MIR Spirobank Smart User manual

Spirobank Smart
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Ver.2.4 User Manual Page 1 of 27
Before you use your spirobank Smart, please read this user manual,
the labels and all the information provided with the product.
User Manual Rev 2.4
Issue Date 16 January 2018
0476
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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CONTENTS
1. INTRODUCTION ....................................................................................................................... 4
1.1 Intended use................................................................................................................. 4
1.1.1 Usage environment .................................................................................................. 4
1.1.2 Restrictions on Use ................................................................................................... 4
1.2 Description of product.................................................................................................. 5
1.3 Information on the parameters measured by SPIROBANK SMART ............................... 5
1.4 Determining your baseline values................................................................................. 6
2. OPERATING THE SPIROBANK SMART....................................................................................... 7
2.1 Inserting the batteries .................................................................................................. 7
2.2 Installing the MIR SPIROBANK SMART application........................................................ 7
2.3 Connection between SPIROBANK SMART and smartphone .......................................... 8
2.4 Performing the test ...................................................................................................... 8
2.4.1 Evaluating the test .................................................................................................... 9
2.4.2 Results diary ........................................................................................................... 10
2.5 Important safety warnings.......................................................................................... 10
2.6 Data security warnings ............................................................................................... 11
2.7 Warnings for use in electromagnetic environments ................................................... 12
2.8 Notes on FCC certification .......................................................................................... 12
3. CARE AND CLEANING ............................................................................................................ 13
3.1 Cleaning and disinfection of the turbine..................................................................... 13
3.2 Cleaning and disinfection of the mouthpiece ............................................................. 14
3.3 Cleaning of the device ................................................................................................ 15
3.4 Replacing batteries ..................................................................................................... 15
4. ERROR MESSAGES & TROUBLESHOOTING............................................................................. 16
4.1 Error messages ........................................................................................................... 16
4.2 Troubleshooting ......................................................................................................... 16
5. Accuracy and Reliability......................................................................................................... 17
6. LABELS & SYMBOLS ............................................................................................................... 18
7. TECHNICAL SPECIFICATIONS.................................................................................................. 19
8. Bluetooth Wireless Technology Information ......................................................................... 20
8.1 Radio frequency (rf) communication .......................................................................... 21
8.2 Radio frequency (rf) interference from other wireless devices................................... 22
9. INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT..................... 23
10. WARRANTY TERMS........................................................................................................... 27

Spirobank Smart
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Ver.2.4 User Manual Page 3 of 27
Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product.
Before you use your SPIROBANK SMART, please read this user manual, the labels and all the
information provided with the product.
Before connecting SPIROBANK SMART to a smartphone, install the application developed to
show data measured by the device.
The package includes:
•The SPIROBANK SMART device
•The turbine sensor
•The plastic mouthpiece
•2 AAA batteries
•User Manual
After removing the device from its packaging, check that there is no visible damage. If there
is, do not use the device and send it straight back to the manufacturer for replacement, where
appropriate.
Keep the original packaging!
If your product has a problem, use the original packaging to ship it back to your local
distributor or the manufacturer.
The manufacturer’s address is as follows:
MIR SRL
VIA DEL MAGGIOLINO, 125 - 00155 ROMA (ITALY)
Tel ++ 39 0622754777 - Fax ++ 39 0622754785
Website: www.spirometry.com - Email: [e-mail]
MIR cannot be held responsible for any damage caused by users failing to follow these
instructions and/or the warnings contained in this manual.

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1. INTRODUCTION
1.1 Intended use
SPIROBANKSMART spirometer is intended to be used by a physician or by a patient under the
instruction of a physician or paramedic. The device is intended to test lung function and can
make spirometry testing in people of all ages, excluding infants and neonates.
SPIROBANKIt can be used in any setting.
1.1.1 Usage environment
SPIROBANKSMART is used in the factory, in the hospital, in the doctor’s office.
1.1.2 Restrictions on Use
Analysis of the test results alone will not be enough to diagnose your clinical condition –you
will need a medical examination which will take your clinical history into account as well as
any other tests recommended by the doctor.
Diagnosis and appropriate treatments are to be given only by a qualified doctor.
The device is intended for use by one person only. If more than one person wishes to use the
device, one user’s measurements must not be attributed to another. If another person intends
to use the device permanently, the previous user data must be erased from the memory and
the new user’s details data (date of birth, origin, weight, height, sex) must be entered.
If you wish to use the device when it has already been used by another person, make sure to
disinfect the mouthpiece and turbine, as explained in the Maintenance section.

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1.2 Description of product
SPIROBANK SMART is a pocket-sized system for measuring the
following respiratory parameters:
•PEF (Peak Expiratory Flow)
•FEV1 (Forced Expiratory Volume in 1 sec)
•FVC (Forced Vital Capacity)
•FEF2575 (Average flow between 25% and 75% of the FVC)
•FEV6 (Volume expired in the initial 6 seconds of the test)
•FEV1/FVC (Tiffeneau index)
The device connects to a smartphone via Bluetooth SMART
technology. Connection is automatic once the MIR SPIROBANK
SMART application has been installed on the smartphone.
Measurement is performed by a turbine sensor, and is based on
the infrared interruption principle. This principle ensures that the
measurement is accurate and reproducible.
The advantages of this type of sensor are:
•Unaffected by the humidity and density of the gas
•Shockproof and unbreakable
•Inexpensive to replace
The measurements are transferred in real time from the device to the smartphone.
1.3 Information on the parameters measured by SPIROBANK
SMART
PEF is the maximum speed of the air when you exhale as hard as possible after filling your
lungs completely.
FEV1 is the volume of air expelled during the first second of the same exhalation.
FVC is the volume of air expelled during the total exhalation.

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FEF2575 is the average flow between 25% and 75% of the total volume of air expelled during
the total exhalation (FVC)
FEV6 is the volume expired in the initial 6 seconds of the test.
For each of these parameters, the result is a number shown on the smartphone screen.
A high number (associated with a green light) usually means that the air is moving easily
through your lungs. If you have asthma (or another respiratory disease) and have an
obstructive episode, the air cannot generally be expelled as forcefully as possible, so your
parameters will be lower.
SPIROBANK SMART thus helps you find out what sort of obstruction you have, if any, at a
particular time.
By using the device on a regular basis, you can track any changes that may occur in the
parameters. These changes may require appropriate treatment, as prescribed by your doctor.
It is recommended to use the device twice a day, in the morning on waking and at bedtime.
If possible, the device should also be used as soon the first signs of respiratory problems occur,
so that you can understand how serious your respiratory problem is and/or how well your
current therapy is working.
In addition to displaying the PEF, FEV1 or FVC measurement, the device also provides a normal
baseline value.
the Calculation of the graphic reading is an alternative to using the standard baseline value,
but the best way of finding out your personal baseline value is to discuss it with your doctor.
This value is normally called the personal best value. Please refer to the section
determining your baseline value for a clear understanding of the baseline value.
1.4 Determining your baseline values
A measure with a high value usually means that your airflow is good.
The best way to determine what are a healthy parameters for you is to discuss this with your
physician or other licensed healthcare professional. In fact the importance of any changes in
airflow from one measuring to the next depends upon how much they are different from your
baseline value you should reach when you are in healthy physical condition.
Your physician or other licensed healthcare professional will use one of two possible ways to
identify your baseline value. The first method adopts the predicted value calculated according

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to the results of epidemiological studies of large groups of healthy subjects of your same age,
height, sex, and origin. The second method adopts the personal best value you can reach when
you are in the healthiest physical condition.
The application can calculate the predicted value, i.e. the expected value for healthy people,
depending on age, height, sex, and origin. Application calculates the predicted value that has
been endorsed by ATS (American Thoracic Society): GLI-2012 All-Age Multi-Ethnic Reference
Values by Philip H. Quanjer, Sanja Stanojevic, Janet Stocks, Tim J. Cole. For PEF the predicted
values are calculated according to Knudson, R. J., Slatin R. C., Lebowitz, M. D., Burrows, B., The
Maximal Expiratory Flow-Volume Curve –Normal Standards, Variability, and Effects of Age,
AM REV RESPIR DIS, 1976 113;587-600.
In this case, the predicted value becomes the baseline value for your treatment plan. If your
physician or other licensed healthcare professional prefers this method, the application
provides the calculation of the predicted value.
It is important to know that these predicted values are average numbers for large groups of
people. You may have a higher measures than the predicted value and you may not be healthy.
Or you may have a lower measures than the average and be healthy.
CAUTION: no matter which method your physician or other licensed healthcare
professional prefers to use, it is important that you clearly understand the meaning of
your baseline value and how it relates to your treatment plan. if you have trouble
determining your baseline value, ask your physician or other licensed healthcare
professional for assistance.
2. OPERATING THE SPIROBANK SMART
2.1 Inserting the batteries
Follow the instructions in the Maintenance section for correct battery insertion.
2.2 Installing the MIR SPIROBANK SMART application
Before measuring the PEF, FEV1or FVC you need to install application on your smartphone.

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2.3 Connection between SPIROBANK SMART and smartphone
Connection between the SPIROBANK SMART and the smartphone is automatic. To check
whether there is a connection, read the messages from the application.
2.4 Performing the test
In order to perform the test properly, please follow the instructions below.
1
Push the turbine into the slot until it stops
2
Turn the turbine clockwise until it stops
3
Insert the mouthpiece at least 0.5 cm into
the turbine socket.
4
Pick up the SPIROBANK SMART with your
hand as if it were a cell phone.
Make sure not to obstruct the turbine
with your hand.
5
Insert the mouthpiece in your mouth beyond your teeth, and close your lips tightly over it so
that the air you breathe has to pass only through the mouthpiece.

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To prevent turbulence that might otherwise affect the results do not put your tongue in the
mouthpiece. Do not bend your neck.
6
Blow out as hard as you can.
It is best to do the test standing or sitting
upright. (makes no difference to test
results)
7
After exhalation, slowly remove the
device from the mouth and check the data
on the smartphone.
When SPIROBANK SMART is out of your
mouth, avoid sudden movements
because this will push air into the turbine
and a flow value will be measured that
may affect the test results.
Repeat the test three times. SPIROBANK
SMART will save the highest value.
2.4.1 Evaluating the test
Three tests are performed per measurement session, after which the MIR SPIROBANK SMART
application automatically selects the highest value and compares it with the baseline value
(normal or personal best) set during configuration

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2.4.2 Results diary
The test results are automatically stored on the smartphone and can be displayed later.
Medical studies have shown that if your doctor examines the test results on a regular basis,
lung disease can be managed much better.
2.5 Important safety warnings
Warning: indicates a potentially hazardous situation which, if not prevented, could
result in minor or moderate injury to the user or patient or damage the device.
Special WARNING should be given to testing elderly subjects, children and
differently-able persons
The manufacturer cannot be held responsible for damage caused by the failure of
the user to follow these instructions correctly.
Only original accessories as specified by the manufacturer must be used with the
device.
Periodically check that no impurities or foreign bodies, such as skin, hairs have
deposited inside the turbine. This may cause errors in measurement or compromise
the correct functioning of the device.
Use of an unsuitable mouthpiece could also damage the turbine or harm the patient.
In the event of an accident of any kind arising from use of the device, you are strongly
recommended to inform your doctor so that he/she can notify the authorities as
required by local legislation.
The device is not designed to be used in direct air currents (e.g. wind), sources of
heat or cold, direct sun rays or other sources of light or energy, dust, sand or
chemical substances.
Use and store the device in compliance with the environmental conditions specified
in the Technical Specifications. If the device is subjected to environmental conditions
other than those specified, it may malfunction and/or display incorrect results.
The maintenance operations set out in the User Manual must be carried out with the
utmost care. Failure to follow the instructions may lead to measurement errors or
misinterpretation of the measured values.
Do not modify the device without authorization from the manufacturer.