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General Specifications OPERATING ENVIRONMENT Temperature: 10 - 40°C (50 - 104°F) Relative humidity: OxyBREATH™ 0 - 95% Atmospheric pressure: 540 - 1060 hPa STORAGE CONDITIONS Temperature: -20 - 45°C (-4 - 113°F) Relative humidity: 0 - 95% Atmospheric pressure: 440 - 1060 hPa Single patient use only. Do not share or use on multiple patients. Not manufactured from natural rubber latex. D • R Burton Healthcare LLC 3936 South Fields Street Farmville, NC 27828 Telephone: (252) 228 - 7038 Optional inhale resistance dial, sold separately NON STERILE ℞ only LATEX Web: www.drburtonhpi.com Reorder # 564 Indications for Use The OxyBREATH is a respiratory muscle trainer (RMT) used by patients with COPD, CHF, Dysphagia, and Neuromuscular Disease. It trains both inspiratory and expiratory muscles independently. Clinical benefits of RMT include improved dyspnea, peak cough flow, laryngeal function, quality of life, vent weaning, and speech and swallow performance. OxyBREATH is a trademark of D • R Burton Healthcare LLC. D R Burton is a registered trademark of D • R Burton Healthcare LLC. ©2020 D • R Burton Healthcare LLC. All rights reserved. The OxyBREATH mouthpiece cover opens and rotates to form a handle for use during respiratory muscle training. IFU part number 358rev03 Cleaning Directions for Use Open port cap during cleaning Setup: 1. Open the OxyBREATH™ mouthpiece cover 2. Rotate the OxyBREATH mouthpiece cover and position the handle perpendicular to the device body* 3. Press the mouthpiece cover together to form a handle 4. Set the expiratory resistance dial to the lowest setting (5) 5. Set the optional inspiratory resistance dial, if attached, to the lowest setting (1) Exhale resistance dial Optional inhale resistance dial *Refer to the diagram on the reverse side for correct handle position. Procedure: 1. Sit upright 2. Hold the handle and position the mouthpiece between your lips 3. Breathe in and out through the OxyBREATH using diaphragmatic (abdominal) breathing 4. Rotate the exhale resistance dial (settings 5—20) to a setting at which you can manage 10 breaths** without puffing your cheeks or getting out of breath 5. Rotate the optional inhale resistance dial (settings 1 - 6), if attached, to a setting at which you can manage 10 breaths** without puffing your cheeks or getting out of breath a. Increase the exhale and inhale resistance dial settings independently of each other if the set of 10 breaths becomes too easy b. Reduce the dial settings if you have not been using your OxyBREATH for a period of time Set the optional inhale resistance dial settings, if attached, to line up with the red indicator **You want to feel as if you’ve been giving 70% of your effort to get the 10th breath. Port can be used for supplemental O2 or to connect a manometer for measuring expiratory pressures During the course of treatment, the OxyBREATH may accumulate secretions or become soiled and require cleaning. Please follow the instructions below to clean the OxyBREATH, as required. Disassembly 1. Open the mouthpiece cover / handle 2. Remove the mouthpiece from the device body 3. Remove the inhale resistance dial from the device body 4. Open the supplemental connector port cap Cleaning 1. Wash the mouthpiece and inhale resistance dial in warm, soapy water 2. Rinse the mouthpiece, inhale resistance dial, and OxyBREATH body under running tap water, taking care not to submerge the exhale resistance dial when rinsing Notes: • A bottle brush or pipe cleaner may be used to remove accumulations from the OxyBREATH body during cleaning • The exhale resistance dial can be cleaned by wiping the outside surface with a tissue moistened with 70% isopropyl alcohol Drying: 1. Air dry the parts thoroughly or dry with a lint free cloth before reassembly 2. Visually inspect the device: a. if any soil is seen, repeat cleaning steps b. if any damage is seen, discard and replace the device Reassembly: 1. Open the mouthpiece cover / handle 2. Insert the mouthpiece into the device body 3. Attach the optional inhale resistance dial to the device body (if necessary) 4. Close the supplemental connector port cap 5. Set the optional inspiratory resistance dial (if attached) to the lowest setting (1) 6. Set the expiratory resistance dial to the lowest setting (5) 7. Inhale and exhale forcefully to release possible moisture seal prior to next use ">
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