INSTRUCTIONS FOR USE (IFU):TRACHEOSTOMY TUBE HOLDER

The Tracheostomy Tube Holder is a sterile, single-patient-use medical accessory designed to secure tracheostomy tubes firmly in place around the patient’s neck. Constructed from soft, breathable, moisture-wicking materials with adjustable hook-and-loop closure tabs, it prevents accidental decannulation while protecting fragile neck skin from pressure injuries and chafing.

INDICATIONS FOR USE
1-Securement and stabilization of cuffed or uncuffed tracheostomy tubes.
2-Reduction of tube movement and stoma irritation.
3-Replacement of traditional twill ties or rigid neck straps.

CONTRAINDICATIONS & WARNINGS
WARNING: Do not over-tighten the neckband. Over-tightening can restrict carotid blood flow, cause neck swelling, or lead to pressure necrosis.
WARNING: Ensure the tracheostomy tube is manually held in position during holder changes to prevent accidental decannulation or displacement.

CONTRAINDICATION: Do not use on patients with known hypersensitivity or allergic reaction to synthetic foam, nylon, or polyester materials.

STEP-BY-STEP CLINICAL PROCEDURE
PHASE 1: INSPECTION & PREPARATION
1-Hand Hygiene: Perform aseptic hand hygiene and wear appropriate personal protective equipment (PPE/gloves).
2-nspect Packaging: Verify that the sterile package is intact and undamaged. Do not use if the sterile barrier is compromised.
3-Inspect Device: Remove the holder and inspect for fraying, broken stitching, or defective hook-and-loop fasteners.
4-Patient Positioning: Position the patient comfortably in a supine or semi-Fowler’s position with the neck clearly exposed.

PHASE 2: APPLICATION & SECUREMENT
1-Stabilize Tube: Have an assistant manually hold the tracheostomy tube flange firmly against the neck to prevent movement or accidental decannulation during strap application.
2-Thread First Tab: Take one end of the holder strap and thread the narrow hook-and-loop tab through the eyelet on the tracheostomy tube neck flange from back to front.
3-Lock First Side: Fold the tab back onto the neck strap and press firmly to lock the hook-and-loop fastener.
4-Wrap Neckband: Carefully pass the main neck strap around the back of the patient's neck. Ensure the padded material rests flat against the skin without twisting, bunching, or creasing.
5-Thread Second Tab: Thread the second narrow tab through the opposite eyelet of the tracheostomy neck flange. Pull smoothly to eliminate slack.
6-Lock Second Side: Fold the tab back onto the neck strap and press firmly to secure.

PHASE 3: TENSION CHECK & MAINTENANCE
1-Verify Clearance (Two-Finger Rule): Test strap tension by sliding two fingers (or one finger for infants/pediatrics) between the holder strap and the back of the patient’s neck.
*If too loose: Re-adjust fasteners to prevent accidental tube displacement.
*If too tight: Loosen fasteners to avoid skin breakdown or circulatory restriction.
2-Skin Integrity Checks: Inspect skin under the holder daily for moisture accumulation, redness, or pressure sores.

TECHNICAL SPECIFICATIONS
1-Material Composition: Non-irritating foam laminate, moisture-wicking fleece, nylon hook-and-loop closure tabs.
2-Latex Status: 100% Latex-Free.
3-Sterility: Supplied Sterile (Ethylene Oxide / EO Sterilization) or Non-Sterile depending on packaging configuration.
4-Storage Conditions: Store in a cool, dry place away from direct sunlight and heat.
5-Replacement Protocol: Replace the holder daily or immediately if it becomes wet, soiled, or loses fastener adhesion. Single-patient use only.