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 to function
improperly, which may deprive thepatient of therapy and cause injury
to the patient.
5.
PRECAUTIONS:
5.1 Bleach is not recommended for use on the acapella
®
choice. 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.
6.
SUGGESTED INSTRUCTIONS FOR USE:
6.1 Initial Settings:
6.1.1 If this is the first use of the acapella
®
choice device, ensure that the
frequency adjustment dial is turned counterclockwise to its lowest
frequency-resistance setting, indicated at “1”. (See Figure 2)
6.1.2 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).
6.1.3 Direct the patient to exhale to Functional Residual Capacity (FRC)
actively, but not forcefully, through the device.
6.1.4 Adjust the dial to increase the resistance.
6.1.5 The patient should be able to exhale for 3-4 seconds while the device
vibrates. Clockwise adjustment increases the resistance of the
vibrating orifice; which will allow the patient to exhale at a lower
flowrate. Counter-clockwise adjustment decreases the resistance.
6.1.6 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 “feels” from the vibratory pressure.
6.2 Procedure for the User:
6.2.1 Ensure the adjustment dial is set to the correct range as identified by
your clinician.
6.2.2 Sit with elbows resting comfortably on table.
6.2.3 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.
6.2.4 Breathe from the diaphragm, as directed by your clinician, taking in a
larger than normal breath, but not filling your lungs to capacity.
6.2.5 Hold your breath for 2-3 seconds.
6.2.6 Exhale actively, but not forcefully, through the device. Exhalation
should last approximately 3 to 4 times longer than inhalation.
6.2.7 Perform 10-20 PEP breaths as recommended by clinician.
6.2.8 Remove mouthpiece (mask) and perform 2-3 “huff” coughs to raise
secretions as needed.Your clinician may direct you on proper cough technique.
6.2.9 Repeat steps 6.2.2 to 6.2.7 as prescribed.
Note: See nebulizer set-up section.
6.3 Set-up Nebulizer
6.3.1 Review the diagrams contained with the devices.
6.3.2 A possible nebulizer and acapella
®
choice set up is reflected below.
(See Figure 3)
6.3.3 Follow set-up instructions for each device.
6.3.4 Follow cleaning instructions contained with each device.
6.3.5 Inspect device(s) on a routine basis to ensure proper use and function.
6.3.6 If damaged, do not use.
6.3.7 Verify all connections are secure.
7.
CLEANING AND DISINFECTING INSTRUCTIONS:
Precaution: Bleach is not recommended for use on the acapella
®
choice.
It may deteriorate the nickel plated mechanism located in the interior of the
device.
7.1 There are four parts to clean:
A. The mouthpiece
B. The base unit (with frequency adjustment dial)
C. The cover
D. The rocker assembly – DO NOT disassemble the rocker arm from
its platform base
7.2 Dissassembly
7.2.1 Detach mouthpiece or mask. (See Figure 4)
7.2.2 Detach the cover by placing your forefinger and thumb on the (3) ribs
located on the unit toward the mouthpiece.
7.2.3 Gently press on the ribbed surface and lift the cover up.
NOTE: The cover should only be lifted to a 90° angle. (See Figure 5)
Warning: 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 to
function improperly, which may deprive the patient of therapy and cause
injury to the patient.
7.2.4 Detach the rocker assembly by placing your forefinger and thumb.
7.3 Cleaning/Disinfecting Instructions
As per the Cystic Fibrosis Foundation’s cleaning and disinfecting guidelines
entitled, “Respiratory, Stopping the Spread of Germs” 2003, below are the
guidelines for acapella
®
choice.
Note: acapella
®
choice is for single patient use
7.3.1 Cleaning: This should be done prior to Disinfecting (7.3.2)
Cleaning with Liquid Dish Detergent:
As needed, detach mouthpiece (mask) then soak the device and mouth-
piece in warm, soapy water as required to remove visible contaminants.
Use a liquid dish detergent (Dawn or equivalent), mixing two (2) table-
spoons of detergent per one (1) gallon water. Rinse thoroughly with sterile
water, and allow parts to air dry.
Drain the device by placing it in a normal resting posiiton. (See Figure 2)
7.3.2 Disinfecting:
• Boiling – Boil device in water (100°C/212°F) up to twice daily for five (5)
minutes. In addition, Smiths Medical suggests the use of distilled or
sterile water to lessen the potential of local community, mineral-rich
tap waters from calcifying acapella
®
choice metallic components.
• Autoclaving – acapella
®
choice will functionally withstand autoclaving
at temperatures not to exceed 136°C/277°F for a maximum of 30 cycles.
• Automatic Dishwasher – acapella
®
choice is dishwasher safe. It is
recommended to place the parts on the top shelf.
• Alcohol –Soak five (5) minutes, twice daily. acapella
®
choice is
compatible with 70% isopropyl alcohol. Rinse with sterile water. You can
make water sterile by boiling for five (5) minutes.
• Glutaraldehydes (Cidex
®
or equivalent) – acapella
®
choice will
maintain its integrity using cold sterilizing solutions such as
glutaraldehydes.
8.
DISPOSAL:
Dispose of acapella
®
choice in a safe manner according to Federal/State/
Local regulations and guidelines for disposal of contaminated medical
waste.
9.
ESTIMATED DEVICE LIFETIME:
Assuming the manufacturer recommended cleaning protocol is followed,
the acapella
®
choice devise should have a useful life of six (6) months
under normal and customary usage.
The six (6) month usage duration is measured from the date of initial use.
REF
acapella
®
choice Quantity
Catalog Number
Per Carton
Mouthpiece
27-7000
10
Smiths Medical is part of the global technology business Smiths Group plc. acapella and
the Portex and the Smiths Medical design marks are trademarks of Smiths Medical. The
symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Office
and certain other countries. All other names and marks mentioned are the trademarks
or service marks of their respective owners. ©2014 Smiths Medical. All rights reserved.
RE194318EN-102014 MKEECA-0059
Smiths Medical ASD, Inc.
Keene, NH 03431, USA
Phone: +1-603-352-3812
Toll-Free USA 1-800-258-5361
www.smiths-medical.com
PRODUCT(S) DESCRIBED MAY NOT BE LICENSED OR AVAILABLE FOR SALE IN CANADA AND OTHER COUNTRIES
Caution • Latex Free • Do not use if package is damaged • Non-sterile
• Contains or Presence of Phthalate: bis(2-ethylhexyl) phthalate (DEHP)
[www.smiths-medical.com/phthalates] • Catalogue Number • Batch Code
• Date of Manufacture
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of
a physician. SINGLE PATIENT USE
f ~ : ; ‚ < = J 26
