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

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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.

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All modifications, adjustments, repairs, reconfigurations must be performed by the
manufacturer or by authorized personnel.
In case of problems, do not try to repair the device yourself.
2.6 Data security warnings
Your smartphone stores your personal data.
Potential threats such as the following:
•Malware installation
•Physical access to the smartphone
•Interception of communications
•Physical damage to the smartphone
•Theft of the smartphone
could have an impact on the integrity or confidentiality of such data, such as:
•Accessing data in memory by unauthorized persons
•Loss of data in memory
•Inability to use smartphone for communications
•The integrity check of the data is made automatically and in case of transmission error it
will create a corruption of the data and the file will be illegible.
The following actions help reduce the risk of such events:
•Do not open or install files from suspicious sources
•Use antivirus software
•Back up your data periodically
•Do not leave your smartphone unattended
•Use a password to access the data
•Verify the correct email address where to send the test results
•When data are transmitted Call the doctor to ask for confirmation of receipt

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2.7 Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones, cell phones,
etc.) medical devices may be susceptible to electromagnetic interference from other
equipment.
Such electromagnetic interference could cause the medical device to malfunction and create
a potentially unsafe situation.
SPIROBANK SMART complies with EN 60601-1-2:2007 on electromagnetic compatibility (EMC
for medical devices) for both immunity and emissions.
For the device to function properly, however, the following precautions must be taken:
•Make sure that the SPIROBANK SMART and the smartphone on which the application is
installed are no more than 2 metres apart.
•Do not use SPIROBANK SMART near other devices (computers, cordless phones, cell
phones, etc.) that generate strong electromagnetic fields. Keep such equipment at a
minimum distance of 7 metres.
2.8 Notes on FCC certification
SPIROBANK SMART complies with Part 15 of the FCC Rules. Operation is subject to the
following conditions:
(1) this device may not cause harmful interference
(2) this device must accept any interference received, including interference that may cause
undesired operation
Any modifications not expressly approved by this company could compromise use of the
device by the user.
N.B.: This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is operated in a residential
installation. This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference to
radio communications.
However there is no guarantee that interference will not occur.

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If this device does cause interference to radio or television reception, which can be
determined by turning the device off and on, the user is encouraged to correct the
interference by taking one of the following measures:
•Reorient or relocate the antenna
•Increase the distance between the equipment and receiver
•Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
•Consult the dealer or an experienced radio/television technician for help.
3. CARE AND CLEANING
SPIROBANK SMART is a device that requires little maintenance. The following operations are
to be performed regularly:
•cleaning and disinfection of the turbine
•cleaning and disinfection of the mouthpiece
•cleaning of the device
•replacing batteries
3.1 Cleaning and disinfection of the turbine
To avoid irreparable damage to the turbine, do not use any alcoholic or oily cleaning
solutions, and do not immerse in hot water or solutions.
Do not try to sterilize the turbine in boiling water.
Never try to clean the turbine under a direct jet of water or other liquids. If there are no
liquid detergents, the turbine must at least be washed in clean water.

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Correct operation of the turbine is guaranteed only if it is "clean" and free of foreign objects
that affect its movement. The presence of dust or foreign bodies (such as hairs, sputum etc.)
could slow or block the moving parts of the turbine and make the result less accurate, or
damage the turbine itself.
After each use, check the cleanliness of the turbine.
To clean the turbine, pull it out of the SPIROBANK SMART socket by turning it
counterclockwise and simply pulling it out. To make it easier to pull out, push the base of the
turbine gently with a finger.
Weekly cleaning is recommended. Immerse the turbine flowmeter in warmy soapy water and
agitate the turbine for 2-3 minutes.
The hand dishwashing detergent that was tested includes these ingredients: Aqua, coco
glucoside, myristyl glucoside, lauryl glucoside, sodium chloride, sodium gluconate, sodium
citrate, allyl caproate, ethylene brassylate, methyldihydrojasmonate).
Rinse in clean water and shake gently to remove any excess water. Allow to air dry on a towel.
Store in a clean, dry place in your home.
After cleaning, insert the turbine into the socket in the direction indicated by the screen-
printed closed padlock symbol on the SPIROBANK SMART. To insert the turbine correctly,
push it down and turn clockwise until it stops, to make sure it is fully inserted into the plastic
container.
3.2 Cleaning and disinfection of the mouthpiece
Make sure to clean the mouthpiece after each use. To clean the mouthpiece, simply pull it
apart from the turbine. Just as for the turbine, Immerse the mouthpiece in warmy soapy water
and agitate the mouthpiece for 2-3 minutes . Rinse in clean water and shake gently to remove
any excess water. Allow to air dry on a towel. Store in a clean, dry place in your home.
After cleaning, insert the mouthpiece in the turbine, by pressing lightly.

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3.3 Cleaning of the device
Clean the device once a day . To clean, wipe the device’s surfaces with a soft damp cloth. Dry
with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry.
Never put the device into water or other fluids.
3.4 Replacing batteries
The device continuously monitors the battery level. A message on the smartphone display
alerts the user when the device battery is low.
1
Remove the battery cover on the back of
the SPIROBANK SMART
2
Remove the two batteries and replace
them with two new ones, following the
polarity as indicated by the symbols in
the compartment
3
Reattach the battery cover

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Used SPIROBANK SMART batteries should only be disposed of in special containers or
preferably returned to the dealer of the device or to a special collection centre.
In any case, all applicable local regulations must be complied with.
4. ERROR MESSAGES & TROUBLESHOOTING
4.1 Error messages
If you encounter any problems when using the SPIROBANK SMART, a message will appear on
the smartphone display to warn of the malfunction.
MESSAGE
POSSIBLE CAUSE
SOLUTION
Bluetooth
Bluetooth is off
To perform measurements with the device, you
must activate Bluetooth on the smartphone.
Exit the application and activate Bluetooth from
the smartphone settings menu.
Battery low
When the SPIROBANK
SMART batteries are
below 15%
Replace the SPIROBANK SMART batteries
4.2 Troubleshooting
If you receive an unusually low reading, it could mean that your SPIROBANK SMART meter is
broken, or it could mean that the reading is accurate and your asthma is getting worse.
Check to make sure that the meter is not broken. You must follow directions exactly as
instructed to obtain accurate results. If your meter is not broken, follow the instructions in
your action plan for low readings and contact your physician or other licensed healthcare
professional.
If problems occur when using the device, the following points should be checked.

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PROBLEM
POSSIBLE CAUSE
SOLUTION
SPIROBANK SMART
can’t connect with the
smartphone
The Bluetooth connection is
not working properly
Look for SPIROBANK SMART on the list
of recognized devices. For correct use,
the smart phone needs Bluetooth
version 4.0 or higher
The test results are
unreliable
The turbine may be dirty
Clean the turbine as described in the
care and cleaning section.
If necessary, replace the turbine with a
new one, if necessary by contacting the
manufacturer
The test was performed
wrongly
Repeat the test, following the directions
on the screen. Avoid sudden movements
when you finish exhaling
The turbine has not been
inserted properly
Insert the turbine from the front of the
device by pushing it all the way down
and turning it clockwise. See the
Performing the test section
5. ACCURACY AND RELIABILITY
This device meets the requirements of the following standard:
ATS/ERS TASK FORCE: Standardization of lung function testing (volume 26/numbers 1-5: 2005)
Volume max 10 L
Volume accuracy 3% or 0.05 L
Flow range 960 L/minute
Flow accuracy 5% or 10.2 L/minute
Time zero

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At the point of peak expiratory flow (PEF), a tangent
is drawn with a slope equal to PEF and its
intersection on the abscissa defines the TIME ZERO.
The back extrapolated volume is the volume of gas
that has already been exhaled at the point of TIME
ZERO as defined by back extrapolation. The method
to determine the time elapsed by TIME ZERO, t0, is
given by equation:
Time zero = tPEF - (VPEF/PEF)
Where
PEF is the the peak expiratory flow;
tPEF is the the elapsed time at PEF;
VPEF is the the expired volume at PEF
6. LABELS & SYMBOLS
ID label
The label shows:
Symbol
Description
REF
Product Name
SN
Device serial number
Manufacturer’s name and address
0476
This product is a certified Class IIa medical device, and complies with the requirements
of Directive 93/42/EEC
In accordance with IEC 60601-1 the product and its applied parts are type BF and thus
protected against the risks of electrical leakage.

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This symbol is required by European directive 2002/96/EEC on waste electrical and
electronic equipment (WEEE). At the end of its useful life this device must not be
disposed of as normal domestic waste. Instead it must be delivered to a WEEE
authorised collection centre.
As an alternative, the device may be returned without charge to the dealer or
distributor, when it is replaced by another equivalent device.
Due to the construction materials used for the device, disposal as normal waste could
cause harm to the environment and/or health.
Failure to observe these regulations can lead to prosecution.
IP22
Indicates the degree of resistance to liquids. The device is protected against falling
drops of water if it is disposed up to 15° from vertical.
The symbol is used in accordance with IEC EN 60601-1-2: 2007 in section 5.1.1 for
products including RF transmitters.
FCC ID
Identification showing traceability to FCC compliance
Instruction for use symbol. Read this manual carefully before using the medical device
Manufacturing date
Rx ONLY
Caution: Federal law restricts this device to sale by or on the order of a physician
7. TECHNICAL SPECIFICATIONS
Parameters measured:
FEV1
Expiratory volume in one second of testing
L
PEF
Peak expiratory flow
L/minute
FVC
Forced Vital Capacity
L
FEV6
Volume expired in the initial 6 seconds of the test
L
FEF2575
Average flow between 25% and 75% of the FVC
L/minute
FEV1/FVC
Tiffeneau index
\
Flow/volume measurement system
Bi-directional turbine (rotating weel)
Measurement principle
Infrared interruption
Dynamic resistance at 12 L/s
<0.5 cm H2O/L/s

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Communication interface
Bluetooth SMART (4.0 or higher)
Power supply
2 x 1.5V AAA alkaline batteries
Size
main body 109x49x21 mm
Weight
60.7 g (including batteries)
Type of electrical protection
Class II
Electrical protection level
BF
IP protection level
IP22
Applicable Standards
Electrical Safety IEC 60601-1
Electromagnetic Compatibility IEC 60601-1-2
ATS/ERS Standardization of spirometry 2005
ISO 26782, ISO 23747
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -40°C, MAX +70°C
Humidity: MIN 10% RH; MAX 95%RH
Transport conditions
Temperature: MIN -40°C, MAX +70°C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN +5°C, MAX +40°C
Humidity: MIN 10% RH; MAX 95%RH
8. BLUETOOTH WIRELESS TECHNOLOGY INFORMATION
Bluetooth Compliance:
Version 4.0 single mode low energy
Operating Frequency:
2.4 to 2.4835 GHz
Max Output Power:
TX: -5.99 dBm; 0.25 mW
Operating Range:
10 meter radius (line of sight)
Network Topology:
Star - bus
Operation:
Server
Antenna Type:
PCB antenna
Modulation Technology:
FHSS
Modulation Type:
GFSK
Data Rate:
1 Mbit/second
Data Latency:
7 –40 ms