Smiths Medical acapella Reference Manual

acapella choice Vibratory PEP System
®
Reference Guide
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
1. DESCRIPTION:
The acapella choice 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 choice Vibratory PEP system with
®
one-way inspiratory valve and 22 mm male fittings
consists of: (See Figure 1)
A. Detachable mouthpiece
(device end adapts to mask)
B. Expiratory resistance/frequency adjustment dial
C. Detachable cover
D. Detachable rocker assembly – DO NOT
disassemble the rocker arm from its
platform base
2. INDICATIONS:
The Smiths Medical acapella choice system 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
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.
4. WARNINGS:
4.1 Use of this device at excessive pressures may
have adverse effects. Expiratory pressures above
20 cm H2O 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 patient's expiratory flow 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
4.3 The rocker assembly is not designed to be
disassembled - do not attempt to separate
the rocker arm from its platform base. Separating
these components may cause the acapella
choice system to function improperly, which may
deprive the patient of therapy and cause injury to
the patient.
5. PRECAUTIONS:
5.1 Bleach is not recommended for use on the
acapella choice system. It may deteriorate the
®
nickel plated mechanism located in the interior
of the device.
5.2 DO NOT MICROWAVE. The metal and magnet
might ignite.
5.3 It is the responsibility of the user to ensure all
sterility verification(s).
5.4 Visually inspect the device to ensure that the
unit is free of contamination and foreign objects.
5.5 Verify all connections are secure.
C.
Figure 1
Figure 2
Figure 3
®
Figure 4
Rib
90°
Figure 5
B.
A.
D.
Figure 6