| Product Name |
AirTouch™ F30i Comfort Full Face CPAP Mask |
| Product Type |
Full face CPAP mask with under-the-nose cushion and top-of-head hose connection |
| Cushion |
Medical-grade silicone with permanently bonded moisture-wicking fabric layer (ComfiSoft™); latex-free, PVC-free; replaceable; fabric not removable |
| Frame |
Flexible hollow medical-grade silicone frame with permanently attached breathable fabric wrap; internal air channels on both sides; latex-free, phthalate-free |
| Elbow & Diffuser |
Medical-grade polycarbonate quick-release elbow; integrated quiet air diffuser; vent flow and CO₂ washout compliant with ISO 17510-2 |
| Headgear |
Woven nylon/elastane with Velcro adjustment and magnetic clips; latex-free |
| Tubing Compatibility |
Standard 22 mm CPAP tubing; AirMini™ compatible only with approved adapters; 360° swivel |
| Pressure & Therapy Compatibility |
4 to 30 cmH₂O; CPAP, APAP, BiLevel |
| Cleaning |
Cushion: hand-wash daily in warm water with a mild liquid detergent, by hand only with no bristle brush; rinse and air dry out of direct sunlight. Frame, elbow, and headgear: hand-wash weekly with warm water (≤30 °C) and mild detergent. Alcohol, bleach, ozone, and UV cleaners not recommended; air dry only; no machine wash, wring, tumble dry, or direct heat. Replace the cushion about every 30 days. |
| Material Compliance |
Latex-free, PVC-free, DEHP-free, BPA-free; RoHS and REACH compliant |
| Certifications |
ISO 17510-2; ISO 10993; FDA 510(k) cleared; CE marked (EU MDR); Health Canada licensed; Class II medical device (US) |
| Intended Use |
Non-invasive PAP interface for adults (≥18 years); single-patient, reusable |
| Operating & Storage |
Use +5 °C to +40 °C; humidity 15% to 95% RH non-condensing; storage -20 °C to +60 °C |
| Typical Service Life |
Cushion ~30 days; headgear ~6 months; frame ~6 to 12 months |
| Country Availability |
Authorized for sale in the United States; FDA 510(k) cleared |
| Magnets |
Yes. This product contains magnets and is not magnet-free. |
| Magnet Safety Warning |
Keep the mask magnets at least 6 inches (150 mm) away from active medical implants such as pacemakers, defibrillators (ICDs), neurostimulators, CSF shunts, and insulin or infusion pumps, and from ferromagnetic metallic implants. If you or anyone sleeping near you has one of these, talk to your doctor before using this product. |