Medical International Research spirobank G User manual
spirobank G User Manual cod. 980026 Rev 2.0 Page 1 of 46
spirobank G
User Manual
User Manual Rev. 2.0
Issued on: 15/06/2009
Approved on: 15/06/2009
spirobank G User Manual cod. 980026 Rev 2.0 Page 2 of 46
Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
The original packaging contains the device with the followings accessories:
Accessories market with spirobank G Code
spirobank G bag 672690
spirobank G device 910575
spirobank G User Manual 980205
USB connection cable 532365
1 x 9V battery mod. 6LR61-PP3 970095
CD winspiroPRO 920100
1 Nose clip 910320
3 Paper mouthpieces*910300
3 disposable turbine sensors*910001
1 Reusable turbine sensor 910002
* accessories for single use only; all other accessories are reusable
Before using your spirobank G …
•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 G to the PC. At the end of the installation,
connect the device to the PC and the hardware will be "recognised" by the PC. The
device can then be used with the winspiroPRO software.
Keep the original packaging!
In the event that your device requires attention then always use the original packaging to
return it to the distributor or manufacturer.
In this case, please follow these guidelines:
•Return the complete device in the original packaging, and
•The transport (plus any customs or taxes) costs must be prepaid.
spirobank G User Manual cod. 980026 Rev 2.0 Page 3 of 46
Manufacturer’s address:
MIR SRL
VIA DEL MAGGIOLINO, 125
00155 ROMA (ITALY)
Tel ++ 39 0622754777
Fax ++ 39 0622754785
Web site: www.spirometry.com
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
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
spirobank G User Manual cod. 980026 Rev 2.0 Page 4 of 46
INDEX
1. INTRODUCTION............................................................................................................6
1.1 Intended Use .........................................................................................................6
1.1.1 User Category ...................................................................................................6
1.1.2 Ability and experience required .........................................................................6
1.1.3 Operating environment......................................................................................6
1.1.4 Who can or must make the installation .............................................................7
1.1.5 Subject effect on the use of the device .............................................................7
1.1.6 Limitations of use - Contraindications ...............................................................7
1.2 Important safety warnings......................................................................................8
1.2.1 Danger of cross-contamination .........................................................................8
1.2.2 Turbine..............................................................................................................8
1.2.3 Mouthpiece........................................................................................................9
1.2.4 Device .............................................................................................................10
1.3 Unforeseen errors ................................................................................................10
1.4 Labels and symbols .............................................................................................11
1.4.1 Identification label ...........................................................................................11
1.4.2 CE mark for medical devices...........................................................................11
1.4.3 Electrical safety symbol...................................................................................12
1.4.4 Warning symbol for the USB port....................................................................12
1.4.5 Warning symbol for the WEEE........................................................................12
1.4.6 FCC Warnings.................................................................................................12
1.4.7 Product description .........................................................................................13
1.5 Technical specifications .......................................................................................15
1.5.1 Features of the spirometer ..............................................................................15
1.5.2 Other features .................................................................................................16
2. FUNCTIONING OF THE spirobank G ..........................................................................17
2.1 Keyboard .............................................................................................................17
2.2 Battery Level........................................................................................................19
2.3 Information...........................................................................................................19
2.4 Service menu.......................................................................................................20
2.4.1 Turbine Calibration..........................................................................................23
2.5 Subject Data ........................................................................................................25
2.6 Displaying data from memory ..............................................................................26
2.7 Online operating mode (connected to a PC)........................................................28
2.8 Spirometry Testing...............................................................................................28
2.8.1 FVC Test.........................................................................................................30
2.8.2 VC Test ...........................................................................................................31
2.8.3 MVV Test ........................................................................................................31
2.8.4 Reading messages .........................................................................................31
2.8.5 Spirometry test interpretation ..........................................................................31
2.8.6 Viewing the spirometric parameters ................................................................33
2.8.7 POST test, after administration of drug ...........................................................34
3DATA TRANSMISSION...................................................................................................35
3.1 Data Transmission via Bluetooth for printing .......................................................35
3.2 Connection to a PC through USB port or via Bluetooth .......................................35
3.3 Upgrade Internal software....................................................................................36
spirobank G User Manual cod. 980026 Rev 2.0 Page 5 of 46
4MAINTENANCE...............................................................................................................36
4.1 Cleaning and controlling the reusable turbine......................................................36
4.2 Changing the Batteries ........................................................................................38
5PROBLEM SOLVING ......................................................................................................38
5.1 Causes and Solutions ..........................................................................................39
LIMITED WARRANTY CONDITIONS.....................................................................................41
ANNEX 1 SPIROMETRY TEST REPORT EXAMPLES ..................................................42
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC
ENVIRONMENT .....................................................................................................................43
spirobank G User Manual cod. 980026 Rev 2.0 Page 6 of 46
1. INTRODUCTION
1.1 Intended Use
Indications for Use: The Spirobank G spirometer 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; it can be used in any setting.
1.1.1 User Category
The spirobank G spirometer 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.
1.1.3 Operating environment
spirobank G 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 monitoring of physical conditions. All information
necessary for the proper use of the device in electromagnetic environments (as required by
the EN 60601-1-2 Standard) is available from the manufacturer.
Used at home, at work, at school or during sports, day by day the device records data and
functional respiratory parameters for a period of weeks or months, assisting the patient in
making a better assessment of his own health.
The procedures for using the device at home are described according to the type of test to be
made; the display will show all instructions (messages, suggestions etc.) step-by-step, which
allows the subject to correctly perform tests and obtain correct results, to be analysed by the
doctor.
spirobank G User Manual cod. 980026 Rev 2.0 Page 7 of 46
The instrument is not intended for use in an operating theatre nor in the presence of
inflammable liquids or detergents, nor in the presence of inflammable anaesthetic gases
(oxygen or nitrogen).
The instrument is not designed to be used in direct air currents (e.g. wind), sources of heat or
cold, direct sun rays or other sources of light or energy, dust, sand or any other chemical
substances.
The user and/or the doctor are responsible for ensuring that the device is stored and used in
appropriate environmental conditions; in this regard reference is made to the specifics
described in paragraph 1.6.3 below.
WARNING
If the device is exposed to unsuitable environmental conditions, this could cause
the device to malfunction and to give incorrect results.
1.1.4 Who can or must make the installation
The device requires installation by qualified personnel. Normally the doctor configures the
instrument before giving it to the patient for use at home.
1.1.5 Subject effect on the use of the device
A spirometry test should only be carried out when the subject is at rest and in good health, and
thus in suitable testing conditions. A spirometry test requires the collaboration of the subject
since the subject must make a complete forced expiration, in order to have a meaningful test
result.
1.1.6 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct
diagnosis of the subject’s clinical condition. A detailed clinical history of the subject is also
required together with the results of any other test(s) suggested by a doctor.
Test comments, a test interpretation and suggested courses of treatment must be given by a
doctor.
Any symptoms that the subject has at the time of the test must be carefully considered before
a spirometry test is made. The user is responsible to assess both the mental and the physical
capacity of the subject in order to make a correct test, and the user, in the evaluation of test
results, must also assess the degree of collaboration of each test carried out.
A spirometry test requires the full collaboration of the subject. The results depend on the
person’s capability to inspire and to expire all air completely and as fast as possible. If these
fundamental conditions are not respected then the results obtained during spirometry testing
will not be considered accurate, and therefore the test results are “not acceptable”.
The acceptability of a test is the responsibility of the user. Special attention should be given
to testing elderly subjects, children and handicapped people.
The device should never be used when it is possible or probable that the validity of the results
may be compromised due to any such external factors.
spirobank G User Manual cod. 980026 Rev 2.0 Page 8 of 46
1.2 Important safety warnings
spirobank G 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 G 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 or other accessories may cause
errors in measurement and/or compromise the correct functioning of the device,
and is therefore not permitted.
The device should not be used beyond the declared life span. The life span is
strictly related to the life of the internal lithium backup battery (CR2032) and in
normal conditions this should be around 10 years. The device constantly monitors
the state of charge of this battery and a message informs the user when the battery
is discharged. Contact Technical Service to have this battery changed.
In the event of any incident or accident of any kind resulting from the use of the
device, the user is required to inform the manufacturer without delay, this
procedure is laid down in Article.9 of the European Regulations No. 46/1997, which
implemented the EC Directive No. 93/42.
1.2.1 Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable and one is
single-patient disposable. A disposable mouthpiece is required in order to connect a subject
to the spirometer. In order to avoid exposing the subject to the critical danger of cross-
contamination, the reusable flow sensor must always be cleaned before each spirometry test,
and a new disposable mouthpiece must always be used for each subject. The use of an anti-
bacterial filter is at the discretion of the doctor. If a single-patient disposable turbine is used,
then a new one must be used for each patient.
1.2.2 Turbine
WARNING
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Disposable
turbine
If you are going to perform the spirometry test with a disposable
turbine it is important to use a new turbine for each new patient.
The characteristics, accuracy and the hygiene of the disposable
turbine can only be guaranteed if it has been conserved beforehand
in its original sealed packaging.
The disposable turbine is made of plastic and its disposal after use
should adhere to the local regulations and norms in force.
Reusable
turbine
The correct functioning of the re-usable turbine can only be
guaranteed if it has been cleaned in the correct manner and is free
from foreign bodies which could alter its movement. If the turbine
has not been cleaned sufficiently this could cause cross-
contamination from one patient to another. Periodic cleaning
should only be done when the instrument is for personal use and
will only be used by one patient. The cleaning of the turbine should
be performed according to the instructions contained in the User’s
Manual.
The following information applies to both turbine models.
The turbine must never be held under a jet of water or air and must never come into contact
with high temperature fluids.
Do not allow dust or foreign bodies to enter the turbine sensor, in order to avoid incorrect
functioning and possible damage. The presence of any impurities such as hair, sputum,
threads etc. within the body of the turbine sensor may seriously compromise the accuracy of
the measurements.
1.2.3 Mouthpiece
Any disposable mouthpieces included with the device are supplied only as a guide to the
correct type and dimensions of the mouthpiece required for this device, they are clean but not
sterile. To purchase appropriate mouthpieces, generally either paper or plastic, but in any
case single use/disposable, we suggest that you contact your local distributor who supplied
the spirometer.
WARNING
Use a bio-compatible mouthpiece to avoid any problems to the patient; unsuitable
materials could cause a bad functioning of the instrument, and therefore the test
results could be incorrect.
The user is responsible for obtaining the correct type of mouthpieces for the device. Those
required are a standard type with an outside diameter of 30 mm, they are commonly used and
in general easily procured.
To avoid environmental contamination caused by the disposal of used
mouthpieces, the user must follow all the relevant local regulations.
spirobank G User Manual cod. 980026 Rev 2.0 Page 10 of 46
1.2.4 Device
WARNING
The maintenance operations detailed in this manual must be fully and accurately
carried out. If these instructions are not followed this can cause measurement
errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfiguration must be made by the
manufacturer or by personnel authorised by the manufacturer. Never attempt to
make a repair oneself. The set-up of configurable parameters should only be made
by qualified personnel. However, an incorrect set-up of the parameters does not put
the patient at risk.
High-frequency emissions from “electronic” devices may interfere with the correct
operation of the instrument. For this reason, certain minimum clearances (a few
metres) should be observed when high-frequency appliances such as a TV, radio,
portable phone, etc. and other electronic units are operated at the same time in the
same room.
The instrument may give inaccurate readings if operated in the presence of strong
electromagnetic sources, such as electrosurgical equipment, or in the presence of
computed tomography (CT) equipment.
If the PC and/or the printer connected to spirobank G 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 G, 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 it is not used for a long period (several
months).
The instrument may be powered through a PC by a USB cable. By this means, the
device works both on line with the PC, or individually powered by the PC.
Keep the device out of reach of children and of any person with mental handicap.
1.3 Unforeseen errors
In case device internal memory data are damaged, when the device is switched on, the
following message appears: Error on RAM memory
Recovery data
Please wait
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If data have been successfully recovered, the device completes the standard switch on
process, otherwise please contact an authorised technical assistance point or the
manufacturer.
In the case of a problem with the device, a message indicating the nature of the problem will
appear on the screen, together with a warning “beep”.
Operation of the device beyond its declared life (see § 1.6 Technical Specifications) could
provoke a loss of data in the memory of the device (SRAM memory).
Errors in measurement or in interpretation can also be caused by:
•use by non-qualified or non-trained personnel, lacking ability or experience
•user error
•use of the instrument outside the guidelines described in this User 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
•CE mark in compliance with the Directive 93/42 EEC.
•Electrical safety symbol
•Warning symbol for the WEEE
•prescription use label
•indication about FCC
1.4.2 CE mark for medical devices
0476
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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 USB port
For connection to other devices such as PC.
Use only the serial cable supplied by the manufacturer and observe the safety regulations of
IEC 60601-1-1.
1.4.5 Warning symbol for the 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.
1.4.6 FCC Warnings
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.
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:
spirobank G User Manual cod. 980026 Rev 2.0 Page 13 of 46
•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 help.
CAUTION
Exposure to Radio Frequency Radiation
This device must not be co-located or operating in
conjunction with any other antenna or transmitter.
Labels and symbols are displayed on the device like shown in the
following images:
1.4.7 Product description
spirobank G is a pocket spirometer. 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: USB, Bluetooth.
spirobank G is specifically designed to measure a range of respiratory parameters. 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.
spirobank G 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 G User Manual cod. 980026 Rev 2.0 Page 14 of 46
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 G 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).
The connection to the PC is made through the USB port or the Bluetooth.
spirobank G gives an automatic interpretation of each spirometry test carried out, and assigns
a “traffic light” feedback (green, yellow or red) for a rapid reading of the interpretation.
spirobank G is able to make FVC, VC, MVV and breathing profile tests, and calculates an
index of test acceptability (quality control) plus the reproducibility of the spirometry tests
spirobank G User Manual cod. 980026 Rev 2.0 Page 15 of 46
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.
The device has two batteries:
•Main power: 9V battery (1 battery is 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 follows:
1.5.1 Features of the spirometer
Measured parameters:
SYMBOL DESCRIPTION Units
*FVC Best FVC L
*FEV1 Best FEV1 L
*PEF Best PEF L/s
FVC Forced Vital Capacity L
FEV1 Volume expired in the 1s
t
second of the test L
FEV1/FVC FEV1/FVC x 100 %
FEV1/VC FEV1 / best between EVC and IVC x 100 %
PEF Peak expiratory flow L/s
FEF2575 Average flow between 25% and 75% of the FVC L/s
FEF25 Forced Expiratory Flow at 25% of FVC L/s
FEF50 Forced Expiratory Flow at 50% of FVC L/s
FEF75 Forced Expiratory Flow at 75% of FVC L/s
FEV3 Volume expired in the initial 3 seconds of the test L
FEV3/FVC FEV3/FVC x 100 %
FEV6 Volume expired in the initial 6 seconds of the test L
FEV6% FEV1/FEV6 x 100 %
FET Forced expiratory time s
EVol Extrapolated volume mL
FIVC Forced inspiratory volume L
FIV1 Volume inspired in the 1s
t
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
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ERV Expiratory reserve volume L
TV Tidal volume L
VE Ventilation per minute, at rest L/min
RR Respiratory frequency Breath/min
tIAverage time of inspiration, at rest s
tEAverage time of expiration, at rest s
TV/tIAverage 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 senso
r
semiconductor (0-45°C)
Measurement principle Infrared interruption
V
olume 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 Other features
Memory
Memory capacity for over 6000 spirometric
tests
The precise number depends on the
individual configuration, so it cannot be
determined more closely
Display grafic LCD type SFTN,128x48 Pixel
Keyboard Membrane keyboard with 5 keys
Interface USB, Bluetooth
Duration of the CR2032 3V lithium battery
(memory backup) Circa 10 years, under normal conditions of
use
Power supply 1 battery 9V DC (type PP3), or through USB
connection
Dimensions 162x49x34 mm
Weight 160 grams (including battery)
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
nitrogen Device not suitable
Conditions of use Device for continuous use
Storage conditions Temperature: MIN -20 °C, MAX + 60 °C
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Humidity :MIN 10% RH; MAX 95%RH
Operating conditions Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Applied norms Electrical Safety Standard IEC 60601-1
Electro Magnetic Compatibility IEC 60601-1-
2
2. FUNCTIONING OF THE SPIROBANK G
2.1 Keyboard
The spirobank G keyboard is composed of 5 keys:
Key functions are as followed:
1 Off
2
esc/ok previous page
OSD key
3 Scroll left
OSD key
4 Scroll up
OSD key
5
On/Scroll down
OSD key
Switching on spirobank G
To switch on spirobank G press and then release.
Switching off spirobank G
To switch off spirobank G press for at least two seconds.
CONFIRM: to confirm and pass to the next phase, use or
Symbols and Icons
The icons used in the various function screens and their meanings are shown in the following
table:
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ICON DESCRIPTION
To access the set up (Service Menu) of spirobank G
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 data of the current subject
To carry out a spirometry test
To access to the previous tests
To access to transmission data area
To search for tests made
Visualize tests for current subject
To view best test of the current subject
To view the second best test of the current subject
To view the third best test of the current subject
To search test by subject ID code
To search test from date and onwards (partial memory)
To scroll through files on memory
To select male patient
To select female patient
To carry out an FVC test
To carry out a VC or MVV test
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To carry out a VC test
To carry out an MVV test
To display previous tests in memory
To display next test in memory
Visualize data for a test in archive
To print data in memory (through Bluetooth connection)
To transfer data through a Bluetooth connection
To exit from the selected screen and return to the main screen
WARNING
IF no key is pressed the instrument after 1 minute will ‘beep’ and if no key is
pressed after a further 10 seconds it will automatically switch off. If spirobank G 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.
2.2 Battery Level
The symbol
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 G by pressing . The display
will show:
spirobank G User Manual cod. 980026 Rev 2.0 Page 20 of 46
•Version 1.0 (version of firmware ie internal software)
•Power source (USB or battery symbol)
•BTPS (Body Temperature Pressure Saturated)
•Current date and time
•icon (Access to the Service Menu)
•icon (Return to the main screen)
Press to go to the second screen.
The second screen will show:
•ATS/ERS Standard
•Subjects in memory (no. of registered
patients)
•Spiro (no. of spirometry tests made)
•Available memory (% value of free memory)
If there is no information or test data in memory, i.e. the memory is empty, then all data is
shown as 0 (null).
WARNING
When the free memory is not sufficient to create a new record, the device shows the
following message:
Archive full
It is not possible to create new patients until the archive is cancelled (see
paragraph 2.4); download the test archive to the PC before proceeding.
2.4 Service menu
Switch on spirobank G by pressing and holding . Press to access the service menu.
The “Service Menu” screen contains the following fields:
•Select Language (English default)
•Turbine Calibration
•Select Predicted
•Delete Test Data
•Change Date/Time
•Date Format
•Units Format
•Select Turbine
•Select Standard
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