MIR Spirobank II User manual

spirobank II User Manual cod. 980200 Rev 3.4 Page 1 of 57
spirobank II
User Manual
User Manual Rev. 3.4
Issued on: 26.04.2011
Approved on: 26.04.2011

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Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
WARNING
The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in
the equipment should be considered disposable products.
Before using your spirobank II …
Read this manual carefully, plus all labels and other product information supplied.
If not fitted, install the operating battery taking care to connect the “+” and “-” battery
poles correctly, as shown in the battery compartment.
Set the device configuration as required (date, time, predicted values, device language
etc.) as described in Paragraph 2.4.
WARNING
The winspiroPRO PC software supplied with the device MUST be installed correctly
to the PC before connecting spirobank II to the PC. At the end of the installation,
connect the device to the PC and the hardware will be "recognised" by the PC. The
device can then be used with the winspiroPRO software.
Keep the original packaging!
In the event that your device requires attention then always use the original packaging to
return it to the distributor or manufacturer.
In this case, please follow these guidelines:
Return the complete device in the original packaging, and
The transport (plus any customs or taxes) costs must be prepaid.
Manufacturer‟s address:
MIR SRL
VIA DEL MAGGIOLINO, 125
00155 ROMA (ITALY)
Tel ++ 39 0622754777
Fax ++ 39 0622754785
Web site: www.spirometry.com
Email: [e-mail]
MIR has a policy of continuous product development and improvement, and the
manufacturer therefore reserves the right to modify and to update the information
contained in this User‟s Manual as required. Any suggestions and or comments
regarding this product should be sent via email to: [e-mail]. Thank you.
MIR accepts no responsibility for any loss or damage caused by the User of the
device due to instructions contained in this Manual and/or due to an incorrect use of
the product.

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Note that due to printing limitations the screenshots shown in this manual may differ
from the display of the machine and/or from the keyboard icons.
Copying this manual in whole or in part is strictly forbidden.
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN

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INDEX
1. INTRODUCTION .......................................................................................................6
1.1 Intended Use.......................................................................................................6
1.1.1 User Category ................................................................................................6
1.1.2 Ability and experience required ......................................................................6
1.1.3 Operating environment ...................................................................................6
1.1.4 Who can or must make the installation ...........................................................7
1.1.5 Subject effect on the use of the device ...........................................................7
1.1.6 Limitations of use - Contraindications.............................................................7
1.2 Important safety warnings...................................................................................8
1.2.1 Danger of cross-contamination.......................................................................8
1.2.2 Turbine ...........................................................................................................8
1.2.3 Mouthpiece .....................................................................................................9
1.2.4 Oximetry sensor .............................................................................................9
1.2.5 Device...........................................................................................................11
1.3 Unforeseen errors .............................................................................................11
1.4 Labels and symbols ..........................................................................................12
1.4.1 Identification label.........................................................................................12
1.4.2 CE mark for medical devices ........................................................................12
1.4.3 Electrical safety symbol ................................................................................12
1.4.4 Warning symbol for the RS232 serial port ....................................................12
1.4.5 Warning symbol for the USB serial port........................................................13
1.4.6 Warning symbol for the SpO2 port for oximetry............................................13
1.4.7 Warning symbol for the WEEE .....................................................................13
1.4.8 FDA and FCC Warnings ...............................................................................13
1.4.9 Product description.......................................................................................14
1.5 Technical specifications ....................................................................................16
1.5.1 Features of the spirometer............................................................................16
1.5.2 Features of the oximeter...............................................................................17
1.5.3 Other features...............................................................................................21
2. FUNCTIONING OF THE spirobank II .......................................................................21
2.1 Keyboard...........................................................................................................21
2.2 Battery Level .....................................................................................................24
2.3 Information ........................................................................................................24
2.4 Initial Set-up......................................................................................................24
2.4.1 Turbine Calibration .......................................................................................27
2.5 Patient Data ......................................................................................................29
2.6 Displaying data in memory................................................................................30
2.7Online operating mode (connected to a PC) .....................................................31
2.8 Spirometry Testing............................................................................................31
2.8.1 FVC Test ......................................................................................................32
2.8.2 VC Test.........................................................................................................33
2.8.3 MVV Test......................................................................................................33
2.8.4 Reading messages.......................................................................................33
2.8.5 Spirometry test interpretation........................................................................34
2.8.6 Viewing the spirometric parameters .............................................................35
2.8.7 POST test, after administration of drug.........................................................35
2.9 Oximetry testing ................................................................................................36
2.9.1 Walk Test (6MWT)........................................................................................39
2.9.2 Sleep Oximetry .............................................................................................40
2.9.3 SPO2 BPM Oximetry Test ............................................................................41
2.9.4 SPO2 BPM Test ...........................................................................................41
2.9.5 Adult Single Patient Sensor –Instructions for Use .......................................41

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3DATA TRANSMISSION ..............................................................................................43
3.1 Data Transmission via Bluetooth to a cell phone ..............................................43
3.1.1 Preliminary Operations .................................................................................43
3.1.2 Setting the Phone Number ...........................................................................43
3.1.3 Bluetooth Data Transmission........................................................................43
3.2 Data Transmission via Bluetooth for printing.....................................................44
3.3 Connection to a PC through USB port ..............................................................44
3.4 Connection to a PC through the RS 232...........................................................45
3.5 Upgrade Internal software.................................................................................45
4MAINTENANCE ..........................................................................................................45
4.1 Cleaning and controlling the reusable turbine ...................................................46
4.2 Cleaning the oximetry sensor............................................................................47
4.3 Changing the adhesive tape of the wrap sensor ...............................................47
4.4 Changing the Batteries .....................................................................................47
5PROBLEM SOLVING..................................................................................................48
5.1 Causes and Solutions .......................................................................................48
ANNEX 1 OXYMETRY TEST REPORT EXAMPLES ...................................................51
ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES................................................54
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC
ENVIRONMENT.................................................................................................................55

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1. INTRODUCTION
1.1 Intended Use
Indications for Use: The Spirobank II spirometer and pulse oximeter is intended to be used
by a physician or by a patient under the instruction of a physician or paramedic.
The device is intended to test lung function and can make:
spirometry testing in people of all ages, excluding infants and neonates
oximetry testing in people of all ages.
It can be used in any setting.
1.1.1 User Category
The spirobank II spirometer + oximeter calculates a series of parameters relating to human
respiratory function.
Typically the doctor “prescribes” a spirometry test and is responsible for analysing and
controlling the results obtained.
1.1.2 Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of the
device all require qualified personnel. In the event that the device is operated by the
patient, then sufficient training must first be given to the patient by the doctor or by the
trained paramedic under the supervision of the doctor.
WARNING
The manufacturer cannot be held responsible for any damage caused by the user of
the device failing to follow the instructions and warnings contained in this manual.
If the user of the device is a person considered to be cognitively impaired, then the
operation of the device must be made under the supervision and responsibility of
whoever is legally charged with the supervision of this person.
The spirobank II when used as a pulse oximeter is intended for spot-checking,
overnight sleep screening and/or continuous monitoring when attended by a trained
healthcare professional.
1.1.3 Operating environment
spirobank II has been designed for use in a doctor‟s office, in a hospital or directly by the
patient during day-to-day activities for the continuous monitoring of physical conditions. All
information necessary for the proper use of the device in electromagnetic environments (as
required by the EN 60601-1-2 Standard) is available from the manufacturer.
Used at home, at work, at school or during sports, day by day the device records data and
functional respiratory parameters for a period of weeks or months, assisting the patient in
making a better assessment of his own health.
The procedures for using the device at home are described according to the type of test to
be made; the display will show all instructions (messages, suggestions etc.) step-by-step,

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which allows the subject to correctly perform tests and obtain correct results, to be
analysed by the doctor.
The instrument is not intended for use in an operating theatre nor in the presence of
inflammable liquids or detergents, nor in the presence of inflammable anaesthetic gases
(oxygen or nitrogen).
The instrument is not designed to be used in direct air currents (e.g. wind), sources of heat
or cold, direct sun rays or other sources of light or energy, dust, sand or any other chemical
substances.
The user and/or the doctor are responsible for ensuring that the device is stored and used
in appropriate environmental conditions; in this regard reference is made to the specifics
described in paragraph 1.6.3 below.
WARNING
If the device is exposed to unsuitable environmental conditions, this could cause the
device to malfunction and to give incorrect results.
1.1.4 Who can or must make the installation
The device requires installation by qualified personnel. Normally the doctor configures the
instrument before giving it to the patient for use at home.
1.1.5 Subject effect on the use of the device
A spirometry test should only be carried out when the subject is at rest and in good health,
and thus in suitable testing conditions. A spirometry test requires the collaboration of the
subject since the subject must make a complete forced expiration, in order to have a
meaningful test result.
1.1.6 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct
diagnosis of the subject‟s clinical condition. A detailed clinical history of the subject is also
required together with the results of any other test(s) suggested by a doctor.
Test comments, a test interpretation and suggested courses of treatment must be given by
a doctor.
Any symptoms that the subject has at the time of the test must be carefully considered
before a spirometry test is made. The user is responsible to assess both the mental and
the physical capacity of the subject in order to make a correct test, and the user, in the
evaluation of test results, must also assess the degree of collaboration of each test carried
out.
A spirometry test requires the full collaboration of the subject. The results depend on the
person‟s capability to inspire and to expire all air completely and as fast as possible. If
these fundamental conditions are not respected then the results obtained during
spirometry testing will not be considered accurate, and therefore the test results are “not
acceptable”.
The acceptability of a test is the responsibility of the user. Special attention should be
given to testing elderly subjects, children and handicapped people.
The device should never be used when it is possible or probable that the validity of the
results may be compromised due to any such external factors.
WARNING
The spirobank II when used as a pulse oximeter has limited alarms, therefore the
device requires frequent display observation of SpO2 and pulse rate.

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1.2 Important safety warnings
spirobank II has been examined by an independent laboratory which has certified the
conformity of the device to the European Safety Standards EN 601-1 and guarantees the
EMC Requirements within the limits laid down in the European Standard EN 60601-1-2.
spirobank II is continually controlled during its production and therefore the product
conforms to the established security levels and quality standards laid down by the Council
Directive 93/42/EEC for MEDICAL DEVICES.
After removing the device from its packaging, check that there is no visible damage. In
case of damage do not use the device, return it to the manufacturer for repair.
WARNING
The safety and the correct performance of the device can only be assured if the user
of the device respects all of the relevant safety rules and regulations.
The manufacturer cannot be held responsible for damage caused by the failure of
the user correctly to follow these instructions.
The device must be used only and exclusively as a spirometer following the
indications given by the manufacturer with particular attention to the paragraph on
INTENDED USE, and utilizing only original spare parts and accessories. Use of non-
original parts such as the turbine flow sensor and oximetry sensor or other
accessories may cause errors in measurement and/or compromise the correct
functioning of the device, and is therefore not permitted.
The device should not be used beyond the declared life span. The life span is strictly
related to the life of the internal lithium backup battery (CR2032) and in normal
conditions this should be around 10 years. The device constantly monitors the state
of charge of this battery and a message informs the user when the battery is
discharged. Contact Technical Service to have this battery changed.
In the event of any incident or accident of any kind resulting from the use of the
device, the user is required to inform the manufacturer without delay, this procedure
is laid down in Article.9 of the European Regulations No. 46/1997, which
implemented the EC Directive No. 93/42.
1.2.1 Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable and
one is single-patient disposable. A disposable mouthpiece is required in order to connect a
subject to the spirometer. In order to avoid exposing the subject to the critical danger of
cross-contamination, the reusable flow sensor must always be cleaned before each
spirometry test, and a new disposable mouthpiece must always be used for each subject.
The use of an anti-bacterial filter is at the discretion of the doctor. If a single-patient
disposable turbine is used, then a new one must be used for each patient.
1.2.2 Turbine
WARNING
Disposable
turbine
If you are going to perform the spirometry test with a disposable
turbine it is important to use a new turbine for each new patient.
The characteristics, accuracy and the hygiene of the disposable
turbine can only be guaranteed if it has been conserved
beforehand in its original sealed packaging.
The disposable turbine is made of plastic and its disposal after
use should adhere to the local regulations and norms in force.

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Reusable
turbine
The correct functioning of the re-usable turbine can only be
guaranteed if it has been cleaned in the correct manner and is
free from foreign bodies which could alter its movement. If the
turbine has not been cleaned sufficiently this could cause cross-
contamination from one patient to another. Periodic cleaning
should only be done when the instrument is for personal use
and will only be used by one patient. The cleaning of the turbine
should be performed according to the instructions contained in
the User‟s Manual.
The following information applies to both turbine models.
The turbine must never be held under a jet of water or air and must never come into
contact with high temperature fluids.
Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect
functioning and possible damage. The presence of any impurities such as hair, sputum,
threads etc. within the body of the turbine sensor may seriously compromise the accuracy
of the measurements.
1.2.3 Mouthpiece
Any disposable mouthpieces included with the device are supplied only as a guide to the
correct type and dimensions of the mouthpiece required for this device, they are clean but
not sterile. To purchase appropriate mouthpieces, generally either paper or plastic, but in
any case single use/disposable, we suggest that you contact your local distributor who
supplied the spirometer.
WARNING
Use a bio-compatible mouthpiece to avoid any problems to the patient; unsuitable
materials could cause a bad functioning of the instrument, and therefore the test
results could be incorrect.
The user is responsible for obtaining the correct type of mouthpieces for the device. Those
required are a standard type with an outside diameter of 30 mm, they are commonly used
and in general easily procured.
To avoid environmental contamination caused by the disposal of used mouthpieces,
the user must follow all the relevant local regulations.
1.2.4 Oximetry sensor
The oximetry sensors which can be used with spirobank II are the following:
MANUFACTURER
MANUFACTURER CODE
DESCRIPTION
BCI
1300
adult sensor (disposable)
BCI
3026
wrap-around sensor for infants
BCI
3043
universal Y sensor
BCI
3078
ear sensor
BCI
3178
pediatric finger sensor, reusable
BCI
3444
adult sensor reusable (Comfort Clip)
BCI
3044
adult sensor, reusable, for finger

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MANUFACTURER
MANUFACTURER CODE
DESCRIPTION
Nellcor
DS-100 A
Adult finger sensor
Nellcor
Oxi Band A/N
Adult/Neonatal finger sensor
Nellcor
D-YS
Pediatric multi site finger sensor
These sensors require the use of an extension cable cod. 919100 to be correctly
connected to the device.
The same sensors are also available with microconnector for the direct connection.
Prolonged use and/or the patient‟s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and correct
alignment at least every 4 hours.
WARNING
Incorrectly applied sensors or damaged cables may cause inaccurate readings.
Using a damaged sensor may cause inaccurate readings, possibly resulting in
patient injury or death. Inspect each sensor before use.
If a sensor appears damaged, do not use it. Use another sensor or contact your
authorized repair centre for assistance.
Use only MIR sensors supplied with, or specifically intended for use with the
spirobank II. Use of sensors not intended for use with the spirobank II may cause
inaccurate readings.
Oximetry measurements may be inaccurate in the presence of high ambient light.
Shield the sensor area (with a surgical towel, for example) if necessary.
WARNING
Dyes introduced into the bloodstream, such as methylene blue, indocyanine green,
indigo carmine, patent blue V (PBV), and fluorescein may adversely affect the
accuracy of the oximetry reading.
Any condition that restricts blood flow, such as the use of a blood pressure cuff or a
device for systemic vascular resistance, may cause an inability to determine
accurate pulse rate and SpO2 readings.
Remove fingernail polish and/or false fingernails before applying SpO2 sensors.
Both may cause inaccurate oximetry measurement.
Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin or
methemoglobin, may adversely affect the accuracy of the oximetry measurement.
Optical cross-talk can occur when two or more sensors are placed in close
proximity. Optical cross-talk may adversely affect the accuracy of the oximetry
readings. The danger can be eliminated by covering each site with opaque material.
Obstructions or dirt on the sensor‟s emitter and/or detector may cause a sensor
failure or inaccurate readings. Make sure there are no obstructions and the sensor is
clean.
Autoclaving, ethylene oxide sterilizing, may cause sensor damage. Do not attempt to
sterilize the sensor.

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Unplug the sensor from spirobank II before cleaning or disinfecting to prevent
damaging sensor or device, and to prevent safety hazards for the user.
1.2.5 Device
WARNING
The maintenance operations detailed in this manual must be fully and accurately
carried out. If these instructions are not followed this can cause measurement errors
and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfiguration must be made by the
manufacturer or by personnel authorised by the manufacturer. Never attempt to
make a repair oneself. The set-up of configurable parameters should only be made
by qualified personnel. However, an incorrect set-up of the parameters does not put
the patient at risk.
High-frequency emissions from “electronic” devices may interfere with the correct
operation of the instrument. For this reason, certain minimum clearances (a few
metres) should be observed when high-frequency appliances such as a TV, radio,
portable phone, etc. and other electronic units are operated at the same time in the
same room.
The instrument may give inaccurate readings if operated in the presence of strong
electromagnetic sources, such as electrosurgical equipment, or in the presence of
computed tomography (CT) equipment.
Do not use the instrument in the presence of magnetic resonance imaging (MRI)
equipment. MRI equipment may cause an induced current to the oximetry sensor,
resulting in patient injury.
If the PC and/or the printer connected to spirobank II come into contact with the area
containing patient data, ref. directive EN 60601-1-1, it is necessary that they conform
to the directive EN 60601-1.
For the recycling of the spirobank II, the accessories, any plastic consumable
materials (mouthpieces) as well as the battery, use only the appropriate containers
or return all such parts to the dealer or to a recycling centre. All applicable local
regulations must be followed.
If any of these rules are not followed then MIR will decline all responsibility for any
direct or indirect damages, however caused.
Use only the battery type indicated in the § Technical specifications.
Remove the battery from the device if the machine is not used for a long period
(several months).
The instrument may be powered through a PC by a USB cable. By this means, the
device works both on line with the PC, or individually powered by the PC.
Keep the device out of reach of children and of any person with mental handicap.
1.3 Unforeseen errors
In case device internal memory data are damaged, when the device is switched on, the
following message appears:
Error on RAM memory
Recovery data
Please wait

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If data have been successfully recovered, the device completes the standard switch on
process, otherwise please contact an authorised technical assistance point or the
manufacturer.
In the case of a problem with the device, a message indicating the nature of the problem
will appear on the screen, together with a warning “beep”.
Operation of the device beyond its declared life (see § 1.6 Technical Specifications) could
provoke a loss of data in the memory of the device (SRAM memory).
Errors in measurement or in interpretation can also be caused by:
use by non-qualified or non-trained personnel, lacking ability or experience
user error
use of the instrument outside the guidelines described in this User's Manual
use of the instrument even when some operational anomalies are encountered
non-authorised servicing of the instrument.
1.4 Labels and symbols
1.4.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
CE mark in compliance with the Directive 93/42 EEC.
1.4.2 CE mark for medical devices
0476
This product is certified to conform to the Class II requirements of the 93/42/EEC medical
device directive.
1.4.3 Electrical safety symbol
In accordance with the IEC 60601-1 Standard, this product and its component parts are of
type BF and therefore protected against the dangers of direct and indirect contact with
electricity.
1.4.4 Warning symbol for the RS232 serial port
RS232

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For connection to other devices such as PC or printer.
Use only the serial cable supplied by the manufacturer and observe the safety regulations
of IEC 60601-1-1.
1.4.5 Warning symbol for the USB serial port
For connection to other devices such as PC or printer.
Use only the serial cable supplied by the manufacturer and observe the safety regulations
of IEC 60601-1-1.
1.4.6 Warning symbol for the SpO2 port for oximetry
SpO2
1.4.7 Warning symbol for the WEEE
As laid down in the European Directive 2002/96/EEC requirements regarding the disposal
of electrical and electronic devices (WEEE), at the end of its useful life this device must not
be thrown away together with normal domestic waste as it contains materials which would
cause damage to the environment and/or represent a health risk. Instead it must be
delivered to a WEEE authorised collection centre, where the device will then be disposed
of correctly.
An alternative is to return the device without charge to the dealer or distributor, when a new
equivalent device is purchased.
Due to the materials used in the manufacturing of the device, disposing it as a normal
waste product could cause harm to the environment and/or health.
Failure to observe these regulations can lead to prosecution.
1.4.8 FDA and FCC Warnings
spirobank II complies with Part 15 of the FCC Rules. The correct operation is subject to the
following conditions:
(1) this device must not cause harmful interference
(2) this device must accept any interference received, including interference that may
cause undesired operation.
Any modifications not expressly approved by this company could void the user's authority
to operate the equipment.
NOTE: This device has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio
communications.
FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
FCC ID:TUK-MIR020
FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
FCC ID:TUK-MIR020

spirobank II User Manual cod. 980200 Rev 3.4 Page 14 of 57
However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct
the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from
that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for
assistance.
Labels and symbols are displayed on the device like shown in the
following images:
1.4.9 Product description
spirobank II is a pocket spirometer, with an optional pulse oximetry module. It can operate
in stand alone mode and it can be connected to a PC or to a printer using any one of
several available methods: RS232, USB, Bluetooth.
spirobank II is specifically designed to measure a range of respiratory parameters and to
monitor the saturation of oxygen in the blood and the heart beat. A quality control check is
carried out internally on the measured parameters and the device has an internal memory
sufficient for over 6000 spirometry tests or for 1000 hours (or 40 days) of oximetry
monitoring.
spirobank II is a powerful and compact measurement device, intended for use by a
respiratory specialist or by a suitably trained generalist. The spirometer calculates up to 30
functional respiratory parameters providing the pharmacodynamic effects, i.e. the data
comparison after the administration of a drug (PRE/POST) for a bronchodilator test or for a
bronchial challenge test. A comparison of data is made between POST (after-drug) and
PRE (before drug administration).
The flow and volume measurement sensor is a digital turbine, based on the infrared
interruption principal. This principal ensures the accuracy and the reproducibility of the
measurements, without requiring a periodic calibration.

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The features of this kind of sensor are listed below:
Accurate measurement even at very low flow rates (end of expiration)
Not influenced by gas humidity nor density
Shockproof and unbreakable
Inexpensive to replace.
The turbine flow measurement sensor is available both in reusable and in single-patient
disposable versions.
REUSEABLE TURBINE
DISPOSABLE TURBINE
The following precautions must be observed to ensure that the characteristics of the
turbine remain unaltered over time:
for the disposable turbine: must always be substituted between patients.
for the reusable turbine: always clean the turbine between patients, to ensure the
maximum level of hygiene and safety for the patient.
For a correct interpretation of a spirometry test, the measured values must be compared
either to the so-called normal or predicted values which are calculated from the
anthropometric details of the patient or, alternatively, to the personal best values from the
clinical history of the subject.
The personal best values can vary considerably from the predicted values, which are taken
from “healthy” subjects.
spirobank II is also able to transfer the stored test data through a simple acoustic coupling
to a PC, so the patient can send test data by phone to the doctor. In this way the doctor
can check the patient‟s condition remotely.
spirobank II can also be connected to a PC (or to another computerised system) to
configure the system. All spirometric test results plus the related subject details stored
inside the device can be transferred from the device to the PC and then viewed on the PC
(Flow/volume curves, spirometry parameters, plus optional oximetry parameters).
The connection to the PC can be made in the following ways:
through the RS232 port or
through the USB port
spirobank II gives an automatic interpretation of each spirometry test carried out, and
assigns a “traffic light” feedback (green, yellow or red) to each test or series of tests. The
set up of the traffic light settings is made by the doctor responsible for the system
configuration.
spirobank II is able to make FVC, VC & IVC, MVV and breathing profile tests, and
calculates an index of test acceptability (quality control) plus the reproducibility of the
spirometry tests carried out. The automatic test interpretation follows the latest 11 level
ATS (American Thoracic Society) classification. Each test can be repeated as required.
The best parameters are always available for review. The normal (predicted) values can be

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selected from several normal “sets”. For example, within the European Union the majority
of doctors use the ERS (European Respiratory Society) predicted values.
Oximetry function
The oximetry sensor has two light emitting diodes (LEDs), one emits in the visible spectre
and one infrared. Both lights then pass through the finger and are “read” by the receiver.
As these lights pass through the finger, a proportion of the light is absorbed by the blood
and by the soft tissue, in function of the concentration of heamoglobin. The quantity of light
absorbed, at each frequency, depends on the degree of oxygenation of the haemoglobin
inside the soft tissue.
This measurement principal ensures accuracy and reproducibility, without requiring regular
calibration.
The oximetry sensor can be disinfected with isopropilic alcohol.
The device has two batteries:
Main power: AAA 1.5V battery (4 batteries are required)
Memory back up: lithium battery type CR2032 of 3V. The battery life is about 10 years,
depending on the use of the device
1.5 Technical specifications
A comprehensive description of the main features of the device, the flow and volume
measurement turbine and also of the oximetry sensor follows:
1.5.1 Features of the spirometer
Measured parameters:
SYMBOL
DESCRIPTION
Units
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
FVC
Forced Vital Capacity
L
FEV1
Volume expired in the 1st second of the test
L
FEV1/FVC
FEV1/FVC x 100
%
FEV1/VC
FEV1 / best between EVC and IVC x 100
%
PEF
Peak expiratory flow
L/s
FEF2575
Average flow between 25% and 75% of the FVC
L/s
FEF25
Forced Expiratory Flow at 25% of FVC
L/s
FEF50
Forced Expiratory Flow at 50% of FVC
L/s
FEF75
Forced Expiratory Flow at 75% of FVC
L/s
FEV3
Volume expired in the initial 3 seconds of the test
L
FEV3/FVC
FEV3/FVC x 100
%
FEV6
Volume expired in the initial 6 seconds of the test
L
FEV6%
FEV1/FEV6 x 100
%
FET
Forced expiratory time
s
EVol
Extrapolated volume
mL
FIVC
Forced inspiratory volume
L
FIV1
Volume inspired in the 1st second of the test
L
FIV1/FIVC
FIV 1 %
%
PIF
Peak inspiratory flow
L/s
MVVcal
Maximum voluntary ventilation calculated on FEV1
L/s
VC
Slow vital capacity (expiratory)
L

spirobank II User Manual cod. 980200 Rev 3.4 Page 17 of 57
SYMBOL
DESCRIPTION
Units
EVC
Slow espiratory vital capacity
L
IVC
Slow inspiratory vital capacity
L
IC
Inspiratory capacity (max between EVC and IVC) - ERV
L
ERV
Expiratory reserve volume
L
TV
Current volume
L
VE
Ventilation per minute, at rest
L/min
RR
Respiratory frequency
Breath/min
tI
Average time of inspiration, at rest
s
tE
Average time of expiration, at rest
s
TV/tI
Average flow of inspiration, at rest
L/min
tI/Ttot
tE/(tI+tE)
\
MVV
Maximum voluntary ventilation
L/min
ELA
Estimated lung age
year
* = best values
Flow/volume measurement system
Bi-directional digital turbine
Temperature sensor
semiconductor (0-45°C)
Measurement principle
Infrared interruption
Volume range
10 L
Flow range
16 L/s
Volume accuracy
3% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH2O/L/s
1.5.2 Features of the oximeter
Definitions:
Desaturation Event
Desaturation events SpO2 fall 4% in a limited period of 8-40 sec and
successive rise 2% within a total period of 150 sec.
Total Pulse rate
Variation
Pulse rate rise 10 BPM in limited period of 8-40 sec and successive
fall 8 BPM during a total period of 150 sec.
Parameters measured during sleep oximetry:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 Average in first three minutes
%
SpO2 Min
SpO2 Minimum during period of analysis
%
SpO2 Max
SpO2 Maximum during period of analysis
%
SpO2 Mean
SpO2 Average during period of analysis
%
BPM Baseline
Average pulse frequency in the first 3 minutes
BPM
BPM Min
Minimum pulse frequency during the period of
analysis
BPM
BPM Max
Maximum pulse frequency during the period of
analysis
BPM
BPM Mean
Average pulse frequency during the period of
analysis
BPM
Recording time
Total time measure of SpO2
hh:mm:ss
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss

spirobank II User Manual cod. 980200 Rev 3.4 Page 18 of 57
SYMBOL
DESCRIPTION
Units
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss
N° Events SpO2
<89%
Fall of SpO2 below 89% for at least 20 seconds
\
Index [12s]
Index of SpO2 fluctuation calculated in intervals of
12 seconds
\
T< 40 BPM
Time passed with pulse frequency < 40 BPM
%
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
%
hh:mm:ss
N° Events < 40
BPM
Bradycardia events during the entire period of
analysis
\
N° Events > 120
BPM
Tachycardia events during the entire period of
analysis
\
Tot. Desat. Events
Desaturation events during the entire period of the
analysis
\
ODI
Desaturation events by hour of analysis
1/h
Mean Duration
Average duration of desaturation events
s
Longest Duration
Longest duration of desaturation events
s
Desaturation Peak
Minimum Sp02 during desaturation events
%
Mean Desaturation
Average duration of desaturation events
%
Mean Drop ∆SpO2
Average SpO2 fall with respect to baseline during
the desaturation events
%
Max Drop ∆SpO2
Maximum fall of SpO2 with respect of baseline
during the desaturation events
%
N° Pulse Variations
Variation of pulse frequency events during the entire
period of the analysis
\
Pulse Index
Variation of pulse frequency by hour of analysis
1/h
NOD 4%
Time passed with SpO2 < 4 % with respect to SpO2
base for continual periods above 5 minutes
\
hh:mm:ss
NOD 89%
Time passed with SpO2 < 89 % for continued
periods above 5 minutes
\
hh:mm:ss
NOD 90%
Time passed with SpO2 < 90 % for continued
periods above 5 minutes with minimum value < 86
% (Nadir)
\
hh:mm:ss
=DELTA
Parameters measured for six minute walk test analysis:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 average before walking
%
SpO2 End
SpO2 after walking
%
SpO2 Min
SpO2 minimum during walking
%
SpO2 Max
SpO2 maximum during walking
%
SpO2 Mean
SpO2 average during walking
%
BPM Vaseline
Average pulse frequency before walking
BPM
BPM End
Pulse frequency after walking
BPM
BPM Min
Pulse frequency minimum during walking
BPM
BPM Max
Pulse frequency maximum during walking
BPM
BPM Mean
Pulse frequency average during walking
BPM
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss

spirobank II User Manual cod. 980200 Rev 3.4 Page 19 of 57
SYMBOL
DESCRIPTION
Units
T2 [SpO2≥2%]
Time passed during walking test with SpO2 < 2 %
with respect to SpO2 base
hh:mm:ss
T4 [SpO2 ≥4%]
Time passed during SpO2 walking test < 4 % with
respect to SpO2 base
hh:mm:ss
T< 40 BPM
Time passed with pulse frequency < 40 BPM
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
hh:mm:ss
N° Events < 40 BPM
Bradycardia events during the entire period of
analysis
\
N° Events > 120 BPM
Tachycardia events during the entire period of
analysis
\
Recording time
Total time measure of SpO2
hh:mm:ss
Baseline Time
Duration of baseline phase
hh:mm:ss
Walking Time
Duration of walking phase
hh:mm:ss
Recovery Time
Time for SpO2 value 99% of the average
base value calculated during the initial phase
of the test.
hh:mm:ss
Predicted
Predicted standard distance
m
Pred. Min
Predicted minimum distance
m
% Predicted Standard
% in variations of the distance covered with respect
to predicted standard distance
%
% Pred. Min
% of variations of distance covered with respect to
predicted minimum distance
%
AUC/Distance
Area under SpO2 curve base relative to distance
covered
\
Dyspnea Borg CHG
Variation in grade of dyspnea during walking
\
Fatigue Borg CHG
Variations in level of fatigue during walking
\
=DELTA
*There follows a description of the method for calculating the area below the SpO2
baseline curve:
Parameters requested for six minute walk test analysis
SYMBOL
DESCRIPTION
Units
Dyspnea Borg Baseline
Grade of dyspnea before walking
\
Dyspnea Borg End
Grade of dyspnea after walking
\
Fatigue Borg Baseline
Level of fatigue before walking
\
Fatigue Borg End
Level of fatigue after walking
\
Walked
Distance covered during walking
m
Parameters measured with SpO2 Analysis:

spirobank II User Manual cod. 980200 Rev 3.4 Page 20 of 57
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 Average in first three minutes
%
SpO2 Min
SpO2 Minimum during period of analysis
%
SpO2 Max
SpO2 Maximum during period of analysis
%
SpO2 Mean
SpO2 Average during period of analysis
%
BPM Baseline
Average pulse frequency in the first 3 minutes
BPM
BPM Min
Minimum pulse frequency during the period of
analysis
BPM
BPM Max
Maximum pulse frequency during the period of
analysis
BPM
BPM Mean
Average pulse frequency during the period of
analysis
BPM
Recording time
Total time measure of SpO2
hh:mm:ss
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss
N° Events SpO2 <
89%
Fall of SpO2 below 89 % for at least 20 seconds
\
Index [12s]
Index of SpO2 fluctuation calculated in intervals of
12 seconds
\
T< 40 BPM
Time passed with pulse frequency < 40 BPM
%
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
%
hh:mm:ss
N° Events < 40 BPM
Bradycardia events during the entire period of
analysis
\
N° Events > 120
BPM
Tachycardia events during the entire period of
analysis
\
=DELTA
Measurement method:
Red and infrared absorption
Range of measurement %SpO2:
0 –100% (with 1% increments)
SpO2 Resolution
1%
%SpO2accuracy:
2% between 70-100% SpO2
Average number of heart beats for the
%SpO2calculation:
8 beats
Range of measurement of cardiac pulse:
20 –300 BPM (with 1 BPM increments)
Cardiac pulse relolution
1 BPM
Accuracy of cardiac pulse:
2 BPM or 2% whichever is greater
Average interval for the calculation of
cardiac pulse:
8 seconds
Signal quality indication:
0 - 8 segments on display
Acoustic signals:
“Beep” with frequency of the cardiac pulse
Continuous beep in the case of either %SpO2or cardiac pulse going outside of the
programmed levels of alarm
Continuous beep during oximetry measurement in the case of a low battery level.
If the patient‟s finger is not inserted correctly or the connecter is not properly attached
there will be an intermittent beeping sound for 10 seconds