PHILIPS Respironics Wisp Nasal Mask Instructions

Instructions for Use

Wisp Nasal Mask
Intended Use
The Wisp Youth Nasal Mask is intended to provide an interface for the 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 7 years or older (>40 lbs/18kg) for whom CPAP or bi-level therapy has been prescribed.
The Wisp Nasal Mask is intended to provide an interface for the 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:

• Exhalation is built into this mask so a separate exhalation device 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.

| Warning or Caution
---|---
| Not Made with Natural
Rubber Latex
| Note
| System One Resistance
Control
| Tip

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 off 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 that have vent holes to allow a continuous flow of air out of the 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 Explanation of the Warning: When the device is not in operation, and the oxygen flow is left on, oxygen is delivered into the ventilator tubing may accumulate within the device enclosure. Oxygen accumulated in the device enclosure will create a risk of fire.
• 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 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 Some rebreathing may occur.
• Attaching an exhalation device requires therapy pressure level adjustment to compensate for increased

If your mask contains magnetic headgear clips, the following warnings apply:

• The headgear clips contain Contact your healthcare professional before you use this mask.
• Some medical devices may be affected by magnetic The magnetic clips in this mask should be kept at least 2 in. (50 mm) away from any active medical device with special attention to implanted devices such as pacemakers, defibrillators and cochlear implants.
• Do not use in or near magnetic resonance imaging (MRI) equipment.
• Keep unassembled magnetic headgear clips out of reach of In case of accidental swallowing, seek medical assistance immediately.

Features

A. Mask Cushion
B. Mask Frame (clear or fabric)
C. Frame Bottom Slot
D. Magnetic Headgear Clip (optional)
E. Headgear Clip
F. Quick Release Tabs
G. Tubing Assembly
H. Swivel
I. Elbow with Built-in Exhalation (do not block)
J. Frame Top Slot
K. Headgear Top Strap
L. Headgear Crown Strap with Loop for Tube Management (optional)
M. Headgear Back Strap
N. Headgear Bottom Strap

Before Use Read and Understand the Instructions Completely.

• Hand washes the entire mask 1.
• Wash face. Do not use moisturizer/lotion on your hands or face.
• Inspect the mask. Replace the cushion if hardened or torn. Replace any parts that are broken or worn.
• If the mask has magnetic headgear clips, ensure that they are assembled properly into the frame and headgear.

Cleaning Instructions
Note: If your mask has magnetic headgear clips, leave them attached to the frame before cleaning.
Daily: Hand washes the non-fabric parts.
Weekly: Hand washes the fabric parts.

1. Wash in warm water with liquid dishwashing detergent.
2. Rinse thoroughly.
3.  Air dry completely before use.

Cautions:

• Do not clean the mask with bleach, alcohol, solutions containing bleach or alcohol, or solutions containing conditioners or moisturizers.
• Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard and replace any components as necessary.
•  Any deviation from these instructions will impact the performance of the product.

Institutional Disinfection
Note: If your mask has magnetic headgear clips, remove them from the frame before institutional disinfection. Refer to the Disassembly/Assembly of Magnetic Headgear Clips section for removal. 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 (the USA or Canada only) or +1-724-387-4000.

Achieving the Right Fit

Before Putting on the Mask

1.  Sizing: Select the cushion that fits the width of the nose without blocking the nostrils. The top of the cushion may sit between the bridge and tip of the nose.
   Putting on the Mask

2.  Headgear tab or clip: Disconnect one, or both 2 . Peel the headgear tabs away from the headgear strap and pull through a slot in the mask frame, or if using the clip twist outward.

3. Headgear: Pull headgear on overhead 3.

4. Cushion: Place cushion over the nose.

5.  Headgear tab or clip: Thread tab through a slot in mask frame or press clip against the headgear slot to reattach 4.
   Adjusting the Mask

6. Headgear: Peel the headgear tabs away from the headgear straps then press tabs against the headgear straps to reattach 5.
   Connect the side straps to the headgear tab located at the base of the crown strap.
   Connect the bottom strap tabs near the back of the headgear.

7. Headgear: Adjust side straps evenly 6.

8. Headgear: Adjust bottom straps evenly 7.
   The mask should rest comfortably against the face 8.
   Note: Do not overtighten the headgear.
   Using Tube Management (Optional)
   The flexible tubing may be placed overhead.

9. Slide the mask tubing through the headgear crown loop  9 before attaching the flexible tubing.
   Using the Mask

10.  Connect the flexible tubing (included with the CPAP or bi-level device) to the swivel.

11.  Turn the therapy device on. Lie down. Breathe normally.

12.  Assume difierent 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 headgear. The headgear should fit loose and comfortably. If the skin bulges around the mask or if red marks appear, loosen the headgear.
• Re-seat the mask by pulling it directly away from the face and gently setting it back into place.
• Adjust the side headgear straps to reduce leaks around the eyes.
  Removing the Mask
  Disconnect a bottom headgear clip. Slide the headgear forward overhead.
  Disassembly / Assembly

Reversible Fabric Frame
Choose the fabric that feels comfortable against the skin. That side will face inward toward the cushion and headgear. The clear frame is not reversible.
Removing the Elbow and Tubing

1. Squeeze the Quick Release Tabs 10.
2. Pull the elbow away from the cushion 11.

Removing the Cushion
Push the cushion backward through the frame 12.
Removing the Headgear

1. Detach the headgear bottom clips from the frame or undo the bottom tabs and pull.
2. Undo the headgear top tabs and pull the straps through the frame.

Attaching the Cushion

1. Push the cushion into the frame towards the front and press into place 12.
2. The bottom of the cushion will match the alignment cutouts of mask frame 13.

Attaching the Elbow and Tubing
Push the elbow into the cushion until the Quick Release Tabs click into place 14.

Attaching the Headgear

• Hold the crown strap upward.
• Make sure the wide strap marked with “Philips Respironics” is outward.
• Slide the headgear tabs into the longer frame arm slots.
• Connect the headgear clips to the frame or slide the tabs into the shorter frame arm slots if not using the headgear clips.

Optional: Disassembly/Assembly of Magnetic Headgear Clips
If your Wisp mask contains magnetic headgear clips 14 , the following instructions apply:

Removing the Magnetic Headgear Clips

1. Pull the front end of the magnetic clip away from the back circular end of the clip to disconnect the magnets.   15
2. Push the circular end back and out of the mask frame bottom slot.  16 You may need to fiex the mask frame to aid with removal.

Attaching the Magnetic Headgear Clips

1.  Push the back circular end of the magnetic headgear clip into the mask frame bottom slot until it clicks into place.  16
2. Connect the front end of the magnetic clip to the back circular end. The clip will snap into place when the magnetic ends are connected.  15

Philips Respironics System One Resistance Control
This mask when combined with a Philips Respironics System One device, provides optimal resistance compensation. This mask value is X1 and should be set by the provider.

Notes:

• Compare the mask to the device. See the device manual if the values do not match.
• System One is not compatible with masks that use a separate exhalation device.

Specifications

Warning: The technical specifications of the mask are provided for the healthcare professional to determine if it is compatible with the 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, 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

Resistance
Drop-in Pressure at

| 50 SLPM| 100 SLPM
---|---|---
All sizes| 0.8 cm H2O| 3.2 cm H2O

Deadspace Volume

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 prots, 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.

Respironics Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 USA

1098148 R14
TC 2/16/2017
© 2017 Koninklijke Philips N.V. All rights reserved.

References

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