MIR Medical Research MIR040 Portable multipurpose and multifunction spirometer User Manual spiro

MIR Medical International Research Portable multipurpose and multifunction spirometer spiro

UserMan

Spirodoc cod. 980156 Rev 1.3 EN 1/67
ENGLISH
Spirodoc
User Manual Rev. 1.3
Issued on 27/04/2010
Approved on 27/04/2010
INDEX
1. EQUIPMENT AND ACCESORY LIST ................................................................ 3
2. INTRODUction ................................................................................................... 4
2.1 Intended use ................................................................................................ 4
2.1.1 User category .......................................................................................... 5
2.1.2 Ability and experience required ............................................................... 5
2.1.3 Operating Environment ........................................................................... 5
2.1.4 Who can or must make the installation.................................................... 6
2.1.5 Patient effect on the use of the device .................................................... 6
2.1.6 Limitations of use - Contraindications...................................................... 6
2.2 Important safety warnings............................................................................ 6
2.2.1 Danger of cross-contamination ............................................................... 7
2.2.2 Turbine .................................................................................................... 7
2.2.3 Mouthpiece .............................................................................................. 8
2.2.4 I Oximetry sensor .................................................................................... 8
2.2.5 Device ................................................................................................... 10
2.3 Unforeseen errors ...................................................................................... 11
2.4 Lithium-ion battery pack warning ............................................................... 11
2.5 Labels and symbols ................................................................................... 14
2.5.1 Identification label.................................................................................. 14
2.5.2 CE mark for medical devices ................................................................. 14
2.5.3 Electrical safety symbol ......................................................................... 14
2.5.4 Warning symbol for the RS232 serial port ............................................. 14
2.5.5 Warning symbol for the USB serial port ................................................ 14
2.5.6 Warning symbol for the SpO2 port for oximetry .................................... 15
2.5.7 Warning symbol for the WEEE .............................................................. 15
2.5.8 FDA and FCC Warnings ........................................................................ 15
2.5.9 Product description................................................................................ 16
2.6 Technical specifications ............................................................................. 18
2.6.1 Features of the spirometer .................................................................... 18
2.6.2 Oximeter features .................................................................................. 19
2.6.3 Other features ....................................................................................... 23
3. Functioning of the SPIRODOC .......................................................................... 23
3.1 Display ....................................................................................................... 23
3.2 Accensione e spegnimento di SPIRODOC ................................................ 24
3.3 Symbols and Icons .................................................................................... 24
3.4 Energy saving ............................................................................................ 25
3.5 Information ................................................................................................. 25
3.6 Service menu ............................................................................................. 26
3.6.1 Patient Mode ......................................................................................... 31
3.6.2 Reusable turbine calibration .................................................................. 32
3.7 Patient Data ............................................................................................... 34
3.7.1 Inserting data of a new patient .............................................................. 34
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3.7.2 Patient data modification ....................................................................... 35
3.8 Visualization of memory data ..................................................................... 36
3.8.1 Database research modality .................................................................. 36
3.8.2 Visualization of database info ................................................................ 36
3.9 Display of last session from current patient. .............................................. 37
3.10 PC On line mode (connected to a PC) ...................................................... 37
3.11 Spirometry testing ...................................................................................... 38
3.11.1 FVC test ................................................................................................ 39
3.11.2 Test VC ................................................................................................. 40
3.11.3 MVV Test .............................................................................................. 40
3.11.4 POST test, after drug administration ..................................................... 40
3.12 Viewing the spirometric results .................................................................. 41
3.12.1 Spirometry Test Interpretation ............................................................... 41
3.13 Oximetry Testing ....................................................................................... 43
3.13.1 Walk test (6MWT).................................................................................. 46
3.13.2 Sleep Oximetry ...................................................................................... 48
3.13.3 Oximetry SpO2/BPM ............................................................................. 49
3.13.4 Instructions for Adult Single Patient Sensor .......................................... 49
4. datA TRANSMISSION ...................................................................................... 50
4.1 Data Transmission via Bluetooth to a cell phone ....................................... 51
4.1.1 Preliminary Operations .......................................................................... 51
4.1.2 Bluetooth data transmission. ................................................................. 51
4.2 Data transmission via Bluetooth for printing .............................................. 52
WARNING ............................................................................................................... 52
4.2.1 How to print a test saved in the database ............................................. 52
4.3 PC connection via USB port ...................................................................... 52
4.4 PC connection via Bluetooth ...................................................................... 53
4.5 Internal software upgrade .......................................................................... 53
5. MAINTENANCE ............................................................................................... 53
5.1 Cleaning and checking the reusable turbine .............................................. 54
5.1.1 Proper turbine operation check ............................................................. 55
5.2 Oximetry sensor cleaning .......................................................................... 55
5.3 Changing the adhesive wrap sensor ......................................................... 56
5.4 Battery charging ........................................................................................ 56
6. PROBLEM SOLVING ....................................................................................... 56
6.1 Causes and solutions ................................................................................ 56
LIMITED WARRANTY CONDITIONS ......................................................................... 59
ALLEGATO 1 OXIMETRY TEST REPORTS EXAMPLES .................................. 60
ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE .................................. 63
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC
ENVIRONMENT.......................................................................................................... 64
Spirodoc cod. 980156 Rev 1.3 EN 3/67
ENGLISH
1. EQUIPMENT AND ACCESORY LIST
Thank you for choosing a MIR product
MEDICAL INTERNATIONAL RESEARCH
The original packaging of the product contains one of the following spirometers with
the following accessories:
spirometer configuration
Spirometer and oximeter configuration
Accesssories sold with
SPIRODOC
COD.
Accessories sold with
SPIRODOC
Carrying bag SPIRODOC
672690
Carrying bag SPIRODOC
Device SPIRODOC
910575
Device SPIRODOC with
oximetry function
User manual SPIRODOC
980205
User manual SPIRODOC
USB cable
532365
USB cable
Lithium-ion battery pack
970080
Lithium-ion battery pack
winspiroPRO CD
920100
winspiroPRO CD
1 noseclip
910320
1 noseclip
4 paper mouthpieces *
910300
4 paper mouthpieces *
1 reusable turbine
910002
1 reusable turbine
3 disposable turbines
910001
3 disposable turbines
1 oximetry sensor
Accessori
COD.
Accessori
Battery charger with micro
USB connector
920680
Battery charger with micro USB
connector
Disposable adult oximetry
sensor for extended length of
time screening*
Extension cable for oximetry
sensor
* disposable accessory: all other accessories are reusable
Before using your SPIRODOC
Read carefully your User Manual and pay attention to all the warnings and labels
including all relevant information included with the product.
If necessary pay attention to the correct polarity “+” & “-“ when inserting the battery
pack as indicated in the battery housing
Set the device configuration (date, hour, predicted set, language, ecc) as described
in paragraph 2.4
WARNING
Before connecting the SPIRODOC to the PC, the winspiroPRO PC software
supplied with the device must be installed correctly in the PC. The device
may be connected to the PC only after the winspiroPRO software has been
installed. Once the new hardware is "recognised" by the PC the device may
now be used with the winspiroPRO software.
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Keep the original packaging!
In the unlikely event that you have a problem with your device please use the original
packaging and return it to the distributor or manufacturer.
Should this be the case, please follow these guidelines:
Return the complete device in the original packaging.
Shipping costs any any customs duties must be paid by the sender.
Manufacturer‟s address:
MIR SRL
VIA DEL MAGGIOLINO, 125
00155 ROME (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. MIR
reserves the right to modify and update the information in this User’s Manual
as deemed necessary. Any suggestions and or comments regarding this
product may be sent via email to: mir@spirometry.com.
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
incorrect use of the product.
Please 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
2. INTRODUCTION
2.1 Intended use
The Spirodoc spirometer and pulse oximeter is intended to be used by a physician or
by a patient under the supervision/instruction of a physician or paramedic.
The lung function testing device is capable of performing:
spirometry testing in people of all ages, excluding infants and neonates
oximetry testing in people of all ages.
It can be used in any setting.
Spirodoc cod. 980156 Rev 1.3 EN 5/67
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2.1.1 User category
SPIRODOC spirometer + oximeter calculates a series of parameters relating to human
respiratory function.
Typically the doctor “prescribes” a spirometry test and is responsible for analysing and
checking the results obtained.
2.1.2 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 to be operated
by a patient, sufficient training must first be given to the patient by the doctor or by a
trained paramedic under the supervision of a doctor.
WARNING
The manufacturer cannot be held responsible for any damage caused by the
user of the device failing to follow instructions and warnings in this manual.
If the user of the device is a person considered to be cognitively impaired the
operation of the device must be made under the supervision and
responsibility of whoever is legally responsible to supervise this person.
WARNING
When used as a pulse-oximeter, the SPIRODOC is intended for spot-
checking, overnight sleep screening and/or continuous monitoring when
used by a trained healthcare professional.
2.1.3 Operating Environment
SPIRODOC has been designed for use in the doctor‟s office, in a hospital or directly by
the patient to continuously monitor her/his physical conditions during routine daily
activities. All information necessary for the proper use of the device in an
electromagnetic environment (as required by the EN 60601-1-2 Standard) is available
in Annex 3 of this manual.
Used at home, at work, at school or during physical activity, day after day the device
records data and functional respiratory parameters for weeks or even months, helping
the patient to better assess her/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 patient to correctly perform tests and obtain correct
results, to be analysed by the doctor.
The device 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 device is not designed to be used in direct air drafts (e.g. wind), sources of heat or
cold, direct sunlight or other sources of light or energy, dust, sand or any chemical
substances.
The user and/or doctor is responsible for ensuring that the device is stored and used in
appropriate environmental conditions; in this regard reference is made to the
specifications described in paragraph 2.7.3 below.
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WARNING
Exposure to unsuitable environmental conditions may cause the device to
malfunction, and to provide incorrect results.
2.1.4 Who can or must make the installation
The device requires installation by qualified personnel. The doctor will configure the
device before handing it over to the patient for homecare use.
2.1.5 Patient effect on the use of the device
A spirometry test should only be carried out when the patient is at rest and in good
health, in suitable testing conditions. A spirometry test requires the full collaboration of
the patient since she/he must perform a complete forced expiration, in order to obtain a
reliable test result.
2.1.6 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 patient‟s clinical condition. A detailed clinical history of the
patient is also required together with the results of any other test(s) suggested by a
doctor.
Test comments, a test interpretation and suggested therapeutic treatment must be
given by a doctor.
Any symptoms that the patient 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 condition of the patient in order to perform a proper test, furthermore,
in the evaluation of test results, the user must also assess the degree of collaboration
of each test carried out.
A spirometry test requires the full collaboration of the patient. The results depend on
the person‟s ability to inspire as much air as possible and to expire all of the air as
fast and for as long as possible. If these fundamental conditions are not achieved the
results obtained during spirometry testing may not be considered accurate, and
“acceptable”.
The acceptability of a test is the responsibility of the doctor. Special attention should
be given when testing elderly patients, children and handicapped people.
The device should not be used if any conceivable or actual anomalies or malfunctions
appear which may compromise the accuracy of the results.
WARNING
When used as a pulse oximeter the SPIRODOC has limited alarms, therefore
the device requires that the user frequently observe the SpO2 and pulse rate
on the display.
2.2 Important safety warnings
SPIRODOC has been examined by an independent laboratory which has certified
the compliance of the device to the European Safety Standards EN 60601-1 and
guarantees the EMC Requirements within the limits laid down in the European
Standard EN 60601-1-2.
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SPIRODOC is continuously checked during manufacturing and therefore the product
complies with 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 to see that there is no visible
damage. In case of damage do not use the device and return it to the manufacturer for
repair.
WARNING
The safety and the correct performance of the device can only be assured if
the user respects all of the relevant safety rules and regulations.
The manufacturer will not be held responsible for damage due to user’s
neglect to correctly to follow these instructions.
The device must be used only and exclusively as a spirometer following the
indications given by the manufacturer with particular attention to the
paragraph on INTENDED USE, and utilizing only original spare parts and
accessories. Use of non-original parts such as the turbine flow sensor and
oximetry sensor or other accessories may cause errors in measurement
and/or compromise the correct functioning of the device, and is therefore not
permitted.
The device should not be used beyond the declared life span. The life span is
strictly related to the life of the internal lithium battery pack. In normal
conditions the lifespan of the battery pack is estimated to 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.
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.
2.2.1 Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable
and the other is single-patient disposable. A disposable mouthpiece is required in
order to connect a patient to the spirometer. In order to avoid exposing the patient to
the critical danger of cross-contamination, the reusable flow sensor must always be
cleaned before each spirometry test, and a new disposable mouthpiece must always
be used for each patient. The use of an anti-bacterial filter is at the discretion of the
doctor. If a single-patient disposable turbine is used, then a new one must be used for
each patient.
2.2.2 Turbine
Disposable turbine
WARNING
If you are going to perform a spirometry test with a
disposable turbine it is important to use a new turbine
for each new patient. The features, accuracy and
hygiene of the disposable turbine can only be
guaranteed if it has been conserved beforehand in its
original sealed packaging.
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The disposable turbine is made of plastic and its disposal
after use should adhere to the local regulations and norms
in force.
Reusable turbine
The correct functioning of the re-usable turbine can only be
guaranteed if it has been cleaned in the correct manner and
is free from foreign bodies which could alter its movement.
If the turbine has not been cleaned sufficiently this could
cause cross-contamination from one patient to another.
Periodic cleaning should only be done when the device 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 running water or direct air pressure and must
never come into contact with hot fluids.
Do not allow dust or foreign bodies to enter the turbine sensor which may alter the
correct functioning and possibly cause 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.
2.2.3 Mouthpiece
Any disposable mouthpieces included with the spirometer are only to be used as a
reference guide to purchase the correct size mouthpiece required. These mouthpieces
are clean but not sterile. To purchase appropriate mouthpieces, generally either paper
or plastic, single-use/disposable, we suggest that you contact your local distributor.
WARNING
Use a bio-compatible mouthpiece to avoid any problems to the patient;
unsuitable materials could cause the device to malfunction, consequently
providing incorrect test results.
The user is responsible for obtaining the proper 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.
WARNING
To avoid environmental contamination caused by the disposal of used
mouthpieces, the user must follow all the relevant local regulations.
2.2.4 I Oximetry sensor
The oximetry sensors which can be used with SPIRODOC are the following:
Manufacturer
Code
Description
BCI
1300
adult sensor (disposable)
BCI
3026
wrap-around sensor for infants
Spirodoc cod. 980156 Rev 1.3 EN 9/67
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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 finger sensor, reusable
These sensors require the use of an extension cable (product code 919200) for a
proper connection to the device.
The same sensors are also available with a microconnector for a direct connection.
Prolonged use and/or the patient‟s condition may require changing the sensor site
periodically. Change sensor site and check skin integrity, blood circulation, and correct
sensor alignment at least every 4 hours.
WARNING
Incorrectly applied oximetry sensors or damaged cables may cause
inaccurate readings. Using a damaged oximetry sensor may cause
inaccurate readings, possibly resulting in patient injury or death. Inspect
each oximetry sensor before use.
If an oximetry sensor appears damaged, do not use it. Use another oximetry
sensor or contact your authorized repair center for assistance.
Use only MIR oximetry sensors supplied with, or specifically intended for use
with SPIRODOC. Use of oximetry sensors not intended for use with the
SPIRODOC may cause inaccurate readings.
Oximetry measurements may be inaccurate in the presence of high ambient
light. Shield the sensor area (with a surgical towel, for example) if necessary.
WARNING
Dyes introduced into the bloodstream, such as methylene blue, indocyanine
green, indigo carmine, patent blue V (PBV), and fluorescein may adversely
affect the accuracy of the oximetry reading.
Any condition that restricts blood flow, such as the use of a blood pressure
cuff or a device for systemic vascular resistance, may cause an inability to
determine accurate pulse rate and SpO2 readings.
Remove fingernail polish and/or false fingernails before applying SpO2
sensors. Both may cause inaccurate oximetry measurement.
Significant levels of dysfunctional hemoglobins, such as carboxyhemoglobin
or methemoglobin, may adversely affect the accuracy of the oximetry
measurement.
Optical cross-talk can occur when two or more sensors are placed in close
proximity. Optical cross-talk may adversely affect the accuracy of the
oximetry readings. The danger can be eliminated by covering each site with
opaque material.
Spirodoc cod. 980156 Rev 1.3 EN 10/67
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Obstructions or dirt on the sensor’s emitter and/or detector may cause a
sensor failure or inaccurate readings. Make sure there are no obstructions
and the sensor is clean.
Autoclaving, ethylene oxide sterilizing, may cause sensor damage. Do not
attempt to sterilize the sensor.
Unplug the sensor from spirodoc before cleaning or disinfecting to prevent
damaging sensor or device, and to prevent safety hazards for the user.
2.2.5 Device
WARNING
The maintenance operations detailed in this manual must be fully and
accurately carried out. If these instructions are not followed this may cause
measurement errors and/or an incorrect test interpretation.
Any modifications, adjustments, repairs or reconfigurations must be made
by the manufacturer or by personnel authorised by the manufacturer. Never
attempt to make a repair on your own. The set-up of configurable parameters
should only be made by qualified personnel. However, an incorrect set-up of
the parameters in no way endagers the patient’s health.
High-frequency emissions from “electronic” devices may interfere with the
correct operation of the device. For this reason, certain minimum clearances
(a few meters) 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 device may give inaccurate readings if operated in the presence of
strong electromagnetic sources, such as electrosurgical equipment, or in the
presence of computed tomography (CT) equipment.
Do not use the device in the presence of magnetic resonance imaging (MRI)
equipment. MRI equipment may cause an induced current to the oximetry
sensor, resulting in patient injury.
If the PC and/or the printer connected to the SPIRODOC 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.
To dispose of the SPIRODOC, the accessories, any plastic consumable
materials (mouthpieces) as well as the battery, use only appropriate
containers or return all such parts to the dealer or to a recycling center. All
applicable local regulations must be followed.
If any of these rules are not followed then MIR will decline all responsibility
for any direct or indirect damages, however caused.
Use only the battery type indicated in the § Technical specifications.
Remove the battery from the device if the machine is not used for a long
period (several months).
The device 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.
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2.3 Unforeseen errors
In case device internal memory data is damaged, when the device is switched on, the
following message appears: Error on RAM memory
Recovery data
Please wait
If data has been successfully recovered, the device completes the standard turn on
procedure, otherwise please contact an authorized technical assistance center or the
manufacturer.
In 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 cause 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 device outside the guidelines described in this User's Manual
use of the device even when some operational anomalies are encountered
non-authorised servicing of the device.
2.4 Lithium-ion battery pack warning
The device is powered by a rechargeable lithium-ion battery pack. A charger is also
supplied with the device which delivers 3.7 volts.
For proper use of the battery pack please read carefully the warning below
WARNING
Do not use the battery pack for any purposes different from those specified. The
battery characteristics may change, consequently the battery life may be
reduced significantly. The battery pack may generate an electrical overcharge
which may cause acid leakage, overheating, smoke, breakage and fire.
Improper use of the battery pack may cause leakage, overheating, smoke,
breakage and fire. This may cause performance deterioration and damage. This
may also damage the protector installed in the battery pack. This may damage
the device and harm the user. Please read the following instructions carefully.
If acid from the battery pack comes into contact with skin or clothing
immediately wash with running water to avoid skin inflammation. If the battery
acid inadvertently enters the eyes do not rub the eyes, instead wash the eyes
with clean running water and call a doctor immediately.
If upon first use there is a bad smell, overheating or other anomalies do not use
the battery pack and return it to the supplier or manufacturer.
Only use suitable battery chargers and follow the instructions.
Do not connect the battery to an electric plug or lighter.
During charging
Before charging the battery pack carefully read the user manual.
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Do not charge near electric static generators,
Do not charge near a fire or extreme heat.
High temperatures may alter the characteristics of the internal protector, stop
recharging or actually cause recharging with higher voltages. This may result in
abnormal chemical reactions, acid leakage, overheating, smoke, breakage and
fire.
The battery pack comes with an internal safety protector. Do not use the device
near static electricity (superior to what is declared by the manufacturer). Static
electricity may damage the internal protector causing acid leakage, overheating,
smoke, breakage and fire.
Do not leave the battery pack charging longer than the average charging length
of time specified.
Do not recharge near electric static generators
During battery pack use
Recharge the battery pack with a specifically designated battery charger and
observe the charging procedure as specified by the manufacturer.
Recharging without adhering to proper recharging conditions may cause the
battery to overcharge at extremely high voltage. Various abnormal chemical
reactions may occur such as acid leakage, overheating of the battery, smoke
emission, breakage and fire.
The battery pack may be used within a temperature range from −20°C e to
approximately 60°C.
Do not heat or throw the battery in a fire.
Do not use or store the battery near a fire or if the temperature inside a vehicle
may reach 60°C or become higher.
Do not immerge the battery pack in water or salt-water, and do not leave it wet.
Such events may damage the inner safety functions which could cause the
battery to be charged at high voltage thus triggering abnormal chemical
reactions leading to acid leakage, overheating, smoke, and fire.
Do not place the battery pack in your pocket or in a bag with other metallic
objects such as coins, necklaces, scissors and screws.
Do not store the battery pack anywhere near these objects.
Do not short-circuit the positive (+) and negative (-) poles with metallic objects.
Do not connect the battery pack to an electric socket or to an automobile
Sigarette lighter, ecc. If the battery is connected to a source of high voltage this
high current surge may cause acid leakage, overheating, smoke, breakage and
fire.
Do not mount the battery pack inside the device with the + and – poles inverted.
If the battery leads do not connect easily to the battery charger or to the device
do not apply excessive force. Check to see that the leads are properly aligned. If
the leads are inverted, an inverse polarity may be caused by the connection thus
creating the possibility for acid leakage, overheating, smoke, breakage and/or
fire.
Do not puncture the battery pack with sharp objects such as a nail.
Do not hammer, step-on, throw or cause a forceful impact to the battery-pack.
A damaged or deformed battery pack may cause internal short-circuits thus
Spirodoc cod. 980156 Rev 1.3 EN 13/67
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creating the possibility for acid leakage, overheating, smoke, breakage and/or
fire.
Do not in any way disassemble or modify the battery-pack; the battery pack
comes with an internal safety protector, which if tampered with may cause acid
leakage, overheating, smoke, breakage and/or fire.
Do not solder the battery pack.
Do not use a heavily scratched or deformed battery back as this may be cause
for acid leakage, overheating, smoke, breakage and/or fire.
If the battery pack emanates a bad odor, if it generates heat, if it fades/deformes
or if anything abnormal happens during storage, usage and recharging
immediately remove the battery pack from the device or the battery charger and
do not use any further, as any of these events may cause acid leakage,
overheating, smoke, breakage and/or fire.
When the battery pack is disconnected from the device or the charger verify the
correct position of the (+) and (-) poles without forcing the connection.
Store the battery pack away from children’s reach so as not to accidentally
swallow the battery pack.
If a child uses the battery pack an adult must explain the proper use to the child.
Before using the battery pack carefully read the manual paying attention to all
the recommendations for proper handling.
For information concerning the installation and removal of the battery pack
carefully read the manual of the device.
The cycle-life of the battery pack is definite. If you notice a much shorter time
usage between charges please substitute the battery pack with a new one.
Remove the battery pack if its cycle life has expired.
When the battery pack has been removed from the device, ensure that the (+)
and (-) leads have been isolated with electrical tape; to properly dispose of the
battery pack please follow the local regulations or hand over the battery pack to
a battery recycling center.
Prior to storage or for long periods of disuse of the device remove the battery
pack and store in a place where the temperature and humidity fall within
specified ranges.
Keep the battery pack away from objects which may emit static electrical
charges.
If the battery pack leads are dirty clean with a dry cloth prior to usage.
The battery pack may be stored within a temperature range between −20°C and
60°C
Do not place the battery in a micro-wave oven or in a pressurized container.
Rapid overheating or loss of proofing may cause acid leakage, overheating,
smoke, breakage and/or fire.
If the battery pack leaks acid or gives off a bad smell, move it away from flames.
Spirodoc cod. 980156 Rev 1.3 EN 14/67
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Electrolyte leakage may cause a fire and the battery pack may emit smoke or
even explode and ignite.
2.5 Labels and symbols
2.5.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
CE mark in compliance with the Directive 93/42 EEC.
WEEE symbol
2.5.2 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.
2.5.3 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.
2.5.4 Warning symbol for the RS232 serial port
RS232
To connect 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.
2.5.5 Warning symbol for the USB serial port
To connect to other devices such as PC or printer.
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Use only the USB cable supplied by the manufacturer and observe the safety
regulations of IEC 60601-1-1.
2.5.6 Warning symbol for the SpO2 port for oximetry
SpO2
2.5.7 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 center, 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.
2.5.8 FDA and FCC Warnings
SPIRODOC…. complies with Part 15 of the FCC Rules. The correct operation is
subject to the following conditions:
(1) this device must not cause harmful interference
(2) this device must accept any interference received, including interference that may
cause undesired operation.
Any modifications not expressly approved by this company could void the user's
authority to operate the equipment.
NOTE: This device has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not
installed and used in accordance with the instructions, may cause harmful interference
to radio communications.
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 simply turning the equipment off and on, the
user is encouraged to try to correct the interference with one or more of the following
ways:
Reposition the receiving antenna.
Increase 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.
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Labels and symbols are displayed on the device as shown in
the following images:
2.5.9 Product description
SPIRODOC…. is a pocket spirometer, with an optional pulse oximetry module. It can
operate either in stand alone mode or it can be connected to a PC or to a printer using
any one of several methods: RS232, USB, Bluetooth.
Spirodoc… 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.
Spirodoc… is a powerful and compact measurement device, intended for use by a
respiratory specialist or by a suitably trained general practitioner. 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 periodic calibration.
The sensor features are listed below:
Accurate measurement even at very low flow rates (end of expiration)
Not affected by relative humidity and air density
Shockproof and unbreakable
Inexpensive to replace.
The turbine flow measurement sensor is available both in reusable and in single-
patient disposable versions.
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REUSABLE 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 from one patient to the other.
for the reusable turbine: always clean the turbine between patients, to ensure the
maximum level of hygiene and safety of 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.
Spirodoc…. 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. This
method allows the doctor can check the patient‟s condition remotely.
SPIRODOC consente al paziente di trasferire i dati immagazzinati all‟interno del
dispositivo, utilizzando la connessione Bluetooth , al PC del medico. Pertanto il medico
può valutare a distanza i parametri legati alla patologia del paziente.
SPIRODOC 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:
via USB connection
via Bluetooth connection
SPIRODOC can perform 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
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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.
2.6 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:
2.6.1 Features of the spirometer
Measured parameters:
SYMBOL
DESCRIPTION
Units
*FVC
Best FVC
L
*FEV1
Best FEV1
L
*PEF
Best PEF
L/s
FVC
Forced Vital Capacity
L
FEV1
Volume expired in the 1st second of the test
L
FEV1/FVC
FEV1/FVC x 100
%
FEV1/VC
FEV1 / best between EVC and IVC x 100
%
PEF
Peak expiratory flow
L/s
FEF2575
Average flow between 25% and 75% of the FVC
L/s
FEF25
Forced Expiratory Flow at 25% of FVC
L/s
FEF50
Forced Expiratory Flow at 50% of FVC
L/s
FEF75
Forced Expiratory Flow at 75% of FVC
L/s
FEV3
Volume expired in the initial 3 seconds of the test
L
FEV3/FVC
FEV3/FVC x 100
%
FEV6
Volume expired in the initial 6 seconds of the test
L
FEV6%
FEV1/FEV6 x 100
%
FET
Forced expiratory time
s
EVol
Extrapolated volume
mL
FIVC
Forced inspiratory volume
L
FIV1
Volume inspired in the 1st second of the test
L
FIV1/FIVC
FIV 1 %
%
PIF
Peak inspiratory flow
L/s
MVVcal
Maximum voluntary ventilation calculated on FEV1
L/s
VC
Slow vital capacity (expiratory)
L
EVC
Slow espiratory vital capacity
L
IVC
Slow inspiratory vital capacity
L
IC
Inspiratory capacity (max between EVC and IVC) - ERV
L
ERV
Expiratory reserve volume
L
TV
Current volume
L
VE
Ventilation per minute, at rest
L/min
RR
Respiratory frequency
Breath/min
tI
Average time of inspiration, at rest
s
tE
Average time of expiration, at rest
s
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TV/tI
Average flow of inspiration, at rest
L/min
tI/Ttot
tE/(tI+tE)
\
MVV
Maximum voluntary ventilation
L/min
ELA
Estimated lung age
year
*= best values
Flow/volume measurement system
Bi-directional digital turbine
Temperature sensor
semiconductor (0-45°C)
Measurement principle
Infrared interruption
Volume range
10 L
Flow range
16 L/s
Volume accuracy
3% or 50 mL
Flow accuracy
5% or 200 mL/s
Dynamic resistance at 12 L/s
<0.5 cmH2O/L/s
2.6.2 Oximeter features
Definitions:
Desaturation Event
Desaturation events SpO2 fall 4% in a limited period of 8-40 sec
and successive rise 2% within a total period of 150 sec.
Total Pulse rate
Variation
Pulse rate rise 10 BPM in limited period of 8-40 sec and
successive fall 8 BPM during a total period of 150 sec.
Parameters measured during sleep oximetry:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 Average in first three minutes
%
SpO2 Min
SpO2 Minimum during period of analysis
%
SpO2 Max
SpO2 Maximum during period of analysis
%
SpO2 Mean
SpO2 Average during period of analysis
%
BPM Baseline
Average pulse frequency in the first 3 minutes
BPM
BPM Min
Minimum pulse frequency during the period of
analysis
BPM
BPM Max
Maximum pulse frequency during the period of
analysis
BPM
BPM Mean
Average pulse frequency during the period of
analysis
BPM
Recording time
Total time measure of SpO2
hh:mm:ss
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss
N° Events SpO2
<89%
Fall of SpO2 below 89% for at least 20 seconds
\
Index [12s]
Index of SpO2 fluctuation calculated in intervals
of 12 seconds
\
T< 40 BPM
Time passed with pulse frequency < 40 BPM
%
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
%
hh:mm:ss
N° Events < 40
BPM
Bradycardia events during the entire period of
analysis
\
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N° Events > 120
BPM
Tachycardia events during the entire period of
analysis
\
Tot. Desat. Events
Desaturation events during the entire period of
the analysis
\
ODI
Desaturation events by hour of analysis
1/h
Mean Duration
Average duration of desaturation events
s
Longest Duration
Longest duration of desaturation events
s
Desaturation Peak
Minimum Sp02 during desaturation events
%
Mean Desaturation
Average duration of desaturation events
%
Mean Drop ∆SpO2
Average SpO2 fall with respect to baseline
during the desaturation events
%
Max Drop ∆SpO2
Maximum fall of SpO2 with respect of baseline
during the desaturation events
%
N° Pulse
Variations
Variation of pulse frequency events during the
entire period of the analysis
\
Pulse Index
Variation of pulse frequency by hour of analysis
1/h
NOD 4%
Time passed with SpO2 < 4 % with respect to
SpO2 base for continual periods above 5
minutes
\
hh:mm:ss
NOD 89%
Time passed with SpO2 < 89 % for continued
periods above 5 minutes
\
hh:mm:ss
NOD 90%
Time passed with SpO2 < 90 % for continued
periods above 5 minutes with minimum value <
86 % (Nadir)
\
hh:mm:ss
=DELTA
Parameters measured for six minute walk test analysis:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 average before walking
%
SpO2 End
SpO2 after walking
%
SpO2 Min
SpO2 minimum during walking
%
SpO2 Max
SpO2 maximum during walking
%
SpO2 Mean
SpO2 average during walking
%
BPM Vaseline
Average pulse frequency before walking
BPM
BPM End
Pulse frequency after walking
BPM
BPM Min
Pulse frequency minimum during walking
BPM
BPM Max
Pulse frequency maximum during walking
BPM
BPM Mean
Pulse frequency average during walking
BPM
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss
T2 [SpO2≥ 2%]
Time passed during walking test with SpO2 < 2 %
with respect to SpO2 base
hh:mm:ss
T4 [SpO2 ≥ 4%]
Time passed during SpO2 walking test < 4 % with
respect to SpO2 base
hh:mm:ss
T< 40 BPM
Time passed with pulse frequency < 40 BPM
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
hh:mm:ss
N° Events < 40 BPM
Bradycardia events during the entire period of
analysis
\
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N° Events > 120 BPM
Tachycardia events during the entire period of
analysis
\
Recording time
Total time measure of SpO2
hh:mm:ss
Baseline Time
Duration of baseline phase
hh:mm:ss
Walking Time
Duration of walking phase
hh:mm:ss
Recovery Time
Time for SpO2 value 99% of the average
base value calculated during the initial phase
of the test.
hh:mm:ss
Predicted
Predicted standard distance
m
Pred. Min
Predicted minimum distance
m
% Predicted Standard
% in variations of the distance covered with respect
to predicted standard distance
%
% Pred. Min
% of variations of distance covered with respect to
predicted minimum distance
%
AUC/Distance
Area under SpO2 curve base relative to distance
covered
\
Dyspnea Borg CHG
Variation in grade of dyspnea during walking
\
Fatigue Borg CHG
Variations in level of fatigue during walking
\
=DELTA
*There follows a description of the method for calculating the area below the SpO2
baseline curve:
Parameters requested for six minute walk test analysis
SYMBOL
DESCRIPTION
Units
Dyspnea Borg
Baseline
Grade of dyspnea before walking
\
Dyspnea Borg End
Grade of dyspnea after walking
\
Fatigue Borg Baseline
Level of fatigue before walking
\
Fatigue Borg End
Level of fatigue after walking
\
Walked
Distance covered during walking
m
Parameters measured with SpO2 Analysis:
SYMBOL
DESCRIPTION
Units
SpO2 Baseline
SpO2 Average in first three minutes
%
SpO2 Min
SpO2 Minimum during period of analysis
%
SpO2 Max
SpO2 Maximum during period of analysis
%
SpO2 Mean
SpO2 Average during period of analysis
%
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BPM Baseline
Average pulse frequency in the first 3 minutes
BPM
BPM Min
Minimum pulse frequency during the period of
analysis
BPM
BPM Max
Maximum pulse frequency during the period of
analysis
BPM
BPM Mean
Average pulse frequency during the period of
analysis
BPM
Recording time
Total time measure of SpO2
hh:mm:ss
T < 90%
Time passed with SpO2 < 90 %
%
hh:mm:ss
T < 89%
Time passed with SpO2 < 89 %
%
hh:mm:ss
T < 88%
Time passed with SpO2 < 88 %
%
hh:mm:ss
T < 87%
Time passed with SpO2 < 87 %
%
hh:mm:ss
N° Events SpO2 <
89%
Fall of SpO2 below 89 % for at least 20 seconds
\
Index [12s]
Index of SpO2 fluctuation calculated in intervals
of 12 seconds
\
T< 40 BPM
Time passed with pulse frequency < 40 BPM
%
hh:mm:ss
T> 120 BPM
Time passed with pulse frequency > 120 BPM
%
hh:mm:ss
N° Events < 40
BPM
Bradycardia events during the entire period of
analysis
\
N° Events > 120
BPM
Tachycardia events during the entire period of
analysis
\
=DELTA
Measurement method:
Red and infrared absorption
Range of measurement %SpO2:
0 – 100% (with 1% increments)
SpO2 Resolution
1%
%SpO2 accuracy:
2% between 70-100% SpO2
Average number of heart beats for the
%SpO2 calculation:
8 beats
Range of measurement of cardiac pulse:
20 – 300 BPM (with 1 BPM increments)
Cardiac pulse relolution
1 BPM
Accuracy of cardiac pulse:
2 BPM or 2% whichever is greater
Average interval for the calculation of
cardiac pulse:
8 seconds
Signal quality indication:
0 - 8 segments on display
Acoustic signals:
“Beep” with frequency of the cardiac pulse
Continuous beep in the case of either %SpO2 or cardiac pulse going outside of
the programmed levels of alarm
Continuous beep during oximetry measurement in the case of a low battery level.
If the patient‟s finger is not inserted correctly or the connecter is not properly
attached there will be an intermittent beeping sound for 10 seconds
If the test has been interrupted due to low battery power an intermittent beeping
will be heard for 10 seconds when the device is switched on again
The specifications for both the oximetry and for the cardiac pulse are the same
regardless of which of the above mentioned oximetry sensors is used.
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2.6.3 Other features
Memory
Memory capacity for over 6000
spirometric tests
The precise number depends on the
individual configuration, so it cannot be
determined more closely
Display
STN graphic LCD,128x64 Pixel
Keyboard
Membrane keyboard with 6 keys
Interface
RS232, USB, Bluetooth
Duration of the CR2032 3V lithium
battery (memory backup)
Circa 10 years, under normal conditions
of use
Power supply
4 x AAA batteries 1.5V DC (type AAA), or
through USB connection
Dimensions
60x145x30 mm
Weight
180 grams (including batteries)
Type of electrical protection
Class II device
Type of electrical protection
BF
Grade of protection against water
ingress
IPX1 device, protected against water
drops
Safety level in the presence of
inflammable anaesthetic gas, oxygen
or nitrogen
Device not suitable
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Applied norms
Electrical Safety Standard IEC 60601-1
Electro Magnetic Compatibility IEC
60601-1-2
3. FUNCTIONING OF THE SPIRODOC
3.1 Display
The device does not have a keyboard. The
touchscreen type display allows access to all
functions by simply touching the display. The
controls on the touchscreen change
dynamically based on the functions
performed.
To access a specific function touch the
corresponding icon on the display.
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To visualize the list of information flick
through the left part of the screen.
3.2 Accensione e spegnimento di SPIRODOC
To turn on the SPIRODOC press and
release the key placed in the middle on
the side of the device.
To turn off the SPIRODOC press the
same key for at least two seconds.
3.3 Symbols and Icons
The icons used in the various function screens are shown in the following table:
ICON
DESCRIPTION
To access the default settings (service menu)
To access patient data from the main display
To perform a new test of a patient recalled from the patient records.
To insert new patient data
To modify patient data.
To display the most recent tests of a patient
To go back
To send data to a mobile phone via Bluetooth
To access the database of the performed tests.
To search a test with the date of birth of a patient
To search a test starting from a specific date onwards..(partial database)
To flick through a database from beginning to end and viceversa (complete
database)
Patient search through family name.
Male sex patient selection
Female sex patient selection
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To access all oximetry test options / To perform an SpO2/BPM test
To perform a sleep oximetry test
To perform a 6MWT/ to move on to the walking phase of the test
Tom move on to the recovery phase of the 6MWT
To access spirometry testing type
to perform a forced vital capacity test FVC
To perform a slow vital capacity spirometry test VC
To perform a maximum voluntary ventilation spimetry test MVV
To perform a spirometry test with a broncodilator
To print via Bluetooth connection
3.4 Energy saving
WARNING
When the device is on after approximately 10 seconds of disuse the display
enters energy saving mode thereby lowering the display contrast level
automatically.
If the device remains in disuse for approximately 5 minutes an acoustic signal
will be emitted, furthermore if the display is not touched within another 10
seconds the device will turn off by itself.
The device can be turned off in any moment by pressing the key.
The charging level of the battery pack is shown upon turning on the device with the
symbol:
This image indicates that the battery pack is fully charged(6 indicators). A drop of the
battery pack charge is displayed with a reduction of the indicators.
3.5 Information
Turn on the SPIRODOC by pressing . The display will read:
device name
information
Current date
Current time
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Without touching the display, after a few seconds the device will automatically return to
the main screen.
The main screen can be customized by choosing one of two types of menus: “simplified
menu” or “extended menu”. To choose the desired setting read the following parapraph
3.6.
3.6 Service menu
To access the menu touch the display when the following icon appears
The service menu provides the following information:
Language selection (English default)
Turbine calibration
Predicted values selection
Delete Memory
Change Date/Time
Date Format
Unit Format
Turbine selection
Standards setting
LCD setting
BLUETOOTH setting
Firmware information
Oximetry alarms
SpO2 sampling rate
Spirodoc mode
Parameter settings
Menu type
Scroll through the various options in the
menu as per paragraph 3.1; once the
option of interest is visualized, touch the
display next to it.
Language selection
Select the language select option by touching the display and choose the desired
language; automatically the desired language is set and the device will return to the
service menu.
Turbine calibration
Once the option is highlighted the following password needs to be inserted:
1 2 2 3 3 3
Please refer to paragraph 3.6.1 per il corretto svolgimento di tale attività si faccia
riferimento al paragrafo 3.6.1.
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Selection of the Predicted values
Select the option by touching the display.
A list of Predicted values is visualized; select the desired Predicted value.
Adults
Pediatric
ERS
Knudson
Knudson
Knudson
USA
Knudson
ERS
Zapletal
MC-Barcelona
Zapletal
Select the pair of Predicted values; automatically the desired predicted values are set
and the device will return to the service menu.
WARNING
If the NAHNES III standard is chosen the Predicted values cannot be set or
modified.
Delete Memory
Select the option by touching the display.
To delete the memory of the device insert the following password by touching the
numbers starting from left to right:
1 2 2 3 3 3
If an error occured during insertion of the password, the following message will appear:
Password Error
Press OK and try again
If you fail to insert the password again the device automatically returns to the service
menu.
If instead the password was inserted correctly, the following message will appear:
Memory has been deleted
Afterward the device will automatically return to the service menu.
Change date and time
Select the option by touching the display.
In the date/time setting, the cursor _ indicates the item which will be modified.
Use the visualized numbers to modify item of interest, move on to the next item with
OK.
Lastly by touching OK the settings will take effect and the device will return to the
service menu; to return to the service menu without modifying any options touch .
Date format
Select the option by touching the display.
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day month year
month day year
year month day
Select the desired format; this will be set automatically and the device will return to the
service menu.
Unit format
Select the option by touching the display.
Imperial (in,lb)
Metric (cm kg)
Scegliere la modalità desiderata; automaticamente questa viene impostata ed il
dispositivo torna al menu di servizio.
Turbine selection
Select the option by touching the display.
Select the type of turbine to be used (reusable or disposable). The selection will be
saved automatically and the device will return to the service menu.
Standards setting
Select the option by touching the display.
Select the standard (ATS/ERS or NHANES III); The selection will be saved
automatically and the device will return to the service menu.
LCD setting
This menu allows for:
Setting of display luminance and contrast.
Two scales ranging from 0 to 31 allow to set these display parameters and see the
effects in real time. Once the best combination has been obtained touch OK in the
bottom right-hand of the display.
Touch screen calibration function
This function allows to check the proper response of the touch screen; the
procedure is comprised of three parts:
- touch the white dot on the upper right side
- touch the white dot on the lower left side
- touch the white dot in the center
The touch screen will be calibrated according to the dimensions of the screen.
Bluetooth setting
Access the menu to search for available devices, touch the option “Search Device”;
Spirodoc will start to search for Bluetooth devices in the area; once one or more
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devices are found the display will list these devices with their respective names. By
touching the device of interest it can be memorized as a printer, a phone, or as a PC –
On line; select an option.
In the “Bluetooth setting” menu the memorized devices can be viewed in the “printer”
list, “telephone” list and the “PC – On line” list. Any device from these lists can be set
as the default device (the device that SPIRODOC will automatically connect to via
Bluetooth) by entering in the lists, touching the display and selecting the device. A listed
device can be eliminated from the list. (in this specific case the user will confirm the
deletion with the OK icon.)
So as not to make any modifications touch the icon in the bottom left side. In
the “Bluetooth setting” menu the “Bluetooth ON/OFF” option allows to enable/disable
the Bluetooth function thereby improving the battery consumption of the device.
Firmware Information
The user can access the menu to view information of the version control of the
following components:
Spirodoc
Bluetooth
After approximately 10 seconds the device automatically displays the Service Menu,
otherwise press .
Oximetry Alarms
Access to this function allows the
setup of reference values for SpO2
and BPM; an acoustic alarm will warn
the user if the SpO2 and BPM during
a test fall below the minimum or rise
above the maximum set reference
SpO2 and BPM values.
The cursor “_” in the beginning will be set on the minimum SpO2 value, use the
visualized numbers to select the desired value. Move on to the next value by touching
OK; once all four values have been set the user may activate or deactivate the acoustic
alarm: Touch ON to activate the acoustic alarm during oximetry testing, or touch OFF to
deactivate the acoustic alarm. To confirm the desired selection touch OK in the bottom
right side of the display, automatically the device will return to the service menu.
SpO2 sampling rate
This function allows to set the time that elapses between values memorised between
consecutive oximetry parameters; touch one of the two visualized icons: 2 seconds or 4
seconds, then touch OK to set the selected value and the device will automatically
return to the service menu.
Spirodoc mode
The device can be setup in one of the following modes:
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Personal mode
Doctor mode
Personal mode is set by the doctor when the device will be used by the patient for
home care use; for health condition screening.
Doctor mode enables full use of the device for expert use.
By touching the desired mode the device is set and automatically returns to the service
menu.
Parameter Settings
Three different types of parameter calculations can be selected for spirometry and
oximetry testing.
simplified
personalized
complete
With the simplified mode the user can only view the main parameters as per actual
standards.
The personalized mode allows to select the parameters of interest.
The complete mode allows to view all the parameters that the device is capable of
calculating.
Type of menu
The last item allows to personalize the menu of the main screen, the options are:
simplified menu
extended menu
Only the following icons can be viewed
with the simplified menu:
patient management
spirometry
oximetry
database
The extended menu includes the same
icons of the simplified menu and the
icons representing the various types of
the tests that the device is capable of
performing.
To exit the settings of the service menu touch in the bottom left hand side.
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3.6.1 Patient Mode
This mode allows to simplify the use of the device for a patient during the day and lets
the doctor setup various functions useful to assess the patient‟s state of health as it
evolves in time.
In patient mode the main screen appears as follows.
The simplified service menu can be accessed by touching the icon in the bottom right-
hand side, the following items are shown:
Patient data
Change date/time
LCD setup
Bluetooth setup
Insert password
To access the service menu select the item “Inser password” and enter the following
password:
1 2 2 3 3 3
In this mode the service menu displays the following items:
Spirodoc mode
Personal best
Turbine setup
Turbine calibration
Oximetry setup
Switch-on setup
Questions setup
Symptoms setup
Predicted source selection
Standard setup
Language selection
Memory deletion
Communication type
Units format
Date format
Furthermore to the items in the previous paragraph the device allows to setup the
following items:
Personal best
Questions setup
Symptoms setup
Personal Best
One of the following four parameters can be used as a reference to be compared with
at the end of a spirometry test:
FVC FEV1 PEF F2575
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For each of the above four parameters it is possible to check the corresponding value
of the test with a personal value set by the doctor or a predicted value taken from a
predicted source, by selecting one of the two following items:
Personal best value setup
Use predicted source
Questions Setup
Specific questions can be written so that when the patient turns-on the device a table
will be displayed with a series of questions. The following table displays the items
which can be selected and the response options which can be used by the patient.
A multiple selection can also be implemented.
Symptoms Setup
Every time that a patient records a test the symptoms setup will have the patient
answer a series of questions; the following table displays the items which can be
selected and the response options that can be chosen by the patient:
Domanda
Possibili risposte
Tiredness on waking
NO
MED
MAX
Daytime drowsiness
NO
MED
MAX
Breathless on waking
NO
MED
MAX
Troubled sleep
NO
MED
MAX
Wheezing
NO
MED
MAX
Cough
NO
MED
MAX
Sputum production
NO
LIGKT
DARK
Sputum increasing
NO
YES
breathlessness
NO
Effort
At rest
Fatigue
NO
MED
MAX
Chest tightness
NO
MED
MAX
Also in this case a multiple selection can be implemented.
3.6.2 Reusable turbine calibration
WARNING
The turbine flow sensor does not require calibration, however regular
cleaning of the turbine is necessary . If a calibration must be performed the
following guidelines should be carefully noted.
A calibration can only be performed with the reusable turbine.
Calibration of the turbine is performed using a calibration syringe to make a FVC test
for the expired parameters and a FIVC test for the inspired parameters.
To access the calibration function, select the “Turbine Calibration” option from the
Service Menu as explained in paragraph 3.6. Once the password has been inserted
correctly the following screen will appear:
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VOL. 300
BTPS
%Corr.
Ultima FVC
300
0.00
UltimaFIVC
300
0.00
Nuova FVC
000
◄
Nuova FIVC
FVC=0 CALIBR. DI FABBRICA
The Old FVC and the Old FIVC values shown are those values from the last
calibration performed.
The values under the %Corr. column indicate the correction factor. These are pre-set
or 0 by default.
To perform a calibration:
1 - Insert the volume in cL of the calibration syringe in use (e.g. for a 3L syringe, insert
300 cL).
2 - Insert in both fields New FVC and New FIVC the FVC & FIVC values obtained by
a measurement made with the calibration syringe, by using the numbers that appear in
the bottom of the screen. After inserting the values of each parameter touch the OK
icon.
Insert both the FVC and the FIVC values. If the calculated correction factors are
acceptable (<10%), these are displayed next to the New FVC and New FIVC
parameters. The message ENTER OK TO CONFIRM will appear.
By touching the ESC icon the device will automatically return to the service menu
without applying any 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 device cannot correct such a
large calibration error. In this case:
- Check the correct functioning of the Spirodoc with a new turbine and/or
- Clean the turbine.
To erase the calibration in use and to reset the original factory calibration, insert
the number 0 in the New FVC and New FIVC fields. With the OK icon return to the
Service Menu.
NOTE
Each time a calibration is made the new correction factors are algebraically
added to the previous correction factor. Therefore, before making a new
calibration make sure to delete the actual calibration in use as described
above.
For an accurate and reliable calibration the syringe volume must be at least 3
L.
WARNING
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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 II is
calibrated correctly then the FVC (syringe) value will be:
3.00 (FVC) x 1.026 (BTPS) = 3.08 L (FVC at BTPS).
If the ambient temperature is 20°C, the FIVC (syringe) value will be:
3.00 (FIVC) x 1.102 (BTPS) = 3.31 L (FIVC at BTPS).
The user must be aware that the volume of the syringe shown by the
machine is converted to BTPS conditions, so that the "increase" of the
results with respect to the expected values does not constitute an error.
For instance, if the calibration procedure is carried out with measured data:
FVC = 3.08 L and FIVC = 3.31 L at an ambient temperature of 20°C the
resulting correction factor becomes:
EXPIRATION .00%
INSPIRATION .00%
This does not represent an error, but is a logical consequence of the above
detailed explanation.
3.7 Patient Data
From the main screen the user can access the patient data management by using the
icon . . By entering in the menu it is possible to:
Modify the current patient data
Create a new patient
3.7.1 Inserting data of a new patient
Touch the icon and insert the patient information in the required sequence.
First screen (name)
Write the name of the patient with the touchscreen keyboard. Touch the OK icon to
move on to the next screen
Second screen (sirname)
As above insert the sirname of the patient and touch the OK icon.
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Third screen (date of birth, weight, height and sex)
By using the visualized numbers in the bottom of the screen, set the day, month, year
of birth, height and weight of the patient. The last data to insert is the sex of the patient,
which can be chosen by selecting one of the following icons:
Male
Female
To move from one item to the next touch the OK icon.
Fourth screen (ethnic group)
Setting of the correction factor: these values allow to adjust the test data as a function
of the ethnic group of the patient (it is possible to opt for “without correction” );
standard ATS/ERS
Standard NAHNES III
Group
% correction
Without correction
100%
Caucasian
Caucasian
100%
Mexican-American
Oriental
100%
Afro-American
Hong Kong Chinese
100%
Other
Giapanese
89%
polinesian
90%
North Indian
90%
South Indian
87%
Pakistani
90%
African descendant
87%
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).
Once the ethnic group is set the device saves the data and autonmatically returns to
the main screen.
To interrupt the data insertion, touch the ESC icon and the device will automatically
return to the main screen.
3.7.2 Patient data modification
The icon allows to modify current patient data; by accessing this function the
patient data is presented on the various screens; modify the data by using the
alfanumerical key which are shown time and again.
Touch the icon to return to the main screen without modifying any data
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3.8 Visualization of memory data
3.8.1 Database research modality
From the main screen it is possible to access the database of the device by using the
icon.
Four methods of research are available:
Reseach by patient date of birth.
Research by the date of testing.
Visual of all tests in the database starting form the most recent.
Research by patient sirname.
Research by patient date of birth: patient date of birth must be inserted; after all the
data has been inserted touch the OK icon. All data visualized concerns tests
performed by patients whose date of birth corresponds to the inserted date of birth.
Database by date of testing: requires the insertion of the date when the test was
performed; once all the date information has been inserted touch the OK icon. The
data returned by the device are all the test sessions performed during that specific
day.
Complete database: shows data starting from the most recent session. The end of
the database is signalled by a double beep. The database search is resumed from the
last session.
Research by surname: requires insertion of patient sirname or sirname initial; once
having inserted the sirname touch the OK icon. Visualized data corresponds to all test
sessions of that particular patient.
NOTE
Test session refers to (spirometry PRE, POST and oximetry) tests gathered from one
patient on the same day. So a visualized session in the database can be composed of
different tests which as a whole allow the doctor to evaluate the health of a patient at
that specific date.
3.8.2 Visualization of database info
The result of a search performed in
one of the described methods in
paragraph 3.8.1 can be viewed in
the adjacent image. By touching
the desired session one may
access the performed tests
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Once a testing session has been
selected the database screen will
show the adjacent image. By
scrolling the screen as in paragraph
3.1 the user may select the desired
test of a session.
The three icons on the lower part of
the screen allow access to the
following functions:
To perform a new testing session with the selected patient.
To send via Bluetooth to a printer the parameters of a selected test.
To view the parameters of a selected test.
The user may return to the previous screen by using the icon.
WARNING
Printing via Bluetooth is possible only after setting at least one printer from the
Bluetooth printer list. Refer to paragraph 3.6 for proper setup of this function. If no
printer has been selected the device will show the following message:
EMPTY LIST
Device search
Touch OK to confirm
By touching the OK icon the device will search for any nearby devices; if any devices
are found these can be memorized in the specific Bluetooth list.
3.9 Display of last session from current patient.
Case Io : simplified menu
To view the last spirometry tests performed by the current patient touch the icon.
In the spirometry menu the icon allows to access the most recently perfomed
tests
To display the most recent oximetry tests performed by the current patient touch the
icon.
Inside the oximetry menu the icon allows to access all data from the most recent
tests.
3.10 PC On line mode (connected to a PC)
In the PC on-line mode the spirometer becomes a fully functional laboratory spirometer
which works in real-time connected to a PC.
PC interface is via USB cable or Bluetooth connection.
The Spirodoc becomes an intelligent transducer for the measurement of volume and
flow while the PC controls the device including the on and off function.
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Connected to a portable PC the Spirodoc can be used for epidemiological studies
conducted in occupational environment, schools, etc etc..
Other than the usual spirometric parameters and the F/V in real-time the Spirodoc also
plots the most refined indices such as the ventilatory profile and the extrapolated
volume (Vext).
The PC software incorporates the most up to date bronchial provocation protocols
displaying the dose-response and time-response of the FEV1
WARNING
When the device is connected to the PC it cannot be remotely controlled from the
device itself. The default settings of the PC software will be transferred to the device
and will remain in the device even when used in stand-alone mode; for example when
the Spirodoc is connected to the PC and the user selects the type of turbine
(disposable or reusable) the selection will be saved in the device and remain effective
even when the Spirodoc is used in stand-alone mode. So pay attention to the type of
turbine setting.
3.11 Spirometry testing
In order to perform proper spirometry testing the following instructions are to be
followed carefully.
Insert the turbine in the appropriate housing until it reaches the mechanic stop and
successively rotate the turbine clockwise until it stops. Insert the mouthpiece at least
0.5 cm inside the groove of the turbine.
Place the noseclips on the nose so as not to let any air out of the patient‟s nostrils.
Hold the Spirodoc from both ends with both hands or grasp it like a mobile phone.
The touchscreen must always face the patient taking the test.
Place the upper part of the mouthpiece in the mouth making sure that no air leaks
from the sides of the mouth.
If possible it is recommended to stand up while performing the test. During expiration
it is recommended to bend forward the upper part of the body so as to release all
the air out with the aid of the abdominal muscles.
WARNING
While performing a test make sure not to interrupt the test prematurely or turn off the
device by accidentally touching the screen.
By touching the icon the user may access the spirometry testing area from the
simplified menu mode. With the extended menu the main screen will display the
different types of spirometry tests as follows:
FVC spirometry testing
VC type spirometry test
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MVV type spirometry test
test with broncodilator
Once a test is selected the screen will display information concerning the type of
turbine in use (reusable or disposable) including the necessary info to complete the
test in the correct manner.
WARNING
A test is saved with the name of the last patient displayed. If a test refers to a
previously saved patient, then prior to performing a test the user must recall that
patient from the database as described in paragraph 3.8.2
3.11.1 FVC test
Proper execution of a FVC test must take into account the phases as described on the
screen, 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 the 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 the air in the lungs as fast as possible.
After 6 seconds of expiration the device will emit a continuous beep, this helps the user
to understand when the minimum expiry time has been reached.
WARNING
Accurate spirometry testing requires that the patient expire absolutely all the air
in the lungs.
The test may be carried out several times by repeating the cycle without taking the
mouthpiece out of the mouth, in which case Spirodoc recognises the best test
(FVC+FEV1) and will automatically display the results of this best test.
To end the test touch the OK icon.
During the test the Spirodoc emits "beeps", the frequency of which are directly
proportional to the inspired and expired velocity of the air.. This helps the doctor
understand when the velocity of the air is approaching zero, and 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
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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, the Spirodoc emits a
continuous beep. This is useful for the doctor to understand if the patient has reached
the minimum expiry time, as per the requirements of the major international
pneumology associations.
3.11.2 Test VC
Ventilatory Profile
The slow vital capacity test can be started by carrying out several breaths at tidal
volume. After three or four such breaths an acoustic signal will be emitted to confirm
that the ventilatory profile has been measured and that the patient may immediately
proceed to perform the VC or IVC test.
Expiratory Slow Vital Capacity: VC
After the acoustic signal inspire slowly as much as air as possible and expire slowly as
much air as possible.
Inspiratory Slow Vital Capacity: IVC
After the acoustic signal exspire slowly as much as air as possible and inspire slowly
as much air as possible.
To end the test touch the OK icon.
Follow the indications on the display to carry out the test properly.
3.11.3 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 per minute. The
test will end automatically after 12 seconds.
WARNING
The disposable mouthpiece and the disposable turbine must be replaced after a
single patient test session.
3.11.4 POST test, after drug administration
WARNING
To carry out a POST test it is necessary to have carried out at least one PRE FVC
test 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 database already
contains at least one PRE test carried out on the same day.
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To carry out a POST test please follow the instructions below:
Simplified menu
To access the spirometry area touch the icon on the main screen and
subsequently touch the icon.
A “POST” test refers to a spirometry test after having administered to a patient a
pharmacological bronchodilation protocol. Before carrying out the test is is necessary
to indicate the drug dosage administered as a reference when checking the results of
the measured parameters.
The following parameters will be displayed related to the selected patient:
Those values related to the test performed
Those values related to the best PRE test performed by the same patient the
same day.(that is in the same test session)
The percentage variation between the PRE and POST values( in the CHG
column)
It is not possible to perform a POST test with a patient whose PRE testing was not
carried out on the same day.
If during a POST session a new patient is inserted or another is recalled from the
archive the device will automatically exit the current POST session.
3.12 Viewing the spirometric results
Following a FVC test, the spirometry test results are shown. The first screen displays:
The main parameters FVC, FEV1, FE1%, PEF of the best trial from all the tests
performed durin the session.
The percentage change compared to the predicted values.
A Flow/Volume graph of the Forced Vital Capacity
The graph is a preview, to view the whole test simply touch the graph and
automatically the device will show the entire graph rotated 90° clockwise on the
display. By touching the graph again the device will return to the original preview.
By scrolling on the right hand side of the screen it is possible to view all the
parameters next to the chosen predicted values.
3.12.1 Spirometry Test Interpretation
Spirometry test interpretation is based on the Forced Vital Capacity (FVC) test. The
test interpretation is indicated with one the following messages:
Normal obstruction
Mild obstruction
Moderate obstruction
Moderately severe obstruction
Severe obstruction
Very severe obstruction
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For a POST test the messages are the same but instead of dealing with an
“obstruction” the POST test refers to a “restriction”.
Through the use of a mathematical analysis applied to certain indices and parameters
calculated in the FVC test , the SPIRODOC is capable of producing a list of quality
control comments useful to assess the quality and reproducibility of the manouvers
performed.
The quality control check assigns a letter for the current spirometry session as
described below:
PRE test
A = At least to acceptable manouvers, 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
An acceptable manoeuvre means: good start and satisfactory exhalation (duration and
flow)
Several comments related to the single test are calculated, however SPIRODOC will
only point out the most relevant to facilitate the test interpretation.
ERROR IN Vext and PEFT
If the extrapolated volume Vext is greater than 500 mL or more than 5% of the FVC, or
if the PEFT (time to peak flow) is greater than 200 ms, this message is shown:
Repeat test and blow faster
FLOW DROP 50%
If there is a drop in the flow of 50% and a recovery within the first second. The
following message appears:
Coughing during test
FET ERROR
If the FET is less than the minimum (6 seconds), this message is shown:
Expiry time insufficient < 6s
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FLOW ERROR
If the last point of the F/V curve is greater than 200 mL/s, this indicates that the
expiration was not complete and thus this message is shown:
Blow out all air in lungs
Between tests, the SPIRODOC checks the repeatability of the following parameters:
PEF repeatable when the difference between the two largest PEF is ≤ 0.67 L/s;
VC repeatable when the difference between the two largest VC ≤ 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;
3.13 Oximetry Testing
SPIRODOC is able to perform 3 different types of oximetry tests, which will be
described in the following paragraphs.
WARNING
If SPIRODOC has been purchased without the oximetry option only spirometry
testing can be performed.
If the oximetry option is purchased afterwards, please contact a service center
or the manufacturer to activate the oximetry function.
WARNING
The oximetry sensor used in the manual is only one of the different types of
sensors which can be used listed in paragraph 2.2.4. MIR does not recommend
any particular sensor; the doctor will chose the sensor which she/he believes to
be more suitable.
During oximetry testing the SPIRODOC cannot be turned off. To turn off the
device the oximetry test must be stopped first. This has been implemented so as
to avoid any unwanted interruptions which could compromise the accuracy of
the data.
Il sensore descritto di seguito rappresenta solamente un esempio. Con
SPIRODOC possono essere utilizzati tutti i sensori descritti nel paragrafo 2.2.4.
MIR non raccomanda l’uso di un particolare sensore; viene lasciata al medico la
scelta in merito.
Durante i test di ossimetria SPIRODOC non può essere spento, per spegnere il
dispositivo bisogna prima interrompere il test che è in esecuzione, questo
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permette di evitare interruzioni indesiderate che potrebbero compromettere la
veridicità dei dati ottenuti.
For the non-invasive measurement of SpO2 oxygen saturation and blood pulse rate,
utilize the re-usable finger sensor. This sensor is recommended for patients weighing
more than 20 Kg while remaining still during testing. For the 6 minute walk test other
types of sensors are recommended which are less influenced by the movement of the
hand.
To carry out an oximetry test:
Connect the sensor to the device: 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 the 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 cannot
be placed properly inside the sensor try
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.
Select one of the tests that can be performed with SPIRODOC
To access the oximetry area touch the icon on the main screen and subsequently
select the type of oximetry test to carry out.
SpO2/BPM spot test
Sleep oximetry test (ODI)
Six minute walk test
If the following message appears upon start-up:
WARNING OXIMETER NOT PRESENT
This means that your device does not have this function.
If instead the following message appears:
WARNING THE OXIMETER IS NOT ENABLED
This means that the oximetry function is included, however the internal application has
yet to be enabled. In this case please contact a service center or the manufacturer.
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WARNING
Before carrying out a test, if the power supply value is low the following
message will appear:
Low battery level
Touch the ESC icon to exit the test, otherwise after a seconds will start the test.
In the event that a test is interrupted due to a complete battery discharge, the
next time the device is turned on the following message is displayed:
WARNING
Wrong interruption of last oximetry test
At the same time an intermittent beep is emitted for ten seconds.
Subsequently the SPIRODOC returns to the main screen.
WARNING
Avoid twisting the sensor’s cable as this may compromise measurement
accuracy and the integrity of the sensor itself, also do not apply excessive force
when using, connecting, disconnecting or storing the oximetry sensor.
The first few seconds are used to find the best signal possible; after which the
SPIRODOC timer resets itself and the device starts recording data.
For any type of oximetry test if the sensor is not properly connected the following
message will be displayed on screen after a few seconds:
WARNING
Sensor not inserted
At the same time SPIRODOC emits an acoustic signal for 10 seconds.
If the sensor has been connected properly but the finger has not been properly
inserted in the sensor the following message will be displayed on screen.
WARNING
FINGER not inserted
At the same time SPIRODOC emits an acoustic signal for 10 seconds.
If the signal reaches the sensor properly, after a few seconds the device will emit an
acoustic signal while also displaying the values on screen.
At the same time SPIRODOC emits an acoustic signal for 10 seconds.
The alarms can be customized for any oximetry test, the procedure is described in
paragraph 3.6.
During oximetry testing if the SpO2 and blood pulse rate fall below the bottom
threshold or raise above the threshold, the SPIRODOC will emit a continuous acoustic
signal „beep‟ until such situation persists. This function can be disabled for sleep
oximetry testing.
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If the alarms are activated during oximetry
testing the icon will always show up on
screen.
The alarms function can be
activated/deactivated even during oximetry
testing. By touching the icon the
screen on the right-hand side will appear
which allows to check the threshold values;
to activate/deactivate the alarms function
simply touch the ON or OFF icons. If the
screen remains untouched for a few
seconds the device will return to the screen
of the oximetry test in progress.
For information concerning the proper setup of this function please refer to paragraph
3.6.
WARNING
A test is saved with the name of the last patient displayed. If a test refers to a
previously saved patient, then prior to performing a test the user must recall that
patient from the database as described in paragraph 3.8.2
WARNING
During any oximetry testing in stand-alone mode the display will always show
the battery pack level:
The numeric values display the hours and minutes left.
During a test the display will show the following information:
3.13.1 Walk test (6MWT)
Access the oximetry area by touching the icon from the main screen, next select
the test by touching the icon.
The walk test is comprised of three stages:
Initial rest
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walking
recovery
Initial Rest
In this stage the display will show the
following data:
Test time duration
Signal quality indication
Current stage
SPO2 percentage value and the
cardiac pulse rate (heart symbol)
The “initial rest” stage must continue for a minimum of 2 minutes, after which the
icon will appear on screen. Simply touch the icon to move on the next “walking”
stage. If the user does not move on to the “walking” stage, a few seconds before
reaching the 6 minute mark the SPIRODOC will emit an acoustic signal “beep” as a
warning, and automatically enter the “walking” stage.
The number of bars (▬ 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 a finger into the sensor in order to obtain the highest
quality signal possible.
Walking Stage
At the beginning of the “walking” stage the timer is reset to zero so that the user can
immediately see of the duration of each single phase. The data on the display is the
same as shown before.
This stage will continue for a minimum of 2 minutes, after which the icon appears
on screen. To move to the next “recovery” stage touch the icon for a few
seconds. If the “walking” stage continues for more than 6 minutes SPIRODOC will emit
an acoustic signal “beep” and after 6 minutes are up the device will automatically move
on to the “recovery” stage and the timer will be reset to zero again.
Recovery stage
The duration of this stage is left up to the doctor. The device does not indicate this
stage. (at the beginning of this stage the timer is reset to zero).To end the test simply
touch the STOP icon.
At the end of the test the data required for the calculation the following parameters
must be inserted;
Baseline DYSPNEA
Final DYSPNEA
Baseline FATIGUE
Final FATIGUE
Distance (meters)
These parameters 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 meters.
The Borg scale coefficients represent the following severity values:
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SCALE
SEVERITY
0
None
0.5
Very Very Slight (Just Noticeable)
1
Very Slight
2
Slight
3
Moderate
4
Some What Severe
5
Severe
6
“
7
Very Severe
8
“
9
Very Very Severe (Almost Maximum)
10
Maximum
All the data from the walk test can be viewed in the following 6 screen shots and can
also be printed by following the instructions found in paragraph 4.2.
If the test results are printed, the paper report will only show the data related to the
“walking” stage of the test; please view the examples attached in this user manual.
Touch the STOP icon to end the test at any time.
WARNING
One of the parameters calculated during a walk test is the so-called Recovery
Time. The Recovery Time is defined as the time taken for the SpO2 value to
return to at least 99% of the average base value calculated during the initial
stage of the test.
3.13.2 Sleep Oximetry
To access the oximetry area from the main screen touch the icon, next select the
icon to select the test.
This test records overnight patient parameter variations.
After approximately 5 minutes, SPIRODOC will enter standby (energy saving) mode; it
stops beeping and the display turns off. The led signal remains on. To check that the
device is functioning properly during standby mode, press , after 1 minute
SPIRODOC will return to standby mode.
Should the signal die during standby mode the device will automatically exit the
standby mode and a warning message will appear (sensor unplugged or finger not
detected correctly).
The data shown is the same as described in the previous test, except for information in
this present mode, 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 4.2.; an example of a test printout report can be found in
this user manual.
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3.13.3 Oximetry SpO2/BPM
To access the oximetry area form the main screen touch the icon, next select the
icon.
The test duration is unlimited and the aim is to record variations of the oximetry values
during a length of time decided by the doctor.
During the test the display shows the
information that appears in the image to the
right. The BEEP and ALARM icons allow to
modify the following settings:
BEEP, allows to activate/deactivate the
heart beat acoustic signal during the
test.
ALARM, allows to activate/deactivate the thershold alarms as descrive in
paragraph 3.6.
Unlike the sleep oximetry test, the display does not enter standby mode, thus always
remaining on.
To end the test simply touch the STOP icon.
Please refer to paragraph 4.2 for a data printout; an example can be found in the
attachments inside this user manual.
3.13.4 Instructions for Adult Single Patient Sensor
WARNING
The oximetry sensor used in the manual is only one of the different types of
sensors which can be used with SPIRODOC listed in paragraph 2.2.4. MIR does
not recommend any one particular sensor, the decision is left to the doctor who
will choose the sensor which she/he believes to be more suitable.
To perform a non-invasive continuous monitoring of arterial oxygen saturation it is
recommended to use the reusable "wrap" type sensor.
WARNING
The materials used for manufacturing the sensor are NATURAL LATEX
PROTEIN FREE, and are subject to biocompatibility tests.
WARNING
The adult single patient sensor is ideal for patients weighing more than 30 kg. It
should not be used on patients who suffer from allergic reactions to adhesive
tape. The sensor is specifically designed for single use only.
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Choose an application site on the patient‟s finger
or toe where the light source will be directly over
and in-line with the detector. The preferred sites
are the forefinger or smaller thumb.
Remove nail polish or artificial fingernails.
Insert the patient‟s digit in the sensor nail-side
up, lining up the digit‟s pad over the detector.
The sensor‟s positioning line runs across the mid
axis of the fingertip
Wrap the bottom adhesive around the digit, being
careful not to cover the nail.
Fold the sensor‟s top over the digit, making sure
the light source is directly over and in-line with
the detector. Wrap the adhesive around the
finger or toe to secure the sensor. Route the
cable along the palm or the bottom of the foot,
and secure with adhesive tape if necessary.
Connect the sensor to the device: insert the connector with the arrow on the
connector face-up and check the proper functioning of the sensor according to the
previous instructions.
WARNING
Do not twist the cable or use excessive force when using, connecting,
disconnecting, or storing the sensor.
Avoid over tightening the adhesive tape; a sensor wrapped too tightly can
produce inaccurate saturation measurements. .
To reduce chances of entanglement it is recommended to fasten the cable to
the wrist with a bandage.
4. DATA TRANSMISSION
WARNING
Please read carefully and make sure to have properly understood the
instructions before commencing the data trasmission.
WARNING
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The BT wireless communication is intended as an add-on functionality. In case
of transmission failure, we recommend to use the more reliable USB technology.
4.1 Data Transmission via Bluetooth to a cell phone
SPIRODOC incorporates a “Bluetooth” wireless data transmission system. This radio
wave connection allows SPIRODOC to connect to a suitable mobile phone. All the
data in SPIRODOC can be transferred with this method of data transmission.
The step by step procedure is described below.
4.1.1 Preliminary Operations
WARNING
Data transmission through Bluetooth connection requires the phone number of
the center where the data will be received (the doctor’s office, a telemedicine
service center, etc.) The telephone number setup is done by means of the
service menu. (please see paragraph 3.6) Furthermore it is necessary to setup a
mobile phone to create a connection; for this matter also refer to paragraph 3.6.
4.1.2 Bluetooth data transmission.
Turn on the SPIRODOC
Touch the icon on the main screen
The type of transmission selected is shown, if this is correct then confirm with OK
to activate the connection to the default device that was initially setup
Upon request from the mobile phone insert the PIN code which corresponds to the
Serial number, SN, of the SPIRODOC which can be found on a label on the
bottom-side of the device.
The next stages of the connection are performed
Once the connection is up and running the data is transferred to the mobile phone
At the end of the data transfer the following message is shown “transmission
complete”
At this stage the screen will show the following information:
The device with which the connection was implemented (described in the initial
setup)
The PIN code (which corresponds to the device serial number)
To stop the Bluetooth connection during the data transfer simply touch the STOP icon,
by doing so the connection will be terminated and the device will return to the main
screen.
If no device was setup for the data transmission a message will appear on screen
which allows the device to search for compatible devices. Once the device is setup the
connection commences automatically.
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Should there be any errors during the data
transfer the message on the right will appear
on screen.
The device will automatically return to the
main screen; repeat the procedure again.
4.2 Data transmission via Bluetooth for printing
WARNING
Data printing from the patient management function will only work if the printer
too has a Bluetooth connection; another possible solution is with the use of a
USB adaptor installed on the printer, thus enabling a Bluetooth connection.
The Bluetooth system enables SPIRODOC to transfer test data directly to a Bluetooth
enabled printer. The procedure is listed below:
4.2.1 How to print a test saved in the database
From the main screen touch the icon
Select a search method
Select the test session in which the test of interest was performed
Upon entering the test session select the test and touch the icon.
If no device was setup to print via Bluetooth a message will appear on screen which
allows the device to search for compatible devices. Once the device is setup the
connection commences automatically for the printout.
During the search for compatible devices to connect via bluetooth, SPIRODOC always
checks the address of the device. If a previously registered device should change
name it will be automatically upgraded.
Should there be any errors during the
data transfer the message on the right
will appear on screen.
The device will automatically return to
the main screen; repeat the procedure
again.
4.3 PC connection via USB port
WARNING
Before connecting spirobank II by USB to a PC, winspiroPro must be installed
to interface with the device.
It is important prior to initiating the following procedure to know the version
of the operating system installed on the PC used for the connection (from
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control panel click on “System”, where the type of operating system installed
on the PC can be checked).
If winspiroPRO is already installed on the PC then a new installation is not
required.
Before connecting the SPIRODOC via USB to the PC, the WinspiroPRO software
must be installed on the PC first to enable the software to interface with the
device.
Before initiating the following procedure it is important to know the operating
system version installed on the PC used for the connection (from control panel
click on “System”, where the type of operating system installed on the PC can
be checked).
If winspiroPRO is already installed on the PC then a new installation is not
required.
To make the connection, insert the mini USB connector
supplied with SPIRODOC as shown in the picture and
attach the other connector to the USB port of the PC.
When initially making a connection, depending on the
version of the operating system, the PC will either
make an automatic driver installation (for Windows 98,
2000, ME) or request some information (for Windows
XP, Vista and Seven). To avoid making any errors at
this stage please read the Advanced section of the
winspiroPRO User Manual carefully.
4.4 PC connection via Bluetooth
The bluetooth connection to the PC allows for the USB ports to remain unused while
still having a connection whereby the SPIRODOC is directly managed by the
winspiroPRO software (as with a USB connection)
SPIRODOC is capable of performing on-line real time spirometry tests via Bluetooth
connection.
WARNING
To function properly the PC must have Bluetooth connectivity embedded or
must be equipped with an external Bluetooth USB dongle. Before starting the
Bluetooth connection procedure it is necessary to have previously performed
the procedure described in paragraph 3.6 (BLUETOOTH setup).
For proper peripheral management please refer to the software user manual on line.
4.5 Internal software upgrade
SPIRODOC internal software can be upgraded from a PC via USB connection.
Upgrades can be downloaded by registering on www.spirometry.com. For further
information on software upgrading please read the “winspiroPro” software manual.
5. MAINTENANCE
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SPIRODOC requires very little maintenance
The operations to perform periodically are:
Cleaning and checking the reusable turbine.
Changing the disposable turbine before each test.
Cleaning 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 with
extreme care. Failing to observe the instructions may cause errors in measurement or
the misinterpretation of the measured values.
Modifications, adjustments, repairs, and reconfigurations must be carried out by the
manufacturer or by qualified personnel.
In the unlikely event of a problem do not attempt to repair the unit.
The parameter configuration setup must be carried out by qualified personnel. In any
case the risks pertaining to an incorrect configuration setting in no way endangers the
patient.
5.1 Cleaning and checking the reusable turbine
Two types of turbines can be used with SPIRODOC. The disposable turbine or the
reusable turbine. Both guarantee precise measurements and have the advantage of
requiring no periodic calibration. In order to maintain the default characteristics of the
reusable turbine a simple cleaning procedure is required before use.
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.
ATTENZIONE
È buona norma controllare periodicamente che all'interno della turbina non
siano depositate impurità o corpuscoli estranei come peli o peggio capelli.
Questa eventualità infatti potrebbe frenare o bloccare l'equipaggio mobile della
turbina compromettendo l'accuratezza della misura.
Prima di ogni utilizzo effettuare il test descritto al paragrafo 5.1.1 seguente che
permette di controllare lo stato di efficienza della turbina, se il risultato del test è
negativo operare come segue.
Per pulire la turbina riutilizzabile estrarla dall‟apposito alloggiamento ricavato su
SPIRODOC ruotando in senso antiorario ed esercitando una semplice trazione. Per
facilitare l‟estrazione è utile esercitare una lieve spinta sulla base della turbina
aiutandosi con un dito.
Immergere la turbina in un liquido detergente a freddo ed agitarla in maniera da
rimuovere le possibili impurità depositate all‟interno; lasciarla immersa per il tempo
suggerito dal produttore della soluzione detergente e riportato nelle istruzioni d‟uso.
WARNING
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To avoid damage beyond remedy to the reusable turbine please do not use any
alcoholic or oily detergent solutions, and do not immerge the turbine in hot
water or hot liquids.
Do not place the turbine under a direct water jet or other liquid. If no detergent
solution is available, clean the turbine in clean water.
MIR suggests the use of Perasafe, manufactured by Dupont, which has been
tested on all MIR sensors.
Rinse the turbine by immerging it in clean water (not hot).
Shake off the excess water from the turbine and let it dry, position the turbine vertically
on a dry surface.
Before inserting the reusable turbine in the device it is good practice to visually check
that the rotor inside turns freely. Hold the turbine horizontally and slowly move it left
and right and vice versa. You should be able to see the mobile equipment (blade)
rotate freely. If this is not the case then the measurement accuracy can no longer be
guaranteed and as such the turbine must be replaced.
Having completed the turbine cleaning procedure, insert the turbine in its housing
making sure to turn it clockwise as shown by the symbol of the lock printed on
SPIRODOC.
The turbine is inserted properly by pushing it all the way in and subsequently rotating it
clockwise until it stops; this bayonet mechanism ensures that the turbine is blocked
inside the plastic casing.
To be absolutely certain that the turbine is functioning properly perform the checklist in
paragraph 5.1.1; if the turbine is still malfunctioning please replace it with a new one.
WARNING
When using disposable turbines, do not carry out any cleaning procedure. A
new disposable turbine must be used for a new patient.
5.1.1 Proper turbine operation check
Turn on SPIRODOC and setup the device to perfom a spirometry test (for example
FVC).
Hold the SPIRODOC with one hand and move it slowly sideways, having the air
pass through the turbine.
If the rotor spins properly the device will emit a series of acoustic signals “beeps”.
The beeping frequency is a function of the air flow passing through the turbine.
If no beeps are heard while moving the device, proceed to clean the turbine
5.2 Oximetry sensor cleaning
Clean the sensor with a soft cloth moistened with water or a mild soap solution. To
disinfect the sensor, rub with isopropylic alcohol. Allow the sensor to dry completely
after cleaning.
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WARNING
Do not sterilize by irradiation, steam or by using ethylene oxide.
Unplug the sensor from the device before cleaning or disinfecting it.
5.3 Changing the adhesive wrap sensor
The adhesive tape is made with latex-free material.
Gently remove the used adhesive tape from the sensor and dispose of it.
The back of the sensor has alignment pins. Place the sensor with the alignment
pins facing the adhesive part of the tape and align the pins to the holes on the
tape.
Push the sensor so as to insert the pins into the holes of the tape. Lift both the
sensor and the tape and check that the pins of the sensor are properly aligned.
WARNING
It is highly suggested to use a new piece of adhesive tape for each patient, or as
required.
5.4 Battery charging
Turn on SPIRODOC and the following icon will appear on the main screen showing the
charge level of the battery pack:
The maximum charge level is displayed with all 6 bars inside the battery.
If only one bar is shown or if the device will not even turn on the battery pack must be
recharged in the following manner:
Plug the battery charger into a socket and the battery charger cable into the micro
USB connector of the device; the device in this phase is always turned on
When the charging is complete the battery icon will display all six bars.
At this point disconnect the battery charger from the device.
WARNING
It is recommended not to use the device while the battery is charging.
Always disconnect the battery charger from the device when the charge cycle
has terminated.
6. PROBLEM SOLVING
Please find below a list of problems that may arise when using SPIRODOC.
Diagnostic messages are also shown on the display indicating the type of malfunction:
6.1 Causes and solutions
The SPIRODOC will not turn on
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- The battery pack could be completely discharged; recharge the device by connecting
it to the battery charger.
- The device internal software is lost. Connect the device to the PC via USB and
proceed to download the internal software. For further information please refer to the
winspiroPRO user manual available inside the software itself.
While in use the device turns off and on again.
- An internal error has occured, please check on the website www.spirometry.com for
new internal software upgrades. Should there be a newer internal software version
please upgrade the device by using the winspiroPRO software. For further information
please refer to the winspiroPRO user manual available inside the software itself.
At the end of a spirometry test the data measurements are not reliable.
- Clean the turbine as shown in paragraph 5.1; if necessary replace the turbine with a
new one.
Memory loss due to an unexpected event
- The database has been lost. Contact a local technical service center.
WARNING
Before contacting a technical assistance center, please try downloading the
database from the device to the PC using the winspiroPRO software. This
procedure is necessary as a backup in case all the data is accidentally lost
during device repair. Furthermore the database could be of confidential nature
and as such not accessible by authorized personnel and also subject to privacy
laws.
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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 Spirometer/Oximeter
Device Name spirobank II
Classification IIa
This Device is marked
Any modifications to the Device which are not authorised by MIR will invalidate
this Declaration
Roma 01 / 01/ 2006
Paolo Sacco Bochetti
President of the Board of Trustees.
Rev.0 – Mod. PO-10DDC_SPIRODOC
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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 device 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 device has been
connected.
If the serial number of the device 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 centers. For details of these centers
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
center.
Any device 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 devices
are returned to MIR.
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MIR – Medical International Research reserves the right to modify the device if
required, and a description of any modification made will be sent along with the
returned goods.
ALLEGATO 1 OXIMETRY TEST REPORTS EXAMPLES
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ALLEGATO 2 SPIROMETRY TEST REPORT EXAMPLE
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ANNEX 3 INFORMATION FOR CORRECT USE IN AN
ELECTROMAGNETIC ENVIRONMENT
Guidance and manufacturer’s declaration – electromagnetic emissions
The spirobank II is intended for use in the electromagnetic environment specified below.
The customer or the user of the Spirobank II should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1
The SPIRODOC 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.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
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Guidance and manufacturer’s declaration – electromagnetic immunity
The spirobank II is intended for use in the electromagnetic environment specified below. The customer
or the user of the spirobank II should assure that it is used in such an environment.
Immunity test
IEC 60601
test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
In the event of disruption due to ESD during
oximetry test, the device recovers from any
disruption within 30 s. (according to ISO
9919).
Electrical fast
transient/burst
IEC 61000-4-4
±1 kV for input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common mode
Not Applicable
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips,
short
interruptions and
voltage
variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0,5 cycle
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
Not Applicable
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
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.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2,5 GHz
[3 ] V
[3 ] V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the spirobank II, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
d=[ 3.5 ] √P
3
d=[ 3.5 ] √P 80 MHz to 800 GHz
3
d=[ 7 ] √P 800 MHz to 2,5 GHz
3
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
Spirodoc cod. 980156 Rev 1.3 EN 66/67
ENGLISH
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.
Spirodoc cod. 980156 Rev 1.3 EN 67/67
ENGLISH
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
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
d=[ 3.5 ] √P
3
80 MHz to 800 MHz
d=[ 3.5 ] √P
3
800 MHz to 2,5 GHz
d=[ 7 ] √P
3
0.01
0.12
0.24
0.24
0.1
0.37
0.37
0.74
1
1.17
1.17
2.34
10
5.28
5.28
1.056
100
11.66
11.66
23.32
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

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