MIR MiniSpir Light User manual

MiniSpir Light
User manual
MINISPIR LIGHT User manual Rev 1.7 page 1 di 13
User Manual Rev. 1.7
Issued on: 09.10.2020
Approved on: 09.10.2020

MiniSpir Light
User manual
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Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
WARNING
The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in the equipment should be considered
disposable products.
Before using your MiniSpir Light …
•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 WinspiroLIGHT
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 Light should only be connected to a computer manufactured in compliance with EN 60950.
WARNING
The winspiroLIGHT PC software supplied with the device MUST be installed correctly to the PC before connecting
MiniSpir Light to the PC. 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 winspiroLIGHT 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 SRL:
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: [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 User Category...........................................................................................................................................................4
1.1.2 Ability and experience required.................................................................................................................................4
1.1.3 Operating environment .............................................................................................................................................4
1.1.4 Who can or must make the installation.....................................................................................................................4
1.1.5 Subject effect on the use of the device .....................................................................................................................4
1.1.6 Limitations of use - Contraindications.......................................................................................................................4
1.2 Important safety warnings .............................................................................................................................................4
1.2.1 Danger of cross-contamination.................................................................................................................................5
1.2.2 Turbine......................................................................................................................................................................5
1.2.3 USB Connection Cable.............................................................................................................................................6
1.2.4 Device.......................................................................................................................................................................6
1.2.5 Warnings for use in electromagnetic environments ..................................................................................................6
1.3 Unforeseen errors .........................................................................................................................................................6
1.4 Labels and symbols.......................................................................................................................................................7
1.4.1 Identification label.....................................................................................................................................................7
Warning symbol for the WEEE................................................................................................................................................7
1.4.2 (ESD) Electrostatic discharge sensitivity symbol ......................................................................................................7
1.5 Product description........................................................................................................................................................8
1.6 Technical features.........................................................................................................................................................9
1.6.1 Features of the spirometer........................................................................................................................................9
1.6.2 Other features.........................................................................................................................................................10
2. FUNCTIONING OF THE MiniSpir Light .............................................................................................................................10
2.1 Connection to PC........................................................................................................................................................10
2.2 Using the MiniSpir Light ..............................................................................................................................................10
2.3 Spirometry Testing......................................................................................................................................................10
2.4 Spirometry test interpretation ......................................................................................................................................11
3. DATA TRANSMISSION.....................................................................................................................................................12
3.1 Transmission with USB cable......................................................................................................................................12
3.2Upgrade Internal software...........................................................................................................................................12
4. MAINTENANCE.................................................................................................................................................................12
5. PROBLEM SOLVING.........................................................................................................................................................12
LIMITED WARRANTY CONDITIONS...........................................................................................................................................13

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1. INTRODUCTION
1.1 Intended Use
MiniSpir Light 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 User Category
MiniSpir Light calculates a series of parameters relating to human respiratory function.
The product is therefore intended for use by a doctor or by a trained paramedic or technician under the supervision of a doctor.
1.1.2 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.
1.1.3 Operating environment
MiniSpir Light 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 1.6.2.
WARNING
If the device is exposed to unsuitable environmental conditions, this could cause the device to malfunction and to give
incorrect results.
1.1.4 Who can or must make the installation
The device requires installation by qualified personnel.
1.1.5 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.
1.1.6 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.
1.2 Important safety warnings
MiniSpir Light has been examined by an independent laboratory which has certified the conformity of the device 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 Light is throughly tested during its production and therefore the product complies with the safety requirements and
quality standards laid down by the Council Directive 93/42/EEC 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.

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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.
In the event of any incident or accident of any kind resulting from the use of the device, the user is required to inform
the manufacturer without delay, according with Directive 93/42/EEC on Medical Devices.
1.2.1 Danger of cross-contamination
One type of turbine sensorcan be used with the device: the single-patient disposable. 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 disposable flow sensor must always be changed
before each subject,. The use of an anti bacterial filter is at the discretion of the doctor.
1.2.2 Turbine
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.
Do not expose the turbine to a direct jet of water or air, and avoid contact with high temperature liquids.
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 turbine
WARNING
The turbine flow sensor does not require calibration. 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 Light 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.

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1.2.3 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 Light. The use of other types of cables can lead
to inaccurate measurements.
1.2.4 Device
WARNING
The maintenance operations detailed in this manual must 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
parameters should only be made by qualified personnel. However, an incorrect set up of the parameters does not put
the patient at risk.
If the PC connected to MiniSpir Light is used in the area containing the patient, it is necessary that the PC complies with
the EN 60601-1 Standard (ref. EN 60601-1-1 Standard).
For the disposal of the MiniSpir Light, 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 center. 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.
1.2.5 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 Light 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 Light 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 Light 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.

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1.4 Labels and symbols
1.4.1 Identification label
SYMBOL
DESCRIPTION
Model:
Product name
SN
Device serial number
Manufacturer symbol
0476
This product is certified to conform to the Class IIa requirements of the 93/42/EEC medical device directive.
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
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
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.

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It is recommended that all staff involved receive an explanation of the ESD warning symbol and training in ESD precautionary
procedures.
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 Light is a 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 Light make it is easy to use and versatile.
Spirometry function
MiniSpir Light calculates 10 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 POST session is available only on the MiniSpir Light BD
version.
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

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•Inexpensive to replace.
The turbine flow measurement sensors, used on MiniSpir 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).
DISPOSABLE TURBINE
In order to maintain the characteristics the turbines must always be substituted between patients.
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 Light is connected to a PC trough a USB port. Data measured by MiniSpir Light are transferred to the PC in real-time.
The Windows “winspiroLIGHT” software allows to view the spirometric test results (flow/volume curves, spirometry parameters)
plus the related subject detail.
The data measured by MiniSpir Light 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 WinspiroLIGHT
Software.
MiniSpir Light is able to make FVC, VC & IVC tests, calculates an index of test acceptability (quality control) plus reproducibility
of the spirometry tests carried out. The automatic test interpretation follows the latest 11 level 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 WinspiroLIGHT 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
FEV6
Volume expired in the initial 6 seconds of the test
L
FEV1%
FEV1/FVC x100
%
PEF
Peak Expiratory Flow
L/min
FEF2575
Flow ratio at 25% and at 75%
L/s
FIVC
Forced inspiratory volume
L
ELA
Estimated lung age
years
EVC
Slow vital capacity (expiratory)
L
IVC
Slow inspiratory vital capacity
L
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

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1.6.2 Other features
Interface
USB
Power supply
USB connection
Dimensions
127x52x15 142x49.7x26mm
Weight
65 grams
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
Humidity :MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Transport condition
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 70kPa, 106 kPa
Applied norms
IEC 60601-1:2005 + A1:2012 (Electrical
Safety)
EN 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 15223:2016
IEC 60601-1-6: 2010+Amd2013
Essential performances (compliant with IEC 60601-1:2005+A1:2012)
Error of displayed numeric value: Flow
measurement percentage error< ± 5%
Emission limits
CISPR 11 Group 1 Class B
Electrostatic discharge protection
8kV contact, 15kV air
Magnetic field immunity
30 A/m
Radio Frequency Immunity
3V/m @ 80-2700 MHz
MIR will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other
information that will assist service personnel to repair those part of the device that are designated by MIR as repairable
by service personnel.
2. FUNCTIONING OF THE MiniSpir Light
2.1 Connection to PC
WARNING
Before connecting MiniSpir Light to a PC, the winspiroLIGHT software must be installed on the PC in order to interface
it with the device.
To connect the device to the PC, it is sufficient to connect the standard USB socket of the device to one of the USB ports 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 winspiroLIGHT User Manual very carefully.
To control the proper connection between the device and the PC check that the led on the device is lit.
2.2 Using the MiniSpir Light
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 winspiroLIGHT 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.

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For correctly carrying out a spirometry test, it is strongly recommended to carefully follow the instructions as described below.
•Fit the nose clip onto the nose of the subject to ensure that air cannot escape through the nostrils.
•Hold MiniSpir Light 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.
Please note it is indispensable for an accurate spirometry that all air must be expired from lungs. It is important to stress
that the turbine must be changed at the end of each test.
After 6 seconds from the initial forced expiratory MiniSpir Light emits a continuous beep. This is useful to the doctor tounderstand
if the patient has reached theminimum expiry time pursuantto the requirements as set forth by the major international associations
of pneumology.
2.4 Spirometry test interpretation
The interpretation of these indices %, according to the ATS standards, generates a series of messages which correspond to
possible levels of obstruction or restriction plus one level of normal spirometry, as shown in the following table:
•normal
•mild
•moderate
•moderately severe
•severe
•very severe
Through an analysis applied to some of the indices and parameters calculated in the FVC test, MiniSpir Light produces a variety
of quality control comments useful to understand the reliability of the test made.
This control quality check assigns a letter for the current session as described below:
PRE Test
A = At least two acceptable manoeuvres, with the highest two FEV1 values matching to within 100 mL and the largest two FEV6
values within 100 mL.
B= At least two acceptable manoeuvres, with the FEV1 values matching to within 101 to 150 mL
C= At least two acceptable manoeuvres, with FEV1 values matching to within 151 to 200 mL
D= only one acceptable manoeuvres, ormore than one, but the FEV1 values not matching towithin 200 mL (with no interpretation).
F= No acceptable manoeuvres (with no interpretation).
POST Test
A = two acceptable (1) FEV1 values matching within 100 mL
B= two acceptable (1) FEV1 values matching within 200 mL
C= two acceptable (1) FEV1 values that do not match within 200 mL
D= only one acceptable (1) FEV1 manoeuvre
F= No acceptable (1) FEV1 manoeuvres
Acceptable manoeuvre means: good start and satisfactory exhalation (duration and flow)
Where several comments related to the single test are calculated, MiniSpir Light will only show the most important to facilitate
the test interpretation.
ERROR IN Vext and PEF
If the extrapolated volume Vext is greater than 500 mL or greater than 5% of the FVC, or if the PEFT (time to peak flow) is greater
than 200 ms, then the following comment is shown:
REPEAT TEST AND BLOW FASTER FET error
If FET is less than the minimum (6 seconds) the message appears:
EXPIRY TIME INSUFFICENT <6s
FLOW ERROR
If the last flow point of the F/V curve is greater than 200 mL/s, this indicates that the expiration was not complete and thus the
following comment is shown:

MiniSpir Light
User manual
MINISPIR LIGHT User manual Rev 1.7 page 12 di 13
BLOW OUT ALL AIR IN LUNGS
Between two tests, MiniSpir Light evaluates the repeatability of the following parameters:
If FVC is > 1.0 L then:
FEV1 repeatable when the difference between the two largest FEV1 is ≤ 150 mL;
FVC repeatable when the difference between the two largest FVC is ≤ 150 mL;
if FVC is ≤ 1.0 L then:
FEV1 repeatable when the difference between the two largest FEV1 is ≤ 100 mL;
FVC repeatable when the difference between the two largest FVC is ≤ 100 mL;
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 Light 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 Light during a spirometry test are sent to the PC in digital form and managed
by the winspiroLIGHT software.
WARNING
Do not disconnect MiniSpir Light from the PC during a test. Before to disconnect MiniSpir Light from the PC close
winspiroLIGHT software. To disconnect MiniSpir Light remove the USB cable from the PC connector. For more details
read the winspiroLIGHT user manual.
3.2 Upgrade Internal software
MiniSpir Light 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 winspiroLIGHT software manual.
4. MAINTENANCE
WARNING
No part can be subjected to maintenance during use.
MiniSpir Light is an instrument that requires very limited maintenance. The only operations to perform periodically is the
•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.
5. PROBLEM SOLVING
PROBLEM
MESSAGE
POSSIBLE CAUSES
REMEDY
MiniSpir Light does not connect with the
PC
\
The USB cable is not
correctly connected
Check the correct connection of the
USB cable side PC and side device.
\
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
use a new turbine
\
The test is performed in
a wrong way
Repeat the test following the
indications on the screen

MiniSpir Light
User manual
MINISPIR LIGHT User manual Rev 1.7 page 13 di 13
LIMITED WARRANTY CONDITIONS
MiniSpir Light, 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 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.