Preparation Steps - Halyard MIC Serie Manual Del Usuario

MIC* Gastric-Jejunal Feeding Tube - Surgical Placement
e
Instructions for Use
Rx Only: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
Disposable, for single patient use only. Do not resterilize.
The MIC* Gastric-Jejunal Feeding Tube Kit contains a dual lumen silicone catheter
(fig. 1) intended for surgical placement. The kit also contains an abdominal
trocar (fig. 2-b), sheath (fig. 2-a) and slotted transpyloric cannula (fig. 2-c). The
use of this tube is clinically indicated when simultaneous gastric decompression
and jejunal feeding are needed.
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 (diethylhexylphthalate) 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 potentially at increased
risk, was performed for this device and the conclusion is that the device is safe
when used as directed.
Key Illustration Terms (Fig. 1)
a. Jejunal Port
b. Gastric Port
c. SECUR-LOK* External Retention Ring
d. Internal Retention Balloon
e. Balloon Port

Preparation Steps

With a Luer syringe, inflate the balloon (fig. 1-d) with sterile water through
•
the balloon port (fig. 1-e). The balloon should not leak and should be
symmetrical. If the silicone balloon adheres to the tube, the balloon may
inflate asymmetrically. If this occurs, roll and bend the inflated balloon
between the fingers until it is symmetrical. Test the integrity of the balloon
by squeezing it gently.
• Check the SECUR-LOK* Ring (fig. 1-c). The ring should slide along the tube
with moderate resistance. Inspect the entire length of the tube for any
irregularities.
Flush both the gastric (fig. 1-b) and jejunal (fig. 1-a) ports to confirm tube
•
patency.
Surgical Placement Procedure
Caution: 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.
Diameter
Do not resterilize
Length Single Use Only
Contains
Rx Only
4. On the anterior parietal peritoneum, select an exit site that approximates
the gastrostomy. Avoid the superior epigastric artery, drains or other stomas.
5. Insert the trocar through the blue plastic sheath.
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* tube through the blue sheath TOWARD the stomach. Insert
the tube from OUTSIDE to INSIDE the abdominal cavity.
9. Remove the sheath.
Stamm Gastrostomy
1. Using two Babcock clamps on the anterior stomach surface, "tent" the
stomach.
2. With electrocautery or a scalpel, open the stomach. Dilate the enterotomy
with a hemostat.
Transpyloric Jejunal Cannulation
1. Generously lubricate the lumen of the slotted (white polyethylene) cannula.
Slide the cannula into the stomach (fig. 4).
2. Cannulate the pylorus and the proximal duodenum. Gently shape the
cannula if needed to accommodate the anatomy of the patient. Advance the
cannula just beyond the pyloric muscle. Forcing the cannula blindly against
the duodenal wall will obstruct passage of the MIC* tube (fig. 5).
3. Generously lubricate the distal end of the MIC* tube. Advance the tube
slowly into the cannula. If the tube does not slide freely, it may be coiled.
Withdraw the tube and repeat the procedure.
4. Hold the cannula stationary and advance the MIC* 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 10–20
cm past the Ligament of Treitz (fig. 6).
5. Stabilize the distal tube by holding it with the fingers through the jejunal
wall to withdraw the cannula from the stomach.
6. Inflate the gastric balloon with 7–10 ml sterile water from the syringe. Do
not exceed 20 ml. volume inside the balloon. Do not use air. Do not
inject contrast into the balloon.
7. Tie the purse string sutures securely around the tube.
8. With traction on the tube, bring the stomach in apposition to the parietal
peritoneum (fig. 7).
9. 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.
10. Position the SECUR-LOK* Ring, allow 1–2 mm space between the skin and
the ring.
11. Tie a suture around the "waist" of the ring. Suture the ring to the skin.
This step is optional. Sutures may prevent inadvertent tube removal or
displacement as the tract matures. However, sutures may also increase the
risk of infection or the development of a fistula.
12. The tungsten stripe on the distal third of the tube is radiopaque. It may be
visualized on a radiograph to confirm that the distal tube is
10–20 cm past the Ligament of Treitz. The use of contrast media in the
balloon is not recommended.
13. To avoid potential placement complications (e.g., bowel irritation or
perforation), ensure the tube is not looped within the stomach or small
bowel. Verify proper tube placement radiographically.
Sterilized Using
Ethylene Oxide
Caution
Do Not Use If
Package Damaged
Consult instructions
for use
3