User Manual Breathwear Series Full Face Mask YF-01
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 singlepatient reuse in the home environment. y The mask is intended for single-patient use in the hospital or institutional environment.
y The vent holes must be kept clear. 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. However, when the CPAP machine is not operating, enough fresh air will not be provided through the mask, and exhaled air will be rebreathed.
be achieved, and leak, or variation in the rate of leak, may affect the function of the flow generator.
have ANY adverse reaction to the use of the mask. y Refer to your flow generator manual for details on settings and operational information. y As with all masks, some rebreathing may occur at low CPAP pressures. y Remove all packaging before using the mask.
Headgear 5
Fitting Use a standard conical connector if pressure readings and / or supplemental oxygen are required.
5 6 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. Undo the fastening tabs on the upper headgear straps. Pull the straps evenly until they are comfortable and firm, and reattach the Velcro. Ensure that the mask fit well. 5. Undo the fastening tabs on the lower headgear straps.
Disassembly Notes: The elbow assembly can may be incurred and the re-installation will become more difficult. 1 2 1. Detach the air tubing. Unclip the lower headgear clips and unhook the upper headgear Straps. 2. Gently separate the cushion from the frame.
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. y The elbow and the valve cannot be dissembled for washing.
after use.
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. Weekly y Hand washes the headgear and all components in warm (approx. 30°C) and soapy water. Use pure soap. Rinse the components well and allow them to air dry out of direct sunlight.
Mask is uncomfortabl e Mask may have been fitted incorrectly. Carefully follow instructions in“Fitting”. Mask cushion may be dirty Clean vents according to Instructions in “Cleaning the Mask at Home”. Technical Specifications Pressure-Flow Curve 70 60 50 Flow Rate (L/min) 40 30 20 10 4 8 12 16 20 25 30 Mask Pressure (cmH2O) Dead Space Information Dead space is the empty volume of the mask up to the swivel.
Resistance Drop in Pressure measured at 50 L/min: ≤ 0.5 cmH2O at 100 L/min: ≤ 1.5 cmH2O Inspiratory and expiratory resistance with the NonRebreathing Valve open-toatmosphere pressure Inspiratory at 50 L/min: ≤ 2 cmH2O Expiratory at 50 L/min: ≤ 2 cmH2O The Non-Rebreathing Valve open-to-atmosphere pressure ≤ 2 cmH2O The Non-Rebreathing Valve closed-to-atmosphere pressure ≤ 2 cmH2O Sound DECLARED DUAL-NUMBER NOISE EMISSION VALUES in accordance with ISO 4871.
Storage Ensure that the mask is thoroughly clean and dry before storing it for any length of time. Store the mask in a dry place out of direct sunlight. Disposal The mask does not contain any hazardous substances and may be disposed of with your normal household refuse.
Single Patient - multiple use Caution, consult accompanying documents. Indicates a Warning or Caution and alerts you to a possible injury or explains special measures for the safe and effective use of the device. CE Mark 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.
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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.
