Respironics 302433, Instructions For Use Manual

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Entrainment Valve (Top)
Do Not Block Opening
Entrainment Valve
Flapper
Accessory
Swivel
Mask
Do not use alcohol, cleaning solutions containing alcohol, or any strong
household cleaners. Do not use vinegar or warm water.
1. Hand wash the mask with a soft bristle brush in cool tap water with a
mild dishwashing detergent. Do not use cleaners containing
conditioners or moisturizers. Do not use bleach.
2. Rinse thoroughly. Air dry. Make sure the mask is dry before use.
3. If any parts are damaged or can not be cleaned, replace the mask.
Respironics
®
Total
™
Face Mask
Instructions for Use Reorder #302433
The Respironics Total Face Mask is intended to provide an interface for adult patients when used with Respironics CPAP or
BiPAP
®
therapy. The mask contains exhalation ports that provide a continuous leak path in the patient circuit. This mask does
not require the use of a separate exhalation device; however, you can use it with additional Respironics exhalation devices if
you remove the accessory swivel. The Total Face Mask is intended for multiple patient use and up to 10 cleaning and
disinfection cycles.
LATEX-FREE
Contraindications
This mask may not be suitable for use on patients with the following conditions: glaucoma, recent eye surgery or
dry eyes, nocturnal vomiting, hiatal hernia; impaired cardiac sphincter function; or on patients unable to remove the mask.
Respironics Total Face
Mask Faceplate
Headgear
Hooks
Entrainment
Valve
Exhalation
Ports
Pressure Pickoff
Port Cap
Accessory
Swivel
1025904
GK 01/26/05
Connecting the Mask and Headgear
1. Set up the CPAP or BiPAP unit and patient circuit according to the unit’s instruction manual.
2. To ensure a proper fit, place the patient’s chin in the mask first, then lightly press the mask against the patient’s face.
3. Pull the headgear straps around each side of the head and secure them to the mask.
Do not overtighten the straps. Overtightening can cause or worsen leaks.
4. Connect the circuit tubing to the mask swivel. Turn the CPAP or BiPAP unit on.
5. Verify that there is only minor lifting of the mask from the patient’s face (approximately 1/4” to 1/2”) during a full
respiratory cycle. Have the patient assume various sleeping positions (e.g., supine, lateral, prone) with the mask in
place. Readjust the straps if necessary. If the inner flap covers the mouth, readjust the mask fit.
Headgear
1. Hand or machine wash with a
standard laundry detergent and warm
water. Rinse thoroughly. Do not use
bleach.
2. Line dry or machine dry at the
medium heat setting.
Removing the Mask and Headgear
To remove the mask quickly, pull on the quick release cord, away from the patient’s face, and remove the mask. The mask
and headgear can also be removed by detaching the headgear straps from the tabs on the mask.
Helpful Tips for Mask Comfort
• Clean the mask thoroughly before every use, including first-time usage.
• Clean the patient’s face thoroughly before each use.
• Make sure the mask and headgear are the correct size for the
patient’s face. If excessive discomfort is experienced, have the mask
readjusted or consider an alternative mask.
• Do not overtighten the headgear. Overtightening can irritate the
patient’s face, increase leaks, or cause damage to the cushion.
Verifying Entrainment Valve Function
With the unit turned off, the entrainment valve flapper (internal blue disk) should be open, allowing the user to breathe
room air. Turn the unit On. The flapper should close, allowing the user to receive airflow from the unit. If the valve still does
not function properly, notify your home care dealer. Do not block the opening on the entrainment valve. Check the valve
before each use for dysfunction or any blockage by patient secretions. To ensure proper entrainment valve function, verify
that the flapper is free moving and dry.
Flexible Tubing
Headgear
Quick Release Cord
Respironics Total Face Mask
with Whisper Swivel II
Respironics Total Face Mask
with Disposable Circuit
ï
Respironics Total Face Mask
Whisper SwivelÆ II
Pressure (cm H
2
O)
Flow
(lpm)
Respironics Total Face Mask
Exhaust Flow/Pressure Performance
0 10 20
0
20
40
60
80
100
5 15 2.5
Caution:
US federal law restricts this device to sale by or on the order of a physician.
Warnings
• The Respironics Total Face Mask is designed for use with CPAP and BiPAP systems recommended by your
physician or respiratory therapist. Do not wear this mask unless the CPAP or BiPAP system is turned on and
operating properly. Do not try to block or seal the exhalation ports in the mask. Most CPAP systems have the
potential to allow rebreathing of exhaled air. CPAP systems are designed for use with masks (or connectors) that
have vent holes or exhalation ports. When the CPAP system is turned on, new air from the system flushes the
exhaled air out through the vent holes. If the CPAP system is not operating, the exhaled air may be rebreathed.
Rebreathing of exhaled air for longer than several minutes can, in some circumstances, lead to suffocation.
• A minimum pressure of 5 cm H
2
O must be maintained when using the Respironics Total Face Mask.
• System pressure and oxygen therapy may be different for a Respironics Total Face Mask than for a nasal or nasal/
oral interface. When changing mask types, determine the appropriate pressure level and oxygen therapy. Because a
small leak exists at the nose area of the mask and through the exhalation ports, you must ensure that the pressure
and oxygen therapy are maintained against this higher leak level.
• When including an additional exhalation device to the patient circuit, you may need to adjust the pressure level to
compensate for the additional leak of the exhalation device.
• The entrainment valve contains a magnet. Do not use this mask in or near magnetic resonance imaging (MRI)
equipment.
• To minimize the risks of vomiting during sleep, the patient should avoid eating or drinking for three hours before use.
• The patient’s physician should be contacted if the patient experiences the following symptoms while using the mask or
after removing it: Unusual chest discomfort, shortness of breath, stomach distension, belching, or severe headache;
drying of the eyes, eye pain, or eye infections; blurred vision. (Consult an opthamologist if symptoms persist.)
Cleaning
For Multi-Patient Use Reusable. See the disinfection instructions later in this document.
Clean all parts of the mask daily. Clean the headgear at least once each week or more often if needed. Remove
headgear before cleaning.
The total volume of the mask is 1500 cc.
The volume of the area around the nose
piece and entrainment valve where most of
the gas exchange occurs is 80 cc.
English