AMT MiniACE Button Gebrauchsanleitung Seite 3

TYPE OF USAGE – INITIAL PLACEMENT VS REPLACEMENT
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The MiniACE Button may be placed either during an initial placement procedure or as a replacement device.
PERFORMING AN INITIAL PLACEMENT
If the patient does not currently have a stoma tract for placement of the MiniACE
need to be created. This process can only be completed by a healthcare professional per proper cecostomy/
appendicostomy surgical procedures.
WARNING: Initial placement of the MiniACE
wall to the anterior abdominal wall. DO NOT use the retaining balloon of the device as an attachment/anchoring
device. An early balloon failure may prevent the intestinal wall from attaching to the anterior abdominal wall.
CAUTION: It is recommended to perform a three point anchoring/securement in a triangle configuration to ensure
attachment of the intestinal wall to the anterior abdominal wall.
REPLACING A DEVICE IN AN ESTABLISHED STOMA SITE
If it is determined that a device placed in an existing stoma needs replaced (due to non-optimal functionality or as a pro-
active replacement), the current device can be removed from the stoma and the new device can be inserted in the same
stoma site. If performing a device replacement, skip straight to the DEVICE PLACEMENT PROCEDURE section for the
proper method of placing the new device.
Note: Device replacement can be performed by the healthcare professional or at home by the patient/caregiver.
Do not attempt to replace the device until first discussing the procedure with your healthcare professional.
CAUTION: Selection of the correct size device is critical for safety and comfort of the patient. An inappropri-
ately sized device can cause necrosis, buried bumper syndrome and/or hypergranulation tissue. If patient
size/weight has changed since the device was placed, fit is too tight or too loose, or it has been over six
months since the device was last measured, it is recommended that you speak to your healthcare profes-
sional to ensure that device size does not need changed.
CAUTION: Selection of the correct size device is critical for the safety and comfort of the patient. Measure
the length of the patient's stoma with a stoma measuring device. The shaft length of the selected device
should be the same as the length of the stoma. An inappropriately sized device can cause necrosis, buried
bumper syndrome and/or hypergranulation tissue.
1. Please refer to Manufacturer's Directions for Use for the stoma measuring device being used.
2. Be sure to select the appropriate size MiniACE
appears to be between two sizes, always select the next larger size MiniACE
should rotate easily.
WARNING: Under-sizing the device may cause embedding with erosion into the colon wall, tissue necrosis, infec-
tion, sepsis and associated sequelae.
CAUTION: Prior to placement, please inspect all contents of the kit for damage. If the package is damaged or
sterile barrier is breached, do not use the product.
CAUTION: Do not attempt to replace the device or check for placement verification until first discussing the proce-
dure with your healthcare professional.
1. Select the correct MiniACE
NOTE: When replacing a device, stoma length should be periodically measured to ensure the correct MiniACE
Button size is being used. If patient size/weight has changed since device was placed, fit is too tight or loose, or it has been
over six months since the device was last measured, it is recommended that you speak to your healthcare professional to
ensure device length does not need changed.
2. Prior to placing the MiniACE
ringe with distilled water or sterile water to the recommended fill volume. The recommended fill-volume can be found on
Table 1 or printed above the balloon inflation port of the device. Remove the syringe and verify
balloon integrity by gently squeezing the balloon to check for leaks. Visually inspect the balloon
to verify symmetry. Verify that sizing information is appropriate for measured length. Reinsert
the syringe and deflate all of the water from the balloon after inspection.
3. Lubricate the tip of the tube with water soluble lubricant. Do not use mineral oil or petroleum
jelly. Insert optional introducer into the irrigation port if increased stiffness is desired during
placement.
4. Gently guide the tube through the stoma and into the colon until the external flange is flush to
the skin.
5. Remove Introducer (if used in step 3).
6. Inflate the balloon with sterile or distilled water according to
the fill volume in the chart in Table 1.
7. Gently lift the tabs and check for signs of intestinal leakage.
8. To reduce risk of misconnection, place the provided tag on the
button strap after device placement.
NOTE: If leakage is observed, increase balloon volume in
increments of 0.5-1 ml. Do not exceed maximum fill volume.
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Button requires that a procedure is performed to affix the intestinal
MEASURE THE STOMA LENGTH
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Button for the abdominal wall thickness measured. If the measurement
DEVICE PLACEMENT PROCEDURE
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Button size for placement.
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Button, inflate balloon through the balloon inflation port (see Fig 3) using a Luer slip sy-
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Button device, a new stoma tract will
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Button. Once placed, the external flange
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