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

Spirolab
Rev.1.8
Page 2 of 60
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

Spirolab
Rev.1.8
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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