Contraindications - AMT MiniACE Button Gebrauchsanleitung

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Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Notice: Peel off ID sticker from

tray and store for future use in patient chart or other convenient location. The device is provided STERILE for single use.

The Bowel Management Device is intended to instill fluids through a stoma into the colon to promote evacuation of the

contents of the lower bowel through the anus and is intended to be an aid in the management of fecal incontinence. The

catheter is placed and maintained in a percutaneously prepared opening, such as a cecostomy or appendicostomy. The

Bowel Management Device is intended to be used in children and adults.

Contraindications for placement of the MiniACE

Initial Placement:

Colonic interposition ● Ascites ● Portal hypertension ● Peritonitis ● Uncorrected coagulopathy ● Infection around stoma

site ● Uncertainty as to cecostomy tract direction and length (colon wall thickness)

Replacement:

Lack of adherence of the cecum/appendix/colon to the abdominal wall ● Lack of a well established cecostomy site ● Evi-

dence of infection ● Uncertainty as to cecostomy tract direction and length (colon wall thickness) ● Presence of multiple

stoma fistulous tracts

Notice:



Please contact a professional health care giver or physician for explanation of the warnings, care, and use of the device.



The MiniACE

Button has been designed to provide irrigation access into the colon. Other applications are not advised.

Potential complications when using the MiniACE

Peristomal pain ● Abscess, wound infection and skin breakdown ● Pressure necrosis ● Hypergranulation tissue ● Intraperi-

toneal leakage ● Buried bumper syndrome ● Peristomal leakage ● Balloon failure or dislodgement ● Tube clog ● Colonic

bleeding and/or ulcerations ● Bowel volvulus

MiniACE

(1) AMT

Button (Fig. 1)

(2) 4 x 4 inch Gauze

(1) Introducer/Stiffener

(1) Water Soluble Lubricant

(1) Luer-Slip Syringe (5ml)

(1) 12" Right Angle Irrigation Set (Fig. 2)

Optional Accessories for Device Placement

(Not Included):

Dilators, Stoma Measuring Device, Introducer

Needle, Scalpel, Guidewire.

Additional Components for Use

(Not Included):

Replacement Irrigation Sets, Irrigation Bag

Figure 2: 12" RA Irrigation Set

AMT MiniACE

Low Profile Antegrade Continence Enema Button

INSTRUCTIONS FOR USE

Please inspect all contents of the kit for damage. If damaged, do not use.

INDICATIONS FOR USE