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OSTOMY PLATE, flat, Ø 45 mm (13-30 mm)

https://unicat.msf.org/cat/product/76392
STD SCTDBACOPF45

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
A10020101 - Colostomy plates
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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INTESTINAL OSTOMY PLATE for 2 pieces system

The plate and the bag are separate articles, both have to be ordered to make the ostomy system.

Definition

Two Piece Ostomy Systems consist of a skin barrier (also called a flange, wafer or base plate) which attaches to the stoma and snaps together with the ostomy bag through a plastic flange. The skin barrier protects the skin and funnels waste to the ostomy bag that collects and stores the waste. The base plate remains attached around the stoma, in general for 2 to 3 days, when the pouch is removed and replaced. This is a single-use device.

Specifications

Clip on system: an easy to use snap-on/snap-off design. the audible clicks indicate the system is locked in position

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Quality standards

  • ISO 8670-2, 1996, edition 2, (confirmed 2017) Ostomy collection bags - Part 2: Requirements and test methods
  • ISO 12505-1, 2014, edition 1, (confirmed 2021) Skin barrier for ostomy aids -- Test methods -- Part 1: Size, surface pH and water-absorbency
  • ISO 12505-2, 2016, edition 1, (confirmed 2022) Skin barrier for ostomy aids -- Test methods -- Part 2: Wet integrity and adhesive strength

Technical specifications

The skin barrier protects the peristomal skin and holds the ostomy bag in place.

  • Flat model
  • Cut-to-fit ostomy bags allow the pouch to fit the shape and size of most stomas:
    • 45 mm ring: cut to 13 – 30 mm
    • 55 mm ring: cut to 13 – 40 mm
    • 70 mm ring: cut to 13 – 55 mm
  • With hydrocolloid protective layer: comfortable on the skin during wear and gentle to skin upon removal
  • Natural rubber latex free
  • Adherent to dry and wet skin
  • Highly durable and resistant to liquid output
  • Flexible
  • Floating ring to secure the attachment of the pouch without pressure on the abdomen
  • Non sterile, for single use

Packaging & Labelling

  • skin barrier (baseplate): box of 5 pieces

To be Ordered Separately

Pouches and plates are ordered separately!

Instructions for use

Cut in the adhesive disc an opening of which the diameter should be as close as possible to that of the ostomy (preferably with curved scissors). Keep the plastic liner from the baseplate and use it as a template for the next appliance change

Preparation of the skin around the ostomy

  • wash the skin with neutral soap and tepid water
  • dry the skin carefully with a soft towel
  • do not use ether or antiseptics as these make the skin more fragile
  • use peristomal dressing paste for a better adhesion and to protect the skin
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MSF requirements

For those who have to change their ostomy bag often, and for patients with sensitive skin, a 2-piece ostomy bag is more practical and less intrusive to the skin; it permits bag changes as often as necessary in order to avoid overload and detachment of the bag due to the weight of the content.

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