric lumen.
Note: For gastrostomy tube placement, the best angle of insertion is a true
right angle to the surface of the skin. The needle should be directed toward the
pylorus if conversion to PEGJ tube is anticipated.
4. 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.
5. Advance a J tip guidewire, up to .038”, through the needle and into stomach.
Confirm position.
6. Remove the introducer needle, keeping the J tip guidewire in place and
dispose of according to facility protocol.
Dilation
1. Use a #11 scalpel blade to create a small skin incision that extends alongside
the guidewire, downward through the subcutaneous tissue and fascia of the
abdominal musculature.
2. Advance a dilator over the guidewire and dilate the stoma tract to the
desired size.
3. Remove the dilator over the guidewire, leaving the guidewire in place.
Tube Placement
Note: A peel-away sheath may be used to facilitate advancement of the tube
through the stoma tract.
1. Select the appropriate gastrostomy feeding tube and prepare according to
the instructions in the Tube Preparation section above.
2. Advance the distal end of the tube over the guidewire, through the stoma
tract and into the stomach.
3. Verify that the tube is in the stomach, remove the guidewire or peel-away
sheath if utilized and inflate the balloon.
4. Using the Luer slip 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 7 ml total balloon volume inside the LV balloon.
Do not use air. Do not inject contrast into the balloon.
Caution: Do not exceed 15 ml total balloon volume in the Standard
balloon. Do not use air. Do not inject contrast into the balloon.
5. Gently pull the tube up and away from the abdomen until the balloon
contacts the inner stomach wall.
6. Clean the residual fluid or lubricant from the tube and stoma.
7. Gently slide the SECUR-LOK* ring to approximately 1-2 mm (approximately
1/8 inch) above the skin.
Verify Tube Position and Patency
1. Attach a catheter tip syringe with 10 ml water to the feeding port. Aspirate
gastric contents. When air or gastric contents are observed, flush the tube.
2. Check for moisture around the stoma. If there are signs of gastric leakage,
check the tube position and SECUR-LOK* ring placement. Add fluid as
needed in 1–2 ml increments. Do not exceed balloon capacity as indicated
previously.
3. Begin feeding only after confirmation of proper patency, placement and
according to physician instructions.
Suggested Endoscopic Placement Procedure
1. 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.
2. Transilluminate through the anterior abdominal wall to 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.
3. Depress the intended insertion site with a finger. The endoscopist should
clearly see the resulting depression on the anterior surface of the gastric
wall.
4. Prep and drape the skin at the selected insertion site.
Gastropexy Placement
Caution: 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.
MIC
*
Gastrostomy Feeding Tube and
Bolus Gastrostomy Feeding Tube
e