SUNSET Sol CM205 Manual de usuario
Instruction Manual
Sol
Full Face CPAP Mask
CM205
Manufactured for
Sunset Healthcare Solutions
180 N Michigan Ave Ste 2000
Chicago, IL 60601
United States
IFU-00047 REV 1.01
2022-02-23
EN English
ES Español
FR Français
Intended use
Contraindications
The mask is a noninvasive accessory used for channeling airflow with or without supplemental
oxygen to a patient from a positive airway pressure (PAP) device such as a continuous positive
airway pressure (CPAP) or bi-level system. The mask is intended for single-patient use. The
mask is for users weighing over 66 pounds.
If the user has the following complications, the product may not be suitable for use. Special
attention should also be given when it must be used. In either case, it is up to the doctor to
decide whether or not to use the mask. These complications include:
• Recent eye surgery or dry eyes
• Glaucoma
• Hiatal hernia
• Impaired cardiac sphincter function, excessive reflux, impaired cough reflex
• Vomiting
• Bullous Lung Disease
• Pathologically Low Blood Pressure
• Bypassed Upper Airway
• Pneumothorax
• Diagnosis of acute sinusitis or otitis media
• Risk of aspiration of gastric contents
• Allergy or hypersensitivity to the mask materials, or inability to remove the mask
CAUTION:
In the United States, Federal law restricts the sale of this device by or on the order of a physician.
WARNINGS:
• Please read the entire guide before use.
• Remove all packaging before using the mask.
• Ensure mask vent holes are clear from obstruction.
• 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. Rebreathing of exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation. This warning applies to most models of CPAP systems.
• At low CPAP pressures the flow through the exhaled port may be inadequate to clear all
exhaled air from the tube. Some rebreathing may occur.
• To minimize the risk of vomiting during sleep, the patient should avoid eating or drinking
for three hours before using the mask. This mask is not recommended if the patient is
taking a prescription drug that may cause vomiting.
• Do not use the mask without the Non-Rebreathing Valve in place.
• This mask should not be used on patients who are uncooperative, obtunded, unresponsive,
or unable to remove the mask.
• Follow all precautions when using supplemental oxygen.
• Oxygen flow must be turned off when the flow generator is not operating, so that unused
oxygen does not accumulate within the flow generator enclosure and create a risk of fire.
• At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration varies,
depending on the pressure settings, patient breathing pattern, mask, point of application
and leak rate.
• The technical specifications of the mask are provided for your clinician to ensure
compatibility with the flow generator. If it is used beyond technical specifications or
used with incompatible devices, the seal and comfort of the mask may not be effective,
optimum therapy may not be achieved, and leak, or variation in the rate of leak, may
affect the function of the flow generator.
• Stop using the mask and consult your physician or sleep therapist, if you have ANY adverse
reaction to the use of the mask.
• Refer to your flow generator manual for details on settings and operational information.
• As with all masks, some rebreathing may occur at low CPAP pressures.
Parts of the mask
Forehead support
Elbow
Swivel
Vent Cushion
Frame assembly
Headgear
Clip
Upper headgear straps
Lower headgear straps
Frame
Fitting
Use a standard conical connector if pressure readings and / or supplemental oxygen
are required.
Continued on next page
1
3
2
4
Removal
5
1
2
3
4
5
6
6
Unclip one of the lower headgear clips from the frame.
To remove the mask, disconnect one of the lower headgear clips and pull the mask and
headgear up over your head.
Hold the mask steadily on your face and pull the headgear over your head.
Bringing the lower headgear straps below your ears, clip the headgear to
the lower part of the frame.
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 fits well.
Undo the fastening tabs on the lower headgear straps. Connect the device air tubing to
the swivel of mask and ensure it is firmly connected. Pull the straps evenly until the mask
is stable and comfortable. Reattach the fastening tabs.
Your mask and headgear should be positioned as shown in the illustration.
CAUTIONS:
• Please confirm that you can remove the clip and headgear freely
• Do not remove the headgear until the clip is released
1
1
2
2
Detach the air tubing. Unclip the lower headgear clips and unhook the upper
headgearstraps.
Fit the cushion into the channel of the frame.
Gently separate the cushion from the frame.
Thread the upper headgear straps through the loop of the frame and secure. Clip the
headgear to the lower part of the frame.
NOTES:
Do not remove elbow assembly unless necessary.
Disassembly
Reassembly
1 2
1 2
Cleaning the Mask at Home
Daily / After Each Use
NOTES:
• Only hand wash the mask and headgear.
• The elbow and the valve cannot be disassembled for washing.
• If any visible deterioration of a mask component is apparent (cracking, tears, etc), the mask
component should be discarded and replaced.
• It is recommended to replace the mask every month or after 30 cleanings.
CAUTIONS:
• Do not use solutions containing bleach, chlorine, alcohol, aromatics, moisturizers, antibacterial
agents, or scented oils to clean any part of the system or air tubing. These solutions may
cause damage and reduce the life of the product.
• Avoid exposing any part of the system or tubing to direct sunlight or heat, which may
cause deterioration.
• Do not use a dishwasher to wash mask.
• Do not air dry mask components in direct sunlight as it may accelerate product aging.
• Do not iron the headgear. It may damage the headgear.
• If cleaning is not done in accordance with the instructions , or if cleaning frequency is
increased, it may result in poor product performance or reduced product life.
• Disassemble the mask components according to the disassembly instructions.
• Thoroughly clean the separated mask components (excluding headgear), by gently rubbing in
warm (approx. 30°C) water using mild soap. Soak in water no more than 10 minutes.
• Use a soft bristle brush to clean the vent.
• To optimise the mask seal, facial oils should be removed from the cushion after use.
• Inspect each component and, if required, repeat washing until visually clean, making sure
there is no soap residue.
• Rinse all components well for 3-5min with drinking quality water and allow to air dry out
of direct sunlight.
• When all components are dry, reassemble according to the reassembly instructions.
Weekly
Troubleshooting
• Hand wash the headgear and all components in warm and soapy water. Use unscented soap.
Rinse the components well and allow them to air dry out of direct sunlight, which may age or
damage the mask.
• If any visible deterioration of a mask component is apparent (cracking, tears,v etc), the mask
component should be discarded and replaced.
Problem Possible cause Solution
Mask is too noisy Vents are blocked or
partially blocked. Mask is
assembledincorrectly.
Clean vents according to
Instructions in “Cleaning
the Mask at Home”.
Reassemblemask.
Mask leaks around
theface
Mask may have been
fittedincorrectly.
Carefully follow instructions
in “Fitting”.
Mask is uncomfortable Mask may have been
fittedincorrectly.
Carefully follow instructions
in “Fitting”.
Mask is difficult to
breathe through
Mask cushion may be dirty. Clean vents according to
Instructions in “Cleaning the
Mask at Home”.
Pressure-Flow Curve
Dead Space Information Dead space is the empty volume of the mask
up to the swivel. The dead space of the mask
varies according to cushion sizes but is less than
208 mL.
Therapy Pressure 4 to 30 cmH2O
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 Non-
Rebreathing Valve open-to-
atmosphere 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
Technical Specifications
Tabla de contenidos
Idiomas:
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