MIR Spirobank Smart User manual

Spirobank Smart
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Ver.2.8 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 2.8
Issue Date 25 March 2021
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 Restrictions on Use ................................................................................................... 4
1.2 Description of product.................................................................................................. 5
1.3 Information on the parameters measured by Spirobank Smart.................................... 6
1.4 Determining your baseline values................................................................................. 8
2. OPERATING THE Spirobank Smart ........................................................................................... 8
2.1 Inserting the batteries .................................................................................................. 8
2.2 Installing the application for Spirobank Smart .............................................................. 8
2.3 Connection between Spirobank Smart and smartphone .............................................. 9
2.4 Performing the test ...................................................................................................... 9
2.5 Evaluating the test...................................................................................................... 11
2.5.1 Results diary ........................................................................................................... 12
2.6 Important safety warnings.......................................................................................... 12
2.7 Data security warnings ............................................................................................... 13
2.8 Warnings for use in electromagnetic environments ................................................... 13
2.9 Notes on FCC certification .......................................................................................... 14
3. CARE AND CLEANING ............................................................................................................ 15
3.1 Cleaning of the reusable turbine................................................................................. 15
3.2 Cleaning and disinfection of the mouthpiece ............................................................. 16
3.3 Replacing of the FlowMir®.......................................................................................... 16
3.4 Cleaning of the device ................................................................................................ 17
3.5 Replacing batteries ..................................................................................................... 17
4. ERROR MESSAGES & TROUBLESHOOTING............................................................................. 18
4.1 Error messages ........................................................................................................... 18
4.2 Troubleshooting ......................................................................................................... 18
5. Accuracy and Reliability......................................................................................................... 19
6. LABELS & SYMBOLS ............................................................................................................... 20
7. TECHNICAL SPECIFICATIONS.................................................................................................. 22
8. Bluetooth Wireless Technology Information ......................................................................... 24
8.1 Radio frequency (rf) communication .......................................................................... 25
8.2 Radio frequency (rf) interference from other wireless devices ................................... 26
9. WARRANTY TERMS................................................................................................................ 26

Spirobank Smart
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Ver.2.8 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:
EUROPE and REST OF THE WORLD
MIR SRL
VIA DEL MAGGIOLINO, 125 - 00155 ROMA (ITALY)
Tel + 39 0622754777 - Fax + 39 0622754785
Sito web: www.spirometry.com ; Email: [email protected]
United States
MIR - Medical International Research USA, Inc
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 –6797 ; Fax + 1 (262) 364 –2030
Website: www.spirometry.com ; Email: [e-mail]

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MIR cannot be held responsible for any damage caused by users failing to follow these
instructions and/or the warnings contained in this manual.
1. INTRODUCTION
1.1 Intended use
Spirobank Smart spirometer is intended to be used by a physician or, by a licensed healthcare
professional or by a patient under the instruction of a physician or of a licensed healthcare
professional to test lung function. The device is designed for adult and pediatric patients,
excluding infants and neonates. It can be used in hospital setting, physician's office, factory,
pharmacy, and home.
1.1.1 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.
At each change of patient clean the device and check that a new FlowMir® is being used or
disinfect the re-usable turbine and the mouthpiece, as described 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 F/V version calculates also the following parameters:
•FIVC - Forced Inhalation Vital Capacity
•FIV1 - Forced Inpiratory Volume in the 1st second
•PIF - Peak Inspiratory Flow
•FEF25 - Forced Expiratory Flow at 25% of FVC
•FEF50 - Forced Expiratory Flow at 50% of FVC
•FEF75 - Forced Expiratory Flow at 75% of FVC
•EVol - Extrapolated Volume
•FEV05 - Forced Expiratory Volume in the initial 0,5 seconds of the test
•FEV075 - Forced Expiratory Volume in the initial 0,75 seconds of the test
•FEV2 - Forced Expiratory Volume in the initial 2 seconds of the test
•FEV3 - Forced Expiratory Volume in the initial 3 seconds of the test
•FET - Forced Expiratory Time
•PEF Time - Time to achieve 90% of the PEF
Also in the F/V version, the Flux / Volume curve (expiratory and inspiratory) is enabled in real
time during the execution of the spirometry.

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For details how to enable the F/V version please contact either your local supplier or the
manufacturer.
The device connects to a smartphone via Bluetooth SMART technology. Connection is
automatic once the 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
Spirobank Smart can use both the FlowMir® disposable turbine
and the reusable turbine with plastic mouthpiece.
The measurements are transferred in real time from the device to
the smartphone.
Reusable
FlowMir®
1.3 Information on the parameters measured by Spirobank
Smart
PEF is the maximal flow of the air when you exhale as hard as possible after filling your lungs
completely.
FEV1 is the volume of air exhaled during the first second of the same exhalation.
FVC is the volume of air exhaled during the total exhalation.
FEF2575 is the average flow between 25% and 75% of the total volume of air exhaled during
the total exhalation (FVC)

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FEV6 is the volume expired in the initial 6 seconds of the test.
In addition to these parameters, the following parameters are also calculated in the F/V
version:
PIF is the maximum speed of the air when you inspire as hard as possible after the exhalation.
FIV1 is the volume of air inspired during the first second after the exhalation.
FIVC is the volume of air inspired during the total inspiration.
FEF25 is the Forced Expiratory Flow at 25% of FVC
FEF50 is the Forced Expiratory Flow at 50% of FVC
FEF75 is the Forced Expiratory Flow at 75% of FVC
EVol is the back Extrapolated Volume
FEV05 is the Forced Expiratory Volume expired in the initial 0,5 seconds of the test
FEV075 is the Forced Expiratory Volume expired in the initial 0,75 seconds of the test
FEV2 is the Forced Expiratory Volume expired in the initial 2 seconds of the test
FEV3 is the Forced Expiratory Volume expired in the initial 3 seconds of the test
FET is the Forced Expiratory Time and measures the length of the expiration in seconds
PEF Time is the Time to achieve 90% of the PEF
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.
In addition to displaying the measurement, the device also provides a normal baseline value.

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1.4 Determining your baseline values
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.
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.
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.
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 application for Spirobank
Smart
Before to start measuring you need to install application on your
smartphone.
The application is available both for iOS and Android smartphones.
Once installed the application insert patient data. Automatically
the application will calculate the baseline values.

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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.

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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.
To prevent turbulence that might otherwise affect the results do not put your tongue in the
mouthpiece. Do not bend your neck.
6
Touch the START icon on the application
to start the test.
7
Blow out as hard as you can.
It is best to do the test standing or sitting
upright. (makes no difference to test
results)
8
After exhalation, slowly remove the device from the mouth and check the data on the
smartphone.