Application Sheet FACE MASK FOR USE WITH RESMON PRO FOT OSCILLOMETRY TESTING PEDIATRIC and ADULT SIZES Series 7900 Product Description: A face mask with adapter independently validated for use with the Resmon Pro Full FOT device (FDA K152585). The Rudolph 7900 series face mask isolates the nose and allows only mouth breathing. An adapter, with a small round port extending to the patient, prevents the mouth from closing during testing. Only masks preventing nasal breathing provide comparable results to the conventional mouthpiece and nose clip setup. Mask straps and headgear are not required. The operator can hold the mask while collecting the few tidal breaths the Resmon Pro requires to complete the testing session. The Hans Rudolph Resmon Pro mask adapter requires an antiviral/antibacterial filter with a round outlet patient side. Environment for Use: This mask is for use in hospitals and other clinical settings by individuals trained on the use of the mask and device. PEDIATRIC MASK SHOWN WITH RESMON PRO FULL SPECIFICATIONS DESCRIPTION Face Mask Silicone Rubber Mask Adapter Pediatric Adult Polycarbonate Thermoplastic Environment Operational: 5ᴼ to 40ᴼ C; 0-95% RH (non-condensing) Extreme Ambient Transport Conditions (temporary): -40ᴼ to 70ᴼ C; 0-95% RH (non-condensing) Cleaning, Disinfection and Service Life Request copy or download IFU 691194 Cautions Federal law restricts this device to sale by or on the order of a physician. Residual Risk Reference the primary device data sheet which the mask is attached. General Information Packaging: Individually poly bagged, shipped clean, non-sterile. Ordering Part Number Infomation PED SM FACE MASK MASK ADAPTER ADULT MASK SHOWN WITH RESMON PRO FULL Validation Data EFFECT OF DIFFERENT MASK DESIGN FOR MEASURING RESPIRATORY INPUT IMPEDANCE IN PRESCHOOL CHILDREN BY FORCED OSCILLATION TECHNIQUE (FOT) P. Pompilio, D. Caroline, A. Gobbi, R. Perissin, R. Dellaca, T. Carvelli 09.01 – Respiratory Function Technologist/Scientists – European Respiratory Society (ERS) congress 2017, Milan, 9-13 Sept 2017 MASK WITH ADAPTER INSIDE VIEW MASK AND MASK ADAPTER COMPLETE (ADULT & PEDIATRIC) MASK WITH ADAPTER • Prices & Specifications subject to change without notice •