MIR Spirobank Smart User manual

Spirobank Smart
ENGLISH
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

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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:
EUROPE and REST OF THE WORLD
MIR SRL
VIA DEL MAGGIOLINO, 125 - 00155 ROMA (ITALY)
Tel + 39 0622754777 - Fax + 39 0622754785
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: mirusa@spirometry.com

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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.

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When the mouthpiece 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. The application will save the highest value.
The device shows an error message if the expiration start was not satisfactory and if the
exhalation is not finished satisfactorily.
2.5 Evaluating the test
Three tests are performed per measurement session, after
which the application for Spirobank Smart automatically
selects the highest value and compares it with the baseline
value (normal or personal best) set during configuration.
ATTENTION: ASK THE DOCTOR OR HEALTH CARE
PROFESSIONAL TO SEE YOU USING THE Spirobank Smart
BEFORE LAYING UP ANY MEASUREMENT.
ATTENTION: IF YOU USE Spirobank Smart TO MONITOR A
PULMONARY CONDITION FOR EXAMPLE IN THE CASE OF
ASTHMA, THE PERSON MUST BE CAREED BY A DOCTOR
OR ANOTHER HEALED HEALTH CARE PROFESSIONAL.
ATTENTION: THE ACTION PLAN PROVIDED BY YOUR
DOCTOR OR ANOTHER APPROVED HEALTH CARE
PROFESSIONAL WILL INDICATE WHICH ACTION YOU TAKE
IF YOU ARE CHANGED IN THE VALUES YOU FIND.
ATTENTION: INDEPENDENTLY OF WHAT YOUR VALUES
ARE, IF THE DEVICE IS FREE OF ALARMS, IF YOU
MANIFEST SIGNS AND SYMPTOMS SUCH AS THORACIC
CONSTRICTION, SHORT BREATH, COUGH CONTACT YOUR
DOCTOR OR AN ACTIVATED HEALTHCARE PROFESSIONAL.

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2.5.1 Results diary
The test results are automatically stored on the smartphone and can be displayed later.
2.6 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.
The supervision of an adult is required for monitoring elderly subjects, children
and differently abled 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 fromuse of the device,you arestrongly
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.
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.

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2.7 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
•Always check that data used to send the results are correct
•When data are transmitted Call the doctor to ask for confirmation of receipt
2.8 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, as a
measurement accuracy lower than stated, and create a potentially unsafe situation.

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Spirobank Smart 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 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 magnetic fields. Keep these devices at a
minimum distance of 30 centimeters. If it is necessary to use it at shorter distances,
SPIROBANK SMART and the other devices must be kept under observation to verify
that they work normally.
2.9 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.
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

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•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 of the reusable turbine
•replacing of the FlowMir®
•cleaning of the mouthpiece
•cleaning of the device
•replacing batteries
It can be possible to check the device calibration performing FVC test using a calibrated 3
Litres syringe.
3.1 Cleaning of the reusable turbine
The following instructions should only be applied if the reusable turbine is used. If the
FlowMir®is used, replace it after each session.
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.
3.3 Replacing of the FlowMir®
After each session, or at each patient change, replace the FlowMir® with a new one. Remove
the turbine applied to Spirobank Smart operating in reverse order to that described in the

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paragraph 2.4; apply then a new FlowMir® to the device before to perform a new session. The
used FlowMir® must be disposed following all applicable local regulations.
3.4 Cleaning of the device
Clean the device at each patient change. 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.
3.5 Replacing batteries
The device continuously monitors the battery level. A message on the smartphone display
alerts the user when the device battery is low. When the batteries are fully charged the
device has an operational life of five years or 1000 tests, depending on which value is
reached first.
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 the turbine is broken, or it could
mean that the reading is accurate and your asthma is getting worse.
Check to make sure that the turbine is not broken. You must follow directions exactly as
instructed to obtain accurate results. 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 (ATS 2019) 2.5% or 0.05 L whichever is greater
Flow range 960 L/minute
Flow accuracy 5% or 0.20 L/s whichever is greater
PEF accuracy 10% or 0.33 L/s whichever is greater
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
Model
Product Name
SN
Device serial number
Manufacturer’s name and address
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