| Manufacturer |
ResMed |
| Intended Use |
Replacement component for a CPAP/BiLevel full face mask system to deliver positive airway pressure therapy |
| Component Type |
Replacement frame assembly with top-of-head elbow |
| Frame Design |
Flexible fabric-wrapped frame with integrated air pathway |
| Tube Connection Location |
Top-of-head connection |
| Elbow Type |
Quick-release elbow |
| Vent Technology |
QuietAir™ diffused venting (integrated into airflow path) |
| Anti-Asphyxia Valve (AAV) |
Integrated into elbow assembly |
| Magnet System |
Magnetic clip attachment interface compatible with F30i magnetic headgear clips |
| Frame Sizes Available |
Small (S), Standard (STD), Large (LGE) |
| Elbow Detachment |
Side squeeze-release buttons |
| Frame-to-Cushion Interface |
Click-in frame connector tabs |
| Headgear Attachment |
Magnetic clip system (lower straps) and upper strap fastening tabs |
| Materials – Frame Exterior |
Textile fabric sleeve (fabric-wrapped construction) |
| Materials – Frame Internal |
Medical-grade polymer air channel structure |
| Materials – Elbow Housing |
Medical-grade polycarbonate/polymer |
| Materials – Anti-Asphyxia Valve |
Silicone-based flexible valve material |
| Cleaning – Frame |
Weekly hand wash in warm water with mild liquid detergent |
| Cleaning – Elbow |
Weekly hand wash; soft bristle brush recommended for vent holes |
| Disinfection |
Refer to ResMed professional disinfection guide for validated procedures |
| Drying Method |
Air dry only, out of direct sunlight |
| Sterilization Compatibility |
Professional reprocessing per ResMed validated hospital guidelines (if applicable) |
| Device Compatibility |
Compatible with ResMed CPAP and bilevel devices using “Full Face” mask setting |
| Air Circuit Compatibility |
Standard 22 mm CPAP tubing connection |
| Mask Setting Requirement |
Full Face |
| Pressure Range |
Compatible with standard CPAP/BiLevel therapy pressure ranges (per mask system validation) |
| Regulatory Classification |
Medical device CPAP mask accessory component |
| Contraindications |
Magnetic components present; contraindicated for patients with certain implanted metallic devices (see ResMed magnet safety notice) |
| Latex Content |
Not made with natural rubber latex |