Smiths Medical PORTEX acapella choice User Manual (English)

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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 Positive Expiratory Pressure Therapy. Review the diagram and the

product to become familiar with all of the product features.

The acapella

choice Vibratory PEP Device 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 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:

• 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 effects.

Expiratory pressures above 20 cm H

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 flow may result in failure to achieve therapeutic objectives of vibratory PEP

therapy or one or more adverse side effects below.

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

choice

Vibratory PEP Device

Reference Guide

Figure 1

Figure 2

Figure 3

Figure 4

Figure 5 Figure 6

C. A.

90°

Rib

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Smiths Medical PORTEX acapella choice Specifications

General

Brand	Smiths Medical
Model	PORTEX acapella choice
Category	Medical Equipment
Usage	Airway Clearance Therapy
Design	Handheld, portable
Resistance	Adjustable
Patient Type	Adults and children
Reusable	Yes
Sterility	Non-sterile
Color	Blue
Type	Oscillating Positive Expiratory Pressure (OPEP) device
Cleaning	Dishwasher Safe
Regulatory Compliance	CE marked