MIR Medical Research MIR024 spirometer device User Manual SBGUSB ENG REV 2 0 ETS

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spirobank G
User Manual
User Manual Rev. 2.0
Issued on:
Approved on:
spirobank G
15/06/2009
15/06/2009
User Manual cod. 980026
Rev 2.0
Page 1 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
spirobank G bag
spirobank G device
spirobank G User Manual
USB connection cable
1 x 9V battery mod. 6LR61-PP3
CD winspiroPRO
1 Nose clip
3 Paper mouthpieces*
3 disposable turbine sensors*
1 Reusable turbine sensor
Code
672690
910575
980205
532365
970095
920100
910320
910300
910001
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 2 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
Email: mir@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
regarding this product should be sent via email to: mir@spirometry.com. 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
spirobank G
User Manual cod. 980026
Rev 2.0
Page 3 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
3 DATA 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
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User Manual cod. 980026
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Page 4 of 46
4
MAINTENANCE ...............................................................................................................36
4.1
Cleaning and controlling the reusable turbine ......................................................36
4.2
Changing the Batteries ........................................................................................38
5 PROBLEM 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 5 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.
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User Manual cod. 980026
Rev 2.0
Page 6 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.
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User Manual cod. 980026
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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 nonoriginal 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 crosscontamination, 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 antibacterial 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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User Manual cod. 980026
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Page 8 of 46
Disposable
turbine
Reusable
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.
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 crosscontamination 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
mouthpieces, the user must follow all the relevant local regulations.
spirobank G
User Manual cod. 980026
Rev 2.0
of
Page 9 of 46
used
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
1.4.1
Labels and symbols
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:
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•
•
•
•
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
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User Manual cod. 980026
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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
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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
*FVC
Best FVC
*FEV1
Best FEV1
*PEF
Best PEF
FVC
Forced Vital Capacity
FEV1
Volume expired in the 1st second of the test
FEV1/FVC
FEV1/FVC x 100
FEV1/VC
FEV1 / best between EVC and IVC x 100
PEF
Peak expiratory flow
FEF2575
Average flow between 25% and 75% of the FVC
FEF25
Forced Expiratory Flow at 25% of FVC
FEF50
Forced Expiratory Flow at 50% of FVC
FEF75
Forced Expiratory Flow at 75% of FVC
FEV3
Volume expired in the initial 3 seconds of the test
FEV3/FVC
FEV3/FVC x 100
FEV6
Volume expired in the initial 6 seconds of the test
FEV6%
FEV1/FEV6 x 100
FET
Forced expiratory time
EVol
Extrapolated volume
FIVC
Forced inspiratory volume
FIV1
Volume inspired in the 1st second of the test
FIV1/FIVC
FIV 1 %
PIF
Peak inspiratory flow
MVVcal
Maximum voluntary ventilation calculated on FEV1
VC
Slow vital capacity (expiratory)
EVC
Slow espiratory vital capacity
IVC
Slow inspiratory vital capacity
IC
Inspiratory capacity (max between EVC and IVC - ERV)
spirobank G
User Manual cod. 980026
Rev 2.0
Units
L/s
L/s
L/s
L/s
L/s
L/s
mL
L/s
L/s
Page 15 of 46
ERV
TV
VE
RR
tI
tE
TV/tI
tI/Ttot
MVV
ELA
Expiratory reserve volume
Tidal volume
Ventilation per minute, at rest
Respiratory frequency
Average time of inspiration, at rest
Average time of expiration, at rest
Average flow of inspiration, at rest
tE/(tI+tE)
Maximum voluntary ventilation
Estimated lung age
L/min
Breath/min
L/min
L/min
year
* = best values
Flow/volume measurement system
Temperature sensor
Measurement principle
Volume range
Flow range
Volume accuracy
Flow accuracy
Dynamic resistance at 12 L/s
1.5.2
Bi-directional digital turbine
semiconductor (0-45°C)
Infrared interruption
10 L
± 16 L/s
± 3% or 50 mL
± 5% or 200 mL/s
<0.5 cmH2O/L/s
Other features
Memory
Display
Keyboard
Interface
Duration of the CR2032 3V lithium battery
(memory backup)
Power supply
Dimensions
Weight
Type of electrical protection
Type of electrical protection
Grade of protection against water ingress
Safety level in the presence of
inflammable anaesthetic gas, oxygen or
nitrogen
Conditions of use
Storage conditions
spirobank G
User Manual cod. 980026
Memory capacity for over 6000 spirometric
tests
The precise number depends on the
individual configuration, so it cannot be
determined more closely
grafic LCD type SFTN,128x48 Pixel
Membrane keyboard with 5 keys
USB, Bluetooth
Circa 10 years, under normal conditions of
use
1 battery 9V DC (type PP3), or through USB
connection
162x49x34 mm
160 grams (including battery)
Class II device
BF
IPX1 device, protected against water drops
Device not suitable
Device for continuous use
Temperature: MIN -20 °C, MAX + 60 °C
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Humidity :MIN 10% RH; MAX 95%RH
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Electrical Safety Standard IEC 60601-1
Electro Magnetic Compatibility IEC 60601-12
Operating conditions
Applied norms
2.
FUNCTIONING OF THE SPIROBANK G
2.1
Keyboard
The spirobank G keyboard is composed of 5 keys:
Key functions are as followed:
Off
esc/ok previous page
OSD key
Scroll left
OSD key
Scroll up
OSD key
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
will show:
spirobank G
. The display
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•
•
•
•
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
The “Service Menu” screen contains the following fields:
•
•
•
•
•
•
•
•
•
to access the service menu.
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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• Bluetooth Settings
• Info Firmware
or
and the ► symbol on the left of the screen; press
Select the required option using
to access options; select the required setup using the
or
, then press
to
return to the Service Menu, press
to return without modifications.
Select Language
to access the Menu, use
or
to select the required language and press
Press
to save 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
, then use
or
to select the
Enter Menu with
again to return to the Service
required value and press
Menu.
Delete Memory
Enter Menu with
Adult
ERS
Knudson
USA
ERS
MC-Barcelona
Paediatric
Knudson
Knudson
Knudson
Zapletal
Zapletal
, 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 indicates the field to modify. Use
or
to modify
to pass to the the following option. Lastly, press
to return to
the selected option; use
the Service Menu. To return to the Service Menu display without making any changes press
Date Format
Use
or
to select the required format and
to enter and return to the Service Menu.
Units Format
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Access with
and select imperial or metric as required with
return to the Service Menu.
or
. Press
Turbine Setup
and select the turbine in use (disposable or reusable) with
Access with
again to return to the Service Menu.
Select Standard
and select the required standard using
Access with
Service Menu.
or
. Press
again to
or
. Press
to return to the
WARNING
With the standard NAHNES III is not possible to select or to modify the predicted
values.
Bluetooth Setting
to search for available devices, select “Search Device” and then press
Access with
spirobank G will start to search for Bluetooth devices in the area; when one or more devices
are found the screen will display the names of the device(s) found, press
to set the device
. On the “Bluetooth
as printer or PC-Online , select one of the two options and then press
Setup” screen all devices entered on the “printer list” and on the “PC-Online list” can be
checked. A device can be set as default by accessing the list with
and then selecting the
device, (to which spirobank G will automatically connect) or deleted from the list (press
on
to go back and to not delete the device).
the bottom to confirm the deletion, or
WARNING
To connect the instrument to a PC via Bluetooth key (PC-Online function) the key
must first be setup as the default device in the list PC Online. In this case the
instrument will function in the “Device” mode.
When connected to a printer the instrument is set up as “Master”.
Info Firmware
Access through
•
spirobank G
•
Bluetooth
to view the version number of the following components, where available:
After approximately 10 seconds spirobank G automatically displays the Service Menu,
otherwise press
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Having set the parameters as required from the Service Menu press
screen, and then the following is shown:
to access the second
Which indicates:
• Patient ID code* and ethnic group
• Birth date (dd/mm/yyyy)
• Height (cm)
• Weight (kg)
• Sex (S)
• Function icons**
* the ID code is created automatically when new patient data is entered and is progressive.
** the icon “VC-MVV” is not shown when the standard NAHNES III is selected. The symbol
is shown only in the POST phase.
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.
Before the calibration procedure, make a FVC test using a calibration syringe (for example 3
litres) and it is vital to make a complete expiratory and inspiratory phase.
To access the calibration function, select “Turbine Calibration” from the Service Menu with the
horizontal scroll key and then press
. The following screen appears:
SYRINGE
300◄
FVC
308
0%
FIVC
333
0%
FOR FACTORY CALIBRATION
INSERT FVC = 0
The Old FVC and the Old FIVC values now shown are from the previous calibration.
The values in % indicate the correction factor. These are pre-set to 0 by default.
or
to set the desired values, use
to go to the following value.
Use
If the difference in percentage between the expected value and the measured value is greater
than 10% then it is not possible to continue the calibration procedure, this means that the
turbine is damaged or requires cleaning.
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To clarify: using a 3 litres syringe, the expected FVC value is 3.08 L, the expected FIVC
instead is in function of the ambient temperature.
Press
to turn to the service menu without applying any calibration factor.
If % FVC and FIVC are more than 10%, the device cannot correct such a value; in this case:
- Check the correct functioning of the spirobank G 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.
Note
Each time a calibration is made, the new correction factors are added to the
previous correction factor. Therefore, before making a new calibration make sure to
delete the 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
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 G 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.
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2.5 Subject Data
, or if already switched on, press
icon); to
Switch on spirobank G by pressing
access the “PATIENT DATA MANAGEMENT” screen, the following table describes the
functions and icons.
Icon
Key
Description
To enter new patient data
Go to the main screen
To modify data of current subject
To make a bronchodilator test (i.e. make a test after drug
administration with defined dosage; to carry out this test, a base PRE
test is required, i.e. a test without drugs assumption)
To enter new patient data
From the “Patient Data Management” menu press
to access the data input screen.
First screen (date of birth, weight, height, sex)
Use
or
to select date of birth, use
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
to go to the following screen; or
to return to the previous data.
operation use
Second screen (ethnic group)
Set an ethnic group: this function allows the correction of the predicted values for a subject
with the ethnic group to which he or she belongs. The function “without correction” can also be
used.
ATS/ERS Standard
NAHNES III Standard
Group
% correc.
Caucasian
Without correction
100%
African-American
100%
Caucasian
Mexican-American
100%
Oriental
Others
100%
Hong Kong Chinese
89%
Japanese
90%
Polynesian
90%
North Indian
87%
South ndian
90%
Pakistan
87%
African Descent
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For ATS/ERS standards, the correction is applied to the predicted values of the following
parameters:
FVC, FEV1, FEV3, FEV6, VC
For NAHNES III standards, the correction is based on several theoretical formulas (as
described in the publication).
press
to complete the setting of the parameters, the main screen then appears. In the
event of an error during the setting of patient data press
to return to the previous screen.
To interrupt data input press
, which then goes back to the main screen.
Once the patient data is set then the ID code appears in the upper left of the main screen; this
code is associated to the new subject.
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 .
POST BD Test
to set the spirometry test in “post” mode, i.e. after bronchodilation. On the next screen
Use
use
to select either a PRE or POST test, using respectively
or
. Once entered,
icon will appear on the upper right of the main screen for POST testing of the subject.
the
For more information about the POST test, please see paragraph 2.8.7.
2.6 Displaying data from memory
From the main screen press
icon), to check data of the relevant patient or to search
for another patient’s data; the following options are available:
KEY
ICON
FUNCTION
To send the last spirometry test to a printer
To return to the main screen
Display the last spirometry tests of the selected patient
Access data in memory
Enter the search menu (
spirobank G
) to display data based on four different methods:
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KEY
ICON
FUNCTION
Search by ID Code
Return to the main screen
Display files from a date onwards (partial memory)
Display files from beginning to end (complete memory)
Search by ID Code: enter the ID Code of the patient required then
to access the data.
Search for date: enter test date of the required file; then press
to access test data. The
data will be shown starting from the date entered up to the most recent file in memory.
Full Memory: to show test data in alphabetical order.
The last data are marked by a double beep, then the data shown restarts from the first one
recordered.
to return to the main screen without searching.
Press
Once in the archive the following screen appears:
WARNING
The ID code is automatically associated by the device when are the patient data are
entered; the test code is like the patient ID for the first test made on the patient. The
following tests on the same patient are then identified sequentially.
To show data of the selected test press
Choosing a test with
spirobank G
twice
icon) the following screen appears:
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At this stage it is possible to:
• Print selected test data via the Bluetooth connection by pressing
• Scroll through the list of data in memory pressing
• Show all results of the selected test, pressing
or
to return to the main screen;
• Make a new test on the selected subject pressing
with the following message:
icon);
icon)
icon) and then using
and
icon); a new screen is shown
Press OK to make NEW Test on the selected subject
Press
to confirm, otherwise
to return to the list of data in memory;
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 the USB cable or the Bluetooth system.
spirobank G thus acts as an intelligent sensor for flow and volume measurement while the PC
controls its functions, including the switching on and off of the unit.
Connected to a portable PC, spirobank G can carry out epidemiologic studies in work
environments, school settings etc.
The PC software also allows the latest bronchial challenge test protocols, with the graph of
the FEV1 dose-response and time-response curves.
The Bluetooth connection allows for real time spirometry testing and downloading of test
results to a PC. To enable this connection the winspiroPRO software must be setup to run
with the RS 232 serial connection.
WARNING
Note that when using spirobank G in online mode, if a turbine (disposable or
reusable) is setup then the same turbine will remain by default the next time the
device is used in stand-alone mode. Thus pay attention to the setting of the turbine.
2.8 Spirometry Testing
To make a correct spirometry test we recommend to follow carefully the following instructions:
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• 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 G at either end in two hands. 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.
The tests available with spirobank G are:
FVC
VC
MVV
Forced Vital Capacity
Slow Vital Capacity
Maximum Voluntary Ventilation
On the main screen, select as follows:
FVC
Press
Press
VC - MVV
to access the FVC test.
to access a new screen and then select either VC or MVV:
VC
MVV
The device displays the information regarding the turbine selected in the initial setting
(reusable or single-patient disposable), and then the relevant test information follows.
to turn to the main screen.
Or press
WARNING
With standard NAHNES III it is not possible to make VC or MVV tests
WARNING
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A test is always memorised together with the details of the current patient. To make
a test on a patient previously inserted then you must firstly recall the patient from
the memory, see the final part of paragraph 2.6 for details.
2.8.1
FVC Test
The phases as described on the screen must be followed, specifically:
EXPIRE quickly
INSPIRE slowly
It is possible (and may be helpful) to start the test by breathing for a few moments at rest.
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 still
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 of the 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.
The test may be repeated several times by repeating the cycle without taking the mouthpiece
out of the mouth, in which case spirobank G recognises the best test (FVC+FEV1) and will
automatically show the results of this best test.
as shown on the screen.
At end of the test press
During testing spirobank G 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 deeply 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 G 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.
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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.
as shown in the screen.
At end of the test press
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
To carry out this test correctly, follow the indications shown 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. At end of the test press
WARNING
It is important that the disposable mouthpiece and turbine are changed at the end
of each test.
2.8.4
Reading messages
A series of measured parameters, based on the international reference standards are
shown at the end of each test. A series of test messages are displayed, followed by the
measured parameters.
A description of these messages and the parameters now follow in the order in which they
appear.
If no key is pressed for circa 6 seconds 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
based on the ATS standard. For a faster comprehension this interpretation is illustrated by
a traffic light code (green, yellow, red). For each test made, an arrow on the right of the
screen indicates the worst level of interpretation of the test session.
The connection between the traffic light colour and the test interpretation is shown below:
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Through an analysis applied to some of the indices and parameters calculated in the FVC
test, spirobank G produces a variety of quality control comments useful to understand
the reliability of the test made.
This control quality check assigns a letter for the current session as described below:
PRE Test
A = At least two acceptable manoeuvres, with the highest two FEV1 values matching to
within 100 mL and the largest two FEV6 values within 100 mL.
B= At least two acceptable manoeuvres, with the FEV1 values matching to within 101 to
150 mL
C= At least two acceptable manoeuvres, with FEV1 values matching to within 151 to 200
mL
D= only one acceptable manoeuvres, or more than one, but the FEV1 values not
matching to within 200 mL (with no interpretation).
F= No acceptable manoeuvres (with no interpretation).
POST Test
A = two acceptable (1) FEV1 values matching within 100 mL
B= two acceptable (1) FEV1 values matching within 200 mL
C= two acceptable (1) FEV1 values that do not match within 200 mL
D= only one acceptable (1) FEV1 manoeuvre
F= No acceptable (1) FEV1 manoeuvres
Acceptable manoeuvre means: good start and satisfactory exhalation (duration and flow)
Where several comments related to the single test are calculated, spirobank G will only
show the most important to facilitate the test interpretation.
ERROR IN Vext and PEF
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:
INITIAL EXPIRATION TOO SLOW
FET error
If FET is under the predicted threshold the following message appears:
EXPIRY TIME INSUFFICENT <6s
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FLOW ERROR
If the last flow point of the F/V curve is greater than 200 mL/s, this indicates that the
expiration was not complete and thus the following comment is shown:
BLOW OUT ALL AIR IN LUNGS
Between two tests, spirobank G evaluates the repeatability of the following parameters:
PEF
VC
repeatable when the difference between the two largest PEF is ≤ 0.67 L/s;
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
I° case: ATS/ERS standard
Following an FVC test, the spirometry test results are shown. The first screen displays the
main parameters *FVC, *FEV1, *PEF, *FEV1%,, the percentage of the predicted values
(or of the PRE values in the case of a POST phase), the Flow/Volume curve plus a traffic
light summary of the test interpretation (in the upper right), as illustrated below.
*= best values
In case of “repeatability” a symbol ® is shown in the graphic area
The following screens show other values compared to the predicted values (or to the PRE
values if is a POST phase).
Parameters shown:
FVC, FEV1, FEV1/FVC, FEV1/VC, PEF, FEF2575, FEF25, FEF50, FEF75, FEV3,
FEV3/FVC, FEV6, FEV6%, FET, EVol, FIVC, FIV1, FIV1/FIVC, PIF, MVVcal, VC, EVC, IVC,
IC, ERV, TV, VE, RR, tI, tE, TV/tI, tI/Ttot, MVV, ELA.
*= best values
II° case: NAHNES III standard
Following an FVC test, the spirometry test results are shown. The first screen displays the
main parameters *FEV6, *FEV1, *FEV1/FEV6%, *PEF, the percentage of the predicted
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values (or to the PRE values in the case of a POST phase), the Flow/Volume curve plus a
traffic light summary of the test interpretation (in the upper right ), as illustrated below.
*= best values
In case of “repeatability” a symbol ® is shown in the graphic area
The following screens show other values compared to the predicted values (or to the PRE
values if is a POST phase).
Parameters shown:
FEV6, FEV1, FEV1/FEV6%, FEF2575, FVC, FEV1/FVC
*= best 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
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 FVC test carried out on the same day.
To carry out a POST test please refer to paragraph 2.5.
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 measured parameters.
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 to carry out a
POST test on a patient if the patient archive only contains PRE tests carried out 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 insert a new patient or recall a patient from the archive, (see
paragraph 2.6).
WARNING
If a new dose is set after a POST test then the device creates a new test session,
still POST. A new test code ID is allocated. The interpretation is not based on the
previous sessions with different drug doses; only the new test is utilized for the
interpretation.
spirobank G
User Manual cod. 980026
Rev 2.0
Page 34 of 46
3
DATA TRANSMISSION
WARNING
Read the instructions carefully before starting data transmission, taking care to
ensure that all the information has been properly understood.
3.1 Data Transmission via Bluetooth for printing
WARNING
Printing is possible only if the printer has a Bluetooth connection; alternatively an
USB adaptor can be installed on the printer in order to enable a Bluetooth
connection.
The printer used must be in the list of printers accepted by the device. To have a
copy of the updated list please contact the manufacturer or send an email to the
following address:
mir@spirometry.com
The Bluetooth system enables spirobank G to transfer test data directly to a Bluetooth
enabled printer. Proceed as follows:
•
From the main screen select the test to be printed with
•
On the next screen press
•
•
icon)
Press
Choose one of the tests of the relevant patient using
icon)
or
Tests stored in memory can also be printed. Use the search method as described in
Paragraph 2.6 to select and print out relevant tests.
•
•
•
and then
On the test screen press
spirobank G will carry out the connection.
At the end of transmission spirobank G 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.
3.2 Connection to a PC through USB port or via Bluetooth
WARNING
Before connecting spirobank G via USB or Bluetooth 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 operating system installed on the PC can be checked).
spirobank G
User Manual cod. 980026
Rev 2.0
Page 35 of 46
If winspiroPRO is already installed on the PC then a new installation is not required.
When using a Bluetooth connection, the instrument can be used for on-line
spirometry testing & internal memory downloading Correct use of the Bluetooth
connection implies the use of a Bluetooth key connected to the PC.
To make the connection, insert the mini USB connector supplied
with spirobank G as shown in the picture and attach the other
connector to the USB port of the PC.
When making an initial 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.
3.3 Upgrade Internal software
spirobank G software can be upgraded when connected to a PC.
Upgrades
can
be
downloaded
by
registering
on
www.spirometry.com. For further information on upgrading
software see the “winspiroPro” software manual.
WARNING
This function is only applicable via USB connection.
MAINTENANCE
spirobank G 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.
Changing the battery.
The maintenance operations described in this User 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.
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
spirobank G
User Manual cod. 980026
Rev 2.0
Page 36 of 46
The turbine utilized by spirobank G belongs to one of two categories: disposable or reusable.
These both 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 G as if to make a spirometry test (for example FVC)
•
Hold spirobank G 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 regular 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 G turning
it anti-clockwise and pulling 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 the turbine immersed for the time specified in
the instructions of the solution.
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.
Never place the turbine under a direct jet of water or any other liquid. Where no
cleaning solutions are available it is however indispensable to 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
surface.
spirobank G
User Manual cod. 980026
Rev 2.0
Page 37 of 46
Once the turbine has been cleaned insert the turbine in its place and follow the instructions
indicated by the closed lock symbol printed on the plastic casing of the spirobank G.
To insert the turbine correctly push it and then turn it clockwise until reaching the stop, which
ensures that the turbine 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 another one.
If the disposable turbine is used do not clean it but change it after each test.
4.2 Changing the Batteries
If the message "BATTERY DISCHARGED" appears on the spirobank G display, or if the
instrument does not switch on, then the battery must be changed as follows:
•
•
•
•
Remove the battery cover by pressing and pushing it away from the device.
Disconnect and remove the battery.
Replace with a new battery, ensuring the connector is correctly connected.
Close the battery compartment by replacing the back cover and sliding it towards the inside
of the device.
WARNING
Use only 9 V type PP3 battery or equivalent. When inserting the battery in the
battery slot, take care to connect the “+” and “-” as shown inside (see figure below).
The device also has an internal lithium battery for the RAM memory and 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.
PROBLEM SOLVING
A list of problems follow that may arise when working with the spirobank G. Diagnostic
messages are also shown on the display to indicate the type of malfunction:
spirobank G
User Manual cod. 980026
Rev 2.0
Page 38 of 46
5.1 Causes and Solutions
•
spirobank G does not switch on
Check that battery is correctly inserted in the compartment on the back of the instrument.
If it is correctly positioned then replace it with new one.
•
During operation the machine switches itself off and on again
Change the battery.
•
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 test
memory from the device to the PC using the Winspiro PRO software. This
procedure is necessary as the test 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 G
User Manual cod. 980026
Rev 2.0
Page 39 of 46
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
Device Name
Classification
Spirometer
spirobank G
IIa
This Device is marked
Any modifications to the Device which are not authorised by MIR will invalidate this
Declaration
Rome 01 / 01/ 2007
Simon Fowler
Sales Manager
Carmine Cerullo
Quality Manager
Rev.0 – Mod. PO-10DDC_spirobank G
spirobank G
User Manual cod. 980026
Rev 2.0
Page 40 of 46
LIMITED WARRANTY CONDITIONS
spirobank G, 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.
spirobank G
User Manual cod. 980026
Rev 2.0
Page 41 of 46
ANNEX 1
SPIROMETRY TEST REPORT EXAMPLES
spirobank G
User Manual cod. 980026
Rev 2.0
Page 42 of 46
ANNEX 3
INFORMATION
FOR
ELECTROMAGNETIC ENVIRONMENT
CORRECT
USE
IN
AN
Guidance and manufacturer’s declaration – electromagnetic emissions
The spirobank G is intended for use in the electromagnetic environment specified below.
The customer or the user of the Spirobank G should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
Class B
The spirobank G uses RF energy only for its internal
function. Therefore, its RF emissions are very low and
are not likely to cause any interference in nearby
electronic equipment.
Not applicable
Not applicable
IEC 61000-3-3
spirobank G
User Manual cod. 980026
Rev 2.0
Page 43 of 46
Guidance and manufacturer’s declaration – electromagnetic immunity
The spirobank G is intended for use in the electromagnetic environment specified below. The customer
or the user of the spirobank G should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
Electromagnetic environment –
test level
guidance
Electrostatic
Floors should be wood, concrete or ceramic
±6 kV contact
±6 kV contact
discharge (ESD)
tile. If floors are covered with synthetic
material, the relative humidity should be at
±8 kV air
±8 kV air
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
IEC 61000-4-5
Voltage
dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
±1
kV
mode
differential
±2 kV common mode
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
Not Applicable
Mains power quality should be that of a
typical commercial or hospital environment.
Not Applicable
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location
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 G, 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
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2,5 GHz
spirobank G
[3 ] V
d=[ 3.5 ] √P 80 MHz to 800 GHz
d=[ 7 ] √P 800 MHz to 2,5 GHz
[3 ] V/m
User Manual cod. 980026
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
and d is the recommended separation
Rev 2.0
Page 44 of 46
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 G is used exceeds the
applicable RF compliance level above, the spirobank G should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank
G.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
spirobank G
User Manual cod. 980026
Rev 2.0
Page 45 of 46
Recommended separation distances between
portable and mobile RF communications equipment and the spirobank G
The spirobank G is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the spirobank G can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the spirobank G as
recommended below, according to the maximum output power of the communications equipment.
Rated
maximum
output
power of transmitter
0.01
0.1
10
100
Separation distance according to frequency of transmitter
80 MHz to 800 MHz
800 MHz to 2,5 GHz
150 kHz to 80 MHz
d=[ 3.5 ] √P
0.12
0.37
1.17
5.28
11.66
d=[ 3.5 ] √P
0.24
0.37
1.17
5.28
11.66
d=[ 7 ] √P
0.24
0.74
2.34
1.056
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.
spirobank G
User Manual cod. 980026
Rev 2.0
Page 46 of 46

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