MIR Medical Research MIR020 Portable multipurpose and mutlifunction spriometer User Manual MANUALE SB II REV 2 2 ENG

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spirobank II
User’s Manual
User’s Manual Rev. 2.2
Issued on: 09/05/2006
Approved on: 09/05/2006
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 1 of 60
Thank you for choosing a product from MIR
MEDICAL INTERNATIONAL RESEARCH
The original packaging contains one of the following spirometers, complete with its standard
accessories:
PRODUCT
spirobank II with oximeter
spirobank II without oximeter
4 x 1.5V AAA batteries
USB connection cable
This spirobank II User’s Manual
WinSpiro Pro installation CD
Oximeter sensor (optional)
Nose clip
4 Paper mouthpieces
3 Single patient turbine sensors
1 Reusable turbine sensor
CODE
910570
910575
970080
532365
980205
920100
919010
910320
910300
910001
910000
Before using your spirobank II …
• Read this manual carefully, plus all labels and other product information supplied.
• If not fitted, install the operating battery taking care to connect the “+” and “-” battery poles
correctly, as shown in the battery compartment.
• Set the device configuration as required (date, time, predicted values, device language etc.)
as described in Paragraph 2.4.
Keep the original packaging!
In the event that your device requires attention then always use the original packaging to
return it to the distributor or manufacturer.
In this case, please follow these guidelines:
•
•
Return the complete device in the original packaging, and
The transport (plus any customs or taxes) costs must be prepaid.
Manufacturer’s address:
MIR SRL
VIA DEL MAGGIOLINO, 125
00155 ROMA (ITALY)
Tel ++ 39 0622754777
Fax ++ 39 0622754785
Web site: www.spirometry.com
Email: mir@spirometry.com
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 2 of 60
!
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A
PHYSICIAN
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 3 of 60
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..........................................................................................7
1.2.1
Danger of cross-contamination.............................................................................8
1.2.2
Turbine ...................................................................................................................8
1.2.3
Mouthpiece ............................................................................................................9
1.2.4
Oximetry sensor.....................................................................................................9
1.2.5
Device ..................................................................................................................11
1.3
Unforeseen errors.....................................................................................................11
1.4
Labels and symbols..................................................................................................12
1.4.1
Identification label................................................................................................12
1.4.2
CE mark for medical devices ..............................................................................12
1.4.3
Electrical safety symbol.......................................................................................12
1.4.4
Warning symbol for the RS232 serial port .........................................................13
1.4.5
Warning symbol for the USB serial port .............................................................13
1.4.6
Warning symbol for the SpO2 port for oximetry ................................................13
1.4.7
Warning symbol for the WEEE ...........................................................................13
1.4.8
Warning symbol for the FCC...............................................................................13
1.5
Product description...................................................................................................14
1.6
Technical specifications ...........................................................................................16
1.6.1
Features of the spirometer..................................................................................16
1.6.2
Features of the oximeter .....................................................................................17
1.6.3
Other features ......................................................................................................21
2.
FUNCTIONING OF THE spirobank II ..............................................................................22
2.1
Keyboard...................................................................................................................22
2.2
Battery Level .............................................................................................................24
2.3
Information ................................................................................................................25
2.4
Initial Set-up ..............................................................................................................25
2.4.1
Turbine Calibration ..............................................................................................27
2.5
Patient Data ..............................................................................................................29
2.6
Displaying data in memory.......................................................................................31
2.7
Online operating mode (connected to a PC) ..........................................................32
2.8
Spirometry Testing ...................................................................................................32
2.8.1
FVC Test ..............................................................................................................33
2.8.2
VC Test ................................................................................................................34
2.8.3
MVV Test .............................................................................................................34
2.8.4
Reading messages..............................................................................................34
2.8.5
Spirometry test interpretation..............................................................................35
2.8.6
Viewing the spirometric parameters ...................................................................36
2.9
Oximetry testing........................................................................................................36
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 4 of 60
2.9.1
Walk Test (6MWT)...............................................................................................38
2.9.2
Sleep Oximetry ....................................................................................................40
2.9.3
SPO2 BPM Oximetry Test ..................................................................................40
2.9.3.1
Wrap Sensor – Instructions for Use ..............................................................40
2.9.3.2
Making a Test .................................................................................................41
2.9.4
SPO2 BPM Test ..................................................................................................42
3 DATA TRANSMISSION........................................................................................................42
3.1
Wireless Data Transmission via Phone Line ..........................................................42
3.2
Data Transmission via Bluetooth to a cell phone ...................................................44
3.2.1
Preliminary Operations........................................................................................44
3.2.2
Setting the Phone Number..................................................................................44
3.2.3
Bluetooth Data Transmission..............................................................................44
3.3
Data Transmission via Bluetooth for printing ..........................................................45
3.4
Connection to a PC through USB port ....................................................................46
3.5
Connection to a PC through the RS 232.................................................................46
3.6
Upgrade Internal software........................................................................................47
4 MAINTENANCE ....................................................................................................................47
4.1
Cleaning and controlling the reusable turbine ........................................................47
4.2
Changing the adhesive tape of the wrap sensor ....................................................48
4.3
Changing the Batteries.............................................................................................49
5 PROBLEM SOLVING ...........................................................................................................49
5.1
Causes and Solutions ..............................................................................................49
LIMITED WARRANTY CONDITIONS .........................................................................................52
ANNEX 1
OXYMETRY TEST REPORT EXAMPLES ........................................................53
ANNEX 2
INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC
ENVIRONMENT ...........................................................................................................................56
ANNEX 3
SPIROMETRY TEST INTERPRETATION FLOW CHART...............................60
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 5 of 60
1.
INTRODUCTION
1.1
1.1.1
Intended Use
User Category
The spirobank II spirometer + oximeter calculates a series of parameters relating to human
respiratory function.
The product is therefore intended for use by a doctor or by a trained paramedic or technician
under the supervision of a doctor, and has also been designed for home care by patients.
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.
!!' $ ! ( $
1.1.3
Operating environment
spirobank II has been designed for use in a doctor’s office, in a hospital or directly by the
patient during day-to-day activities for the continuous monitoring of physical conditions. All
information necessary for the proper use of the device in electromagnetic environments (as
required by the EN 60601-1-2 Standard) is available from the manufacturer.
Used at home, at work, at school or during sports, day by day the device records data and
functional respiratory parameters for a period of weeks or months, assisting the patient in
making a better assessment of his own health.
The procedures for using the device at home are described according to the type of test to be
made; the display will show all instructions (messages, suggestions etc.) step-by-step, which
allows the subject to correctly perform tests and obtain correct results, to be analysed by the
doctor.
The instrument is not intended for use in an operating theatre nor in the presence of
inflammable liquids or detergents, nor in the presence of inflammable anaesthetic gases
(oxygen or nitrogen).
spirobank II
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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 ambiental conditions.
!!' $ ! ( $
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.
1.2
Important safety warnings
spirobank II
spirobank II
User’s Manual cod. 980200
' $ + , -.*
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Rev 2.2
Page 7 of 60
spirobank II
1 2 #3 / #' ' &
'0 &
4 0 '5 & '*
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$ !' $ 0 ' 0
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1.2.1
Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable and one is
single-patient disposable. A disposable mouthpiece is required in order to connect a subject
to the spirometer. In order to avoid exposing the subject to the critical danger of 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
!!' $ ! ( $
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 8 of 60
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 mono-use/disposable, we suggest that you contact your local distributor who supplied
the spirometer
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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.
1.2.4
Oximetry sensor
The oximetry sensors which can be used with spirobank II are the following:
•
•
•
•
•
•
•
•
BCI 1300 adult sensor (disposable)
BCI 1310 reusable sensor
BCI 3026 wrap-around sensor for infants
BCI 3043 universal Y sensor
BCI 3078 ear sensor
BCI 3178 pediatric finger sensor, reusable
BCI 3444 adult sensor reusable (Comfort Clip)
BCI 3044 adult sensor, reusable, for finger.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 9 of 60
Prolonged use and/or the patient’s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, circulatory status, and correct
alignment at least every 4 hours.
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spirobank II
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5 ;8 = 5 <
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spirobank II
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 10 of 60
1.2.5
Device
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Unforeseen errors
In case device internal memory data are damaged, when the device is switched on, the
following message appears:
warning reparing test memory, please wait
If data have been succesfully repaired, the device completes the standard switch on process,
otherwise please contact an authorised technical assistance point or the manufacturer.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 11 of 60
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 B 1.6 Technical Specifications) could
provoke a loss of data in the memory of the device (SRAM memory).
Errors in measurement or in interpretation can also be caused by:
•
•
•
•
•
use by non-qualified or non-trained personnel, lacking ability or experience
user error
use of the instrument outside the guidelines described in this User'
s Manual
use of the instrument even when some operational anomalies are encountered
non-authorised servicing of the instrument.
1.4
1.4.1
Labels and symbols
Identification label
The label shows:
•
Serial number of the device
•
Product name
•
Name and address of the manufacturer
•
Electrical safety symbol
•
CE mark in compliance with the Directive 93/42 EEC.
1.4.2
CE mark for medical devices
0476
This product is certified to conform to the Class II requirements of the 93/42/EEC medical
device directive.
1.4.3
Electrical safety symbol
In accordance with the IEC 60601-1 Standard, this product and its component parts are of
type BF and therefore protected against the dangers of direct and indirect contact with
electricity.
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Rev 2.2
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1.4.4
Warning symbol for the RS232 serial port
RS232
For connection to other devices such as PC or printer.
Use only the serial cable supplied by the manufacturer and observe the safety regulations of
IEC 60601-1-1.
1.4.5
Warning symbol for the USB serial port
For connection to other devices such as PC or printer.
Use only the serial cable supplied by the manufacturer and observe the safety regulations of
IEC 60601-1-1.
1.4.6
Warning symbol for the SpO2 port for oximetry
SpO2
1.4.7
Warning symbol for the WEEE
As laid down in the European Directive 2002/96/EEC requirements regarding the disposal of
electrical and electronic devices (WEEE), at the end of its useful life this device must not be
thrown away together with normal domestic waste as it contains materials which would cause
damage to the environment and/or represent a health risk. Instead it must be delivered to a
WEEE authorised collection centre, where the device will then be disposed of correctly.
An alternative is to return the device without charge to the dealer or distributor, when a new
equivalent device is purchased.
Due to the materials used in the manufacturing of the device, disposing it as a normal waste
product could cause harm to the environment and/or health.
Failure to observe these regulations can lead to prosecution.
1.4.8
FDA and FCC Warnings
FEDERAL LAW RESTRICTS THIS
DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN
FCC ID:TUK-MIR020
spirobank II complies with Part 15 of the FCC Rules. The correct operation is subject to the
following conditions:
(1) this device must not cause harmful interference
(2) this device must accept any interference received, including interference that may cause
undesired operation.
spirobank II
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Any modifications not expressly approved by this company could void the user'
s authority to
operate the equipment.
NOTE: This device has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed and used in
accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•
•
•
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver
is connected.
Consult the dealer or an experienced radio/TV technician for assistance.
•
1.5
Product description
spirobank II is a pocket spirometer, with an optional pulse oximetry module. It can operate in
stand alone mode and it can be connected to a PC or to a printer using any one of several
available methods: RS232, USB, Bluetooth.
spirobank II is specifically designed to measure a range of respiratory parameters and to
monitor the saturation of oxygen in the blood and the heart beat. A quality control check is
carried out internally on the measured parameters and the device has an internal memory
sufficient for over 6000 spirometry tests or for 1000 hours (or 40 days) of oximetry monitoring.
spirobank II is a powerful and compact measurement device, intended for use by a
respiratory specialist or by a suitably trained generalist. The spirometer calculates up to 30
functional respiratory parameters providing the pharmacodynamic effects, i.e. the data
comparison after the administration of a drug (PRE/POST) for a bronchodilator test or for a
bronchial challenge test. A comparison of data is made between POST (after-drug) and PRE
(before drug administration).
The flow and volume measurement sensor is a digital turbine, based on the infrared
interruption principal. This principal ensures the accuracy and the reproducibility of the
measurements, without requiring a periodic calibration.
The features of this kind of sensor are listed below:
spirobank II
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Rev 2.2
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•
•
•
•
Accurate measurement even at very low flow rates (end of expiration)
Not influenced by gas humidity nor density
Shockproof and unbreakable
Inexpensive to replace.
The turbine flow measurement sensor is available both in reusable and in single-patient
disposable versions.
REUSEABLE TURBINE
DISPOSABLE TURBINE
The following precautions must be observed to ensure that the characteristics of the turbine
remain unaltered over time:
• for the disposable turbine: must always be substituted between patients.
• for the reusable turbine: always clean the turbine between patients, to ensure the maximum
level of hygiene and safety for the patient.
For a correct interpretation of a spirometry test, the measured values must be compared
either to the so-called normal or predicted values which are calculated from the
anthropometric details of the patient or, alternatively, to the personal best values from the
clinical history of the subject.
The personal best values can vary considerably from the predicted values, which are taken
from “healthy” subjects.
spirobank II is also able to transfer the stored test data through a simple acoustic coupling to
a PC, so the patient can send test data by phone to the doctor. In this way the doctor can
check the patient’s condition remotely.
spirobank II can also be connected to a PC (or to another computerised system) to configure
the system. All spirometric test results plus the related subject details stored inside the device
can be transferred from the device to the PC and then viewed on the PC (Flow/volume
curves, spirometry parameters, plus optional oximetry parameters).
The connection to the PC can be made in the following ways:
• through the RS232 port or
• through the USB port
spirobank II gives an automatic interpretation of each spirometry test carried out, and assigns
a “traffic light” feedback (green, yellow or red) to each test or series of tests. The set up of the
traffic light settings is made by the doctor responsible for the system configuration.
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Page 15 of 60
spirobank II is able to make FVC, VC & IVC, MVV and breathing profile tests, and calculates
an index of test acceptability (quality control) plus the reproducibility of the spirometry tests
carried out. The automatic test interpretation follows the latest 11 level ATS (American
Thoracic Society) classification. Each test can be repeated as required. The best parameters
are always available for review. The normal (predicted) values can be selected from several
normal “sets”. For example, within the European Union the majority of doctors use the ERS
(European Respiratory Society) predicted values.
Oximetry function
The oximetry sensor has two light emitting diodes (LEDs), one emits in the visible spectre and
one infrared. Both lights then pass through the finger and are “read” by the receiver. As these
lights pass through the finger, a proportion of the light is absorbed by the blood and by the
soft tissue, in function of the concentration of heamoglobin. The quantity of light absorbed, at
each frequency, depends on the degree of oxygenation of the haemoglobin inside the soft
tissue.
This measurement principal ensures accuracy and reproducibility, without requiring regular
calibration.
The oximetry sensor can be disinfected with isopropilic alcohol.
The operating battery is a 3V lithium battery, and the battery life is about 5 years, depending
on the use of the device.
1.6
Technical specifications
A comprehensive description of the main features of the device, the flow and volume
measurement turbine and also of the oximetry sensor follows:
1.6.1
Features of the spirometer
Measured parameters:
SYMBOL
DESCRIPTION
*FVC
Best FVC
*FEV1
Best FEV1
*PEF
Best PEF
FVC
Forced Vital Capacity
st
FEV1
Volume expired in the 1 second of the test
FEV1%
FEV1/FVC x 100
FEV1/VC%
FEV1/VC 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
FEV6
Volume expired in the initial 6 seconds of the test
FEV6%
FEV1/FEV6 x 100
FET
Forced expiratory time
VEXT
Extrapolated volume
FIVC
Forced inspiratory volume
spirobank II
User’s Manual cod. 980200
Rev 2.2
L/s
L/s
L/s
L/s
L/s
L/s
mL
Units
Page 16 of 60
st
FIV1
FIV1%
PIF
MVVcal
VC
IVC
IC
ERV
TV
VE
RR
tI
tE
TV/tI
tI/Ttot
MVV
Volume inspired in the 1 second of the test
FIV 1 %
Peak inspiratory flow
Maximum voluntary ventilation calculated on FEV1
Slow vital capacity (expiratory)
Slow inspiratory vital capacity
Inspiratory capacity
Expiratory reserve volume
Current 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
L/s
L/s
L/min
Breath/min
L/min
L/min
* = best values
Flow/volume measurement system
Temperature sensor
Measurement principle
Volume range
Flow range
Volume accuracy
Flow accuracy
Dynamic resistance at 12 L/s
1.6.2
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
Features of the oximeter
Definitions:
Desaturation events SpO2 fall >= 4% in a limited period of 8-40 sec
and successive rise > = 2% within a total period of 150 sec.
rate Pulse rate rise >= 10 BPM in limited period of 8-40 sec and
successive fall >=8 BPM during a total period of 150 sec.
Desaturation Event
Total Pulse
Variation
Parameters measured during sleep oximetry:
SYMBOL
SpO2 Baseline
SpO2 Min
SpO2 Max
SpO2 Mean
BPM Baseline
BPM Min
BPM Max
spirobank II
DESCRIPTION
Units
SpO2 Average in first three minutes
SpO2 Minimum during period of analysis
SpO2 Maximum during period of analysis
SpO2 Average during period of analysis
Average pulse frequency in the first 3 minutes
BPM
Minimum pulse frequency during the period of
BPM
analysis
Maximum pulse frequency during the period of BPM
User’s Manual cod. 980200
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analysis
Average pulse frequency during the period of
BPM Mean
BPM
analysis
Recording time
Total time measure of SpO2
hh:mm:ss
T < 90%
Time passed with SpO2 < 90 %
% hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
% hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
% hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
% hh:mm:ss
N° Events
SpO2 Fall of SpO2 below 89% for at least 20 seconds
<89%
Index of SpO2 fluctuation calculated in intervals of
∆ Index [12s]
12 seconds
T< 40 BPM
Time passed with pulse frequency < 40 BPM
% hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
% hh:mm:ss
Bradycardia events during the entire period of
N° Events < 40 BPM
analysis
Tachycardia events during the entire period of
N° Events > 120 BPM
analysis
Desaturation events during the entire period of the
Tot. Desat. Events
analysis
ODI
Desaturation events by hour of analysis
1/h
Mean Duration
Average duration of desaturation events
Longest Duration
Longest duration of desaturation events
Desaturation Peak
Minimum Sp02 during desaturation events
Mean Desaturation
Average duration of desaturation events
Average SpO2 fall with respect to baseline during
Mean Drop SpO2
the desaturation events
Maximum fall of SpO2 with respect of baseline
Max Drop SpO2
during the desaturation events
Variation of pulse frequency events during the
N° Pulse Variations
entire period of the analysis
Pulse Index
Variation of pulse frequency by hour of analysis
1/h
Time passed with SpO2 < 4 % with respect to SpO2
NOD 4%
hh:mm:ss
base for continual periods above 5 minutes
Time passed with SpO2 < 89 % for continued
NOD 89%
hh:mm:ss
periods above 5 minutes
Time passed with SpO2 < 90 % for continued
NOD 90%
hh:mm:ss
periods above 5 minutes with minimum value < 86 \
% (Nadir)
∆=DELTA
Parameters measured for six minute walk test analysis:
SYMBOL
SpO2 Baseline
SpO2 End
SpO2 Min
spirobank II
DESCRIPTION
SpO2 average before walking
SpO2 after walking
SpO2 minimum during walking
User’s Manual cod. 980200
Rev 2.2
Units
Page 18 of 60
SpO2 Max
SpO2 Mean
BPM Vaseline
BPM End
BPM Min
BPM Max
BPM Mean
T < 90%
T < 89%
T < 88%
T < 87%
T∆2 [∆SpO2 2%]
T∆4 [∆SpO2
4%]
T< 40 BPM
T> 120 BPM
N° Events < 40 BPM
N° Events > 120 BPM
Recording time
Baseline Time
Walking Time
Recovery Time
Predicted
Pred. Min
% Predicted Standard
% Pred. Min
AUC/Distance
Dyspnea Borg CHG
Fatigue Borg CHG
SpO2 maximum during walking
SpO2 average during walking
Average pulse frequency before walking
Pulse frequency after walking
Pulse frequency minimum during walking
Pulse frequency maximum during walking
Pulse frequency average during walking
Time passed with SpO2 < 90 %
Time passed with SpO2 < 89 %
Time passed with SpO2 < 88 %
Time passed with SpO2 < 87 %
Time passed during walking test with SpO2 < 2 %
with respect to SpO2 base
Time passed during SpO2 walking test < 4 % with
respect to SpO2 base
Time passed with pulse frequency < 40 BPM
Time passed with pulse frequency > 120 BPM
Bradycardia events during the entire period of
analysis
Tachycardia events during the entire period of
analysis
Total time measure of SpO2
Duration of baseline phase
Duration of walking phase
Duration of recovery phase
Predicted standard distance
Predicted minimum distance
% in variations of the distance covered with respect
to predicted standard distance
% of variations of distance covered with respect to
predicted minimum distance
Area under SpO2 curve base relative to distance
covered
Variation in grade of dyspnea during walking
Variations in level of fatigue during walking
BPM
BPM
BPM
BPM
BPM
% hh:mm:ss
% hh:mm:ss
% hh:mm:ss
% hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
hh:mm:ss
∆=DELTA
*There follows a description of the method for calculating the area below the SpO2 baseline
curve:
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 19 of 60
Parameters requested for six minute walk test analysis
SYMBOL
Dyspnea Borg Baseline
Dyspnea Borg End
Fatigue Borg Baseline
Fatigue Borg End
Walked
DESCRIPTION
Grade of dyspnea before walking
Grade of dyspnea after walking
Level of fatigue before walking
Level of fatigue after walking
Distance covered during walking
Units
Parameters measured with SpO2 Analysis:
SYMBOL
SpO2 Baseline
SpO2 Min
SpO2 Max
SpO2 Mean
BPM Baseline
BPM Min
BPM Max
BPM Mean
Recording time
T < 90%
T < 89%
T < 88%
T < 87%
N° Events SpO2 < 89%
∆ Index [12s]
T< 40 BPM
T> 120 BPM
N° Events < 40 BPM
N° Events > 120 BPM
spirobank II
DESCRIPTION
SpO2 Average in first three minutes
SpO2 Minimum during period of analysis
SpO2 Maximum during period of analysis
SpO2 Average during period of analysis
Average pulse frequency in the first 3 minutes
Minimum pulse frequency during the period of
analysis
Maximum pulse frequency during the period of
analysis
Average pulse frequency during the period of
analysis
Total time measure of SpO2
Time passed with SpO2 < 90 %
Time passed with SpO2 < 89 %
Time passed with SpO2 < 88 %
Time passed with SpO2 < 87 %
Fall of SpO2 below 89 % for at least 20 seconds
Index of SpO2 fluctuation calculated in intervals of
12 seconds
Time passed with pulse frequency < 40 BPM
Time passed with pulse frequency > 120 BPM
Bradycardia events during the entire period of
analysis
Tachycardia events during the entire period of
User’s Manual cod. 980200
Rev 2.2
BPM
BPM
Units
BPM
BPM
hh:mm:ss
% hh:mm:ss
% hh:mm:ss
% hh:mm:ss
% hh:mm:ss
hh:mm:ss
hh:mm:ss
Page 20 of 60
analysis
∆=DELTA
Measurement method:
Range of measurement %SpO2:
%SpO2 accuracy:
Average number of heart beats for the
%SpO2 calculation:
Range of measurement of cardiac pulse:
Accuracy of cardiac pulse:
Average interval for the calculation of
cardiac pulse:
Signal quality indication:
Red and infrared absorption
0 – 99% (with 1% increments)
± 2% between 70-99% SpO2
8 beats
30 – 254 BPM (with 1 BPM increments)
± 2 BPM or 2%
8 seconds
0 - 8 segments on display
Acoustic signals:
•
“Beep” with frequency of the cardiac pulse
•
Continuous beep in the case of either %SpO2 or cardiac pulse going outside of the
programmed levels of alarm
•
Continuous beep during oximetry measurement in the case of a low battery level.
The specifications for both the oximetry and for the cardiac pulse are the same regardless of
which of the above mentioned oximetry sensors is used.
1.6.3
Other features
Memory
Display
Keyboard
Interface
Power supply
Dimensions
Weight
Type of electrical protection
Type of electrical protection
Grade of protection against water
ingress
Level of safety in the presence of
inflammable anaesthetic gas,
oxygen or nitrogen
Conditions of use
spirobank II
Memory capacity for over 6000 spirometric
tests
The precise number depends on the individual
configuration, so it cannot be determined more
closely
STN graphic LCD,128x64 Pixel
Membrane keyboard with 6 keys
RS232, USB, Bluetooth
4 x AAA batteries 1.5V DC (type AAA), or
through USB connection
60x145x30 mm
180 grams (including batteries)
Class II device
BF
IPX1 device, protected against water drops
Device not suitable
Device for continuous use
User’s Manual cod. 980200
Rev 2.2
Page 21 of 60
Temperature: MIN 0 °C, MAX + 40 °C
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 60601-1-2
Storage conditions
Operating conditions
Applied norms
FUNCTIONING OF THE SPIROBANK II
2.
2.1
Keyboard
The spirobank II keyboard is composed of 7 keys:
Key functions are as followed:
On/Off
ESC
OK
esc/ok previous page
OSD key
Scroll left
OSD key
Scroll up
OSD key
Scroll down
OSD key
Scroll right
OSD key
Switching on spirobank II
To switch on spirobank II press
and then release.
Switching off spirobank II
To switch off spirobank II press
for at least two seconds.
CONFIRM: to confirm and pass to the next phase, use
or OK
Symbols and Icons
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 22 of 60
The icons used in the various function screens and their meanings are shown in the following
table:
ICON
DESCRIPTION
To access the set up (Service Menu) of spirobank II
To manage or enter new patient data from the main screen
To enter new patient data
To carry out a bronchodilator test
To make the test following the administration of a bronchodilator
To modify patient data
To carry out a spirometry or oximetry test
To access previous tests
To access to transmission data area
To search for tests made
To display oximetry test results of selected subject
To display spirometry test results of selected subject
To search test by subject ID code
To search test from date and onwards (partial memory)
To scroll through files on memory
To search patient by subject surname
To select male patient
To select female patient
To carry out a sleep oximetry test
To carry out an oximetry test while walking/Go to walking phase during test
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 23 of 60
To pass to the recovery phase during a walk test
To carry out a FVC spirometry test
To carry out a VC spirometry test
To carry out a MVV spirometry test
To access oximetry tests/To carry out an SpO2/BPM
To display previous tests in memory
To display next test in memory
To print data in memory (through Bluetooth connection)
To transfer data through a Bluetooth connection
To transfer data through acoustic coupling
% D
spirobank II
8&
-,
*=
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
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 24 of 60
2.3 Information
Switch on spirobank II by pressing
•
•
•
•
. The display will show:
spirobank II – 0.1 (device name and software revision number)
Power means (USB or battery symbol)
Current date and time
BTPS (Body Temperature Pressure Saturated)
•
icon (Access to the Service Menu)
• SpO2/BPM icon
Press OK to go to the second display. Press ESC to go directly to the main screen.
The second display will show:
•
•
•
•
•
ATS/ERS Standard
Subjects in memory (no. of registered patients)
Spiro (no. of spirometry tests made)
SpO2 (no. of oximetry tests made)
Available memory (% value).
If there is no information or test data in memory, i.e. the memory is empty, all data is shown
with 0 (null).
2.4 Initial Set-up
and wait for the second screen. Press
Switch on spirobank II by pressing and holding
to access the service menu. The following screen “Service Menu” contains the following menu:
•
•
•
•
•
•
•
•
•
•
•
•
Select Language (English default)
Turbine Calibration
Select Predicted Values
Delete MEMORY
Change Date/Time
Date Format
Units Format
Turbine Setup
Standard
Phone Setup
Bluetooth Setup
Firmware Info
Select the required option using
or
and the
symbol on the left of the screen; press OK
to access options; select the required setup using the
or
arrow, then press OK to return
to the Service Menu.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 25 of 60
Select Language
Press OK to access the Menu, use
or
to select the required language and then press
OK to register the change and return to the Service Menu.
Turbine Calibration
See Paragraph 2.4.1.
Select Predicted Values
Enter Menu with OK, then use
return to the Service Menu.
or
to select the required value and press OK again to
Delete Memory
Enter Menu with OK, then enter the password (
once, twice , three times
press OK; if the password inserted in correct, the following message appears:
) and then
Test data has been cancelled
Change Date/Time
In the date and time setting, the
arrow shown to the right of the field indicates the field to
modify. Use or
to modify the selected option; use
for the following option. Lastly, press
OK to return to the Service Menu. To return to the Service Menu display without entering any
changes press ESC.
Date Format
Use
or
to select the required format and press OK to enter and return to the Service
Menu.
Units Format
Access with OK and select imperial or metric, as required. Press OK again to return to the
Service Menu.
Turbine Setup
Access with OK and select the required turbine (disposable or reusable). Press OK again to
return to the Service Menu.
Standard
Access with OK and select the required standard using
Service Menu.
or
. Press OK to return to the
Phone Setup
Access with OK and then use the horizontal scroll arrow to select phone number (click on
number to insert in connect list). Having set the option, press OK to confirm and to return to
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 26 of 60
the Service Menu.
Bluetooth Setup
Access with OK to search for available devices, select “Search Device” and then press OK;
spirobank II will start to search for Bluetooth devices in the area; once one or more devices
are found the screen will display profiles, press OK to set the device as printer or phone, select
one of the two options and then press OK. On the “Bluetooth Setup” screen all devices
entered on the “printer list” and on the “phone list” can be checked. A device can be set as
default by accessing the lists with OK and then selecting the device, (to which spirobank II will
automatically connect) or deleted from the list (in this case press OK on the bottom to confirm
the deletion, or press ESC to go back and to not delete the device).
Firmware Info
Access through OK to view information on the revision of the following components, where
available, of spirobank II:
•
spirobank II
•
Bluetooth
•
Display
•
Oximetry
After approximately 10 seconds spirobank II automatically displays the Service Menu,
otherwise press ESC.
Having set the parameters (from the Service Menu) press ESC to access the second screen,
and then the main screen, as follows:
Which indicates:
• Patient name (A.Martin)
• Date of birth (dd mm yy)
• Height (cm)
• Weight (kg)
• Sex (S)
• Patient ID code
• Function icons
2.4.1
Turbine Calibration
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 27 of 60
Calibration of the turbine is performed using a calibration syringe to make an FVC test for the
expired parameters and an FIVC test for the inspired parameters.
To access the calibration function, select the “Turbine Calibration” option from the Service
Menu with the horizontal scroll key and then press OK. The following screen appears:
VOL. 300
Old FVC
Old FIVC
New FVC
New FIVC
BTPS
300
300
000
%Corr.
0.00
0.00
FVC=0 FACTORY CALIBRATION
The Old FVC and the Old FIVC values now shown are the ones from the last calibration.
The values under the %Corr. column indicate the correction factor. These are pre-set or 0 by
default.
To make the calibration:
1 - Insert the volume in cL of the calibration syringe in use (e.g. for a 3L syringe, insert 300
cL).
2 - Insert both the FVC and FIVC values, obtained by the measurement made with the
calibration syringe, in the New FVC and New FIVC field.
Press
to select the value to be modified (SIRIN, New FVC, New FIVC).
Use or
to modify the parameter value selected.
Insert both the FVC and the FIVC values. If the calculated correction factors are acceptable
(<10%), they are displayed beside the New FVC and New FIVC parameters. The message
ENTER OK TO CONFIRM will appear.
Press ESC to return to the Service Menu without entering the correction.
If the FVC and FIVC values produce a correction factor that is >10%, the FVC and FIVC
values will not be accepted. This means that the system cannot correct for such a large
calibration error. In this case:
- Check the correct functioning of the spirobank II with a new turbine and/or
- Clean the turbine.
To erase the calibration in use and reset to the factory calibration, input 0 in the New FVC
and New FIVC fields.
Then press OK to return to the Service Menu.
spirobank II
2 4
User’s Manual cod. 980200
Rev 2.2
Page 28 of 60
%
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2.5 Patient Data
Switch on spirobank II by pressing
, or if already switched on, press
icon); to
access the “PATIENT DATA MANAGEMENT” screen, the following table describes the
functions and displayed icons.
Icon
Key
Description
To enter new patient data
To make a bronchodilator test (i.e. make a test after drug
administration with defined dosage; to carry out this test, a pre test is
required)
To modify patient data already on file
To access memory
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 29 of 60
To enter new patient data
From the “Patient Data Management” menu press
to access the data input screen.
First screen (name and surname)
Use
and
to select required letters; confirm or delete using or . To input surname
press OK. The letters can also be selected automatically after a few seconds using the
cursor.
Press OK to go to the next screen.
Second screen (date of birth, weight, height, sex)
Use or
to select date of birth, use
to the right to set month, repeat to set year; continue
setting data by entering patient height, weight and sex using the same
key. The arrow
shown to the right of the field indicates the numerical value that is being changed. After this
operation use OK to go to the following screen; to return to the previous screen press , or
press ESC to exit set-up mode and go to the main screen.
Third screen (ethnic group)
Setting the correction factor: this value allows to adapt test data according to the patient ethnic
group (the “no correction” option can also be set); press OK to complete the setting of
parameters, the main screen then appears. In the event of an error during the setting of patient
data press
to go back to the previous screen.
' * & #( C
" .
;( C <9
'* &
To interrupt data input press ESC, which then goes back to the main screen.
POST BD Test
Use to set the spirometry test in “post” mode, i.e. after pharmacological bronchodilation. On
next screen use
to select either a POST or PRE test, using respectively
or ESC. Once
entered, the
icon will appear on the upper right of the main screen for POST testing of the
subject.
Before making the test enter the administered drug dosage in order to obtain an accurate
comparison of the two phases.
After carrying out the POST test, press OK to return to the PRE phase after viewing results in
memory; the following message appears: “Press OK to make new test on selected subject”.
To access memory
From the “Patient Data Management” screen use
four memory search methods (§ 2.6).
spirobank II
User’s Manual cod. 980200
to directly access the screen with the
Rev 2.2
Page 30 of 60
Modifying patient data
In the “Patient Data Management” menu press
which corresponds to the
icon. Modify
data in the following screens by using the keys as described for entering new patient data.
To return to the main screen without changing any data press ESC.
2.6 Displaying data in memory
From the main screen press
icon), to check patient data (choose between spirometry
and oximetry) or to search for another patient’s data; the following options are available:
KEY
ICON
FUNCTION
Display spirometry tests of the selected patient
Display oximetry tests of the selected patient
Access data in memory
Press ESC to return to the main screen.
Access the search menu to display data based on four different methods:
KEY
ICON
FUNCTION
Search by ID Code
Display files from a date and onwards
(partial memory)
Display files from beginning to end (full
memory)
Search by initial letter of surname
Search by ID Code: enter the ID Code of the patient to be searched for; then press OK to
access the data.
Partial Memory: enter test date of required file; after entering the date press OK to access
data. The data will be shown starting from the date entered up to the last file on memory.
Full Memory: to show data in alphabetical order.
The last data are marked by a double beep, then the data shown begin from the first one
recordered.
Search by Surname: enter patient surname, or first initial; then press OK to access the data.
Use
and
to display relevant patient test data.
Press ESC to return to the main screen without searching.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 31 of 60
Use
from the data screen (
icon) to print out data through a Bluetooth connection
(automatic); use
to display all test data of relevant file on memory, use
and
to scroll
through data; press OK to go back to the memory screen.
From this screen press OK to make a new test on the subject selected (press OK again),
press ESC to return to the data stored.
2.7 Online operating mode (connected to a PC)
This operating mode is comparable to a laboratory spirometer, connected to a PC the device
operates in real time. Connect the unit to a PC using either the USB cable or the RS 232
serial cable.
spirobank II thus acts as an intelligent sensor for flow and volume measurement while the PC
controls functions, including the switching on and off of the unit.
Connected to a portable PC, spirobank II can carry out epidemiologic studies in work
environments, school settings etc..
As well as the standard spirometric parameters and F/V curves in real time, the instrument
also calculates more refined indices such as the ventilatory profile and the extrapolated
volume (Vext).
The PC software also allows the latest bronchial challenge test protocols, with the graph of
the FEV1 dose-response and time-response curves.
!!' $ ! ( $
spirobank II
2.8 Spirometry Testing
To make a correct spirometry test we recommend to follow carefully the following instructions:
• Insert the mouthpiece into the protruding part of the turbine, by at least 0.5 cm;
• Fit the nose clip onto the nose of the subject to ensure that air cannot escape through
the nostrils;
• Hold spirobank II at either end in two hands, or alternatively hold it in one hand as you
would a cell phone. In either case, the display should be facing the user;
• Insert the mouthpiece well into the mouth beyond the teeth, being careful to ensure that
air cannot escape from the sides of the mouth;
• It is suggested to make testing in a standing position and during an expiration to lean
forward, to help the expiratory action with a compression of the abdomen.
!!' $ ! ( $
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 32 of 60
On the main screen press corresponding to
Then these icons are shown:
FVC
VC
icon.
MVV
SPO2
Press the key corresponding to the test required:
FVC
VC
MVV
SPO2
Forced Vital Capacity
Slow Vital Capacity
Maximum Voluntary Ventilation
Oximetry/Heart beat
The device displays the information regarding the turbine selected in the initial setting
(reusable or single-patient disposable), there follows the necessary information for each
screen in order to correctly carry out a test.
2.8.1
FVC Test
The phases as described on the screen must be followed, more specifically:
INSPIRE slowly
EXPIRE quickly
INSPIRE slowly
It is possible (and may be helpful) to start the test by breathing at rest for a few moments.
When ready to start inspire slowly as much air as possible (made easier by holding arms wide
apart) and then make a complete expiration as fast as possible. Then with the mouthpiece
always held firmly in the mouth, complete the cycle by inspiring again as quickly as possible.
This final inspiration may be left out if the inspiratory parameters (FIVC, FIV1, FIV1%, PIF) are
not of interest.
The optional initial inspiration phase can also be performed before inserting the mouthpiece in
the mouth.
After inspiring slowly and deeply, the following expiration must be made with the maximum
effort by expiring all air as fast as possible.
After 6 seconds of expiration the instrument will emit a continuous beep, this helps the user to
understand when the minimum expiry time has been reached.
!!' $ ! ( $
The test may be repeated several times by repeating the cycle without taking the mouthpiece
out of the mouth, in which case spirobank II recognises the best test (FVC+FEV1) and will
automatically show the results of this best test.
spirobank II
User’s Manual cod. 980200
Rev 2.2
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To end the test press OK.
During the test spirobank II emits "beeps", the frequency of which is directly proportional to the
inspired and expired air velocity. This is useful to the doctor to understand when the velocity of
the air is approaching zero, and therefore the patient has almost exhausted all of the inspired
or expired volume.
In the maintenance section an explanation is given as to how this feature can also function as
a very simple check system for the correct operation of the mobile “rotor” of the turbine.
For the FVC test to be judged as acceptable, besides breathing as deep as possible, it is also
required that the forced expiratory time (FET) is sufficiently long to allow for the complete
expiration of all air contained in the lungs.
Six seconds from the start of the forced expiratory test, spirobank II emits a continuous beep.
This is useful to the doctor to understand if the patient has reached the minimum expiry time,
as per the requirements of the major international pneumology associations.
2.8.2
VC Test
Ventilatory Profile
The Slow Vital Capacity test can be started by carrying out several complete breaths at rest.
After three or four such breaths a beep will sound to confirm that the ventilatory profile has
been measured and now you can proceed to carry out the VC or IVC test.
Expiratory Slow Vital Capacity: VC
After the beep inspire slowly as much air as possible and then expire slowly as much air as
possible.
Inspiratory Slow Vital Capacity: IVC
After the beep expire slowly as much air as possible and then inspire slowly as much air as
possible.
To end the test press OK.
To correctly carry out this test, follow the indications as described on the display.
2.8.3
MVV Test
Start the test by carrying out a series of forced inspirations and expirations with the
maximum possible amplitude. The suggested frequency is 30 breaths/min.
The test will terminate automatically after 12 seconds.
2.8.4
Reading messages
At the end of a test, a series of test messages are displayed followed by the measured
parameters.
There follows first a description of these messages and the parameters, in the order in
which they appear.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 34 of 60
If for 6 seconds no key is pressed then the unit moves automatically to the next message
or parameter.
2.8.5
Spirometry test interpretation
Spirometry test interpretation is based on the Forced Vital Capacity (FVC) test and is
indicated both by a message and a traffic light code (green, yellow, red). For each test
made, an arrow on the upper left part of the screen indicates the interpretation of that test.
The connection between the traffic light colour and the test interpretation is shown below:
The algorithm utilized for the spirometry test interpretation is obtained by means of the
flow chart in annex 3 of this manual.
Through an analysis applied to some of the indices and parameters calculated in the FVC
test, spirobank II produces a variety of quality control comments useful for
understanding the reliability of the test made.
Where several comments related to the single test are calculated, spirobank II will only
show the most important to facilitate the test interpretation.
ERROR IN Vext and PEFT
If the extrapolated volume Vext is greater than 500 mL or greater than 5% of the FVC, or if
the PEFT (time to peak flow) is greater than 300 ms, then the following comment is
shown:
FIRST EXPIRATION TOO SLOW
FLOW DROP 50%
If the flow rate falls and then increases again by over 50% during the first second of a
forced expiry, the following comment is shown:
COUGH DETECTED DURING TEST
FET error
If FET is under the predicted threshold the following message appears:
EXPIRY TIME INSUFFICENT <6S
FLOW ERROR
If the last flow point of the F/V curve is greater than 200 mL/s, this indicates that the
expiration was not complete and thus the following comment is shown:
BLOW OUT ALL AIR IN LUNGS
Between two tests, spirobank II evaluates the reproducibility of the following parameters:
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 35 of 60
repeatible if ∆PEF < 10 %
repeatible if ∆FVC < 150 mL
repeatible if ∆FEV1 < 150 mL
PEF
FVC
FEV1
2.8.6
Viewing the spirometric parameters
Following an FVC test, the spirometry test results are shown. The first screen displays the
main parameters FVC, FEV1, FE1%, PEF, the percentage of the predicted values, the
Flow/Volume chart plus a traffic light summary of the test interpretation (in the upper left
part), as illustrated below.
The following screens show other values compared to the predicted values.
2.9 Oximetry testing
spirobank II can carry out 4 different types of oximetry tests, which are described in the
following paragraphs.
!!' $ ! ( $
spirobank II
* (/
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spirobank II
!!' $ ! ( $
spirobank II
--3
spirobank II
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 36 of 60
For the non-invasive measurement of the SpO2 oxygen saturation and the blood pulse rate,
utilize the re-usable finger sensor. This sensor is recommended for patients weighing > 20 Kg
with limited activity.
spirobank II memorises the two oximetry values every 2 seconds.
Carry out an oximetry test as follows:
•
Connect the sensor to the instrument: insert the connector with the arrow (printed on the
connector) face-up, as shown:
•
•
Choose a high perfusion site, easily adaptable to the sensor.
Insert finger into the sensor until the finger touches the end of the probe.
Ensure that the bottom part of the finger completely covers the detector. If the finger is not
able to be correctly positioned, use another finger.
•
Position the sensor so that the cable is underneath the palm of the hand. This enables the
light source to remain on the fingernail and the detector on the bottom part of the finger.
From the main screen press to access the test menu.
Press
to access oximetry.
•
•
If this message appears:
WARNING THE OXIMETRY DEVICE IS NOT AVAILABLE
your instrument does not include an oximeter.
Instead, If this message appears:
WARNING THE OXIMETRY DEVICE IS NOT ENABLED
your instrument includes an oximeter but the function has not been enabled. In this case
contact a service centre or the manufacturer.
spirobank II
User’s Manual cod. 980200
Rev 2.2
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Alternatively, the display will show the screen with the oximetry tests that can be performed,
specifically:
ICON
KEY
DESCRIPTION
Walk test - 6MWT
Sleep oximetry
Oximetry (SpO2/BPM)
!!' $ ! ( $
During the first few seconds of the test the device searches for the best signal, after which the
timer re-sets to zero and spirobank II starts to memorise the data.
If the sensor has not been correctly inserted, the following message will appear:
WARNING
Sensor unplugged
If the sensor has been inserted but the finger is not inserted correctly, the following message
will appear:
WARNING
FINGER not detected correctly
If the sensor correctly receives the signal, after a few seconds the device starts to ‘beep’ and
the values will be displayed on the screen.
2.9.1
Walk Test (6MWT)
To make a walk test press .
This test is made up of 3 phases:
•
•
•
Initial rest
Walking
Recovery
Initial Rest
In this phase the display will show the following data:
•
•
•
Test time duration
Signal quality indication
Current phase
spirobank II
User’s Manual cod. 980200
Rev 2.2
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•
SPO2 % value and the instant cardiac pulse (heart symbol)
The duration of the test is minimum 2 minutes, then the screen shows
corresponding to
the
key; press this key to pass to the following phase. If the phase lasts for more than 6
minutes then spirobank II will emit a ‘beep’ as a reminder to pass to the following walking
phase.
The number of bars (“I” symbol), on the right upper of the screen is proportional to the quality
of the oximetry signal: the higher the quality of the signal the more bars will be shown
(maximum 7). Place finger into the sensor in order to obtain the highest quality of the signal.
Walking Phase
At the beginning of the phase the timer is reset to zero to give an accurate control of the
duration of each single phase. The data on the display is the same as shown before.
The duration of this phase is minimum 2 minutes, then the
icon appears corresponding
to . Press this key for a few seconds to pass to the initial rest phase. If this phase lasts for
more than 6 minutes then spirobank II will emit a ‘beep’ after which the device passes to the
initial phase and the timer is re-set to zero.
Recovery Phase
The user can decide freely on the duration of this phase, the duration is not suggested (at the
beginning of the phase the time is re-set to zero).
To end test press ESC and then
. This must be done each time the current test is
interrupted.
At the end of the test the data required for the calculation of the parameters must be inserted;
more specifically:
•
•
•
•
•
Baseline DYSPNEA
Final DYSPNEA
Baseline FATIGUE
Final FATIGUE
Distance (m)
These follow the Borg scale and can have the following values: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9,
10, the distance covered is indicated in m. Use and
to enter data; use OK to pass to next
data.
Walk test data results are given in the following 6 screens.
To print data see Paragraph 3.3. The printout version of the test will only show the walk test
results; an example of a test printout report is attached.
Press ESC and then
spirobank II
to end test at any moment.
User’s Manual cod. 980200
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2.9.2
Sleep Oximetry
To activate this type of test press
). This test records the variations that the
parameters of the patient undergo over night.
After approximately 5 minutes, spirobank II will go on standby i.e., it stops beeping and the
display turns off. The led signal remains on. To control the correct functioning while on
standby, press
, after 5 minutes spirobank II will return to standby.
If there is no signal while on standby the device will automatically exit this phase and a
warning message will appear (sensor unplugged or finger not detected correctly).
The data shown are the same as described in the preceding test, except for information on
this present phase, which has not been envisaged for this test.
After the required time the test can be interrupted as previously described.
To print data see Paragraph 3.3.; an example of a test printout report is attached.
2.9.3
SPO2 BPM Oximetry Test
!!' $ ! ( $
spirobank II
--3
To perform a non-invasive continuous monitoring of arterial oxygen saturation it is
recommended to use the reusable "wrap" sensor. The use of this sensor is indicated for
patients weighing more than 30 Kg and contraindicated for patients with allergy to adhesive
tape.
! !' $ ! ( $
4 4 !' L 8 ( ! ' $
2.9.3.1 Wrap Sensor – Instructions for Use
•
Select the most suitable point to apply the sensor. The
index finger is preferred. Other suggested points may
be the thumb, big toe or the smallest finger.
•
It is recommended to use a new piece of adhesive tape
for each patient or according to needs.
See instructions for changing the adhesive tape.
spirobank II
User’s Manual cod. 980200
Rev 2.2
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•
Hold onto the shell at the corner and remove it gently
from the sensor.
•
Place finger, with nail face-up, on the bottom pad
(longer probe) as shown. Fold the adhesive wing
upwards over the sides of the patient’s finger. Do not
pull or stretch the adhesive tape. Do not cover the nail.
•
Fold the pad of the emitter probe over the tip of the
patient’s finger. Separate the window of the emitter so
that it is diametrically opposite the window of the
detector.
•
Fold the adhesive wings downwards around the finger.
Do not pull or stretch the adhesive tape. Check that the
positioning lines of the emitter and of the detector are
aligned.
Positioning
lines
•
Connect the sensor to the instrument: insert the
connector with the arrow on the connector face-up and
control the correct functioning according to the previous
instructions.
!!' $ ! ( $
2.9.3.2 Making a Test
To start the test, press
spirobank II
from the oximetry test menu screen.
User’s Manual cod. 980200
Rev 2.2
Page 41 of 60
The display will show “oximeter (SpO2/BPM)”. The test duration is unlimited and the aim is to
record variations of the oximetry values during a period as decided by the doctor.
As with the sleep oximetry test, after circa 5 minutes the spirobank II goes into standby, so
the acoustic signal ceases and the display switches off, only the led remains illuminated. To
control the correct functioning during the standby phase, press the key
, then after 5
minutes spirobank II will return automatically to standby.
To end test press ESC and then .
To print data see Paragraph 3.3.; an example of a test printout report is attached.
If the finger is removed from the sensor during the test, the following message will appear
(even if on standby):
WARNING
Searching for signal, finger not inserted correctly
2.9.4
SPO2 BPM Test
This test allows the control of the oximetric data plus the cardiac pulse of a patient in real
time.
The test can only be accessed when the device is switched on by pressing
corresponding
to
on the first screen. To confirm press OK.
Relative data is memorised according to instructions shown on the screen prior to making the
test (ID#: “1234” and SURNAME: “OXYTEST”). This data is required when searching the
memory for related test data.
Test duration, SpO2 value and heart beat data are shown.
To end test see instructions contained in the previous paragraph.
DATA TRANSMISSION
!!' $ ! ( $
3.1 Wireless Data Transmission via Phone Line
This type of data transmission allows for the transfer of all data in the memory of spirobank II.
Through this method the doctor can control the information sent directly from the patient and
assess any changes to the therapy in course from his/her PC.
To transfer the data memorised during various tests to the doctor’s PC, follow this procedure:
•
•
Dial the doctor’s phone number (for example, the doctor’s office, telemedicine services,
or any other structure) directly on the telephone at use.
Place spirobank II and the phone on a level surface as shown in the figure:
spirobank II
User’s Manual cod. 980200
Rev 2.2
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The suitable distance between
spirobank II and the phone receiver is
between 2 and 5 cm
•
Place the microphone of the telephone (the microphone is near the cable) near to the
spirobank II as shown in the figure, with the phone receiver (beneath the device’s ID
label). The hole should be close to (2 to 5 cm) the microphone’s hole positioned on the
receiver.
spirobank II
spirobank II
•
From the main screen press
•
•
Then press
corresponding to the
icon.
A confirmation for the transmission is requested by pressing OK, otherwise it is possible
to exit the programme by pressing ESC.
spirobank II now emits a series of acoustic signals indicating that the data transmission
has started.
Wait until spirobank II has completed the transmission (the instrument ceases to emit an
acoustic signal).
At the end of the transmission the message “TRANSMISSION TERMINATED” will
appear.
•
•
•
corresponding to the
icon.
At any time during the transmission the process may be terminated by pressing ESC.
During this procedure it is strongly suggested to:
•
•
•
Eliminate all external noises;
Do not touch or move spirobank II and the receiver;
Be sure to have fully understood the procedure before starting the transmission.
spirobank II
User’s Manual cod. 980200
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!!' $ ! ( $
High frequencies emitted by electronic devices can cause interference with the correct
functioning of the instrument. For this reason a minimum safety distance (a few metres) must
be maintained when in the same room another apparatus or device such as TV, radio,
appliances, cell phones, radio phones etc. are being used.
If the instrument is connected to other devices (PC, printers, modem etc.) to preserve the
characteristics of the safety system pursuant to the IEC 601-1-1 Standards, it is required that
only devices complying with these safety regulations are used.
3.2 Data Transmission via Bluetooth to a cell phone
spirobank II includes a “Bluetooth” wireless data transmission system. This connection is
through radio and allows spirobank II to be connected to a suitable cell phone. The method of
data transmission allows the transferring of all the data in spirobank II.
The sequence of operations to follow is described below.
3.2.1
Preliminary Operations
!!' $ ! ( $
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3.2.2
•
•
•
•
•
•
•
/3
Setting the Phone Number
Turn on spirobank II by pressing
On the first screen press
From the “Service Menu” select the option “phone set up” using and
Press OK
Enter the number by using
and
to select digits, and the OK to confirm the selected
number.
Return to the Service Menu by pressing OK
From the “Service Menu” access the main screen by pressing ESC.
3.2.3
•
< !
Bluetooth Data Transmission
From the main screen press
spirobank II
corresponding to the
User’s Manual cod. 980200
Rev 2.2
icon.
Page 44 of 60
•
•
Press
corresponding to the
icon.
The selected transmission will be shown, to confirm press OK to activate the connection
with the default device set up.
When required by the cell phone, enter the PIN code shown on the spirobank II display
(corresponding to the serial number (SN) of the machine shown on the spirobank II ID
label).
The connection phases then follow.
When the connection is completed the data transfer to the default modem starts.
The message “transmission completed” appears at the end of the transfer.
•
•
•
•
The following information is now shown on the display:
•
•
•
The device used for the connection (as described in the initial settings).
The telephone number (as described in the initial settings).
The preset PIN (corresponding to the serial number of the machine).
To interrupt the data transmission during the Bluetooth connection press ESC, to end the
connection and return to the main screen.
Where no device has been setup for data transmission, a message will appear on the display
to start searching for enabled devices. After setting the device the connection will start
automatically.
3.3 Data Transmission via Bluetooth for printing
!!' $ ! ( $
*= "
The Bluetooth system enables spirobank II to transfer test data directly to a Bluetooth
enabled printer. The sequence of activities to be followed is:
•
From the main screen select the test to be printed with
•
On the next screen press
•
•
Print either a spirometry or an oximetry test by selecting respectively
or .
By choosing to print spirometry tests, the last test of the patient selected on the main
screen will be shown.
By selecting oximetry tests, the last test made pertaining to that patient will be printed.
•
icon).
Tests stored on memory can also be printed. Use the search method as described in
Paragraph 2.6 to print out relevant tests.
•
•
On the relevant test screen press .
spirobank II will carry out the connection.
spirobank II
User’s Manual cod. 980200
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•
At the end of transmission spirobank II will show “CONNECTION COMPLETED”, and
return automatically to the main screen.
To interrupt the Bluetooth connection during transmission press ESC to return to the main
screen.
Where no printer has been set up, a message will appear to search for devices. After the
device has been set up it will automatically be enabled for printing data.
When searching for enabled for Bluetooth devices, spirobank II will check the address of that
device and where a previously registered device has changed name, it will be automatically
updated.
3.4 Connection to a PC through USB port
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spirobank II
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To make the connection, insert the mini USB connector supplied
with spirobank II as shown in the picture and attach the other
connector to the USB port of the PC.
At the first connection, the PC will request the installation of the
driver corresponding to the new device being used; follow the
automatic procedure in the operating system, enter the following
path when the request for the driver appears.
For Windows 2000 and higher versions enter the following path:
C\Programmi\MIR\winspiroPro\DriverUSB\win2000-xp,
For Windows 98 enter the following:
C\Programmi\MIR\winspiroPro\DriverUSB\win98
To check the connection between the device and the PC, ensure that the led on the device is
illuminated.
3.5 Connection to a PC through the RS 232
spirobank II
User’s Manual cod. 980200
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spirobank II can also be connected to a PC
through the RS 232 serial port. This leaves
the USB port free and the device is run
directly by the software (as a USB
connection). The picture shows the RS 232
connector attached to spirobank II.
For the correct management of the device
see the online manual of the software.
3.6 Upgrade Internal software
spirobank II software can be upgraded when connected to a PC (USB or RS232). Upgrades
can be downloaded by registering on www.spirometry.com. For further information on
upgrading software see the “winspiroPro” software manual.
MAINTENANCE
spirobank II is an instrument that requires very little maintenance. The operations to perform
periodically are:
•
•
•
•
•
Cleaning and controlling of the reusable turbine.
Changing the disposable turbine before each test.
Cleaning of the oximetry sensor (for reusable sensors).
Changing the adhesive tape of the oximetry wrap sensor.
Changing the battery.
The maintenance operations described in the User’s Manual must be carried out carefully.
Failing to observe the instructions may cause errors in measurement or in the interpretation of
the measured values.
Modifications, adjustments, repairs, and reconfiguration must be carried out by the
manufacturer or by authorised persons.
In case of problems do not attempt to repair the unit.
The setting of configuration parameters must be carried out by qualified personnel. In any
case the risks pertaining to incorrect configuration settings do not constitute a danger for the
patient.
4.1 Cleaning and controlling the reusable turbine
The turbine utilized by spirobank II belongs to one of two categories: disposable and
reusable. These guarantee precise measurements and have the great advantage of requiring
no periodic calibration. In order to maintain the characteristics of the turbine a simple cleaning
is required prior to each use (only for the reusable turbine). This operation will also
guarantee perfect hygiene and the highest possible safety conditions for the patients.
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.
spirobank II
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!!' $ ! ( $
To clean the reusable turbine, first remove it by pulling it gently from the spirobank II turning
it anti-clockwise and pressing lightly. It can be helpful to push it gently from underneath with
one finger.
Immerse the turbine in a cold sterilising liquid and move it within the liquid to remove any
impurities which may be deposited inside. Leave it to soak for at least the time recommended
by the producer of the cleaning solution, as shown in the relevant instructions (in general at
least 20 minutes).
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.
To ensure that the turbine is functioning correctly before replacing it inside the instrument, it is
good practice to make a visual check of the rotation blade. Placing the turbine tube
horizontally and moving it gently from left to right and vice versa, the rotation blade (rotor)
must rotate freely. Otherwise, accurate measurement is no longer guaranteed and the turbine
must be replaced.
Once the turbine has been cleaned insert the turbine tube in its place following the
instructions indicated by the closed lock symbol printed on the plastic casing of the spirobank
II.
To insert the turbine correctly push it and then turn it clockwise until it reaching the stop,
which ensures that the tube has been blocked inside the casing.
4.2 Changing the adhesive tape of the wrap sensor
The adhesive tape is made with latex-free material.
•
•
Gently remove the used adhesive tape from the sensor and dispose of it.
The back of the sensor has alignment pins. Place the sensor with the alignment pins
facing the adhesive part of the tape and align the pins to the holes on the tape.
spirobank II
User’s Manual cod. 980200
Rev 2.2
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•
Push the sensor so as to insert the pins into the holes of the tape. Lift both the sensor
and the tape and check that the pins of the sensor are correctly aligned.
4.3 Changing the Batteries
If the message "BATTERY DISCHARGED" appears on spirobank II display, or if the
instrument does not switch on, the batteries inside the compartment shown here under must
be changed as per the following points:
•
•
•
•
Remove the back cover by pressing and pushing it away from the device.
Remove the discharged batteries.
Replace with new batteries, inserting them properly into the slots.
Close the battery compartment by replacing the back cover and sliding it towards the inside
of the device.
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The device has an internal lithium battery for RAM memory; the average life is approximately
10 years. If the display shows the following message:
Warning change lithium battery
Call a service centre or the manufacturer for replacement.
PROBLEM SOLVING
There follows a list of problems that may arise when working with spirobank II. Diagnostic
messages are also shown on the display indicating the type of malfunction:
5.1 Causes and Solutions
•
spirobank II does not switch on
spirobank II
User’s Manual cod. 980200
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Check that batteries are correctly inserted in the compartment on the back of the
instrument. If they are correctly positioned then replace them with new ones.
•
During operation the machine switches itself off and on again
Change the batteries. Contact the technical service centre.
•
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.
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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/Oximeter
spirobank II
II
This Device is marked
Any modifications to the Device which are not authorised by MIR will invalidate this
Declaration
Rome 01 / 01/ 2006
Simon Fowler
Sales Manager
Carmine Cerullo
Quality Manager
Rev.0 – Mod. PO-10DDC_spirobank II
spirobank II
User’s Manual cod. 980200
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LIMITED WARRANTY CONDITIONS
spirobank II, together with its standard accessories is guaranteed for a period of:
•
12 months if intended for professional use (doctors, hospitals, etc.)
•
24 months if the product has been purchased directly by the end user.
The warranty is effective from the date of purchase shown on the relevant sales invoice or
proof of purchase.
The warranty is effective from date of sale which must be shown on the relevant sales invoice
or proof of purchase.
The instrument must be checked at the time of purchase, or upon delivery, and any claims
must be made immediately in writing to the manufacturer.
This warranty covers the repair or the replacement (at the discretion of the manufacturer) of
the product or of the defective parts without charge for the parts or for the labour.
All batteries and other consumable parts are specifically excluded from the terms of this
guarantee.
This warranty is not valid, at the discretion of the manufacturer, in the following cases:
•
•
•
•
•
•
•
If the fault is due to an improper installation or operation of the machine, or if the
installation does not conform to the current safety norms in the country of installation.
If the product is utilised differently from the use described in the User’s Manual.
If any alteration, adjustment, modification or repair has been carried out by personnel not
authorised by the manufacturer.
If the fault is caused by lack of or incorrect routine maintenance of the machine.
If the machine has been dropped, damaged or subjected to physical or electrical stress.
If the fault is caused by the mains, or by a product to which the instrument has been
connected.
If the serial number of the instrument is missing, tampered with and/or not clearly legible.
The repair or replacement described in this warranty is supplied for goods returned at the
customers’ expense to our certified service centres. For details of these centres please
contact your local supplier of the spirometer or contact the manufacturer directly.
The customer is responsible for the transportation and for all transport and customs charges
as well as for delivery charges of the goods both to and from the service centre.
Any instrument or accessory returned must be accompanied by a clear and detailed
explanation of the defect or problem found. If units are to be returned to the manufacturer then
written or verbal permission must be received before any instruments are returned to MIR.
MIR – Medical International Research reserves the right to modify the instrument if required,
and a description of any modification made will be sent along with the returned goods.
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ANNEX 1
spirobank II
OXYMETRY TEST REPORT EXAMPLES
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spirobank II
User’s Manual cod. 980200
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spirobank II
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ANNEX 2
INFORMATION
FOR
ELECTROMAGNETIC ENVIRONMENT
CORRECT
USE
IN
Guidance and manufacturer’s declaration – electromagnetic emissions
The spirobank II is intended for use in the electromagnetic environment specified below.
The customer or the user of the Spirobank II should assure that it is used in such an
environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions
Group 1
The spirobank II uses RF energy
CISPR 11
only for its internal function.
Therefore, its RF emissions are very
low and are not likely to cause any
interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
Harmonic emissions
Not applicable
IEC 61000-3-2
Voltage fluctuations/
Not applicable
flicker emissions
IEC 61000-3-3
spirobank II
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AN
Guidance and manufacturer’s declaration – electromagnetic immunity
The spirobank II is intended for use in the electromagnetic environment specified below. The customer
or the user of the spirobank II should assure that it is used in such an environment.
Immunity test
IEC 60601
Compliance level
Electromagnetic environment –
test level
guidance
Electrostatic
Floors should be wood, concrete or
±6 kV contact
±6 kV contact
discharge (ESD)
ceramic tile. If floors are covered with
synthetic material, the relative humidity
±8 kV air
±8 kV air
IEC 61000-4-2
should be at 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
Not Applicable
Mains power quality should be that of a
±1
kV
differential
typical
commercial
or
hospital
mode
IEC 61000-4-5
environment.
±2 kV common mode
<5 % UT
Voltage
dips,
Not Applicable
(>95 % dip in UT)
short
interruptions and
for 0,5 cycle
voltage
variations
40 % UT
on power supply
(60 % dip in UT)
input lines
for 5 cycles
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
3 A/m
3 A/m
IEC 61000-4-8
Portable and mobile RF communications
equipment should be used no closer to any
part of the spirobank II, including cables,
than
the
recommended
separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance
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 II
Power frequency magnetic fields should be
at levels characteristic of a typical location
in a typical commercial or hospital
environment.
[3 ] V
[3 ] V/m
User’s Manual cod. 980200
d=[ 3.5 ]
d=[ 3.5 ]
P 80 MHz to 800 GHz
d=[ 7
P 800 MHz to 2,5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter manufacturer
Rev 2.2
Page 57 of 60
and d is the recommended separation
distance in metres (m).
Field strengths from fixed RF transmitters,
as determined by an electromagnetic site
survey,
should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE UT is the a.c. mains voltage prior to application of the test level.
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the spirobank II is used exceeds the
applicable RF compliance level above, the spirobank II should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or relocating the spirobank
II.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [3] V/m.
spirobank II
User’s Manual cod. 980200
Rev 2.2
Page 58 of 60
Recommended separation distances between
portable and mobile RF communications equipment and the spirobank II
The spirobank II is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the spirobank II can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
the spirobank II as recommended below, according to the maximum output power of the communications
equipment.
Rated
maximum
output
power of transmitter
0.01
0.1
10
100
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d=[ 3.5 ]
d=[ 3.5 ]
0.12
0.37
1.17
5.28
11.66
d=[ 7 ]
0.24
0.37
1.17
5.28
11.66
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 II
User’s Manual cod. 980200
Rev 2.2
Page 59 of 60
ANNEX 3
spirobank II
SPIROMETRY TEST INTERPRETATION FLOW CHART
User’s Manual cod. 980200
Rev 2.2
Page 60 of 60

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