The DHD Acapella is intended for use in conjunction with a medical need for Positive Expiratory Pressure (PEP) Therapy. It may also be used simultaneously with nebulized aerosol drug delivery.

The Acapella system consists of:

1. Removable mouthpiece (Mask options are also available).

2. Acapella vibratory PEP device with 22 mm male fittings including:

A. Expiratory resistance/frequency adjustment dial.

B. One-way inspiratory valve.

C. Patient end which adapts to mouthpiece, or mask (if pressure monitoring feedback is desired the DHD TheraPEP pressure port may be inserted).

D. Mouthpiece (detachable).

Acapella System Set-Up:

• Review the diagram and the product to become familiar with all of the product features.
• Visually inspect the device to ensure that the unit is free of contamination and foreign objects.
• If using a pressure gauge/indicator, ensure it is connected to the pressure port between the mouthpiece and the device.
• Verify all connections are secure.

Acapella Principle of Operation:

Acapella directs exhaled air through an opening which is periodically closed by a pivoting cone. As air passes through the opening, the cone alternately closes and opens the air flow path. The result is a vibrating pressure waveform. For most users, frequencies between 0-30 Hz are obtained while maintaining positive pressure throughout the exhalation process. This is referred to as vibratory PEP therapy.

Through adjusting the dial, the frequency of the vibrating pressure-waves and the resistance of the opening changes. The higher the frequency of vibrations, the higher the effective resistance will be. GREEN  Acapella DH is recommended for patients able to maintain an expiratory flow 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.

Acapella is available with mouthpiece, masks(three sizes) and may be used with a pressure gauge (for visual feedback) through the addition of the pressure port referenced in the chart on the back cover.

Acapella Initial Settings

• If this is the first use of Acapella, ensure that frequency adjustment dial is turned counterclockwise to lowest frequency-resistance setting.
• Instruct the patient to relax while performing diaphragmatic breathing and inspiring a volume of air larger than normal tidal volume (but not to total lung capacity).
• Direct the patient to exhale to functional residual capacity (FRC) actively, but not forcefully through the device.
• The patient should be able to exhale for 3-4 seconds while the device vibrates. If the patient cannot maintain an exhalation for this length of time, adjust the dial clockwise. Clockwise adjustment increases the resistance of the vibrating orifice, which will allow the patient to exhale at a lower flow-rate.
• Selection of the proper resistance range produces the desired inspiratory to expiratory (I:E) ratio of 1:3 to 1:4.

            Note: If the desired resistance and I:E ratio cannot be achieved, consider use of      an Acapella device designed for alternate flow ranges.

• Once the proper range has been identified, the patient may be instructed to exhale harder or softer, or dial adjustments may be made to optimize the response the user ""feel"" from the vibratory pressure.
• Several uses may be needed to ensure that the individual patient needs are being met.

1. Ensure the adjustment dial is set to correct range as identified by your clinician.

2. Sit with elbows resting comfortably on table.

3. Place mouthpiece lightly in mouth.

• Be sure to maintain a tight seal on the mouthpiece during exhalation.
• Your clinician may recommend the use of a nose clip if necessary.
• If using a mask, apply mask tightly but comfortably over nose and mouth.

4. Breathe from the diaphragm, as directed by your clinician, taking in a larger than normal breath, but not filling your lungs to capacity.

5. Hold your breath for 2-3 seconds.

6. Exhale actively, but not forcefully, through the device. Exhalation should last approximately 3 to 4 times longer than inhalation.

7. Perform 10-20 PEP breaths as recommended by clinician. Remove mouthpiece (mask) and perform 2-3 ""huff"" coughs to raise secretions as needed. Your clinician may direct you on proper cough technique.

8. Repeat steps 2 to 7 as prescribed.

Cleaning instructions:

As needed, detach mouthpiece (mask) then soak the parts in warm soapy water, rinse and dry. Drain the device by placing the unit with the mouthpiece (mask) end downward, or by resting the unit on its side.

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.
• Intracranial pressure (ICP) > 20 mm Hg.
• Recent facial, oral, or skull surgery or trauma.
• Esophageal surgery.
• Untreated pneumothorax.
• Known or suspected tympanic membrane rupture or other middle ear pathology.
• Hemodynamic instability.
• Acute sinusitis.
• Epistaxis.
• Active hernoptysis.
• Nausea

Warnings:

Use of this device at excessive pressures may have adverse effects. Expert clinical judgment should be exercised in the selection of the appropriate settings for each individual patient.

Adverse Reactions:

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; and pulmonary barotrauma.

Non-Sterile

Single Patient Use

Do Not Autoclave

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Caution: It is important that the device instructions for the Acapella, as well as the intended nebulizer, are understood and used according to the manufacturer's Instructions For Use.

Set-Up Nebulizer: Review the diagrams contained with the devices. Follow set-up instructions for each device. Follow cleaning instructions contained with each device. Inspect device(s) on a routine basis to ensure proper use and function. If damage

Acapella and TheraPEP are registered trademarks of DHD Healthcare Corporation.