Medical International Research Spirolab User manual

Spirolab
Page 1 of 36
Rev.1.4
User manual
User manual Rev. 1.4
Date issued 19.08.2015
Date approved 19.08.2015

Spirolab
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Rev.1.4
User manual
TABLE OF CONTENTS
1. INTRODUCTION ................................................................................................................................................................................................................................................. 4
1.1 Intended use ............................................................................................................................................................................................................................................... 4
1.1.1 User type ..................................................................................................................................................................................................................................................... 4
1.1.2 Ability and experience required................................................................................................................................................................................................................ 4
1.1.3 Where the device is used........................................................................................................................................................................................................................... 4
1.1.4 Individual patient factors that can affect use of the product ................................................................................................................................................................ 4
1.1.5 Limitations of use –Contraindications ................................................................................................................................................................................................... 4
1.2 Important safety warnings ........................................................................................................................................................................................................................ 5
1.2.1 Risk of cross contamination ..................................................................................................................................................................................................................... 5
1.2.2 Turbine........................................................................................................................................................................................................................................................ 5
1.2.3 Mouthpiece................................................................................................................................................................................................................................................. 6
1.2.4 Sensor for oximetry ................................................................................................................................................................................................................................... 6
1.2.5 The unit....................................................................................................................................................................................................................................................... 7
1.3 Labels and symbols.................................................................................................................................................................................................................................... 7
1.3.1 ID label........................................................................................................................................................................................................................................................ 7
1.3.2 CE mark for medical devices.................................................................................................................................................................................................................... 8
1.3.3 Electrical safety symbol............................................................................................................................................................................................................................. 8
1.3.4 USB port warning label ............................................................................................................................................................................................................................. 8
1.3.5 SpO2 oximetry port warning label........................................................................................................................................................................................................... 8
1.3.6 WEEE label................................................................................................................................................................................................................................................ 8
1.3.7 Label relating to the method for charging the battery pack.................................................................................................................................................................. 8
1.3.8 FCC certification label............................................................................................................................................................................................................................... 8
1.3.9 Electrostatic discharge symbol ................................................................................................................................................................................................................. 9
1.3.10 Information on protection against ingress of liquids....................................................................................................................................................................... 9
1.3.11 Symbol for devices that include RF transmitters ............................................................................................................................................................................. 9
1.3.12 Symbol for reading the operating instructions ............................................................................................................................................................................... 10
1.4 Product description.................................................................................................................................................................................................................................. 10
1.5 Technical specifications........................................................................................................................................................................................................................... 11
1.5.1 Spirometer specifications ........................................................................................................................................................................................................................ 11
1.5.2 Oximeter specifications........................................................................................................................................................................................................................... 12
1.5.3 Other features........................................................................................................................................................................................................................................... 13
2. USING THE SPIROLAB .................................................................................................................................................................................................................................... 13
2.1 Turning the spirolab on and off............................................................................................................................................................................................................. 13
2.2 Saving energy............................................................................................................................................................................................................................................ 14
2.3 Main screen............................................................................................................................................................................................................................................... 14
2.4 Symbols and icons ................................................................................................................................................................................................................................... 15
2.5 Service menu ............................................................................................................................................................................................................................................ 15
2.5.1 Calibrating turbines.................................................................................................................................................................................................................................. 17
2.6 Patient data ............................................................................................................................................................................................................................................... 19
2.6.1 Entering new patient data ....................................................................................................................................................................................................................... 19
2.6.2 Editing patient data.................................................................................................................................................................................................................................. 20
2.7 Viewing stored data ................................................................................................................................................................................................................................. 20
2.7.1 How to search the archives..................................................................................................................................................................................................................... 20
2.7.2 Viewing archived data.............................................................................................................................................................................................................................. 20
2.7.3 Displaying the last test session ............................................................................................................................................................................................................... 21
2.8 Online mode (connected to a PC) ......................................................................................................................................................................................................... 21
2.9 Performing a spirometry test .................................................................................................................................................................................................................. 22
2.9.1 FVC test.................................................................................................................................................................................................................................................... 22
2.9.2 VC test....................................................................................................................................................................................................................................................... 23
2.9.3 MVV test................................................................................................................................................................................................................................................... 23
2.9.4 Running POST tests after the administration of a drug...................................................................................................................................................................... 23
2.10 Displaying and reading spirometry results ............................................................................................................................................................................................ 24
2.10.1 Interpreting spirometry results......................................................................................................................................................................................................... 24
2.11 Performing oximetry................................................................................................................................................................................................................................ 25
2.11.1 Instructions for using the sensor on individual adult patients...................................................................................................................................................... 27
3. DATA TRANSMISSION..................................................................................................................................................................................................................................... 27
3.1 Data transmission via Bluetooth ............................................................................................................................................................................................................ 28
3.2 Connecting with a PC via USB port ...................................................................................................................................................................................................... 28
3.3 Printing data.............................................................................................................................................................................................................................................. 29
3.4 Up-dating internal software .................................................................................................................................................................................................................... 29
4. MAINTENANCE................................................................................................................................................................................................................................................. 29
4.1 Cleaning and checking reusable turbines............................................................................................................................................................................................... 29
4.1.1 Checking correct turbine function......................................................................................................................................................................................................... 30
4.2 Cleaning the oximetry sensor ................................................................................................................................................................................................................. 30
4.3 Replacing wrap sensor adhesive tape..................................................................................................................................................................................................... 30
4.4 Recharging the battery pack.................................................................................................................................................................................................................... 30
5. TROUBLE SHOOTING AND SOLUTIONS ................................................................................................................................................................................................ 31
Guarantee conditions....................................................................................................................................................................................................................................................... 34
APPENDIX 3 INFORMATION ABOUT THE CORRECT USE OF DEVICE IN AN ELECTROMAGNETIC ENVIRONMENT......................................... 35

Spirolab
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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
Italian
French
Russian
Spanish
German
Portuguese
Polish
Turkish
Brazilian
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.
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 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: [e-mail]. 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 + oximeter is intended for use by qualified medical personnel or by patients under the supervision of a
doctor. The device has been designed to test lung function and can be used:
for spirometry tests on patients of any age excluding babies and infants;
for oximetry tests on patients of any age.
It may be used in any environment, except for transporting the patient outside a hospital.
1.1.1 User type
The spirolab spirometer + oximeter 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, sleep checks during the night and/or
monitoring in the presence of a specialist doctor.
1.1.3 Where the device is used
The spirolab device was designed for use in doctors' surgeries and in hospital wards The appendix to this manual contains the
information needed for the correct use of the device in places where electromagnetic factors affect the surrounding environment (as
required by EN 60601-1-2).
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.
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".

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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.
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.
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.
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.

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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.
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
BCI
1300
Single use sensor for adults
BCI
3026
Reusable neonatal wrap sensor
BCI
3043
Reusable universal Y sensor
BCI
3078
Reusable paediatric ear sensor
BCI
3178
Reusable paediatric finger sensor
BCI
3444
Reusable finger sensor for adults (Comfort Clip)
BCI
3044
Reusable finger sensor for adults
These sensors require the use of an extension cable for connection with the spirolab device. Two lengths of extension cable are
available:
item code 919200 length 1.5 m
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
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.

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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 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 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 high frequencies emitted by an "electronic" device can interfere with the functioning of the device. For this reason, a
minimum distance (of several metres), must be observed if there are other devices in operation in the same area. Examples
of such devices include TVs, radios, domestic appliances, mobile phones, cordless phones etc.
The device may provide inaccurate readings in the presence of strong electromagnetic sources such as electrosurgical
scalpels or medical devices such as CT equipment.
Do not use the device in the presence of MRI equipment that can generate an induced current in the oximetry sensor and
harm the patient.
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 6060160601-1; 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.
The device can also be powered using a USB cable connected to a computer, thus also allowing online operation.
Keep the device out of the reach of children and differently-able persons.
1.3 Labels and symbols
1.3.1 ID label
The label shows:
Device serial number (SN)
Product name (REF)
Antenna symbol for devices that include RF transmitters
Manufacturer's name and address

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Electrical safety symbol
CE mark as per Council Directive 93/42 CEE
WEEE symbol
FCC Identification code (FCC ID)
Reference to US FDA regulations (Rx Only)
Degree of protection against penetration by external agents (IPX1)
1.3.2 CE mark for medical devices
0476
This product is a Class IIa medical device that is certified and in compliance with the requirements of Council Directive 93/42/EEC
1.3.3 Electrical safety symbol
As per IEC601-1, the product and its component parts are type BF and therefore offer protection against electrical shocks.
1.3.4 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.
1.3.5 SpO2 oximetry port warning label
SpO2
1.3.6 WEEE label
This symbol applies to European Directive 2002/96/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.
1.3.7 Label relating to the method for charging the battery pack
DC IN 12V
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
1.3.8 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 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.

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Contact the supplier or radio/TV technician for expert advice.
The symbols defined may be found on the device ID label.
1.3.9 Electrostatic discharge symbol
This symbol, required by the EN 60601-1-2 International Standard, 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
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
1.3.10 Information on protection against ingress of liquids
The label bearing the inscription:
IPX1
indicates the degree of protection against ingress of liquids (IPX1). The device is protected against vertically falling drops of water.
1.3.11 Symbol for devices that include RF transmitters

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The symbol is applied in accordance with standard IEC EN 60601-1-2: 2007, section 5.1.1, for products that include RF transmitters.
1.3.12 Symbol for reading the operating instructions
Where applied, the symbol refers the user to this manual for the correct use of the device.
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.
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.
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.

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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
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
%
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

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Symbol
Description
U.m.
VT
Tidal Volume
L
VE
Minute ventilation at rest
L/min
Rf
Respiratory frequency
Breaths/min
tI
Average inspiratory time at rest
s
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
3% 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
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.
Pulse variation event
Rise in Pulse >= 10 BPM in a 8- 40 sec limited period and subsequent drop >=8 BPM inside an
overall period of 150 sec.
Oximetry test parameters:
Symbol
Description
u. m.
%SPO2 min
Minimum SPO2 during the test
%
%SPO2 max
Maximum SPO2 during the test
%
BPM min
Minimum BPM during the test
BPM
BPM max
Maximum BPM during the test
BPM
Median %SPO2
Median SPO2
%
Median BPM
Median BPM
BPM
T Total
Duration of the test
hh:mm:ss
Analysis T
Total measuring time (duration of test excluding zeroes)
hh:mm:ss
T<90%
Time with SpO2 less than 90%
%-hh:mm:ss
T<89%
Time with SpO2 less than 89%
%-hh:mm:ss
T5
Time with SpO2 less than 5% of the mean value
%-hh:mm:ss
T<40BPM
Time passed with Pulse rate <40 BPM
%-hh:mm:ss
T>120BPM
Time passed with Pulse rate <120 BPM
%-hh:mm:ss
Method of detection
Red and infra-red light absorption
Measuring range of %SpO2
0 –99% (with 1% increments)
Resolution of SpO2
1%
Accuracy of %SpO2
2% between 70-99% SpO2
Number of beats for calculating the median SpO2%
8 beats
Pulse rate measuring range
18 –300 BPM
Resolution of pulse rate
1 BPM
Pulse rate accuracy
2 BPM or 2% of highest value
Interval for calculating median pulse rate
8 seconds
Signal quality
0 - 8 display segments
Acoustic signalling:
Beeps with frequency depending on pulse rate
Sounds in the event of exceeding pre-set threshold values of the %SpO2or pulse rate
Sounds during oximetry if battery low
Sounds in the event of no signal present (finger not inserted properly, connector not properly attached)
Sounds the next time the device is turned on following an interrupted test due to low battery

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The specifications that apply to oximetry and pulse rate are the same regardless of the sensor used as long as it is one of those
mentioned beforehand.
1.5.3 Other features
Memory
The memory can store the data from over 10,000 spirometric tests. The exact number has
not be established as it depends on the configuration set by the doctor
Display
7 inch colour touch screen LCD Display with 800x480 resolution
Keypad
Touch screen
Interface
USB, Bluetooth
Bluetooth interface
Frequency range: 2402-2480 MHz
Output power: 0,001W
Frequency tolerance: 20 ppm
Type of antenna: permanently attached
Antenna gain: 0 max dBi
Battery pack lifespan
About 10 years of use
Power supply
NiMH rechargeable 7.2V battery pack (6 batteries, 1.2V each), 4000 mAh
Battery charger
Model AC/DC 12W-N1EFM
Autonomy
~10 hours
Dimensions
Main body 220x210x51 mm;
Weight
Central unit 1450 g (including battery pack)
Type of electrical protection
Class II
Degree of electrical protection
BF
Degree of protection against water
penetration
IPX1 appliance protected against water leaks
Safety level in the presence of
flammable anaesthetic gases, oxygen
and nitrogen
Appliance not suitable
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Transport 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
Applicable standards
Electrical Safety IEC 60601-1
Electro Magnetic Compatibility IEC 60601-1-2
Key performance (in accordance with
EN 60601-1: 2007)
Accuracy in measuring spirometry parameters in accordance with the ATS standard
Measurement of oximetry parameters with accuracy as defined in the table on page 13
2. USING THE SPIROLAB
2.1 Turning the spirolab on and off
To turn the spirolab on, press then release the button on the front of
the unit.

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When you turn on the device, the first screenshot shows the internal
software loading progress.
The display will automatically display the main menu after a few
seconds.
To turn spirolab off, press the power button on the front of the unit.
WARNING
Spirolab does not turn off completely but enters an ultra-low standby mode; some features remain active to allow the device
to keep the date and time updated and to be activated remotely if required. For this reason, the power key's symbol is ,
corresponding to the standby mode.
2.2 Saving energy
The internal battery pack charge is shown in the upper right hand corner of the display by the symbol:
If the battery symbol is all green, then the battery pack is charged.
WARNING
To charge the battery pack, only use the charger supplied by the manufacturer.
2.3 Main screen
The device’s features can be accessed from the main screen.
The following section details the features of each icon.

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2.4 Symbols and icons
The following table shows the icons displayed on the various screens and what they mean
ICON
DESCRIPTION
To access initial settings (service menu)
To enter new patient data
To edit patient data/To rerun an archived patient test
To access file containing tests performed
To save the settings and return to the main screen
To view the last spirometry session for the current patient
To view the last oximetry session for the current patient
To test oximetry
To test FVC spirometry
To test VC spirometry
To test MVV spirometry
To run a bronchodilator test (POST)
To check the alarms and thresholds set during an oximetry test
To check the oximetry sensor is properly connected during testing
To check the presence of a signal during the oximetry test
To print a test
To delete a test
To cancel an operation and return to the previous step
2.5 Service menu
To access the menu, press the icon .
To view headings, enter the following code using the virtual numeric keypad:
1 2 2 3 3 3
In this screen, you can also change the brightness of the display by tapping the orange cursor vertically. The
brightness will change in real time.
The service menu will display the following heading sequence:
Device
Spirometry
Calibration
Oximetry
References
Delete archive
Tap the desired heading to select it.
Device
The section is divided into:
General
Date and time
Info
Printer

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Select the desired settings by tapping the white box; the selection is
highlighted by an orange box.
For the brightness of the display, move the orange cursor vertically
until the desired brightness.
To set the correct date and time, tap the box to bring up the cursor;
use the numeric keypad on the lower right to set the correct value.
The area “Daylight saving time” allows to set the automatic time
change depending on the geographic area which you stay. The
device recognize the date changes until 2026.
The "Info" section displays the hardware and software versions of
the device's most significant components, in addition to the serial
number.
In the "Printer" section, you can set the print header. Tap the white
space under "printout header" to bring up the virtual numeric
keyboard. You can enter characters until the string is complete.
In the area “External printer” it is possible to choose the printing
colour type in case of use of the external printer via USB. The
printer to use must be postscript type.
Spirometry
The section is divided into:
Parameters
Outcome
Incentives
In the “Parameters”section, you can select the values that will be
displayed at the end of a test; these will be stated on the printout.
Here too, the selection is highlighted by an orange box.
In the “Results”section, you can choose what to include in the
printout from among the following items:
Best values
Interpretation of spirometry results
F/V and V/t curves
Only F/V EXPIRATORY curve

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In the "Incentive" section, you can configure the paediatric
incentive to improve spirometric performance.
The incentive may be enabled or disabled; should it be enabled, by
selecting "ON" on the left, you must enter the age threshold up to
which the incentive is displayed; use the numeric keypad on the
bottom to set this value.
Calibration
For calibration, see paragraph 2.5.1 below.
Oximetry
In this section, you can configure all alarms related to an oximetry
test. By setting the desired alarms to "ON", you will activate a box
where you can set the relevant threshold value using the numeric
keypad.
WARNING
If the maximum value of a parameter is less than or equal to the minimum value, the setting process will not proceed. A
beep will sound and the device will automatically return to the screen for setting the minimum value.
References
This section allows you to set the predicted value used between:
Adults
Children
ERS
Knudson
Knudson
Knudson
USA
Knudson
ERS
Zapletal
MC-Barcelona
Zapletal
JRS-JAPAN
JRS-JAPAN
Pereira
Pereira
CECA1971
Knudson
NHANES III
NHANES III
If you choose the last predicted value NHANES III, the limitations provided for in the past by the standard NHANES III will be
applied.
WARNING
If you set the predicted value Wang/Hankinson are disabled the VC and MVV tests.
Delete archive
Using the numeric keypad, enter the following code to permanently delete all the tests stored in the device:
1 2 2 3 3 3
2.5.1 Calibrating turbines
WARNING
The turbine does not need calibration, just a periodical clean.

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The disposable turbine is inspected before it is sealed in the package, and hence does not need calibration.
If, however, if you want to carry out a calibration, bear the following in mind.
Calibration can be carried out on reusable and disposable turbines.
Calibration takes place based on the FVC (expiratory) and FIVC (inspiratory) values measured during a test performed with a
calibrated syringe.
To access the calibration setting, select the service menu item "Calibration"; the first screen, "Last values", allows you to check current
percentages applied by the device.
By choosing "New calibration", you can calculate new conversion
factors. Make a test using the syringe calibration.
Make the following acts in the same sequence:
Make an inspiration manoeuvre
Make an expiration manoeuvre
Make an inspiration manoeuvre once again
On the display it is shown the graphic of the test.
Then tap .
If calibration correction is < 10% then the values are shows as in the
following screen.
Tap “OK” to set the new correction values.
If the values are > 10 % then the following message appears on the
screen:
The FVC and FIVC values are not accepted. This means that the system is unable to correct such a large calibration error. In this case:
- check that the spirolab is working properly by fitting a new turbine and/or
- clean the turbine in question.
To cancel the calibration in use and restore the factory settings, select “Factory values” from the calibration menu.
Then tap .
WARNING
According to the "Standardised Lung Function Testing" publication of the European Respiratory Society (Vol 6,
Supplement 16, March 1993), air expelled from the mouth has a temperature of about 33/34°C.
To convert the volumes and air flow rates to BTPS (37 °C) conditions, they must be increased by a factor of 2.6%. The
BTPS factor for a temperature of 33°C is 1.026, which is in fact a correction of 2.6%. In practice, the BTPS factor for
expiratory volumes and flow rates is constant and equal to 1.026.
The BTPS factor for inspiratory volumes and flow rates depends on ambient temperature, as air that is inhaled is at that
temperature.
For instance, with an ambient temperature of 20 °C with Relative Humidity of 50%, the BTPS factor is 1.102, which
represents a correction of +10.2%.
The correction of inspiratory volumes and flow rates is performed automatically thanks to an ambient temperature sensor
that measures the temperature inside the device and allows the BTPS factor to be calculated.
If a 3-litre syringe is used for the test and if the spirolab device is perfectly calibrated, the FVC (syringe) value measured will
be:
3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
If the ambient air temperature is 20 °C, the FIVC (syringe) value measured 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 was converted to BTPS and the "alterations" of the results
when compared with expected values do not therefore represent an error.
For example, if you perform calibration with the data measures:
WARNING! CORRECTION too high

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FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20 °C, the correction coefficient will be:
EXPIRATORY .00%
INSPIRATORY .00%
To repeat, this is NOT an error but the logical consequence of what was explained above.
NOTE
Calibration can also be performed using the winspiroPRO software that comes supplied with the device. For details about
the calibration procedure using this software, refer to the winspiroPRO online manual.
2.6 Patient data
From the main screen, you can access the patient data management area:
create a new patient profile or check for existing patients in the archives
change current patient data
2.6.1 Entering new patient data
This screen provides access to all patient data. The ID code is not
required. Tap the grey space to access the various fields and make
entries using the virtual numeric keyboard on the screen. Tapping the
"Ethnic group" field brings up a drop down menu where you can
choose the desired value.
The icon allows you to delete the last character entered.
The icon allows you to enter uppercase characters.
The icon allows you to enter information in the next field.
The icon allows you to save your entries and return to the main
screen.
WARNING
The data required to create a patient profile is:
name
surname
sex
If any of these items of information are not inserted, the patient profile is not created when you tap .
In the "Ethnic group" field, the following options will appear:
ATS/ERS standards
NHANES III standards
Group
% correction
No group selected
100%
Caucasian
Caucasian
100%
Afro-American
Oriental
100%
Mexican-American
Hong Kong Chinese
100%
Others
Japanese
89%
Polynesian
90%
North Indian
90%
South Indian
87%
Pakistani
90%
Of African descent
87%
Aborigine
85%
In the case of ATS/ERS standards: depending on the ethnic group set, the correction percentage acts on the predicted values of the
following parameters:
FVC, FEV1, FEV3, FEV6, FIVC, FIV1, EVC, IC, VC, ERV, TV, TV/ti

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In the case of NHANES III standards: depending on the ethnic group set, different predicted formulae are taken into account (in
accordance with the reference standard).
Once the desired ethnic group has been selected, the device completes defining the patient parameters and returns automatically to the
main screen.
2.6.2 Editing patient data
Select the icon and use the screen as described in section 2.6.1.
WARNING
Selecting this function does not create a new patient as described beforehand, but changes the data of the same patient and
associates future test data with that patient, who is always identified with the same unique ID code.
2.7 Viewing stored data
2.7.1 How to search the archives
In the main screen, you can access the data present in the device
archive by using the above icon.
You can choose to search by:
ID
Surname
Date of birth
Test date
All
Or select the type of test:
FVC
POST
VC
MVV
OXY
Each option selected will bring up a box in which you can enter the search data.
2.7.2 Viewing archived data
The archive displays the list of patients, starting with the most recent.
Select the patient required by tapping the line (which becomes
orange) and choose one of the enabled functions listed at the
bottom of the screen.
The enabled icons are coloured, while the grey ones are disabled.
To quit the archive, use the icon .