MIR 911080 User Manual

Spirolab
Spirolab
User manual Rev. 1.8
Rev.1.8
Date issued
Date approved
04.05.2020
04.05.2020
Page 1 of 60
Spirolab
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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Spirolab
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
German
Spanish
Portuguese
Brazilian
Polish
Russian
Turkish
Czechoslovak
Vietnamese
Romanian
The following table describes the contents of the package and the accessories that can be
used with spirolab:
REF
672684
910320
532367
910300
\
910350
920690XX
900595
910002
910004
912024
✓ included
Description
Carrying case
Plastic noseclip
USB cable
cardboard mouthpiece
User manual - winspiroPRO CD
Thermal printer paper
Battery charger
MiniFlowmeter
Reusable Turbine
Disposable Turbine
Oximetry Sensor
 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
Website: www.spirometry.com
Fax + 39 0622754785
Email: [email protected]
MIR USA, Inc.
5462 S. Westridge Drive
New Berlin, WI 53151 - USA
Tel + 1 (262) 565 – 6797
Sito web: www.spirometry.com
Fax + 1 (262) 364 – 2030
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:
[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
Envitec
Envitec
Envitec
Code
RS-3222-12
RM-3222-12
R-3222-12
Description
Reusable small soft sensor (paediatric)
Reusable medium soft sensor (adults )
Reusable large soft sensor (adults)
MIR code
939006
939007
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
1.3.1
Labels and symbols
ID label
The symbols are described in the table below:
SYMBOL
Model
SN
DESCRIPTION
Product name
Device serial number
Manufacturer's name and address
0476
IPX1
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
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.
Label relating to the method for charging the battery pack. The
symbol is screen-printed next to the connector for connecting the
DC IN 12V 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
Walking on an untreated vinyl floor
Rev.1.8
1500-35000 Volts
250-12000 Volts
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Vinyl envelopes used to organise documents
Worker at a table
600-7000 Volts
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.
Rev.1.8
Page 17 of 60
Spirolab
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
*FVC
Best FVC
*FEV1
Best FEV1
*PEF
Best PEF
FVC
Forced Vital Capacity
FEV1
Volume exhaled in 1st second of the test
FEV1/FVC
FEV1/FVC x100
Rev.1.8
U.m.
L
L
L/s
L
L
%
Page 18 of 60
Spirolab
Symbol
FEV1/VC
PEF
PEF Time
FEF-2575
FEF7585
FEF25
FEF50
FEF75
FEV05
FEV05/FVC
FEV075
FEV075/FVC
FEV2
FEV2/FVC
FEV3
FEV3/FVC
FEV6
FEV1/FEV6
FEV1/PEF
FEV1/FEV0.5
FET
EVOL
FIVC
FIV1
FIV1/FIVC
PIF
FIF25
FIF50
FIF75
FEF50/FIF50
MVVcal
VC
EVC
IVC
IC
ERV
IRV
VT
VE
RR
tI
Rev.1.8
Description
FEV1/ best between EVC and IVC x 100
Peak expiratory flow
Time to achieve 90% of the PEF
Median flow between 25% and 75% of FVC
Median flow between 75% and 85% of FVC
Maximum flow at 25% of FVC
Maximum flow at 50% of FVC
Maximum flow at 75% of FVC
Volume exhaled after 0.5 seconds
FEV05/FVC x 100
Volume exhaled after 0.75 seconds
FEV075/FVC x 100
Volume exhaled in the first 2 seconds of the test
FEV2/FVC x 100
Volume exhaled in the first 3 seconds of the test
FEV3/FVC x 100
Volume exhaled in the first 6 seconds of the test
FEV1/FEV6x100
FEV1/PEF (empey’s index)
FEV1/FEV0.5
Forced exhalation time
Extrapolated volume
Forced Inhalation Vital Capacity
Volume inspired in the 1st second
FIV 1 %
Peak inspiratory flow
Maximum flow at 25% of FIVC
Maximum flow at 50% of FIVC
Maximum flow at 75% of FIVC
FEF50/FIF50 x 100
Max. voluntary ventilation calculated based on FEV1
Slow Expiratory Vital Capacity
Expiratory Vital Capacity
Inspiratory Vital Capacity
Inspiratory capacity: (maximum between EVC and
IVC) -ERV
Expiratory reserve volume
Inspiratory reserve volume
Tidal Volume
Minute ventilation at rest
Respiratory frequency
Average inspiratory time at rest
U.m.
%
L/s
s
L/s
L/s
L/s
L/s
L/s
L
%
L
%
L
%
L
%
L
%
L/L/s
\
s
mL
L
L
%
L/s
L/s
L/s
L/s
%
L/s
L
L
L
L
L
L
L
L/min
Breaths/min
s
Page 19 of 60
Spirolab
Symbol
tE
TV/tI
tI/tTOT
MVV
ELA
Description
Average exhalation time at rest
Mean inspiratory flow at rest
tI/(tI+tE)
Maximum voluntary ventilation
Estimated Lung Age
U.m.
s
L/min
\
L/min
years
*= best values
Flow/volume sensor
Temperature sensor
Method of detection
Maximum volume measured
Flow rate
Volume accuracy (ATS 2019)
Flow accuracy
Dynamic resistance at 12 L/s
1.5.2
Bi-directional turbine
semiconductor (0-45°C)
Infra-red interruption
10 L
 16 L/s
 2.5% or 50 mL
 5% or 200 mL/s
<0.5 cmH2O/L/s
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 %
70-80 %
80-90 %
90-100 %
± 1.470
± 1.626
± 1.667
± 0.941
Reusable paediatric soft sensor
Range (SpO2)
Arms (%)
70-100 %
70-80 %
80-90 %
90-100 %
± 1.390
± 1.851
± 1.397
± 0.652
The Arms (Accuracy Root Mean Square), as recalled in the above mentioned standard,
represents the accuracy of the device in terms of the mean square error of each SpO2
measurement, obtained by pulse oximetry, in relation to the respective SaO2 reference
value, obtained by co-oximetry.
The ranges listed show the different oxygen saturation ranges for which the accuracy has
been calculated.
The accuracy of the device can be assessed with a tester.
Definitions
Desaturation event
Rev.1.8
Drop in SpO2 >= 4% in a 8- 40 sec period limited and
subsequent rise >=2% inside an overall period of 150 sec.
Page 20 of 60
Spirolab
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
%SPO2 min
Minimum SPO2 during the test
%SPO2 max
Maximum SPO2 during the test
BPM min
Minimum BPM during the test
BPM max
Maximum BPM during the test
Median %SPO2 Median SPO2
Median BPM
Median BPM
T Total
Duration of the test
Total measuring time (duration of test excluding
Analysis T
zeroes)
T<90%
Time with SpO2 less than 90%
T<89%
Time with SpO2 less than 89%
T5
Time with SpO2 less than 5% of the mean value
T<40BPM
Time passed with Pulse rate <40 BPM
T>120BPM
Time passed with Pulse rate <120 BPM
u. m.
%
%
BPM
BPM
%
BPM
hh:mm:ss
hh:mm:ss
%-hh:mm:ss
%-hh:mm:ss
%-hh:mm:ss
%-hh:mm:ss
%-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
8 beats
median SpO2 %
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
8 seconds
rate
Signal quality
0 - 8 display segments
Wavelengths and maximum optical
Red light: 660 nm, 2.0 mW (**)
output power average of oximetry
Infrared light: 905 nm, 2.4 mW (**)
sensors (919024)
Wavelengths and optical output power
Red light: 660 nm, 3.5-4.5 mW (**)
of oximetry sensors (Envitec sensors)
Infrared light: 905 nm, 3.5-4.5 mW (**)
(**) This information may be useful to the doctor.
Acoustic signalling:
• Beeps with frequency depending on pulse rate
• Sounds in the event of exceeding pre-set threshold values of the %SpO2 or pulse rate
Rev.1.8
Page 21 of 60
Spirolab
•
•
•
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
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
Display
Keypad
Interface
Bluetooth interface
Battery pack lifespan
Power supply
Battery charger
Autonomy
Dimensions
Weight
Type of electrical protection
Degree of electrical protection
Degree of protection against
water penetration
Safety level in the presence of
flammable anaesthetic gases,
oxygen and nitrogen
Conditions of use
Storage conditions
Rev.1.8
The memory can store the data from over 10,000
spirometric tests. The exact number has not been
established as it depends on the configuration set
by the doctor
7 inches colour touch screen LCD Display
with 800x480 resolution
Touch screen
USB, Bluetooth
Frequency range: 2402-2480 MHz
Output power: 0,001W
Frequency tolerance: 20 ppm
Type of antenna: permanently attached
Antenna gain: 0 max dBi
About 10 years of use
NiMH rechargeable 7.2V battery pack (6
batteries, 1.2V each), 4000 mAh
Model AC/DC 12W-N1EFM
~10 hours
Main body 220x210x51 mm
Central unit 1450 g (including battery pack)
Internally powered
Class II while charging battery
BF
IPX1 appliance protected against water leaks
Appliance not suitable
Device for continuous use
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Page 22 of 60
Spirolab
Transport conditions
Operating conditions
Applicable standards
Key performance (in
accordance with IEC 60601-1:
2005 + A1: 2012)
Emission limits
Electrostatic discharge
protection
Magnetic field immunity
Radio Frequency Immunity
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 70kPa, 106 kPa
IEC 60601-1:2005 + A1: 2012 (Electrical Safety)
IEC 60601-1-2:2015 (EMC)
ATS/ERS Guidelines: 2005
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2012
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223:2016
EN IEC 60601-1-6: 2010+Amd2013
ISO 80601-2-61: 2017
IEC 60601-1-8: 2006
Error of displayed numeric value: Flow
measurement percentage error < ± 5%
Measurement of oximetry parameters with
accuracy as defined in the table on § 1.5.2
CISPR 11 Group 1 Class B
8kV contact, 15kV air
30 A/m
3V/m @ 80-2700 MHz
MIR will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair
those part of the device that are designated by MIR as repairable by service personnel.
Rev.1.8
Page 23 of 60
Spirolab
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.
When you turn on the device, the
first screenshot shows the internal
software loading progress.
Only the first time the device will ask
the user to protect the access with a
PIN:
According to GDPR (General Data
Protection Regulation) the user, can
do this by inserting a PIN.
Press OK if you want to set a
personal PIN
or
Press Undo to skip this function.
Pressing OK then a message requires
to confirm the use of a PIN: press
OK to continue or Undo to skip this
function.
Rev.1.8
Page 24 of 60
Spirolab
• Press OK on the following screen
• The PIN must have 4 numbers.
• Insert a PIN in the field “New
PIN”
using
the
numeric
keyboard,
• Repeat the PIN in the field
“Confirm new PIN”.
• If the PIN is correct a popup will
appear with the following
message:
Change PIN
Successful
• Press OK
• Press
to return to the main
screen.
From this moment each time the
device is switched on the PIN needs
to be inserted.
If the PIN is incorrect the user can
try again; (the device allows 20
attempts per day).
After 20 attempts the user needs to
wait for the next day to unlock the
device.
If the user forgot the PIN send an
inquiry to the following website:
www.spirometry.com/getpin
Complete the fields and insert the
DEVICE ID shown on the popup
on the screen.
After the registration the system will
send an e-mail to the address
inserted on the web site with the
PIN to unlock the device.
Rev.1.8
Page 25 of 60
Spirolab
At the end the main screen will appear
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.
Rev.1.8
Page 26 of 60
Spirolab
2.3
Main screen
The device’s features can be
accessed from the main screen.
The following section details the
features of each icon.
2.4
Symbols and icons
The following table shows the icons displayed on the various screens and what they mean
ICON
2.5
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 exit without save and to return to the previous 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
Service menu
To access the menu, press the icon
Rev.1.8
.
Page 27 of 60
Spirolab
To view headings, enter the PIN set or, if was not inserted a personal PIN, enter the default
PIN which is the following:
1223
If the personal PIN is missed touch the ? to unlock the device sending
an enquire on the internet site described before (point 2.1).
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/Time
• Info
• Printer
• Privacy
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.
Rev.1.8
Page 28 of 60
Spirolab
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 recognizes 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 enable or disable the external
printout via USB connection, or to
choose the printing colour type in case
of use of the external printer via USB.
The printer to use must be postscript
type.
In the “Privacy” section the user can
enable or disable:
• the PIN
• the Privacy information
The device has a default PIN set, which
is the following:
1223
In this section it is possible to change the
PIN enabling “Change PIN”.
Rev.1.8
Page 29 of 60
Spirolab
On the screen a numeric keyboard will
appear with the fields to change the PIN.
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
(expiratory
+
inspiratory) and V/t curves
F/V expiratory only curve
and V/t curves
Rev.1.8
Page 30 of 60
Spirolab
This section allows to choose the
unit of measure to show the PEF
value: L/sec or L/min
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
ERS
Knudson
Rev.1.8
Children
Knudson
Knudson
Page 31 of 60
Spirolab
Adults
USA
ERS
MC-Barcelona
JRS-JAPAN
Chinese H.K.
Pereira
CECA1971
NHANES III
GLI
Padilla-Perez
Children
Knudson
Zapletal
Zapletal
JRS-JAPAN
Chinese H.K.
Pereira
Knudson
NHANES III
GLI
Knudson
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 NHANES III are disabled the VC and MVV tests.
Delete archive
Using the numeric keyboard, enter the PIN set to permanently delete all the tests stored in
the device.
2.5.1
Calibrating turbines
WARNING
The turbine does not need calibration, just a periodical clean.
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.
Rev.1.8
Page 32 of 60
Spirolab
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:
WARNING! CORRECTION too high
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
.
Rev.1.8
Page 33 of 60
Spirolab
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:
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
Rev.1.8
Page 34 of 60
Spirolab
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
"Origin" field brings up a drop
down menu where you can
choose the desired value.
The icon
delete the
entered.
allows you to
last character
The icon
allows you to
enter uppercase characters.
The icon
allows you to
enter information in the next
field.
The icon
allows you to
return to the main screen
without saving data.
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 "Origin" field, the following options will appear:
Rev.1.8
Page 35 of 60
Spirolab
ATS/ERS standards
Group
No group selected
Caucasian
Oriental
Hong Kong Chinese
Japanese
Polynesian
North Indian
South Indian
Pakistani
Of African descent
Aborigine
NHANES III standards
% correction
100%
100%
100%
100%
89%
90%
90%
87%
90%
87%
85%
Caucasian
Afro-American
Mexican-American
Others
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
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.
In the case of GLI for every Ethnic group the device applies a different table to calculate
the predicted values and not a correction percentage.
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.
Rev.1.8
Page 36 of 60
Spirolab
2.7
2.7.1
Viewing stored data
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
.
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To view the spirometry tests
performed by the selected patient,
use the icon
.
The information is displayed as in
the image on the right. On the left
you have the test trend in graph
form
(Flow/Volume
and
Volume/Time), while on the right
you have various quality-related
messages and the values of the
parameters selected in the service
menu. By swiping your finger in the
parameter area, you can view other
parameters selected in the service
menu.
You can delete one of the tests
performed as follows: tap the
column relating to the test data to
be deleted; the data will be selected
by two bands on the left and right;
now tap the icon
on the lower
right. And tap “OK” in the popup
window which appears on the
screen.
At each screen, you can go back to
the previous step by tapping
To view the selected patient's
oximetry tests, use the icon
.
The data is displayed as in the image
to the right, with the graphic trend
of the % SpO2 and BPM always on
the left and the numerical values of
the various parameters on the right.
You may cancel the test by using the
icon
on the lower right.
If you want to perform a new test
on the selected patient from this
screen, you can use the icon for the
test to be performed; a message is
displayed to confirm whether or not
you wish to perform a new test on
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the selected patient. Tap "YES" to
confirm or "NO" to go back.
If the patient has performed several spirometry or oximetry tests, the initial list indicates
(in brackets next to the type of test) the number of tests saved.
To view tests other than the first, tap the icons
oxymetry).
2.7.3
(for spirometry) or
(for
Displaying the last test session
During test sessions, the spirometer automatically saves up to 8 FVC tests. From the main
screen, using the icon:
•
in the case of spirometry tests
•
in the case of oximetry tests
you can view the best three session tests (where PRE1 is the best). At the end of the
session, when you enter a new subject or switch to a POST phase, the 3 best tests of the
previous session are automatically saved in the archive. These, therefore, can be retrieved
from the archive and printed, either together or individually.
Numbers may appear on the main screen, next to the spirometry test icons, for example:
The number inside the red circle represents, in this case, the FVC tests performed in the
current session.
2.8
Online mode (connected to a PC)
This function acts like an actual laboratory-based real time spirometer connected to a PC.
Connection to the PC can be performed by USB or by a wireless Bluetooth connection.
Spirolab becomes an intelligent sensor for measuring volume and flow rate while the PC
controls the functions, including turning on and off.
When connected to a laptop, spirolab can be used for epidemiological tests in workplaces,
schools etc.
In addition to the usual spirometric parameters and F/V curves in real time, this system
can also gather more sophisticated information such as ventilatory profiles and
extrapolated volume (Vext) data.
The computer software allows the use of more up-dated bronchial provocation protocols
and can display FEV1 dose and time-responses.
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WARNING
When the device is connected to a PC, it cannot be remotely operated. The settings
on the PC are transferred to the device and remain active any other time you use
the device remotely. For example, if you use spirolab connected to the PC and you
set a particular turbine (disposable or reusable), this will remain the default turbine
any other time you use the device remotely. It is important, therefore, to be careful
when setting the type of turbine.
2.9
Performing a spirometry test
WARNING
While performing tests, unplug the charger from spirolab.
To correctly perform a spirometry test, observe the following instructions to the letter.
• Slide the turbine fully into position in the
MiniFlowmeter then turn it clockwise
until it clicks into place.
• Connect the MiniFlowmeter to spirolab
as show in the image on the right.
• Slide the mouthpiece at least 0.5 cm along
the groove on the turbine.
• Fit the nose clamp over the patient's
nostrils to prevent air from escaping.
• Take the MiniFlowmeter with both hands or, alternatively, hold it as you would a mobile
phone.
• Introduce the mouthpiece into the mouth behind the teeth, making sure that air does
not escape from the sides of the mouth
WARNING
The proper positioning of the mouthpiece behind the teeth is essential to eliminate
any turbulence that might have a negative effect on the test parameters.
WARNING
We recommend that the patient stays upright during the test and bends forward
during exhalation to allow the abdominal muscles to facilitate the expulsion of air.
The main screen contains the following icons to perform various types of tests:
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FVC Spirometry test
VC spirometry test
MVV spirometry test
Test with bronchodilator (POST)
To end a test, tap
2.9.1
.
FVC test
To perform an FVC test, follow the instructions below:
INHALE all the air
EXHALE forcefully (6s)
INHALE forcefully
The test can be started (optionally) by breathing at rest. When you are ready, inhale as
quickly as possible (it is easier if you open your arms wide) and expel all the air in your lungs
with as much force as you can. Without removing the mouthpiece, complete the cycle by
inhaling as quickly as possible. The latter step can be omitted if calculation of the inhalation
parameters (FIVC, FIV1, FIV1%, PIF) is not required.
The inhalation stage can also be performed before putting the mouthpiece in your mouth.
Following a slow deep intake of breath, the next exhalation should be performed with as
much force as possible and as quickly as possible.
After 6 seconds of exhalation, the device will emit a continuous beep that tells you that the
minimum exhalation time has passed. This is the minimum time required by the main
International Pulmonology Associations.
WARNING
Remember that for accurate spirometry results, it is essential that all the air is
expelled from the lungs.
The test can be repeated as often as required without the mouthpiece having to be removed
from the mouth. In this case, the spirolab will automatically recognise the longer cycle
(longer FVC+FEV1) and present the relative readings.
On completion of the test, tap
.
During the test, the spirolab emits repeated beeps, the frequency of which is directly
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proportional to the speed at which air is being inhaled and exhaled. This helps the doctor
understand when the rate of air flow is approaching zero and therefore when the patient
has exhausted the volume available in exhalation and inhalation.
The section dedicated to maintenance also describes how this feature is also useful for easily
checking that the volume and air flow sensors are working properly.
Apart from requiring a deep exhalation of breath for the results of an FVC test to be reliable,
the Forced Expiratory Time (FET) must also be long enough to allow the complete
expulsion of all the air in the lungs.
2.9.2
VC test
Ventilatory profile
You can start testing Slow Vital Capacity by breathing at rest. After three or four similar
consecutive breaths, a continuous beep warns the user that the ventilatory profile has been
measured and that VC or IVC can now be measured.
Slow Expiratory Vital Capacity: VC
After the beep, inhale as slowly as possible and subsequently exhale as slowly as possible.
Slow Inhalatory Vital Capacity: IVC
After the beep, exhale as slowly as possible and subsequently inhale as slowly as possible.
On completion of the test, tap
2.9.3
.
MVV test
Start the test with a series of forced inhalations and exhalations at the fastest speed
possible. The recommended frequency is 30 breaths/minute.
The test ends automatically after 12 seconds.
WARNING
To test the service menu test, check that the parameter relating to said test is
enabled in "Set parameters"; otherwise, the icon will be disabled.
WARNING
It is important to remember to change the disposable mouthpiece and the
disposable turbine at the end of a patient's test session.
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2.9.4
Running POST tests after the administration of a drug
WARNING
To perform a POST test, the patient must have performed at least one PRE FVC
test on the same day (i.e. in the same session); you cannot perform POST tests on
PRE VC or MVV tests; conversely, you can perform POST VC or MVV tests,
provided at least one PRE FVC test has been performed and archived on the same
day.
To perform a POST test, proceed
as follows:
Tap
on the main screen.
The screen on the right shows the
list of all the patients who have
performed a PRE test on the same
day.
Select the patient required and
choose one of the features enabled
below.
The user is prompted to confirm
the move to POST mode: tap
"YES" to carry out the test in
POST mode, or tap "NO" to go
back.
By "POST" test, we mean a spirometry test performed after administering the patient a
bronchodilator. The tests subsequently performed on the selected patient show the
following parameters:
•
•
•
The values for the test performed;
The values of the best PRE test performed by the same patient on the same day (i.e.
in the same session);
The percentage change between PRE and POST values (in the column labelled CHG).
You cannot perform a POST test on a patient if the archive only contains PRE tests carried
out on previous days (sessions other than the current one).
If, during a POST session, you create a new patient or retrieve another patient from the
archive, the device automatically exits the current POST session.
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2.10
Displaying and reading spirometry results
Once the FVC test has been
completed. the spirometry results
are displayed. The screen shows
the
Flow/Volume
and
Volume/Time
graphs,
the
parameters selected in the settings
relating to the best test among
those performed in the session,
and the percentage ratio compared
to predicted values. Scroll through
the parameters area to view any
other parameters set.
2.10.1
Interpreting spirometry results
The interpretation of spirometry refers to Forced Vital Capacity (FVC) and is seen by
means of indicator lighting.
The messages can include the following:
 Normal spirometry
 Slight obstruction/restriction
 Moderate obstruction/restriction
 Moderately severe obstruction/restriction
 Severe obstruction/restriction
 Very severe obstruction/restriction
The final interpretation level is "restriction + obstruction", where the indicator light
indicates the worst parameter between restriction and obstruction.
Thanks to a mathematical analysis known as quality control that is applied to some indices
and parameters calculated in FVC tests, the spirolab device can produce different
comments that help to understand the reliability of tests carried out.
The quality control system uses letters as described below:
1st case: PRE test
A = at the end of two acceptable tests, the variation of the two highest FEV1 values and
the two highest FEV6 values are less than or equal to 100 mL.
B = at the end of two acceptable tests, the variation of the two highest FEV1 values is
between 101 and 150 mL
C = at the end of two acceptable tests, the variation of the two highest FEV1 values is
between 151 and 200 mL
D = only one test was acceptable or there is more than one acceptable test but the variation
of the two highest FEV1 values is greater than 200 mL
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F = no acceptable test.
2nd case: POST bronchodilator test
A = two acceptable tests, the variation of the two highest FEV1 values is less than or equal
to 100 mL.
B = two acceptable tests, the variation of the two highest FEV1 values is between 100 and
200 mL.
C = two acceptable tests, the variation of the two highest FEV1 values is greater than 200
mL.
D = one acceptable test
F = no acceptable test
"Acceptable" means: a good start and satisfactory exhalation (in duration and flow)
To facilitate understanding where much information is available regarding the same test,
the spirolab device will only display the most significant data.
Vext and PEFT ERROR
If the extrapolated volume is :
For patients with age > 6 years
For patients with age < 6 years
> 150 mL or > 5% of FVC
> 80 mL or > 12.5% of FVC
PEFT (peak flow time) > 160 msec.
FET Error
If the FET is:
For patients with age < 10 years
For patients with age > 10 years
FET < 2 sec
FET < 6 sec
FLOW ERROR
If:
Flow > 100 mL in the last ½ second
Flow > 40 mL in the last ½ second
Between one test and the next, the spirolab device evaluates the repeatability of the
following parameters:
PEF
repeatable when the difference between the two furthest apart PEF values is ≤
10%;
FEV1 repeatable when the difference between the two furthest apart FEV1 values is ≤
150mL;
FVC
repeatable when the difference between the two furthest apart FVC values is ≤
150mL;
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2.11
Performing oximetry
WARNING
While performing tests, unplug the charger from spirolab.
WARNING
Check that the oximetry function is available on the device you are using as it is
optional on several models.
WARNING
The description of the following sensor serves solely as an example. All the sensors
described in section 1.2.4 can be used with the spirolab device. MIR does not
recommend any particular sensor; the decision is left to the doctor's discretion.
During oximetry tests, the spirolab device cannot be turned off. To turn it off, you
have to interrupt an on-going test. This system prevents unwanted interruptions
that might compromise the reliability of data.
To take a non-invasive reading of oxygen saturation SpO2 and pulse rate, use the reusable
finger sensor. This sensor is recommended for patients weighing over 20 Kg and with
limited mobility or who remain still during tests; for tests carried out with the patient
walking, other types of sensors that are less affected by movements of the hands are
recommended.
To perform an oximetry test, proceed as follows:
Connect the sensor to the device: insert
the connector with the arrow facing up.
Choose a site with a good blood flow that
is suitable for the sensor
Insert the finger all the way into the
sensor. Make sure that the under part of
the finger completely covers the
detector. If you cannot position the
finger properly, use a different finger.
Position the sensor so that the cable runs
over the back of the hand. This ensures
that the light source stays on the same
side as the nails while the detector
remains under the finger.
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To enter the oximetry area, press
on the main screen. If the button is not enabled it
means that your device is not equipped with the oximetry function.
WARNING
If, before starting a test, the power supply is low, the following message will appear:
Low battery
In this case, press
to exit the test, otherwise the device will start the test a few
seconds later.
If a test is interrupted for some unexpected reason, the next time the device is
turned on, the following message will appear:
WARNING
the last oximetry test was improperly interrupted
At the same time, the device will beep intermittently for 4 seconds.
The spirolab will then display the main screen.
WARNING
To avoid compromising the reliability of readings and to protect the sensor, do not
twist the sensor cable without reason or use excessive force when using,
connecting, disconnecting or putting away the oximeter sensor.
The first few seconds of a test are used for finding the strongest signal; once this has been
found, the timer resets itself and the spirolab starts saving data.
If the sensor is not inserted correctly, icon
appears alongside it.
transforms into
and the icon
At the same time, the spirolab will beep (if set to do so in the service menu).
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If the sensor has been inserted but the finger is not positioned correctly, the icon
transforms into
and the icon
appears alongside it.
At the same time, the spirolab will beep (if set to do so in the service menu).
By tapping the
icon, you can pause the alarm for a few minutes. If the alert situation
persists, after a few minutes the beeping resumes.
If the signal is received properly by the sensor, after a few seconds the device will begin to
beep and display readings on the screen.
Alarms can be set for oximetry tests as explained in section 2.5.
If during a test, the %SpO2 or BPM rate goes above or below its threshold, the spirolab
emits a beep (if set to do so in the service menu) for as long as this anomaly continues.
WARNING
Tests are stored with the code of the last patient displayed; if this relates to a patient
previously inserted, before carrying out the test retrieve a test carried out previously
on the subject in question and proceed as described in paragraph 2.7.2.
During oximetry tests , the battery level is displayed. This lets you estimate how
long the device will run for given the condition in which it is operating (display at
maximum or energy saving mode).
To end a test, tap
2.11.1
.
Instructions for using the sensor on adult patients
WARNING
The description of the following sensor serves solely as an example. Any of the
sensors described in §1.2.4 can be used with the spirolab device MIR do not
recommend any particular sensor; that decision is left to the doctor's discretion.
To monitor non-invasive readings of arterial blood oxygen saturation, we recommend the
use of soft reusable sensors.
WARNING
The sensors are made from PROTEIN FREE NATURAL LATEX materials. The
materials used in making the sensors have been subjected to stringent
biocompatibility tests.
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•
Choose a suitable site for application on the
patient's finger or toe that will allow the light
source to line up directly with the detector. The
preferred sites are the index finger or thumb.
•
•
Remove any nail polish or false nails.
Position the patient's finger in the sensor with the nail face up and place the pad
of the finger over the detector. An imaginary line through the middle of the sensor
should pass through the tip of the finger.
Apply the adhesive tape to under part of the finger taking care not to cover the
nail
Fold the upper part of the sensor over the finger making sure that the light source
is directly in line with the detector below it. Run the wire along the palm of the
hand or sole of the foot and, if necessary, tape it in place.
Connect the sensor to the device: insert the connector with the arrow (stamped on
the connector) facing up and make sure that everything is working properly as
described previously.
•
•
•
WARNING
Do not twist the sensor cable without reason or use excessive force when using,
connecting, disconnecting or putting away the oximeter sensor.
If the sensor is fitted too tightly, it may create inaccurate saturation readings.
We recommend using a sticking plaster to fix the sensor wire to the wrist.
3.
DATA TRANSMISSION
WARNING
Before beginning data transmission, read the instructions carefully and make sure
you have fully understood them.
WARNING
Bluetooth communication is considered ad additional function. In the event of an
interruption in transmission, we recommend the use of a more reliable USB port
technology.
3.1
Data transmission via Bluetooth
Spirolab can be connected as a "slave device" to any other "master device”. Therefore,
you can connect spirolab to a PC or a mobile phone and control it using special
applications.
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The connection uses the SPP (Serial Port Profile) protocol.
The following are required for such a connection to be made:
•
•
Spirolab must have a Bluetooth feature (this feature is optional on some models).
The "Bluetooth" setting must be set to "ON".
If these conditions are met, you can search for enabled devices from the "master" device.
Once spirolab has been identified, you
will be prompted to enter your PIN;
this information is found in the service
menu in the "Device", "Info" section,
as shown to the right.
Enter the value displayed and continue
with the so-called "pairing" activity, i.e.
pairing the spirolab "device" and the
"master" device.
At this point, spirolab can use the connection via SPP (Serial Port Profile) protocol. For
details on using the protocol, please contact the manufacturer.
Similarly, spirolab can be connected to a PC on which you have installed winspiroPRO.
Once connected as described above, winspiroPRO becomes an interactive panel to control
spirolab, and hence perform wireless "online" spirometry and oximetry tests that will be
stored directly within the software.
3.2
Connecting with a PC via USB port
WARNING
Before connecting the spirolab to the PC via USB, you need to install the
winspiroPro program that allows you interface with the device.
Before starting to use the following procedure it is important to know the version
of the operating system on the PC you will be connecting with (click on "system"
in the Control Panel to see information the installed OS).
If winspiroPRO has already been installed, the following actions are not necessary.
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To make the connection, insert the
micro USB connector supplied with
the spirolab into the USB port on the
PC.
When you first connect, your PC,
depending on the operating system
version in use, will automatically
install the Microsoft certified driver.
For more support at this stage, refer
to the WinspiroPRO software
manual.
3.3
Printing data
Spirolab enables you to print both the last test performed and those stored in the archive.
To print the last test performed, retrieve
the test using the icon
for
spirometry or
for oximetry. When
you have viewed the test, press the icon
.
If in the service menu it was enabled the
direct USB printing, then on the screen
appears a banner which allows to choose
the type of printer to use:
thermal printer
USB direct connection printer
Choose one function in 5 seconds (when all the balls become orange); if no function is
selected, then after 5 seconds the thermal printed will start automatically.
If the direct USB printing is disabled, then touching the icon
will start automatically
the thermal printer.
To print a test carried out in the past and stored in the archive, perform a search as
described in section 2.7.1; once displayed, tap
.
Also in this case it will appear the banner to select the printing type: thermal printer or via
USB connection.
The system prints the information selected in the "Spirometry" - "Results" settings.
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3.4
Up-dating internal software
When the device is connected to a PC via the USB port, the spirolab internal software
can be up-dated. Up-dates can be downloaded on registration from: www.spirometry.com.
For further information about downloading up-dates, refer to the “winspiroPro” manual.
4.
MAINTENANCE
WARNING
No part can be subjected to maintenance during use.
Spirolab devices need little maintenance. You should periodically:
•
•
•
•
Clean and check reusable turbines
Replacement disposable turbines at each test
Clean the oximetry sensor (for reusable sensors)
Recharge the internal battery pack
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.
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. In no case
does the incorrect setting of the device place a patient at risk.
4.1
Cleaning and checking reusable turbines
The volume and flow turbine sensors usable with spirolab are of two types: disposable
and reusable. These guarantee great accuracy and have the added benefit of not needing to
be periodically calibrated. A simple clean before every use will ensure that the turbine keeps
working as it should (only for reusable turbines).
For disposable turbines, cleaning is not necessary as they are supplied clean and packaged
in sealed envelopes. When you have finished using them, they should be discarded.
WARNING
It is good practice to periodically check that no impurities or foreign bodies such
as skin or even worse, hairs have deposited inside the turbine. Such obstacles could
slow or block the turbine blades and compromise the accuracy of readings.
Before every use, perform the test described in section 4.1.1 below that allows you to test
the efficiency of the turbine. If the result is negative, act as follows.
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To clean a reusable turbine, remove it from its housing in the MiniFlowmeter by turning
it anti-clockwise and pulling gently. To facilitate removal, you can push the bottom of the
turbine gently with a finger.
Soak the turbine in a cold liquid detergent and shake it so as to remove any impurities that
have deposited inside; leave to soak for the period of time recommended by the detergent
manufacturer that is shown in the instructions for use.
WARNING
To avoid irreparable damage to the turbine, do not use alcohol or oil based
detergent solutions and do not soak in water or hot solutions.
Never place the turbine in an autoclave. Do not sterilise the turbine.
Never clean the turbine under running water or spray with other liquids. If no liquid
detergents are available, clean the turbine with at least clean water.
MIR recommends the use of Dupont Perasafe that has been tested on all MIR
sensors.
Rinse the turbine by immersing it in clean water (not hot).
Shake off any excess water off the turbine. Leave the sensor to dry by placing it in an upright
position on a dry surface.
Before re-fitting the turbine, check that it is working properly. It is good practice to visually
check that the blades are moving freely. Place the turbine on its side and slowly move the
blades left and right. They should rotate freely. If this is not the case, the accuracy of
readings is no longer guaranteed and the turbine will have to be replaced.
On completion of cleaning, replace the turbine in its housing making sure that it is in the
right position as shown by the closed padlock symbol on the MiniFlowmeter.
To insert the turbine correctly, push it fully in and turn it clockwise until it clicks into place
inside the plastic housing.
To double check that the turbine is working correctly, repeat the checks described in 4.1.1;
if the turbine is still problematic, replace it with another.
WARNING
If disposable turbines are being used, do not perform any cleaning operations, but
replace the turbine for a new patient.
4.1.1
•
•
•
Checking correct turbine function
Turn the spirolab on and act as if you wanted to perform a spirometry test
Take the MiniFlowmeter in one hand and move it slowly from right to left and vice
versa so that air passes through the turbine,
If the blades move correctly, the device will emit repeated beeps that vary in frequency
with the flow of the air passing through
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•
If no beeps are emitted during this movement, clean the turbine.
4.2
Cleaning the oximetry sensor
The reusable oximetry sensor must be cleaned at every change of the patient, i.e. before
applying it to a new patient.
Clean the sensor with a damp cloth containing water or a delicate soap solution. To
disinfect the sensor, rub it with isopropyl alcohol. After cleaning, allow the sensor to fully
dry.
Do not use abrasive or caustic agents to clean the sensor.
WARNING
Do not sterilise by means of radiation, steam or ethylene oxide.
Always disconnect the sensor before cleaning or disinfection.
Spirolab sensors are latex free.
4.3
Recharging the battery pack
WARNING
To charge the battery pack, only use the charger supplied by the manufacturer.
When the spirolab device is turned on, an icon shows the condition of the battery in the
top right hand corner:
The maximum charge level is reached when the symbol is completely green.
If only part of the symbol is green or if the device doesn't turn on, you will need to recharge
the battery pack as follows:
•
•
Connect the battery charger to both the connector and
the mains supply. A blue LED will light up in the lower
right-hand corner.
When charging is completed, the LED will turn green.
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•
When charged, disconnect the battery charger from the
device and from the mains.
WARNING
Do not use the device when it is recharging Always disconnect the charger when
recharging has been completed
4.4
Replacing the thermal paper
The following procedure describes the steps to perform in order to replace in the correct
way the thermal paper roll.
1) Open the lid of the
thermal paper compartment
and remove it from the
device.
Remove the paper roll
holder.
2) Insert the new roll of
paper onto the paper roll
holder and guide the thermal
paper into the slots for the
roller holder
3) Push the paper into the
slot located under the
traction reel (black rubber
reel on the thermal printer);
A sensor detects the paper
and will automatically
advance it.
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If necessary make the paper
advance by pressing the icon
on the touch screen.
When done, press OK icon.
4) Slide the paper through
the slot on the lid of the
thermal paper
compartment.
Close the lid of the
compartment
WARNING
Operator shall not touch simultaneously the patient and the parts of non-medical
equipment that are accessible to the operator during routine maintenance after
removal of covers without the use of a tool.
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Spirolab
5.
TROUBLE SHOOTING AND SOLUTIONS
PROBLEM
spirolab
doesn't turn
on
Message
during switch
on
Message
when the
privacy info
is enabled
Problems
turning the
device on
MESSAGE
\
\
Too many
attempts for
today
To comply with
privacy policy
please update
all connected
devices
Ram error
data recovery
Please wait
POSSIBLE CAUSE
Battery pack may be
flat
The device may have
lost internal software
The user has exceeded
the maximum number
of attempts to insert
the pin
The privacy info is
enabled
The data in the device
memory has been
damaged
\
There is an internal
error
\
On
completion of
spirometry
tests, the
\
readings are
not credible
The turbine may be
dirty
The device
turns itself off
then reboots
while being
used.
Rev.1.8
The test was
performed in the
wrong manner
SOLUTION
Charge the device using the
charger unit
Connect the device to a PC
via USB and up-date the
software; for further
information, consult the
online winspiroPRO User
Manual
Wait for the next day. The
number of attempts will be
resetted.
The message advises the
user to update the software
winspiroPRO installed on
the PC to comply with
privacy policy
If the data has been
correctly restored, the last
standard turning on process
will be repeated; if not,
contact an authorised
assistance centre or the
manufacturer.
Check ww.spirometry.com
to see if an up-dated
version of the software is
available; if this is the case,
download the software then
up-date the device with the
latest software
winspiroPRO version. For
further information, consult
the online winspiroPRO
User Manual.
Clean the turbine as
described in section 4.1; if
necessary, replace the
turbine with a new one
Repeat the test following
the instructions shown on
the screen
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Spirolab
PROBLEM
On
completion of
a spirometer
test, some
parameters
are not
displayed
During an
oximeter test
the readings
displayed are
irregular,
intermittent
or wrong
The display is
not very
bright during
tests
Problems
with charging
the battery
pack
MESSAGE
\
POSSIBLE CAUSE
Personalised
parameter settings in
the service menu
SOLUTION
Check the heading
parameter settings in the
“Spirometry”, "Parameters"
section of the service menu
as described in section 2.5
\
The sensor is wrongly
positioned or the
patient's perfusion is
poor
The patient moved
Reposition the oximeter
sensor
\
\
Defective
battery
Error in
Unforeseen
memory
memory error
The device
will freeze
when
unforeseen
events occur
\
The brightness level
of the display
automatically dims 5
minutes after a test
starts. This function
extends battery life
The battery pack is
damaged or wrongly
positioned
The data stored in the
archive have been
damaged
\
For accurate results, the
patient must not make any
sudden movements.
None
Contact technical services
Contact technical services
Press the on button 3 times;
wait a few seconds and the
device will reset then turn
itself on,
WARNING
Before contacting the service centre, if possible, download the device archive to the
PC using the winspiroPRO program. This is necessary as the data may be lost
during repair activities and also to protect the patient's privacy, as neither the
manufacturer nor authorised personnel are allowed to see such data.
Rev.1.8
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Spirolab
GUARANTEE CONDITIONS
The spirolab device and authorized accessories are guaranteed for a period of:
• 12 months in the case of professional use (doctor, hospital, etc.)
• 24 months where the product has been purchased by a patient for private use.
The guarantee takes effect from the date of purchase shown on the invoice or other
document.
The guarantee period starts from the date of sale that must be confirmed by an invoice or
sales receipt.
The product must be checked at the time of purchase or upon receipt and the
manufacturer must be informed immediately of any complaints.
The guarantee covers repair, or (at the manufacturer's discretion) replacement of the
product or defective components without any cost for labour or spare parts.
The batteries and components subject to wear and tear, including the reusable turbine, are
excluded from the terms of this guarantee.
At the manufacturer's discretion, the guarantee does not apply to the following cases:
•
•
•
•
•
•
•
Uses that are incorrect, improper or do not conform to the technical or safety
standards in force in the country where the product is being used.
Use of the product for purposes that differ from those in the Instructions for Use or
failure to observe such instructions.
Repair, adaptation, modification or manhandling by personnel who have not been
authorised by the manufacturer.
Damage caused by a lack of or by incorrect maintenance
Damage caused by physical or abnormal electrical stress
Damage caused by faults in the electrical systems or in items of equipment to which
the device has been connected.
Series number modified, erased, removed or obliterated.
The repairs and replacements mentioned in the guarantee take place on goods that have
been returned to our authorised service centres. For further information about service
centres, please contact your local distributor or the manufacturer.
The customer is responsible for the costs incurred for shipping, customs and the delivery
of goods.
Every product or component part thereof sent for repair must be accompanied by a clear
and detailed explanation of the fault. If the product or component part thereof is to be
Rev.1.8
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Spirolab
sent to the manufacturer, this must be authorised in writing or by phone beforehand by
the manufacturer.
MIR Medical International Research reserves the right to replace the product or make any
changes to it that the company deems necessary.
Rev.1.8
Page 60 of 60
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