Micro Direct PulmoLife Manuale utente
Pu
lmoLife Spirometer
Operating Manual
F
ederal (U
SA) law restricts this device to sale by or on the order of a physician or licensed
practitioner.
Micro Direct, Inc.
803 Webster Street
Lewiston, ME 04240
1-800-588-3381
www.mdspiro.com
064-45 US
Issue 1.9
February 2016
Table of Contents
Introduction ........................................................................................................................ 2
Contraindications................................................................................................................ 2
Warnings and Cautions ...................................................................................................... 2
Intended Use...................................................................................................................... 4
Entering Patient Details ...................................................................................................... 4
Performing a Test............................................................................................................... 5
Cleaning............................................................................................................................. 7
Calibration Check ............................................................................................................. 10
Service ............................................................................................................................. 10
Battery.............................................................................................................................. 11
Product Lifetime ............................................................................................................... 12
Predicted Value Set Up .................................................................................................... 12
Version............................................................................................................................. 13
Troubleshooting Information ............................................................................................. 13
Safety Designation Per IEC 60601-1 ................................................................................ 15
Electromagnetic Compatibility (EMC) ............................................................................... 16
Specifications ................................................................................................................... 22
Accessories...................................................................................................................... 23
Symbols ........................................................................................................................... 24
References....................................................................................................................... 25
I
nt
roduction
The PulmoLife unit measures the Forced Expiratory Volume in the First Second of
Expiration (FEV1) and the FEV1 as a Percentage of the Predicted Value (FEV1
%
predicted). The use of FEV1 is a useful diagnostic tool for early detection of C
OPD
1
. The
B
EFORE USING YOUR PULMOLIFE YOU MUST REMOVE THE BATTERY
CONNECTION TAB
Contraindications
Acute disorder affecting test performance (e.g. Vomiting, nausea, vertigo)
Recent eye surgery (increases in intraocular pressure spirometry.
Oral or facial pain exacerbated by mouthpiece
Recent myocardial infarction
PLEASE NOTE
: Extensive exhalation might lead to syncope
Warnings and Cautions
The following terms are used as follows in this manual
CAUTION
: Possibility of injury or serious damage
WARNING
: Conditions or practices that could result in personal injury
PLEASE NOTE
: Important information for avoiding damage to the instrument or facilitating
operation of the instrument.
CAUTION: Read the manual before use
CAUTION: For batteries, do not attempt to charge, connect
improperly, or dispose of in fire as there is possibility of leakage
disposal.
WARNING: The instrument is not suitable for use in the presence
of explosive or flammable gases, flammable anesthetic mixtures
or in oxygen rich environments.
P
L
E
A
S
E
N
O
T
E
: The product and the battery you have
purchased should not be disposed of as unsorted waste. Please
utilize your local recycling facility for the disposal of this product.
PLEASE NOTE: Degree of protection against Ingress of Water is
IPX0.
Intended Use
The intended use of PulmoLife is to quickly and easily screens smokers for early detection
of Chronic Obstructive Pulmonary Disease (COPD). The effects of COPD in smokers are
normally detectable from the age of 35.
The measurement taken from the unit can help in the diagnosis, management and
treatment during the early stages of COPD development.
smokers to understand the physical damage caused by smoking
The PulmoLife is designed for use by clinicians and health care professional.
Entering Patient Details
Patients predicted values are based on their Sex, Height, Age and Race (default predicted
value set shown on box, to change see Predicted Value Set Up)
Switch the unit On to begin.
When entering the details use the Scroll Up / Down keys to change
values and the Enter key to accept and proceed.
Enter Sex (Male/Female)
Enter Height (cm for ECCS and Asian, inches for NHANES III)
Enter Age (Default is 45)
Enter Race (for ECCS and NHANES III only)
The display will show the blow symbol and 0.00.
Perfor
ming a Test
See further instructions on flap in the PulmoLife box.
Insert a new disposable one-way valve mouthpiece into the turbine holder. With the display
showing the blow symbol and 0.00.
Instruct the patient to breathe in until their lungs are completely full, seal
their lips around the mouthpiece, and blast out as hard and as fast as possible for at least
one second. After one second the unit will emit a beep to signal the end of the blow.
IMPORTANT NOTE:
The rear of the turbine must not be obstructed during the blow.
The FEV1 and FEV1% predicted will be displayed.
If a blow is too slow at the beginning of the manuveur
3
, the blow icon will flash
assessing this test as poor quality and the test should be repeated. After a full inspiration,
the patient should be encouraged to blast out the air as fast as possible without hesitation.
When FEV1% predicted is less than or equal to 80% of predicted, the FEV1% predicted
value will flash indicating the possibility of airways obstruction.
Press the Scrolling Down -90 years) and
smoker visual. A patien
to a maximum age of 90.
Use the scrolling Up / Down keys to move back and forth between both results
screens.
Press Enter to perform a new blow.
It is recommended that a spirometry result should be taken from the best of 3 technically
correct blows.
To test another patient the unit must be switched off and on and then enter the new patient
details.
Cleaning
Disinfection of contaminated parts is only effective after careful preliminary cleaning.
It is recommended that you use a MicroCheck one-way valve disposable mouthpiece
(3395) with the PulmoLife unit. With the use of a new disposable mouthpiece for each
patient, the transducer and must be sterilized once a week.
CAUTION
: Switch off the device before cleaning.
The external housing of the PulmoLife may be wiped may be wiped with a disinfection wipe
such as a Protex wipe (order #48-70). This should be performed after every patient.
To remove the turbine, simply press the turbine from the rear, without excessive force, and
the turbine will pop out.
The turbine may now be immersed in warm soapy water for routine cleaning or immersed
in cold disinfecting solutions for a maximum of 10 minutes (Alcohol and chlorine solutions
MUST be avoided).
PLEASE NOTE
: Do not use alcohol or chloride based solutions.
After cleaning/sterilizing, the turbine should be rinsed in distilled water and left to dry.
Do not use objects, such as pens or cotton buds, to clean or dry the turbine, as this may
cause irreparable physical damage.
Indice
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