These instructions contain important information for safe use of the product. Read the entire contents of the Instructions for Use, including Warnings and
Cautions, before using this product. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient.
It is the responsibility of the healthcare practitioner to assure that the instructions for use and maintenance are understood by and provided to the caregiver.
1. DESCRIPTION
The acapella
®
vibratory PEP system is a single
patient use device that provides Positive
Expiratory Pressure (PEP) Therapy for patients
who have Cystic Fibrosis, COPD, asthma, and
lung diseases with secretory problems, and
patients with atelectasis. All patients must be
capable of following instructions for PEP
Therapy. Review the diagram and the product to
become familiar with all of the product features.
The acapella
®
system consists of:
•
1. Removable mouthpiece
(mask options are also available)
•
2. acapella
®
Vibratory PEP Device
with 22 mm male fi ttings (See Figure 1)
•
including:
A. Expiratory resistance/
frequency adjustment dial
B. One-way inspiratory valve
C. Patient end which adapts to a
mouthpiece, or mask. (if pressure
monitoring feedback is desired,
the TheraPEP
®
pressure port may be
inserted
(See Figure 4).
D. Mouthpiece (detachable)
acapella
®
is available in:
GREEN:
acapella
®
DH is recommended
for patients able to maintain an expiratory fl ow
of 15 liters per minute or greater for 3 seconds.
BLUE:
acapella
®
DM is recommended for
patients capable of less than 15 liters per
minute for 3 seconds.
2.
INDICATIONS
acapella
®
is intended for use as a PEP device. It
may also be used simultaneously with nebulized
aerosol drug delivery.
3.
CONTRAINDICATIONS
Although no absolute contraindications to
the use of PEP Therapy have been reported,
the following should be carefully evaluated
before a decision is made to initiate therapy:
•
•
Inability to tolerate increased
work of breathing
•
•
Hemodynamic instability
•
•
Intracranial pressure (ICP) > 20 mm Hg
•
•
Acute sinusitis
•
•
Recent facial, oral or skull surgery or trauma
•
•
Epistaxis
•
•
Esophageal surgery
•
•
Active hemoptysis
•
•
Untreated pneumothorax
•
•
Nausea
•
•
Known or suspected tympanic membrane
rupture or other middle ear pathology
Figure 4
Figure 1
A
B
D
C
Figure 2
Counter-
clockwise
decreases
frequency-
resistance.
Clockwise
increases
frequency-
resistance.
Figure 3
acapella
®
with
TheraPEP
®
pressure
indicator, tubing
and pressure port.
4.
WARNINGS
4.1
Use of this device at excessive pressures
may have adverse effects. Expiratory
pressures above 20 cm H
2
O in patients
sensitive to increased transpulmonary
pressure may develop one or more of
the adverse side effects listed below.
4.2
Expert clinical judgment should be
exercised in the selection of the appropriate
setting for each individual patient. Failure to
match the appropriate resistance setting on the
+/- dial indicator with the patients expiratory
fl ow may result in failure to achieve therapeutic
objectives of vibratory PEP therapy or one or
more adverse side effects below.
Adverse reactions may include:
•
•
Increased work of breathing that may
lead to hypoventilation and hypercarbia
•
•
Increased cranial pressure
•
•
Cardiovascular compromise
•
•
Myocardial ischemia
•
•
Decreased venous return
•
•
Air swallowing with increased likelihood
of vomiting and aspiration
•
•
Claustrophobia
•
•
Skin break down and discomfort from mask
•
•
Pulmonary barotraumas
acapella
®
Vibratory PEP Therapy System
Reference Guide
