spirobank II

User Manual

User Manual Rev. 3.3

Issued on: 19/12/2008

Approved on: 19/12/2008

spirobank II User Manual cod. 980200 Rev 3.3 Page 1 of 64

Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH

The original packaging contains one of the following spirometers, complete with its standard
accessories:

PRODUCT WITHOUT OXIMETRY PRODUCT WITH OXIMETRY

FUNCTION FUNCTION
Accessories market with Accessories market with
CODE CODE
spirobank II spirobank II
spirobank II bag 672690 spirobank II bag 672690
spirobank II device with oximetry
spirobank II device 910575 910570
function
spirobank II User Manual 980205 1 Oximeter sensor 919010
USB connection cable 532365 spirobank II User Manual 980205
4 x 1.5V AAA batteries 970080 USB connection cable 532365
CD winspiroPRO 920100 4 x 1.5V AAA batteries 970080
1 Nose clip 910320 CD winspiroPRO 920100
4 Paper mouthpieces* 910300 1 Nose clip 910320
3 disposable turbine sensors* 910001 4 Paper mouthpieces* 910300
1 Reusable turbine sensor 910002 3 disposable turbine sensors* 910001
1 Reusable turbine sensor 910002

OPTION CODE OPTION CODE

RS232 connection cable 532367 RS232 connection cable 532367
wrap finger sensor for oximetry 919001
over a long period*

* accessories for single use only; all other accessories are reusable

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.

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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: [email protected]

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: [email protected]. 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.
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 ..................................................................... 9
1.2.2 Turbine ........................................................................................................ 9
1.2.3 Mouthpiece .................................................................................................. 9
1.2.4 Oximetry sensor ......................................................................................... 10
1.2.5 Device ....................................................................................................... 11
1.3 Unforeseen errors ........................................................................................... 12
1.4 Labels and symbols ........................................................................................ 13
1.4.1 Identification label ...................................................................................... 13
1.4.2 CE mark for medical devices ...................................................................... 13
1.4.3 Electrical safety symbol .............................................................................. 13
1.4.4 Warning symbol for the RS232 serial port ................................................... 13
1.4.5 Warning symbol for the USB serial port....................................................... 14
1.4.6 Warning symbol for the SpO2 port for oximetry ........................................... 14
1.4.7 Warning symbol for the WEEE.................................................................... 14
1.4.8 FDA and FCC Warnings ............................................................................. 14
1.4.9 Product description .................................................................................... 15
1.5 Technical specifications .................................................................................. 17
1.5.1 Features of the spirometer.......................................................................... 17
1.5.2 Features of the oximeter ............................................................................. 18
1.5.3 Other features ............................................................................................ 22
2. FUNCTIONING OF THE spirobank II ...................................................................... 23
2.1 Keyboard........................................................................................................ 23
2.2 Battery Level .................................................................................................. 25
2.3 Information ..................................................................................................... 26
2.4 Initial Set-up ................................................................................................... 26
2.4.1 Turbine Calibration ..................................................................................... 29
2.5 Patient Data ................................................................................................... 31
2.6 Displaying data in memory .............................................................................. 33
2.7 Online operating mode (connected to a PC) .................................................... 34
2.8 Spirometry Testing.......................................................................................... 34
2.8.1 FVC Test ................................................................................................... 35
2.8.2 VC Test ..................................................................................................... 36
2.8.3 MVV Test................................................................................................... 36
2.8.4 Reading messages .................................................................................... 36
2.8.5 Spirometry test interpretation ...................................................................... 37
2.8.6 Viewing the spirometric parameters ............................................................ 38
2.8.7 POST test, after administration of drug ....................................................... 38

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 2.9 Oximetry testing.............................................................................................. 39
2.9.1 Walk Test (6MWT) ..................................................................................... 42
2.9.2 Sleep Oximetry .......................................................................................... 44
2.9.3 SPO2 BPM Oximetry Test .......................................................................... 44
2.9.4 SPO2 BPM Test......................................................................................... 45
2.9.5 Adult Single Patient Sensor – Instructions for Use ....................................... 45
3 DATA TRANSMISSION.............................................................................................. 47
3.1 Wireless Data Transmission via Phone Line .................................................... 47
3.2 Data Transmission via Bluetooth to a cell phone .............................................. 48
3.2.1 Preliminary Operations ............................................................................... 48
3.2.2 Setting the Phone Number ......................................................................... 49
3.2.3 Bluetooth Data Transmission ...................................................................... 49
3.3 Data Transmission via Bluetooth for printing .................................................... 49
3.4 Connection to a PC through USB port ............................................................. 50
3.5 Connection to a PC through the RS 232 .......................................................... 51
3.6 Upgrade Internal software ............................................................................... 51
4 MAINTENANCE ......................................................................................................... 51
4.1 Cleaning and controlling the reusable turbine................................................... 52
4.2 Cleaning the oximetry sensor .......................................................................... 53
4.3 Changing the adhesive tape of the wrap sensor ............................................... 53
4.4 Changing the Batteries.................................................................................... 53
5 PROBLEM SOLVING ................................................................................................. 54
5.1 Causes and Solutions ..................................................................................... 54
LIMITED WARRANTY CONDITIONS ................................................................................ 56
ANNEX 1 OXYMETRY TEST REPORT EXAMPLES .................................................. 57
ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES ............................................... 60
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC
ENVIRONMENT ............................................................................................................... 61

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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

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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, 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

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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.

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.

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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
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.
Disposable The disposable turbine is made of plastic and its disposal after use
turbine should adhere to the local regulations and norms in force.

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
Reusable will only be used by one patient. The cleaning of the turbine should
turbine 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.

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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
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.

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 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.

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.

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 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

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:

spirobank II User Manual cod. 980200 Rev 3.3 Page 12 of 64

• 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
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.

spirobank II User Manual cod. 980200 Rev 3.3 Page 13 of 64

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

FEDERAL LAW RESTRICTS THIS

DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
FCC ID:TUK-MIR020

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.

spirobank II User Manual cod. 980200 Rev 3.3 Page 14 of 64

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

spirobank II User Manual cod. 980200 Rev 3.3 Page 15 of 64

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.
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

spirobank II User Manual cod. 980200 Rev 3.3 Page 16 of 64

• 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 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
st
FEV1 Volume expired in the 1 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
spirobank II User Manual cod. 980200 Rev 3.3 Page 17 of 64
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
st
FIV1 Volume inspired in the 1 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
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 events SpO2 fall ≥ 4% in a limited period of 8-40 sec and
Desaturation Event
successive rise ≥ 2% within a total period of 150 sec.
Total Pulse rate Pulse rate rise ≥ 10 BPM in limited period of 8-40 sec and successive

spirobank II User Manual cod. 980200 Rev 3.3 Page 18 of 64

 Variation 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
Maximum pulse frequency during the period of
BPM Max BPM
analysis
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 Fall of SpO2 below 89% for at least 20 seconds
\
<89%
Index of SpO2 fluctuation calculated in intervals of 12
∆ Index [12s] \
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 Bradycardia events during the entire period of analysis
\
BPM
N° Events > 120 Tachycardia events during the entire period of analysis
\
BPM
Desaturation events during the entire period of the
Tot. Desat. Events \
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 %
Average SpO2 fall with respect to baseline during the
Mean Drop ∆SpO2 %
desaturation events
Maximum fall of SpO2 with respect of baseline during
Max Drop ∆SpO2 %
the desaturation events
Variation of pulse frequency events during the entire
N°Pulse Variations \
period of the analysis
Pulse Index Variation of pulse frequency by hour of analysis 1/h
Time passed with SpO2 < 4 % with respect to SpO2
NOD 4% \ hh:mm:ss
base for continual periods above 5 minutes
Time passed with SpO2 < 89 % for continued periods
NOD 89% \ hh:mm:ss
above 5 minutes

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 Time passed with SpO2 < 90 % for continued periods
NOD 90% \ hh:mm:ss
above 5 minutes with minimum value < 86 % (Nadir)
∆=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
Time passed during walking test with SpO2 < 2 %
T∆2 [∆SpO2≥ 2%] hh:mm:ss
with respect to SpO2 base
Time passed during SpO2 walking test < 4 % with
T∆4 [∆SpO2 ≥ 4%] hh:mm:ss
respect to SpO2 base
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
Bradycardia events during the entire period of
N° Events < 40 BPM \
analysis
Tachycardia events during the entire period of
N° Events > 120 BPM \
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
Time for SpO2 value ≥ 99% of the average
Recovery Time base value calculated during the initial phase hh:mm:ss
of the test.
Predicted Predicted standard distance m
Pred. Min Predicted minimum distance m
% in variations of the distance covered with respect
% Predicted Standard %
to predicted standard distance
% of variations of distance covered with respect to
% Pred. Min %
predicted minimum distance
Area under SpO2 curve base relative to distance
AUC/Distance \
covered
Dyspnea Borg CHG Variation in grade of dyspnea during walking \
Fatigue Borg CHG Variations in level of fatigue during walking \

spirobank II User Manual cod. 980200 Rev 3.3 Page 20 of 64

∆=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:

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
Minimum pulse frequency during the period of BPM
BPM Min
analysis
Maximum pulse frequency during the period of BPM
BPM Max
analysis
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 < Fall of SpO2 below 89 % for at least 20 seconds
\
89%
Index of SpO2 fluctuation calculated in intervals of 12
∆ Index [12s] \
seconds
T< 40 BPM Time passed with pulse frequency < 40 BPM % hh:mm:ss

spirobank II User Manual cod. 980200 Rev 3.3 Page 21 of 64

T> 120 BPM Time passed with pulse frequency > 120 BPM % hh:mm:ss
Bradycardia events during the entire period of
N°Events < 40 BPM \
analysis
Tachycardia events during the entire period of
N°Events > 120 BPM \
analysis
∆=DELTA

Measurement method: Red and infrared absorption

Range of measurement %SpO2: 0 – 100% (with 1% increments)
SpO2 Resolution 1%
%SpO2 accuracy: ± 2% between 70-100% SpO2
Average number of heart beats for the
8 beats
%SpO2 calculation:
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
8 seconds
cardiac pulse:
Signal quality indication: 0 - 8 segments on display

Acoustic signals:
• “Beep” with frequency of the cardiac pulse
• Continuous beep in the case of either %SpO2 or 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
• If the test has been interrupted due to low battery power an intermittent beeping will be
heard for 10 seconds when the device is switched on again

The specifications for both the oximetry and for the cardiac pulse are the same regardless of
which of the above mentioned oximetry sensors is used.

1.5.3 Other features

Memory capacity for over 6000 spirometric
tests
Memory The precise number depends on the
individual configuration, so it cannot be
determined more closely
Display STN graphic LCD,128x64 Pixel
Keyboard Membrane keyboard with 6 keys
Interface RS232, USB, Bluetooth
Duration of the CR2032 3V lithium battery Circa 10 years, under normal conditions of
(memory backup) use

spirobank II User Manual cod. 980200 Rev 3.3 Page 22 of 64

 4 x AAA batteries 1.5V DC (type AAA), or
Power supply
through USB connection
Dimensions 60x145x30 mm
Weight 180 grams (including batteries)
Type of electrical protection Class II device
Type of electrical protection BF
Grade of protection against water ingress IPX1 device, protected against water drops
Safety level in the presence of
inflammable anaesthetic gas, oxygen or Device not suitable
nitrogen
Conditions of use Device for continuous use
Temperature: MIN -20 °C, MAX + 60 °C
Storage conditions
Humidity :MIN 10% RH; MAX 95%RH
Temperature: MIN + 10 °C, MAX + 40 °C;
Operating conditions
Humidity: MIN 10% RH; MAX 95%RH
Electrical Safety Standard IEC 60601-1
Applied norms Electro Magnetic Compatibility IEC 60601-1-
2

2. FUNCTIONING OF THE SPIROBANK II

2.1 Keyboard

The spirobank II keyboard is composed of 7 keys:

Key functions are as followed:

1 On/Off
2 ESC esc/ok previous page
3 OK OSD key
Scroll left
4
OSD key
Scroll up
5 − OSD key
Scroll down
6
OSD key
Scroll right
7  OSD key

spirobank II User Manual cod. 980200 Rev 3.3 Page 23 of 64

Switching on spirobank II

To switch on spirobank II press and then release.

Switching off spirobank II

To switch off spirobank II press for at least two seconds.

CONFIRM: to confirm and pass to the next phase, use  or OK

Symbols and Icons

The icons used in the various function screens and their meanings are shown in the following
table:

ICON DESCRIPTION
To access the set up (Service Menu) of spirobank II

To manage or enter new patient data from the main screen

To enter new patient data

To carry out a bronchodilator test

To make the test following the administration of a bronchodilator

To modify patient data

To carry out a spirometry or oximetry test

To access previous tests

To access to transmission data area

To search for tests made

To display oximetry test results of selected subject

To display spirometry test results of selected subject

To search test by subject ID code

To search test from date and onwards (partial memory)

To scroll through files on memory

spirobank II User Manual cod. 980200 Rev 3.3 Page 24 of 64

 To search patient by subject surname

To select male patient

To select female patient

To carry out a sleep oximetry test

To carry out an oximetry test while walking/Go to walking phase during test

To pass to the recovery phase during a walk test

To carry out a FVC spirometry test

To carry out a VC spirometry test

To carry out a MVV spirometry test

To access oximetry tests/To carry out an SpO2/BPM

To display previous tests in memory

To display next test in memory

To print data in memory (through Bluetooth connection)

To transfer data through a Bluetooth connection

To transfer data through acoustic coupling

WARNING
IF no key is pressed the instrument after 1 minute will ‘beep’ and if no key is
pressed after 10 seconds it will automatically switch off. If spirobank II is powered
by a USB connection to a PC, the aforementioned function is disabled and the
device is switched off using .
The instrument can be switched off at any time by pressing and holding the key
for two seconds.

2.2 Battery Level

The symbol

spirobank II User Manual cod. 980200 Rev 3.3 Page 25 of 64

shown in the second screen when the unit is turned on indicates that the battery is charged.
The following symbol indicates Low Battery:

If the battery is discharged the following message appears:

BATTERY DISCHARGED

2.3 Information

Switch on spirobank II by pressing . The display will show:

• spirobank II – 0.1 (device name and software revision number)

• Power means (USB or battery symbol)
• Current date and time
• BTPS (Body Temperature Pressure Saturated)
• icon (Access to the Service Menu)
• SpO2/BPM icon

Press OK to go to the second display. Press ESC to go directly to the main screen.

The second display will show:

• ATS/ERS Standard
• Subjects in memory (no. of registered patients)
• Spiro (no. of spirometry tests made)
• SpO2 (no. of oximetry tests made)
• Available memory (% value).

If there is no information or test data in memory, i.e. the memory is empty, all data is shown
with 0 (null).

2.4 Initial Set-up

Switch on spirobank II by pressing and holding and wait for the second screen. Press

to access the service menu. The following screen “Service Menu” contains the following menu:

• Select Language (English default)

• Turbine Calibration
• Select Predicted Values
• Delete MEMORY
• Change Date/Time
• Date Format
• Units Format
• Turbine Setup

spirobank II User Manual cod. 980200 Rev 3.3 Page 26 of 64

• Standard
• Phone Setup
• Bluetooth Setup
• Firmware Info
• Oximetry alarms
• SpO2 sampling time

Select the required option using
or  and the ► symbol on the left of the screen; press OK
to access options; select the required setup using the
or  arrow, then press OK to return
to the Service Menu.

Select Language
Press OK to access the Menu, use
or  to select the required language and then press
OK to register the change and return to the Service Menu.

Turbine Calibration
Insert the following password to access the calibration function:

−−

For the correct use of this function, please see Paragraph 2.4.1.

Select Predicted Values

Adult Paediatric
Enter Menu with OK, then use
or  to select the ERS Knudson
required value and press OK again to return to the Service Knudson Knudson
Menu. USA Knudson
ERS Zapletal
Delete Memory MC-Barcelona Zapletal
Enter Menu with OK, then enter the password

−−

if the password inserted in correct, the following message appears:

Test data has been cancelled
Change Date/Time
In the date and time setting, the ◄ arrow shown to the right of the field indicates the field to
modify. Use − or
to modify the selected option; use  for the following option. Lastly, press
OK to return to the Service Menu. To return to the Service Menu display without entering any
changes press ESC.

Date Format

spirobank II User Manual cod. 980200 Rev 3.3 Page 27 of 64

Use
or  to select the required format and press OK to enter and return to the Service
Menu.

Units Format
Access with OK and select imperial or metric, as required. Press OK again to return to the
Service Menu.

Turbine Setup
Access with OK and select the required turbine (disposable or reusable). Press OK again to
return to the Service Menu.

Standard
Access with OK and select the required standard using
or . Press OK to return to the
Service Menu.

Phone Setup
Access with OK and then use the horizontal scroll arrow to select phone number (click on
number to insert in connect list). Having set the option, press OK to confirm and to return to
the Service Menu.

Bluetooth Setup
Access with OK to search for available devices, select “Search Device” and then press OK;
spirobank II will start to search for Bluetooth devices in the area; once one or more devices
are found the screen will display profiles, press OK to set the device as printer or phone, select
one of the two options and then press OK. On the “Bluetooth Setup” screen all devices
entered on the “printer list” and on the “phone list” can be checked. A device can be set as
default by accessing the lists with OK and then selecting the device, (to which spirobank II will
automatically connect) or deleted from the list (in this case press OK on the bottom to confirm
the deletion, or press ESC to go back and to not delete the device).

Firmware Info
Access through OK to view information on the revision of the following components, where
available, of spirobank II:
• spirobank II
• Bluetooth
• Display
• Oximetry

After approximately 10 seconds spirobank II automatically displays the Service Menu,

otherwise press ESC.

spirobank II User Manual cod. 980200 Rev 3.3 Page 28 of 64

Oximetry Alarms
This function permits the setting up of reference values for Sp02 and BPM; if, during a test,
these values go below the minimum or above the maximum values in the set up an acoustic
alarm will ring to alert the user.
The cursor at the beginning will rest on the minimum Sp02 value, use the − or
keys to
select the desired value, then pass to the next value by pressing the OK; once the four values
have been set up you can then, if required, activate or disactivate the acoustic alarm by
pressing − or
keys. To confirm the selection press OK, a service menu will then be
displayed.

SpO2 sampling time

Through this function it is possible to define the time that elapses between the values
memorised between one oximetry parameter and the next one; use − o
to select the
desired value (− for 2 seconds,
for 4 seconds), press OK to set the value selected and then
pass to the service menu.

Having set the parameters (from the Service Menu) press ESC to access the second screen,
and then the main screen, as follows:

Which indicates:
• Patient name (A.Martin)
• Date of birth (dd mm yy)
• Height (cm)
• Weight (kg)
• Sex (S)
• Patient ID code
• Function icons

2.4.1 Turbine Calibration

WARNING
The turbine flow sensor does not require calibration but needs only a regular
cleaning. If a calibration must be made then the following guidelines should be
carefully noted.
Calibration can be made only on the reusable turbine.

Calibration of the turbine is performed using a calibration syringe to make an FVC test for the
expired parameters and an FIVC test for the inspired parameters.
To access the calibration function, select the “Turbine Calibration” option from the Service
Menu with the horizontal scroll key and then press OK. The following screen appears:

VOL. 300 BTPS %Corr.

Old FVC 300 0.00

spirobank II User Manual cod. 980200 Rev 3.3 Page 29 of 64

 Old FIVC 300 0.00
New FVC 000 ◄
New FIVC
FVC=0 FACTORY CALIBRATION

The Old FVC and the Old FIVC values now shown are the ones from the last calibration.
The values under the %Corr. column indicate the correction factor. These are pre-set or 0 by
default.

To make the calibration:

1 - Insert the volume in cL of the calibration syringe in use (e.g. for a 3L syringe, insert 300
cL).
2 - Insert both the FVC and FIVC values, obtained by the measurement made with the
calibration syringe, in the New FVC and New FIVC field.

Press  to select the value to be modified (SIRIN, New FVC, New FIVC).
Use − or
to modify the parameter value selected.
Insert both the FVC and the FIVC values. If the calculated correction factors are acceptable
(<10%), they are displayed beside the New FVC and New FIVC parameters. The message
ENTER OK TO CONFIRM will appear.
Press ESC to return to the Service Menu without entering the correction.
If the FVC and FIVC values produce a correction factor that is >10%, the FVC and FIVC
values will not be accepted. This means that the system cannot correct for such a large
calibration error. In this case:
- Check the correct functioning of the spirobank II with a new turbine and/or
- Clean the turbine.
To erase the calibration in use and reset to the factory calibration, input 0 in the New FVC
and New FIVC fields.
Then press OK to return to the Service Menu.

Note
Each time a calibration is made the new correction factors are algebraically added
to the previous correction factor. Therefore, before making a new calibration make
sure to delete the actual calibration in use as described above.
For an accurate and reliable calibration the syringe volume must be at least 3 L.

WARNING
In line with the publication "Standardised Lung Function Testing" of the European
Respiratory Society (Vol 6, Supplement 16, March 1993), the air expired from the
mouth is at a temperature of circa 33/34 °C.
The expired flow and volume, to be converted to BTPS conditions (37 °C) must be
increased by 2.6% - this is derived from the BTPS factor of 1.026 at a temperature of

spirobank II User Manual cod. 980200 Rev 3.3 Page 30 of 64

 33°C, which represents a correction of 2.6%. In practice the BTPS factor for the
expired flow and volumes is therefore constant and equal to 1.026.
For the inspired volumes and flows, the BTPS factor depends upon the ambient
temperature as the air inspired is at ambient temperature.
For instance at an ambient temperature of 20°C with relative humidity at 50%, the
BTPS factor is 1.102, a correction of +10.2%.
The correction of the inspired volumes and flows is made automatically as the
machine has an internal temperature sensor; the BTPS values are thus calculated.
If a 3L syringe is used to make the calibration and if the spirobank II is calibrated
correctly then the FVC (syringe) value will be:
3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
If the ambient temperature is 20°C, the FIVC (syringe) value 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 by the machine is
converted to BTPS conditions, so that the "increase" of the results with respect to
the expected values does not constitute an error.
For instance, if the calibration procedure is carried out with measured data:
FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the resulting
correction factor becomes:
EXPIRATION .00%
INSPIRATION .00%
This does not represent an error, but is a logical consequence of the explanation
detailed above.

2.5 Patient Data

Switch on spirobank II by pressing , or if already switched on, press
( icon); to

access the “PATIENT DATA MANAGEMENT” screen, the following table describes the
functions and displayed icons.

Icon Key Description

To enter new patient data
To make a bronchodilator test (i.e. make a test after drug
− administration with defined dosage; to carry out this test, a pre test is
required)

To modify patient data already on file

 To access memory

To enter new patient data

From the “Patient Data Management” menu press
to access the data input screen.

First screen (name and surname)

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Use
and  to select required letters; confirm or delete using − or
. To input surname
press OK. The letters can also be selected automatically after a few seconds using the
cursor.
Press OK to go to the next screen.

Second screen (date of birth, weight, height, sex)

Use − or
to select date of birth, use  to the right to set month, repeat to set year; continue
setting data by entering patient height, weight and sex using the same  key. The arrow ◄
shown to the right of the field indicates the numerical value that is being changed. After this
operation use OK to go to the following screen; to return to the previous screen press
, or
press ESC to exit set-up mode and go to the main screen.

Third screen (ethnic group)

Setting the correction factor: this value allows to adapt test data according to the patient ethnic
group (the “no correction” option can also be set); press OK to complete the setting of
parameters, the main screen then appears. In the event of an error during the setting of patient
data press
to go back to the previous screen.

WARNING
The ESC/OK is a rocker-type key, i.e. it has two functions in one; press the bottom
to use the enter function (OK); press the top to use ESC.

To interrupt data input press ESC, which then goes back to the main screen.

POST BD Test
Use − to set the spirometry test in “post” mode, i.e. after pharmacological bronchodilation. On
next screen use to select either a POST or PRE test, using respectively − or ESC. Once

entered, the icon will appear on the upper right of the main screen for POST testing of the
subject.
For more information about POST test, please see paragraph 2.7.8.

To access memory
From the “Patient Data Management” screen use  to directly access the screen with the
four memory search methods (§ 2.6).

Modifying patient data

In the “Patient Data Management” menu press
which corresponds to the icon. Modify
data in the following screens by using the keys as described for entering new patient data.
To return to the main screen without changing any data press ESC.

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2.6 Displaying data in memory

From the main screen press
( icon), to check patient data (choose between spirometry
and oximetry) or to search for another patient’s data; the following options are available:

KEY ICON FUNCTION

Display spirometry tests of the selected patient

− Display oximetry tests of the selected patient

 Access data in memory

Press ESC to return to the main screen.

Access the search menu to display data based on four different methods:

KEY ICON FUNCTION

Search by ID Code

− Display files from a date and onwards (partial memory)

Display files from beginning to end (full memory)

 Search by initial letter of surname

Search by ID Code: enter the ID Code of the patient to be searched for; then press OK to
access the data.

Partial Memory: enter test date of required file; after entering the date press OK to access
data. The data will be shown starting from the date entered up to the last file on memory.

Full Memory: to show data in alphabetical order.

The last data are marked by a double beep, then the data shown begin from the first one
recordered.

Search by Surname: enter patient surname, or first initial; then press OK to access the data.

Use
and  to display relevant patient test data.

Press ESC to return to the main screen without searching.

Use − from the data screen ( icon) to print out data through a Bluetooth connection
(automatic); use
to display all test data of relevant file on memory, use
and  to scroll
through data; press OK to go back to the memory screen.
From this screen press OK to make a new test on the subject selected (press OK again),
press ESC to return to the data stored.

spirobank II User Manual cod. 980200 Rev 3.3 Page 33 of 64

2.7 Online operating mode (connected to a PC)

This operating mode is comparable to a laboratory spirometer, connected to a PC the device

operates in real time. Connect the unit to a PC using either the USB cable or the RS 232
serial cable.
spirobank II thus acts as an intelligent sensor for flow and volume measurement while the PC
controls functions, including the switching on and off of the unit.
Connected to a portable PC, spirobank II can carry out epidemiologic studies in work
environments, school settings etc.
As well as the standard spirometric parameters and F/V curves in real time, the instrument
also calculates more refined indices such as the ventilatory profile and the extrapolated
volume (Vext).
The PC software also allows the latest bronchial challenge test protocols, with the graph of
the FEV1 dose-response and time-response curves.

WARNING
If a turbine (disposable or reusable) is setup while using spirobank II, the same will
remain by default the next time the device is used in the remote mode. Attention
must be given in the setting of the turbine.

2.8 Spirometry Testing

To make a correct spirometry test we recommend to follow carefully the following instructions:

• Insert the mouthpiece into the protruding part of the turbine, by at least 0.5 cm;
• Fit the nose clip onto the nose of the subject to ensure that air cannot escape through
the nostrils;
• Hold spirobank II at either end in two hands, or alternatively hold it in one hand as you
would a cell phone. In either case, the display should be facing the user;
• Insert the mouthpiece well into the mouth beyond the teeth, being careful to ensure that
air cannot escape from the sides of the mouth;
• It is suggested to make testing in a standing position and during an expiration to lean
forward, to help the expiratory action with a compression of the abdomen.
WARNING
Do not touch the keys during a test to avoid switching off the machine or stopping
a test too soon.

On the main screen press − corresponding to icon.

Then these icons are shown:

FVC VC MVV SPO2

spirobank II User Manual cod. 980200 Rev 3.3 Page 34 of 64


−

Press the key corresponding to the test required:

FVC Forced Vital Capacity

VC Slow Vital Capacity
MVV Maximum Voluntary Ventilation
SPO 2 Oximetry/Heart beat

The device displays the information regarding the turbine selected in the initial setting
(reusable or single-patient disposable), there follows the necessary information for each
screen in order to correctly carry out a test.
WARNING
A test is archived using the name of last patient visualised. If this refers to a patient
whose data has already been inserted in the past, call up a previous test carried out
on the patient in question and procede as described in the final part of paragraph
2.6.

2.8.1 FVC Test

The phases as described on the screen must be followed, more specifically:

INSPIRE slowly
EXPIRE quickly
INSPIRE slowly

It is possible (and may be helpful) to start the test by breathing at rest for a few moments.
When ready to start inspire slowly as much air as possible (made easier by holding arms wide
apart) and then make a complete expiration as fast as possible. Then with the mouthpiece
always held firmly in the mouth, complete the cycle by inspiring again as quickly as possible.
This final inspiration may be left out if the inspiratory parameters (FIVC, FIV1, FIV1%, PIF) are
not of interest.
The optional initial inspiration phase can also be performed before inserting the mouthpiece in
the mouth.
After inspiring slowly and deeply, the following expiration must be made with the maximum
effort by expiring all air as fast as possible.
After 6 seconds of expiration the instrument will emit a continuous beep, this helps the user to
understand when the minimum expiry time has been reached.

WARNING
For accurate spirometry testing it is indispensable that all of the air contained in the
lungs is expired.

spirobank II User Manual cod. 980200 Rev 3.3 Page 35 of 64

The test may be repeated several times by repeating the cycle without taking the mouthpiece
out of the mouth, in which case spirobank II recognises the best test (FVC+FEV1) and will
automatically show the results of this best test.
To end the test press OK.
During the test spirobank II emits "beeps", the frequency of which is directly proportional to the
inspired and expired air velocity. This is useful to the doctor to understand when the velocity of
the air is approaching zero, and therefore the patient has almost exhausted all of the inspired
or expired volume.
In the maintenance section an explanation is given as to how this feature can also function as
a very simple check system for the correct operation of the mobile “rotor” of the turbine.
For the FVC test to be judged as acceptable, besides breathing as deep as possible, it is also
required that the forced expiratory time (FET) is sufficiently long to allow for the complete
expiration of all air contained in the lungs.

Six seconds from the start of the forced expiratory test, spirobank II emits a continuous beep.
This is useful to the doctor to understand if the patient has reached the minimum expiry time,
as per the requirements of the major international pneumology associations.

2.8.2 VC Test
Ventilatory Profile
The Slow Vital Capacity test can be started by carrying out several complete breaths at rest.
After three or four such breaths a beep will sound to confirm that the ventilatory profile has
been measured and now you can proceed to carry out the VC or IVC test.

Expiratory Slow Vital Capacity: VC

After the beep inspire slowly as much air as possible and then expire slowly as much air as
possible.

Inspiratory Slow Vital Capacity: IVC

After the beep expire slowly as much air as possible and then inspire slowly as much air as
possible.
To end the test press OK.

To correctly carry out this test, follow the indications as described on the display.

2.8.3 MVV Test

Start the test by carrying out a series of forced inspirations and expirations with the
maximum possible amplitude. The suggested frequency is 30 breaths/min.
The test will terminate automatically after 12 seconds.

The disposable mouthpiece and turbine must be changed at the end of each test.

2.8.4 Reading messages

A series of measured parameters, based on international standards of reference, are

spirobank II User Manual cod. 980200 Rev 3.3 Page 36 of 64

shown at the conclusion of the test.
At the end of a test, a series of test messages are displayed followed by the measured
parameters.
There follows first a description of these messages and the parameters, in the order in
which they appear.
If for 6 seconds no key is pressed then the unit moves automatically to the next message
or parameter.

2.8.5 Spirometry test interpretation

Spirometry test interpretation is based on the Forced Vital Capacity (FVC) test and is
indicated both by a message and a traffic light code (green, yellow, red). For each test
made, an arrow on the upper left part of the screen indicates the interpretation of that test.
The connection between the traffic light colour and the test interpretation is shown below:

Through an analysis applied to some of the indices and parameters calculated in the FVC
test, spirobank II produces a variety of quality control comments useful for
understanding the reliability of the test made.
Where several comments related to the single test are calculated, spirobank II will only
show the most important to facilitate the test interpretation.

ERROR IN Vext and PEFT

If the extrapolated volume Vext is greater than 500 mL or greater than 5% of the FVC, or if
the PEFT (time to peak flow) is greater than 300 ms, then the following comment is
shown:
FIRST EXPIRATION TOO SLOW
FLOW DROP 50%
If the flow rate falls and then increases again by over 50% during the first second of a
forced expiry, the following comment is shown:
COUGH DETECTED DURING TEST
FET error
If FET is under the predicted threshold the following message appears:
EXPIRY TIME INSUFFICENT <6s
FLOW ERROR
If the last flow point of the F/V curve is greater than 200 mL/s, this indicates that the

spirobank II User Manual cod. 980200 Rev 3.3 Page 37 of 64

expiration was not complete and thus the following comment is shown:
BLOW OUT ALL AIR IN LUNGS
Between two tests, spirobank II evaluates the repeatability of the following parameters:
PEF repeatable when the difference between the two largest PEF is ≤ 0.67 L/s;
VC repeatable when the difference between the two largest VC is ≤ 150 mL;

If FVC is > 1.0 L then:

FEV1 repeatable when the difference between the two largest FEV1 is ≤ 150 mL;
FVC repeatable when the difference between the two largest FVC is ≤ 150 mL;

if FVC is ≤ 1.0 L then:

FEV1 repeatable when the difference between the two largest FEV1 is ≤ 100 mL;
FVC repeatable when the difference between the two largest FVC is ≤ 100 mL;

2.8.6 Viewing the spirometric parameters

Following an FVC test, the spirometry test results are shown. The first screen displays the
main parameters FVC, FEV1, FE1%, PEF, the percentage of the predicted values, the
Flow/Volume chart plus a traffic light summary of the test interpretation (in the upper left
part), as illustrated below.

The following screens show other values compared to the predicted values.
2.8.7 POST test, after administration of drug

WARNING
To carry out a POST test it is necessary to have carried out at least one PRE FVC
type test on the patient on the same day; it is not possible to do a POST test on the
PRE VC or MVV tests; it is however possible to do a POST VC or MVV test if the
archive already contains at least one PRE test carried out on the same day.

To carry out a POST test please refer to paragraph 2.5.

spirobank II User Manual cod. 980200 Rev 3.3 Page 38 of 64

Before carrying out the test it is necessary to indicate the drug dosage administered in order
to have a reference when controlling the results of the parameters measured.
The results allow the confrontation of the spirometry parameters calculated in the POST test
against the best results obtained in the PRE test already present in the patient archive for that
session* (*session refers to tests carried out on that day). It is not possible therefore to
carryout a POST test on a patient if the patient archive only contains PRE tests carried out
only on previous days. When the results are displayed it is possible to see the variation
between the PRE and POST values (shown in column headed CHG)

To exit the POST session select a new patient from the archive and press OK, the following
message is then shown:

Press OK to make new test on the selected subject

Press OK again.

2.9 Oximetry testing

spirobank II can carry out 4 different types of oximetry tests, which are described in the
following paragraphs.

WARNING
If spirobank II as been purchased without the oximetry option, then only spirometry
tests can be made. If the oximetry option is purchased afterwards, then contact the
service centre or the manufacturer to enable the function.
If during the oximetry testing the SpO2 blood pulse rate goes below the bottom
threshold or goes over the top threshold, spirobank II will ‘beep’ until such situation
persists. This option can be disenabled during sleep tests.
The values shown are set by default by spirobank II.

WARNING
The sensor described below is for illustration purposes only. spirobank II is enabled
for the use of any of the sensors described in the previous Paragraph 1.2.4. MIR
does not recommend the use of a specific type of senor; any decision in regard is
made by the individual doctor.
During the oximetry test spirobank II cannot be switched off, to switch off the device
it is necessary to interrupt the test in progress, this avoids unwanted interruptions
which could compromise the accuracy of the data obtained.

For the non-invasive measurement of the SpO2 oxygen saturation and the blood pulse rate,
utilize the re-usable finger sensor. This sensor is recommended for patients weighing > 20 Kg
with limited activity.

Carry out an oximetry test as follows:

spirobank II User Manual cod. 980200 Rev 3.3 Page 39 of 64

• Connect the sensor to the instrument: insert the connector with the arrow (printed on the
connector) face-up, as shown:

• Choose a high perfusion site, easily adaptable to the sensor.

• Insert finger into the sensor until the finger touches the end of the probe.
Ensure that the bottom part of the finger completely covers the detector. If the finger is not
able to be correctly positioned, use another finger.

• Position the sensor so that the cable is underneath the palm of the hand. This enables the
light source to remain on the fingernail and the detector on the bottom part of the finger.
• From the main screen press − to access the test menu.
• Press  to access oximetry.

If this message appears:

WARNING THE OXIMETRY DEVICE IS NOT AVAILABLE

your instrument does not include an oximeter.

Instead, If this message appears:
WARNING THE OXIMETRY DEVICE IS NOT ENABLED
your instrument includes an oximeter but the function has not been enabled. In this case
contact a service centre or the manufacturer.
WARNING
Before starting the test check to see that the battery is fully charged, if it is low the
following message will be shown:

Batteries are low and may not be sufficient for an oximetry test.

spirobank II User Manual cod. 980200 Rev 3.3 Page 40 of 64

 In this case select ESC to exit the test, by pressing any key you can continue with
the test already set up.
If the test is interrupted, due to low battery charge, the following message will
appear on the display when the device is switched on again:

The last oximetry test was interrupted before being properly completed

A beeping sound will be simultaneously heard for 10 seconds.

After which the device main screen will appear.

Alternatively, the display will show the screen with the oximetry tests that can be performed,
specifically:

ICON KEY DESCRIPTION

Walk test - 6MWT

− Sleep oximetry

 Oximetry (SpO2/BPM)

WARNING
In order not to compromise the reproducibility of the measurements and the
integrity of the sensor, avoid twisting the sensor cable and handle with due care
when using, connecting, disconnecting and when placing the finger into it.

During the first few seconds of the test the device searches for the best signal, after which the
timer re-sets to zero and spirobank II starts to memorise the data.

If the sensor has not been correctly inserted, the following message will appear:
WARNING
Sensor unplugged

Contemporaneously spirobank II emits a beep for 10 seconds.

If the sensor has been inserted but the finger is not inserted correctly, the following message
will appear:
WARNING
FINGER not inserted

Contemporaneously spirobank II emits a beep for 10 seconds.

If the sensor correctly receives the signal, after a few seconds the device starts to ‘beep’ and
the values will be displayed on the screen.
For all oximtery tests alarms can be set up in the case that the critical values are exceeded as
described in paragraph 2.4.

spirobank II User Manual cod. 980200 Rev 3.3 Page 41 of 64

If an alarm is activated then the symbol
is shown on the display during that test.
Alarms can be activated or disactivated
during a test by pressing ; this brings up a
menu showing the preset alarm thresholds.
Press OK to confirm the disactivate or to
activate the alarm function. If OK is NOT
pressed then the device continues the test
without changing the alarm settings.
For further information on the correct set up for this function please refer to paragraph 2.4.

WARNING
A test is archived using the name of last patient visualised. If this refers to a patient
whose data has already been inserted in the past, call up a previous test carried out
on the patient in question and proceed as described in the final part of paragraph
2.6.

WARNING
During all "stand alone" oximetry testing, the remaining battery life is always
shown: the battery symbol is shown on the lower left side of the display, together
with the value of the battery life in hours and minutes.

This information is shown as follows:

2.9.1 Walk Test (6MWT)

To make a walk test press
.
This test is made up of 3 phases:

• Initial rest
• Walking
• Recovery

Initial Rest
In this phase the display will show the following data:

spirobank II User Manual cod. 980200 Rev 3.3 Page 42 of 64

• Test time duration
• Signal quality indication
• Current phase
• SPO2 % value and the instant cardiac pulse (heart symbol)

The duration of the test is minimum 2 minutes, then the screen shows corresponding to
the − key; press this key to pass to the following phase. If the phase lasts for more than 6
minutes then spirobank II will emit a ‘beep’ as a reminder to pass to the following walking
phase.
The number of bars (“I” symbol), on the right upper of the screen is proportional to the quality
of the oximetry signal: the higher the quality of the signal the more bars will be shown
(maximum 7). Place finger into the sensor in order to obtain the highest quality of the signal.

Walking Phase
At the beginning of the phase the timer is reset to zero to give an accurate control of the
duration of each single phase. The data on the display is the same as shown before.
The duration of this phase is minimum 2 minutes, then the icon appears corresponding
to
. Press this key for a few seconds to pass to the initial rest phase. If this phase lasts for
more than 6 minutes then spirobank II will emit a ‘beep’ after which the device passes to the
initial phase and the timer is re-set to zero.

Recovery Phase
The user can decide freely on the duration of this phase, the duration is not suggested (at the
beginning of the phase the time is re-set to zero).
To end test press ESC and then
. This must be done each time the current test is
interrupted.
At the end of the test the data required for the calculation of the parameters must be inserted;
more specifically:

• Baseline DYSPNEA
• Final DYSPNEA
• Baseline FATIGUE
• Final FATIGUE
• Distance (m)

These follow the Borg scale and can have the following values: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, the distance covered is indicated in m.
The Borg scale coefficients represent the following severity values:

SCALE SEVERITY
0 None
0.5 Very Very Slight (Just Noticeable)
1 Very Slight
2 Slight
3 Moderate
spirobank II User Manual cod. 980200 Rev 3.3 Page 43 of 64
 4 Some What Severe
5 Severe
6 “
7 Very Severe
8 “
9 Very Very Severe (Almost Maximum)
10 Maximum

Use − and
to enter data; use OK to pass to next data.

Walk test data results are given in the following 6 screens.
To print data see Paragraph 3.3. The printout version of the test will only show the walk test
results; an example of a test printout report is attached.
Press ESC and then
to end test at any moment.

WARNING
One of the parameters calculated by the spirobank II during an oximetry test is the
so-called Recovery Time. The Recovery Time is defined as the time taken for the
SpO2 value to return to at least 99% of the average base value calculated during the
initial phase of the test.

2.9.2 Sleep Oximetry

To activate this type of test press − ( ). This test records the variations that the
parameters of the patient undergo over night.
After approximately 5 minutes, spirobank II will go on standby i.e., it stops beeping and the
display turns off. The led signal remains on. To control the correct functioning while on
standby, press , after 1 minute spirobank II will return to standby.

If there is no signal while on standby the device will automatically exit this phase and a
warning message will appear (sensor unplugged or finger not detected correctly).
The data shown are the same as described in the preceding test, except for information on
this present phase, which has not been envisaged for this test.
After the required time the test can be interrupted as previously described.
To print data see Paragraph 3.3.; an example of a test printout report is attached.

2.9.3 SPO2 BPM Oximetry Test

To start the test, press  from the oximetry test menu screen.
The display will show “oximeter (SpO2/BPM)”. The test duration is unlimited and the aim is to
record variations of the oximetry values during a period as decided by the doctor.

spirobank II User Manual cod. 980200 Rev 3.3 Page 44 of 64

During the test the display will show the
information shown here. The icons BEEP and
ALARM enable the user to modify the set up:
• BEEP, use
to activate/disactivate the
acoustic heart rate signal
• ALARM, use  to activate/disactivate the
various alarms, as described in paragraph 2.8

As a difference of the sleep oximetry test, the display has not the standby function, and it
always shows test data.
To end test press ESC and then
.
To print data see Paragraph 3.3.; an example of a test printout report is attached.
If the finger is removed from the sensor during the test, the following message will appear
(even if on standby):

WARNING
Searching for signal, finger not inserted correctly

2.9.4 SPO2 BPM Test

This test allows the control of the oxymetric data plus the cardiac pulse of a patient in real
time.
The test can only be accessed when the device is switched on by pressing  corresponding
to on the first screen. To confirm press OK.
During the test use
to activate/disactivate the acoustic beep.
Relative data is memorised according to instructions shown on the screen prior to making the
test (ID#: “1234” and SURNAME: “OXYTEST”). This data is required when searching the
memory for related test data.
Test duration, SpO2 value and heart beat data are shown.
To end test see instructions contained in the previous paragraph.

2.9.5 Adult Single Patient Sensor – Instructions for Use

WARNING
The sensor described below is for illustration purposes only spirobank II is enabled
for the use of any of the sensors described in the previous Paragraph 1.2.4. MIR
does not recommend the use of a specific type of senor; any decision in made by
each individual doctor.

To perform a non-invasive continuous monitoring of arterial oxygen saturation it is

recommended to use the reusable "wrap" sensor. The use of this sensor is indicated for
patients weighing more than 30 Kg and contraindicated for patients with allergy to adhesive
tape.
WARNING

spirobank II User Manual cod. 980200 Rev 3.3 Page 45 of 64

 The materials used for manufacturing the sensor are NATURAL LATEX PROTIEN
free. The materials used for the sensor are subject to biocompatibility tests.

WARNING
This sensor is contraindicated for use on patients who exhibit allergic reactions to
the adhesive tape. Do not reuse. One use on one patient.

• Choose an application site on the patient’s finger or

toe where the light source will be directly over and in-
line with the detector. The preferred sites are the
forefinger or smaller thumb.

• Remove nail polish or artificial fingernails

• Place the patient’s digit in the sensor nail-side up,
lining up the digit’s pad over the detector. The
sensor’s positioning line runs across the mid axis of
the fingertip

• Wrap the bottom adhesive around the digit, being

careful not to cover the nail.

• Fold the sensor’s top over the digit, making sure the
light source is directly over and in-line with the
detector. Wrap the adhesive around the finger or toe
to secure the sensor. Route the cable along the palm
or the bottom of the foot, and secure with adhesive
tape if necessary.

Connect the sensor to the instrument: insert the connector with the arrow on the connector
face-up and control the correct functioning according to the previous instructions.

WARNING

spirobank II User Manual cod. 980200 Rev 3.3 Page 46 of 64

 Do not twist unnecessarily or use excessive force when using, connecting,
disconnecting, or storing the sensor.
An over-tight sensor can produce inaccurate saturation measurements. Therefore
avoid over tightening the adhesive tape.
It is recommended to fasten the cable to the wrist with a bandage.

3 DATA TRANSMISSION
WARNING
Read the instructions carefully before starting the data transmission, taking due
care to ensure that all the information has been properly understood.

3.1 Wireless Data Transmission via Phone Line

This type of data transmission allows for the transfer of all data in the memory of spirobank II.
Through this method the doctor can control the information sent directly from the patient and
assess any changes to the therapy in course from his/her PC.
To transfer the data memorised during various tests to the doctor’s PC, follow this procedure:

• Dial the doctor’s phone number (for example, the doctor’s office, telemedicine services,
or any other structure) directly on the telephone at use.
• Place spirobank II and the phone on a level surface as shown in the figure:

The suitable distance between

spirobank II and the phone receiver is
between 2 and 5 cm

• Place the microphone of the telephone (the microphone is near the cable) near to the
spirobank II as shown in the figure, with the phone receiver (beneath the device’s ID
label). The hole should be close to (2 to 5 cm) the microphone’s hole positioned on the
receiver.

Where necessary the distance between spirobank II and the receiver can be up to 1
metre, depending on the environmental noise, however the closer the receiver is to
the hole of the spirobank II the more reliable will be the data transmission. The
suggested distance for a reliable transmission is a few centimetres.

spirobank II User Manual cod. 980200 Rev 3.3 Page 47 of 64

• From the main screen press  corresponding to the icon.

• Then press
corresponding to the icon.

• A confirmation for the transmission is requested by pressing OK, otherwise it is possible
to exit the programme by pressing ESC.
• spirobank II now emits a series of acoustic signals indicating that the data transmission
has started.
• Wait until spirobank II has completed the transmission (the instrument ceases to emit an
acoustic signal).
• At the end of the transmission the message “TRANSMISSION TERMINATED” will
appear.

At any time during the transmission the process may be terminated by pressing ESC.

During this procedure it is strongly suggested to:

• Eliminate all external noises;

• Do not touch or move spirobank II and the receiver;
• Be sure to have fully understood the procedure before starting the transmission.

WARNING
The data transmission is made through the fixed phone line of which the care and
proper functioning depends on the national phone operators. The manufacturer is
not liable for any eventual disservice or dysfunction caused by either the fixed or
mobile operators.

High frequencies emitted by electronic devices can cause interference with the correct
functioning of the instrument. For this reason a minimum safety distance (a few metres) must
be maintained when in the same room another apparatus or device such as TV, radio,
appliances, cell phones, radio phones etc. are being used.
If the instrument is connected to other devices (PC, printers, modem etc.) to preserve the
characteristics of the safety system pursuant to the IEC 601-1-1 Standards, it is required that
only devices complying with these safety regulations are used.

3.2 Data Transmission via Bluetooth to a cell phone

spirobank II includes a “Bluetooth” wireless data transmission system. This connection is

through radio and allows spirobank II to be connected to a suitable cell phone. The method of
data transmission allows the transferring of all the data in spirobank II.
The sequence of operations to follow is described below.

3.2.1 Preliminary Operations

WARNING

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 The transmission of data through a Bluetooth connection requires the phone
number of the unit where the data shall be transferred (the doctor’s office,
telemedicine service, etc.). To enter the telephone number, see the main menu
when the machine is turned on. (Refer to Paragraph 2.4). A device must also be set
up for the connection; refer to Paragraph 2.4 for further details.

3.2.2 Setting the Phone Number

• Turn on spirobank II by pressing

• On the first screen press

• From the “Service Menu” select the option “phone set up” using − and

• Press OK
• Enter the number by using
and  to select digits, and the OK to confirm the selected
number.
• Return to the Service Menu by pressing OK
• From the “Service Menu” access the main screen by pressing ESC.

3.2.3 Bluetooth Data Transmission

• From the main screen press  corresponding to the icon.

• Press
corresponding to the icon.

• The selected transmission will be shown, to confirm press OK to activate the connection
with the default device set up.
• When required by the cell phone, enter the PIN code shown on the spirobank II display
(corresponding to the serial number (SN) of the machine shown on the spirobank II ID
label).
• The connection phases then follow.
• When the connection is completed the data transfer to the default modem starts.
• The message “transmission completed” appears at the end of the transfer.

The following information is now shown on the display:

• The device used for the connection (as described in the initial settings).
• The telephone number (as described in the initial settings).
• The preset PIN (corresponding to the serial number of the machine).

To interrupt the data transmission during the Bluetooth connection press ESC, to end the
connection and return to the main screen.
Where no device has been setup for data transmission, a message will appear on the display
to start searching for enabled devices. After setting the device the connection will start
automatically.

3.3 Data Transmission via Bluetooth for printing

spirobank II User Manual cod. 980200 Rev 3.3 Page 49 of 64

WARNING
Printing of data from the patient management function is enabled only if the printer
has a Bluetooth connection; alternatively a USB key can be installed on the printer
in order to enable a Bluetooth connection.

The Bluetooth system enables spirobank II to transfer test data directly to a Bluetooth
enabled printer. The sequence of activities to be followed is:

• From the main screen select the test to be printed with .

• On the next screen press − ( icon).
• Print either a spirometry or an oximetry test by selecting respectively
or −.
• By choosing to print spirometry tests, the last test of the patient selected on the main
screen will be shown.
• By selecting oximetry tests, the last test made pertaining to that patient will be printed.

Tests stored on memory can also be printed. Use the search method as described in
Paragraph 2.6 to print out relevant tests.

• On the relevant test screen press
.

• spirobank II will carry out the connection.
• At the end of transmission spirobank II will show “CONNECTION COMPLETED”, and
return automatically to the main screen.

To interrupt the Bluetooth connection during transmission press ESC to return to the main
screen.
Where no printer has been set up, a message will appear to search for devices. After the
device has been set up it will automatically be enabled for printing data.
When searching for enabled for Bluetooth devices, spirobank II will check the address of that
device and where a previously registered device has changed name, it will be automatically
updated.

3.4 Connection to a PC through USB port

WARNING
Before connecting spirobank II by USB to a PC, winspiroPro must be installed to
interface with the device.
It is important prior to initiating the following procedure to know the version of the
operating system installed on the PC used for the connection (from control panel
click on “System”, where the type of operating system installed on the PC can be
checked).
If winspiroPRO is already installed on the PC then a new installation is not required.

spirobank II User Manual cod. 980200 Rev 3.3 Page 50 of 64

 To make the connection, insert the mini USB connector supplied
with spirobank II as shown in the picture and attach the other
connector to the USB port of the PC.
When initially making a connection, the PC will, depending on the
version of the operating system, either make an automatic driver
installation or request some information. To avoid errors in this
phase please read the winspiroPRO User Manual very carefully.
To check the connection between the device and the PC, ensure
that the led on the device is illuminated.

3.5 Connection to a PC through the RS 232

spirobank II can also be connected to a PC through

the RS 232 serial port. This leaves the USB port free
and the device is run directly by the software (as a
USB connection). The picture shows the RS 232
connector attached to spirobank II.
For the correct management of the device see the
online manual of the software.

3.6 Upgrade Internal software

spirobank II software can be upgraded when connected to a PC (USB or RS232). Upgrades
can be downloaded by registering on www.spirometry.com. For further information on
upgrading software see the “winspiroPro” software manual.

4 MAINTENANCE

spirobank II is an instrument that requires very little maintenance. The operations to perform
periodically are:

• Cleaning and controlling of the reusable turbine.

• Changing the disposable turbine before each test.
• Cleaning of the oximetry sensor (for reusable sensors).
• Changing the adhesive tape of the oximetry wrap sensor.
• Changing the battery.

The maintenance operations described in the User’s Manual must be carried out carefully.
Failing to observe the instructions may cause errors in measurement or in the interpretation of
the measured values.
Modifications, adjustments, repairs, and reconfiguration must be carried out by the
manufacturer or by authorised persons.
In case of problems do not attempt to repair the unit.

spirobank II User Manual cod. 980200 Rev 3.3 Page 51 of 64

The setting of configuration parameters must be carried out by qualified personnel. In any
case the risks pertaining to incorrect configuration settings do not constitute a danger for the
patient.

4.1 Cleaning and controlling the reusable turbine

The turbine utilized by spirobank II belongs to one of two categories: disposable and
reusable. These guarantee precise measurements and have the great advantage of requiring
no periodic calibration. In order to maintain the characteristics of the turbine a simple cleaning
is required prior to each use (only for the reusable turbine).
Cleaning of the disposable turbine is not required, as it is supplied clean in a sealed plastic
bag. It must be disposed of after use.

WARNING
It is good practice to control from time to time that dirt or foreign bodied are not
deposited inside the turbine, such as threads or hair. Any such deposits could
brake or block the rotation of the turbine blade and thus compromise the
measurement accuracy.

Verify the free movement of the turbine.

• Switch on spirobank II as if to make a spirometry test (for example FVC)
• Hold spirobank II in one hand and move it gently from side to side so that air passes
through the turbine
• If the rotor within the turbine is turning correctly then you will hear a beep that indicates
that the turbine is moving within the specific low flow range indicated by the beeping
• If moving the turbine from side to side at a constant velocity, the regular beeps or no
beeps at all are heard, then proceed with the cleaning of the turbine.

To clean the reusable turbine, first remove it by pulling it gently from the spirobank II turning
it anti-clockwise and pressing lightly. It can be helpful to push it gently from underneath with
one finger.
Immerse the turbine in a cold detergent solution and move it within the liquid to remove any
impurities which may be deposited inside. Leave it to soak for at least the time recommended
by the producer of the cleaning solution, as shown in the relevant instructions (in general at
least one hour).

To avoid any kind of damage to the reusable turbine please do not use any alcoholic or
oily substances, do not immerge the turbine in hot water or hot solution.
Do not put the turbine under a direct jet of water or other liquid. If no detergent solution
is available, clean the turbine in clean water.
MIR suggest the use of Perasafe, manufactured by Dupont, which has been tested with
positive results on all MIR sensors.

Rinse the turbine by immerging it in clean water (not hot).

Shake off the excess water from the turbine and leave it to dry, standing it vertically on a dry
spirobank II User Manual cod. 980200 Rev 3.3 Page 52 of 64
surface.

Once the turbine has been cleaned insert the turbine tube in its place following the
instructions indicated by the closed lock symbol printed on the plastic casing of the spirobank
II.
To insert the turbine correctly push it and then turn it clockwise until it reaching the stop,
which ensures that the tube has been blocked inside the casing.

To ensure the turbine is functioning correctly repeat the controls described above; if it doesn’t
works correctly, replace with an other one.

If the disposable turbine is used do not clean it but change it after each test.

4.2 Cleaning the oximetry sensor

Clean the sensor with a soft cloth moistened with water or a mild soap solution. To disinfect
the sensor, rub with isopropylic alcohol. Allow the sensor to dry completely after cleaning.

WARNING
Do not sterilize by irradiation, steam, or, ethylene oxide. Do not immerse in liquids.
Before cleaning or disinfecting the sensor, unplug it from the monitor.

4.3 Changing the adhesive tape of the wrap sensor

The adhesive tape is made with latex-free material.

• Gently remove the used adhesive tape from the sensor and dispose of it.
• The back of the sensor has alignment pins. Place the sensor with the alignment pins
facing the adhesive part of the tape and align the pins to the holes on the tape.
• Push the sensor so as to insert the pins into the holes of the tape. Lift both the sensor
and the tape and check that the pins of the sensor are correctly aligned.

It is suggested to use a new piece of adhesive tape for each sensor for each patient,
or as required.

4.4 Changing the Batteries

If the message "BATTERY DISCHARGED" appears on spirobank II display, or if the

instrument does not switch on, the batteries inside the compartment shown here under must
be changed as per the following points:

• Remove the back cover by pressing and pushing it away from the device.
• Remove the discharged batteries.
• Replace with new batteries, inserting them properly into the slots.

spirobank II User Manual cod. 980200 Rev 3.3 Page 53 of 64

• Close the battery compartment by replacing the back cover and sliding it towards the inside
of the device.

WARNING
Use only 1.5 V type AAA batteries or equivalent. When inserting the batteries in the
battery slot, take care to correctly connect the “+” and “-” as shown inside (see
figure below).

The device has an internal lithium battery for RAM memory; the average life is approximately
10 years. If the display shows the following message:

Warning change lithium battery

Call a service centre or the manufacturer for replacement.

5 PROBLEM SOLVING

There follows a list of problems that may arise when working with spirobank II. Diagnostic
messages are also shown on the display indicating the type of malfunction:

5.1 Causes and Solutions

• spirobank II does not switch on

Check that batteries are correctly inserted in the compartment on the back of the
instrument. If they are correctly positioned then replace them with new ones.
• During operation the machine switches itself off and on again
Change the batteries.
• At the end of spirometry testing the test data is incorrect
Clean the turbine and then control it; use a new turbine.
• All data in memory lost due to an unforeseeable event
All data in memory has been deleted. Contact the technical service centre.

WARNING
Before contacting the centre for technical assistance, please download the archive
from the device on to the PC using the Winspiro PRO software. This procedure is
necessary as the data could be lost whilst repairing the device and could also be of
a confidential nature and therefore subject to laws on data privacy.

spirobank II User Manual cod. 980200 Rev 3.3 Page 54 of 64

 srl MEDICAL INTERNATIONAL RESEARCH
Via del Maggiolino 125, 00155 Roma - ITALY

Declaration of CE Conformity

Quality Management System according to the requirements of Annex II of the Medical Device
Directive 93/42/EEC implemented by the Legislative Decree 46 dated 24/02/97

Notified Body CERMET No. 0476 - Certificate No. MED – 9826

MIR srl Medical International Research, declares that the Device subject of this
declaration together with its standard accessories conforms to the requirements of the
Council Directive 93/42/EEC Annex I.

Device Description Spirometer/Oximeter

Device Name spirobank II
Classification IIa
This Device is marked

Any modifications to the Device which are not authorised by MIR will invalidate this
Declaration

Rome 01 / 01/ 2006

Simon Fowler Carmine Cerullo
Sales Manager Quality Manager

Rev.0 – Mod. PO-10DDC_spirobank II

spirobank II User Manual cod. 980200 Rev 3.3 Page 55 of 64

LIMITED WARRANTY CONDITIONS

spirobank II, together with its standard accessories is guaranteed for a period of:
• 12 months if intended for professional use (doctors, hospitals, etc.)
• 24 months if the product has been purchased directly by the end user.
The warranty is effective from the date of purchase shown on the relevant sales invoice or
proof of purchase.

The warranty is effective from date of sale which must be shown on the relevant sales invoice
or proof of purchase.

The instrument must be checked at the time of purchase, or upon delivery, and any claims
must be made immediately in writing to the manufacturer.

This warranty covers the repair or the replacement (at the discretion of the manufacturer) of
the product or of the defective parts without charge for the parts or for the labour.

All batteries and other consumable parts are specifically excluded from the terms of this
guarantee.

This warranty is not valid, at the discretion of the manufacturer, in the following cases:

• If the fault is due to an improper installation or operation of the machine, or if the

installation does not conform to the current safety norms in the country of installation.
• If the product is utilised differently from the use described in the User’s Manual.
• If any alteration, adjustment, modification or repair has been carried out by personnel not
authorised by the manufacturer.
• If the fault is caused by lack of or incorrect routine maintenance of the machine.
• If the machine has been dropped, damaged or subjected to physical or electrical stress.
• If the fault is caused by the mains, or by a product to which the instrument has been
connected.
• If the serial number of the instrument is missing, tampered with and/or not clearly legible.

The repair or replacement described in this warranty is supplied for goods returned at the
customers’ expense to our certified service centres. For details of these centres please
contact your local supplier of the spirometer or contact the manufacturer directly.

The customer is responsible for the transportation and for all transport and customs charges
as well as for delivery charges of the goods both to and from the service centre.

Any instrument or accessory returned must be accompanied by a clear and detailed

explanation of the defect or problem found. If units are to be returned to the manufacturer then
written or verbal permission must be received before any instruments are returned to MIR.

MIR – Medical International Research reserves the right to modify the instrument if required,
and a description of any modification made will be sent along with the returned goods.

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ANNEX 1 OXYMETRY TEST REPORT EXAMPLES

spirobank II User Manual cod. 980200 Rev 3.3 Page 57 of 64

spirobank II User Manual cod. 980200 Rev 3.3 Page 58 of 64
spirobank II User Manual cod. 980200 Rev 3.3 Page 59 of 64
ANNEX 2 SPIROMETRY TEST REPORT EXAMPLES

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ANNEX 3 INFORMATION FOR CORRECT USE IN AN
ELECTROMAGNETIC ENVIRONMENT
Guidance and manufacturer’s declaration – electromagnetic emissions

The spirobank II is intended for use in the electromagnetic environment specified below.
The customer or the user of the Spirobank II should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The spirobank II uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
RF emissions Class B
CISPR 11
Harmonic emissions Not applicable
IEC 61000-3-2
Voltage fluctuations/ Not applicable
flicker emissions

IEC 61000-3-3

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 Guidance and manufacturer’s declaration – electromagnetic immunity

The spirobank II is intended for use in the electromagnetic environment specified below. The customer
or the user of the spirobank II should assure that it is used in such an environment.
Immunity test IEC 60601 Compliance level Electromagnetic environment –
test level guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic
discharge (ESD) tile. If floors are covered with synthetic
±8 kV air ±8 kV air material, the relative humidity should be at
IEC 61000-4-2 least 30 %.
Electrical fast ±1 kV for input/output Mains power quality should be that of a
transient/burst lines typical commercial or hospital environment.

IEC 61000-4-4
Surge ±1 kV differential Not Applicable Mains power quality should be that of a
mode typical commercial or hospital environment.
IEC 61000-4-5
±2 kV common mode
Voltage dips, <5 % UT Not Applicable
short (>95 % dip in UT)
interruptions and for 0,5 cycle
voltage
variations 40 % UT
on power supply (60 % dip in UT)
input lines for 5 cycles

IEC 61000-4-11 70 % UT
(30 % dip in UT)
for 25 cycles

<5 % UT
(>95 % dip in UT)
for 5 sec
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location
magnetic field in a typical commercial or hospital
environment.
IEC 61000-4-8
Portable and mobile RF communications
equipment should be used no closer to any
part of the spirobank II, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance

d=[ 3.5 ] √P
3

d=[ 3.5 ] √P 80 MHz to 800 GHz

Conducted RF 3 Vrms [3 ] V 3

IEC 61000-4-6 150 kHz to 80 MHz d=[ 7 ] √P 800 MHz to 2,5 GHz
3

Radiated RF 3 V/m [3 ] V/m where P is the maximum output power

rating of the transmitter in watts (W)
IEC 61000-4-3 80 MHz to 2,5 GHz according to the transmitter manufacturer
and d is the recommended separation

spirobank II User Manual cod. 980200 Rev 3.3 Page 62 of 64

 distance in metres (m).

Field strengths from fixed RF transmitters,

as determined by an electromagnetic site
survey, should be less than the compliance
level in each frequency range.

Interference may occur in the vicinity of

equipment marked with the following
symbol:

NOTE UT is the a.c. mains voltage prior to application of the test level.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the spirobank II is used exceeds the
applicable RF compliance level above, the spirobank II should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank
II.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.

spirobank II User Manual cod. 980200 Rev 3.3 Page 63 of 64

 Recommended separation distances between
portable and mobile RF communications equipment and the spirobank II

The spirobank II is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the spirobank II can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the spirobank II as
recommended below, according to the maximum output power of the communications equipment.

Separation distance according to frequency of transmitter

m
Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
output
power of transmitter
d=[ 3.5 ] √P d=[ 3.5 ] √P d=[ 7 ] √P
W 3 3 3
0.01 0.12 0.24 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 5.28 5.28 1.056
100 11.66 11.66 23.32

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres
(m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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