B.Braun Iryfix Instrucciones De Uso página 2

Instructions for use Iryfix®
en
The Iryfix® stoma cap is indicated for patients with a left colostomy who irrigate and whose
stoma does not exceed 35 mm.
It should be used right after the irrigation for occasions where collecting effuents is not
necessary. It allows gas adsorption without noise. It provides discretion for a few hours. Beyond
that limit, it is recommended to wear a pouch specifically designed for output collection.
Patient population: Iryfix® is to be used on adults.
Special note: Children, pregnancy and breastfeeding women: Studies realized in animal
models are insufficient to conclude on the toxicity of Iryfix® components over children, pregnant
or breastfeeding women. There is no available data on the use of Iryfix® in these specific
populations. In the absence of data, it is not advised to use Iryfix® in these cases.
Skin preparation: Wash your hands. Clean the skin around your stoma using only water. Dry
the skin carefully. Avoid ether, alcohol or any antiseptic which could interfere with the skin
protector adhesion.
Applying Iryfix®: Peel off the protective paper from the adhesive. Place Iryfix® in position while
gently introducing the filter into the stoma. Smooth the adhesive onto the skin ensuring that
there are no wrinkles. Apply light pressure to ensure complete adhesion.
Removing Iryfix®: To remove Iryfix® unstick one corner of the adhesive and peel off gently.
National regulations for the destruction of potentially infectious materials must be observed.
Warnings: Re-use of single-use devices creates a potential risk to the patient. It may
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lead to contamination and/or impairment of functional capability. In the rare event
of sensitivity or allergic reaction to Iryfix® or any of its materials, discontinue use of the medical
device. If your stoma morphology is not adapted, or if the diameter of your stoma exceeds 35mm,
Iryfix® will not fit correctly. It is not advised to use Iryfix® in these cases. Colostomy irrigation
itself is contra-indicated under the following circumstances: Current chemotherapy treatment,
Induced radiation damages to the bowel, Irritable bowel syndrome, Crohn's disease, Diverticulitis,
Peristomal hernias, Diarrhoea, Ulcerous inflammation of the large intestine, Improper fistula.