PHILIPS L1071614b10 PerformaTrak Full Face Mask User Manual
- June 5, 2024
- Philips
Table of Contents
PHILIPS L1071614b10 PerformaTrak Full Face Mask Instructions for Use
PerformaTrak Full Face Mask
Intended Use
The PerformaTrak Full Face Mask is intended to provide an interface for
application of CPAP or bi-level therapy to patients. The mask is for single
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 not built into the PerformaTrak Full Face
Mask. A separate exhalation device must be used with this mask.
Note: This mask is not made with natural rubber latex or DEHP.
Caution: US Federal law restricts this device to sale by or on the order
of a physician.
Symbols
- Warning or Caution
- Note
- Leak Symbol and Value
- Not Made with Natural Rubber Latex
- Do Not Reuse
Warnings
- This mask is not suitable for providing life support ventilation.
- This mask requires a separate exhalation device.
- 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.
- Oxygen supports combustion. Oxygen should not be used while smoking or in the presence of an open flame.
- 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.
- Monitor or intervene if the patient experiences skin redness, irritation, or discomfort.
- Monitor or intervene if any of the following symptoms occur: Unusual chest discomfort, shortness of breath, stomach distension, belching, severe headache, blurred vision, drying of the eyes, eye pain or eye infections.
- 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.
- A minimum of 3 cm H2O (hPa) must be maintained when using this mask.
- This mask should not be used on patients who are uncooperative, obtunded, unresponsive, or unable to remove the mask.
- This mask is not recommended if the patient is taking a prescription drug that may cause vomiting.
- If an additional exhalation device is added to the patient circuit, you may need to adjust the pressure level to compensate for the additional leak of the exhalation device.
- Hand wash prior to first use. Inspect the mask for damage or wear (cracking, crazing, tears, etc). Discard and replace any components as necessary.
- This mask is for single use only and is not intended to be disinfected or cleaned after patient use. Dispose of the mask after patient use. Multi-patient use without disinfection between patients increases the risk of infection.
- This mask is not designed for reuse. Respironics cannot guarantee the performance specifications once this mask has been disinfected or cleaned after patient use.
- Monitor or intervene if the patient encounters tooth, gum, or jaw soreness. Use of a mask may aggravate a patient’s existing dental conditions.
- Do not block or try to seal the entrainment valve.
Contraindications
- This mask may not be suitable for persons with the following conditions: impaired cardiac sphincter function, excessive reflux, impaired cough reflex, and hiatal hernia. It should not be used if the patient is unable to remove the mask by themselves.
Before Use
-
Read and understand the instructions completely.
-
Wipe with a 70% v/v isopropyl alcohol swab, or hand wash the mask in warm water with liquid dishwashing detergent and rinse thoroughly. Air dry completely before use. Make sure the mask is dry before use.
Caution: Do not use bleach, cleaning solutions containing bleach, or cleaning solutions containing conditioners or moisturizers.
Caution: Any deviation from these instructions may impact the performance of the product.
Caution: Inspect the mask for damage or wear (cracking, crazing, tears, etc.). Discard and replace any components as necessary. -
Wash the patient’s face. Do not use moisturizer/lotion on your hands or the patient’s face.
-
Verify that the mask and headgear are the correct sizes.
-
If a nasogastric (NG) tube or similar device is in place, use the optional NG tube sealing pad. Position the pad so that its flat surface is against the patient’s face and the C-shaped opening surrounds the tube.
-
Verify that the therapy device, i.e., ventilator, including the alarms and safety systems has been validated prior to use.
-
Check the entrainment valve (Figure 1). With the non-invasive ventilator turned off, verify that the entrainment valve flapper is positioned so that room air can flow through the large opening in the valve. Turn on the system; the flapper should close, and system air should flow into the mask. If the flapper does not close or does not function properly, replace the mask. Do not block the opening on the entrainment valve or the openings on the exhalation device. Ensure that the valve is not blocked with secretions and that the flapper is dry.
-
Ispect the mask and replace it if the cushion has hardened or is torn, or if any parts are broken.
-
Verify therapy device pressure(s).
Leak Symbol and Port Settings
Some ventilators may incorporate the use of a leak symbol and value in the
mask selection setup procedures. The leak characteristic of this mask is leak
symbol . The leak symbol and value represents the intentional leak
characteristics of the interface. On ventilators equipped with a Mask
Selection control, enter the leak symbol value ) that corresponds with the
leak symbol value on the mask.
Achieving the Right Fit
-
Hold the mask lightly against the patient’s face and slide the headgear over their head. You may want to disconnect one of the swivel clips before putting the head strap on the patient. Reconnect the swivel clip E after the head strap is in position.
-
Adjust the four-position Forehead Arm to ensure minimal mask contact pressure on the nasal bridge while achieving minimal mask cushion leak. The lowest position provides the highest contact pressure at the bridge of the nose and provides the best mask cushion seal. The highest position provides the lowest contact pressure at the bridge of the nose and provides a lower mask cushion seal. Position the forehead arm until you achieve a comfortable fit for the patient with minimal mask cushion leak in the nasal bridge area.
-
Connect the patient circuit (exhalation device and flexible tubing) to the entrainment valve.
-
Unfasten the Velcro tabs on the head strap and gradually tighten to ensure the mask is tight enough to achieve minimal mask cushion leak and a comfortable fit.
-
Turn on the noninvasive ventilator. Instruct the patient to breathe normally.
-
Adjust the head strap until the mask has minimal cushion leaks and fits comfortably. Adjust the upper side straps first, making sure that they are above the ears. Adjust the lower leaks and fits comfortably. Adjust the upper side straps first, making sure that they are above the ears. Adjust the lower straps, making sure the head strap securely fits the back of the head. Re-adjust the strap tension if leaks occur as the patient’s position changes.
Caution: Do not overtighten the straps. Overtightening can cause or worsen leaks. -
A = Forehead Support
-
B = Support Arm
-
C = Adjustment Tabs
-
D = Mask Faceplate
-
E = Entrainment Valve
-
(Do not block)
-
F = Exhalation Device
-
(Separate from Mask)
-
G = Flexible Tubing
-
H = Swivel Clip
-
I = Mask Cushion
-
J = Headstrap
Removing the Mask
Disconnect the neck-straps by removing the swivel clips from their sockets.
Reconnecting the Mask and Headgear
- Slide the headgear swivel clips into the faceplate until they lock.
- Insert the two lower straps through the appropriate swivel clip. Fold back and press the hook tab on each strap until the strap is secure.
- Insert the upper straps through the slots in the forehead support. Fold back and press the hook tab on each strap until the strap is secure.
- Position the upper straps so they are comfortably above the ears, and tighten as necessary.
Disposal
Dispose of in accordance with local regulations.
Specifications
Warning: The technical specifi 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 specifi cations, or if used with incompatible devices, the mask may be uncomfortable, the seal of the mask may not be eff ective, optimum therapy may not be achieved, and leak, or variation in the rate of leak, may aff ect device function. The pressure fl ow curve shown below is an approximation of expected performance. Exact measurements may vary.
Intentional Leak
Pressure Drop cm H2O (hPa)
Deadspace
Between 244 cc and 366 cc
Storage Conditions
Temperature: -4º to +140º F (-20º to +60º C) Relative Humidity: 15% to
95%, non-condensing