Medical International Research spirodoc User manual

spirodoc
SPIRODOC cod. 980156 Rev 2.4 EN 1/46
User manual
User manual rev. 2.4
Issue date 10.04.2014
Approval date 10.04.2014

spirodoc
SPIRODOC cod. 980156 Rev 2.4 EN 2/46
User manual
INDEX
1. INTRODUCTION............................................................................................................................................................................................... 3
1.1 Intended use.......................................................................................................................................................................................... 3
1.1.1 User category ................................................................................................................................................................................... 3
1.1.2 Ability and experience required......................................................................................................................................................... 3
1.1.3 Operating Environment..................................................................................................................................................................... 4
1.1.4 Who can or must make the installation.............................................................................................................................................. 4
1.1.5 Patient effect on the use of the device............................................................................................................................................... 4
1.1.6 Limitations of use - Contraindications................................................................................................................................................ 4
1.2 Important safety warnings...................................................................................................................................................................... 4
1.2.1 Danger of cross-contamination ......................................................................................................................................................... 5
1.2.2 Turbine ............................................................................................................................................................................................. 5
1.2.3 Mouthpiece....................................................................................................................................................................................... 5
1.2.4 Oximetry sensors.............................................................................................................................................................................. 5
1.2.5 Device............................................................................................................................................................................................... 6
1.3 Lithium-ion battery pack warning............................................................................................................................................................ 6
1.4 Unforessen errors.................................................................................................................................................................................. 8
1.5 Labels and symbols............................................................................................................................................................................... 8
1.5.1 Identification label............................................................................................................................................................................. 8
1.5.2 CE mark for medical devices............................................................................................................................................................. 8
1.5.3 Electrical safety symbol..................................................................................................................................................................... 8
1.5.4 Warning symbol for the USB............................................................................................................................................................. 8
1.5.5 Warning symbol for the SpO2 port for oximetry................................................................................................................................. 8
1.5.6 Warning symbol for the WEEE.......................................................................................................................................................... 8
1.5.7 FDA and FCC Warnings ................................................................................................................................................................... 8
1.5.8 (ESD) Electrostatic discharge sensitivity symbol............................................................................................................................... 9
1.6 Product description................................................................................................................................................................................ 9
1.7 Technical specification......................................................................................................................................................................... 10
1.7.1 Features of the spirometer.............................................................................................................................................................. 10
1.7.2 Oximeter features ........................................................................................................................................................................... 11
1.7.3 Other features................................................................................................................................................................................. 14
2. FUNCTIONING OF THE SPIRODOC.............................................................................................................................................................. 15
2.1 Display................................................................................................................................................................................................. 15
2.2 Switching on and off the SPIRODOC................................................................................................................................................... 15
2.3 Energy saving...................................................................................................................................................................................... 16
2.4 Main screen......................................................................................................................................................................................... 16
2.5 Symbols and Icons .............................................................................................................................................................................. 16
2.6 Service menu....................................................................................................................................................................................... 17
2.6.1 Doctor Mode................................................................................................................................................................................... 18
2.6.2 Patient Mode................................................................................................................................................................................... 22
2.6.3 Reusable turbine calibration............................................................................................................................................................ 23
2.7 Patient Data......................................................................................................................................................................................... 24
2.7.1 Inserting data of a new patient ........................................................................................................................................................ 24
2.7.2 Patient data modification................................................................................................................................................................. 24
2.8 Visualization of memory data............................................................................................................................................................... 24
2.8.1 Database research modality............................................................................................................................................................ 24
2.8.2 Visualization of database info.......................................................................................................................................................... 25
2.9 Display of last test session from current patient ................................................................................................................................... 26
2.10 PC On line mode (connected to a PC)................................................................................................................................................. 26
2.11 Spirometry testing................................................................................................................................................................................ 26
2.11.1 FVC test.......................................................................................................................................................................................... 27
2.11.2 Test VC........................................................................................................................................................................................... 27
2.11.3 MVV Test........................................................................................................................................................................................ 28
2.11.4 POST test, after drug administration ............................................................................................................................................... 28
2.12 Viewing the spirometric results ............................................................................................................................................................ 28
2.12.1 Spirometry test interpretation.......................................................................................................................................................... 28
2.13 Oximetry Testing.................................................................................................................................................................................. 29
2.13.1 Walk test (6MWT)........................................................................................................................................................................... 31
2.13.2 Sleep Oximetry............................................................................................................................................................................... 33
2.13.3 Oximetry SpO2/BPM....................................................................................................................................................................... 33
2.13.4 Patient mode oximetry .................................................................................................................................................................... 33
2.13.5 Instructions for Adult Single Patient Sensor..................................................................................................................................... 34
2.14 Testing without patient data................................................................................................................................................................. 35
3. DATA TRANSMISSION .................................................................................................................................................................................. 35
3.1 Data Transmission via Bluetooth to a SERVER by cell phone.............................................................................................................. 35
3.2 Data transmission via Bluetooth for printing......................................................................................................................................... 35
3.2.1 How to print a test saved in the database........................................................................................................................................ 35
3.2.2 How to print a test of the last session.............................................................................................................................................. 36
3.3 PC connection via USB port................................................................................................................................................................. 36
3.4 Internal software upgrade .................................................................................................................................................................... 36
4. MAINTENANCE.............................................................................................................................................................................................. 36
4.1 Cleaning and checking the reusable turbine......................................................................................................................................... 36
4.1.1 Proper turbine operation check ....................................................................................................................................................... 37
4.2 Oximetry sensor cleaning .................................................................................................................................................................... 37
4.3 Changing the adhesive wrap sensor.................................................................................................................................................... 37
4.4 Battery charging................................................................................................................................................................................... 37
5. PROBLEM SOLVING...................................................................................................................................................................................... 38
LIMITED WARRANTY CONDITIONS ..................................................................................................................................................................... 40
ANNEX 1 OXIMETRY TEST REPORTS EXAMPLES..................................................................................................................................... 41
ANNEX 2 SPIROMETRY TEST REPORT EXAMPLE..................................................................................................................................... 44
ANNEX 3 INFORMATION FOR CORRECT USE IN AN ELECTROMAGNETIC ENVIRONMENT .................................................................. 45

spirodoc
SPIRODOC cod. 980156 Rev 2.4 EN 3/46
User manual
Thank you for choosing a MIR product MEDICAL INTERNATIONAL RESEARCH
WARNING
The paper mouthpiece, the nose clip and the disposable turbine with mouthpiece in the equipment should be considered disposable
products.
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.
Set the device configuration (date, hour, predicted set, language, etc etc) as described in paragraph 3.6
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 "recognized"
by the PC the device may now be used with the winspiroPRO software.
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 and 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 are appreciated and may be sent via
email to: [e-mail].
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
1. INTRODUCTION
1.1 Intended use
The SPIRODOC spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician.
The device is intended to test lung function and can make:
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, excluding during patient transport outside a healthcare facility.
1.1.1 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.
1.1.2 Ability and experience required
The correct use of the device, the interpretation of the results and the maintenance of the device all require qualified personnel. In the event that
the device is to be operated by a patient, sufficient training must first be given to the patient by the 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 the person legally responsible to supervise the cognitively impaired person.

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SPIRODOC cod. 980156 Rev 2.4 EN 4/46
User manual
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.
1.1.3 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.
WARNING
Exposure to unsuitable environmental conditions may cause the device to malfunction, and to provide incorrect results.
1.1.4 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.
1.1.5 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.
1.1.6 Limitations of use - Contraindications
An analysis of the results of a spirometry test is not by itself sufficient to make a correct diagnosis of the 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 respected then the results obtained during spirometry
testing will not be considered accurate, and therefore the test results are “not acceptable”.
The acceptability of a test is the responsibility of the 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 frequent display observation of SpO2
and pulse rate.
1.2 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.
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.. In normal conditions the lifespan of the device 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.

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1.2.1 Danger of cross-contamination
Two different types of turbine sensors can be used with the device, one is reusable and 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.
1.2.2 Turbine
Disposable turbine
WARNING
For spirometry testing with a disposable turbine it is important to use a new turbine for
each new patient. The accuracy and hygiene of the disposable turbine can only be
guaranteed if it has been conserved beforehand in its original sealed packaging
The disposable turbine is made of plastic and its disposal after use should adhere to
the local regulations and norms in force.
Reusable turbine
WARNING
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 types of turbine.
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 matter 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 measurement accuracy.
1.2.3 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. The required mouthpiece is a standard type with an outside diameter
of 30 mm, is of common use 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.
1.2.4 Oximetry sensors
The included sensor code 919024_INV and the following oximetry sensors can be used with SPIRODOC:
Manufacturer
Code
Description
BCI
1300
adult sensor (disposable)
BCI
3026
wrap-around sensor for infants
BCI
3043
universal Y sensor
BCI
3078
ear sensor
BCI
3178
pediatric finger sensor, reusable
BCI
3444
adult sensor reusable (Comfort Clip)
BCI
3044
adult finger sensor, reusable
These sensors require the use of an extension cable (product code 919200) for a proper connection to SPIRODOC. Two cable lengths are
available:
Cod. 919200 length 1.5 m
Cod. 919210_INV length 0.5 m
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.

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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 (for example; to perform a diagnostic tests) 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
the 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 measurements.
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.
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.
1.2.5 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.
The use of accessories and cables other than those specified by the manufacturer may result in increased emissions or decreased
immunity of the device.
SPIRODOC should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, SPIRODOC
should be observed to verify normal operation in the configuration in which it will be used.
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 device is connected to other instruments, to satisfy the safety requirements of the system required by the standard CEI EN 60601-1,
it is necessary to use exclusively devices compliant to the safety standard. Therefore the PC or the printer which the SPIRODOC is
connected must be compliant to the standard CEI 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.
To supply power to the device use only the battery type indicated in the § Technical specifications.
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.
1.3 Lithium-ion battery pack warning
The device is powered by a rechargeable lithium-ion battery pack with a supply voltage of 3.7 V.
For proper use of the battery pack please read carefully the warning below
WARNING
Use only battery packs supplied by MIR
Improper use of the battery pack may cause acid leakage, overheating, smoke, breakage an explosion and/or fire. Consequently the
battery pack may be damaged or suffer a drop in overall performance. The internal battery pack safety sensor could also be damaged as
well by any of the above events. Furthermore the user of the device could be harmed and other nearby appliances could be damaged as
well.
Please read the following instructions carefully.

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DANGER
Do not disassemble or modify the battery pack. The battery pack comes with an internal safety sensor; which if tampered with may cause
acid leakage, overheating, smoke, breakage an explosion and/or fire.
Do not short-circuit the positive(+) and negative (-) poles with any metal objects.
Do not carry the battery pack in your pocket or in a bag with other metallic objects like necklaces, hairpins, coins or screws.
Do not store the battery pack near any such objects.
Do not warm-up or throw the battery pack in a fire.
Do not use or store the battery pack near a fire or in a vehicle where the temperature may reach 60°C or higher
Do not immerge the battery pack in water or salt-water, and do not leave it wet.
Such events may damage the internal battery safety sensor, thus causing the battery to be charged at a higher voltage, triggering
abnormal chemical reactions leading to acid leakage, overheating, smoke, an explosion and/or fire
Do not charge the battery pack near a fire or in an extremely hot environment. High temperature may activate the internal battery safety
sensor thus inhibiting the charge. The high temperature may also damage the internal battery safety sensor causing extremely high
current surge; and consequently causing abnormal chemical reactions in the battery pack triggering acid leakage, overheating, smoke
breakage, an explosion and/or fire.
Use only the battery charger supplied by MIR to recharge the battery pack. Recharging with an unsuitable charger in unconforming
conditions may cause the battery pack to overcharge or the charging current to be extremely high thus causing abnormal chemical
reactions in the battery pack triggering acid leakage, overheating, smoke breakage an explosion 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 creating the possibility for acid leakage, overheating, smoke,
breakage and/or fire.
Do not use a heavily scratched or deformed battery back as this may be cause for acid leakage, overheating, smoke, breakage and/or
fire.
Do not solder directly on the battery pack.
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 connection may provoke acid leakage, overheating, smoke, breakage
and/or fire.
Do not connect the battery pack leads to a wall socket or to the car lighter Under high voltage the battery may leak acid, overheat, emit
smoke, explode and/or catch fire.
Do not use the battery pack for any other purpose other than those specified otherwise its features may be compromised, and its useful
life reduced
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.
WARNING
Do not leave the battery pack charging longer than the average charging length of time specified.
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 gives off a bad smell, 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 it any longer, as any of these
events may cause acid leakage, overheating, smoke, breakage and/or fire.
NOTA
The battery pack includes an internal safety protector. Do not use the battery pack where static electricity is present(higher than what is
declared by the manufacturer.
If acid from the battery pack comes into contact with skin or clothing immediately wash with running water to avoid skin inflammation
Store the battery pack away from children’s reach to avoid any accidental swallowing.
If a child uses the battery pack an adult must explain the proper use to the child.
Before using the battery pack read the manual carefully paying attention to all the recommendations for proper handling.
Please read the manual carefully to insert and remove of the battery pack in the device properly.
Before charging the battery pack read the manual carefully.
The battery pack life cycle 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.
If the battery pack leads are dirty clean with a dry cloth prior to usage.

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SPIRODOC cod. 980156 Rev 2.4 EN 8/46
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The battery pack can be charged within a temperature range between 0°C and approximately 40°C
The battery pack may be used within a temperature range between -20°C and approximately 60°C.
The battery pack may be stored within a temperature range between -20°C and approximately 60°C.
1.4 Unforessen errors
In case device internal memory data are damaged, when the device is switched on, the following message appears:
ERROR IN MEMORY
In this case switch off the device and contact a technical service center.
1.5 Labels and symbols
1.5.1 Identification label
The label shows:
Serial number of the device
Product name
Name and address of the manufacturer
Electrical safety symbol
Antenna symbol for devices whom include RF transmission
CE mark in compliance with the Directive 93/42 EEC.
WEEE symbol
ID code for FCC regulation
Symbol for FDA regulation (Rx ONLY)
Ingress Protection rating (IPX1)
1.5.2 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.
1.5.3 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.
1.5.4 Warning symbol for the USB
To connect to other devices such as PC or printer.
Use only the USB cable supplied by the manufacturer and observe the safety regulations of IEC 60601-1-1.
1.5.5 Warning symbol for the SpO2 port for oximetry
SpO2
1.5.6 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.
1.5.7 FDA and FCC Warnings
SPIRODOC complies with Part 15 of the FCC Rules. The correct operation is subject to the following conditions:

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(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.
Labels and symbols are displayed on the device as shown in the following images:
1.5.8 (ESD) Electrostatic discharge sensitivity symbol
The (ESD) symbol required by the international standard EN 60601-1-2 is used in the vicinity of any connector which has not undergone
electrostatic discharge testing.
WARNING
Pins of connectors identified with the ESD warning symbol should not be touched and the connections should not be made to these
connectors unless ESD precautionary procedures are used.
Precautionary procedures are the following:
Environmental procedures as: air conditioning, humidification, conductive floor coverings, non-synthetic clothing
User procedures as: discharging one’s body to a large metal object, using wrist strap connected to earth.
It is recommended that all staff involved receive an explanation of the ESD warning symbol and training in ESD precautionary procedures.
the electrostatic discharge is defined as an electric charge at rest. It is the sudden flow of electricity between two objects caused by contact, an
electrical short, or dielectric breakdown. ESD can be caused by a buildup of static electricity by tribocharging, or by electrostatic induction. At lower
relative humidity, as the environment is drier, charge generation will increase significantly. Common plastics generally will create the greatest static
charges.
Typical electrostatic voltage values:
Walking across a carpet
1.500 –35.000 volts
Walking over untreated vinyl floor
250 –12.000 volts
Vinyl envelope used for work instructions
600 –7.000 volts
Worker at a bench
700 –6.000 volts
If two items are at different electrostatic charge levels, as they approach one another, a spark or Electrostatic Discharge (ESD) can occur. This
rapid, spontaneous transfer of electrostatic charge can generate heat and melt circuitry in electronic components.
A latent defect can occur when an ESD sensitive item is exposed to an ESD event and is partially degraded. It may continue to perform its intended
function, so may not be detected by normal inspection. Intermittent or permanent failures may occur at a later time.
Static dissipative material will allow the transfer of charge to ground or to other conductive objects. The transfer of charge from a static dissipative
material will generally take longer than from a conductive material of equivalent size. Some well known insulators are common plastics, and glass.
An insulator will hold the charge and cannot be grounded and conduct. the charge away.
Both conductors and insulators may become charged with static electricity and discharge. Grounding is a very effective ESD control tool, however,
only conductors (conductive or dissipative) can be grounded.
The fundamental ESD control principles are:
Ground all conductors including people
Remove insulators, substitute with ESD protective versions
neutralize with ionizers
ESDS outside the EPA (ESD protected area) to be in packaging having ESD shielding property
1.6 Product description
The 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: USB, Bluetooth.

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SPIRODOC cod. 980156 Rev 2.4 EN 10/46
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The device 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
approximately 10.000 spirometry tests or at least 300 hours 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 principle. This transducer 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.
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 disinfect the turbine for testing from one patient to the next, to ensure the maximum level of hygiene and safety.
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 can also be connected to a PC (or to another computerised system) to configure the instrument. All spirometry test data including the
related patient 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 winspiroPRO can be made via USB 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 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 principle ensures accuracy and reproducibility, without requiring regular calibration.
The oximetry sensor can be disinfected with isopropilic alcohol.
1.7 Technical specification
A comprehensive description of the main features of the device, the flow and volume measurement turbine and also of the oximetry sensor follows:
1.7.1 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
%

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Symbol
Description
Units
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
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
1.7.2 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 for the oximetry test:
Symbol
Description
Units
%SPO2 min
Minimum SPO2 during the test
%
%SPO2 max
Maximum SPO2 during the test
%
BPM min
Minimum BPM during the test
BPM
BPM max
Maximum BPM during the test
BPM
%SPO2 mean
Average SPO2
%
BPM mean
Average BPM
BPM
T Total
Total test time
hh:mm:ss
T Analysis
Total measurement time (test time minus the zeros)
hh:mm:ss
T<90%
Time with SPO2 below 90%
%-hh:mm:ss
T<89%
Time with SPO2 below 89%
%-hh:mm:ss
T<88%
Time with SPO2 below 88%
%-hh:mm:ss
T<87%
Time with SPO2 below 87%
%-hh:mm:ss
Ev%SPO2<89
SpO2 fall below 89% for at least 20 seconds
/
Δ Index
SpO2 Fluctuation index calculated on 12 second intervals
/
T<40BPM
Test time with pulse rate <40 BPM
%-hh:mm:ss
T>120BPM
Test time with pulse rate >120 BMP
%-hh:mm:ss
Ev<40BPM
High heart rate events, during the analysis period
/
Ev>120BPM
Tachycardiac (high heart rate) events, during the analysis period
/
%SPO2 start
Initial phase %SpO2 base value, before walking test
%

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Symbol
Description
Units
%SPO2 end
Final SPO2 reading during walking phase
%
BPM end
Final BPM reading during walking phase
BPM
%SPO2 Base
Initial phase SPO2 base value, before walking test
%
BPM start
Initial phase BMP base value, before walking test
BPM
T Baseline
Duratation of base phase
hh:mm:ss
T Walking
Duration of walking phase
hh:mm:ss
T Recovery
Duration of recovery phase
hh:mm:ss
Distance
Distance covered
m
T2%Δ SPO2
Time spent during the walking test, with SpO2<2% compared to the SpO2 base value
hh:mm:ss
T4%Δ SPO2
Time spent during the walking test, with SpO2<4% compared to the SpO2 base value
hh:mm:ss
Predicted
Standard predicted distance
m
Predicted min
Minimum predicted distance
m
% Predicted
% variation of the distance covered compared to the standard predicted distance
%
%Predicted min
% variation of the distance covered compared to the minimum predicted distance
%
AUC/Distance*
Area below the SpO2 base curve compared to the distance covered
/
Dyspnea Base
Degree of breathlessness prior to the walking test
Borg
Dyspnea End
Degree of breathlessness at the end of the walking test
Borg
Dyspnea CHG
Variation in the degree of breathlessness during the walking test
/
Fatigue Base
Degree of tiredness prior to the walking test
Borg
Fatigue End
Degree of tiredness at the end of the walking test
Borg
Fatigue CHG
Variation in the degree of tiredness during the walking test
/
Diastolic Base
Starting diastolic value
mmHg
Systolic Base
Starting systolic value
mmHg
Diastolic Fine
Final diastolic value
mmHg
Systolic Fine
Final systolic value
mmHg
Steps
Estimation of the steps taken by the patient during the test
/
VMU**
Number of movements made by the patient during the test
/
O2-GAP***
Estimation of the percentage of oxygen to administer to the patient
%
O2
percentage of oxygen administered to the patient before test
L/min-%
SPO2 Base
SPO2 base value for the SPO2 and ODI tests
%
BPM Base
BPM base value for the SPO2 and ODI tests
BPM
ODI
Desaturation events per hour of analysis
1/h
Mean Dur. Desat.
Average duration of the desaturation event
s
Tot Desaturat.
Number of desaturation events during the entire analysis period
/
Longest Desat.
Duration of the longest desaturation event
s
Desatur. Peak
Minimum SpO2 value during a desaturation event
%
BPM Index
Number of events of variation of the Pulse rate per hour of a analysis
/
Mean Desaturat.
Average of the desaturation troughs
s
Mean Drop
Average SpO2 fall compared to the base value during the desaturation events
s
Max Drop
Maximum fall in the SpO2 compared to the saturation events
s
BPM Variation
Number of variations in the Pulse Rate during the entire analysis period
/
NOD4%
Number of events with SpO2<4% compared to the SpO2 base value for a continuous period of at least 5
minutes
/
NOD89%
Number of events with SpO2<89% for a continuous period of at least 5 minutes
/
NOD90%
Number of events with SpO2<90% for a continuous period of at least 5 minutes with min value <86% (Nadir)
/
t.NOD4%
Time with SpO2<4% compared to the SpO2 base value for a continuous period of at least 5 minutes
hh:mm:ss
t.NOD89%
Time with SpO2<89% for a continuous period of at least 5 minutes
hh:mm:ss
t.NOD90%
Time with SpO2<90% for continuous periods of at least 5 minutes with mim value <86% (Nadir)
hh:mm:ss
*Below is a description of the method for calculating the area below the SpO2 baseline curve:
** “index movement”. The parameter is expressed in VMU and is used to quantify patient movement during oximetry testing.
*** O2GAP index estimates the percentage of oxygen to be administered to a patient by using the (6MWT) For more information please refer to the
publication: “The six minute walk test (6MWT) can predict O2 flows required to prevent exercise-induced O2 desaturation”; Authors: G. Pezzuto, L.

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Calzetta, MC. Basili, MA. Porretta, L. Senis, P. Rogliani, M. Cazzola, C. Saltini, University of Roma "Tor Vergata” Italy, presented at: ERS
(European Respiratoty Society Congress), Barcelona - Spain: 21 September 2010
The following table lists all the symbols used for the parameters in the service menu under item “Set parameters” describing to which test each is
related to and if optional:
Symbol
Symbol in menu "Set parameters"
Test
Optional
%SPO2 min
\
all
no
%SPO2 max
\
all
no
BPM min
\
all
no
BPM max
\
all
no
%SPO2 mean
\
all
no
BPM mean
\
all
no
T Total
\
all
no
T Analysis
\
all
no
T<90%
T<90%
all
yes
T<89%
T<89%
all
yes
T<88%
T<88%
all
yes
T<87%
T<87%
all
yes
Ev%SPO2<89
Ev%SPO2<89
all
yes
Δ Index
Δ INDEX
all
yes
T<40BPM
t<40BPM
all
yes
T>120BPM
t>120BPM
all
yes
Ev<40BPM
Ev<40BPM
all
yes
Ev>120BPM
Ev>120BPM
all
yes
%SPO2 start
\
6MWT
no
%SPO2 end
\
6MWT
no
BPM end
\
6MWT
no
%SPO2 Base
\
6MWT
no
BPM start
\
6MWT
no
T Baseline
\
6MWT
no
T Walking
\
6MWT
no
T Recovery
\
6MWT
no
Distance
\
6MWT
no
T2%Δ SPO2
T2%ΔSPO2
6MWT
yes
T4%Δ SPO2
T4%ΔSPO2
6MWT
yes
Predicted
PREDICTED
6MWT
yes
Predicted min
PRED.MIN
6MWT
yes
% Predicted
%PREDICT.
6MWT
yes
%Predicted min
%PRED.MIN
6MWT
yes
AUC/Distance
AUC/DIST.
6MWT
yes
Dyspnea Base
BASE DYSP
6MWT
yes
Dyspnea End
END DYSP
6MWT
yes
Dyspnea CHG
CHG DYSPN
6MWT
yes
Fatigue Base
BASE FATIG
6MWT
yes
Fatigue End
END FATIG
6MWT
yes
Fatigue CHG
CHG FATIG
6MWT
yes
Diastolic Base
BASE DIAST.
6MWT
yes
Systolic Base
BASE SYST.
6MWT
yes
Diastolic Fine
END DIAST.
6MWT
yes
Systolic Fine
END SYST.
6MWT
yes
Steps
STEPS
6MWT
yes
VMU
VMU
6MWT
yes
O2-GAP
O2 GAP
6MWT
yes
O2
O2
6MWT
yes
SPO2 Base
\
ODI
no
BPM Base
\
ODI
no
ODI
ODI
ODI
yes
Mean Dur. Desat.
MEAN DUR
ODI
yes
Tot Desaturat.
TOT DESAT
ODI
yes
Longest Desat.
LONG.DURAT
ODI
yes
Desatur. Peak
DES.PEAK
ODI
yes
BPM Index
BPM INDEX
ODI
yes
Mean Desaturat.
MEAN DESAT
ODI
yes
Mean Drop
MEAN DROP
ODI
yes

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Symbol
Symbol in menu "Set parameters"
Test
Optional
Max Drop
MAX DROP
ODI
yes
BPM Variation
BPM VAR.
ODI
yes
NOD4%
NOD4%
ODI
yes
NOD89%
NOD89%
ODI
yes
NOD90%
NOD90%
ODI
yes
t.NOD4%
t.NOD4%
ODI
yes
t.NOD89%
t.NOD89%
ODI
yes
t.NOD90%
t.NOD90%
ODI
yes
=DELTA
Parameters requested for six minute walk test analysis
Symbol
Description
Units
Dyspnea Baseline
Grade of dyspnea before walking
Borg
Dyspnea End
Grade of dyspnea after walking
Borg
Fatigue Baseline
Level of fatigue before walking
Borg
Fatigue End
Level of fatigue after walking
Borg
Diastolic Base
Starting diastolic value
mmHg
Systolic Base
Starting systolic value
mmHg
Diastolic Fine
Final diastolic value
mmHg
Systolic Fine
Final systolic value
mmHg
O2
Percentage of oxygen administered to the patient before test
L/min-%
Walked
Distance covered during walking
m
Measurement method:
Red and infrared absorption
Range of measurement %SpO2:
0 –99% (with 1% increments)
SpO2 Resolution
1%
%SpO2accuracy:
2% between 70-100% SpO2
Average number of heart beats for the %SpO2
calculation:
8 beats
Range of measurement of cardiac pulse:
30 –254 BPM (with 1 BPM increments)
Cardiac pulse resolution
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
“Beep” with special alarm frequency in the case of either %SpO2or cardiac pulse going outside of the programmed levels of alarm
“Beep” with special alarm frequency 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 unexpected event an intermittent beeping will be heard for 5 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.
1.7.3 Other features
Memory
Memory capacity for over 10000 spirometric tests
The precise number depends on the individual configuration, so it cannot be determined more
closely
keyboard
Absent, display touch screen
Display
Display LCD touch screen r 128x64 resolution black and white
Interface
USB, Bluetooth
Bluetooth interface
frequenzy range = 2402-2480 MHz
rated RF power output = 0.001 W
frequency tolerance = 20 ppm
type of antenna = permanently attached
gain of antenna = 0 max dBi
Duration of the 3,7V lithium battery
Approx 500 charge cycles, under normal conditions of use
Power supply
Battery pack Li-ion 3.7 V 1100mAh
Battery charger
Voltage = 5VDC
Current = 500 mA
Connector = micro USB type B
Dimensions
101x48x16 mm;
turbine housing 46x47x24 mm
Weight
Central unit 99g (including batteries)
Turbine housing 17g
Type of electrical protection
Class II device
Type of electrical protection
BF
Grade of protection against water ingress
IPX1 device, protected against water drops

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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
Transport condition
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
Essential performances (according to EN
60601-1:2007)
Accuracy of spirometry parameters compliant to ATS standard
Measure of the oximetry parameters with accuracy defined in table on page 13
2. FUNCTIONING OF THE SPIRODOC
2.1 Display
The device does not have a keyboard. The touch screen type display allows access to all functions
by simply touching the display. The controls on the touch screen change dynamically based on the
functions performed.
To access a specific function touch the corresponding icon on the display.
To visualize the list of information scroll through the left part of the screen.
2.2 Switching on and off the SPIRODOC
To turn on the SPIRODOC press and release the power key placed in the middle on the side of
the device.
If the spirodoc is connected to USB or power supply is not possible to switched OFF
Upon turning on the device the very first image displayed refers to the manufacturer including
the date and time setting.
Without touching the display after a few seconds the device automatically moves on to the
main screen
By touching the icon different information is visualized according to which mode; Doctor or
Patient the device has been set to
Doctor Mode
The information displayed are:
Spirometry parameter setting
Oximetry parameter setting
Spirometry and oximetry tests in memory
Free memory available

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Patient Mode
The information displayed are:
Number of activated symptoms
Number of activated questions
Spirometry and oximetry tests in memory
Free memory available
To turn off SPIRODOC press the key placed on top and subsequently touch OK on the bottom
right side of the screen. It is possible to turn off the device by keeping the top key pressed.
The message on the right side is shown after pressing the key on top It serves as a guide to
follow the procedure properly.
2.3 Energy saving
WARNING
When the device is turned on after approximately 1 minute of disuse the display enters energy saving mode thereby automatically
lowering the display contrast level.
If the device remains in disuse for approximately 5 minutes and is not connected to a PC or battery charger; the device will emit an
acoustic warning signal and turn off.
When the device is turned on the battery charge level is shown 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.
2.4 Main screen
On the main screen, while in Doctor Mode the following areas can be accessed :
patient data management area
oximetry area
spirometry area
archive area
testing without patient data area
If the device is set on “Patient” mode (see paragraph 3.6.1) the main screen will show a
different configuration as displayed on the right side:
symptoms questions
oximetry test
spirometry test
most recent test archive
send data via Bluetooth
This screen allows the patient to access more quickly the dedicated functions. For further information please view paragraph 3.6.1.
2.5 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 show the last test performed
To go back

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ICON
DESCRIPTION
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
To perform tests without having to insert patient data
To access all oximetry test options / To perform an SpO2/BPM test
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/search FVC tests in memory
To perform a slow vital capacity spirometry test VC/ search VC tests in memory
To perform a maximum voluntary ventilation spimetry test MVV/ search MVV tests in
memory
To perform a spirometry test with a broncodilator
Search in memory oximetry tests lasting more than 12 hours
To print via Bluetooth connection
To view the pletismographic curve in real-time while performing an oximetry test
To check the alarms and alarm thresholds during oximetry testing
To check the alarms and alarm thresholds during oximetry testing when at least one
parameter is turned OFF
Enabled alarm waring during oximetry testing
To temporarily disable the alarm
Disabled alarm warning during oximetry testing
To temporarily enable the alarm
Symptoms selection in PATIENT mode
2.6 Service menu
To enter the service menu touch the display when the following icon appears and keep pressing for a few seconds.
The service menu shows different items according to whether the device is set to either Patient or Doctor mode; The item “SPIRODOC mode” is the
first one displayed in both modes. The configuration of the item menus for the two modes is the following:
Patient Mode
Doctor Mode
Doctor/Patient
Turn-ON Mode
Patient data
OXIMETRY setup
Set questions
Set symptoms
Personal best
Select predicted
Select standard
Select turbine
Turbine calibration
Select language
DATE format
UNIT format
Delete memory
Doctor/Patient
Change date/time
LCD settings
Bluetooth settings
Turn-ON mode
Oximetry setup
Select predicted
Select standard
Set parameters
Select turbine
Turbine calibration
Select language
Date format
Unit format
Delete memory
Info firmware
Demo Oxi

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Scroll through the various items of the menu as explained in paragraph 2.1; once the
item of interest is shown touch the corresponding item.
2.6.1 Doctor Mode
In Doctor Mode the user has access to all the functions of the device for professional use, unlike Patient Mode which is restricted to a simplified use
of the device. (Please view paragraph 3.6.2).
The following items are those shown in the service menu when in Doctor Mode.
Doctor/Patient
This function allows to set one of the two modes:
Patient mode
Doctor mode
The first one is set by the doctor when the device will be used by the patient for homecare use; the second mode instead allows full access to all the
functions of the device when used directly by the doctor.
Select the desired mode, press the OK icon, automatically the mode will be set and the device will return to the service menu. The service menu will
show a different configuration according to which mode has been selected.
For more information concerning device functioning in patient mode please view paragraph 3.6.2
Change date/time
Select the item by touching the display.
When setting the date and time, the cursor _ indicates the data item which is being modified. Use the numbers shown to modify the data item of
interest, move on to the next data item by touching OK. Touch OK so that the new settings will take effect and to return to the service menu. To
return to the service menu without modifying the item data touch .
LCD Settings
This item allows to:
Brightness and contrast setting of the display
With two scales which go from 0 to 31 it is possible to set the parameters of the display and view in real time its effect. Once the best
combination of brightness and contrast is obtained touch OK on the bottom right side of the display
Calibrate the touch screen function
This function is used to check the proper response of the touch screen; the device initially request a confirmation, touching OK icon the
calibration begin
There are four phases as follows:
Touch three times the top left-hand point of the display
Touch three times the top right-hand point
Touch three times the bottom right hand point
Touch three times the bottom right hand point
The reference area is the one inside the flashing outline.
This procedure will then be set up in function of the dimensions of the display.
This procedure must be carried out using the tip of a touch-screen “pointer” held vertically at 90 degrees to the display.
if the calibration is made correctly then the device shows: Calibration is OK
Otherwise the user is requested to repeat the calibration procedure.
The procedure cannot be cancelled once started, so carry out the procedure correctly to return to the service menu.
Bluetooth Settings
Once in the menu it is possible to to select the activation mode of the Bluetooth function. The “Activation” item allows to select from the following
options;”On request” and “always on”;in the first case the function is activated only when requested(for example to print a test),otherwise it remains
off thus allowing to save energy; by selecting the option “Always on” this function is always activate and ready for use(for example to transfer data to
a mobile phone.)
Access this menu to search for active Bluetooth devices, touch the option “Search Device”; SPIRODOC will start to search for Bluetooth devices in
the area; once one or more devices are found the display will list these devices with their respective names. By touching the device of interest it will
be memorized as a printer, a phone, or as a PC –On line; select an option.
In the “Bluetooth setting” menu any previously memorized devices can be viewed in the “printer” list, “telephone” list or the “PC – On line” list. Next
to the device name a corresponding icon (telephone,printer or PC) will appear. 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

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User manual
Turn ON mode
This function enables the device to turn on automatically at a predetermined time. The device will automatically turn on and commence a sleep
oximetry test (this test is also capable of monitoring the patient all day long, and includes as a step counter and a triaxial accelerometer to measure
the VMU)
The device will turn off automatically at a predetermined time.
WARNING
If the automatic turn-ON function is set it will be impossible to turn off the device during
the test. The closed lock icon located on the top center of the screen warns the user of
the current setting.
Select the item by touching the display and choose between the following options:
Manual
Automatic
Manual turn-ON: allows to set the turning on of the device by using the specific ON/OFF key.
Automatic turn-on: enables the programming of the frequency and duration the device turns on. Select the desired item and press OK. If the user
selects automatic turn-on she/he may choose from the following options:
One time only
Once a week
Monday to Friday
Saturday-Sunday
Every day
For each option a menu appears to set the day and time that the device will turn on and off.
If turn ON mode was previously enabled, and the user turns on the device at a different time
from that of the programmed time, the device will show the screen on the right. To continue
touch the OK icon and insert the password 1 2 2 3 3 3; by touching the the device will
turn off.
Oximetry setup
When entering the Oximetry Setting menu the following items are shown:
Alarms Setting
SpO2 Sampling Rate
Pulse tone ON/OFF
Default alarms
Alarms setting
Access to this function allows to setup 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 threshold or rise above the maximum threshold of the SpO2 and BPM values previously set.
The first configurable parameter is the sound: it is possible to select the type of sound and
volume; both parameters have two values:
Type of sound 1 kHz 4 kHz
Volume min MAX
As can be seen in the image on the right.
Touch the corresponding squares/panes to select the desired values.
By touching OK in the bottom right side the user will access the minimum and maximum
threshold of the two oximetry parameters. For each parameter the screen allows to set the
alarm on or off. (By touching the ON and OFF icons) or to change the threshold value with
the icon .

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SPIRODOC cod. 980156 Rev 2.4 EN 20/46
User manual
The sequence of values is the following:
Parameter
Min value setting
Max value setting
SpO2 min
60
99
SpO2 max
60
99
BPM min
60
120
BPM max
60
120
WARNING
If the maximum value of a SpO2/BPM parameter is set lower or equal to the minimum value the setting will not take effect. The device
will emit an acoustic warning and automatically return to the setting of the minimum value.
After having set the maximum BPM value touch OK to set the acoustic alarms. The sequence
is the following:
Finger not inserted
Sensor not inserted
Battery discharged
The image on the right is an example of the on-off alarm for the finger being used with the oximetry sensor.
SpO2 sampling rate
This function allows to set the time that elapses between the sampling/recording of two consecutive oximetry readings; 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.
Pulse tone ON/FF
This setting enables the heart rate tone (beep) during oximetry testing
WARNING
The heart rate tone (beep) is always disabled during sleep oximetry testing
(please view paragraph 3.13.2).
Default alarms
This function allows to restore all default settings. To confirm touch the “YES” icon. The
settings return to the standard values. The image on the right shows the factory default
settings.
After a few seconds the device will return to the oximetry setting screen.
Select predicted
Select the item by touching the display.
A list of predicted values is shown; select the Predicted value desired.
Adult
Pediatric
ERS
Knudson
Knudson
Knudson
USA
Knudson
ERS
Zapletal
MC-Barcelona
Zapletal
JRS
Knudson
Select the pair to use and touch OK. The Predicted values are set and the device returns to the Service Menu.
Select standard
Select the item by toughing the display.
Select the standard to be used (ATS/ERS, or NHANES III) and touch OK, the setting takes effect and the device returns to the Service Menu.
WARNING
If the NHANES III standard is selected it is not possible to set or modify the predicted values.
Set parameters
It is possible to select the type of calculated parameters during spirometry and oximetry testing. For each of the two categories the user may select
from the following three options:
simplified
personal