Philips Respironics Nuance Instructions For Use Manual
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Nuance gel pillows mask
Instructions for Use - English
Intended Use
This mask is intended to provide an interface for application of CPAP or bi-level therapy to patients.
The mask is for single patient use in the home or multi-patient use in the hospital/institutional
environment. The mask is to be used on patients (>66lbs/30kg) for whom CPAP or bi-level therapy
has been prescribed.
Note:
• An exhalation port is built into this mask so a separate exhalation port is not required.
• This mask is not made with natural rubber latex or DEHP.
Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.
Symbols
Warning or Caution
Note
Tip
Consult Instructions for
Use
Not Made with Natural
Rubber Latex
X2
System One Resistance
Control
Warnings
• This mask is not suitable for providing life support ventilation.
• Hand wash prior to use. Inspect the mask for damage or wear (cracking, crazing, tears, damage resulting in gel
exposure, etc). Discard and replace any components as necessary.
• Some users may experience skin redness, irritation, or discomfort. If this happens, discontinue use and contact
your healthcare professional.
• Consult a physician or dentist if you encounter tooth, gum, or jaw soreness. Use of a mask may aggravate an
existing dental condition.
• Consult a physician if you experience the following symptoms while using the mask or after removing it: Drying
of the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
• The mask material should be away from your eyes.
• Do not overtighten the straps. Watch for signs of overtightening, such as excessive redness, sores, or bulging skin
around the edges of the mask. Loosen the straps to alleviate symptoms.
• This mask is designed for use with CPAP or bi-level systems recommended by your health care professional
or respiratory therapist. Do not wear this mask unless the CPAP or bi-level system is turned on and operating
properly. Do not block or try to seal the exhalation port. Explanation of the 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 may 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.
• If oxygen is used with the device, the oxygen flow must be turned off when the device is not operating.
Explanation of the Warning: When the device is not in operation, and the oxygen flow is left on, oxygen
delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen accumulated in the
device enclosure will create a risk of fire.
• Do not block or seal off the exhalation ports.
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• At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the
pressure settings, patient breathing pattern, mask selection, and the leak rate. This warning applies to most types
of CPAP and bi-level machines.
• 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.
• Attaching an exhalation device requires therapy pressure level adjustment to compensate for increased leak.
Features
F
G
H
E
I
K
L
J
C
A
B
D
APillows Cushion Tip
BPillows Cushion Gel Base (Do not insert into nostrils)
CPillows Cushion Platform
DElbow with Built-in Exhalation (Do not block)
ERetaining Ring
FTube (Permanently attached to Elbow D and Swivel G)
GSwivel (connects to CPAP tubing)
HFabric Frame with Retaining Ring E
IFabric Frame Side Strap and Tab
JHeadgear Back Strap (Philips Respironics logo)
KHeadgear Crown Strap and Tab
LHeadgear Tube Management Loop (Optional)
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Cleaning / Fitting
Disassembly / Assembly
Before Use Read and Understand the Instructions Completely.
• Hand wash the entire mask .
• Wash your face. Do not use moisturizer/lotion on your hands or face.
• Inspect the entire mask. Replace the cushions if hardened or torn, or any parts that are
damaged or worn.
Cleaning Instructions
Hand wash the entire mask before first use . The non-fabric parts A -G should be hand washed
daily. The fabric parts H -L should be hand washed weekly, or as needed.
1. Hand wash in warm water with a mild liquid dish washing detergent.
Cautions:
• Do not use bleach, alcohol, cleaning solutions containing bleach or alcohol, or cleaning solutions
containing conditioners or moisturizers.
• Do not place the fabric parts into the dryer.
• Any deviation from these instructions may impact the performance of the product.
• Inspect the mask for damage or wear (cracking, crazing, tears, damage resulting in gel exposure,
etc). Discard and replace any components as necessary.
2. Rinse thoroughly. Air dry completely before use. Make sure the entire mask is dry before use.
Lay the fabric parts flat or line dry.
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Institutional Disinfection
Refer to the Disinfection Guide for Professional Users to reprocess between patients in a clinical
setting. Access the latest version of the Disinfection Guide at www.healthcare.philips.com or by
contacting customer service at 1-800-345-6443 (USA or Canada only) or +1-724-387-4000.
Achieving the Right Fit
Note: Do not overtighten the straps.
Before putting on the mask
1. Sizing: Place the pillows cushion tips A into your nostrils .
2. Choose the cushion so the pillows gel bases B sit comfortably under the nose without any
gaps.
Note: Do not push the pillows gel bases into your nostrils.
Putting on the Mask
3. Headgear: Pull the headgear on over your head .
4. Pillows: Insert the pillows cushion tips A into your nostrils .
Adjusting the Mask
5. Headgear: Adjust the crown strap K . The headgear should sit just above the ears similar to
glasses.
Warning: The mask parts should be away from your eyes. Loosen the crown strap K to move
the frame side straps I away from your eyes.
6. Frame: Peel the tabs I away from the straps, adjust the length evenly, then press the tabs
against the straps to reattach .
The mask should rest comfortably against your face .
Tube Management (Optional)
7. Slip the mask tube F through the headgear tube management loop L.
8. Position the mask tubing over your head and away from your eyes.
Using the Mask
9. Connect the flexible tubing (included with your CPAP or bi-level device) to the swivel G.
10. Turn the therapy device on. Lie down. Breathe normally.
11. Assume different sleeping positions. Move around until comfortable. If there are any excessive
air leaks, make final adjustments. Some air leaking is normal.
Comfort Tips
• The most common mistake is overtightening. The mask should fit loose and comfortable. If
your skin bulges around the mask or if you see red marks on your face, loosen the straps.
• Re-seat the mask by pulling it away from your face and gently setting back into place.
Removing the Mask
Keep your adjustments! Easily remove the mask by grabbing the headgear back strap J and slide
the headgear forward over your head.
Disassembly
1. Cushion: Grasp the pillows cushion platform C and peel from elbow D .
Caution: Do not pull on the pillows cushion tips A to remove from elbow D.
2. Elbow: Pull from frame H .
Caution: The elbow D, tube F, and swivel G are permanently attached. Do not attempt to
separate the elbow or swivel from the tube.
Caution: Do not pull on mask tube F to separate from CPAP tubing.
3. Frame: Undo the frame tabs I and pull through the slots in the headgear.
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Assembly
Note: The correct position for the elbow D, retaining ring E, and cushion platform C is to
point down ( ) .
1. Elbow: Press into the retaining ring until all sides are flush.
2. Cushion: Push onto the back of the elbow .
Note: The elbow, frame and cushion will fit tightly together without any gaps . If there are
gaps or the cushion angle is low remove the cushion and reattach. The cushion should fit
securely on the elbow with the pillows at an angle towards the nose .
3. Frame: Position the frame with the retaining ring E pointing down ( ).
4. Headgear: Position the tube management loop L on top.
5. Slide the frame tabs through the headgear slots and fold forward.
Note: The Philips Respironics logo is on the outside of the headgear back strap J when
correctly assembled.
Philips Respironics System One Resistance Control
Your mask when combined with a Philips Respironics System One device, provides optimal
resistance compensation. This value is identified below and should be set by your provider.
Size Setting
S, M, L X2
Notes:
• Compare the mask to the device. See your device manual if the values do not match.
• System One is not compatible with masks that use a separate exhalation device.
Specications
Warning: The technical specifications of the mask are provided for your healthcare
professional to determine if it is compatible with your CPAP or bi-level therapy device. If used
outside these specifications, or if used with incompatible devices, the mask may be
uncomfortable, the seal of the mask may not be effective, optimum therapy may not be
achieved, disconnect alarms may not be detected, and leak, or variation in the rate of leak, may
affect device function. The pressure flow curve shown below is an approximation of expected
performance. Exact measurements may vary.
Pressure Flow Curve
Flow Rate (SLPM)
Pressure cm H2O
Resistance (cm H2O)
Drop in Pressure at
50 SLPM 100 SLPM
Small 1.4 5.5
Medium 1.3 5.0
Large 1.2 4.4
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Deadspace
Small 16.1 mL
Medium 16.6 mL
Large 16.6 mL
Sound Levels
A-weighted Sound Power Level 27 dBA
A-weighted Sound Pressure Level at 1 m 19 dBA
Disposal
Dispose of in accordance with local regulations.
Storage Conditions
Temperature: -4° F to 140° F (-20° C to 60° C)
Relative Humidity: 15% to 95%, non-condensing
LIMITED WARRANTY
Respironics, Inc. warrants that its mask systems (including mask frame and cushion)
(the “Product”) shall be free from defects of workmanship and materials for a
period of ninety (90) days from the date of purchase (the “Warranty Period”).
If the Product fails under normal conditions of use during the Warranty Period and the Product
is returned to Respironics within the Warranty Period, Respironics will replace the Product. This
warranty is non-transferable and only applies to the original owner of the Product. The foregoing
replacement remedy will be the sole remedy for breach of the foregoing warranty. This warranty
does not cover damage caused by accident, misuse, abuse, negligence, alteration, failure to use
or maintain the Product under conditions of normal use and in accordance with the terms of the
product literature, and other defects not related to materials or workmanship. This warranty does
not apply to any Product that may have been repaired or altered by anyone other than Respironics.
Respironics disclaims all liability for economic loss, loss of profits, overhead, or indirect,
consequential, special or incidental damages which may be claimed to arise from any sale
or use of the Product. Some states do not allow the exclusion or limitation of incidental
or consequential damages, so the above limitation or exclusion may not apply to you.
THIS WARRANTY IS GIVEN IN LIEU OF ALL OTHER EXPRESS WARRANTIES. IN ADDITION,
ANY IMPLIED WARRANTY, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE, IS SPECIFICALLY DISCLAIMED. SOME STATES
DO NOT ALLOW DISCLAIMERS OF IMPLIED WARRANTIES, SO THE ABOVE LIMITATION
MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC LEGAL RIGHTS,
AND YOU MAY ALSO HAVE OTHER RIGHTS, WHICH VARY FROM STATE TO STATE.
To exercise your rights under this limited warranty, contact your local authorized
Respironics, Inc. dealer or Respironics, Inc. at 1001 Murry Ridge Lane, Murrysville,
Pennsylvania 15668, 1-800-345-6443 (USA and Canada only) or 1-724-387-4000.
Masque en gel Nuance à embouts intra-narinaires
Mode d’emploi - Français
Usage préconisé
Ce masque sert d’interface patient pour l’application d’un traitement par PPC ou à deux niveaux. Il
est destiné à un usage unique à domicile ou à un usage multipatient dans un établissement hospitalier
ou une institution spécialisée. Il est réservé aux patients (> 66 livres/30 kg) pour lesquels un
traitement par PPC ou à deux niveaux a été prescrit.
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