MIR Spirodoc User manual

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

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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
COD.
Carrying bag SPIRODOC
672690
Carrying bag SPIRODOC
672690
Device SPIRODOC
910575
Device SPIRODOC with
oximetry function
910570
User manual SPIRODOC
980205
User manual SPIRODOC
980205
USB cable
532365
USB cable
532365
Lithium-ion battery pack
970080
Lithium-ion battery pack
970080
winspiroPRO CD
920100
winspiroPRO CD
920100
1 noseclip
910320
1 noseclip
910320
4 paper mouthpieces *
910300
4 paper mouthpieces *
910300
1 reusable turbine
910002
1 reusable turbine
910002
3 disposable turbines
910001
3 disposable turbines
910001
1 oximetry sensor
919010
Accessori
COD.
Accessori
COD.
Battery charger with micro
USB connector
920680
Battery charger with micro USB
connector
920680
Disposable adult oximetry
sensor for extended length of
time screening*
919007
Extension cable for oximetry
sensor
919090
* 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: [e-mail]
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: [email protected].
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.

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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

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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.

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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

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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.

Spirodoc cod. 980156 Rev 1.3 EN 15/67
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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.

Spirodoc cod. 980156 Rev 1.3 EN 16/67
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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

Spirodoc cod. 980156 Rev 1.3 EN 19/67
ENGLISH
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
\

Spirodoc cod. 980156 Rev 1.3 EN 20/67
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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
T2 [SpO2≥2%]
Time passed during walking test with SpO2 < 2 %
with respect to SpO2 base
hh:mm:ss
T4 [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
\