Philips Respironics AF531 Mode D'emploi page 2

Intended Use
Medium and Large Size: The AF531 Oro-Nasal EE Leak 1 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 only. The mask is to be used on patients (>30 kg) for whom
CPAP or bi-level therapy has been prescribed.
Small Size: The AF531 Oro-Nasal EE Leak 1 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 only. The mask is to be used on patients 7 years or older (>20 kg) for
whom CPAP or bi-level therapy has been prescribed.
Note: An exhalation port is not built into the AF531 Oro-Nasal EE Leak 1 Face Mask. A
separate exhalation device must be used with this mask.
Note:
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.
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. This warning applies to most models
of CPAP systems. Rebreathing of exhaled air for longer than several minutes can, in some
circumstances, lead to suffocation.
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.
Some users may experience skin redness, irritation, or discomfort. If this happens,
discontinue use and contact your healthcare professional.
The patient's physician should be contacted if the patient experiences the following
symptoms while using the masks or after removing it: Unusual chest discomfort, shortness
of breath, stomach distension, belching, or severe headache; drying of the eyes, eye pain, or
eye infections; blurred vision. (Consult an ophthalmologist if symptoms persist.)
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 H O (hPa) must be maintained when using this mask.
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This mask should not be used for patients who are uncooperative, obtunded, unresponsive,
or unable to remove the mask.
This mask is not recommended for patients who are taking a prescription drug that may
cause vomiting.
Appropriate patient monitoring should be used as medically necessary.
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, circuit, and filter are for single use only and are not intended to be disinfected
or cleaned after patient use. Dispose of the mask and circuit components after patient use.
Multi-patient use without disinfection between patients increases the risk of infection.
This mask, circuit, and filter are not designed for reuse. Respironics cannot guarantee the
performance specifications once this mask, circuit or filter has been disinfected or cleaned
after patient use.
Use of a nasal or full face mask may cause tooth, gum, or jaw soreness or aggravate an
existing dental condition. Consult your physician or dentist if symptoms occur.
Do not block or try to seal the entrainment valve.
If using a filtered exhalation port, prevent increased expiratory resistance due to an occluded
exhalation port filter; monitor the filter closely and replace it as per your institution's
protocol. Check the patient for adequate ventilation. Occlusion may occur due to
environmental conditions or use of an active humidification.
Do not pull or stretch the tubing. This could result in circuit leaks.
Before instituting mechanical ventilation, confirm the proper connection of the circuit and
verify ventilator operation. Patient, ventilator, and circuit must be monitored on a regular
basis per established standards of care.
The mask contains small parts which could result in a choking hazard.
Contraindications
This mask may not be suitable for patients with the following conditions: hiatal hernia, impaired
cardiac sphincter function, excessive reflux, impaired cough reflex; or patients who are unable
to remove the mask by themselves.
Before Use
Read and understand the instructions completely.
Hand wash the mask.
Clean the patient's face.
Verify that the mask and headgear are the correct size.
If a nasogastric tube or similar device is in place, use the optional nasogastric 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.
Inspect the mask and replace it if the cushion has hardened or is torn, or if any parts
are broken.
Verify therapy device pressure(s).
Entrainment Valve
With the airflow turned off, verify that the entrainment valve flapper is
lying flat so that room air can flow in and out through the fresh air inlet
(large opening) in the valve (Figure 3A). Next, with the airflow on, the
flapper should now cover the fresh air inlet and air from the therapy
device should flow into the mask (Figure 3B). If the flapper does not close
or does not function properly, replace.
Warning
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.
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 characteristics 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. If using the mask and circuit, set the exhalation port selection to
DEP.
Achieving the Right Fit
1. Hold the mask lightly against the patient's face and slide the headgear over their head.
If using the CapStrap Headgear, connect the bottom clips to the mask with a gentle push
(Figure 1).
If using the Four Point Headgear strap, connect the bottom clips to the mask with a gentle
push (Figure 2).
Disengage the headgear tabs from the bottom clips and tighten the straps to achieve a
comfortable fit with minimal leak.
2. 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 lower mask cushion seal.
3. Connect the patient circuit (exhalation device and flexible tubing) to the entrainment valve.
4. Unfasten the headgear tabs on the top strap and gradually adjust to ensure the mask is tight
enough to achieve minimal mask cushion leak and a comfortable fit. DO NOT OVERTIGHTEN.
Adjust the crown strap as necessary to achieve proper mask support.
5. Turn on the noninvasive ventilator. Instruct the patient to breathe normally.
6. Make final adjustments to all adjustment points to lessen leaks and to provide a comfortable
fit.
Note:
Re-adjust the strap tension if leaks occur as the patient's position changes. Do not
overtighten the straps. Overtightening can cause or worsen leaks.
Connecting and Disconnecting the Mask and Headgear
The AF531 Oro-Nasal EE Leak 1 Face Mask can be used with either the CapStrap Headgear or
the Four Point Headstrap. Use the following instructions to disconnect
and reconnect the headgear to the mask.
Removing the CapStrap Headgear
First, disconnect one or both of the bottom clips. Next, gently twist
the CapStrap hook so that it disconnects from the forehead support
bracket (Figure 4).
Replacing the CapStrap Headgear
Press the CapStrap hook into the back of the slot on the forehead
support bracket and press until they snap together. On the lower straps,
press the bottom clips into place on the faceplate.
Removing the Four Point Headstrap
First, undo the bottom clips. Next, open the headgear tabs and pull
them out of the slots on the forehead support arm.
Replacing the Four Point Headstrap
On the top strap, thread the headgear tabs through the slots in the
forehead support bracket (Figure 5). Fold the tabs back so that they
catch onto the headgear straps.
Removing the Mask and Headgear from the Patient
Disconnect the bottom clips and swing the mask upward (Figure 6).
This allows easy access to the patient. To remove completely, pull the
entire assembly over the patient's head.
Replacing the Mask Elbow
To remove: Hold the faceplate hub and gently pull and twist the elbow from the faceplate hub.
To replace: Press the mask elbow into the faceplate hub and slightly twist while holding the
faceplate hub. Do not use excessive force or any tools.
Disposal
Dispose of in accordance with local regulations.
ENGLISH
A
B
Figure 3
1
Figure 4
CapStrap Hook
Figure 5
Figure 6