MIR SPIROBANK Oxi User manual

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Oxi
Before you use your Spirobank Oxi, please read this user manual, the
labels and all the information provided with the product.
User Manual Rev 1.5
Publication date 04.02.2022
0476
WARNING: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR BY REQUEST 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 Oxi ........................................ 7
1.4 Determining your baseline values................................................................................. 9
2. USE OF Spirobank Oxi.............................................................................................................. 9
2.1 Inserting the batteries .................................................................................................. 9
2.2 Installing the MIR SPIROBANK application .................................................................... 9
2.3 Connection between Spirobank Oxi and smartphone................................................. 10
2.4 Performing the spirometry test .................................................................................. 10
2.5 Performing the oximetry test ..................................................................................... 13
2.6 Evaluating the test...................................................................................................... 14
2.6.1 Results diary ........................................................................................................... 15
2.7 Important safety warnings.......................................................................................... 15
2.8 Data security warnings ............................................................................................... 16
2.9 Warnings for use in electromagnetic environments ................................................... 17
2.10 Notes on FCC certification .......................................................................................... 17
3. MAINTENANCE AND CLEANLINESS ........................................................................................ 18
3.1 Cleaning the reusable turbine..................................................................................... 19
3.2 Cleaning of the mouthpiece........................................................................................ 20
3.3 Replacing the FlowMir® turbine ................................................................................. 20
3.4 Cleaning of the device ................................................................................................ 20
3.5 Replacing batteries ..................................................................................................... 21
4. ERROR MESSAGES & TROUBLESHOOTING............................................................................. 23
4.1 Error messages ........................................................................................................... 23
4.2 Troubleshooting ......................................................................................................... 23
5. ACCURACY and reliability ...................................................................................................... 24
6. LABELS & SYMBOLS ............................................................................................................... 26
7. TECHNICAL SPECIFICATIONS.................................................................................................. 27
8. Bluetooth Wireless Technology Information ......................................................................... 30
8.1 Communication at radiofrequency (RF)...................................................................... 31
8.2 Interference in radiofrequency (RF) caused by other wireless devices ....................... 31
9. WARRANTY TERMS................................................................................................................ 33

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Thank you for choosing a MIR MEDICAL INTERNATIONAL RESEARCH product.
Before you use your Spirobank Oxi, please read this user manual, the labels and all the
information provided with the product.
Before connecting Spirobank Oxi to a smartphone, install the MIR SPIROBANK application,
available by smartphone in both iOS and Android operating systems. The application enables
display of the data measured by the device.
The package includes:
•The Spirobank Oxi device
•The turbine sensor (FlowMir®) disposable or turbine reusable
•plastic mouthpiece
•2 AAA batteries
•The User Manual
After removing the device from its packaging, check that there is no visible damage. If it looks
damaged, 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 to the manufacturer.
The manufacturer’s address is as follows:
EUROPE and WORLDWIDE:
MIR SRL VIA DEL MAGGIOLINO, 125 - 00155 ROME (ITALY)
Tel. [phone] - Fax [phone]
Website: www.spirometry.com - Email: [e-mail]
United States of America
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 Oxi, spirometer and pulse oximeter, is intended to be used by a physician or
by a subject under the instruction of a physician or the patient to assess lung function.
The device is designed for adult and pediatric patients, excluding infants and neonates,
and can be used at home, in a factory, pharmacy, hospital or medical surgery.
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 physician.
Diagnosis and appropriate treatments are to be made and given only by a qualified physician.
The device is intended for use by one patient only at a time. Take care not to attribute the
measurements from one patient to another. Before using the device on a new patient, first
erase the previous patient’s data from the memory and enter the new user’s details data (date
of birth, origin, weight, height, gender).
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 point 3.

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1.2 Description of product
Spirobank Oxi 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 also measures the parameters related to the oximetry
test in particular:
•SpO2 (percentage of oxygen saturation in the blood)
•BPM (heart rate)
The device connects to a smartphone via Bluetooth SMART technology. Connection is automatic
once the MIR SPIROBANK 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 Oxi can use either the FlowMir® disposable turbine or
the reusable turbine with plastic mouthpiece.
The F/V version calculates also the following parameters:
•FIVC - Forced Inhalation Vital Capacity
•FIV1 - Forced Inspiratory 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

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•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.
The measurements are transferred in real time from the device to the smartphone.

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1.3 Information on the parameters measured by Spirobank Oxi
Spirometry tests
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.
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.
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.

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Spirobank Oxi is a valid help in identifying whether there is an obstruction at a determined
time and of what type of obstruction it is.
Regular use of the device enables tracing the possible variations of the parameters. These
variations might require suitable treatment, according to the prescription of the physician.
As well as viewing the measurements of the respiratory parameters, the device also provides
a normal baseline value.
Oximetry tests
During the oximetry test the device provides the instantaneous value of:
SpO2 (percentage of saturated oxygen in the blood)
BPM (heart rate)

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1.4 Determining your baseline values
The importance of any changes in airflow from one measurement to the next depends upon
how much they are different from thebaseline 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, gender, and origin. The 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 the PEF
parameter, 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. The patient may have a higher measurements than the predicted value while not
being healthy. Or the patient may have lower measurements than the average and still be
healthy.
2. USE OF Spirobank Oxi
2.1 Inserting the batteries
Follow the instructions in the Maintenance section for correct battery insertion.
2.2 Installing the MIR SPIROBANK application
First you need to install application on your remote device (smartphone
or tablet). The application is available for smartphone/tablet in both iOS
and Android environments.
Once the application is available, enter the patient's data; MIR
SPIROBANK application will automatically calculate the baseline
reference values.

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2.3 Connection between Spirobank Oxi and
smartphone
The connection between the Spirobank Oxi and the smartphone is
automatic. To check whether there is a connection, read the messages
from the application.
2.4 Performing the spirometry test
To perform the test correctly, follow the instructions below.
1
Push the FLowMir® turbine into the slot
until it stops
2
Turn the turbine clockwise until it stops

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3
Insert the mouthpiece at least 0.5 cm into
the turbine socket
4
Pick up the Spirobank Oxi with your hands
as if it were a mobile 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 itso that theair 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
Tap the “Start Test” icon under
SPIROMETRY on the app MIR SPIROBANK.

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7
Take a deep breath and blow out as hard
as you can.
It is best to do the test standing or sitting
upright. (it makes no difference to test
results)
8
After exhalation, slowly remove the device from the mouth and check the data on the
smartphone.
After taking the mouthpiece 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. The MIR SPIROBANK will save the highest value.
The device shows an error message if the exhalation start-up was not satisfactory and if
the exhalation did not finish satisfactorily.

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2.5 Performing the oximetry test
To perform the test correctly, follow the instructions below.
1
Place the thumb of the hand holding the
Spirobank Oxi on the sensor as in the image
2
Tap the "Start Test" icon under OXIMETRY
on the MIR SPIROBANK application.
3
During the test the perfusion index is
reported with a bar indicator.
Minimum duration of a test is 30 seconds.
The device displays an error message if the sensor is not functioning and if the finger is
not positioned on the sensor.
If the signal detected is not of sufficient quality to estimate the oximetry parameters;
the parameters are not displayed.

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2.6 Evaluating the test
For the spirometry measurements, three individual tests are
made in each test, after which the MIR SPIROBANK application
automatically selects the highest value and compares it with
the baseline value (personal best value) set during
configuration.
For the oximetry measurements, each test saved in the
memory appears in the Results section, which contains the
value of SpO2, the value of cardiac frequency, the date and
time of the test and any notes.
WARNING: ASK YOUR PHYSICIAN OR LICENSED HEALTHCARE
PROFESSIONAL TO WATCH YOU USING THE Spirobank Oxi
BEFORE RELYING ON ANY MEASUREMENT.
WARNING: WHEN Spirobank Oxi IS USED TO MONITOR A LUNG
CONDITION SUCH AS FOR EXAMPLE ASTHMA YOU SHOULD BE
UNDER THE CARE OF A PHYSICIAN OR OTHER LICENSED
HEALTHCARE PROFESSIONAL.
WARNING: THE PLAN OF ACTION PROVIDED BY YOUR
PHYSICIAN OR OTHER LICENSED HEALTHCARE PROFESSIONAL
WILL INDICATE WHICH ACTION TO TAKE IN A CASE IN WHICH
THERE ARE RELEVANT VARIATIONS IN VALUES.
WARNING: INDEPENDENTLY OF YOUR VALUES, AND EVEN
WHERE THE DEVICE IS NOT INDICATING ALARMS, IF YOU ARE
SHOWING SIGNS AND SYMPTOMS SUCH AS THORACIC
CONSTRICTION, SHORT BREATH, COUGH OR DYSPNOEA,
CONTACT YOUR PHYSICIAN OR LICENSED HEALTHCARE
PROFESSIONAL.

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2.6.1 Results diary
The test results are automatically stored on the smartphone and
can be displayed later.
2.7 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.
For monitoring elderly patients and children, and differently-able persons, the
supervision of an adult is required.
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.
Check that no impurities or foreign bodies, such as skin or hairs, have accumulated
inside the turbine. Any modifications not expressly approved by this Company could
compromise use of the device by the user.
Check that there are no elements obstructing the oximetry sensor. Any modifications
not expressly approved by this Company could compromise use of the device by the
user.
In the event of an accident of any kind arising from use of the device, you arestrongly
recommended to inform your physician 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 exposed to environmental conditions
other than those specified, it might 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.

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Do not modify the device without authorization from the manufacturer.
All modifications, adjustments, repairs, reconfigurations must be performed by the
manufacturer or by authorized personnel.
If problems arise, do not try to repair the device yourself.
2.8 Data security warnings
The smartphone stores the user’s 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 of 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
•Always check that the data used to send the results of the tests are correct

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2.9 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.
This electromagnetic interference could cause the medical device to malfunction, such as an
accuracy of measurement that is lower than the declared one, and create a potentially
unsafe situation.
Spirobank Oxi complies with EN 60601-1-2:2015 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 Oxi and the smartphone on which the MIR SPIROBANK
application is installed are no more than 2 metres apart.
•Do not use Spirobank Oxi near other devices (computers, cordless phones, cell phones,
etc.) that generate strong electromagnetic fields. Keep the above-described equipment
at a distance of at least 30 centimetres. If a use under lower distances is necessary,
Spirobank Oxi and the other devices should be kept under observation to verify that they
are functioning normally.
2.10 Notes on FCC certification
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) This device may not cause harmful interference, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance
could void the user's authority to operate the equipment.
NOTE: 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 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 in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be

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determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
−Reorient or relocate the receiving antenna.
−Increase the separation 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/TV technician for help.
3. MAINTENANCE AND CLEANLINESS
Spirobank Oxi is a device requiring little maintenance. The following operations must be
carried out regularly:
•Cleaning the reusable turbine
•Replacing the FlowMir® turbine
•cleaning of the device
•replacing batteries
The calibration of the device can be verified by carrying out a test for measuring FVC by using
a calibration 3 litre syringe.

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3.1 Cleaning of the reusable turbine
The following instruction should be applied in a case of reusable turbine. If the FlowMir
is used, replace it after each session.
To avoid irreparable damage to the turbine, do not use detergents including alcohol
or oily substances and do not immerse the turbine in water or solutions at high
temperatures. Never try to sterilise the turbine in boiling water. Never try to clean
the turbine under a direct jet of water or other liquids. If you do not have liquid
detergents available, the turbine must be washed at least with clean water.
Correct functioning of the turbine is guaranteed only if it is “clean” and free of foreign
bodies which interfere with 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 Oxi 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
warm soapy water and shake the turbine for 2-3 minutes.

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The hand dishwashing detergent that was tested includes the following ingredients:
Aqua, coco glucoside, myristyl glucoside, lauryl glucoside, sodium chloride, sodium
gluconate, sodium citrate, allyl caproate, ethylene brassylate, methyldihydrojas-
monate).
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 Oxi. 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 of the mouthpiece
Make sure to clean the mouthpiece after each use. To clean the mouthpiece, simply pull
it apart from the turbine. Using the same method as for the turbine, immerse the
mouthpiece in warm soapy water and shake 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.
3.3 Replacing the FlowMir® turbine
After each session, then every time you change patients, replace the FlowMir® turbine with a
new one. Then detach the one applied to Spirobank Oxi, operating in reverse order to the one
described in point 2.4; then apply a new FlowMir® before performing a new test session. The
FLowMir® used must be disposed of in accordance with the local laws in force.
3.4 Cleaning of the device
Clean the device every time you change patients.
Use only the substances and methods listed in this chapter to clean the device.
Recommended cleaning agents are:
•Mild soap (diluted)