The STOMA PROTECTOR device is designed for people who have a Stoma; which is the result of having had Ileostomy, Colostomy, or Urostomy surgery.
STOMA PROTECTOR has been classsified as a Medical Device by the Health Products Regulatory Authority (HPRA) under Class One Medical Devices, Rule One.
It was created by a person with a Stoma and is designed to help solve three of the main problems most ostomates have to deal with every day; which are:
It is a unique patented design, and, unlike other protection devices, it does not require a fixed-belt to keep it in place. It uses the construction of the stoma pouch and the wearer’s elasticised underwear or an elasticised waistband to keep it in position. This means it is comfortable to wear for long periods of time, and, unlike other belted devices the stoma pouch cannot be pulled off!
STOMA PROTECTOR is comprised of three parts; a Cover, a Baseplate and a Keyhole plate, and it is CE marked under EU Council Medical Device Directive 93/42/EEC
The outer Stoma Cover is made from a strong lightweight plastic and is designed primarily to protect the Stoma. It is ergonomically designed to fit comfortably on the abdomen and has an elevated channel that allows the faecal matter to enter the stoma pouch without obstruction.
The back of the Stoma Cover is formed in a “keyhole” shape. This “keyhole” shape fits over the Stoma and is designed to help with the following issues:
The Baseplate is made from a soft flexible plastic mixed with rubber material. Because it is worn against a person’s abdomen for long periods of time it must have a high degree of flexibility to allow it to move in conjunction with normal body movements.
It is covered with a skin-friendly material to ensure the highest skincare and hygiene standards.
The primary function of the Baseplate is to exert a constant and gentle pressure on the adhesive flange of the stoma pouch. During the normal course of day-to-day living the wearer walks, sits, bends, etc., which can reduce or loosen the adhesion of the adhesive flange. The Baseplate is designed to prevent this problem under normal circumstances
The Keyhole Plate is made from the same lightweight plastic material as the Cover. It is constructed in a slightly curved shape to fit around the abdomen and keep a gentle pressure on the Baseplate.
When protection of the Stoma is not a priority; but protection from leakage and pancaking is, the “keyhole” plate can be worn instead of the Cover. For example; for females wearing dresses, tops etc., or for males wearing casual clothes like track-suit bottoms, or elasticised trousers or shorts, the “keyhole” plate can be worn instead of the Cover.
The “keyhole” plate is similar to the back of the Cover but, without the elevated section.