Westmed Acoustical Percussor User manual

Westmed, Inc. ◆ 5580 S. Nogales Highway ◆ Tucson, AZ 8570 ◆ 800.975.7987
www.westmedinc.com

71944 Revision 03 Page 1
Indications for Use. The Vibralung Acoustical Percussor is indicated as an airway
secretion clearance device that creates vibrations in the airways and as a lung expansion
device that applies Positive Expiratory Pressure (PEP) as a patient breathes through the
device. It may be used to promote bronchial drainage, airway clearance and
expectoration and to prevent or reverse atelectasis. The Vibralung may be used
simultaneously with aerosol drug delivery.
Patient Population. Cystic Fibrosis, COPD, asthma and lung diseases with secretory
problems, patients with neuromuscular disease affecting the ability to effectively cough,
and patients with or at risk of developing atelectasis. Anyone who is able to read and/or
follow verbal instructions.
Environment of Use. Hospital and home.
Contraindications. ACT or use of the Vibralung Acoustical Percussor, especially with
Positive Expiratory Pressure, may be contraindicated in patients who have untreated air
leaks, tension pneumothorax, bronchopleural fistula, recent hemoptysis, or pulmonary
hemorrhage as it may exacerbate those conditions. Prescribers should weigh the
benefits against the risks in patients with these conditions.
Adverse Reactions. If the patient complains of dry throat or mouth brought about by
treatment with the Vibralung, consider adding nebulization with normal saline if it is not
already being done. If the patient complains of sore mouth, jaw or teeth brought about
by using the Vibralung device, the healthcare practitioner should assess the patient. If
the patient complains of dizziness or light-headedness, assess the patient for possible
hyperventilation while using the device. If the patient appears to be hyperventilating,
pause the treatment and coach the patient to alter their breathing pattern appropriately.
Any other adverse reactions should be fully assessed before continuing therapy with the
Vibralung Acoustical Percussor.

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Acoustical Percussor
Instructions for Use
The Vibralung Acoustical Percussor® is used for airway clearance therapy and helps
patients with lung disease to clear mucus and phlegm from their lungs through the use of
sound waves. The patient simply breathes through a mouthpiece attached to the “Hand
Held Transducer,” or HHT, while holding on to the handle. The HHT is connected to a
small battery-operated electronic box called the “Treatment Control Unit” or TCU. The
TCU generates the sound waves and controls the treatment. See the pictures and
instructions inside this pamphlet before operating .
DEVICE DESCRIPTI N
WARNINGS!
PATIENT INJURY R INEFFECTIVE THERAPY CAN RESULT FR M IMPR PER
ASSEMBLY R PERATI N. READ THE F LL WING WARNINGS BEF RE
ASSEMBLING R PERATING DEVICE
•Federal law restricts this device to sale by or on the order of a physician.
•Read this Instructions for Use manual before use.
•Unskilled or untrained personnel should not operate or apply this device to patients.
•Use only as intended and described in this manual and supporting documentation.
•Use only on cooperative patients who can properly self-administer following training.
•Use only with the supplied mouthpiece and accessory adapters.
•Be prepared to help patient with removal of secretions (cough coaching, suction) as
needed.
•The HHT, Cone and related Y-adapters are for single patient use, multiple treatment
sessions during single hospitalization and should be changed as directed.
•Do not hold Hand-Held Transducer up to your ear. Hearing damage may result. Foam
ear plugs are provided to lessen the sound to which your ears are exposed. Wear the
ear plugs during each treatment.
•Do not connect or interface the Vibralung Acoustical Percussor to any airway clearance
device or aerosol delivery system other than the Westmed Circulaire® II or Circulaire II
Hybrid™ aerosol drug delivery system and Westmed Variable Expiratory Resistor for
Positive Expiratory Pressure (PEP) because other devices have not been designed or
ascertained to function properly with the inspiratory and exhalation gas flow pathways
of the Vibralung.

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CAUTI NS
• Do not open or attempt to disassemble either the TCU or the HHT. There are no
user-serviceable parts inside. Internal batteries are not user-serviceable. The TCU
must be returned to Westmed for service. The HHT is disposable and, if it is
damaged, it should be discarded and replaced.
• Do not over-tighten the “Cone” onto the HHT. Ensure the outlet port of the Cone is
properly aligned and the outlet port on the Cone should be aligned to the “3 o’clock”
position. See inset diagrams on page 4.
• Do not use the TCU and HHT in extremely moist and humid environments such as a
shower or outside during rain.
• Do not immerse the TCU or the HHT in liquid or allow liquid to seep into the case.
• Do not attempt to disinfect either the HHC or the TCU with boiling water, steam,
baby bottle sterilizers, dishwashers or microwave ovens.
• Use only the Battery Charger that is supplied with the TCU. Use of a different charger
may damage the batteries and/or the electronics.
• Do not operate the Vibralung Acoustical Percussor in potentially explosive, highly
flammable or oxygen-enriched atmospheres such as an operating room during use of
flammable anesthetics or in an oxygen tent, croup tent, head hood or incubator with
oxygen flowing.
• Do not use the Vibralung Acoustical Percussor with a facemask of any kind because of
the uncertainty of coupling the acoustic energy to the airways.
C MP NENT PARTS
The Vibralung Acoustical Percussor is supplied in two boxes. One box holds the reusable
Treatment Control Unit (A), and Battery Charger (C). The other box holds the disposable
Hand-held Transducer assembly (D) plus Standard Y-adapter, mouthpiece and Variable
Expiratory Resistor (E), plus an Aerosol Y-adapter (F) that can be used for aerosol
delivery. You should have all the following parts (images not to scale):
A
B
C
D
E F
Mouthpiece
Inspiratory
Valve
(purple cap)
Variable
Expiratory
Resistor
for PEP
S
crew
-
on Cone
Handle
Treatment Control
Unit (TCU)
Battery
Charger
Standard Y- Aerosol Y-adapter
Pole-mount
Clamp
(not included)
Hand-held Transducer (HHT)
A cable (not shown)
emerges from the bottom of
the handle for connecting
the HHT to the TCU

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PREPARING THE TCU F R FIRST USE
Follow these steps to charge, test and set up the Treatment Control Unit (TCU) for the
first time.
1. Remove the TCU (A) and Battery Charger (C) from their shipping box.
2. Peel adhesive backing from the four rubber feet (included in the package), and
affix them to the underside of the TCU to level it.
3. Plug the Battery Charger into a standard 120 volt electrical outlet and plug the
end of the battery charger cable into the bottom jack on the left side of the
TCU. (The Battery Charger plug will not fit in the top jack on the left side of the
TCU). All 9 Light Emitting Diodes (LEDs) should flash 3 times quickly and then
the Charging and Power LEDs should stay on during the charging process.
4. Leave the Battery Charger plugged in and connected to the TCU until the TCU’s
internal batteries are fully charged (which should take no more than 4 hours).
The Charging LED will go out and the Power LED will flash when the unit is fully
charged.
5. Disconnect the Battery Charger after batteries are charged, as the TCU will not
operate while the charger is connected.
6. After charging is completed and the charger is disconnected from the TCU,
perform a Power On Self Test (POST) to verify that the TCU software and
processor is operating properly: Turn the TCU on by pressing the Power control
button once. The POST will occur immediately as shown by all 9 LEDs flashing 3
times. If the TCU passes the POST, the Pause and Power LEDs will remain
illuminated. If other LEDs are illuminated, or if no LEDs are illuminated, the
TCU failed the POST and should not be used. Contact Westmed Customer
Service (see page 10).
7. The Treatment Control Unit (TCU) is now ready for use. Repeat these steps
every time the battery needs to be recharged, as indicated by the Low Battery
LED.
HHT ASSEMBLY WITHOUT AER S L
The assembled Vibralung Acoustical Percussor Hand-held Transducer (HHT) is shown
below. This assembly uses the Standard Y-adapter (E). Connect the long end of the
Standard Y-adapter to the cone. The mouthpiece should be at the other end and the
Variable Expiratory Resistor should be on the tail of the Y. The outlet port of the cone
should be at the 3 o’clock position as you are facing it, and the assembly should be
aligned as shown in the
“
user
’
s view
”
below:
User’s View,
“3 o’clock” alignment

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If simultaneous aerosol therapy is required, obtain and attach the Circulaire II Hybrid
aerosol delivery system as shown below. Remove the Standard Y-adapter (E), replace
with the Aerosol Y-adapter (F), and transfer the mouthpiece to the Aerosol Y-adapter.
Insert the Circulaire II Hybrid aerosol delivery system on to the tail of the Aerosol Y-
adapter as shown. The outlet port of the cone should be at the 3 o’clock position as you
are facing it, and the assembly should be aligned as shown in the
‘
Bird
’
s Eye View
’
below:
Operate the nebulizer with oxygen or compressed air. Adjust the opening of the Variable
Expiratory Resistor to apply PEP. See the Circulaire II or Circulaire II Hybrid package
insert for further instructions for use.
Bird’s Eye View
HHT ASSEMBLY WITH AER S L
BUTT NS AND SETTINGS N THE TCU
The TCU has 2 electrical jacks on the left side panel. The top jack is for connecting the
TCU to the Hand-held Transducer (HHT) and the bottom jack is for connecting the Battery
Charger.
Seven user-selectable buttons contain LEDs that illuminate when pressed. The buttons
also make a “clicking” feeling to provide tactile feedback when they are pressed. These
buttons enable the user to select from 5 control settings as shown in the legend below,
as well as a “Start/Pause” function and Power On/Off. Additionally, two LED indicators
(“Charging” and “Low Battery”) illuminate as needed to show the status of the internal
battery.
Connect HHT here
Connect Battery Charger here
ote: The TCU will not operate while the Battery Charger is plugged into it.

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Refer to physician’s prescription or caregivers instructions for appropriate settings for
the Vibralung Acoustical Percussor. Regardless of which Y-adapter is used, operation of
the Vibralung Acoustic Percussor is the same. The patient should hold the device in
one or both hands while inserting the mouthpiece into the mouth and breathing
normally throughout the treatment.
1. Power. To power on the TCU, disconnect it from the charger, plug the HHT into it,
and then press the Power On/Off button.
•The LEDs embedded in the Power and Start/Pause buttons illuminate.
•The Low Battery LED illuminates if the battery is in need of recharging.
•The Unit is in Pause mode upon powering on.
2. Mode Selection. To select and activate a setting,
•Press one of the 5 setting buttons in the top row (L, M, H, R2 or R5).
-The LED embedded in the selected setting button illuminates.
•Press the Pause button to activate the device and emit sound at the selected
setting.
-The LED embedded in the Pause button extinguishes.
•Unless stopped, paused, or held (see #5 Treatment Hold below) the unit will
operate at the selected setting for 10 minute and then
terminate.
•Press the Pause button at any time while activated to
pause the session.
-The LED embedded in the Pause button illuminates.
•Press the Pause button while paused to resume the
session.
-The LED embedded in the Pause button extinguishes.
•If a paused session is not resumed within 2 minutes by pressing the Pause
button again, the session automatically terminates.
Important: If a different treatment mode is desired before the currently selected mode
has terminated, it is necessary to power the TCU off, then power it on again and select
the desired mode.
Button Label Action
Control button to select “Low” frequency setting (~5 – 350 Hz).
Control button to select “Medium” frequency setting (~5 – 0 Hz).
Control button to select “High” frequency setting (~5 – 1,200 Hz).
Control buttons to select either a 2- or 5-minute period of Random Noise.
Control button to Start, Pause or Resume a treatment session.
Control button to turn the TCU on or off.
PERATING INSTRUCTI NS
Charging & Low
Battery LEDs

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PERATING INSTRUCTI NS (continued)
TREATMENT SETTINGS
A selected treatment setting with the Vibralung Acoustical Percussor takes up to 10
minutes, depending upon the setting that has been selected, and provided the session
has not been paused or held at any time. Five settings, representing a designated
sequence of frequency ranges, have been programmed into the Treatment Control Unit
as shown in the following table.
SETTING DESCRIPTION
L (Low) ~ 5-350 Hz 10 minutes of Low Frequency Tones
M (Medium) ~ 5- 0 Hz 10 minutes of Medium Frequency Tones
H (High) ~ 5-1,200 Hz 10 minutes of High Frequency Tones
R2 5-1,200Hz 2 minutes of Random Noise
R5 5-1,200Hz 5 minutes of Random Noise
3. Resume, Terminate, Repeat. To resume an automatically terminated session, or
repeat a session with the same settings, or start a different session with different
settings, repeat steps 1 and 2 above and select the appropriate settings.
4. Treatment Mode. To take the treatment, the patient should place the
mouthpiece in his or her mouth and seal their lips around it just tightly enough
to maintain a comfortable seal. The teeth may rest gently on the mouthpiece
but the patient should be cautioned to not bite down or chew on the soft plastic
mouthpiece.
5. Treatment Hold. The patient has the option to hold the therapy for up to 2
minutes. This may be indicated if the patient perceives a point in time that the
treatment feels especially beneficial. The treatment hold is applied by pressing
and releasing the mode button (L, M, or H) that is currently selected. The
treatment hold will be indicated by the blinking LED embedded in the Power
button. The treatment hold may be discontinued before the 2 minutes has
expired by again pressing and releasing the mode button that is currently
selected. The LED embedded in the Power button will stop blinking. Treatment
hold time will be added to the total treatment time.
6. Patient Position. Avoid recumbent patient positioning while using the Vibralung
Acoustical Percussor. Patient should be sitting upright or at no more than a 30°
recumbent angle to facilitate coughing and expectoration.
7. Breathing Pattern. The patient should breathe normally during the treatment.
As with any breathing treatment, hyperventilation or excessively deep or fast
breathing may result in dizziness or light-headedness. The treatment may be
paused at any time and resumed if the patient needs to rest.
8. Positive Expiratory Pressure (PEP) Therapy. Adjust the Variable Expiratory
Resistor to apply PEP during resting breathing. Minimal PEP is applied when the
orifice is wide open ( 0°) and maximal PEP when the orifice is at the minimal
position (10°). An optional PEP manometer is available so that PEP levels can be
monitored. Minimal PEP levels will be observed during quiet tidal breathing due
to relatively low respiratory flowrates. If desired, the patient may be instructed
to perform an extended PEP maneuver by taking a deep breath and then
exhaling slowly while maintaining an expiratory flowrate sufficient to keep the
PEP manometer in the 10 to 20 cmH2O pressure range for 3 to 5 seconds. This
maneuver can be repeated 10 to 20 times or as often as desired for the patient.

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TREATMENT SETTINGS (continued)
A treatment session may consist of the application of one or more settings,
depending upon the target area(s) of the lungs to which therapy should be
directed, patient preference and patient response to therapy. In theory, lower
frequency tones are effective on larger, wider airways while higher frequency
tones are effective on smaller, thinner airways. Therapeutic benefit(s) may not
necessarily be rendered on the first treatment, or even the first few treatments.
It may require an indeterminate number of treatment sessions, 2 to 4 times
daily, before benefits become apparent.
SIMULTANE US AER S L THERAPY
The Circulaire II Hybrid aerosol delivery system may be used with the Vibralung
Acoustical Percussor if wetting agents or inhalation medications are prescribed. The
Circulaire II Hybrid is the only nebulizer system approved for use with the Vibralung
Acoustical Percussor. The Vibralung includes an Aerosol Y-adapter that allows connecting
the Circulaire II Hybrid to the HHT, as shown in the bottom figure on page 5.
The Circulaire II Hybrid, when attached to the Vibralung Acoustical Percussor with the
Aerosol Y-adapter, provides a direct pathway for inhalation and exhalation. The Aerosol
Y-adapter provides a direct pathway for the sound waves to travel through to enter the
mouth and the lung. In this manner, the acoustical energy remains coupled to the
patient’s lungs during inhalation and exhalation while the aerosol treatment is taking
place.
Further, PEP therapy can also be administered by way of the Circulaire II Hybrid, which
has a Variable Expiratory Resistor on the exhalation port. Finally, because many of the
patients who may benefit from airway clearance therapy and aerosol therapy with the
Vibralung Acoustical Percussor also have pulmonary infections, an exhalation filter is
included in the exhalation pathway of the Circulaire II Hybrid to prevent medications and
patient droplets from being emitted into the room and possibly inhaled by caregivers or
other patients.
WARNING - Do not connect or interface the Vibralung Acoustical Percussor to
any airway clearance device or aerosol delivery system other than the
Westmed Circulaire® II or Circulaire II Hybrid™ aerosol drug delivery system
and/or Westmed Variable Expiratory Resistor for Positive Expiratory Pressure
(PEP) because other devices have not been designed or ascertained to
function properly with the inspiratory and exhalation gas flow pathways of
the Vibralung.