RUDOLPH MOUTH BREATHING FACE MASK TWO-WAY NON-REBREATHING
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RUDOLPH MOUTH BREATHING FACE MASK TWO-WAY NON-REBREATHING - 1

Data Sheet RUDOLPH MOUTH BREATHING FACE MASK TWO-WAY NON-REBREATHING Stress/Exercise/Pulmonary Function Testing & Metabolic Measurements Pediatric Small 7970, Large 7950 PRODUCT DESCRIPTION The Rudolph Mouth Breathing Two-Way Non-Rebreathing Face Mask is primarily designed for Stress/Exercise Testing, Pulmonary Function Studies, & Metabolic Measurements. This is a Mouth Breathing only mask where the nose chamber of the mask does not communicate in the breathing circuit. The lower rebreathing dead space volume is created by dividing the mask cavity into a sealed nose chamber which is not part of the rebreathing volume of the mask. Two-Way Non-Rebreathing Face Masks are especially useful for subjects who have difficulty in using a mouthpiece and nose clip with a Two-Way Non-Rebreathing Valve. Subject comfort and the secure fit afforded with this Mouth Breathing Face Mask will result in more accurate test results. As compared to a mouthpiece / nose clip technique, face masks have the advantage of eliminating jaw fatigue, saliva build up, dry mouth, and throat irritation. This Pediatric Size Series has Large and Small Mask Face Pieces available adapted with Hans Rudolph Y-Shape™ and T-Shape™ Two-Way Non-Rebreathing Valves. The user can select from these valve sizes to obtain your optimum parameters such as dead space and flow characteristics. PRODUCT FEATURES • Face masks are molded of silicone rubber material for a skin safe, biocompatible, resilient, comfortable, superior sealing interface • Face masks are mouth breathing only designed for low volume dead space to minimize rebreathing • Face masks incorporate a chin cup which prevents the mask from slipping up on the face especially when perspiring during exercise testing • Four integral head gear attachment buttons molded in the face mask for a secure mask fit • Head gear fabricated of a polyester net cap and elastic straps ensures a secure mask fit during exercise testing • Head gear strap connections to the mask are adjustable, locking two piece quick release plastic clips for ease of use • Two female luer sampling ports are mounted 180º apart on the Two-Way valve mask adapter • Additional couplers are included that mate the female luer sampling ports and have hose barbs for .062” (1.6mm), .093” (22.4mm) and .125” (3.2mm) inside diameter tubing. • Tubing for sampling port couplers is available in the sizes listed. • Two pediatric size mask face pieces and two sizes of Two-Way non-rebreathing valves in both T & Y Shape configurations are available • Two-Way non-rebreathing valves utilize Hans Rudolph low resistance Spiral-Type Diaphragms • Three smaller and three larger sizes of this mask series available Left: T-Shape Valve Right: Y-Shape Valve Partition Seal 7900 Series Two-Way Non-Rebreathing Valve SIDE VIEW DIMENSIONS A B C GENERAL INFORMATION INTENDED USE AND PATIENT POPULATION Two-Way Non-Rebreathing Face Masks are designed for use with Two-Way Respiratory NRB Valves (including Accessory Connectors) and other mask adapters designed for respiratory circuits with spontaneously breathing patients where the application requires a valve to separate the patient’s inspiratory and expiratory flows or a special connector to mate directly to a respiratory flowmeter or other device. They shall be supplied clean, non-sterile. The typical mouthpiece and nose clip is replaced by this face mask assembly and Headgear. These Masks are indicated for use in pulmonary function testing, exercise testing, metabolic measurements, and respiratory research applications involving pediatric patients or subjects in hospitals and other clinical settings by individuals that have had at least minimal instructions or training on the use of the Masks as well as the devices to which the Masks are intended to connect. The Masks are not indicated for use in critical care or life support applications. REBREATHING VOLUME DEAD SPACE Includes the internal air volume of the mask after installation on the patient plus the volume of the mask adapter and Two-Way non-rebreathing valve housing between the inhalation and exhalation diaphragms. Estimations of the dead space for each mask and valve configuration is listed in the Physical Characteristics section of this data sheet. CLEANING AND DISINFECTION • These products are packaged and shipped clean, non-sterile. • For cleaning and disinfection care refer to our Instructions for Use 691195. CAUTIONS 1. Federal Law restricts this device to sale by or on the order of a physician. 2. Patients with facial hair, especially beards, may experience mask leakage which may require shaving the hair. 3. Do not use these masks and valves in a life support system such as a ventilator circuit. WARNING AND RISKS Refer to the Instructions for Use 691195 shipped with the product. INTERIOR VIEW Size Pediatric Small Large GUIDELINES FOR MASK FIT SELECTION MASK SIZE Pediatric Small Pediatric Large REFERENCES 1. Farley RS, Ray PS. Evaluation of Three Gas Collection Devices. International J Industrial Ergonomics 1998; 22: 431-437. 2. Hirsch JA, Bishop B. Human Breathing Patterns on Mouthpiece or Face Mask During Air, CO2, or Low 02. J Appl Physi0l 1982; 53(5): 1281-90 3. Mahon AD, Stolen KQ. Using a Facemask and Sealant to Measure Respiratory Gas Exchange in Children During Exercise. Pediatric Exercise Science 1998; 10:347-55. 4. Danhoff GW, Dohmeier TE. Comparison of the Rudolph facemask with the standard Mouthpiece-Nose Clip apparatus in measuring respiratory variables. Med and Sci in Sports and Exerc. 24: S99, 1992. 5. Baran DA, Rosenwinkel E Validating Facemask Use for Gas Exchange Analysis in Patients with Congestive Heart Failure. J Cardiopulm Rehab 2001; 20: 94-100. AMBIENT CONDITIONS • Temperature range: 5º – 40ºC • Relative Humidity: 0-95% (non-condensing) • Prices & Specifications subject to chang

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