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Yuwell Breathwear Series User Manual
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Yuwell Breathwear Series User Manual

Nasal mask
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User Manual
Breathwear Series
Nasal Mask
YN-02

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Summary of Contents for Yuwell Breathwear Series

  • Page 1 User Manual Breathwear Series Nasal Mask YN-02...
  • Page 3 Intended use The mask is a noninvasive accessory used for channeling airflow (With or without supplemental oxygen) to a patient from a positive airway. y Pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. y The mask is to be used by patients(weighing ＞ 30kg), intended for single- patient reuse in the home environment.
  • Page 4 y Explanation of Warning: CPAP systems are intended to be used with special masks with connectors which have vent holes to allow continuous flow of air out of the mask. When the CPAP machine is turned on and functioning properly, new air from the CPAP machine flushes the exhaled air out through the attached mask exhalation port.
  • Page 5 y Stop using the mask and consult your physician or sleep therapist, if you have ANY adverse reaction to the use of the mask. y Refer to your flow generator manual for details on settings and operational...
  • Page 6 information. y As with all masks, some rebreathing may occur at low CPAP pressures. y Remove all packaging before using the mask. Parts of the mask Forehead support Frame Vent Elbow Clip Swivel Frame assembly Cushion Upper headgear straps Lower headgear straps...
  • Page 7 Headgear...
  • Page 8 Fitting Use a standard conical connector if pressure readings and / or supplemental oxygen are required.
  • Page 9 1. Unclip one of the lower headgear clips from the frame. 2. Hold the mask steadily on your face and pull the headgear over your head. 3. Bringing the lower headgear straps below your ears, clip the headgear to the lower part of the frame. 4.
  • Page 10 Disassembly Notes: The elbow assembly can may be incurred and the re-installation will become more difficult. 1. Detach the air tubing. Unclip the lower headgear clips and unhook the upper headgear straps. 2. Gently separate the cushion from the frame. Reassembly...
  • Page 11 1. Fit the cushion into the channel of the frame. 2. Threading the upper headgear straps through the loop of the frame. Keep the clips attached to the lower headgear straps and clip the headgear to the lower part of the frame. Cleaning the Mask at Home Notes: y The mask and headgear can only be cleaned through hand washing.

  • Page 12: Troubleshooting

    y Inspect each component and, if required, repeat washing until visually clean, making sure there is no soap residue. y Rinse all components well with drinking quality water and allow to air dry out of direct sunlight. y When all components are dry, reassemble according to the reassembly instructions.

  • Page 13: Technical Specifications

    Mask is un- Mask may have been Carefully follow comfortable fitted incorrectly instructions in“Fitting”. Mask cushion may be Clean vents according to dirty Instructions in “Cleaning the Mask at Home”. Technical Specifications Pressure-Flow Curve Flow Rate (L/min) Mask Pressure (cmH Dead Space Information Dead space is the empty volume of the mask up to the swivel.
  • Page 14 Resistance Drop in Pressure measured at 50 L/min: ≤ 0.5 cmH at 100 L/min: ≤ 1.5 cmH DECLARED DUAL-NUMBER NOISE EMIS- Sound SION VALUES in accordance with ISO 4871. The A-weighted sound power level of the mask is less than 38 dBA, with uncertain- ty 3 dBA.
  • Page 15 Symbols System and Packaging Batch code Date of manufacture Catalog number Not made with natural rubber latex +60℃ Temperature limitation +14 0℉ -20℃ -4℉ Humidity limitation Manufacturer Authorized Representative in the European Community Medical Device Use-by date Consult instructions for use Single Patient - multiple use Caution, consult accompanying documents.

  • Page 16: Limited Warranty

    Limited Warranty It is warranted that the Mask, including Frame assembly, Cushion, Headgear shall be free from defects in material and workmanship for a period of ninety (90) days from the date of purchase by the initial consumer. This warranty does not cover damage caused by accident, misuse, abuse, negligence, alteration, failure to use or maintain the Product under conditions of normal use and in accordance with the terms of the product literature, and other defects not related to materials or workmanship.
  • Page 18 Suzhou Yuyue Medical Technology Co., Ltd. No.9 Jinfeng Road., Suzhou Science & Technology Town, 215163 Suzhou, Jiangsu, PRC Tel: +86-512-67373001 web address: www.yuyue.com.cn Metrax GmbH Rheinwaldstr.22, D-78628 Rottweil, Germany Tel: +49-741-257-0 +49-741-257-223 Fax: +49-741-257-214 E-mail: vigilance@primedic.com heiko.borkowsky@primedic.com IFU-V-24(01) version: B Prepared date：2020-02...

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