MIR Spirolab User manual

Spirolab
Rev.1.8
Page 1 of 60
Spirolab
User manual Rev. 1.8
Date issued 04.05.2020
Date approved 04.05.2020

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TABLE OF CONTENTS
1. INTRODUCTION ................................................................................................................................................ 6
1.1 Intended use ..............................................................................................................................................6
1.1.1 User type ....................................................................................................................................................6
1.1.2 Ability and experience required...............................................................................................................6
1.1.3 Where the device is used..........................................................................................................................6
1.1.4 Individual patient factors that can affect use of the product ...............................................................7
1.1.5 Limitations of use –Contraindications ..................................................................................................7
1.2 Important safety warnings .......................................................................................................................8
1.2.1 Risk of cross contamination ....................................................................................................................8
1.2.2 Turbine.......................................................................................................................................................9
1.2.3 Mouthpiece................................................................................................................................................9
1.2.4 Sensor for oximetry ................................................................................................................................10
1.2.5 USB connection cable ............................................................................................................................11
1.2.6 The unit....................................................................................................................................................11
1.2.7 Warnings for use in electromagnetic environments............................................................................12
1.3 Labels and symbols.................................................................................................................................13
1.3.1 ID label.....................................................................................................................................................13
1.3.2 FCC certification label............................................................................................................................14
1.3.3 Electrostatic discharge symbol ..............................................................................................................15
1.4 Product description.................................................................................................................................16
1.5 Technical specifications..........................................................................................................................18
1.5.1 Spirometer specifications .......................................................................................................................18
1.5.2 Oximeter specifications..........................................................................................................................20
1.5.3 Other features..........................................................................................................................................22
2. USING THE SPIROLAB ...................................................................................................................................24
2.1 Turning the spirolab on and off............................................................................................................24
2.2 Saving energy...........................................................................................................................................26
2.3 Main screen..............................................................................................................................................27
2.4 Symbols and icons ..................................................................................................................................27
2.5 Service menu ...........................................................................................................................................27
2.5.1 Calibrating turbines.................................................................................................................................32
2.6 Patient data ..............................................................................................................................................34
2.6.1 Entering new patient data ......................................................................................................................35
2.6.2 Editing patient data.................................................................................................................................36
2.7 Viewing stored data ................................................................................................................................37
2.7.1 How to search the archives....................................................................................................................37
2.7.2 Viewing archived data.............................................................................................................................37
2.7.3 Displaying the last test session ..............................................................................................................39
2.8 Online mode (connected to a PC) ........................................................................................................39
2.9 Performing a spirometry test .................................................................................................................40
2.9.1 FVC test...................................................................................................................................................41
2.9.2 VC test......................................................................................................................................................42
2.9.3 MVV test..................................................................................................................................................42
2.9.4 Running POST tests after the administration of a drug.....................................................................43
2.10 Displaying and reading spirometry results ...........................................................................................44
2.10.1 Interpreting spirometry results........................................................................................................44
2.11 Performing oximetry...............................................................................................................................46
2.11.1 Instructions for using the sensor on adult patients.......................................................................48
3. DATA TRANSMISSION....................................................................................................................................49
3.1 Data transmission via Bluetooth ...........................................................................................................49
3.2 Connecting with a PC via USB port .....................................................................................................50
3.3 Printing data.............................................................................................................................................51
3.4 Up-dating internal software ...................................................................................................................52

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4. MAINTENANCE................................................................................................................................................ 52
4.1 Cleaning and checking reusable turbines..............................................................................................52
4.1.1 Checking correct turbine function ........................................................................................................53
4.2 Cleaning the oximetry sensor ................................................................................................................54
4.3 Recharging the battery pack...................................................................................................................54
4.4 Replacing the thermal paper ..................................................................................................................55
5. TROUBLE SHOOTING AND SOLUTIONS ...............................................................................................57
Guarantee conditions......................................................................................................................................................59

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Thank you for choosing a MIR product
MEDICAL INTERNATIONAL RESEARCH
This manual refers to the spirolab generation with serial number as follows:
A23-0J.xxxxx
Where:
A23-0J is the root
xxxxx is a sequential number.
The internal software is available in the following languages:
English
Spanish
Russian
Romanian
Italian
Portuguese
Turkish
French
Brazilian
Czechoslovak
German
Polish
Vietnamese
The following table describes the contents of the package and the accessories that can be
used with spirolab:
REF
Description
672684
Carrying case
✓
910320
Plastic noseclip
✓
532367
USB cable
✓
910300
cardboard mouthpiece
✓
\
User manual - winspiroPRO CD
✓
910350
Thermal printer paper
✓
920690XX
Battery charger
✓
900595
MiniFlowmeter
✓
910002
Reusable Turbine

910004
Disposable Turbine

912024
Oximetry Sensor

✓included optional
WARNING
The nose clip, mouthpiece and turbine with mouthpiece that come supplied with
the device are to be treated as single-use disposable items.
The accessories supplied are ticked on the cover of the "New spirolab device equipment",
supplied with the device.

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Before using your spirolab…
•Carefully read the user manual, the labels and all the information supplied with the device
•Configure the device (date, time, assigned values, language etc.) as described in section
2.5
WARNING
Before connecting spirolab to a PC, install the winspiroPRO software supplied with
the device.
Once the software has been correctly installed, connect the device to the PC; a
message will appear that confirms the recognition of a new peripheral device.
Keep the original packaging!
In the event of a problem with the product, use the original packaging and send it to your
local distributor or to the manufacturer.
If the device is being sent for repair, the following rules apply:
•Goods must be sent in their original packaging;
•Costs involved in sending the product are at the sender's expense.
Manufacturer's address
MIR SRL
Via del Maggiolino, 125
00155 ROMA (ITALY)
Tel + 39 0622754777 Fax + 39 0622754785
Website: 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
Sito web: www.spirometry.com Email: [e-mail]
MIR implements a policy of constant product improvement and the technology we
use is in a state of continuous evolution. For this reason, the company reserves the
right to up-date these instructions if necessary. If you have any suggestions that you
consider useful, please send an e-mail to the following address:
[email protected]. Thank you.
MIR does not accept any responsibility for any harm or damage caused by users
failing to follow the instructions or failing to heed the warnings in this manual.
Total or partial copying of this manual is forbidden.

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1. INTRODUCTION
1.1 Intended use
The Spirolab spirometer and pulse oximeter is intended to be used by a physician, by a
licensed healthcare professional or by a patient under the instruction of a physician or of
a licensed healthcare professional.
The device is intended to test lung function and can make:
•for spirometry tests in adult and pediatric patients, excluding infants and neonates
•for oximetry tests in people of all age.
It may be used in in hospital setting, physician's office, factory, pharmacy.
1.1.1 User type
The spirolab spirometer and oximeter (optional) provides information about 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 technique for using and maintaining the device along with the ability to interpret the
results provided calls for a qualified health worker.
WARNING
MIR will not be held responsible for any harm or damage of any kind caused by
mistakes made by users failing to heed the warnings in this manual.
If a spirolab user is a person who is incapable of looking after him or herself, the
device must be used under the supervision and responsibility of the person who is
legally in charge of that person.
When the spirolab device is used as an oximeter, it is intended for spot checks.
1.1.3 Where the device is used
The spirolab device was designed for use in hospital setting, physician's office, factory,
pharmacy.
The product is not suitable for use in operating theatres or in the presence of flammable
liquids or detergents, or where there are anaesthetic gas mixtures that become flammable
in the presence of air, oxygen or nitrous oxide.
The product is not suitable for use where it may be exposed to air currents (e.g. the wind),
sources of heat or cold, direct sunlight or other sources of light or energy, dust, grit or
chemical substances.

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It is the responsibility of the user to ensure that the product is used and stored under the
proper environmental conditions. For further information, refer to the instructions in
section 1.5.3 below.
WARNING
If the device is subject to climate conditions other than those shown in section 1.5.3,
it is possible that malfunctions may occur and/or that incorrect results may be
displayed.
1.1.4 Individual patient factors that can affect use of the product
The spirometer can only be used when the patient is resting and in good health, or at least
in a state of health that is compatible with the test being carried out. Performing the test
calls for the collaboration of the patient, who must exhale forcefully to ensure that the
parameters measured provide reliable results.
1.1.5 Limitations of use –Contraindications
An analysis of the results of spirometry alone is not sufficient to provide a diagnosis of a
patient's clinical condition. A diagnosis can only be made in conjunction with an
examination that takes the patient's case history into account, as well as the results of other
tests recommended by the doctor.
Comments, diagnoses and appropriate therapeutic treatments are made by the doctor.
Any symptoms must be evaluated before spirometry is carried out. The doctor who
prescribes use of the device must first ascertain the physical/psychological capacity of the
patient to assess his or her suitability for performing the test. The same doctor must
subsequently evaluate the data gathered by the device to estimate the degree of
collaboration for each test carried out.
A correct spirometry test calls for a patient's complete collaboration. The results obtained
depend on the patient's ability to inhale and exhale as quickly as possible. If these key
conditions cannot be met, the spirometry results will not be reliable or, as doctors say, will
be "unacceptable". The acceptability of a test is the doctor's responsibility. Extra care
must be taken when dealing with elderly patients, children or differently-able persons.
The product must not be used if malfunctions or faults are detected or suspected as these
may compromise results.
WARNING
When the spirolab device is used as an oximeter, it has a limited alarm system and
for this reason the SpO2 and pulse rate shown on the display need to be checked
frequently.

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1.2 Important safety warnings
Spirolab devices have been examined by an independent laboratory that has certified their
conformity with EN 60601-1 safety standards and guaranteed that their electromagnetic
compatibility is within the limits laid out in EN 60601-1-2.
Spirolab devices are subject to continuous checks during production and therefore comply
with the safety and quality standards laid down in Council Directive 93/42/EEC for
Medical Devices.
Once the device has been removed from its packaging, examine it carefully to make sure
there are no signs of damage. In the event of any damage, do not use the device but return
it immediately to the manufacturer for possible replacement.
WARNING
Patient safety and device performance are only guaranteed if warnings and current
safety standards are complied with.
The manufacturer declines all responsibility for harm or damage caused by failure
to follow the instructions of use.
The product must be used as described in the User Manual, especially as regards §
Intended Use, and only original accessories as specified by the manufacturer are to
be used. The use or non-original turbine sensors, oximetry sensors or other
accessories might cause erroneous readings or compromise the correct functioning
of the device. For this reason, the use of such items is not permitted.
In particular, the use of cables other than those specified by the manufacturer could
cause increased emissions or lower electromagnetic immunity from the device and
result in improper operation.
Do not use the product if it has passed its shelf life. In normal working conditions,
this is equal to approximately 10 years.
The battery charge level is constantly monitored by the device itself. The device will
display a message warning the user if the battery is flat.
In the event of any incident arising from use of the device, we strongly advise the
user to inform his or her doctor, who will then complete the procedure laid down by
Article 9 of Legislative Decree No. 46/1997 implementing EC Directive No. 93/42.
1.2.1 Risk of cross contamination
So as to avoid any risk of cross contamination, it is imperative to use a single-use
mouthpiece for each individual patient.
The device may be used with two types of turbine sensors: a reusable one and a disposable
one.
Reusable turbine sensors must be cleaned before being used on a new patient. The use of
an anti-bacterial viral filter is left to the doctor's discretion.
The disposable turbine sensor must be replaced for each patient.

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1.2.2 Turbine
Disposable turbine
WARNING
If you decide to use the spirometer with a “disposable”
turbine, it is important to use a new turbine for each
patient.
Adequate hygiene, safety and operational conditions of
“disposable” turbines are only guaranteed if said
turbines are preserved in the original, sealed packaging.
“Disposable” turbines are made of plastic; to dispose of
the turbines, please comply with local legal
requirements.
Reusable turbine
WARNING
The correct use of a “reusable” turbine is guaranteed
only and exclusively if it is “clean” and free from foreign
bodies that alter the motion of the blades. If a reusable
turbine is not properly cleaned, it can cause cross
infection between patients. Periodical cleaning of the
device is only sufficient if that device is used exclusively
by the same patient. For further details about cleaning,
refer to the appropriate section in this User Manual.
The following information is valid for both types of turbine.
Never expose turbine sensors to jets of water or air or allow contact with hot liquids.
To avoid malfunctions or damage, do not introduce dust or foreign bodies into the turbine
sensor. The presence of foreign bodies (such as hairs, saliva etc.) inside the turbine flow
meter can compromise the accuracy of readings.
1.2.3 Mouthpiece
The single-use mouthpieces that come supplied with the device are provided as a sample
to demonstrate the correct type and size. They must be considered clean but not sterile.
We recommend that you contact the local distributor where you bought your spirometer
to obtain additional mouthpieces. These are usually made of cardboard or plastic and are
always for single use only.
WARNING
Use biocompatible mouthpieces to avoid problems for the patient; unsuitable
materials might cause the device to malfunction and compromise the accuracy of
readings.

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It is the responsibility of the user to provide suitable mouthpieces. These items generally
have a standard 30 mm external diameter and are commonly used by health workers. They
are widely available.
WARNING
To avoid contamination of the environment caused by the disposal of used
mouthpieces, the user must comply with all the local regulations in force.
1.2.4 Sensor for oximetry
In addition to the sensor code number 919024 supplied with the device, the following
specific sensors can also be used for different types of patients:
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
These sensors require the use of the extension cable item code 919200 (length 1.5 m) for
connection with the spirolab device.
Prolonged use of a sensor or the patient's condition may mean that the location of the
sensor has to be changed periodically. Change the position of sensors every 4 hours.
Moreover, check the condition of the skin and blood flow, and ensure the sensor is
properly aligned.
WARNING
The incorrect use of a sensor or sensor cable and the use of a faulty sensor or sensor
cable may compromise the accuracy of readings, and indeed generate seriously
incorrect readings of the patient's condition. Check every sensor carefully before
use.
Do not use sensors that appear to be or are damaged. If you do not have any more
working sensors, contact your local distributor who supplied the device.
Only use MIR sensors that have been specifically designed to work with spirolab.
The use of other sensors may provide faulty readings.
Oximetry results may be faulty if the test is performed under very bright conditions.
If necessary, cover the sensor (e.g. with a clean cloth).
WARNING

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Any colouring agent present in the blood (e.g. for performing diagnostic tests), such
as methylene blue, indocyanine green, indigo carmine, patent blue-V (PBV), can
compromise the accuracy of oximetry readings.
Any condition that restricts the flow of blood, e.g. the use of a cuff to measure blood
pressure, can compromise the accuracy of SpO2 and pulse rate readings.
False nails and nail varnish must be removed before using the sensor as they might
compromise the accuracy of oximetry readings.
Significant levels of dysfunctional haemoglobin such as carboxyhemoglobin or
methemoglobin affect the accuracy of oxygen readings.
If two or more oximetry sensors are positioned near each other, optical interference
may occur. Such interference can compromise the accuracy of oxygen readings. To
eliminate any such interference, cover the sensors with an opaque material.
Dirt or obstructions that block the red light on the sensor or that block the detector
may provide inaccurate readings or sensor malfunctions. Always make sure that the
sensor is clean and free of obstructions.
Never place the sensor in an autoclave. Do not sterilise the sensor.
Before cleaning the sensor, disconnect it from the spirolab unit to prevent damage
to the sensor and device and to avoid compromising user safety.
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 Spirolab. The use
of other types of cables can lead to inaccurate measurements.
1.2.6 The unit
WARNING
All the maintenance operations described in the User Manual must be carried out
with great care. Failure to follow these instructions may lead to incorrect readings
or the incorrect interpretation of readings that have been taken.
Do not modify the device without authorisation from the manufacturer.
All modifications, adjustments, repairs and reconfigurations must be performed by
the manufacturer or by personnel authorised by the manufacturer. In the event of
problems, do not attempt to make repairs. The setting of configurable parameters

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must be performed by qualified staff. The incorrect setting of parameters, however,
will not compromise a patient's state of health.
On request, the manufacturer can provide electrical diagrams, parts lists,
descriptions and calibration instructions to assist the technicians with repairs.
The use of accessories and cables other than those specified by the manufacturer
may result in increased emissions or decreased device immunity.
The spirolab device should not be used close to or stacked with other equipment; if
it must be used close to or stacked with other equipment, spirolab should be
observed to verify normal operation in the configuration in which it will be used.
If the device is used in conjunction with other items of equipment, only equipment
that complies with current safety regulations can be used so as meet the safety
standards laid down by IEC EN 60601-1; consequently, the PC or printer to which
spirolab is connected should comply with IEC EN 60601-1.
As regards the disposal of spirolab devices, accessories, plastic consumables
(mouthpieces), removable components and items that are subject to ageing (e.g.
the battery pack), only use suitable containers or, better, send the materials to the
device retailer or an approved disposal centre. Local legal requirements in force
must be complied with in all cases.
Failure to comply with the above mentioned regulations will relieve MIR of all
responsibility from any direct or indirect claim for damages.
Use only the battery pack specified in § Technical Specifications.
Keep the device out of the reach of children and differently-able persons.
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.
Spirolab 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 Spirolab
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, Spirolab 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.

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1.3 Labels and symbols
1.3.1 ID label
The symbols are described in the table below:
SYMBOL
DESCRIPTION
Model
Product name
SN
Device serial number
Manufacturer's name and address
0476
CE mark for medical devices: this product is a Class IIa medical
device that is certified and in compliance with the requirements of
Council Directive 93/42/EEC
Electrical safety symbol: as per IEC60601-1, the product and its
component parts are type BF and therefore offer protection against
electrical shocks
Class II equipment symbol: as per IEC60601-1, the product complies
safety requirements of Class II equipment while so charging the
battery
WEEE symbol is mandatory to European Directive 2012/19/EEC
on Waste Electrical and Electronic Equipment. On completion of its
useful life, this appliance must not be disposed of as urban waste but
must be sent to an authorised WEEE waste disposal centre. The
device can also be sent back to the original supplier free of charge
when a new equivalent model is bought.
Due to the materials used in its manufacture, disposal of the device
as urban waste could harm the environment and/or health.
There are legal penalties in place for those who fail to observe the
legal requirements mentioned here
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

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SYMBOL
DESCRIPTION
Antenna symbol for devices that include RF transmitters
FCC ID
FCC Identification code indicating traceability to FCC compliance
Rx ONLY
Reference to US FDA regulations: use the device on prescription
Instruction for use symbol. Refer to instruction manual. Read this
manual carefully before using the medical device
Production date of the device
USB port warning label. For connecting the device to a PC. Only use
cables supplied by the manufacturer and observe the IEC 60601-1
safety standards
SpO2
SpO2 oximetry port warning label
Electrostatic discharge symbol. This symbol is used near every
connector that has been excluded from the electrostatic discharge
test. In this device the electrostatic discharge tests have been
performed.
DC IN 12V
Label relating to the method for charging the battery pack. The
symbol is screen-printed next to the connector for connecting the
battery charger. Only use the charger supplied by the manufacturer.
Features of the battery charger: model AC/DC 12W-N1EFM
Temperature limits: indicates the temperature limits to which the
medical device can be safely exposed
Humidity limitation: indicates the range of humidity to which the
medical device can be safely exposed
Pressure limitation: indicates the range of pressure to which the
medical device can be safely exposed
1.3.2 FCC certification label
Spirolab complies with section 15 of the FCC standards. Operation of the device is subject
to the following conditions:
(1) This device must not cause harmful interference
(2) This device can be subjected to all types of interference, including those which may
cause undesired effects
Any modifications made without the express approval of this company may compromise
the use of the device by the user.
NOTE: This device has been subjected to tests that confirm it complies with the limits of
a class B digital instrument as per section 15 of the FCC Standards. These limits have been

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set to provide appropriate protection against interference when the device is used in the
home. This device generates, uses and can emit radio signals and, if not installed or used
as per instructions, can create interference with radio communications.
The absence of interference cannot however be guaranteed for all installations.
If this device causes interference to radio or TV reception (that can be determined by
turning the device on and off), we recommend the user corrects the interference by
adopting one of more of the counter measures listed below:
•Change the angle or position of the antenna.
•Increase the distance between the device and the appliance receiving the signal.
•Connect the device to a different power socket than the one used by the appliance
receiving the signal.
•Contact the supplier or radio/TV technician for expert advice.
The symbols defined may be found on the device ID label.
1.3.3 Electrostatic discharge symbol
This symbol is used near every connector that has been excluded from the electrostatic
discharge test.
WARNING
The contacts of connectors identified with the ESD warning symbol should not be
touched and connections should not be performed before appropriate precautionary
electrostatic discharge (ESD) measures are undertaken.
Below are examples of such precautionary measures:
Environmental procedures: air conditioning, humidification, conductive floor-covering
substances, use of non-synthetic clothing
User procedures: discharge using large metal objects; use of an ESD wrist strap.
Any staff that uses devices affected by electrostatic discharge should receive adequate
explanations concerning the ESD symbol and adequate training on the effects of
electrostatic discharge and on the measures to be undertaken to prevent such effects.
An electrostatic discharge is defined as an electric charge at rest. It is the sudden flow of
electricity between two objects in contact, an electrical short or a dielectric breakdown.
ESD may be caused by a build-up of static electricity or by electrostatic induction. At low
relative humidity, charge generation will increase significantly due to the dry environment.
Common plastics create higher charge levels.
Typical values of voltages caused by electrostatic discharges are shown below:
Walking on a carpet
1500-35000 Volts
Walking on an untreated vinyl floor
250-12000 Volts

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Vinyl envelopes used to organise documents
600-7000 Volts
Worker at a table
700-6000 Volts
If two elements have different charge values, their coming into contact could cause an
electrostatic discharge spark. This quick and spontaneous transfer of charge can lead to
overheating or melting of circuits in electronic components.
A latent defect can occur when an element sensitive to ESD is exposed to an ESD event
and is partially damaged by it. The device can continue to function normally and the
damage may not be detected by routine checks, but intermittent or persistent damage can
occur even after a long time.
With ESD materials, charges go to ground or to another conductive object that the
material contacts. Dissipative materials allow charges to flow to ground more slowly than
with conductive materials of equal size. Common plastics and glass can act as insulators.
An insulator retains charges and these cannot be transferred to ground. Both conductors
and insulators can be charged with electrostatic charges and discharged. Grounding is a
very efficient instrument against ESD, but only conductors can be connected to ground.
The fundamental principles of control against ESD are:
Grounding of all conductors, including people
Removing insulators and replacing them with ESD-safe versions
Using ionisers
Paying attention to areas that are not ESD-safe, e.g. using ESD-safe product packaging
1.4 Product description
Spirolab is a portable spirometer that can also features a pulse oximeter feature (optional).
The device can operate completely autonomously or can be connected to a personal
computer by means of USB or Bluetooth connections; the device can be connected to an
external printer via USB.

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The device is intended for measuring respiratory parameters and monitoring oxygen
saturation and pulse rate. The device carries out a control test on the quality of the readings
taken and can save the results of about 10,000 spirometric tests or about 500 hours of
oximetry data.
Spirolab is intended for use by medical specialists and it provides them with a powerful
but compact tool that can process about 30 functional parameters. The device also
provides a pharmacodynamic response, i.e. the % comparison of spirometric data
measured before and after (PRE/POST) administration of a drug for bronchial
provocation or bronchodilation. The POST data measured after administering the drug is
compared with the PRE data obtained before administration.
A turbine inside the device that uses the interruption of infra-red light as its operating
principle, measures volume and flow rate. This operating principle ensures accurate,
reproducible results without needing periodic recalibration.
The key features of this type of sensor are as follows:
•Accurate readings even with low air flow rates (end of exhalation)
•Not affected by humidity and gas density
•Unbreakable and shock resistant
•Inexpensive to replace
The turbine volume and flow sensor is available in disposable and reusable versions.
REUSABLE TURBINE
DISPOSABLE TURBINE
In order to preserve the characteristics of the turbines, it is important to observe the
following precautions:
•For the disposable turbine: always replace following patient spirometric tests
•For the reusable turbine: always disinfect before use on a new patient to ensure the best
possible hygiene and safety standards
To properly interpret the results of a spirometry test, it is essential to compare them with
the so-called normality values that are calculated using standardised patient data or with
personal reference values associated with that specific patient's clinical history.
An individual patient's clinical history values van vary significantly from normality values
that always refer to a “healthy”subject.

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Spirolab can be connected to a PC or another computerised system. The spirometric data
from every test is stored in the device and can be transferred to a PC and displayed
(flow/volume curves, spirometric parameters, oximetric parameters optional).
The device can be connected to a PC via a micro USB port.
Spirolab performs FVC, VC & IVC and MVV tests and the ventilatory profile, as well as
an acceptability (quality control) and reproducibility index of the spirometry test carried
out by the patient. The automatic interpretation function uses 11 levels as per ATS
(American Thoracic Society) classification. Every single test can be repeated. The best
functional parameters will always be available for fast re-reading. The normality values
(theoretic) can be selected from those available. For instance, in European Union
countries. doctors generally use the values recommended by the ERS (European
Respiratory Society).
Oximetry function
The oximetry sensor features two light emitting diodes (LED); one emits visible red light
and the other infra-red. Both bands of light pass through the finger to reach a light
detector. During the passage through the finger, some of the light is absorbed by the blood
and soft tissue depending on the concentration of haemoglobin. The amount of each light
frequency absorbed depends on how oxygenated the blood is inside the tissue.
This operating principle ensures accurate and reproducible readings without the need to
constantly calibrate the device.
The oximetry sensor can be disinfected with Isopropyl alcohol.
1.5 Technical specifications
Below is a complete description of the specifications for the device, the turbine volume
and flow sensor and the oximetry sensor.
1.5.1 Spirometer specifications
This device meets the requirements of the following standard:
•ATS Standardization of Spirometry 2005
•ISO 23747: 2015
•ISO 26782: 2009
Parameters measured:
Symbol
Description
U.m.
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
FVC
Forced Vital Capacity
L
FEV1
Volume exhaled in 1st second of the test
L
FEV1/FVC
FEV1/FVC x100
%

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Symbol
Description
U.m.
FEV1/VC
FEV1/ best between EVC and IVC x 100
%
PEF
Peak expiratory flow
L/s
PEF Time
Time to achieve 90% of the PEF
s
FEF-2575
Median flow between 25% and 75% of FVC
L/s
FEF7585
Median flow between 75% and 85% of FVC
L/s
FEF25
Maximum flow at 25% of FVC
L/s
FEF50
Maximum flow at 50% of FVC
L/s
FEF75
Maximum 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
%
FEV3
Volume exhaled in the first 3 seconds of the test
L
FEV3/FVC
FEV3/FVC x 100
%
FEV6
Volume exhaled in the first 6 seconds of the test
L
FEV1/FEV6
FEV1/FEV6x100
%
FEV1/PEF
FEV1/PEF (empey’s index)
L/L/s
FEV1/FEV0.5
FEV1/FEV0.5
\
FET
Forced exhalation time
s
EVOL
Extrapolated volume
mL
FIVC
Forced Inhalation Vital Capacity
L
FIV1
Volume inspired in the 1st second
L
FIV1/FIVC
FIV 1 %
%
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
%
MVVcal
Max. voluntary ventilation calculated based on FEV1
L/s
VC
Slow Expiratory Vital Capacity
L
EVC
Expiratory Vital Capacity
L
IVC
Inspiratory Vital Capacity
L
IC
Inspiratory capacity: (maximum between EVC and
IVC) -ERV
L
ERV
Expiratory reserve volume
L
IRV
Inspiratory reserve volume
L
VT
Tidal Volume
L
VE
Minute ventilation at rest
L/min
RR
Respiratory frequency
Breaths/min
tI
Average inspiratory time at rest
s

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Symbol
Description
U.m.
tE
Average exhalation time at rest
s
TV/tI
Mean inspiratory flow at rest
L/min
tI/tTOT
tI/(tI+tE)
\
MVV
Maximum voluntary ventilation
L/min
ELA
Estimated Lung Age
years
*= best values
Flow/volume sensor
Bi-directional turbine
Temperature sensor
semiconductor (0-45°C)
Method of detection
Infra-red interruption
Maximum volume measured
10 L
Flow rate
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/L/s
1.5.2 Oximeter specifications
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 soft sensor for adults
Range (SpO2)
Arms (%)
70-100 %
±1.470
70-80 %
± 1.626
80-90 %
± 1.667
90-100 %
± 0.941
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.
Definitions
Desaturation event
Drop in SpO2 >= 4% in a 8- 40 sec period limited and
subsequent rise >=2% inside an overall period of 150 sec.
Reusable paediatric soft sensor
Range (SpO2)
Arms (%)
70-100 %
±1.390
70-80 %
± 1.851
80-90 %
± 1.397
90-100 %
± 0.652