Coloplast
Coloplast SenSura Mio One Piece System Drainable Stoma Bag 10-43mm | 16455
Coloplast SenSura Mio One Piece System Drainable Stoma Bag 10-43mm | 16455
无法加载取货服务可用情况
Product Overview
SenSura Mio is Coloplast's flagship one-piece drainable ostomy system for adult patients living with a colostomy, ileostomy, or post-surgical stoma requiring a drainable appliance. REF 16455 is the cut-to-fit configuration with a maximum aperture of 43 mm, suitable for round, oval, or moderately irregular stomas where intra-operative or post-operative stoma swelling necessitates a flexible cutting range. The integrated baseplate combines a hydrocolloid skin barrier with Coloplast's proprietary BodyFit elastic adhesive technology, engineered to stretch and retract with abdominal movement during respiration, walking, bending, and lifting.
The opaque neutral-grey pouch is constructed from a soft non-woven cover that minimises rustle and skin-on-plastic friction. A full-circle pre-filter incorporated into the pouch wall manages flatus discharge while reducing pancaking and ballooning, with peer-reviewed audit data published by Coloplast indicating up to 52 percent reduction in ballooning for colostomy users and 61 percent for ileostomy users. The Easi-Close outlet provides a hook-and-loop hygienic closure for repeated drainage without manual rolling or clipping. Each pouch is sterilised, packaged individually, and supplied as a 30-piece carton in line with Coloplast's commercial unit.
Specifications
| Manufacturer | Coloplast A/S, Denmark |
|---|---|
| Reference Code | 16455 |
| System Type | One-piece drainable ostomy pouch (baseplate and pouch integrated) |
| Stoma Aperture | Cut-to-fit, 10 mm to 43 mm |
| Baseplate Profile | Flat with BodyFit elastic adhesive (twice the stretch of standard hydrocolloid) |
| Pouch Colour / Cover | Opaque neutral grey, soft non-woven textile cover |
| Filter | Full-circle pre-filter, ballooning reduction up to 52% (colostomy) / 61% (ileostomy) |
| Outlet | Easi-Close hook-and-loop drainable outlet |
| Indication | Colostomy, ileostomy, drainable post-surgical stoma management |
| Sterility / Latex | Sterile (single use), latex-free |
| Packaging | Individually wrapped; carton of 30 pouches |
| Regulatory | CE marked under EU MDR 2017/745; US FDA 510(k) cleared (Class II); HSA Singapore notified medical device; ISO 13485 quality management |
Clinical Indications
- Adult colostomy management, including post-Hartmann's, sigmoid, descending, and transverse colostomies
- Ileostomy management following total colectomy, proctocolectomy, or J-pouch diversion
- Post-operative stoma sites requiring a flexible cut-to-fit aperture during the swelling and remodelling phase (typically 6-8 weeks)
- Patients with peristomal complications such as scarring, hernia, retraction, or uneven skin contour where elastic adhesive performance is required
- Active patients seeking a discreet, low-rustle pouch suitable for daily wear under fitted clothing
- Hospital and home-care settings where standardised single-use, sterile drainable pouches are stocked
Frequently Asked Questions
How is BodyFit Technology different from a standard hydrocolloid baseplate?
Conventional hydrocolloid wafers are designed for adhesion but have limited elasticity. Coloplast's BodyFit elastic adhesive incorporates an elastomer matrix that allows the baseplate to stretch and retract with the abdomen during respiratory and postural movement, reducing shear forces at the stoma-skin junction. This is clinically relevant for patients with parastomal hernia, post-surgical scarring, or moderate-to-deep abdominal folds, where rigid baseplates are prone to lifting and leakage.
How is the cut-to-fit aperture trimmed?
The baseplate is supplied with concentric guideline rings printed on the release liner. Using sharp curved scissors, the user (or stoma care nurse) trims to a diameter 1-2 mm larger than the measured stoma to allow for movement without exposing peristomal skin to effluent. Correct sizing is essential — over-cutting causes leakage and skin breakdown, under-cutting causes mucocutaneous separation and trauma. WCET and ASCN UK guidelines recommend re-measuring the stoma at each appliance change for the first 8 weeks post-operatively.
How often should the pouch be changed?
Manufacturer guidance and ASCN UK best-practice consensus suggest one-piece drainable pouches typically be replaced every 1-3 days, with the drainable outlet emptied 4-6 times per 24 hours or when the pouch is one-third to one-half full. Wear time depends on output volume, ambient temperature, perspiration, and individual skin chemistry.
Is REF 16455 reimbursable in Singapore?
Stoma appliances including SenSura Mio are eligible for partial subsidy through the Medication Assistance Fund (MAF) at participating Singapore public restructured hospitals for stoma patients with a registered chronic disease, and through the Assistive Technology Fund (ATF) for community-based use, subject to means-testing. EMIS+ stocks SenSura Mio through the Coloplast Singapore authorised distributor with full batch traceability.
What size carton is supplied and how should the product be stored?
The standard commercial unit is a carton of 30 individually wrapped pouches. Storage should be at 5-25°C in a dry environment away from direct sunlight; the hydrocolloid baseplate is humidity-sensitive and prolonged storage in tropical ambient conditions above 30°C may reduce baseplate adhesion. Use within the printed expiry date on each pouch.
分享
