Sleepnet Phantom2 Nasal Vented Mask User Guide

Phantom2 Nasal Vented Mask
User Guide

Phantom2 Nasal Vented Mask

Explanation of Symbols

Fitting Disassembly

Assembly

1. Phantom®2 Cushion
2. Trait Headgear
3. Vent
4. Mask Posts
5. Hose
6. Swivel Frame
7. Magnet

VENT HOLE PRESSURE/FLOW CHARACTERISTICS (Approx.) Vent Flow (L/min)
Mask Pressure (cm H2O)

Phantom® 2 Nasal Vented Mask User Instructions

The Phantom® 2 Nasal Vented Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2
O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.
NOTES

• This product is not manufactured with natural rubber latex.
• If the patient has ANY reaction to any part of the mask system, discontinue use.
• An exhalation port is built into this mask so a separate exhalation port is not required.

CAUTIONS

• U.S. Federal Law restricts this device for sale by or on the order of a physician.
• Do not expose the Phantom ® 2 Nasal Vented Mask to temperatures above 122˚F (50˚C).
• This mask is intended for single patient use only. It may be cleaned and used repeatedly on the same person but must not be used on multiple persons. Do not sterilize or disinfect.

WARNINGS

• This mask is not suitable for providing life support ventilation.
•  Do not use the Phantom® 2 Nasal Vented Mask with baseline pressure less than 3 cm H2O.
• If oxygen is used with this CPAP mask, the oxygen flow must be turned off when the CPAP machine is not operating. Explanation of the warning: When the CPAP device is not in operation, and the oxygen flow is left on, oxygen delivered into the ventilator tubing may accumulate within the CPAP machine enclosure. Oxygen accumulated in the CPAP machine enclosure will create a risk of fire.
• At a fixed 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.
• No smoking or open flames such as candles may be used when oxygen is in use.
• To minimize the risk of vomiting during sleep, avoid eating or drinking for three (3) hours before using the mask.
• Any unusual skin irritation, chest discomfort, shortness of breath, gastric distension, abdominal pain, belching or flatulence from ingested air, or severe headache experienced by the patient during or immediately after use should be immediately reported to a healthcare professional.
•  Using a mask may cause tooth, gum or jaw soreness or aggravate an existing dental condition. If symptoms occur, consult a physician or dentist.
• Consult a physician if any of the following symptoms occur while using the mask: drying of the eyes, eye pain, eye infections, or blurred vision. Consult an ophthalmologist if symptoms persist.
• Do not overtighten the headgear straps. Signs of overtightening include: excessive redness, sores, or bulging skin around the edges of the mask. Loosen headgear straps to alleviate symptoms.
• At low CPAP pressures, the flow through the exhalation ports may be inadequate to clear all exhaled gas from the tubing. Some rebreathing may occur.
• This mask should be used with the positive airway pressure device recommended by a physician or respiratory therapist. The mask should not be used unless the positive airway pressure device is turned on and operating properly. Do not block or try to seal the exhalation port (vent holes). The vent holes allow a continuous flow of air out of the mask. When the positive airway pressure device is turned on and functioning properly, new air from the device flushes the exhaled air out through the mask’s vent holes. When the positive airway pressure device is not operating, exhaled air may be rebreathed. Rebreathing of exhaled air can, in some circumstances, lead to suffocation. This warning applies to most models of CPAP machines and masks.
• This mask is not intended for patients without a spontaneous respiratory drive. This mask should not be used on patients who are uncooperative, obtunded, unresponsive,  or unable to remove the mask. This mask may not be suitable for persons with the following conditions: impaired cardiac sphincter function, excessive reflux, impaired cough reflux, and hiatal hernia.
• Significant leak may occur without properly fitting the mask.
• Magnets are used in the swivel frame/tube set and the headgear clips. The magnetic field strength is 380 mT. Ensure that the magnets are kept at least 2.25 inches (6 cm) away from any active medical implant or medical device that can be impacted by the magnetic field (e.g., pacemaker, defibrillators, neurostimulators, cochlear implants, hearing aids) to avoid possible effects from localized magnetic fields.

GENERAL INFORMATION

Dispose of the mask and accessories in accordance with local and regional guidelines.
This mask has a non-transferable three month limited warranty for manufacturer’s defects from the date of purchase by the initial consumer (or maximum service life, if shorter). If a mask used under normal conditions should fail, Sleeper will replace the mask. For additional information about the Sleeper Warranty, please visit http://www.sleepnetmasks.com/.
NOTE: The mask cushion has a service life of the 1 month. The swivel frame/tube set has a service life of 3 months. The Trait Headgear and magnetic clips have a service life of 6 months.

CLEANING AND MAINTENANCE

Cleaning is recommended on a daily basis. Refer to disassembly instructions. Wash the mask and components in warm water using a mild soap such as Ivory®. Rinse the mask thoroughly after washing. Visually verify that the vent holes are clear and allow the mask to air dry. Washing your face prior to fitting the mask will remove excess facial oils and help extend the life of the mask.
NOTE: The gel cushion, although silky to touch, will not tear, leak or detach from the mask under normal use and following recommended cleaning and maintenance protocols. However, the gel cushion is not indestructible. It will tear, cut and rip if subjected to mishandling or abuse. Do not clean in a dishwashing machine. The warranty does not cover these types of product failures. Therefore, please handle your new Phantom® 2 Nasal Vented Mask with care.
WARNING: Frequency of cleaning, methods of cleaning or the use of cleaning agents, other than those specified above, or exceeding the service life of the components can have an adverse effect on the device and consequently the safety or the quality of the therapy.

TECHNICAL INFORMATION

Therapy pressure range: 3 to 30 cm H2O
Resistance to air flow at 50 L/min: 0.45 cm H2 O
Resistance to air flow at 100 L/min: 2.06 cm H2O
DEAD SPACE VOLUME (mL approx.): Mask – 30.7ml Tube – 68.3ml
Operating Temperature: Do not expose the mask to temperatures above 122˚F (50˚C).

BEFORE USE

•  Inspect mask daily or prior to each use. Replace the mask if vent holes are blocked, if parts are damaged, or if gel is exposed due to tears or punctures.

PHANTOM 2 FITTING INSTRUCTIONS

1. Take mask out of the bag. Adjust the base strap according to your general size by aligning the tab at the indicated size markings (S, M, L, XL). (Figure 1).
2. Detach one magnetic clip from the mask. (Figure 2).
3. After placing the mask on your head, reattach the magnetic clip. (Figure 3).
4. First, adjust the top strap to raise or lower the mask. (Figure 4).
5. Second, adjust the left/right straps to make sure the bottom of the mask is sealed comfortably between the bridge of the nose and just above the upper lip. (Figure 5).
6. Connect the mask to the possible airway pressure device tubing and turn the device on to the prescribed pressure. Turn head from side to side while lying on the bed to assure secure fit. (Figure 6).
7. If unacceptable leaks occur, try moving the mask higher or lower around the nose to find the best fit. (Figure 7).
8. Gently press edges of the mask to change mask shape, create a comfortable fit, and reduce leaks. (Figure 8).
9. If leaks persist, try moving the mask higher or lower around the nose to find the best fit. (Figure 9).

DISASSEMBLY INSTRUCTIONS

1. Firmly hold the mask cushion in one hand to one side. (Figure 1).
2. Grasp the swivel frame by one of the magnets. (Figure 2).
3. Firmly pull to separate the Swivel Frame from the cushion in a peeling motion. (Figure 3).

ASSEMBLY INSTRUCTIONS

1. Hold the Swivel Frame up to the mask, slightly tilted up (Figure 1). Using your fingers, support the mask seal ring from inside.
2. Slide the top part of the Swivel Frame into the mask until the mask posts lock into the Swivel Frame grooves (Figure 2).
3. Softly push the bottom part of the Swivel Frame into the mask until the Swivel Frame tab locks into place (Figure 3).
4. Visually inspect inside the mask to ensure that the seal ring is properly seated onto the Swivel Frame (Figure 4). Phantom ®2 is a trademark of Sleeper Corporation.
   Visit our website at www.sleepnetmasks.com.

Sleepnet Corporation
5 Merrill Industrial Drive
Hampton, NH 03842 USA
Tel: 603-758-6600
Fax: 603-758-6699
Toll Free: 1-800-742-3646 (USA)
www.sleepnetmasks.com

References

• Home - Sleepnet Respiratory Masks for NIV, CPAP, & Pediatric
• Home - Sleepnet Corporation

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