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• At low CPAP or EPAP pressures the flow through the exhalation port may be inadequate
to clear all exhaled gas from the tubing. Some rebreathing may occur.
• A minimum of 3 cm H
• This mask should not be used on patients who are uncooperative, obtunded,
unresponsive, or unable to remove the mask.
• This mask is not recommended if the patient is taking a prescription drug that may
cause vomiting.
• If an additional exhalation device is added to the patient circuit, you may need to adjust
the pressure level to compensate for the additional leak of the exhalation device.
• Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing,
tears, etc). Discard and replace any components as necessary.
• This mask is for single use only and is not intended to be disinfected or cleaned after
patient use. Dispose of the mask after patient use. Multi-patient use without disinfection
between patients increases the risk of infection.
• This mask is not designed for reuse. Respironics cannot guarantee the performance
specifications once this mask has been disinfected or cleaned after patient use.
• Monitor or intervene if the patient encounters tooth, gum, or jaw soreness. Use of a mask
may aggravate a patient's existing dental conditions.
• Do not block or try to seal the entrainment valve.
Contraindications
This mask may not be suitable for persons with the following conditions: impaired cardiac
sphincter function, excessive reflux, impaired cough reflex, and hiatal hernia. It should not be
used if the patient is unable to remove the mask by themselves.
Before Use
• Read and understand the instructions completely.
• Wipe with a 70% v/v isopropyl alcohol swab, or hand wash the mask in warm water with
liquid dishwashing detergent and rinse thoroughly. Air dry completely before use. Make
sure the mask is dry before use.
Caution: Do not use bleach, cleaning solutions containing bleach, or cleaning solutions
containing conditioners or moisturizers.
Caution: Any deviation from these instructions may impact the performance of the
product.
Caution: Inspect the mask for damage or wear (cracking, crazing, tears, etc.). Discard and
replace any components as necessary.
• Wash the patient's face. Do not use moisturizer/lotion on your hands or the patient's
face.
• Verify that the mask and headgear are the correct size.
• If a nasogastric (NG) tube or similar device is in place, use the
optional NG tube sealing pad. Position the pad so that its flat
surface is against the patient's face and the C-shaped opening
surrounds the tube.
• Verify that the therapy device, i.e., ventilator, including the alarms
and safety systems, has been validated prior to use.
• Check the entrainment valve (Figure 1). With the noninvasive
ventilator turned off, verify that the entrainment valve flapper is
positioned so that room air can flow through the large opening
in the valve. Turn on the system; the flapper should close, and
system air should flow into the mask. If the flapper does not
close or does not function properly, replace the mask. Do not
block the opening on the entrainment valve or the openings on
the exhalation device. Ensure that the valve is not blocked with
secretions and that the flapper is dry.
O (hPa) must be maintained when using this mask.
2
2
Figure 1
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