Pari O-PEP System Instructions For Use

Instructions For Use
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PARI O-PEP
SYSTEM
For Single Patient Use (One Person) Only
CAUTION
U.S. Federal Law restricts this device to sale by or on the order of a
physician. Read all warnings and instructions before use. Improper
use can result in serious or fatal illness or injury. PARI O-PEP device
is not sterile.
WARNING
1. To reduce the risk of increased bacterial growth, infection, illness
or injury from contamination, thoroughly clean and dry all parts
of the PARI O-PEP at the end of every treatment following the
included instructions.
2. Close supervision is necessary when this product is used by or
near children and physically or mentally impaired. Never use
when sleeping or drowsy.
3. This product contains small parts that may present a choking
hazard to small children. ALWAYS USE CLOSE ADULT
SUPERVISION WHEN ADMINISTERING A TREATMENT TO
A CHILD. DO NOT LEAVE CHILD UNATTENDED DURING
TREATMENT.
4. Before use, inspect the PARI O-PEP for proper assembly as
indicated in these instructions. Use of improperly assembled
PARI O-PEP could diminish the effectiveness of the treatment.
INTRODUCTION
Positive Expiratory Pressure (PEP) therapy has been shown to
be beneficial for opening of airways in the lungs, and can assist
with secretion clearance. It may also be used as a substitute for
pursed-lip-breathing in order to promote muscle strengthening and
endurance. Such therapy requires a controlled breathing technique
that results in an increase of air pressure in the lungs when
exhaling. One effect of such an increased pressure is that air can be
pushed slightly deeper into the lungs, where it may help to loosen
secretions, which can then be coughed up.
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O-PEP OPERATING PRINCIPLE
The PARI O-PEP (Oscillating Positive Expiratory Pressure) is a respiratory
therapy device designed for temporary application to mobilize secretions
or mucous in the lower respiratory tract, strengthen the respiratory tract
and alleviate shortness of breath. The patient exhales repeatedly into
the device against a movable ball, causing a vibration that is transmitted
to the lungs. This causes the deeper respiratory tract to open. By doing
this, the lungs are exercised and secretions are mobilized and able to
move up the airways.
The O-PEP produces a range of oscillation frequencies between 6
and 20 Hz, which corresponds to the range of the pulmonary resonant
frequencies in humans. The efficacy of the O-PEP relies on attaining
oscillation frequencies in this range during treatment.
The oscillation frequency produced by the O-PEP when in the
horizontal position is approximately 15 Hz. This frequency can be
adjusted by changing the incline of the O-PEP slightly up to reach a
higher frequency, or down to reach a lower frequency from its original
horizontal position. Patients can adjust the O-PEP to the resonant
frequency by selecting a tilt angle that results in the best transmission of
vibrations to the airways.
INDICATIONS FOR USE
The PARI O-PEP is intended for use as a Positive Expiratory Pressure
Device, and is designed to help patients improve secretion clearance.
The PARI O-PEP is intended for adult and pediatric patients ages 5 and
older, for use in home, hospital, and sub-acute institutions.
CONTRAINDICATIONS AND SIDE EFFECTS
O-PEP must not be used by individuals who are coughing up blood
or suffering from pneumothorax, right ventricular insufficiency or
tuberculosis.
The following side effects can occur: dizziness or lung over-expansion.
If you notice any of these side effects, discontinue the treatment
immediately. Contact your doctor or therapist to discuss how to proceed
with treatment. Inform your doctor or therapist if you notice any side
effects that are not listed in these instructions for use.
GETTING STARTED
1. Make sure that you have all of the components illustrated (See
Components Section). If not, contact the dealer where you purchased
your PARI O-PEP.
2. Read these Instructions for Use. Make note of all warnings and
safety instructions. If you do not understand any portion of these
Instructions for Use, contact PARI Patient Connection at 1.800.FAST.
NEB (327.8632), then press 2.
3. Clean your PARI O-PEP System prior to first use as described on page 5.
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COMPONENTS
(1) Lower part with mouthpiece
(2) Funnel
(3) Ball
(4) Upper part
(5) Carrying Case
(6) Lanyard
HOW TO USE PARI O-PEP
WARNING
To reduce risk of injury and improper treatment, you must be
alert throughout the PARI O-PEP therapy in order to control your
breathing technique and to dispose of any secretions that are
coughed up. This device is not recommended for children under 5
years of age. The creation of a higher-than-recommended pressure
in the lungs may, in some circumstances, result in injection of air
into the pleural space around the lungs (pneumothorax), which
could lead to lung collapse. To reduce risk of pneumothorax and
lung collapse, avoid excessive "pushing" when exhaling.
Use Only According To Your Physician's Instructions
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