Kimberly-Clark MIC-KEY G Instrucciones De Uso página 4

K -C
imberly larK
For Use with: MIC-KEY* Low-Profile
Caution: Verify package integrity of each pouch prior to opening. Do not use if package is damaged or sterile barrier is compromised.
Caution: The SAF-T-PEXY* needle point is sharp.
Note: It is recommended to perform a three-point gastropexy that approximates an equilateral triangle to help ensure secure and uniform attachment
of the gastric wall to the anterior abdominal wall. An alternate pattern will need to be identified if placing a low volume balloon gastrostomy tube. For
additional suture security, a knot may be tied in the suture strand at the surface of the suture lock.
1. Place a skin mark at the tube insertion site and define the gastropexy pattern by placing three skin marks equidistant from the tube insertion site
and in a triangle configuration. Allow adequate distance between the insertion site and SAF-T-PEXY* placement so as to prevent interference of
the anchor set and balloon once inflated. (Fig 3)
2. Localize the puncture sites with 1% lidocaine and administer local anesthesia to the skin and peritoneum.
3. Carefully remove the pre-loaded SAF-T-PEXY* device from the protective sheath and maintain slight tension on the trailing suture, noting that the
suture is held to the needle by a retaining snap on the side of the needle hub.
4. Attach a Luer slip syringe containing 1-2 ml of sterile water or saline to the needle hub. (Fig 4)
5. Under endoscopic guidance, insert the preloaded SAF-T-PEXY* slotted needle with a single sharp thrust through one of the marked corners
of the triangle until it is within the gastric lumen. The simultaneous return of air into the syringe and endoscopic visualization confirms correct
Intragastric position. After confirmation of correct position, remove the syringe from the device. (Fig 5)
6. Release the suture strand and bend the locking tab on the needle hub. (Fig 6) Firmly push the inner hub into the outer hub until the locking
mechanism clicks into place. (Fig 7) This will dislodge the T-Bar from the end of the needle and lock the inner stylet into position. (Fig 8)
7. Withdraw the needle while continuing to gently pull the T-Bar until it is flush against the gastric mucosa. Discard the needle according to facility
protocol.
8. Gently slide the suture lock down to the abdominal wall. A small hemostat may be clamped above the suture lock to temporarily hold it in place.
9. Repeat the procedure until all three anchor sets have been inserted in the corners of the triangle. After the three SAF-T-PEXY* devices are
properly positioned, pull on the sutures to appose the stomach to the anterior abdominal wall. Close the suture lock with the supplied
hemostat until an audible "click" is heard securing the suture. Any excess suture may be cut and removed. (Fig 9)
Creating the Stoma Tract:
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.
Caution: Avoid the epigastric artery that courses at the junction of the medial two-thirds and lateral one-third of the rectus muscle.
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 a PEGJ tube is anticipated.
1. With the stomach still insufflated and in apposition to the abdominal wall, identify the puncture site at the center of the Gastropexy pattern.
With endoscopic guidance confirm that the site overlies the distal body of the stomach below the costal margin and above the transverse colon.
2. Anesthetize the puncture site (location marked earlier) with local injection of 1% lidocaine down to the peritoneal surface (distance from skin to
the anterior gastric wall is usually 4-5 cm).
3. Insert the Safety Introducer needle into the gastric lumen. (Fig 10)
Endoscopic Verification:
Use endoscopic visualization to verify correct needle placement. (Fig 11)
Guidewire Placement:
Note: DO NOT PULL UP on the J-guidewire in the subsequent steps requiring its use as the guidewire could become dislodged. (Fig 15)
1. Advance the J-guidewire, J end first, through the needle into the gastric lumen and confirm position.
2. Remove the safety introducer needle (keeping the J-guidewire in place) and activate the safety collar. (Fig 12) Slide the introducer needle safety
collar down the needle shaft while removing the safety introducer needle to prevent inadvertent needle stick. (Fig 13-14) Dispose of according
to facility protocol.
Dilation:
Caution: Excess lubricant may cause difficulty in gripping the dilator segments.
Note: Stay perpendicular to the skin while dilating so as not to kink the J-guidewire
of the dilators over the J-guidewire during endoscopic placement. During dilation, the J-guidewire may be left in place to insure maintenance of gastric
lumen access.
1. Use the #11 safety scalpel blade to create a small skin incision that extends alongside the guidewire, downward through the subcutaneous
tissue and the fascia of the abdominal musculature. (Fig 16) After the incision is made, lock the scalpel cover in place and discard according to
facility protocol.
2. Apply water soluble lubricant at incision site.
3. Advance the serial dilator over the guidewire. Use a firm clockwise/counter clockwise twisting motion while advancing to create a tract into
the gastric lumen. (Fig 17)
4. Endoscopically verify placement of the dilator tip into the stomach.
5. While holding the serial dilator stationary, grasp the next dilator sleeve and with firm downward pressure and a clockwise/counter clockwise
twisting motion advance the subsequent dilator into the stoma tract. Slide the segment forward until a physical stop is felt.
6. Advance the red color-coded sleeve through the stoma tract and into the stomach.
Measuring the Stoma Length:
1. Moisten the tip of the Stoma Measuring Device with water soluble lubricant.
2. Remove the dilator, leaving the guidewire in place and place on a clean surface.
3. Advance the Stoma Measuring Device over the guidewire, through the stoma tract and into the stomach. DO NOT USE FORCE. (Fig 18)
4. Fill the Luer slip syringe with 5 ml of sterile or distilled water and attach to the balloon port. Depress the syringe plunger and inflate the
balloon. Pull the device toward the abdomen until the balloon rests against the inside of the stomach wall.
5. Slide the plastic disc down to the abdomen and record the measurement proximal to the disc. Add an additional 4-5 mm to the measured shaft
length to ensure a proper fit post tube placement. Record final measurement. (Fig 19)
6. Remove all the water in the balloon and the stoma measuring device leaving the guidewire in place.
MIC-KEY G Introducer Kit
*
*
Gastrostomy
Feeding Tube
.
Snaring and holding the J-guidewire taut will facilitate passage
Single
Sterilized Using
Use Only
Ethylene Oxide
(continued)
Resume Dilation:
1. Resume dilation by advancing the dilator over the guidewire, through the stoma tract and into the stomach using firm pressure and a clockwise/
counter clockwise twisting motion.
2. Continue dilation until all dilator sleeves have been advanced.
3. Twist the dilator hub to release the peel-away sheath from the dilator. (Fig 20)
4. Lubricate the exterior of the peel-away sheath with a water soluble lubricant and advance the sheath through the tract and into the stomach.
5. Remove the dilator and J-guidewire, leaving the peel-away sheath in the stomach with the remainder securely maintaining position through the
tract and exiting the stoma site.
Tube Placement:
1. Select the appropriate Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube while maintaining stomach and stoma tract access via the pre-
positioned peel-away sheath. Peel the sheath down to skin level.
2. Inspect and prepare the gastrostomy tube according to the Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube Instructions for Use.
Advance the tube down the peel-away sheath and into the stomach. (Fig 21)
3. After the gastrostomy tube has been advanced through the peel-away sheath and is in position in the stomach, peel the sheath away from the
tube, remove and dispose of according to facility protocol. (Fig 22)
4. Complete the placement procedure according to the Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube Instructions for Use.
5. Upon completion of the procedure, refer to the Kimberly-Clark* MIC-KEY* Low-Profile Gastrostomy Tube Instructions for Use for specific
instructions regarding use of the device.
Post Procedure:
1. Inspect the stoma and gastropexy sites daily and assess for signs of infection, including: redness, irritation, edema, swelling, tenderness, warmth,
rashes, purulent or gastrointestinal drainage. Assess for any signs of pain, pressure or discomfort.
2. After the assessment, routine care should include cleansing the skin around the stoma site and gastropexy sites with warm water and mild soap,
using a circular motion, moving from the tube and external bolsters outward, followed by a thorough rinsing and drying well.
The sutures may be absorbed or they may be cut and removed if indicated by the placing physician. After the sutures dissolve (or are cut) the
suture locks may be removed and discarded. The internal T-bars will release and pass through GI tract.
Biosyn® is a registered trademark of US Surgical Corporation.
For more information, please call 1-800-KCHELPS in the United States, or visit our web site at www.kchealthcare.com.
For more information about these products, please call 1-800-528-5591 in the United States.
Internationally, please call +801-572-6800
Educational Materials: "A Guide to Proper Care" and "A Stoma Site and Enteral Feeding Tube Troubleshooting Guide" is available upon request. Please contact your local
representative or Customer Care.
Do Not Use If
Do Not
Latex-Free
Packaged Is Damaged
Resterilize
4
Attention:
Rx Only
Read
Instructions