Philips Wisp Instructions For Use

Instructions for Use
Wisp Nasal Mask
1098148 R04
JAW 07/25/2013
Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA
Intended Use
The Wisp Nasal 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.
Notes:
• An exhalation port is built into this mask so a separate exhalation port is not required.
• This mask does not contain 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
Does Not Contain
Natural Rubber Latex
X1
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, 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 block or seal o the exhalation ports.
• Do not overtighten the headgear straps. Watch for signs of overtightening, such as excessive
redness, sores, or bulging skin around the edges of the mask. Loosen the headgear 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 ow of air out of the mask. When the CPAP machine is turned on and
functioning properly, new air from the CPAP machine ushes 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 suocation. This warning applies to most
models of CPAP systems.
• If oxygen is used with the device, the oxygen ow must be turned o when the device is not
operating. Explanation of the Warning: When the device is not in operation, and the oxygen ow
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 re.
• At a xed ow rate of supplemental oxygen ow, 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 ow 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.
Specications
Warning: The technical specications 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 specications, or if used
with incompatible devices, the mask may be uncomfortable, the seal of the mask may not be eective,
optimum therapy may not be achieved, and leak, or variation in the rate of leak, may aect device function.
Pressure Flow Curve
0
10
20
30
40
50
60
0 5 10 15 20 25 30
Flow Rate (SLPM)
Pressure cm H
2
O
Resistance
Drop in Pressure at
50 SLPM 100 SLPM
All sizes 0.8 cm H
2
O 3.2 cm H
2
O
Deadspace Volume
P 37 mL
S/M 49 mL
L 73 mL
XL 85 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: -4º to 140º F (-20º to +60º 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 prots, 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.

Philips Wisp Specifications

General

Brand	Philips
Model	Wisp
Category	Personal Care Products
Language	English