Descrizione Clinica
Coloplast
SenSura
Description
Single-piece bag indicated in the collection of the deities of the bearers of ileostomy.
Treatment of a medical device under Directive 93/42/EEC - Class I
• The bag is open with hide-awa integrated exhaust system. The exclusive triple safety closure has been perfected: it is easier to clean, and thanks to the folding guides, it is easier to use even with one hand. The concealed fastening system now has a new Velcro fastening point for further safety.
• The bag is available both in transparent and opaque version (covered in TNT) both versions have the back in nonwoven fabric.
• The bag is available in two different sizes: midi and maxi for the bag in TNT and in Maxi format for the transparent bag (see table codes).
• The newly developed adhesive consists of two layers, has oval shape and its structure is reticular to ensure safety and skin protection:
- in the upper layer the special hydrocolloid ingloba reticle structure of small dimensions: in contact with the deiations is transformed into a cohesive and compact gel, with high resistance to erosion. This creates a protective seal that reduces infiltration;
- in the lower layer the structure with large hydrocolloid ingloba reticulum that guarantee an excellent absorption capacity and the creation of the humid environment that favors tissue repair. The softer polymer mesh allows this layer to adapt perfectly to skin irregularities while offering high instant adhesiveness.
• The particular rombi texture ensures maximum flexibility and adaptability to the skin, the 5 flex cut-out areas and concentric channels further improve peripheral adaptability.
• The adhesive is available both in cut-out version to the desired size (following the printed guide on the silicone paper that protects the adhesive surface) and pre-cut version.
• The adhesive has a simple cut guide: cutting circles are soft, there are different cutting dimensions with strong contrasts for users with poor visual capacity, circles do not intersect.
• The product has a tab for removing the adhesive very visible, with easy thumb-shaped handle.
• The bag is equipped with a wave filter system. The filter consists of a pre-filter zone with wave patented design that allows it to block any type of effluent before it comes in contact with the goretex filter membranes. It is an active carbon filter placed inside the bag itself in the upper back which ensures deodoration.
Indications
Single-piece bag indicated in the collection of the deities of the bearers of ileostomy.
Treatment of medical device within the meaning of Directive 93/42/EEC - Class I.
Contraindications and incompatibility
No contraindications.
Composition
• The product is composed of a quadruple layer of polyethylene-ethylvinylacetate-polyvinyldicloruro-ethylene-ethylene-ethylene-ethylvinylacetate.
• The back of nonwoven fabric is made of polyester.
• The adhesive: the new mix contains two types of polymers:
1) PIB (polypolysis): makes the adhesive more sticky.
2) SIS (stirene-isoprene-stirene): guarantees extreme and high cohesion to the adhesive.
• The filter is composed from the top down (in the table all the components of the filter):
Sterilization
No.
Validity
3 years from the date of production.
Codes
Packaging
Unit of use: 1 single-piece bag.
Ordering units: 30 units of use in cardboard box containing instructions for use in italian.
Conservation
We recommend the preservation in the original package protected from light and moisture, at a constant temperature between 15° and 30°C.
Disposal
The product does not contain Ecotoxic components therefore does not require special disposal protocols.
Do not disperse in the environment as it is not Biodegradable.
Single-piece bag indicated in the collection of the deities of the bearers of ileostomy.
Treatment of a medical device under Directive 93/42/EEC - Class I
• The bag is open with hide-awa integrated exhaust system. The exclusive triple safety closure has been perfected: it is easier to clean, and thanks to the folding guides, it is easier to use even with one hand. The concealed fastening system now has a new Velcro fastening point for further safety.
• The bag is available both in transparent and opaque version (covered in TNT) both versions have the back in nonwoven fabric.
• The bag is available in two different sizes: midi and maxi for the bag in TNT and in Maxi format for the transparent bag (see table codes).
• The newly developed adhesive consists of two layers, has oval shape and its structure is reticular to ensure safety and skin protection:
- in the upper layer the special hydrocolloid ingloba reticle structure of small dimensions: in contact with the deiations is transformed into a cohesive and compact gel, with high resistance to erosion. This creates a protective seal that reduces infiltration;
- in the lower layer the structure with large hydrocolloid ingloba reticulum that guarantee an excellent absorption capacity and the creation of the humid environment that favors tissue repair. The softer polymer mesh allows this layer to adapt perfectly to skin irregularities while offering high instant adhesiveness.
• The particular rombi texture ensures maximum flexibility and adaptability to the skin, the 5 flex cut-out areas and concentric channels further improve peripheral adaptability.
• The adhesive is available both in cut-out version to the desired size (following the printed guide on the silicone paper that protects the adhesive surface) and pre-cut version.
• The adhesive has a simple cut guide: cutting circles are soft, there are different cutting dimensions with strong contrasts for users with poor visual capacity, circles do not intersect.
• The product has a tab for removing the adhesive very visible, with easy thumb-shaped handle.
• The bag is equipped with a wave filter system. The filter consists of a pre-filter zone with wave patented design that allows it to block any type of effluent before it comes in contact with the goretex filter membranes. It is an active carbon filter placed inside the bag itself in the upper back which ensures deodoration.
Indications
Single-piece bag indicated in the collection of the deities of the bearers of ileostomy.
Treatment of medical device within the meaning of Directive 93/42/EEC - Class I.
Contraindications and incompatibility
No contraindications.
Composition
• The product is composed of a quadruple layer of polyethylene-ethylvinylacetate-polyvinyldicloruro-ethylene-ethylene-ethylene-ethylvinylacetate.
• The back of nonwoven fabric is made of polyester.
• The adhesive: the new mix contains two types of polymers:
1) PIB (polypolysis): makes the adhesive more sticky.
2) SIS (stirene-isoprene-stirene): guarantees extreme and high cohesion to the adhesive.
| Wall decal | Gelatin Pec C PIB (polypolysis) SIS (stirene-isoprene-stirene) Rubber of gas |
• The filter is composed from the top down (in the table all the components of the filter):
| Component | Material |
| Member Active coal filter | PTFE /PVC / EVA/ PVDC Foam (foam) |
Sterilization
No.
Validity
3 years from the date of production.
Codes
| Type | Code Commercial | Diameter in mm | Code C | Code ISO | Code GMDN |
| Bag in TNT Midi capacity 420 ml | 15550 | Rit 15/66 | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Midi capacity 420 ml | 15552 | 25 mm | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Midi capacity 420 ml | 15553 | 30 mm | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Midi capacity 420 ml | 15554 | 35 mm | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Maxi capacity 650 ml | 15580 | Rit 15/76 | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Maxi capacity 650 ml | 15582 | 25 mm | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Maxi capacity 650 ml | 15583 | 30 mm | A100102 | 09.18.04.006 | 31075 |
| Bag in TNT Maxi capacity 650 ml | 15584 | 35 mm | A100102 | 09.18.04.006 | 31075 |
| Transparent bag Midi capacity 420 ml | 15541 | 15/66 | A100102 | 09.18.04.006 | 31075 |
| Transparent bag Maxi capacity 650 ml | 15570 | 15/76 | A100102 | 09.18.04.006 | 31075 |
| Transparent bag Maxi capacity 650 ml | 15572 | 25 mm | A100102 | 09.18.04.006 | 31075 |
| Transparent bag Maxi capacity 650 ml | 15573 | 30 mm | A100102 | 09.18.04.006 | 31075 |
| Transparent bag Maxi capacity 650 ml | 15574 | 35 mm | A100102 | 09.18.04.006 | 31075 |
Packaging
Unit of use: 1 single-piece bag.
Ordering units: 30 units of use in cardboard box containing instructions for use in italian.
Conservation
We recommend the preservation in the original package protected from light and moisture, at a constant temperature between 15° and 30°C.
Disposal
The product does not contain Ecotoxic components therefore does not require special disposal protocols.
Do not disperse in the environment as it is not Biodegradable.
