MIR SMARTONE User manual

SmartOne
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SmartOne
DRAFT VERSION
User manual rev. 0.1
Issue date 05.01.2015
Approval date 05.01.2015

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INDEX
1. INTRODUCTION ............................................................................................................................................................................................ 3
1.1 Intended Use ............................................................................................................................................................................................ 3
1.1.1 User Category...................................................................................................................................................................................... 3
1.1.2 Ability and experience required ....................................................................................................................................................... 4
1.1.3 Operating environment ..................................................................................................................................................................... 4
1.1.4 Subject effect on the use of the device........................................................................................................................................... 4
1.1.5 Limitations of use - Contraindications ........................................................................................................................................... 4
1.2 Important safety warnings ..................................................................................................................................................................... 4
1.2.1 Danger of cross-contamination ....................................................................................................................................................... 5
1.2.2 Turbine.................................................................................................................................................................................................5
1.2.3 Mouthpiece.......................................................................................................................................................................................... 6
1.2.4 Device................................................................................................................................................................................................... 6
1.3 Unforeseen errors.................................................................................................................................................................................... 6
1.4 Labels and symbols ................................................................................................................................................................................. 6
1.4.1 Identification label.............................................................................................................................................................................. 7
1.4.2 Electrical safety symbol ..................................................................................................................................................................... 7
1.4.3 Warning symbol for the WEEE Directive .................................................................................................................................... 7
1.4.4 Mark of conformity with the Medical Device Directive ............................................................................................................. 7
1.5 Product description................................................................................................................................................................................. 7
1.6 Technical features.................................................................................................................................................................................... 8
1.6.1 Features of the spirometer................................................................................................................................................................ 8
1.6.2 Other features ..................................................................................................................................................................................... 9
2. FUNCTIONING OF THE Smart One®.....................................................................................................................................................10
2.1 Connection to PC..................................................................................................................................................................................10
2.2 Using the Smart One®..........................................................................................................................................................................10
2.3 Spirometry Testing ................................................................................................................................................................................10
2.4 Spirometry test interpretation .............................................................................................................................................................10
3. MAINTENANCE ............................................................................................................................................................................................12
3.1 Cleaning and controlling the reusable turbine..................................................................................................................................12
4. PROBLEM SOLVING ...................................................................................................................................................................................12
ANNEX 1 INFORMATION FOR CORRECT USE IN ELECTROMAGNETIC ENVIRONMENTS.......................................16

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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 Smart One®…
Read this manual carefully, plus all labels and other product information supplied.
Smart One®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 Smart
One®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 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: [e-mail]. 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
1. INTRODUCTION
1.1 Intended Use
Smart One®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 any setting.
1.1.1 User Category
Smart One®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.

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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 Smart One®when used as a pulse oximeter is intended for spot-checking oximetry.
1.1.3 Operating environment
Smart One®has been designed for use in a doctor’s office or in a hospital setting.
All information necessary for the proper use of the device in surrounding electromagnetic environments (as required by the EN
60601-1-2) is specified in Annex I.
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 1.7.3.
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 Subject effect on the use of the device
A spirometry test should only be carried out when the subject is at rest and in good health, and thus in a suitable condition for the
test. A spirometry test requires the collaboration of the subject since the subject must make a complete forced expiration, in order
to have a meaningful test result.
1.1.5 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the subject’s clinical condition.
A detailed clinical history of the subject is also required together with the results of any other test(s) suggested by a doctor.
Test comments, a test interpretation and suggested courses of treatment must be given by a doctor.
A spirometry test requires the collaboration of the subject. The results depend on the person’s capability to inspire and to expire all
air completely and as fast as possible. If these fundamental conditions are not respected then the results obtained during spirometry
testing will not be considered accurate, and therefore the test results are “not acceptable”.
The acceptability of a test is the responsibility of the user. Special attention should be given to testing elderly subjects, children
and handicapped people.
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
Smart One®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.
Smart One® 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

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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 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
The correct functioning 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. Periodic
cleaning should only be done when the device is for personal use and will
only be used by one patient. The cleaning of the turbine should be
performed according to the instructions contained in the User’s Manual.
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.
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 Smart One® 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 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 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.
High-frequency emissions from “electronic” devices may interfere with the correct operation of the instrument. For this
reason, certain minimum clearances (a few metres) should be observed when high-frequency appliances such as a TV,
radio, portable phone, etc. and other electronic units are operated at the same time in the same room.
The instrument may give inaccurate readings if operated in the presence of strong electromagnetic sources or in the
presence of other medical devices such as echographies.
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 or the printer which the Smart One® is
connected must be compliant with IEC 60601-1.
If the PC connected to Smart One®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 Smart One®, the accessories, plastic consumable materials (mouthpieces) plus the battery, 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.
1.3 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

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1.4.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
Warning symbol for the WEEE Directive
Mark of conformity with the Medical Device Directive
1.4.2 Electrical safety symbol
In accordance with IEC 60601-1 this product and its component parts are of type BF and therefore protected against the hazards
of direct and indirect contact with electricity.
1.4.3 Warning symbol for the WEEE Directive
This symbol is laid down in the 2002/96/EEC regarding the waste of electrical and electronic equipment (WEEE). At the end of
its useful life this device must not be disposed of as normal domestic waste. Instead it must be delivered to a WEEE authorised
collection centre.
As an alternative, the device may be returned without charge to the dealer or distributor, when it is replaced by another equivalent
device.
Due to the construction materials used for 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.
1.4.4 Mark of conformity with the Medical Device Directive
0476
This product is certified to conform to the Class IIa requirements of the 93/42/EEC Medical Devices Directive.
1.5 Product description
Smart One® is a spirometer and pulse oximeter, 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.

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The main features of this multipurpose Smart One® make it is easy to use and versatile.
Spirometry function
Smart One®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 Smart One®(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
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.
Smart One®is connected to a PC trough a USB port. Data measured by Smart One®are transferred to the PC in real-time. The
Windows “winspiroPro” software allows to view the spirometric test results (flow/volume curves, spirometry parameters) plus the
related subject detail.
The data measured by Smart One®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.
Smart One®is able to make FVC and 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
WinSpiroPro Software.
1.6 Technical features
There follows a comprehensive description of the main features of the device.
1.6.1 Features of the spirometer

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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
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
FEF2575
Flow ratio at 25% and at 75%
%
FET
Forced expiratory time
S
Vext
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
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
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/t-tot
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
3% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH2O
1.6.2 Other features
Interface
Bluetooth low energy (4.0 or higher)
Power supply
2 x 1.5 V AAA type alkaline battery
Dimensions
142x49.7x26mm
Weight
65 grams
Storage conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Shipping conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;

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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
IPX0
Level of safety in the presence of
inflammable anaesthetic gas, oxygen
or nitrogen
Not suitable
Conditions of use
Device for continuous use
Essential performances (compliant
with EN 60601-1: 2007)
Accuracy in spirometry parameters measuring, compliant with standard ATS
2. FUNCTIONING OF THE Smart One®
2.1 Connection to PC
WARNING
Before connecting Smart One®to a PC, the winspiroPro software must be installed on the PC in order to interface it with
the device.
To make the connection, performe a Bluetooth pairing between device and PC.
To control the proper connection between the device and the PC check that the led on the device is lit.
2.2 Using the Smart One®
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.
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 Smart One®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
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 Smart One®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: