RECTAL CATHETER PERISTEEN PLUS REGULAR 10 PIECES LABCARE

Description
Retrograde colon irrigation system.
Transanal irrigation with Peristeen Plus is intended to promote the evacuation of the contents of the lower colon and descending colon through the use of a rectal catheter with an inflatable balloon.
The product is indicated for patients suffering from fecal incontinence, chronic constipation and/or time-consuming bowel management procedures.
The product is indicated for adults (both sexes) and children over 3 years of age. The Peristeen catheter package consists of ten regular rectal catheters that self-lubricate when in contact with water.
The rectal catheter is for single use only.
The rectal balloon catheter is available in two sizes:
- the small catheter, labeled with a smiley face, is normally used for children;
- the regular catheter is normally used for adults.
For hygienic reasons, the Peristeen Plus transanal irrigation system is for single-patient use.
Reuse of the pre-lubricated rectal catheter is not recommended due to the risk of cross-contamination.
Reprocessing, washing, disinfection and/or re-sterilization may compromise the characteristics of the product, resulting in a further risk of physical harm or infection for the patient.
Coloplast assumes no liability for any injury or loss that may occur if the product is used in a manner not in accordance with Coloplast's current recommendations.
Transanal irrigation with Peristeen Plus should not be performed in the following situations, since mechanical obstruction or weakening of the colon tissue caused by any of the following factors increases the risk of intestinal perforation, trauma or bleeding:
- known anal or colorectal stenosis;
- colorectal carcinoma (active/recurrent);
- within 3 months of anal or colorectal surgery;
- within 4 weeks of endoscopic polypectomy;
- ischemic colitis;
- acute inflammatory bowel disease;
- acute diverticulitis.

Warnings
- Transanal irrigation with Peristeen Plus is not recommended in case of ongoing or planned pregnancy as the product has not been evaluated in this patient population.
- It is essential for patient safety to consult a physician/healthcare professional experienced in the use of transanal irrigation with Peristeen Plus before performing the irrigation procedure.
- Before using this product, you must receive thorough instructions from a healthcare professional, who must also supervise the first irrigation.
- The transanal irrigation procedure must always be performed with caution.
- Make sure the catheter size (Regular or Small) indicated on the packaging corresponds to that recommended by your healthcare provider. The balloon catheter should not be forced into place. Bowel perforation occurs very rarely with transanal irrigation, but is a serious and potentially life-threatening complication requiring immediate hospitalization and often surgery. Seek immediate medical attention if any of the following conditions occur during or after the Peristeen Plus transanal irrigation procedure:
- severe or prolonged abdominal pain or back pain, especially if associated with fever;
- severe or prolonged anal bleeding.
- Reuse and/or washing or disinfection of the balloon catheter is not recommended as it is pre-lubricated; these operations could compromise the characteristics of the product, causing a further risk of intestinal perforation.
- Store the Peristeen Plus Transanal Irrigation System out of the reach of small children and supervise children who may be present while using the system to avoid the risk of strangulation from the tubing and suffocation from small parts that may have become detached from the product.

Conservation
Store all components at room temperature and away from direct sunlight, e.g. in the pouch. Ensure that all components are kept away from sharp objects.

Format
10 regular rectal catheters.

Code 29143