1.
DESCRIPTION:
The acapella
®
duet vibratory PEP system is a single patient use device that provides Positive Expi-
ratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, lung diseases
with secretory problems, and patients with atelectasis. All patients must be capable of following
instructions for Positive Expiratory Pressure Therapy. Review the diagram and the product to
become familiar with all of the product features.
The acapella
®
duet system consists of:
1. Removable mouthpiece (device end adapts to mask)
2. Small volume nebulizer (SVN)
3. Collapsible reservoir tubing
4. 2.13m (7’) Oxygen tubing
5. acapella
®
duet Vibratory PEP Device with 22 mm male fittings including: (See Figure 1)
A. Expiratory resistance/frequency adjustment dial
B. One-way inspiratory valve
C. Detachable cover
D. Detachable rocker – DO NOT disassemble the rocker
2.
INDICATIONS:
The Smiths Medical acapella
®
duet is intended for use as a Positive Expiratory Pressure (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:
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
4.
WARNINGS:
4.1 Use of this device at excessive pressures may have adverse reactions. Expiratory pressures
above 20 cm H
2
0 in patients sensitive to increased transpulmonary pressure may develop one or
more of the adverse reactions 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 flow may result in failure to achieve therapeutic objectives of vibratory PEP
therapy or one or more adverse reactions listed 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
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 care giver.
acapella
®
duet Vibratory PEP Therapy System
with Medicated Aerosol Nebulizer
Reference Guide
Figure 1
Figure 3
Figure 2
Figure 4
Figure 5
Figure 6
Figure 7
C.
A.
1
B.
D.
