Why Flexible Coupling Transforms Ostomy Comfort

Traditional ostomy systems use rigid plastic flange rings creating stiff, uncomfortable connections between skin barrier and pouch. This inflexibility causes several problems: the rigid ring digs into skin during movement, creates visible bulging under clothing, restricts natural body motion during bending or sitting, and causes premature adhesive failure from constant stress at the connection point. The result is discomfort, self-consciousness, reduced mobility, and frequent pouch changes due to seal breakdown. Coloplast's Flex coupling revolutionizes this design with a soft, flexible adhesive ring that moves with the body rather than against it. The elastic coupling absorbs body movement eliminating pressure points, lies flat against skin for invisible wear under clothing, maintains secure attachment through all daily activities, and significantly extends wear time by reducing stress on the adhesive seal.

Key Features

• Flex coupling system featuring soft, flexible adhesive ring replacing rigid plastic flange for comfort during all body movements
• Closed-end pouch design intended for single-use disposal after filling (not drainable) promoting hygiene and convenience
• Midi capacity providing moderate output storage suitable for formed stool consistency typical of colostomy patients
• 35mm flange compatibility designed to click securely onto matching SenSura Mio Flex 35mm skin barriers
• Neutral grey fabric exterior matching diverse skin tones for discretion under white, beige, and colored clothing
• Full-circle filter technology (360-degree carbon filter placement) preventing ballooning and continuously neutralizing odors
• Soft textile cover material using breathable, skin-friendly fabric that follows natural body contours without stiffness
• Whisper-quiet construction with non-rustling materials eliminating embarrassing crinkling sounds during movement
• Transparent inspection window (back side) allowing visual monitoring of output and pouch fullness without removal
• Sterile packaging with each pouch individually sealed maintaining hygiene standards until use
• Box of 30 pouches providing approximately 10-30 day supply depending on output frequency and pouch change routine

Benefits

• Enables natural movement with flexible coupling following body motion during walking, bending, sitting, exercising without restriction
• Superior odor management through full-circle carbon filter continuously absorbing gases before they escape the pouch
• Eliminates ballooning discomfort as filter releases gas buildup preventing pouch inflation and embarrassing visible bulging
• Enhances confidence under clothing with ultra-low-profile design and neutral grey fabric creating invisible wear
• Protects sensitive skin using soft, gentle materials reducing irritation and pressure on delicate peristomal tissue
• Simplifies daily routine with easy click-on/click-off Flex attachment enabling quick pouch changes without skin barrier removal
• Reduces adhesive trauma by keeping skin barrier in place multiple days while changing pouches as needed
• Extends barrier wear time (typically 3-5 days) because flexible coupling reduces stress causing premature adhesive failure
• Cost-effective management allowing barrier reuse multiple times before replacement reducing overall supply costs
• Supports active lifestyle designed for work, exercise, social activities without compromise or special accommodations

Clinical Applications

✓ Colostomy patients with formed or semi-formed stool preferring closed pouches for convenient disposal
✓ Ileostomy patients with thicker output who prefer closed pouches over drainable systems for specific situations
✓ Post-operative ostomy patients during initial healing phase requiring gentle, flexible pouch systems
✓ Active adults and working professionals requiring discreet, comfortable ostomy wear during employment
✓ Elderly ostomy patients with arthritis or dexterity limitations finding Flex coupling easier to manage
✓ Patients with sensitive or damaged peristomal skin needing minimal adhesive disruption during pouch changes
✓ Individuals experiencing leakage with rigid flange systems due to body contour incompatibility
✓ Ostomy patients with hernias or protrusion requiring flexible systems accommodating anatomical irregularities
✓ Athletes and physically active individuals needing secure pouching during sports and exercise
✓ Patients self-conscious about ostomy appearance desiring maximum discretion under business or formal clothing
✓ Irrigation users (colostomy patients) using closed pouches between irrigation sessions for security
✓ Travel situations requiring convenient disposal without access to pouch emptying and cleaning facilities

Usage & Application

Initial Setup - Matching with Skin Barrier

Understanding 2-Piece System Components: The SenSura Mio Flex is a TWO-PIECE system requiring both:

1. Skin barrier (baseplate) - Adheres to peristomal skin, stays in place 3-5 days
2. Pouch (this product) - Clicks onto barrier, changed as needed (typically 2-5× daily for closed pouches)

Critical Compatibility Requirement: This 35mm pouch ONLY fits SenSura Mio Flex 35mm skin barriers. Before ordering, verify:

• Current skin barrier brand: Must be Coloplast SenSura Mio Flex (not SenSura standard, not other brands)
• Flange size: Must be 35mm (not 45mm, 50mm, or other sizes)
• Coupling type: Must be Flex (soft adhesive ring), not Click (rigid ring)

If Starting New with SenSura Mio Flex:

1. Consult enterostomal therapy (ET) nurse or ostomy nurse for proper stoma measurement
2. Order matching SenSura Mio Flex skin barriers in 35mm flange size
3. Skin barriers typically purchased separately (10-30 per box) lasting much longer than pouches
4. Calculate needs: If changing pouch 3× daily, one 30-pouch box lasts 10 days

Attaching Pouch to Skin Barrier

Pre-Attachment Preparation:

1. Ensure skin barrier is already applied to peristomal skin and adhesive is secure
2. Verify barrier has been in place at least 15-30 minutes allowing adhesive to warm and bond
3. Empty existing pouch if present (remove by gently pulling downward while supporting barrier with other hand)
4. Inspect barrier adhesive seal - if loose, wrinkled, or leaking, replace entire barrier before attaching new pouch
5. Clean barrier flange surface with dry tissue if any stool residue present (must be dry for pouch attachment)

Flex Coupling Attachment Steps:

1. Remove new pouch from sterile packaging
2. Hold pouch with opening facing down toward barrier flange
3. Align pouch coupling ring with barrier flange (should see both rings matching in size)
4. Position pouch coupling slightly above barrier flange (1-2 inches distance)
5. Press top edge of pouch ring onto top edge of barrier ring
6. Using smooth downward motion, press pouch ring onto barrier ring working around circumference
7. You should hear/feel series of soft "clicks" as Flex adhesive bonds to barrier flange
8. Complete full circle ensuring no gaps or loose spots (run finger around entire coupling verifying secure connection)
9. Gently tug pouch downward to verify secure attachment (should not release with gentle pull)

Attachment Troubleshooting:

• Won't click: Barrier flange may have moisture/stool - clean and dry before reattaching
• Partial attachment: Ensure working around entire circle, not just top and bottom
• Releases easily: Flex coupling may be incompatible with barrier (verify both are SenSura Mio FLEX)
• Gaps visible: Apply even pressure around full circumference - uneven pressure causes incomplete seal

Daily Wearing and Monitoring

Optimal Pouch Positioning: After attachment, ensure pouch hangs naturally downward in comfortable position:

• For standing/walking: Pouch hangs straight down along leg
• For sitting: Pouch may be positioned slightly to side to avoid compression between legs
• For sleeping: Many users empty/change pouch before bed, then position to side during sleep

When to Change Closed Pouches: Closed pouches require changing when:

• Approximately 1/3 to 1/2 full: Optimal emptying point before weight becomes uncomfortable
• Every 8-12 hours minimum: Even if not full, hygiene practice suggests regular changing
• Before social/work activities: Fresh pouch provides confidence in odor control
• After meals: Colostomy patients often change 30-90 minutes post-meal as stool passes
• Before exercise/physical activity: Secure fresh pouch reduces worry during movement
• Any signs of leakage: Immediately change if detecting output around flange or dampness

Typical Change Frequency:

• Colostomy patients (formed stool): 2-4 pouches daily average
• Ileostomy patients (liquid output): May use drainable pouches primarily, closed for specific situations
• Low output days: May extend to 2 pouches daily
• High output days: May require 5+ pouches daily

Monitoring Pouch Fullness:

• Check pouch through clothing by gently feeling for weight/bulk
• Use restroom privacy to visually inspect through transparent back window
• Watch for filter exhaustion: Pouch beginning to balloon indicates filter saturation (time to change)
• Empty before 1/2 full to prevent weight pulling on skin barrier adhesive

Removing and Disposing of Pouch

Pouch Removal Technique:

1. Stand or sit in comfortable position near toilet
2. Support skin barrier with one hand (pressing gently on barrier to keep it in place)
3. With other hand, grasp bottom of pouch
4. Gently pull pouch downward while maintaining upward pressure on barrier
5. The Flex coupling should release smoothly with steady gentle pressure (if resistant, ensure barrier supported)
6. Pull pouch completely free from barrier flange
7. Barrier remains in place on skin - do NOT remove unless changing barrier

Disposal Methods:

Home Disposal:

• Fold pouch in half enclosing contents (closed pouches cannot be emptied - whole pouch disposed)
• Wrap in toilet paper, paper towel, or place in small disposal bag
• Dispose in household trash (not biohazard in home setting)
• Can place in bathroom trash can with lid
• Some users keep discrete disposal bags in bathroom for immediate wrapping

Public Restroom Disposal:

• Many ostomy patients carry small opaque disposal bags when away from home
• Wrap pouch in disposal bag before placing in public trash receptacle
• Alternative: Fold in toilet paper and place in feminine hygiene disposal bins (widely available in restrooms)
• NEVER flush pouches down toilet (causes plumbing blockages)

Odor Control During Disposal:

• Disposal bags with odor barriers available from ostomy supply companies
• Pouch deodorizing drops can be added to pouches before use (reduces odor when disposing)
• Immediate disposal after removal minimizes odor spread in living spaces

Filter Maintenance and Balloning Prevention

Understanding Full-Circle Filter Function:

• Carbon filter continuously absorbs gas produced by intestinal bacteria
• 360-degree filter placement (full circle design) provides maximum gas filtering capacity
• Filter allows gas to escape preventing pouch inflation while blocking odor molecules
• Filter has limited lifespan - saturates after several hours requiring pouch change

Signs Filter is Working Properly:

• Pouch remains flat against body despite gas production
• No visible ballooning or inflation of pouch
• Minimal odor detected around pouch area
• Gentle gas release without loud noises or sudden inflation

Signs Filter is Exhausted:

• Pouch begins to inflate with gas (ballooning)
• Increased odor around pouch indicating gas escaping unfiltered
• Pouch becomes taut and rigid from internal gas pressure
• Visible bulging under clothing from inflated pouch

Filter Failure Prevention:

• Change pouches before filter saturates (typically 8-12 hours maximum wear)
• Avoid getting filter wet (shower with pouch positioned away from direct water spray)
• Some users place small sticker over filter during bathing (remove immediately after)
• High-gas-producing foods may overwhelm filter faster (beans, carbonated beverages, cruciferous vegetables)

Managing Excessive Gas Production:

• Dietary modification: Reduce gas-producing foods (beans, broccoli, cabbage, carbonated drinks)
• Eat slowly: Swallowing less air during meals reduces intestinal gas
• Avoid chewing gum and drinking through straws (increases air swallowing)
• Consider gas-reduction tablets: Simethicone or activated charcoal products (consult physician)
• More frequent pouch changes on high-gas days maintains filter effectiveness

Troubleshooting Common Issues

Pouch Won't Stay Attached: Cause: Moisture or stool on barrier flange surface preventing Flex adhesive bond Solution: Remove pouch, thoroughly clean and dry barrier flange, reattach fresh pouch Prevention: Wipe barrier flange clean before every pouch change ensuring dry surface

Cause: Incompatible coupling systems (mixing Flex with Click or other brands) Solution: Verify both pouch and barrier are SenSura Mio FLEX 35mm - cannot mix systems Prevention: Order matching sets from same product line

Cause: Worn or damaged Flex coupling on barrier after multiple pouch changes Solution: Replace skin barrier if coupling becomes less adhesive after repeated pouch attachments Prevention: Barriers typically last 3-5 days / 10-15 pouch changes before coupling degrades

Pouch Leakage Around Flange: Cause: Incomplete coupling attachment leaving gaps between pouch and barrier Solution: Remove pouch, verify barrier adhesive intact, press new pouch firmly around ENTIRE circumference Prevention: Always check full-circle attachment with finger sweep around coupling after attaching

Cause: Skin barrier adhesive failing allowing output to seep under barrier Solution: This is BARRIER failure, not pouch failure - must remove and replace entire barrier system Prevention: Change barriers at first sign of loosening (typically before 3-5 day maximum wear time)

Excessive Odor Despite Filter: Cause: Filter saturated from extended wear (over 12 hours) or high gas production Solution: Change pouch more frequently - aim for 8-12 hour maximum wear Prevention: Change pouch proactively before filter exhaustion rather than waiting for odor

Cause: Diet producing strong-smelling output (garlic, onions, asparagus, fish) Solution: Dietary modification reducing odor-producing foods, use pouch deodorizing drops Prevention: Plan pouch changes strategically after meals containing strong-odor foods

Visible Bulging Under Clothing: Cause: Pouch ballooning from saturated filter unable to release gas Solution: Change pouch immediately - ballooning indicates filter failure Prevention: More frequent changes before filter saturation occurs

Cause: Pouch overfilled beyond 1/2 capacity creating bulk Solution: Change pouches earlier when reaching 1/3 to 1/2 full Prevention: Monitor fullness throughout day, change proactively before discomfort

Skin Irritation Around Stoma: Cause: Usually barrier-related, not pouch-related (adhesive sensitivity, improper fit, leakage) Solution: Consult ET nurse for barrier assessment - may need different barrier type or size Note: Flex pouch materials hypoallergenic and gentle - irritation typically from barrier or leakage, not pouch

Storage and Supply Management

Proper Storage Conditions:

• Store in cool, dry location away from direct sunlight (optimal 15-25°C / 59-77°F)
• Avoid bathroom storage if high humidity environment (steam from showers degrades adhesive)
• Keep in original box until use maintaining sterility
• Protect from temperature extremes (don't leave in hot car or freezing garage)
• Check expiration dates - typical 3-5 year shelf life from manufacture

Supply Planning:

• Calculate monthly needs: (Number of pouch changes daily) × 30 days
• Example: 3 changes daily = 90 pouches monthly = 3 boxes
• Order refills when 10-15 days supply remaining (prevent running out)
• Consider bulk purchasing (3-6 month supply) for cost savings if storage space available

Travel Supply Management:

• Pack 50% more than anticipated need for trip (unexpected delays, output changes)
• Carry supplies in carry-on luggage (checked bags can be lost/delayed)
• Bring disposal bags for convenient discreet pouch disposal
• Consider travel-size adhesive remover wipes and barrier wipes for supplies

Technical Specifications

Product Identification:

• Brand: Coloplast
• Product Line: SenSura Mio Flex 2-Piece System
• Component: Pouch (requires separate matching skin barrier)
• Pouch Type: Closed-end (non-drainable, intended for disposal when full)
• Pouch Size: Midi (moderate capacity for formed stool)
• Flange Size: 35mm (must match barrier flange - verify compatibility)
• Coupling Type: Flex (soft, flexible adhesive ring, NOT rigid Click system)

Physical Specifications:

• Pouch Capacity: Approximately 250-350 mL depending on fill method (manufacturer does not specify exact volume for closed pouches)
• Pouch Dimensions: Approximately 230mm length × 150mm width when empty (varies slightly by batch)
• Filter Type: Full-circle (360-degree) integrated carbon filter with moisture-resistant covering
• Filter Lifespan: Approximately 8-12 hours under normal conditions before saturation
• Coupling Ring Diameter: 35mm inner diameter matching 35mm flange skin barriers
• Coupling Material: Soft elastic adhesive (latex-free, hypoallergenic)
• Outer Cover Material: Textile fabric (polyethylene with soft cloth-like finish)
• Inner Film: Medical-grade plastic (odor-barrier film containing output and liquid)
• Color: Neutral grey exterior (discreet under most clothing colors)
• Transparency: Transparent back panel allowing visual output monitoring without pouch removal
• Weight (Empty): Approximately 15-20 grams per pouch

Packaging & Sterility:

• Quantity per Box: 30 individually sealed pouches
• Sterility: Each pouch individually sealed maintaining sterility until opening (not steam-sterilized, but manufactured in clean environment)
• Shelf Life: Typically 5 years from manufacture date (check lot code on box)
• Box Dimensions: Approximately 8" × 6" × 3" (compact storage)
• Storage Requirements: Cool, dry environment away from direct heat and sunlight

Clinical & Regulatory:

• Device Classification: Class II Medical Device (FDA) / CE Marked (European standards)
• Latex Content: Latex-free (safe for latex-sensitive patients)
• DEHP Content: DEHP-free materials (phthalate-free for patient safety)
• Standards Compliance: Meets ISO 8670 standards for ostomy collection pouches
• Intended Use: External collection of intestinal output from colostomy or ileostomy
• Single Use: Disposable, non-reusable device intended for one-time use and disposal

Compatibility:

• Compatible Skin Barriers: SenSura Mio Flex 35mm skin barriers ONLY (Coloplast product line)
• NOT Compatible With:
  • SenSura standard (non-Flex) barriers
  • SenSura Mio Click systems (rigid coupling)
  • Other brands (Hollister, ConvaTec, etc.)
  • Different flange sizes (45mm, 50mm, etc.)
• Verify Before Ordering: Confirm existing barrier brand, model, and flange size

Usage Guidelines:

• Recommended Wear Time: 8-12 hours maximum per pouch (based on filter lifespan and hygiene)
• Maximum Capacity Use: Change when approximately 1/3 to 1/2 full for comfort
• Skin Barrier Coordination: Barrier typically lasts 3-5 days with multiple pouch changes
• Change Frequency: Average 2-5 pouches daily depending on output volume and frequency