Secretion Induction
Device for Diagnostic Use
INSTRUCTION FOR USE
The Lung FLuTe
®
is indicated for the collection of
sputum samples for laboratory analysis and pathologic
examination.
The Lung FLuTe
®
has been designed to induce
sputum for diagnostic purposes. Over the past 45
years, sputum induction has been used for multiple
diagnostic applications. In 1997, the Canadian Thoracic
Society published a training manual entitled “Sputum
examination for Indices of Airway Inflammation:
Laboratory Procedures”.
1
A significant portion of the
manual focused on sputum induction and asthma. The
following conditions have been diagnosed with the
assistance of induced sputum:
n
Pneumonia
2
n
Tuberculosis
3
n
Chronic bronchitis
4, 5, 12
n
eosinophilic bronchitis
5, 6
n
emphysema
5
n
Asthma
1, 4, 7, 8
n
Childhood asthma
9
n
Occupational asthma
10
n
Lung cancer
11
n
Cystic fibrosis
12, 13
n
Bronchiectasis
12
n
Pulmonary sarcoidosis
14, 15
n
Pneumoconiosis
15
n
nongranulomatous ILD
15
To Healthcare Professionals:
If there are any questions about the Lung FLuTe
®
or
these instructions, contact Medical Acoustics at the
address on the cover panel of these Instructions for
use.
The patient may notice thinned secretions collecting
at the back of his/her throat for several hours after the
session. This is normal. A drink of water can prevent
minor throat irritation.
7
Recommended length of a session
A session should range between 5 to 10 minutes,
depending on the patient’s pulmonary condition.
8
Important Tips
•
When inhaling, the patient should remove the
Lung FLuTe
®
from his/her mouth.
•
Pointing the Lung FLuTe
®
slightly toward the floor
may make it work more efficiently.
•
To avoid dizziness or shortness of breath while
using the Lung FLuTe
®
, he/she should take more
time between each set of two blows.
9
Product Performance Data
Frequency
16–25Hz
Minimal flow rate
128.4 L/min
Minimal pressure
1.0 cm H
2
O
Sound output
68 dBA
*
Pressure resistance
1.0 cm H
2
O
*
Measured with a standard general Radio 1933 Precision
Sound Level Meter. OSHA limit over a 15 min. interval is 115dBA
CFR 29.1910.95 (b)(2)
Bibliography
1
efthimiadis, A., Pizzichini, e., Pizzichini, M. M. M., & Hargreave, F. e. (1997).
Sputum examination for indices of airway inflammation: laboratory procedures.
Canadian Thoracic Society; Astra Draco AB, Lund Sweden.
2
Bigby, T. D., et al (1986). The usefulness of induced sputum in the diagnosis of
Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency
syndrome. Am. Rev. Respir. Dis. Apr., 133(4), 515-518.
3
Hensler, n. M., Spiney, Jr., C. g., & Dees, T. M. (1961). The use of hypertonic
aerosol in production of sputum in diagnosis of tuberculosis. Comparison with
gastric specimens. Dis. Chest. 40, 639-642.
4
Tomaki, M., et al (1995). elevated substance P content in induced sputum from
patients with asthma and patients with chronic bronchitis. Am J. Respir Crit. Care
Med., Mar, 151(3 Pt 1), 613-617.
5
Hargreave, F., Leigh, R. (1999). Induced sputum, eosinophilic bronchitis, and chronic
obstructive pulmonary disease. Am. J. Respir. Crit. Care. Med., 160, S53-57.
6
gibson, P. g., Fujimura, M., niimi, A. (2002). eosinophilic bronchitis: clinical
manifestations and implications for treatment. Thorax, 57, 178-182.
7
Pin, I., et al (1992). use of induced sputum cell counts to investigate airway
inflammation in asthma. Thorax, Jan, 47(1), 25-9.
8
de la Fuente, P. T., et al (1998). Safety of inducing sputum in patients with asthma
of varying severity. Am J. Respir. Care Med., 157, 1127-1130.
9
Li, A. M., et al (2005). Induced sputum in childhood asthma. Hong Kong Med.
J.,11, 289-94.
10
Moscato, g., Malo, J. L., Bernstein, D. (2003). Diagnosing occupational asthma:
how, how much, how far? eur. Respir. J., 21, 879-885.
11
Fontana, R.S., et al (1965). Value of induced sputum in cytologic diagnosis of lung
cancer. JAMA, Jan 11, 191, 134-6.
12
Richman-eisenstat J. B., et al (1993). Interleukin-8: an important chemoattractant
in sputum of patients with chronic inflammatory airway diseases. Am J. Physiol.,
Apr, 264(4 Pt 1), L413-8.
13
Ordonez, C. L., et al (2003). Inflammatory and microbiologic markers in induced
sputum after intravenous antibiotics in cystic fibrosis. Am J. Respir. Crit. Care Med.,
168,1471-1475.
14
Aisner, S. C., gupta, P. K., Frost, J. K. (1997). Sputum cytology in pulmonary
sarcoidosis. Acta. Cytol., May-Jun, 21(3), 394-398.
15
Olivieri D., D’Ippolito, R., Chetta, A. (2000). Induced sputum: diagnostic value in
interstitial lung disease. Curr. Opin. Pulm. Med., Sept, 6(5), 411-414.
REED
(shown installed in horn)
Mouthpiece
Lung FLuTe is a registered trademark of Medical Acoustics, LLC
©2010 Medical Acoustics, LLC
u806 Rev. A (06 /2011)
2
How the LUNG FLUTE
®
works
When the patient blows out through the Lung FLuTe
®
,
as if blowing out a candle, his/her breath moves the
reed inside. This causes acoustic vibrations that thin
and loosen secretions deep in the lungs and results in
the secretions moving progressively up the patient’s
airway until they collect at the back of the throat (see
Figure 2 below).
3
Proper use of the LUNG FLUTE
®
Proper use of the Lung FLuTe
®
is important to
successfully obtain a sputum sample. Although the
method presented here works well for most users,
“individualizing” the technique for the patient’s specific
condition may be necessary in order to obtain the best
results.
4
Preparing to use the LUNG FLUTE
®
1.
The patient may want to have a glass of water
available to drink after use of the device.
2.
The patient should get into a relaxed position.
He/she should sit up straight so his/her back is not
touching the back of the chair, and should tilt the
head slightly downward so the throat and
windpipe are wide open (See Figure 2, left). This
allows acoustic waves to flow into the lungs from
the Lung FLuTe
®
.
3.
If the patient is bedridden, have him/her sit as
upright as possible in a position that will not restrict
the smooth breathing effort.
5
Stage One: Secretion Loosening and
Mobilization
The patient should hold the Lung FLuTe
®
pointing
down, as shown in Figure 2, inhale a little deeper than
normal, place his/her lips completely around the
mouthpiece, and gently blow out through the Lung
FLuTe
®
as if trying to blow out a candle. As the patient
blows, he/she will hear the reed inside the Lung
FLuTe
®
make a fluttering noise as it moves. The
patient should concentrate on making this sound.
next, the patient should remove the mouthpiece from
his/her mouth, quickly inhale again, put the
mouthpiece back in his/her mouth, and blow gently
through the Lung FLuTe
®
.
The patient should then remove the mouthpiece again
and wait five seconds, taking several normal breaths.
To achieve adequate results, it is suggested that the
patient complete 20 sets of 2 blows each. Individual
results may vary (See Section 3).
Reminder: The patient only needs to blow through the
mouthpiece with as much force as they would to blow
out a candle. They should not force a cough or use
their diaphragm or stomach muscles to try to force out
more air.
6
Stage Two: Secretion Elimination
The patient should let the Lung FLuTe
®
do the work.
The Lung FLuTe
®
will thin and loosen secretions.
The patient should wait five minutes after the session
for secretions to collect at the back of the throat and
then start to cough vigorously. The patient should then
spit sputum produced by coughing into a sample
collection cup.
WARNINGS
• The patient should not attempt to inhale through
the Lung FLuTe
®
.
• For single patient use only – do not sterilize.
• If the patient experiences shortness of breath and/or
dizziness, discontinue use of the Lung FLuTe
®
.
• A transient throat irritation, lasting less than 24 hours,
was noted in some participants in clinical trials.
• Bronchoconstriction may occur (approx. 5%
frequency based on clinical trial).
• Individuals who cannot follow a healthcare professional’s
verbal instructions should not use the Lung
FLuTe
®
:
Specifically, young individuals who cannot follow
verbal instructions and adults who, due to physical or
mental challenges, cannot follow verbal instructions
from a healthcare professional.
1
What is the LUNG FLUTE
®
?
The Lung FLuTe
®
is a disposable device used to help
loosen, mobilize, and obtain a sputum sample from the
airways. The Lung FLuTe
®
consists of the following
components: a mouthpiece and a reed inside a horn
(see Figure 1 below).
2
REED
(shown installed in horn)
Mouthpiece
1
Secretion Mobilization
and Induction Device
Dual-Indication for
Diagnostic & Therapeutic Use
u.S. Patent numbers: 6,702,769 & 6,984,214
Manufactured in the uSA for:
Medical Acoustics, LLC
640 ellicott St., Buffalo, nY 14203 uSA
(716) 759-6339 (888) 820-0970
www.lungflute.com
REED
(shown installed in horn)
Mouthpiece
INDICATIONS FOR USE
•
The Lung FLuTe
®
(Therapeutic) is indicated for
Positive expiratory Pressure (PeP) therapy.
•
The Lung FLuTe
®
is indicated for the collection
of sputum samples for laboratory analysis and
pathologic examination.
The Lung FLuTe
®
is a disposable device.
Single patient use device
nOn-STeRILe
1004-01
Quantity:
1
REF
CAUTION: Federal law restricts this
device to sale by or on the order of
a physician.
U806_U806 6/29/11 12:02 PM Page 1
