MIR MiniSpir Light User manual

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 1 of 18
User Manual Rev. 1.9
Issued on: 09.10.2020
Approved on: 09.10.2020

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 2 of 18
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 …
•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 WinspiroPro 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
The winspiroPRO PC software supplied with the device MUST be installed correctly to the PC before connecting MiniSpir
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 winspiroPRO 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: 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

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 3 of 18
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 .............................................................................................................................................5
1.2.1 Danger of cross-contamination.................................................................................................................................5
1.2.2 Turbine......................................................................................................................................................................5
1.2.3 Mouthpiece ...............................................................................................................................................................6
1.2.4 Oximetry sensor........................................................................................................................................................6
1.2.5 USB Connection Cable.............................................................................................................................................7
1.2.6 Device.......................................................................................................................................................................7
1.2.7 Warnings for use in electromagnetic environments ..................................................................................................7
1.3 Unforeseen errors .........................................................................................................................................................8
1.4 Labels and symbols.......................................................................................................................................................8
1.4.1 Identification label.....................................................................................................................................................8
1.4.2 (ESD) Electrostatic discharge sensitivity symbol ......................................................................................................9
1.5 Product description........................................................................................................................................................9
1.6 Technical features.......................................................................................................................................................10
1.6.1 Features of the spirometer......................................................................................................................................10
1.6.2 Features of the oximeter.........................................................................................................................................12
1.6.3 Other features.........................................................................................................................................................12
2. FUNCTIONING OF THE MiniSpir......................................................................................................................................13
2.1 Connection to PC........................................................................................................................................................13
2.2 Using the MiniSpir.......................................................................................................................................................13
2.3 Spirometry Testing......................................................................................................................................................13
2.4 Spirometry test interpretation ......................................................................................................................................14
2.5 Oximetry testing ..........................................................................................................................................................15
3. DATA TRANSMISSION.....................................................................................................................................................16
3.1 Transmission with USB cable......................................................................................................................................16
3.2 Upgrade Internal software...........................................................................................................................................17
4. MAINTENANCE.................................................................................................................................................................17
4.1 Cleaning and controlling the reusable turbine .............................................................................................................17
4.2 Cleaning the oximetry sensor......................................................................................................................................17
5. PROBLEM SOLVING.........................................................................................................................................................18
6. LIMITED WARRANTY CONDITIONS................................................................................................................................18

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 4 of 18
1. INTRODUCTION
1.1 Intended Use
MiniSpir spirometer and pulse oximeter (optional) 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
•oximetry testing in people of all ages.
It can be used in hospital setting, physician's office, factory, pharmacy.
1.1.1 User Category
MiniSpir calculates a series of parameters relating to human respiratory function.
Use of the device is usually "prescribed" by a doctor, who is responsible for analysing and checking the results and the data
gathered during the test period .
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.
The MiniSpir when used as a pulse oximeter is intended for spot-checking oximetry.
1.1.3 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.
1.1.4 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.
WARNING
MiniSpir when used as a pulse oximeter has limited alarms, therefore the device requires frequent PC display observation
of SpO2 and pulse rate.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 5 of 18
1.2 Important safety warnings
MiniSpir has been examined by an independent laboratory which hascertified the conformity ofthe 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 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.
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
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.
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.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 6 of 18
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 Oximetry sensor
The included sensor code 919024_INV and the following oximetry sensors can be used with MiniSpir:
Manufacturer
Code
Description
MIR code
Envitec
RS-3222-12
Reusable small soft sensor (paediatric)
939006
Envitec
RM-3222-12
Reusable medium soft sensor (adults )
939007
Envitec
R-3222-12
Reusable large soft sensor (adults)
939008
BCI
3044
Reusable hard finger sensor (adults)
919020
These sensors, with the exception of the sensor MIR code 919020 which has the MIR connector with orange arrow, require the
use of an extension cable to be correctly connected to the device: the extension cables available are:
code 919200_INV lenght 1,5 m
code 919210_INV lenght 0,5 m
Prolonged use and/or the patient’s condition may require changing the sensor site periodically. Change sensor site and check
skin integrity, circulatory status, and correct alignment at least every 4 hours.
WARNING
Incorrectly applied sensors or damaged cables may cause inaccurate readings. Using a damaged sensor may cause
inaccurate readings, possibly resulting in patient injury or death. Inspect each sensor before use.
If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair centre for assistance.
Use only MIR sensors supplied with, or specifically intended for use with the MiniSpir. Use of sensors not intended for
use with the MiniSpir may cause inaccurate readings.
Oximetry measurements may be inaccurate in the presence of high ambient light. Shield the sensor area (with a surgical
towel, for example) if necessary.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 7 of 18
WARNING
Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue V (PBV),
and fluorescein may adversely affect the accuracy of the oximetry reading.
Any condition that restricts blood flow, such as the use of a blood pressure cuff or a device for systemic vascular
resistance, may cause an inability to determine accurate pulse rate and SpO2 readings.
Remove fingernail polish and/or false fingernails before applying SpO2 sensors. Both may cause inaccurate oximetry
measurement.
Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or methemoglobin, may adversely affect
the accuracy of the oximetry measurement.
Optical cross-talk can occur when two or more sensors are placed in close proximity. Optical cross-talk may adversely
affect the accuracy of the oximetry readings. The danger can be eliminated by covering each site with opaque material.
Obstructions or dirt on the sensor’s emitter and/or detector may cause a sensor failure or inaccurate readings. Make
sure there are no obstructions and the sensor is clean.
Autoclaving, ethylene oxide sterilizing, may cause sensor damage. Do not attempt to sterilize the sensor.
Unplug the sensor from MiniSpir before cleaning or disinfecting to prevent damaging sensor or device, and to prevent
safety hazards for the user.
1.2.5 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.
1.2.6 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.
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.
1.2.7 Warnings for use in electromagnetic environments
Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may
be 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.
Do not use the instrument in the presence of MRI equipment, which can generate an induced current in the sensor to
measure oximetry, causing injury to the patient.
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.”

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 8 of 18
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
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
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.
SpO2
Warning symbol for the SpO2 port for oximetry (Oximetry function is on request)
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

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 9 of 18
Symbol
Description
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.
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 is a spirometer spirometer that can also features a pulse oximeter feature (optional), and is connected to a Personal
Computer using a USB cable.
The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart beat.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 10 of 18
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).
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
“winspiroPro” 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 WinSpiroPro
Software.
MiniSpir is able to make FVC, VC & IVC, MVV and breathing profile tests, calculates an index of test acceptability (qualitycontrol)
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 WinSpiroPro Software.
Oximetry function (optional)
The oximetry sensor has two light emitting diodes (LEDs), one emits in the visible spectre and one infrared. Both lights then pass
through the finger and are “read” by the receiver. As these lights pass through the finger, a proportion of the light is absorbed by
the blood and by the soft tissue, in function of the concentration of heamoglobin. The quantity of light absorbed, at each frequency,
depends on the degree of oxygenation of the haemoglobin inside the soft tissue.
This measurement principal ensures accuracy and reproducibility, without requiring regular calibration.
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
•ISO 23747: 2015
•ISO 26782: 2009

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 11 of 18
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
%
FEV3
Volume expired in the initial 3 seconds of the test
L
FEV3/FVC
FEV3/FVC x 100
%
FEV6
Volume expired in the initial 6 seconds of the test
L
FEV6%
FEV1/FEV6 x 100
%
PEF
Peak Expiratory Flow
L/min
PEF Time
Time to achieve 90% of the PEF
s
FEF2575
Flow ratio at 25% and at 75%
L/s
FEF7585
Median flow between 75% and 85% of FVC
L/s
FEF25
Forced Expiratory Flow at 25% of FVC
L/s
FEF50
Forced Expiratory Flow at 50% of FVC
L/s
FEF75
Forced Expiratory Flow at 75% of FVC
L/s
FEV05
Volume exhaled after 0.5 seconds
L
FEV05/FVC
FEV05/FVC x 100
%
FEV075
Volume exhaled after 0.75 seconds
L
FEV075/FVC
FEV075/FVC x 100
%
FEV2
Volume exhaled in the first 2 seconds of the test
L
FEV2/FVC
FEV2/FVC x 100
%
FEV1/PEF
FEV1/PEF (empey’s index)
L/L/s
FEV1/FEV0.5
FEV1/FEV0.5
\
FET
Forced expiratory time
s
EVOL
Extrapolated volume
mL
FIVC
Forced inspiratory volume
L
FIV1
Volume inspired in the 1st second of the test
L
FIV1/FIVC
FIV1/FIVC x 100
%
PIF
Peak inspiratory flow
L/s
FIF25
Maximum flow at 25% of FIVC
L/s
FIF50
Maximum flow at 50% of FIVC
L/s
FIF75
Maximum flow at 75% of FIVC
L/s
FEF50/FIF50
FEF50/FIF50 x 100
%
ELA
Estimated lung age
years
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
VC
Slow vital capacity (expiratory)
L
IVC
Slow inspiratory vital capacity
L
IC
Inspiratory capacity (max between EVC and IVC) - ERV
L
ERV
Expiratory reserve volume
L
IRV
Inspiratory reserve volume
L
FEV1/VC
FEV1/VC x 100
%
VT
Tidal volume
L
VE
Ventilation per minute, at rest
L/min
Rf
Respiratory frequency
tI
Average time of inspiration, at rest
S
tE
Average time of expiration, at rest
S
ti/ttot
Average time of inspiration / total time
min
VT/tI
Average inspiratory flow, at rest
L/s
MVV(cal)
Maximum voluntary ventilation calculated on FEV1
L/min
*= 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

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 12 of 18
1.6.2 Features of the oximeter
For oximetry measurements, the device complies with the requirements of the following standard:
ISO 80601-2-61:2017 Medical electrical equipment - particular requirements for basic safety and essential performance of pulse
oximeter equipment
Reusable hard sensor for adults
Reusable soft sensor for adults
Reusable paediatric soft sensor
Range (SpO2)
Arms (%)
Range (SpO2)
Arms (%)
Range (SpO2)
Arms (%)
70-100 %
1.19
70-100 %
±1.470
70-100 %
±1.390
70-80 %
0.554
70-80 %
± 1.626
70-80 %
± 1.851
80-90 %
1.32
80-90 %
± 1.667
80-90 %
± 1.397
90-100 %
1.45
90-100 %
± 0.941
90-100 %
± 0.652
The Arms (Accuracy Root Mean Square), as recalled in the above mentioned standard, represents the accuracy of the device in
terms of the mean square error of each SpO2 measurement, obtained by pulse oximetry, in relation to the respective SaO2
reference value, obtained by co-oximetry.
The ranges listed show the different oxygen saturation ranges for which the accuracy has been calculated.
The accuracy of the device can be assessed with a tester.
Measured parameters:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 Average in first three minutes
%
SpO2 Min
SpO2 Minimum during analysis period
%
SpO2 Max
SpO2 Maximum during analysis period
%
SpO2 Mean
SpO2 Average during analysis period
%
BPM Baseline
Average pulse frequency in the first 3 minutes
BPM
BPM Min
Minimum pulse frequency during the analysis period
BPM
BPM Max
Maximum pulse frequency during the analysis period
BPM
BPM Mean
Average pulse frequency during the analysis period
BPM
Recording time
Total time measure of SpO2
hh:mm:ss
Analysis Time
Total time of analysis
hh:mm:ss
T90
Time passed with SpO2 < 90 %
%
hh:mm:ss
T89
Time passed with SpO2 < 89 %
%
hh:mm:ss
T88
Time passed with SpO2 < 88 %
%
hh:mm:ss
T87
Time passed with SpO2 < 87 %
%
hh:mm:ss
N. SpO2 Events < 89%
Fall of SpO2 below 89 % for at least 20 seconds
\
Index (12sec)
Index of SpO2 fluctuation calculated in intervals of 12 seconds
\
T< 40 BPM
Time passed with pulse frequency < 40 BPM
%
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
%
hh:mm:ss
Bradycar. Events < 40 BPM
Bradycardia events during the entire analysis period
\
Tachycar. Events>120 BPM
Tachycardia events during the entire analysis period
\
=DELTA
Measurement method
Red and infrared absorption
%SpO2range
0 –99% (with 1% increments)
%SpO2accuracy
2% between 70-99% SpO2
Average number of heart beats for %SpO2calculation
8 beats
cardiac pulse range
30 –300 BPM (with 1 BPM increments)
cardiac pulse accuracy
2 BPM or 2%
Average interval for the calculation of cardiac pulse
8 seconds
Signal quality indication
0 - 8 segments on display
Wavelengths and maximum optical output power
average of the oximetry sensors (919024, 919020)
Red light: 660 nm, 2.0 mW (**)
Infrared light: 905 nm, 2.4 mW (**)
Wavelengths and optical output power of oximetry
sensors (Envitec sensors)
Red light: 660 nm, 3.5-4.5 mW (**)
Infrared light: 905 nm, 3.5-4.5 mW (**)
** This information may be useful to the doctor.
The specifications for both the oximetry and for the cardiac pulse are the same, regardless of which of the above mentioned
oximetry sensors is used.
A more detailed specification of oximetry accuracy for some of the oximetry probes is given in Annex 2.
1.6.3 Other features
Interface
USB
Power supply
USB connection
Dimensions
142x49.7x26mm

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 13 of 18
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
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
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2012
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223:2016
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 B
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 winspiroPro 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 winspiroPRO User Manual very carefully.
To control the proper connection between the device and the PC use the communication check available on winspiroPRO.
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 winspiroPro 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.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 14 of 18
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.
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 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 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 to within 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 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, this message is shown
EXPIRY TIME INSUFFICENT <6s
FLOW ERROR

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 15 of 18
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:
BLOW OUT ALL AIR IN LUNGS
Between two tests, MiniSpir 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;
2.5 Oximetry testing
WARNING
If MiniSpir as been purchased without the oximetry option, then only spirometry tests can be made
WARNING
The sensors described below are for illustration purposes only. MiniSpir is enabled for the use of any of the sensors
described in the Paragraph 1.2.4. MIR does not recommend the use of a specific type of sensor; any decision in regard
is made by the individual doctor.
Re-usable finger sensor
This sensor is recommended for patients weighing >20 Kg with limited activity.
Carry out an oximetry test as follows:
•Connect the sensor to the instrument: insert the connector with the arrow (printed on
the connector) face-up, as shown:
•Choose a high perfusion site, easily adaptable to the sensor
•Insert finger into the sensor until the finger touches the end of the probeEnsure that the
bottom part of the finger completely covers the detector. If the finger is not able to be
correctly positioned, use another finger.
•Position the sensor so that the cable is underneath the top of the hand. This enables
the light source to remain on the fingernail and the detector on the bottom part of the
finger.
WARNING
In order not to compromise the reproducibility of the measurements and the integrity of the sensor, avoid twisting the
sensor cable and handle it with care when using, connecting, disconnecting and when placing the finger into it.
During the first few seconds of the test the device searches for the best signal, after which the timer re-sets to zero and MiniSpir
starts to memorise the data.
If the sensor has not been correctly inserted, the message “Sensor unplugged” will appear on the PC screen.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 16 of 18
If the sensor has been inserted but the finger is not inserted correctly, the message “Finger not detected correctly” will appear on
the PC screen.
If the sensor correctly receives the signal, after a few seconds the device starts to ‘beep’ and the values will be displayed on the
PC screen.
WARNING
A test is archived using the name of last patient visualised. If this refers to a patientwhose data has already been inserted
in the past, call up a previous test carried out on the patient in question and proceed as described in the final part of
paragraph 2.6.
WARNING
For archiviations method of the tests please see on line manual of winspiroPRO software
Reusable "soft" sensor
WARNING
The materials used for manufacturing the sensor are NATURAL LATEX PROTEIN free. The materials used for the sensor
are subject to biocompatibility tests.
Adult Patient Sensor –Instructions for Use
•Choose an application site on the patient’s finger or toe where the light source will be directly over and in-line with the
detector. The preferred sites are the forefinger or smaller thumb.
•Remove nail polish or artificial fingernails
•Place the patient’s digit in the sensor nail-side up, lining up the digit’s pad over
the detector. The sensor’s positioning line runs across the mid axis of the fingertip
•Wrap the bottom adhesive around the digit, being careful not to cover the nail.
•Fold the sensor’s top over the digit, making sure the light source is directly over and in-line with the detector. Route the cable
along the palm or the bottom of the foot, and secure with adhesive tape if necessary.
•Connect the sensor to the instrument: insert the connector with the arrow on the connector face-up and control the correct
functioning according to the previous instructions.
WARNING
Do not twist unnecessarily or use excessive force when using, connecting, disconnecting, or storing the sensor.
An over-tight sensor can produce inaccurate saturation measurements.
It is recommended to fasten the cable to the wrist with a bandage.
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
winspiroPro software.
WARNING
Do not disconnect MiniSpir from the PC during a test. Before to disconnect MiniSpir from the PC close winspiroPRO
software. To disconnect MiniSpir remove the USB cable from the PC connector. For more details read the winspiroPRO
user manual.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 17 of 18
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 winspiroPro 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
•Cleaning of the oximetry sensor (for reusable sensors)
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.
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.
4.2 Cleaning the oximetry sensor
The reusable oximetry sensor must be cleaned whenhever the patient changes, before to apply the sensor to another patient.
Clean the sensor with a soft cloth moistened with water or a mild soap solution. To disinfect the sensor, rub with isopropylic
alcohol. Allow the sensor to dry completely after cleaning.
WARNING
Do not sterilize by irradiation, steam, or, ethylene oxide. Do not immerse in liquids.
Unplug the sensor from the device before cleaning or disinfecting it.

MiniSpir
User manual
MINISPIR User manual Rev 1.9 page 18 of 18
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.