Contour Deluxe™ Single Patient Use Nasal Mask and Headstrap
Intended Use -
The Contour Deluxe Single Patient Use Nasal Mask is intended to provide a patient interface
for application of noninvasive ventilation. The mask is disposable and for single patient use. It is intended for use on
adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation, in the hospital/institutional
environment only. Latex free.
Warnings
•
This mask does not include an anti-asphyxia valve that would allow a patient to breath if
the ventilator failed.
• Apply this mask to a patient ONLY when the CPAP or bi-level system is turned on and operating properly.
In normal CPAP system operation, new air from the system flushes out exhaled air through vent holes or
exhalation ports in the mask (or connectors). If the CPAP system is off or not operating properly, the
patient may rebreathe exhaled air. Rebreathing exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation.
• This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to
remove the mask.
• Consult the physician if the patient experiences unusual chest discomfort, shortness of breath, stomach
distention, belching, or severe headache when awakening or when receiving positive airway pressure.
• If the patient experiences skin irritation, consult the physician.
Cautions
• When using this mask with the Respironics disposable circuit,
do not expose the tubing to temperatures above 130°F.
Notes
• The mask has one pressure pick-off port with a removable port cap that may be
used to monitor airway pressure. Close the port cap when it is not in use.
•
Verify that the mask and headgear are the correct size.
• Dispose of the mask in accordance with local regulations.
Before Each Use
• Verify that the therapy device (i.e., ventilator) and any
alarms and safety systems that are used with the
ventilator (if applicable), have been validated prior to
use.
• Check for the swivel elbow on the mask, and note that
the mask does not include an anti-asphyxia valve that
would allow a patient to breathe if the ventilator failed.
• With the headgear disconnected, wash the mask cushion
and inner mask shell in warm water with a mild
dishwashing detergent. Do not use bleach, alcohol,
cleaning solutions containing alcohol, or any strong
household cleaners. Do not use cleaners containing
conditioners or moisturizers. Rinse thoroughly. Air dry.
Note: Do not attempt to clean the headstrap. Replace the
headstrap if it becomes soiled.
• Inspect the mask and replace it if the cushion has
hardened or is torn, or if any parts are broken.
• Wash the patient's face.
• Verify the therapy device pressure(s).
Instructions for Use
Using the Mask
1. Hold the mask lightly against the patient's face, and
slide the headstrap over his/her head. Use the tabs on
the headstrap to adjust strap length.
2.
Connect the disposable circuit to the swivel elbow.
Turn the CPAP or bi-level system on.
3. Instruct the pati
through his/her nose with lips closed. Unhook and
gradually tighten the straps until the mask has
minimal leaks and fits comfortably. Do NOT
overtighten the straps. Overtightening can cause or
worsen leaks.
To remove the headstrap
and mask
Simply unfasten either bottom strap
and slide the mask and headstrap over
the patient's head.
Reorder Numbers
1016981 Petite (5/pack)
1016983 Petite (10/pack)
1016697 Small (5/pack)
1016698 Small (10/pack)
1016695 Medium/Large (5/pack)
1016696 Medium/Large (10/pack)
1007365 Disposable Headstrap (5/pack)
1018472 Disposable Petite Headstrap (5/pack)
•
•
•
•
e
nt to recline and breathe normally
T
Exhalation Port
Disposable Circuit
www.respironics.com
SINGLE PATIENT
USE ONLY
Foam
Forehead
Removable
Spacer
Port Cap
Mask
Cushion
Swivel Elbow
Tips for Mask Comfort
Thoroughly clean the mask and
patient's face before use.
Make sure the mask is the correct
size for the patient's face.
Do not overtighten the headstrap.
Overtightening can irritate the
patient's face, increase leaks, or
cause damage to the mask.
Replace the mask if the cushion
becomes hardened or deformed.
English
1016995
Patent Pending
HM 12/2/03