MIR MiniSpir Light User manual

MiniSpir
User manual
MINISPIR User manual Rev 2.2.1 page 1 of 17
MiniSpir
User Manual Rev. 2.2.1
Issued on: 14.03.2023
Approved on: 14.03.2023
ENGLISH (EN)

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User manual
MINISPIR User manual Rev 2.2.1 page 2 of 17
Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
Before using your MiniSpir …
•Read this manual carefully, plus all labels and other product information supplied.
•Set the device configuration (date, time, predicted values, language etc.) as described in the Software MIR Spiro Manual.
•Check PC system requirements for compatibility with the device (RAM: 512 Mb minimum, 1024 Mb preferred; Operating
system: Windows 2000 –XP Windows Vista (32bit/64bit)- Windows 7 (32bit/64bit); Windows 10 (32bit/64bit); Minimum disk
space: 500 Mb; CPU Pentium IV-class PC 1 GHz; display resolution 1024x768 or higher.
•MiniSpir should only be connected to a computer manufactured in compliance with EN 60950/1992.
WARNING
Before connecting MiniSpir to a PC, carry out all the steps necessary for the correct installation of the MIR Spiro software
which can be downloaded from the MIR website At the end of the installation, connect the device to the PC and the
hardware will be "recognised" by the PC. The device can then be used with the MIR Spiro software.
Keep the original packaging!
In the event that your device requires attention then always use the original packaging to return it to the distributor or the
manufacturer.
In such an event then please follow these guidelines:
•Return the complete device in the original packaging, and
•The transport (plus any customs or taxes) costs must be prepaid.
Manufacturer’s address
MIR S.P.A:
Via del Maggiolino, 125
00155 ROME (ITALY)
Tel + 39 0622754777 Fax + 39 0622754785
Web site: www.spirometry.com Email: [email protected]
MIR USA, Inc.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 –6797 Fax + 1 (262) 364 –2030
Web site: www.spirometry.com Email: [email protected]
MIR has a policy of continuous product development and improvement, and the manufacturer therefore reserves the
right to modify and to update the information contained in this User’s Manual as required Any suggestions and or
comments regarding this product should be sent via email to: m[email protected]. Thank you.
MIR accepts no responsibility for any loss or damage caused by the User of the device due to the use of this Manual
and/or due to an incorrect use of the product.
Copying this manual in whole or in part is strictly forbidden.
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

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INDEX
1. INTRODUCTION..................................................................................................................................................................4
1.1 Intended Use.................................................................................................................................................................4
1.1.1 Ability and experience required.................................................................................................................................4
1.1.2 Operating environment .............................................................................................................................................4
1.1.3 Who can or must make the installation.....................................................................................................................4
1.1.4 Subject effect on the use of the device .....................................................................................................................4
1.1.5 Limitations of use - Contraindications.......................................................................................................................4
1.2 Important safety warnings .............................................................................................................................................5
1.2.1 Danger of cross-contamination.................................................................................................................................5
1.2.2 Turbine......................................................................................................................................................................5
1.2.3 Mouthpiece ...............................................................................................................................................................6
1.2.4 USB Connection Cable.............................................................................................................................................6
1.2.5 Device.......................................................................................................................................................................6
1.2.6 Warnings for use in electromagnetic environments ..................................................................................................7
1.3Unforeseen errors .........................................................................................................................................................7
1.4 Labels and symbols.......................................................................................................................................................7
1.4.1 Identification label and symbols................................................................................................................................7
1.4.2 (ESD) Electrostatic discharge sensitivity symbol ......................................................................................................8
1.5Product description........................................................................................................................................................9
1.6 Technical features.......................................................................................................................................................10
1.6.1 Features of the spirometer......................................................................................................................................10
1.6.2 Other features.........................................................................................................................................................11
2. FUNCTIONING OF THE MiniSpir......................................................................................................................................12
2.1 Connection to PC........................................................................................................................................................12
2.2 Using the MiniSpir.......................................................................................................................................................12
2.3 Spirometry Testing......................................................................................................................................................12
2.4 Acceptability, Repeatability and quality messages......................................................................................................13
2.5 Interpreting spirometry results.....................................................................................................................................14
3. DATA TRANSMISSION.....................................................................................................................................................16
3.1 Transmission with USB cable......................................................................................................................................16
3.2 Upgrade Internal software...........................................................................................................................................16
4. MAINTENANCE.................................................................................................................................................................16
4.1 Cleaning and controlling the reusable turbine .............................................................................................................16
5. PROBLEM SOLVING.........................................................................................................................................................17
6. LIMITED WARRANTY CONDITIONS................................................................................................................................17

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1. INTRODUCTION
1.1 Intended Use
MiniSpir spirometer is intended to be used either by a physician, respiratory therapist or technician.
The device is intended to test lung function and can make:
•spirometry testing in people of all ages, excluding infants and neonates
It can be used in hospital setting, physician's office, factory, pharmacy.
1.1.1 Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of the device, with particular attention to
disinfection (cross-contamination risk), all require qualified personnel.
WARNING
The manufacturer cannot be held responsible for any damage caused by the user of the device failing to follow the
instructions and warnings contained in this manual.
1.1.2 Operating environment
MiniSpir has been designed for use in hospital setting, physician's office, factory, pharmacy.
The instrument is not intended for use in an operating theatre nor in the presence of inflammable liquids or detergents, nor in the
presence of inflammable anaesthetic gases, oxygen or nitrogen.
The instrument 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 any other chemical substances.
The user is responsible for ensuring that the device is stored and used in appropriate environmental conditions as specified in
paragraph 1.6.3.
WARNING
If the device is exposed to unsuitable environmental conditions, this could cause the device to malfunction and to give
incorrect results.
1.1.3 Who can or must make the installation
The device requires installation by qualified personnel.
1.1.4 Subject effect on the use of the device
A spirometry test should only be carried out when the subject is at rest and in good health, and thus in a suitable condition for the
test. A spirometry test requires the collaboration of the subject since the subject must make a complete forced expiration, in order
to have a meaningful test result.
1.1.5 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the subject’s clinical condition.
A detailed clinical history of the subject is also required together with the results of any other test(s) suggested by a doctor.
Test comments, a test interpretation and suggested courses of treatment must be given by a doctor.
A spirometry test requires the collaboration of the subject. The results depend on the person’s capability to inspire and to expire
all air completely and as fast as possible. If these fundamental conditions are not respected then the results obtained during
spirometry testing will not be considered accurate, and therefore the test results are “not acceptable”.
The acceptability of a test is the responsibility of the user. Special attention should be given to testing elderly subjects, children
and people with disabilities.
The device should never be used when it is possible or probable that the validity of the results may be compromised due to any
such external factors.
Spirometry has relative contraindications, as reported by the 2019 update of the ATS/ERS guideline:
Due to increased myocardial demand or changes in blood pressure
- Acute myocardial infarction within 1 week
- Systemic hypotension or severe hypertension
- Significant atrial/ventricular arrhythmia
- Uncompensated heart failure
- Uncontrolled pulmonary hypertension
- Acute cor pulmonale
- Clinically unstable pulmonary embolism
- History of syncope related to forced expiration/cough
Due to increased intracranial/intraocular pressure
- Cerebral aneurysm
- Brain surgery within 4 weeks
- Recent concussion with persistent symptoms

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- Eye surgery within 1 week
Due to increased sinus and middle ear pressure
- Sinus or middle ear surgery or infection within 1 week
Due to increased intrathoracic and intraabdominal pressure
- Presence of pneumothorax
- Thoracic surgery within 4 weeks
- Abdominal surgery within 4 weeks
- Post-term pregnancy
Due to infection control issues
- Active or suspected transmissible respiratory or systemic infection, including tuberculosis
- Physical conditions that predispose to the transmission of infections, such as hemoptysis, significant discharge or oral lesions
or oral bleeding.
1.2 Important safety warnings
MiniSpir has been examined by an independent laboratory which hascertified theconformity of thedevice to the Safety Standards
IEC 60601-1 and guarantees the EMC Requirements within the limits laid down in the Standard IEC 60601-1-2.
MiniSpir is throughly tested during its production and therefore the product complies with the safety requirements and quality
standards laid down by the Regulation 2017/745/UE for MEDICAL DEVICES.
After removing the device from its packaging, check that there is no visible damage. In case of damage do not use the device and
return it to the manufacturer for replacement.
WARNING
The safety and the correct performance of the device can only be assured if the user of the device respects all of the
relevant safety rules and regulations.
The manufacturer cannot be held responsible for damage caused by the failure of the user to follow these instructions
correctly.
The device must be used according with the indications given by the manufacturer in the User Manual with particular
attention to § Intended Use utilizing only original spare parts and accessories. Use of non original parts such as the
turbine flow sensor and oximetry sensor or other accessories may cause errors in measurement and/or compromise the
correct functioning of the device, and is therefore not permitted.
In particular, the use of cables other than those specified by the manufacturer could cause increased emissions or lower
electromagnetic immunity fom the device and result in improper operation.
The device should not be used beyond the declared life span. In normal conditions the lifespan of the device is estimated
to be around 10 years.
It is necessary to report any serious incident that has occurred in relation to the device to the manufacturer and the
competent authority of the Member State in which the user and/or the patient is established, in accordance with
Regulation 2017/745.
1.2.1 Danger of cross-contamination
Two different types of turbine sensors can be used with the device: one is single-patient disposable and one is reusable. A
mouthpiece is required in order to connect a subject to the spirometer.
In order to avoid exposing the subject to the hazard of cross-contamination, the reusable flow sensor must always be cleaned
before each spirometry test, and a new disposable mouthpiece must always be used for each subject. The use of an anti bacterial
filter is at the discretion of the doctor.
If a disposable turbine is used, then a new one must be used for each patient.
1.2.2 Turbine
Disposable turbine
If you are going to perform the spirometry test with a disposable turbine, it
is important to use a new turbine for every new patient. The characteristics,
accuracy and the hygiene of the disposable turbine can only be guaranteed
if it has been stored beforehand in its original sealed packaging.
The disposable turbine is made of plastic and its disposal after use should
adhere to the local authority guidelines / norms.
Reusable turbine
The correct funtioning of the re-usable turbine can only be guaranteed if it
has been cleaned in the correct manner and is free from foreign bodies
which could alter its movement. If the turbine has not been cleaned
sufficiently this could cause cross contamination from one patient to
another.
The cleaning of the turbine should be done following the guidelines in the
user manual.
The following informations are valid for both models of turbine.
Do not expose the turbine to a direct jet of water or air, and avoid contact with high temperature liquids.

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Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect functioning and possible damage. The
presence of any impurities (such as hair, sputum, threads etc.) within the body of the turbine sensor may seriously compromise
the accuracy of the measurements.
Notes about calibration of reusable turbine
WARNING
The turbine flow sensor does not require calibration but needs only a regular cleaning. If a calibration must be made then
the following guidelines should be carefully noted.
Calibration can be made using a siring a calibration syringe ad making a FVC test.
In line with the publication "Standardised Lung Function Testing" of the European Respiratory Society (Vol 6,
Supplement 16, March 1993), the air expired from the mouth is at a temperature of circa 33/34 °C.
The expired flow and volume, to be converted to BTPS conditions (37 °C) must be increased by 2.6% - this is derived
from the BTPS factor of 1.026 at a temperature of 33°C, which represents a correction of 2.6%. In practice the BTPS factor
for the expired flow and volumes is therefore constant and equal to 1.026.
For the inspired volumes and flows, the BTPS factor depends upon the ambient temperature as the air inspired is at
ambient temperature.
For instance at an ambient temperature of 20°C with relative humidity at 50%, the BTPS factor is 1.102, a correction of
+10.2%.
The correction of the inspired volumes and flows is made automatically as the machine has an internal temperature
sensor; the BTPS values are thus calculated.
If a 3L syringe is used to make the calibration and if the MiniSpir is calibrated correctly then the FVC (syringe) value will
be:
3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
If the ambient temperature is 20°C, the FIVC (syringe) value will be:
3.00 (FIVC) x 1.102 (BTPS) = 3.31 L (FIVC at BTPS).
The user must be aware that the volume of the syringe shown by the machine is converted to BTPS conditions, so that
the "increase" of the results with respect to the expected values does not constitute an error.
For instance, if the calibration procedure is carried out with measured data:
FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the resulting correction factor becomes:
EXPIRATION .00%
INSPIRATION .00%
This does not represent an error, but is a logical consequence of the explanation detailed above.
1.2.3 Mouthpiece
Any disposable mouthpieces included with the device are supplied only as a guide to the correct type and dimensions of the
mouthpiece required for this device, they are clean but not sterile. To purchase appropriate mouthpieces, generally either paper
or plastic but in any case mono-use/disposable, we suggest that you contact your local distributor who supplied the spirometer.
WARNING
The use of a mouthpiece made from an inappropriate material could modify the bio-compatibility and could be the cause
of an incorrect functioning of the device and thus of incorrect test results, and create inconvenience to the patient.
The user is responsible for obtaining the correct type of mouthpieces for the device. Those required are a standard type with an
outside diameter of 30 mm, they are commonly used and in general easily procured.
To avoid contamination of the environment, caused by the disposal of used mouthpieces, the user must follow all of the
relevant local regulations in force.
1.2.4 USB Connection Cable
Incorrect use or application of the USB cable may produce inaccurate measurements, which will show very inaccurate values of
the patient’s condition. Carefully inspect each cable before use.
Do not use cables that appear to be or are damaged. If a new cable is required, contact your local distributor.
Use only cables supplied by MIR, specifically designed to be used with MiniSpir. The use of other types of cables can lead to
inaccurate measurements.
1.2.5 Device
WARNING
The maintenance operationsdetailed in this manualmust be carried out to the letter. If these instructions are not followed
this can cause measurement errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfiguration must be made by the manufacturer or by personnel
authorised by the manufacturer. In case of problems, never attempt to make a repair oneself. The set-up of configurable

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parameters should only be made by qualified personnel. However, an incorrect set up of the parameters does not put
the patient at risk.
When connected to other devices to preserve the safety oft he system as required in the IEC 60601-1 standard, it is
necessary to use exclusively device compliants with the safety rules. So the PC which the MiniSpir is connected must
be compliant with IEC 60601-1.
If the PC connected to MiniSpir is used in the area containing the patient, it is necessary that the PC complies with the
EN 60601-1 Standard (ref. EN 60601-1 Standard).
For the disposal of the MiniSpir, the accessories, plastic consumable materials (mouthpieces), use only the appropriate
containers or return all such parts to the seller of the instrument or to a recycling centre. All applicable local regulations
must be followed.
If any of these rules are not followed then MIR will decline all responsibility for any direct or indirect damages, however
caused.
1.2.6 Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may
be subject to electromagnetic interference caused by other equipment.
Such electromagnetic interference could cause the medical device to malfunction, such as a lower measurement
accuracy than stated, and create a potentially dangerous situation.
MiniSpir complies with the EN 60601-1-2:2015 standard on electromagnetic compatibility (EMC for electromedical
devices) both in terms of immunity and emissions.
For the correct operation of the device, however, it is necessary not to use MiniSpir 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, MiniSpir and the other devices must be kept under
observation to verify that they work normally.
Note: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals
(IEC/CISPR 11 Class A). If it is used in a residential environment (for which IEC/CISPR 11 Class B is normally required)
this equipment might not offer adequate protection to radio-frequency communication services. The user might need to
take mitigation measures, such as relocating or re-orienting the equipment.”
1.3 Unforeseen errors
If any problems should arise with the device, a message indicating the nature of the problem will appear on the screen of the PC,
together with a warning “beep”.
Errors in measurement or in interpretation can also be caused by:
•use by non-qualified or non-trained personnel, lacking ability or experience
•user error
•use of the instrument outside the guidelines described in this User's Manual
•use of the instrument even when some operational anomalies are encountered
•non-authorised servicing of the instrument.
1.4 Labels and symbols
1.4.1 Identification label and symbols
Symbol
Description
Model:
Product name
SN
Device serial number

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Symbol
Description
Manufacturer symbol
0476
This product is certified to conform to the Class IIa requirements of the Regulation 2017/745/UE.
In accordance with the IEC 60601-1 Standard, this product and its component parts are of type BF and
therefore protected against the dangers of direct and indirect contact with electricity.
Class II equipment symbol: as per IEC60601-1, the product complies safety requirements of Class II equipment
IPX1
Information on protection against ingress of liquids. The label indicates the degree of protection against ingress
of liquids (IPX1). The device is protected against vertically falling drops of water
To connect to other devices such as PC or printer.
Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1.
Warning symbol for the WEEE
As laid down in the European Directive 2012/19/EEC requirements regarding the disposal of electrical and
electronic devices (WEEE), at the end of its useful life this device must not be thrown away together with
normal domestic waste as it contains materials which would cause damage to the environment and/or
represent a health risk. Instead it must be delivered to a WEEE authorised collection center, where the device
will then be disposed of correctly.
An alternative is to return the device without charge to the dealer or distributor, when a new equivalent device
is purchased. Due to the materials used in the manufacturing of the device, disposing it as a normal waste
product could cause harm to the environment and/or health. Failure to observe these regulations can lead to
prosecution.
The (ESD) symbol required by the international standard is used in the vicinity of any connector which has not
undergone electrostatic discharge testing.
Rx ONLY
Symbol for FDA regulation: use the device under the prescription of the physician
Instruction for use symbol. Refer to instruction manual. Read this manual carefully before using the medical
device.
Manufacturing date of the device
Temperature limits: indicates the temperature limits to which the medical device can be safely exposed
Humidity limitation: indicates the range of humidity to which the medical device can be safely exposed
Pressure limitation: indicates the range of pressure to which the medical device can be safely exposed
The symbol indicates that the product is a medical device
The symbol indicates the Unique Identification of the Device
The symbol indicates that the device should not be exposed to direct sunlight
The symbol indicates that the device must be kept dry
1.4.2 (ESD) Electrostatic discharge sensitivity symbol
WARNING
Pins of connectors identified with the ESD warning symbol should not be touched and the connections should not be
made to these connectors unless ESD precautionary procedures are used.
Precautionary procedures are the following:
•Environmental procedures as: air conditioning, humidification, conductive floor coverings, non-synthetic clothing
•User procedures as: discharging one’s body to a large metal object, using wrist strap connected to earth.
It is recommended that all staff involved receive an explanation of the ESD warning symbol and training in ESD precautionary
procedures.

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the electrostatic discharge is defined as an electric charge at rest. It is the sudden flow of electricity between two objects caused
by contact, an electrical short, or dielectric breakdown. ESD can be caused by a buildup of static electricity by tribocharging, or
by electrostatic induction. At lower relative humidity, as the environment is drier, charge generation will increase significantly.
Common plastics generally will create the greatest static charges.
Typical electrostatic voltage values:
Walking across a carpet
1.500 –35.000 volts
Walking over untreated vinyl floor
250 –12.000 volts
Vinyl envelope used for work instructions
600 –7.000 volts
Worker at a bench
700 –6.000 volts
If two items are at different electrostatic charge levels, as they approach one another, a spark or Electrostatic Discharge (ESD)
can occur. This rapid, spontaneous transfer of electrostatic charge can generate heat and melt circuitry in electronic components.
A latent defect can occur when an ESD sensitive item is exposed to an ESD event and is partially degraded. It may continue to
perform its intended function, so may not be detected by normal inspection. Intermittent or permanent failures may occur at a later
time.
Static dissipative material will allow the transfer of charge to ground or to other conductive objects. The transfer of charge from
a static dissipative material will generally take longer than from a conductive material of equivalent size. Some well known
insulators are common plastics, and glass. An insulator will hold the charge and cannot be grounded and conduct. the charge
away.
Both conductors and insulators may become charged with static electricity and discharge. Grounding is a very effective ESD
control tool, however, only conductors (conductive or dissipative) can be grounded.
The fundamental ESD control principles are:
•Ground all conductors including people
•Remove insulators, substitute with ESD protective versions
•neutralize with ionizers
•ESDS outside the EPA (ESD protected area) to be in packaging having ESD shielding property
1.5 Product description
MiniSpir is a spirometer spirometer and is connected to a Personal Computer using a USB cable.
The device measures a range of respiratory parameters.
The main features of this multipurpose MiniSpir make it is easy to use and versatile.
Spirometry function
MiniSpir calculates up to 30 functional respiratory parameters, as well as the parameter comparison after the administration of
a drug (PRE/POST) for a bronchodilator test or for a bronchial challenge test. A comparison of data is made between POST (after-
drug) and PRE (before drug administration). The Pre test data relates to percentage variations between the measured results and
the predicted values based on the anthropometric data inserted.
The flow and volume measurement sensor is a digital turbine, based on the infrared interruption principal, which ensures accuracy
in time as required from a professional device.
The special features of this kind of sensor are listed below:
•Accurate measurement even at very low flow rates (end of expiration)
•Not affected by gas humidity nor density
•Shockproof and unbreakable
•Inexpensive to replace.
The two versions of the turbine flow measurement sensors, used on MiniSpir (single-patient disposable or reusable), ensure high
precision in measurements and have the great advantage of requiring no periodic calibration (however, the turbines can be
calibrated if required by the doctor).

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REUSEABLE TURBINE
DISPOSABLE TURBINE
In order to maintain the characteristics of the turbines the following precautions must be closely observed:
•for the single-patient disposable turbine: they must always be substituted between patients.
•for the reusable turbine: always clean the turbine between patients, to ensure the maximum level of hygiene and safety for the
patient.
For a correct interpretation of a spirometry test, the measured values must be compared either to the so-called normal or
predicted values which are calculated from the anthropometric details of the patient or, alternatively, to the personal best values
from the clinical history of the subject.
The personal best values can vary considerably from the predicted values, which are taken from “healthy” subjects.
MiniSpir is connected to a PC trough a USBport. Data measured by MiniSpir are transferred to the PC in real-time. The Windows
“MIR Spiro” software allows to view the spirometric test results (flow/volume curves, spirometry parameters, oximetric parameters
optional) plus the related subject detail.
The data measured by MiniSpir and arranged by the software are available for interpretation by specialised personnel.
The software gives an interpretation of each spirometry test by assigning a “traffic light” code and by comparing the previous values
of the same subject or the reference values of the subject’s group. For further details see the online manual of the MIR Spiro
Software.
MiniSpir is able to make FVC, VC & IVC, MVV and breathing profile tests, calculates an index of test acceptability (quality control)
plus reproducibility of the spirometry tests carried out. The automatic functional interpretation foresees the levels defined by the
ATS (American Thoracic Society) classification.. Each test can be repeated as required. The best parameters are always available
for review. The normal (predicted) values can be selected from several normal “sets”. For example, within the European Union
the majority of doctors use the ERS (European Respiratory Society) predicted values. For the configuration of parameters and
storing tests, see the online manual of the MIR Spiro Software.
1.6 Technical features
There follows a comprehensive description of the main features of the device.
1.6.1 Features of the spirometer
This device meets the requirements of the following standard:
•ATS Standardization of Spirometry 2005, 2019 update
•ISO 23747: 2015
•ISO 26782: 2009
Measured parameters:
SYMBOL
DESCRIPTION
m.u.
FVC
Forced Vital Capacity
L
FEV1
Volume expired in the 1st second of the test
L
FEV1%
FEV1/FVC x100
%
PEF
Peak expiratory flow
L/s
TPEF
Time to reach 90% of PEF
s
FEF2575
Average flow 25%-75% FVC
L/s
FEF7585
Average flow between the values at 75% and 85% of the FVC
L/s
FEF25
Maximum flow at 25% FVC
L/s
FEF50
Maximum flow at 50% FVC
L/s
FEF75
Maximum flow at 75% FVC
L/s
FEV05
Exhaled volume after 0.5 seconds
L
FEV05%
FEV05/FVC x 100
%
FEV075
Exhaled volume after 0.75 seconds
L
FEV075%
FEV075/FVC x 100
%
FEV2
Exhaled volume in the first 2 seconds of testing
L
FEV2%
FEV2/FVC x 100
%
FEV3
Exhaled volume in the first 3 seconds of testing
L
FEV3%
FEV3/FVC x 100
%
FEV6
Exhaled volume in the initial 6 seconds of the test
L
FEV1/FEV6
FEV1/FEV6 x100
%
EI
FEV1/PEF ( empey's index)
L/L/s
RFEV
FEV1/FEV0.5
\
FET
Forced expiration time
s
BEV
Extrapolated volume (also VEXT or EVOL)
mL

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FIVC
Inspiratory forced vital capacity
L
FIV1
Volume inspired in the 1st second
L
FIV1/FIVC
FIV1/IVF x 100
%
ELA
Estimated lung age
years
PIF
Peak inspiratory flow
L/s
FIF25
Maximum flow at 25% FIVC
L/s
FIF50
Maximum flow at 50% FIVC
L/s
FIF75
Maximum flow at 75% FIVC
L/s
R50
FEF50/FIF50 x 100
%
FEV1/VC
FEV1/VC per 100
%
MVV cal
Max Ventilation _ voluntary calculated on the basis of FEV1
L/min
VC
Improved slow expiratory vital capacity
L
EVC
Slow expiratory vital capacity
L
IVC
Slow inspiratory vital capacity
L
IC
Inspiratory capacity (maximum between EVC and IVC) - ERV
L
ERV
Expiratory reserve volume
L
IRV
Inspiratory reserve volume
L
TV
tidal volume
L
VE
Minute ventilation at rest
L/min
RR
Breath frequency
Breath/min
tI
Average inspiratory time at rest
s
tE
Mean expiratory time at rest
s
TV/tI
Average inspiratory flow at rest
L/s
tI/tTOT
Average inspiratory time at rest versus total time
\
MVV
Maximum voluntary ventilation
L/min
tE/tI
t E / t I
/
MV
Minute ventilation
L/min
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
*= best values
Flow/volume measurement system
Bi-directional digital turbine
Temperature sensor
semiconductor (0-45°C)
Measurement principle
Infrared interruption
Volume range
10 L
Flow range
16 L/s
Volume accuracy (ATS 2019)
2.5% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH2O
1.6.2 Other features
Interface
USB
Power supply
USB connection
Dimensions
142x49.7x26mm
Weight
65 grams
Storage conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Shipping conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Compliance with standards
Electrical Safety Standard IEC 60601-1
EMC Standard IEC 60601-1-2
Type of electrical protection
Class II
Grade of electrical protection
BF
Grade of protection against water ingress
IPX1
Level of safety in the presence of inflammable
anaesthetic gas, oxygen or nitrogen
Not suitable
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -20 °C, MAX + 60 °C

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Humidity :MIN 10% RH; MAX 95%RH
Atmospheric pressure: 50kPa, 106 kPa
Transport condition
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Atmospheric pressure: 50kPa, 106 kPa
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Atmospheric pressure: 70kPa, 106 kPa
Applied norms
IEC 60601-1:2005 + A1: 2012 (Electrical Safety)
IEC 60601-1-2:2015 (EMC)
ATS/ERS Guidelines: 2005, 2019 update
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2019
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223-1:2021
IEC 60601-1-6: 2010+Amd2013
Essential performances (compliant with EN
60601-1:2005 + A1:2012)
Error of displayed numeric value: Flow measurement
percentage error < ± 5%
Oximetry parameters measuring with accuracy defined in table
on §1.6.2
Emission limits
CISPR 11 Group 1 Class A
Electrostatic discharge protection
8kV contact, 15kV air
Magnetic field immunity
30 A/m
Radio Frequency Immunity
3V/m @ 80-2700 MHz
2. FUNCTIONING OF THE MiniSpir
2.1 Connection to PC
WARNING
Before connecting MiniSpir to a PC, the MIR Spiro software must be installed on the PC in order to interface it with the
device.
To make the connection, attach the other connector to the USB port of the PC.
When initially making a connection, the PC will, either make an automatic driver installation or request some information. To avoid
errors in this phase please read the MIR Spiro User Manual very carefully.
To control the proper connection between the device and the PC use the communication check available on MIR Spiro.
2.2 Using the MiniSpir
For correct use of the device and for setup of data required for the interpretation of the results (initial setup, turbine calibration,
patient data management, viewing previous data and interpretation of results) see the MIR Spiro software manual.
2.3 Spirometry Testing
WARNING
The device must only be used by qualified personnel with complete knowledge of spirometry; this is important for the
correct execution of the tests, for the acceptability of measured parameters as well as for the correct interpretation of
results.
For correctly carrying out a spirometry test, it is strongly recommended to carefully follow the instructions as described below.
•Insert the mouthpiece supplied into the hollow part of the turbine by at least 0.5 cm.
•Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils.
•Hold MiniSpir in one hand as you would a cell phone. The side with the ID label should be in the hand of the user.
•Insert the mouthpiece well into the mouth beyond the teeth, being carefully to ensure that air cannot escape from the sides
of the mouth.
•It is suggested to make testing in a standing position and during an expiration lean forward, in order to help the expiratory action
with a compression of the abdomen.
WARNING
Do not touch the USB cable during a test to avoid interfering with the transfer of data to the PC or stopping a test
too soon.

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Please note it is indispensable for an accurate spirometry that all air must be expired from lungs. It is important to stress
that the disposable mouthpiece and turbine must be changed at the end of each test.
After 6 seconds from the initial forced expiratory MiniSpir emits a continuous beep,. This is useful to the doctor to understand if
the patient has reached the minimum expiry time pursuant to the requirements as set forth by the major international associations
of pneumology.
2.4 Acceptability, Repeatability and quality messages
Acceptability, usability, and repeatability of FVC and FEV1 parameters for each single test are defined as summarized in Table 7
of the ATS/ERS 2019 guideline:
For FEV1 and FVC
Required for
Acceptability
Required for
Usability
Acceptability and Usability Criterion
FEV1
FVC
FEV1
FVC
Must have EVOL (VEXT or BEV) <5% of FVC or 0.100 L, whichever is greater
YES
YES
YES
YES
Must have no cough in the first second of expiration*
YES
NO
YES
NO
Must have no glottic closure in the first second of expiration*
YES
YES
YES
YES
Must have no glottic closure after 1 second of expiration
NO
YES
NO
NO
Must achieve one of these three end of forced expiration (EOFE) indicators:
1. Expiratory plateau (<0.025 L in the last 1 second of expiration)
2. Expiratory time >15 seconds
3. FVC is within the repeatability tolerance of or is greater than the largest prior
observed FVC †
NO
YES
NO
NO
Must have no evidence of obstructed mouthpiece or spirometer
YES
YES
NO
NO
Must have no evidence of a leak
YES
YES
NO
NO
If the maximal inspiration after EOFE is greater than FVC, then FIVC - FVC must
be <0.100 L or 5% of FVC, whichever is greater‡
YES
YES
NO
NO
Repeatability criteria (applied to acceptable FVC and FEV1 values)
Age > 6
years:
The difference between the two largest FVC values must be <0.150 L, and the difference between
the two largest FEV1 values must be <0.150 L
Age < 6
years:
The difference between the two largest FVC values must be <0.100 L or 10% of the highest value,
whichever is greater, and the difference between the two largest FEV1 values must be <0.100 L or
10% of the highest value, whichever is greater
Abbreviations: EVOL (VEXT o BEV) = back-extrapolated volume; EOFE = end of forced expiration; FEV075 = forced
expiratory volume in the first 0.75 seconds.
The grading system (above Table 10) will inform the interpreter if values are reported from usable maneuvers not
meeting all acceptability criteria.
*For children aged 6 years or younger, must have at least 0.75 seconds of expiration without glottic closure or cough
for acceptable or usable measurement of FEV0.75.
† Occurs when the patient cannot expire long enough to achieve a plateau (e.g., children with high elastic recoil or
patients with restrictive lung disease) or when the patient inspires or comes off the mouthpiece before a plateau. For
within-maneuver acceptability, the FVC must be greater than or within the repeatability tolerance of the largest FVC
observed before this maneuver within the current prebronchodilator or the current post-bronchodilator testing set.
‡ Although the performance of a maximal forced inspiration is strongly recommended, its absence does not preclude a
maneuver from being judged acceptable, unless extrathoracic obstruction is specifically being investigated.
The design of MIR spirometers with turbine is such that they are not subject to faulty zero-flow setting.
For VC test the acceptability criteria according to ATS/ERS 2019 guideline is defined as follows: the VC test is considered
acceptable is there is less than a 0.025 L volume increase over 1 second; in this case the test is deemed as having a plateau.
The Repeatability criteria in case of VC test is defined as follows:
Number of tests
3 acceptable tests are required
VC
The difference in VC between the largest and next largest manoeuvre must be ≤ smaller of the
following:
0.150 L or 10% VC, for patient older than 6 years of age
Or
0.100 L or 10% VC. For those aged 6 years or younger
Otherwise, additional trials should be performed.
After each maneuver, ATS/ERS 2019 guideline provides a quality messages based on acceptability criteria define in table 7 of
ATS/ERS 2019 guideline, as follows:
Warning message
Warning trigger
Instruction to patient
No plateau
no plateau and expiration < 15 s
keep going until completely empty
Hesitant start
EVOL (VEXT o BEV) exceeds limit
blast out immediately when completely full
Slow start
rise time > 150 ms
blast out immediately when completely full

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Warning message
Warning trigger
Instruction to patient
Abrupt stop
suspected glottis closure
if you feel your throat closing, relax, but keep
pushing
Cough in expiration
suspected cough in first second of expiration
try having a sip of water before the next blow
Hesitation at
maximum volume
hesitation time > 2 s
blast out when completely full
Slow filling
mean inspiratory flow of the breath just prior
to forced expiration is less than 2 L/s
breathe in faster before blasting out
Low final inspiration
FIVC < 90% FVC
after completely emptying your lungs,
remember to breathe in - back to the top
Incomplete inspiration
FIVC < FVC
fill your lungs completely before blasting out –
take the deepest breath possible
WARNING
The best test with the criteria defined in the 2019 ATS guideline is not considered the one with the best FVC+FEV1 sum, but is
chosen among the tests that meet the acceptability criteria set by the aforementioned guideline. Then it is chosen among those
tests that did not provide error messages.
The following table defined in the ATS 2019 guideline defines the criteria for choosing tests for acceptability and repeatability.
Further consideration and management of particular cases are detailed in the ATS/ERS 2019 guideline.
The quality grade of a test session is expressed with a letter, which separately refers to FVC and FEV1, as described in Table 10
of the ATS/ERS 2019 guideline:
Grade
Number of Measurements
Repeatability:
Age > 6 years
Repeatability:
Age <6 years*
A
> 3 acceptable
Within0.150 L
Within0.100 L*
B
2 acceptable
Within0.150 L
Within0.100 L*
C
> 2 acceptable
Within0.200 L
Within0.150 L*
D
> 2 acceptable
Within0.250 L
entro 0.200 L*
E
> 2 acceptable
or 1 acceptable
> 0.250 L
N/A
> 0.200 L*
N/A
U
0 acceptable AND > 1 usable
N/A
N/A
F
0 acceptable AND 0 usable
N/A
N/A
The repeatability grade is determined for the set of prebronchodilator maneuvers
and the set of post-bronchodilator maneuvers separately. The repeatability criteria
are applied to the differences between the two largest FVC values and the two
largest FEV1 values. Grade U indicates that only usable but not acceptable
measurements were obtained. Although some maneuvers may be acceptable or
usable at grading levels lower than A, the overriding goal must be to always achieve
the best possible testing quality for each patient. Adapted from Am. J. Respir. Crit.
Care Med. 2017;196:1463–1472.
*Or 10% of the highest value, whichever is greater; applies for age 6 years or
younger only
2.5 Interpreting spirometry results
The interpretation of spirometry refers to Forced Vital Capacity (FVC) and is seen by means of indicator lighting.
This interpretation is calculated on the best manoeuvre according to the ATS /ERS 2019 guideline.

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The messages can include the following:
Normal spirometry
Light obstruction/restriction
Moderate obstruction/restriction
Moderately severe obstruction/restriction
Severe obstruction/restriction
Very severe obstruction/restriction
The final interpretation level is "restriction + obstruction", where the indicator light indicates the worst parameter between restriction
and obstruction.

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3. DATA TRANSMISSION
WARNING
Read the instructions carefully before starting the transmission of data taking due care in ensuring that all the
information has been properly understood.
3.1 Transmission with USB cable
All data in the MiniSpir is transferred through a USB cable connection. Refer to Paragraph 2.1 of this Manual to connect the
device to a PC. The data measured by MiniSpir during a spirometry test are sent to the PC in digital form and managed by the
MIR Spiro software.
WARNING
Do not disconnect MiniSpir from the PC during a test. Before to disconnect MiniSpir from the PC close MIR Spiro
software. To disconnect MiniSpir remove the USB cable from the PC connector. For more details read the MIR Spiro user
manual.
3.2 Upgrade Internal software
MiniSpir software can be upgraded when connected to a PC via USB.Upgrades can be downloaded by registering on
www.spirometry.com. For further information on upgrading software see the MIR Spiro software manual.
4. MAINTENANCE
WARNING
No part can be subjected to maintenance during use.
MiniSpir is an instrument that requires very limited maintenance. The operations to perform periodically are:
•Cleaning and controlling of the reusable turbine
•Changing the single-patient disposable turbine at each test
The maintenance operations set forth in the User’s Manual must be carried out carefully. Failing to observe the instructions
contained in the manual may cause errors in measurement or in the interpretation of measured values.
Modifications, adjustments, repairs, and reconfiguration must be carried out by the manufacturer or authorised persons.
In case problems arise do not attempt to personally repair the unit.
The setting of configuration parameters must be carried out by qualified personnel. In any case the risks pertaining to incorrect
settings do not constitute a hazard for the patient.
4.1 Cleaning and controlling the reusable turbine
The turbine utilized on MiniSpir belongs to one of two categories: disposable and reusable. Both guarantee precise measurements
and have the great advantage of requiring no periodic calibration. In order to maintain the characteristics of the turbine a simple
cleaning is required prior to each use (only for the reusable turbine).
Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic bag. It must be disposed of after use.
It is a good practice to control from time to time that dirt or foreign bodies are not deposited inside the turbine such as
threads or hair. Any such deposit could brake or block the rotation of the turbine blade and thus compromise the
measurement accuracy.
To clean the reusable turbine, remove it from its compartment on the MiniSpir by turning it anti-clockwise and pressing lightly. It
can be helpful to push it gently from underneath with one finger.
Immerse the turbine in the recommended cold detergent solution, and move it within the liquid to remove any impurities which may
be deposited inside. Leave the turbine immersed for the time specified in the instruction of the solution.
To avoid any kind of damage to the reusable turbine please do not use any alcoholic or oily substances, do not immerge
the turbine in hot water or hot solution.
Do not put the turbine under a direct jet of water or other liquid. If no detergent solution is available, clean the turbine in
clean water.
MIR suggest the use sodium hypochlorite which has been tested on all MIR sensors.
Rinse the turbine by immerging it in clean water (not hot).
Shake off the excess water from the turbine and leave it to dry, standing it vertically on a dry surface.
Once the turbine has been cleaned insert the turbine tube in its place according to the direction as indicated by the closed lock
symbol printed on the plastic casing of the MiniSpir.

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To correctly insert the turbine push it to the end and turn it clockwise until reaching the wedge which ensures that the tube has
been blocked inside the plastic casing.
When using the disposable turbine, do not clean it, but change it after each patient.
5. PROBLEM SOLVING
PROBLEM
MESSAGE
POSSIBLE CAUSES
REMEDY
MiniSpir does not
connect with the PC
\
The USB cable is not correctly
connected
Check the correct connection of the USB
cable side Pc
\
The driver doesn’t work correctly
Check the presence of the device in the list
of USB devices connected. Try to remove
and connect the device.
Spirometry data at the
end of the test are not
acceptable
\
The turbine don’t rotate correctly
Clean the turbine and check another time;
use a new turbine
\
The test is performed in a wrong
way
Repeat the test following the indications on
the screen
During an oximetry test
the values are wrong,
irregular
\
The sensor is positioned in a
wrong way or the perfusion
index of the patient is low
Put the sensor in another position.
\
The patient is moving
To obtain an accurate measurement the
patient should not make sudden
movements.
6. LIMITED WARRANTY CONDITIONS
MiniSpir, together with its standard accessories is guaranteed for a period of 12 months if intended for professional use (doctors,
hospitals, etc.).
The warranty is effective from the date of purchase contained in the relevant sales invoice or proof of purchase.
The instrument must be checked at the time of purchase, or upon delivery, and any claims must be made immediately in writing
to the manufacturer.
This warranty covers the repair or the replacement (at the discretion of the manufacturer) of the product or of the defective parts
without charge for the parts or for the labour.
All batteries and other consumable parts, reusable turbine included, are specifically excluded from the terms of this guarantee.
This warranty is not valid, at the discretion of the manufacturer, in the following cases:
•If the fault is due to an improper installation or operation of the machine, or if the installation does not conform to the current
safety norms in the country of installation.
•If the product is utilised differently from the use described in the Users Manual.
•If any alteration, adjustment, modification or repair has been carried out by personnel not authorised by MIR.
•If the fault is caused by lack of or incorrect routine maintenance of the machine.
•If the machine has been dropped, damaged or subjected to physical or electrical stress.
•If the fault is caused by the mains or by another product to which the instrument has been connected.
•If the serial number of the instrument is missing, tampered with and/or not clearly legible.
The repair or replacement described in this warranty is supplied for goods returned at the customers’ expense to our certified
service centres. For details of these centres please contact your local supplier of the spirometer or contact the manufacturer
directly.
The customer is responsible for the transportation and for all transport and customs charges as well as for delivery charges of the
goods both to and from the service centre.
Any instrument or accessory returned must be accompanied by a clear and detailed explanation of the defect or problem found.
If units are to be returned to the manufacturer then written or verbal permission must be received before any instruments are
returned to MIR.
MIR Medical International Research, reserves the right to modify the instrument if required, and a description of any modification
made will be sent along with the returned goods.